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UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, DC 20549
FORM 10-Q
x |
QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 |
For the quarterly period ended July 31,
2024
OR
¨ |
TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 |
Commission File Number: 001-40483
ALZAMEND NEURO, INC.
(Exact name of registrant as specified in its
charter)
Delaware |
81-1822909 |
(State or other jurisdiction of incorporation or organization) |
(I.R.S. Employer Identification Number) |
3480 Peachtree Road NE, Second Floor Suite 103, Atlanta, GA |
30326 |
(844) 722-6303 |
(Address of principal executive offices) |
(Zip Code) |
(Registrant’s telephone number, including area code) |
Securities registered under Section 12(b) of the
Act:
Title of Each Class |
Trading Symbol |
Name of each exchange on which registered |
Common Stock, $0.0001 par value per share |
ALZN |
NASDAQ Capital Market |
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. Yes x No ¨
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 during the preceding
12 months (or for such shorter period that the registrant was required to submit such files). Yes x No ¨
Indicate by check mark whether the registrant
is a large accelerated filer, an accelerated filer, a non-accelerated filer, a 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 ¨ |
Non-accelerated filer |
x |
Smaller reporting company x |
Emerging growth company |
x |
|
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
is a shell company (as defined in Rule 12b-2 of the Exchange Act). Yes ¨ No x
As of September 11, 2024 there were 3,890,064 shares
of registrant’s common stock, $0.0001 par value per share, outstanding.
Table of Contents
|
|
Page |
|
|
|
PART I. |
FINANCIAL INFORMATION |
3 |
Item 1. |
Financial Statements (unaudited) |
3 |
|
Condensed Balance Sheets |
3 |
|
Condensed Statements of Operations |
4 |
|
Condensed Statements of Stockholders’ (Deficit) Equity |
5 |
|
Condensed Statements of Cash Flows |
7 |
|
Notes to Condensed Financial Statements |
8 |
Item 2. |
Management’s Discussion and Analysis of Financial Condition and Results of Operations |
18 |
Item 3. |
Quantitative and Qualitative Disclosures About Market Risk |
27 |
Item 4. |
Controls and Procedures |
27 |
|
|
|
PART II. |
OTHER INFORMATION |
29 |
Item 1. |
Legal Proceedings |
29 |
Item 1A. |
Risk Factors |
29 |
Item 2. |
Unregistered Sales of Equity Securities and Use of Proceeds |
29 |
Item 3. |
Defaults Upon Senior Securities |
29 |
Item 4. |
Mine Safety Disclosures |
29 |
Item 5. |
Other Information |
29 |
Item 6. |
Exhibits |
30 |
|
Signatures |
31 |
PART I – FINANCIAL INFORMATION
| ITEM 1. | FINANCIAL STATEMENTS |
Alzamend Neuro, Inc.
Condensed Balance Sheets
(Unaudited)
| |
| | | |
| | |
| |
July 31,
2024 | | |
April 30,
2024 | |
ASSETS | |
| | | |
| | |
| |
| | | |
| | |
CURRENT ASSETS | |
| | | |
| | |
| |
| | | |
| | |
Cash | |
$ | 1,193,950 | | |
$ | 376,048 | |
Prepaid expenses and other current assets | |
| 222,241 | | |
| 79,194 | |
TOTAL CURRENT ASSETS | |
| 1,416,191 | | |
| 455,242 | |
Property, plant and equipment, net | |
| 253,661 | | |
| 176,346 | |
TOTAL ASSETS | |
$ | 1,669,852 | | |
$ | 631,588 | |
| |
| | | |
| | |
| |
| | | |
| | |
LIABILITIES AND STOCKHOLDERS’ DEFICIT | |
| | | |
| | |
| |
| | | |
| | |
CURRENT LIABILITIES | |
| | | |
| | |
| |
| | | |
| | |
Accounts payable and accrued liabilities | |
$ | 2,882,171 | | |
$ | 2,925,059 | |
Note payable | |
| - | | |
| 300,714 | |
TOTAL LIABILITIES, ALL CURRENT | |
| 2,882,171 | | |
| 3,225,773 | |
| |
| | | |
| | |
COMMITMENTS AND CONTINGENCIES | |
| | | |
| | |
| |
| | | |
| | |
STOCKHOLDERS’ DEFICIT | |
| | | |
| | |
| |
| | | |
| | |
Series A Convertible Preferred Stock, $0.0001
stated value per share, 3,000
shares designated; 188
and nil 0 issued and outstanding as of July 31, 2024 and April 30, 2024, respectively | |
| - | | |
| - | |
Series B Convertible Preferred Stock, $0.0001 stated value per share, 6,000 designated; 2,100 issued and outstanding as of July
31, 2024 and April 30, 2024 | |
| - | | |
| - | |
Common stock, $0.0001 par value: 300,000,000 shares authorized; 861,332 and 687,999 issued and outstanding as of July 31, 2024
and April 30, 2024, respectively | |
| 86 | | |
| 69 | |
Additional paid-in capital | |
| 53,782,414 | | |
| 51,426,154 | |
Accumulated deficit | |
| (54,994,819 | ) | |
| (54,020,408 | ) |
TOTAL STOCKHOLDERS’ DEFICIT | |
| (1,212,319 | ) | |
| (2,594,185 | ) |
TOTAL LIABILITIES AND STOCKHOLDERS’ DEFICIT | |
$ | 1,669,852 | | |
$ | 631,588 | |
The accompanying notes are an integral part of
these unaudited condensed financial statements.
Alzamend Neuro, Inc.
Condensed Statements of Operations
(Unaudited)
| |
| | | |
| | |
| |
For the Three Months Ended July 31, | |
| |
2024 | | |
2023 | |
OPERATING EXPENSES | |
| | | |
| | |
Research and development | |
$ | 206,571 | | |
$ | 2,366,137 | |
General and administrative | |
| 755,834 | | |
| 1,159,794 | |
Total operating expenses | |
| 962,405 | | |
| 3,525,931 | |
Loss from operations | |
| (962,405 | ) | |
| (3,525,931 | ) |
| |
| | | |
| | |
OTHER EXPENSE, NET | |
| | | |
| | |
Interest expense | |
| (12,006 | ) | |
| (1,835 | ) |
Total other expense, net | |
| (12,006 | ) | |
| (1,835 | ) |
NET LOSS | |
$ | (974,411 | ) | |
$ | (3,527,766 | ) |
| |
| | | |
| | |
Basic and diluted net loss per common share | |
$ | (1.25 | ) | |
$ | (5.38 | ) |
| |
| | | |
| | |
Basic and diluted weighted average common shares outstanding | |
| 777,821 | | |
| 656,267 | |
The accompanying notes are an integral part of
these unaudited condensed financial statements.
Alzamend Neuro, Inc.
Condensed Statements of Stockholders’
Deficit
For the Three Months Ended July 31, 2024
(Unaudited)
| |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | |
| |
Series A Convertible | | |
Series B Convertible | | |
| | |
| | |
Additional | | |
| | |
| |
| |
Preferred Stock | | |
Preferred Stock | | |
Common Stock | | |
Paid-In | | |
Accumulated | | |
| |
| |
Shares | | |
Amount | | |
Shares | | |
Amount | | |
Shares | | |
Amount | | |
Capital | | |
Deficit | | |
Total | |
BALANCES, April 30, 2024 | |
| - | | |
$ | - | | |
| 2,100 | | |
$ | - | | |
| 687,999 | | |
$ | 69 | | |
$ | 51,426,154 | | - |
$ | (54,020,408 | ) | |
$ | (2,594,185 | ) |
| |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | |
Issuance of preferred stock for cash | |
| 250 | | |
| - | | |
| - | | |
| - | | |
| - | | |
| - | | |
| 1,963,644 | | |
| - | | |
| 1,963,644 | |
| |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | |
Conversion of note payable and interest to preferred stock | |
| - | | |
| - | | |
| - | | |
| - | | |
| - | | |
| - | | |
| 311,356 | | |
| - | | |
| 311,356 | |
| |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | |
Conversion of preferred stock to common stock | |
| (62 | ) | |
| - | | |
| - | | |
| - | | |
| 173,333 | | |
| 17 | | |
| (17 | ) | |
| - | | |
| - | |
| |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | |
Stock-based compensation to employees and consultants | |
| - | | |
| - | | |
| - | | |
| - | | |
| - | | |
| - | | |
| 81,277 | | |
| - | | |
| 81,277 | |
| |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | |
Net loss | |
| - | | |
| - | | |
| - | | |
| - | | |
| - | | |
| - | | |
| - | | - |
| (974,411 | ) | |
| (974,411 | ) |
| |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | |
BALANCES, July 31, 2024 | |
| 188 | | |
$ | - | | |
| 2,100 | | |
$ | - | | |
| 861,332 | | |
$ | 86 | | |
$ | 53,782,414 | | - |
$ | (54,994,819 | ) | |
$ | (1,212,319 | ) |
The accompanying notes are an integral part of
these unaudited condensed financial statements.
Alzamend Neuro, Inc.
Condensed Statements of Stockholders’
Equity (Deficit)
For the Three Months Ended July 31, 2023
(Unaudited)
| |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | |
| |
Series A Convertible | | |
| | |
| | |
Additional | | |
Note Receivable for | | |
| | |
| |
| |
Preferred Stock | | |
Common Stock | | |
Paid-In | | |
Common Stock - | | |
Accumulated | | |
| |
| |
Shares | | |
Amount | | |
Shares | | |
Amount | | |
Capital | | |
Related Party | | |
Deficit | | |
Total | |
BALANCES, April 30, 2023 | |
| - | | |
$ | - | | |
| 646,267 | | |
$ | 65 | | |
$ | 62,001,395 | | |
$ | (14,883,295 | ) | |
$ | (44,072,662 | ) | |
$ | 3,045,503 | |
| |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | |
Stock-based compensation to employees and consultants | |
| - | | |
| - | | |
| - | | |
| - | | |
| 369,380 | | |
| - | | |
| - | | |
| 369,380 | |
| |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | |
Net loss | |
| - | | |
| - | | |
| - | | |
| - | | |
| - | | |
| - | | |
| (3,527,766 | ) | |
| (3,527,766 | ) |
| |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | |
BALANCES, July 31, 2023 | |
| - | | |
$ | - | | |
| 646,267 | | |
$ | 65 | | |
$ | 62,370,775 | | |
$ | (14,883,295 | ) | |
$ | (47,600,428 | ) | |
$ | (112,883 | ) |
The accompanying notes are an integral part of
these unaudited condensed financial statements.
Alzamend Neuro, Inc.
Condensed Statements of Cash Flows
(Unaudited)
| |
| | | |
| | |
| |
For the Three Months Ended July 31, | |
| |
2024 | | |
2023 | |
Cash flows from operating activities: | |
| | | |
| | |
Net loss | |
$ | (974,411 | ) | |
$ | (3,527,766 | ) |
Adjustments to reconcile net loss to net cash used in operating activities: | |
| | | |
| | |
Depreciation expense | |
| 12,685 | | |
| 12,685 | |
Interest expense - debt discount | |
| 9,286 | | |
| - | |
Stock-based compensation to employees and consultants | |
| 81,277 | | |
| 369,380 | |
Changes in operating assets and liabilities: | |
| | | |
| | |
Prepaid expenses and other current assets | |
| (143,047 | ) | |
| (270,599 | ) |
Prepaid expenses - related party | |
| - | | |
| 247,334 | |
Accounts payable and accrued liabilities | |
| (41,532 | ) | |
| (129,234 | ) |
Net cash used in operating activities | |
| (1,055,742 | ) | |
| (3,298,200 | ) |
Cash flows from investing activities: | |
| | | |
| | |
Purchase of equipment | |
| (90,000 | ) | |
| (147,243 | ) |
Net cash used in investing activities | |
| (90,000 | ) | |
| (147,243 | ) |
Cash flows from financing activities: | |
| | | |
| | |
Net proceeds from the issuance of preferred stock | |
| 1,963,644 | | |
| - | |
Net cash provided by financing activities | |
| 1,963,644 | | |
| - | |
Net increase (decrease) in cash | |
| 817,902 | | |
| (3,445,443 | ) |
Cash at beginning of period | |
| 376,048 | | |
| 5,140,859 | |
Cash at end of period | |
$ | 1,193,950 | | |
$ | 1,695,416 | |
| |
| | | |
| | |
Supplemental disclosures of cash flow information: | |
| | | |
| | |
Non-cash financing activities: | |
| | | |
| | |
Conversion of Series A convertible preferred stock | |
$ | 624,770 | | |
$ | - | |
Fair value of warrants issued in connection with Series A convertible preferred stock | |
$ | 510,209 | | |
$ | - | |
Conversion of note payable and accrued interest into Series B convertible preferred stock | |
$ | 311,356 | | |
$ | - | |
The accompanying notes are an integral part of
these unaudited condensed financial statements.
Alzamend Neuro, Inc.
Notes to Unaudited Condensed Financial Statements
| 1. | DESCRIPTION OF BUSINESS |
Organization
Alzamend Neuro, Inc. (the
“Company” or “Alzamend”), is a clinical-stage biopharmaceutical company focused on developing novel products for
the treatment of Alzheimer’s disease (“Alzheimer’s”), bipolar disorder (“BD”), major depressive disorder
(“MDD”) and post-traumatic stress disorder (“PTSD”). With two current product candidates, Alzamend aims to bring
treatments or cures to market at a reasonable cost as quickly as possible. The Company’s current pipeline consists of two novel
therapeutic drug candidates: (i) a patented ionic cocrystal technology delivering a therapeutic combination of lithium, proline and salicylate,
known as AL001, through two royalty-bearing exclusive worldwide licenses from the University of South Florida Research Foundation, Inc.,
as licensor (the “Licensor”); and (ii) a patented method using a mutant peptide sensitized cell as a cell-based therapeutic
vaccine that seeks to restore the ability of a patient’s immunological system to combat Alzheimer’s, known as ALZN002, through
a royalty-bearing exclusive worldwide license from the same Licensor.
The Company is devoting substantially
all its efforts towards research and development of its two product candidates and raising capital. The Company has not generated any
product revenue to date. The Company has financed its operations to date primarily through debt financings and through the sale of its
common stock, par value $0.0001 per share (“Common Stock”) and its preferred stock, par value $0.0001 per share. The Company
expects to continue to incur net losses in the foreseeable future.
Reverse Stock Split
On
October 27, 2023, pursuant to the authorization provided by the Company’s stockholders at a special meeting of stockholders, the
Company filed an amendment to the Certificate of Incorporation to effectuate a reverse stock split of the Company’s issued and outstanding
Common Stock by a ratio of one-for-fifteen (the “First Reverse Split”). The First Reverse Split did not affect the number
of authorized shares of Common Stock, preferred stock or their respective par value per share. As a result of the First Reverse Split,
each fifteen shares of Common Stock issued and outstanding prior to the First Reverse Split were converted into one share of Common Stock.
The First Reverse Split became effective in the State of Delaware on October 31, 2023. All share amounts in these financial statements
have been updated for all periods presented to reflect the First Reverse Split.
On
July 10, 2024, pursuant to the authorization provided by the Company’s stockholders at its annual meeting of stockholders, the Company
filed an amendment to the Certificate of Incorporation to effectuate a reverse stock split of the Company’s issued and outstanding
Common Stock by a ratio of one-for-ten (the “Second Reverse Split”). The Second Reverse Split did not affect the number of
authorized shares of Common Stock, preferred stock or their respective par value per share. As a result of the Second Reverse Split, each
ten shares of Common Stock issued and outstanding prior to the Second Reverse Split were converted into one share of Common Stock. The
Second Reverse Split became effective in the State of Delaware on July 16, 2024. All share amounts in these financial statements have
been updated for all periods presented to reflect the Second Reverse Split.
| 2. | LIQUIDITY AND GOING CONCERN |
The accompanying condensed
financial statements have been prepared on the basis that the Company will continue as a going concern. As of July 31, 2024, the Company
had cash of $1.2 million, a working capital deficiency of $1.5 million, an accumulated deficit of $55.0 million and a stockholders’
deficit of $1.2 million. For the three months ended July 31, 2024, the Company had a net loss of $1.0 million. For the three months ended
July 31, 2024, cash used in operating activities was $1.1 million. Historically, the Company has financed its operations principally through
issuances of equity and debt instruments.
Management
believes its current cash on hand is not sufficient to fund its planned operations through one year after the date the condensed financial
statements are issued. These factors create substantial doubt about the Company’s ability to continue as a going concern for at
least one year after the date that these condensed financial statements are issued.
The Company’s inability to
continue as a going concern could have a negative impact on the Company, including its ability to obtain
needed financing. The Company’s condensed financial statements do not include any adjustments relating to the recoverability
and classification of recorded assets, or the amounts and classifications of liabilities that might be necessary should it be unable to
continue as a going concern.
The Company expects to continue
to incur losses for the foreseeable future and needs to raise additional capital until it is able to generate revenues from operations
sufficient to fund its development and commercial operations. These factors create substantial doubt
about our ability to continue as a going concern. However, based on the Company’s current business plan, management believes
that the Company’s cash and cash equivalents at July 31, 2024, together with the anticipated receipt of funds from the sale of its
Series A and Series B Convertible Preferred Stock pursuant to the securities purchase agreements related thereto, will be sufficient to
meet the Company’s anticipated cash requirements during the twelve-month period subsequent to the issuance of the financial statements
included in this Quarterly Report.
| 3. | SIGNIFICANT ACCOUNTING POLICIES |
Basis of Presentation
The accompanying condensed
financial statements of the Company have been prepared in accordance with accounting principles generally accepted in the United States
of America (“U.S. GAAP”) and the rules of the Securities and Exchange Commission (“SEC”) applicable to interim
reports of companies filing as a smaller reporting company. These condensed financial statements should be read in conjunction with the
audited financial statements and notes thereto contained in the Company’s Report on Form 10-K for the year ended April 30, 2024,
filed with the SEC on July 30, 2024. In the opinion of management, the accompanying condensed interim financial statements include all
adjustments necessary in order to make the condensed financial statements not misleading. The results of operations for interim periods
are not necessarily indicative of the results to be expected for the full year or any other future period. Certain notes to the condensed
financial statements that would substantially duplicate the disclosures contained in the audited financial statements for the most recent
fiscal year as reported in the Company’s Report on Form 10-K have been omitted. The accompanying condensed balance sheet at April
30, 2024 has been derived from the audited balance sheet at April 30, 2024 contained in such Form 10-K.
Accounting Estimates
The preparation of condensed
financial statements, in conformity with U.S. GAAP, requires management to make estimates and assumptions that affect the reported amounts
of assets and liabilities and disclosure of contingent assets and liabilities at the date of the condensed financial statements and the
reported amounts of expenses during the reporting period. The Company’s significant accounting policies that involve significant
judgment and estimates include stock-based compensation, warrant valuation, and valuation of deferred income taxes. Actual results could
differ from those estimates.
Cash and Cash Equivalents
The Company considers all
highly liquid investments with a remaining maturity of three months or less when purchased to be cash equivalents. As of July 31, 2024
and April 30, 2024, the Company had no cash equivalents.
Fair Value of Financial
Instruments
Financial Accounting Standards
Board (“FASB”) Accounting Standards Codification (“ASC”) 820, Fair Value Measurement, defines fair value
as the exchange price that would be received for an asset or paid to transfer a liability (an exit price) in the principal or most advantageous
market for the asset or liability in an orderly transaction between market participants on the measurement date. Valuation techniques
used to measure fair value must maximize the use of observable inputs and minimize the use of unobservable inputs. The fair value hierarchy
is based on three levels of inputs that may be used to measure fair value, of which the first two are considered observable and the last
is considered unobservable:
Level 1: Quoted prices in
active markets for identical assets or liabilities.
Level 2: Inputs other than
Level 1 that are observable, either directly or indirectly, such as quoted prices for similar assets or liabilities; quoted prices in
markets that are not active; or other inputs that are observable or can be corroborated by observable market data for substantially the
full term of the assets or liabilities.
Level 3 assumptions: Unobservable
inputs that are supported by little or no market activity and that are significant to the fair value of the assets or liabilities including
liabilities resulting from imbedded derivatives associated with certain warrants to purchase Common Stock.
The fair values of warrants
are determined using the Black-Scholes valuation model, a “Level 3” fair value measurement, based on the estimated fair value
of Common Stock, volatility based on the historical volatility data of similar companies, considering the industry, products and market
capitalization of such other entities, the expected life based on the remaining contractual term of the warrants and the risk free interest
rate based on the implied yield available on U.S. Treasury Securities with a maturity equivalent to the warrants’ contractual life.
Property and Equipment,
Net
Property and equipment
are stated at cost, net of accumulated depreciation. Depreciation is computed using the straight-line method over the estimated
useful life of 5 five years. Significant additions and improvements are capitalized, while repairs and maintenance are charged to
expense as incurred.
Research and Development
Expenses
Research and development costs
are expensed as incurred. Research and development costs consist of scientific consulting fees, clinical trial fees and lab supplies,
as well as fees paid to other entities that conduct certain research and development activities on behalf of the Company.
The Company has acquired and
may continue to acquire the rights to develop and commercialize new product candidates from third parties. The upfront payments to acquire
license, products or rights, as well as any future milestone payments, are immediately recognized as research and development expenses,
provided that there is no alternative future use of the rights in other research and development projects.
Stock-Based Compensation
The Company recognizes stock-based
compensation expense for stock options on a straight-line basis over the requisite service period and account for forfeitures as they
occur. The Company’s stock-based compensation costs are based upon the grant date fair value of options estimated using the Black-Scholes
option pricing model. To the extent any stock option grants are made subject to the achievement of a performance-based milestone, management
evaluates when the achievement of any such performance-based milestone is probable based on the relative satisfaction of the performance
conditions as of the reporting date.
The Company recognizes stock-based
compensation expense for restricted stock units on a straight-line basis over the requisite service period and account for forfeitures
as they occur. The Company’s stock-based compensation for restricted stocks is based upon the estimated fair value of the Common
Stock.
The Black-Scholes option pricing
model utilizes inputs which are highly subjective assumptions and generally require significant judgment. Certain of such assumptions
involve inherent uncertainties and the application of significant judgment. As a result, if factors or expected outcomes change and the
Company uses significantly different assumptions or estimates, the Company’s stock-based compensation could be materially different.
Warrants
The Company accounts for stock
warrants as either equity instruments, derivative liabilities, or liabilities in accordance with FASB ASC 480, Distinguishing
Liabilities from Equity and FASB ASC 815, Derivatives and Hedging (“ASC 815”), depending on the
specific terms of the warrant agreement.
Based on the terms of the
Company’s warrant agreements, the Company accounted for the warrants as equity instruments as the warrants were indexed to the Common
Stock, required settlement in shares and would be classified as equity under ASC 815.
Loss per Common Share
The Company utilizes FASB
ASC 260, Earnings per Share. Basic loss per share is computed by dividing loss available to common stockholders by the weighted-average
number of common shares outstanding. Diluted loss per share is computed similar to basic loss per share except that the denominator is
increased to include the number of additional common shares that would have been outstanding if the potential common shares had been issued
and if the additional common shares were dilutive. Diluted loss per common share reflects the potential dilution that could occur if convertible
preferred stock, options and warrants were to be exercised or converted or otherwise resulted in the issuance of Common Stock that then
shared in the earnings of the entity.
