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| Share Name | Share Symbol | Market | Type |
|---|---|---|---|
| NanoViricides Inc | AMEX:NNVC | AMEX | Common Stock |
| Price Change | % Change | Share Price | High Price | Low Price | Open Price | Shares Traded | Last Trade | |
|---|---|---|---|---|---|---|---|---|
| -0.0101 | -0.73% | 1.3699 | 1.385 | 1.35 | 1.38 | 38,154 | 20:54:24 |
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
FORM
SECURITIES EXCHANGE ACT OF 1934
FOR THE FISCAL YEAR ENDED
Commission File Number
(Name of Business Issuer in Its Charter)
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(State or other jurisdiction of incorporation or |
| (I.R.S. Employer Identification No.) |
(Address of principal executive offices)
(Issuer’s telephone number, including area code)
SECURITIES REGISTERED PURSUANT TO SECTION 12(b) OF THE ACT: NONE
SECURITIES REGISTERED PURSUANT TO SECTION 12(g) OF THE ACT:
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(Title of Class) |
| (Name of exchange on which registered) |
Indicate by check mark if the registrant is a well-known seasoned issuer, as defined in Rule 405 of the Securities Act.
Yes ☐
Indicate by a check mark if the registrant is not required to file reports pursuant to Section 13 or Section 15(d) of the Act.
Yes ☐
Indicate by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days.
Indicate by check mark whether the registrant has submitted electronically every Interactive Data File required to be submitted pursuant to Rule 405 of Regulation S-T (§ 232.405 of this chapter) during the preceding 12 months (or for such shorter period that the registrant was required to submit such files).
Indicate by check mark if disclosure of delinquent filers pursuant to Item 405 of Regulation S-K is not contained herein, and will not be contained, to the best of registrant’s knowledge, in definitive proxy or information statements incorporated by reference in Part III of this Form 10-K or any amendment to this Form 10-K. ☒
Indicate by check mark whether the Company is a larger accelerated filer, an accelerated filer, a non-accelerated filer, smaller reporting company, or an emerging growth company. See the definitions of “large accelerated filer,” “accelerated filer,” “smaller reporting company,” and “emerging growth company” in Rule 12b-2 of the Exchange Act.
Large accelerated filer | ☐ | Accelerated filer | ☐ |
☒ | Smaller reporting company | ||
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| Emerging growth company |
If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐
Indicate by check mark whether the registrant has filed a report on an attestation to its management’s assessment of the effectiveness of its internal control over financial reporting under Section 404(b) of the Sarbanes-Oxley Act (15 U.S.C. 726(b)) by the registered public accounting firm that prepared or issued its audit report.
If securities are registered pursuant to Section 12(b) of the Act, indicate by check mark whether the financial statements of the registrant included in the filing reflect the correction of an error to previously issued financial statements.
Indicate by check mark whether any of those error corrections are restatements that required a recovery analysis of incentive-based compensation received by any of the registrant’s executive officers during the relevant recovery period pursuant to §240.10D-1(b). ☐
Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act.).
Yes
On September 27, 2024 there were approximately
The aggregate market value of the voting stock held on December 31, 2023, by non-affiliates of the registrant was approximately $
TABLE OF CONTENTS
Page 1 of 106
PART I
SPECIAL NOTE REGARDING FORWARD-LOOKING STATEMENTS
This Report contains forward-looking statements within the meaning of the federal securities laws. All statements other than statements of historical fact made in this report are forward looking. In particular, the statements herein regarding industry prospects and future results of operations or financial position are forward-looking statements. These include statements about our expectations, beliefs, intentions or strategies for the future, which we indicate by words or phrases such as “anticipate,” “expect,” “intend,” “plan,” “will,” “we believe,” “Company believes,” “management believes” and similar language. These forward-looking statements can be identified by the use of words such as “believes,” “estimates,” “could,” “possibly,” “probably,” “anticipates,” “projects,” “expects,” “may,” “will,” or “should,” or other variations or similar words. No assurances can be given that the future results anticipated by the forward-looking statements will be achieved. Forward-looking statements reflect management’s current expectations and are inherently uncertain. The forward-looking statements are based on the current expectations of NanoViricides, Inc. and are inherently subject to certain risks, uncertainties and assumptions, including those set forth in the discussion under “Management’s Discussion and Analysis of Financial Condition and Results of Operations” in this report. Our actual results may differ materially from results anticipated in these forward-looking statements.
Investors are also advised to refer to the information in our previous filings with the Securities and Exchange Commission (SEC), especially on Forms 10-K, 10-Q and 8-K, in which we discuss in more detail various important factors that could cause actual results to differ from expected or historic results. It is not possible to foresee or identify all such factors. As such, investors should not consider any list of such factors to be an exhaustive statement of all risks and uncertainties or potentially inaccurate assumptions.
Although these forward-looking statements reflect the good faith judgment of our management, such statements can only be based upon facts and factors currently known to us. Forward-looking statements are inherently subject to risks and uncertainties, many of which are beyond our control. As a result, our actual results could differ materially from those anticipated in these forward-looking statements as a result of various factors, including those set forth below under the caption “Risk Factors.” For these statements, we claim the protection of the safe harbor for forward-looking statements contained in the Private Securities Litigation Reform Act of 1995. You should not unduly rely on these forward-looking statements, which speak only as of the date on which they were made. They give our expectations regarding the future but are not guarantees. We undertake no obligation to update publicly or revise any forward-looking statements, whether as a result of new information, future events or otherwise, unless required by law.
Glossary of Terms
Nano - When used as a prefix for something other than a unit of measure, as in “nanoscience,” nano means relating to nanotechnology, or on a scale of nanometers (one billionth of a meter or greater).
Viricide - An agent that reliably deactivates or destroys a virus.
Nanoviricide ™ - An agent that is made by attaching ligands against a certain virus or family of viruses to a nanomicelle based on the Company’s patent-pending and proprietary technologies.
Ligand - A short peptide or chemical molecule fragment that has been designed to specifically recognize one particular type of virus.
Micelle - an aggregate of molecules in a solution, such as those formed by detergents.
Nanomicelle - A term coined to describe the micelles formed from the backbone polymer of a nanoviricide sans attached ligands.
Pendant polymeric micelles - A polymeric micelle forms from a polymer whose chemical constitution is such that even a single chain of the polymer forms a micelle. A pendant polymer is a polymer that has certain units in its backbone that extend short chains branched away from the backbone. Pendant Polymeric Micelles therefore are polymeric micelle materials that are a class of pendant polymers, and naturally form exceptionally well-defined, self-assembling, globular micelles with a core-shell architecture.
Mutations - The ability (of a virus) to change its genetic structure to avoid the body’s natural defenses. Mutant viruses are created from a parent virus strain through a process of natural selection under pressure as it replicates in a host.
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P-Value - In statistical hypothesis testing, the p-value is the probability of obtaining a result at least as extreme as that obtained, assuming that the null hypothesis is true; wherein the truth of the null hypothesis states that the finding was the result of chance alone. The fact that p-values are based on this assumption is crucial to their correct interpretation. The smaller the p-value, the greater is the probability that the observed study results and the comparison control are distinct, and therefore that the study results are not a result of chance alone.
More technically, the p-value of an observed value observed of some random variable T used as a test statistic is the probability that, given that the null hypothesis is true, T will assume a value as or more unfavorable to the null hypothesis as the observed value observed. “More unfavorable to the null hypothesis” can in some cases mean greater than, in some cases less than and in some cases further away from a specified center value.
Investigational New Drug Application (Investigational New Drug (“IND”) - The process of licensure of a new drug in the US goes through several steps. A simplified explanation of these steps is as follows. Initially a Company may file a pre-IND application to seek meetings with the United States Food and Drug Administration (FDA) for guidance on work needed for filing an IND application. The Company obtains data on the safety and effectiveness of the drug substance in various laboratory studies including cell cultures and animal models. The Company also obtains data on chemical manufacturing of the drug substance. These and certain additional data are used to create an IND that the Company files with the FDA. After the FDA approves an IND application, the Company may conduct human clinical studies. A Phase I human clinical trial is designed typically to evaluate safety of the drug and maximum permissible dosage level. A Phase II human clinical trial that follows is designed to evaluate effectiveness of the drug against the disease in a small cohort of patients. A Phase III human clinical trial thereafter is designed to evaluate effectiveness and safety in larger groups of patients, often at multiple sites. The Company may then submit an NDA (New Drug Application) with the data collected in the clinical trials. The FDA may approve the NDA. Once the NDA is approved, the Company can sell the drug in the USA. European countries have similar processes under the European Medicines Agency (EMA). Other countries have similar processes.
SAR - Structure-Activity-Relationship study. When an initial lead drug compound is found that has activity, further studies on drug compounds obtained by suitably modifying it are performed with the goal of improving efficacy, safety, or both. Such studies are called SAR studies.
ITEM 1: BUSINESS
Organization and Nature of Business
NanoViricides, Inc. (the “Company”, “NanoViricides”, “we,” or “us”) was incorporated in Nevada on April 1, 2005, and redomiciled to Delaware effective May 30, 2023. Our corporate offices are located at 1 Controls Drive, Shelton, Connecticut 06484 and our telephone number is (203) 937-6137. Our Website is located at http://www.Nanoviricides.com. We do not incorporate by reference into this Annual Report the information on or accessible through our website, and you should not consider it part of this Annual Report.
On September 25, 2013, the Company’s common stock began trading on the New York Stock Exchange American under the symbol, “NNVC”.
We are a clinical stage company with our first drug in Phase Ia/Ib clinical trial and several additional drug candidates in various stages of pre-clinical development, including IND-filing stage and late stage IND-enabling non-clinical studies. We have no customers, products or revenues to date, and may never achieve revenues or profitable operations.
We are engaged in the application of nanomedicine technologies to the complex issues of viral diseases. We are developing a class of drugs, that we call nanoviricides™, using a platform technology. This approach enables rapid development of effective new drugs against a number of different viruses.
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NanoViricides Technology Platform in Brief
We are a clinical stage company developing (a) host-mimetic, and (b) direct-acting, nanomachines capable of dismantling a targeted virus, (c) without assistance from the human immune system.
| a. | As a host-mimetic, viruses cannot escape a nanoviricide drug by generating mutants and variants in the field, because all variants still require the same signature host features that our drugs mimic. In contrast, vaccines, antibodies and small chemical drugs are readily escaped by viruses as mutations occur, rendering these medical countermeasures ineffective. |
| b. | As a direct-acting antiviral, a nanoviricide drug is not expected to interfere with human bodily systems or enzymes, which is expected to result in significant levels of safety, unlike most of the antiviral drugs that interfere with cellular processes. |
| c. | Any viral infection that causes significant pathology does so by virtue of host immune system disrepair, either pre-existing, or caused by the virus itself. Therefore, nanoviricides can be expected to be superior to approaches such as vaccines and antibodies that require a good functional host immune system for antiviral response. |
These distinctive features that set nanoviricides apart from the entire world of current antiviral approaches are made possible by our novel nanoviricide chemical nanomachine design. After decades of development, this novel nanoviricide technology has now successfully reached clinical stage.
NV-387, Phase II-Ready Broad-Spectrum Nanoviricide Drug Development Against Multiple Viruses
Our first clinical stage drug candidate, NV-387, has recently completed Phase Ia/Ib human clinical trial for the evaluation of safety and tolerability in healthy subjects. NV-387 is the active ingredient in the two drug product formulations labeled “NV-CoV-2 Oral Syrup” and “NV-CoV-2 Oral Gummies” that were then indicated for the treatment for COVID infection in this clinical trial. There were no drop-outs. There were no reported adverse events, and the drugs were well-tolerated even at the highest level of dosing given multiple times in this trial. These results are indicative of safety and tolerability that have been successfully achieved for NV-387. Additional detailed evaluations based on the subject treatment data records are in progress.
As the next step, we are focusing on developing NV-387 as a therapeutic drug for the treatment of pediatric RSV infection. We are planning Phase II clinical trial for the treatment of RSV infection in adults to lead into a Phase II/III clinical trial in RSV infection in children in this program.
NV-387 is a uniquely broad-spectrum antiviral drug that has demonstrated strong activity in lethal lung infection animal model studies of Coronavirus, RSV, Influenza and even an Orthopoxvirus model for Smallpox and MPox. Over 90% of human pathogenic viruses are known to use sulfated proteoglycans (“S-PG”) such as heparan sulfate proteoglycans (HSPG), dermatan sulfate, chondroitin sulfate, and others. NV-387 mimics the essential, invariant, feature of S-PG onto which the virus lands first as it infects a human cell.
This extremely broad antiviral spectrum of NV-387 is reminiscent of the broad antibacterial spectrum of antibiotics such as penicillin and we believe NV-387 could revolutionize the treatment of viral infections the same way that penicillin revolutionized the treatment of bacterial infections.
Antibiotics such as penicillin directly attack the bacterial surface and thereby kill the bacteria. Similarly, NV-387 is designed to directly attack the viral surface and destroy the virus particle. Similar to antibiotics that possess a broad-spectrum to treat bacterial infections, NV-387 could be a much needed, ultra-broad-spectrum, direct acting, antiviral agent to treat multiple different viral infections.
We believe that a safe and effective antiviral drug, when approved, with an extensive broad-spectrum activity across multiple, distinct, virus families is an unmet medical need. Currently available broad-spectrum antivirals such as Remdesivir, Ribavirin, Cidofovir, etc. suffer from extensive and varied dose-limiting toxicities, and thereby present limitations on eligible patient populations as well as on clinical effectiveness.
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NV-HHV-1, Clinical-Ready Drug Candidate and the HerpeCide Program
We are also developing several other virus-family-specific drug candidates. Of these, NV-HHV-1, developed as a skin cream for the treatment of Shingles rash, has completed non-clinical safety/pharmacology studies required for a U.S. Food and Drug Administration (“FDA”) Investigational New Drug (“IND”) submission. We believe that the NV-HHV-1 skin cream, when approved, can also be additionally indicated to treat HSV-1 “cold sores” and HSV-2 “genital ulcers” based on successful animal studies.
Additionally, we are developing an oral drug for the systemic treatment of most of the herpesvirus family related infections, including HSV-1 “cold sores” and HSV-2 “genital herpes” that is based on the same active ingredient as NV-HHV-1.
Other Drug Development Programs in the Pipeline
Of note, we have drug candidates in HIVCide™ program that have shown substantial antiviral activities in animal studies warranting further clinical development. We have several other drug candidates at different preclinical drug development stages in our pipeline for the treatment of other viral infections including Dengue viruses, Ebola viruses, etc.
Fully Integrated Development and Manufacturing Capabilities
NanoViricides is one of a few pharmaceutical drug developers with its own facilities that support the entire drug development process from design and discovery, to chemical synthesis, to initial antiviral evaluation (in cell culture models), to scale-up of drug candidates of interest, to set-up and cGMP-compatible manufacture of the candidate drug substances and cGMP-compatible formulation, fill-and-finished packaging, of drug products for clinical trials. We also have both R&D developmental analytical laboratory as well as cGLP compatible analytical laboratory in the same facility. The facility is located at 1 Controls Drive, Shelton, CT.
Having such integrated facility available enabled us to develop the NV-CoV-2 COVID drug from concept to completion of safety/pharmacology studies required for clinical trials within a matter of just one year.
We depend upon external parties, that may be collaborators, consultants, and sub-contractors, for the regulatory development of drug candidates including animal efficacy studies, non-clinical safety/pharmacology studies, regulatory requirements assessments, and regulatory affairs such as advice on regulatory strategy, regulatory documentation, design of clinical trials, preparation of clinical trial applications, as well as conducting clinical trials and preparing required reports.
Strong Intellectual Property and Collaborative Relationships
Our “nanoviricide” platform-based drugs are based on several patents, patent applications, provisional patent applications, and other proprietary intellectual property held by TheraCour Pharma, Inc. (“TheraCour”), to which we have broad, exclusive licenses. The licenses are to entire fields and not to specific compounds. In all, we have exclusive, worldwide licenses for the treatment of the following human viral diseases: Human Immunodeficiency Virus (HIV/AIDS), Hepatitis B Virus (HBV), Hepatitis C Virus (HCV), Herpes Simplex Virus (HSV-1 and HSV-2), Influenza and Asian Bird Flu Virus, Dengue viruses, Ebola/Marburg viruses, Japanese Encephalitis virus, viruses causing viral Conjunctivitis (a disease of the eye) and Ocular Herpes (restated). In all cases, the discovery of ligands and polymer materials, formulations, chemistry and chemical characterization, as well as process development and related work (the “Development Activities”) will be performed by TheraCour, a related party substantially owned by Dr. Anil Diwan, under the same compensation terms across various agreements between the parties, with no duplication of costs allowed. Upon commercialization, NanoViricides will pay 15% of net sales to TheraCour, although these licenses do not specify the terms of milestone payments during clinical development that are customary in the pharmaceutical industry. In addition, we have perfected a license for the field of Varicella Zoster Virus (“VZV License”) infections i.e. Shingles and Chickenpox (the “Shingles License”), and another one for the field of treatment of SARS-CoV-2 infections (the “COVID License Agreement”); both of which specify the same terms for the Development Activities as the prior agreements, and further specify certain milestone payment terms specifically for the individual fields, details of which have been disclosed at the time the agreements were entered into. We have later amended the COVID License on February 12, 2024, so that any cash milestone payments that remained un-earned or unpaid by that date would not be payable in cash until the Company receives sufficient revenue from its commercialization activities including out-licensing, collaborations, co-development agreements, and commercialization, as more fully described in the amendment to the COVID License Agreement (“Amendment to the COVID License Agreement”). Certain milestone payments were made under the VZV License as well as under the COVID License Agreement prior to the Amendment to the COVID License Agreement, details of which have been disclosed. We negotiate and license specific verticals of therapeutic applications from TheraCour if promising drug candidates are found in early research and development against a virus target. TheraCour has not denied any such licenses when requested.
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We executed a Memorandum of Understanding (“MOU”) with TheraCour September 23, 2024 effective as of September 20, 2024, subsequent to the reported period, whereby we have obtained a right of first refusal for all antiviral drug developments including unlicensed developments that occur during the course of the Development Activities as specified in our license agreements, and have set out the process of development of drugs for unlicensed viral indications towards completion of appropriate license agreements. The Company and TheraCour have also agreed in this MOU that any cash milestone payments related to development activities, that are awardable, will become payable only upon NanoViricides having sufficient revenue, as defined in and more fully described in the Amendment to the COVID License Agreement referred to above, thereby including the provisions previously incorporated in the Amendment to the COVID License Agreement, to all present and future license agreements.
We have out-licensed NV-CoV-2 and NV-CoV-2-R for further clinical drug development and commercialization in the territory of India to Karveer Meditech Pvt. Ltd. (“KMPL”), a company of which Dr. Anil Diwan is a passive investor and advisor, enabling KMPL to sponsor our drug products originally developed for COVID treatment, namely NV-CoV-2 Oral Syrup and NV-CoV-2 Oral Gummies into Phase I human clinical trial. The Phase Ia/Ib human clinical trial began in June 2023 and the healthy subjects treatment and observation part was completed as of the end of December 2023. The clinical trial drug products, NV-CoV-2 Oral Syrup, and NV- CoV-2 Oral Gummies, were manufactured at our Shelton, CT campus, and then shipped to and received by KMPL. Under the agreement with KMPL, we will pay for the expenses of the clinical trials, and in return we will benefit from having the data and reports made available for regulatory filings in other territories of the world. Upon commercialization by KMPL in India, we will receive royalties from KMPL equal to 70% of sales net of costs to unaffiliated third parties.
NV-387 is the active pharmaceutical ingredient of both the oral formulations, namely NV-CoV-2 Oral Syrup and NV-CoV-2 Oral Gummies drug products. In various animal models of lethal virus infection challenge, NV-387 was found to lead to substantial increase in survival, compared to even approved drugs where available, indicating potential for successful clinical regulatory development as a treatment for these viruses. Additional criteria studied in these animal models also further bolstered these expectations of potentially successful regulatory development. The viruses we have tested and found to support expectations of potentially successful regulatory development include RSV and Influenza in addition to Coronaviruses, covering the so-called “tripledemic” viruses with a single drug to treat them. In addition, similar strong results were found for treatment with NV-387 of orthopoxvirus infection in animal models, both by dermal route, as well as by direct lung infection route. In these animal model studies, the dermal infection route models MPOX infection, whereas the lung infection route models potential bioterrorist attack with Smallpox virus.
Our Plan for Regulatory Development and Commercialization of Our Drugs
The above mentioned broad-spectrum antiviral effect of NV-387 as found in animal models of lethal virus challenge infection suggests that NV-387 is eligible for regulatory clinical development as a potential treatment for RSV, Influenza, MPOX, and Smallpox, in addition to Coronaviruses, based on the current data at hand. It is possible that NV-387 may have similar antiviral effect against many other viruses, something that we plan on continuing to evaluate as our programs advance. This expectation is based on the mechanism of NV-387 in that it mimics sulfated proteoglycan structures associated with host cells that over 90% of human pathogenic viruses are known to use as attachment receptors.
We therefore plan on further developing NV-387 in a regulatory process towards treatment of pediatric patients with RSV infection, an unmet medical need. In parallel, we plan to continue evaluating NV-387 as a treatment of various respiratory viral infections including infections caused by Influenza, Coronaviruses, as well as potentially other respiratory viruses such as human metapneumovirus (hMPV), and others.
Having a single drug with broad applications enables us to minimize the regulatory development workload, minimize costs, as well as develop rapid timelines due to common or overlapping workload across the various indications. We believe this would lead to significantly robust commercial footing as well as significantly improved returns on investments if and when NV-387 reaches commercialization resulting in revenues.
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In addition, we have a strong and wide drug pipeline developed over a number of years. NV-HHV-1, our drug candidate formulated as a skin cream for the treatment of Shingles, has completed regulatory required safety-pharmacology studies towards filing a US FDA IND for this drug. NV-HHV-1 skin cream could be further developed for the indications of HSV-1 cold sores treatment and HSV-2 genital ulcers treatment. In addition, we are developing a single systemic drug that would potentially be indicated for the treatment of HSV-1, HSV-2 as well as Shingles and Chickenpox viruses. Our other drug candidates are at earlier pre-clinical development stages. NV-HIV-1 has demonstrated anti-HIV activity in the standard SCID-Hu-Thy-Liv mouse model of HIV infection that we believe is strong enough to warrant further regulatory development of this drug candidate. In all, we have been working on over forty different viral disease indications with the purpose of developing drug candidates that are well-differentiated from existing drugs if any against these indications as described further down in this report.
The drug development process is long and expensive. As of the date of this report, we do not have any approved drugs on the market. We have no customers, products or revenues to date, and may never achieve revenues or profitable operations. We continue to add to our existing portfolio of products through our robust internal discovery and clinical development programs.
We believe we have developed several assets worthy of partnering for further regulatory development and commercialization. We seek to partner and out-license our drug candidates for these purposes. Such partnering may potentially involve initial license fees, milestone payments, and royalty payments to us that could result in an early revenue stream prior to commercial product sales.
Our business plan is based on developing the drug candidates into regulatory approvals, and partnering and sub-licensing for commercialization of the drugs whenever possible. We have begun the process of actively seeking partnerships by retaining a consulting firm, Aagami, Inc., based in Illinois. Aagami specializes in developing pharma collaborations primarily with Indian and Japanese big pharma companies, and also world-wide. We anticipate adding business development efforts in the western countries as we further develop NV-387 towards initiation of a Phase II clinical trial. A Phase II clinical trial is designed for the evaluation of effectiveness of a drug for its indication and is considered a “proof-of-concept” in humans that the drug is likely to succeed in regulatory approvals. Prior to entering clinical trials, we have developed substantial “proof-of-concept” information regarding our drug candidates in relevant animal models.
We plan on seeking non-dilutive grants and contracts funding for our drug candidates that are responsive to bio-defense and pandemic-preparedness objectives, in particular, the drug development of NV-387 for Smallpox under the US FDA Animal Rule. However, there can be no assurance that we will be able to obtain grants or funding for these projects or that it will be on terms favorable to us.
There is no guarantee that we will be successful in partnering our drug candidates or obtaining non-dilutive funding for furtherance of our drug development programs. We plan on continuing drug development on our own all the way through regulatory approvals if successful collaborations are not established. We plan on continuing to finance our efforts using equity-based financing, at least until an appropriate collaboration with a suitable pharma company for one or more indications of our drug candidates takes place.
To date, we have financed our drug development programs using equity-based financing from the sale of our shares in private and public offerings including registered direct offerings as well as “At the Market” (ATM) offerings.
The Nanoviricide Platform Technology in Brief
“Resistance is Futile”: NanoViricide Platform Promises Antiviral Drugs That The Virus Is Unlikely To Escape Even As It Evolves
The greatest “pain” or intractable problem in antivirals development has been that viruses rapidly evolve to evade the vaccines, antibodies, and small therapeutics that are the traditional antiviral approaches. Small changes in enzymes attacked by the small chemical antivirals lead to antiviral drug resistance. Small changes in the virus “antigens” lead to resistance to vaccines and antibodies, because these antiviral approaches are highly specific to the antigens that they are designed against. Antibodies are extremely specific and therefore even minor changes in the virus tend to make them ineffective. Antibodies and vaccines are readily evaded by viruses under the evolutionary pressure in a natural process itself.
We believe this is now common knowledge after the COVID pandemic.
In contrast, novel nanoviricide™ platform technology enables a host-mimetic, direct-acting, antiviral nanomachine drug which the virus cannot escape even as it evolves.
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Our novel nanoviricide class of drug candidates are designed to specifically attack and dismantle enveloped virus particles, by mimicking the host-side features that the virus particle lands on as it infects a host cell. In spite of even relatively large changes in a specific virus’s surface glycoproteins as it evolves, the viral glycoprotein continues to retain, and often enhances, its ability to attach to specific host-side “attachment” receptors, and thereafter by transferring to a more specific “cognate receptor” on the cell to gain cell entry and cause infection. For example, Influenza viruses use Heparan Sulfate Proteoglycan (HSPG) as “Attachment Receptor” and Sialic Acid (or sialylated glycoproteins) as the “Cognate Receptor.”
Nanoviricides mimic either the attachment receptors or the cognate receptors and present a large number of viral binding sites on each nanoviricide polymeric micelle. Further, the nanoviricide polymeric micelle is designed to “look like” a cell to the virus.
Even as new virus variants develop that evade existing antibodies and vaccines, the variants continue to bind to their cellular attachment receptor(s) and the cellular cognate receptor(s) at the same sites and in the same manner, despite changes in the viral glycoprotein itself. Thus, if we design the ligands correctly, the nanoviricide would continue to be effective even as the virus keeps changing in the field, in stark contrast to antibodies and vaccines that readily lose effectiveness as the virus evolves.
A nanoviricide is a “biomimetic” - it is designed to appear to the virus like the cell surface bearing the sites that the virus binds to. The nanoviricide technology enables direct attacks at multiple points on a virus particle. Since the host-side or cell-side binding sites for a given virus do not change despite mutations and other changes in the virus, we believe that the virus would be highly unlikely to escape our drug candidates even as a virus changes rapidly as it evolves.
Therefore, we believe that our unique host-mimetic approach would result in a nanoviricide drug that a virus cannot escape even as it changes in the field, because it will continue to use the same host-side landing site features (attachment receptors and/or cognate receptors) despite all the changes in its own glycoproteins that bind to those features, if the virus-binding ligands we design for the nanoviricide drug perform as designed.
As described further below, the Nanoviricides Platform provides for modalities that can result in potential cures for viruses that do not establish latent virus infection in humans.
A NanoViricide is a Nanomachine that Does Not Require Competent Immune System and Completes the Task of Dismantling Virus Particles Without Host Machinery Involvement
There are two principal parts to a virus’s lifecycle. The first is to infect a new cell, called “Re-Infection” in virology (the very first virus acquisition, from an external source, is called the “Primary Infection”). The second is to replicate in the infected cell, make new virus particles and then egress into bodily fluids outside the cell, called “Replication.” Most small chemical drugs are designed to affect the replication part, and must go into cells, raising toxicity concerns or reduced safety margins as they interfere with the cellular machinery. Thus, almost all currently existing nucleoside/nucleotide drugs are toxic by their very nature to varying extents.
Vaccines and antibodies have been regarded as the standard pillars of antiviral medical countermeasures. Vaccines generate antibodies, and antibodies (from vaccine or externally applied drug), block the virus by directly binding to it, but these countermeasures are (a) highly specific and thus readily escaped by viruses, and (b) require the human immune system to be in good shape. Vaccines depend upon the patient’s immune system to generate new antibodies, whereas antibodies depend upon the patient’s immune system for proper destruction of the virus particle that the antibody “tells” the immune system to “take care of this enemy.”
Nanoviricides, in contrast, do not require the patient to have a functionally good immune system because a nanoviricide is designed as a complete nanomachine that completes the task of dismantling the virus particle. This is important because most persons with good immune systems, when infected with a virus, experience only mild infections, and may not even notice symptoms. Persons with an immune system that is not sufficiently active are the ones that would suffer severe viral infections. Additionally, viruses have evolved to block various steps in the human immune system response, thus derailing the immune system once the infection takes hold.
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NanoViricide Drugs Are Designed To Act By A Novel Mechanism of Action, “Re-Infection Inhibition”, To Reduce Viremia
A nanoviricide exposes a very high density of virus binding sites on its surface, in contrast to a human cell. Thus, a virus would be more likely to be captured by the nanoviricide than to bind to a cell. As the nanoviricide polymeric micelle interacts with the virus particle, the nanoviricide is capable of binding to the virus at multiple points, and while doing so, wrapping itself around the virus by virtue of a well-known physical chemistry effect called “lipid-lipid mixing.” In the process, the specific glycoproteins that the virus uses for binding to the cell (for example, the HIV gp120, RSV-G protein, Influenza H and N proteins, Coronavirus S or “Spike” protein) are expected to be neutralized and dismantled. It is believed that such attack would lead to the virus particle becoming ineffective at infecting cells.
Therefore, we call this novel mechanism of action of nanoviricide by the name “Re-Infection Inhibition.”
Nanoviricides are designed to work by binding to and eliminating virus particles from the blood stream, just as antibodies do, only potentially much better. Treating a patient that has a viral infection with a nanoviricide against that virus is expected to result in reduction in viremia. Reduction in viremia is an important goal in diseases caused by all viral infections. Nanoviricides are designed to accomplish this using a “Bind-Engulf-Destroy” strategy to eliminate the free virus.
It is important to realize that the flexible, “shape-shifting” nanoviricides nanomedicines show substantial advantages over hard sphere nanoparticles in this antiviral drug application as the nanoviricides enable lipid-lipid mixing with the viral envelope and can wrap around or merge with the virus surface. Hard sphere nanomaterials such as dendritic materials (dendrimers), nanogold shells, silica, gold or titanium nanospheres, polymeric particles (such as PLA-PLGA, others), etc., were never designed to be capable of completely enveloping and neutralizing the virus particle.
NanoViricides Platform is Designed for Safety
We create the polymer that makes the nanoviricide micelle by using naturally metabolizable and safe components. Additionally, the antiviral ligands that we attach to the base polymer are designed using molecular modeling (or “in-silico” design) while using generally safe component chemicals and chemistries.
The nanoviricide polymer structure is designed to directly attack the virus particles outside the cell. Therefore, we believe that interference from such nanoviricide drug with cellular machinery is likely to be minimal, thereby resulting in improved safety over drugs that must enter cells and interfere with cellular processes such as most available small chemical antivirals.
We believe that our approach for improved drug safety is validated by the demonstration of strong relevant results in animal studies of NV-387 for safety and tolerability. In a safety/toxicity evaluation of single injection in rats, NV-387 was found to have a No-Observed-Adverse-Effect-Level (NOAEL) of 1,200 mg/Kg/dose, and a Maximum Tolerated Dose (MTD) of 1,500 mg/Kg/dose, which are considered to be relatively high numbers. A drug with higher values of NOAEL and MTD is safer than one with a lower values.
Further, in the non-clinical GLP safety/toxicology studies in relevant animal models, NV-387 was found to lead to no reportable observations (i.e. no adverse events) in respiratory and neurological studies in rats and cardiotoxicity studies in a non-human primate model (Cynomolgus monkey). Intravenous infusion of NV-387 did not have any toxicologic effects on cardiac rhythm or ECG morphology in cynomolgus monkeys. Intravenous infusion of NV-387 did not affect respiratory function and no significant neuropharmacological or behavioral effects were observed in rats. Body temperature was not affected by the drug treatment in either the rat or the NHP animal model study. All of these results are indicators that the drug NV-387 was well-tolerated in these animal models and thereby enabled us to obtain regulatory approvals to begin Phase Ia/Ib human safety/tolerability studies in healthy subjects.
Nanoviricides Platform Has Enabled Industry-Leading Orally Available Nanomedicines And Multiple Routes of Administration
We found that unlike almost all other nanomedicine platforms, our nanoviricide NV-387, the active pharmaceutical ingredient (API) of NV-CoV-2, demonstrated strong activity when administered orally in multiple animal models. Most nanomedicines do not possess significant oral bioavailability and therefore they have to be administered as injections or infusions. This oral bioavailability of our nanoviricides distinguishes our technology from almost all of the rest of the nanomedicines world.
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We developed two different oral formulations of NV-387, namely “NV-CoV-2 Oral Syrup” and “NV-CoV-2 Oral Gummies.” The latter is a semi-solid fixed-dose form. The oral syrup enables body-weight-based dose titration as needed for pediatric treatments. Both of these formulations have been evaluated in the Phase Ia/Ib human clinical trial of NV-387.
The oral dosage forms are expected to provide wide-spread adoption across the entire population from children to senior citizens, and special cases such as immune-compromised patients outside the hospital. The Oral Gummies fixed dosage form has the advantage that it is suitable even for patients that cannot swallow the usual hard tablets or capsules, because it slowly dissolves in the mouth as it is absorbed.
We have also developed a NV-387 formulation called “NV-387 Solution for Injection, Infusion and Inhalation.” We believe treatment of severe cases that are not yet hospitalized would be best performed by an injection. Hospitalized patients would benefit most from the 100% bio-availability of the injection route, and may be dosed with an infusion if larger quantity of dosing is warranted.
Importantly, the same injectable solution can be readily delivered directly into the lungs as a fog created using standard portable battery operated nebulizer devices. This enables direct and quick action at the most important site of infection by a respiratory virus such as coronaviruses, RSV, influenzas, human meta-pneumovirus (hMPV), certain adenoviruses, and others, that can lead to severe pneumonia.
Thus, the unique versatility of the Nanoviricide Platform has enabled creation of a drug NV-387 in multiple formulations that allow usage across all segments of the population from children to healthy adults to geriatric patients, as well as administration across all levels of disease severity from at-home mild to moderate cases (oral syrup and oral gummies) and out-patient moderate-to-severe cases (injections), to in-patient severe cases (injections and infusions), to in-patient severe-to-morbid cases (infusions and inhalations).
Nanoviricides Represent the Next Generation Development Beyond Classical Immunotherapeutics (Antibodies and Vaccines)
Our nanoviricide technology relies on copying the human cell-surface receptor to which the virus binds, and making small chemicals that are called “ligands” that will bind to the virus in the same fashion as the host side attachment receptor or the cognate receptor (see below). These ligands are chemically attached to the base polymer or “nanomicelle,” to create a nanoviricide.
When a nanoviricide nanomicelle “sees” a virus particle, several of these ligands associated with the nanomicelle are expected to bind to the virus particle. Once bound to the virus, it is thought that the nanoviricide would wrap itself around the virus, and the interior lipidic chains of the nanoviricide would merge into the lipid envelope of an enveloped virus, thus destabilizing the virus, in a “nano-Velcro” effect. This attack is expected to result in loss of the viral glycoproteins that the virus uses to bind to cell and to fuse with the cell membrane, thus rendering the virus particle non-infectious.
A class of small molecules called entry inhibitors exists. These drugs are designed to bind to the virus to stop it from binding to cells. A very large number of these small molecules must simultaneously attack the virus particle for the particle to be fully inhibited – a task that has very low probability in vivo (“kinetic hurdle”). Also, for small molecules to possess sufficient affinity to the virus particle, they must be designed to be very specific to the viral glycoprotein structures. Therefore, entry inhibitors can be rapidly rendered ineffective as the virus changes.
Antibodies can bind a virus particle at only a maximum of two attachment points per antibody. Several antibodies are required to simultaneously bind to the virus particle to neutralize it, in contrast to a nanoviricide that is expected to bind to the virus at multiple points.
For an antibody to be successful as an antiviral drug, as many as ten to fifteen antibodies must bind to saturate the virus surface. Therefore successful antiviral antibodies are highly specific to the virus glycoproteins and rapidly become ineffective as the virus changes.
The resulting antibody-virus complex then may be subject to the complement protein system in the bloodstream, or it may bind to antibody-receptors on human immune cells. Thus, the human immune system needs to be functional for an antibody to be effective as a “drug”.
In a sense, antibodies only “flag” the virus particle as foreign. In contrast, a nanoviricide would complete the job of making the virus particle non-infectious, without any help from the human immune system.
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Almost any virus that causes pathology in humans is able to do so because it has developed intelligent and complicated pathways for disabling the human immune system at one or more points. This may be one of the reasons why many antiviral antibodies fail in the field use. Additionally, viruses readily escape antibodies by mutations, and, in some cases, reassortment. Such viral escape from antibodies has been witnessed in almost every viral epidemic, be it HIV/AIDS, the Influenza pandemic of 2009, the Ebola epidemic of 2014-15, or the COVID epidemic that is continuing now as a perennial phenomenon. In contrast, despite mutations and other changes, a virus is unlikely to escape a nanoviricides drug designed against it.
It is anticipated that when a virus comes in contact with the nanoviricide, not only would it land on the nanoviricide surface, binding to the copious number of ligands presented on the nanomicelle, but it would also get entrapped because the nanomicelle polymer would turn around and fuse with the virus lipid envelop, harnessing a well-known biophysical phenomenon called “lipid-lipid mixing.” In a sense, a nanoviricide drug acts against viruses like a “venus-fly-trap” flower does against insects. Unlike antibodies that tag the virus and thereafter require the human immune system to take over and complete the task of dismantling the virus, a nanoviricide is a nanomachine that is designed to not only bind to the virus but also complete the task of rendering the virus particle ineffective.
Thus, the Nanoviricide Platform technology can be viewed as the next step in evolution of antibody-based approach, taking into account and eliminating the limitations of antibodies.
Drug Manufacturing and Quality Control Considerations Are Inherent in the Design of a Nanoviricide
Uniform Polymer Nature Of The Nanoviricide Polymer Enables Simplified Nanomedicine Manufacturing Quality Assurance
A major problem in the field of nanomedicines as well as lipid-nanoparticles (LNPs) has been that most nanomedicines and LNPs have been found to be notoriously difficult to manufacture in a consistent manner from batch to batch. This is because of the complexity inherent in making large molecules, the very nature of polymer and particle making processes, particularly in the case of block-copolymers that are commonly employed, and the fact that many nanomedicines and particularly LNPs are mixtures of multiple components.
The Nanoviricide Platform technology has been designed from the ground up to enable consistent manufacture and control. Thus, the nanoviricide backbone is a “homopolymer” (i.e. it is made up of a single repeating unit or monomer), which enables a naturally uniform structure. This is unlike block-copolymers wherein there is structural heterogeneity along the polymer chain that is generally difficult to control and characterize. In addition, the nanoviricide polymer is designed to dynamically and naturally self-assemble into micelles in a solution. Also, the virus-binding ligands are chemically attached to the polymer. The extent of attachment can be characterized by analytical techniques that we have developed and continue to develop as needed. Further, we use specialized techniques in the polymer processing to minimize any contamination with endotoxins or other foreign particles as well as to remove impurities. The final nanoviricide solutions are sterile filtered using standard membrane filtration processes.
Formulation is Inherent in the Design Aspect of a Nanoviricide
Since developing our lead clinical drug candidate API NV-387, development of its formulations, injectable, infusion, inhalation, oral syrup, and oral gummies (semi-solid form) was relatively quick, accomplished within months, including formulation design and scale-up with cGMP-compliance manufacturing considerations. Similarly, since declaring our shingles clinical candidate, NV-HHV-1, its formulation as a skin cream for topical treatment of shingles rash, and scale-up, and cGMP-compliant manufacture was accomplished relatively rapidly, within a few months.
In the nanoviricide approach, the nanomicelle polymeric backbone itself takes care of the formulation aspects. The nanomicelle is designed to optimize the drug for its intended route of administration, be it injectable, skin cream, eye drops, or even oral. Thus, no specific or extensive formulation development is expected to be required during drug development.
In contrast, formulation development for novel drugs in normal pharmaceutical paradigm often takes years. In particular, formulation development with nanomedicines or LNPs generally takes longer than that for small chemical drugs, due to inherent complexities discussed earlier.
Thus, the Nanoviricides Platform has been designed from the ground up to enable simplifications in processes and analyses that need to be implemented in order to develop robust, reproducible, and scalable processes.
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NanoViricide Platform Enables Drugs That Can Be Designed To Block the Complete Virus Lifecycle, Thus Enabling Potential Cure for Non-Latency Viruses
A nanoviricide is made by chemically covalently linking a “nanomicelle” - a globular polymeric micelle with pendant lipid chains inside - to one or more different small chemical ligands designed to mimic the cellular receptor to which the virus binds. In addition, the nanoviricide can carry additional active pharmaceutical ingredients (APIs), which may be chosen to affect the intracellular virus life cycle. Thus, the nanoviricide platform enables construction of complete virus-killing nanomachines that block the virus from entering the cell as well as that block further production of the virus inside the cell.
We are implementing the nanoviricides platform in different modalities leading to different types of drugs to meet the different challenges of different viruses and enable cures for viral diseases.
Nanoviricides Platform Modality 1: Broad-Spectrum Antiviral “Reinfection Inhibitors”
There are certain classes of cellular features that a very large number of viruses commonly use to get access to cells. As a first step, the virus binds to one so called “Attachment Receptor(s).” This allows the virus to concentrate near the target cells, and enables the virus particles to latch onto more specific receptors on the cell surface itself that are termed “Cognate Receptor(s).” Some viruses can directly fuse with the cell membrane without such a cognate receptor.
The attachment receptors employed by most viruses fall into very few families. One such family is “Sulfated Proteoglycans (S-PG),” or “Glycosaminoglycans (GAGs).” We loosely include a number of sulfated proteoglycan types in this “S-PG class”. They differ in exact structures but share a number of commonalities. This family includes proteoglycans that have attached onto them heparan sulfate (HSPG), dermatan sulfate (DSPG), chondroitin sulfate (CSPG), or keratan sulfate (CSPG). Over 90% of known pathogenic viruses bind to one or more of these S-PG class attachment receptors. These viruses include Coronaviruses, Paramyxoviruses (RSV - Respiratory Syncytial Virus, and HMPV- human Metapneumovirus), Dengue Viruses, Herpesviruses, Human Papillomavirus (HPV), HIV, Hendra and Nipah Viruses, Ebola and Marburg Viruses, among others.
For many of these viruses there are no antivirals available, or the antivirals have limited applicability. Nanoviricides that mimics the host-side S-PG can be expected to be capable of attacking many of these viruses, enabling very broad-spectrum antiviral agent. This is reminiscent of the development of beta-lactam antibiotics starting with penicillin, that have broad-spectrum antibacterial properties because they attack a common feature of a large number of bacteria, the peptidoglycan cell wall.
NV-387, our clinical drug candidate, is the first example, to our knowledge, of such a broad-spectrum antiviral agent. NV-387 was designed using our knowledge of the commonalities in this S-PG class of attachment receptors for mimicking the host-side S-PG common motif that is used by viruses for attachment. A developed small chemical ligands that embody the characteristics of this common motif, and attached them to the base nanomicelle polymer to create NV-387. Thus, NV-387 is designed as a broad-spectrum antiviral agent. After its success in attacking multiple unrelated coronaviruses, we have undertaken a program to expand the potential indications of NV-387. Effectiveness in any of these additional indications would enable direct entry into Phase II/III clinical trials for that indication now that a Phase I clinical trial of NV-387 has been completed, after the final clinical trial report for this clinical trial becomes available.
In July 2023, we reported that NV-387 was found to demonstrate increase in survival upon treatment with NV-387 indicating antiviral effectiveness against a lethal RSV infection in a mouse model study. Subsequently, in May 2024, we reported that in a subsequent study with improved dosing regimen, NV-387 was able to lead to complete survival of the animals lethally infected with RSV, and that the lungs of the NV-387 treated animals did not show lung damage caused by the RSV. In contrast, ribavirin treatment did not protect the lungs of the RSV infected animals leading to their death with a small increase in survival over the untreated animals.
In June 2024, we reported that NV-387 treatment was found to demonstrate increase in survival, substantially surpassing the increase that occurred upon treatment with three of well-known approved anti-influenza drugs, a parameter used for indicating antiviral effectiveness, in a lethal Influenza A/H3N2 lung infection mouse model study. We believe that these results suggest that NV-387 promises to be effective against the “bird flu” influenza virus H5N1 (and other similar H5Nx viruses) as well. In fact, it is well-known that the highly pathogenic avian influenza (HPAI) viruses carry a “polybasic site” that possesses HSPG binding capability. Therefore, HPAI viruses can be expected to be susceptible to NV-387.
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In the reported year, we have also reported on the antiviral activity of NV-387 in animal models relevant to Smallpox/Mpox (orthopoxvirus) infections, measured by increase in survival in relevant lethal virus-challenge animal models. MPox has caused sporadic epidemics in the Western world, and a more pathogenic strain, MPOX CladeI/Ib is currently causing an epidemic in certain parts of Central Africa, which has led the WHO to declare it a “public health emergency of international concern” (PHEIC). Smallpox is considered a bioterrorism threat. Of note, tecovirimat, approved for Smallpox treatment in the USA, has failed to show effectiveness in an NIH co-sponsored international clinical trial for the treatment of MPOX Clade 1 infections (https://www.nih.gov/news-events/news-releases/antiviral-tecovirimat-safe-did-not-improve-clade-i-mpox-resolution-democratic-republic-congo). Therefore, we believe it would be of interest to assess whether NV-387 has effectiveness in MPOX infected patients.
We would like to continue to further explore the effectiveness of NV-387 against many other important human pathogenic viruses that are known to utilize S-PG attachment receptors. For example, Nipah virus causes sporadic lethal outbreaks in India and Bangladesh in particular. We would be like to explore if NV-387 can be an effective drug against Nipah and the related Hendra viruses. Such expansion of use of NV-387 would significantly expand the market size, provide much needed medical countermeasures for public health protection globally, and substantially improve the return on investments (ROI).
Another important class of attachment receptors is Sialic Acids (SA). We are working on developing broad-spectrum antivirals mimicking SA. SA is well known as the initial site of binding for Influenza viruses, as well as many of the infectious Adenoviruses and many other viruses.
It would be very difficult for a virus to become resistant to a nanoviricide that mimics the virus’ attachment receptor. This is firstly because the nanoviricides based on mimicking attachment receptors are broad-spectrum in nature, capable of antiviral effect against not just a specific virus type or subtype, strain or variant, but entire families of viruses (as defined in the virus classification system), and secondly, because, no matter how much a virus mutates or changes, its binding to the host-side receptor(s) does not change.
Nanoviricides Platform Modality 2: Specific, Highly Effective, Antiviral “Reinfection Inhibitors”
Choosing a specific antiviral ligand that mimics the cognate receptor on the host cell that is used by the virus would lead to specific nanoviricide agents that would attack the viruses that use that particular cognate receptor. This technique is what we call Modality 2.
In addition to developing bio-mimetics of the broad-spectrum attachment receptors, we have also developed nanoviricides that mimic the specific cognate receptor(s) used by a particular type of virus to develop highly specific drugs against that type of virus.
Our antiviral drug candidate NV-HHV-1 is based on mimicking the cognate receptor HVEM (“herpesvirus entry mediator”) that is known to be used by HSV-1 and HSV-2. We found that NV-HHV-1 demonstrated antiviral activity against VZV (Varicella Zoster Virus) in human skin patch infection model studies, although it was not then known whether VZV uses HVEM as the cognate receptor. VZV causes chickenpox in children and immune-compromised persons, and its reactivation causes Shingles in adults. NV-HHV-1 has completed pre-clinical IND-enabling studies as a skin cream for the treatment of VZV Shingles. During the development of NV-HHV-1, nanoviricides made with the same or related ligands as the one used in NV-HHV-1 were found to have demonstrated antiviral activity against HSV-1 in cell culture studies as well as in lethal infection animal model studies. Since HSV-2 also uses HVEM as entry receptor, we believe NV-HHV-1 should be effective against HSV-2 as well. In addition to developing NV-HHV-1 for the indications involving infection by VZV, HSV-1, and HSV-2, we further plan to explore the activity of NV-HHV-1 against other herpesviruses such as CMV and EBV as well.
Additionally, we have developed drug candidates in the HIVCide™ Program that mimic the cellular CD4 binding site used by HIV to gain cell entry. Another important HIV cognate receptor is CCR5. The Nanoviricides Platform enables using mimics of one or more cellular receptors attached into a single nanoviricide drug. Thus, this platform has the capability of mimicking both the CD4 binding site and the CCR5 binding site of HIV on one nanoviricide, which is expected to enable the most effective drug against HIV. The only countable number of patients that have been “cured” of HIV were recipients of stem cells that possess a modified CCR5 lacking its HIV-binding region, attesting to the importance of mimicking both CD4 and CCR5 simultaneously.
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Attacking the “Achilles Heel” of the Virus- Unchanging Ability of the Virus to Bind to Its Cognate Receptor on Cell
We strive hard to develop virus-binding small chemical ligands that mimic the cognate cellular receptor of the virus, using rational design and molecular modeling strategies and our internal, accumulated expertise. Some viruses use more than one receptor. The nanoviricide platform technology allows use of different ligands on the same nanoviricide drug to be able to attack such difficult viruses.
It would be very difficult for a virus to become resistant to a nanoviricide that mimics the virus’ cognate cellular receptor. This is because, no matter how much a virus mutates or changes, its binding to the cellular receptor does not change. If the virus does not bind to the nanoviricide efficiently, it would likely have lost its ability to bind to the cellular receptor efficiently as well, resulting in an attenuated version with limited pathogenicity.
Nanoviricides Platform Modality 3: Nanoviricides Platform Enables Cures for Viruses that Do Not Become Latent
To date most viral infections do not even have effective drugs, let alone cures.
Most viruses do not become latent in the human body. Such viruses have a relatively simple life cycle: after a virus is transmitted to the person and infects some cells, it replicates inside the infected cell (the replication part), thereafter the new virus copies exit the cell and then infect new cells (the “re-infection” part) thus starting the cycle over again. If both parts of the life cycle can be blocked effectively, then such a virus infection can be readily cured. The Nanoviricide Platform Modality 3 enables such cures.
In this modality, the nanoviricide technology simultaneously enables attacking the external virus particle, as well as blocking the rapid intracellular reproduction of the virus by incorporating one or more APIs within the “belly” of the nanoviricide. The nanoviricide® technology is the only technology in the world, to the best of our knowledge, that is capable of both (a) attacking extracellular virus, thereby breaking the reinfection cycle, and simultaneously (b) disrupting intracellular production of the virus, thereby enabling complete control of a virus infection.
The nanoviricides built using Modality 1 as well as Modality 2 can be employed to add the replication-inhibition capability in this manner.
NV-CoV-2-R, our other drug in development for treatment of coronaviruses contains the API NV-387-R. This API is made up of remdesivir encapsulated within the belly of the polymeric micelles of NV-387. While NV-387 is designed to directly attack the virus outside the cell, the remdesivir component is known to block the virus replication inside the cell. By blocking both of these pathways, NV-387-R would result in a cure of the viral infection. Remdesivir is a broad-spectrum antiviral agent that has been approved for COVID-19 and has shown strong pre-clinical activity against many RNA viruses. Its clinical activity is limited by its rapid metabolism in the bloodstream. NV-387 holds remdesivir like in a bottle and releases it slowly, thus limiting the metabolism and enhancing the pharmacokinetics and thereby the effectiveness of remdesivir.
Remdesivir, sponsored by Gilead, is a known antiviral drug that has received full FDA approval for treatment of COVID-19 and has received Emergency Use Authorization (“EUA”) in many countries. We are developing NV-CoV-2-R on our own, independent of Gilead.
We have also developed other drugs based on this concept of curing the viral infection. One such drug is NV-387-Rp, which contains a modified and improved form of Remdesivir. Another drug is NV-387-Ribvp, which contains a prodrug of Ribavirin. Ribavirin is a highly toxic but highly effective antiviral drug. It is approved in the USA only for the treatment of RSV infection as a drug of last resort. However, it is used in the case of many viral infections for which no antivirals are known in severe hospitalized cases. NV-387-Ribvp is expected to enable cures for such viruses by combining the Re-Infection Inhibition activity of NV-387 with the Replication Inhibition activity of Ribavirin, while at the same time enabling lower doses of Ribavirin to stay well below its toxicity level.
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Nanoviricides Platform Modality 4: Nanoviricides Platform Has the Capability to Enable Cures for Viruses that Do Become Latent
HIV and many viruses in the herpesviridae family form “latent reservoirs” in human cells making them difficult to cure. HIV and the class of lentiviruses achieve this by directly copying its genomic information into the human chromosomal DNA itself. Two of the herpes viruses, namely HHV-6A and HHV-6B, are known to copy their genetic information into the telomere region of the chromosome, shortening the number of cell divisions the modified cell can undergo, effectively a phenomenon of aging. All other herpesviruses create episomal islands in the cell’s nucleus which are their own “factories” for making progeny copies. The nanoviricides technology platform can be harnessed against these viruses in another different modality that can potentially produce cures. We are working on such cures of latent viruses in our research and development (“R&D”) projects.
Broad and Expanding Pipeline Based on the Nanoviricide Platform Technology – in Brief
Our powerful Nanoviricides Platform technology has enabled us to develop several drug candidates against a large number of different viruses that could be further improved into clinical drug candidates, thus building a very broad drug pipeline that may lead to exponential growth of the Company upon the approval of our first drug candidate. While our first drug candidate, NV-387, is now in human clinical trials, and another one, NV-HHV-1, is awaiting to go into the clinic, over the years we have developed more than ten drug candidates that, we believe, can be rapidly moved into the clinical stage, for nearly forty different antiviral drug development programs. Our progress to clinic is limited by our resources. We anticipate that once our first drug goes successfully through Phase I and Phase II clinical trials thereby proving our capabilities and our Nanoviricides Platform technology, the Company, assuming it acquires the necessary financings, could enter a phase of exponential growth and rapid clinical development of additional candidates thereby transforming the way viral infections are treated.
We have several drugs in our pipeline, enabled by our strong and extensive nanoviricide technology platform. Of these, NV-387 is in Phase Ia/Ib Clinical Trial, wherein the healthy subjects treatment and observation phase was completed about the end of December, 2023 and we are now working towards data analysis and Phase I report with the CRO and the clinical trial manager, KMPL.
We are now planning a Phase II clinical trial to evaluate efficacy in the use of NV-387 for the treatment of RSV infection. We are focusing on the RSV indication towards regulatory approval for use of NV-387 to treat pediatric patients with RSV infection.
We also plan on further developing NV-387 for the treatment of Smallpox/Mpox as a biodefense application. We plan to focus our Smallpox related work on enabling non-dilutive funding for this development.
We plan on further exploring the use of NV-387 as an influenza treatment in non-clinical efficacy studies that may be required for a regulatory IND Phase II application.
Additionally, we believe that NV-387 may have effectiveness against many other viruses including viruses that do not have current treatments such as Henipaviruses (Hendra and Nipa viruses), many hemorrhagic viruses of interest to the Department of Defense, and others. NV-387 mimics Sulfated Proteoglycans that more than 90% of human pathogenic viruses utilize as the first landing site in causing an infection. We plan on seeking collaborations with labs that can broadly test our drugs against multiple viruses as well as non-dilutive funding for such developments.
We have also completed pre-clinical development of a nanoviricide drug showcasing Modality 2, namely NV-HHV-1. We plan on undertaking Phase I and further clinical development of NV-HHV-1 as and when enabled by our financial resources. NV-HHV-1 is currently formulated as a Skin Cream for the treatment of Shingles.
We also have several additional pre-clinical drug development programs including Herpes Simplex Viruses (HSV-1 that causes cold sores, and HSV-2 that causes genital ulcers), HIV/AIDS, Influenza, Dengue viruses, and Ebola/Marburg, that we plan to advance further towards clinical drug candidates as they progress further. Thus, we have a strong and broad pipeline that is expected to continue to result in highly effective drug candidates against a number of viral diseases.
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We are now at the stage of clinically harnessing the development of Modality 1 and Modality 2 nanoviricides drugs. To recap, Modality 1 drugs mimic Attachment Receptors and possess a very broad spectrum of antiviral activity that includes a large number of different types of viruses. Modality 2 drugs mimic Cognate Receptors and possess a very strong antiviral activity against a set of specific types of viruses. In both cases, the targeted viruses are highly unlikely to escape the drug by evolving variants. NV-387, a Phase II-ready clinical stage drug candidate, is an example of Modality 1 nanoviricides, and NV-HHV-1 is an example of Modality 2 nanoviricides. We are in the process of completing the IND-enabling studies for NV-387 to enter Phase II clinical trials for the treatment of RSV. NV-HHV-1 has completed IND-enabling studies as a Skin Cream for the treatment of Shingles.
We have also continued R&D on Modality 3 nanoviricide drugs that promise potential cures for non-latency viruses. NV-387-Rp and NV-387-Ribvp have shown strong effectiveness against Coronaviruses and RSV in animal models respectively, and are expected to be highly active against a number of other viruses based on the known activities of their components. We plan on developing these Modality 3 potential cures of a number of viral diseases after the Modality 1 and Modality 2 drugs.
Overall, since our founding, we have worked on development of approximately 40 different indications of different viral diseases in a number of drug development programs. In the process, we have built an extensive library of both the (i) Nanoviricides Platform know-how and (ii) the actual synthesized chemical drugs.
Additional details of our drug pipeline can be found in this Annual Report in the section “NanoViricides Drug Pipeline” further below.
NanoViricides Drug Development Process
Our drug programs begin from initial R&D to understand the virus and advance to design antiviral medical countermeasures. Then we chemically synthesize selected potential small molecules to act as the ligands that mimic the cellular receptor(s) of both Modality 1 (broad spectrum) type as well as Modality 2 (specific to the virus family) type, to bind to the virus. Separately we have been engaged in evolving and optimizing various versions of the nanoviricide backbone polymer. We then choose some of the select polymers and attach the selected antiviral ligands chemically to the polymer to create a library of antiviral nanoviricides. We then evaluate these antivirals in cell cultures against the target viruses. We further evaluate selected antiviral ligands from this screen in animal model studies. We then down-select from the effective drug candidates about five to seven candidates for further development based on a number of considerations including the level (or potency) and spectrum of activity, any likely issues with safety/tolerability, drug stability, pharmacokinetics, pharmacodynamics, ease of manufacturing, ease of formulations, and the desired routes of administration.
Along the way, we refine the methods of preparation of these drug candidates, from chemical synthesis all the way to formulation and packaging of the final drug product, developing and implementing the Chemistry, Manufacture and Controls information for the resulting drug substances as well as the potential drug products.
The selected candidates then undergo additional studies. Typically about two of them are advanced into IND-enabling GLP Safety/Tolerability studies. One of these is then selected for further evaluation in human clinical trials.
NanoViricides, Inc. is a Fully Integrated Pharma Company
We have strived to minimize the risks inherent in the drug development process. One of the major risks is the manufacture of our nanoviricide drug candidates in a manner to produce consistently quality drugs.
NanoViricides c-GMP-capable Kilogram-Scale Manufacturing Facility for Drug Substance and Drug Products
Manufacturing of drug products for sale, as well as for late stage clinical trials is required to be performed in FDA-registered cGMP manufacturing facilities. Manufacture of drugs for earlier stage clinical trials as well as for IND-enabling GLP Safety/Toxicology studies needs to be performed in a c-GMP-compliant manner.
We discovered early in our development that the existing contract manufacturing operations in the pharmaceutical industry have very limited expertise that would be applicable to our kind of drugs. In order to speed up nanoviricide drug development, save on costs, and ensure quality, we have set up our own manufacturing facility that can scale from discovery quantities of a few grams to clinical trials quantities of a few kilograms.
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We believe we are one of the very few small pharmaceutical drug innovators that possess its own cGMP or cGMP-capable manufacturing facility. With our Shelton, Connecticut campus and pilot-scale cGMP-capable manufacturing facility, we have now demonstrated that we are in a position to rapidly advance our drug candidates into clinical trials, produce the pre-clinical “tox package” batches, and the clinical drug substance batches, as well as the completely finished and packaged clinical drug product batches.
We have produced and plan to continue to produce our nanoviricide drugs for clinical trials in this facility. We have the capability to produce sufficient drugs for about 1,000 patients in a single batch of production, depending upon dosage. This production capacity is anticipated to be sufficient for the clinical trials of NV-387 for RSV, as well as for the anticipated clinical trials of NV-HHV-1 skin cream for the treatment of Shingles. Further, this cGMP-compliant manufacturing capacity is anticipated to be sufficient for commercialization of our RSV drug candidate subsequent to required regulatory approvals thus enabling rapid market entry and revenue generation.
Our cGMP-compliant manufacturing facility is equipped with Class 100 (ISO 5), Class 1,000 (ISO 6), and Class 10,000 (ISO 7) clean room suites for injectables and other manufacturing operations as appropriate.
We have in-house all the capabilities necessary for formulation, filling and finishing of our drug products in the following forms: (i) oral syrup, (ii) oral gummies (semi-solid form), (iii) skin creams and (iv) ointments. We plan to either employ an external Contract Manufacturing Organization (CMO) for our injectable drug products for clinical trials, or develop in-house injectables manufacturing capabilities utilizing our Class 10,000 suites, as and when required.
We believe that we are in compliance with all material environmental regulations related to the manufacture of our products.
NanoViricides State-of-the-Art Nanomedicines Characterization Lab Supports In-Process QC, Release Testing of Manufactured Drug Substance, Drug Products, as well as R&D
We have a state-of-the-art nanomedicines characterization facility in-house in the same campus that has all the capabilities necessary for in-process quality control as well as release testing and quality assurance of our drug products and for supporting our manufacturing operations as well as our R&D operations. We also have a Bio-Analytical laboratory that we use for various quantitative and semi-quantitative analyses.
NanoViricides BSL2 Virology Lab for Evaluation of Drug Candidates in Cell Culture Studies
In addition to the cGMP-capable manufacturing facilities, we have also brought in-house the capability for testing of our nanoviricide drug candidates against a number of viruses in cell culture studies for early evaluation. We have built a Biological Safety Level-2 (BSL2) Virology Laboratory with attendant cell culture and biochemistry capabilities in our campus in Shelton, CT, certified by the State of Connecticut. We are able to perform drug efficacy and safety studies in cell cultures for multiple different viruses at the same time in this facility, in isolated lab rooms.
We can also study antivirals against certain BSL3 and BSL4 viruses in this facility by developing what are called “pseudovirions.” Pseudovirions are virus particles that cannot replicate, but that have the surface glycoprotein of the virus that we want to study (e.g. H5 for H5Nx Bird Flu, GP for Ebola, Marburg, S for SARS-CoV-2, etc.) on a viral backbone that is a BSL2 compatible virus. We only require and employ pseudovirions technology where the resulting virus particles cannot replicate. The pseudovirion systems allow evaluation of drug candidates that block the entry of the virus particle into cells, such as entry inhibitors, antibodies, and nanoviricides.