Since the effects of outstanding
stock options, restricted stock units and warrants are anti-dilutive in the periods presented, shares of Common Stock underlying these
instruments have been excluded from the computation of loss per common share.
The following sets forth the
number of shares of Common Stock underlying outstanding stock options, restricted stock units and warrants that have been excluded from
the computation of loss per common share:
Schedule of antidilutive securities excluded from computation of earnings per share | |
| | | |
| | |
| |
For the Three Months Ended July 31, | |
| |
2024 | | |
2023 | |
Stock options (1) | |
| 116,999 | | |
| 121,055 | |
Restricted stock units | |
| 167 | | |
| 333 | |
Warrants | |
| 438,879 | | |
| 67,665 | |
| |
| 556,045 | | |
| 189,053 | |
Recent Accounting Standards
From time to time, new accounting
pronouncements are issued by the FASB and adopted by the Company as of the specified effective date. Unless otherwise discussed, the impact
of recently issued standards that are not yet effective are not expected to have a material impact on the Company’s financial position
or results of operations upon adoption.
Management has considered
all other recently issued accounting standards and does not believe the adoption of such standards will have a material impact on its
condensed financial statements.
| 4. | PREPAID EXPENSES AND OTHER CURRENT ASSETS |
Prepaid expenses and other
current assets were as follows:
Schedule of prepaid expenses and other current assets | |
| | | |
| | |
| |
July 31, 2024 | | |
April 30, 2024 | |
Prepaid insurance | |
$ | 209,619 | | |
$ | 60,522 | |
Other prepaid expenses | |
| 12,622 | | |
| 18,672 | |
Total prepaid expenses and other current assets | |
$ | 222,241 | | |
$ | 79,194 | |
On June 14, 2024, the Company
purchased directors’ and officers’ insurance for 12 months in the amount of $227,000. Prepaid insurance at July 31, 2024 represented
the unamortized portion of directors’ and officers’ insurance.
| 5. | STOCK-BASED COMPENSATION |
2016 Stock Incentive
Plan
On April 30, 2016, the Company’s
stockholders approved the Company’s 2016 Stock Incentive Plan (the “Plan”). The Plan provides for the issuance of a
maximum of 83,333 shares of Common Stock to be offered to the Company’s directors, officers, employees, and consultants. On March
1, 2019, the Company’s stockholders approved an additional 50,000 shares to be available for issuance under the Plan. Options granted
under the Plan have an exercise price equal to or greater than the fair value of the underlying Common Stock at the date of grant and
become exercisable based on a vesting schedule determined at the date of grant. The options expire between five and 10 years from the
date of grant. Restricted stock awards granted under the Plan are subject to a vesting period determined at the date of grant.
2021 Stock Incentive
Plan
In February 2021, the Company’s
board of directors (the “Board”) adopted, and the stockholders approved, the Alzamend Neuro, Inc. 2021 Stock Incentive Plan
(the “2021 Plan”). The 2021 Plan authorizes the grant to eligible individuals of (1) stock options (incentive and non-statutory),
(2) restricted stock, (3) stock appreciation rights, or SARs, (4) restricted stock units, and (5) other stock-based compensation.
Stock Subject to the 2021
Plan. The maximum number of shares of Common Stock that may be issued under the 2021 Plan is 66,667 shares, which number will
be increased to the extent that compensation granted under the 2021 Plan is forfeited, expires or is settled for cash (except as otherwise
provided in the 2021 Plan). Substitute awards (awards made or shares issued by the Company in assumption of, or in substitution or exchange
for, awards previously granted, or the right or obligation to make future awards, in each case by a company that the Company acquires
or any subsidiary of the Company or with which the Company or any subsidiary combines) will not reduce the shares authorized for grant
under the 2021 Plan, nor will shares subject to a substitute award be added to the shares available for issuance or transfer under the
2021 Plan.
Restricted Stock. In
May 2021, the Company issued restricted stock awards pursuant to the 2021 Plan to one employee. The restricted stock award vests over
48 months. The award requires continued service to the Company during the vesting period. The vesting provisions of individual awards
may vary as approved by the Board. Compensation expense for restricted stock is generally recorded based on its market value on the date
of grant and recognized ratably over the associated service and performance period.
Stock Options. All
options that the Company grants are granted at the per share fair value on the grant date. Vesting of options differs based on the terms
of each option. The Company has valued the options at their date of grant utilizing the Black Scholes option pricing model. As of the
date of issuance of these options, there was not an active public market for the Company’s shares. Accordingly, the fair value of
the underlying options was determined based on the historical volatility data of similar companies, considering the industry, products
and market capitalization of such other entities. The risk-free interest rate used in the calculations is based on the implied yield available
on U.S. Treasury issues with an equivalent term approximating the expected life of the options as calculated using the simplified method.
The expected life of the options used was based on the contractual life of the option granted. Stock-based compensation is a non-cash
expense because the Company settles these obligations by issuing shares of Common Stock from its authorized shares instead of settling
such obligations with cash payments.
A summary of stock option
activity for the three months ended July 31, 2024 is presented below:
Schedule of share-based payment arrangement, option, activity |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Outstanding Options |
|
|
|
Shares
Available
for Grant |
|
|
Number of
Shares |
|
|
Weighted
Average
Exercise
Price |
|
|
Weighted
Average
Remaining
Contractual
Life (years) |
|
|
Aggregate Intrinsic
Value |
|
Balance at April 30, 2024 |
|
|
62,000 |
|
|
|
98,000 |
|
|
$ |
178.12 |
|
|
|
5.22 |
|
|
$ |
70,500 |
|
Options granted |
|
|
- |
|
|
|
- |
|
|
$ |
- |
|
|
|
- |
|
|
|
|
|
Options exercised |
|
|
- |
|
|
|
- |
|
|
$ |
- |
|
|
|
- |
|
|
|
|
|
Options expired |
|
|
3,333 |
|
|
|
(3,333 |
) |
|
$ |
150.00 |
|
|
|
- |
|
|
|
|
|
Balance at July 31, 2024 |
|
|
65,333 |
|
|
|
94,667 |
|
|
$ |
179.11 |
|
|
|
5.15 |
|
|
$ |
35,100 |
|
Options vested and expected to vest at July 31, 2024 |
|
|
|
|
|
|
88,001 |
|
|
$ |
179.39 |
|
|
|
4.91 |
|
|
$ |
35,100 |
|
Options exercisable at July 31, 2024 |
|
|
|
|
|
|
87,043 |
|
|
$ |
178.72 |
|
|
|
4.88 |
|
|
$ |
35,100 |
|
The aggregate intrinsic value
in the table above represents the total pretax intrinsic value (i.e., the difference between the estimated fair value on the respective
date and the exercise price, times the number of shares) that would have been received by the option holders had all option holders exercised
their options.
Restricted stock unit activity
for the three months ended July 31, 2024 is presented below:
Schedule of nonvested restricted stock units activity |
|
|
|
|
|
|
|
|
|
|
Shares |
|
|
Weighted Average
Grant Date Fair Value |
|
Unvested at April 30, 2024 |
|
|
167 |
|
|
$ |
375.00 |
|
Granted |
|
|
- |
|
|
|
- |
|
Vested |
|
|
- |
|
|
|
- |
|
Cancelled |
|
|
- |
|
|
|
- |
|
Unvested at July 31, 2024 |
|
|
167 |
|
|
$ |
375.00 |
|
Performance Contingent
Stock Options Granted to Employee
On November 26, 2019, the
Board granted 28,333 performance and market contingent awards to certain key employees and a director. These grants were made outside
of the Plan. These awards have an exercise price of $225.00 per share. These awards have multiple separate market triggers for vesting
based upon either (i) the successful achievement of stepped target closing prices on a national securities exchange for 90 consecutive
trading days later than 180 days after the Company’s initial public offering (“IPO”) for its common stock, or (ii) stepped
target prices for a change in control transaction. The target prices ranged from $1,500 per share to $6,000 per share. In the event any
of the stock price milestones are not achieved within three years, the unvested portion of the performance options will be reduced by
25%.
On November 22, 2022, the
Compensation Committee of the Board modified the performance criteria for these awards. The target price range is now $1,500 per share
to $3,000 per share. Additionally, if the stock price milestones are now not achieved by November 27, 2026, as opposed to within three
years, the unvested portion of the portion of the performance options will be reduced by 25%. Due to the significant risks and uncertainties
associated with achieving the market-contingent awards, as of July 31, 2024, the Company believes that the achievement of the requisite
performance conditions is not probable and, as a result, no compensation cost has been recognized for these awards.
On November 29, 2022, the
Compensation Committee of the Board granted 13,333 performance-based stock option to the Chief Executive Officer at an exercise price
of $175.50 per share, of which 50% vest upon the completion and announcement of topline data from the Company’s Phase II clinical
trial of AL001 within three years from grant date and the remaining 50% vest upon the completion and announcement of topline data from
the Company’s Phase II clinical trial of ALZN002 within four years from the grant date. During the three months ended July 31, 2023,
management believed that it was probable that the performance condition of the completion and announcement of topline data from the Company’s
Phase II clinical trial of AL001 would be achieved and had recognized the related stock-based compensation. As of July 31, 2024, management
believed that the achievement of the second performance condition was not probable and, as a result, no compensation cost has been recognized
related to Phase I/IIA of ALZN002.
Performance Contingent
Stock Options Granted to TAMM Net
On March 23, 2021, the Company
issued performance-based stock options to certain team members at TAMM Net, Inc. (“TAMM Net”) to purchase an aggregate of
3,000 shares of Common Stock at a per share exercise price of $225.00 per share, of which 50% would vest upon the completion of Phase
I of AL001 by March 31, 2022, and the remaining 50% would vest upon completion of Phase I/IIA of ALZN002 by December 31, 2022.
On January 19, 2023, the Board
modified the performance criteria for these awards. The remaining 50% of the grant will now vest upon the completion and announcement
of topline data of the first cohort from a Phase I/IIA clinical trial of ALZN002 on/or before March 31, 2024. The modified performance
criteria was not met on or before March 31, 2024 and, as a result, the remaining unvested stock options were cancelled and no compensation
cost has been recognized for these awards related to ALZN002.
Performance Contingent
Stock Options Granted to Consultants
On October 14, 2021, the Company
issued performance-based stock options to two consultants to purchase an aggregate of 1,334 shares of Common Stock with an exercise price
of $363.00 per share, of which 333 vest upon completion of each of the Phase II clinical trials of AL001 for a BD indication, AL001 for
a PTSD indication, AL001 for an MDD indication and ALZN002 for an Alzheimer’s indication.
On January 19, 2023, the Board
modified the performance criteria for these awards. The revised grant will vest 25% if the Company (a) completes and announces topline
data from a Phase II clinical trial of AL001 and ALZN002, as applicable, that would support a new drug application for the drug candidate
and the indication listed below, and (b) obtained a “Study May Proceed” letter from the U.S. Food and Drug Administration
(“FDA”) for the additional Investigational New Drug (“IND”) on/or before December 31, 2023, as follows: (i) AL001
– BD; (ii) AL001- MDD; (iii) AL001 – PTSD; and (iv) ALZN002 – Alzheimer’s.
During the year ended April
30, 2024, the Company filed INDs for BD, MDD and PTSD and received a “Study May Proceed” letter for BD in October 2023, MDD
in November 2023 and PTSD in December 2023. As a result, 75% of the performance grant vested and the Company recognized stock-based compensation
related to the vesting. As of July 31, 2024, management believed that the achievement of the remaining requisite performance condition
was not probable and, as a result, no compensation cost has been recognized for these awards related to ALZN002 – Alzheimer’s.
Stock-Based Compensation
Expense
The Company’s results
of operations included expenses relating to stock-based compensation for three months ended July 31, 2024 and 2023, were comprised as
follows:
Schedule of stock-based compensation | |
| | |
| |
| |
For the Three Months Ended July 31, | |
| |
2024 | | |
2023 | |
General and administrative | |
$ | 81,277 | | |
$ | 369,380 | |
As of July 31, 2024, total
unamortized stock-based compensation expense related to unvested employee and non-employee awards that are expected to vest was $287,000.
The weighted-average period over which such stock-based compensation expense will be recognized was approximately 1.1 years.
During the three months ended
July 31, 2024, the Company issued warrants to purchase an aggregate of 200,000 shares of common stock at an exercise price of $12.50 per
share.
| (i) | On May 10, 2024, the Company issued a warrant to purchase 80,000 shares of Common Stock at an exercise
price of $12.50 in connection with the sale of convertible preferred stock to Orchid Finance, LLC (“Orchid”) for $1,000,000.
Based on the terms of the Company’s warrant agreement, the Company accounted for the warrant as an equity instrument as the warrant
is indexed to the common stock, requires settlement in shares and would be classified as equity under ASC 815. |
| (ii) | On June 25, 2024, the Company issued a warrant to purchase 120,000 shares of Common Stock at an exercise
price of $12.50 in connection with the sale of convertible preferred stock to Orchid for $1,500,000. Based on the terms of the Company’s
warrant agreement, the Company accounted for the warrant as an equity instrument as the warrant is indexed to the common stock, requires
settlement in shares and would be classified as equity under ASC 815. |
Warrant activity for the three
months ended July 31, 2024 is presented below:
Schedule of warrant activity |
|
|
|
|
|
|
|
|
|
Number
Outstanding |
|
|
Weighted Average
Exercise Price |
|
Outstanding at April 30, 2024 |
|
|
240,449 |
|
|
$67.45 |
|
Granted |
|
|
200,000 |
|
|
$12.50 |
|
Cancelled/Expired |
|
|
(1,570 |
) |
|
$450.14 |
|
Outstanding at July 31, 2024 |
|
|
438,879 |
|
|
$106.96 |
|
The following table summarizes
information about Common Stock warrants outstanding and exercisable at July 31, 2024:
Schedule of common stock warrants outstanding |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Outstanding |
|
|
Exercisable |
|
|
|
|
|
|
|
Weighted |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Average |
|
|
Weighted |
|
|
|
|
|
Weighted |
|
|
|
|
|
|
|
Remaining |
|
|
Average |
|
|
|
|
|
Average |
|
Exercise |
|
|
Number |
|
|
Contractual |
|
|
Exercise |
|
|
Number |
|
|
Exercise |
|
Price |
|
|
Outstanding |
|
|
Life (years) |
|
|
Price |
|
|
Exercisable |
|
|
Price |
|
$12.00-$12.50 |
|
|
|
410,000 |
|
|
|
4.9 |
|
|
$ |
12.24 |
|
|
|
322,000 |
|
|
$ |
12.31 |
|
$262.50 |
|
|
|
1,076 |
|
|
|
0.3 |
|
|
$ |
262.50 |
|
|
|
1,076 |
|
|
$ |
262.50 |
|
$450.00 |
|
|
|
27,395 |
|
|
|
1.8 |
|
|
$ |
450.00 |
|
|
|
27,395 |
|
|
$ |
450.00 |
|
$937.50 |
|
|
|
408 |
|
|
|
1.9 |
|
|
$ |
937.50 |
|
|
|
408 |
|
|
$ |
937.50 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
$12.00 - $937.50 |
|
|
|
438,879 |
|
|
|
4.7 |
|
|
$ |
41.04 |
|
|
|
350,879 |
|
|
$ |
48.33 |
|
| 7. | COMMITMENTS AND CONTINGENCIES |
Contractual Obligations
On
July 2, 2018, the Company entered into two Standard Exclusive License Agreements with Sublicensing Terms for AL001 with the Licensor and
its affiliate, the University of South Florida (the “AL001 Licenses”), pursuant to which the Licensor granted the Company
a royalty bearing exclusive worldwide licenses limited to the field of Alzheimer’s, under United States Patent Nos. (i) 9,840,521,
entitled “Organic Anion Lithium Ionic Cocrystal Compounds and Compositions”, filed September 24, 2015 and granted December
12, 2017, and (ii) 9,603,869, entitled “Lithium Co-Crystals for Treatment of Neuropsychiatric Disorders”, filed May 21, 2016
and granted March 28, 2017. On February 1, 2019, the Company entered into the First Amendments to the AL001 Licenses, on March 30, 2021,
the Company entered into the Second Amendments to the AL001 Licenses and on June 8, 2023, the Company entered into the Third Amendments
to the AL001 Licenses (collectively, the “AL001 License Agreements”). The Third Amendments to the AL001 Licenses modified
the timing of the payments of the license fees.
The
AL001 License Agreements require that the Company pay combined royalty payments of 4.5% on net sales of products developed from
the licensed technology for AL001. The Company has already paid an initial license fee of $200,000 for AL001. As an additional
licensing fee for the license of the AL001 technologies, the Licensor received 14,853 shares of Common Stock. Minimum royalties for
AL001 License Agreements are $40,000 on the first anniversary of the first commercial sale, $80,000 on the second anniversary
of the first commercial sale and $100,000 on the third anniversary of the first commercial sale and every year thereafter, for the
life of the AL001 License Agreements.
On
May 1, 2016, the Company entered into a Standard Exclusive License Agreement with Sublicensing Terms for ALZN002 with the Licensor (the
“ALZN002 License”), pursuant to which the Licensor granted the Company a royalty-bearing exclusive worldwide license limited
to the field of Alzheimer’s Immunotherapy and Diagnostics, under United States Patent No. 8,188,046, entitled “Amyloid Beta
Peptides and Methods of Use,” filed April 7, 2009 and granted May 29, 2012. On August 18, 2017, the Company entered into the First
Amendment to the ALZN002 License, on May 7, 2018, the Company entered into the Second Amendment to the ALZN002 License, on January 31,
2019, the Company entered into the Third Amendment to the ALZN002 License, on January 24, 2020, the Company entered into the Fourth Amendment
to the ALZN002 License, on March 30, 2021, the Company entered into the Fifth Amendment to the ALZN002 License, on April 17, 2023, the
Company entered into the Sixth Amendment to the ALZN002 License and on December 11, 2023, the Company entered into the Seventh Amendment
to the ALZN002 License (collectively, the “ALZN002 License Agreement”). The Seventh Amendment to the ALZN002 License modified
the timing of the payments of the license fees.
The
ALZN002 License Agreement requires the Company to pay royalty payments of 4% on net sales of products developed from the licensed
technology for ALZN002. The Company has already paid an initial license fee of $200,000 for ALZN002. As an additional licensing
fee for the license of ALZN002, the Licensor received 24,012 shares of Common Stock. Minimum royalties for ALZN002 are $20,000 on
the first anniversary of the first commercial sale, $40,000 on the second anniversary of the first commercial sale and $50,000 on
the third anniversary of the first commercial sale and every year thereafter, for the life of the ALZN002 License Agreement.
On
November 19, 2019, the Company entered into two Standard Exclusive License Agreements with Sublicensing Terms for two additional indications
of AL001 with the Licensor (the “November AL001 License”), pursuant to which the Licensor granted the Company a royalty bearing
exclusive worldwide licenses limited to the fields of (i) neurodegenerative diseases excluding Alzheimer’s and (ii) psychiatric
diseases and disorders. On March 30, 2021, the Company entered into the First Amendments to the November AL001 License and on April 17,
2023, the Company entered into the Second Amendments to the November AL001 License (collectively, the “November AL001 License Agreements”).
The Second Amendments to the November AL001 License modified the timing of the payments for the license fees.
The
November AL001 License Agreements require the Company to pay royalty payments of 3% on net sales of products developed from
the licensed technology for AL001 in those fields. The Company paid an initial license fee of $20,000 for the additional indications.
Minimum royalties for November AL001 License Agreements are $40,000 on the first anniversary of the first commercial sale, $80,000 on
the second anniversary of the first commercial sale and $100,000 on the third anniversary of the first commercial sale and every
year thereafter, for the life of the November AL001 License Agreements.
These
license agreements have an indefinite term that continue until the later of the date no licensed patent under the applicable agreement
remains a pending application or enforceable patent, the end date of any period of market exclusivity granted by a governmental regulatory
body, or the date on which the Company’s obligations to pay royalties expire under the applicable license agreement. Under the various
license agreements, if the Company fails to meet a milestone by its specified date, Licensor may terminate the license agreement. The
Licensor was also granted a preemptive right to acquire such shares or other equity securities that may be issued from time to time by
the Company while the Licensor remains the owner of any equity securities of the Company.
Additionally,
the Company is required to complete milestones and make payments on the due dates to the Licensor for the license of the AL001 technologies
and for the ALZN002 technology, as follows:
Original AL001 Licenses:
|
Schedule of contractual obligation, fiscal year maturity |
|
|
|
|
Payment |
|
Due Date |
|
Event |
$ |
50,000 |
* |
Completed September 2019 |
|
Pre-IND meeting |
|
|
|
|
|
|
$ |
65,000 |
* |
Completed June 2021 |
|
IND application filing |
|
|
|
|
|
|
$ |
190,000 |
* |
Completed December 2021 |
|
Upon first dosing of patient in a clinical trial |
|
|
|
|
|
|
$ |
500,000 |
* |
Completed March 2022 |
|
Upon completion of first clinical trial |
|
|
|
|
|
|
$ |
1,250,000 |
|
March 2025 |
|
Upon first patient treated in a Phase III clinical trial |
|
|
|
|
|
|
$ |
10,000,000 |
|
8 years from the effective date of the agreement |
|
Upon FDA new drug application approval |
| * | Milestone met and payment made |
ALZN002 License:
Payment |
|
Due Date |
$ |
50,000 |
* |
Completed January 2022 |
|
|
|
|
$ |
50,000 |
|
Upon first dosing of patient in first Phase I clinical trial |
|
|
|
|
$ |
500,000 |
|
Upon completion of first Phase IIB clinical trial |
|
|
|
|
$ |
1,000,000 |
|
Upon first patient treated in a Phase III clinical trial |
|
|
|
|
$ |
10,000,000 |
|
Upon first commercial sale |
| * | Milestone met and payment made |
Additional
AL001 Licenses:
Payment |
|
Due Date |
|
Event |
$ |
2,000,000 |
|
March 2026 |
|
Upon first patient treated in a Phase III clinical trial |
|
|
|
|
|
|
$ |
16,000,000 |
|
August 1, 2029 |
|
First commercial sale |
The
Company is authorized to issue 10,000,000 shares of Preferred Stock, $0.0001 par value. The Board has designated 3,000 shares as Series
A Convertible Preferred Stock and 6,000 shares as Series B Convertible Preferred Stock. The rights, preferences, privileges and restrictions
on the remaining authorized 9,991,000 shares of Preferred Stock have not been determined. The Board is authorized to create a new series
of preferred shares and determine the number of shares, as well as the rights, preferences, privileges and restrictions granted to or
imposed upon any series of preferred shares.
Series A Convertible
Preferred Stock
On
May 8, 2024, the Company and Orchid entered into a securities purchase agreement (the “Orchid SPA”) for the purchase
of up to 2,500 shares of Series A Convertible Preferred Stock and warrants to purchase shares up to 2,000,000 shares of Common Stock in
several tranche closings.
On May 10, 2024, the Company
sold 100 shares of Series A Convertible Preferred Stock and warrants to purchase 80,000 shares of Common Stock with an exercise price
of $12.50, for a total purchase price of $1.0 million. The purchase price was paid by the surrender
and cancellation of a term note issued by the Company to Orchid of $311,356, consisting of $310,000 of principal and $1,356 of accrued
and unpaid interest, $100,000 discount and net cash of $588,644.
On June 25, 2024, the Company
sold 150 shares of Series A Convertible Preferred Stock and warrants to purchase 120,000 shares of Common Stock with an exercise price
of $12.50, for a total purchase price of $1.5 million. The purchase price was paid in cash.
Series B Convertible
Preferred Stock
On January 31, 2024, the
Company and Ault Lending, LLC (“Ault Lending”) entered into a securities purchase agreement (the “AL SPA”)
for the purchase of up to 6,000 shares of Series B Convertible Preferred Stock and warrants to purchase shares up to 600,000
shares of the Company’s Common Stock. The AL SPA provides that Ault Lending may purchase up to $6 million of Series B
Convertible Preferred Stock in one or more closings. Ault
Lending has the right to purchase up to $2 million of Series B Convertible Preferred Stock, on or before March 31, 2024, and the
right to purchase up to $4 million of Series B Convertible Preferred Stock after March 31, 2024, but on or before March 31, 2025
(the “Termination Date”). The Agreement will automatically terminate if the final closing has not occurred prior
to the Termination Date.
On January 31, 2024, the Company
sold 1,220 shares of Series B Convertible Preferred Stock and warrants to purchase 122,000 shares of Common Stock with an exercise price
of $12.00, for a total purchase price of $1.22 million. The purchase price was paid by the cancellation
of $1.15 million of cash advances made by Ault Lending to the Company between November 9, 2023 and January 31, 2024 and a subscription
receivable of $70,000.
On March 26, 2024, the Company
sold 780 shares of Series B Convertible Preferred Stock and warrants to purchase 78,000 shares of Common Stock with an exercise price
of $12.00, for a total purchase price of $780,000.
On April 29, 2024, the Company
sold 100 shares of Series B Convertible Preferred Stock and warrants to purchase 10,000 shares of Common Stock with an exercise price
of $12.00, for a total purchase price of $100,000.
The
Series B Convertible Preferred Stock has a stated value of $1,000 per share (“Stated
Value”) and does not accrue dividends. Each share of Series B Convertible Preferred Stock is convertible into a number of
shares of Common Stock determined by dividing the Stated Value by $10.00 (the “Conversion
Price”). The Conversion Price is subject to adjustment in the event of an issuance of Common Stock at a price per share lower than
the Conversion Price then in effect, as well as upon customary stock splits, stock dividends, combinations or similar events. The holders
of the Series B Convertible Preferred Stock are entitled to vote with the Common Stock as a single class on an as-converted basis, subject
to applicable law provisions of the Delaware General Company Law and Nasdaq, provided, however, that for purposes of complying with Nasdaq
regulations, the conversion price, for purposes of determining the number of votes the holder of Series B Convertible Preferred Stock
is entitled to cast, shall not be lower than $8.73 (the “Voting Floor Price”), which represents the closing sale price of
the Common Stock on the trading day immediately prior to the Execution Date. The Voting Floor Price shall be adjusted for stock dividends,
stock splits, stock combinations and other similar transactions. Upon a liquidation event the holders of Series B Convertible Preferred
Stock receive a liquidation preference ahead of holders of Common Stock.
The warrants have an exercise
price of $12.00 (the “Exercise Price”) and become exercisable on the first business day after the six-month anniversary of
issuance (the “Initial Exercise Date”) and have a five-year term, expiring on the fifth anniversary of the Initial Exercise
Date. The Exercise Price is subject to adjustment in the event of an issuance of Common Stock at a price per share lower than the Exercise
Price then in effect, as well as upon customary stock splits, stock dividends, combinations or similar events.
Common Stock
Orchid SPA
During the three months ended
July 31, 2024, Orchid converted 62.477 shares of Series A Convertible Preferred Stock into 173,333 shares of Common Stock.
| 9. | RELATED PARTY TRANSACTIONS |
In connection with the Orchid
SPA, the Company agreed to pay Ault Lending an origination fee of five percent (5%) of the total
gross proceeds we receive from Orchid upon each purchase of Series A Convertible Preferred Stock. During the three months ended July 31,
2024, origination fees due to Ault Lending were $125,000.
On August 19, 2024, the Company
sold 200 shares of Series A Convertible Preferred Stock and warrants to purchase 160,000 shares of Common Stock with an exercise price
of $12.50 to Orchid, for a total purchase price of $2.0 million. The purchase price was paid in
cash.
On August 21, 2024, the Company
sold 250 shares of Series A Convertible Preferred Stock and warrants to purchase 200,000 shares of Common Stock with an exercise price
of $12.50 to Orchid, for a total purchase price of $2.5 million less $100,000 discount. The purchase
price was paid in cash.
From August 1, 2024 to September 10, 2024, Orchid converted 632.4909
shares of Series A Convertible Preferred Stock into 3,196,825 shares of Common Stock.
| ITEM 2. | MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS |
You should read the following
management’s discussion and analysis of financial condition and results of operations in conjunction with our unaudited condensed
financial statements and notes thereto included in Part I, Item 1 of this Quarterly Report on Form 10-Q and with our audited financial
statements and related notes thereto and Management’s Discussion and Analysis of Financial Condition and Results of Operations included
in our Annual Report on Form 10-K, filed with the Securities and Exchange Commission, or the SEC, on July 30, 2024.
NOTE ABOUT FORWARD-LOOKING STATEMENTS
This Quarterly Report on Form
10-Q contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended (the “Securities
Act”), and Section 21E of the Securities Exchange Act of 1934, as amended (the “Exchange Act”). This section should
be read in conjunction with our unaudited condensed financial statements and related notes included in Part I, Item 1 of this report.
The statements contained in this report that are not purely historical are forward-looking statements within the meaning of Section 27A
of the Securities Act and Section 21E of the Exchange Act.
These statements relate to
future events or our future financial performance. We have attempted to identify forward-looking statements by terminology including “anticipates,”
“believes,” “expects,” “can,” “continue,” “could,” “estimates,”
“expects,” “intends,” “may,” “plans,” “potential,” “predict,”
“should” or “will” or the negative of these terms or other comparable terminology. These statements are only predictions;
uncertainties and other factors may cause our actual results, levels of activity, performance or achievements to be materially different
from any future results, levels or activity, performance or achievements expressed or implied by these forward-looking statements. Although
we believe that the expectations reflected in the forward-looking statements are reasonable, we cannot guarantee future results, levels
of activity, performance or achievements.
In this Quarterly Report,
unless the context requires otherwise, references to the “Company,” “Alzamend,” “we,” “our company”
and “us” refer to Alzamend Neuro, Inc., a Delaware corporation.
Overview
We were incorporated on February
26, 2016, as Alzamend Neuro, Inc. under the laws of the State of Delaware. We were formed to acquire and commercialize patented intellectual
property and know-how to prevent, treat and potentially cure the crippling and deadly Alzheimer’s disease (“Alzheimer’s”).
With our two product candidates, we aim to bring treatment or cures not only for Alzheimer’s, but also bipolar disorder (“BD”),
major depressive disorder (“MDD”) and post-traumatic stress disorder (“PTSD”). Existing Alzheimer’s treatments
only temporarily relieve symptoms but do not, to our knowledge, slow or halt the underlying progression of the disease. We have developed
a novel approach to combat Alzheimer’s through immunotherapy.
Critical Accounting Policies and Estimates
Research and Development
Expenses. Research and development costs are expensed as incurred. Research and development costs consist of scientific consulting
fees and lab supplies, as well as fees paid to other entities that conduct certain research and development activities on behalf of our
company.
We have acquired and may continue to acquire the rights to develop
and commercialize new product candidates from third parties. The upfront payments to acquire license, product or rights, as well as any
future milestone payments, are immediately recognized as research and development expense, provided that there is no alternative future
use of the rights in other research and development projects.
Stock-Based Compensation. We
maintain a stock-based compensation plan as a long-term incentive for employees, non-employee directors and consultants. The plan allows
for the issuance of incentive stock options, non-qualified stock options, restricted stock units, and other forms of equity awards.
We recognize stock-based compensation
expense for stock options on a straight-line basis over the requisite service period and account for forfeitures as they occur. Our stock-based
compensation costs are based upon the grant date fair value of options estimated using the Black-Scholes option pricing model. To the
extent any stock option grants are made subject to the achievement of a performance-based milestone, management evaluates when the achievement
of any such performance-based milestone is probable based on the relative satisfaction of the performance conditions as of the reporting
date.
The Black-Scholes option pricing
model utilizes inputs which are highly subjective assumptions and generally require significant judgment. These assumptions include:
| · | Risk-Free Interest Rate. The risk-free interest rate is based on the U.S. Treasury
zero coupon issues in effect at the time of grant for periods corresponding with the expected term of the option. |
| · | Expected Volatility. Because we do not have a sufficient trading history for our common
stock (“Common Stock”), the expected volatility was estimated based on the average volatility for comparable publicly traded
life sciences companies over a period equal to the expected term of the stock option grants. The comparable companies were chosen based
on the similar size, stage in life cycle or area of specialty. We will continue to apply this process until a sufficient amount of historical
information regarding the volatility of our own stock price becomes available. |
| · | Expected Term. The expected term represents the period that the stock-based awards
are expected to be outstanding and is determined using the simplified method (based on the mid-point between the vesting date and the
end of the contractual term), as we do not have sufficient historical data to use any other method to estimate expected term. |
| · | Expected Dividend Yield. We have never paid dividends on our Common Stock and have
no plans to pay dividends on our Common Stock. Therefore, we used an expected dividend yield of zero. |
Certain of these assumptions
involve inherent uncertainties and the application of significant judgment. As a result, if factors or expected outcomes change and we
use significantly different assumptions or estimates, our stock-based compensation could be materially different.
Preferred Stock Classification.
We analyze the terms of our preferred stock using Accounting Standards Codification (“ASC”) 480, Distinguishing Liabilities
from Equity, to determine whether our preferred stock should be classified as a liability or equity, and if classified as equity,
permanent or temporary. Common criteria we consider are redemption provisions, conversion options, cumulative of mandatory fixed dividends,
discretionary dividends based on earning, voting rights and collateral requirements.
Plan of Operations
We
intend to develop and commercialize therapeutics and vaccines that are better than existing treatments and have the potential to significantly
improve the lives of individuals afflicted by Alzheimer’s, BD, MDD and PTSD. To achieve these goals, we are pursuing the following
key business strategies:
| · | Advance clinical development of AL001 for Alzheimer’s, BD, MDD and PTSD treatment; |
| · | Advance clinical development of ALZN002 for Alzheimer’s treatment; |
| · | Expand our pipeline of pharmaceuticals to include additional indications for AL001 and delivery methods; |
| · | Focus on translational and functional endpoints to efficiently develop product candidates; and |
| · | Optimize the value of AL001 and ALZN002 in major markets. |
Our
pipeline consists of two novel therapeutic drug candidates:
| · | AL001 - A patented ionic cocrystal technology delivering a therapeutic combination of lithium, salicylate
and proline through three royalty-bearing exclusive worldwide licenses from the University of South Florida Research Foundation, Inc.,
as licensor (the “Licensor”); and |
| · | ALZN002 - A patented method using a mutant peptide sensitized cell as a cell-based therapeutic vaccine
that seeks to restore the ability of a patient’s immunological system to combat Alzheimer’s through a royalty-bearing exclusive
worldwide license from the Licensor. |
Our
most advanced product candidate (lead product) licensed and in clinical development in humans is AL001, an ionic cocrystal of lithium
for the treatment of Alzheimer’s, BD, MDD and PTSD. Based on our preclinical data involving mice models, AL001 treatment prevented
cognitive deficits, depression and irritability and is superior in improving associative learning and memory and irritability compared
with lithium carbonate treatments, supporting the potential of this lithium formulation for the treatment of Alzheimer’s, BD, MDD
and PTSD in humans. Lithium has been marketed for more than 35 years and human toxicology regarding lithium use has been well characterized,
potentially mitigating the regulatory burden for safety data.
On
May 5, 2022, we initiated a multiple-dose, steady-state, double-blind, ascending dose safety, tolerability, pharmacokinetic clinical trial
of AL001 in patients with mild to moderate Alzheimer’s and healthy subjects. We completed the Phase IIA clinical trial in March
2023 and announced positive topline data in June 2023.
We
announced that we successfully identified a maximum tolerated dose (“MTD”) for development of AL001 from a multiple-ascending
dose study as assessed by an independent safety review committee. This dose, providing lithium at a lithium carbonate equivalent dose
of 240 mg 3-times daily (“TID”), is designed to be unlikely to require lithium therapeutic drug monitoring (“TDM”).
Also, this MTD is risk mitigated for the purpose of treating fragile populations, such as Alzheimer’s patients.
Lithium is a commonly prescribed
drug for manic episodes in BD type 1 as well as maintenance therapy of BD in patients with a history of manic episodes. Lithium is also
prescribed off-label for MDD, BD and treatment of PTSD, among other disorders. Lithium was the first mood stabilizer approved by the U.S.
Food and Drug Administration (“FDA”) and is still a first-line treatment option (considered the “gold standard”)
but is underutilized perhaps because of the need for TDM. Lithium was the first drug that required TDM by regulatory authorities in product
labelling because the effective and safe range of therapeutic drug blood concentrations is narrow and well defined for treatment of BD
when using lithium salts. Excursions above this range can be toxic, and below can impair effectiveness.
Based
on the results from our Phase IIA MAD study, we plan to initiate two safety and efficacy clinical trials in subjects with mild to moderate
dementia of the Alzheimer’s type. Additionally, we are investigating the potential of AL001 for patients suffering from BD, MDD
and PTSD, and submitted investigational new drug (“IND”) applications to the FDA for these indications. The IND for BD was
submitted in August 2023 and we received a “study may proceed” letter from the FDA in September 2023. The IND for MDD was
submitted in October 2023 and we received a “study may proceed” letter from the FDA in November 2023. The IND for PTSD was
submitted in November 2023 and we received a “study may proceed” from the FDA in December 2023.
We
intend to initiate clinical trials in 2025 at this MTD to determine relative increased lithium levels in the brain compared to a marketed
lithium salt for Alzheimer’s, BD, MDD and PTSD, based on published mouse studies that predict that lithium can be given at lower
doses for equivalent therapeutic benefit when treating with AL001. For example, the goal is to replace a 300 mg TID lithium carbonate
dose for treatment of BD with a 240 mg TID AL001 lithium equivalent, which represents a daily decrease of 20% of lithium given to a patient.
In August 2024, we announced that we had partnered with Massachusetts General Hospital to serve as the CRO for these clinical trials.
On
September 28, 2022, we submitted an IND application to the FDA for ALZN002 and received a “study may proceed” letter on October
31, 2022. The product candidate is an immunotherapy vaccine designed to treat mild to moderate dementia of the Alzheimer’s type.
ALZN002 is a proprietary “active” immunotherapy product, which means it is produced by each patient’s immune system.
It consists of autologous DCs that are activated white blood cells taken from each individual patient so that they can be engineered outside
of the body to attack Alzheimer’s-related amyloid-beta proteins. These DCs are pulsed with a novel amyloid-beta peptide (E22W) designed
to bolster the ability of the patient’s immune system to combat Alzheimer’s, with the goal being to foster tolerance to treatment
for safety purposes while stimulating the immune system to reduce the brain’s beta-amyloid protein burden, resulting in reduced
Alzheimer’s signs and symptoms. Compared to passive immunization treatment approaches that use foreign blood products (such as monoclonal
antibodies), active immunization with ALZN002 is anticipated to offer a more robust and long-lasting effect on the clearance of amyloid.
This could provide a safer approach due to its reliance on autologous immune components, using each individual patient’s own white
blood cells rather than foreign cells and/or blood products.
On
April 3, 2023, we announced the initiation of a Phase I/IIA clinical trial for ALZN002 to treat mild to moderate dementia of the Alzheimer’s
type. The purpose of this trial is to assess the safety, tolerability, and efficacy of multiple ascending doses of ALZN002 compared with
that of a placebo in 20-30 subjects with mild to moderate morbidity. The primary goal of this clinical trial is to determine an appropriate
dose of ALZN002 for treatment of patients with Alzheimer’s in a larger Phase IIB efficacy and safety clinical trial. On February
13, 2024, we received notice from the company we engaged as our contract research organization (“CRO”), Biorasi, LLC (“Biorasi”)
that Biorasi was terminating our contract with them. We are currently pursuing the engagement of a replacement CRO.
The
continuation of our current plan of operations with respect to initiating and conducting the series of human clinical trials for each
of our therapeutics requires us to raise additional capital to fund our operations.
Because
our working capital requirements depend upon numerous factors, including the progress of our preclinical and clinical testing, timing
and cost of obtaining regulatory approvals, changes in levels of resources that we devote to the development of manufacturing and marketing
capabilities, competitive and technological advances, status of competitors, and our ability to establish collaborative arrangements with
other organizations, we will require additional financing to fund future operations.
Results of Operations
Results of Operations for the Three Months Ended July 31,
2024 and 2023
The following table summarizes
the results of our operations for the three months ended July 31, 2024 and 2023:
| |
For the Three Months Ended July 31, | |
| |
2024 | | |
2023 | | |
$ Change | | |
% Change | |
OPERATING EXPENSES | |
| | | |
| | | |
| | | |
| | |
Research and development | |
$ | 206,571 | | |
$ | 2,366,137 | | |
$ | (2,159,566 | ) | |
| -91 | % |
General and administrative | |
| 755,834 | | |
| 1,159,794 | | |
| (403,960 | ) | |
| -35 | % |
Total operating expenses | |
| 962,405 | | |
| 3,525,931 | | |
| (2,563,526 | ) | |
| -73 | % |
Loss from operations | |
| (962,405 | ) | |
| (3,525,931 | ) | |
| 2,563,526 | | |
| 73 | % |
| |
| | | |
| | | |
| | | |
| | |
OTHER EXPENSE, NET | |
| | | |
| | | |
| | | |
| | |
Interest expense | |
| (12,006 | ) | |
| (1,835 | ) | |
| (10,171 | ) | |
| -554 | % |
Total other expense, net | |
| (12,006 | ) | |
| (1,835 | ) | |
| (10,171 | ) | |
| -554 | % |
| |
| | | |
| | | |
| | | |
| | |
NET LOSS | |
$ | (974,411 | ) | |
$ | (3,527,766 | ) | |
$ | 2,553,355 | | |
| 72 | % |
| |
| | | |
| | | |
| | | |
| | |
Basic and diluted net loss per common share | |
$ | (1.25 | ) | |
$ | (5.38 | ) | |
$ | 4.12 | | |
| * | |
| |
| | | |
| | | |
| | | |
| | |
Basic and diluted weighted average common shares outstanding | |
| 777,821 | | |
| 656,267 | | |
| | | |
| * | |
Revenue
We
currently have only two product candidates, AL001 and ALZN002. These products are in the clinical stage of development and will require
extensive clinical study, review and evaluation, regulatory review and approval, significant marketing efforts and substantial investment
before either or both of them, and any respective successors, will provide us with any revenue. We did not generate any revenues
during the three months ended July 31, 2024 and 2023, and we do not anticipate that we will generate revenue for the foreseeable future.
Research and Development Expenses
Research and development expenses
for the three months ended July 31, 2024 and 2023 were $207,000 and $2.4 million, respectively. As reflected in the table below, research
and development expenses primarily consisted of professional fees and clinical trial fees:
| |
For the Three Months Ended July 31, | |
| |
2024 | | |
2023 | | |
$ Change | | |
% Change | |
Professional fees | |
$ | 184,164 | | |
$ | 1,069,589 | | |
$ | (885,425 | ) | |
| -83 | % |
Clinical trial fees | |
| - | | |
| 1,245,118 | | |
| (1,245,118 | ) | |
| -100 | % |
Other research and development expenses | |
| 22,407 | | |
| 51,430 | | |
| (29,023 | ) | |
| -56 | % |
Total research and development expenses | |
$ | 206,571 | | |
$ | 2,366,137 | | |
$ | (2,159,566 | ) | |
| -91 | % |
Professional Fees
During the three months ended
July 31, 2024 and 2023, we incurred professional fees of $184,000 and $1.1 million, respectively, which were primarily comprised of professional
fees attributed to various types of scientific services, including FDA consulting services. The decrease relates to lower professional
fees incurred related to minimal clinical trial activities.
Clinical Trial Fees
During the three months ended
July 31, 2024 and 2023, we incurred clinical trial fees of nil and $1.2 million, respectively. We had no clinical trial activity for the
three months ended July 31, 2024. Clinical trial fees for the three months ended July 31, 2023 were for our Phase IIA clinical trial for
AL001 and our Phase I/IIA clinical trial for ALZN002.
Other Research and Development Expenses
During the three months ended
July 31, 2024 and 2023, we incurred other fees of $22,000 and $51,000, respectively, which were primarily comprised of scientific materials
required for our clinical trials.
General and Administrative Expenses
General and administrative
expenses for the three months ended July 31, 2024 and 2023 were $756,000 and $1.2 million, respectively. As reflected in the table below,
general and administrative expenses primarily consisted of the following expense categories: salaries and benefits; professional fees;
insurance; stock-based compensation expense; marketing fees; as well as board of director fees. For the three months ended July 31, 2024
and 2023, the remaining general and administrative expenses of $62,000 and $83,000, respectively, primarily consisted of payments for
filing fees, transfer agent fees, travel and entertainment and other office expenses, none of which was significant individually.
| |
For the Three Months Ended July 31, | |
| |
2024 | | |
2023 | | |
$ Change | | |
% Change | |
Salaries and benefits | |
$ | 227,795 | | |
$ | 153,324 | | |
$ | 74,471 | | |
| 49 | % |
Professional fees | |
| 222,427 | | |
| 151,180 | | |
| 71,247 | | |
| 47 | % |
Insurance | |
| 78,395 | | |
| 117,696 | | |
| (39,301 | ) | |
| -33 | % |
Stock-based compensation expense | |
| 81,277 | | |
| 369,380 | | |
| (288,103 | ) | |
| -78 | % |
Marketing fees | |
| 40,000 | | |
| 247,334 | | |
| (207,334 | ) | |
| -84 | % |
Board of director fees | |
| 43,750 | | |
| 37,500 | | |
| 6,250 | | |
| 17 | % |
Other general and administrative expenses | |
| 62,190 | | |
| 83,380 | | |
| (21,190 | ) | |
| -25 | % |
Total general and administrative expenses | |
$ | 755,834 | | |
$ | 1,159,794 | | |
$ | (403,960 | ) | |
| -35 | % |
Salaries and Benefits
During the three months ended
July 31, 2024 and 2023, we incurred $228,000 and $153,000, respectively, in employee-related expenses. The decrease in salaries and benefits
was due to a reversal of bonus accrual. As of July 31, 2024, we had four full-time and three part-time employees.