We have developed in-house cell culture screening capability for developing drug candidates against human Coronaviruses (h-CoV) including SARS-CoV-2 pseudovirions, VZV, HSV-1 and HSV-2, Influenzas, HIV, RSV, Ectromelia Mousepox Virus (a model for MPox and Smallpox viruses), and pseudovirion technology for Ebola/Marburg viruses, among others. We believe that this internal screening enables speedy evaluation of a much larger number of candidates than external collaborations allow. We believe this has significantly improved our ability to find highly effective ligands and performing structure-activity-relationship studies of the same in a short time period.
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External CROs for GLP and Non-GLP Animal Model Studies, Regulatory Affairs Support, and Clinical Trials
We depend upon external collaborators and Contract Research Organizations (“CROs”) for all of our animal studies that include antiviral efficacy studies, safety and tolerability studies, in both GLP and non-GLP practices. We also depend upon external collaborators and CROs for completing our regulatory filings, designing suitable clinical protocols, as well as for conducting human clinical trials, compiling the resulting data, biostatistics evaluations, and preparation of reports for regulatory filings. We plan on bringing some of the regulatory affairs capabilities in-house in the near future in order to speed up our regulatory processes.
NanoViricides Campus – Fully Owned Asset Group
All of the facilities described above, the land, building, improvements, and equipment, are fully owned by NanoViricides, Inc. This forms a significant and stable part of our long term assets, accounting for over $7.5 million in long term assets post-depreciation and amortization as of June 30, 2024. The replacement cost of these assets was estimated, in April 2024, at $18 million by a third party consultant, which we believe is a low-end estimate.
We believe NanoViricides, Inc. is one of a few innovation-led small pharma companies that has or is close to having a fully integrated pharmaceutical operation from drug discovery to drug product manufacturing. This sets us apart in the field by substantially de-risking our development programs as well as enabling time and cost savings in the new drug development process.
Fiscal Year 2024 in Review
In the fiscal year 2024, we have achieved a substantial level of accomplishments. We have focused on evaluating the broad spectrum of antiviral activity of NV-387. We have been able to significantly expand the potential indications of viral infections wherein NV-387 could be a drug candidate worthy of pursuing into clinical trials, to include the respiratory viral infections RSV and Influenza, in addition to the coronaviruses, as well as Smallpox/Mpox. The results are summarized below:
NV-CoV-2 Phase Ia/Ib Human Clinical Trial; Update on the Status
NV-387 was developed during the COVID pandemic in a very rapid timeframe. In just about a year, we went from design and synthesis to completing the required non-clinical GLP safety pharmacology studies in animals by January 2021. The progress slowed down primarily due to lack of internal regulatory expertise and dependence on external consultants that became unavailable. We successfully completed a Clinical Trial Application for the simultaneous evaluation of two oral drug products containing the same API NV-387, namely NV-CoV-2 Oral Syrup and NV-CoV-2 Oral Gummies, sponsored by our licensee, collaborator, and clinical trial manager, Karveer Meditech Pvt. Ltd. (KMPL) who sponsored the drug in India, with a local CRO, around September 2022, and KMPL obtained regulatory permission for the clinical trial towards the end of January 2023.
The Phase Ia/Ib clinical trial began with the first human dosing in June 2023. The healthy subjects part of the clinical trial, comprising both Phase Ia – Single Ascending Dose – Healthy Subjects, and Phase Ib – Multiple Ascending Dose – Healthy Subjects was completed with discharge of the last subject around December 2023. There were no dropouts and no reported adverse events. These results are generally taken as indicators that a drug is well-tolerated under the conditions of treatment in a clinical trial.
The results of this Phase Ia/Ib healthy subjects part of the clinical trial are consistent with the results of the non-clinical studies in multiple animal models in which good tolerability was observed and no respiratory, cardiological, or neurophysiological effects were found.
The clinical trial application for this clinical trial was submitted during the COVID-19 pandemic and for expediency towards use of the drug in the pandemic, a separate part of the clinical trial for the treatment of COVID-19 patients with NV-387 was also proposed. Upon completion of the Healthy Subjects part, the Sponsor and the CRO went through tremendous efforts and obtained regulatory permission to add another site where a COVID-19 wave was going on during January 2024. However, by the time all of the approvals required to start enrollment were completed, the COVID-19 wave was completely gone. After performing a large number of RT-PCR tests on potential subjects with respiratory symptoms, with all tests turning up negative results for SARS-CoV-2, this second part of the clinical trials was canceled due to the inability to find patients to enroll in spite of adding a second site. The second site was subsequently closed around April/May 2024.
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Concurrently data upload and crosschecking activities for the healthy subjects Phase Ia/Ib part have now been completed. After appropriate external audits, the drug sponsor is now getting ready to close the first clinical trial site where the healthy subjects part was executed. Thereafter, subsequent to database lock, statistical analysis of the observations of the subjects will be performed. These include a number of parameters including clinical observations, blood chemistry, and specific organ-related blood chemistry parameters, among others. The report from these studies will be compiled by the CRO into a final Phase Ia/Ib clinical trial report.
The relevant Indian regulatory body has adopted guidelines that are consistent with ICH guidelines of clinical trials. (ICH = The International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use). We therefore believe that the clinical trial in India would be applicable for the US FDA regulatory purposes as well. We note that the clinical trial was not conducted under US FDA regulatory approval. We plan on conducting a Pre-IND Meeting with the US FDA for the use of NV-387 as a treatment for RSV infection in pediatric patients to discuss the suitability of this clinical trial and the data from the same for progressing into a Phase II clinical trial for the purpose of evaluating the efficacy of NV-387 for RSV infection treatment indication.
Evaluating the Broad Antiviral Activity Spectrum of NV-387 Against Multiple Different Types of Viruses
During the reported year, in parallel to working on the clinical trial in India, we embarked on determining whether NV-387 could be sufficiently active to be chosen as a clinical drug candidate against different types of viruses other than coronaviruses.
NV-387 was designed as a Sulfated Proteoglycan (S-PG) Mimetic. Over 90% of human pathogenic viruses are known to use heparan sulfate proteoglycan (HSPG) in particular as an attachment receptor to enable them to infect cells. NV-387 mimics the critical feature that the viruses look for in not just HSPG but other related S-PGs such as Chondroitin Sulfate (used by the Chikengunya virus), Dermatan Sulfate (used by Human Papilloma Viruses - HPV), among others. HSPG is used by almost all respiratory viruses. We therefore focused on viruses that use HSPG for our first studies. In particular, we studied activity of NV-387 in animal models of lethal lung infections by the respiratory viruses RSV and Influenza. Since orthopoxviruses are known to bind to HSPG, we also evaluated activity of NV-387 against lethal infection by the model mousepox virus (Ectromelia) that is used as a part of the US FDA Animal Rule for the development and approval of Smallpox therapeutics.
Activity of NV-387 in Lethal Lung RSV Infection in Mice – NV-387 Oral Treatment Appears to Have Cured Lethal Lung RSV Infection Based on Complete Survival and No Lung Damage
In the first animal trial, we compared the effect of NV-387 given as both injectable and as oral treatment in mice infected lethally into the lungs with RSV A2 virus. We found that NV-387 demonstrated excellent anti-RSV activity, almost matching the activity of ribavirin as shown in the table below. Ribavirin is the only drug currently approved for treatment of RSV infection. However it is used only as a last resort drug because of its significant toxicities, including hematological and nephrological (kidney) adverse effects.
Survival Lifespan of Lethally Infected Mice - Lung Infection with RSV A2 | |||
|---|---|---|---|
Treatment | Survival, Days | Increase in Survival, | Increase in |
NV-387, Injection | 15 | 8 | 115% |
Ribavirin, Injection | 16 | 9 | 129% |
Vehicle for Injection | 7 | 0 | - |
NV-387, Oral | 15 | 8 | 115% |
Ribavirin, Oral | 16 | 9 | 129% |
Vehicle for Oral | 7 | 0 | - |
Treatment of lethally infected mice in this study with NV-387 or ribavirin led to statistically equivalent positive effect on the outcome of the disease. Since ribavirin is highly toxic, the activity of NV-387 demonstrated in this study is of great significance.
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Importantly, NV-387 given orally at approximately twice the total dose of NV-387 given as an injection produced equivalent results in terms of effect on animal survival. Thus, the oral bioavailability of NV-387 can be estimated, in terms of actual biological effects, to be approximately 50% based on this animal study. We believe that this level of effective bioavailability is excellent and it would permit development of NV-387 as an oral drug for treatment of RSV infection.
We reported on this study in a press release dated July 11, 2023.
Encouraged by the results of this animal trial, we initiated a new trial with oral dosing of NV-387 extended to ten days with two doses on first day for a total of eleven doses. We also increased the dosing of ribavirin in this second animal trial. The results of this trial are shown in the table below.
Survival Lifespan of Lethally Infected Mice - Lung Infection with RSV A2 | |||||
|---|---|---|---|---|---|
Treatment | Survival, Days | Increase in Survival, | Increase in Survival, | ||
NV-387, Oral | 22+ (Complete) | > | 14 | > | 175% |
Ribavirin, Oral | 14 | 6 | 75% | ||
Vehicle, Oral | 8 | 0 | 0% | ||
We were pleasantly surprised to find that the increased oral dosing of NV-387 led to complete survival of all of the lethally lung-RSV-infected mice, well beyond the 21 day study length, and they remained healthy until final sacrifice as per protocol at 30 days. The performance of oral ribavirin was similar to its performance in the previous trial, and possibly slightly worse, indicating that the dosing level of ribavirin in this trial might be close to evidencing its toxicity.
We reported on these results in a press release on May 14, 2024.
Further analysis of gross histology as well as micro- histopathology of lungs from the animals treated with NV-387 compared to ribavirin was also conducted.
The lethally RSV-infected animals in the NV-387-treated group showed no lung damage in lung histo-pathology study at all-time points during the study, including at the end of the study. This demonstrates that the NV-387 oral treatment completely protected the animals from the lethal effect of RSV infection. These results are consistent with the complete and healthy survival of the animals.
In contrast, lethally infected animals in the ribavirin oral treatment group showed progressive lung pathology, demonstrating progressive inflammation in the lung tissue which resulted in moderate levels of inflammation as well as infected cells in the inflammatory infiltrate on day 10, increasing to severely infected lungs with alveolitis and severe pneumonia by day 13. All animals in the ribavirin-treated RSV infected group died by 14 days as shown in the table.
These lung histo-pathology results in conjunction with the complete survival of NV-387 orally treated animals support our belief that NV-387 oral treatment led to complete cure of the lethal RSV infection in mice in this animal trial.
We reported on these results in a press release on May 20, 2024.
Based on these results, we have determined to seek regulatory approval for a Phase II human clinical trial for the evaluation of efficacy of oral NV-387 treatment in RSV infection.
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Activity of NV-387 in Lethal Lung Influenza Infection in Mice - NV-387 Treatment Resulted in Significantly Greater Survival Improvement Compared to Three Approved Influenza Drugs, and Significantly Increased Protection of Lungs from Virally Induced Damage
We evaluated the activity of NV-387 given orally (twice on first day then once daily, 8 days, total 9 doses) in comparison with the three approved drugs, oseltamivir (Tamiflu®, Roche) given orally (twice daily for 8 days), baloxavir (Xofluza®, Shionogi, Roche) given orally as a single dose, and peramivir (Rapivab®, Biocryst) given by tail-vein injection once daily for 8 days. The survival lifespan results are shown in the table below.
Survival Lifespan of Lethally Infected Mice - Lung Infection with Influenza A/H3N2 | |||
|---|---|---|---|
Treatment | Survival, Days | Increase in Survival, | Increase in Survival, |
NV-387, Oral | 15 | 7 | 88% |
Oseltamivir (Tamiflu), Oral | 10 | 2 | 25% |
Peramivir (Rapivab), Injection | 11 | 3 | 38% |
Baloxavir (Xofluza), Oral | 11 | 3 | 38% |
Vehicle, Oral | 8 | 0 | - |
We were pleasantly surprised to find that the NV-387 oral treatment led to nearly 2.5 to 3 three times more increased survival compared to the three approved drugs, by 7 days, whereas the three approved drugs led to a survival of only 2 to 3 days over vehicle-treated animals that survived 8 days.
We reported on these results in a press release dated May 6, 2024.
We also studied the effect of NV-387 treatment on the lung mucus index, as well as lung immune cell infiltration in this animal trial. Lung mucus index is a parameter that measures the lung congestion and relates to pneumonia symptoms. Lung immune cell infiltration relates to virally induced lung damage that is actually caused by the cytotoxic cells of the immune system that kill infected cells. The results are shown in the table below.
NV-387 Oral Treatment Significantly Protected Lungs of Balb-c Mice | ||
|---|---|---|
Treatment | Lung Mucus Index | % Immune Cell Infiltration |
NV-387, Oral | 53 | 31% |
Untreated Infected Control | 138 | 68% |
We found that NV-387 significantly reduced lung mucus index, as well as cell-killing immune cell infiltration into the lungs. The results indicate that NV-387 oral treatment resulted in significant reduction in lung infiltration and lung cell death. Lungs of infected animals treated with NV-387, orally, showed very limited presence of infiltrating cell-killing immune cells that are known to be an important cause of lung damage, in addition to the direct lung damage from infected cell death caused by the virus itself. Further, the overall lung damage was found to be significantly reduced upon NV-387 treatment.
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The results further indicated that NV-387 treatment resulted in significant reduction in mucus load in the lungs. The extent of mucus in the lung tissue was substantially reduced in the case of NV-387 treatment a positive finding. The mucus index value in the case of NV-387 oral treatment was about 53, as compared to the infected untreated animals that had a mucus index value of 138. Mucus is secreted by secretory cells in response to viral infection in an attempt to clear the virus, but it results in reduced lung capacity and eventually can lead to pneumonia. Thus, reduction in mucus load is an important sign that the progress of the viral infection is arrested.
These results indicate that NV-387 treatment led to a significant level of protection of lungs in Balb-c mice lethally infected with Influenza A H3N2 virus.
We reported on these results in a press release on June 20, 2024.
Given the broad range of activity of NV-387 against different types of viruses, we believe that these results of activity of NV-387 against Influenza A/H3N2 lead us to believe that NV-387 likely possesses significant activity against other influenza viruses as well, including high path avian influenza (HPAI; H5Nx Bird Flu).
It is important to note that resistance against small chemical influenza drugs has emerged. The amantadine class of drugs is now largely ineffective. Oseltamivir resistant mutants are known. Peramivir is not used very much for various reasons. In a Phase III clinical trial of baloxavir, over 10% of the patients were found to have the virus evolved into resistant mutants.
Thus NV-387 with its broad spectrum and unlikely escape of virus is expected to become an important weapon in the treatment of influenza virus infections.
Activity of Oral NV-387 in Lethal Intra-digital Poxvirus Infection in Mice Matched that of Approved Drug Tecovirimat; Activity of Combination of NV-387 and Tecovirimat was Significantly Better than Either Drug Alone
We conducted evaluation of activity of NV-387compared to the approved drug tecovirimat (TPOXX®, SIGA) in a lethal model of mousepox (ectromelia) virus intra-digital footpad infection in mice. This model emulates the virus infection by transfer of virus via skin abrasion, a mode of infection that has been found to be the dominant mode in Mpox virus epidemics in the West. The results are shown in the table below.
Survival Lifespan of Lethally Infected Mice – Intra-digital Footpad Infection with Ectromelia Virus | |||
|---|---|---|---|
Treatment | Survival, Days | Increase in Survival, | Increase in Survival, |
NV-387, Oral | 14 | 6 | 75% |
Tecovirimat (TPOXX), Oral | 14 | 6 | 75% |
NV-387-m-T, Oral | 17 | 9 | 112% |
Vehicle, Oral | 8 | 0 | - |
In this trial, we found that the activity of NV-387 matched that of tecovirimat, the approved drug for smallpox which was used in the recent MPox epidemics in the West. Both drugs led to approximately 75% increase in survival of the animals. Moreover, treatment with an oral co-formulation of NV-387 and tecovirimat together developed by us (that we call NV-387-m-T, “m” for “mixed-in”), led to a significantly increased survival improvement of about 112% compared to either drug given alone.
We reported on these results in a press release dated November 14, 2023.
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Activity of Oral NV-387 in Lethal Lung Poxvirus Infection in Mice Matched that of Approved Drug Tecovirimat; Activity of Combination of NV-387 and Tecovirimat was Significantly Better than Either Drug Alone
We also conducted evaluation of activity of NV-387 compared to the approved drug tecovirimat (TPOXX®, SIGA) in a lethal model of mousepox (ectromelia) virus lung infection in mice. This model emulates the virus infection that would be caused in the case of aerosolized virus, a mode of infection likely in a potential bio-terrorism attack, and that was also observed in natural smallpox epidemics. The results are shown in the table below.
Survival Lifespan of Lethally Infected Mice – Intra-digital Footpad Infection with Ectromelia Virus | |||
|---|---|---|---|
Treatment | Survival, Days | Increase in Survival, | Increase in Survival, |
NV-387, Oral | 15 | 7 | 88% |
Tecovirimat (TPOXX), Oral | 16 | 8 | 100% |
NV-387-m-T, Oral | 19 | 11 | 138% |
Vehicle, Oral | 8 | 0 | - |
In this trial, we found that the activity of NV-387 substantially matched that of tecovirimat, the approved drug for smallpox which was used in the recent MPox epidemics in the West. Both drugs led to approximately 85-100% increase in survival of the animals. Moreover, treatment with an oral co-formulation of NV-387 and tecovirimat together developed by us (that we call NV-387-m-T, “m” for “mixed-in”), led to a significantly increased survival improvement of about 138% compared to either drug given alone.
We reported on these results in a press release dated May 8, 2024.
Smallpox, Biodefense, and the US FDA Animal Rule
Tecovirimat (“TPOXX®”, SIGA Pharmaceuticals) is an approved smallpox therapeutic. It was mobilized from the US Government stockpile for the treatment of Mpox infection during the recent MPox epidemic. Additional therapeutics that work with Tecovirimat such as NV-387 may reduce the required dosage and dosing period enabling rapid patient recovery.
Smallpox-causing Variola virus is considered a significant biodefense threat. While smallpox vaccines are available, their general public health usage has stopped after Smallpox was declared eradicated in 1980, leaving persons under the age of about 45 vulnerable.
Tecovirimat is stockpiled by the Biomedical Advanced Research and Development Authority (BARDA) under Project BioShield. BARDA awarded an original development and procurement contract worth approximately $435 million to SIGA in 2011, followed by another procurement contract in 2018 upon regulatory approval worth approximately $629 million. SIGA announced in July 2023 that it has received new procurement orders of approximately $138 million for TPOXX from the U.S. Government.
There is significant interest in the development of a smallpox therapeutic drug that works well by itself, as well as in combination with the known drug, tecovirimat. Tecovirimat has a low barrier of virus escape - a single mutation in one protein can enable the virus to escape this drug, adding to the significance of additional smallpox drug development.
Since human clinical trials are not feasible for the deadly Variola virus, infection of the related animal viruses in their native species is used for evaluation of drug effectiveness under the FDA “Animal Rule.” Variola (Humans), Mpox (Monkeys), Ectromelia (Mice), and Rabbitpox (Rabbits) are some of the closely related pathogenic viruses belonging to the Orthopoxvirus genus (with their native hosts listed in parentheses).
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The animal-rule based efficacy studies conducted under GLP conditions substitute for the usual Phase II/III human clinical efficacy trials for regulatory approval under the Animal Rule. Additional human safety clinical studies are expected to be required.
The Animal Rule pathway may enable rapid regulatory development of NV-387 as a smallpox therapeutic towards approval.
The Importance of Treatment for RSV Infection in Pediatric Population – An Unmet Medical Need
Each year in the United States, an estimated 58,000–80,000 children younger than five years old are hospitalized due to RSV infection. Globally, RSV is a common cause of childhood Acute Lower Respiratory Infection (ALRI, which includes pneumonia) and a major cause of hospital admissions in young children. Globally in 2015, 33 million episodes of RSV-ALRI, resulted in about 3.2 million hospital admissions, and 59,600 in-hospital deaths in children younger than five years. About 45% of hospital admissions and in-hospital deaths due to RSV-ALRI occur in children younger than six months old.
There are No Effective Treatments for RSV
Three vaccines have recently been approved for RSV prophylaxis. Arexvy (GSK), and Abrysvo (Pfizer) were approved in May 2023 for use in adults over 60 years of age and both reduced severity of RSV infection. Mresvia (Moderna), an mRNA vaccine, was approved for medical use in the United States in May 2024. Abrysvo also received approval for use by pregnant women at 32-36 weeks of pregnancy in order to confer protective antibodies against RSV to the fetus for protection of infant when born despite concerns regarding premature childbirths. There are no RSV vaccines currently approved for infants and children.
However, there are no effective therapeutics for RSV to date. Ribavirin is conditionally approved only for patients with high risk of progressively severe RSV disease, due to significant side effects including hemolytic anemia and kidney failure. Synagis (palivizumab), an antibody, is approved only as a prophylactic in children and infants at high risk of severe RSV infection, but it is not approved for treatment of RSV infection. Nirsevimab (Beyfortus, AstraZenecka), another antiviral monoclonal antibody, has been approved for the prevention of RSV lower respiratory tract disease in newborns and infants during their first RSV season that requires a single dose to confer season-long protection from RSV infection. None of these drugs are approved for treatment of RSV infection after it occurs.
Market Size of RSV Therapeutics is Expected to Hit $8.73 Billion by 2031
In June 2023, GrowthPlus Reports reported that the market size for RSV therapeutics was worth $1.8 billion in 2022, and is expected to grow at a CAGR of 18.9%, reaching $8.73 billion by 2031 (https://www.growthplusreports.com/report/respiratory-syncytial-virus-rsv-therapeutics-market/8519).
NV-387 for the Treatment of Influenza Infections
The market size for Influenza and Bird Flu is estimated at $4.6 billion in 2024, growing to an estimated $5.9 billion in three years, at a rate of 8.5% as reported by DelveInSight (https://www.delveinsight.com/report-store/influenza-a-infections-market? utm_source=cision&utm_medium=pressrelease&utm_campaign=spr). In case a pandemic occurs, reality may outrun such projections by magnitudes, as was seen with the COVID pandemic.
Strong Market Potential of NV-387
Thus, we believe NV-387 alone may propel NanoViricides towards great success in a near-term horizon. We plan to license or co-develop our various drug candidates against multiple viral diseases to other Pharma Companies. In addition, we plan to seek non-dilutive funding for the development of drugs that are of interest for biodefense.
Our IND-Ready Drug Candidate, NV-HHV-1 Skin Cream for the Treatment of Shingles
We have previously developed NV-HHV-1 and formulated it as a skin cream for the treatment of Shingles rash, NV-HHV-1 has completed IND-enabling studies. We plan on undertaking further development of NV-HHV-1 into human clinical trials once our NV-387 based drug candidates progress further in clinical trials.
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Licenses, Patents, Trademarks, Proprietary Rights: Intellectual Property
Licenses from TheraCour
Our drug development business model was formed in May 2005 with a license to the patents and intellectual property held by TheraCour Pharma, Inc. (TheraCour) that enabled creation of drugs engineered specifically to combat viral diseases in humans. This exclusive license from TheraCour serves as a foundation for our intellectual property. We have a worldwide exclusive license to this technology for several field of application verticals with specific targeting mechanisms for the treatment of a number of human viral diseases. TheraCour owns approximately 21% of our voting capital stock and, Anil Diwan, our Founder, President and Executive Chairman, owns approximately 90% of TheraCour’s capital stock.
Our drug candidates are licensed from TheraCour, and are developed by TheraCour for the Company on the basis of several patents, patent applications, provisional patent applications, and other proprietary intellectual property know-how held by TheraCour. Unlike usual pharma industry licenses that are specified for single chemical entities or for groups of similar chemical entities, our licenses are specified for the vertical application field of use, thereby providing us with a large universe of diverse development candidates under the same umbrella. Further, the licenses are held by NanoViricides for worldwide use and can be sub-licensed. The licenses can revert only in the case of a default by NanoViricides. The terms of default are such that, effectively, TheraCour would be able to take the licenses back only in the event that NanoViricides declares insolvency and inability to conduct its business.
We have exclusive licenses from TheraCour for drug candidates derived from and based on TheraCour’s technologies for several viruses. In 2005, we obtained a license from TheraCour for the treatment of the following human viral diseases: Human Immunodeficiency Virus (HIV/AIDS), Influenza including Asian Bird Flu Virus (INF), Herpes Simplex Virus (HSV-1 and HSV-2), Hepatitis C Virus (HCV), Hepatitis B Virus (HBV), and Rabies. Thereafter, on February 15, 2010, we entered into an TheraCour-Nanoviricides Additional License Agreement (“Additional License Agreement”) with TheraCour granting the Company the exclusive licenses for technologies developed by TheraCour for the additional virus types for Dengue viruses (DENV), Japanese Encephalitis (JEV), West Nile Virus (WNV), viruses causing viral Conjunctivitis (a disease of the eye) and Ocular Herpes Keratitis, and Ebola/Marburg viruses. While herpes simplex viruses were already specified as licensed previously, the term “ocular herpes keratitis” was added to this additional license agreement at the specific request of the Company for clarity only. In addition, we completed the process of licensing the VZV (shingles, chicken pox virus) field from TheraCour in November 2019. We further completed the process of licensing antivirals for the field of human coronavirus indications in September 2021 under the COVID agreement. As in the past, as and when advised by counsel, we will seek additional licenses to verticals of antiviral fields from TheraCour. To date, TheraCour has not withheld any licenses for antiviral nanomedicines that NanoViricides has requested.
We retain worldwide exclusive rights to commercially develop, commercialize, and market the licensed products. We pay TheraCour for the R&D work asked to be performed by the Company to develop these drugs, their chemistries, formulations, and manufacturing processes, substantially at cost, with a certain fee as specified in the license agreements. We may perform initial developmental testing by ourselves and through third parties, such as academic labs, government institutions, contract research organizations, for safety and effectiveness, among other tests. The Company may perform further IND-enabling advanced pre-clinical studies using third parties, such as contract research organizations, usually on clinical drug candidates. We expect to perform human clinical trials using contract research organizations with expertise in such clinical trials. We intend to sponsor the drugs for commercialization activities and obtain the rights of commerce under various regulatory authorities for its own use.
We focus our research and clinical programs on specific anti-viral therapeutics and are seeking to add to its existing portfolio of products through our internal discovery and clinical development programs and through an in-licensing strategy. To date, we have not commercialized any product.
For all the licensed fields, we control the research and work TheraCour performs on our behalf and no costs may be incurred without the prior authorization or approval by us.
The TheraCour technologies and patents required for execution of our work in the licensed fields and licensed products are automatically licensed to us even if such technologies and patents are developed after the license agreements themselves.
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Patents, Patent Applications, Proprietary Rights
Patents and other proprietary rights are essential for our operations. If our drugs are protected by a properly designed and enforceable patent, it can be more difficult for our competitors to use our technology to create competitive products and more difficult for our competitors to obtain a patent that prevents us from using technology we create. As part of our business strategy, in conjunction with TheraCour, we actively seek patent protection both in the United States and internationally and intend to file additional patent applications, when appropriate, to cover improvements in our compounds, products and technology. We also rely on trade secrets, internal know-how, technological innovations and agreements with third parties to develop, maintain and protect our competitive position. Our ability to be competitive will depend on the success of this strategy.
A new international PCT patent application regarding coronavirus drug candidates, PCT/US21/39050, entitled “Self-Assembling Amphiphilic Polymers As Anti-Covid-19 Agents,” was filed under the Patent Cooperation Treaty (PCT) on June 25, 2021. An additional international PCT patent application that builds on this application regarding coronavirus drug candidates, PCT/US22/35210, entitled “Self-Assembling Amphiphilic Polymers As Anti-Covid-19 Agents,” was filed on June, 28, 2022, with a requested priority date of the 2021 application. Our anti-COVID drugs are based on polymeric micelle nanomedicine technologies developed by TheraCour and its affiliate, AllExcel, Inc. (“AllExcel”). The inventors at AllExcel have filed these two broad PCT patent applications that form the basis of our two lead drug candidates, namely, NV-CoV-2 and NV-CoV-2-R. These new patent applications cover the new technologies, compositions, formulations, processes, manufactured products, and methods of use, among other specifics.
The nominal expiry date for patents resulting from these two PCT applications would be 20 years, after filing and if issued, i.e. June 24, 2041, and could be extended in certain countries under regulatory extensions to as late as into the year 2043, providing a significant commercial runway.
We believe that our drugs by themselves may be eligible for patent protection. We, in conjunction with TheraCour, plan on filing patent applications for protecting these drugs when we have definitive results that enable clinical drug development. We believe this strategy would maximize the available commercial patent life for many of our future drugs well beyond 2043. We intend to file the patent application for HerpeCide before entering human clinical trials, as we have done for our Coronavirus program. The estimated expiry date for the HerpeCide patents, if and when issued, would be no earlier than 2044-2049.
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The Company has licenses to key patents, patent applications and rights to proprietary and patent-pending technologies related to our compounds, products and technologies (see Table 1), but we cannot be certain that issued patents will be enforceable or provide adequate protection or that pending patent applications will result in issued patents.
Table 1: Intellectual Property, Patents, and Pending Patents Licensed by the Company | ||||
Patent or Application | Date of Issue/ | US Expiry Date | International | Owners |
PCT/US06/01820 SOLUBILIZATION AND TARGETED DELIVERY OF DRUGS WITH SELF-ASSEMBLING AMPHIPHILIC POLYMERS | Applied: Jan 19, 2006 PCT U.S. Issuance: May 8, 2012. | Oct. 2028 (estimated) | Applications are in various prosecution stages. Fifty-two of these have been issued or validated. | TheraCour Pharma, Inc. [Exclusive License]. |
PCT/US2007/001607 SELF-ASSEMBLING AMPHIPHILIC POLYMERS AS ANTIVIRAL AGENTS | Applied: Jan 22, 2007 | Ca. 2029 (estimated) | Applications are in various prosecution stages. Nine of these have been issued or validated. | TheraCour Pharma, Inc. [Exclusive License]. |
PCT/US21/39050 - SELF-ASSEMBLING AMPHIPHILIC POLYMERS AS ANTI-COVID-19 AGENTS | Applied: June 25, 2021 | Ca. 2043 (estimated) | PCT Application filed. | TheraCour Pharma, Inc. [Exclusive License]. |
PCT/US22/35210 – SELF-ASSEMBLING AMPHIPHILIC POLYMERS AS ANTI-COVID-19 AGENTS (**) | Applied: June 28, 2022 | Ca. 2043 (estimated) | PCT Application filed. | TheraCour Pharma, Inc. [Exclusive License]. |
**: The PCT application PCT/US22/35210 was filed with request for priority of PCT/US21/39050. | ||||
We have previously announced certain important issuances of patents on the TheraCour® technology underlying our Nanoviricides® drugs. A total of at least 61 patents have been issued globally, on the basis of the first two international PCT patent families that cover the fundamental aspects of the platform technology we license from TheraCour. Additional patent grants are expected to continue as the applications progress through prosecution processes. All of the resulting patents have substantially broad claims. These patents have nominal expiry dates in 2026 to 2029.
The patent expiry dates can be further extended in several countries and regions for the additional allowances due to the regulatory burden of drug development processes, or other local considerations, such as licensing to a local majority held company. Many countries allow up to five years extension for regulatory delays.
We believe that the novel compositions disclosed in these patent applications, and additional proprietary intellectual property provide the necessary features that enable the development of nanoviricides. We believe that no other published literature materials or existing patents are capable of providing all of the necessary features for this development, to the best of our knowledge. However, we have no knowledge of the extensive active internal developments at a number of companies in the targeted therapeutics area.
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TheraCour may obtain patents for the compounds many years before we obtain marketing approval for them. Because patents have a limited life, which may begin to run prior to the commercial sale of the related product, the commercial value of the patent may be limited. However, we may be able to apply for patent term extensions, based on delays experienced in marketing products due to regulatory requirements. There is no assurance we would be able to obtain such extensions. Patents relating to pharmaceutical, biopharmaceutical and biotechnology products, compounds and processes such as those that cover our existing compounds, products and processes and those that we will likely file in the future, do not always provide complete or adequate protection. Future litigation or reexamination proceedings regarding the enforcement or validity of our licensor, TheraCour’s existing patents or any future patents, could invalidate TheraCour’s patents or substantially reduce their protection. In addition, the pending patent applications and patent applications filed by TheraCour, may not result in the issuance of any patents or may result in patents that do not provide adequate protection. As a result, we may not be able to prevent third parties from developing the same compounds and products that we have developed or are developing. In addition, certain countries do not permit enforcement of these patents, and manufacturers are able to sell generic versions of our products in those countries. We also rely on unpatented trade secrets and improvements, unpatented internal know-how and technological innovation. In particular, a great deal of our material manufacturing expertise, which is a key component of our core material technology, is not covered by patents but is instead protected as a trade secret. We protect these rights mainly through confidentiality agreements with our corporate partners, employees, consultants and vendors. These agreements provide that all confidential information developed or made known to an individual during the course of their relationship with us will be kept confidential and will not be used or disclosed to third parties except in specified circumstances. In the case of employees, the agreements provide that all inventions made by the individual while employed by us will be our exclusive property. We cannot be certain that these parties will comply with these confidentiality agreements, that we have adequate remedies for any breach, or that our trade secrets will not otherwise become known or be independently discovered by our competitors.
Out-Licensing to Karveer Meditech Private Limited, India (KMPL)
On March 27, 2023 we entered into a license agreement with KMPL wherein we granted to KMPL a limited, non-transferable, exclusive license for the use, sale, or offer of sale in India of the two clinical test drug candidates titled as NV-CoV-2 and NV-CoV-2-R for the treatment of COVID in patients in India. KMPL has engaged in further drug development in India including sponsoring of drug candidates for human clinical trials in India and has acted as clinical trials manager for such clinical trials. KMPL shall provide NanoViricides with all reports of the clinical trials and the Company can use such reports for further advancement of the drug candidates with regulatory authorities outside India. In consideration, KMPL will be reimbursed by us for all direct and indirect costs incurred for the clinical trials and development activities with a customary clinical trials manager fee of thirty (30%) of such costs and applicable taxes. Upon commercial sales of any resulting approved drugs, KMPL will pay the Company a royalty of seventy (70%) percent of the final invoiced sales less costs to unaffiliated third parties. Dr. Anil Diwan, our Founder, President and Executive Chairman, is a passive investor in KMPL. His ownership interest does not provide him with control or significant influence over KMPL.
Trademarks
The Company currently has no registered trademarks.
Corporate Events - Financing
We had approximately $4.8 million cash in hand as of June 30, 2024, the end of the reporting period. In addition, in February 2024, we obtained a $2 million financing in the form of a line of credit from Dr. Anil Diwan, our founder, President and Executive Chairman. By signing on September 23, 2024 and being effective as of September 20, 2024, this credit line was increased to $3 million, and extended to cover the period ending March 31, 2026, with no other changes in the terms.
We spent approximately $6.3 million in cash on operating activities during the year ended June 30, 2024, a small increase over the $5.7 million in cash expenditures in the prior year ending June 30, 2023; the increase primarily due to clinical trial expenditures.
Additionally, we have long term assets of $7.5 million post-depreciation and amortization that represent our facilities that we plan on obtaining financing against in order to increase available cash for operations.
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We believe we have sufficient financing to close the Phase Ia/Ib clinical trial of NV-387 with completion of a final clinical study report, the healthy subjects treatment phase of which was recently completed and data analysis and reporting has been undertaken, and additionally to perform the necessary regulatory activities in preparation of initiating a Phase II clinical trial for the evaluation of efficacy of NV-387 for the treatment of RSV infection.
On May 5, 2023, we filed a registration statement on Form S-3 (File No. 333-271706) with the Securities and Exchange Commission (the “SEC”), as amended on May 8, 2023, which registration statement was declared effective by the SEC on May 22, 2023. Under this shelf registration process, we may, from time to time, sell up to $150 million in the aggregate of shares of common stock, shares of preferred stock, debt securities, warrants and units.
On or about August 1, 2023, our ATM Sales Agreement was amended to name EF Hutton, division of Benchmark Investments, LLC as the only sales agent (the “Agent”) and to remove B. Riley Securities, Inc. as a sales agent. On August 4, 2023, we filed a prospectus supplement relating to the issuance and sale of our common stock, par value $0.00001 per share, having an aggregate offering price of up to $5,713,022 from time to time through or to our Agent. These sales, if any, will be made pursuant to the terms of the amended ATM Sales Agreement between us and the Agent.
On April 5, 2024 we entered into a new sales agreement (“Sales Agreement”) with EF Hutton LLC, the Sales Agent, pursuant to which we may offer and sell, from time to time, through or to the Sales Agent, shares of common stock having an aggregate offering price of up to $50 million (the “ATM Offering”). As of June 30, 2024 we sold 1,308,651 shares of our $0.00001 par value common stock at an average price of $2.47 under the Sales Agreement. The net proceeds from the offering were approximately $3,120,000 after deducting underwriting discounts and other offering expenses.
We believe that we have several important milestones, including data from and final reports from the Phase Ia/Ib human clinical trial for our broad-spectrum drug NV-387 that is now in progress. Additional milestones include clinical trial applications for Phase II clinical trial of NV-387 for RSV indication, Pre-IND and IND filing to the US FDA, clinical trial applications to other regulatory agencies, etc. We plan on initiating the Phase II study as soon as feasible. To this end, we are also evaluating the possibility of a Phase II RSV Infection Challenge in Humans Clinical Trial. We are also looking at multiple worldwide jurisdictions for the Phase II clinical trial.
We believe that as we achieve these milestones, our ability to raise additional funds in the public markets would be enhanced. However, there is no guarantee that the Company will be able to raise funds on terms acceptable to it, or at all.
Our drug development strategies may be influenced by considerations regarding the ability to engage into licensing or co-development relationships with other pharmaceutical companies. Pharmaceutical drug development is an expensive and long duration proposition. Our current plan is focused on developing NV-387 for RSV indication to the necessary stage(s) for potential collaborations, followed by similarly developing NV-HHV-1 for shingles and the follow on systemic anti-herpesviruses drug candidate in the HerpeCide program to the necessary stage(s) for fruitful collaborations. Such licensing or co-development relationships may entail upfront payments, milestones payments, cost sharing, and eventual revenue sharing, including royalties on sales. There is no guarantee that we will be able to negotiate agreements that are financially beneficial to us. We intend to develop our drugs on our own if a suitable collaboration does not occur. As and when needed, management plans to continue to raise additional funds for our continuing drug development efforts from public markets. However, there can be no assurance that we will be successful in obtaining sufficient financing on terms acceptable to us.
Investor Outreach
We have retained Tradigital, Inc. as our investor relations firm. In addition, we have presented at various investor conferences.
On June 5, 2023, Dr. Anil Diwan, our President and Executive Chairman, presented our NV-387 COVID-related work and our Technology Assets at the BIO International Conference in Boston, MA.
On October 16, 2023, Dr. Anil Diwan presented the NanoViricides Platform for Targeted Drug Delivery at the PODD Conference in Boston, MA. The PODD Conference is focused on Partnership Opportunities in Drug Delivery.
On January 9, 2024, Dr. Anil Diwan presented the NanoViricides Platform, NV-387 and COVID drug development at the Biotech ShowCase Conference in San Francisco, CA.
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On May 15, 2024, Dr. Anil Diwan presented our work in one-one meetings with investors and investor groups at the EF Hutton Annual Global Conference, held at The Plaza Hotel in New York, NY.
Additionally, we routinely provide updates on our progress via press releases.
Business Development
As NV-387 matures past Phase I human clinical trials and towards Phase II efficacy evaluation “human proof-of-concept” stage, we believe that it should be of interest to potential collaborators for co-development and other opportunities. We have recently retained Aagami, Inc., for business development, specifically to seek licensing and partnering opportunities for our assets and platform technology. Aagami, Inc. is a life sciences consulting firm based in the suburbs of Chicago which offers strategic consulting services, business development support in regions where the client is unable to reach out due to bandwidth, technology licensing services, and business research & market intelligence services.
We plan on further enhancing our business development efforts in the coming year.
NanoViricides Drug Programs
We are currently focused on developing NV-387 for multiple antiviral indications that include RSV, Influenza, Smallpox for Biodefense and possibly COVID.
Expansion of Indications for NV-387 and NV-387-based Modality 3 Drug Candidates
As previously noted, NV-387 is based on the S-PG class of attachment receptor(s) to which over 90% of human pathogenic viruses are known to bind. We plan on continuing evaluation of activity of NV-387 against additional viruses of interest in order to better define and harness its broad-spectrum antiviral potential.
Our Drug Programs for RSV (Table 2.A):
We plan to pursue NV-387 as a treatment for RSV infection towards the goal of regulatory approval for the treatment of pediatric RSV infections.
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NV-387 may be eligible to advance directly into Phase II Human clinical trials for RSV treatment.
It is expected that NV-387 can be advanced into Phase II studies against RSV once the current Phase I studies of NV-CoV-2 drug products (which contain the same API, NV-387) are completed. This will significantly speed up the development of the RSV drug, save costs, and improve return on investments (ROI).
Table 2.A. Broad-Spectrum Antiviral NV-387 - Additional Indications : RSV (Modality 1) | ||||
No. | Drug | Indications | Development | Priority |
1 | Oral Gummies, | ● RSV Infection ● Non-hospitalized ● Patients of all ages, pediatric to over 65; with or without co-morbidities | Phase II ready | A |
2 | Oral Syrup, | ● RSV Infection ● Non-hospitalized ● Patients that require drug titration (i.e. specified mg/Kg dosing, as with younger pediatric populations); with or without co-morbidities | Phase II ready | A |
3 | Injectable Solution, Use for Injection or for Infusion | ● RSV Infection ● Hospitalized ● Patients of all ages, pediatric to over 65; with or without co-morbidities | IND-Preparation | B |
4 | Injectable Solution, Use for Inhalation and for Infusion | ● RSV Infection ● Hospitalized, Severe Disease ● Patients of all ages, pediatric to over 65; with or without co-morbidities | IND-Preparation | B |
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The FluCide™ Program
We are now advancing NV-387 for the treatment of Influenza virus infections. The drugs we plan to develop towards regulatory approvals and corresponding development priorities we have assigned are shown in Table 2.B.
Table 2.B. Broad-Spectrum Antiviral NV-387 - Additional Indications : Influenzas (Modality 1) | ||||
No. | Drug | Indications | Development | Priority |
1 | Oral Gummies, | ● Influenza virus Infection ● Non-hospitalized ● Patients of all ages, pediatric to over 65; with or without co-morbidities | Phase II ready | B |
2 | Oral Syrup, | ● Influenza virus Infection ● Non-hospitalized ● Patients that require drug titration (i.e. specified mg/Kg dosing, as with younger pediatric populations); with or without co-morbidities | Phase II ready | B |
3 | Injectable Solution, | ● Influenza virus Infection ● Hospitalized ● Patients of all ages, pediatric to over 65; with or without co-morbidities | IND-Preparation | C |
4 | Injectable Solution, | ● Influenza virus Infection ● Hospitalized, Severe Disease ● Patients of all ages, pediatric to over 65; with or without co-morbidities | IND-Preparation | C |
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The Smallpox/Mpox Biodefense Program
We are planning to advance NV-387 for the treatment of Smallpox virus infections by itself and possibly in combination with tecovirimat. We plan on developing NV-387 on our own to the extent that is necessary for engagement of non-dilutive governmental funding partners. We plan on performing the definitive regulatory trials under the US FDA Animal Rule if we can obtain non-dilutive financing support. The drugs we plan to develop towards regulatory approvals and corresponding development priorities we have assigned are shown in Table 2.C.
Table 2.C. Broad-Spectrum Antiviral NV-387 - Additional Indications : Smallpox (Modality 1) | ||||
No. | Drug | Indications | Development | Priority |
1 | Oral Gummies, | ● Smallpox virus Infection ● Non-hospitalized ● Patients of all ages, pediatric to over 65; with or without co-morbidities | Phase II ready | C |
2 | Oral Syrup, | ● Smallpox virus Infection ● Non-hospitalized ● Patients that require drug titration (i.e. specified mg/Kg dosing, as with younger pediatric populations); with or without co-morbidities | Phase II ready | C |
3 | Injectable Solution, | ● Smallpox virus Infection ● Hospitalized ● Patients of all ages, pediatric to over 65; with or without co-morbidities | IND-Preparation | D |
4 | Injectable Solution, | ● Smallpox virus Infection ● Hospitalized, Severe Disease ● Patients of all ages, pediatric to over 65; with or without co-morbidities | IND-Preparation | D |
Further Development of NV-387 As Treatment for Coronavirus Infections
Even though it has fallen off the public sight, SARS-CoV-2 infection and the COVID caused by it continues to cause significant hospitalizations and mortality year over year. Most recently, the annual fatalities ascribed to COVID alone were approximately twice those ascribed to Influenza infections. In addition, residual SARS-CoV-2 infection is linked to a large fraction of so called “Long COVID” cases.
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We plan on further developing NV-387 for treatment of COVID, Long COVID, and severe seasonal coronavirus infections, only in appropriate collaborations, including but not limited to governmental and non-governmental agencies or other pharma companies. The drugs we plan to develop towards regulatory approvals and corresponding development priorities we have assigned are shown in Table 2.D.
Table 2.D. Broad-Spectrum Antiviral NV-387 - Coronavirus Infections | ||||
No. | Drug | Indications | Development | Priority |
1 | NV-CoV-2 | ● Mild to Moderate COVID-19 ● Non-hospitalized ● Patients of all ages, pediatric to over 65; with or without co-morbidities ● Long COVID (patient positive for SARS-CoV-2 in ultra-sensitive test) ● Seasonal coronavirus afflictions ● MERS, SARS-CoV-1 | Phase II ready | C |
2 | NV-CoV-2 | ● Mild to Moderate COVID-19 ● Non-hospitalized ● Patients that require drug titration (i.e. specified mg/Kg dosing, as with younger pediatric populations); with or without co-morbidities ● Long COVID (patient positive for SARS-CoV-2 in ultra-sensitive test) ● Seasonal coronavirus afflictions ● MERS, SARS-CoV-1 | Phase II ready | C |
3 | NV-CoV-2 Injectable Solution for Injection, Infusion or Inhalation: | ● Moderate to Severe COVID-19 ● Hospitalized or with Urgent Risk of Hospitalization ● Patients of all ages, pediatric to over 65; with or without co-morbidities ● Long COVID (patient positive for SARS-CoV-2 in ultra-sensitive test) ● Seasonal coronavirus afflictions ● MERS, SARS-CoV-1 | IND-Preparation | D |
4 | NV-CoV-2 Injectable Solution for Injection, Infusion or Inhalation: | ● Moderate to Severe COVID-19, requiring Oxygen Support ● Hospitalized or with Urgent Risk of Hospitalization ● Patients of all ages, pediatric to over 65; with or without co-morbidities ● Long COVID (patient positive for SARS-CoV-2 in ultra-sensitive test) ● Seasonal coronavirus afflictions ● MERS, SARS-CoV-1 | IND-Preparation | D |
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Our Drug Programs for Varicella Zoster Virus (VZV), Cause of Shingles and Chickenpox (Table 2.E):
NV-HHV-1 skin cream for the treatment of shingles rash
NV-HHV-1 is our lead drug candidate in the HerpeCide™ program. It has advanced as a skin cream through pre-clinical development stages and at present it is at the IND application stage, with the design of clinical protocols, clinical site selection, and preparing for clinical trials, in process. Shingles is caused by reactivation of VZV (Varicella-Zoster Virus), which causes chickenpox in children.
Several additional indications in the HerpeCide™ program, including skin creams for the treatment of “genital ulcers” (HSV-2), and for the treatment of “cold sores” (HSV-1”) are expected to follow the shingles candidate into clinical development.
NV-HHV-1 is a Virus-Family-Specific drug candidate based on the Nanoviricides Platform Modality 2. The ligand used therein copies features of the HerpesVirus Entry Mediator (HVEM), which is the receptor used for cell entry by HSV-1 and HSV-2. It was not known whether VZV uses HVEM.
As part of the IND-enabling development of our topical skin cream for treatment of shingles rash, we have performed a substantial amount of safety and toxicology studies. We performed non-GLP safety toxicology studies in a rat model with two of the development stage candidates first. Both candidates were extremely well tolerated and no adverse events occurred. These safety/toxicology studies along with efficacy studies in the Human Skin Organ Culture model of Dr. Moffat, led us to identify a clinical candidate, namely, NV-HHV-1. We have performed IND-enabling non-GLP Safety Toxicology studies of this clinical candidate in multiple animal species. NV-HHV-1 was well tolerated at all dosages tested and none of the parameters tested were affected. A GLP Safety/Toxicology study of dermal treatment in mini-pigs also found that NV-HHV-1 was well-tolerated as a skin cream. These safety results are in agreement with histopathological observations in the human skin organ culture model studies.
We manufactured NV-HHV-1 in a cGMP-compliant manner at our own facility for its IND-enabling GLP Safety/Toxicology study. The drug substance, or active pharmaceutical ingredient (API) was produced at approximately 1Kg-scale. Drug products, i.e. different dose levels of the skin cream, were made at scales of 3-5kg batches.
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We have conducted a Pre-IND Meeting with the FDA regarding NV-HHV-1 as treatment for Shingles rash, and received a response from the FDA in May 2019. In particular, the FDA agreed that the Company’s strategy for drug substance and drug product acceptance criteria is adequate. The FDA further agreed that the IND-enabling non-clinical studies proposed by the Company are generally adequate. The FDA also stated that the proposed design of the IND-opening human clinical studies appears reasonable at this time. The FDA made valuable suggestions in the pre-IND response. The additional non-clinical studies recommended by the Agency were generally consistent with our then-planned IND-enabling non-clinical studies. These studies have been completed subsequent to the Pre-IND Meeting.
Table 2.E. VZV Program; NanoViricides Drug Products in Development (Modality 2) | |||||
No. | Virus | Drug | Indications | Development | Priority |
1 | Varicella-Zoster Virus (VZV) Causes Chickenpox in children and immuno-compromised persons. Causes Shingles in adults. Causes Post-herpetic Neuralgia (long lasting pain after obvious shingles ulcers have healed). | NV-HHV-1 Dermal Topical (“Skin Cream”) | ● Mild to Moderate Shingles with Limited Body Coverage ● Non-hospitalized | IND-Preparation (Phase I/II). Pre-IND Meeting with US FDA Conducted. | C |
2 | NV-HHV-1 Oral Gummies | ● Mild to Moderate Shingles with More Extensive Body Coverage ● Mild to Moderate Chickenpox ● Non-hospitalized | Pre-Clinical | C | |
3 | Oral Syrup (Systemic Drug In Development) | ● Mild to Moderate Shingles ● Mild to Moderate Chickenpox ● Non-hospitalized ● Patients that require drug titration (i.e. specified mg/Kg dosing, as with younger pediatric populations); with or without co-morbidities | Pre-Clinical | D | |
4 | Injectable Solution, for Injection or Infusion (Systemic Drug In Development) | ● Moderate to Severe Shingles ● Moderate to Severe Chickenpox ● Hospitalized or with Urgent Risk of Hospitalization | Pre-Clinical | D | |
5 | NV-HHV-1 Oral Gummies | ● Post-Herpetic Neuralgia (PHN) ● Non-hospitalized | Pre-Clinical | E | |
6 | Oral Syrup (Systemic Drug In Development) | ● Post-Herpetic Neuralgia (PHN) ● Non-hospitalized ● Patients that require drug titration | Pre-Clinical | E | |
7 | Injectable Solution, for Injection or Infusion (Systemic Drug In Development) | ● Post-Herpetic Neuralgia (PHN) ● Hospitalized or with Urgent Risk of Hospitalization | Pre-Clinical | E | |
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Shingles and associated pain, post-herpetic neuralgia (PHN)
Shingles is caused by re-activation of the chickenpox virus that most humans acquire in childhood. The chickenpox vaccine for children is a live, attenuated virus (LAV). The LAV is not as pathogenic as the wild-type virus. However, this means the virus is present in the vaccinated individual, but remains suppressed by the immune system. In both vaccinated and unvaccinated persons, re-activation occurs when the immune system is suppressed which may be simply because of stress, advanced age, or some other immune modifying circumstances including immune-compromise due to organ transplants or other diseases. Generally, humans in the age range of 50-60 are more prone to shingles, with next reactivation occurring about 10-15 years later. There is a shingles vaccine approved for adults aged 60 and above which is also available for adults younger than that.
Acyclovir-based oral drugs, such as valacyclovir (Valtrex®), are available as systemic therapy for shingles. Intravenous acyclovir is also employed for treatment of various VZV indications. However, VZV is substantially less sensitive to (val) acyclovir than is HSV-1. Thus, the oral drug generally does not result in optimal level of the active drug at the site of VZV viral production, and does not result in significant control of the pathology. The antiviral drugs may be given for a period of 14 days or longer, with as much as 5g of dose per day, due to poor efficacy. In some indications, the treatment has been continued for a year or so. Thus, there is an unmet need for developing anti-VZV antivirals with high efficacy and safety.
Most adults with shingles recover in about 15-30 days from the shingles rash. While the rash is unsightly, its stinging pain is often the debilitating pathology that leads to lost workdays and other effects. Further, 65-70% of patients develop Postherpetic neuralgia, or PHN, a stinging, debilitating pain that lasts more than 30 days, and, in some patients, may last for years.
It is generally believed that PHN results from damage to the local nerve endings and nerve cells caused by the uncontrolled production of the shingles virus. However, VZV has been found to be present in at least 75% of PHN cases in a study, indicating a role for antivirals in controlling PHN. We believe that an effective therapy, such as our nanoviricide against VZV, which blocks progression of the virus to infect new cells and thereby limits further production of virus, would minimize the damage to nerve endings and nerve cells caused by the virus. We believe that this would minimize the occurrence, severity, and time period of PHN, in addition to having significant effects on the severity of shingles rash, lesions, and healing time.
In light of this we have conducted an animal study regarding the effect of our nanoviricide drug candidates against shingles on neuropathic pain in a classical animal model of pain (without VZV infection). On August 7, 2018, we reported that our anti-Shingles drug candidates were effective in ameliorating pain sensations in an animal model of abnormal pain. In this animal study, topical treatment with the nanoviricides® anti-VZV compounds significantly reduced the measures of abnormal pain sensations in a rat model of neuropathic pain. The study was conducted at AR BioSystems in Tampa, FL. A characteristic excruciating pain is a debilitating pathology of shingles presentation. Thus a direct pain-reducing effect of the Company’s anti-shingles drug candidates would be very important in ameliorating the pathology of shingles, in addition to the already demonstrated significant antiviral effect.
We believe that a skin cream would be the best form of treatment to provide rapid control of the virus and shingles lesions patch expansion, since the shingles outbreak remains highly localized. A skin cream would afford much greater local exposure of drug to virus compared to a systemic oral or injectable treatment.
An effective therapy for patients with severe shingles continues to be an unmet need.
NV-HHV-1 Skin Cream is intended for topical (dermal) application directly onto the shingles rash. It is expected to be useful in mild to moderate cases with limited body coverage of the rash in non-hospitalized patients.
Importantly, NV-HHV-1 has shown broad-spectrum activity against HSV-1 (cause of “cold sores”), HSV-2 (cause of “genital ulcers”), and VZV (the varicella-zoster virus, that causes chickenpox in children and immune-compromised humans, and shingles in adults). We therefore believe that NV-HHV-1 Skin Cream may be useful as a topical treatment of HSV-1 “cold sores” and HSV-2 “genital ulcers” in addition to treatment of Shingles skin rash.
Our other HerpeCide program candidates in progress at present are mostly based on NV-HHV-1, thereby maximizing return on investments and shareholder value.
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HerpeCide™ Drug Candidates Based on HVEM, the Potential Common Cognate Entry Receptor for the Nine Human Viruses in the Orthoherpesviridae Family Enable Additional Indications (Table 2.F – HSV-1 Programs, Table 2.G HSV-2 Programs, Drugs with Modality 2, Modality 3):
As previously noted, NV-HHV-1 is based on copying the herpesvirus binding site on the human cellular receptor HVEM. Therefore, NV-HHV-1 is likely to be a potential pan-herpesviridae nature of our anti-HSV drug candidates is expected to enable several anti-herpes viral indications. HSV-1 primarily affects skin and mucous membranes causing “cold sores.” HSV-2 primarily affects skin and mucous membranes leading to genital herpes. HSV-1 infection of the eye causes herpes keratitis that can lead to blindness in some cases. In addition, human herpesvirus-3 (HHV-3), aka varicella-zoster virus (VZV) causes chickenpox in children and, when reactivated in adults, causes shingles. Shingles breakouts are amenable to topical treatment, as are the HSV cold sores, genital lesions, and herpes keratitis of the eye.
Topical treatment is expected to result in extremely high antiviral efficacy. This is because such treatment would provide higher concentrations of the antiviral at the site where the virus is manifesting at its highest levels. Highly effective topical treatments in most of these scenarios remain unmet medical needs. Most of these indications do not have satisfactory treatments at present, if any.
Many of the herpesvirus family infections may also warrant systemic therapeutics (oral or injectable) in addition to topical therapeutics, for greater effectiveness. As demonstrated with NV-387 oral bioavailability, we believe we have potentially orally available drug candidates in the herpesvirus drugs pipeline.
We are also developing possibly even more effective pan-herpes drugs compared to NV-HHV-1 based on Modality 3, i.e. by encapsulating replication inhibitors inside the polymeric micelle “belly” of NV-HHV-1. We have developed derivatives of the well-known anti-herpes drug acyclovir for efficient encapsulation within NV-387 for this purpose. Further, the treatment of herpes virus infections caused by acyclovir- and famciclovir- resistant mutants is currently an unmet medical need. We are developing replication-inhibitors addressing this resistance issue as well, that we plan on encapsulating within NV-HHV-1.
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It is known that many of the human herpesvirus infections produce lifelong latent infections. The Modality 3 drugs we are making are expected to reduce the breakout frequency of such latent infections and may eventually cure the infection completely after repeated treatment. This is likely because it is well known that even repeated application of acyclovir-class of drugs in some patients leads to reduction in the breakout frequency or recurrence of herpes labilis (“cold sores”) caused by HSV-1. We do not expect that HHV-6A or HHV-6B infection could be cured by the Modality 3 approach because these two viruses are known to integrate their genome into human cells.
Table 2.F. HSV-1 Programs; NanoViricides Drug Products in Development (Modality 2, Modality 3) | |||||
No. | Virus | Drug | Indications | Development | Priority |
1 | Herpes Simplex Virus -1 (HSV-1) Causes Orolabial ulcers (“Cold Sores”); Recurrent Herpes Labialis (RHL) Causes Ocular Herpes Keratitis (HK) Causes viral Acute Retinal Necrosis (vARN) Also Linked to Alzheimer’s Disease (ALZD) | Dermal Topical (“Skin Cream”) | ● Mild to Moderate “Cold Sores” with Limited Body Coverage ● Non-hospitalized | Pre-Clinical | D |
2 | Oral Gummies | ● Mild to Moderate “Cold Sores” with More Extensive Body Coverage ● Non-hospitalized ● Recurrent Herpes Labialis | Pre-Clinical | D | |
3 | Oral Syrup | ● Mild to Moderate “Cold Sores” with More Extensive Body Coverage ● Non-hospitalized ● Recurrent Herpes Labialis ● Patients that require drug titration (i.e. specified mg/Kg dosing, as with younger pediatric populations); with or without co-morbidities | Pre-Clinical | E | |
4 | Injectable Solution, for Injection or Infusion | ● Moderate to Severe HSV-1 Lesions ● Hospitalized or with Urgent Risk of Hospitalization | Pre-Clinical | E | |
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With additional indications in the diseases caused by viruses in the herpes virus family, it is likely that our HerpeCide program could expand into a much broader product pipeline than previously anticipated. We anticipate that many of these new drugs would be variations on our current drug candidate for VZV, namely, NV-HHV-1. This should simplify drug development pathway and also maximize the Return on Investments (ROI).
Table 2.G. HSV-2 Programs; NanoViricides Drug Products in Development (Modality 2, Modality 3) | |||||
No. | Virus | Drug | Indications | Development | Priority |
1 | Herpes Simplex Virus -2 (HSV-2) Causes genital ulcers; Recurrent Herpes Genitalis (RHG) Causes Ocular Herpes Keratitis (HK) Causes viral Acute Retinal Necrosis (vARN) | Dermal Topical (“Skin Cream”) | ● Mild to Moderate Genital Ulcers with Limited Body Coverage ● Non-hospitalized | Pre-Clinical | D |
2 | Oral Gummies | ● Mild to Moderate Genital Ulcers with More Extensive Body Coverage ● Non-hospitalized ● Recurrent Herpes Genitalis | Pre-Clinical | D | |
3 | Oral Syrup | ● Mild to Moderate Genital Ulcers with More Extensive Body Coverage ● Non-hospitalized ● Recurrent Herpes Genitalis ● Patients that require drug titration (i.e. specified mg/Kg dosing, as with younger pediatric populations); with or without co-morbidities | Pre-Clinical | E | |
4 | Injectable Solution, for Injection or Infusion | ● Moderate to Severe HSV-2 Lesions ● Hospitalized or with Urgent Risk of Hospitalization | Pre-Clinical | E | |
We are developing drugs against three indications in the HerpeCide program in parallel at present, namely, HSV-1 “cold sores” (orolabial herpes and recurrent herpes labialis or RHL), HSV-2 “genital ulcers,” and VZV shingles. We are developing topical treatments (skin creams or lotions) for these three indications. All of the drug candidates in these three leading indications comprise common chemistry features and are based on the same family of ligands and polymers, enabling efficient parallel development.
We believe that our parallel development of these indications maximizes return on investment and shareholder value.
Of these, the shingles indication program has resulted in the clinical drug candidate NV-HHV-1, for which we are in the process of clinical trial design and clinical site selection, which will be a part of the IND application.
Our HerpeCide™ program has matured towards multiple drug indications. Besides the three indications listed above, modifications of the same drug candidates are anticipated to be developed into (iv) Eye Drops to treat ocular (i.e. external eye) Herpes Keratitis (HK) caused by HSV-1 or HSV-2, and possibly (v) Intra-Ocular injections to treat viral Acute Retinal Necrosis (vARN) caused by herpes viruses, primarily VZV, shingles (varicella zoster virus) and HSV-2, a cause of blindness.
In addition, we believe that the shingles drug candidate may be eligible for the PHN indication as well. PHN clinical studies are long and expensive, and we plan to advance the candidate for this indication only after its shingles indication clinical trials are completed. Further, the same drug candidate is expected to work against chickenpox in children. Chickenpox remains a sporadic epidemic disease despite vaccines.
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Expansion to additional indications is likely, as we perform further studies. It is likely that some of these drug candidates with variations may be able to address diseases caused by the remaining human herpes viruses, namely EBV, HCMV, HHV-6A, HHV-6B, and HHV-7. We believe that such expansions would enable maximization of return on investment (ROI) and maximization of shareholder value.
Including the HerpeCide program explained above, we currently have about 11 different drug development programs, attesting to the strength of our platform technology.
We have chosen to focus strategically on the applications of NV-387 which was developed as a pan-coronavirus drug initially, and which appears to have a much broader spectrum of activity.
We believe that a skin cream for the control of HSV-1 “cold sores” (herpes labialis, and recurrent herpes labialis or RHL) is another drug candidate that may be close to entering human clinical trials. We have already achieved strong success in animal studies against HSV-1, as discussed above.
Eye Diseases Caused by Herpesviruses (HSV-1, HSV-2, VZV), Ocular Herpes Keratitis, viral Acute Retinal Necrosis (Table 2.H, Drug Modality 2, Modality 3)
We believe that we will be able to successfully develop a drug candidate for Ocular Herpes Keratitis (HK) as well. HK is caused by HSV-1 or HSV-2 infection of the external eye. We are developing this drug as topical eye drops or eye lotion, in order to achieve maximum local drug effect while minimizing systemic exposure. We plan on testing these drug candidates against adenoviruses as well, to determine if the same drug would also be effective against epidemic keratoconjunctivitis (EKC, the severe “pink eye” disease). If the same drug works against herpes virus and adenovirus infections of the eye, we expect this drug may cover almost 99% of all external eye viral pathologies.
We also believe that we will be able to develop a drug against HSV-2 genital herpes. We plan on developing a skin cream for this indication, to maximize local effectiveness.
Viral Acute Retinal Necrosis (v-ARN)
We are also exploring additional indications of its anti-herpes drug candidates that are expected to broaden the pipeline and require limited development work. In particular, certain eye diseases of the retina have been causatively linked to herpes viruses. For example, most cases of viral Acute Retinal Necrosis (ARN), a disease that leads to severe loss of vision and can lead to blindness, have been linked to VZV and HSV-2, with some also associated with HSV-1 or CMV infection of the eye. It is believed that, HSV-2 ARN in children and adolescents may result from undiagnosed and asymptomatic neonatal HSV-2 infection, which has reactivated several years later from latency in a cranial nerve and entered the retina. Currently, intravenous treatment followed with oral acyclovir derivatives daily for several months to years and sometimes intravitreal (into the eye) foscarnet injections are therapeutically employed with limited effectiveness, establishing the potential of effective antiviral therapy to avoid blindness as well as multiple surgeries related to retinal detachment. A highly effective antiviral that can be injected into the eye infrequently and provides sustained antiviral therapeutic effect over a long period of time for ARN is an unmet medical need.
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Neonatally acquired herpes virus infections, even when asymptomatic, are thought to have led to ARN as late as age 22. There are approximately 2,500 cases per year of diagnosed neonatal herpes virus infections in the USA.
Table 2.H. Eye Diseases Caused by Herpesviruses (HSV-1, HSV-2, VZV); NanoViricides Drug Products in Development (Modality 2, Modality 3) | |||||
No. | Disease | Drug | Indications | Development | Priority |
1 | Herpes Keratitis (HK) Generally Caused by | Ocular Solution | ● Mild to Moderate Herpes Keratitis ● Non-hospitalized | Pre-Clinical | F |
2 | Oral Gummies | ● Mild to Moderate Herpes Keratitis ● Non-hospitalized | Pre-Clinical | F | |
3 | Oral Syrup | ● Mild to Moderate Herpes Keratitis ● Non-hospitalized ● Patients that require drug titration (i.e. specified mg/Kg dosing, as with younger pediatric populations); with or without co-morbidities | Pre-Clinical | F | |
4 | Injectable | ● Moderate to Severe Herpes Keratitis | Pre-Clinical | F | |
5 | viral Acute Retinal Necrosis Generally Caused by HSV-1, HSV-2, or VZV. | Injectable Solution | ● Moderate to Severe viral Acute Retinal Necrosis (v-ARN) | Pre-Clinical | F |
Our DengueCide™ Program
We intend to reengage the DengueCide program if and when non-dilutive funding such as research grants become available to us. At present we have not applied for any grants for this program.
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Our HIVCide™ Program
We intend to re-engage the HIVCide program once the HerpeCide drug candidates enter human clinical trials, resource permitting. Previously, the drug candidates in the HIVCide™ program were found to have effectiveness equal to that of a triple drug HAART cocktail therapy in the standard humanized SCID-hu Thy/Liv mouse model. Moreover, the nanoviricides were long acting. Viral load suppression continued to hold for more than four weeks after stopping HIVCide treatment. We believe that this strong effect and sustained effect together indicate that HIVCide can be developed as a single agent that would provide “Functional Cure” from HIV/AIDS. We believe that substantially all HIV viruses can be cleared upon HIVCide treatment, except the integrated viral genome in latent cells. This would enable discontinuation of treatment until HIV reemerges from the latent reservoir, which may be several months without any drugs. Moreover, we believe that this therapy would also minimize the chances of HIV transmission. These drug candidates are effective against both the R5 and X4 subtypes of HIV-1 in cell cultures. We believe that these drug candidates are “broad-spectrum”, i.e. they are expected to be effective against most strains and mutants of HIV, and therefore escape of mutants from our drugs is expected to be minimal. Certain anti-HIV nanoviricides have already been demonstrated that appear to provide extended viral load suppression for as long as 30 days or more even after stopping the drug, in animal studies. Given the chronic nature of HIV/AIDS, such a drug that has long sustained effect is expected to provide significant benefits to the patient. We believe once a week dosing is possible for our anti-HIV drugs. Anti-HIV drug development is both expensive and slow because of the nature of the animal studies that require SCID mice whose immune system is destroyed and then replaced by surgically implanting and growing human immune system tissues in the mouse body. Due to our limited resources, HIVCide development is further hampered.
Adenoviral EKC
The Company is developing broad-spectrum eye drops that are expected to be effective against a majority of the viral infections of the external eye. Most of these viral infections are from adenoviruses or from herpes viruses. The Company has shown excellent efficacy of its drug candidates against EKC (adenoviral epidemic keratoconjunctivitis) in an animal model. If feasible, we are planning to merge the anti-EKC drug development program and the ocular Herpes Keratitis drug development program, to develop a single drug that is effective against both diseases, i.e. effective against both adenoviruses and herpes viruses. This work is in research stage.
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Other Drug Programs: “Disease X”, MPox, Smallpox, Acute Flaccid Myelitis (AFM, EV68), Polio, Pediatric Acute Adenoviral Hepatitis, Ebola/Marburg, Rabies and Others (Table 2.I)
In addition, the Company also has research programs against Rabies virus, Ebola and Marburg viruses, and others. We will not be undertaking socially important programs such as the development of an anti-Zika virus drug candidate, or continuation of our efforts in developing anti-Ebola drug candidate, unless non-dilutive funding for such efforts becomes available. At present we have not applied for any grants for these programs.
Table 2.I. All Other Programs; NanoViricides Drug Products in Development | |||||
|---|---|---|---|---|---|
Program | Virus | Indications | Drug Candidate & | Priority | |
1 | “Disease X”, | Unknown or Novel Virus | Treatment | NV-387-Rp, | TBD |
2 | Mpox Treatment | Mpox Virus, Smallpox, Poxviruses | Poxvirus family viral infection | NV-387, Ready for Development Under US FDA Animal Rule | TBD |
3 | Enterovirus 68 Treatment | Enterovirus 68 or Related Viruses | Acute Flaccid Myelitis (AFM) | Screening Existing Drugs in Our Pipeline (Modality 1, 2, 3)) | TBD |
4 | Adenovirus 71 Treatment | Adenovirus 71 or Related Viruses | Severe Pediatric Hepatitis Caused by Adenovirus 71 | Screening Existing Drugs in Our Pipeline (Modality 1, 2, 3)) | TBD |
5 | HerpeCide™ Program Expansion Drug Projects | EBV, HCMV, HHV- 6A, HHV-6B, HHV7, KSHV | Broad-Spectrum nanoviricides against different herpes viruses for different indications | Screening Existing Drugs in Our Pipeline (Modality 1, 2, 3)) | E |
6 | HIVCide ™ | HIV/AIDS | Escape-resistant | NV-HIV-2, | E |
7 | HIVCide ™ | HIV/AIDS | Escape-resistant | R&D | E |
8 | FluCide™ Broad-Spectrum | All Influenza A | Injectable FluCide™ for hospitalized patients | Preclinical | F |
All Influenza A | Oral Flucide™ for outpatients | NV-387, Phase II ready | F | ||
9 | Nanoviricide Eye Drops | Adenoviruses, HSV-1 | Viral Diseases of the External Eye | Preclinical | F |
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Table 2.I. All Other Programs; NanoViricides Drug Products in Development | |||||
|---|---|---|---|---|---|
Program | Virus | Indications | Drug Candidate & | Priority | |
10 | DengueCide™ | Dengue viruses, all types | Broad-Spectrum nanoviricide | Preclinical (Modality 1, Modality 3) | F |
11 | Other Nanoviricides | Ebola/Marburg, Rabies, Others | Broad-Spectrum nanoviricide | R&D | G |
12 | Long Term Projects | Various Persistent Viruses | Technologies for Cures for | R&D | G |
Large Market Sizes –Targeting an Overall Anti-Viral Drug Market Size that Exceeds $40 Billion
The current market size for RSV drugs is estimated to be about $2 billion, and expected to grow to about $8 billion by 2030.
The current market size for drugs for the treatment of different herpes simplex infections is estimated to be approximately $2-4 billion. We believe that when an effective topical treatment is introduced, the market size is likely to expand substantially, as it has for several drugs in the antivirals, oncology, and other areas.
If a highly effective drug against HSV-1 and HSV-2 recurrences is developed, we believe the Herpesvirus Drugs market size would explode, as was seen with Hepatitis C virus.
Severe cases of shingles may lead to hospitalization in several thousand cases in the U.S. every year. In addition, shingles appearing on the face may reach the eye and may cause significant vision issues. In addition to the older inactivated chickenpox virus vaccine, Shingrix®, a two-dose vaccine has recently been introduced. However, due to the severe side effects in a significant percentage of persons taking this vaccine at its first dose, compliance as well as market penetration may be limited.
The outpatient treatment market size for shingles at present is limited, because of the limited effectiveness of existing drugs. An effective drug could expand this market into billions of dollars globally.
The market size for severe cases of shingles may be approximately one billion dollars. These estimates take into account the Shingrix® vaccine as well as existing vaccines. About 500,000 to 1 million cases of shingles occur every year in the U.S. alone.
In addition, the estimated market size for an effective anti-Influenza drug is expected to be in tens of billions of dollars. The current estimate of anti-influenza drug market size is approximately $4 billion. The current market size for anti-HIV treatments is in excess of $20 billion. Other drugs in our pipeline, taken together, are estimated to be several billion dollars in market sizes.
Presently, our focus is on developing NV-387 for treatment of RSV infections and other viral infections. Our next priority is the topical treatments for different herpes virus infections in the HerpeCide program, as listed elsewhere in this report. We plan on re-engaging our HIV programs when sufficient resources become available.
About the Priority Levels for Our Drug Development Programs:
The priority levels for our drug development programs are set forth in the tables below. The priority levels of A and B are our current focus, with priority level C to be taken up next for advanced preclinical and clinical development. Priority levels D, E, F, and G are longer term than priority levels A, B, C, and we work on those projects as we have resources available.
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Broad and Expanding Drug Pipeline Enabled by the NanoViricides Platform Technology
As can be seen from these extensive lists of drug development programs and targets, we have been making tremendous progress year-over-year in bringing successful anti-viral drugs based on our novel technology platform into human clinical studies.
We believe that with the human clinical trials of NV-387, we will be able to accumulate the evidence of human safety and effectiveness that would help us achieve meaningful partnerships with Big Pharma. We are also working on obtaining non-dilutive funding for various programs and projects in our pipeline. At present, we have sufficient funding to take us through the ongoing Phase Ia/Ib clinical trials for the NV-387 drug candidate. We believe that as we achieve proof of principle in human studies, we will be able to attract substantially greater market valuation and investor funding for further progress of these drugs towards approval and commercialization. We believe that once we have revenues from commercialization of our first drug or from partnership, we will be able to engage in further speeding up the development of programs in Tables 2.D through 2.I.
Our beliefs are based on results of pre-clinical cell culture studies, ex vivo tissue-based studies (e.g. human skin patch or a culture model), in vivo animal studies using small animals, and Phase I human clinical trials.
Drug Development Plan
We intend to perform the regulatory filings and own all the regulatory licenses for the drugs we are currently developing. We will develop these drugs in part via subcontracts to TheraCour, the exclusive source for these nanomaterials. With sourcing of materials from TheraCour, we prefer to manufacture these drugs in our own facility. However, we may manufacture these drugs under subcontract arrangements with external manufacturers that carry the appropriate regulatory licenses and have appropriate capabilities. We intend to distribute these drugs via subcontracts with distributor companies or in partnership arrangements. We plan to market these drugs either on our own or in conjunction with marketing partners. We also plan to actively pursue co-development, as well as other licensing agreements with other pharmaceutical companies, both in the US and internationally. Such agreements may entail up-front payments, milestone payments, royalties, and/or cost sharing, profit sharing and many other instruments that may bring early revenues to us. Such licensing and/or co-development agreements may shape the manufacturing and development options that we may pursue.
Competition
Our products in development target a number of diseases and conditions that include several different kinds of viral infections. There are many commercially available products for some of these diseases and a large number of companies and institutions are spending considerable amounts of money and other resources to develop additional products to treat some of these diseases. Most of these companies have substantially greater financial and other resources, larger research and development staffs, and extensive marketing and manufacturing organizations. When and if we are able to successfully develop products, they would compete with existing products based primarily on:
| ● | efficacy; |
| ● | safety; |
| ● | tolerability; |
| ● | acceptance by doctors; |
| ● | patient compliance; |
| ● | patent protection; |
| ● | ease of use; |
| ● | price; |
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| ● | insurance and other reimbursement coverage; |
| ● | distribution; |
| ● | marketing; and |
| ● | adaptability to various modes of dosing. |
Several companies have advanced drug candidates for the management of COVID-19. Remdesivir, an antiviral drug, has received full approval, but requires repeated infusions and has limited clinical effectiveness. Oral Molnupiravir (Merck and Ridgeback) has received EUA, but it has very poor effectiveness and has well-known risks of mutagenicity, and is not widely used. Oral Paxlovid (a combination of nirmatrelvir and ritonavir tablets taken together, Pfizer) has received full approval but was only effective in the population at high-risk of hospitalizations such as persons with co-morbidities and over age 65. Its use in persons not listed is considered off-label, and a recent clinical report has shown that it has no benefits relative to placebo treatment in these groups. Also in a certain percentage of cases Paxlovid has been shown to cause viral resurgence after achieving COVID-negative status upon treatment. Several antibodies had received EUAs, but all of these have been revoked due to loss of efficacy as new variants emerged. None of the available drugs attack the external circulating virus particles or block the re-infection cycle as NV-CoV-2 is designed to do. Thus, their mode is complementary to NV-CoV-2 and combination therapy with one of these drugs and NV-CoV-2 may yield substantial benefits. We also note that none of these drugs in development attack the complete lifecycle of the virus as NV-387-Rp is designed to do, to the best of our knowledge.
There are several drugs in the market that effectively control HSV cold sores and genital herpes lesions in most patients. These include the nucleoside analogues idoxuridine, vidarabine, acyclovir, famciclovir, ganciclovir, and derivatives. However, their efficacy is limited or toxicities are high. Brincidofovir, based on the toxic drug cidofovir, is in development by Chimerix, but certain clinical trials involving brincidofovir have failed to meet the desired end points and have actually shown a greater fatality rate in brincidofovir treated subjects compared to placebo. Foscarnet is also used for VZV and ARN, but its toxicity is high. FV-100 was in clinical development against VZV, but these clinical developments appear to have been abandoned. In addition, pritelivir, antibodies, and some other drugs are in advanced stages of development against HSV-1 or HSV-2. A gamma globulin was recently approved.
The prevalence of herpes simplex virus type 1 (HSV-1) and HSV-2 is 47.8% and 11.9%, respectively, for individuals aged 14 to 49 years, and increases with age, in the USA, according to CDC. HSV-2 causes a more severe disease that also has significant social costs to the patient. In spite of the existing drugs, both HSV-1 and HSV-2 cause lifelong infection that continues to reactivate at different rates in different patients. Thus, in spite of several existing drugs that are already generic, the market size for a highly effective drug is estimated to be in tens of billions of dollars for each of HSV-1 and HSV-2 treatments.
There are currently no approved drugs for the treatment of diseases caused by VZV, namely, Shingles, PHN, and Chickenpox. Valcyclovir or other acyclovir-class drugs are often prescribed orally but have little effect on shingles because VZV has an ineffective vTK enzyme, as opposed to HSV-1 and HSV-2, that is required for activating these drugs. Cidofovir is used in extreme cases of Shingles, but it is highly toxic, limiting benefit of the drug, limiting drug dosage and causing significant side effects. Several pain relievers are being developed to treat shingles pain and also the PHN pain.
Thus, a safe and effective treatment against VZV is an unmet medical need.
We are currently not aware of any approved drugs for the treatment of viral diseases of the external eye.
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The current approved drugs for influenza include the neuraminidase inhibitors Tamiflu, Relenza, and Peramivir, anti-influenza drugs that are sold by Roche, Glaxo SmithKline (GSK), and BioCryst partners, respectively. In addition, M2 channel inhibitors, generic drugs include amantadine and rimantadine, both oral tablets that only inhibit the replication of the influenza a virus have generally become ineffective because of significant viral resistance to the approved M2 channel inhibitors especially in the US. A viral endonuclease inhibitor, baloxavir (Xofluza, Shionogi/Roche) has recently been introduced as a single dose treatment. In its Phase III clinical trial, as many as 10% of patients were found to have drug-resistant virus mutants. Several companies are developing anti-influenza drugs at present. Small chemical classes include neuraminidase inhibitors, M2-channel inhibitors, and RDRP inhibitors, among others. There are also monoclonal, polyclonal, and mixed antibodies, as well as enzymes as drugs in development. Importantly, the resistance barrier for all of these drugs is rather low, and resistant mutants have arisen in the field. Thus, we believe that there is an unmet medical need for an effective and safe pan-Influenza drug that the virus is unlikely to escape.
There are a growing number of anti-HIV drugs being sold or in advanced stages of clinical development. Companies with HCV and HIV products include Gilead, Bristol-Myers Squibb Company (BMS), Roche, Boehringer Ingelheim, Merck & Co., Inc. (Merck), in addition to several other pharmaceutical and biotechnology firms.
Some antibody drugs have become available for Ebola/Marburg viruses, but are generally expensive, require infusion, and have poor acceptance. There are no drugs available for the treatment of Dengue viruses, Hendra/Nipah Viruses, and many others that are considered potential pandemic threats.
Currently there are two accepted methods of rabies prophylaxis: rabies vaccines and rabies immune globulin, manufactured by many foreign and multinational manufacturers including Aventis Pasteur and Chiron (acquired by Novartis). These accepted methods would be the standard against which our new anti-rabies drug in development will be judged.
Vaccines are in development for many of these viral diseases. Many vaccines have significant side effects. According to the Western Australian Vaccine Safety Surveillance – Annual Report 2021, the rates of serious adverse events with COVID-19 vaccines were at 260-300 per 100,000 whereas the rates for all other vaccines were about 11 per 100,000. The rate of myocarditis/myopericarditis was 0.4 per 100,000 doses of Vaxzevria (Astra-Zenecka), 4.5 per 100,000 doses of Comirnaty (Pfizer), and 7.3 per 100,000 doses of Spikevax (Moderna). The mRNA vaccines appear to have greater numbers of serious adverse events while overall COVID vaccines had thirty-times more events than the other vaccines in general use. (https://www.health.wa.gov.au).
In order to compete successfully, we must develop proprietary positions in patented drugs for therapeutic markets. Our products, even if successfully tested and developed, may not be adopted by physicians over other products and may not offer economically feasible alternatives to other therapies.
Government Regulation
Our operations and activities are subject to extensive regulation by numerous government authorities in the United States and other countries. In the United States, drugs are subject to rigorous regulation by the FDA. The Federal Food, Drug and Cosmetic Act and other federal and state statutes and regulations govern the testing, manufacture, safety, effectiveness, labeling, storage, record keeping, approval, advertising and promotion of our products. As a result of these regulations, product development and the product approval process is very expensive and time consuming.
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Regulation by governmental authorities in the United States and other countries is a significant factor in our research and development and will be a significant factor in the manufacture and marketing of our proposed products. The nature and extent to which such regulation applies to us will vary depending on the nature of any products we may develop. Governmental authorities, including the FDA and comparable regulatory authorities in other countries, regulate the design, development, testing, manufacturing, safety, efficacy, labeling, storage, record-keeping, advertising, promotion and marketing of pharmaceutical products, including drugs and biologics, under the Federal Food, Drug, and Cosmetic Act, or FFDCA, and its implementing regulations, and, for biologics, under the Public Health Service Act, or PHSA, and its implementing regulations. Non-compliance with applicable requirements can result in fines and other judicially imposed sanctions, including product seizures, import restrictions, injunctive actions and criminal prosecutions of both companies and individuals. In addition, administrative remedies can involve requests to recall violative products; the refusal of the government to enter into supply contracts; or the refusal to approve pending product approval applications until manufacturing or other alleged deficiencies are brought into compliance. The FDA also has the authority to cause the withdrawal of approval of a marketed product or to impose labeling restrictions. The process of obtaining approvals and the subsequent compliance with appropriate statutes and regulations require the expenditure of substantial time and money, and there can be no guarantee that approvals will be granted.
FDA Approval Process
The FDA must “license” a drug before it can be sold in the United States. Other countries have similar regulatory processes, and most are being harmonized under the ICH guidelines (ICH stands for The International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use). As of the date of this filing, the FDA has approved other nano-particulate drugs including Emend® by Merck and Rapamune® by Wyeth, as well as others.
The general process for FDA approval is as follows:
Preclinical Testing
The process required by the FDA before a drug or biological product may be marketed in the United States generally involves the following:
| ● | Completion of preclinical testing of new pharmaceutical or biological products, generally conducted in the laboratory and in animal studies in accordance with GLP standard, and applicable requirements for the humane use of laboratory animals or other applicable regulations to evaluate the potential efficacy and safety of the product candidate; |
| ● | Submission of the results of these studies to the FDA as part of an Investigational New Drug application, which must become effective before clinical testing in humans can begin; |
| ● | Manufacturing of investigational medicine under cGMP standard; |
| ● | Performance of adequate and well-controlled human clinical trials according to GCPs and any additional requirements for the protection of human research patients and their health information, to establish the safety and efficacy of the product candidate for its intended use; |
| ● | Submission to the FDA of a new drug application, or NDA, for any new chemical entity drug we seek to market that includes substantive evidence of safety, purity, and potency, or safety and effectiveness from results of nonclinical testing and clinical trials; |
| ● | Satisfactory completion of an FDA inspection of the manufacturing facility or facilities where the product is produced, packaged and distributed, to assess compliance with cGMPs, to assure that the facilities, methods and controls are adequate to preserve the product’s identity, strength, quality and purity; |
| ● | Potential FDA audit of the nonclinical study and clinical trial sites that generated the data in support of the NDA; and |
| ● | FDA review and approval of the NDA. |
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Clinical Trials
If the FDA accepts the investigational new drug application, we study the drug in human clinical trials to determine if the drug is safe and effective. These clinical trials involve a time-consuming and costly three-phase process that often overlap, can take many years to compile and are very expensive. These three phases, which are themselves subject to considerable regulation, are as follows:
| ● | Phase I. The drug is given to a small number of healthy human subjects or patients to test for safety, dose tolerance, pharmacokinetics, metabolism, distribution and excretion. |
| ● | Phase II. The drug is given to a limited patient population to determine the effect of the drug in treating the disease, the best dose of the drug, and the possible side effects and safety risks of the drug. |
| ● | Phase III. If a compound appears to be effective and safe in Phase II clinical trials, Phase III clinical trials are commenced to confirm those results. Phase III clinical trials are long-term, involve a significantly larger population, are conducted at numerous sites in different geographic regions and are carefully designed to provide reliable and conclusive data regarding the safety and benefits of a drug. It is not uncommon for a drug that appears promising in Phase II clinical trials to fail in the more rigorous and reliable Phase III clinical trials. |
If we believe that the data from the Phase III clinical trials show an adequate level of safety and effectiveness, we will file a new drug application (NDA) with the FDA seeking approval to sell the drug for a particular use. The FDA will review the NDA and often will hold a public hearing where an independent advisory committee of expert advisors asks additional questions regarding the drug. This committee makes a recommendation to the FDA that is not binding on the FDA but is generally followed. If the FDA agrees that the compound has met the required level of safety and effectiveness for a particular use, it will allow us to sell the drug in the United States for that use. It is not unusual, however, for the FDA to reject an application because it believes that the drug is not safe enough or effective enough or because it does not believe that the data submitted is reliable or conclusive.
At any point in this process, the development of a drug could be stopped for a number of reasons including safety concerns and lack of treatment benefit. We cannot be certain that any clinical trials that we are currently conducting or any that we conduct in the future, will be completed successfully or within any specified time period, or will be acceptable to the appropriate regulatory agency (e.g. CDSCO/DCGI in India) or FDA without further work. We may choose, or the FDA may require us, to delay or suspend our clinical trials at any time if it appears that the patients are being exposed to an unacceptable health risk or if the drug candidate does not appear to have sufficient treatment benefit.
The FDA may also require us to complete additional testing, provide additional data or information, improve our manufacturing processes, procedures or facilities or may require extensive post-marketing testing and surveillance to monitor the safety or benefits of our product candidates if it determines that our new drug application does not contain adequate evidence of the safety and benefits of the drug. In addition, even if the FDA approves a drug, it could limit the uses of the drug. The FDA can withdraw approvals if it does not believe that we are complying with regulatory standards or if problems are uncovered or occur after approval.
United States Review and Approval Process
After the completion of clinical trials of a product candidate, FDA approval of a NDA must be obtained before commercial marketing of the product. The NDA must include results of product development, laboratory and animal studies, human trials, information on the manufacture and composition of the product, proposed labeling and other relevant information as well as a significant user fee. The FDA may grant deferrals for submission of data, or full or partial waivers. The testing and approval processes require substantial time and effort and there can be no assurance that the FDA will accept the NDA for filing and, even if filed, that any approval will be granted on a timely basis, if at all.
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The FDA may refuse to file any NDA that it deems incomplete or not properly reviewable at the time of submission and may request additional information. Once the submission is accepted for filing, the FDA reviews the NDA to determine, among other things, whether the proposed product is safe, potent, and/or effective for its intended use, and has an acceptable purity profile, and whether the product is safe and effective for its intended use, and in each case, whether the product is being manufactured in accordance with cGMP or GTP, if applicable. During the product approval process, the FDA also will determine whether a Risk Evaluation and Mitigation Strategy, or REMS, is necessary to assure the safe use of the product. If the FDA concludes a REMS is needed, the sponsor of the NDA must submit a proposed REMS. The FDA will not approve a NDA without a REMS, if required.
Notwithstanding the submission of relevant data and information, the FDA may ultimately decide that the NDA does not satisfy its regulatory criteria for approval and deny approval via a letter detailing such deficiencies. Data obtained from clinical trials are not always conclusive and the FDA may interpret data differently than we interpret the same data. If the FDA denies an application, the applicant may either resubmit the NDA, addressing all of the deficiencies identified by the FDA, or withdraw the application.
Expedited FDA Review Programs
The FDA has four expedited program designations -Fast Track, Breakthrough Therapy, Accelerated Approval, and Priority Review - to facilitate and expedite development and review of new drugs to address unmet medical needs in the treatment of serious or life-threatening conditions.
The Fast Track program that is intended to expedite or facilitate the process for reviewing new drug products that treat a serious condition and fill an unmet medical need. Fast Track designation applies to the combination of the product and the specific indication for which it is being studied. In Fast Track, the FDA may consider for “rolling review” of sections of the IND on a rolling basis before the complete application is submitted. Once a drug receives Fast Track designation, early and frequent communication between the FDA and a drug company is encouraged throughout the entire drug development and review process. The frequency of communication assures that questions and issues are resolved quickly, often leading to earlier drug approval and access by patients.
The FDA may also accelerate the approval of a designated drug through the Breakthrough Therapy designation by expediting the development and review of drugs that are intended to treat a serious condition and preliminary clinical evidence indicates that the drug may demonstrate substantial improvement over available therapy on one or more clinically significant endpoints. If the FDA designates a drug as a breakthrough therapy, the drug is eligible for all Fast Track designation features, intensive guidance on an efficient drug development program, potentially beginning at Phase I and organizational commitment involving senior managers regarding the development of the drug to ensure that the development program and the design of the clinical trials is as efficient as practicable.
The Accelerated Approval designation allows the FDA to approve a product based on an effect on a surrogate or intermediate endpoint that is reasonably likely to predict a product’s clinical benefit and generally requires the manufacturer to conduct required post-approval confirmatory trials to verify the clinical benefit.
The Priority Review designation means that the FDA’s goal is to take action on the application within six months, compared to ten months under standard review.
Fast Track designation, Priority Review, Accelerated Approval and Breakthrough Therapy designations do not change the standards for approval but may expedite the development or approval process.
Orphan Drug Designation
The Orphan Drug Act provides granting special status to drugs or biological products for rare diseases and conditions affecting fewer than 200,000 persons. The first developer to receive FDA marketing approval for an orphan drug is entitled to a seven-year exclusive marketing period in the United States for that product where the FDA will not approve another version of the same product. However, a drug that the FDA considers to be clinically superior to, or different from, another approved orphan drug, even though for the same indication, may also obtain approval in the United States during the seven-year exclusive marketing period. In addition, if the holder of the orphan drug designation cannot assure the availability of sufficient quantities of their orphan drugs to meet the needs of patients, the FDA could also grant approval to another product.
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United States Post-Approval Requirements
Any products for which we receive FDA approvals are subject to continuing regulation by the FDA, including, among other things, record-keeping requirements, reporting of adverse experiences with the product, providing the FDA with updated safety and efficacy information, product sampling and distribution requirements, and complying with FDA promotion and advertising requirements, which include, among others, standards for direct-to-consumer advertising, restrictions on promoting products for uses or in patient populations that are not described in the product’s approved uses, known as off-label use, limitations on industry-sponsored scientific and educational activities and requirements for promotional activities involving the internet.
In addition, quality control and manufacturing procedures must continue to conform to applicable manufacturing requirements after approval to ensure the long-term stability of the product. We rely, and expect to continue to rely, on third parties for the production of some, or all, clinical and commercial quantities of our products in accordance with cGMP and GTP regulations, as applicable. Manufacturers and other entities involved in the manufacture and distribution of approved products are required to register their establishments with the FDA and certain state agencies and are subject to periodic unannounced inspections by the FDA and certain state agencies for compliance with cGMP, GTP and other laws.
The FDA also may require post-marketing testing, known as Phase 4 testing, and surveillance to monitor the effects of an approved product. Discovery of previously unknown problems with a product or the failure to comply with applicable FDA requirements can have negative consequences, including adverse publicity, judicial or administrative enforcement, warning letters from the FDA, mandated corrective advertising or communications with doctors, and civil or criminal penalties, among others. Also, new government requirements, including those resulting from new legislation, may be established, or the FDA’s policies may change, which could delay or prevent regulatory approval of our product candidates under development.
Regulatory Review and Approval Process in India
The Central Drugs Standard Control Organization (CDSCO) under Directorate General of Health Services, Ministry of Health & Family Welfare, Government of India is the National Regulatory Authority (NRA) of India. The Drug Controller General of India (DCGI) heads CDSCO. The Drugs & Cosmetics Act,1940 and rules 1945 have entrusted various responsibilities to central & state regulators for regulation of drugs & cosmetics. It envisages uniform implementation of the provisions of the Act & Rules made thereunder for ensuring the safety, rights and well-being of the patients by regulating the drugs and cosmetics. Under the Drugs and Cosmetics Act, CDSCO is responsible for approval of Drugs, Conduct of Clinical Trials, laying down the standards for Drugs, control over the quality of imported Drugs in the country and coordination of the activities of State Drug Control Organizations by providing expert advice with a view of bring about the uniformity in the enforcement of the Drugs and Cosmetics Act.
The regulatory process in India operates under ICH guidelines. After submission of a Clinical trial Application, the Office of DCGI reviews the application, and usually holds a briefing meeting with the Drug Sponsor. If satisfactory, the DCGI would approve the clinical trial application, generally with conditions that have to be satisfied prior to actually beginning dosing. There are requirements for interim reports as well as there are provisions for unannounced inspections. After completion of a given phase of clinical trial, the drug sponsor would then prepare a report and file for the next phase of clinical trials. In case of a health emergency, applications may be processed in an expedited timeframe and approvals for commercial use of the drug may be provided at the end of Phase II with requirements for further data collection. Normally, the new drug approval application would be submitted after completion of a Phase III clinical trial. Thereafter, the CDSCO and expert committees organized by the CDSCO will review the application for approval or denial.
Other Foreign Regulatory Review and Approval
Whether or not FDA approval has been obtained, approval of a product by comparable regulatory authorities in other countries will be necessary prior to commencement of marketing the product in such countries. The regulatory authorities in each country may impose their own requirements and may refuse to grant an approval, or may require additional data before granting it, even though the relevant product has been approved by the FDA or another authority. As with the FDA, the regulatory authorities in the European Union, China and other developed countries have lengthy approval processes for pharmaceutical products. The process for gaining approval in particular countries varies, but generally follows a similar sequence to that described for FDA approval.
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In the European Union, there is a centralized approval procedure that authorizes marketing of a product in all countries in the European Union (which includes most major countries in Europe). If this procedure is not used, under a decentralized system, an approval in one country of the European Union can be used to obtain approval in another country of the European Union under a simplified application process at present. After approval under the centralized procedure, pricing and reimbursement approvals are also required in most countries. These procedures are undergoing revision and modification at present. We have never received approval for a product in the European Union to date.
We must obtain the requisite approvals from regulatory authorities in foreign countries prior to the commencement of clinical trials or marketing of such product in those countries. The requirements and processes governing the conduct of clinical trials, product licensing, pricing and reimbursement vary from country to country. In addition, we, and our partners, may be subject to foreign laws and regulations and other compliance requirements, including, without limitation, anti-kickback laws, false claims laws and other fraud and abuse laws, as well as laws and regulations requiring transparency of pricing and marketing information and governing the privacy and security of personal information. If we, or our partners, fail to comply with applicable foreign regulatory requirements, we may be subject to, among other things, fines, suspension or withdrawal of regulatory approvals, product recalls, seizure of products, operating restrictions and criminal prosecution.
Other Health Care Laws
In the event any of proposed products are ever approved for marketing, we may also be subject to healthcare regulation and enforcement by the federal government and the states and foreign governments where we may market our product candidates, if approved. These laws include, without limitation, state and federal anti-kickback, fraud and abuse, false claims, physician sunshine and privacy and security laws and regulations.
In addition to obtaining FDA approval for each drug, we obtain FDA approval of the manufacturing facilities for any drug we sell, including those of companies who manufacture our drugs for us as well as our own and these facilities are subject to periodic inspections by the FDA. The FDA must also approve foreign establishments that manufacture products to be sold in the United States and these facilities are subject to periodic regulatory inspection.
We are also subject to other federal, state and local regulations regarding workplace safety and protection of the environment. We use hazardous materials, chemicals, viruses and various radioactive compounds in our research and development activities and cannot eliminate the risk of accidental contamination or injury from these materials. Any misuse or accidents involving these materials could lead to significant litigation, fines and penalties.
Time Schedules, Milestones and Development Costs
In the upcoming fiscal year, we hope to meet several important milestones towards establishing human proof-of-concept for the Nanoviricides Platform:
| ● | Completion of the final report of the Phase Ia/Ib clinical trial of the API NV-387, as drug products NV-CoV-2 Oral Syrup and NV-CoV-2 Oral Gummies. |
| ● | File an IND for RSV treatment for Phase I/Phase II human clinical trials for NV-387 as a treatment of RSV infection, and resources permitting, begin human clinical trials for RSV treatment indication. |
After the RSV program clinical trials are in progress, we plan on completing an effective clinical trial plan for our Shingles drug candidate to reengage human clinical trials for the shingles treatment program.
All of these studies are dependent on external collaborators providing available time slots for us. Thus, there can be delays in achieving the milestones that are beyond our control.
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We believe we have sufficient financing to complete the current Phase Ia/Ib human clinical trial of API NV-387 with a full report based on currently available finances. There is no assurance we will be successful in obtaining sufficient financing on terms acceptable to us to fund complete drug development through approval. We cannot provide assurance that our plans will not change or that changed circumstances will not result in the depletion of our capital resources more rapidly than we currently anticipate. We have estimated approximately $1,500,000 for the Phase II clinical trial for RSV indication. The total cost of the Phase II trial could be significantly more. If so, we may need to raise additional funds to support continued program development through Phase II and Phase III studies at least and revenue realization.
Drug Development Status
The Company has limited experience with pharmaceutical drug development. Thus, our budget estimates are not based on experience, but rather based on advice given by our associates and consultants. As such, these budget estimates may not be accurate. In addition, the actual work to be performed is not known at this time, other than a broad outline, as is normal with any scientific work. As further work is performed, additional work may become necessary or change in plans or workload may occur. Such changes may have an adverse impact on our estimated budget, and our projected timeline of drug development.
The work-plan we have developed for the next twelve months is expected to enable us to complete the Phase Ia/Ib clinical trial of API NV-387 with a final report and, provided that our clinical plan is approved by the regulatory agency, to begin Phase II human clinical trials for RSV indication. Given our dependence on external collaborators for the regulatory affairs, IND-enabling studies and study reports, Clinical Trial CROs and other services providers, we cannot provide time estimates. Our work-plan is extremely dependent on external factors, collaborations, and unanticipated delays can occur. We are experiencing extreme staffing constraints as well as facility and resources constraints. We note as a risk factor that these resource constraints may cause further delays in our estimated timelines.
We have taken on the most important risk in nanomedicines, that of enabling cGMP manufacture, to achieve consistent product from batch to batch, “head on” so to speak. Having established critical quality parameters in our manufacturing processes and having accomplished cGMP-compliant scale-up of manufacturing from starting materials to API to formulation to fill-finish-packaged-labeled drug products, we believe that we have minimized the risk related to manufacturing capabilities.
During the scale up and optimization of our production level operations, we continue to work on a number of different polymer backbones (“nanomicelles”) and several antiviral ligands in order to make sure that different formulation and pharmacokinetic-pharmacodynamic (PK-PD) needs can be met during the PK-PD programs for our various drug candidates. While this loads up our initial activities, it is expected to minimize the risk for further drug development towards IND or regulatory filings by making available backup drug candidates with different PK-PD profiles.
Our work-plan is expected to reduce certain risks of drug development. We believe that the data we have collected particularly for the manufacture of NV-387 drug substance and drug products, and the non-clinical studies of NV-387, will enable us to file appropriate IND application(s) to the FDA for the RSV indications. We believe that in the ensuing fiscal year we will be able to obtain valuable information on the safety and tolerability of NV-387 in humans. Additionally, we believe that we may be able to begin Phase II evaluation of efficacy of NV-387 in RSV infected adults in the ensuing year, resources permitting. If our human clinical trials RSV program are not successful, we will have to develop additional drug candidates and perform further studies, or further advance our other programs, for example, Influenza, VZV, HSV-1 or HSV-2 drug candidates, into human clinical trials. If our studies are successful, we would be more confident in further developing our, RSV, FluCide, HerpeCide as well as other program drug candidates and may be in a position to re-engage our highly valuable drug programs including HIVCide.
Based on our pre-clinical study data, and based on our own studies of approved drugs in the COVID-19 space, we believe that we have a very high probability that NV-CoV-2 would be demonstrated to be a highly effective and safe drug for the treatment of most if not all Coronavirus infections including SARS-CoV-2 (COVID-19) as well as seasonal coronaviruses, in most if not all segments of the human population including pediatric, geriatric, immune-compromised, and other high risk and low risk populations.
We further believe NV-387 could be a revolutionary drug for the treatment of pediatric RSV infections, based on our data that NV-387 treatment appears to have cured mice of lethal lung RSV infection, with no lung damage.
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We intend to pursue non-diluting funding sources such as government grants and contracts as well as licensing agreements with other pharmaceutical companies for further development of NV-387 and other drugs in our pipeline. We intend to use equity-based and debt financing, as required, to fund the operations and to raise additional capital for conducting human clinical trials as we advance our pipeline further towards regulatory approvals. There can be no assurance that we will be able to obtain the additional financial resources necessary to fund our anticipated obligations over the next year.
We are a clinical stage company and will continue in this drug development stage until generating revenues from the sales of our products or services.
Our Collaborations and Service Contract Agreements
Our development model is to employ collaborations and service contract relationships with renowned academic labs, government labs, as well as service contracts with external service providers in order to minimize our capital requirements.
All of our agreements provide for the evaluation of nanoviricides substances created and provided by us to the Laboratory (or Collaborator). In general, the Laboratory is compensated for certain material and personnel costs for these evaluations. The evaluations involve in vitro and in vivo scientific studies at the Laboratory using their established protocols. In some cases, we provide scientific input regarding certain modifications to their protocols as may be needed. The Laboratory returns the results and data to us. The Laboratory is allowed to publish the results after allowing time for us to protect intellectual property (IP) as needed. We send nanoviricides as well as positive control (i.e. known therapeutics) and negative control (i.e. known not to work) compounds as needed in a fully formulated, ready to use form, to the Laboratory. All IP related to the nanoviricide materials, their formulations and reformulations, and their usage, rests with us. Any IP developed by the Laboratory regarding their own know-how, such as laboratory tests and protocols, their modifications, etc. rests with the Laboratory. Joint inventions are treated as per applicable US Laws.
We try to choose the scientific laboratories with the most appropriate facilities and know-how relating to a particular field for the evaluation of an antiviral agent developed by us. In addition, we try to work with more than one laboratory for the evaluation of an antiviral agent developed by us. We also try to work with more than one laboratory for a given group of viruses whenever possible. We seek to improve confidence by obtaining independent datasets for corroboration of the efficacy and safety of the nanoviricides we develop. Further, we try to minimize dependence on a particular Laboratory for the development of any specific drug candidate in our product pipeline.
To date, we have engaged in GLP and non-GLP Efficacy and Safety evaluations in both in vitro (cell culture models, pseudovirion models) and in vivo (animal models) of our different nanoviricide research materials and drug candidates at different laboratories. NV-387 has progressed into clinical stage and we are gearing towards final report of the Phase Ia/Ib human clinical trial evaluating safety and tolerability of oral formulations of NV-387 in healthy subjects.
Related Parties
TheraCour Pharma, Inc.
Pursuant to an exclusive license agreement we entered into with TheraCour, the Company was granted exclusive licenses for technologies developed by TheraCour for the virus types: Human Immunodeficiency Virus (HIV/AIDS), Influenza including Asian Bird Flu Virus, Herpes Simplex Virus (HSV-1 and HSV-2), Hepatitis C Virus (HCV), Hepatitis B Virus (HBV), and Rabies. The Company has entered into an Additional License Agreement with TheraCour granting the Company the exclusive licenses for technologies developed by TheraCour for the additional virus types for Dengue viruses, Japanese Encephalitis virus, West Nile Virus, Viruses causing viral Conjunctivitis (a disease of the eye) and Ocular Herpes, and Ebola/Marburg viruses.
On November 1, 2019, the Company entered into an Agreement with TheraCour for an exclusive, worldwide license to use, promote, offer for sale, import, export, sell and distribute products for the treatment of VZV derived indications. The Company was not required to make any upfront payments to TheraCour and agreed to milestone payments to TheraCour.
TheraCour has not denied any licenses sought by the Company in the past.
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On September 7, 2021, the Company entered into a license agreement with TheraCour for an exclusive, worldwide license to use, promote, offer for sale, import, export, sell and distribute products for the field comprising anti-viral treatments for coronavirus derived human infections (the “COVID License Agreement”). The licensed field includes antiviral drugs to treat SARS-CoV-2 and its variants that cause the COVID-19 disease resulting in a global pandemic that continues to rage through the world, wave after wave, as new variants develop and take hold. There was no upfront cash payment for the license and the compensation terms were generally consistent with prior licenses, and are summarized below.
Under the COVID License Agreement, we have obtained a world-wide, exclusive, sub-licensable, license to use, promote, offer for sale, import, export, sell and distribute antiviral drugs that treat human Coronavirus infections using TheraCour’s proprietary as well as patented technology and intellectual property, including the new patent application cited above. The discovery of ligands and polymer materials as well as formulations, the chemistry and chemical characterization, as well as process development and related work will be performed by TheraCour under the same compensation terms as prior agreements between the parties, with no duplication of costs allowed. We will not make any upfront cash payments to TheraCour and we have agreed to the following milestone payments to TheraCour: 100,000 shares of the Company’s Series A preferred stock, par value $0.00001 per share (the “Series A preferred stock”) upon the execution of the Agreement; 50,000 shares of Series A preferred stock after the grant of the approval of Licensee’s Investigational New Drug (IND) Application, or its equivalent; cash payments of $1,500,000 after the initiation of Phase I clinical trials or its equivalent; $2,000,000 after the completion of Phase I clinical trials or its equivalent for at least one product within twelve (12) months from the date of the acceptance of the IND; $2,500,000 no later than six (6) months after the completion of Phase IIA clinical trials or its equivalent for at least one product within twenty (24) months from the date of the completion of Phase I or its equivalent; 100,000 shares of Series A preferred stock after the initiation of Phase III clinical trials or its equivalent; and, at TheraCour’s option, $5,000,000 in cash or 500,000 shares of Series A preferred stock, no later than six (6) months after the completion of Phase III clinical trials or its equivalent for at least one product within thirty-six (36) months from the completion of Phase II clinical trials or its equivalent. In addition, we agreed to pay to TheraCour fifteen percent (15%) of income from licensed products and any income from sublicensed products, consistent with previous agreements. Under the COVID License Agreement, TheraCour retains the exclusive right to develop and manufacture the licensed products. The Agreement contemplates that the parties will enter into a separate manufacturing and supply agreement for the commercial manufacture and supply of the drug products if and when we intend to engage into commercialization of the drugs. The COVID License Agreement provides that the manufacturing and supply agreement would be on customary and reasonable terms, on a cost-plus basis, using a market rate based on then-current industry standards, and include customary backup manufacturing rights, as with prior agreements. The Series A Preferred Stock are only convertible upon a “change of control” of the Company as defined in its full specification, are non-transferrable and have no trading market. Each share of Series A preferred stock votes at the rate of 9 votes per share, and is convertible only upon a change of control into 3.5 shares of the Company’s common stock.
To assist in the analysis of the terms of the COVID License Agreement, we commissioned research reports on Coronavirus drug market sizes for the Coronavirus antiviral field from an independent consulting agency, Nanotech Plus, LLC. Additionally, we obtained business analysis and valuation reports for potential licensing terms for a coronavirus drug from an independent consultant. NanoViricides was represented by McCarter & English, LLP while TheraCour was represented by DuaneMorris LLP.
In consideration for the COVID License Agreement, the Company issued 100,000 shares of the Company’s Series A Preferred Stock upon execution of the agreement in 2021. The Company also issued 50,000 shares of the Company’s Series A preferred stock upon the grant of an IND to perform clinical trials which are being sponsored by our licensee and collaborator KMPL in India, in April 2023. On June 19, 2023, the Company was notified that the Company’s licensee, KMPL had commenced volunteer recruitments for Phase Ia/Ib clinical trials of the NV-CoV-2 Oral Syrup and NV-CoV-2 Oral Gummies. Pursuant to the COVID License Agreement a third milestone payment of $1,500,000 became due 5 days after the start of Phase Ia/Ib clinical trials.
On July 19, 2023, the Company entered into an agreement with TheraCour, to accept the Company’s unsecured convertible promissory note (the “Note”) in payment of the milestone award. The Note accrued simple interest at the rate of 12% per annum and was due and payable on January 19, 2025, the maturity date. The principal of the Note is convertible, at TheraCour’s option, into 331,859 shares of the Company’s Series A Preferred Stock, par value $0.00001 at the conversion price, specified as the fair value of the Series A shares on July 19, 2023 in the terms and conditions contained within the Note. On October 27, 2023, TheraCour exercised its right to convert the principal of the July 19, 2023 Note into 331,859 shares of the Company’s Series A Preferred Stock. Furthermore, TheraCour cancelled all of the accrued interest on the Note totaling $49,808 which has been reported as a capital transaction credit to additional paid in capital on the accompanying statements of changes in stockholders’ equity. Total interest incurred under the Note for the year ended June 30, 2024 was $49,808.
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On February 12, 2024, the Company entered into an Amendment to the COVID License Agreement with TheraCour dated September 7, 2021, whereby any further cash milestone payments that would be earned upon milestone event would only become payable upon the Company having sufficient revenues, with only a portion of revenues to be used for satisfying such milestone payments.
By signing on September 23, 2024, and being effective as of September 20, 2024 the Company entered into a “Memorandum of Understanding for All Antivirals Drug Development” (the “MOU”) with TheraCour that granted to the Company, a limited, non-assignable, non-sublicensable, exclusive right of first refusal to License to any antiviral drugs in development or to be developed by TheraCour for research and development purposes only, for all as-yet unlicensed viral infection treatment indications. The MOU also clarified the roles and responsibilities of the Parties and essentially codified the process that the Parties have adopted since inception. The MOU further codified the treatment of all future milestone payments arising from any current or future license agreements to TheraCour to be consistent with the principles adopted in the February 12, 2024 Amendment to the COVID License Agreement.
Development fees and other costs charged by TheraCour for the years ended June 30, 2024 and 2023 were approximately $2,550,000 and $2,536,000, respectively. At June 30, 2024, approximately $720,000, was due to TheraCour.
No royalties are due TheraCour from the Company’s inception through June 30, 2024.
TheraCour is affiliated with the Company through Dr. Anil Diwan, our Founder, President, and Executive Chairman, who owns approximately 90% of the capital stock of TheraCour which itself owns 470,961 shares of the Company’s outstanding common stock and 681,859 shares of the Company’s Series A preferred stock as of June 30, 2024.
Line of Credit - Related Party – Anil Diwan
On November 13, 2023, the Company’s President and CEO, Dr. Anil Diwan, entered into a Line of Credit Agreement whereby Dr. Diwan agreed to provide a standby Line of Credit to the Company in the maximum amount of $2,000,000. All amounts outstanding under the Line of Credit, including principal, accrued interest and other fees and charges, will be due and payable on December 31, 2024. Amounts drawn down under the Line of Credit shall bear interest at a fixed rate of 12%. Advancements under the Line of Credit will be collateralized by an Open End Mortgage Deed on the Company’s real property at 1 Controls Drive, Shelton, Connecticut and a Chattel Mortgage (U.C.C - 1 filing) against the Company’s equipment and fixtures. Any draw down under the Line of Credit requires the approval of the Company’s Board of Directors. On February 12, 2024, the Company, pursuant to Article 2.5 of the Company’s Line of Credit Agreement with Dr. Anil Diwan, signed an Extension Agreement which extended the maturity of the Company’s Line of Credit from December 31, 2024 to December 31, 2025. There were no other amendments to the original Line of Credit. By signing pn September 23, 2024 and being effective as September 20, 2024 the Company, pursuant to Article 2.5 of the Company’s Line of Credit Agreement with Dr. Anil Diwan, signed an Amendment Agreement which increased the available line of credit from $2 million to $3 million, and extended the maturity of the Company’s Line of Credit from December 31, 2025 to March 31, 2026.
The Company has not drawn against the Line of Credit facility as of June 30, 2024.
Karveer Meditech, Private Limited (KMPL)
On March 27, 2023 the Company entered into a License Agreement with KMPL, wherein the Company granted to KMPL a limited, non-transferable, exclusive license for the use, sale, or offer of sale in India of the Company’s two clinical test drug candidates titled as NV-CoV-2 and NV-CoV-2-R for the treatment of COVID-19 in patients in India (“KMPL COVID License”). KMPL has engaged in further drug development in India including sponsoring of drug candidates for human clinical trials in India and is acting as clinical trials manager for such clinical trials. KMPL is in the process of establishing a manufacturing plant for some of those medicines. KMPL shall provide NanoViricides with all reports of the clinical trials and the Company has the rights to use such reports for further advancement of the drug candidates with regulatory authorities outside India. In consideration, KMPL will be reimbursed by the Company for all direct and indirect costs incurred for the clinical trials and development activities with a customary clinical trials manager fee of thirty (30%) of such costs and applicable taxes. Upon commercial sales of any resulting approved drugs, KMPL will pay the Company a royalty of seventy percent (70%) of the final invoiced sales less the cost of sales and goods sold to unaffiliated third parties. On June 19, 2023 KMPL commenced the equivalent of Phase I clinical trials in India. The Company has incurred clinical trial costs to KMPL of $442,845 and $100,000 for the years ended June 30, 2024 and 2023 respectively, As of June 30, 2024 and 2023, respectively, $227,435 and $100,000 of such costs were accrued by the Company pursuant to the license agreement between the Company and KMPL.
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KMPL is owned by the Diwan family, consisting of four siblings and their immediate families. Dr. Diwan has an undivided share in the Diwan family interest in KMPL. The number of shares is not currently available. Consequent to and subsequent to the KMPL COVID License, KMPL is deemed to be a related party.
Meeta Vyas
Meeta Vyas is the Company’s Chief Financial Officer and is married to Dr. Anil Diwan. Due to her marriage to Dr. Anil Diwan, Meeta Vyas is deemed to be a related party,
Employees
As of June 30, 2024, the Company had approximately seven full-time employees. In addition, most of the business activities of the Company including accounting and legal work and business development are provided by subcontractors and consultants. Further, the Company has subcontracted nanomaterials research and development (“R&D”) to TheraCour under the license agreement with TheraCour. The Company has subcontracted its animal studies to various contract research organizations, government institutes, academic labs, and private institutions. In the future, the Company anticipates having additional service providers. We believe that we have good relations with our employees and subcontractors.
Reports to Security Holders
The public may read and copy any materials the Company files with the Securities and Exchange Commission (the “Commission”) at the Commission’s Public Reference Room at 100 F Street, NE, Washington, DC 20549. The public may obtain information on the operation of the Public Reference Room by calling the Commission at 1-800-SEC-0030. The Commission maintains an Internet site (www.sec.gov) that contains reports, proxy and information statements and other information regarding issuers that file electronically with the Commission. Information about the Company is also available on its website at www.nanoviricides.com. Information included on the website is not part of this Form 10-K.
Further, the Company’s common stock is listed on the NYSE-American. The NYSE-American Exchange requires additional corporate governance, financial and reporting requirements.
The Company is fully compliant with the requirements of the NYSE-American regarding requirements for independent board members and board committee compositions.
Website
Our website address is www.nanoviricides.com. Information on our website is not incorporated by reference herein.
We intend to make available through our website, all of our filings with the Commission and all amendments to these reports as soon as reasonably practicable after filing, by providing a hyperlink to the EDGAR website containing our reports.
Our Contact Information
Our principal executive offices are currently located at 1 Controls Drive, Shelton, Connecticut 06484 and our telephone number is (203) 937-6137 (voicemail). We can be contacted by email at info@nanoviricides.com.
Description of Property
The Company’s principal executive offices are located at 1 Controls Drive, Shelton, CT, and include approximately 18,000 square feet of office, laboratory, and cGMP-capable drug manufacturing space. These facilities are fully owned by the Company, and not subject to any mortgage or debt.
We subcontract the laboratory research and development work to TheraCour, pursuant to the License Agreement with TheraCour. The work is performed in our own laboratory facility in Shelton, CT. Management believes that the space is sufficient for the Company to monitor the developmental progress at its subcontractors.
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Legal Proceedings
From time to time, we are subject to various legal proceedings arising in the ordinary course of business, including proceedings for which we have insurance coverage. There are no pending legal proceedings against the Company to the best of the Company’s knowledge as of the date hereof and to the Company’s knowledge no action, suit or proceeding has been threatened against the Company that we believe will have a material adverse effect to our business, financial position, results of operations, or liquidity.
ITEM 1A. RISK FACTORS
Our business, financial condition, operating results and prospects are subject to the following risks. Additional risks and uncertainties not presently foreseeable to us may also impair our business operations. If any of the following risks or the risks described elsewhere in this report actually occurs, our business, financial condition or operating results could be materially adversely affected. In such case, the trading price of our common stock could decline, and our stockholders may lose all or part of their investment in the shares of our common stock.
This Form 10-K contains forward-looking statements that involve risks and uncertainties. These statements can be identified by the use of forward-looking terminology such as “believes,” “expects,” “intends,” “plans,” “may,” “will,” “should,” “predict” or “anticipation” or the negative thereof or other variations thereon or comparable terminology. Actual results could differ materially from those discussed in the forward-looking statements as a result of certain factors, including those set forth below and elsewhere in this Form 10-K.
Summary of Risk Factors
Our business is subject to numerous risks and uncertainties that you should consider before investing in our common stock. Some of the principal risk factors that make an investment in the Company speculative or risky are summarized as follows:
| ● | Our company is in the developmental stage and has no products approved for commercial sale, no generated revenue, and may never achieve profitability. |
| ● | The Company will need to raise substantial additional capital in the future to fund operations. |
| ● | Due to the nature of the process involved in the development process of pharmaceuticals, the Company can provide no assurance of the successful and timely development of new drugs. |
| ● | The Company must comply with significant and complex government regulations, which may delay or prevent the commercialization of drug candidates. |
| ● | The Company can provide no assurance that drug candidates will obtain regulatory approval or that the results of clinical studies will be favorable. |
| ● | In the event that regulatory approvals are obtained, drug candidates will be subject to regulatory review. Failing to comply with U.S. and foreign regulations could result in loss of approvals to market such drugs and would harm the business. |
| ● | Development of drug candidates requires significant research and development, which will lead to significant research and development costs. |
| ● | The Company will be unable to proceed with its business plan without obtaining additional financing. |
| ● | The Company has limited experience in conducting or supervising clinical trials and must outsource clinical trials. Additionally, we lack suitable facilities for clinical testing which leads to a reliance on third parties. |
| ● | The Company may be unable to attract or retain and motivate skilled personnel which will delay product development programs and research and development efforts. |
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| ● | The Company has no sales or marketing personnel. |
| ● | The Company’s collaborative relationships with third parties could cause the Company to expend significant resources and incur substantial business risk with no assurance of financial return. |
| ● | The Company may be liable for damages caused by biological and hazardous material. |
| ● | The Company depends on senior management and their loss or unavailability could put the Company at a competitive disadvantage. |
| ● | There exist conflicts of interest among officers, directors and stockholders. |
| ● | Risks relating to dependence on U.S. government contracts. |
| ● | Company common stock may be considered “penny stock”. |
| ● | Management of the Company has identified a material weakness in internal controls that if not remediated could result in material misstatements in our financial statements. |
These and other material risks we face are described more fully herein which investors should carefully review prior to making an investment decision with respect to the Company or its securities.
Risks Specific to Our Business
Our company is a development stage company that has no products approved for commercial sale, never generated any revenues and may never achieve revenues or profitability.
Our company is a development stage company that has no products approved for commercial sale, never generated any revenues and may never achieve revenues or profitability. Our ability to generate revenue depends heavily on:
| ● | demonstration and proof of principle in pre-clinical trials that a nanoviricide is safe and effective; |
| ● | successful development of our first product candidate in our pipeline; |
| ● | our ability to seek and obtain regulatory approvals, including with respect to the indications we are seeking; |
| ● | the successful commercialization of our product candidates; and |
| ● | market acceptance of our products. |
All of our existing product candidates are in early stages of development. It will be several years, if ever, until we have a commercial drug product available for resale. If we do not successfully develop and commercialize these products, we will not achieve revenues or profitability in the foreseeable future, if at all. If we are unable to generate revenues or achieve profitability, we may be unable to continue our operations.
We are a clinical drug development stage company with a limited operating history, making it difficult for you to evaluate our business and your investment. Our proposed products are subject to all of the risks inherent in the establishment of a new business enterprise, including but not limited to:
| ● | the absence of an operating history; |
| ● | the lack of commercialized products; |
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| ● | insufficient capital; |
| ● | expected substantial and continual losses for the foreseeable future; |
| ● | limited experience in dealing with regulatory issues; the lack of manufacturing experience and limited marketing experience; |
| ● | an expected reliance on third parties for the development and commercialization of our proposed products; |
| ● | a competitive environment characterized by numerous, well-established and well capitalized competitors; |
| ● | reliance on key personnel. |
Because we are subject to these risks, you may have a difficult time evaluating our business and your investment in our company.
Our ability to become profitable depends primarily on the following factors:
| ● | our ability to develop drugs, obtain approval for such drugs, and if approved, to successfully commercialize our nanoviricide drug(s); |
| ● | our R&D efforts, including the timing and cost of clinical trials; and |
| ● | our ability to enter into favorable alliances with third parties who can provide substantial capabilities in clinical development, regulatory affairs, sales, marketing and distribution. |
Even if we successfully develop and market our drug candidates, we may not generate sufficient or sustainable revenue to achieve or sustain profitability.
We have incurred significant operating losses and may not ever be profitable. As of June 30, 2024, we had a cash and cash equivalent balance of $4,797,778. Also, we have incurred significant operating losses since its inception, resulting in an accumulated deficit of $139,374,895 at June 30, 2024. Such losses are expected to continue for the foreseeable future.
We will need to raise substantial additional capital in the future to fund our operations and we may be unable to raise such funds when needed and on acceptable terms.
Management believes that the Company’s cash and cash equivalents balance of approximately $4.8 million, additional capital raised of approximately $1.5 million by ATM sales of our common stock from July 1, 2024 through September 10, 2024, and the Company’s existing resources, including availability under its $3 million line of credit will not be sufficient to fund the Company’s planned operations and expenditures for at least 12 months from the date of the filing of this Form 10-K. As a result substantial doubt exists about the Company’s ability to continue as a going concern. Management is actively exploring additional required funding through non-dilutive grants and contracts, partnering, debt or equity financing pursuant to its plan. There is no assurance that we will be successful in obtaining sufficient financing on terms acceptable to us to fund continuing operations.
We cannot provide assurance that the Company’s plans will not change or that changed circumstances will not result in the depletion of its capital resources more rapidly than it currently anticipates.
In the event that we cannot obtain acceptable financing, or that we are unable to secure additional financing on acceptable terms, we would be unable to complete development of our various drug candidates. This would necessitate implementing staff reductions and operational adjustments that would include reductions in the following business areas:
| ● | research and development programs; |
| ● | preclinical studies and clinical trials; material characterization studies, regulatory processes; |
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| ● | a search for third party marketing partners to market our products for us. |
The amount of capital we may need will depend on many factors, including the:
| ● | progress, timing and scope of our research and development programs; |
| ● | progress, timing and scope of our preclinical studies and clinical trials; |
| ● | time and cost necessary to obtain regulatory approvals; |
| ● | time and cost necessary to establish our own marketing capabilities or to seek marketing partners; |
| ● | time and cost necessary to respond to technological and market developments; |
| ● | changes made or new developments in our existing collaborative, licensing and other commercial relationships; and |
| ● | new collaborative, licensing and other commercial relationships that we may establish. |
Our fixed expenses, such as real estate taxes and facility and equipment maintenance, rent, and other contractual commitments, may increase in the future, as we may:
| ● | enter into leases for new facilities and capital equipment; |
| ● | enter into additional licenses and collaborative agreements; and |
| ● | incur additional expenses associated with being a public company. |
We have limited experience in drug development, and may not be able to successfully develop any drugs.
Our ability to achieve revenues and profitability in our business will depend, among other things, on our ability to:
| ● | develop products internally or obtain rights to them from others on favorable terms; |
| ● | complete laboratory testing and human studies; |
| ● | obtain and maintain necessary intellectual property rights to our products; |
| ● | successfully complete regulatory review to obtain requisite governmental agency approvals; |
| ● | enter into arrangements with third parties to manufacture our products on our behalf; and |
| ● | enter into arrangements with third parties to provide sales and marketing functions. |
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Development of pharmaceutical products is a time-consuming process, subject to a number of factors, many of which are outside of our control. Consequently, we can provide no assurance of the successful and timely development of new drugs.