Professional Fees
During the three months ended
July 31, 2024 and 2023, we incurred professional fees of $222,000 and $151,000, respectively. During the three months ended July 31, 2024,
we incurred $85,000 in investor relations fees, $74,000 in legal fees, $56,000 in audit fees, and $7,000 in tax preparation fees. During
the three months ended July 31, 2023, we incurred $78,000 in audit fees, $29,000 in investor relations fees, $16,000 in tax preparation
fees, $13,000 in related party consulting, $6,000 in Sarbanes-Oxley compliance fees and $9,000 in other professional fees. The increase
in professional fees was due mainly to investor relations related to our reverse split and legal fees, partially offset by lower related
party consulting, audit fees and tax preparation fees.
Insurance Expense
During the three months ended
July 31, 2024 and 2023, we incurred insurance expense of $78,000 and $118,000, respectively, which was primarily directors’ and
officers’ insurance.
Stock-Based Compensation Expense
During the three months ended
July 31, 2024 and 2023, we incurred general and administrative stock-based compensation expense of $81,000 and $369,000, respectively,
related to stock option grants and restricted stock grants to executives, employees and consultants. The decrease in stock-based compensation
expense for the three months ended July 31, 2024 was a result of fewer stock options vesting during the period compared to the prior year
period.
Marketing Fees
During the three months ended
July 31, 2024 and 2023, we incurred marketing fees of $40,000 and $247,000, respectively. The decrease was due to the completion of the
marketing and branding agreement with Ault Alliance, Inc.
Liquidity and Capital Resources
The accompanying condensed
financial statements have been prepared assuming that we will continue as a going concern. We have incurred recurring net losses and operations
have not provided sufficient cash flows. We believe that we will continue to incur operating and net losses each quarter until at least
the time we are able to generate revenues from operations. We believe our current cash on hand is
insufficient to fund our planned operations through one year after the date the condensed financial statements are issued. These factors
create substantial doubt about our ability to continue as a going concern for at least one year after the date that our condensed financial
statements are issued.
Our inability to continue as
a going concern could have a negative impact on our company, including our ability to obtain needed financing.
We intend to finance our future development activities and our working capital needs largely through the sale of equity securities with
some additional funding from other sources, including debt financing, until such time as funds provided by operations are sufficient to
fund working capital requirements. Our condensed financial statements do not include any adjustments relating to the recoverability and
classification of recorded assets, or the amounts and classifications of liabilities that might be necessary should we be unable to continue
as a going concern. As of July 31, 2024, we had cash of $1.2 million, a working capital deficiency of $1.5 million, an accumulated deficit
of $55.0 million and stockholders’ deficit of $1.2 million. We have incurred recurring losses and reported losses for the three
ended July 31, 2024 totaling $974,000. In the past, we have financed our operations principally through sales of equity securities and
debt instruments.
We will need to obtain substantial
additional funding in the future for our clinical development activities and continuing operations. If we are unable to raise capital
when needed or on favorable terms, we would be forced to delay, reduce, or eliminate our research and development programs or future commercialization
efforts. Our future capital requirements will depend on many factors, including:
| · | successful enrollment in and completion of clinical trials; |
| · | our ability to establish agreements with third-party manufacturers for clinical supply for our clinical
trials and, if our product candidates are approved, commercial manufacturing; |
| · | our ability to maintain our current research and development programs and establish new research and development
programs; |
| · | addition and retention of key research and development personnel; |
| · | our efforts to enhance operational, financial, and information management systems, and hire additional
personnel, including personnel to support development of our product candidates; |
| · | negotiating favorable terms in any collaboration, licensing, or other arrangements into which we may enter
and performing our obligations in such collaborations; |
| · | the timing and amount of milestone and other payments we may receive under our collaboration arrangements; |
| · | our eventual commercialization plans for our product candidates; |
| · | the costs involved in prosecuting, defending, and enforcing patent claims and other intellectual property
claims; and |
| · | the costs and timing of regulatory approvals. |
A change in the outcome of
any of these or other variables with respect to the development of any of our product candidates could significantly change the costs
and timing associated with the development of that product candidate. Furthermore, our operating plans may change in the future, and we
may need additional funds to meet operational needs and capital requirements associated with such operating plans.
Series
B Preferred Financing
On
January 31, 2024, we entered into a securities purchase agreement (“AL SPA”) with Ault Lending, LLC (“Ault Lending”)
whereby Ault Lending may purchase of up to 6,000 shares of series B convertible preferred stock (“Series B Convertible Preferred
Stock”) and warrants to purchase shares up to 600,000 shares of our common stock. The AL SPA provides that Ault Lending may purchase
up to $6 million of Series B Convertible Preferred Stock in one or more closings. Ault Lending has the right to purchase up to $2 million
of Series B Convertible Preferred Stock, on or before March 31, 2024, and the right to purchase up to $4 million of Series B Convertible
Preferred Stock after March 31, 2024, but on or before March 31, 2025 (the “Termination Date”). The Agreement will automatically
terminate if the final closing has not occurred prior to the Termination Date.
During
the year ended April 30, 2024, we sold an aggregate of 2,100 shares of Series B Convertible Preferred Stock and warrants to purchase 210,000
shares of common stock with an exercise price of $12.00, for a total purchase price of $2.1 million. The
purchase price was paid by the cancellation of $1.15 million of cash advances made by Ault Lending to us between November 9, 2023 and
January 31, 2024 and the remaining $950,000 in cash.
The Series
B Convertible Preferred Stock has a stated value of $1,000 per share (“Series B Stated
Value”) and does not accrue dividends. Each share of Series B Convertible Preferred Stock is convertible into a number
of shares of common stock determined by dividing the Series B Stated Value by $10.00 (the
“Series B Conversion Price”). The Series
B Conversion Price is subject to adjustment in the event of an issuance of common stock at a price per share lower than the Series
B Conversion Price then in effect, as well as upon customary stock splits, stock dividends, combinations or similar events.
The holders of the Series B Convertible Preferred Stock are entitled to vote with the common stock as a single class on an as-converted
basis, subject to applicable law provisions of the Delaware General Corporation Law and Nasdaq, provided however, that for purposes of
complying with Nasdaq regulations, the conversion price, for purposes of determining the number of votes the holder of Series B Convertible
Preferred Stock is entitled to cast, shall not be lower than $8.73 (the “Voting Floor Price”), which represents the closing
sale price of the common stock on the trading day immediately prior to the date of execution of the AL SPA. The Voting Floor Price shall
be adjusted for stock dividends, stock splits, stock combinations and other similar transactions.
The
warrants have an exercise price of $12.00 (the “Series B Exercise Price”)
and become exercisable on the first business day after the six-month anniversary of issuance (the “Series
B Initial Exercise Date”) and have a five-year term, expiring on the fifth anniversary of the Series
B Initial Exercise Date. The Series B Exercise Price is subject to
adjustment in the event of an issuance of common stock at a price per share lower than the Series
B Exercise Price then in effect, as well as upon customary stock splits, stock dividends, combinations or similar events.
Series A Preferred Financing
On
May 8, 2024, we and Orchid Finance, LLC (“Orchid”), entered into a securities purchase agreement (the “Orchid
SPA”) for the purchase of up to 2,500 shares of Series A Convertible Preferred Stock (“Series A Convertible Preferred Stock”)
and warrants to purchase shares up to 2,500,000 shares of common stock in several tranche closings.
On May 10, 2024, we sold 100
shares of Series A Convertible Preferred Stock and warrants to purchase 80,000 shares of common stock with an exercise price of $12.50,
for a total purchase price of $1.0 million. The purchase price was paid by the surrender and cancellation
of a term note issued by us to Orchid of $311,356, consisting of $310,000 of principal and $1,356 of accrued and unpaid interest, $100,000
discount and net cash of $588,644. On June 25, 2024, we sold 150 shares of Series A Convertible Preferred Stock and warrants to
purchase 120,000 shares of common stock with an exercise price of $12.50, for a total purchase price of $1.5 million. The
purchase price was paid in cash. On August 19, 2024, we sold 200 shares of Series A Convertible Preferred Stock and warrant to purchase
160,000 shares of common stock with an exercise price of $12.50, for a total purchase price of $2.0 million. The purchase price was paid
in cash. On August 21, 2024, we sold 250 shares of Series A Convertible Preferred Stock and warrant to purchase 200,000 shares of common
stock with an exercise price of $12.50, for a total purchase price of $2.5 million less $100,000 discount. The purchase price was paid
in cash.
Pursuant
to the Orchid SPA, Orchid has agreed to purchase the remaining 1,800 Preferred Shares based on our achievement of the milestones set forth
below (the “Milestones”):
|
• |
200 Preferred Shares, for $2,000,000, within 60 days of the effectiveness of the resale registration statement (the “Registration Statement”) and the execution of a partnership agreement with a nationally renowned research facility for a clinical trial (the “Fourth Tranche”); and |
|
• |
100 Preferred Shares, for $1,000,000, on each monthly anniversary of the effectiveness of the resale registration statement, which was declared effective on July 9, 2024, until all remaining 1,600 Preferred Shares have been sold (each, a “Final Tranche”). |
Notwithstanding
the foregoing Milestones, Orchid has the ability to invest any amount in its sole discretion in advance of the dates that the foregoing
Milestones shall have been met. In the event that the average closing price of the common stock during the three trading days preceding
the date of a tranche closing shall not be equal to or greater than $2.50 a share (the “Floor Price”), then the applicable
closing shall be delayed until such time as the price meets the required threshold. We agreed to
pay Ault Lending an origination fee of five percent (5%) of the total gross proceeds we receive from Orchid upon each purchase of Series
A Convertible Preferred Stock. We also agreed to pay Orchid a fee of $100,000 upon the first closing, which occurred on May 10, 2024,
the Fourth Tranche and the third, eighth and thirteenth closings constituting parts of the Final Tranche.
The
Registration Statement registering for resale the shares of common stock issuable upon conversion of the Series A Convertible Preferred
Stock and exercise of the warrants was declared effective on July 9, 2024. In addition, we agreed to use our best efforts to hold a special
meeting of our stockholders within 90 days of the execution date of the Orchid SPA for purposes of seeking stockholder approval of the
issuance of all the shares of common stock issuable upon conversion of the Series A Convertible Preferred Stock and the exercise of the
warrants in excess of the “Nasdaq Limit,” which is 19.99% of our shares of common stock issued and outstanding on the execution
date of the Orchid SPA. We held a special meeting of stockholders on July 8, 2024, at which time, the stockholders approved the issuance
of all the shares of common stock issuable upon conversion of the Series A Convertible Preferred Stock and the exercise of the warrants
in excess of the “Nasdaq Limit.”
The
Series A Convertible Preferred Stock has a stated value of $10,000 per share (“Series
A Stated Value”) and accrues dividends at the rate of 15% per annum, payable quarterly in arrears in cash or paid-in-kind
shares, in Orchid’s sole discretion. Each share of Series A Convertible Preferred Stock is convertible into a number of shares of
common stock determined by dividing the Series A Stated Value by (y)
the greater of (i) the Floor Price and (ii) the lesser of (A) $15.00 and (B) 80% of the lowest closing price of our common stock during
the three trading days immediately prior to the date of conversion into conversion shares (the “Series
A Conversion Price”). The Series A Conversion Price is subject to adjustment
in the event of an issuance of common stock at a price per share lower than the Series A Conversion
Price then in effect, as well as upon customary stock splits, stock dividends, combinations or similar events. The holders of the Series
A Convertible Preferred Stock are entitled to vote with the common stock as a single class on an as-converted basis, subject to applicable
law provisions of the Delaware General Corporation Law and Nasdaq, provided however, that for purposes of complying with Nasdaq regulations,
the conversion price, for purposes of determining the number of votes the holder of Series B Convertible Preferred Stock is entitled to
cast, shall not be lower than $5.63 (the “Series A Voting Floor Price”), which represents the closing sale price of the common
stock on the trading day immediately prior to the date of execution of the Orchid SPA. The Series A Voting Floor Price shall be adjusted
for stock dividends, stock splits, stock combinations and other similar transactions.
The warrants have an exercise
price of $12.50 (the “Series A Exercise Price”) and are exercisable upon issuance
and have a five-year term, expiring on the fifth anniversary of issuance. The Series A Exercise
Price is subject to adjustment in the event of an issuance of common stock at a price per share lower than the Series
A Exercise Price then in effect, as well as upon customary stock splits, stock dividends, combinations or similar events. The warrants
are exercisable on a cashless basis in the event that there is not then an effective resale registration statement for the common stock
issuable upon exercise of the warrants.
Cash Flows
The following table summarizes
our cash flows for the three months ended July 31, 2024 and 2023:
| |
For the Three Months Ended July 31, | |
| |
2024 | | |
2023 | |
Net cash provided by (used in): | |
| | | |
| | |
Operating activities | |
$ | (1,055,742 | ) | |
$ | (3,298,200 | ) |
Investing activities | |
| (90,000 | ) | |
| (147,243 | ) |
Financing activities | |
| 1,963,644 | | |
| - | |
Net increase (decrease) in cash and cash equivalents | |
$ | 817,902 | | |
$ | (3,445,443 | ) |
Operating Activities
During the three months ended
July 31, 2024, net cash used in operating activities was $1.1 million. This consisted primarily of a net loss of $974,000 and a decrease
in our net operating assets and liabilities of $185,000, partially offset by non-cash charges of $103,000. The non-cash charges primarily
consisted of stock-based compensation expense. The decrease in our net operating assets and liabilities was due to a decrease in accounts
payable and accrued liabilities and an increase in prepaid expenses and other current assets.
Investing Activities
During the three months ended
July 31, 2024, net cash used in investing activities was $90,000 from the purchase of equipment. We purchased equipment, which measures
lithium levels in the brain, to be used in the AL001 clinical trial.
Financing Activities
During the three months ended
July 31, 2024, net cash provided by financing activities was $2.0 million from the sale of Series A Convertible Preferred Stock.
Contractual Obligations
On July 2, 2018, we entered
into two Standard Exclusive License Agreements with Sublicensing Terms for AL001 with the Licensor and its affiliate, the University of
South Florida (the “AL001 Licenses”), pursuant to which the Licensor granted us a royalty bearing exclusive worldwide licenses
limited to the field of Alzheimer’s, under United States Patent Nos. (i) 9,840,521, entitled “Organic Anion Lithium Ionic
Cocrystal Compounds and Compositions,” filed September 24, 2015 and granted December 12, 2017, and (ii) 9,603,869, entitled “Lithium
Co-Crystals for Treatment of Neuropsychiatric Disorders,” filed May 21, 2016 and granted March 28, 2017. On February 1, 2019, we
entered into the First Amendments to the AL001 Licenses, on March 30, 2021, we entered into the Second Amendments to the AL001 Licenses
and on June 8, 2023, we entered into the Third Amendments to the AL001 Licenses (collectively, the “AL001 License Agreements”).
The Third Amendments to the AL001 Licenses modified the timing of the payments of the license fees.
The AL001 License Agreements
require that we pay combined royalty payments of 4.5% on net sales of products developed from the licensed technology for AL001. We have
already paid an initial license fee of $200,000 for AL001. As an additional licensing fee for the license of the AL001 technologies, the
Licensor received 14,853 shares of our common stock. Minimum royalties for AL001 License Agreements are $40,000 on the first anniversary
of the first commercial sale, $80,000 on the second anniversary of the first commercial sale and $100,000 on the third anniversary of
the first commercial sale and every year thereafter, for the life of the AL001 License Agreements.
On May 1, 2016, we entered
into a Standard Exclusive License Agreement with Sublicensing Terms for ALZN002 with the Licensor (the “ALZN002 License”),
pursuant to which the Licensor granted us a royalty bearing exclusive worldwide license limited to the field of Alzheimer’s Immunotherapy
and Diagnostics, under United States Patent No. 8,188,046, entitled “Amyloid Beta Peptides and Methods of Use,” filed April
7, 2009 and granted May 29, 2012. On August 18, 2017, we entered into the First Amendment to the ALZN002 License, on May 7, 2018, we entered
into the Second Amendment to the ALZN002 License, on January 31, 2019, we entered into the Third Amendment to the ALZN002 License, on
January 24, 2020, we entered into the Fourth Amendment to the ALZN002 License, on March 30, 2021, we entered into the Fifth Amendment
to the ALZN002 License, on April 17, 2023, we entered into the Sixth Amendment to the ALZN002 License and on December 11, 2023, we entered
into the Seventh Amendment to the ALZN002 License (collectively, the “ALZN002 License Agreement”). The Seventh Amendment to
the ALZN002 License modified the timing of the payments of the license fees.
The ALZN002 License Agreement
requires us to pay royalty payments of 4% on net sales of products developed from the licensed technology for ALZN002. We have already
paid an initial license fee of $200,000 for ALZN002. As an additional licensing fee for the license of ALZN002, the Licensor received
24,012 shares of our common stock. Minimum royalties for ALZN002 are $20,000 on the first anniversary of the first commercial sale, $40,000
on the second anniversary of the first commercial sale and $50,000 on the third anniversary of the first commercial sale and every year
thereafter, for the life of the ALZN002 License Agreement.
On November 19, 2019, we entered
into two Standard Exclusive License Agreements with Sublicensing Terms for two additional indications of AL001 with the Licensor (the
“November AL001 License”), pursuant to which the Licensor granted us a royalty bearing exclusive worldwide licenses limited
to the fields of (i) neurodegenerative diseases excluding Alzheimer’s and (ii) psychiatric diseases and disorders. On March 30,
2021, we entered into the First Amendments to the November AL001 License and on April 17, 2023, we entered into the Second Amendments
to the November AL001 License (collectively, the “November AL001 License Agreements”). The Second Amendments to the November
AL001 License modified the timing of the payments of the license fees.
The November AL001 License
Agreements require us to pay royalty payments of 3% on net sales of products developed from the licensed technology for AL001 in those
fields. We paid an initial license fee of $20,000 for the additional indications. Minimum royalties for November AL001 License Agreements
are $40,000 on the first anniversary of the first commercial sale, $80,000 on the second anniversary of the first commercial sale and
$100,000 on the third anniversary of the first commercial sale and every year thereafter, for the life of the November AL001 License Agreements.
These license agreements have
an indefinite term that continue until the later of the date no licensed patent under the applicable agreement remains a pending application
or enforceable patent, the end date of any period of market exclusivity granted by a governmental regulatory body, or the date on which
the licensee’s obligations to pay royalties expire under the applicable license agreement. Under our various license agreements,
if we fail to meet a milestone by its specified date, Licensor may terminate the license agreement. The Licensor was also granted a preemptive
right to acquire such shares or other equity securities that may be issued from time to time by us while the Licensor remains the owner
of any equity securities of our company.
Additionally, we are required
to complete milestones and make payments on the due dates to the Licensor for the license of the AL001 technologies and for the ALZN002
technology, as follows:
Original AL001 Licenses:
Payment |
|
Due Date |
|
Event |
$ |
50,000 |
* |
Completed September 2019 |
|
Pre-IND meeting |
|
|
|
|
|
|
$ |
65,000 |
* |
Completed June 2021 |
|
IND application filing |
|
|
|
|
|
|
$ |
190,000 |
* |
Completed December 2021 |
|
Upon first dosing of patient in a clinical trial |
|
|
|
|
|
|
$ |
500,000 |
* |
Completed March 2022 |
|
Upon completion of first clinical trial |
|
|
|
|
|
|
$ |
1,250,000 |
|
March 2025 |
|
Upon first patient treated in a Phase III clinical trial |
|
|
|
|
|
|
$ |
10,000,000 |
|
8 years from the effective date of the agreement |
|
Upon FDA new drug application approval |
| * | Milestone met and payment made |
ALZN002 License:
Payment |
|
Due Date |
$ |
50,000 |
* |
Upon IND application - completed January 2022 |
|
|
|
|
$ |
50,000 |
|
Upon first dosing of patient in first Phase I clinical trial |
|
|
|
|
$ |
500,000 |
|
Upon completion of first Phase IIB clinical trial |
|
|
|
|
$ |
1,000,000 |
|
Upon first patient treated in a Phase III clinical trial |
|
|
|
|
$ |
10,000,000 |
|
Upon first commercial sale |
| * | Milestone met and payment made |
Additional AL001 Licenses:
Payment |
|
Due Date |
|
Event |
$ |
2,000,000 |
|
March 2026 |
|
Upon first patient treated in a Phase III clinical trial |
|
|
|
|
|
|
$ |
16,000,000 |
|
August 1, 2029 |
|
First commercial sale |
Recent Accounting Standards
None.
| ITEM 3. | QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK |
Because we are a smaller reporting
company, this section is not applicable.
| ITEM 4. | CONTROLS AND PROCEDURES |
Evaluation of Disclosure
Controls and Procedures
We have established disclosure
controls and procedures designed to ensure that information required to be disclosed in the reports that we file or submit under the Exchange
Act is recorded, processed, summarized, and reported within the time periods specified in SEC rules and forms and is accumulated and communicated
to management, including the principal executive officer and principal financial officer, to allow timely decisions regarding required
disclosure.
Our principal executive officer
and principal financial officer, with the assistance of other members of the Company’s management, have evaluated the effectiveness
of the design and operation of our disclosure controls and procedures (as such term is defined in Rules 13a-15(e) and 15d-15(e) under
the Exchange Act) as of the end of the period covered by this quarterly report. Based upon our evaluation, each of our principal executive
officer and principal financial officer has concluded that the Company’s internal control over financial reporting was not effective
as of the end of the period covered by this Quarterly Report on Form 10-Q because the Company has not yet completed its remediation of
the material weakness previously identified and disclosed in the Company’s Annual Report on Form 10-K for the year ended April 30,
2024, the end of its most recent fiscal year.
Specifically, management has
identified the following material weaknesses:
| 1. | we do not have sufficient resources in our accounting function, which
restricts our ability to perform sufficient reviews and approval of manual journal entries posted to the general ledger and to consistently
execute review procedures over general ledger account reconciliations, financial statement preparation and accounting for non-routine
transactions; and |
| 2. | our primary user access controls (i.e., provisioning, de-provisioning,
privileged access and user access reviews) to ensure appropriate authorization and segregation of duties that would adequately restrict
user and privileged access to the financially relevant systems and data to appropriate personnel were not designed and/or implemented
effectively. We did not design and/or implement sufficient controls for program change management to certain financially relevant systems
affecting our processes. |
A material weakness is a control
deficiency or combination of control deficiencies that result in more than a remote likelihood that a material misstatement of the annual
or interim financial statements will not be prevented or detected.