Our drug candidates are in their clinical and pre-clinical developmental stages. Further development and extensive testing will be required to determine their technical feasibility and commercial viability. Our success will depend on our ability to achieve scientific and technological advances and to translate such advances into reliable, commercially competitive drugs on a timely basis. Drugs that we may develop are not likely to be commercially available for several years. The proposed development schedules for our drug candidates may be affected by a variety of factors, including technological difficulties, proprietary technology of others, and changes in government regulation, many of which will not be within our control. Any delay in the development, introduction or marketing of our drug candidates could result either in such drugs being marketed at a time when their cost and performance characteristics would not be competitive in the marketplace or in the shortening of their commercial lives. In light of the long-term nature of our projects, the unproven technology involved and the other factors described elsewhere in “Risk Factors”, we may not be able to complete successfully the development or marketing of any drugs.
We may fail to successfully develop and commercialize our drug candidates if they:
| ● | are found to be unsafe or ineffective or fail to meet the appropriate endpoints in clinical trials; |
| ● | do not receive necessary approval from the FDA or foreign regulatory agencies; |
| ● | fail to conform to a changing standard of care for the diseases they seek to treat; or |
| ● | are less effective or more expensive than current or alternative treatment methods. |
Drug development failure can occur at any stage of clinical trials and as a result of many factors and there can be no assurance that we or our collaborators will reach our anticipated clinical targets. Even if we or our collaborators complete our clinical trials, we do not know what the long-term effects of exposure to our drug candidates will be. Furthermore, our drug candidates may be used in combination with other treatments and there can be no assurance that such use will not lead to unique safety issues. Failure to complete clinical trials or to prove that our drug candidates are safe and effective would have a material adverse effect on our ability to generate revenue and could require us to reduce the scope of or discontinue our operations.
We have limited manufacturing expertise and we may have to rely on external manufacturers.
We believe that the technology we use to manufacture our products and compounds is proprietary, although some of the generalities are patented or patent-pending. For our products, we may have to disclose all necessary aspects of this technology to contract manufacturers to enable them to manufacture the products and compounds for us. We plan to have discussions with manufacturers under non-disclosure and non-compete agreements that are intended to restrict them from using or revealing this technology, but we cannot be certain that these manufacturers will comply with these restrictions. In addition, these manufacturers could develop their own technology related to the work they perform for us that we may need to manufacture our products or compounds. We could be required to enter into an agreement with that manufacturer if we wanted to use that technology ourselves or allow another manufacturer to use that technology. The manufacturer could refuse to allow us to use their technology or could demand terms to use their technology that are not acceptable.
We must comply with significant and complex government regulations, compliance with which may delay or prevent the commercialization of our drug candidates.
The R&D, manufacture and marketing of drug candidates are subject to regulation, primarily by the FDA in the United States and by comparable authorities in other countries. These national agencies and other federal, state, local and foreign entities regulate, among other things, R&D activities (including testing in primates and in humans) and the testing, manufacturing, handling, labeling, storage, record keeping, approval, advertising and promotion of the products that we are developing. Noncompliance with applicable requirements can result in various adverse consequences, including approval delays or refusals to approve drug licenses or other applications, suspension or termination of clinical investigations, revocation of approvals previously granted, fines, criminal prosecution, recalls or seizures of products, injunctions against shipping drugs and total or partial suspension of production and/or refusal to allow a company to enter into governmental supply contracts.
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The process of obtaining FDA approval has historically been costly and time consuming. Current FDA requirements for a new human drug or biological product to be marketed in the United States include: (1) the successful conclusion of pre-clinical laboratory and animal tests, if appropriate, to gain preliminary information on the product’s safety; (2) filing with the FDA of an IND application to conduct human clinical trials for drugs or biologics; (3) the successful completion of adequate and well-controlled human clinical investigations to establish the safety and efficacy of the product for its recommended use; and (4) filing by a company and acceptance and approval by the FDA of a New Drug Application, or NDA, for a drug product or a biological license application, or BLA, for a biological product to allow commercial distribution of the drug or biologic. A delay in one or more of the procedural steps outlined above could be harmful to us in terms of getting our drug candidates through clinical testing and to market.
The FDA reviews the results of the clinical trials and may order the temporary or permanent discontinuation of clinical trials at any time if it believes the drug candidate exposes clinical subjects to an unacceptable health risk. Investigational drugs used in clinical studies must be produced in compliance with current good manufacturing practice, or GMP, rules pursuant to FDA regulations.
Sales outside the United States of products that we develop will also be subject to regulatory requirements governing human clinical trials and marketing for drugs and biological products and devices. The requirements vary widely from country to country, but typically the registration and approval process takes several years and requires significant resources. In most cases, even if the FDA has not approved a product for sale in the United States, the product may be exported to any country if it complies with the laws of that country and has valid marketing authorization by the appropriate authority. There are specific FDA regulations that govern this process.
We also are subject to the following risks and obligations, related to the approval of our products:
| ● | The FDA or foreign regulators may interpret data from pre-clinical testing and clinical trials in different ways than we interpret them. |
| ● | If regulatory approval of a product is granted, the approval may be limited to specific indications or limited with respect to its distribution. |
| ● | In addition, many foreign countries control pricing and coverage under their respective national social security systems. |
| ● | The FDA or foreign regulators may not approve our manufacturing processes or manufacturing facilities. |
| ● | The FDA or foreign regulators may change their approval policies or adopt new regulations. |
| ● | Even if regulatory approval for any product is obtained, the marketing license will be subject to continual review, and newly discovered or developed safety or effectiveness data may result in suspension or revocation of the marketing license. |
| ● | If regulatory approval of the product candidate is granted, the marketing of that product would be subject to adverse event reporting requirements and a general prohibition against promoting products for unapproved or “off-label” uses. |
| ● | In some foreign countries, we may be subject to official release requirements that require each batch of the product we produce to be officially released by regulatory authorities prior to its distribution by us. |
| ● | We will be subject to continual regulatory review and periodic inspection and approval of manufacturing modifications, including compliance with current GMP regulations. |
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We can provide no assurance that our drug candidates will obtain regulatory approval or that the results of clinical studies will be favorable.
The testing, marketing and manufacturing of any product for use in the United States will require approval from the FDA. We cannot predict with any certainty the amount of time necessary to obtain such FDA approval and whether any such approval will ultimately be granted. Preclinical and clinical trials may reveal that one or more products are ineffective or unsafe, in which event further development of such products could be seriously delayed or terminated. Moreover, obtaining approval for certain products may require testing on human subjects of substances whose effects on humans are not fully understood or documented. Delays in obtaining FDA or any other necessary regulatory approvals of any proposed drug and failure to receive such approvals would have an adverse effect on the drug’s potential commercial success and on our business, prospects, financial condition and results of operations. In addition, it is possible that a proposed drug may be found to be ineffective or unsafe due to conditions or facts that arise after development has been completed and regulatory approvals have been obtained. In this event, we may be required to withdraw such proposed drug from the market. To the extent that our success will depend on any regulatory approvals from government authorities outside of the United States that perform roles similar to that of the FDA, uncertainties similar to those stated above will also exist.
Preclinical and clinical studies of our product candidates may not be successful. If we are unable to generate successful results from preclinical and clinical studies of our product candidates, or experience significant delays in doing so, our business may be materially harmed.
We have no products on the market and except NV-CoV-2 (NV-387) which is in Phase Ia/Ib clinical trials, all of our other product candidates are in preclinical development. In particular, none of our product candidates, other than NV-CoV-2 (NV-387), have ever been tested in a human subject. Our ability to achieve and sustain profitability depends on obtaining regulatory approvals for and, if approved, successfully commercializing our product candidates, either alone or with third parties. Before obtaining regulatory approval for the commercial distribution of our product candidates, we or an existing or future collaborator must conduct extensive preclinical tests and clinical trials to demonstrate the safety, purity and potency of our product candidates.
The success of our product candidates will depend on several factors, including the following:
| ● | successfully designing preclinical studies which may be predictive of clinical outcomes; |
| ● | successful results from preclinical and clinical studies; |
| ● | receipt of marketing approvals from applicable regulatory authorities; |
| ● | obtaining and maintaining patent and trade secret protection for future product candidates; |
| ● | establishing and maintaining manufacturing relationships with third parties or establishing our own manufacturing capability; and |
| ● | successfully commercializing our products, if and when approved, whether alone or in collaboration with others. |
If we do not achieve one or more of these factors in a timely manner or at all, we could experience significant delays or an inability to successfully complete the development or commercialization of our product candidates, which would materially harm our business.
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Because the results of preclinical testing are not necessarily predictive of future results, our products may not have favorable results in our planned clinical trials.
Even if we have positive results from our preclinical testing of our products, this may not necessarily be predictive of the results from our planned clinical trials in humans. Many companies in the pharmaceutical and biotechnology industries have suffered significant setbacks in clinical trials after achieving positive results in preclinical development, and we cannot be certain that we will not face similar setbacks. Moreover, preclinical and clinical data are often susceptible to varying interpretations and analyses, and many companies that believed their product candidates performed satisfactorily in preclinical studies and clinical trials nonetheless failed to obtain FDA approval. If we fail to produce positive results in our clinical trials, the development timeline and regulatory approval and commercialization prospects for our products, and, correspondingly, our business and financial prospects, would be materially adversely affected.
Even if we obtain regulatory approvals, our marketed drug candidates will be subject to ongoing regulatory review. If we fail to comply with continuing U.S. and foreign regulations, we could lose our approvals to market these drugs and our business would be seriously harmed.
Following any initial regulatory approval of any drugs we may develop, we will also be subject to continuing regulatory review, including the review of adverse experiences and clinical results that are reported after our drug candidates are made commercially available. This would include results from any post-marketing tests or vigilance required as a condition of approval. The manufacturer and manufacturing facilities we use to make any of our drug candidates will also be subject to periodic review and inspection by the FDA. The discovery of any previously unknown problems with the drug, manufacturer or facility may result in restrictions on the drug or manufacturer or facility, including withdrawal of the drug from the market. If we are required to withdraw all or more of our drugs from the market, we may be unable to continue revenue-generating operations. Reliance on third-party manufacturers entails risks to which we would not be subject if we manufactured drugs ourselves, including reliance on the third-party manufacturer for regulatory compliance. Our drug promotion and advertising is also subject to regulatory requirements and continuing FDA review.
Development of our drug candidates requires a significant investment in R&D. Our R&D expenses in turn, are subject to variation based on a number of factors, many of which are outside of our control. A sudden or significant increase in our R&D expenses could materially and adversely impact our results of operations.
Our R&D cost estimates and budgets are based on discussions with industry professionals and service providers. These may not take into account all of the activities involved for the development. Additionally, regulatory requirements may change from time to time and may dictate additional activities that lead to increased expenditures beyond budgeted.
Because we expect to expend substantial resources on R&D, our success depends in large part on the results as well as the costs of our R&D. A failure in our R&D efforts or substantial increase in our R&D expenses would adversely affect our results of operations. R&D expenditures are uncertain and subject to much fluctuation. Factors affecting our R&D expenses include, but are not limited to:
| ● | the number and outcome of clinical studies we are planning to conduct; for example, our R&D expenses may increase based on the number of late-stage clinical studies that we may be required to conduct; |
| ● | the number, extent, and outcome of pre-clinical studies we are planning to conduct; for example, our R&D expenses may increase based on the number and extent of IND-enabling pre-clinical studies including CMC Studies, Tox Package Studies, and Quality Programs that we may be required to conduct; |
| ● | the number of drugs entering into pre-clinical development from research; for example, there is no guarantee that internal research efforts will succeed in generating sufficient data for us to make a positive development decision; |
| ● | licensing activities, including the timing and amount of related development funding or milestone payments; for example, we may enter into agreements requiring us to pay a significant up-front fee for the purchase of in-process R&D that we may record as R&D expense; and |
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| ● | maintenance of our relationship with our licensing partner TheraCour and our rights and obligations under the license agreements, including any conflict, dispute or disagreement arising from our failure to satisfy payment obligations under such agreement, our ability to develop and commercialize the affected product candidate may be adversely affected. Any loss of our rights under our license agreements could delay or completely terminate our product development efforts for the affected product candidate. |
We will be unable to proceed with our business plan without obtaining additional financing to support our budgeted Clinical Development, Pre-Clinical Research and Development and other costs.
We believe we have sufficient funds on hand to complete the remaining tasks of the Phase I clinical trial and obtain a completed clinical study report, and to develop and file a Phase II clinical trial application to evaluate use of NV-387 for the treatment of RSV infection.
We have estimated a total cash expenditure budget of approximately $7.9 million for the period of July 2024 through October 2025 of which approximately $4.9 million is expected to be spent on research and development for our drug candidates, including completion and reporting of the Phase I clinical trial and preparation for the Phase II clinical trial of our lead drug candidate NV-387 for treatment of RSV, an IND filing for RSV indication, and approximately $3 million is budgeted for general and administrative expenses.
We are aware of numerous products under development or manufactured by competitors that are used for the prevention or treatment of certain diseases we have targeted for drug development. Various companies are developing biopharmaceutical products that potentially directly compete with our drug candidates even though their approach to such treatment is different.
We hope that our drug candidates under development and in clinical trials will address major markets within the anti-viral sector. Our competition will be determined in part by the potential indications for which drugs are developed and ultimately approved by regulatory authorities. Additionally, the timing of the market introduction of some of our potential drugs or of competitors’ products may be an important competitive factor. Accordingly, the relative speed with which we can develop drugs, complete pre-clinical testing, clinical trials, approval processes and supply commercial quantities to market are important competitive factors. We expect that competition among drugs approved for sale will be based on various factors, including product efficacy, safety, reliability, availability, price and patent protection.
The successful development of biopharmaceuticals is highly uncertain. A variety of factors including, pre-clinical study results or regulatory approvals, could cause us to abandon development of our drug candidates.
Successful development of biopharmaceuticals is highly uncertain and is dependent on numerous factors, many of which are beyond our control. Products that appear promising in the early phases of development may fail to reach the market for several reasons including:
| ● | pre-clinical study results that may show the product to be less effective than desired (e.g., a clinical trial fails to meet its primary objectives) or to have harmful or problematic side effects; |
| ● | failure to receive the necessary regulatory approvals or a delay in receiving such approvals. Among other things, such delays may be caused by slow enrollment in clinical studies, length of time to achieve study endpoints, additional time requirements for data analysis or an IND and later NDA, preparation, discussions with the FDA, an FDA request for additional pre-clinical or clinical data or unexpected safety or manufacturing issues; |
| ● | manufacturing costs, pricing or reimbursement issues, or other factors that make the product not economical; and |
| ● | the proprietary rights of others and their competing products and technologies that may prevent the product from being commercialized. |
Success in pre-clinical and early clinical studies does not ensure that large-scale clinical studies will be successful. Clinical results are frequently susceptible to varying interpretations that may delay, limit or prevent regulatory approvals. The length of time necessary to complete clinical studies and to submit an application for marketing approval for a final decision by a regulatory authority varies significantly from one product to the next, and may be difficult to predict.
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We have limited experience in conducting or supervising clinical trials and must outsource all clinical trials.
We have limited experience in conducting or supervising clinical trials that must be performed to obtain data to submit in concert with applications for approval by the FDA. The regulatory process to obtain approval for drugs for commercial sale involves numerous steps. Drugs are subjected to clinical trials that allow development of case studies to examine safety, efficacy, and other issues to ensure that sale of drugs meets the requirements set forth by various governmental agencies, including the FDA. In the event that our protocols do not meet standards set forth by the FDA, or that our data is not sufficient to allow such trials to validate our drugs in the face of such examination, we might not be able to meet the requirements that allow our drugs to be approved for sale.
Because we have limited experience in conducting or supervising clinical trials, we plan to continue to outsource our clinical trials to third parties. We have no control over their compliance with procedures and protocols used to complete clinical trials in accordance with standards required by the agencies that approve drugs for sale. If these subcontractors fail to meet these standards, the validation of our drugs would be adversely affected, causing a delay in our ability to meet revenue-generating operations.
We are subject to risks inherent in conducting clinical trials. The risk of non-compliance with FDA-approved good clinical practices by clinical investigators, clinical sites, or data management services could delay or prevent us from developing or ever commercializing our drug candidates.
Agreements with clinical investigators and medical institutions for clinical testing and with other third parties for data management services place substantial responsibilities on these parties, which could result in delays in, or termination of, our clinical trials if these parties fail to perform as expected. For example, if any of our clinical trial sites fail to comply with FDA-approved good clinical practices, we may be unable to use the data gathered at those sites. If these clinical investigators, medical institutions or other third parties do not carry out their contractual duties or obligations or fail to meet expected deadlines, or if the quality or accuracy of the clinical data they obtain is compromised due to their failure to adhere to our clinical protocols or for other reasons, our clinical trials may be extended, delayed or terminated, and we may be unable to obtain regulatory approval for or successfully commercialize our drug candidates.
We or regulators may suspend or terminate our clinical trials for a number of reasons. We may voluntarily suspend or terminate our clinical trials if at any time we believe that they present an unacceptable risk to the patients enrolled in our clinical trials. In addition, regulatory agencies may order the temporary or permanent discontinuation of our clinical trials at any time if they believe that the clinical trials are not being conducted in accordance with applicable regulatory requirements or that they present an unacceptable safety risk to the patients enrolled in our clinical trials.
Our clinical trial operations will be subject to regulatory inspections at any time. If regulatory inspectors conclude that we or our clinical trial sites are not in compliance with applicable regulatory requirements for conducting clinical trials, we may receive reports of observations or warning letters detailing deficiencies, and we will be required to implement corrective actions. If regulatory agencies deem our responses to be inadequate, or are dissatisfied with the corrective actions that we or our clinical trial sites have implemented, our clinical trials may be temporarily or permanently discontinued, we may be fined, we or our investigators may be precluded from conducting any ongoing or any future clinical trials, the government may refuse to approve our marketing applications or allow us to manufacture or market our drug candidates or we may be criminally prosecuted. If we are unable to complete clinical trials and have our products approved due to our failure to comply with regulatory requirements, we will be unable to commence revenue-generating operations.
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Efforts of government and third-party payers to contain or reduce the costs of health care may adversely affect our revenues even if we were to develop an FDA approved drug.
Our ability to earn sufficient returns on our drug candidates may depend in part on the extent to which government health administration authorities, private health coverage insurers and other organizations will provide reimbursement for the costs of such drugs and related treatments. Significant uncertainty exists as to the reimbursement status of newly approved health care drugs, and we do not know whether adequate third-party coverage will be available for our drug candidates. If our current and proposed drugs are not considered cost-effective, reimbursement to the consumers may not be available or sufficient to allow us to sell drugs on a competitive basis. The failure of the government and third-party payers to provide adequate coverage and reimbursement rates for our drug candidates could adversely affect the market acceptance of our drug candidates, our competitive position and our financial performance
We will rely upon licensed patents to protect our technology. We may be unable to obtain or protect such intellectual property rights, and we may be liable for infringing upon the intellectual property rights of others.
Our ability to compete effectively will depend on our ability to maintain the proprietary nature of our technologies and the proprietary technology of others for which we have entered into licensing agreements. We have exclusive licenses from TheraCour to novel technologies, proprietary technologies, and knowhow, some of which has been filed in patent applications, and we expect to file patents of our own in the coming years. There can be no assurance that any of these patent applications will ultimately result in the issuance of a patent with respect to the technology owned by us or licensed to us. The patent position of pharmaceutical or biotechnology companies, including ours, is generally uncertain and involves complex legal and factual considerations. The standards that the United States Patent and Trademark Office use to grant patents are not always applied predictably or uniformly and can change. There is also no uniform, worldwide policy regarding the subject matter and scope of claims granted or allowable in pharmaceutical or biotechnology patents. Accordingly, we do not know the degree of future protection for our proprietary rights or the breadth of claims that will be allowed in any patents issued to us or to others. Further, we rely on a combination of trade secrets, know-how, technology and nondisclosure, and other contractual agreements and technical measures to protect our rights in the technology. If any trade secret, know-how or other technology not protected by a patent were to be disclosed to or independently developed by a competitor, our business and financial condition could be materially adversely affected.
We do not believe that any of the drug candidates we are currently developing infringe upon the rights of any third parties nor are they infringed upon by third parties; however, there can be no assurance that our technology will not be found in the future to infringe upon the rights of others or be infringed upon by others. In such a case, others may assert infringement claims against us, and should we be found to infringe upon their patents, or otherwise impermissibly utilize their intellectual property, we might be forced to pay damages, potentially including treble damages, if we are found to have willfully infringed on such parties’ patent rights. In addition to any damages we might have to pay, we may be required to obtain licenses from the holders of this intellectual property, enter into royalty agreements, or redesign our drug candidates so as not to utilize this intellectual property, each of which may prove to be uneconomical or otherwise impossible. Conversely, we may not always be able to successfully pursue our claims against others that infringe upon our technology and the technology exclusively licensed from the TheraCour Pharma. Thus, the proprietary nature of our technology or technology licensed by us may not provide adequate protection against competitors.
Moreover, the cost to us of any litigation or other proceeding relating to technology we license and other intellectual property rights, even if resolved in our favor, could be substantial, and the litigation would divert our management’s efforts. Uncertainties resulting from the initiation and continuation of any litigation could limit our ability to continue our operations.
Other companies or organizations may assert patent rights that prevent us from developing and commercializing our drug candidates.
We are in a relatively new scientific field that has generated many different patent applications from organizations and individuals seeking to obtain important patents in the field. Because the field is so new, very few of these patent applications have been fully processed by government patent offices around the world, and there is a great deal of uncertainty about which patents will issue, when, to whom, and with what claims. It is possible that there will be significant litigation and other proceedings, such as interference proceedings in various patent offices, relating to patent rights in the field. Others may attempt to invalidate TheraCour’s patents or other intellectual property rights. Even if our rights are not directly challenged, disputes among third parties could lead to the weakening or invalidation of those intellectual property rights.
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Thus, it is possible that one or more organizations will hold patent rights to which we will need a license. Any license required under any patent may not be made available on commercially acceptable terms, if at all. In addition, such licenses are likely to be non-exclusive and, therefore, our competitors may have access to the same technology licensed to us. If we fail to obtain a required license and are unable to design around a patent, we may be unable to effectively market some of our technology and drug candidates, which could limit our ability to generate revenues or achieve profitability and possibly prevent us from generating revenue sufficient to sustain our operations.
We are dependent upon TheraCour for the rights to develop the products we intend to sell and our license agreements with TheraCour require that TheraCour is the sole developer and supplier of our licensed products.
Our ability to develop, manufacture and sell the products the Company plans to develop is derived from our licensing agreements with TheraCour. The Agreements may be terminated by TheraCour as a result of: the insolvency or bankruptcy proceedings by or against the Company, a general assignment by the Company to its creditors, the dissolution of the Company, cessation by the Company of business operations for ninety (90) days or more or the commencement by the Company or an affiliate to challenge or invalidate the issued patents.
The Company does not hold the rights to any other patents nor does the Company conduct its own research and development to develop other products to manufacture and sell. In addition, TheraCour is the sole developer of our licensed products and we are required to pay TheraCour fees for indirect and direct costs incurred by TheraCour for its licensed products. Therefore, we are dependent upon TheraCour for all of our product development needs. If the Company’s Agreement with TheraCour is terminated, it is unlikely we will be able to commence revenue-generating operations or that the Company could continue operating at all.
The expiration or loss of patent protection may adversely affect our future revenues and operating earnings.
We rely on patent, trademark, trade secret and other intellectual property protection in the discovery, research and of our product candidates. In particular, patent protection is important in the development and eventual commercialization of our products and product candidates. Patents covering our products and product candidates normally provide market exclusivity, which is important in order for our products and product candidates to become profitable.
Certain of the patents, which comprise the intellectual property that we license, expire between 2026 and 2028. While we believe the patent holders may seek additional patent coverage that may protect the technology underlying these patents, there can be no assurances that such additional patent protection will be granted, or if granted, that these patents will not be infringed upon or otherwise held enforceable. Even if we are successful in obtaining a patent, patents have a limited lifespan and we currently do not have any products for sale. In the United States, the natural expiration of a utility patent typically is generally 20 years after it is filed. Various extensions may be available; however, the life of a patent, and the protection it affords, is limited. Without patent protection for our products and product candidates, we may be open to competition from generic versions of such methods and devices.
We lack suitable facilities for clinical testing; and rely on third parties.
The Company does not have facilities that could be used to conduct clinical testing. We expect to contract with third parties to conduct all clinical testing required to obtain approvals for any drugs that we might develop. We currently outsource all testing to a number of third parties in various collaborations and service contracts. Any of our collaborators or service providers may discontinue the service contract or collaboration. If this were to occur, then we would be required to modify our priorities and goals, obtain other collaborators or service providers to replace the ones we lose, or we may even be forced to abandon certain drug development programs. In addition, any failures by third parties to adequately perform their responsibilities may delay the submission of our proposed products for regulatory approval, impair our ability to deliver our products on a timely basis, increase our costs, or otherwise impair our competitive position.
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We have limited manufacturing experience.
We have not previously manufactured products in the highly regulated environment of pharmaceutical manufacturing. There are numerous regulations and requirements that must be maintained to obtain licensure and the permits required to commence manufacturing, as well as additional requirements to continue manufacturing pharmaceutical products. We own facilities that we use to manufacture clinical quantities of any products that might be developed by us. We believe that this cGMP-capable facility may allow us to produce limited quantities of a drug after approval for initial market entry, and that such an effort may make commercial sense if the treatment course requirements and afflicted patient populations are limited, and if the remuneration for the treatment course is appropriate. However, we do not own, nor lease facilities suitable for cGMP manufacture of any of our drug candidates in large commercial quantities, nor do we have the resources at this time to acquire or lease suitable facilities. At present, we have not retained any contract manufacturing organizations (CMO) for commercial manufacture or for clinical product manufacture.
We may be unable to attract, retain, and motivate skilled personnel which will delay our product development programs and our research and development efforts.
Our success depends on our continued ability to attract, retain, and motivate highly qualified scientific personnel who must undergo extensive training to assist in our research programs. Competition for skilled and qualified personnel and academic and other research collaborations is intense. If we lose the services of personnel with the necessary skills, or if there are extensive delays in training such personnel, it could significantly impede the achievement of our research and development objectives. We are currently experiencing extreme staffing constraints as well as financing constraints that have already caused substantial delays and may continue to cause further delays in our estimated timelines, unless we are successful at raising additional funds and at attracting and retaining highly skilled employees with specific skill-sets. There can be no assurance that we will be able to raise sufficient funding or that even if we are able to raise funding on terms favorable to the Company, that we will be able to hire and retain such qualified employees, The inability to hire and retain these employees will significantly delay our objectives including filing an IND with the FDA.
We have no sales and marketing personnel.
We are an early stage development company with limited resources. We do not currently have any products available for sale, and have not secured sales and marketing staff at this early stage of operations. We cannot generate sales without a sales or marketing staff and we cannot guarantee we will be successful in developing one. Even if we were to successfully develop approvable drugs, we will not be able to sell these drugs if we or our third-party manufacturers fail to comply with manufacturing regulations.
Since we cannot predict whether or when we will obtain regulatory approval to commercialize our product candidates, we cannot predict the timing of any future revenue from these product candidates.
We cannot commercialize any of our product candidates to generate revenue until the appropriate regulatory authorities have reviewed and approved the marketing applications for the product candidates. We cannot ensure that the regulatory agencies will complete their review processes in a timely manner or that we will obtain regulatory approval for any product candidate that we or our collaborators develop. Satisfaction of regulatory requirements typically takes many years, is dependent upon the type, complexity and novelty of the product and requires the expenditure of substantial resources. Regulatory approval processes outside the United States include all of the risks associated with the FDA approval process. In addition, we may experience delays or rejections based upon additional government regulation from future legislation or administrative action or changes in FDA policy during the period of product development, clinical trials and FDA regulatory review.
We license our core technology from TheraCour and we are dependent upon them as they have exclusive development rights. If we lose the right to utilize any of the proprietary information that is the subject of this license agreement, we may incur substantial delays and costs in development of our drug candidates
We have entered into Material License Agreements with TheraCour. TheraCour has exclusive rights to develop exclusively for us, the materials that comprise the core drugs of our planned business. TheraCour is a development stage company with limited financial resources and needs the Company’s progress payments to further the development of the nanoviricides. We control the research and work TheraCour performs on our behalf and no costs may be incurred without our prior authorization or approval.
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We depend on TheraCour and other third parties to perform manufacturing activities effectively and on a timely basis. If these third parties fail to perform as required, this could impair our ability to deliver our products on a timely basis or cause delays in our clinical trials and applications for regulatory approval, and these events could harm our competitive position and adversely affect our ability to commence revenue-generating operations. The manufacturing process for pharmaceutical products is highly regulated, and regulators may shut down manufacturing facilities that they believe do not comply with regulations. We, and our manufacturers are subject to the FDA’s current Good Manufacturing Practices, which are extensive regulations governing manufacturing processes, stability testing, record keeping and quality standards and similar regulations are in effect in other countries. In addition, our manufacturing operations are subject to routine inspections by regulatory agencies.
Our collaborative relationships with third parties could cause us to expend significant resources and incur substantial business risk with no assurance of financial return.
We anticipate substantial reliance upon strategic collaborations for marketing and the commercialization of our drug candidates and we may rely even more on strategic collaborations for R&D of our other drug candidates. Our business depends on our ability to sell drugs to both government agencies and to the general pharmaceutical market. Offering our drug candidates for non-medical applications to government agencies does not require us to develop new sales, marketing or distribution capabilities beyond those already existing in the company. Selling antiviral drugs, however, does require such development. We plan to sell antiviral drugs through strategic partnerships with pharmaceutical companies. If we are unable to establish or manage such strategic collaborations on terms favorable to us in the future, our revenue and drug development may be limited. To date, we have not entered into any strategic collaboration with third parties capable of providing these services. In addition, we have not yet marketed or sold any of our drug candidates or entered into successful collaborations for these services in order to ultimately commercialize our drug candidates.
If we determine to enter into R&D collaborations during the early phases of drug development, our success will in part depend on the performance of our research collaborators. We will not directly control the amount or timing of resources devoted by our research collaborators to activities related to our drug candidates. Our research collaborators may not commit sufficient resources to our programs. If any research collaborator fails to commit sufficient resources, our preclinical or clinical development programs related to such collaboration could be delayed or terminated. Also, our collaborators may pursue existing or other development-stage products or alternative technologies in preference to those being developed in collaboration with us. Finally, if we fail to make required milestone or royalty payments to our collaborators or to observe other obligations in our agreements with them, our collaborators may have the right to terminate those agreements.
Manufacturers producing our drug candidates must follow current GMP regulations enforced by the FDA and foreign equivalents. If a manufacturer of our drug candidates does not conform to the current GMP regulations and cannot be brought up to such a standard, we will be required to find alternative manufacturers that do conform. This may be a long and difficult process and may delay our ability to receive FDA or foreign regulatory approval of our drug candidates and cause us to fall behind on our business objectives.
Establishing strategic collaborations is difficult and time-consuming. Our discussion with potential collaborators may not lead to the establishment of collaborations on favorable terms, if at all. Potential collaborators may reject collaborations based upon their assessment of our financial, regulatory or intellectual property position. Even if we successfully establish new collaborations, these relationships may never result in the successful development or commercialization of our drug candidates or the generation of sales revenue. To the extent that we enter into collaborative arrangements, our drug revenues are likely to be lower than if we directly marketed and sold any drugs that we may develop.
Management of our relationships with our collaborators will require:
| ● | significant time and effort from our management team; |
| ● | coordination of our marketing and R&D programs with the marketing and R&D priorities of our collaborators; and |
| ● | effective allocation of our resources to multiple projects. |
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We employ the use of certain chemical and biological agents and compounds that may be deemed hazardous and we are therefore subject to various environmental laws and regulations. Compliance with these laws and regulations may result in significant costs, which could materially reduce our ability to become profitable.
We use hazardous materials, including chemicals and biological agents and compounds that could be dangerous to human health and safety or the environment. As appropriate, we safely store these materials and wastes resulting from their use at our laboratory facility pending their ultimate use or disposal. We contract with a third party to properly dispose of these materials and wastes. We are subject to a variety of federal, state and local laws and regulations governing the use, generation, manufacture, storage, handling and disposal of these materials and wastes. We may incur significant costs complying with environmental laws and regulations adopted in the future.
We cannot eliminate the risk of contamination or injury from these materials. In the event of contamination or injury resulting from our use of hazardous materials, we could be held liable for any resulting damages, and any liability could exceed our resources. We also could incur significant costs associated with civil or criminal fines and penalties for failure to comply with such laws and regulations. We may incur substantial costs in order to comply with current or future environmental, health and safety laws and regulations. These current or future laws and regulations may impair our research, development or production efforts. Our failure to comply with these laws and regulations also may result in substantial fines, penalties or other sanctions.
If we use biological and hazardous materials in a manner that causes injury, we may be liable for damages.
Our R&D and manufacturing activities will involve the use of biological and hazardous materials. Although we believe our safety procedures for handling and disposing of these materials comply with federal, state and local laws and regulations, we cannot entirely eliminate the risk of accidental injury or contamination from the use, storage, handling or disposal of these materials. We carry $7,000,000 casualty and general liability insurance policies. Accordingly, in the event of contamination or injury, we could be held liable for damages or penalized with fines in an amount exceeding our resources and insurance coverage, and our clinical trials or regulatory approvals could be suspended.
We depend upon our senior management and their loss or unavailability could put us at a competitive disadvantage.
We currently depend upon the efforts and abilities of our management team. The loss or unavailability of the services of any of these individuals for any significant period of time could have a material adverse effect on our business, prospects, financial condition and results of operations. We have not obtained, do not own, nor are we the beneficiary of key-person life insurance for all of our key personnel.
The Company believes that Dr. Anil Diwan, our President and Executive Chairman is critical to the success of the Company. The Company is a limited beneficiary of a certain amount of key man insurance for Anil Diwan that the Company maintains. However, there can be no assurances that the amount of the key man insurance coverage would be sufficient to provide replacement of this key officer for continuing the Company’s operations in a timely manner, should such an event arise.
The Company also maintains a limited amount of Directors and Officers Liability insurance coverage to protect all of its directors and executive officers taken together. There can be no assurance that this D&O coverage will be sufficient to cover the costs of the events that may lead to its invocation, in which case, there could be a substantial impact on the Company’s ability to continue operations, should such an unforeseen event occur.
There are conflicts of interest among our officers, directors and stockholders.
Certain of our executive officers and directors and their affiliates are engaged in other activities and have interests in other entities on their own behalf or on behalf of other persons. Neither we, nor our stockholders will have any rights in these ventures or their income or profits. Specifically, Dr. Anil Diwan owns approximately 90% of the capital stock of TheraCour, which as of June 30, 2024, owned 3.6% of our common stock, and 681,859 shares of the Company’s Series A preferred stock, and provides the nanomaterials to the Company with which it intends to develop its products and is the holder of the intellectual property rights the Company uses to conduct its operations. While the Company is not aware of any conflict that has arisen to date, Dr. Diwan may have conflicting fiduciary duties between the Company and TheraCour, for which he must recuse himself from certain decision-making processes of the Company.
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The Company does not allow a conflicted shareholder, director, or executive officer to vote on matters wherein a conflict may be perceived. The conflicted person or entity is not allowed to nominate an alternate person to vote for them either. Other than this safeguard, the Company currently does not have any policy in place, should such a conflict arise.
In particular:
| ● | Our executive officers or directors or their affiliates may have an economic interest in, or other business relationship with, partner companies that invest in us. |
| ● | Our executive officers or directors or their affiliates have interests in entities that provide products or services to us. |
In any of these cases:
| ● | Our executive officers or directors may have a conflict between our current interests and their personal financial and other interests in another business venture. |
| ● | Our executive officers or directors may have conflicting fiduciary duties to us and the other entity. |
| ● | The terms of transactions with the other entity may not be subject to arm’s length negotiations and therefore may be on terms less favorable to us than those that could be procured through arm’s length negotiations. |
We anticipate entering into contracts with various U.S. government agencies. In contracting with government agencies, we will be subject to various federal contract requirements. Future sales to U.S. government agencies will depend, in part, on our ability to meet these requirements, certain of which we may not be able to satisfy.
We may enter into contracts with various U.S. government agencies which have special contracting requirements that give the government agency various rights or impose on the other party various obligations that can make the contracts less favorable to the non- government party. Consequently, if a large portion of our revenue is attributable to these contracts, our business may be adversely affected should the governmental parties exercise any of these additional rights or impose any of these additional obligations.
U.S. government contracts typically contain unfavorable termination provisions and are subject to audit and modification by the government at its sole discretion, which subjects us to additional risks. These risks include the ability of the U.S. government to unilaterally:
| ● | suspend or prevent us for a set period of time from receiving new contracts or extending existing contracts based on violations or suspected violations of laws or regulations; |
| ● | terminate our existing contracts; |
| ● | reduce the scope and value of our existing contracts; |
| ● | audit and object to our contract-related costs and fees, including allocated indirect costs; |
| ● | control and potentially prohibit the export of our drug candidates; and |
| ● | change certain terms and conditions in our contracts. |
The U.S. government may terminate any of its contracts with us either for its convenience or if we default by failing to perform in accordance with the contract schedule and terms. Termination for convenience provisions generally enable us to recover only our costs incurred or committed, and settlement expenses and profit on the work completed prior to termination. Termination for default provisions do not permit these recoveries and make us liable for excess costs incurred by the U.S. government in procuring undelivered items from another source.
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As a U.S. government contractor, we may become subject to periodic audits and reviews. Based on the results of these audits, the U.S. government may adjust our contract-related costs and fees, including allocated indirect costs. As part of any such audit or review, the U.S. government may review the adequacy of, and our compliance with, our internal control systems and policies, including those relating to our purchasing, property, compensation and/or management information systems. In addition, if an audit or review uncovers any improper or illegal activity, we may be subject to civil and criminal penalties and administrative sanctions, including termination of our contracts, forfeiture of profits, suspension of payments, fines and suspension or prohibition from doing business with the U.S. government. We could also suffer serious harm to our reputation if allegations of impropriety were made against us. In addition, under U.S. government purchasing regulations, some of our costs, including most financing costs, amortization of intangible assets, portions of our R&D costs and some marketing expenses, may not be reimbursable or allowed under our contracts. Further, as a U.S. government contractor, we may become subject to an increased risk of investigations, criminal prosecution, civil fraud, whistleblower lawsuits and other legal actions and liabilities to which purely private sector companies are not.
We may fail to obtain contracts to supply the U.S. government, and we may be unable to commercialize our drug candidates.
The U.S. government has undertaken commitments to help secure improved countermeasures against bio-terrorism. The process of obtaining government contracts is lengthy and uncertain, and we would compete for each contract. Moreover, the award of one government contract would not necessarily secure the award of future contracts covering the same drug. If the U.S. government makes significant future contract awards for the supply of its emergency stockpile to our competitors, our business will be harmed and it is unlikely that we will be able to ultimately commercialize our competitive drug candidate.
In addition, the determination of when and whether a drug is ready for large scale purchase and potential use will be made by the government through consultation with a number of government agencies, including the FDA, the NIH, the CDC and the Department of Homeland Security. Congress has approved measures to accelerate the development of bio-defense drugs through NIH funding, the review process by the FDA and the final government procurement contracting authority. While this may help speed the approval of our drug candidates, it may also encourage competitors to develop their own drug candidates.
We cannot predict with certainty the size of the market, if any for all of the antiviral drugs that the governments may want to stockpile. Consequently, we cannot predict whether sales, if any, to governments will be sufficient to fund our business plan and commence revenue-generating operations.
If the U.S. government fails to continue funding bio-defense drug candidate development efforts or fails to purchase sufficient quantities of any future bio-defense drug candidate, we may be unable to generate sufficient revenues to continue operations.
While we have not yet received U.S. government funding, we hope to receive funding from the U.S. government for the development of our bio-defense drug candidates. Changes in government budgets and agendas, however, may result in future funding being decreased and de-prioritized, and government contracts typically contain provisions that permit cancellation in the event that funds are unavailable to the government agency. Furthermore, we cannot be certain of the timing of any future funding, and substantial delays or cancellations of funding could result from protests or challenges from third parties. If the U.S. government fails to continue to adequately fund R&D programs, we may be unable to generate sufficient revenues to continue operations. Similarly, if we develop a drug candidate that is approved by the FDA, but the U.S. government does not place sufficient orders for this drug, our future business may be harmed.
Risks Related to the Biotechnology/Biopharmaceutical Industry
The biotechnology and biopharmaceutical industries are characterized by rapid technological developments and a high degree of competition. We may be unable to compete with enterprises equipped with more substantial resources than us.
The biotechnology and biopharmaceutical industries are characterized by rapid technological developments and a high degree of competition based primarily on scientific and technological factors. These factors include the availability of patent and other protection for technology and products, the ability to commercialize technological developments and the ability to obtain government approval for testing, manufacturing and marketing.
Our Coronavirus drug candidates would compete with the already approved therapies (either EUA or full approvals) and are subject to the COVID pandemic dissipating.
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Our RSV drug does not have any direct competition at present but there are two protective antibodies as well as three vaccines for RSV, although there are no approved treatments other than the highly toxic last-resort drug, ribavirin.
Our shingles drug candidate would compete with Valtrex®, an approved drug (valacyclovir), and other acyclovir-related nucleoside analogs, and new drugs in the pipeline. FV-100, a VZV-specific nucleoside analog was in Phase III clinical trials that were terminated. Development of ASP2151, a helicase/primase inhibitor, was terminated due to adverse events in healthy persons in clinical trials. We are not aware of any further drugs in clinical trials for the treatment of shingles. Painkillers such as lidocaine formulations and oxycodone formulations were in clinical trials for symptomatic relief of PHN.
Our HSV-1 and HSV-2 skin cream drug candidates would compete with branded and unbranded available skin creams, such as Abreva™, as well as with branded and unbranded oral drug candidates against herpes, such as those based on acyclovir, valacyclovir, gancyclovir, among others. It is not known until after human clinical trials whether our drug candidates provide patient benefits beyond those of these drugs. Other drugs against herpes that are in the pipeline, if approved prior to our drug approval, would also be competition. Several drugs are in clinical trials for HSV-1 and/or HSV-2 treatment. These include brincidofovir, cyclopropavir, valamocyclovir, pritelivir, letermovir, as well as antibodies. Their patient benefit profiles are not known at present.
Our anti-influenza drug in development, Flucide, would compete with neuraminidase inhibitors Tamiflu and Relenza, anti-influenza drugs that are sold by Roche and Glaxo SmithKline (GSK), respectively. Generic competitors include amantadine and rimantadine, both oral. BioCryst Pharmaceuticals, Inc. has achieved FDA approval for IV Infusions formulations of peramivir, an influenza neuraminidase inhibitor, for the treatment of uncomplicated influenza. Peramivir is approved in Japan and had obtained emergency use authorization in the US. Its effectiveness during multiple clinical trials was found to be severely limited. Recently, a new drug, Xofluza (Baloxavir marboxil), developed by Shionogi, Inc., and licensed by Roche, has been approved in Japan, USA, and most of the world. It is an influenza viral endonuclease PA inhibitor. Other drugs in this class are in clinical trials. So are drugs targeting the m7G cap-snatching activity (PB2) of influenza virus such as VX787, and antibodies. Several H5N1 bird flu, and influenza novel H1N1/2009 vaccines are also in development worldwide. Several companies are developing anti-influenza drugs and vaccines.
We compete with specialized biopharmaceutical firms in the United States, Europe and elsewhere, as well as a growing number of large pharmaceutical companies that are applying biotechnology to their operations, many of which have greater market presence and resources than we do. Many biopharmaceutical companies have focused their development efforts in the human therapeutics area, including cancer. Many major pharmaceutical companies have developed or acquired internal biotechnology capabilities or made commercial arrangements with other biopharmaceutical companies. These companies, as well as academic institutions, government agencies and private research organizations, also compete with us in recruiting and retaining highly qualified scientific personnel and consultants. Our ability to compete successfully with other companies in the pharmaceutical field will also depend to a considerable degree on the continuing availability of capital to us.
We are aware of numerous products under development or manufactured by competitors that are used for the prevention or treatment of certain diseases we have targeted for drug development. Various companies are developing biopharmaceutical products that potentially directly compete with our drug candidates even though their approach to such treatment is different.
We hope that our drug candidates under development and in clinical trials will address major markets within the anti-viral sector. Our competition will be determined in part by the potential indications for which drugs are developed and ultimately approved by regulatory authorities. Additionally, the timing of the market introduction of some of our potential drugs or of competitors’ products may be an important competitive factor. Accordingly, the relative speed with which we can develop drugs, complete pre-clinical testing, clinical trials, approval processes and supply commercial quantities to market are important competitive factors. We expect that competition among drugs approved for sale will be based on various factors, including product efficacy, safety, reliability, availability, price and patent protection.
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The successful development of biopharmaceuticals is highly uncertain. A variety of factors including, pre-clinical study results or regulatory approvals, could cause us to abandon development of our drug candidates.
Successful development of biopharmaceuticals is highly uncertain and is dependent on numerous factors, many of which are beyond our control. Products that appear promising in the early phases of development may fail to reach the market for several reasons including:
| ● | pre-clinical study results that may show the product to be less effective than desired (e.g., the study failed to meet its primary objectives) or to have harmful or problematic side effects; |
| ● | failure to receive the necessary regulatory approvals or a delay in receiving such approvals. Among other things, such delays may be caused by slow enrollment in clinical studies, length of time to achieve study endpoints, additional time requirements for data analysis or a IND and later NDA, preparation, discussions with the FDA, an FDA request for additional pre-clinical or clinical data or unexpected safety or manufacturing issues; |
| ● | manufacturing costs, pricing or reimbursement issues, or other factors that make the product not economical; and |
| ● | the proprietary rights of others and their competing products and technologies that may prevent the product from being commercialized. |
Success in pre-clinical and early clinical studies does not ensure that large-scale clinical studies will be successful. Clinical results are frequently susceptible to varying interpretations that may delay, limit or prevent regulatory approvals. The length of time necessary to complete clinical studies and to submit an application for marketing approval for a final decision by a regulatory authority varies significantly from one product to the next, and may be difficult to predict.
Risks Related to the Securities Markets and Investments in Our Common Stock
General securities market uncertainties resulting from international turmoil.
International securities markets have become highly unstable in the aftermath of extensive spending by the governments to combat COVID-19, the rise in energy prices resulting from the Russian war in Ukraine, the political, social and economic effects of this war, changes in governments leading to changes in monetary and fiscal policies, inflation, and other external factors. As a result, the markets may not be available to us for purposes of raising required capital at the time we need it. Should we not be able to obtain financing when required, in the amounts necessary to execute on our plans in full, or on terms which are economically feasible we may be unable to sustain the level of spending required to pursue our strategic plan and may have to reduce the planned future growth and scope of our operations.
If we do not meet the continued listing standards of the NYSE American our common stock could be delisted from trading, which could limit investors’ ability to make transactions in our common stock and subject us to additional trading restrictions.
Our common stock is listed on the NYSE American, a national securities exchange, which imposes continued listing requirements with respect to listed shares. If, however, we fail to satisfy the continued listing standards, such as, for example, the requirement that our shares not trade “for a substantial period of time at a low price per share,” fail to meet stockholders equity requirements, or that we not dispose of our principal operating assets or discontinue a substantial portion of our operations, among other requirements, the NYSE American may issue a non-compliance letter or initiate delisting proceedings. If our securities are delisted from trading on the NYSE American and we are not able to list our securities on another exchange or to have them quoted on NASDAQ, our securities could be quoted on the OTC Bulletin Board or on the “pink sheets.” As a result, we could face significant adverse consequences including:
| ● | a limited availability of market quotations for our securities; |
| ● | a determination that our common stock is a “penny stock” which will require brokers trading in our common stock to adhere to more stringent rules and possibly result in a reduced level of trading activity in the secondary trading market for our securities; |
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| ● | a limited amount of news and analyst coverage for us; and |
| ● | a decreased ability to issue additional securities (including pursuant to short-form registration statements on Form S-3 or obtain additional financing in the future). |
Our Company is subject to the periodic reporting requirements of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), which will require us to incur audit fees and legal fees in connection with the preparation of such reports. These additional costs will reduce or might eliminate our ability to reach profitability.
Our Company is required to file periodic reports with the Commission pursuant to the Exchange Act and the rules and regulations promulgated thereunder. To comply with these requirements, our independent registered auditors will have to review our quarterly financial statements and audit our annual financial statements. Moreover, our legal counsel will have to review and assist in the preparation of such reports. The costs charged by these professionals for such services cannot be accurately predicted at this time, because factors such as the number and type of transactions that we engage in and the complexity of our reports cannot be determined at this time and will have a major effect on the amount of time to be spent by our auditors and attorneys. However, the incurrence of such costs will obviously be an expense to our operations and thus have a negative effect on our ability to meet our overhead requirements and earn a profit. We may be exposed to potential risks under Section 404 of the Sarbanes-Oxley Act of 2002. If we cannot provide reliable financial reports or prevent fraud, our business and operating results could be harmed, investors could lose confidence in our reported financial information, the trading price of our common stock, if a market ever develops, could drop significantly, or we could become subject to Commission enforcement proceedings.
Our Common Stock may be considered a “penny stock” and may be difficult to sell.
The Commission has adopted regulations which generally define “penny stock” to be an equity security that has a market price of less than $5.00 per share or an exercise price of less than $5.00 per share, subject to specific exemptions. Historically, the price of our common stock has fluctuated greatly. If, the market price of the common stock is less than $5.00 per share and the common stock does not fall within any exemption, it therefore may be designated as a “penny stock” according to Commission rules. The “penny stock” rules impose additional sales practice requirements on broker-dealers who sell securities to persons other than established customers and accredited investors (generally those with assets in excess of $1,000,000 or annual income exceeding $200,000 or $300,000 together with their spouse). For transactions covered by these rules, the broker-dealer must make a special suitability determination for the purchase of securities and have received the purchaser’s written consent to the transaction before the purchase. Additionally, for any transaction involving a penny stock, unless exempt, the broker-dealer must deliver, before the transaction, a disclosure schedule prescribed by the Commission relating to the penny stock market. The broker-dealer also must disclose the commissions payable to both the broker-dealer and the registered representative and current quotations for the securities. Finally, monthly statements must be sent disclosing recent price information on the limited market in penny stocks. These additional burdens imposed on broker-dealers may restrict the ability or decrease the willingness of broker-dealers to sell our common shares, and may result in decreased liquidity for our common shares and increased transaction costs for sales and purchases of our common shares as compared to other securities.
Our stock price may be volatile and your investment in our common stock could suffer a decline in value.
The price of our Common Stock, as quoted on the NYSE American, may fluctuate significantly in response to a number of factors, many of which are beyond our control. These factors include but are not limited to:
| ● | progress of our products through the regulatory process |
| ● | results of preclinical studies and clinical trials; |
| ● | announcements of technological innovations or new products by us or our competitors; |
| ● | government regulatory action affecting our products or our competitors’ products in both the United States and foreign countries; |
| ● | developments or disputes concerning patent or proprietary rights; |
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| ● | general market conditions for emerging growth and pharmaceutical companies; |
| ● | economic conditions in the United States or abroad; |
| ● | actual or anticipated fluctuations in our operating results; |
| ● | broad market fluctuations; and |
| ● | changes in financial estimates by securities analysts. |
There is a risk of market fraud.
Shareholders should be aware that, according to SEC Release No. 34-29093, the market for penny stocks has suffered in recent years from patterns of fraud and abuse. Such patterns include (1) control of the market for the security by one or a few broker-dealers that are often related to the promoter or issuer; (2) manipulation of prices through prearranged matching of purchases and sales and false and misleading press releases; (3) boiler room practices involving high-pressure sales tactics and unrealistic price projections by inexperienced sales persons; (4) excessive and undisclosed bid-ask differential and markups by selling broker-dealers; and (5) the wholesale dumping of the same securities by promoters and broker-dealers after prices have been manipulated to a desired level, along with the resulting inevitable collapse of those prices and with consequent investor losses. We are aware of the abuses that have occurred historically in the penny stock market. Although we do not expect to be in a position to dictate the behavior of the market or of broker-dealers who participate in the market, management will strive within the confines of practical limitations to prevent the described patterns from being established with respect to our securities. The occurrence of these patterns or practices could increase the volatility of our share price.
A registration of a significant amount of our outstanding restricted stock may have a negative effect on the trading price of our stock.
At June 30, 2024, shareholders of the Company held 1,330,156 shares of restricted common stock, or approximately 10.1% of the outstanding Common Stock. If we were to file a registration statement including all of these shares, and the registration is allowed by the SEC, these shares would be freely tradable upon the effectiveness of the planned registration statement. If investors holding a significant number of freely tradable shares decide to sell them in a short period of time following the effectiveness of a registration statement, such sales could contribute to significant downward pressure on the price of our stock.
We do not intend to pay any cash dividends in the foreseeable future and, therefore, any return on your investment in our capital stock must come from increases in the fair market value and trading price of the capital stock.
We have not paid any cash dividends on our common stock and do not intend to pay cash dividends on our common stock in the foreseeable future. We intend to retain future earnings, if any, for reinvestment in the development and expansion of our business. Any credit agreements, which we may enter into with institutional lenders, may restrict our ability to pay dividends. Whether we pay cash dividends in the future will be at the discretion of our board of directors and will be dependent upon our financial condition, results of operations, capital requirements and any other factors that the board of directors decides is relevant. Therefore, any return on your investment in our capital stock must come from increases in the fair market value and trading price of the capital stock.
We may issue additional equity shares to fund the Company’s operational requirements, which would dilute share ownership.
The Company’s continued viability depends on its ability to raise capital. Changes in economic, regulatory or competitive conditions may lead to cost increases. Management may also determine that it is in the best interest of the Company to develop new services or products. In any such case additional financing is required for the Company to meet its operational requirements. The sale or the proposed sale of substantial amounts of our common stock in the public markets may adversely affect the market price of our common stock and our stock price may decline substantially.
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The Company is authorized to issue up to 150,000,000 shares of common stock without additional approval by shareholders. As of June 30, 2024, we had 13,144,055 shares of common stock outstanding, 6,862 warrants convertible to 6,862 shares of common stock, and 892,625 shares of Series A preferred stock convertible into 3,124,188 shares of common stock only in the event of a change in control.
Large amounts of our common stock will be eligible for resale under Rule 144.
As of June 30, 2024, 1,330,156 of 13,144,055 issued and outstanding shares of the Company’s common stock were restricted securities as defined under Rule 144 of the Securities Act of 1933, as amended (the “Act”) and under certain circumstances may be resold without registration pursuant to Rule 144. In addition 892,625 shares of Series A preferred stock are restricted and convertible into 3,124,188 shares of common stock only upon of a change of control of the Company.
Approximately 668,384 shares of our restricted shares of common stock are held by non-affiliates who may avail themselves of the public information requirements and sell their shares in accordance with Rule 144. As a result, some or all of these shares may be sold in accordance with Rule 144 potentially causing the price of the Company’s shares to decline.
In general, under Rule 144, a person (or persons whose shares are aggregated) who has satisfied a six month holding period may, under certain circumstances, sell within any three-month period a number of securities which does not exceed the greater of 1% of the then outstanding shares of common stock or the average weekly trading volume of the class during the four calendar weeks prior to such sale. Rule 144 also permits, under certain circumstances, the sale of securities, without any limitation, by a person who is not an Affiliate, as such term is defined in Rule 144(a)(1), of the Company and who has satisfied a one-year holding period. Any substantial sale of the Company’s common stock pursuant to Rule 144 may have an adverse effect on the market price of the Company’s shares. This filing will satisfy certain public information requirements necessary for such shares to be sold under Rule 144.
The requirements of complying with the Sarbanes-Oxley act may strain our resources and distract management.
We are subject to the reporting requirements of the Exchange Act, and the Sarbanes-Oxley Act of 2002. The costs associated with these requirements may place a strain on our systems and resources. The Exchange Act requires that we file annual, quarterly and current reports with respect to our business and financial condition. The Sarbanes-Oxley Act requires that we maintain effective disclosure controls and procedures and internal controls over financial reporting. Historically, we have maintained a small accounting staff, but in order to maintain and improve the effectiveness of our disclosure controls and procedures and internal control over financial reporting, significant additional resources and management oversight will be required. This effort may divert management’s attention from other business concerns, which could have a material adverse effect on our business, financial condition, results of operations and cash flows. In addition, we may need to hire additional accounting and financial persons with appropriate public company experience and technical accounting knowledge, and we cannot assure you that we will be able to do so in a timely fashion.
Sales of additional equity securities may adversely affect the market price of our common stock and your rights in the Company may be reduced.
We expect to continue to incur drug development and selling, general and administrative costs, and in order to satisfy our funding requirements, we may need to sell additional equity securities. Our stockholders may experience substantial dilution and a reduction in the price that they are able to obtain upon sale of their shares. Also, any new securities issued may have greater rights, preferences or privileges than our existing common stock that may adversely affect the market price of our common stock and our stock price may decline substantially.
ITEM 1B: UNRESOLVED STAFF COMMENTS.
None.
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ITEM 1C: CYBERSECURITY
Cybersecurity Risk Management and Strategy
We are a clinical stage biotechnology company focused on developing and commercializing new treatments for viral diseases. We and our third-party service providers, collect, process, transmit, and store sensitive data on our systems, including intellectual property, proprietary or confidential business information, and a variety of personal data.
We rely on third parties, including cloud vendors, for various business functions. We select key third-party service providers based on several factors, including the type of data processed and the nature of services offered, and we oversee such key third-party service providers by conducting vendor diligence upon onboarding and ongoing monitoring, including a review of SOC-1 reports on an annual basis, where applicable.
We have adopted processes designed to identify, assess and manage material risks from cybersecurity threats. Those processes include response to and an assessment of internal and external threats to the security, confidentiality, integrity and availability of our data and information systems, along with other material risks to our operations. In addition, we have implemented procedures over certain areas such as access on/offboarding and account management to help govern the processes put in place by management designed to protect our IT assets, data, and services from threats and vulnerabilities.
Governance
Management is responsible for the day-to-day management of the risks we face, while our board of directors has responsibility for the oversight of risk management, including risks from cybersecurity threats. The audit committee has primary responsibility for oversight of cybersecurity and is briefed on cybersecurity risks at least once a year and following any material cybersecurity incidents. Our board of directors receives periodic updates from our audit committee regarding matters of cybersecurity. Our board members also engage in ad hoc conversations with management on cybersecurity-related news events and discuss any significant updates to our cybersecurity risk management and initiatives.
As of the date of this Annual Report on Form 10-K, we have not experienced a cybersecurity incident that resulted in a material effect on our business strategy, results of operations, or financial condition.
ITEM 2: PROPERTIES
Description of Property
The Company’s principal executive offices are located at 1 Controls Drive, Shelton, CT, and include approximately 18,000 square feet of office, laboratory, and cGMP-capable drug manufacturing space. These facilities are fully owned by the Company with no outstanding debt or mortgage.
ITEM 3: LEGAL PROCEEDINGS.
From time to time, we are a party to legal proceedings arising in the ordinary course of business. We are not currently a party to any legal proceedings that we believe could have a material adverse effect on financial condition or results of operations.
ITEM 4: MINE SAFETY DISCLOSURES.
Not applicable.
PART II
ITEM 5: MARKET FOR REGISTRANT’S COMMON EQUITY RELATED SHAREHOLDER MATTERS AND ISSUER PURCHASES OF EQUITY SECURITIES.
Our Common Stock is listed on the NYSE-American under the symbol “NNVC”.
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Number of Shareholders.
As of June 30, 2024, a total of 13,144,055 shares of the Company’s common stock are outstanding and held by 146 shareholders of record. This number of shareholders does not reflect the persons or entities that hold their stock in nominee or street name through various brokerage firms. Of this amount, 11,813,899 shares are unrestricted, of which 0 shares are held by affiliates, 668,384 shares are restricted securities held by non-affiliates, and the remaining 661,772 shares are restricted securities held by affiliates. These shares may only be sold in accordance with Rule 144.
Dividends.
The Company has not paid any cash dividends since its inception. The Company currently intends to retain any earnings for use in its business, and therefore does not anticipate paying dividends in the foreseeable future.
ITEM 6: [RESERVED]
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ITEM 7: MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS
The following discussion should be read in conjunction with the information contained in the financial statements of the Company and the notes thereto appearing elsewhere herein and in conjunction with the Company’s Annual Report on Form 10-K for the year ended June 30, 2024. Readers should carefully review the risk factors disclosed in this Form 10-K and other documents filed by the Company with the SEC.
As used in this report, the terms “Company”, “we”, “our”, “us” and “NNVC” refer to NanoViricides, Inc., a Delaware corporation.
PRELIMINARY NOTE REGARDING FORWARD-LOOKING STATEMENTS
This Annual Report contains forward-looking statements within the meaning of the federal securities laws. These include statements about our expectations, beliefs, intentions or strategies for the future, which we indicate by words or phrases such as “anticipate,” “expect,” “intend,” “plan,” “will,” “we believe,” “NNVC believes,” “management believes” and similar language. The forward-looking statements are based on the current expectations of NNVC and are subject to certain risks, uncertainties and assumptions, including those set forth in the discussion under “Management’s Discussion and Analysis of Financial Condition and Results of Operations” in this report. Actual results may differ materially from results anticipated in these forward-looking statements. We base the forward-looking statements on information currently available to us, and we assume no obligation to update them.
Investors are also advised to refer to the information in our previous filings with the Securities and Exchange Commission (SEC), especially on Forms 10-K, 10-Q and 8-K, in which we discuss in more detail various important factors that could cause actual results to differ from expected or historic results. It is not possible to foresee or identify all such factors. As such, investors should not consider any list of such factors to be an exhaustive statement of all risks and uncertainties or potentially inaccurate assumptions.
Management’s Plan of Operation
The Company’s drug development business model was formed in May 2005 with a license to the patents and intellectual property held by TheraCour that enabled creation of drugs engineered specifically to combat viral diseases in humans. This exclusive license from TheraCour serves as a foundation for our intellectual property. The Company was granted a worldwide exclusive license to this technology for several drugs with specific targeting mechanisms for the treatment of the following human viral diseases: Human Immunodeficiency Virus (HIV/AIDS), Hepatitis B Virus (HBV), Hepatitis C Virus (HCV), Rabies, Herpes Simplex Virus (HSV-1 and HSV-2), Influenza and Asian Bird Flu Virus. The Company entered into an additional license agreement with TheraCour granting the Company the exclusive licenses for technologies developed by TheraCour for the additional virus types: Dengue viruses, Japanese Encephalitis virus, West Nile Virus, Viruses causing viral Conjunctivitis (a disease of the eye) and Ocular Herpes, and Ebola/Marburg viruses. The Company completed a license agreement for the field of VZV indications in November 2019 from TheraCour. The Company completed a license agreement for the field of human Coronavirus indications in September 2021 from TheraCour. TheraCour has not denied any licenses sought by the Company in the past.
The Company may seek to add additional virus types to its drug pipeline as the Company progresses further. The Company would then need to negotiate with TheraCour or an unrelated party appropriate license agreements to include those of such additional viruses that the Company determines it wants to follow for further development. Historically, the Company initiates negotiations for additional licenses when initial exploratory research determines that a viable drug candidate for the targeted field is possible. We are seeking to add to our existing portfolio of products through our internal discovery pre-clinical development programs and through an in-licensing strategy.
The licenses granted by TheraCour are for entire set of pathologies that the licensed virus is a causative agent for. The licenses are not for single drug/indication pairs, which is the customary mode of licensing in the pharmaceutical industry. Thus, these are very broad licenses and enable NanoViricides to pursue a number of indications as well as develop drug candidates with different characteristics as is best suited for the indications, without having to license the resulting drugs for each indication separately, as with normal pharmaceutical industry licensing.
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The Company plans to develop several drugs through the preclinical studies and clinical trial phases with the goal of eventually obtaining approval from the United States Food and Drug Administration (“FDA”) for these drugs. The Company plans, when appropriate, to seek regulatory approvals in several international markets, including developed markets such as Europe, Japan, Canada, Australia, and Emerging Regions such as Southeast Asia, India, China, Central and South America, as well as the African subcontinent. Seeking these regulatory approvals would only occur when and if one or more of our drugs have significantly advanced through the FDA and international regulatory process. If and as these advances occur, the Company may attempt to partner with more established pharmaceutical companies to advance the various drugs through the approval process.
The Company intends to perform the regulatory filings for the drugs it is currently developing. The Company will develop these drugs in part via subcontracts to TheraCour, the exclusive source for these nanomaterials. The Company may manufacture these drugs itself, or under subcontract arrangements with external manufacturers that carry the appropriate regulatory licenses and have appropriate capabilities. The Company intends to distribute these drugs via subcontracts with distributor companies or in partnership arrangements. The Company plans to market these drugs either on its own or in conjunction with marketing partners. The Company also plans to actively pursue co-development, as well as other licensing agreements with other pharmaceutical companies. Such agreements may entail up-front payments, milestone payments, royalties, and/or cost sharing, profit sharing and many other instruments that may bring early revenues to the Company. Such licensing and/or co-development agreements may shape the manufacturing and development options that the Company may pursue.
Although we have been able to develop nanoviricide drug candidates for multiple indications that are safe and effective in pre-clinical studies there can be no assurance that we will have sufficient resources to be able to successfully obtain regulatory approvals, manufacture, and market these products to commence revenue-generating operations.
There can be no assurance that other developments in the field would not impact our business plan adversely. For example, successful creation and availability of an effective vaccine may reduce the potential market size for a particular viral disease, or an effective drug may be developed by competitors that becomes difficult to compete against with our limited resources. Our goal, which we can give no assurance that we will achieve, is for NanoViricides, Inc. to become the premier company developing highly safe and effective drugs that employ an integrated multiplicity of actions as enabled by our nanomedicine approach for anti-viral therapy.
In summary, we are developing and sourcing compounds and preparing nano-materials; performing experiments involving preclinical studies using cell cultures and animal models of efficacy and safety, advancing drug candidates against different indications into IND-enabling safety/toxicology studies, and we have advanced our first drug candidate for treatment of COVID into Phase Ia/Ib clinical studies. We have generated funding through the issuances of debt and the sales of securities under our shelf registration and the private placement of common stock. We have not generated any revenues and we do not expect to generate revenues in the near future. We may not be successful in developing our drugs and start selling our products when planned, or we may not become profitable in the future. We have incurred net losses in each fiscal period since inception of our operations.
Results of Operations
The Company is a biopharmaceutical company and does not have any revenue for the years ended June 30, 2024 and June 30, 2023.
Comparison of the Year End June 30, 2024 to the Year Ended June 30, 2023
Revenues - The Company is a non-revenue producing entity.
Research and Development Expenses - Research and development expenses for the year ended June 30, 2024 decreased approximately $955,000, to approximately $5,437,000 from approximately $6,392,000 for the year ended June 30, 2023. This year-to-year decrease is generally attributable to the decrease in license fees, offset by the increase in outside laboratory services.
General and Administration Expenses - General and administrative expenses increased approximately $528,000 to approximately $3,079,000 for the year ended June 30, 2024 from approximately $2,551,000 for the year ended June 30, 2023. The increase in general and administrative expenses is generally attributable to an increase in professional services including, legal, accounting and investor outreach expenditures.
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Interest Income - Interest income was approximately $272,000 and approximately $356,000 for the years ended June 30, 2024 and 2023, respectively. Interest income decreased due to lower cash balances.
Interest Expense- The Company has incurred interest expense of approximately $50,000 and $900 for the years ended June 30, 2024 and June 30, 2023 respectively. The increase in interest expense for the year ended June 30, 2024 is a result of interest expense charged pursuant to the milestone payment note with TheraCour. The interest charged pursuant to the milestone payment note was cancelled by TheraCour on October 27, 2023. The cancellation of the note interest reduced accrued expenses and increased additional paid in capital by approximately $50,000.
Income Taxes - There is no provision for income taxes due to ongoing operating losses. As of June 30, 2024, we had estimated cumulative tax benefits and development tax credits and other deferred tax credits resulting in a deferred tax asset of approximately $39,772,000. This amount has been offset by a full valuation allowance.
Net Loss - For the year ended June 30, 2024, the Company had a net loss of approximately $8,294,000, or a basic and fully diluted loss per share of $0.70 compared to a net loss of approximately $8,589,000, or a basic and fully diluted loss per share of $0.74 for the year ended June 30, 2023. The decrease in the Company’s net loss for the year ended June 30, 2024 from the year ended June 30, 2023 of $295,000 is generally attributable to the items discussed above.
Research and Development Costs
The Company does not maintain separate accounting line items for each project in development. The Company maintains aggregate expense records for all research and development conducted. Because at this time all of the Company’s projects share a common core material, the Company allocates expenses across all projects at each period-end for purposes of providing accounting basis for each project. Project costs are allocated based upon labor hours performed for each project.
The Company has signed several cooperative research and development agreements with TheraCour, and expects to enter into additional cooperative agreements with other governmental and non-governmental, academic, or commercial, agencies, institutions, and companies. There can be no assurance that a final agreement may be achieved and that the Company will execute any of these agreements. However, should any of these agreements materialize, the Company will implement a system to track these costs by project and account for these projects as customer-sponsored activities and show these project costs separately.
The following table summarizes the primary components of our research and development expenses as allocated, during the periods presented in this Annual Report on Form 10-K.
Table : R&D Costs Allocation
Year Ended | |||||||
Program |
| June 30, 2024 |
| June 30, 2023 | |||
1 | Pan-Coronavirus Drug Program (Including COVID) – NV-387 | $ | 4,937,297 | $ | 6,092,414 | ||
2 | RSV | 250,000 | 200,000 | ||||
3 | HerpeCide™ Program. Herpes Simplex virus infections (HSV-1, HSV-2) and VZV Indications: Cold Sores, Genital Ulcers, Shingles and ARN | — | 100,000 | ||||
4 | Smallpox/Mpox | 150,000 | — | ||||
5 | Influenza | 100,000 | — | ||||
Total | $ | 5,437,297 | $ | 6,392,414 | |||
As many of our programs share a substantial amount of materials as well as laboratory work, we do not maintain project-based accounting of costs at present. The table above represents estimated cost allocations for specific activities in the different programs, with the bulk of common activities reported under the “Pan-coronavirus drug program – NV-387” heading.
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Financings
On May 5, 2023, we filed a registration statement on Form S-3 (File No. 333-271706) with the Securities and Exchange Commission (the “SEC”), as amended on May 8, 2023, which registration statement was declared effective by the SEC on May 22, 2023. Under this shelf registration process, we may, from time to time, sell up to $150 million in the aggregate of shares of common stock, shares of preferred stock, debt securities, warrants and units. Approximately $145 million remains available for sale as of the date of this filing.
On or about August 1, 2023, the ATM Sales Agreement that we previously had with EF Hutton, division of Benchmark Investments, LLC and B. Riley Securities, Inc., taken together as the Sales Agent, was amended to name EF Hutton as the only sales agent (the “Agent”) and to remove B. Riley as a sales agent. On August 4, 2023, we filed a prospectus supplement relating to the issuance and sale of our common stock, par value $0.00001 per share, having an aggregate offering price of up to $5,713,022, from time to time through or to our sole sales agent, EF Hutton. These sales, if any, would have been made pursuant to the terms of the August 1, 2023 ATM Sales Agreement.
On April 5, 2024, the Company entered into a new ATM sales agreement with. E.F. Hutton Securities (now EF Hutton, LLC), the sales agent, replacing the prior August 1, 2023 sales agreement, pursuant to which the Company may offer and sell, from time to time, through or to the Sales Agents, shares of common stock having an aggregate offering price of up to $50 million (each such offering an “At-the-Market” or ATM Offering). As of June 30, 2024, the Company sold 1,308,651 shares of common stock at an average price of approximately $2.47 per share. The shares were issued pursuant to a prospectus supplement dated May 5, 2023 and filed with the Securities and Exchange Commission on May 5, 2023 in connection with the Company’s shelf registration statement on Form S-3, as amended (File No. 333-271706), which became effective on May 22, 2023. The net proceeds to the Company from the offering was approximately $3,120,000 after placement agent fees and other estimated offering expenses.
From July 1, 2024 through September 10, 2024, subsequent to the Company’s fiscal year end, the Company sold 772,836 shares of common stock at an average price of approximately $1.98 per share. The net proceeds to the Company from the offering was approximately $1,533,000 after placement agent fees and other estimated offering expenses.
Liquidity and Capital Reserves
As of June 30, 2024, we had approximately $4,798,000 in cash and cash equivalents. Our liabilities as of June 30, 2024 are approximately $1,359,000, including accounts payable of approximately $376,000 payable to third parties, accounts payable to TheraCour of approximately $720,000, accrued expenses approximately $262,000.
The Company has an accumulated deficit at June 30, 2024 of approximately $139,375,000 and net cash used in operating activities of approximately $6,316,000 for the fiscal year then ended. In addition, the Company has not generated any revenues and no revenues are anticipated in the foreseeable future. Since May 2005, the Company has been engaged exclusively in research and development activities focused on developing targeted antiviral drugs. The Company has not yet commenced any product commercialization. Such losses are expected to continue for the foreseeable future and until such time, if ever, as the Company is able to attain sales levels sufficient to support its operations.
Management believes that the Company’s cash and cash equivalents balance of approximately $4.8 million and additional capital raised of approximately $1.5 million by ATM sales of our common stock from July 1, 2024 through September 10, 2024 and the Company’s existing resources, including availability under its $3 million line of credit will not be sufficient to fund the Company’s planned operations and expenditures for at least 12 months from the date of the filing of this Form 10-K. As a result substantial doubt exists about the Company’s ability to continue as a going concern.
Management is actively exploring additional required funding through non-dilutive grants and contracts, partnering, debt or equity financing pursuant to its plan. There is no assurance that we will be successful in obtaining sufficient financing on terms acceptable to us to fund continuing operations.
The Company believes that it has several important milestones, including data from and final reports from the Phase Ia/Ib human clinical trial for the Company’s broad-spectrum, antiviral drug NV-387. This Phase Ia/Ib human clinical trial is for evaluating the safety and tolerability of two oral formulations of NV-387, namely (i) NV-CoV-2 Oral Gummies, and (ii) NV-387 Oral Syrup, as described elsewhere, with COVID as the indication. The safety and tolerability data from this clinical trial is expected to be applicable as Phase
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Ia/Ib data for other indications of NV-387 as well, including RSV, MPOX, Influenza and others. Additional milestones include Pre-IND and IND filing to the US FDA for RSV and clinical trial application for Phase II clinical trial of NV-387 for the treatment of RSV infection in adults with the goal towards further regulatory advancement and approval of NV-387 for the treatment of pediatric RSV infection. Additionally, we believe that NV-387 qualifies for a Phase II clinical trial for the treatment of MPOX infection in Central African nations under the MEURI protocol of WHO because there is no other treatment available for this epidemic that is declared by the WHO as a public health emergency of international concern (MEURI = Monitored Emergency Use of Unregistered and Investigational Interventions.). We plan on initiating the Phase II study for MPOX as soon as feasible if we get the appropriate regulatory clearances. Additionally, we continue towards developing the Pre-IND and IND applications for a Phase IIa clinical trial of NV-387 for the treatment of RSV infection in adults, to be followed by a Phase IIb/III clinical trial of NV-387 for the treatment of RSV infection in hospitalized pediatric patients. To this end, we are also evaluating the possibility of a Phase IIa clinical trial of a RSV Infection Challenge in Humans.
As these milestones are achieved, the Company would likely experience improvement in the liquidity of the Company’s stock, and such improvement, if any, would enhance the Company’s ability to raise funds on the public markets at terms that may be favorable to the terms offered at present.
Management believes that it has on-going access to the capital markets including the “At-The-Market” (ATM) agreement with EF Hutton, the Sales Agent, that became active around April 5, 2024. However, we cannot provide assurance that the Company’s plans will not change or that changed circumstances will not result in the depletion of its capital resources more rapidly than it currently anticipates.
Requirement for Additional Capital
As of June 30, 2024 we have a cash balance of approximately $4,798,000 and raised an approximate additional $1.5 through September 10, 2024 through ATM sales of our common stock.
We believe we will need additional funding to continue further development of our drug candidates through later stages of human clinical trials into regulatory approvals if we do not form a collaborative licensing or partnership agreement with a party that would provide such funding such as Big Pharma.
These anticipated expenses for the subsequent period commencing on July 1, 2024 can be summarized as follows:
| 1. | Planned costs for remaining activities in the Phase Ia/Ib human clinical trial of NV-CoV-2 Oral Syrup and NV-CoV-2 Oral Gummies, including bioanalytical activities and reports. |
| 2. | Planned costs for the preparation of regulatory documents for filing an IND with the FDA to enter Phase II clinical trial for NV-387 as treatment of RSV infection in humans. These costs include staffing costs for the scientific staff and consulting firms to assist with FDA compliance, as well as material characterization, pharmaco-kinetic, pharmaco-dynamic and toxicology studies, and other items related to FDA compliance, as required for development of necessary data. We believe that we will be eligible to enter Phase II clinical trial for RSV indication based on the preliminary safety and tolerability data from the Phase Ia/Ib clinical trial; |
| 3. | Additional R&D Expenditures for RSV Project including regulatory non-clinical studies to enable treatment of children with NV-387. |
| 4. | Drug Substance and Drug Product Manufacturing costs, and |
| 5. | Corporate overhead. This includes budgeted office salaries, legal, accounting, investor relations, public relations, business development, and other costs expected to be incurred by being a public reporting company. |
As our programs mature and as we are able to move additional drug candidates into human clinical trials we will continue to require additional funding for such activities. The estimates assume that our drug candidates demonstrate effectiveness in humans that is consistent with the activity observed in animal studies, and therefore would require relatively few patients in each arm of each trial in order to establish statistically significant results.
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We believe that as our programs mature towards FDA approval, the Company’s market capitalization should improve substantially, based on market capitalizations of comparable public companies in clinical stages.
Management believes that as a result of the management plan, our existing resources and access to the capital markets will permit us to fund planned operations and expenditures for at least one year from the filing of the 10-K. However, we cannot provide assurance that our plans will not change or that changed circumstances will not result in the depletion of our capital resources more rapidly than we currently anticipate.
The Company has limited experience with pharmaceutical drug development. Thus, our budget estimates are not based on experience, but rather based on advice given by our associates and consultants. As such, these budget estimates may not be accurate. In addition, the actual work to be performed is not known at this time, other than a broad outline, as is normal with any scientific work. As further work is performed, additional work may become necessary or change in plans or workload may occur. Such changes may have an adverse impact on our estimated budget. Such changes may also have an adverse impact on our projected timeline of drug development.
Our strategy is to minimize capital expenditure. We therefore rely on third party collaborations for the testing of our drug candidates. We continue to engage with our previous collaborators.
Management further intends to use capital and debt financing, as required, to fund the Company’s operations. There can be no assurance that we will be able to obtain the additional capital resources, non-dilutive financings, grants and contracts, or pharmaceutical partnerships.
We are considered to be a clinical drug development stage company and will continue in the clinical drug development stage until we can get regulatory approvals and thereafter generate revenues from the sales of our products or services.
CRITICAL ACCOUNTING POLICIES AND ESTIMATES
Accounting for Stock Based Compensation – The Company follows the provisions of ASC 718 – Stock Compensation, which requires the measurement of compensation expense for all shared-based payment awards made to employees, non-employee directors, and non-employees including employee stock options. Shared-based compensation expense is based on the grant date fair value estimated in accordance with the provisions of ASC 718 and is generally recognized as an expense over the requisite service period, net of forfeitures.
RECENT ACCOUNTING PRONOUNCEMENTS
Recently Issued Accounting Pronouncements
The Company considers the applicability and Impact of all Accounting Standard Updates (“ASU’s”). ASU’s not discussed below were assessed and determined to be either not applicable or are expected to have minimal impact on the Company’s financial statements.
ASU 2023-09 Income Taxes (Topic 740) Improvements to Income Tax Disclosures. The amendments in this Update require that public business entities on an annual basis (1) disclose specific categories in the rate reconciliation and (2) provide additional information for reconciling items that meet a quantitative threshold (if the effect of those reconciling items is equal to or greater than 5 percent of the amount computed by multiplying pretax income (or loss) by the applicable statutory income tax rate). Additionally, the ASU requires all entities to disclose the amount of income taxes paid disaggregated by federal, state, and foreign taxes, as well as individual jurisdictions where income taxes paid are equal to or greater than 5 percent of total income taxes paid. ASU 2023-09 is effective for annual periods beginning after December 31, 2024. Early adoption is permitted and this ASU should be applied on a prospective basis. While the Company is currently evaluating the adoption impact of this ASU on its financial statements, the preliminary assessment is that the adoption of this standard is not expected to have a material effect on the Company’s financial statements and the Company’s disclosures.
ASU 2023-07 Segment Reporting (Topic 280): Improvements to Reportable Segment Disclosures. The requirements of this update require disclosure of significant segments expenses and increase the frequency of segment reporting to interim periods. The ASU is effective for all public companies for fiscal years beginning after December 15, 2023 and for interim period beginning after December 15, 2024. Early adoption is permitted and is applicable to all periods presented in the financial statements unless retrospective application is impracticable. While the Company is currently evaluating the adoption impact of this ASU on its financial statements, the preliminary
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assessment is that the adoption of this standard is not expected to have a material effect on the Company’s financial statements and the Company’s disclosures.
There have been certain changes in ASU 2020-06, Debt - Debt with Conversion and Other Options (Subtopic 470-20) and Derivatives and Hedging - Contracts in Entity’s Own Equity (Subtopic 815-40) - Accounting for Convertible Instruments and Contracts in an Entity’s Own Equity, which simplifies accounting for convertible instruments by removing major separation models required under GAAP. The ASU also removes certain settlement conditions that are required for equity-linked contracts to qualify for the derivative scope exception, and it also simplifies the diluted earnings per share calculation in certain areas. The Company adopted this guidance on July 1, 2023 using the modified retrospective method. The adoption of this standard did not have a material effect on the Company’s financial statements.
ITEM 7A. QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK
We are a smaller reporting company as defined by 17 C.F.R. 229 (10) (f) (i) and are not required to provide information under this item.
ITEM 8. FINANCIAL STATEMENTS AND SUPPLEMENTARY DATA
The information required by Item 8 appears after the signature page to this report.
ITEM 9. CHANGES IN AND DISAGREEMENTS WITH ACCOUNTANTS ON ACCOUNTING AND FINANCIAL DISCLOSURES
None.
ITEM 9A. CONTROLS AND PROCEDURES.
Evaluation of Disclosure Controls and Procedures
Disclosure controls and procedures (as defined in Rules 13a-15(e) and 15(d)-15(e) under the Securities Exchange Act of 1934, as amended (the “Exchange Act”) are controls and other procedures that are designed to ensure that information required to be disclosed by us in the reports that we file or submit under the Exchange Act is recorded, processed, summarized and reported within the time periods specified in the rules and forms of the Securities and Exchange Commission (the “SEC”). Disclosure controls and procedures include, without limitation, controls and procedures designed to ensure that information required to be disclosed in the reports that we file under the Exchange Act is accumulated and communicated to our management including our chief executive officer and our chief financial officer, as appropriate, to allow timely decisions regarding required disclosure. In designing and evaluating the disclosure controls and procedures, management recognizes that any controls and procedures, no matter how well designed and operated, can provide only reasonable assurance of achieving the desired control objectives. Due to the inherent limitation of controls systems, not all misstatements may be detected. These inherent limitations include the realities that judgments in decision-making can be faulty and that breakdowns can occur because of a simple error or mistakes. Additionally, controls can be circumvented by the individual acts of some persons, by collusion of two or more people, or by management override of the control. Controls and procedures can only provide reasonable, not absolute, assurance that the above objectives have been met.
As of June 30, 2024, an evaluation was carried out under the supervision and with the participation of our management, of the effectiveness of our disclosure controls and procedures (as defined in Rule 13a-15(e) and Rule 15d-15(f) under the Securities Exchange Act of 1934). Based on this evaluation, our Chief Executive Officer and Chief Financial Officer have concluded that the Company’s disclosure controls and procedures are effective as of June 30, 2024.
Management’s Report on Internal Control Over Financial Reporting
Management is responsible for establishing and maintaining adequate internal control over financial reporting, as such term is defined in Rules 13a-15(f) and 15d-15(f) under the Exchange Act. Under the supervision and with the participation of management, including our Chief Executive Officer and Chief Financial Officer, we conducted an evaluation of the effectiveness, as of June 30, 2024, of our internal control over financial reporting based on the framework in 2013 Internal Control – Integrated Framework issued by the
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Committee of Sponsoring Organizations of the Treadway Commission. Based on our evaluation under this framework, our management concluded that our internal control over financial reporting was effective as of June 30, 2024.
Management has remediated the previously identified material weakness by maintaining effective procedures pertaining to the timely review of the Form 10-K. Specifically, the Company has established procedures for thorough review by Management, on a timely basis, of the Form 10-K. Management’s responsibility is to oversee that the Company is capable of developing accurate and timely financial information.
Changes in Internal Controls over Financial Reporting
Other than what was described below, there were no material changes in our system of internal control over financial reporting (as defined in Rule 13a-15(f) under the Securities Exchange Act of 1934) during the three months ended June 30, 2024 that has materially affected, or is likely to materially affect, our internal control over financial reporting. During the year ended June 30, 2024, we have implemented changes in our internal control over financial reporting to remediate the prior years’ material weakness.
ITEM 9B. OTHER INFORMATION
On August 5, 2024, NanoViricides, Inc. consummated an Extension Agreement (the “Extension”) of the Employment Agreement with Dr. Anil Diwan entered into on July 1, 2018 (the “Employment Agreement”) to continue to serve as the President of the Company, effective July 1, 2024 under the same general terms and conditions. The Extension provides that Dr. Diwan will continue to serve as the Company’s President until June 30, 2025 at a base annual base salary of $400,000. Dr. Diwan shall be entitled to participate in all fringe benefits the Company provides for its employees generally and such other benefits as the Company provides for its senior executives. In addition, the Company shall maintain a Term Life Insurance policy for Dr. Diwan, valued at $2 million, of which $1 million shall be assigned to the Company and the remaining balance to Dr. Diwan’s estate. In addition, as an incentive towards the ultimate success of the Company, and to provide leadership authority to Dr. Diwan, the Company granted 10,204 shares of the Company’s Series A preferred stock, par value $0.00001 per share to Dr. Diwan. Dr. Diwan’s rights in the shares shall vest in equal, quarterly installments commencing on September 30, 2024 and fully vest on June 30, 2025. The Company will recognize non-cash compensation expense related to the issuance of the Series A Preferred Stock of $49,795 during the year ended June 30, 2025. Dr. Diwan will be eligible to receive severance if he is terminated by the Company other than for cause in which event the Company shall pay to Dr. Diwan an amount equal to six (6) month’s salary as severance compensation (without regard to compensation or benefits Dr. Diwan receives from any other source). Dr. Diwan shall be eligible for all benefits during this six (6) month period including bonuses, vesting of previously awarded stock options, health care insurance and other fringe benefits that have been ongoing. The Company may elect to pay such severance compensation in a lump sum or in equal payments over the six month period.
On August 5, 2024, NanoViricides, Inc. consummated an Extension to the CFO Agreement with its Chief Financial Officer Meeta Vyas effective July 1, 2024 (the “CFO Agreement Extension”) of the agreement originally entered into on May 30, 2013. The agreement is renewable on an annual basis. The original agreement provided for a term of three years with a base compensation of $9,000 per month and 129 shares of Series A Preferred Stock, also on a monthly basis. On January 1, 2015, her cash compensation was increased to $10,800 per month. The CFO Agreement Extension is for a period of one year from July 1, 2024 through June 30, 2025 under the same general terms as the prior CFO Agreement with amendments to provide that the CFO shall be reimbursed up to 50% of all costs of Health Insurance including any Medical, Dental, and any and all parts and subparts of Medicare Insurance that she subscribes to, not to exceed $2,500 per month.
By signing on September 23, 2024 and being effective as of September 20, 2024 the Company and its President and CEO, Dr. Anil R. Diwan, entered into an Amendment to Line of Credit Agreement whereby Dr. Diwan agreed to amend certain provisions of the standby Line of Credit with the Company to increase the maximum loan amount from $2,000,000 to $3,000,000 and to extend the maturity date for all amounts outstanding under the under the Line of Credit, including principal, accrued interest and other fees and charges, to March 31, 2026. Amounts drawn down under the Line of Credit shall bear interest at a fixed rate of 12%. Advancements under the Line of Credit are collateralized by an Open End Mortgage Deed on the Company’s real property at 1 Controls Drive, Shelton, Connecticut and a Chattel Mortgage (U.C.C-1 filing) against the Company’s equipment and fixtures. Any draw down under the Line of Credit requires the approval of the Company’s Board of Directors. The Amendment to the Line of Credit Agreement became effective as of September 22, 2024.
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By signing on September 23, 2024, and being effective as of September 20, 2024, the Company entered into a “Memorandum of Understanding for All Antivirals Drug Development” (the “MOU”) with TheraCour that granted to the Company, a limited, non-assignable, non-sublicensable, exclusive right of first refusal to license to any antiviral drugs in development or to be developed by TheraCour for research and development purposes only, for all as-yet unlicensed viral infection treatment indications. The MOU also clarified the roles and responsibilities of the parties and essentially codified the process that the parties have adopted since inception. The MOU further codified the treatment of all future milestone payments arising from any current or future license agreements to TheraCour to be consistent with the principles adopted in the February 12, 2024 Amendment to the COVID License Agreement.
(a) None.
(b) Corporate Governance
During the period covered by this Annual Report on Form 10-K, there were no changes to the procedures by which security holders may recommend nominees to the Company’s Board of Directors.
(c) Insider Trading Arrangements and Policies
During the three months ended June 30, 2024,
The Company has adopted insider trading policies and procedures governing the purchase, sale and other disposition of its securities by directors, officers and employees that management believes are reasonably designed to promote compliance with insider trading laws, rules, and regulations, and any listing standards applicable to the company. A copy of the Company’s insider trading policy is attached as Exhibit 19.1 hereto.
ITEM 9C. DISCLOSURE REGARDING FOREIGN JURISDICTIONS THAT PREVENT INSPECTIONS.
Not applicable.
ITEM 10. DIRECTORS, EXECUTIVE OFFICERS AND CORPORATE GOVERNANCE
The following table sets forth the names and ages of our current directors and executive officers, their principal offices and positions. Each executive officer holds the office until he/she resigns, is removed by the Board or his/her successor is appointed by the Board upon appropriate due diligence. Directors are elected biannually by our stockholders at the annual meeting. Each director holds his/her office until the successor is elected and qualified or his/her earlier resignation or removal.
The following persons are the directors and executive officers of our Company:
Name |
| Age |
| Title |
Anil Diwan, PhD. | 65 |
| President and Executive Chairman of the Board | |
Makarand “Mak” Jawadekar |
| 73 |
| Director, Independent |
Theodore Edward (“Todd”) Rokita |
| 54 |
| Director, Independent |
Brian Zucker |
| 62 |
| Director, Independent |
Meeta Vyas |
| 65 |
| Chief Financial Officer |
Anil Diwan, PhD, age 65, has been President and the Chairman of the Board of Directors of the Company since consummation of the merger on June 1, 2005. Dr. Diwan simultaneously therewith and since its formation, has also served as the Chief Executive Officer and Director of AllExcel, Inc. (from 1995 to the present) and TheraCour Pharma, Inc. (from 2004 to the present) and is the original inventor of the technologies licensed to NanoViricides Inc., as well as the TheraCour polymeric micelle technologies and products based on
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them. Since 1992, he has researched and developed TheraCour nanomaterials. Dr. Diwan was the first to propose the development of novel pendant polymers for drug delivery that led to an explosion of research in pharmacological applications of polymeric micelles. Dr. Diwan has won over 12 NIH SBIR grants. Dr. Diwan holds several issued patents, and three PCT international patent applications in various stages of prosecution in a number of countries, and also has several additional patentable discoveries. Dr. Diwan has held several scholastic distinctions, including an All-India 9th rank on the Joint Entrance Examination of all IIT’s. He holds a Ph.D. in Biochemical Engineering from Rice University (1986) and B.S. in Chemical Engineering from Indian Institute of Technology (IIT) Bombay (1980). We concluded Dr. Diwan’s experience plus his status as creator of the Company’s technologies render him uniquely qualified to serve in these capacities.
Makarand “Mak” Jawadekar, 73, was appointed as an Independent Member of the Board of Directors, and serves as a member of the Company’s Audit, Compensation and Nominating Committees. Dr. Jawadekar has over 35 years of experience in the pharma industry spanning both business and research activities. Dr. Jawadekar has extensive experience in joint ventures, alliance management, contracting, outsourcing, benchmarking, performance metrics, pharmaceutical research and development, drug delivery technologies, formulations, clinical supply manufacturing and packaging, clinical trial materials, pharmaceutics, and pharmaceutical sciences. He also has deep knowledge and global experience working across the United States, Europe, India, and other parts of Asia, including Japan and China. He has helped create several pharma R&D partnerships, joint ventures, and collaborations during his career. Dr. Jawadekar serves as a strategic advisor to pharmaceutical and biotechnology companies through his independent consultancy, founded in 2010, after retiring from Pfizer, Inc., as Director, Portfolio Management & Analytics, and as Vice President, Asia Colleague Resource Group, in Pfizer Global R&D division. From 1982 to 2010, Dr. Jawadekar held roles of increasing responsibility in technical, management, and business development positions at Pfizer, in the areas of Drug Delivery Technology Assessment, Strategic External Alliance Management, Strategic CMC, Pharma R&D, Clinical Manufacturing, Manufacturing Technology Transfer and Scale-up, beginning as a research scientist in formulations development. Dr. Jawadekar serves on the boards of two public companies, namely: Preveceutical Medical Inc. (CSE: PREV), and Cardax, Inc. (OTC: CDXI), as an independent board member. He also serves on the Strategic and Scientific Advisory Boards of several companies, including Actinium Pharma (NYSE-Amer.: ATNM), Saama Technologies, Inc., and Diant Pharma, Inc., as well as Tonino Lamborghini SpA, Italy. He also serves as a member of the Board of Directors at Abilities Inc., a New York based, non-profit organization. Mak holds a Ph.D. in Pharmaceutics from the University of Minnesota, and was honored with an honorary D.Sc. degree by DYP Mumbai University, recommended by the President of India. The Company believes Dr. Jawadekar’s long history as a pharmaceutical and biotech professional, particularly in alliance development and management, in business strategy, and in pharmaceutical sciences and CMC in drug delivery, render him well qualified to serve as an independent member of the Board of Directors.
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Theodore Edward (“Todd”) Rokita, 54, Director. Mr. Rokita was appointed as an Independent Member of the Board of Directors, and serves as a member of the Company’s Audit, Compensation and Nominating Committees. Mr. Rokita currently serves as the Attorney General of the State of Indiana, an elected office. Prior to that, he was co-owner and General Counsel and Vice President of External Affairs, Apex Benefits Group, Inc. where he served as a member of the executive team and the corporate board. He was responsible for legal strategies, including litigation, acquisitions and other matters, primarily involving ERISA and employment laws, and is responsible for the regulatory compliance of Apex’s clients. In his role, he served as the public face of the company and was responsible for external messaging, events, and other outreach functions. Mr. Rokita was elected to the United States Congress as a Representative from the State of Indiana, serving four terms from 2011 to 2019. As a member of the US Congress, he served as the Chairman, House Subcommittee on Early Childhood, Elementary, and Secondary Education, as the Vice Chairman, House Committee on the Budget, as a Member, House Committee on Education and the Workforce (Health, Employment, Labor and Pensions subcommittee), as a Member, House Committee on Transportation and Infrastructure, (aviation, railroad, and pipeline subcommittees), as a Member, Committee on House Administration (2011-2014), as a Member, Steering Committee (2011-2012) (elected by peers to make their committee assignments), and also as a Director, Republican Study Committee (2014- 2019) (group affecting policy direction and tactics). Prior thereto Mr. Rokita served as the Secretary of State, Indiana, from 2003 to 2011) and as Chief Operating Officer and General Counsel, Office of Indiana Secretary of State from 2000-2002. Mr. Rokita serves or has served as a Member of the Board of Directors on a number of commercial and charitable institutions, among them: Aircraft Owners and Pilots Association Foundation, (2014-Present); Achieve International, Indianapolis, IN (helping troubled teens), (2012-2018); Saint Vincent Hospital Foundation, (2011-2013); Indiana Council for Economic Education, (2004-2010). Mr. Rokita also serves or has served as an Advisory Board Member for several institutions, among them: Merchandise Warehouse, Inc. Indianapolis, IN, (2019-Present); WishBone Medical, Inc., Warsaw, IN, (2019-Present); and Acel 360, Inc., Reston, VA (2019-Present). Mr. Rokita has also served as a Member, Board of Trustees of Saint Joseph’s College, Rensselaer, IN, (2007-2017). In addition to his public service, Mr. Rokita is involved as a Volunteer for the Veterans Airlift Command and Angel Flight, Volunteer (2011- Present), actively flying missions for Veterans Airlift Command and other similar non-profits dedicated to providing free air transportation to children and post-9/11 combat wounded veterans and their families for medical and other compassionate purposes. Mr. Rokita holds a Bachelor of Arts degree from Wabash College in Crawfordsville, Indiana, where he was an Eli Lilly Fellow and a Juris Doctor from IUPUI’s Indiana University Robert H. McKinney School of Law. The Company believes Mr. Rokita’s long history as an executive and as a board member of a number of institutions and his long record of public service, uniquely qualifies him to serve as a member of the Company’s Board of Directors.
Brian Zucker, 62, Director. Since October 2011, Mr. Zucker has been a Partner at CFO Financial Partners, LLC, a firm that provides outsourced CFO (Chief Financial Officer), Controller and Financial Operations services as well as back office reporting and bookkeeping services for public and private companies, broker dealers, hedge funds, and family offices and high net worth individuals, among others. Mr. Zucker also serves as the CFO and Financial Operations Principal for numerous broker dealers and hedge funds. In addition to and simultaneously therewith, Mr. Zucker has served as a Partner at RRBB Accountants & Advisors, (aka Rosenberg Rich Baker Berman & Co.), a full-service accounting, advisory and consulting firm located in Central New Jersey. Mr. Zucker has over thirty years of experience as a CPA specializing in the securities industry. From 1983 through 1986, Mr. Zucker was a Senior Consultant at Deloitte Haskins and Sells and at Price Waterhouse from January 1987 through September 1989. He has previously served as the President and Chairman of Atlantis Business Development Corp. (ABDV), CFO of Natcore Solar Technology, Inc. (NTCXF) and as a Managing Director of American Frontier Financial Corp. (EVIS). He is on the Board of Directors of National Investment Banking Association (NIBA). Mr. Zucker obtained a B.S. in Public Accounting from Pace University. The Company believes Mr. Zucker’s extensive career as a public accountant and experience providing sophisticated accounting services to public companies and broker dealers, render him well qualified to serve as an independent member of the Board of Directors, as well as its Audit, Compensation, Nominating and Governance Committees. Mr. Zucker was appointed as a director in 2020 and as Chair of the Audit Committee in 2022.
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Meeta Vyas, SB, MBA, 65, is known as a strong leader with board level experience and successful achievements as a Senior Executive in a broad range of entities including publicly listed corporations, non-revenue generating entities, and medium to large size companies. Ms. Vyas has over twenty-five years of experience in performance and process improvement of both publicly listed companies and non-revenue producing entities, in areas ranging from Finance and Operations to Strategy and Management. Meeta holds the distinction of being the first Indian woman to be named CEO of a publicly listed U.S. corporation, Signature Brands, Inc., best known for “Mr. Coffee” and “Health-O-Meter” brand products. As CEO, acting COO and Vice Chairman of the Board of Signature Brands, Inc., she was responsible for the development and implementation of a turnaround plan, resulting in Signature’s return to profitability and growth. Later, as the CEO of the World-Wide Fund for Nature - India (WWF-India) and then as a Vice President of the National Audubon Society (USA), both non-revenue generating entities, Meeta successfully raised unrestricted funding that significantly exceeded annual requirements and also instituted financial processes to measure a variety of performance metrics. Earlier in her career, she was responsible for designing the strategy and initiating the implementation plan for the highly successful information technology outsourcing program at General Electric (“GE”). Also at GE, Ms. Vyas ran GE Appliances’ Range Products business unit having revenues exceeding $1 billion where her team doubled operating income in less than two years. Prior to that, as a management consultant with McKinsey and Company, she served publicly listed companies in chemicals, industrial, and technology markets, primarily focusing on growth strategies, valuations, post-merger integrations, and logistics operations. Ms. Vyas is married to Anil Diwan, the Company’s President and Chairman and principal shareholder of TheraCour Pharma, Inc. Ms. Vyas holds a MBA in Finance from Columbia University’s Graduate School of Business, and a SB in Chemical Engineering from the Massachusetts Institute of Technology. We concluded that Ms. Vyas’ experience and training render her qualified to serve as the Company’s Chief Financial Officer. Meeta Vyas has been the Company’s Chief Financial Officer since 2013.
AUDIT COMMITTEE
On November 13, 2020 Brian Zucker was appointed as independent director and member of the Audit Committee. Due to his education and extensive experience as a Certified Public Accountant, Mr. Zucker meets the criteria of an independent director and an “Audit Committee Financial Expert” as provided in Release 33-8173 and 34-47235. In 2022 Brian Zucker was appointed Chairman of the Audit Committee.
CODE OF ETHICS
We have adopted a code of ethics meeting the requirements of Section 406 of the Sarbanes-Oxley Act of 2002. We believe our code of ethics is reasonably designed to deter wrongdoing and promote honest and ethical conduct; provide full, fair, accurate, timely and understandable disclosure in public reports; comply with applicable laws; ensure prompt internal reporting of violations; and provide accountability for adherence to the provisions of the code of ethic. Our code of ethics is filed as an exhibit to this Form 10-K.
INSIDER TRADING POLICY
We have adopted an Insider Trading Policy that provides guidance to employees (including officers) and directors with respect to transactions in the Company’s securities. The Insider Trading Policy is designed to promote compliance with insider trading laws, rules and regulations and any listing standards applicable to the Company. The policy also prohibits directors, officers and other employees from purchasing financial instruments (including prepaid variable forward contracts, equity swaps, collars, and exchange funds), or otherwise engaging in transactions, that hedge or offset, or are designed to hedge or offset, any decrease in the market value of our equity securities without our prior approval.
A copy of the Company’s Insider Trading Policy is filed as Exhibit 19.1 to this Annual Report on Form 10-K.
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ITEM 11. EXECUTIVE COMPENSATION
The following table reflects all forms of compensation for the years ended June 30, 2024, and 2023.
Name and |
|
|
|
|
| Stock |
|
|
| All Other |
|
| ||||||||
Principal | Bonus | Award(s) | Option | Compensation |
| |||||||||||||||
Position |
| Year |
| Salary |
| ($) |
| ($) |
| Awards |
| ($) |
| Total ($) | ||||||
Anil Diwan |
| 2024 | $ | 400,000 | $ | — | $ | 32,498 | — | $ | — |
| $ | 432,498 | ||||||
CEO, President, Director |
| 2023 | $ | 400,000 | $ | — | $ | 43,721 | — | $ | — |
| $ | 443,721 | ||||||
Meeta Vyas |
| 2024 | $ | 129,600 | $ | — | $ | 5,907 |
| — | $ | — | $ | 135,507 | ||||||
CFO |
| 2023 | $ | 129,600 | $ | — | $ | 7,748 |
| — | $ | — | $ | 137,348 | ||||||
The following table sets forth for each named executive officer certain information concerning equity awards as of June 30, 2024.
|
|
|
|
|
|
|
|
|
|
|
|
|
| Equity | |||
Incentive | |||||||||||||||||
Equity | Plan | ||||||||||||||||
Incentive | Awards: | ||||||||||||||||
Plan | Market or | ||||||||||||||||
Number | Market | Awards: | Payout | ||||||||||||||
of | Value of | Number of | Value of | ||||||||||||||
Shares | Shares | Unearned | Unearned | ||||||||||||||
Number of | Number | or Units | or Units | Shares, | Shares, | ||||||||||||
Securities | of Securities | of Stock | of Stock | Units or | Units or | ||||||||||||
Underlying | Underlying | that | that | Other | Other | ||||||||||||
Name and | Unexercised | Unexercised | Option | Option | Have | Have | Rights that | Rights that | |||||||||
Principal | Options | Options | Exercise | Expiration | Not | Not | Have Not | Have Not | |||||||||
Position |
| Exercisable |
| Unexercisable |
| Price ($) |
| Date |
| Vested |
| Vested |
| Vested |
| Vested | |
Anil Diwan, President, Director, and CEO |
| — |
| — | $ | — |
| — |
| — |
| — |
| — |
| — | |
Meeta Vyas Chief Financial Officer |
| — |
| — | $ | — |
| — |
| — |
| — |
| — |
| — | |
COMPENSATION OBJECTIVES
We believe that the compensation programs for the Company’s executive officers should reflect the Company’s performance and the value created for the Company’s stockholders. In addition, the compensation programs should support the short-term and long-term strategic goals and values of the Company, and should reward individual contributions to the Company’s success. Our compensation plans are consequently designed to link individual rewards with Company’s performance by applying objective, quantitative factors including the Company’s own business performance and general economic factors. We also rely upon subjective, qualitative factors such as technical expertise, leadership and management skills, when structuring executive compensation in a manner consistent with our compensation philosophy.
ELEMENTS OF COMPENSATION
BASE SALARY. All full-time executives are paid a base salary. Base salaries for our executives are established based on the scope of their responsibilities, professional qualifications, academic background, and the other elements of the executive’s compensation, including stock-based compensation. However, at this time current total annual compensation is not in line with comparable companies, because our philosophy was to pay modest salaries with minimum bonuses to conserve capital resources for future company growth. Our intent is to set executives’ base salaries near the median of the range of salaries for executives in similar positions with similar responsibilities at comparable companies, in line with our compensation philosophy. Base salaries are reviewed annually, and may be increased to align salaries with market levels after taking into account the subjective evaluation described previously.
EQUITY INCENTIVE COMPENSATION. We believe that long-term performance is achieved through an ownership culture participated in by our executive officers through the use of stock-based awards. Currently, we do not maintain any incentive compensation plans based on pre-defined performance criteria. The Board of Directors has the general authority, however, to award equity incentive compensation, i.e. stock options, to our executive officers in such amounts and on such terms as the committee
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determines in its sole discretion. The Board of Directors does not have a determined formula for determining the number of options available to be granted. The Board of Directors will review each executive’s individual performance and his or her contribution to our strategic goals periodically. Our Board of Directors grants equity incentive compensation at times when we do not have material non-public information to avoid timing issues and the appearance that such awards are made based on any such information.
DETERMINATION OF COMPENSATION
The Company’s executive compensation program for the named executive officers (NEOs) is administered by the Board of Directors. The Board of Directors makes independent decisions about all aspects of NEO compensation, and takes into account compensation data and benchmarks for comparable positions and companies in different applicable geographical areas. The Compensation Committee of the Board assists the Board in achieving these objectives.
ERRONEOUS COMPENSATION RECOVERY POLICY
The Company adopted an Erroneous Compensation Recovery Policy in order to comply with NYSE Rule 811 and Rule 10D-1 under the Exchange Act. In the event the Company is required to prepare an accounting restatement to correct an error in previously issued financial statements that is material to the previously issued financial statements or that would result in a material misstatement if the error were corrected in the current period or left uncorrected in the current period, subject to the terms of the policy, the Company must recover reasonably promptly from its current and former executive officers the amount of any erroneously awarded incentive based compensation received on or after October 2, 2023 and during the three (3) years preceding the date that the Company is required to prepare such accounting restatement. The Erroneous Compensation Recovery Policy has been filed as Exhibit 97.1 of this Annual Report.
ITEM 12. SECURITY OWNERSHIP OF CERTAIN BENEFICIAL OWNERS, MANAGEMENT, AND RELATED STOCKHOLDERS MATTERS.
The following table sets forth, as of June 30, 2024, certain information regarding the beneficial ownership of the Company’s Common Stock and Series A Convertible preferred stock outstanding by (i) each person known to us to own or control 5% or more of our Common Stock, (ii) each of our directors, (iii) each of our “Named Executive Officers” (as defined in Item 402(a)(3) of Regulation S-K) and (iv) our current Named Executive Officers and directors as a group. Unless otherwise indicated, each person named in the table below has sole voting and investment power with respect to the shares beneficially owned.
|
|
|
| Series A Convertible |
| ||||||
Common Stock | Preferred Stock(1) |
| |||||||||
Amount and | Amount and | Percent |
| ||||||||
Nature of | Percent | Nature of | Percent | of |
| ||||||
Beneficial | of | Beneficial | of | Voting |
| ||||||
Name and Address of Beneficial Owner |
| Owner(2) |
| Class(2) |
| Owner(2) |
| Class(2) |
| Power(3) |
|
TheraCour Pharma, Inc.(4) |
| 470,961 |
| 3.6 | % | 681,859 |
| 76.4 | % | 31.2 | % |
Anil Diwan(4)(5) |
| — |
| — |
| 116,683 |
| 13.1 | % | 5.0 | % |
Meeta Vyas(6) |
| 7,129 |
| — |
| 17,140 |
| 1.9 | % | 0.8 | % |
Makarand Jawadekar |
| 30,496 |
| 0.2 | % | — |
| — |
| 0.1 | % |
Theodore Rokita |
| 29,969 |
| 0.2 | % | — |
| — |
| 0.1 | % |
Brian Zucker |
| 28,746 |
| 0.2 | % | — |
| — |
| 0.1 | % |
All Directors and Executive Officers as a Group (6 persons) |
| 567,301 |
| 4.2 | % | 815,682 |
| 91.4 | % | 37.3 | % |
| (1) | The Series A Convertible preferred shares (the “Series A”) vote at the rate of nine shares of common stock per each share of Series A and is convertible into three and one half shares of common stock upon a change in control of the Company. |
| (2) | For each shareholder, the calculation of percentage of beneficial ownership is based upon 13,144,055 shares of common stock and 892,625 shares of Series A preferred stock outstanding, and shares of common stock subject to options, warrants and/or conversion rights held by the shareholder that are currently exercisable or exercisable within 60 days, which are deemed to be outstanding and to be beneficially owned by the shareholder holding such options, warrants, or conversion rights. The percentage ownership of any |
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| shareholder is determined by assuming that the shareholder has exercised all options, warrants and conversion rights to obtain additional securities and that no other shareholder has exercised such rights. |
| (3) | Amount stated reflects the number of votes held on all matters submitted to a vote of our stockholders. |
| (4) | Anil Diwan, the Company’s President and Chairman, also serves as the CEO and Director of TheraCour Pharma Inc. and owns approximately 90% of the outstanding capital stock of TheraCour. Anil Diwan has both investment and dispositive power over the NanoViricides shares held by TheraCour Pharma, Inc. |
| (5) | Does not include 470,961 shares of common stock nor the 681,859 shares of Series A preferred stock owned by TheraCour Pharma, Inc. which votes at the rate of nine shares of common stock for each Share of Series A preferred stock (the “Series A preferred stock”), over which Anil Diwan holds voting and dispositive power. Does not include the beneficial ownership of the securities held by Meeta Vyas, the wife of Anil Diwan, and Armstoo Irrevocable Trust over which Dr. Diwan disclaims beneficial ownership and voting and dispositive control. |
| (6) | Includes 1,072 shares held by Connect Capital LLC, over which Ms. Vyas holds voting and dispositive power. Does not include the beneficial ownership of the securities held by Anil Diwan, the husband of Ms. Vyas, TheraCour, nor 94,471 common shares held by Armstoo Irrevocable Trust over which Ms. Vyas disclaims beneficial ownership and voting and dispositive control. |
EMPLOYMENT AGREEMENTS
The Company and Dr. Diwan entered into an extension of employment agreement effective July 1, 2018 for a term of three years. Dr. Diwan’s will be paid an annual base salary of $400,000. Additionally, Dr. Diwan was awarded a grant of 26,250 shares of the Company’s Series A preferred stock. 8,750 shares vest equally on June 30, 2019, 2020 and 2021. Any unvested shares are subject to forfeiture. On September 24, 2021, the Company and Dr. Diwan entered into extension of the employment agreement for a period of one year from July 1, 2021 through June 30, 2022 under the same general terms and conditions. The Company granted Dr. Diwan an award of 10,204 shares of the Company’s Series A Preferred Stock. The shares will be deemed partially vested in quarterly installments following the grant date and fully vested on June 30, 2022. The employment agreement is renewable annually with approval by the Board of Directors. On October 6, 2022, the Company agreed to the extension of the employment agreement for a period of one year from July 1, 2022 through June 30, 2023 under the same general terms and conditions. The Company granted Dr. Anil Diwan an award of 10,204 shares of the Company’s Series A Preferred Stock. The shares will be deemed partially vested in quarterly installments following the grant date and fully vested on June 30, 2023. As of July 1, 2023, the Company agreed to the extension of the employment agreement for a period of one year from July 1, 2023 through June 30, 2024 under the same general terms and conditions. The Company granted Dr. Anil Diwan an award of 10,204 shares of the Company’s Series A Preferred Stock. The shares will be deemed partially vested in quarterly installments following the grant date and fully vested on June 30, 2024. As of July 1, 2024, the Company agreed to the extension of the employment agreement for a period of one year from July 1, 2024 through June 30, 2025 under the same general terms and conditions. The Company granted Dr. Anil Diwan an award of 10,204 shares of the Company’s Series A preferred stock. The shares will be deemed partially vested in quarterly installments following the grant date and fully vested on June 30, 2025.
On March 3, 2010, the Company entered into an employment agreement with Dr. Jayant Tatake to serve as Vice President of Research and Development. The employment agreement provides for a term of four years with a base salary of $150,000. In addition, the Company issued 1,340 shares of Series A preferred stock and 1,786 shares of common stock upon entering into the agreement, and will issue an additional 1,340 shares of Series A Preferred Stock and 1,786 shares of common stock on each anniversary date of the agreement. The shares of Series A preferred stock were issued in recognition of Dr. Tatake’s work towards the achievement of several patents by the Company. The Compensation Committee of the Board of Directors has extended the current provisions of the employment agreement pending its review of current industry compensation arrangements and employment agreements.
On May 30, 2013, the Company entered into an agreement with Meeta Vyas, to serve as its Chief Financial Officer. Ms. Vyas incidentally is married to our President and Chairman of the Board, Anil Diwan. The CFO agreement provided for a term of three years with a base compensation of $9,000 per month and 129 shares of Series A Preferred Stock, also on a monthly basis. On January 1, 2015, her cash compensation was increased to $10,800 per month. The agreement is renewable on an annual basis. As of July 1, 2023, the Company agreed to the extension of the CFO agreement for a period of one year from July 1, 2023 through June 30, 2024 under the same general terms as the prior CFO Agreement with amendment to provide that the CFO shall be reimbursed up to 50% of all costs of Health Insurance including any Medical, Dental, and any and all parts and subparts of Medicare Insurance that she subscribes to, not to
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exceed $2,500 per month. As of July 1, 2024, the Company agreed to the extension of the CFO agreement for a period of one year from July 1, 2024 through June 30, 2025 under the same general terms as the prior CFO Agreement.
COMPENSATION OF DIRECTORS
At this time, directors, who are officers of the Company, receive no remuneration for their services as directors of the Company. The Company reimburses directors for expenses incurred in their service to the Board of Directors. The Company paid fees to its independent directors of $45,000 to each Director, of which $11,250 is to be paid in the Company’s common stock commensurate with their contracts.
COMPENSATION OF SCIENTIFIC ADVISORY BOARD
The Company anticipates holding four Scientific Advisory Board (SAB) meetings per annum. As compensation, each member of the Scientific Advisory Board will be granted 286 warrants each quarter to purchase the Company’s common stock at 120% of the Company’s closing stock quote on the day following the meeting. Should the Company not call a quarterly meeting, quarterly warrants will be granted on May 15, August 15, November 15, and February 15. The warrants have a four-year expiration date. In addition, the Company will reimburse each SAB member for travel and other out-of-pocket expenses incurred in the course of performing their services. For the years ended June 30, 2024 and 2023, the SAB was granted a total of 1,144 and 1,144 of stock warrants, respectively. The warrants are exercisable into common shares at prices from $1.43 to $2.43, and $1.39 to $3.40 per share, respectively.
ITEM 13. CERTAIN RELATIONSHIPS AND RELATED TRANSACTIONS AND DIRECTOR INDEPENDENCE
NanoViricides, Inc, the Company, has adopted a “Code of Conduct and Ethics” in its corporate governance as well as policies and procedures regarding related party transactions.
Management, under the direction of the Board of Directors, follows the policies and procedures regarding related party transactions.
TheraCour Pharma, Inc.
TheraCour currently holds 470,961 shares of the Company’s common stock and 681,859 shares of the Company’s Series A preferred stock.
On May 12, 2005, we entered into a material license agreement, amended as of January 8, 2007 (the “License”) with TheraCour Pharma, Inc. (“TheraCour”). Anil Diwan, our founder, President and Chairman, owns approximately 90% of TheraCour’s capital stock. We were granted exclusive licenses in perpetuity for technologies developed by TheraCour for the virus types: Human Immunodeficiency Virus (HIV/AIDS), Influenza including Asian Bird Flu Virus, Herpes Simplex Virus (HSV-1 and HSV-2), Hepatitis C Virus (HCV), Hepatitis B Virus (HBV), and Rabies. On February 15, 2010, we entered into an Additional License Agreement with TheraCour. Pursuant to the exclusive Additional License Agreement, in consideration for the issuance of 100,000 shares of our Series A preferred stock, (the “Series A preferred”), we were granted exclusive licenses, in perpetuity, for technologies, developed by TheraCour, for the development of drug candidates for the treatment of Dengue viruses, Ebola/Marburg viruses, Japanese Encephalitis, viruses causing viral Conjunctivitis (a disease of the eye) and Ocular Herpes.
In consideration for obtaining these exclusive licenses, we agreed: (1) that TheraCour can charge its costs (direct and indirect) plus no more than 30% of a specified portion of certain direct costs as a Development Fee and such development fees shall be due and payable in periodic installments as billed; (2) we will pay the greater $2,000 or actual costs monthly, whichever is higher, for other general and administrative expenses incurred by TheraCour on our behalf; (3) make royalty payments (calculated as a percentage of net sales of the licensed drugs) of 15% (calculated as a percentage of net sales of the licensed drugs) to TheraCour; (4) TheraCour retains the exclusive right to develop and manufacture the licensed drugs. TheraCour will manufacture the licensed drugs exclusively for us, and unless such license is terminated, will not manufacture such product for its own sake or for others; and (5) TheraCour may request and we will pay an advance payment (refundable) equal to twice the amount of the previous month’s invoice to be applied as a prepayment towards expenses. TheraCour may terminate the license upon a material breach by us as specified in the agreement. However, we may avoid such termination if within 90 days of receipt of such termination notice we cure the breach.
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On November 1, 2019, the Company entered into a License Agreement (the “Agreement”) with TheraCour for an exclusive, worldwide license to use, promote, offer for sale, import, export, sell and distribute products for the treatment of Varicella Zoster Virus derived indications. The Company was not required to make any upfront payments to TheraCour and agreed to the following milestone payments to TheraCour; the issuance of 75,000 shares of Series A preferred stock upon the grant of an IND application; $1,500,000 in cash upon completion of Phase I clinical trials; $2,500,000 in cash upon completion of Phase II clinical trials; and $5,000,000 in cash upon completion of Phase III clinical trials. In addition, the Company is required to pay to TheraCour fifteen percent (15%) of net sales of licensed products, and any income from sublicensed products. Under the Agreement, TheraCour retains the exclusive right to develop and manufacture the Licensed Products. As in previous licensing agreements with TheraCour, the Company agreed to pay the following amounts to TheraCour to the extent not previously paid under existing licensing agreements: (1) costs (direct and indirect) plus 30%, subject to certain specified exclusions, as a Development Fee and such development fees shall be due and payable in periodic installments as billed and (2) a deposit equal to estimated development costs for two months (refundable), such estimates to be reconciled quarterly. Payments not made within 90 days after due date will be charged an interest at the rate of 1% per month. TheraCour and the Company have agreed to enter into a manufacture and supply agreement, under which TheraCour would manufacture the licensed products exclusively for the Company, and the Company would also have customary backup manufacture rights, as specified in the Agreement. TheraCour may terminate the license upon a material breach by the Company as specified in the agreement. However, the Company may avoid such termination if the breach is cured within 90 days of receipt of such termination.
On September 7, 2021, the Company entered into a license agreement for the field comprising anti-viral treatments for coronavirus derived human infections with TheraCour (the “COVID License Agreement”). Previously, on June 9, 2020, we had announced signing of a Memorandum of Understanding (“CoV MoU”) with respect to anti-viral treatments for coronavirus derived human infections (the “Field”) with TheraCour Pharma, Inc., which is now perfected into this licensing Agreement. The licensed field includes antiviral drugs to treat SARS-CoV-2 and its variants that cause the COVID-19 disease resulting in a global pandemic that continues to rage through the world, wave after wave, as new variants develop and take hold. There was no upfront cash payment for the license and the compensation terms were generally consistent with prior licenses, and are summarized below.
Under the COVID License Agreement, the Company obtained a world-wide, exclusive, sub-licensable, license to use, promote, offer for sale, import, export, sell and distribute antiviral drugs that treat human Coronavirus infections using TheraCour’s proprietary as well as patented technology and intellectual property, including the new patent application cited above. The discovery of ligands and polymer materials as well as formulations, the chemistry and chemical characterization, as well as process development and related work will be performed by TheraCour under the same compensation terms as prior agreements between the parties, with no duplication of costs allowed. We will not make any upfront cash payments to TheraCour and we have agreed to the following milestone payments to TheraCour: 100,000 shares of the Company’s Series A preferred stock, par value $0.00001 per share (the “Series A preferred stock”) upon the execution of the Agreement; 50,000 shares of Series A preferred stock after the grant of the approval of Licensee’s Investigational New Drug (IND) Application, or its equivalent; cash payments of $1,500,000 after the initiation of Phase I clinical trials or its equivalent; $2,000,000 after the completion of Phase I clinical trials or its equivalent for at least one product within twelve (12) months from the date of the acceptance of the IND; $2,500,000 no later than six (6) months after the completion of Phase IIA clinical trials or its equivalent for at least one product within twenty (24) months from the date of the completion of Phase I or its equivalent; 100,000 shares of Series A preferred stock after the initiation of Phase III clinical trials or its equivalent; and, at TheraCour’s option, $5,000,000 in cash or 500,000 shares of Series A preferred stock, no later than six (6) months after the completion of Phase III clinical trials or its equivalent for at least one product within thirty-six (36) months from the completion of Phase II clinical trials or its equivalent. In addition, we agreed to pay to TheraCour fifteen percent (15%) of net sales of licensed products and any income from sublicensed products, consistent with previous agreements. Under the COVID License Agreement, TheraCour retains the exclusive right to develop and manufacture the licensed products. The Agreement contemplates that the parties will enter into a separate manufacturing and supply agreement for the commercial manufacture and supply of the drug products if and when we intend to engage into commercialization of the drugs. The COVID License Agreement provides that the Manufacturing and Supply agreement would be on customary and reasonable terms, on a cost-plus basis, using a market rate based on then-current industry standards, and include customary backup manufacturing rights, as with prior agreements. The Series A preferred stock is only convertible upon a “change of control” of the Company as defined in its full specification, are non-transferrable and have no trading market. Each Series A share carries 9 votes, and is convertible only upon a change of control into 3.5 shares of the Company’s common stock.
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On April 20, 2023, the Company was notified that the Company’s licensee, KMPL, was authorized to enter into Phase Ia/Ib clinical trials of its COVID, NV-CoV-2 Oral Syrup and its NV-CoV-2 Oral Gummies after satisfying the conditions of a conditional authorization received on or about January 27, 2023. Pursuant to the TheraCour – Nanoviricides COVID License Agreement a milestone payment of 50,000 shares of the Company’s Series A preferred shares was issued to Theracour Pharma, Inc. On June 14, 2023, the Company was notified that the Company’s licensee, KMPL, has commenced volunteer recruitments for Phase Ia/Ib clinical trials of the NV-CoV-2 Oral Syrup and NV-CoV-2 Oral Gummies. Pursuant to the TheraCour–Nanoviricides COVID License Agreement a milestone payment of $1,500,000 became due and has been recorded as a non-current liability on the accompanying balance sheet.
Pursuant to a COVID License Agreement dated September 7, 2021 between the Company and TheraCour, the Company is obligated to make certain milestone payments to TheraCour upon achieving certain milestones. TheraCour had achieved the milestone regarding the “Initiation of Phase I Clinical Trials or Equivalent” within 3 months from regulatory approval. Upon achieving this milestone, the Company was obligated to pay TheraCour a cash milestone payment in the amount of $1,500,000. In lieu of this cash payment, TheraCour agreed to accept a Convertible Promissory Note in the principal amount of $1,500,000 effective July 19, 2023 (the “Note”). The Note accrues interest at the rate of twelve percent (12%) per annum and is due and payable on January 19, 2025. The Note is convertible, at TheraCour’s option, into shares of the Company’s Series A preferred stock, par value $0.00001 (the “Series A Shares”) at the conversion price specified in the terms and conditions contained within the Note. Dr. Diwan recused himself from voting on any action of the Registrant’s Board of Directors in connection with the License Agreement and the Note (as that term is defined herein), and any discussions related thereto. On October 27, 2023 TheraCour exercised its right to convert the principal of the July 19, 2023 Note into 331,859 shares of the Company’s Series A preferred stock. Furthermore, TheraCour cancelled all of the accrued interest on the Note totaling approximately $49,800 which has been reported as a capital transaction credit to additional paid in capital on the accompanying statements of changes in stockholders’ equity.
On February 12, 2024 the Company requested and TheraCour agreed to suspend the existing license requirement to maintain an advance with TheraCour equal to two months of projected TheraCour invoices which is recalculated quarterly. The suspension will remain in effect until such time as the Company is able to raise sufficient capital. The existing available advance will be applied towards payment of TheraCour invoices.
On February 13, 2024, the Company and TheraCour amended the COVID License Agreement (the “Amendment”). The Amendment provides that the as yet unearned and unremitted cash awards specified in the COVID License Agreement for milestone payments shall not be due and payable until the Company achieves a revenue event which shall mean, but not be limited to, the receipt of revenue by the Company generated from, but not limited to, sources such as (1) research and development grants, government contracts, non-profit organizations and other sources to the extent that the amount of recognized revenue (as defined in the Amendment) is only considered to be the profit portion of revenue event, if any; (2) licensing of third-party development partnerships to the extent recognized revenue is considered to include only the profit or retained earnings portion received from such deals (and exclude any at-cost-reimbursements); (3) drug commercialization wherein recognized revenue shall be the amount of gross profit (i.e., net sales less cost of net sales); or (4) other sources of revenue such as gross profits from private contract work. Additionally, the Amendment provides that no more than 50% of the recognized revenue shall be applied for remitting such consideration at the time of payment. Further the Amendment clarifies that financing raised by the Company from sale of equity, mortgage or debt transactions, and such other instruments shall not be regarded as recognized revenue.
By signing on September 23, 2024 and being effective as of September 20, 2024, the Company entered into a “Memorandum of Understanding for All Antivirals Drug Development” (the “MOU”) with TheraCour that granted to the Company, a limited, non-assignable, non-sublicensable, exclusive right of first refusal to license to any antiviral drugs in development or to be developed by TheraCour for research and development purposes only, for all as-yet unlicensed viral infection treatment indications. The MOU also clarified the roles and responsibilities of the parties and essentially codified the process that the parties have adopted since inception. The MOU further codified the treatment of all future milestone payments arising from any current or future license agreements to TheraCour to be consistent with the principles adopted in the February 12, 2024 Amendment to the COVID License Agreement.