Planned Remediation
We are implementing measures
designed to improve our internal control over financial reporting to remediate material weaknesses, including the following:
| · | Continue to formalize our internal control documentation and strengthening supervisory reviews by our
management; and |
| · | Developing plans to add additional accounting personnel and segregating duties amongst accounting personnel. |
Management continues to work
to improve its controls related to our material weaknesses, specifically relating to user access and change management surrounding our
information technology systems and applications. Management will continue to implement measures to remediate material weaknesses, such
that these controls are designed, implemented, and operating effectively. The remediation actions include: (i) enhancing design and documentation
related to both user access and change management processes and control activities; and (ii) developing and communicating additional policies
and procedures to govern the area of information technology change management. In order to achieve the timely implementation of the above,
management has commenced the following actions and will continue to assess additional opportunities for remediation on an ongoing basis:
| · | Engaging a third-party specialist to assist management with improving the Company’s overall control
environment, focusing on change management and access controls; and |
| · | Implementing new applications and systems that are aligned with management’s focus on creating strong
internal controls. |
We are currently working to
improve and simplify our internal processes and implement enhanced controls, as discussed above, to address the material weaknesses in
our internal control over financial reporting and to remedy the ineffectiveness of our disclosure controls and procedures. These material
weaknesses will not be considered to be remediated until the applicable remediated controls are operating for a sufficient period of time
and management has concluded, through testing, that these controls are operating effectively.
Despite the existence of these
material weaknesses, we believe that the condensed financial statements included in the period covered by this Quarterly Report on Form
10-Q fairly present, in all material respects, our financial condition, results of operations and cash flows for the periods presented
in conformity with U.S. generally accepted accounting principles.
Changes in Internal Control
Except as detailed above,
during the quarter ended July 31, 2024, there was no change in our internal control over financial reporting that materially affected,
or is reasonably likely to materially affect, our internal control over financial reporting.
PART II — OTHER INFORMATION
From time to time, we may
be subject to legal proceedings. We are not currently a party to or aware of any proceedings that we believe will have, individually or
in the aggregate, a material adverse effect on our business, financial condition or results of operations. Regardless of the outcome,
litigation can have an adverse impact on us because of defense and settlement costs, diversion of management resources, and other factors.
The risks described in Part
I, Item 1A, “Risk Factors,” in our 2024 Annual Report on Form 10-K, could materially and adversely affect our business,
financial condition and results of operations, and the trading price of our Common Stock could decline. These risk factors do not identify
all risks that we face; our operations could also be affected by factors that are not presently known to us or that we currently consider
to be immaterial to our operations. Due to risks and uncertainties, known and unknown, our past financial results may not be a reliable
indicator of future performance and historical trends should not be used to anticipate results or trends in future periods. The Risk Factors
section of our 2024 Annual Report on Form 10-K remains current in all material respects.
| ITEM 2. | UNREGISTERED SALES OF EQUITY SECURITIES AND USE OF PROCEEDS |
On May 10, 2024, we sold 100
shares of Series A Convertible Preferred Stock and warrants to purchase 80,000 shares of common stock with an exercise price of $12.50,
for a total purchase price of $1.0 million. The purchase price was paid by the surrender and cancellation
of a term note issued by us to Orchid of $311,356, consisting of $310,000 of principal and $1,356 of accrued and unpaid interest, $100,000
discount and net cash of $588,644.
On June 25, 2024, we sold
150 shares of Series A Convertible Preferred Stock and warrants to purchase 120,000 shares of common stock with an exercise price of $12.50,
for a total purchase price of $1.5 million. The purchase price was paid in cash.
| ITEM 3. | DEFAULTS UPON SENIOR SECURITIES |
None.
| ITEM 4. | MINE SAFETY DISCLOSURES |
Not applicable.
None of the Company’s
directors and officers adopted, modified, or terminated a Rule 10b5-1 trading arrangement or a non-Rule 10b5-1 trading arrangement during
the Company's fiscal quarter ended July 31, 2024 (each as defined in Item 408 of Regulation S-K under the Securities Exchange Act of 1934,
as amended).
Exhibit
No. |
|
Exhibit Description |
3.1 |
|
Certificate of Incorporation (incorporated by reference to Exhibit 2.1 of Form DOS filed with the SEC on August 19, 2016). |
3.2 |
|
Certificate of Amendment to the Certificate of Incorporation, filed with the Delaware Secretary of State on June 10, 2016 (incorporated by reference to Exhibit 3.2 of the Quarterly Report on Form 10-Q filed with the SEC on December 15, 2023). |
3.3 |
|
Certificate of Amendment to the Certificate of Incorporation, filed with the Delaware Secretary of State on December 22, 2020 (incorporated by reference to Exhibit 3.3 of the Quarterly Report on Form 10-Q filed with the SEC on December 15, 2023). |
3.4 |
|
Certificate of Amendment to the Certificate of Incorporation, filed with the Delaware Secretary of State on October 27, 2023 (incorporated by reference to Exhibit 3.1 of the Current Report on Form 8-K filed with the SEC on October 30, 2023). |
3.5 |
|
Amended and Restated Certificate of Designations of Preferences, Rights and Limitations of Series B Convertible Preferred Stock, filed with the Delaware Secretary of State on March 1, 2024 (incorporated by reference to Exhibit 3.1 of the Current Report on Form 8-K filed with the SEC on March 7, 2024). |
3.6 |
|
Certificate of Amendment to the Amended and Restated Certificate of Designations of Preferences, Rights and Limitations of Series B Convertible Preferred Stock, filed with the Delaware Secretary of State on March 21, 2024 (incorporated by reference to Exhibit 3.1 of the Current Report on Form 8-K filed with the SEC on March 22, 2024). |
3.7 |
|
Certificate of Designations of Preferences and Rights of Series A Preferred Stock, as filed with the Delaware Secretary of State on May 9, 2024 (incorporated by reference to Exhibit 3.1 of the amended Current Report on Form 8-K/A filed with the SEC on May 10, 2024). |
3.8 |
|
Amended and Restated Bylaws (incorporated by reference to Exhibit 3.2 of the registration statement on Form S-1 filed with the SEC on May 10, 2021). |
10.1 |
|
Form of Securities Purchase Agreement (incorporated by reference to Exhibit 10.1 of the Current Report on Form 8-K filed with the SEC on May 9, 2024). |
10.2 |
|
Form of Registration Rights Agreement (incorporated by reference to Exhibit 10.2 of the Current Report on Form 8-K filed with the SEC on May 9, 2024). |
31.1* |
|
Certification of Chief Executive Officer required by Rule 13a-14(a) or Rule 15d-14(a). |
31.2* |
|
Certification of Chief Financial Officer required by Rule 13a-14(a) or Rule 15d-14(a). |
32.1** |
|
Certification of Chief Executive and Financial Officer required by Rule 13a-14(b) or Rule 15d-14(b) and Section 1350 of Chapter 63 of Title 18 of the United States Code. |
101.INS* |
|
XBRL Instance Document. The instance document does not appear in the Interactive Data File because its XBRL tags are embedded within the Inline XBRL document. |
101.SCH* |
|
Inline XBRL Taxonomy Extension Schema Document. |
101.CAL* |
|
Inline XBRL Taxonomy Extension Calculation Linkbase Document. |
101.DEF* |
|
Inline XBRL Taxonomy Extension Definition Linkbase Document. |
101.LAB* |
|
Inline XBRL Taxonomy Extension Label Linkbase Document. |
101.PRE* |
|
Inline XBRL Taxonomy Extension Presentation Linkbase Document. |
104 |
|
Cover Page Interactive Data File (formatted as Inline XBRL and contained in Exhibit 101). |
*Filed herewith.
** This certification will not be deemed “filed”
for purposes of Section 18 of the Exchange Act, or otherwise subject to the liability of that section. Such certification will 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 specifically incorporated by reference into such filing.
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.
|
ALZAMEND NEURO, INC. |
|
|
|
|
Date: September 11, 2024 |
By: |
|
/s/ Stephan Jackman
Stephan Jackman
Chief Executive Officer (principal executive officer) |
Date: September 11, 2024 |
By: |
|
/s/ David J. Katzoff
David J. Katzoff
Chief Financial Officer (principal financial and accounting officer) |
31
Exhibit 31.1
CERTIFICATION
I, Stephan Jackman, certify that:
1. I have reviewed
this quarterly report on Form 10-Q of Alzamend Neuro, 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.
Dated: September 11, 2024
/s/ Stephan Jackman |
|
Name: Stephan Jackman |
|
Title: Chief Executive Officer |
|
(Principal Executive Officer) |
|
Exhibit 31.2
CERTIFICATION
I, David J. Katzoff, certify that:
1. I have reviewed
this quarterly report on Form 10-Q of Alzamend Neuro, 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.
Dated: September 11, 2024
/s/ David J. Katzoff |
|
Name: David J. Katzoff |
|
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 quarterly
report of Alzamend Neuro, Inc. (the “Company”) on Form 10-Q for the period ended July 31, 2024, as filed with the
Securities and Exchange Commission on the date hereof (the “Report”), the undersigned certify, pursuant to 18 U.S.C.
Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002, that:
(1) the 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 Report fairly presents, in all material respects, the financial condition and result of operations of the Company.
Date: September 11, 2024 |
|
|
|
|
By: /s/ Stephan Jackman |
|
Name: Stephan Jackman |
|
Title: Chief Executive Officer |
|
(Principal Executive Officer) |
Date: September 11, 2024 |
|
|
|
|
By: /s/ David J. Katzoff |
|
Name: David J. Katzoff |
|
Title: Chief Financial Officer |
|
(Principal Financial and Accounting Officer) |
v3.24.2.u1
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Sep. 11, 2024 |
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Entity File Number |
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|
|
Entity Registrant Name |
ALZAMEND NEURO, INC.
|
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Entity Central Index Key |
0001677077
|
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Entity Tax Identification Number |
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v3.24.2.u1
Condensed Balance Sheets (Unaudited) - USD ($)
|
Jul. 31, 2024 |
Apr. 30, 2024 |
CURRENT ASSETS |
|
|
Cash |
$ 1,193,950
|
$ 376,048
|
Prepaid expenses and other current assets |
222,241
|
79,194
|
TOTAL CURRENT ASSETS |
1,416,191
|
455,242
|
Property, plant and equipment, net |
253,661
|
176,346
|
TOTAL ASSETS |
1,669,852
|
631,588
|
CURRENT LIABILITIES |
|
|
Accounts payable and accrued liabilities |
2,882,171
|
2,925,059
|
Note payable |
|
300,714
|
TOTAL LIABILITIES, ALL CURRENT |
2,882,171
|
3,225,773
|
STOCKHOLDERS’ DEFICIT |
|
|
Common stock, $0.0001 par value: 300,000,000 shares authorized; 861,332 and 687,999 issued and outstanding as of July 31, 2024 and April 30, 2024, respectively |
86
|
69
|
Additional paid-in capital |
53,782,414
|
51,426,154
|
Accumulated deficit |
(54,994,819)
|
(54,020,408)
|
TOTAL STOCKHOLDERS’ DEFICIT |
(1,212,319)
|
(2,594,185)
|
TOTAL LIABILITIES AND STOCKHOLDERS’ DEFICIT |
1,669,852
|
631,588
|
Series A Preferred Stock [Member] |
|
|
STOCKHOLDERS’ DEFICIT |
|
|
Preferred Stock, Value |
|
|
Series B Preferred Stock [Member] |
|
|
STOCKHOLDERS’ DEFICIT |
|
|
Preferred Stock, Value |
|
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v3.24.2.u1
Condensed Balance Sheets (Unaudited) (Parenthetical) - $ / shares
|
Jul. 31, 2024 |
Apr. 30, 2024 |
Preferred stock, par value (in dollars per share) |
$ 0.0001
|
$ 0.0001
|
Common stock, par value (in dollars per share) |
$ 0.0001
|
$ 0.0001
|
Common stock, shares authorized |
300,000,000
|
300,000,000
|
Common stock, shares issued |
861,332
|
687,999
|
Common stock, shares outstanding |
861,332
|
687,999
|
Series A Preferred Stock [Member] |
|
|
Preferred stock, par value (in dollars per share) |
$ 0.0001
|
$ 0.0001
|
Preferred stock shares designated |
3,000
|
3,000
|
Preferred stock, shares issued |
188
|
0
|
Preferred stock, shares outstanding |
188
|
0
|
Series B Preferred Stock [Member] |
|
|
Preferred stock, par value (in dollars per share) |
$ 0.0001
|
$ 0.0001
|
Preferred stock shares designated |
6,000
|
6,000
|
Preferred stock, shares issued |
2,100
|
2,100
|
Preferred stock, shares outstanding |
2,100
|
2,100
|
X |
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v3.24.2.u1
Condensed Statements of Operations (Unaudited) - USD ($)
|
3 Months Ended |
Jul. 31, 2024 |
Jul. 31, 2023 |
OPERATING EXPENSES |
|
|
Research and development |
$ 206,571
|
$ 2,366,137
|
General and administrative |
755,834
|
1,159,794
|
Total operating expenses |
962,405
|
3,525,931
|
Loss from operations |
(962,405)
|
(3,525,931)
|
OTHER EXPENSE, NET |
|
|
Interest expense |
(12,006)
|
(1,835)
|
Total other expense, net |
(12,006)
|
(1,835)
|
NET LOSS |
$ (974,411)
|
$ (3,527,766)
|
Basic net loss per common share |
$ (1.25)
|
$ (5.38)
|
Diluted net loss per common share |
$ (1.25)
|
$ (5.38)
|
Basic weighted average common shares outstanding |
777,821
|
656,267
|
Diluted weighted average common shares outstanding |
777,821
|
656,267
|
X |
- DefinitionThe amount of net income (loss) for the period per each share of common stock or unit outstanding during the reporting period.
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v3.24.2.u1
Condensed Statements of Stockholders' (Deficit) Equity (Unaudited) - USD ($)
|
Series A Convertible Preferred Stock [Member] |
Series B Convertible Preferred Stock [Member] |
Common Stock [Member] |
Additional Paid-in Capital [Member] |
Note Recievable For Common Stock Related Party [Member] |
Retained Earnings [Member] |
Total |
Beginning balance, value at Apr. 30, 2023 |
|
|
$ 65
|
$ 62,001,395
|
$ (14,883,295)
|
$ (44,072,662)
|
$ 3,045,503
|
Beginning balance, shares at Apr. 30, 2023 |
|
|
646,267
|
|
|
|
|
Stock-based compensation to employees and consultants |
|
|
|
369,380
|
|
|
369,380
|
Net loss |
|
|
|
|
|
(3,527,766)
|
(3,527,766)
|
Ending balance, value at Jul. 31, 2023 |
|
|
$ 65
|
62,370,775
|
(14,883,295)
|
(47,600,428)
|
(112,883)
|
Ending balance, shares at Jul. 31, 2023 |
|
|
646,267
|
|
|
|
|
Beginning balance, value at Apr. 30, 2024 |
|
|
$ 69
|
51,426,154
|
|
(54,020,408)
|
(2,594,185)
|
Beginning balance, shares at Apr. 30, 2024 |
|
2,100
|
687,999
|
|
|
|
|
Issuance of preferred stock for cash |
|
|
|
1,963,644
|
|
|
1,963,644
|
Issuance of preferred stock for cash, shares |
250
|
|
|
|
|
|
|
Conversion of note payable and interest to preferred stock |
|
|
|
311,356
|
|
|
311,356
|
Conversion of preferred stock to common stock |
|
|
$ 17
|
(17)
|
|
|
|
Conversion of preferred stock to common stock, shares |
(62)
|
|
173,333
|
|
|
|
|
Stock-based compensation to employees and consultants |
|
|
|
81,277
|
|
|
81,277
|
Net loss |
|
|
|
|
|
(974,411)
|
(974,411)
|
Ending balance, value at Jul. 31, 2024 |
|
|
$ 86
|
$ 53,782,414
|
|
$ (54,994,819)
|
$ (1,212,319)
|
Ending balance, shares at Jul. 31, 2024 |
188
|
2,100
|
861,332
|
|
|
|
|
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v3.24.2.u1
Condensed Statements of Cash Flows (Unaudited) - USD ($)
|
3 Months Ended |
Jul. 31, 2024 |
Jul. 31, 2023 |
Cash flows from operating activities: |
|
|
Net loss |
$ (974,411)
|
$ (3,527,766)
|
Adjustments to reconcile net loss to net cash used in operating activities: |
|
|
Depreciation expense |
12,685
|
12,685
|
Interest expense - debt discount |
9,286
|
|
Stock-based compensation to employees and consultants |
81,277
|
369,380
|
Changes in operating assets and liabilities: |
|
|
Prepaid expenses and other current assets |
(143,047)
|
(270,599)
|
Prepaid expenses - related party |
|
247,334
|
Accounts payable and accrued liabilities |
(41,532)
|
(129,234)
|
Net cash used in operating activities |
(1,055,742)
|
(3,298,200)
|
Cash flows from investing activities: |
|
|
Purchase of equipment |
(90,000)
|
(147,243)
|
Net cash used in investing activities |
(90,000)
|
(147,243)
|
Cash flows from financing activities: |
|
|
Net proceeds from the issuance of preferred stock |
1,963,644
|
|
Net cash provided by financing activities |
1,963,644
|
|
Net increase (decrease) in cash |
817,902
|
(3,445,443)
|
Cash at beginning of period |
376,048
|
5,140,859
|
Cash at end of period |
1,193,950
|
1,695,416
|
Non-cash financing activities: |
|
|
Conversion of Series A convertible preferred stock |
624,770
|
|
Fair value of warrants issued in connection with Series A convertible preferred stock |
510,209
|
|
Conversion of note payable and accrued interest into Series B convertible preferred stock |
$ 311,356
|
|
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v3.24.2.u1
DESCRIPTION OF BUSINESS
|
3 Months Ended |
Jul. 31, 2024 |
Accounting Policies [Abstract] |
|
DESCRIPTION OF BUSINESS |
| 1. | DESCRIPTION OF BUSINESS |
Organization
Alzamend Neuro, Inc. (the
“Company” or “Alzamend”), is a clinical-stage biopharmaceutical company focused on developing novel products for
the treatment of Alzheimer’s disease (“Alzheimer’s”), bipolar disorder (“BD”), major depressive disorder
(“MDD”) and post-traumatic stress disorder (“PTSD”). With two current product candidates, Alzamend aims to bring
treatments or cures to market at a reasonable cost as quickly as possible. The Company’s current pipeline consists of two novel
therapeutic drug candidates: (i) a patented ionic cocrystal technology delivering a therapeutic combination of lithium, proline and salicylate,
known as AL001, through two royalty-bearing exclusive worldwide licenses from the University of South Florida Research Foundation, Inc.,
as licensor (the “Licensor”); and (ii) a patented method using a mutant peptide sensitized cell as a cell-based therapeutic
vaccine that seeks to restore the ability of a patient’s immunological system to combat Alzheimer’s, known as ALZN002, through
a royalty-bearing exclusive worldwide license from the same Licensor.
The Company is devoting substantially
all its efforts towards research and development of its two product candidates and raising capital. The Company has not generated any
product revenue to date. The Company has financed its operations to date primarily through debt financings and through the sale of its
common stock, par value $0.0001 per share (“Common Stock”) and its preferred stock, par value $0.0001 per share. The Company
expects to continue to incur net losses in the foreseeable future.
Reverse Stock Split
On
October 27, 2023, pursuant to the authorization provided by the Company’s stockholders at a special meeting of stockholders, the
Company filed an amendment to the Certificate of Incorporation to effectuate a reverse stock split of the Company’s issued and outstanding
Common Stock by a ratio of one-for-fifteen (the “First Reverse Split”). The First Reverse Split did not affect the number
of authorized shares of Common Stock, preferred stock or their respective par value per share. As a result of the First Reverse Split,
each fifteen shares of Common Stock issued and outstanding prior to the First Reverse Split were converted into one share of Common Stock.
The First Reverse Split became effective in the State of Delaware on October 31, 2023. All share amounts in these financial statements
have been updated for all periods presented to reflect the First Reverse Split.
On
July 10, 2024, pursuant to the authorization provided by the Company’s stockholders at its annual meeting of stockholders, the Company
filed an amendment to the Certificate of Incorporation to effectuate a reverse stock split of the Company’s issued and outstanding
Common Stock by a ratio of one-for-ten (the “Second Reverse Split”). The Second Reverse Split did not affect the number of
authorized shares of Common Stock, preferred stock or their respective par value per share. As a result of the Second Reverse Split, each
ten shares of Common Stock issued and outstanding prior to the Second Reverse Split were converted into one share of Common Stock. The
Second Reverse Split became effective in the State of Delaware on July 16, 2024. All share amounts in these financial statements have
been updated for all periods presented to reflect the Second Reverse Split.
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- DefinitionThe entire disclosure for the business description and basis of presentation concepts. Business description describes the nature and type of organization including but not limited to organizational structure as may be applicable to holding companies, parent and subsidiary relationships, business divisions, business units, business segments, affiliates and information about significant ownership of the reporting entity. Basis of presentation describes the underlying basis used to prepare the financial statements (for example, US Generally Accepted Accounting Principles, Other Comprehensive Basis of Accounting, IFRS).
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v3.24.2.u1
LIQUIDITY AND GOING CONCERN
|
3 Months Ended |
Jul. 31, 2024 |
Organization, Consolidation and Presentation of Financial Statements [Abstract] |
|
LIQUIDITY AND GOING CONCERN |
| 2. | LIQUIDITY AND GOING CONCERN |
The accompanying condensed
financial statements have been prepared on the basis that the Company will continue as a going concern. As of July 31, 2024, the Company
had cash of $1.2 million, a working capital deficiency of $1.5 million, an accumulated deficit of $55.0 million and a stockholders’
deficit of $1.2 million. For the three months ended July 31, 2024, the Company had a net loss of $1.0 million. For the three months ended
July 31, 2024, cash used in operating activities was $1.1 million. Historically, the Company has financed its operations principally through
issuances of equity and debt instruments.
Management
believes its current cash on hand is not sufficient to fund its planned operations through one year after the date the condensed financial
statements are issued. These factors create substantial doubt about the Company’s ability to continue as a going concern for at
least one year after the date that these condensed financial statements are issued.
The Company’s inability to
continue as a going concern could have a negative impact on the Company, including its ability to obtain
needed financing. The Company’s condensed financial statements do not include any adjustments relating to the recoverability
and classification of recorded assets, or the amounts and classifications of liabilities that might be necessary should it be unable to
continue as a going concern.
The Company expects to continue
to incur losses for the foreseeable future and needs to raise additional capital until it is able to generate revenues from operations
sufficient to fund its development and commercial operations. These factors create substantial doubt
about our ability to continue as a going concern. However, based on the Company’s current business plan, management believes
that the Company’s cash and cash equivalents at July 31, 2024, together with the anticipated receipt of funds from the sale of its
Series A and Series B Convertible Preferred Stock pursuant to the securities purchase agreements related thereto, will be sufficient to
meet the Company’s anticipated cash requirements during the twelve-month period subsequent to the issuance of the financial statements
included in this Quarterly Report.