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COVID-19 Related Drugs: Patent Coverage and Lifetime
Two International PCT patent applications have been filed relating to the application of the TheraCour polymeric micelle technology to drug development for Coronavirus antiviral drugs including ones for the treatment of COVID-19; PCT/US21/39050 was filed on June 25, 2021. Additionally, PCT/US22/35210 was filed on June 28, 2022, with a request for the same priority date as that of the prior PCT/US21/39050 application. These new broad patents cover new compositions of matter, methods of making them (processes), drug formulations, and uses of the articles of manufacture. The patents resulting from these are expected to have expiry dates extending at least into the year 2043, with additional specific extensions possible in various countries based on regulatory extensions for pharmaceutical products. All ensuing patents will be automatically exclusively licensed to NanoViricides for anti-coronavirus drugs pursuant to the “CoV License Agreement”. The nominal expiry date for these PCT applications would be 20 years, after filing and if issued, i.e. June 24, 2041, and could be extended in certain countries under regulatory extensions to as late as into the year 2043, providing a significant commercial runway.
TheraCour acquired property and equipment on behalf of the Company from third party vendors and transferred property and equipment, to the Company, at cost, in the approximate amounts of $115,000 and $32,000 for the fiscal years ended June 30, 2024 and 2023 respectively.
Accounts payable to TheraCour were approximately $720,000 and $233,000 (net of a $500,000 advance) at June 30, 2024 and June 30, 2023, respectively.
Development fees and other costs charged by TheraCour were approximately $2,550,000 and $2,536,000 for the years ended June 30, 2024 and 2023, respectively. No royalties are due or have been paid from inception through June 30, 2024.
As of June 30, 2024 TheraCour owned 470,961 shares of the Company’s outstanding common stock and 681,859 shares of Series A Preferred Stock, which votes at the rate of nine shares of common stock per each share of Series A Preferred Stock and is convertible into three and one half shares of common stock upon a change in control of the Company. Dr. Diwan, also serves as the CEO and Director of TheraCour and owns approximately 90% of the outstanding capital stock of TheraCour.
Line of Credit - Related Party – Anil Diwan
On November 13, 2023, the Company’s President and Executive Chairman, Dr. Anil Diwan, entered into a Line of Credit Agreement whereby Dr. Diwan agreed to provide a standby Line of Credit to the Company in the maximum amount of $2,000,000. All amounts outstanding under the Line of Credit, including principal, accrued interest and other fees and charges, will be due and payable on December 31, 2024. Amounts drawn down under the Line of Credit shall bear interest at a fixed rate of 12%. Advancements under the Line of Credit will be collateralized by an Open End Mortgage Deed on the Company’s real property at 1 Controls Drive, Shelton, Connecticut and a Chattel Mortgage (U.C.C - 1 filing) against the Company’s equipment and fixtures. Any draw down under the Line of Credit requires the approval of the Company’s Board of Directors. On February 12, 2024 the Company, pursuant to Article 2.5 of the Company’s Line of Credit Agreement with Dr. Anil Diwan, signed an Extension Agreement which extended the maturity of the Company’s Line of Credit from December 31, 2024 to December 31, 2025. By signing on September 23, 2024 and by being effective as of September 20, 2024, the Company, pursuant to Article 2.5 of the Company’s Line of Credit Agreement with Dr. Anil Diwan, signed an amendment agreement which increased the available line of credit from $2 million to $3 million, and extended the maturity of the Company’s Line of Credit from December 31, 2025 to March 31, 2026. There were no other amendments to the original Line of Credit.
The Company has not drawn against the Line of Credit facility as of June 30, 2024.
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Karveer Meditech, Private Limited (KMPL)
On March 27, 2023 the Company entered into a License Agreement with KMPL, wherein the Company granted to KMPL a limited, non-transferable, exclusive license for the use, sale, or offer of sale in India of the Company’s two clinical test drug candidates titled as NV-CoV-2 and NV-CoV-2-R for the treatment of COVID in patients in India. KMPL has engaged in further drug development in India including sponsoring of drug candidates for human clinical trials in India and has acted as clinical trials manager for such clinical trials. KMPL shall provide NanoViricides with all reports of the clinical trials and the Company can use such reports for further advancement of the drug candidates with regulatory authorities outside India. In consideration, KMPL will be reimbursed by the Company for all direct and indirect costs incurred for the clinical trials and development activities with a customary clinical trials manager fee of thirty (30%) of such costs and applicable taxes. Upon commercial sales of any resulting approved drugs, KMPL will pay the Company a royalty of seventy (70%) percent of the final invoiced sales to unaffiliated third parties.
On April 20, 2023, the Company was notified that the Company’s licensee, KMPL, was authorized to enter into Phase Ia/Ib clinical trials of its COVID, NV-CoV-2 Oral Syrup and its NV-CoV-2 Oral Gummies after satisfying the conditions of a conditional authorization received on or about January 27, 2023.
On June 19, 2023 KMPL commenced the equivalent of Phase I clinical trials in India. The Company has incurred clinical trial costs payable to KMPL of $442,845 and $100,000 for the years ended June 30, 2024 and 2023 respectively, As of June 30, 2024 and 2023, respectively, $227,435 and $100,000 of such costs were accrued by the Company pursuant to the license agreement between the Company and KMPL.
ITEM 14. PRINCIPAL ACCOUNTING FEES AND SERVICES
Audit Fees
The aggregate fees for each of the last two years for professional services rendered by EisnerAmper, our independent registered public accounting firm for our audits of our annual financial statements and interim reviews of our financial statements included in our fillings with Securities and Exchange Commission on Form 10-K and 10-Qs or services that are normally provided by the accountant in connection with statutory and regulatory filings or engagements for those years were approximately:
June 30, 2024 |
| $ | 251,370 |
June 30, 2023 | $ | 248,010 |
No other fees were paid to EisnerAmper for the last two years.
Pre-Approval Policies
The Board of Directors, and the Audit Committee appointed by the Board, currently does not have any pre-approval policies or procedures concerning services performed by EisnerAmper LLP. All the services performed by EisnerAmper LLP as described above were pre-approved by the Audit Committee.
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ITEM 15. EXHIBITS
Exhibits |
| Description |
| Filed / furnished / |
| Incorporated by |
| Date filed | |
3.1 |
|
| Schedule 14C |
| A |
| April 23, 2009 | ||
2 |
|
| Form 10-Q |
| 3.1 |
| February 22, 2010 | ||
3.3 | Plan of Conversion of NanoViricides, Inc. into NanoViricides, Inc. dated May 22, 2023 | Form 8-K | 2.1 | May 25, 2023 | |||||
4.1 |
|
| Form 10-SB |
| 4.1 |
| November 14, 2006 | ||
10.1 |
|
| Form 10-SB |
| 10.5 |
| November 14, 2006 | ||
10.2 |
|
| Form 10-SB |
| 10.6 |
| November 14, 2006 | ||
10.3 |
|
| Form 10-SB |
| 10.11 |
| January 17, 2007 | ||
10.4 |
|
| Form S-1 |
| 10.7 |
| November 29, 2019 | ||
10.5 |
| Agreement of Purchase and Sale between the Registrant and Inno-Haven, LLC |
| Form 8-K |
| 10.1 |
| January 7, 2015 | |
10.6 |
|
| Form 8-K |
| 10.1 |
| February 13, 2017 | ||
10.7 |
|
| Form 8-K |
| 10.1 |
| July 23, 2018 | ||
10.8 |
| Underwriting with Aegis Capital Corp. dated January 21, 2020 |
| Form 8-K |
| 10.1 |
| January 27, 2020 | |
10.9 |
|
| Form 8-K |
| 10.1 |
| January 28, 2020 | ||
10.10 | Form 8-K | 10.2 | January 28, 2020 | ||||||
10.11 |
|
| Form 8-K |
| 10.3 |
| January 28, 2020 | ||
10.12 |
| Director Retainer Agreement between NanoViricides, Inc. and Makarand Jawadekar |
| Form 8-K |
| 10.1 |
| February 11, 2020 | |
10.13 |
| Director Retainer Agreement, dated as of May 15, 2020, between NanoViricides, Inc. and Todd Rokita |
| Form 8-K |
| 10.1 |
| May 19, 2020 | |
10.14 |
|
| Form 8-K |
| 10.1 |
| May 22, 2020 | ||
10.15 |
|
| Form 8-K |
| 10.2 |
| May 22, 2020 | ||
10.16 |
|
| Form 8-K |
| 10.1 |
| July 13, 2020 | ||
10.17 |
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| Form 8-K |
| 1.1 |
| August 3, 2020 | ||
10.18 | Director Retainer Agreement dated November 13, 2020 between NanoViricides, Inc. and Brian Zucker | Form 8-K | 10.1 | November 13, 2020 | |||||
10.19 | License Agreement dated September 7, 2021 between NanoViricides, Inc. and TheraCour Pharma, Inc. | Form 8-K | 10.1 | September 9, 2021 | |||||
10.20 | Form 8-K | 10.2 | September 9, 2021 | ||||||
10.21 | Form 8-K | 10.2 | October 11, 2022 | ||||||
10.22 | Form 8-K | 10.1 | March 27, 2023 | ||||||
10.23 | Deferred Expense Exchange Agreement between NanoViricides, Inc. and TheraCour Pharma, Inc. | Form 8-K | 10.2 | August 29, 2023 | |||||
Page 103 of 106
10.24 | Form 8-K | 10.3 | August 29, 2023 | ||||||
10.25 | Extension to Employment Agreement with A. Diwan effective July 1, 2023 | Form 10-K | 10.25 | October 13, 2023 | |||||
10.26 | Extension to CFO Agreement with Meeta Vyas effective July 1, 2023 | Form 10-K | 10.26 | October 13, 2023 | |||||
10.27 | Amendment to License Agreement between NanoViricides, Inc. and TheraCour, dated February 13, 2024 | Form 8-K | 10.2 | February 16, 2024 | |||||
10.28 | Line of Credit Agreement between NanoViricides, Inc. and Dr. Anil R. Diwan, dated November 13, 2023 | Form 8-K | 10.3 | February 16, 2024 | |||||
10.29 | Extension Agreement between the Company and Dr. Anil R. Diwan, dated February 12, 2024 | Form 8-K | 10.4 | February 16, 2024 | |||||
10.30 | Form 8-K | 10.5 | February 16, 2024 | ||||||
10.31 | At Market Issuance Sales Agreement by and between NanoViricides, Inc. and EF Hutton LLC | Form 8-K | 1.1 | April 5, 2024 | |||||
10.32 | Extension of Employment Agreement with Anil Diwan effective July 1, 2024 | Form 8-K | 10.1 | August 9, 2024 | |||||
10.33 | Form 8-K | 10.2 | August 9, 2024 | ||||||
10.34* | |||||||||
14.1 |
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| Form 10-SB |
| 10.10 |
| November 14, 2006 | ||
19.1* | NanoViricides, Inc. Insider Trading Policy effective September 20, 2024 | ||||||||
23 | |||||||||
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31.2 |
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32.1 |
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32.2 |
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101.INS |
| Inline XBRL Instance Document. |
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101.SCH |
| Inline XBRL Schema Document. |
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101.CAL |
| Inline XBRL Calculation Linkbase Document. |
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101.DEF |
| Inline XBRL Definition Linkbase Document. |
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101.LAB |
| Inline XBRL Label Linkbase Document. |
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101.PRE |
| Inline XBRL Presentation Linkbase Document. |
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104 | Cover Page Interactive Data File (Embedded within the Inline XBRL document and included in Exhibit) | ||||||||
* | Filed herewith | ||||||||
Page 104 of 106
SIGNATURES
Pursuant to the requirements of Section 13 or 15(d) of the Securities Exchange Act of 1934, the Registrant has duly caused this report to be signed on its behalf by the undersigned, thereunto duly authorized.
Dated: September 27, 2024
| NANOVIRICIDES, INC. | |
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| |
| /s/ Anil Diwan, PhD | |
| Name: | Anil Diwan, PhD. |
| Title: | President and Executive Chairman of the Board of Directors |
| (Principal Executive Officer) | |
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| /s/ Meeta Vyas | |
| Name: | Meeta Vyas |
| Title: | Chief Financial Officer |
| (Principal Accounting Officer) | |
Pursuant to the requirements of the Securities Exchange Act of 1934, this report has been signed below by the following persons on behalf of the registrant and in the capacities and on the dates indicated:
September 27, 2024 | /s/ Anil Diwan, PhD | |
| Name: | Anil Diwan, PhD |
| Title: | President and Executive Chairman of the Board of Directors |
| (Principal Executive Officer) | |
September 27, 2024 | /s/ Meeta Vyas | |
| Name: | Meeta Vyas |
| Title: | Chief Financial Officer |
| (Principal Accounting Officer) | |
September 27, 2024 | /s/ Brian Zucker | |
| Name: | Brian Zucker |
| Title: | Director |
September 27, 2024 | /s/ Makarand Jawadekar | |
| Name: | Makarand Jawadekar |
| Title: | Director |
September 27, 2024 | /s/ Theodore Rokita | |
| Name: | Theodore Rokita |
| Title: | Director |
Page 106 of 106
NanoViricides, Inc.
Index to the Financial Statements
Contents |
| Page(s) |
Report of Independent Registered Public Accounting Firm (PCAOB ID Number |
| F-2 – F-3 |
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| F-4 | |
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Statements of Operations for the years ended June 30, 2024 and 2023 |
| F-5 |
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Statement of Changes in Stockholders’ Equity for the years ended June 30, 2024 and 2023 |
| F-6 |
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Statements of Cash Flows for the years ended June 30, 2024 and 2023 |
| F-7 |
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| F-8 |
F-1
REPORT OF INDEPENDENT REGISTERED PUBLIC ACCOUNTING FIRM
To the Board of Directors and Stockholders of
NanoViricides, Inc.
Opinion on the Financial Statements
We have audited the accompanying balance sheets of NanoViricides, Inc. (the “Company”) as of June 30, 2024 and 2023, and the related statements of operations, changes in stockholders’ equity, and cash flows for each of the years then ended, and the related notes (collectively referred to as the “financial statements”). In our opinion, the financial statements present fairly, in all material respects, the financial position of the Company as of June 30, 2024 and 2023, and the results of its operations and its cash flows for each of the years then ended, in conformity with accounting principles generally accepted in the United States of America.
Going Concern
The accompanying financial statements have been prepared assuming that the Company will continue as a going concern. As discussed in Note 2 to the financial statements, the Company has recurring net losses and net cash flow used in operations that raise substantial doubt about its ability to continue as a going concern. Management’s plans in regard to these matters are also described in Note 2. The financial statements do not include any adjustments that might result from the outcome of this uncertainty.
Basis for Opinion
These financial statements are the responsibility of the Company’s management. Our responsibility is to express an opinion on the Company’s financial statements based on our audits. We are a public accounting firm registered with the Public Company Accounting Oversight Board (United States) (“PCAOB”) and are required to be independent with respect to the Company in accordance with the U.S. federal securities laws and the applicable rules and regulations of the Securities and Exchange Commission and the PCAOB.
We conducted our audits in accordance with the standards of the PCAOB. Those standards require that we plan and perform the audit to obtain reasonable assurance about whether the financial statements are free of material misstatement, whether due to error or fraud. The Company is not required to have, nor were we engaged to perform, an audit of its internal control over financial reporting. As part of our audits, we are required to obtain an understanding of internal control over financial reporting but not for the purpose of expressing an opinion on the effectiveness of the Company’s internal control over financial reporting. Accordingly, we express no such opinion.
Our audits included performing procedures to assess the risks of material misstatement of the financial statements, whether due to error or fraud, and performing procedures that respond to those risks. Such procedures included examining, on a test basis, evidence regarding the amounts and disclosures in the financial statements. Our audits also included evaluating the accounting principles used and significant estimates made by management, as well as evaluating the overall presentation of the financial statements. We believe that our audits provide a reasonable basis for our opinion.
Critical Audit Matter
The critical audit matter communicated below is a matter arising from the current period audit of the financial statements that was communicated or required to be communicated to the audit committee and that: (1) relates to accounts or disclosures that are material to the financial statements and (2) involved our especially challenging, subjective, or complex judgments. The communication of the critical audit matter does not alter in any way our opinion on the financial statements, taken as a whole, and we are not, by communicating the critical audit matter below, providing a separate opinion on the critical audit matter or on the accounts or disclosures to which it relates.
Related Party Transactions
As discussed in Note 4 to the financial statements, the Company enters into certain agreements with related parties which (i) grant exclusive licenses for technologies developed by a related party to the Company for various virus types and (ii) grant exclusive licenses for development and commercialization rights to a related party for certain of the Company’s drug candidates. As part of these agreements, the Company is required to pay certain costs charged by the related parties. These costs include research and development
F-2
costs resulting from their research and development activities which include the performance of preclinical and/or clinical studies and a clinical trial management fee, compensation and other expenses for research and development personnel, supplies and development material. The Company recorded accounts payable – related party and accrued expense for research and development activities of approximately $720,000 and $227,000, respectively, as of June 30, 2024 and research and development costs incurred with related parties of approximately $2,993,000 included in research and development expenses for the year ended June 30, 2024.
We identified the accounting for related party transactions as a critical audit matter due to the materiality of the related party transactions occurring throughout the year and the significant judgment by management to ensure costs being charged are accurate, complete, and properly disclosed. This is turn led to a high degree of auditor judgement, subjectivity, and significant audit effort in applying procedures related to those transactions.
Addressing the matter involved performing procedures and evaluating audit evidence in connection with forming our overall opinion on the financial statements. We obtained an understanding and evaluated the design of the controls related to the Company’s process for identifying related parties and the approval and disclosure of related party transactions. We performed procedures to test the completeness of related party liabilities at the balance sheet date and expenses for the year then ended. Our procedures included, among others, (i) reading agreements and subsequent amendments; (ii) testing invoices on a sample basis to ensure purchases, expenses and milestones are properly recorded in accordance with the agreements and that appropriate approval from management and the audit committee was received; (iii) confirming the accounts payable – related party balance, equipment purchases made on behalf of the Company and the research and development costs paid to the related parties; and (iv) obtaining agreements, budgets and patient enrollment data related to the clinical trial to support amounts accrued as of the balance sheet date. We also made direct inquiries of management and viewed public filings, minutes, and agreements for evidence of related parties, the nature of the relationship and that related party transactions were accounted for and disclosed properly.
/s/ EisnerAmper LLP
We have served as the Company’s auditor since 2014.
September 27, 2024
F-3
NanoViricides, Inc.
Balance Sheet
| June 30, 2024 |
| June 30, 2023 | |||
ASSETS |
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CURRENT ASSETS: |
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Cash and cash equivalents | $ | | $ | | ||
Prepaid expenses |
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Total current assets |
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Property and equipment, net |
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Intangible assets, net |
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OTHER ASSETS |
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Service agreements |
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Total assets | $ | | $ | | ||
LIABILITIES AND STOCKHOLDERS’ EQUITY |
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CURRENT LIABILITIES: |
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Accounts payable | $ | | $ | | ||
Accounts payable – related party |
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Accrued expenses |
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Total current liabilities |
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| — |
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Total liabilities | | | ||||
COMMITMENTS AND CONTINGENCIES (NOTE 11) |
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STOCKHOLDERS’ EQUITY: |
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Series A convertible preferred stock, $ |
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Common stock, $ |
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Additional paid-in capital |
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Accumulated deficit |
| ( |
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Total stockholders’ equity |
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Total liabilities and stockholders’ equity | $ | | $ | | ||
See accompanying notes to the financial statements
F-4
NanoViricides, Inc.
Statements of Operations
Year Ended June 30, | ||||||
| 2024 |
| 2023 | |||
OPERATING EXPENSES |
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Research and development | $ | | $ | | ||
General and administrative |
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Total operating expenses |
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LOSS FROM OPERATIONS |
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OTHER INCOME (EXPENSE): |
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Interest income |
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Interest expense |
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Other income, net |
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NET LOSS | $ | ( | $ | ( | ||
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Net loss per common share- basic and diluted | $ | ( | $ | ( | ||
Weighted average common shares – basic and diluted | | | ||||
See accompanying notes to the financial statements.
F-5
NanoViricides, Inc.
Statement of Changes in Stockholders’ Equity
For the period from July 1, 2022 through June 30, 2024
Series A Preferred | |||||||||||||||||||
Stock: | Common Stock: | ||||||||||||||||||
| Par $0.00001 |
| Par $0.00001 |
| Additional |
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| Total | |||||||||||
Number of | Number of | Paid-in | Accumulated | Stockholders’ | |||||||||||||||
| Shares |
| Amount |
| Shares |
| Amount |
| Capital |
| Deficit |
| Equity | ||||||
Balance, July 1, 2022 |
| | $ | | * | | $ | | * | $ | | * | $ | ( | $ | | |||
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Series A preferred stock issued for employee stock compensation |
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Series A preferred stock issued for license agreement | | | | | | | | ||||||||||||
Common stock issued for consulting and legal services rendered | | | | | | | | ||||||||||||
Warrants issued to Scientific Advisory Board |
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Common stock issued for employee compensation |
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Common stock issued for Directors fees |
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Net loss |
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Balance, June 30, 2023 |
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Proceeds from sale of common stock in connection with equity financings net of issuance costs of $ |
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Series A preferred stock issued for employee stock compensation |
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Series A preferred stock issued upon conversion of related party promissory note |
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Common stock issued for consulting and legal services rendered |
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Warrants issued to Scientific Advisory Board |
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Common stock issued for employee compensation |
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Forgiveness of interest on related party debt | | | | | | | | ||||||||||||
Common stock issued for Directors fees | — | — | | — | | — | | ||||||||||||
Net loss |
| — |
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| — |
| — |
| — |
| ( |
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Balance, June 30, 2024 |
| | $ | |
| | $ | | $ | | $ | ( | $ | | |||||
*
See accompanying notes to the financial statements
F-6
NanoViricides, Inc.
Statements of Cash Flows
Year Ended June 30, | ||||||
| 2024 |
| 2023 | |||
CASH FLOWS FROM OPERATING ACTIVITIES: |
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Net loss | $ | ( | $ | ( | ||
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Adjustments to reconcile net loss to net cash used in operating activities |
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Preferred shares issued as compensation |
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Preferred shares issued pursuant to license agreement | — | | ||||
Common shares issued as compensation and for services | | | ||||
Warrants granted to Scientific Advisory Board |
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Depreciation |
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Amortization | | | ||||
Changes in operating assets and liabilities: |
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Prepaid expenses |
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Other assets |
| ( |
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Accounts payable |
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Accounts payable - related parties |
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Accrued expenses | | | ||||
Other non-current liability-related party |
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NET CASH USED IN OPERATING ACTIVITIES |
| ( |
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CASH FLOWS FROM INVESTING ACTIVITIES: |
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Purchase of property and equipment |
| ( |
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NET CASH USED IN INVESTING ACTIVITIES | ( | ( | ||||
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CASH FLOWS FROM FINANCING ACTIVITIES: |
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Payment of loan payable | — | ( | ||||
Net proceeds from sale of common stock |
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| — | ||
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NET CASH PROVIDED BY / (USED) IN FINANCING ACTIVITIES | | ( | ||||
NET CHANGE IN CASH AND CASH EQUIVALENTS |
| ( |
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Cash and cash equivalents at beginning of period |
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Cash and cash equivalents at end of period | $ | | $ | | ||
SUPPLEMENTAL DISCLOSURE OF CASH FLOWS INFORMATION: |
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Interest paid | $ | — | $ | | ||
NON CASH FINANCING AND INVESTING ACTIVITIES: |
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Fair value of Series A Preferred shares issued upon conversion of related party convertible promissory note | $ | | $ | — | ||
Forgiveness of interest on related party debt | $ | | $ | — | ||
See accompanying notes to the financial statements
F-7
NanoViricides, Inc.
June 30, 2024, and 2023
Notes to the Financial Statements
Note 1 – Organization and Nature of Business
NanoViricides, Inc. (the “Company”) is a clinical stage nano-biopharmaceutical company specializing in the discovery, development, and commercialization of drugs to combat viral infections using its unique and novel nanomedicines technology. NanoViricides possesses its own facility that supports research and development and drug discovery, drug candidate optimization, cGMP-compliant drug substance manufacturing, cGMP-compliant manufacturing and packaging of drug products for human clinical trials, and early commercialization. The Company has several drugs in various stages of development.
NanoViricides, Inc. is domiciled under the laws of the State of Delaware, with its principal operations located in the State of Connecticut. The Company’s fiscal year begins on July 1st and ends on the next June 30th of the calendar year. The Company operates in
The Company devotes substantially all its activity to advancing research and development, including efforts in connection with clinical trials. The Company’s lead drug candidate is the active pharmaceutical ingredient (API) NV-387. NV-387 is a uniquely broad-spectrum antiviral drug that has demonstrated strong activity in lethal lung infection animal model studies of Coronavirus, RSV, Influenza and even an Orthopoxvirus model for Smallpox and MPox. The Company plans on developing NV-387 first as a treatment of RSV infection in pediatric patients.
At present, NV-387 is undergoing a PhaseIa/Ib human clinical trial for safety and tolerability in healthy subjects for the treatment of COVID-19, sponsored by our licensee and collaborator in India, Karveer Meditech Private Limited (KMPL). The trial involved Phase Ia single-ascending dose and Phase Ib multiple ascending dose studies in healthy subjects. Subjects were sequestered upon enrollment in a dedicated ward of the hospital clinical trial site during treatment. All subjects have been discharged and follow-up visits have been completed as of approximately the end of December 2023. The results of this clinical trial were consistent with the results of a single-injection safety/tolerability study in rats performed in support of the clinical trial application.
The clinical trial application for this clinical trial was submitted during the pandemic and a separate part of the clinical trial for the treatment of COVID patients with NV-387 was also proposed. This second part of the clinical trials was cancelled due to inability to find patients to enroll despite opening a second site. The second site was subsequently closed around April/May 2024. Meanwhile, data upload and crosschecking activities for the healthy subjects Phase Ia/Ib part have now been completed.
The Company is now working on developing the necessary datasets, documentation, and clinical trial pathway and trial designs, for a Phase II clinical trial application for the use of NV-387 for the treatment of RSV infection, as the Phase Ia/Ib study progresses into the data analysis phase.
The Company further plans on expanding the indications of NV-387 to other respiratory viral infections including Influenzas, Coronaviruses, and others.
Additionally, the Company has previously developed a clinical drug candidate, NV-HHV-1 formulated as skin cream, for the treatment of Shingles. The Company plans on taking NV-HHV-1 into human clinical trials, and further develop the HerpeCide™ program after engaging into clinical trials of NV-387 in Phase II for RSV and possibly for multiple indications, including Influenzas. In the HerpeCide program alone, the Company has drug candidates against at least five indications at different stages of development. The Company’s drug candidates against HSV-1 “cold sores” and HSV-2 “genital herpes” are in advanced pre-clinical studies and are expected to follow the shingles drug candidate into human clinical trials. In addition, the Company has drug candidates against HIV/AIDS, Dengue, Ebola/Marburg, and other viruses.
F-8
The Company’s drugs are based on several patents, patent applications, provisional patent applications, and other proprietary intellectual property held by TheraCour Pharma, Inc. (“TheraCour”), a related party substantially owned by Dr. Anil Diwan, to which the Company has broad, exclusive licenses. The licenses are to entire fields and not to specific compounds. In all, the Company has exclusive, worldwide licenses for the treatment of the following human viral diseases: Human Immunodeficiency Virus (HIV/AIDS), Hepatitis B Virus (HBV), Hepatitis C Virus (HCV), Herpes Simplex Virus (HSV-1 and HSV-2), Influenza and Asian Bird Flu Virus, Dengue viruses, Ebola/Marburg viruses, Japanese Encephalitis virus, viruses causing viral Conjunctivitis (a disease of the eye) and Ocular Herpes (restated), Varicella Zoster Virus (“VZV”) infections (i.e. Shingles and Chickenpox), and SARS-CoV-2 infections. In all cases, the discovery of ligands and polymer materials as well as formulations, the chemistry and chemical characterization, as well as process development and related work will be performed by TheraCour, a related party substantially owned by Dr. Anil Diwan, under the same compensation terms as prior agreements between the parties, with no duplication of costs allowed. Upon commercialization, NanoViricides will pay
The Company has executed a new Memorandum of Understanding with TheraCour by signing as of September 23, 2024 and becoming effective as of September 20, 2024, subsequent to the reported period, whereby the Company has obtained a right of first refusal for all antiviral drug developments including unlicensed ones, and has codified the process of development of drugs for unlicensed viral indications leading later to appropriate license agreements. The Parties have also agreed in this MoU that any cash milestone payments related to development activities, that are awardable, will become payable only upon the Company having sufficient revenue, thus extending the provisions previously incorporated in the Amendment to the COVID License Agreement, to all present and future license agreements. This removes any potential cash flow stress that may occur due to such milestone payments while the Company continues its developments while not raising profits.
The Company has out-licensed NV-CoV-2 and NV-CoV-2-R for further clinical drug development and commercialization in the territory of India to KMPL, a company of which Dr. Anil Diwan is a passive investor and advisor. KMPL has sponsored NV-CoV-2 for human clinical trials and has obtained regulatory approvals in India. KMPL has retained a local clinical research organization (CRO) to conduct the clinical trials. NV-CoV-2, Phase Ia/Ib human clinical trials in India, sponsored by KMPL began on June 17, 2023. The clinical trial drug products, NV-CoV-2 Oral Syrup, and NV-CoV-2 Oral Gummies, were manufactured at the Company’s Shelton campus, and then shipped to and received by KMPL. Under the agreement with KMPL, the Company will pay for the expenses of the clinical trials, and in return will benefit from having the data and reports made available for regulatory filings in other territories of the world. Upon commercialization, the Company will receive royalties from KMPL equal to
Note 2 – Liquidity
The Company’s financial statements have been prepared assuming that it will continue as a going concern, which contemplates continuity of operations, realization of assets and liquidation of liabilities in the normal course of business. As reflected in the financial statements, the Company has an accumulated deficit at June 30, 2024 of approximately $
As of June 30, 2024, the Company had approximately $
F-9
The ability of the Company to continue as a going concern is dependent upon controlling its overall expenses and identifying and securing additional financing.
The Company believes that it has several important milestones, including data from and final reports from the Phase Ia/Ib human clinical trial for the Company’s broad-spectrum, antiviral drug NV-387. This Phase Ia/Ib human clinical trial is for evaluating the safety and tolerability of two oral formulations of NV-387, namely (i) NV-CoV-2 Oral Gummies, and (ii) NV-387 Oral Syrup, as described elsewhere, with COVID as the indication. The safety and tolerability data from this clinical trial is expected to be applicable as Phase Ia/Ib data for other indications of NV-387 as well, including RSV, MPOX, Influenza and others. Additional milestones include Pre-IND and IND filing to the US FDA for RSV and clinical trial application for Phase II clinical trial of NV-387 for the treatment of RSV infection in adults with the goal towards further regulatory advancement and approval of NV-387 for the treatment of pediatric RSV infection. To this end, the Company is also evaluating the possibility of a Phase IIa clinical trial of a RSV Infection Challenge in Humans.
Management believes that as these milestones are achieved, the Company would likely experience improvement in the liquidity of the Company’s stock, and such improvement, if any, would enhance the Company’s ability to raise funds on the public markets at terms that may be favorable to the terms offered at present.
Management is actively exploring additional required funding through non-dilutive grants and contracts, partnering, debt or equity financing pursuant to its plan. There is no assurance that we will be successful in obtaining sufficient financing on terms acceptable to us to fund continuing operations.
Management believes that it has on-going access to the capital markets including the “At-The-Market” (ATM) agreement with EF Hutton, the Sales Agent, that became active around April 5, 2024.
From July 1, 2024 through September 10, 2024, subsequent to the Company’s fiscal year end, the Company sold
There can be no assurance that the Company’s plans will not change or that changed circumstances will not result in the depletion of its capital resources more rapidly than it currently anticipates. The Company will need to raise additional capital to fund its long-term operations and research and development plans including human clinical trials for its various drug candidates until it generates revenue that reaches a level sufficient to provide self-sustaining cash flows. There can be no assurance that the Company will be able to raise the necessary capital or that it will be on acceptable terms. The accompanying financial statements do not include any adjustments that may result from the outcome of such unidentified uncertainties.
Note 3 – Summary of Significant Accounting Policies
Basis of Presentation
The Company’s financial statements have been prepared in accordance with accounting principles generally accepted in the United States (“GAAP”) and include all adjustments necessary for the fair presentation of the Company’s financial position for the periods presented.
Net Loss per Common Share
Basic net loss per common share is computed by dividing net loss by the weighted average number of shares of common stock outstanding during the period. Diluted net loss per common share is computed by dividing net loss by the weighted average number of shares of common stock and potentially outstanding shares of common stock during the period to reflect the potential dilution that could occur from common shares issuable through warrants and convertible preferred stock.
F-10
The following table shows the number of potentially outstanding dilutive common shares excluded from the diluted net loss per common share calculation, as their effects were anti-dilutive:
Potentially Outstanding | ||||
Dilutive Common Shares | ||||
For the Years Ended | ||||
| June 30, 2024 |
| June 30, 2023 | |
Warrants |
| |
| |
The Company has
Use of Estimates
The preparation of financial statements in conformity with GAAP requires management to make estimates and assumptions that affect the amounts reported in the financial statements and accompanying notes. The Company bases its estimates on historical experience and on various assumptions that are believed to be reasonable under the circumstances. The amounts of assets and liabilities reported in the Company’s balance sheet and the amounts of expenses reported for each of the periods presented are affected by estimates and assumptions, which are used for but not limited to, accounting for share-based compensation. Actual results could differ from those estimates.
Fair Value of Financial Instruments
Fair value is defined as the price that would be received from selling an asset or paid to transfer a liability in an orderly transaction between market participants at the measurement date. When determining the fair value for applicable assets and liabilities, the Company considers the principal or most advantageous market in which we would transact and we consider assumptions market participants would use when pricing the asset or liability, such as inherent risk, transfer restrictions, and risk of nonperformance. This guidance also establishes a fair value hierarchy to prioritize inputs used in measuring fair value as follows:
| ● | Level 1: Observable inputs such as quoted prices in active markets; |
| ● | Level 2: Inputs, other than quoted prices in active markets, that are observable either directly or indirectly; and |
| ● | Level 3: Unobservable inputs in which there is little or no market data, which require the reporting entity to develop its own assumptions. |
Long-Lived Assets
Long-lived assets are reviewed for impairment whenever events or changes in circumstances indicate that the carrying amount of an asset may not be recoverable. Recoverability of assets to be held and used is measured by a comparison of the carrying amount of the assets to the future undiscounted net cash flows expected to be generated by the asset. If such assets are considered to be impaired, the impairment to be recognized is measured by the amount by which the carrying amount of the assets exceeds the fair value of the assets and would be charged to earnings. Fair value is determined through various valuation techniques including discounted cash flow models, quoted market values and third-party independent appraisals, as considered necessary. The Company did not identify any indicators or impairment and has not recorded an impairment charge for the years ended June 30, 2024 and 2023.
F-11
Cash and Cash Equivalents
The Company considers all highly liquid instruments with original maturities of three months or less to be cash equivalents.
Property and Equipment
Property and equipment is stated at cost and depreciated over the estimated useful lives of the assets, using the straight-line method. The Company generally assigns useful lives of
Intangible Assets
NanoViricides, Inc.’s intangible assets include acquired licenses and capitalized patent costs representing legal fees associated with filing patent applications. Intangible assets with finite lives, licenses and patent costs, are amortized using the straight- line method over the estimated economic lives of the assets, which range from to
Research and Development
All costs of research and development are expensed as incurred.
When preparing our financial statements, we are required to estimate our accrued clinical expenses. This process involves reviewing contracts and communicating with the personnel to identify services that have been performed on our behalf and estimating the level of service performed and the associated cost incurred for the service when we have not yet been invoiced or otherwise notified of actual cost. Payments under some of the contracts we have with third parties depend on factors, such as successful enrollment of certain numbers of patients, site initiation and the completion of clinical trial milestones, which is usually the case with clinical services contracts.
When accruing clinical expenses, we estimate the time period over which services will be performed and the level of effort to be expended in each period. If possible, we obtain information regarding unbilled services directly from our service providers. However, we may be required to estimate the cost of these services based only on information available to us. If we underestimate or overestimate the cost associated with a trial or service at a given point in time, adjustments to research and development expenses may be necessary in future periods. Historically, our estimated accrued clinical expenses have approximated actual expense incurred.
Stock-Based Compensation
The Company follows the provisions of ASC 718 – “Stock Compensation”, which requires the measurement of compensation expense for all shared-based payment awards made to employees, non-employee directors, and non-employees, including employee stock options and grants of warrants to non-employees. Stock-based compensation expense is based on the grant date fair value estimated in accordance with the provisions of ASC 718 and is generally recognized as an expense over the requisite service period, net of forfeitures.
The fair value of common stock issued as employee and non-employee compensation is the average of the open and close share price on the date the common shares are issued.
F-12
The Series A preferred shares are not traded in any market. The assumptions used to determine the fair value of the Series A preferred shares issued as employee and non-employee compensation are presented in Note 8 to the financial statements.
The fair value of each option or warrant award is estimated on the date of grant using a Black-Scholes option-pricing valuation model. The ranges of assumptions for inputs are as follows:
| ● | Expected term of share options and warrants: The expected term of share options and similar instruments represents the period of time the options and similar instruments are expected to be outstanding taking into consideration the contractual term of the instruments and employees’ expected exercise and post-vesting employment termination behavior into the fair value of the instruments. The Company uses the simplified method to calculate expected term of share options and similar instruments, as the Company does not have sufficient historical exercise data to provide a reasonable basis upon which to estimate the expected term. |
| ● | Expected volatility of the Company’s shares and the method used to estimate it: Expected volatility is based on the average historical volatility of the Company’s common stock over the expected term of the option. |
| ● | Expected annual rate of quarterly dividends: The expected dividend yield is based on the Company’s current dividend yield as the best estimate of projected dividend yield for periods within the expected term of the option and similar instruments. |
| ● | Risk-free rate(s): The risk-free interest rate is based on the U.S. Treasury yield curve in effect at the time of grant for periods within the expected term of the option and similar instruments. |
The Company’s policy is to recognize compensation cost for awards with only service conditions and a graded vesting schedule on a straight-line basis over the requisite service period for the entire award.
Income Tax Provision
The Company uses the asset and liability method of accounting for deferred income taxes. Deferred income taxes are measured by applying enacted statutory rates to net operating loss carryforwards and to the differences between the financial reporting and tax bases of assets and liabilities. Deferred tax assets are reduced, if necessary, by a valuation allowance if it is more likely than not that some portion or all of the deferred tax assets will not be realized.
The Company recognizes uncertainty in income taxes in the financial statements using a recognition threshold and measurement attribute of a tax position taken or expected to be taken in a tax return. The Company applies the “more-likely-than-not” recognition threshold to all tax positions, which resulted in
Concentrations of Risk
Financial instruments that potentially subject the Company to a significant concentration of credit risk consist primarily of cash and cash equivalents. The Company maintains deposits in FDIC or SIPC insured institutions in excess of federally insured limits under the FDIC. Although the Company currently believes that the financial institutions with whom it does business will be able to fulfill their commitments to the Company, there is no assurance that those institutions will be able to continue to do so. The Company has not experienced any credit losses associated with its balances in such accounts for the fiscal years ended June 30, 2024 and 2023.
Recently Issued Accounting Pronouncements
The Company considers the applicability and Impact of all Accounting Standard Updates (“ASU’s”). ASU’s not discussed below were assessed and determined to be either not applicable or are expected to have minimal impact on the Company’s financial statements.
F-13
ASU 2023-09 Income Taxes (Topic 740) Improvements to Income Tax Disclosures. The amendments in this Update require that public business entities on an annual basis (1) disclose specific categories in the rate reconciliation and (2) provide additional information for reconciling items that meet a quantitative threshold (if the effect of those reconciling items is equal to or greater than 5 percent of the amount computed by multiplying pretax income [or loss] by the applicable statutory income tax rate). Additionally, the ASU requires all entities to disclose the amount of income taxes paid disaggregated by federal, state, and foreign taxes, as well as individual jurisdictions where income taxes paid are equal to or greater than 5 percent of total income taxes paid. ASU 2023-09 is effective for annual periods beginning after December 31, 2024. Early adoption is permitted and this ASU should be applied on a prospective basis. While the Company is currently evaluating the adoption impact of this ASU on its financial statements, the preliminary assessment is that the adoption of this standard is not expected to have a material effect on the Company’s financial statements and the Company’s disclosures.
ASU 2023-07 Segment Reporting (Topic 280): Improvements to Reportable Segment Disclosures. The requirements of this update require disclosure of significant segments expenses and increase the frequency of segment reporting to interim periods. The ASU is effective for all public companies for fiscal years beginning after December 15, 2023 and for interim period beginning after December 15, 2024. Early adoption is permitted and is applicable to all periods presented in the financial statements unless retrospective application is impracticable. While the Company is currently evaluating the adoption impact of this ASU on its financial statements, the preliminary assessment is that the adoption of this standard is not expected to have a material effect on the Company’s financial statements and the Company’s disclosures.
There have been certain changes in ASU 2020-06, Debt - Debt with Conversion and Other Options (Subtopic 470-20) and Derivatives and Hedging - Contracts in Entity’s Own Equity (Subtopic 815-40) - Accounting for Convertible Instruments and Contracts in an Entity’s Own Equity, which simplifies accounting for convertible instruments by removing major separation models required under GAAP. The ASU also removes certain settlement conditions that are required for equity-linked contracts to qualify for the derivative scope exception, and it also simplifies the diluted earnings per share calculation in certain areas. The Company adopted this ASU as of July 1, 2023, using the modified retrospective approach without a material impact on its financial statements.
Note 4 – Related Party Transactions
Related Parties
Related parties with whom the Company had transactions are:
Related Parties |
| Relationship |
Dr. Anil Diwan |
| Chairman, President, CEO, significant stockholder through his ownership of TheraCour, and Director |
TheraCour Pharma, Inc. (“TheraCour”) |
| An entity owned and controlled by Dr. Anil Diwan |
Karveer Meditech Private Limited (“KMPL”) |
| An entity where Dr. Anil Diwan is a passive investor and advisor without operating control |
Property and Equipment
For the Year Ended | ||||||
| June 30, 2024 |
| June 30, 2023 | |||
During the reporting period, TheraCour acquired property and equipment on behalf of the Company from third party vendors and transferred such property and equipment, at cost, to the Company | $ | | $ | | ||
F-14
Accounts Payable- Related Party
As of | ||||||
| June 30, 2024 |
| June 30, 2023 | |||
Pursuant to an Exclusive License Agreement entered into with TheraCour, the Company was granted exclusive licenses for technologies developed by TheraCour for the virus types: HIV, HCV, Herpes, Asian (bird) flu, Influenza and rabies. On November 1, 2019, the Company entered into the VZV Licensing Agreement with TheraCour. In consideration for obtaining these exclusive licenses it was agreed: (1) that TheraCour can charge its costs (direct and indirect) plus no more than | $ | | $ | | ||
Research and Development Costs - Related Party
For the Year Ended | ||||||
| June 30, |
| June 30, | |||
2024 | 2023 | |||||
Development fees and other costs charged by TheraCour pursuant to the Exclusive License Agreements between TheraCour and the Company for the development of the Company’s drug pipeline. | $ | | $ | | ||
Clinical Trial Costs - Related Party
For the Year Ended | ||||||
| June 30, |
| June 30, | |||
| 2024 |
| 2023 | |||
Clinical trial related and other costs charged by KMPL pursuant to the license between KMPL and the Company amounted to $ |
| $ | |
| $ | |
F-15
License Milestone Fee – Related Party
On September 7, 2021, the Company entered into a COVID-19 license agreement (the “TheraCour – Nanoviricides COVID License Agreement”) to use, promote, offer for sale, import, export, sell and distribute drugs that treat COVID-19 infections, using TheraCour’s proprietary as well as patented technology and intellectual property. Pursuant to such license agreement, the Board of Directors authorized the issuance of
On July 19, 2023, the Company entered into an agreement with TheraCour, to accept the Company’s unsecured convertible promissory note (the “Note”) in payment of the milestone award. The Note accrues simple interest at the rate of
On February 12, 2024, the Company entered into an Amendment to the COVID License Agreement with TheraCour dated September 7, 2021, whereby any further cash milestone payments that would be earned upon milestone event would only become payable upon the Company having sufficient revenues, with only a portion of revenues to be used for satisfying such milestone payments.
Line of Credit - Related Party
On November 13, 2023, the Company’s President and CEO, Dr. Anil R. Diwan, entered into a Line of Credit Agreement whereby Dr. Diwan agreed to provide a standby Line of Credit to the Company in the maximum amount of $
By signing on September 23, 2024 and becoming effective as of September 20, 2024, subsequent to the reporting period, the Company, pursuant to Article 2.5 of the Company’s Line of Credit Agreement with Dr. Anil R. Diwan, signed an Amendment Agreement which increased the available line of credit from $
F-16
Note 5 – Property and Equipment
Property and equipment, stated at cost, less accumulated depreciation consisted of the following:
| June 30, |
| June 30, | |||
2024 | 2023 | |||||
GMP Facility | $ | | $ | | ||
|
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Land |
| |
| | ||
|
| |||||
Office Equipment |
| |
| | ||
|
| |||||
Furniture and Fixtures |
| |
| | ||
|
| |||||
Lab Equipment |
| |
| | ||
|
| |||||
Total Property and Equipment |
| |
| | ||
|
| |||||
Less Accumulated Depreciation |
| ( |
| ( | ||
Property and Equipment, Net | $ | | $ | | ||
Depreciation expense for the years ended June 30, 2024 and 2023 was $
Note 6 – Intangible Assets
Intangible assets, net consists of the following:
| June 30, 2024 |
| June 30, 2023 | |||||||||||||||
Finite Lived | Indefinite Lived | Finite Lived | Indefinite Lived | |||||||||||||||
| Intangible Assets | Intangible Assets | Total | Intangible Assets | Intangible Assets | Total | ||||||||||||
Intangible Assets | $ | | $ | | $ | | $ | | $ | | $ | | ||||||
Less Accumulated Amortization | ( |
| — | ( | ( |
| — | ( | ||||||||||
Intangible Assets, Net | $ | | $ | | $ | | $ | | $ | | $ | | ||||||
Amortization expense amounted to $
NanoViricides, Inc.’s intangible assets include acquired licenses and capitalized patent costs representing legal fees associated with filing patent applications.
Note 7 – Accrued expenses
Accrued expenses consisted of the following:
| June 30, |
| June 30, | |||
2024 | 2023 | |||||
Personnel and compensation costs | $ | $ | ||||
Consultant | | | ||||
Clinical trial costs due to KPML |
| |
| | ||
$ | | $ | | |||
F-17
Note 8 – Equity Transactions
Fiscal Year Ended June 30, 2024 Transactions
On July 19, 2023, the Company entered into an agreement with TheraCour, to accept the Company’s unsecured convertible promissory note (the “Note”) in payment of the milestone award earned under the COVID License Agreement. The Note accrued simple interest at the rate of
On October 6, 2023, the Board of Directors and Dr. Anil Diwan, President and Chairman of the Board agreed to the extension of Dr. Diwan’s employment agreement for a period of
On April 15, 2024, the Company entered into a new ATM sales agreement with. E.F. Hutton Securities, the Sales Agent, pursuant to which the Company may offer and sell, from time to time, through or to the Sales Agent, shares of common stock having an aggregate offering price of up to $
The Company accounted for the proceeds of the ATM Offering, approximately, as follows:
Gross proceeds |
| $ | |
Less: offering costs and expenses | |||
Net proceeds from issuance of common stock | $ |
For the year ended June 30, 2024, the Scientific Advisory Board was granted fully vested warrants to purchase
For the year ended June 30, 2024, the Company estimated the fair value of the warrants granted quarterly to the Scientific Advisory Board on the date of grant using the Black-Scholes Option-Pricing Model with the following assumptions:
Expected life (year) |
| ||
Expected volatility |
| % | |
Expected annual rate of quarterly dividends |
| | % |
Risk-free rate(s) |
| % |
For the year ended June 30, 2024, the Company’s Board of Directors authorized the issuance of
F-18
There is currently no market for the shares of Series A preferred stock and they can only be converted into shares of common stock upon a change of control of the Company as more fully described in the Certificate of Designation. The Company, therefore, estimated the fair value of the Series A preferred stock granted to various employees and others on the date of grant. The fair value of the Series A preferred stock at each issuance was estimated based upon the price of the Company’s common stock after an application for a reasonable discount for lack of marketability.
For the year ended June 30, 2024, the Company’s Board of Directors authorized the issuance of
For the year ended June 30, 2024, the Company’s Board of Directors authorized the issuance of
For the year ended June 30, 2024, the Company’s Board of Directors authorized the issuance of
Fiscal Year Ended June 30, 2023 Transactions
On February 7, 2023, the Board of Directors and a majority of the shareholders of the Company approved the redomiciling of the Company wherein the Company would redomicile from a Nevada corporation to a Delaware corporation. The redomicile became effective on May 30, 2023 pursuant to Section 265 of the Delaware General Corporation Law and Sections 92A.120 and 92A.250 of the Nevada Revised Statutes. The redomicile occurred according to the Plan of Conversion whereby each share of the Company’s $
On April 20, 2023, the Company was notified that the Company’s licensee, KMPL was authorized to enter into Phase Ia/Ib clinical trials of its COVID, NV-CoV-2 Oral Syrup and its NV-CoV-2 Oral Gummies after satisfying the conditions of a conditional authorization received on or about January 27, 2023. Pursuant to the TheraCour – Nanoviricides COVID License Agreement, the Board authorized
On October 6, 2022, the Board of Directors and Dr. Anil Diwan, President and Chairman of the Board agreed to the extension of Dr. Diwan’s employment agreement for a period of
For the year ended June 30, 2023, the Scientific Advisory Board was granted fully vested warrants to purchase
F-19
For the year ended June 30, 2023, the Company estimated the fair value of the warrants granted quarterly to the Scientific Advisory Board on the date of grant using the Black-Scholes Option-Pricing Model with the following assumptions:
Expected life (year) |
| ||
Expected volatility |
| % | |
Expected annual rate of quarterly dividends |
| | % |
Risk-free rate(s) |
| % |
For the year ended June 30, 2023, the Company’s Board of Directors authorized the issuance of
There is currently no market for the shares of Series A preferred stock and they can only be converted into shares of common stock upon a change of control of the Company as more fully described in the Certificate of Designation. The Company, therefore, estimated the fair value of the Series A preferred stock granted to various employees and others on the date of grant. The fair value of the Series A Convertible preferred stock at each issuance was estimated based upon the price of the Company’s common stock after an application for a reasonable discount for lack of marketability.
For the year ended June 30, 2023, the Company’s Board of Directors authorized the issuance of
For the year ended June 30, 2023, the Company’s Board of Directors authorized the issuance of
For the year ended June 30, 2023, the Company’s Board of Directors authorized the issuance of
Note 9 – Common Stock Warrants
Stock Warrants
|
|
| Weighted |
| ||||||
Weighted | Average | |||||||||
Average | Remaining | |||||||||
Number of | Exercise | Contractual life at | Aggregate | |||||||
Shares | Price | June 30, 2024 | Intrinsic | |||||||
Outstanding and exercisable at July 1, 2022 |
| | $ | |
| — | $ | | ||
Granted |
| | | — |
|
| — | |||
Exercised |
| — |
| — |
| — |
|
| — | |
Expired |
| |
| |
| — |
|
| — | |
Canceled |
| — |
| — |
| — |
|
| — | |
Outstanding and exercisable at June 30, 2023 |
| | $ | | — |
| $ | | ||
Granted |
| | |
|
| — | ||||
Exercised |
| — |
| — |
| — |
|
| — | |
Expired |
| |
| |
| — |
|
| — | |
Canceled |
| — |
| — |
| — |
|
| — | |
Outstanding and exercisable at June 30, 2024 |
| | $ | |
| $ | | |||
Of the above warrants;
F-20
Note 10 – Income Tax Provision
The Company has
The income tax expense for the years ended June 30, 2024 and 2023 differed from the amounts computed by applying the U.S. federal income tax rate of
For the Year Ended |
| ||||
|
| June 30, |
| June 30, |
|
2024 | 2023 |
| |||
Federal statutory rate |
| ( | % | ( | % |
Research and development credit |
| | % | | % |
State tax rate |
| ( | % | ( | % |
Other |
| ( | % | ( | % |
Valuation allowance |
| | % | | % |
Effective tax rate |
| |
| | |
The significant components of the Company’s deferred tax assets at June 30, 2024 and 2023 are as follows:
| June 30, |
| June 30, | |||
2024 | 2023 | |||||
Net operating loss | $ | | $ | | ||
Research and development credit |
| |
| | ||
IRC Sec.174 R&E capitalization |
| |
| | ||
Other |
| |
| | ||
Total gross deferred tax assets |
| |
| | ||
Less: valuation allowance |
| ( |
| ( | ||
Net deferred tax asset | $ | | $ | | ||
At June 30, 2024 and 2023, the Company has recorded a full valuation allowance against its net deferred tax assets of
As of June 30, 2024, the Company has approximately $
Due to the change in ownership provisions of the Internal Revenue Code, the availability of the Company’s net operating loss carry-forwards could be subject to annual limitations against taxable income in future periods, which could substantially limit the eventual utilization of such carryforwards. The Company has not analyzed the historical or potential impact of its equity financings on beneficial ownership and therefore no determination has been made whether the net operating loss carryforward is subject to any Internal Revenue Code Section 382 limitation. To the extent there is a limitation, there could be a reduction in the deferred tax asset with an offsetting reduction in the valuation allowance.
The Company does not have any uncertain tax positions at June 30, 2024 and June 30, 2023 that would affect its effective tax rate. The Company does not anticipate a significant change in the amount of unrecognized tax benefits over the next twelve months. Because the Company is in a loss carryforward position, the Company is generally subject to US federal and state income tax examinations by tax authorities for all years for which a loss carryforward is available. If and when applicable, the Company will recognize interest and penalties as part of income tax expense.
F-21
Note 11 – Commitments and Contingencies
Legal Proceedings
From time to time, we are subject to various legal proceedings arising in the ordinary course of business, including proceedings for which we have insurance coverage. There are no pending legal proceedings against the Company to the best of the Company’s knowledge as of the date hereof and to the Company’s knowledge no action, suit or proceeding has been threatened against the Company that we believe will have a material adverse effect to our business, financial position, results of operations, or liquidity.
Employment Agreements
As of July 1, 2024, NanoViricides, Inc. entered into an Extension Agreement (the “Extension”) of the 2024 Employment Agreement with Dr. Anil Diwan entered into on July 1, 2018 (the “Employment Agreement”) to continue to serve as the President of the Company, effective July 1, 2024 under the same general terms and conditions. The Extension provides that Dr. Diwan will continue to serve as the Company’s President until June 30, 2025 at a base annual base salary of $
On March 3, 2010, the Company entered into an employment agreement with Dr. Jayant Tatake to serve as Vice President of Research and Development. The employment agreement provides for a term of
On May 30, 2013, the Company entered into an agreement with Meeta Vyas, wife of our President and Chairman of the Board, to serve as its Chief Financial Officer. The agreement provided for a term of
F-22
License Agreements
The Company is dependent upon its license agreements with TheraCour (See Notes 1 and 4). If the Company lost the right to utilize any of the proprietary information that is the subject of the TheraCour license agreement on which it depends, the Company will incur substantial delays and costs in development of its drug candidates. On November 1, 2019, the Company entered into a Licensing Agreement (the “Agreement”) with TheraCour for an exclusive license for the Company to use, promote, offer for sale, import, export, sell and distribute products for the treatment of VZV derived indications. Process development and related work will be performed by TheraCour under the same compensation terms as prior agreements between the parties, with no duplication of costs allowed. Upon commercialization, NanoViricides will pay
On September 7, 2021, the Company entered into a world-wide, exclusive, sub-licensable, license (“COVID License Agreement”) to use, promote, offer for sale, import, export, sell and distribute drugs that treat COVID-19 infections, using TheraCour’s proprietary as well as patented technology and intellectual property. The discovery of ligands and polymer materials as well as formulations, the chemistry and chemical characterization, as well as process development and related work will be performed by TheraCour under the same compensation terms as prior agreements between the parties, with no duplication of costs allowed. The Company was not required to make any upfront cash payments to TheraCour and agreed to the following milestone payments to TheraCour: (i) the issuance of
On March 27, 2023 the Company entered into a license agreement with KMPL wherein the Company granted to KMPL a limited, non-transferable, exclusive license for the use, sale, or offer of sale in India of the Company’s
On February 12, 2024, the Company entered into an Amendment to the COVID License Agreement with TheraCour dated September 7, 2021, whereby any further cash milestone payments that would be earned upon milestone event would only become payable upon the Company having sufficient revenues, with only a portion of revenues to be used for satisfying such milestone payments.
F-23
Note 12 - Subsequent Events
As discussed at Note 8 to the financial statements, on April 15, 2024, the Company entered into a sales agreement with. E.F. Hutton Securities (now EF Hutton, LLC), the Sales Agent, pursuant to which the Company may offer and sell, from time to time, through or to the Sales Agents, shares of common stock At-the-Market or ATM Offering. From July 1, 2024 through September 10, 2024 the Company sold
By signing on September 23, 2024 and being effective as of September 20, 2024, the Company, pursuant to Article 2.5 of the Company’s Line of Credit Agreement with Dr. Anil R. Diwan, signed an Amendment Agreement which increased the available line of credit from $
By signing on September 23, 2024 and being effective as of September 20, 2024, the Company entered into a “Memorandum of Understanding for All Antivirals Drug Development” (the MoU) with TheraCour that granted to the Company, a limited, non-assignable, non-sublicensable, exclusive Right of First Refusal to License to any antiviral drugs in development or to be developed by TheraCour for research and development purposes only, for all as-yet unlicensed viral infection treatment indications. The MoU also clarified the roles and responsibilities of the Parties and essentially codified the process that the parties have adopted since inception. The MoU further codified the treatment of all future milestone payments arising from any current or future license agreements to TheraCour to be consistent with the principles adopted in the February 12, 2024 Amendment to the COVID-19 License Agreement.
F-24
Exhibit 10.34
AMENDMENT TO LINE OF CREDIT AGREEMENT
This AMENDMENT TO LINE OF CREDIT AGREEMENT (this “Amendment”), dated as of the 20th day of September, 2024 (the “Effective Date”), is entered into by Anil R. Diwan and/or his successors and assigns (collectively, the “Lender”) and NanoViricides, Inc., a Delaware corporation (“Borrower”). Lender and Borrower are each referred to herein individually as a “Party” and collectively as the “Parties.” Capitalized terms not defined herein shall have the meaning set forth in the Line of Credit Agreement.
W I T N E S E T H:
WHEREAS, on November 13, 2023, the Parties entered into a Line of Credit Agreement (the “Line of Credit Agreement”), pursuant to which the Borrower obtained a line of credit of up to $2,000,000 from the Lender; and
WHEREAS, in connection with the Line of Credit, the Borrower entered into an Open Ended Promissory Note with the Lender to borrow up to $2,000,000; and
WHEREAS, the original Maturity Date of the Line of Credit was December 31, 2024; and
WHEREAS, on February 12, 2024, the Parties entered into a Line of Credit Extension Agreement (“Extension Agreement”) whereby the Maturity Date of the Line of Credit, Note, and Mortgage Deed were extended to December 31, 2025; and
WHEREAS, the Parties desire to increase the Line of Credit from $2,000,000 to $3,000,000 and to further extend the Maturity Date of the Line of Credit to March 31, 2026 pursuant to Article 2.5 of the Line of Credit Agreement; and
WHEREAS, as of the Effective Date, the Company has not drawn against the Line of Credit and the Parties have agreed to amend the Line of Credit Agreement and Note pursuant to and in accordance with the provisions set forth herein.
NOW, THEREFORE, in consideration of the foregoing premises and the mutual covenants contained herein, and for other good and valuable consideration, the receipt and sufficiency of which are hereby acknowledged, the Parties agree as follows:
1.Incorporation of Whereas Clauses. The parties hereto adopt as part of this Amendment each of the recitals in the License Agreement which are set forth in the WHEREAS clauses, and agree that such recitals shall be binding upon the Parties hereto by way of contract and not merely by way of recital or inducement. Such WHEREAS clauses are hereby confirmed and ratified as being true and accurate by each Party to this Amendment.
2.Amendments to Line of Credit Agreement.
A.The Recitals shall be amended in its entirety to read as follows:
A.The Borrower wishes to obtain from the Lender, a line of credit facility of up to Three Million ($3,000,000) Dollars (the “Line of Credit”).
B.In connection with the Line of Credit, the Borrower entered into an Open Ended Promissory Note with the Lender up even date herewith (the “Note”) to borrow up to $3,000,000.
C.In full reliance on the representations made by Borrower in this Agreement and the Line of Credit Documents, Lender is willing to extend such financing to Borrower upon the terms, covenants and conditions contained in this Agreement and in the Line of Credit Documents.
NOW, THEREFORE, in consideration of the mutual promises, covenants and agreements contained in this Agreement, Borrower and Lender mutually agree as follows:
B. The following definitions from the Definitions Section of the Line of Credit Agreement shall be amended in their entirety to read as follows:
“Line of Credit” shall mean the financing provided by Lender to Borrower under the terms of this Agreement in the maximum principal amount of Three Million ($3,000,000) Dollars.
“Maturity Date” shall mean March 31, 2026, being the date that all sums evidenced by the Note shall be due and payable;
C. Section 2.1 of the Line of Credit Agreement shall be amended in its entirety to read as follows:
2.1 | Line of Credit. On the Effective Date, the Lender shall provide the Borrower with a Line of Credit up to the maximum amount of Three Million ($3,000,000) Dollars, representing the maximum aggregate amount of the advances of funds from the Line of Credit (each an “Advance”) that may be outstanding and any time under the Line of Credit (the “Principal Indebtedness”), from which Borrower may draw down, at any time and from time to time during the period from and including the date of this Line of Credit through the day immediately preceding the Maturity Date, a principal amount not to exceed at any one time outstanding, as to all such Advances in the aggregate, the Principal Indebtedness. The entire Principal Indebtedness of the Line of Credit shall be due and payable on the earlier to occur of (a) the occurrence and continuation of a Default hereunder, or (b) the Maturity Date (as the same may be extended as herein provided). |
3.Amendments to Note.
A. The reference to $2,000,000 is hereby replaced with “$3,000,000.”
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B. The first paragraph of the Note shall be replaced in its entirety with the following new paragraph:
FOR VALUE RECEIVED, on the Line of Credit Maturity Date, NanoViricides, Inc., a Delaware corporation, having a principal office at 1 Controls Drive, Shelton, Connecticut 06484 (the “Borrower”), hereby promises to pay to the order of Anil R. Diwan, or any subsequent holder of this Note (collectively, the “Lender”), under the terms herein, the principal amount of Three Million ($3,000,000) Dollars (the “Principal Amount”), plus interest accrued thereon as herein provided with respect to the Principal Amount. Fixed annual interest shall accrue only on the unpaid Principal Amount from the date of original issuance until paid in accordance herewith, as applicable, at a rate equal to twelve percent (12%) per annum. The unpaid Principal Amount, together with any then-unpaid accrued interest thereon, shall be due and payable or converted, as the case may be, on March 31, 2026 (the “Maturity Date”) or (ii) when such amounts are made due and payable upon or after the occurrence of an Event of Default in accordance with Section 1 hereof. All payments due on this Note shall be made in cash via certified check or other immediately available funds. The Holder shall only be entitled to receive a cash payment for a payment due on this Note (i) upon the demand of the Required Holders on or after the Maturity Date or (ii) upon the occurrence and continuance of Event of Default.
4.Validity of Open End Mortgage Deed. The Borrower hereby acknowledges the Open End Mortgage Deed is valid and in full force and effect and creates a valid lien against the Covering Premises to secure the Principal Amount.
5.Parties Representations. The Parties each represents, warrants and covenants the following to the other party:
A.The undersigned has the full authority, right, power and legal capacity to enter into this Amendment and to consummate the transactions contemplated herein. The execution of this Amendment by the undersigned and its delivery to the other party, and the consummation by the undersigned of the transactions which are contemplated in this Amendment have been duly approved and authorized by all necessary action by the undersigned’s Board of Directors and no further authorization shall be necessary on the part of the undersigned for the performance and consummation by the undersigned of the transactions which are contemplated by this Amendment. The execution, delivery and performance of this Amendment shall not require approval, consent or authorization of any third party, including any governmental agency or authority or any political subdivision thereof. This Amendment constitutes the legal, valid and binding obligation of the undersigned and is enforceable as to the undersigned in accordance with the terms of this Amendment, subject to the enforcement of remedies by applicable bankruptcy, insolvency, fraudulent conveyance, reorganization, moratorium or other laws affecting creditors’ rights generally and by generally applicable equitable principles, whether considered in an action at law or in equity.
B.The undersigned agrees to cooperate with the other party and shall make, execute, acknowledge, deliver, or cause to be made, executed, acknowledged, and delivered, at
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such times and places as either party may reasonably deem necessary, all other documents and instruments as may be reasonably necessary in order to effectuate the purposes of this Amendment.
C.The performance of this Amendment shall not result in any breach of, or constitute a default under, or result in the imposition of any lien or encumbrance upon any property of the undersigned or cause an acceleration under any arrangement, agreement or other instrument to which the undersigned is a party or by which any of its assets are bound. The undersigned has performed in all respects all of its obligations which are, as of the date of this Amendment, required to be performed by it pursuant to the terms of any such agreement, contract or commitment.
D.No representation or warranty of the undersigned which is contained in this Amendment, or in a writing furnished or to be furnished pursuant to this Amendment contains or shall contain any untrue statement of a material fact, omits or shall omit to state any material fact which is required to make the statements which are contained herein or therein, in light of the circumstances under which they were made, not misleading.
E.The undersigned acknowledges that its decision to enter into this Amendment was based entirely upon its own determination, and not upon any representations made to the undersigned by the other party with respect to this Amendment.
6.Miscellaneous.
A.Headings. The headings contained in this Amendment are for reference purposes only and shall not affect in any way the meaning or interpretation of this Amendment.
B.Enforceability. If any provision which is contained in this Amendment, should, for any reason, be held to be invalid or unenforceable in any respect under the laws of any State of the United States, such invalidity or unenforceability shall not affect any other provision of this Amendment and this Amendment shall be construed as if such invalid or unenforceable provision had not been contained in this Amendment.
C.Governing Law; Disputes. The Parties agree that this Amendment shall in all respects be construed, governed, applied and enforced in accordance with the laws of the State of Connecticut and be deemed to be an agreement entered into in the State of Connecticut and made pursuant to the laws of the State of Connecticut, without giving effect to the principles of conflicts of law.
D.Expenses. Each party to this Amendment shall bear and pay its own costs and expenses incurred in connection with the execution and delivery of this Amendment and the transactions set forth in this Amendment.
E.Entire Agreement. This Amendment and all documents and instruments referred to herein constitute the entire agreement and supersede all prior agreements and understandings, both written and oral, among the parties with respect to the subject matter hereof and thereof.
F.Confidentiality. The Parties agree that the terms of this Amendment are confidential and they shall not make public disclosure of the terms of this Amendment, except: (i)
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as may be required by law, (ii) in connection with litigation or other legal proceeding against a party, (iii) by judicial or other compulsory process, including, without being limited to, any court order, (iv) as may be required by any federal and/or state regulatory agency, or (v) as may be required in connection with its obligations under federal securities laws and pursuant to the Securities and Exchange Commission or listing requirements. If either party intends to make a disclosure of the terms of this Amendment as required by law, by judicial or other compulsory process, including, without being limited to, any court order, by any federal and/or state regulatory agency, or as may be required in connection with its obligations under federal securities laws, such party shall notify the other party, if feasible, in advance of any such disclosure. The Parties agree that the terms of this Amendment regarding confidentiality are not material to this Amendment and any breach of this paragraph shall not be considered a material breach of this Amendment. In the event of such a breach of this Paragraph, the non-breaching party shall only be entitled to injunctive relief and/or monetary damages for actual harms caused by the breach.
G.Assignment. The Parties hereby agree that the obligations under this Amendment shall be freely transferred or assigned to any third parties without the prior written consent of Assignee.
H.Enforceability. If any provision which is contained in this Amendment, should, for any reason, be held to be invalid or unenforceable in any respect under the laws of any State of the United States, such invalidity or unenforceability shall not affect any other provision of this Amendment and in this Amendment shall be construed as if such invalid or unenforceable provision had not been contained herein.
I.Further Assurances. The Parties agree to execute any and all such other further instruments and documents, and to take any and all such further actions which are reasonably required to effectuate this Amendment and the intents and purposes hereof.
J.Non-Waiver. Except as otherwise expressly provided herein, no waiver of any covenant, condition, or provision of this Amendment shall be deemed to have been made unless expressly in writing and signed by the party against whom such waiver is charged; and (i) the failure of any party to insist in any one or more cases upon the performance of any of the provisions, covenants or conditions of this Amendment or to exercise any option herein contained shall not be construed as a waiver or relinquishment for the future of any such provisions, covenants or conditions, (ii) the acceptance of performance of anything required by this Amendment to be performed with knowledge of the breach or failure of a covenant, condition or provision hereof shall not be deemed a waiver of such breach or failure and (iii) no waiver by any party of one breach by another party shall be construed as a waiver of any other or subsequent breach.
K.Counterparts. This Amendment may be executed simultaneously in one or more counterparts, each of which shall be deemed an original, but all of which together shall constitute one and the same instrument.
L.Facsimile and E-mail Signatures. Any signature which is delivered via facsimile or via E-mail in portable document format (“.pdf”) shall be deemed to be an original and have the same force and effect as if such facsimile or .pdf signature were the original thereof.
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M.Binding upon Execution and Delivery. No party to this Amendment shall be bound hereby until fully executed counterparts to this Amendment have been executed by, and delivered to, each party, or their respective attorneys, by all other parties or their respective attorneys.
N.Modifications. This Amendment may not be changed, modified, extended, terminated or discharged orally, but only by an agreement in writing signed by all of the parties to this Amendment.
[REMAINDER OF PAGE INTENTIONALLY LEFT BLANK; SIGNATURE PAGE FOLLOWS.]
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IN WITNESS WHEREOF, each Party hereto has caused this Amendment to be signed and delivered as of the date first written above.
| /s/ Anil R. Diwan | ||
| Anil R. Diwan | ||
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| NANOVIRICIDES, INC. | ||
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| By: | /s/ Brian Zucker | |
| | Name: | Brian Zucker |
| | Title: | Director |
[Signature Page to First Amendment to Line of Credit Agreement]
Exhibit 19.1
NanoViricides, Inc. Policy on Insider Trading
This Insider Trading Policy describes the standards of NanoViricides, Inc. (the “Company”) on trading, and causing the trading of, the Company’s securities or securities of certain other publicly traded companies while in possession of confidential information. This Policy is divided into two parts: the first part prohibits trading in certain circumstances and applies to all directors, officers and employees and their respective immediate family members, and the second part imposes special additional trading restrictions and applies to all (i) directors of the Company, (ii) executive officers of the Company/officers of the Company (together with the directors, “Company Insiders”) and (iii) the employees listed on Appendix A (collectively, “Covered Persons”).
One of the principal purposes of the federal securities laws is to prohibit so-called “insider trading.” Insider trading occurs when a person uses material nonpublic information obtained through involvement with the Company to make decisions to purchase, sell, give away or otherwise trade the Company’s securities or the securities of certain other companies or to provide that information to others outside the Company. The prohibitions against insider trading apply to trades, tips and recommendations by virtually any person, including all persons associated with the Company, if the information involved is “material” and “nonpublic.” These terms are defined in this Policy under Part I, Section 3 below. The prohibitions would apply to any director, officer or employee who buys or sells securities on the basis of material nonpublic information that he or she obtained about the Company, its customers, suppliers, partners, competitors or other companies with which the Company has contractual relationships or may be negotiating transactions.
PART I
1. Applicability
This Policy applies to all trading or other transactions in (i) the Company’s securities, including common stock, options and any other securities that the Company may issue, such as preferred stock, notes, bonds and convertible securities, as well as to derivative securities relating to any of the Company’s securities, whether or not issued by the Company and (ii) the securities of certain other companies, including common stock, options and other securities issued by those companies as well as derivative securities relating to any of those companies’ securities, where the person trading used information obtained while working for the Company.
This Policy applies to all employees and officers of the Company and to all members of the Company’s board of directors and their respective family members and the Covered Persons.
2. General Policy: No Trading or Causing Trading While in Possession of Material Nonpublic Information
(a) No director, officer or employee or any of their immediate family members, or any Covered Persons may purchase or sell, or offer to purchase or sell, any Company security, whether or not issued by the Company, while in possession of material nonpublic information about the Company. (The terms “material” and “nonpublic” are defined in Part I, Section 3(a) and (b) below.)
(b) No director, officer or employee or any of their immediate family members, or any Covered Persons who knows of any material nonpublic information about the Company may communicate
that information to (“tip”) any other person, including family members and friends, or otherwise disclose such information without the Company’s authorization.
(c) No director, officer or employee or any of their immediate family members, or any Covered Persons may purchase or sell any security of any other publicly traded company while in possession of material nonpublic information that was obtained in the course of his or her involvement with the Company. No director, officer or employee or any of their immediate family members, or any Covered Persons who knows of any such material nonpublic information may communicate that information to, or tip, any other person, including family members and friends, or otherwise disclose such information without the Company’s authorization.
(d) For compliance purposes, you should never trade, tip or recommend securities (or otherwise cause the purchase or sale of securities) while in possession of information that you have reason to believe is material and nonpublic unless you first consult with, and obtain the advance approval of, the Compliance Officer (which is defined in Part I, Section 3(c) below).
(e) Covered Persons must “pre-clear” all trading in securities of the Company in accordance with the procedures set forth in Part II, Section 3 below.
3. Definitions
(a) Material. Insider trading restrictions come into play only if the information you possess is “material.” Materiality, however, involves a relatively low threshold. Information is generally regarded as “material” if it has market significance, that is, if its public dissemination is likely to affect the market price of securities, or if it otherwise is information that a reasonable investor would want to know before making an investment decision. Meaning, a person would be more or less likely to trade the security if they had such information.
Information dealing with the following subjects is reasonably likely to be found material in particular situations:
(i) significant changes in the Company’s prospects;
(ii) significant write-downs in assets or increases in reserves;
(iii) developments regarding significant litigation or government agency investigations;
(iv) liquidity problems;
(v) changes in earnings estimates or unusual gains or losses in major operations;
(vi) major changes in the Company’s management or the board of directors;
(vii) changes in dividends;
(viii) extraordinary borrowings;
(ix) major changes in accounting methods or policies;
(x) award or loss of a significant contract;
(xi) cybersecurity risks and incidents, including vulnerabilities and breaches;
(xii) changes in debt ratings;
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(xiii) proposals, plans or agreements, even if preliminary in nature, involving mergers, acquisitions, divestitures, recapitalizations, strategic alliances, licensing arrangements, or purchases or sales of substantial assets; and
(xiv) offerings of Company securities.
Material information is not limited to historical facts but may also include projections and forecasts. With respect to a future event, such as a merger, acquisition or introduction of a new product, the point at which negotiations or product development are determined to be material is determined by balancing the probability that the event will occur against the magnitude of the effect the event would have on a company’s operations or stock price should it occur. Thus, information concerning an event that would have a large effect on stock price, such as a merger, may be material even if the possibility that the event will occur is relatively small. When in doubt about whether particular nonpublic information is material, you should presume it is material. If you are unsure whether information is material, you should either consult the Compliance Officer before making any decision to disclose such information (other than to persons who need to know it) or to trade in or recommend securities to which that information relates or assume that the information is material.
(b) Nonpublic. Insider trading prohibitions come into play only when you possess information that is material and “nonpublic.” The fact that information has been disclosed to a few members of the public does not make it public for insider trading purposes. To be “public” the information must have been disseminated in a manner designed to reach investors generally, and the investors must be given the opportunity to absorb the information. Even after public disclosure of information about the Company, you must wait until the close of business on the second trading day after the information was publicly disclosed before you can treat the information as public.
Nonpublic information may include:
(i) information available to a select group of analysts or brokers or institutional investors;
(ii) undisclosed facts that are the subject of rumors, even if the rumors are widely circulated; and
(iii) information that has been entrusted to the Company on a confidential basis until a public announcement of the information has been made and enough time has elapsed for the market to respond to a public announcement of the information in two trading days.
As with questions of materiality, if you are not sure whether information is considered public, you should either consult with the Compliance Officer or assume that the information is nonpublic and treat it as confidential.
(c) Compliance Officer. The Company has appointed the Chief Financial Officer as the Compliance Officer for this Policy. The duties of the Compliance Officer include, but are not limited to, the following:
(i) assisting with implementation and enforcement of this Policy;
(ii) circulating this Policy to all employees and ensuring that this Policy is amended as necessary to remain up-to-date with insider trading laws;
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(iii) pre-clearing all trading in securities of the Company by Covered Persons in accordance with the procedures set forth in Part II, Section 3 below; and
(iv) providing approval of any Rule 10b5-1 plans under Part II, Section 1(c) below and any prohibited transactions under Part II, Section 4 below.
(v) providing a reporting system with an effective whistleblower protection mechanism.
4. Exceptions
The trading restrictions of this Policy do not apply to the following:
(a) 401(k) Plan. Investing 401(k) plan contributions in a Company stock fund in accordance with the terms of the Company’s 401(k) plan. However, any changes in your investment election regarding the Company’s stock are subject to trading restrictions under this Policy.
(b) ESPP. Purchasing Company stock through periodic, automatic payroll contributions to the Company’s Employee Stock Purchase Plan (“ESPP”). However, electing to enroll in the ESPP, making any changes in your elections under the ESPP and selling any Company stock acquired under the ESPP are subject to trading restrictions under this Policy.
(c) Options. Exercising stock options granted under the Company’s Executive Equity Incentive Plan for cash or the delivery of previously owned Company stock. However, the sale of any shares issued on the exercise of Company-granted stock options and any cashless exercise of Company-granted stock options are subject to trading restrictions under this Policy.
5. Violations of Insider Trading Laws
Penalties for trading on or communicating material nonpublic information can be severe, both for individuals involved in such unlawful conduct and their employers and supervisors, and may include jail terms, criminal fines, civil penalties and civil enforcement injunctions. Given the severity of the potential penalties, compliance with this Policy is absolutely mandatory.
(a) Legal Penalties. A person who violates insider trading laws by engaging in transactions in a company’s securities when he or she has material nonpublic information can be sentenced to a substantial jail term and required to pay a criminal penalty of several times the amount of profits gained or losses avoided. In addition, a person who tips others may also be liable for transactions by the tippees to whom he or she has disclosed material nonpublic information. Tippers can be subject to the same penalties and sanctions as the tippees, and the SEC has imposed large penalties even when the tipper did not profit from the transaction. The SEC can also seek substantial civil penalties from any person who, at the time of an insider trading violation, “directly or indirectly controlled the person who committed such violation.”
(b) Company-Imposed Penalties. Employees who violate this Policy may be subject to disciplinary action by the Company, including dismissal for cause. Any exceptions to the Policy, if permitted, may only be granted by the Compliance Officer and must be provided before any activity contrary to the above requirements takes place.
6. Inquiries
If you have any questions regarding any of the provisions of this Policy, please contact the Compliance Officer at mvyas@nanoviricides.com.
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PART II
1. Blackout Periods
All Covered Persons are prohibited from trading in the Company’s securities during blackout periods as defined below.
(a) Quarterly Blackout Periods. Trading in the Company’s securities is prohibited during the period beginning at the close of the market on two weeks before the end of each fiscal quarter and ending at the close of business on the second trading day following the date the Company’s financial results are publicly disclosed and Form 10-Q or Form 10-K is filed. During these periods, Covered Persons generally possess or are presumed to possess material nonpublic information about the Company’s financial results.
(b) Other Blackout Periods. From time to time, other types of material nonpublic information regarding the Company (such as negotiation of mergers, acquisitions or dispositions, investigation and assessment of cybersecurity incidents or new product developments) may be pending and not be publicly disclosed. While such material nonpublic information is pending, the Company may impose special blackout periods during which Covered Persons are prohibited from trading in the Company’s securities. If the Company imposes a special blackout period, it will notify the Covered Persons affected.
(c) Exception. These trading restrictions do not apply to transactions under a pre-existing written plan, contract, instruction, or arrangement under Rule 10b5-1 under the Securities Exchange Act of 1934 (an “Approved 10b5-1 Plan”) that meet the following requirements:
(i) the plan has been reviewed and approved by the Compliance Officer at least five days in advance of being entered into;
(ii) the plan provides that no trades may occur thereunder until expiration of the applicable cooling-off period specified in Rule 10b5-1(c)(ii)(B), and no trades occur until after that time. The appropriate cooling-off period will vary based on the status of the Covered Person. For directors and officers, the cooling-off period ends on the later of (x) ninety days after adoption or certain modifications of the 10b5-1 plan; or (y) two business days following disclosure of the Company’s financial results in a Form 10-Q or Form 10-K for the quarter in which the 10b5-1 plan was adopted. For all other Covered Persons, the cooling-off period ends 30 days after adoption or modification of the 10b5-1 plan. This required cooling-off period will apply to the entry into a new 10b5-1 plan and any revision or modification of a 10b5-1 plan;
(iii) the plan is entered into in good faith by the Covered Person, and not as part of a plan or scheme to evade the prohibitions of Rule 10b5-1, at a time when the Covered Person is not in possession of material nonpublic information about the Company; and, if the Covered Person is a director or officer, the 10b5-1 plan must include representations by the Covered Person certifying to that effect;
(iv) the plan gives a third party the discretionary authority to execute such purchases and sales, outside the control of the Covered Person, so long as such third party does not possess any material nonpublic information about the Company; or explicitly specifies the security or securities to be purchased or sold, the number of shares, the prices and/or dates of transactions, or other formula(s) describing such transactions; and
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(iv) the plan is the only outstanding Approved 10b5-1 Plan entered into by the Covered Person (subject to the exceptions set out in Rule 10b5-1(c)(ii)(D)).
If you are considering entering into, modifying or terminating an Approved 10b5-1 Plan or have any questions regarding Approved Rule 10b5-1 Plans, please contact the Compliance Officer. You should consult your own legal and tax advisors before entering into, or modifying or terminating, an Approved 10b5-1 Plan. A trading plan, contract, instruction or arrangement will not qualify as an Approved 10b5-1 Plan without the prior review and approval of the Compliance Officer as described above.
2. Trading Window
Covered Persons are permitted to trade in the Company’s securities when no blackout period is in effect. Generally, this means that Covered Persons can trade during the period set forth in Section 1(A) and ending as set forth in Section 1(A). However, even during this trading window, a Covered Person who is in possession of any material nonpublic information should not trade in the Company’s securities until the information has been made publicly available or is no longer material. In addition, the Company may close this trading window if a special blackout period under Part II, Section 1(b) above is imposed and will re-open the trading window once the special blackout period has ended.
3. Pre-Clearance of Securities Transactions
(a) Because Company Insiders are likely to obtain material nonpublic information on a regular basis, the Company requires all such persons to refrain from trading, even during a trading window under Part II, Section 2 above, without first pre-clearing all transactions in the Company’s securities.
(b) Subject to the exemption in subsection (d) below, no Company Insider may, directly or indirectly, purchase or sell (or otherwise make any transfer, gift, pledge or loan of) any Company security at any time without first obtaining prior approval from the Compliance Officer. These procedures also apply to transactions by such person’s spouse, other persons living in such person’s household and minor children and to transactions by entities over which such person exercises control.
(c) The Compliance Officer shall record the date each request is received and the date and time each request is approved or disapproved. Unless revoked, a grant of permission will normally remain valid until the close of trading two business days following the day on which it was granted. If the transaction does not occur during the two-day period, pre-clearance of the transaction must be re-requested.
(d) Pre-clearance is not required for purchases and sales of securities under an Approved 10b5-1 Plan once the applicable cooling-off period has expired. No trades may be made under an Approved 10b5-1 Plan until expiration of the applicable cooling-off period. With respect to any purchase or sale under an Approved 10b5-1 Plan, the third party effecting transactions on behalf of the Company Insider should be instructed to send duplicate confirmations of all such transactions to the Compliance Officer.
4. Prohibited Transactions
(a) Company Insiders are prohibited from trading in the Company’s equity securities during a blackout period imposed under an “individual account” retirement or pension plan of the
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Company, during which at least 50% of the plan participants are unable to purchase, sell or otherwise acquire or transfer an interest in equity securities of the Company, due to a temporary suspension of trading by the Company or the plan fiduciary.
(b) Covered Persons, including any person’s spouse, other persons living in such person’s household and minor children and entities over which such person exercises control, are prohibited from engaging in the following transactions in the Company’s securities unless advance approval is obtained from the Compliance Officer:
(i) Short-term trading. Company Insiders who purchase Company securities may not sell any Company securities of the same class for at least six months after the purchase;
(ii) Short sales. Company Insiders/Covered Persons] may not sell the Company’s securities short;
(iii) Options trading. Covered Persons may not buy or sell puts or calls or other derivative securities on the Company’s securities;
(iv) Trading on margin or pledging. Covered Persons may not hold Company securities in a margin account or pledge Company securities as collateral for a loan; and
(v) Hedging. Covered Persons may not enter into hedging or monetization transactions or similar arrangements with respect to Company securities.
5. Acknowledgment and Certification
All Covered Persons are required to sign the attached acknowledgment and certification.
ACKNOWLEDGMENT AND CERTIFICATION
The undersigned does hereby acknowledge receipt of the Company’s Insider Trading Policy. The undersigned has read and understands (or has had explained) such Policy and agrees to be governed by such Policy at all times in connection with the purchase and sale of securities and the confidentiality of nonpublic information.
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| | (Signature) | |
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| | (Please print name) | |
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Date: | | | |
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APPENDIX A
[INSERT LIST OF EMPLOYEES TO WHOM THE INSIDER TRADING POLICY IS APPLICABLE]
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Exhibit 23
CONSENT OF INDEPENDENT REGISTERED PUBLIC ACCOUNTING FIRM
We consent to the incorporation by reference in the Registration Statement of NanoViricides, Inc. on Form S-3 (No. 333-271706) of our report dated September 27, 2024, on our audits of the financial statements as of June 30, 2024 and 2023 and for each of the years then ended, which report is included in this Annual Report on Form 10-K to be filed on or about September 27, 2024. Our report includes an explanatory paragraph about the existence of substantial doubt concerning the Company’s ability to continue as a going concern.
/s/ EisnerAmper LLP | |
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EISNERAMPER LLP | |
Iselin, New Jersey | |
September 27, 2024 | |
Exhibit 31.1
CERTIFICATION OF PRINCIPAL EXECUTIVE OFFICER
I, Anil Diwan, certify that:
1. I have reviewed this Annual Report on Form 10-K of NanoViricides, Inc.;
2. Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the statements made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by this report;
3. Based on my knowledge, the financial statements, and other financial information included in this report, fairly present in all material respects the financial condition, results of operations and cash flows of the registrant as of, and for, the periods presented in this report;
4. The registrant’s other certifying officer(s) and I are responsible for establishing and maintaining disclosure controls and procedures (as defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) and internal control over financial reporting (as defined in Exchange Act Rules 13a-15(f) and 15d-15(f)) for the registrant and have:
a) Designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our supervision, to ensure that material information relating to the registrant, including its consolidated subsidiaries, is made known to us by others within those entities, particularly during the period in which this report is being prepared;
b) Designed such internal control over financial reporting, or caused such internal control over financial reporting to be designed under our supervision, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles;
c) Evaluated the effectiveness of the registrant’s disclosure controls and procedures and presented in this report our conclusions about the effectiveness of the disclosure controls and procedures, as of the end of the period covered by this report based on such evaluation; and
d) Disclosed in this report any change in the registrant’s internal control over financial reporting that occurred during the registrant’s most recent fiscal quarter (the registrant’s fourth fiscal quarter in the case of an annual report) that has materially affected, or is reasonably likely to materially affect, the registrant’s internal control over financial reporting; and
5. The registrant’s other certifying officer(s) and I have disclosed, based on our most recent evaluation of internal control over financial reporting, to the registrant’s auditors and the audit committee of the registrant’s board of directors (or persons performing the equivalent functions):
a) All significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which are reasonably likely to adversely affect the registrant’s ability to record, process, summarize and report financial information; and
b) Any fraud, whether or not material, that involves management or other employees who have a significant role in the registrant’s internal control over financial reporting.
September 27, 2024 | By: | /s/ Anil Diwan | |
| | Name: | Anil Diwan |
| | Title: | President, Chief Executive Officer, Chairman |
| | | (Principal Executive Officer) |
Exhibit 31.2
CERTIFICATION OF PRINCIPAL FINANCIAL OFFICER
I, Meeta Vyas, certify that:
1. I have reviewed this Annual Report on Form 10-K of NanoViricides, Inc.;
2. Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the statements made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by this report;
3. Based on my knowledge, the financial statements, and other financial information included in this report, fairly present in all material respects the financial condition, results of operations and cash flows of the registrant as of, and for, the periods presented in this report;
4. The registrant’s other certifying officer(s) and I are responsible for establishing and maintaining disclosure controls and procedures (as defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) and internal control over financial reporting (as defined in Exchange Act Rules 13a-15(f) and 15d-15(f)) for the registrant and have:
a)Designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our supervision, to ensure that material information relating to the registrant, including its consolidated subsidiaries, is made known to us by others within those entities, particularly during the period in which this report is being prepared;
b)Designed such internal control over financial reporting, or caused such internal control over financial reporting to be designed under our supervision, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles;
c)Evaluated the effectiveness of the registrant’s disclosure controls and procedures and presented in this report our conclusions about the effectiveness of the disclosure controls and procedures, as of the end of the period covered by this report based on such evaluation; and
d)Disclosed in this report any change in the registrant’s internal control over financial reporting that occurred during the registrant’s most recent fiscal quarter (the registrant’s fourth fiscal quarter in the case of an annual report) that has materially affected, or is reasonably likely to materially affect, the registrant’s internal control over financial reporting; and
5. The registrant’s other certifying officer(s) and I have disclosed, based on our most recent evaluation of internal control over financial reporting, to the registrant’s auditors and the audit committee of the registrant’s board of directors (or persons performing the equivalent functions):
a)All significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which are reasonably likely to adversely affect the registrant’s ability to record, process, summarize and report financial information; and
b)Any fraud, whether or not material, that involves management or other employees who have a significant role in the registrant’s internal control over financial reporting.
September 27, 2024 | By: | /s/ Meeta Vyas |
| Name: | Meeta Vyas |
| Title: | Chief Financial Officer |
|
| (Principal Financial and Accounting Officer) |
Exhibit 32.1
CERTIFICATION PURSUANT TO 18 U.S.C. SECTION 1350,
AS ADOPTED PURSUANT TO SECTION 906 OF THE SARBANES-OXLEY ACT OF 2002
In connection with the annual report of NanoViricides, Inc. (the “Company”) on Form 10-K for the fiscal year ended June 30, 2024, as filed with the Securities and Exchange Commission on the date hereof, I, Anil Diwan, certify, pursuant to 18 U.S.C. §1350, as adopted pursuant to §906 of the Sarbanes-Oxley Act of 2002, that to my knowledge:
1. The annual report fully complies with the requirements of section 13(a) or 15(d) of the Securities Exchange Act of 1934 and
2. The information contained in the annual report fairly presents, in all material respects, the financial condition and results of operations of the Company.
September 27, 2024 | By: | /s/ Anil Diwan |
| Name: | Anil Diwan |
| Title: | President, Chief Executive Officer, Chairman |
|
| (Principal Executive Officer) |
The foregoing certification is being furnished solely pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002, and is not being “filed” as part of the Form 10-K or as a separate disclosure document for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise subject to liability under that section. This certification shall not be deemed to be incorporated by reference into any filing under the Securities Act of 1933, as amended, or the Exchange Act except to the extent that this Exhibit 32.1 is expressly and specifically incorporated by reference in any such filing.
A signed original of this written statement required by Section 906 has been provided to the Company and will be retained by the Company and furnished to the Securities and Exchange Commission or its staff upon request.
Exhibit 32.2
CERTIFICATION PURSUANT TO 18 U.S.C. SECTION 1350,
AS ADOPTED PURSUANT TO SECTION 906 OF THE SARBANES-OXLEY ACT OF 2002
In connection with the annual report of NanoViricides, Inc. (the “Company”) on Form 10-K for the fiscal year ended June 30, 2024, as filed with the Securities and Exchange Commission on the date hereof, I, Meeta Vyas, certify, pursuant to 18 U.S.C. §1350, as adopted pursuant to §906 of the Sarbanes-Oxley Act of 2002, that to my knowledge:
1. The annual report fully complies with the requirements of section 13(a) or 15(d) of the Securities Exchange Act of 1934 and
2. The information contained in the annual report fairly presents, in all material respects, the financial condition and results of operations of the Company.
September 27, 2024 | By: | /s/ Meeta Vyas |
| Name: | Meeta Vyas |
| Title: | Chief Financial Officer |
|
| (Principal Financial and Accounting Officer) |
The foregoing certification is being furnished solely pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002, and is not being “filed” as part of the Form 10-K or as a separate disclosure document for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise subject to liability under that section. This certification shall not be deemed to be incorporated by reference into any filing under the Securities Act of 1933, as amended, or the Exchange Act except to the extent that this Exhibit 32.2 is expressly and specifically incorporated by reference in any such filing.
A signed original of this written statement required by Section 906 has been provided to the Company and will be retained by the Company and furnished to the Securities and Exchange Commission or its staff upon request.
Balance Sheet (Parenthetical) - $ / shares |
Jun. 30, 2024 |
Jun. 30, 2023 |
|---|---|---|
| Common stock, par value (in dollars per share) | $ 0.00001 | $ 0.00001 |
| Common stock, shares authorized | 150,000,000 | 150,000,000 |
| Common stock, shares issued | 13,144,055 | 11,698,497 |
| Common stock, shares, outstanding | 13,144,055 | 11,698,497 |
| Series A convertible preferred stock | ||
| Preferred stock, par value (in dollars per share) | $ 0.00001 | $ 0.00001 |
| Preferred stock, shares authorized | 10,000,000 | 10,000,000 |
| Preferred stock, shares issued | 892,625 | 547,674 |
| Preferred stock, shares outstanding | 892,625 | 547,674 |
Statements of Operations - USD ($) |
12 Months Ended | |
|---|---|---|
Jun. 30, 2024 |
Jun. 30, 2023 |
|
| OPERATING EXPENSES | ||
| Research and development | $ 5,437,297 | $ 6,392,414 |
| General and administrative | 3,078,814 | 2,551,054 |
| Total operating expenses | 8,516,111 | 8,943,468 |
| LOSS FROM OPERATIONS | (8,516,111) | (8,943,468) |
| OTHER INCOME (EXPENSE): | ||
| Interest income | 271,773 | 355,833 |
| Interest expense | (49,808) | (938) |
| Other income, net | 221,965 | 354,895 |
| NET LOSS | $ (8,294,146) | $ (8,588,573) |
| Net loss/Weighted average common shares | ||
| Net loss per common share- basic | $ (0.70) | $ (0.74) |
| Net loss per common share- diluted | $ (0.70) | $ (0.74) |
| Weighted average common shares - basic | 11,871,054 | 11,626,220 |
| Weighted average common shares - diluted | 11,871,054 | 11,626,220 |
Statement of Changes in Stockholders' Equity (Parenthetical) |
12 Months Ended |
|---|---|
|
Jun. 30, 2024
USD ($)
| |
| Statement of Changes in Stockholders' Equity | |
| Net of issuance costs | $ 117,314 |
Statements of Cash Flows - USD ($) |
12 Months Ended | |
|---|---|---|
Jun. 30, 2024 |
Jun. 30, 2023 |
|
| CASH FLOWS FROM OPERATING ACTIVITIES: | ||
| Net loss | $ (8,294,146) | $ (8,588,573) |
| Adjustments to reconcile net loss to net cash used in operating activities | ||
| Preferred shares issued as compensation | 43,245 | 56,357 |
| Preferred shares issued pursuant to license agreement | 156,987 | |
| Common shares issued as compensation and for services | 178,940 | 157,822 |
| Warrants granted to Scientific Advisory Board | 563 | 1,012 |
| Depreciation | 750,744 | 739,259 |
| Amortization | 8,270 | 8,270 |
| Changes in operating assets and liabilities: | ||
| Prepaid expenses | 122,744 | 54,535 |
| Other assets | (201) | 28,079 |
| Accounts payable | 219,213 | 99,096 |
| Accounts payable - related parties | 486,605 | 19,037 |
| Accrued expenses | 168,516 | 98,068 |
| Other non-current liability-related party | 1,500,000 | |
| NET CASH USED IN OPERATING ACTIVITIES | (6,315,507) | (5,670,051) |
| CASH FLOWS FROM INVESTING ACTIVITIES: | ||
| Purchase of property and equipment | (156,560) | (151,712) |
| NET CASH USED IN INVESTING ACTIVITIES | (156,560) | (151,712) |
| CASH FLOWS FROM FINANCING ACTIVITIES: | ||
| Payment of loan payable | (94,788) | |
| Net proceeds from sale of common stock | 3,120,037 | |
| NET CASH PROVIDED BY / (USED) IN FINANCING ACTIVITIES | 3,120,037 | (94,788) |
| NET CHANGE IN CASH AND CASH EQUIVALENTS | (3,352,030) | (5,916,551) |
| Cash and cash equivalents at beginning of period | 8,149,808 | 14,066,359 |
| Cash and cash equivalents at end of period | 4,797,778 | 8,149,808 |
| SUPPLEMENTAL DISCLOSURE OF CASH FLOWS INFORMATION: | ||
| Interest paid | $ 938 | |
| NON CASH FINANCING AND INVESTING ACTIVITIES: | ||
| Fair value of Series A Preferred shares issued upon conversion of related party convertible promissory note | 1,500,000 | |
| Forgiveness of interest on related party debt | $ 49,808 | |
Organization and Nature of Business |
12 Months Ended |
|---|---|
Jun. 30, 2024 | |
| Organization and Nature of Business | |
| Organization and Nature of Business | Note 1 – Organization and Nature of Business NanoViricides, Inc. (the “Company”) is a clinical stage nano-biopharmaceutical company specializing in the discovery, development, and commercialization of drugs to combat viral infections using its unique and novel nanomedicines technology. NanoViricides possesses its own facility that supports research and development and drug discovery, drug candidate optimization, cGMP-compliant drug substance manufacturing, cGMP-compliant manufacturing and packaging of drug products for human clinical trials, and early commercialization. The Company has several drugs in various stages of development. NanoViricides, Inc. is domiciled under the laws of the State of Delaware, with its principal operations located in the State of Connecticut. The Company’s fiscal year begins on July 1st and ends on the next June 30th of the calendar year. The Company operates in one reportable business segment. The Company devotes substantially all its activity to advancing research and development, including efforts in connection with clinical trials. The Company’s lead drug candidate is the active pharmaceutical ingredient (API) NV-387. NV-387 is a uniquely broad-spectrum antiviral drug that has demonstrated strong activity in lethal lung infection animal model studies of Coronavirus, RSV, Influenza and even an Orthopoxvirus model for Smallpox and MPox. The Company plans on developing NV-387 first as a treatment of RSV infection in pediatric patients. At present, NV-387 is undergoing a PhaseIa/Ib human clinical trial for safety and tolerability in healthy subjects for the treatment of COVID-19, sponsored by our licensee and collaborator in India, Karveer Meditech Private Limited (KMPL). The trial involved Phase Ia single-ascending dose and Phase Ib multiple ascending dose studies in healthy subjects. Subjects were sequestered upon enrollment in a dedicated ward of the hospital clinical trial site during treatment. All subjects have been discharged and follow-up visits have been completed as of approximately the end of December 2023. The results of this clinical trial were consistent with the results of a single-injection safety/tolerability study in rats performed in support of the clinical trial application. The clinical trial application for this clinical trial was submitted during the pandemic and a separate part of the clinical trial for the treatment of COVID patients with NV-387 was also proposed. This second part of the clinical trials was cancelled due to inability to find patients to enroll despite opening a second site. The second site was subsequently closed around April/May 2024. Meanwhile, data upload and crosschecking activities for the healthy subjects Phase Ia/Ib part have now been completed. The Company is now working on developing the necessary datasets, documentation, and clinical trial pathway and trial designs, for a Phase II clinical trial application for the use of NV-387 for the treatment of RSV infection, as the Phase Ia/Ib study progresses into the data analysis phase. The Company further plans on expanding the indications of NV-387 to other respiratory viral infections including Influenzas, Coronaviruses, and others. Additionally, the Company has previously developed a clinical drug candidate, NV-HHV-1 formulated as skin cream, for the treatment of Shingles. The Company plans on taking NV-HHV-1 into human clinical trials, and further develop the HerpeCide™ program after engaging into clinical trials of NV-387 in Phase II for RSV and possibly for multiple indications, including Influenzas. In the HerpeCide program alone, the Company has drug candidates against at least five indications at different stages of development. The Company’s drug candidates against HSV-1 “cold sores” and HSV-2 “genital herpes” are in advanced pre-clinical studies and are expected to follow the shingles drug candidate into human clinical trials. In addition, the Company has drug candidates against HIV/AIDS, Dengue, Ebola/Marburg, and other viruses. The Company’s drugs are based on several patents, patent applications, provisional patent applications, and other proprietary intellectual property held by TheraCour Pharma, Inc. (“TheraCour”), a related party substantially owned by Dr. Anil Diwan, to which the Company has broad, exclusive licenses. The licenses are to entire fields and not to specific compounds. In all, the Company has exclusive, worldwide licenses for the treatment of the following human viral diseases: Human Immunodeficiency Virus (HIV/AIDS), Hepatitis B Virus (HBV), Hepatitis C Virus (HCV), Herpes Simplex Virus (HSV-1 and HSV-2), Influenza and Asian Bird Flu Virus, Dengue viruses, Ebola/Marburg viruses, Japanese Encephalitis virus, viruses causing viral Conjunctivitis (a disease of the eye) and Ocular Herpes (restated), Varicella Zoster Virus (“VZV”) infections (i.e. Shingles and Chickenpox), and SARS-CoV-2 infections. In all cases, the discovery of ligands and polymer materials as well as formulations, the chemistry and chemical characterization, as well as process development and related work will be performed by TheraCour, a related party substantially owned by Dr. Anil Diwan, under the same compensation terms as prior agreements between the parties, with no duplication of costs allowed. Upon commercialization, NanoViricides will pay 15% of net sales to TheraCour. Milestone payments were made or are specified in certain of the license agreements, details of which have been disclosed at the time the agreements were entered into. The Company negotiates and licenses specific verticals of therapeutic applications from TheraCour if promising drug candidates are found in early research and development against a virus target. TheraCour has not denied any such licenses when requested. The Company has executed a new Memorandum of Understanding with TheraCour by signing as of September 23, 2024 and becoming effective as of September 20, 2024, subsequent to the reported period, whereby the Company has obtained a right of first refusal for all antiviral drug developments including unlicensed ones, and has codified the process of development of drugs for unlicensed viral indications leading later to appropriate license agreements. The Parties have also agreed in this MoU that any cash milestone payments related to development activities, that are awardable, will become payable only upon the Company having sufficient revenue, thus extending the provisions previously incorporated in the Amendment to the COVID License Agreement, to all present and future license agreements. This removes any potential cash flow stress that may occur due to such milestone payments while the Company continues its developments while not raising profits. The Company has out-licensed NV-CoV-2 and NV-CoV-2-R for further clinical drug development and commercialization in the territory of India to KMPL, a company of which Dr. Anil Diwan is a passive investor and advisor. KMPL has sponsored NV-CoV-2 for human clinical trials and has obtained regulatory approvals in India. KMPL has retained a local clinical research organization (CRO) to conduct the clinical trials. NV-CoV-2, Phase Ia/Ib human clinical trials in India, sponsored by KMPL began on June 17, 2023. The clinical trial drug products, NV-CoV-2 Oral Syrup, and NV-CoV-2 Oral Gummies, were manufactured at the Company’s Shelton campus, and then shipped to and received by KMPL. Under the agreement with KMPL, the Company will pay for the expenses of the clinical trials, and in return will benefit from having the data and reports made available for regulatory filings in other territories of the world. Upon commercialization, the Company will receive royalties from KMPL equal to 70% of sales net of costs to unaffiliated third parties.
|
Liquidity |
12 Months Ended |
|---|---|
Jun. 30, 2024 | |
| Liquidity | |
| Liquidity | Note 2 – Liquidity The Company’s financial statements have been prepared assuming that it will continue as a going concern, which contemplates continuity of operations, realization of assets and liquidation of liabilities in the normal course of business. As reflected in the financial statements, the Company has an accumulated deficit at June 30, 2024 of approximately $139.4 million and a net loss of approximately $8.3 million and net cash used in operating activities of approximately $6.3 million for the year then ended. In addition, the Company has not generated any revenues and no revenues are anticipated in the foreseeable future. Since May 2005, the Company has been engaged exclusively in research and development activities focused on developing targeted antiviral drugs. The Company is in the regulatory drug development phase. It has not yet commenced any product commercialization. Such losses are expected to continue for the foreseeable future and until such time, if ever, as the Company is able to attain sales levels sufficient to support its operations. There can be no assurance that the Company will achieve or maintain profitability in the future. As of June 30, 2024, the Company had approximately $4,798,000 in cash and cash equivalents. The Company’s liabilities at June 30, 2024 were approximately $1,359,000, including accounts payable of approximately $376,000 payable to third parties, accounts payable to TheraCour of approximately $720,000, and accrued expenses of approximately $262,000. Management believes that the Company’s cash and cash equivalents balance of approximately $4.8 million, additional capital raised of approximately $1.5 million by ATM sales of our common stock from July 1, 2024 through September 10, 2024, and the Company’s existing resources, including availability under its $3 million line of credit will not be sufficient to fund the Company’s planned operations and expenditures for at least 12 months from the date of the filing of this Form 10-K. As a result substantial doubt exists about the Company’s ability to continue as a going concern. The ability of the Company to continue as a going concern is dependent upon controlling its overall expenses and identifying and securing additional financing. The Company believes that it has several important milestones, including data from and final reports from the Phase Ia/Ib human clinical trial for the Company’s broad-spectrum, antiviral drug NV-387. This Phase Ia/Ib human clinical trial is for evaluating the safety and tolerability of two oral formulations of NV-387, namely (i) NV-CoV-2 Oral Gummies, and (ii) NV-387 Oral Syrup, as described elsewhere, with COVID as the indication. The safety and tolerability data from this clinical trial is expected to be applicable as Phase Ia/Ib data for other indications of NV-387 as well, including RSV, MPOX, Influenza and others. Additional milestones include Pre-IND and IND filing to the US FDA for RSV and clinical trial application for Phase II clinical trial of NV-387 for the treatment of RSV infection in adults with the goal towards further regulatory advancement and approval of NV-387 for the treatment of pediatric RSV infection. To this end, the Company is also evaluating the possibility of a Phase IIa clinical trial of a RSV Infection Challenge in Humans. Management believes that as these milestones are achieved, the Company would likely experience improvement in the liquidity of the Company’s stock, and such improvement, if any, would enhance the Company’s ability to raise funds on the public markets at terms that may be favorable to the terms offered at present. Management is actively exploring additional required funding through non-dilutive grants and contracts, partnering, debt or equity financing pursuant to its plan. There is no assurance that we will be successful in obtaining sufficient financing on terms acceptable to us to fund continuing operations. Management believes that it has on-going access to the capital markets including the “At-The-Market” (ATM) agreement with EF Hutton, the Sales Agent, that became active around April 5, 2024. From July 1, 2024 through September 10, 2024, subsequent to the Company’s fiscal year end, the Company sold 772,836 shares of common stock at an average price of approximately $1.98 per share. The net proceeds to the Company from the offering was approximately $1,533,000 after placement agent fees and other estimated offering expenses. There can be no assurance that the Company’s plans will not change or that changed circumstances will not result in the depletion of its capital resources more rapidly than it currently anticipates. The Company will need to raise additional capital to fund its long-term operations and research and development plans including human clinical trials for its various drug candidates until it generates revenue that reaches a level sufficient to provide self-sustaining cash flows. There can be no assurance that the Company will be able to raise the necessary capital or that it will be on acceptable terms. The accompanying financial statements do not include any adjustments that may result from the outcome of such unidentified uncertainties. |
Summary of Significant Accounting Policies |
12 Months Ended | |||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Jun. 30, 2024 | ||||||||||||||||||||||||||||||||||||||||||||||||||||
| Summary of Significant Accounting Policies | ||||||||||||||||||||||||||||||||||||||||||||||||||||
| Summary of Significant Accounting Policies | Note 3 – Summary of Significant Accounting Policies Basis of Presentation The Company’s financial statements have been prepared in accordance with accounting principles generally accepted in the United States (“GAAP”) and include all adjustments necessary for the fair presentation of the Company’s financial position for the periods presented. Net Loss per Common Share Basic net loss per common share is computed by dividing net loss by the weighted average number of shares of common stock outstanding during the period. Diluted net loss per common share is computed by dividing net loss by the weighted average number of shares of common stock and potentially outstanding shares of common stock during the period to reflect the potential dilution that could occur from common shares issuable through warrants and convertible preferred stock. The following table shows the number of potentially outstanding dilutive common shares excluded from the diluted net loss per common share calculation, as their effects were anti-dilutive:
The Company has 892,625 and 547,674 shares of Series A preferred stock outstanding as of June 30, 2024 and 2023, respectively. Only in the event of a “change of control” of the Company, each Series A preferred share is convertible to 3.5 shares of its new common stock. A “change of control” is defined as an event in which the Company’s shareholders become 60% or less owners of a new entity as a result of a change of ownership, merger or acquisition of the Company or the Company’s intellectual property. In the absence of a change of control event, the Series A preferred stock is not convertible into common stock, and does not carry any dividend rights or any other financial effects. At June 30, 2024 and 2023 the number of potentially dilutive shares of the Company’s common stock into which these Series A preferred shares can be converted into is 3,124,188 and 1,916,859, respectively, and is not included in diluted earnings per share since the shares are contingently convertible only upon a change of control. Use of Estimates The preparation of financial statements in conformity with GAAP requires management to make estimates and assumptions that affect the amounts reported in the financial statements and accompanying notes. The Company bases its estimates on historical experience and on various assumptions that are believed to be reasonable under the circumstances. The amounts of assets and liabilities reported in the Company’s balance sheet and the amounts of expenses reported for each of the periods presented are affected by estimates and assumptions, which are used for but not limited to, accounting for share-based compensation. Actual results could differ from those estimates. Fair Value of Financial Instruments Fair value is defined as the price that would be received from selling an asset or paid to transfer a liability in an orderly transaction between market participants at the measurement date. When determining the fair value for applicable assets and liabilities, the Company considers the principal or most advantageous market in which we would transact and we consider assumptions market participants would use when pricing the asset or liability, such as inherent risk, transfer restrictions, and risk of nonperformance. This guidance also establishes a fair value hierarchy to prioritize inputs used in measuring fair value as follows:
Long-Lived Assets Long-lived assets are reviewed for impairment whenever events or changes in circumstances indicate that the carrying amount of an asset may not be recoverable. Recoverability of assets to be held and used is measured by a comparison of the carrying amount of the assets to the future undiscounted net cash flows expected to be generated by the asset. If such assets are considered to be impaired, the impairment to be recognized is measured by the amount by which the carrying amount of the assets exceeds the fair value of the assets and would be charged to earnings. Fair value is determined through various valuation techniques including discounted cash flow models, quoted market values and third-party independent appraisals, as considered necessary. The Company did not identify any indicators or impairment and has not recorded an impairment charge for the years ended June 30, 2024 and 2023. Cash and Cash Equivalents The Company considers all highly liquid instruments with original maturities of three months or less to be cash equivalents. Property and Equipment Property and equipment is stated at cost and depreciated over the estimated useful lives of the assets, using the straight-line method. The Company generally assigns useful lives of thirty years for assets classified as GMP facility, fifteen years for assets classified as furniture and fixtures, ten years for assets classified as lab equipment, and five years for assets classified as office equipment. Expenditures for major additions and betterments are capitalized. Maintenance and repairs are charged to operations as incurred. Upon sale or retirement of property and equipment, the related cost and accumulated depreciation are removed from the accounts and any gain or loss is reflected in the statements of operations. Intangible Assets NanoViricides, Inc.’s intangible assets include acquired licenses and capitalized patent costs representing legal fees associated with filing patent applications. Intangible assets with finite lives, licenses and patent costs, are amortized using the straight- line method over the estimated economic lives of the assets, which range from to twenty years. The Company’s intangible assets with finite lives are reviewed for impairment whenever events or changes in circumstances indicate that the carrying amount of such assets may not be recoverable. Intangible assets determined to have indefinite useful lives, primarily patent costs, are not amortized but are tested for impairment during the fourth quarter, or more frequently if events or changes in circumstances indicate the asset may be impaired. The Company accounts for patent costs in accordance with the Financial Accounting Standards Board (“FASB”) Accounting Standards Codification (“ASC”) ASC 350-30, General Intangibles Other than Goodwill. The Company will begin amortizing the patent costs when they are brought to the market or otherwise commercialized. In accordance with ASC 350, each year the Company may assess qualitative factors to determine whether it is more likely than not that the fair value of each patent is less than its carrying amount as a basis for determining whether it is necessary to complete quantitative impairment assessments. Research and Development All costs of research and development are expensed as incurred. When preparing our financial statements, we are required to estimate our accrued clinical expenses. This process involves reviewing contracts and communicating with the personnel to identify services that have been performed on our behalf and estimating the level of service performed and the associated cost incurred for the service when we have not yet been invoiced or otherwise notified of actual cost. Payments under some of the contracts we have with third parties depend on factors, such as successful enrollment of certain numbers of patients, site initiation and the completion of clinical trial milestones, which is usually the case with clinical services contracts. When accruing clinical expenses, we estimate the time period over which services will be performed and the level of effort to be expended in each period. If possible, we obtain information regarding unbilled services directly from our service providers. However, we may be required to estimate the cost of these services based only on information available to us. If we underestimate or overestimate the cost associated with a trial or service at a given point in time, adjustments to research and development expenses may be necessary in future periods. Historically, our estimated accrued clinical expenses have approximated actual expense incurred. Stock-Based Compensation The Company follows the provisions of ASC 718 – “Stock Compensation”, which requires the measurement of compensation expense for all shared-based payment awards made to employees, non-employee directors, and non-employees, including employee stock options and grants of warrants to non-employees. Stock-based compensation expense is based on the grant date fair value estimated in accordance with the provisions of ASC 718 and is generally recognized as an expense over the requisite service period, net of forfeitures. The fair value of common stock issued as employee and non-employee compensation is the average of the open and close share price on the date the common shares are issued. The Series A preferred shares are not traded in any market. The assumptions used to determine the fair value of the Series A preferred shares issued as employee and non-employee compensation are presented in Note 8 to the financial statements. The fair value of each option or warrant award is estimated on the date of grant using a Black-Scholes option-pricing valuation model. The ranges of assumptions for inputs are as follows:
The Company’s policy is to recognize compensation cost for awards with only service conditions and a graded vesting schedule on a straight-line basis over the requisite service period for the entire award. Income Tax Provision The Company uses the asset and liability method of accounting for deferred income taxes. Deferred income taxes are measured by applying enacted statutory rates to net operating loss carryforwards and to the differences between the financial reporting and tax bases of assets and liabilities. Deferred tax assets are reduced, if necessary, by a valuation allowance if it is more likely than not that some portion or all of the deferred tax assets will not be realized. The Company recognizes uncertainty in income taxes in the financial statements using a recognition threshold and measurement attribute of a tax position taken or expected to be taken in a tax return. The Company applies the “more-likely-than-not” recognition threshold to all tax positions, which resulted in no unrecognized tax benefits as of June 30, 2024 and 2023. The Company has opted to classify interest and penalties that would accrue, if any, according to the provisions of relevant tax law as general and administrative expenses, in the statements of operations. Concentrations of Risk Financial instruments that potentially subject the Company to a significant concentration of credit risk consist primarily of cash and cash equivalents. The Company maintains deposits in FDIC or SIPC insured institutions in excess of federally insured limits under the FDIC. Although the Company currently believes that the financial institutions with whom it does business will be able to fulfill their commitments to the Company, there is no assurance that those institutions will be able to continue to do so. The Company has not experienced any credit losses associated with its balances in such accounts for the fiscal years ended June 30, 2024 and 2023. Recently Issued Accounting Pronouncements The Company considers the applicability and Impact of all Accounting Standard Updates (“ASU’s”). ASU’s not discussed below were assessed and determined to be either not applicable or are expected to have minimal impact on the Company’s financial statements. ASU 2023-09 Income Taxes (Topic 740) Improvements to Income Tax Disclosures. The amendments in this Update require that public business entities on an annual basis (1) disclose specific categories in the rate reconciliation and (2) provide additional information for reconciling items that meet a quantitative threshold (if the effect of those reconciling items is equal to or greater than 5 percent of the amount computed by multiplying pretax income [or loss] by the applicable statutory income tax rate). Additionally, the ASU requires all entities to disclose the amount of income taxes paid disaggregated by federal, state, and foreign taxes, as well as individual jurisdictions where income taxes paid are equal to or greater than 5 percent of total income taxes paid. ASU 2023-09 is effective for annual periods beginning after December 31, 2024. Early adoption is permitted and this ASU should be applied on a prospective basis. While the Company is currently evaluating the adoption impact of this ASU on its financial statements, the preliminary assessment is that the adoption of this standard is not expected to have a material effect on the Company’s financial statements and the Company’s disclosures. ASU 2023-07 Segment Reporting (Topic 280): Improvements to Reportable Segment Disclosures. The requirements of this update require disclosure of significant segments expenses and increase the frequency of segment reporting to interim periods. The ASU is effective for all public companies for fiscal years beginning after December 15, 2023 and for interim period beginning after December 15, 2024. Early adoption is permitted and is applicable to all periods presented in the financial statements unless retrospective application is impracticable. While the Company is currently evaluating the adoption impact of this ASU on its financial statements, the preliminary assessment is that the adoption of this standard is not expected to have a material effect on the Company’s financial statements and the Company’s disclosures. There have been certain changes in ASU 2020-06, Debt - Debt with Conversion and Other Options (Subtopic 470-20) and Derivatives and Hedging - Contracts in Entity’s Own Equity (Subtopic 815-40) - Accounting for Convertible Instruments and Contracts in an Entity’s Own Equity, which simplifies accounting for convertible instruments by removing major separation models required under GAAP. The ASU also removes certain settlement conditions that are required for equity-linked contracts to qualify for the derivative scope exception, and it also simplifies the diluted earnings per share calculation in certain areas. The Company adopted this ASU as of July 1, 2023, using the modified retrospective approach without a material impact on its financial statements.