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v3.24.2.u1
SIGNIFICANT ACCOUNTING POLICIES
|
3 Months Ended |
Jul. 31, 2024 |
Accounting Policies [Abstract] |
|
SIGNIFICANT ACCOUNTING POLICIES |
| 3. | SIGNIFICANT ACCOUNTING POLICIES |
Basis of Presentation
The accompanying condensed
financial statements of the Company have been prepared in accordance with accounting principles generally accepted in the United States
of America (“U.S. GAAP”) and the rules of the Securities and Exchange Commission (“SEC”) applicable to interim
reports of companies filing as a smaller reporting company. These condensed financial statements should be read in conjunction with the
audited financial statements and notes thereto contained in the Company’s Report on Form 10-K for the year ended April 30, 2024,
filed with the SEC on July 30, 2024. In the opinion of management, the accompanying condensed interim financial statements include all
adjustments necessary in order to make the condensed financial statements not misleading. The results of operations for interim periods
are not necessarily indicative of the results to be expected for the full year or any other future period. Certain notes to the condensed
financial statements that would substantially duplicate the disclosures contained in the audited financial statements for the most recent
fiscal year as reported in the Company’s Report on Form 10-K have been omitted. The accompanying condensed balance sheet at April
30, 2024 has been derived from the audited balance sheet at April 30, 2024 contained in such Form 10-K.
Accounting Estimates
The preparation of condensed
financial statements, in conformity with U.S. GAAP, requires management to make estimates and assumptions that affect the reported amounts
of assets and liabilities and disclosure of contingent assets and liabilities at the date of the condensed financial statements and the
reported amounts of expenses during the reporting period. The Company’s significant accounting policies that involve significant
judgment and estimates include stock-based compensation, warrant valuation, and valuation of deferred income taxes. Actual results could
differ from those estimates.
Cash and Cash Equivalents
The Company considers all
highly liquid investments with a remaining maturity of three months or less when purchased to be cash equivalents. As of July 31, 2024
and April 30, 2024, the Company had no cash equivalents.
Fair Value of Financial
Instruments
Financial Accounting Standards
Board (“FASB”) Accounting Standards Codification (“ASC”) 820, Fair Value Measurement, defines fair value
as the exchange price that would be received for an asset or paid to transfer a liability (an exit price) in the principal or most advantageous
market for the asset or liability in an orderly transaction between market participants on the measurement date. Valuation techniques
used to measure fair value must maximize the use of observable inputs and minimize the use of unobservable inputs. The fair value hierarchy
is based on three levels of inputs that may be used to measure fair value, of which the first two are considered observable and the last
is considered unobservable:
Level 1: Quoted prices in
active markets for identical assets or liabilities.
Level 2: Inputs other than
Level 1 that are observable, either directly or indirectly, such as quoted prices for similar assets or liabilities; quoted prices in
markets that are not active; or other inputs that are observable or can be corroborated by observable market data for substantially the
full term of the assets or liabilities.
Level 3 assumptions: Unobservable
inputs that are supported by little or no market activity and that are significant to the fair value of the assets or liabilities including
liabilities resulting from imbedded derivatives associated with certain warrants to purchase Common Stock.
The fair values of warrants
are determined using the Black-Scholes valuation model, a “Level 3” fair value measurement, based on the estimated fair value
of Common Stock, volatility based on the historical volatility data of similar companies, considering the industry, products and market
capitalization of such other entities, the expected life based on the remaining contractual term of the warrants and the risk free interest
rate based on the implied yield available on U.S. Treasury Securities with a maturity equivalent to the warrants’ contractual life.
Property and Equipment,
Net
Property and equipment
are stated at cost, net of accumulated depreciation. Depreciation is computed using the straight-line method over the estimated
useful life of 5 five years. Significant additions and improvements are capitalized, while repairs and maintenance are charged to
expense as incurred.
Research and Development
Expenses
Research and development costs
are expensed as incurred. Research and development costs consist of scientific consulting fees, clinical trial fees and lab supplies,
as well as fees paid to other entities that conduct certain research and development activities on behalf of the Company.
The Company has acquired and
may continue to acquire the rights to develop and commercialize new product candidates from third parties. The upfront payments to acquire
license, products or rights, as well as any future milestone payments, are immediately recognized as research and development expenses,
provided that there is no alternative future use of the rights in other research and development projects.
Stock-Based Compensation
The Company recognizes stock-based
compensation expense for stock options on a straight-line basis over the requisite service period and account for forfeitures as they
occur. The Company’s stock-based compensation costs are based upon the grant date fair value of options estimated using the Black-Scholes
option pricing model. To the extent any stock option grants are made subject to the achievement of a performance-based milestone, management
evaluates when the achievement of any such performance-based milestone is probable based on the relative satisfaction of the performance
conditions as of the reporting date.
The Company recognizes stock-based
compensation expense for restricted stock units on a straight-line basis over the requisite service period and account for forfeitures
as they occur. The Company’s stock-based compensation for restricted stocks is based upon the estimated fair value of the Common
Stock.
The Black-Scholes option pricing
model utilizes inputs which are highly subjective assumptions and generally require significant judgment. Certain of such assumptions
involve inherent uncertainties and the application of significant judgment. As a result, if factors or expected outcomes change and the
Company uses significantly different assumptions or estimates, the Company’s stock-based compensation could be materially different.
Warrants
The Company accounts for stock
warrants as either equity instruments, derivative liabilities, or liabilities in accordance with FASB ASC 480, Distinguishing
Liabilities from Equity and FASB ASC 815, Derivatives and Hedging (“ASC 815”), depending on the
specific terms of the warrant agreement.
Based on the terms of the
Company’s warrant agreements, the Company accounted for the warrants as equity instruments as the warrants were indexed to the Common
Stock, required settlement in shares and would be classified as equity under ASC 815.
Loss per Common Share
The Company utilizes FASB
ASC 260, Earnings per Share. Basic loss per share is computed by dividing loss available to common stockholders by the weighted-average
number of common shares outstanding. Diluted loss per share is computed similar to basic loss per share except that the denominator is
increased to include the number of additional common shares that would have been outstanding if the potential common shares had been issued
and if the additional common shares were dilutive. Diluted loss per common share reflects the potential dilution that could occur if convertible
preferred stock, options and warrants were to be exercised or converted or otherwise resulted in the issuance of Common Stock that then
shared in the earnings of the entity.
Since the effects of outstanding
stock options, restricted stock units and warrants are anti-dilutive in the periods presented, shares of Common Stock underlying these
instruments have been excluded from the computation of loss per common share.
The following sets forth the
number of shares of Common Stock underlying outstanding stock options, restricted stock units and warrants that have been excluded from
the computation of loss per common share:
Schedule of antidilutive securities excluded from computation of earnings per share | |
| | | |
| | |
| |
For the Three Months Ended July 31, | |
| |
2024 | | |
2023 | |
Stock options (1) | |
| 116,999 | | |
| 121,055 | |
Restricted stock units | |
| 167 | | |
| 333 | |
Warrants | |
| 438,879 | | |
| 67,665 | |
| |
| 556,045 | | |
| 189,053 | |
| (1) | The Company has excluded 10,000 stock options for the three months ended July 31, 2024 and 2023, with
an exercise price of $0.06, from its anti-dilutive securities as these shares have been included in our determination of basic loss per
share as they represent shares issuable for little or no cash consideration upon the satisfaction of certain conditions pursuant to FASB
ASC 260-10-45-14. |
Recent Accounting Standards
From time to time, new accounting
pronouncements are issued by the FASB and adopted by the Company as of the specified effective date. Unless otherwise discussed, the impact
of recently issued standards that are not yet effective are not expected to have a material impact on the Company’s financial position
or results of operations upon adoption.
Management has considered
all other recently issued accounting standards and does not believe the adoption of such standards will have a material impact on its
condensed financial statements.
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v3.24.2.u1
PREPAID EXPENSES AND OTHER CURRENT ASSETS
|
3 Months Ended |
Jul. 31, 2024 |
Deferred Costs, Capitalized, Prepaid, and Other Assets Disclosure [Abstract] |
|
PREPAID EXPENSES AND OTHER CURRENT ASSETS |
| 4. | PREPAID EXPENSES AND OTHER CURRENT ASSETS |
Prepaid expenses and other
current assets were as follows:
Schedule of prepaid expenses and other current assets | |
| | | |
| | |
| |
July 31, 2024 | | |
April 30, 2024 | |
Prepaid insurance | |
$ | 209,619 | | |
$ | 60,522 | |
Other prepaid expenses | |
| 12,622 | | |
| 18,672 | |
Total prepaid expenses and other current assets | |
$ | 222,241 | | |
$ | 79,194 | |
On June 14, 2024, the Company
purchased directors’ and officers’ insurance for 12 months in the amount of $227,000. Prepaid insurance at July 31, 2024 represented
the unamortized portion of directors’ and officers’ insurance.
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v3.24.2.u1
STOCK-BASED COMPENSATION
|
3 Months Ended |
Jul. 31, 2024 |
Share-Based Payment Arrangement [Abstract] |
|
STOCK-BASED COMPENSATION |
| 5. | STOCK-BASED COMPENSATION |
2016 Stock Incentive
Plan
On April 30, 2016, the Company’s
stockholders approved the Company’s 2016 Stock Incentive Plan (the “Plan”). The Plan provides for the issuance of a
maximum of 83,333 shares of Common Stock to be offered to the Company’s directors, officers, employees, and consultants. On March
1, 2019, the Company’s stockholders approved an additional 50,000 shares to be available for issuance under the Plan. Options granted
under the Plan have an exercise price equal to or greater than the fair value of the underlying Common Stock at the date of grant and
become exercisable based on a vesting schedule determined at the date of grant. The options expire between five and 10 years from the
date of grant. Restricted stock awards granted under the Plan are subject to a vesting period determined at the date of grant.
2021 Stock Incentive
Plan
In February 2021, the Company’s
board of directors (the “Board”) adopted, and the stockholders approved, the Alzamend Neuro, Inc. 2021 Stock Incentive Plan
(the “2021 Plan”). The 2021 Plan authorizes the grant to eligible individuals of (1) stock options (incentive and non-statutory),
(2) restricted stock, (3) stock appreciation rights, or SARs, (4) restricted stock units, and (5) other stock-based compensation.
Stock Subject to the 2021
Plan. The maximum number of shares of Common Stock that may be issued under the 2021 Plan is 66,667 shares, which number will
be increased to the extent that compensation granted under the 2021 Plan is forfeited, expires or is settled for cash (except as otherwise
provided in the 2021 Plan). Substitute awards (awards made or shares issued by the Company in assumption of, or in substitution or exchange
for, awards previously granted, or the right or obligation to make future awards, in each case by a company that the Company acquires
or any subsidiary of the Company or with which the Company or any subsidiary combines) will not reduce the shares authorized for grant
under the 2021 Plan, nor will shares subject to a substitute award be added to the shares available for issuance or transfer under the
2021 Plan.
Restricted Stock. In
May 2021, the Company issued restricted stock awards pursuant to the 2021 Plan to one employee. The restricted stock award vests over
48 months. The award requires continued service to the Company during the vesting period. The vesting provisions of individual awards
may vary as approved by the Board. Compensation expense for restricted stock is generally recorded based on its market value on the date
of grant and recognized ratably over the associated service and performance period.
Stock Options. All
options that the Company grants are granted at the per share fair value on the grant date. Vesting of options differs based on the terms
of each option. The Company has valued the options at their date of grant utilizing the Black Scholes option pricing model. As of the
date of issuance of these options, there was not an active public market for the Company’s shares. Accordingly, the fair value of
the underlying options was determined based on the historical volatility data of similar companies, considering the industry, products
and market capitalization of such other entities. The risk-free interest rate used in the calculations is based on the implied yield available
on U.S. Treasury issues with an equivalent term approximating the expected life of the options as calculated using the simplified method.
The expected life of the options used was based on the contractual life of the option granted. Stock-based compensation is a non-cash
expense because the Company settles these obligations by issuing shares of Common Stock from its authorized shares instead of settling
such obligations with cash payments.
A summary of stock option
activity for the three months ended July 31, 2024 is presented below:
Schedule of share-based payment arrangement, option, activity |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Outstanding Options |
|
|
|
Shares
Available
for Grant |
|
|
Number of
Shares |
|
|
Weighted
Average
Exercise
Price |
|
|
Weighted
Average
Remaining
Contractual
Life (years) |
|
|
Aggregate Intrinsic
Value |
|
Balance at April 30, 2024 |
|
|
62,000 |
|
|
|
98,000 |
|
|
$ |
178.12 |
|
|
|
5.22 |
|
|
$ |
70,500 |
|
Options granted |
|
|
- |
|
|
|
- |
|
|
$ |
- |
|
|
|
- |
|
|
|
|
|
Options exercised |
|
|
- |
|
|
|
- |
|
|
$ |
- |
|
|
|
- |
|
|
|
|
|
Options expired |
|
|
3,333 |
|
|
|
(3,333 |
) |
|
$ |
150.00 |
|
|
|
- |
|
|
|
|
|
Balance at July 31, 2024 |
|
|
65,333 |
|
|
|
94,667 |
|
|
$ |
179.11 |
|
|
|
5.15 |
|
|
$ |
35,100 |
|
Options vested and expected to vest at July 31, 2024 |
|
|
|
|
|
|
88,001 |
|
|
$ |
179.39 |
|
|
|
4.91 |
|
|
$ |
35,100 |
|
Options exercisable at July 31, 2024 |
|
|
|
|
|
|
87,043 |
|
|
$ |
178.72 |
|
|
|
4.88 |
|
|
$ |
35,100 |
|
The aggregate intrinsic value
in the table above represents the total pretax intrinsic value (i.e., the difference between the estimated fair value on the respective
date and the exercise price, times the number of shares) that would have been received by the option holders had all option holders exercised
their options.
Restricted stock unit activity
for the three months ended July 31, 2024 is presented below:
Schedule of nonvested restricted stock units activity |
|
|
|
|
|
|
|
|
|
|
Shares |
|
|
Weighted Average
Grant Date Fair Value |
|
Unvested at April 30, 2024 |
|
|
167 |
|
|
$ |
375.00 |
|
Granted |
|
|
- |
|
|
|
- |
|
Vested |
|
|
- |
|
|
|
- |
|
Cancelled |
|
|
- |
|
|
|
- |
|
Unvested at July 31, 2024 |
|
|
167 |
|
|
$ |
375.00 |
|
Performance Contingent
Stock Options Granted to Employee
On November 26, 2019, the
Board granted 28,333 performance and market contingent awards to certain key employees and a director. These grants were made outside
of the Plan. These awards have an exercise price of $225.00 per share. These awards have multiple separate market triggers for vesting
based upon either (i) the successful achievement of stepped target closing prices on a national securities exchange for 90 consecutive
trading days later than 180 days after the Company’s initial public offering (“IPO”) for its common stock, or (ii) stepped
target prices for a change in control transaction. The target prices ranged from $1,500 per share to $6,000 per share. In the event any
of the stock price milestones are not achieved within three years, the unvested portion of the performance options will be reduced by
25%.
On November 22, 2022, the
Compensation Committee of the Board modified the performance criteria for these awards. The target price range is now $1,500 per share
to $3,000 per share. Additionally, if the stock price milestones are now not achieved by November 27, 2026, as opposed to within three
years, the unvested portion of the portion of the performance options will be reduced by 25%. Due to the significant risks and uncertainties
associated with achieving the market-contingent awards, as of July 31, 2024, the Company believes that the achievement of the requisite
performance conditions is not probable and, as a result, no compensation cost has been recognized for these awards.
On November 29, 2022, the
Compensation Committee of the Board granted 13,333 performance-based stock option to the Chief Executive Officer at an exercise price
of $175.50 per share, of which 50% vest upon the completion and announcement of topline data from the Company’s Phase II clinical
trial of AL001 within three years from grant date and the remaining 50% vest upon the completion and announcement of topline data from
the Company’s Phase II clinical trial of ALZN002 within four years from the grant date. During the three months ended July 31, 2023,
management believed that it was probable that the performance condition of the completion and announcement of topline data from the Company’s
Phase II clinical trial of AL001 would be achieved and had recognized the related stock-based compensation. As of July 31, 2024, management
believed that the achievement of the second performance condition was not probable and, as a result, no compensation cost has been recognized
related to Phase I/IIA of ALZN002.
Performance Contingent
Stock Options Granted to TAMM Net
On March 23, 2021, the Company
issued performance-based stock options to certain team members at TAMM Net, Inc. (“TAMM Net”) to purchase an aggregate of
3,000 shares of Common Stock at a per share exercise price of $225.00 per share, of which 50% would vest upon the completion of Phase
I of AL001 by March 31, 2022, and the remaining 50% would vest upon completion of Phase I/IIA of ALZN002 by December 31, 2022.
On January 19, 2023, the Board
modified the performance criteria for these awards. The remaining 50% of the grant will now vest upon the completion and announcement
of topline data of the first cohort from a Phase I/IIA clinical trial of ALZN002 on/or before March 31, 2024. The modified performance
criteria was not met on or before March 31, 2024 and, as a result, the remaining unvested stock options were cancelled and no compensation
cost has been recognized for these awards related to ALZN002.
Performance Contingent
Stock Options Granted to Consultants
On October 14, 2021, the Company
issued performance-based stock options to two consultants to purchase an aggregate of 1,334 shares of Common Stock with an exercise price
of $363.00 per share, of which 333 vest upon completion of each of the Phase II clinical trials of AL001 for a BD indication, AL001 for
a PTSD indication, AL001 for an MDD indication and ALZN002 for an Alzheimer’s indication.
On January 19, 2023, the Board
modified the performance criteria for these awards. The revised grant will vest 25% if the Company (a) completes and announces topline
data from a Phase II clinical trial of AL001 and ALZN002, as applicable, that would support a new drug application for the drug candidate
and the indication listed below, and (b) obtained a “Study May Proceed” letter from the U.S. Food and Drug Administration
(“FDA”) for the additional Investigational New Drug (“IND”) on/or before December 31, 2023, as follows: (i) AL001
– BD; (ii) AL001- MDD; (iii) AL001 – PTSD; and (iv) ALZN002 – Alzheimer’s.
During the year ended April
30, 2024, the Company filed INDs for BD, MDD and PTSD and received a “Study May Proceed” letter for BD in October 2023, MDD
in November 2023 and PTSD in December 2023. As a result, 75% of the performance grant vested and the Company recognized stock-based compensation
related to the vesting. As of July 31, 2024, management believed that the achievement of the remaining requisite performance condition
was not probable and, as a result, no compensation cost has been recognized for these awards related to ALZN002 – Alzheimer’s.
Stock-Based Compensation
Expense
The Company’s results
of operations included expenses relating to stock-based compensation for three months ended July 31, 2024 and 2023, were comprised as
follows:
Schedule of stock-based compensation | |
| | |
| |
| |
For the Three Months Ended July 31, | |
| |
2024 | | |
2023 | |
General and administrative | |
$ | 81,277 | | |
$ | 369,380 | |
As of July 31, 2024, total
unamortized stock-based compensation expense related to unvested employee and non-employee awards that are expected to vest was $287,000.
The weighted-average period over which such stock-based compensation expense will be recognized was approximately 1.1 years.
|
X |
- DefinitionThe entire disclosure for share-based payment arrangement.
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v3.24.2.u1
WARRANTS
|
3 Months Ended |
Jul. 31, 2024 |
Warrants |
|
WARRANTS |
During the three months ended
July 31, 2024, the Company issued warrants to purchase an aggregate of 200,000 shares of common stock at an exercise price of $12.50 per
share.
| (i) | On May 10, 2024, the Company issued a warrant to purchase 80,000 shares of Common Stock at an exercise
price of $12.50 in connection with the sale of convertible preferred stock to Orchid Finance, LLC (“Orchid”) for $1,000,000.
Based on the terms of the Company’s warrant agreement, the Company accounted for the warrant as an equity instrument as the warrant
is indexed to the common stock, requires settlement in shares and would be classified as equity under ASC 815. |
| (ii) | On June 25, 2024, the Company issued a warrant to purchase 120,000 shares of Common Stock at an exercise
price of $12.50 in connection with the sale of convertible preferred stock to Orchid for $1,500,000. Based on the terms of the Company’s
warrant agreement, the Company accounted for the warrant as an equity instrument as the warrant is indexed to the common stock, requires
settlement in shares and would be classified as equity under ASC 815. |
Warrant activity for the three
months ended July 31, 2024 is presented below:
Schedule of warrant activity |
|
|
|
|
|
|
|
|
|
Number
Outstanding |
|
|
Weighted Average
Exercise Price |
|
Outstanding at April 30, 2024 |
|
|
240,449 |
|
|
$67.45 |
|
Granted |
|
|
200,000 |
|
|
$12.50 |
|
Cancelled/Expired |
|
|
(1,570 |
) |
|
$450.14 |
|
Outstanding at July 31, 2024 |
|
|
438,879 |
|
|
$106.96 |
|
The following table summarizes
information about Common Stock warrants outstanding and exercisable at July 31, 2024:
Schedule of common stock warrants outstanding |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Outstanding |
|
|
Exercisable |
|
|
|
|
|
|
|
Weighted |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Average |
|
|
Weighted |
|
|
|
|
|
Weighted |
|
|
|
|
|
|
|
Remaining |
|
|
Average |
|
|
|
|
|
Average |
|
Exercise |
|
|
Number |
|
|
Contractual |
|
|
Exercise |
|
|
Number |
|
|
Exercise |
|
Price |
|
|
Outstanding |
|
|
Life (years) |
|
|
Price |
|
|
Exercisable |
|
|
Price |
|
$12.00-$12.50 |
|
|
|
410,000 |
|
|
|
4.9 |
|
|
$ |
12.24 |
|
|
|
322,000 |
|
|
$ |
12.31 |
|
$262.50 |
|
|
|
1,076 |
|
|
|
0.3 |
|
|
$ |
262.50 |
|
|
|
1,076 |
|
|
$ |
262.50 |
|
$450.00 |
|
|
|
27,395 |
|
|
|
1.8 |
|
|
$ |
450.00 |
|
|
|
27,395 |
|
|
$ |
450.00 |
|
$937.50 |
|
|
|
408 |
|
|
|
1.9 |
|
|
$ |
937.50 |
|
|
|
408 |
|
|
$ |
937.50 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
$12.00 - $937.50 |
|
|
|
438,879 |
|
|
|
4.7 |
|
|
$ |
41.04 |
|
|
|
350,879 |
|
|
$ |
48.33 |
|
|
X |
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v3.24.2.u1
COMMITMENTS AND CONTINGENCIES
|
3 Months Ended |
Jul. 31, 2024 |
Commitments and Contingencies Disclosure [Abstract] |
|
COMMITMENTS AND CONTINGENCIES |
| 7. | COMMITMENTS AND CONTINGENCIES |
Contractual Obligations
On
July 2, 2018, the Company entered into two Standard Exclusive License Agreements with Sublicensing Terms for AL001 with the Licensor and
its affiliate, the University of South Florida (the “AL001 Licenses”), pursuant to which the Licensor granted the Company
a royalty bearing exclusive worldwide licenses limited to the field of Alzheimer’s, under United States Patent Nos. (i) 9,840,521,
entitled “Organic Anion Lithium Ionic Cocrystal Compounds and Compositions”, filed September 24, 2015 and granted December
12, 2017, and (ii) 9,603,869, entitled “Lithium Co-Crystals for Treatment of Neuropsychiatric Disorders”, filed May 21, 2016
and granted March 28, 2017. On February 1, 2019, the Company entered into the First Amendments to the AL001 Licenses, on March 30, 2021,
the Company entered into the Second Amendments to the AL001 Licenses and on June 8, 2023, the Company entered into the Third Amendments
to the AL001 Licenses (collectively, the “AL001 License Agreements”). The Third Amendments to the AL001 Licenses modified
the timing of the payments of the license fees.
The
AL001 License Agreements require that the Company pay combined royalty payments of 4.5% on net sales of products developed from
the licensed technology for AL001. The Company has already paid an initial license fee of $200,000 for AL001. As an additional
licensing fee for the license of the AL001 technologies, the Licensor received 14,853 shares of Common Stock. Minimum royalties for
AL001 License Agreements are $40,000 on the first anniversary of the first commercial sale, $80,000 on the second anniversary
of the first commercial sale and $100,000 on the third anniversary of the first commercial sale and every year thereafter, for the
life of the AL001 License Agreements.
On
May 1, 2016, the Company entered into a Standard Exclusive License Agreement with Sublicensing Terms for ALZN002 with the Licensor (the
“ALZN002 License”), pursuant to which the Licensor granted the Company a royalty-bearing exclusive worldwide license limited
to the field of Alzheimer’s Immunotherapy and Diagnostics, under United States Patent No. 8,188,046, entitled “Amyloid Beta
Peptides and Methods of Use,” filed April 7, 2009 and granted May 29, 2012. On August 18, 2017, the Company entered into the First
Amendment to the ALZN002 License, on May 7, 2018, the Company entered into the Second Amendment to the ALZN002 License, on January 31,
2019, the Company entered into the Third Amendment to the ALZN002 License, on January 24, 2020, the Company entered into the Fourth Amendment
to the ALZN002 License, on March 30, 2021, the Company entered into the Fifth Amendment to the ALZN002 License, on April 17, 2023, the
Company entered into the Sixth Amendment to the ALZN002 License and on December 11, 2023, the Company entered into the Seventh Amendment
to the ALZN002 License (collectively, the “ALZN002 License Agreement”). The Seventh Amendment to the ALZN002 License modified
the timing of the payments of the license fees.
The
ALZN002 License Agreement requires the Company to pay royalty payments of 4% on net sales of products developed from the licensed
technology for ALZN002. The Company has already paid an initial license fee of $200,000 for ALZN002. As an additional licensing
fee for the license of ALZN002, the Licensor received 24,012 shares of Common Stock. Minimum royalties for ALZN002 are $20,000 on
the first anniversary of the first commercial sale, $40,000 on the second anniversary of the first commercial sale and $50,000 on
the third anniversary of the first commercial sale and every year thereafter, for the life of the ALZN002 License Agreement.
On
November 19, 2019, the Company entered into two Standard Exclusive License Agreements with Sublicensing Terms for two additional indications
of AL001 with the Licensor (the “November AL001 License”), pursuant to which the Licensor granted the Company a royalty bearing
exclusive worldwide licenses limited to the fields of (i) neurodegenerative diseases excluding Alzheimer’s and (ii) psychiatric
diseases and disorders. On March 30, 2021, the Company entered into the First Amendments to the November AL001 License and on April 17,
2023, the Company entered into the Second Amendments to the November AL001 License (collectively, the “November AL001 License Agreements”).
The Second Amendments to the November AL001 License modified the timing of the payments for the license fees.
The
November AL001 License Agreements require the Company to pay royalty payments of 3% on net sales of products developed from
the licensed technology for AL001 in those fields. The Company paid an initial license fee of $20,000 for the additional indications.
Minimum royalties for November AL001 License Agreements are $40,000 on the first anniversary of the first commercial sale, $80,000 on
the second anniversary of the first commercial sale and $100,000 on the third anniversary of the first commercial sale and every
year thereafter, for the life of the November AL001 License Agreements.
These
license agreements have an indefinite term that continue until the later of the date no licensed patent under the applicable agreement
remains a pending application or enforceable patent, the end date of any period of market exclusivity granted by a governmental regulatory
body, or the date on which the Company’s obligations to pay royalties expire under the applicable license agreement. Under the various
license agreements, if the Company fails to meet a milestone by its specified date, Licensor may terminate the license agreement. The
Licensor was also granted a preemptive right to acquire such shares or other equity securities that may be issued from time to time by
the Company while the Licensor remains the owner of any equity securities of the Company.
Additionally,
the Company is required to complete milestones and make payments on the due dates to the Licensor for the license of the AL001 technologies
and for the ALZN002 technology, as follows:
Original AL001 Licenses:
|
Schedule of contractual obligation, fiscal year maturity |
|
|
|
|
Payment |
|
Due Date |
|
Event |
$ |
50,000 |
* |
Completed September 2019 |
|
Pre-IND meeting |
|
|
|
|
|
|
$ |
65,000 |
* |
Completed June 2021 |
|
IND application filing |
|
|
|
|
|
|
$ |
190,000 |
* |
Completed December 2021 |
|
Upon first dosing of patient in a clinical trial |
|
|
|
|
|
|
$ |
500,000 |
* |
Completed March 2022 |
|
Upon completion of first clinical trial |
|
|
|
|
|
|
$ |
1,250,000 |
|
March 2025 |
|
Upon first patient treated in a Phase III clinical trial |
|
|
|
|
|
|
$ |
10,000,000 |
|
8 years from the effective date of the agreement |
|
Upon FDA new drug application approval |
| * | Milestone met and payment made |
ALZN002 License:
Payment |
|
Due Date |
$ |
50,000 |
* |
Completed January 2022 |
|
|
|
|
$ |
50,000 |
|
Upon first dosing of patient in first Phase I clinical trial |
|
|
|
|
$ |
500,000 |
|
Upon completion of first Phase IIB clinical trial |
|
|
|
|
$ |
1,000,000 |
|
Upon first patient treated in a Phase III clinical trial |
|
|
|
|
$ |
10,000,000 |
|
Upon first commercial sale |
| * | Milestone met and payment made |
Additional
AL001 Licenses:
Payment |
|
Due Date |
|
Event |
$ |
2,000,000 |
|
March 2026 |
|
Upon first patient treated in a Phase III clinical trial |
|
|
|
|
|
|
$ |
16,000,000 |
|
August 1, 2029 |
|
First commercial sale |
|
X |
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- DefinitionThe entire disclosure for commitments and contingencies.
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v3.24.2.u1
EQUITY TRANSACTIONS
|
3 Months Ended |
Jul. 31, 2024 |
Equity [Abstract] |
|
EQUITY TRANSACTIONS |
The
Company is authorized to issue 10,000,000 shares of Preferred Stock, $0.0001 par value. The Board has designated 3,000 shares as Series
A Convertible Preferred Stock and 6,000 shares as Series B Convertible Preferred Stock. The rights, preferences, privileges and restrictions
on the remaining authorized 9,991,000 shares of Preferred Stock have not been determined. The Board is authorized to create a new series
of preferred shares and determine the number of shares, as well as the rights, preferences, privileges and restrictions granted to or
imposed upon any series of preferred shares.
Series A Convertible
Preferred Stock
On
May 8, 2024, the Company and Orchid entered into a securities purchase agreement (the “Orchid SPA”) for the purchase
of up to 2,500 shares of Series A Convertible Preferred Stock and warrants to purchase shares up to 2,000,000 shares of Common Stock in
several tranche closings.
On May 10, 2024, the Company
sold 100 shares of Series A Convertible Preferred Stock and warrants to purchase 80,000 shares of Common Stock with an exercise price
of $12.50, for a total purchase price of $1.0 million. The purchase price was paid by the surrender
and cancellation of a term note issued by the Company to Orchid of $311,356, consisting of $310,000 of principal and $1,356 of accrued
and unpaid interest, $100,000 discount and net cash of $588,644.
On June 25, 2024, the Company
sold 150 shares of Series A Convertible Preferred Stock and warrants to purchase 120,000 shares of Common Stock with an exercise price
of $12.50, for a total purchase price of $1.5 million. The purchase price was paid in cash.
Series B Convertible
Preferred Stock
On January 31, 2024, the
Company and Ault Lending, LLC (“Ault Lending”) entered into a securities purchase agreement (the “AL SPA”)
for the purchase of up to 6,000 shares of Series B Convertible Preferred Stock and warrants to purchase shares up to 600,000
shares of the Company’s Common Stock. The AL SPA provides that Ault Lending may purchase up to $6 million of Series B
Convertible Preferred Stock in one or more closings. Ault
Lending has the right to purchase up to $2 million of Series B Convertible Preferred Stock, on or before March 31, 2024, and the
right to purchase up to $4 million of Series B Convertible Preferred Stock after March 31, 2024, but on or before March 31, 2025
(the “Termination Date”). The Agreement will automatically terminate if the final closing has not occurred prior
to the Termination Date.
On January 31, 2024, the Company
sold 1,220 shares of Series B Convertible Preferred Stock and warrants to purchase 122,000 shares of Common Stock with an exercise price
of $12.00, for a total purchase price of $1.22 million. The purchase price was paid by the cancellation
of $1.15 million of cash advances made by Ault Lending to the Company between November 9, 2023 and January 31, 2024 and a subscription
receivable of $70,000.
On March 26, 2024, the Company
sold 780 shares of Series B Convertible Preferred Stock and warrants to purchase 78,000 shares of Common Stock with an exercise price
of $12.00, for a total purchase price of $780,000.
On April 29, 2024, the Company
sold 100 shares of Series B Convertible Preferred Stock and warrants to purchase 10,000 shares of Common Stock with an exercise price
of $12.00, for a total purchase price of $100,000.
The
Series B Convertible Preferred Stock has a stated value of $1,000 per share (“Stated
Value”) and does not accrue dividends. Each share of Series B Convertible Preferred Stock is convertible into a number of
shares of Common Stock determined by dividing the Stated Value by $10.00 (the “Conversion
Price”). The Conversion Price is subject to adjustment in the event of an issuance of Common Stock at a price per share lower than
the Conversion Price then in effect, as well as upon customary stock splits, stock dividends, combinations or similar events. The holders
of the Series B Convertible Preferred Stock are entitled to vote with the Common Stock as a single class on an as-converted basis, subject
to applicable law provisions of the Delaware General Company Law and Nasdaq, provided, however, that for purposes of complying with Nasdaq
regulations, the conversion price, for purposes of determining the number of votes the holder of Series B Convertible Preferred Stock
is entitled to cast, shall not be lower than $8.73 (the “Voting Floor Price”), which represents the closing sale price of
the Common Stock on the trading day immediately prior to the Execution Date. The Voting Floor Price shall be adjusted for stock dividends,
stock splits, stock combinations and other similar transactions. Upon a liquidation event the holders of Series B Convertible Preferred
Stock receive a liquidation preference ahead of holders of Common Stock.
The warrants have an exercise
price of $12.00 (the “Exercise Price”) and become exercisable on the first business day after the six-month anniversary of
issuance (the “Initial Exercise Date”) and have a five-year term, expiring on the fifth anniversary of the Initial Exercise
Date. The Exercise Price is subject to adjustment in the event of an issuance of Common Stock at a price per share lower than the Exercise
Price then in effect, as well as upon customary stock splits, stock dividends, combinations or similar events.
Common Stock
Orchid SPA
During the three months ended
July 31, 2024, Orchid converted 62.477 shares of Series A Convertible Preferred Stock into 173,333 shares of Common Stock.
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v3.24.2.u1
RELATED PARTY TRANSACTIONS
|
3 Months Ended |
Jul. 31, 2024 |
Related Party Transactions [Abstract] |
|
RELATED PARTY TRANSACTIONS |
| 9. | RELATED PARTY TRANSACTIONS |
In connection with the Orchid
SPA, the Company agreed to pay Ault Lending an origination fee of five percent (5%) of the total
gross proceeds we receive from Orchid upon each purchase of Series A Convertible Preferred Stock. During the three months ended July 31,
2024, origination fees due to Ault Lending were $125,000.
|
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v3.24.2.u1
SUBSEQUENT EVENTS
|
3 Months Ended |
Jul. 31, 2024 |
Subsequent Events [Abstract] |
|
SUBSEQUENT EVENTS |
On August 19, 2024, the Company
sold 200 shares of Series A Convertible Preferred Stock and warrants to purchase 160,000 shares of Common Stock with an exercise price
of $12.50 to Orchid, for a total purchase price of $2.0 million. The purchase price was paid in
cash.
On August 21, 2024, the Company
sold 250 shares of Series A Convertible Preferred Stock and warrants to purchase 200,000 shares of Common Stock with an exercise price
of $12.50 to Orchid, for a total purchase price of $2.5 million less $100,000 discount. The purchase
price was paid in cash.
From August 1, 2024 to September 10, 2024, Orchid converted 632.4909
shares of Series A Convertible Preferred Stock into 3,196,825 shares of Common Stock.
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v3.24.2.u1
SIGNIFICANT ACCOUNTING POLICIES (Policies)
|
3 Months Ended |
Jul. 31, 2024 |
Accounting Policies [Abstract] |
|
Basis of Presentation |
Basis of Presentation
The accompanying condensed
financial statements of the Company have been prepared in accordance with accounting principles generally accepted in the United States
of America (“U.S. GAAP”) and the rules of the Securities and Exchange Commission (“SEC”) applicable to interim
reports of companies filing as a smaller reporting company. These condensed financial statements should be read in conjunction with the
audited financial statements and notes thereto contained in the Company’s Report on Form 10-K for the year ended April 30, 2024,
filed with the SEC on July 30, 2024. In the opinion of management, the accompanying condensed interim financial statements include all
adjustments necessary in order to make the condensed financial statements not misleading. The results of operations for interim periods
are not necessarily indicative of the results to be expected for the full year or any other future period. Certain notes to the condensed
financial statements that would substantially duplicate the disclosures contained in the audited financial statements for the most recent
fiscal year as reported in the Company’s Report on Form 10-K have been omitted. The accompanying condensed balance sheet at April
30, 2024 has been derived from the audited balance sheet at April 30, 2024 contained in such Form 10-K.
|
Accounting Estimates |
Accounting Estimates
The preparation of condensed
financial statements, in conformity with U.S. GAAP, requires management to make estimates and assumptions that affect the reported amounts
of assets and liabilities and disclosure of contingent assets and liabilities at the date of the condensed financial statements and the
reported amounts of expenses during the reporting period. The Company’s significant accounting policies that involve significant
judgment and estimates include stock-based compensation, warrant valuation, and valuation of deferred income taxes. Actual results could
differ from those estimates.
|
Cash and Cash Equivalents |
Cash and Cash Equivalents
The Company considers all
highly liquid investments with a remaining maturity of three months or less when purchased to be cash equivalents. As of July 31, 2024
and April 30, 2024, the Company had no cash equivalents.
|
Fair Value of Financial Instruments |
Fair Value of Financial
Instruments
Financial Accounting Standards
Board (“FASB”) Accounting Standards Codification (“ASC”) 820, Fair Value Measurement, defines fair value
as the exchange price that would be received for an asset or paid to transfer a liability (an exit price) in the principal or most advantageous
market for the asset or liability in an orderly transaction between market participants on the measurement date. Valuation techniques
used to measure fair value must maximize the use of observable inputs and minimize the use of unobservable inputs. The fair value hierarchy
is based on three levels of inputs that may be used to measure fair value, of which the first two are considered observable and the last
is considered unobservable:
Level 1: Quoted prices in
active markets for identical assets or liabilities.
Level 2: Inputs other than
Level 1 that are observable, either directly or indirectly, such as quoted prices for similar assets or liabilities; quoted prices in
markets that are not active; or other inputs that are observable or can be corroborated by observable market data for substantially the
full term of the assets or liabilities.
Level 3 assumptions: Unobservable
inputs that are supported by little or no market activity and that are significant to the fair value of the assets or liabilities including
liabilities resulting from imbedded derivatives associated with certain warrants to purchase Common Stock.
The fair values of warrants
are determined using the Black-Scholes valuation model, a “Level 3” fair value measurement, based on the estimated fair value
of Common Stock, volatility based on the historical volatility data of similar companies, considering the industry, products and market
capitalization of such other entities, the expected life based on the remaining contractual term of the warrants and the risk free interest
rate based on the implied yield available on U.S. Treasury Securities with a maturity equivalent to the warrants’ contractual life.
|
Property and Equipment, Net |
Property and Equipment,
Net
Property and equipment
are stated at cost, net of accumulated depreciation. Depreciation is computed using the straight-line method over the estimated
useful life of 5 five years. Significant additions and improvements are capitalized, while repairs and maintenance are charged to
expense as incurred.
|
Research and Development Expenses |
Research and Development
Expenses
Research and development costs
are expensed as incurred. Research and development costs consist of scientific consulting fees, clinical trial fees and lab supplies,
as well as fees paid to other entities that conduct certain research and development activities on behalf of the Company.
The Company has acquired and
may continue to acquire the rights to develop and commercialize new product candidates from third parties. The upfront payments to acquire
license, products or rights, as well as any future milestone payments, are immediately recognized as research and development expenses,
provided that there is no alternative future use of the rights in other research and development projects.
|
Stock-Based Compensation |
Stock-Based Compensation
The Company recognizes stock-based
compensation expense for stock options on a straight-line basis over the requisite service period and account for forfeitures as they
occur. The Company’s stock-based compensation costs are based upon the grant date fair value of options estimated using the Black-Scholes
option pricing model. To the extent any stock option grants are made subject to the achievement of a performance-based milestone, management
evaluates when the achievement of any such performance-based milestone is probable based on the relative satisfaction of the performance
conditions as of the reporting date.
The Company recognizes stock-based
compensation expense for restricted stock units on a straight-line basis over the requisite service period and account for forfeitures
as they occur. The Company’s stock-based compensation for restricted stocks is based upon the estimated fair value of the Common
Stock.
The Black-Scholes option pricing
model utilizes inputs which are highly subjective assumptions and generally require significant judgment. Certain of such assumptions
involve inherent uncertainties and the application of significant judgment. As a result, if factors or expected outcomes change and the
Company uses significantly different assumptions or estimates, the Company’s stock-based compensation could be materially different.
|
Warrants |
Warrants
The Company accounts for stock
warrants as either equity instruments, derivative liabilities, or liabilities in accordance with FASB ASC 480, Distinguishing
Liabilities from Equity and FASB ASC 815, Derivatives and Hedging (“ASC 815”), depending on the
specific terms of the warrant agreement.
Based on the terms of the
Company’s warrant agreements, the Company accounted for the warrants as equity instruments as the warrants were indexed to the Common
Stock, required settlement in shares and would be classified as equity under ASC 815.
|
Loss per Common Share |
Loss per Common Share
The Company utilizes FASB
ASC 260, Earnings per Share. Basic loss per share is computed by dividing loss available to common stockholders by the weighted-average
number of common shares outstanding. Diluted loss per share is computed similar to basic loss per share except that the denominator is
increased to include the number of additional common shares that would have been outstanding if the potential common shares had been issued
and if the additional common shares were dilutive. Diluted loss per common share reflects the potential dilution that could occur if convertible
preferred stock, options and warrants were to be exercised or converted or otherwise resulted in the issuance of Common Stock that then
shared in the earnings of the entity.
Since the effects of outstanding
stock options, restricted stock units and warrants are anti-dilutive in the periods presented, shares of Common Stock underlying these
instruments have been excluded from the computation of loss per common share.
The following sets forth the
number of shares of Common Stock underlying outstanding stock options, restricted stock units and warrants that have been excluded from
the computation of loss per common share:
Schedule of antidilutive securities excluded from computation of earnings per share | |
| | | |
| | |
| |
For the Three Months Ended July 31, | |
| |
2024 | | |
2023 | |
Stock options (1) | |
| 116,999 | | |
| 121,055 | |
Restricted stock units | |
| 167 | | |
| 333 | |
Warrants | |
| 438,879 | | |
| 67,665 | |
| |
| 556,045 | | |
| 189,053 | |
| (1) | The Company has excluded 10,000 stock options for the three months ended July 31, 2024 and 2023, with
an exercise price of $0.06, from its anti-dilutive securities as these shares have been included in our determination of basic loss per
share as they represent shares issuable for little or no cash consideration upon the satisfaction of certain conditions pursuant to FASB
ASC 260-10-45-14. |
|
Recent Accounting Standards |
Recent Accounting Standards
From time to time, new accounting
pronouncements are issued by the FASB and adopted by the Company as of the specified effective date. Unless otherwise discussed, the impact
of recently issued standards that are not yet effective are not expected to have a material impact on the Company’s financial position
or results of operations upon adoption.
Management has considered
all other recently issued accounting standards and does not believe the adoption of such standards will have a material impact on its
condensed financial statements.
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v3.24.2.u1
SIGNIFICANT ACCOUNTING POLICIES (Tables)
|
3 Months Ended |
Jul. 31, 2024 |
Accounting Policies [Abstract] |
|
Schedule of antidilutive securities excluded from computation of earnings per share |
Schedule of antidilutive securities excluded from computation of earnings per share | |
| | | |
| | |
| |
For the Three Months Ended July 31, | |
| |
2024 | | |
2023 | |
Stock options (1) | |
| 116,999 | | |
| 121,055 | |
Restricted stock units | |
| 167 | | |
| 333 | |
Warrants | |
| 438,879 | | |
| 67,665 | |
| |
| 556,045 | | |
| 189,053 | |
| (1) | The Company has excluded 10,000 stock options for the three months ended July 31, 2024 and 2023, with
an exercise price of $0.06, from its anti-dilutive securities as these shares have been included in our determination of basic loss per
share as they represent shares issuable for little or no cash consideration upon the satisfaction of certain conditions pursuant to FASB
ASC 260-10-45-14. |
|
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v3.24.2.u1
PREPAID EXPENSES AND OTHER CURRENT ASSETS (Tables)
|
3 Months Ended |
Jul. 31, 2024 |
Deferred Costs, Capitalized, Prepaid, and Other Assets Disclosure [Abstract] |
|
Schedule of prepaid expenses and other current assets |
Schedule of prepaid expenses and other current assets | |
| | | |
| | |
| |
July 31, 2024 | | |
April 30, 2024 | |
Prepaid insurance | |
$ | 209,619 | | |
$ | 60,522 | |
Other prepaid expenses | |
| 12,622 | | |
| 18,672 | |
Total prepaid expenses and other current assets | |
$ | 222,241 | | |
$ | 79,194 | |
|
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v3.24.2.u1
STOCK-BASED COMPENSATION (Tables)
|
3 Months Ended |
Jul. 31, 2024 |
Share-Based Payment Arrangement [Abstract] |
|
Schedule of share-based payment arrangement, option, activity |
Schedule of share-based payment arrangement, option, activity |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Outstanding Options |
|
|
|
Shares
Available
for Grant |
|
|
Number of
Shares |
|
|
Weighted
Average
Exercise
Price |
|
|
Weighted
Average
Remaining
Contractual
Life (years) |
|
|
Aggregate Intrinsic
Value |
|
Balance at April 30, 2024 |
|
|
62,000 |
|
|
|
98,000 |
|
|
$ |
178.12 |
|
|
|
5.22 |
|
|
$ |
70,500 |
|
Options granted |
|
|
- |
|
|
|
- |
|
|
$ |
- |
|
|
|
- |
|
|
|
|
|
Options exercised |
|
|
- |
|
|
|
- |
|
|
$ |
- |
|
|
|
- |
|
|
|
|
|
Options expired |
|
|
3,333 |
|
|
|
(3,333 |
) |
|
$ |
150.00 |
|
|
|
- |
|
|
|
|
|
Balance at July 31, 2024 |
|
|
65,333 |
|
|
|
94,667 |
|
|
$ |
179.11 |
|
|
|
5.15 |
|
|
$ |
35,100 |
|
Options vested and expected to vest at July 31, 2024 |
|
|
|
|
|
|
88,001 |
|
|
$ |
179.39 |
|
|
|
4.91 |
|
|
$ |
35,100 |
|
Options exercisable at July 31, 2024 |
|
|
|
|
|
|
87,043 |
|
|
$ |
178.72 |
|
|
|
4.88 |
|
|
$ |
35,100 |
|
|
Schedule of nonvested restricted stock units activity |
Schedule of nonvested restricted stock units activity |
|
|
|
|
|
|
|
|
|
|
Shares |
|
|
Weighted Average
Grant Date Fair Value |
|
Unvested at April 30, 2024 |
|
|
167 |
|
|
$ |
375.00 |
|
Granted |
|
|
- |
|
|
|
- |
|
Vested |
|
|
- |
|
|
|
- |
|
Cancelled |
|
|
- |
|
|
|
- |
|
Unvested at July 31, 2024 |
|
|
167 |
|
|
$ |
375.00 |
|
|
Schedule of stock-based compensation |
Schedule of stock-based compensation | |
| | |
| |
| |
For the Three Months Ended July 31, | |
| |
2024 | | |
2023 | |
General and administrative | |
$ | 81,277 | | |
$ | 369,380 | |
|
X |
- DefinitionTabular disclosure of share-based payment arrangement.