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Related Party Transactions |
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| Related Party Transactions | Note 4 – Related Party Transactions Related Parties Related parties with whom the Company had transactions are:
Property and Equipment
Accounts Payable- Related Party
Research and Development Costs - Related Party
Clinical Trial Costs - Related Party
License Milestone Fee – Related Party On September 7, 2021, the Company entered into a COVID-19 license agreement (the “TheraCour – Nanoviricides COVID License Agreement”) to use, promote, offer for sale, import, export, sell and distribute drugs that treat COVID-19 infections, using TheraCour’s proprietary as well as patented technology and intellectual property. Pursuant to such license agreement, the Board of Directors authorized the issuance of 100,000 fully vested shares of the Company’s Series A preferred stock as a license milestone payment and recorded an expense to Research and Development of $935,088 for the year ended June 30, 2022. On April 20, 2023, the Company was notified that the Company’s licensee, KMPL was authorized to enter into Phase Ia/Ib clinical trials of its COVID, NV-CoV-2 Oral Syrup and its NV-CoV-2 Oral Gummies after satisfying the conditions of a conditional authorization received on or about January 27, 2023. Pursuant to the TheraCour – Nanoviricides COVID License Agreement a milestone payment of 50,000 shares fully vested shares of the Company’s Series A preferred stock was issue as a license milestone payment and recorded as an expense to research and development of approximately $157,000 for the year ended June 30, 2023 representing the fair value of the shares on the date of grant. On June 19, 2023, the Company was notified that the Company’s licensee, KMPL had commenced volunteer recruitments for Phase Ia/Ib clinical trials of the NV-CoV-2 Oral Syrup and NV-CoV-2 Oral Gummies. Pursuant to the TheraCour–Nanoviricides COVID License Agreement a milestone payment of $1,500,000 became due 5 days thereafter and was recorded as a non-current liability and research and development expense. On July 19, 2023, the Company entered into an agreement with TheraCour, to accept the Company’s unsecured convertible promissory note (the “Note”) in payment of the milestone award. The Note accrues simple interest at the rate of 12% per annum and is due and payable on January 19, 2025, the maturity date. The principal of the Note is convertible, at TheraCour’s option, into 331,859 shares of the Company’s Series A preferred stock, par value $0.00001 at the conversion price, specified as the fair value of the Series A shares on July 19, 2023 in the terms and conditions contained within the Note. On October 27, 2023 TheraCour exercised its right to convert the principal of the July 19, 2023 Note into 331,859 shares of the Company’s Series A preferred stock. Furthermore, TheraCour cancelled all of the accrued interest on the Note totaling $49,808 which has been reported as a capital transaction credit to additional paid in capital on the accompanying statements of changes in stockholders’ equity. Total interest incurred under the Note for the year ended June 30, 2024 was $49,808. On February 12, 2024, the Company entered into an Amendment to the COVID License Agreement with TheraCour dated September 7, 2021, whereby any further cash milestone payments that would be earned upon milestone event would only become payable upon the Company having sufficient revenues, with only a portion of revenues to be used for satisfying such milestone payments. Line of Credit - Related Party On November 13, 2023, the Company’s President and CEO, Dr. Anil R. Diwan, entered into a Line of Credit Agreement whereby Dr. Diwan agreed to provide a standby Line of Credit to the Company in the maximum amount of $2,000,000. All amounts outstanding under the Line of Credit, including principal, accrued interest and other fees and charges, will be due and payable on December 31, 2024. Amounts drawn down under the Line of Credit shall bear interest at a fixed rate of 12%. Advancements under the Line of Credit will be collateralized by an Open End Mortgage Deed on the Company’s real property at 1 Controls Drive, Shelton, Connecticut and a Chattel Mortgage (U.C.C - 1 filing) against the Company’s equipment and fixtures. Any draw down under the Line of Credit requires the approval of the Company’s Board of Directors. On February 12, 2024 the Company, pursuant to Article 2.5 of the Company’s Line of Credit Agreement with Dr. Anil R. Diwan, signed an Extension Agreement which extended the maturity of the Company’s Line of Credit from December 31, 2024 to December 31, 2025. By signing on September 23, 2024 and becoming effective as of September 20, 2024, subsequent to the reporting period, the Company, pursuant to Article 2.5 of the Company’s Line of Credit Agreement with Dr. Anil R. Diwan, signed an Amendment Agreement which increased the available line of credit from $2,000,000 to $3,000,000, and extended the maturity of the Company’s Line of Credit from December 31, 2025 to March 31, 2026. There were no other amendments to the original Line of Credit. The Company has not drawn against the Line of Credit facility as of June 30, 2024. |
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Property and Equipment |
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| Property and Equipment | Note 5 – Property and Equipment Property and equipment, stated at cost, less accumulated depreciation consisted of the following:
Depreciation expense for the years ended June 30, 2024 and 2023 was $750,744 and $739,259 respectively. |
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Intangible Assets |
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| Intangible Assets | Note 6 – Intangible Assets Intangible assets, net consists of the following:
Amortization expense amounted to $8,270 and $8,270 for the years ended June 30, 2024 and 2023, respectively. NanoViricides, Inc.’s intangible assets include acquired licenses and capitalized patent costs representing legal fees associated with filing patent applications. |
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Accrued expenses |
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| Accrued expenses | Note 7 – Accrued expenses Accrued expenses consisted of the following:
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Equity Transactions |
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| Equity Transactions | Note 8 – Equity Transactions Fiscal Year Ended June 30, 2024 Transactions On July 19, 2023, the Company entered into an agreement with TheraCour, to accept the Company’s unsecured convertible promissory note (the “Note”) in payment of the milestone award earned under the COVID License Agreement. The Note accrued simple interest at the rate of 12% per annum and was due and payable on January 19, 2025, the maturity date. The principal of the Note was convertible, at TheraCour’s option, into 331,859 shares of the Company’s Series A preferred stock, par value $0.00001 at the conversion price, specified as the fair value of the Series A shares on July 19, 2023 in the terms and conditions contained within the Note. On October 27, 2023 TheraCour exercised its right to convert the principal of the July 19, 2023 Note into 331,859 shares of the Company’s Series A preferred stock. Furthermore, TheraCour cancelled all of the accrued interest on the Note totaling $49,808 which has been reported as a capital transaction credit to additional paid in capital on the accompanying statements of changes in stockholders’ equity. Total interest incurred under the Note for the year ended June 30, 2024 was $49,808. On October 6, 2023, the Board of Directors and Dr. Anil Diwan, President and Chairman of the Board agreed to the extension of Dr. Diwan’s employment agreement for a period of one year from July 1, 2023 through June 30, 2024 under the same general terms and conditions. The Company granted Dr. Diwan an award of 10,204 shares of the Company’s Series A preferred stock. The shares vested in quarterly installments of 2,551 shares on September 30, 2023, December 31, 2023, March 31, 2024 and June 30, 2024. The Company recognized non-cash compensation expense related to the issuance of the Series A preferred stock of $32,498 during the year ended June 30, 2024, which was the fair value on the date of issuance. On April 15, 2024, the Company entered into a new ATM sales agreement with. E.F. Hutton Securities, the Sales Agent, pursuant to which the Company may offer and sell, from time to time, through or to the Sales Agent, shares of common stock having an aggregate offering price of up to $50 million. From May 8, 2024 through June 30, 2024 the Company sold 1,308,651 shares of common stock at an average price of approximately $2.47 per share. The shares were issued pursuant to a prospectus supplement dated May 5, 2023 and filed with the Securities and Exchange Commission on May 5, 2023 in connection with the Company’s shelf registration statement on Form S-3, as amended (File No. 333-271706, which became effective on May 22, 2023). The net proceeds to the Company from the offering was approximately $3,120,000 after placement agent fees and other estimated offering expenses. The Company accounted for the proceeds of the ATM Offering, approximately, as follows:
For the year ended June 30, 2024, the Scientific Advisory Board was granted fully vested warrants to purchase 1,144 shares of common stock at exercise prices between $1.43- $1.66 per share expiring in the fiscal year ending June 30, 2028. The fair value of the warrants was $563 for the year ended June 30, 2024 and recorded as consulting expense. For the year ended June 30, 2024, the Company estimated the fair value of the warrants granted quarterly to the Scientific Advisory Board on the date of grant using the Black-Scholes Option-Pricing Model with the following assumptions:
For the year ended June 30, 2024, the Company’s Board of Directors authorized the issuance of 2,888 shares of its Series A preferred stock, which are fully vested with a restrictive legend for employee compensation. The Company recorded an expense of $10,747 during the year ended June 30, 2024, which is the fair value on the date of issuance. There is currently no market for the shares of Series A preferred stock and they can only be converted into shares of common stock upon a change of control of the Company as more fully described in the Certificate of Designation. The Company, therefore, estimated the fair value of the Series A preferred stock granted to various employees and others on the date of grant. The fair value of the Series A preferred stock at each issuance was estimated based upon the price of the Company’s common stock after an application for a reasonable discount for lack of marketability. For the year ended June 30, 2024, the Company’s Board of Directors authorized the issuance of 1,786 fully vested shares of its common stock for employee compensation. The Company recognized a noncash compensation expense of $2,340 which was the fair value on the date of issuance. For the year ended June 30, 2024, the Company’s Board of Directors authorized the issuance of 101,542 fully vested shares of its common stock with a restrictive legend for consulting and legal services. The Company recorded an expense of $131,600, which was the fair value on the dates of issuance. For the year ended June 30, 2024, the Company’s Board of Directors authorized the issuance of 33,579 fully vested shares of its common stock with a restrictive legend for director services. The Company recorded an expense of $45,000, which was the fair value on the dates of issuance. Fiscal Year Ended June 30, 2023 Transactions On February 7, 2023, the Board of Directors and a majority of the shareholders of the Company approved the redomiciling of the Company wherein the Company would redomicile from a Nevada corporation to a Delaware corporation. The redomicile became effective on May 30, 2023 pursuant to Section 265 of the Delaware General Corporation Law and Sections 92A.120 and 92A.250 of the Nevada Revised Statutes. The redomicile occurred according to the Plan of Conversion whereby each share of the Company’s $0.001 par value common stock was converted into one share of $0.00001 par value common stock, and each share of the Company’s $0.001 par value preferred stock was converted into one share of $0.00001 par value preferred stock. The effect of the conversion decreased the total par value of common stock as reported on the Company’s Balance Sheet at June 30, 2022 from $11,592 to $116, and decreased the total par value of preferred stock as reported on the Company’s June 30, 2022 balance sheet from $485 to $5, and increased additional paid in capital as reported on the Company’s balance sheet at June 30, 2022 by $11,596. On April 20, 2023, the Company was notified that the Company’s licensee, KMPL was authorized to enter into Phase Ia/Ib clinical trials of its COVID, NV-CoV-2 Oral Syrup and its NV-CoV-2 Oral Gummies after satisfying the conditions of a conditional authorization received on or about January 27, 2023. Pursuant to the TheraCour – Nanoviricides COVID License Agreement, the Board authorized 50,000 shares of the Company’s Series A preferred shares to be issued to Theracour as a license milestone payment and recorded an expense to research and development of approximately $157,000 which was the fair value on the date the milestone was met for the year ended June 30, 2023. On October 6, 2022, the Board of Directors and Dr. Anil Diwan, President and Chairman of the Board agreed to the extension of Dr. Diwan’s employment agreement for a period of one year from July 1, 2022 through June 30, 2023 under the same general terms and conditions. The Company granted Dr. Diwan an award of 10,204 shares of the Company’s Series A preferred stock. The shares vested in quarterly installments of 2,551 shares on September 30, 2022, December 31, 2022, March 31, 2023 and June 30, 2023. The Company recognized non-cash compensation expense related to the issuance of the Series A preferred stock of approximately $44,000 during the year ended June 30, 2023, which is the fair value on the date of issuance. For the year ended June 30, 2023, the Scientific Advisory Board was granted fully vested warrants to purchase 1,144 shares of common stock at exercise prices between $1.39- $3.40 per share expiring in the fiscal year ending June 30, 2027. The fair value of the warrants was $1,012 for the year ended June 30, 2023 and recorded as consulting expense. For the year ended June 30, 2023, the Company estimated the fair value of the warrants granted quarterly to the Scientific Advisory Board on the date of grant using the Black-Scholes Option-Pricing Model with the following assumptions:
For the year ended June 30, 2023, the Company’s Board of Directors authorized the issuance of 2,888 shares of its Series A preferred stock, which are fully vested with a restrictive legend for employee compensation. The Company recorded an expense of approximately $12,000 during the year ended June 30, 2023, which is the fair value on the date of issuance. There is currently no market for the shares of Series A preferred stock and they can only be converted into shares of common stock upon a change of control of the Company as more fully described in the Certificate of Designation. The Company, therefore, estimated the fair value of the Series A preferred stock granted to various employees and others on the date of grant. The fair value of the Series A Convertible preferred stock at each issuance was estimated based upon the price of the Company’s common stock after an application for a reasonable discount for lack of marketability. For the year ended June 30, 2023, the Company’s Board of Directors authorized the issuance of 3,572 fully vested shares of its common stock for employee compensation. The Company recognized a noncash compensation expense of $4,822 which was the fair value on the date of issuance. For the year ended June 30, 2023, the Company’s Board of Directors authorized the issuance of 72,668 fully vested shares of its common stock with a restrictive legend for consulting services. The Company recorded an expense of $108,000, which was the fair value at the dates of issuance. For the year ended June 30, 2023, the Company’s Board of Directors authorized the issuance of 30,084 fully vested shares of its common stock with a restrictive legend for director services. The Company recorded an expense of $45,000, which was the fair value at date of issuance. |
Common Stock Warrants |
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| Common Stock Warrants | Note 9 – Common Stock Warrants Stock Warrants
Of the above warrants; 2,286 expire in fiscal year ending June 30, 2025; 2,288 expire in fiscal year ending June 30, 2026; 1,144 expire in fiscal year ending June 30, 2027 and 1,144 expire in fiscal year ending June 30, 2028. |
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Income Tax Provision |
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| Income Tax Provision | Note 10 – Income Tax Provision The Company has no current tax expense due to its losses. The income tax expense for the years ended June 30, 2024 and 2023 differed from the amounts computed by applying the U.S. federal income tax rate of 21% and 21% respectively as follows:
The significant components of the Company’s deferred tax assets at June 30, 2024 and 2023 are as follows:
At June 30, 2024 and 2023, the Company has recorded a full valuation allowance against its net deferred tax assets of 39,771,969 and $37,390,846, respectively, since in the judgment of management, these assets are not more than likely than not to be realized. As of June 30, 2024, the Company has approximately $109 million of gross net operating loss carryforwards available to reduce future taxable income, if any for federal and state tax purposes. The aggregate federal net operating losses generated for the years ended June 30, 2024 and 2023 of approximately $8.1 million can be carried forward indefinitely. However, the deduction for net operating losses incurred in tax years beginning after January 1, 2018 is limited to 80% of annual taxable income. Net operating losses generated in years ended June 30, 2018 and prior have a 20-year carryforward and will begin expiring in 2025. As of June 30, 2024 and 2023, research and development credit carryforwards for federal and state purposes are $8,154,686, and $7,868,816, respectively. The state net operating loss and credit carryforwards begin to expire in 2025. Due to the change in ownership provisions of the Internal Revenue Code, the availability of the Company’s net operating loss carry-forwards could be subject to annual limitations against taxable income in future periods, which could substantially limit the eventual utilization of such carryforwards. The Company has not analyzed the historical or potential impact of its equity financings on beneficial ownership and therefore no determination has been made whether the net operating loss carryforward is subject to any Internal Revenue Code Section 382 limitation. To the extent there is a limitation, there could be a reduction in the deferred tax asset with an offsetting reduction in the valuation allowance. The Company does not have any uncertain tax positions at June 30, 2024 and June 30, 2023 that would affect its effective tax rate. The Company does not anticipate a significant change in the amount of unrecognized tax benefits over the next twelve months. Because the Company is in a loss carryforward position, the Company is generally subject to US federal and state income tax examinations by tax authorities for all years for which a loss carryforward is available. If and when applicable, the Company will recognize interest and penalties as part of income tax expense. |
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Commitments and Contingencies |
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| Commitments and Contingencies | |
| Commitments and Contingencies | Note 11 – Commitments and Contingencies Legal Proceedings From time to time, we are subject to various legal proceedings arising in the ordinary course of business, including proceedings for which we have insurance coverage. There are no pending legal proceedings against the Company to the best of the Company’s knowledge as of the date hereof and to the Company’s knowledge no action, suit or proceeding has been threatened against the Company that we believe will have a material adverse effect to our business, financial position, results of operations, or liquidity. Employment Agreements As of July 1, 2024, NanoViricides, Inc. entered into an Extension Agreement (the “Extension”) of the 2024 Employment Agreement with Dr. Anil Diwan entered into on July 1, 2018 (the “Employment Agreement”) to continue to serve as the President of the Company, effective July 1, 2024 under the same general terms and conditions. The Extension provides that Dr. Diwan will continue to serve as the Company’s President until June 30, 2025 at a base annual base salary of $400,000. Dr. Diwan shall be entitled to participate in all fringe benefits the Company provides for its employees generally and such other benefits as the Company provides for its senior executives. In addition, the Company shall maintain a Term Life Insurance policy for Dr. Diwan, valued at $2 million, of which $1 million shall be assigned to the Company and the remaining balance to Dr. Diwan’s estate. In addition, as an incentive towards the ultimate success of the Company, and to provide leadership authority to Dr. Diwan, the Company granted 10,204 shares of the Company’s Series A preferred stock, par value $0.00001 per share to Dr. Diwan. Dr. Diwan’s rights in the shares shall vest in equal, quarterly installments commencing on September 30, 2024 and fully vest on June 30, 2025. The Company will recognize non-cash compensation expense related to the issuance of the Series A preferred stock of $49,795 during the year ended June 30, 2025. Dr. Diwan will be eligible to receive severance if he is terminated by the Company other than for cause in which event the Company shall pay to Dr. Diwan an amount equal to six (6) month’s salary as severance compensation (without regard to compensation or benefits Dr. Diwan receives from any other source). Dr. Diwan shall be eligible for all benefits during this six (6) month period including bonuses, vesting of previously awarded stock options, health care insurance and other fringe benefits that have been ongoing. The Company may elect to pay such severance compensation in a lump sum or in equal payments over the six month period. On March 3, 2010, the Company entered into an employment agreement with Dr. Jayant Tatake to serve as Vice President of Research and Development. The employment agreement provides for a term of four years with a base salary of $150,000. In addition, the Company issued 1,340 shares of Series A preferred stock and 1,786 shares of common stock upon entering into the agreement, and will issue an additional 1,340 shares of Series A preferred stock and 1,786 shares of common stock on each anniversary date of the agreement. The shares of Series A preferred stock were issued in recognition of Dr. Tatake’s work towards the achievement of several patents by the Company. The Compensation Committee of the Board of Directors has extended the current provisions of the employment agreement pending its review of current industry compensation arrangements and employment agreements. On May 30, 2013, the Company entered into an agreement with Meeta Vyas, wife of our President and Chairman of the Board, to serve as its Chief Financial Officer. The agreement provided for a term of three years with a base compensation of $9,000 per month and 129 shares of Series A preferred stock, also on a monthly basis. On January 1, 2015, her cash compensation was increased to $10,800 per month. The agreement is renewable on an annual basis. The Compensation Committee of the Board of Directors has extended the current provisions of the agreement pending its review of current industry compensation arrangements and employment agreements. As of July 1, 2024 the Company’s Board of Directors approved the extension of the agreement with Meeta Vyas, Chief Financial Officer of the Company. On August 5, 2024 the Company and Meeta Vyas signed an extension of the agreement for a period of one year from July 1, 2024 through June 30, 2025 under the same general terms and conditions as the current agreement. License Agreements The Company is dependent upon its license agreements with TheraCour (See Notes 1 and 4). If the Company lost the right to utilize any of the proprietary information that is the subject of the TheraCour license agreement on which it depends, the Company will incur substantial delays and costs in development of its drug candidates. On November 1, 2019, the Company entered into a Licensing Agreement (the “Agreement”) with TheraCour for an exclusive license for the Company to use, promote, offer for sale, import, export, sell and distribute products for the treatment of VZV derived indications. Process development and related work will be performed by TheraCour under the same compensation terms as prior agreements between the parties, with no duplication of costs allowed. Upon commercialization, NanoViricides will pay 15% of net sales to TheraCour, as defined in the agreement. The Company was not required to make any upfront payments to TheraCour and agreed to the following milestone payments to TheraCour; the issuance of 75,000 shares of the Company’s Series A preferred stock upon the grant of an IND Application; $1,500,000 in cash upon completion of Phase I clinical trials; $2,500,000 in cash upon completion of Phase II clinical trials; and $5,000,000 in cash upon completion of Phase III clinical trials. On September 7, 2021, the Company entered into a world-wide, exclusive, sub-licensable, license (“COVID License Agreement”) to use, promote, offer for sale, import, export, sell and distribute drugs that treat COVID-19 infections, using TheraCour’s proprietary as well as patented technology and intellectual property. The discovery of ligands and polymer materials as well as formulations, the chemistry and chemical characterization, as well as process development and related work will be performed by TheraCour under the same compensation terms as prior agreements between the parties, with no duplication of costs allowed. The Company was not required to make any upfront cash payments to TheraCour and agreed to the following milestone payments to TheraCour: (i) the issuance of 100,000 shares of the Company’s Series A preferred stock within 30 days upon execution of this agreement; (ii) the issuance of 50,000 shares of the Company’s Series A preferred stock upon the approval of the Company’s Investigational New Drug (IND) Application or its equivalent by a competent regulatory authority; (iii) $1,500,000 upon initiation of Phase I clinical trials, or its equivalent, for at least one Licensed Product within the field on, or before, three (3) months from the date of the Authority’s acceptance of the IND, or its equivalent; (iv) $2,000,000 in cash upon completion of Phase I clinical trials; (v) $2,500,000 in cash upon completion of Phase IIA clinical trials, or, its equivalent; (vi) the issuance of 100,000 shares of the Company’s Series A preferred stock upon the initiation of Phase III clinical trials, or, its equivalent, for at least one Licensed Product within the field; and (vii) $5,000,000 in cash, or 500,000 shares of the Company’s Series A preferred stock upon completion of Phase III clinical trials, or its equivalent. Upon commercialization, NanoViricides will pay 15% of net sales to TheraCour, as defined in the agreement. On March 27, 2023 the Company entered into a license agreement with KMPL wherein the Company granted to KMPL a limited, non-transferable, exclusive license for the use, sale, or offer of sale in India of the Company’s two clinical test drug candidates titled as NV-CoV-2 and NV-CoV-2-R for the treatment of COVID in patients in India. KMPL has engaged in further drug development in India including sponsoring of drug candidates for human clinical trials in India and has acted as clinical trials manager for such clinical trials. KMPL shall provide NanoViricides with all reports of the clinical trials and the Company can use such reports for further advancement of the drug candidates with regulatory authorities outside India. In consideration, KMPL will receive a customary clinical trials manager fee of thirty percent (30%) of such costs and applicable taxes. Upon commercial sales of any resulting approved drugs, KMPL will pay the Company a royalty of seventy (70%) percent of the final invoiced sales to unaffiliated third parties. On February 12, 2024, the Company entered into an Amendment to the COVID License Agreement with TheraCour dated September 7, 2021, whereby any further cash milestone payments that would be earned upon milestone event would only become payable upon the Company having sufficient revenues, with only a portion of revenues to be used for satisfying such milestone payments.
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Subsequent Events |
12 Months Ended |
|---|---|
Jun. 30, 2024 | |
| Subsequent Events | |
| Subsequent Events | Note 12 - Subsequent Events As discussed at Note 8 to the financial statements, on April 15, 2024, the Company entered into a sales agreement with. E.F. Hutton Securities (now EF Hutton, LLC), the Sales Agent, pursuant to which the Company may offer and sell, from time to time, through or to the Sales Agents, shares of common stock At-the-Market or ATM Offering. From July 1, 2024 through September 10, 2024 the Company sold 772,836 shares of common stock at an average price of approximately $1.98 per share. The shares were issued pursuant to a prospectus supplement dated May 5, 2023 and filed with the Securities and Exchange Commission on May 5, 2023 in connection with the Company’s shelf registration statement on Form S-3, as amended File No. 333-271706, which became effective on May 22, 2023. The net proceeds to the Company from the offering from July 1, 2024 through September 10, 2024 was $1,533,000 after placement agent fees and other estimated offering expenses. By signing on September 23, 2024 and being effective as of September 20, 2024, the Company, pursuant to Article 2.5 of the Company’s Line of Credit Agreement with Dr. Anil R. Diwan, signed an Amendment Agreement which increased the available line of credit from $2,000,000 to $3,000,000, and extended the maturity of the Company’s Line of Credit from December 31, 2025 to March 31, 2026. There were no other amendments to the original Line of Credit. The Company has not drawn against the Line of Credit facility as of June 30, 2024. By signing on September 23, 2024 and being effective as of September 20, 2024, the Company entered into a “Memorandum of Understanding for All Antivirals Drug Development” (the MoU) with TheraCour that granted to the Company, a limited, non-assignable, non-sublicensable, exclusive Right of First Refusal to License to any antiviral drugs in development or to be developed by TheraCour for research and development purposes only, for all as-yet unlicensed viral infection treatment indications. The MoU also clarified the roles and responsibilities of the Parties and essentially codified the process that the parties have adopted since inception. The MoU further codified the treatment of all future milestone payments arising from any current or future license agreements to TheraCour to be consistent with the principles adopted in the February 12, 2024 Amendment to the COVID-19 License Agreement. |
Pay vs Performance Disclosure - USD ($) |
12 Months Ended | |
|---|---|---|
Jun. 30, 2024 |
Jun. 30, 2023 |
|
| Pay vs Performance Disclosure | ||
| Net Income (Loss) | $ (8,294,146) | $ (8,588,573) |
Insider Trading Arrangements |
3 Months Ended |
|---|---|
Jun. 30, 2024 | |
| Trading Arrangements, by Individual | |
| Rule 10b5-1 Arrangement Adopted | false |
| Non-Rule 10b5-1 Arrangement Adopted | false |
| Rule 10b5-1 Arrangement Terminated | false |
| Non-Rule 10b5-1 Arrangement Terminated | false |
Summary of Significant Accounting Policies (Policies) |
12 Months Ended | ||||||||||||||||||||||||||||||
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Jun. 30, 2024 | |||||||||||||||||||||||||||||||
| Summary of Significant Accounting Policies | |||||||||||||||||||||||||||||||
| Basis of Presentation | Basis of Presentation The Company’s financial statements have been prepared in accordance with accounting principles generally accepted in the United States (“GAAP”) and include all adjustments necessary for the fair presentation of the Company’s financial position for the periods presented. |
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| Net Loss per Common Share | Net Loss per Common Share Basic net loss per common share is computed by dividing net loss by the weighted average number of shares of common stock outstanding during the period. Diluted net loss per common share is computed by dividing net loss by the weighted average number of shares of common stock and potentially outstanding shares of common stock during the period to reflect the potential dilution that could occur from common shares issuable through warrants and convertible preferred stock. The following table shows the number of potentially outstanding dilutive common shares excluded from the diluted net loss per common share calculation, as their effects were anti-dilutive:
The Company has 892,625 and 547,674 shares of Series A preferred stock outstanding as of June 30, 2024 and 2023, respectively. Only in the event of a “change of control” of the Company, each Series A preferred share is convertible to 3.5 shares of its new common stock. A “change of control” is defined as an event in which the Company’s shareholders become 60% or less owners of a new entity as a result of a change of ownership, merger or acquisition of the Company or the Company’s intellectual property. In the absence of a change of control event, the Series A preferred stock is not convertible into common stock, and does not carry any dividend rights or any other financial effects. At June 30, 2024 and 2023 the number of potentially dilutive shares of the Company’s common stock into which these Series A preferred shares can be converted into is 3,124,188 and 1,916,859, respectively, and is not included in diluted earnings per share since the shares are contingently convertible only upon a change of control. |
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| Use of Estimates | Use of Estimates The preparation of financial statements in conformity with GAAP requires management to make estimates and assumptions that affect the amounts reported in the financial statements and accompanying notes. The Company bases its estimates on historical experience and on various assumptions that are believed to be reasonable under the circumstances. The amounts of assets and liabilities reported in the Company’s balance sheet and the amounts of expenses reported for each of the periods presented are affected by estimates and assumptions, which are used for but not limited to, accounting for share-based compensation. Actual results could differ from those estimates. |
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| Fair Value of Financial Instruments | Fair Value of Financial Instruments Fair value is defined as the price that would be received from selling an asset or paid to transfer a liability in an orderly transaction between market participants at the measurement date. When determining the fair value for applicable assets and liabilities, the Company considers the principal or most advantageous market in which we would transact and we consider assumptions market participants would use when pricing the asset or liability, such as inherent risk, transfer restrictions, and risk of nonperformance. This guidance also establishes a fair value hierarchy to prioritize inputs used in measuring fair value as follows:
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| Long-Lived Assets | Long-Lived Assets Long-lived assets are reviewed for impairment whenever events or changes in circumstances indicate that the carrying amount of an asset may not be recoverable. Recoverability of assets to be held and used is measured by a comparison of the carrying amount of the assets to the future undiscounted net cash flows expected to be generated by the asset. If such assets are considered to be impaired, the impairment to be recognized is measured by the amount by which the carrying amount of the assets exceeds the fair value of the assets and would be charged to earnings. Fair value is determined through various valuation techniques including discounted cash flow models, quoted market values and third-party independent appraisals, as considered necessary. The Company did not identify any indicators or impairment and has not recorded an impairment charge for the years ended June 30, 2024 and 2023. |
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| Cash and Cash Equivalents | Cash and Cash Equivalents The Company considers all highly liquid instruments with original maturities of three months or less to be cash equivalents. |
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| Property and Equipment | Property and Equipment Property and equipment is stated at cost and depreciated over the estimated useful lives of the assets, using the straight-line method. The Company generally assigns useful lives of thirty years for assets classified as GMP facility, fifteen years for assets classified as furniture and fixtures, ten years for assets classified as lab equipment, and five years for assets classified as office equipment. Expenditures for major additions and betterments are capitalized. Maintenance and repairs are charged to operations as incurred. Upon sale or retirement of property and equipment, the related cost and accumulated depreciation are removed from the accounts and any gain or loss is reflected in the statements of operations. |
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| Intangible Assets | Intangible Assets NanoViricides, Inc.’s intangible assets include acquired licenses and capitalized patent costs representing legal fees associated with filing patent applications. Intangible assets with finite lives, licenses and patent costs, are amortized using the straight- line method over the estimated economic lives of the assets, which range from to twenty years. The Company’s intangible assets with finite lives are reviewed for impairment whenever events or changes in circumstances indicate that the carrying amount of such assets may not be recoverable. Intangible assets determined to have indefinite useful lives, primarily patent costs, are not amortized but are tested for impairment during the fourth quarter, or more frequently if events or changes in circumstances indicate the asset may be impaired. The Company accounts for patent costs in accordance with the Financial Accounting Standards Board (“FASB”) Accounting Standards Codification (“ASC”) ASC 350-30, General Intangibles Other than Goodwill. The Company will begin amortizing the patent costs when they are brought to the market or otherwise commercialized. In accordance with ASC 350, each year the Company may assess qualitative factors to determine whether it is more likely than not that the fair value of each patent is less than its carrying amount as a basis for determining whether it is necessary to complete quantitative impairment assessments. |
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| Research and Development | Research and Development All costs of research and development are expensed as incurred. When preparing our financial statements, we are required to estimate our accrued clinical expenses. This process involves reviewing contracts and communicating with the personnel to identify services that have been performed on our behalf and estimating the level of service performed and the associated cost incurred for the service when we have not yet been invoiced or otherwise notified of actual cost. Payments under some of the contracts we have with third parties depend on factors, such as successful enrollment of certain numbers of patients, site initiation and the completion of clinical trial milestones, which is usually the case with clinical services contracts. When accruing clinical expenses, we estimate the time period over which services will be performed and the level of effort to be expended in each period. If possible, we obtain information regarding unbilled services directly from our service providers. However, we may be required to estimate the cost of these services based only on information available to us. If we underestimate or overestimate the cost associated with a trial or service at a given point in time, adjustments to research and development expenses may be necessary in future periods. Historically, our estimated accrued clinical expenses have approximated actual expense incurred. |
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| Stock-Based Compensation | Stock-Based Compensation The Company follows the provisions of ASC 718 – “Stock Compensation”, which requires the measurement of compensation expense for all shared-based payment awards made to employees, non-employee directors, and non-employees, including employee stock options and grants of warrants to non-employees. Stock-based compensation expense is based on the grant date fair value estimated in accordance with the provisions of ASC 718 and is generally recognized as an expense over the requisite service period, net of forfeitures. The fair value of common stock issued as employee and non-employee compensation is the average of the open and close share price on the date the common shares are issued. The Series A preferred shares are not traded in any market. The assumptions used to determine the fair value of the Series A preferred shares issued as employee and non-employee compensation are presented in Note 8 to the financial statements. The fair value of each option or warrant award is estimated on the date of grant using a Black-Scholes option-pricing valuation model. The ranges of assumptions for inputs are as follows:
The Company’s policy is to recognize compensation cost for awards with only service conditions and a graded vesting schedule on a straight-line basis over the requisite service period for the entire award. |
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| Income Tax Provision | Income Tax Provision The Company uses the asset and liability method of accounting for deferred income taxes. Deferred income taxes are measured by applying enacted statutory rates to net operating loss carryforwards and to the differences between the financial reporting and tax bases of assets and liabilities. Deferred tax assets are reduced, if necessary, by a valuation allowance if it is more likely than not that some portion or all of the deferred tax assets will not be realized. The Company recognizes uncertainty in income taxes in the financial statements using a recognition threshold and measurement attribute of a tax position taken or expected to be taken in a tax return. The Company applies the “more-likely-than-not” recognition threshold to all tax positions, which resulted in no unrecognized tax benefits as of June 30, 2024 and 2023. The Company has opted to classify interest and penalties that would accrue, if any, according to the provisions of relevant tax law as general and administrative expenses, in the statements of operations. |
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| Concentrations of Risk | Concentrations of Risk Financial instruments that potentially subject the Company to a significant concentration of credit risk consist primarily of cash and cash equivalents. The Company maintains deposits in FDIC or SIPC insured institutions in excess of federally insured limits under the FDIC. Although the Company currently believes that the financial institutions with whom it does business will be able to fulfill their commitments to the Company, there is no assurance that those institutions will be able to continue to do so. The Company has not experienced any credit losses associated with its balances in such accounts for the fiscal years ended June 30, 2024 and 2023. |
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| Recently Issued Accounting Pronouncements | Recently Issued Accounting Pronouncements The Company considers the applicability and Impact of all Accounting Standard Updates (“ASU’s”). ASU’s not discussed below were assessed and determined to be either not applicable or are expected to have minimal impact on the Company’s financial statements. ASU 2023-09 Income Taxes (Topic 740) Improvements to Income Tax Disclosures. The amendments in this Update require that public business entities on an annual basis (1) disclose specific categories in the rate reconciliation and (2) provide additional information for reconciling items that meet a quantitative threshold (if the effect of those reconciling items is equal to or greater than 5 percent of the amount computed by multiplying pretax income [or loss] by the applicable statutory income tax rate). Additionally, the ASU requires all entities to disclose the amount of income taxes paid disaggregated by federal, state, and foreign taxes, as well as individual jurisdictions where income taxes paid are equal to or greater than 5 percent of total income taxes paid. ASU 2023-09 is effective for annual periods beginning after December 31, 2024. Early adoption is permitted and this ASU should be applied on a prospective basis. While the Company is currently evaluating the adoption impact of this ASU on its financial statements, the preliminary assessment is that the adoption of this standard is not expected to have a material effect on the Company’s financial statements and the Company’s disclosures. ASU 2023-07 Segment Reporting (Topic 280): Improvements to Reportable Segment Disclosures. The requirements of this update require disclosure of significant segments expenses and increase the frequency of segment reporting to interim periods. The ASU is effective for all public companies for fiscal years beginning after December 15, 2023 and for interim period beginning after December 15, 2024. Early adoption is permitted and is applicable to all periods presented in the financial statements unless retrospective application is impracticable. While the Company is currently evaluating the adoption impact of this ASU on its financial statements, the preliminary assessment is that the adoption of this standard is not expected to have a material effect on the Company’s financial statements and the Company’s disclosures. There have been certain changes in ASU 2020-06, Debt - Debt with Conversion and Other Options (Subtopic 470-20) and Derivatives and Hedging - Contracts in Entity’s Own Equity (Subtopic 815-40) - Accounting for Convertible Instruments and Contracts in an Entity’s Own Equity, which simplifies accounting for convertible instruments by removing major separation models required under GAAP. The ASU also removes certain settlement conditions that are required for equity-linked contracts to qualify for the derivative scope exception, and it also simplifies the diluted earnings per share calculation in certain areas. The Company adopted this ASU as of July 1, 2023, using the modified retrospective approach without a material impact on its financial statements.
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Summary of Significant Accounting Policies (Tables) |
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| Summary of Significant Accounting Policies | |||||||||||||||||||||||||||||||
| Schedule of potentially outstanding dilutive common shares excluded from the diluted net loss per common share calculation |
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Related Party Transactions (Tables) |
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| Summary of related party |
Property and Equipment
Accounts Payable- Related Party
Research and Development Costs - Related Party
Clinical Trial Costs - Related Party
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Property and Equipment (Tables) |
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| Schedule of property and equipment |
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Intangible Assets (Tables) |
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| Schedule of intangible assets |
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Accrued expenses (Tables) |
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| Accrued expenses | ||||||||||||||||||||||||||||||||||||||||||||||||||
| Schedule of accrued expenses |
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Equity Transactions (Tables) |
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Jun. 30, 2024 | |||||||||||||||||||||||||||||||||||||||||
| Equity Transactions | |||||||||||||||||||||||||||||||||||||||||
| Schedule of proceeds from sale of stock |
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| Schedule of estimation of estimated the fair value of the warrants granted | For the year ended June 30, 2024, the Company estimated the fair value of the warrants granted quarterly to the Scientific Advisory Board on the date of grant using the Black-Scholes Option-Pricing Model with the following assumptions:
For the year ended June 30, 2023, the Company estimated the fair value of the warrants granted quarterly to the Scientific Advisory Board on the date of grant using the Black-Scholes Option-Pricing Model with the following assumptions:
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Common Stock Warrants (Tables) |
12 Months Ended | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Jun. 30, 2024 | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Common Stock Warrants | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Schedule of common stock warrants activity |
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Income Tax Provision (Tables) |
12 Months Ended | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Jun. 30, 2024 | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Income Tax Provision | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Schedule of income tax expense differed from the amounts computed by applying the U.S. federal income tax rate | The income tax expense for the years ended June 30, 2024 and 2023 differed from the amounts computed by applying the U.S. federal income tax rate of 21% and 21% respectively as follows:
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| Schedule of components of the Company's deferred tax assets | The significant components of the Company’s deferred tax assets at June 30, 2024 and 2023 are as follows:
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Organization and Nature of Business (Details) |
12 Months Ended |
|---|---|
|
Jun. 30, 2024
segment
| |
| Organization and Nature of Business | |
| Number of Reportable Segments | 1 |
| Royalties on sales (in percent) | 70.00% |
| TheraCour Pharma Inc | |
| Organization and Nature of Business | |
| Percentage of net sales allocated for royalty payments (in percent) | 15.00% |
Liquidity (Details) - USD ($) |
2 Months Ended | 12 Months Ended | |||
|---|---|---|---|---|---|
Nov. 01, 2019 |
Sep. 10, 2024 |
Jun. 30, 2024 |
Jun. 30, 2024 |
Jun. 30, 2023 |
|
| Liquidity | |||||
| Accumulated deficit | $ 139,374,895 | $ 139,374,895 | $ 131,080,749 | ||
| Net loss | 8,294,146 | 8,588,573 | |||
| Net cash used in operating activities | 6,315,507 | 5,670,051 | |||
| Revenue | 0 | ||||
| Cash and cash equivalents | 4,797,778 | 4,797,778 | 8,149,808 | ||
| Liabilities | 1,358,776 | 1,358,776 | 2,034,250 | ||
| Accrued expenses | 262,467 | 262,467 | 143,760 | ||
| Line of credit | $ 3,000,000 | 3,000,000 | |||
| Net proceeds from sale of common stock | 3,120,037 | ||||
| Subsequent event | |||||
| Liquidity | |||||
| Issuance of shares | 772,836 | ||||
| Average price | $ 1.98 | ||||
| Net proceeds from sale of common stock | $ 1,533,000 | ||||
| ATM Offering | |||||
| Liquidity | |||||
| Gross proceeds | $ 3,237,000 | ||||
| Issuance of shares | 1,308,651 | ||||
| Average price | $ 2.47 | $ 2.47 | |||
| ATM Offering | Subsequent event | |||||
| Liquidity | |||||
| Gross proceeds | $ 1,500,000 | ||||
| Average price | $ 1.98 | ||||
| Nonrelated party | |||||
| Liquidity | |||||
| Accounts payable | $ 376,270 | $ 376,270 | 157,056 | ||
| Related party | |||||
| Liquidity | |||||
| Accounts payable | 720,039 | 720,039 | 233,434 | ||
| TheraCour Pharma Inc | Related party | |||||
| Liquidity | |||||
| Accounts payable | $ 720,039 | $ 720,039 | $ 233,434 | ||
| Issuance of shares | 75,000 | ||||
Summary of Significant Accounting Policies - Anti-dilutive warrants (Details) - shares |
12 Months Ended | |
|---|---|---|
Jun. 30, 2024 |
Jun. 30, 2023 |
|
| Warrants | ||
| Summary of Significant Accounting Policies | ||
| Potentially outstanding dilutive common shares | 6,862 | 8,004 |
Summary of Significant Accounting Policies - Additional Information (Details) |
12 Months Ended | |
|---|---|---|
|
Jun. 30, 2024
USD ($)
shares
|
Jun. 30, 2023
USD ($)
shares
|
|
| Summary of Significant Accounting Policies | ||
| Unrecognized tax benefits | $ | $ 0 | $ 0 |
| Series A convertible preferred stock | ||
| Summary of Significant Accounting Policies | ||
| Preferred stock, shares outstanding | 892,625 | 547,674 |
| Reverse stock split | 3.5 | |
| Percentage of change of control | 60 | |
| Number of potentially dilutive common shares | 3,124,188 | 1,916,859 |
| Minimum | ||
| Summary of Significant Accounting Policies | ||
| Economic lives of the assets | 17 years | |
| Maximum | ||
| Summary of Significant Accounting Policies | ||
| Economic lives of the assets | 20 years | |
Summary of Significant Accounting Policies - Property and Equipment (Details) |
Jun. 30, 2024 |
|---|---|
| GMP facility | |
| Property, plant and equipment | |
| Property and equipment, estimated useful lives | 30 years |
| Furniture and fixtures | |
| Property, plant and equipment | |
| Property and equipment, estimated useful lives | 15 years |
| Lab equipment | |
| Property, plant and equipment | |
| Property and equipment, estimated useful lives | 10 years |
| Office equipment | |
| Property, plant and equipment | |
| Property and equipment, estimated useful lives | 5 years |
Related Party Transactions - Summary of related parties (Details) - USD ($) |
12 Months Ended | |
|---|---|---|
Jun. 30, 2024 |
Jun. 30, 2023 |
|
| Related party | TheraCour Pharma Inc | ||
| Related Party Transaction | ||
| Property and Equipment | $ 114,651 | $ 31,936 |
Related Party Transactions (Details) - USD ($) |
2 Months Ended | 12 Months Ended | |||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Sep. 20, 2024 |
Nov. 13, 2023 |
Oct. 27, 2023 |
Jul. 19, 2023 |
Apr. 20, 2023 |
Jan. 27, 2023 |
Sep. 07, 2021 |
Nov. 01, 2019 |
Sep. 10, 2024 |
Jun. 30, 2024 |
Jun. 30, 2023 |
Jun. 30, 2022 |
Jun. 19, 2023 |
|
| Related Party Transaction | |||||||||||||
| Royalties on sales (in percent) | 70.00% | ||||||||||||
| Research and Development Costs - Related Party | $ 5,437,297 | $ 6,392,414 | |||||||||||
| Interest expense | 49,808 | ||||||||||||
| Related party | |||||||||||||
| Related Party Transaction | |||||||||||||
| Account Payable - Related Party | 720,039 | 233,434 | |||||||||||
| Subsequent event | |||||||||||||
| Related Party Transaction | |||||||||||||
| Number of shares upon principle of note convertible | 772,836 | ||||||||||||
| Dr. Anil Diwan | Subsequent event | Minimum | |||||||||||||
| Related Party Transaction | |||||||||||||
| Line of credit | $ 2,000,000 | ||||||||||||
| Maturity of the Company's line of Credit | Dec. 31, 2025 | ||||||||||||
| Dr. Anil Diwan | Subsequent event | Maximum | |||||||||||||
| Related Party Transaction | |||||||||||||
| Line of credit | $ 3,000,000 | ||||||||||||
| Maturity of the Company's line of Credit | Mar. 31, 2026 | ||||||||||||
| Line of credit agreement | Dr. Anil Diwan | |||||||||||||
| Related Party Transaction | |||||||||||||
| Line of Credit Facility, Maximum Borrowing Capacity | $ 2,000,000 | ||||||||||||
| Fixed rate of interest on the amount drawn under the line of credit facility | 12.00% | ||||||||||||
| Drew down amount | 0 | ||||||||||||
| KMPL | |||||||||||||
| Related Party Transaction | |||||||||||||
| Clinical trial related and other costs | 442,845 | 100,000 | |||||||||||
| KMPL | Related party | |||||||||||||
| Related Party Transaction | |||||||||||||
| Accrued clinical trial related and other costs | 227,435 | 100,000 | |||||||||||
| Clinical trial Costs Accrued - Related Party | $ 442,845 | 100,000 | |||||||||||
| TheraCour Pharma Inc | |||||||||||||
| Related Party Transaction | |||||||||||||
| Percentage of direct costs | 30.00% | ||||||||||||
| Other general and administrative expense | $ 2,000 | ||||||||||||
| Percentage of net sales allocated for royalty payments (in percent) | 15.00% | ||||||||||||
| Accounts payable | 733,434 | ||||||||||||
| Accounts payable offset by advance | $ 0 | 500,000 | |||||||||||
| Accrued royalties | 0 | 0 | |||||||||||
| TheraCour Pharma Inc | Related party | |||||||||||||
| Related Party Transaction | |||||||||||||
| Account Payable - Related Party | 720,039 | 233,434 | |||||||||||
| Percentage of net sales allocated for royalty payments (in percent) | 15.00% | ||||||||||||
| Research and Development Costs - Related Party | 2,550,466 | 2,535,862 | |||||||||||
| Number of shares upon principle of note convertible | 331,859 | ||||||||||||
| Gain on extinguishment | $ 49,808 | ||||||||||||
| TheraCour Pharma Inc | COVID 19 License Agreement | Related party | |||||||||||||
| Related Party Transaction | |||||||||||||
| Research and Development Costs - Related Party | $ 157,000 | $ 157,000 | $ 935,088 | ||||||||||
| Milestone payment amount due | $ 1,500,000 | ||||||||||||
| Unsecured promissory note | TheraCour Pharma Inc | Related party | |||||||||||||
| Related Party Transaction | |||||||||||||
| Interest rate per annum (as a percent) | 12.00% | ||||||||||||
| Series A Preferred stock | TheraCour Pharma Inc | |||||||||||||
| Related Party Transaction | |||||||||||||
| Number of shares upon principle of note convertible | 331,859 | ||||||||||||
| Debt instrument, conversion stock, par value | $ 0.00001 | ||||||||||||
| Series A Preferred stock | TheraCour Pharma Inc | Related party | |||||||||||||
| Related Party Transaction | |||||||||||||
| Percentage of net sales allocated for royalty payments (in percent) | 15.00% | ||||||||||||
| Series A Preferred stock | TheraCour Pharma Inc | COVID 19 License Agreement | Related party | |||||||||||||
| Related Party Transaction | |||||||||||||
| Number of shares authorized for license milestone payment | 50,000 | 100,000 | |||||||||||
| Shares issued for milestone payment | 50,000 | ||||||||||||
Property and Equipment - Schedule of property and equipment (Details) - USD ($) |
Jun. 30, 2024 |
Jun. 30, 2023 |
|---|---|---|
| Property and Equipment | ||
| GMP Facility | $ 8,168,045 | $ 8,168,045 |
| Land | 260,000 | 260,000 |
| Office Equipment | 63,056 | 60,347 |
| Furniture and Fixtures | 5,607 | 5,607 |
| Lab Equipment | 6,469,578 | 6,315,727 |
| Total Property and Equipment | 14,966,286 | 14,809,726 |
| Less Accumulated Depreciation | (7,453,823) | (6,703,079) |
| Property and Equipment, Net | $ 7,512,463 | $ 8,106,647 |
Property and Equipment - Additional information (Details) - USD ($) |
12 Months Ended | |
|---|---|---|
Jun. 30, 2024 |
Jun. 30, 2023 |
|
| Property and Equipment | ||
| Depreciation expense | $ 750,744 | $ 739,259 |
Intangible Assets (Details) - USD ($) |
Jun. 30, 2024 |
Jun. 30, 2023 |
|---|---|---|
| Intangible Assets | ||
| Intangible Assets | $ 458,954 | $ 458,954 |
| Less Accumulated Amortization | (133,646) | (125,376) |
| Intangible Assets, Net | 325,308 | 333,578 |
| Finite Lived Intangible Assets | ||
| Intangible Assets | ||
| Intangible Assets | 153,393 | 153,393 |
| Less Accumulated Amortization | (133,646) | (125,376) |
| Intangible Assets, Net | 19,747 | 28,017 |
| Indefinite Lived Intangible Assets | ||
| Intangible Assets | ||
| Intangible Assets | 305,561 | 305,561 |
| Intangible Assets, Net | $ 305,561 | $ 305,561 |
Intangible Assets - Additional Information (Details) - USD ($) |
12 Months Ended | |
|---|---|---|
Jun. 30, 2024 |
Jun. 30, 2023 |
|
| Trademark and patents | ||
| Intangible Assets | ||
| Amortization expense | $ 8,270 | $ 8,270 |
Accrued expenses (Details) - USD ($) |
Jun. 30, 2024 |
Jun. 30, 2023 |
|---|---|---|
| Accrued expenses | ||
| Personnel and compensation costs | $ 23,532 | $ 39,060 |
| Consultant | 11,500 | 4,700 |
| Clinical trial costs due to KPML | 227,435 | 100,000 |
| Accrued expenses | $ 262,467 | $ 143,760 |
Equity Transactions - Additional Information (Details) - USD ($) |
2 Months Ended | 12 Months Ended | |||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Apr. 15, 2024 |
Oct. 27, 2023 |
Oct. 06, 2023 |
Jul. 19, 2023 |
Oct. 06, 2022 |
Sep. 07, 2021 |
Nov. 01, 2019 |
Jun. 30, 2024 |
Jun. 30, 2024 |
Jun. 30, 2023 |
Jul. 01, 2024 |
Feb. 07, 2023 |
Jun. 30, 2022 |
|
| Equity Transactions | |||||||||||||
| Interest expense | $ 49,808 | ||||||||||||
| Number of fully vested warrants granted to purchase shares of common stock | 1,144 | ||||||||||||
| Non-cash compensation expense recognized | $ 563 | $ 44,000 | |||||||||||
| Common stock, $0.00001 par value; 150,000,000 shares authorized, 13,144,055 and 11,698,497 shares issued and outstanding at June 30, 2024 and 2023, respectively. (Note 8) | $ 131 | $ 131 | $ 117 | ||||||||||
| Common stock, par value (in dollars per share) | $ 0.00001 | $ 0.00001 | $ 0.00001 | ||||||||||
| Increased additional paid in capital | $ 11,596 | ||||||||||||
| Common shares issued as compensation and for services | $ 178,940 | 157,822 | |||||||||||
| Employees | |||||||||||||
| Equity Transactions | |||||||||||||
| Stock-based compensation expense | $ 2,340 | ||||||||||||
| Shares granted | 1,786 | ||||||||||||
| share-based payment arrangement, for consulting services | |||||||||||||
| Equity Transactions | |||||||||||||
| Vested shares | 101,542 | ||||||||||||
| Share-based payment arrangement, nonemployee | |||||||||||||
| Equity Transactions | |||||||||||||
| Vested shares | 33,579 | ||||||||||||
| Common shares issued as compensation and for services | $ 131,600 | 45,000 | |||||||||||
| ATM Offering | |||||||||||||
| Equity Transactions | |||||||||||||
| Aggregate offering price | $ 50,000,000 | ||||||||||||
| Issuance of shares | 1,308,651 | ||||||||||||
| Average price | $ 2.47 | $ 2.47 | |||||||||||
| Net proceeds | $ 3,120,000 | ||||||||||||
| Net proceeds from issuance of common stock | $ 3,237,000 | ||||||||||||
| After Redomiciliation | |||||||||||||
| Equity Transactions | |||||||||||||
| Number of shares issued on conversion of each share | 1 | ||||||||||||
| Minimum | |||||||||||||
| Equity Transactions | |||||||||||||
| Exercise price of warrants | $ 1.43 | ||||||||||||
| Maximum | |||||||||||||
| Equity Transactions | |||||||||||||
| Exercise price of warrants | $ 1.66 | ||||||||||||
| Warrants | |||||||||||||
| Equity Transactions | |||||||||||||
| Number of fully vested warrants granted to purchase shares of common stock | 1,144 | ||||||||||||
| Non-cash compensation expense recognized | $ 1,012 | ||||||||||||
| Warrants | Minimum | |||||||||||||
| Equity Transactions | |||||||||||||
| Exercise price (in dollars per share) | 1.39 | $ 1.39 | |||||||||||
| Warrants | Maximum | |||||||||||||
| Equity Transactions | |||||||||||||
| Exercise price (in dollars per share) | $ 3.40 | $ 3.40 | |||||||||||
| Founder, Chairman and President | |||||||||||||
| Equity Transactions | |||||||||||||
| Employment agreement extension term (in years) | 1 year | ||||||||||||
| Founder, Chairman and President | Related party | |||||||||||||
| Equity Transactions | |||||||||||||
| Employment agreement extension term (in years) | 1 year | ||||||||||||
| Preferred stock, par value (in dollars per share) | $ 0.00001 | ||||||||||||
| TheraCour Pharma Inc | |||||||||||||
| Equity Transactions | |||||||||||||
| Accounts payable | $ 733,434 | ||||||||||||
| TheraCour Pharma Inc | Related party | |||||||||||||
| Equity Transactions | |||||||||||||
| Number of shares upon principle of note convertible | 331,859 | ||||||||||||
| Gain on extinguishment | $ 49,808 | ||||||||||||
| Issuance of shares | 75,000 | ||||||||||||
| TheraCour Pharma Inc | Related party | Unsecured promissory note | |||||||||||||
| Equity Transactions | |||||||||||||
| Interest rate per annum (as a percent) | 12.00% | ||||||||||||
| Director | |||||||||||||
| Equity Transactions | |||||||||||||
| Stock-based compensation expense | $ 45,000 | ||||||||||||
| Number of shares authorized | 30,084 | 30,084 | |||||||||||
| Employee compensation | |||||||||||||
| Equity Transactions | |||||||||||||
| Stock-based compensation expense | $ 4,822 | ||||||||||||
| Number of shares authorized | 3,572 | 3,572 | |||||||||||
| Consulting services | |||||||||||||
| Equity Transactions | |||||||||||||
| Stock-based compensation expense | $ 108,000 | ||||||||||||
| Number of shares authorized | 72,668 | 72,668 | |||||||||||
| Common Stock | |||||||||||||
| Equity Transactions | |||||||||||||
| Issuance of shares | 1,308,651 | ||||||||||||
| Common stock issued for consulting and legal services rendered (in shares) | 101,542 | 72,668 | |||||||||||
| Common stock issued for Directors fees (in shares) | 33,579 | 30,084 | |||||||||||
| Common Stock | Before Redomiciliation | |||||||||||||
| Equity Transactions | |||||||||||||
| Common stock, par value (in dollars per share) | $ 0.001 | $ 0.001 | |||||||||||
| Common Stock | After Redomiciliation | |||||||||||||
| Equity Transactions | |||||||||||||
| Common stock, $0.00001 par value; 150,000,000 shares authorized, 13,144,055 and 11,698,497 shares issued and outstanding at June 30, 2024 and 2023, respectively. (Note 8) | $ 116 | $ 11,592 | |||||||||||
| Common stock, par value (in dollars per share) | 0.00001 | 0.00001 | |||||||||||
| Preferred Stock | Before Redomiciliation | |||||||||||||
| Equity Transactions | |||||||||||||
| Preferred stock par value | $ 485 | ||||||||||||
| Preferred stock, par value (in dollars per share) | 0.001 | 0.001 | |||||||||||
| Preferred Stock | After Redomiciliation | |||||||||||||
| Equity Transactions | |||||||||||||
| Number of shares issued on conversion of each share | 1 | ||||||||||||
| Preferred stock par value | 5 | ||||||||||||
| Preferred stock, par value (in dollars per share) | $ 0.00001 | $ 0.00001 | |||||||||||
| Series A Preferred Stock | Founder, Chairman and President | |||||||||||||
| Equity Transactions | |||||||||||||
| Number of shares vest on quarterly installments | 2,551 | ||||||||||||
| Shares granted | 10,204 | ||||||||||||
| Series A Preferred Stock | Founder, Chairman and President | Related party | |||||||||||||
| Equity Transactions | |||||||||||||
| Number of shares vest on quarterly installments | 2,551 | ||||||||||||
| Non-cash compensation expense recognized | $ 49,795 | ||||||||||||
| Shares granted | 10,204 | ||||||||||||
| Series A Preferred Stock | TheraCour Pharma Inc | |||||||||||||
| Equity Transactions | |||||||||||||
| Number of shares upon principle of note convertible | 331,859 | ||||||||||||
| Debt instrument, conversion stock, par value | $ 0.00001 | ||||||||||||
| Series A Preferred Stock | TheraCour Pharma Inc | Related party | |||||||||||||
| Equity Transactions | |||||||||||||
| Issuance of shares | 50,000 | ||||||||||||
| Series A Preferred Stock | Employee compensation | |||||||||||||
| Equity Transactions | |||||||||||||
| Stock-based compensation expense | $ 10,747 | ||||||||||||
| Number of shares authorized | 2,888 | 2,888 | |||||||||||
| Series A Preferred Stock | Founder, Chairman and President | |||||||||||||
| Equity Transactions | |||||||||||||
| Non-cash compensation expense | $ 32,498 | ||||||||||||
| Series A convertible preferred stock | |||||||||||||
| Equity Transactions | |||||||||||||
| Preferred stock par value | $ 9 | $ 9 | $ 5 | ||||||||||
| Preferred stock, par value (in dollars per share) | $ 0.00001 | $ 0.00001 | $ 0.00001 | ||||||||||
| Number of shares authorized | 2,888 | ||||||||||||
| Series A convertible preferred stock | Employee compensation | |||||||||||||
| Equity Transactions | |||||||||||||
| Stock-based compensation expense | $ 12,000 | ||||||||||||
Equity Transactions - Proceeds of ATM offering (Details) - ATM Offering |
12 Months Ended |
|---|---|
|
Jun. 30, 2024
USD ($)
| |
| Equity Transactions | |
| Gross proceeds | $ 3,237,000 |
| Less: offering costs and expenses | 117,000 |
| Net proceeds from issuance of common stock | $ 3,120,000 |
Equity Transactions - Estimated the fair value of warrants granted quarterly to the Scientific Advisory Board (Details) - Scientific Advisory Board |
12 Months Ended | |
|---|---|---|
Jun. 30, 2024 |
Jun. 30, 2023 |
|
| Equity Transactions | ||
| Expected life (year) | 4 years | |
| Expected volatility, minimum | 50.13% | 51.39% |
| Expected volatility, maximum | 55.28% | 85.12% |
| Expected annual rate of quarterly dividends | 0.00% | 0.00% |
| Risk-free rate(s), minimum | 4.29% | 3.025% |
| Risk-free rate(s), maximum | 4.60% | 4.195% |
Common Stock Warrants- Common Stock Warrants (Details) - Common Stock Warrants - USD ($) |
12 Months Ended | ||
|---|---|---|---|
Jun. 30, 2024 |
Jun. 30, 2023 |
Jun. 30, 2022 |
|
| Common Stock Warrants | |||
| Number of Shares, Outstanding and exercisable (in shares) | 8,004 | 9,146 | |
| Number of Shares, Granted (in shares) | 1,144 | 1,144 | |
| Number of Shares, Expired (in shares) | (2,286) | (2,286) | |
| Number of Shares, Outstanding and exercisable (in shares) | 6,862 | 8,004 | |
| Weighted Average Exercise Price per share, Outstanding and exercisable (dollars per share) | $ 4.96 | $ 6.06 | |
| Weighted Average Exercise Price per share, Granted (dollars per share) | 1.76 | 2.17 | |
| Weighted Average Exercise Price per share, Expired (dollars per share) | 5.26 | 7.98 | |
| Weighted Average Exercise Price per share, Outstanding and exercisable (dollars per share) | $ 3.64 | $ 4.96 | |
| Weighted Average Remaining Contractual life Term (years), Granted | 3 years 6 months | ||
| Weighted Average Remaining Contractual life Term (years), Outstanding and exercisable | 1 year 8 months 1 day | ||
| Aggregate Intrinsic Value, Outstanding and exercisable (in dollars) | $ 399 | $ 238 | $ 238 |
Common Stock Warrants - Additional Information (Details) |
12 Months Ended |
|---|---|
|
Jun. 30, 2024
shares
| |
| June 30, 2025 | |
| Common Stock Warrants | |
| Warrants exercisable | 2,286 |
| June 30, 2026 | |
| Common Stock Warrants | |
| Warrants exercisable | 2,288 |
| June 30, 2027 | |
| Common Stock Warrants | |
| Warrants exercisable | 1,144 |
| June 30, 2028 | |
| Common Stock Warrants | |
| Warrants exercisable | 1,144 |
Income Tax Provision - Computation of Income tax expense (Details) |
12 Months Ended | |
|---|---|---|
Jun. 30, 2024 |
Jun. 30, 2023 |
|
| Income Tax Provision | ||
| Federal statutory rate | (21.00%) | (21.00%) |
| Research and development credit | 3.45% | 1.10% |
| State tax rate | (5.93%) | (5.93%) |
| Other | (0.95%) | (0.65%) |
| Valuation allowance | 24.43% | 26.48% |
| Effective tax rate | 0.00% | 0.00% |
Income Tax Provision - Components of deferred tax assets (Details) - USD ($) |
Jun. 30, 2024 |
Jun. 30, 2023 |
|---|---|---|
| Income Tax Provision | ||
| Net operating loss | $ 29,351,534 | $ 27,960,157 |
| Research and development credit | 8,154,686 | 7,868,816 |
| IRC Sec.174 R&E capitalization | 2,243,662 | 1,536,679 |
| Other | 22,087 | 25,194 |
| Total gross deferred tax assets | 39,771,969 | 37,390,846 |
| Less: valuation allowance | (39,771,969) | (37,390,846) |
| Net deferred tax asset | $ 0 | $ 0 |
Income Tax Provision - Additional Information (Details) - USD ($) |
12 Months Ended | ||
|---|---|---|---|
Jun. 30, 2024 |
Jun. 30, 2023 |
Jun. 30, 2018 |
|
| Income Tax Provision | |||
| Deferred tax assets, valuation allowance | $ 39,771,969 | $ 37,390,846 | |
| Operating loss carryforwards | 109,000,000 | ||
| Net operating loss that can be carried forward indefinitely | 8,100,000 | $ 8,100,000 | |
| Net operating losses income tax payable | 80.00% | ||
| Current tax expense | $ 0 | ||
| Federal income tax rate | 21.00% | 21.00% | |
| Research and development credit carryforwards | |||
| Income Tax Provision | |||
| Tax credit carryforwards | $ 8,154,686 | $ 7,868,816 | |
Commitments and Contingencies - Employment Agreements (Details) - USD ($) |
2 Months Ended | 12 Months Ended | |||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|
Jul. 01, 2024 |
Oct. 06, 2023 |
Oct. 06, 2022 |
Sep. 07, 2021 |
Nov. 01, 2019 |
Jan. 01, 2015 |
May 30, 2013 |
Mar. 03, 2010 |
Sep. 10, 2024 |
Jun. 30, 2024 |
Jun. 30, 2023 |
|
| Commitments and Contingencies | |||||||||||
| Common stock, shares issued | 13,144,055 | 11,698,497 | |||||||||
| Non-cash compensation expense recognized | $ 563 | $ 44,000 | |||||||||
| Subsequent event | |||||||||||
| Commitments and Contingencies | |||||||||||
| Issuance of shares | 772,836 | ||||||||||
| Founder, Chairman and President | |||||||||||
| Commitments and Contingencies | |||||||||||
| Employment agreement extension term (in years) | 1 year | ||||||||||
| Founder, Chairman and President | Related party | |||||||||||
| Commitments and Contingencies | |||||||||||
| Employment agreement extension term (in years) | 1 year | ||||||||||
| Base salary | $ 400,000 | ||||||||||
| Term life insurance value | 2,000,000 | ||||||||||
| Term life insurance value assigned to company | $ 1,000,000 | ||||||||||
| Preferred stock, par value (in dollars per share) | $ 0.00001 | ||||||||||
| Founder, Chairman and President | Series A Preferred stock | |||||||||||
| Commitments and Contingencies | |||||||||||
| Shares granted | 10,204 | ||||||||||
| Founder, Chairman and President | Series A Preferred stock | Related party | |||||||||||
| Commitments and Contingencies | |||||||||||
| Shares granted | 10,204 | ||||||||||
| Non-cash compensation expense recognized | $ 49,795 | ||||||||||
| Number of shares granted | 10,204 | ||||||||||
| TheraCour Pharma Inc | Related party | |||||||||||
| Commitments and Contingencies | |||||||||||
| Issuance of shares | 75,000 | ||||||||||
| TheraCour Pharma Inc | Series A Preferred stock | Related party | |||||||||||
| Commitments and Contingencies | |||||||||||
| Issuance of shares | 50,000 | ||||||||||
| Vice President | |||||||||||
| Commitments and Contingencies | |||||||||||
| Employment agreement term | 4 years | ||||||||||
| Common stock, shares issued | 1,786 | ||||||||||
| Base salary | $ 150,000 | ||||||||||
| Additional common stock shares issued | 1,786 | ||||||||||
| Vice President | Series A Preferred stock | |||||||||||
| Commitments and Contingencies | |||||||||||
| Preferred Stock, Shares Issued | 1,340 | ||||||||||
| Additional preferred stock shares issued | 1,340 | ||||||||||
| Chief Financial Officer | |||||||||||
| Commitments and Contingencies | |||||||||||
| Employment agreement extension term (in years) | 1 year | ||||||||||
| Employment agreement term | 3 years | ||||||||||
| Increase In base salary | $ 10,800 | $ 9,000 | |||||||||
| Chief Financial Officer | Series A Preferred stock | |||||||||||
| Commitments and Contingencies | |||||||||||
| Preferred Stock, Shares Issued | 129 | ||||||||||
Commitments and Contingencies - License Agreements (Details) |
1 Months Ended | 12 Months Ended | |||||
|---|---|---|---|---|---|---|---|
|
Oct. 27, 2023
shares
|
Jul. 19, 2023
$ / shares
shares
|
Sep. 07, 2021
USD ($)
shares
|
Nov. 01, 2019
USD ($)
shares
|
Mar. 31, 2023 |
Jun. 30, 2024
USD ($)
|
Mar. 27, 2023
item
|
|
| Commitments and Contingencies | |||||||
| Interest expense | $ 49,808 | ||||||
| TheraCour Pharma Inc | |||||||
| Commitments and Contingencies | |||||||
| Percentage of net sales allocated for royalty payments (in percent) | 15.00% | ||||||
| Related party | KMPL | |||||||
| Commitments and Contingencies | |||||||
| Percentage of clinical trials fees | 30.00% | ||||||
| Percentage of royalty fee | 70.00% | ||||||
| Number of clinical test drug candidates granted for the use, sale, or offer of sale in India | item | 2 | ||||||
| Related party | TheraCour Pharma Inc | |||||||
| Commitments and Contingencies | |||||||
| Cash upon completion of Phase I Clinical Trials | $ 1,500,000 | ||||||
| Cash upon completion of Phase II Clinical Trials | 2,500,000 | ||||||
| Cash upon completion of Phase III Clinical Trials | $ 5,000,000 | ||||||
| Stock Issued During Period, Shares, New Issues | shares | 75,000 | ||||||
| Number of shares upon principle of note convertible | shares | 331,859 | ||||||
| Gain on extinguishment | $ 49,808 | ||||||
| Percentage of net sales allocated for royalty payments (in percent) | 15.00% | ||||||
| Related party | TheraCour Pharma Inc | Unsecured promissory note | |||||||
| Commitments and Contingencies | |||||||
| Interest rate per annum (as a percent) | 12.00% | ||||||
| Series A Preferred Stock | TheraCour Pharma Inc | |||||||
| Commitments and Contingencies | |||||||
| Number of shares upon principle of note convertible | shares | 331,859 | ||||||
| Debt instrument, conversion stock, par value | $ / shares | $ 0.00001 | ||||||
| Series A Preferred Stock | Related party | |||||||
| Commitments and Contingencies | |||||||
| Shares value upon initiation of Phase III Clinical Trials | $ 100,000 | ||||||
| Series A Preferred Stock | Related party | TheraCour Pharma Inc | |||||||
| Commitments and Contingencies | |||||||
| Cash upon completion of Phase I Clinical Trials | 2,000,000 | ||||||
| Cash upon completion of Phase II Clinical Trials | 2,500,000 | ||||||
| Cash upon completion of Phase III Clinical Trials | $ 5,000,000 | ||||||
| Number of shares issuable upon execution of agreement | shares | 100,000 | ||||||
| Threshold Period for Issuance of Shares Upon Execution of Agreement | 30 days | ||||||
| Stock Issued During Period Value New Issues Initiation Of Phase1 Clinical Trials | $ 1,500,000 | ||||||
| Shares value upon completion of Phase III Clinical Trials | $ 500,000 | ||||||
| Stock Issued During Period, Shares, New Issues | shares | 50,000 | ||||||
| Percentage of net sales allocated for royalty payments (in percent) | 15.00% |
Subsequent Events (Details) - USD ($) |
2 Months Ended | |||
|---|---|---|---|---|
Sep. 20, 2024 |
Apr. 15, 2024 |
Sep. 10, 2024 |
Jun. 30, 2024 |
|
| ATM Offering | ||||
| Subsequent Events | ||||
| Average price | $ 2.47 | |||
| Net proceeds | $ 3,120,000 | |||
| Subsequent event | ||||
| Subsequent Events | ||||
| Number of shares upon principle of note convertible | 772,836 | |||
| Average price | $ 1.98 | |||
| Subsequent event | ATM Offering | ||||
| Subsequent Events | ||||
| Average price | $ 1.98 | |||
| Net proceeds | $ 1,533,000 | |||
| Subsequent event | Minimum | Dr. Anil Diwan | ||||
| Subsequent Events | ||||
| Line of credit | $ 2,000,000 | |||
| Maturity of the Company's line of Credit | Dec. 31, 2025 | |||
| Subsequent event | Maximum | Dr. Anil Diwan | ||||
| Subsequent Events | ||||
| Line of credit | $ 3,000,000 | |||
| Maturity of the Company's line of Credit | Mar. 31, 2026 |
1 Year NanoViricides Chart |
1 Month NanoViricides Chart |
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