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v3.24.2.u1
WARRANTS (Tables)
|
3 Months Ended |
Jul. 31, 2024 |
Warrants |
|
Schedule of warrant activity |
Schedule of warrant activity |
|
|
|
|
|
|
|
|
|
Number
Outstanding |
|
|
Weighted Average
Exercise Price |
|
Outstanding at April 30, 2024 |
|
|
240,449 |
|
|
$67.45 |
|
Granted |
|
|
200,000 |
|
|
$12.50 |
|
Cancelled/Expired |
|
|
(1,570 |
) |
|
$450.14 |
|
Outstanding at July 31, 2024 |
|
|
438,879 |
|
|
$106.96 |
|
|
Schedule of common stock warrants outstanding |
Schedule of common stock warrants outstanding |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Outstanding |
|
|
Exercisable |
|
|
|
|
|
|
|
Weighted |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Average |
|
|
Weighted |
|
|
|
|
|
Weighted |
|
|
|
|
|
|
|
Remaining |
|
|
Average |
|
|
|
|
|
Average |
|
Exercise |
|
|
Number |
|
|
Contractual |
|
|
Exercise |
|
|
Number |
|
|
Exercise |
|
Price |
|
|
Outstanding |
|
|
Life (years) |
|
|
Price |
|
|
Exercisable |
|
|
Price |
|
$12.00-$12.50 |
|
|
|
410,000 |
|
|
|
4.9 |
|
|
$ |
12.24 |
|
|
|
322,000 |
|
|
$ |
12.31 |
|
$262.50 |
|
|
|
1,076 |
|
|
|
0.3 |
|
|
$ |
262.50 |
|
|
|
1,076 |
|
|
$ |
262.50 |
|
$450.00 |
|
|
|
27,395 |
|
|
|
1.8 |
|
|
$ |
450.00 |
|
|
|
27,395 |
|
|
$ |
450.00 |
|
$937.50 |
|
|
|
408 |
|
|
|
1.9 |
|
|
$ |
937.50 |
|
|
|
408 |
|
|
$ |
937.50 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
$12.00 - $937.50 |
|
|
|
438,879 |
|
|
|
4.7 |
|
|
$ |
41.04 |
|
|
|
350,879 |
|
|
$ |
48.33 |
|
|
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v3.24.2.u1
COMMITMENTS AND CONTINGENCIES (Tables)
|
3 Months Ended |
Jul. 31, 2024 |
Commitments and Contingencies Disclosure [Abstract] |
|
Schedule of contractual obligation, fiscal year maturity |
|
Schedule of contractual obligation, fiscal year maturity |
|
|
|
|
Payment |
|
Due Date |
|
Event |
$ |
50,000 |
* |
Completed September 2019 |
|
Pre-IND meeting |
|
|
|
|
|
|
$ |
65,000 |
* |
Completed June 2021 |
|
IND application filing |
|
|
|
|
|
|
$ |
190,000 |
* |
Completed December 2021 |
|
Upon first dosing of patient in a clinical trial |
|
|
|
|
|
|
$ |
500,000 |
* |
Completed March 2022 |
|
Upon completion of first clinical trial |
|
|
|
|
|
|
$ |
1,250,000 |
|
March 2025 |
|
Upon first patient treated in a Phase III clinical trial |
|
|
|
|
|
|
$ |
10,000,000 |
|
8 years from the effective date of the agreement |
|
Upon FDA new drug application approval |
| * | Milestone met and payment made |
ALZN002 License:
Payment |
|
Due Date |
$ |
50,000 |
* |
Completed January 2022 |
|
|
|
|
$ |
50,000 |
|
Upon first dosing of patient in first Phase I clinical trial |
|
|
|
|
$ |
500,000 |
|
Upon completion of first Phase IIB clinical trial |
|
|
|
|
$ |
1,000,000 |
|
Upon first patient treated in a Phase III clinical trial |
|
|
|
|
$ |
10,000,000 |
|
Upon first commercial sale |
| * | Milestone met and payment made |
Additional
AL001 Licenses:
Payment |
|
Due Date |
|
Event |
$ |
2,000,000 |
|
March 2026 |
|
Upon first patient treated in a Phase III clinical trial |
|
|
|
|
|
|
$ |
16,000,000 |
|
August 1, 2029 |
|
First commercial sale |
|
X |
- DefinitionTabular disclosure of contractual obligation by timing of payment due. Includes, but is not limited to, long-term debt obligation, lease obligation, and purchase obligation.
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SIGNIFICANT ACCOUNTING POLICIES (Details) - shares
|
3 Months Ended |
Jul. 31, 2024 |
Jul. 31, 2023 |
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] |
|
|
|
Antidilutive securities excluded from computation of earnings per share, amount |
|
556,045
|
189,053
|
Equity Option [Member] |
|
|
|
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] |
|
|
|
Antidilutive securities excluded from computation of earnings per share, amount |
[1] |
116,999
|
121,055
|
Restricted Stock Units (RSUs) [Member] |
|
|
|
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] |
|
|
|
Antidilutive securities excluded from computation of earnings per share, amount |
|
167
|
333
|
Warrant [Member] |
|
|
|
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] |
|
|
|
Antidilutive securities excluded from computation of earnings per share, amount |
|
438,879
|
67,665
|
|
|
X |
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v3.24.2.u1
PREPAID EXPENSES AND OTHER CURRENT ASSETS (Details) - USD ($)
|
Jul. 31, 2024 |
Apr. 30, 2024 |
Deferred Costs, Capitalized, Prepaid, and Other Assets Disclosure [Abstract] |
|
|
Prepaid insurance |
$ 209,619
|
$ 60,522
|
Other prepaid expenses |
12,622
|
18,672
|
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$ 222,241
|
$ 79,194
|
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v3.24.2.u1
STOCK-BASED COMPENSATION (Details)
|
3 Months Ended |
Jul. 31, 2024
USD ($)
$ / shares
shares
|
Share-Based Payment Arrangement [Abstract] |
|
Shares available for grant begining (in shares) |
62,000
|
Number of shares begining (in shares) |
98,000
|
Weighted average exercise price begining (in dollars per share) | $ / shares |
$ 178.12
|
Weighted average remaining contractual life begining (years) |
5 years 2 months 19 days
|
Aggregate intrinsic value begining | $ |
$ 70,500
|
Shares available for grant, Options granted |
|
Number of shares, Options granted |
|
Weighted average exercise price, Options granted | $ / shares |
|
Shares available for grant, Options exercised |
|
Number of shares, Options exercised |
|
Weighted average exercise price, Options exercised | $ / shares |
|
Shares available for grant, Options expired |
3,333
|
Number of shares, Options expired |
(3,333)
|
Weighted average exercise price, Options expired | $ / shares |
$ 150.00
|
Shares available for grant end (in shares) |
65,333
|
Number of shares end (in shares) |
94,667
|
Weighted average exercise price end (in dollars per share) | $ / shares |
$ 179.11
|
Weighted average remaining contractual life end (years) |
5 years 1 month 24 days
|
Aggregate intrinsic value end | $ |
$ 35,100
|
Number of shares, Options vested and expected to vest at end |
88,001
|
Weighted average exercise price, Options vested and expected to vest at end | $ / shares |
$ 179.39
|
Weighted average remaining contractual life, Options vested and expected to vest at end |
4 years 10 months 28 days
|
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$ 35,100
|
Number of shares, Options exercisable at end |
87,043
|
Weighted average exercise price, Options exercisable at end | $ / shares |
$ 178.72
|
Weighted average remaining contractual life, Options exercisable at end |
4 years 10 months 17 days
|
Aggregate intrinsic value, Options exercisable at end | $ |
$ 35,100
|
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v3.24.2.u1
STOCK-BASED COMPENSATION (Details 1)
|
3 Months Ended |
Jul. 31, 2024
$ / shares
shares
|
Share-Based Payment Arrangement [Abstract] |
|
Unvested shares, Beginning balance | shares |
167
|
Unvested Weighted Average Grant Date Fair Value, Beginning balance | $ / shares |
$ 375.00
|
Unvested shares, Granted | shares |
|
Unvested Weighted Average Grant Date Fair Value, Granted | $ / shares |
|
Unvested shares, Vested | shares |
|
Unvested Weighted Average Grant Date Fair Value, Vested | $ / shares |
|
Unvested shares, Cancelled | shares |
|
Unvested Weighted Average Grant Date Fair Value, Cancelled | $ / shares |
|
Unvested shares, Ending balance | shares |
167
|
Unvested Weighted Average Grant Date Fair Value, Ending balance | $ / shares |
$ 375.00
|
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- DefinitionThe number of equity-based payment instruments, excluding stock (or unit) options, that were forfeited during the reporting period.
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v3.24.2.u1
STOCK-BASED COMPENSATION (Details Narrative) - USD ($)
|
|
|
|
3 Months Ended |
Nov. 26, 2019 |
Mar. 01, 2019 |
Apr. 30, 2016 |
Jul. 31, 2024 |
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] |
|
|
|
|
Options granted |
|
|
|
|
Unamortized Stock Based Compensation [Member] |
|
|
|
|
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] |
|
|
|
|
Unamortized stock-based compensation expense related to unvested employee and non-employee awards |
|
|
|
$ 287,000
|
Stock Based Compensation [Member] |
|
|
|
|
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] |
|
|
|
|
Weighted-average period |
|
|
|
1 year 1 month 6 days
|
Perfromance Contingent Stock Options [Member] | Key Employees and Director [Member] |
|
|
|
|
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] |
|
|
|
|
Options granted |
28,333
|
|
|
|
Terms of award |
In the event any
of the stock price milestones are not achieved within three years
|
|
|
|
Stock Incentive Plan2016 [Member] |
|
|
|
|
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] |
|
|
|
|
Share-based compensation arrangement by share-based payment award, number of shares authorized |
|
|
83,333
|
|
Share-based compensation arrangement by share-based payment award, number of additional shares authorized |
|
50,000
|
|
|
Stock Incentive Plan2016 [Member] | Maximum [Member] |
|
|
|
|
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] |
|
|
|
|
Share-based compensation arrangement by share-based payment award, expiration period |
|
|
10 years
|
|
X |
- DefinitionAmount of cost not yet recognized for nonvested award under share-based payment arrangement.
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|
3 Months Ended |
Jul. 31, 2024
$ / shares
shares
|
Warrants |
|
Class of Warrant or Right, Outstanding, Beginning | shares |
240,449
|
Weighted Average Exercise Price, Beginning | $ / shares |
$ 67.45
|
Class of Warrant or Right, Outstanding, Granted | shares |
200,000
|
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$ 12.50
|
Class of Warrant or Right, Outstanding, Cancelled/Expired | shares |
(1,570)
|
Weighted Average Exercise Price, Cancelled/Expired | $ / shares |
$ 450.14
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438,879
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v3.24.2.u1
WARRANTS (Details 1) - $ / shares
|
Aug. 21, 2024 |
Aug. 19, 2024 |
Jul. 31, 2024 |
Apr. 30, 2024 |
Share-Based Payment Arrangement, Option, Exercise Price Range [Line Items] |
|
|
|
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$ 12.50
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$ 12.50
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$ 106.96
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$ 67.45
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|
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438,879
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240,449
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$12.00 [Member] |
|
|
|
|
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|
|
|
|
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|
|
410,000
|
|
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|
|
4 years 10 months 24 days
|
|
Warrant outstanding, weighted average exercise price (in dollars per share) |
|
|
$ 12.24
|
|
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|
|
322,000
|
|
Warrant exercisable, weighted average exercise price (in dollars per share) |
|
|
$ 12.31
|
|
$12.00 [Member] | Minimum [Member] |
|
|
|
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|
|
|
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12.00
|
|
$12.00 [Member] | Maximum [Member] |
|
|
|
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|
|
|
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|
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12.50
|
|
$262.50 [Member] |
|
|
|
|
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|
|
|
|
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|
|
$ 262.50
|
|
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|
|
1,076
|
|
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|
|
3 months 18 days
|
|
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|
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$ 262.50
|
|
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|
1,076
|
|
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|
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$ 262.50
|
|
$450.00 [Member] |
|
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|
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|
$ 450.00
|
|
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|
|
27,395
|
|
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|
|
1 year 9 months 18 days
|
|
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|
|
$ 450.00
|
|
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|
|
27,395
|
|
Warrant exercisable, weighted average exercise price (in dollars per share) |
|
|
$ 450.00
|
|
$937.50 [Member] |
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|
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|
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$ 937.50
|
|
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|
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408
|
|
Weighted average remaining contractual life (years) |
|
|
1 year 10 months 24 days
|
|
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|
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$ 937.50
|
|
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|
408
|
|
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|
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438,879
|
|
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|
|
4 years 8 months 12 days
|
|
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|
|
$ 41.04
|
|
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|
|
350,879
|
|
Warrant exercisable, weighted average exercise price (in dollars per share) |
|
|
$ 48.33
|
|
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v3.24.2.u1
WARRANTS (Details Narrative) - USD ($)
|
|
1 Months Ended |
3 Months Ended |
|
|
|
May 10, 2024 |
Jun. 25, 2024 |
Jul. 31, 2024 |
Aug. 21, 2024 |
Aug. 19, 2024 |
Apr. 30, 2024 |
Exercise price (in dollars per share) |
|
|
$ 106.96
|
$ 12.50
|
$ 12.50
|
$ 67.45
|
Warrant 2024 [Member] |
|
|
|
|
|
|
Aggregate number of stock repurchase |
80,000
|
120,000
|
200,000
|
|
|
|
Exercise price (in dollars per share) |
$ 12.50
|
$ 12.50
|
$ 12.50
|
|
|
|
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|
$ 1,500,000
|
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COMMITMENTS AND CONTINGENCIES (Details)
|
3 Months Ended |
Jul. 31, 2024
USD ($)
|
Pre Ind Meeting [Member] | A L001 License [Member] |
|
Product Liability Contingency [Line Items] |
|
Payment |
$ 50,000
|
Due date |
Completed September 2019
|
Ind Application Filing [Member] | A L001 License [Member] |
|
Product Liability Contingency [Line Items] |
|
Payment |
$ 65,000
|
Due date |
Completed June 2021
|
Upon First Dosing of Patient in Clinical Trial [Member] | A L001 License [Member] |
|
Product Liability Contingency [Line Items] |
|
Payment |
$ 190,000
|
Due date |
Completed December 2021
|
Upon Completion of First Clinical Trial [Member] | A L001 License [Member] |
|
Product Liability Contingency [Line Items] |
|
Payment |
$ 500,000
|
Due date |
Completed March 2022
|
Upon First Patient Treated In A Phase III Clinical [Member] | A L001 License [Member] |
|
Product Liability Contingency [Line Items] |
|
Payment |
$ 1,250,000
|
Due date |
March 2025
|
Upon First Patient Treated In A Phase III Clinical [Member] | Additional A L001 License [Member] |
|
Product Liability Contingency [Line Items] |
|
Payment |
$ 2,000,000
|
Due date |
March 2026
|
Upon Fda Approval [Member] | A L001 License [Member] |
|
Product Liability Contingency [Line Items] |
|
Payment |
$ 10,000,000
|
Due date |
8 years from the effective date of the agreement
|
Upon IND Application Filing [Member] | ALZN002 License [Member] |
|
Product Liability Contingency [Line Items] |
|
Payment |
$ 50,000
|
Due date |
Completed January 2022
|
Upon First Dosing Of Patient In First Phase I Clinical Trial [Member] | ALZN002 License [Member] |
|
Product Liability Contingency [Line Items] |
|
Payment |
$ 50,000
|
Due date |
Upon first dosing of patient in first Phase I clinical trial
|
Upon Completion Of First Phase II Clinical Trial [Member] | ALZN002 License [Member] |
|
Product Liability Contingency [Line Items] |
|
Payment |
$ 500,000
|
Due date |
Upon completion of first Phase IIB clinical trial
|
Upon First Patient Treated In Phase III Clinical Trial [Member] | ALZN002 License [Member] |
|
Product Liability Contingency [Line Items] |
|
Payment |
$ 1,000,000
|
Due date |
Upon first patient treated in a Phase III clinical trial
|
Upon FDA BLA Approval [Member] | ALZN002 License [Member] |
|
Product Liability Contingency [Line Items] |
|
Payment |
$ 10,000,000
|
Due date |
Upon first commercial sale
|
First Commercial Sale [Member] | Additional A L001 License [Member] |
|
Product Liability Contingency [Line Items] |
|
Payment |
$ 16,000,000
|
Due date |
August 1, 2029
|
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v3.24.2.u1
COMMITMENTS AND CONTINGENCIES (Details Narrative) - USD ($)
|
|
|
1 Months Ended |
Jul. 02, 2018 |
May 02, 2016 |
Nov. 19, 2019 |
A L001 License [Member] |
|
|
|
Product Liability Contingency [Line Items] |
|
|
|
Percentage of royalty payments on net sales of product |
4.50%
|
|
|
Description of licenses agreements |
The Company has already paid an initial license fee of $200,000 for AL001. As an additional
licensing fee for the license of the AL001 technologies, the Licensor received 14,853 shares of Common Stock. Minimum royalties for
AL001 License Agreements are $40,000 on the first anniversary of the first commercial sale, $80,000 on the second anniversary
of the first commercial sale and $100,000 on the third anniversary of the first commercial sale and every year thereafter, for the
life of the AL001 License Agreements.
|
|
|
Initial license fees |
$ 200,000
|
|
|
A L001 License [Member] | First Anniversary [Member] |
|
|
|
Product Liability Contingency [Line Items] |
|
|
|
Payments for royalties |
40,000
|
|
|
A L001 License [Member] | Second Anniversary [Member] |
|
|
|
Product Liability Contingency [Line Items] |
|
|
|
Payments for royalties |
80,000
|
|
|
A L001 License [Member] | Third Anniversary [Member] |
|
|
|
Product Liability Contingency [Line Items] |
|
|
|
Payments for royalties |
$ 100,000
|
|
|
ALZN002 License [Member] |
|
|
|
Product Liability Contingency [Line Items] |
|
|
|
Percentage of royalty payments on net sales of product |
|
4.00%
|
|
Description of licenses agreements |
|
The Company has already paid an initial license fee of $200,000 for ALZN002. As an additional licensing
fee for the license of ALZN002, the Licensor received 24,012 shares of Common Stock. Minimum royalties for ALZN002 are $20,000 on
the first anniversary of the first commercial sale, $40,000 on the second anniversary of the first commercial sale and $50,000 on
the third anniversary of the first commercial sale and every year thereafter, for the life of the ALZN002 License Agreement.
|
|
Initial license fees |
|
$ 200,000
|
|
ALZN002 License [Member] | First Anniversary [Member] |
|
|
|
Product Liability Contingency [Line Items] |
|
|
|
Payments for royalties |
|
20,000
|
|
ALZN002 License [Member] | Second Anniversary [Member] |
|
|
|
Product Liability Contingency [Line Items] |
|
|
|
Payments for royalties |
|
40,000
|
|
ALZN002 License [Member] | Third Anniversary [Member] |
|
|
|
Product Liability Contingency [Line Items] |
|
|
|
Payments for royalties |
|
$ 50,000
|
|
Additional A L001 License [Member] |
|
|
|
Product Liability Contingency [Line Items] |
|
|
|
Percentage of royalty payments on net sales of product |
|
|
3.00%
|
Initial license fees |
|
|
$ 20,000
|
Additional A L001 License [Member] | First Anniversary [Member] |
|
|
|
Product Liability Contingency [Line Items] |
|
|
|
Payments for royalties |
|
|
40,000
|
Additional A L001 License [Member] | Second Anniversary [Member] |
|
|
|
Product Liability Contingency [Line Items] |
|
|
|
Payments for royalties |
|
|
80,000
|
Additional A L001 License [Member] | Third Anniversary [Member] |
|
|
|
Product Liability Contingency [Line Items] |
|
|
|
Payments for royalties |
|
|
$ 100,000
|
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v3.24.2.u1
EQUITY TRANSACTIONS (Details Narrative) - USD ($)
|
|
|
1 Months Ended |
3 Months Ended |
|
May 10, 2024 |
May 08, 2024 |
Sep. 10, 2024 |
Aug. 21, 2024 |
Aug. 19, 2024 |
Jun. 25, 2024 |
Apr. 29, 2024 |
Apr. 26, 2024 |
Mar. 26, 2024 |
Jan. 31, 2024 |
Jul. 31, 2024 |
Apr. 30, 2024 |
Class of Stock [Line Items] |
|
|
|
|
|
|
|
|
|
|
|
|
Preferred stock, shares authorized |
|
|
|
|
|
|
|
|
|
|
10,000,000
|
|
Preferred stock, par value (in dollars per share) |
|
|
|
|
|
|
|
|
|
|
$ 0.0001
|
$ 0.0001
|
Exercise price |
|
|
|
$ 12.50
|
$ 12.50
|
|
|
|
|
|
$ 106.96
|
67.45
|
Converted shares |
|
|
|
|
|
|
|
|
|
|
173,333
|
|
Warrant [Member] |
|
|
|
|
|
|
|
|
|
|
|
|
Class of Stock [Line Items] |
|
|
|
|
|
|
|
|
|
|
|
|
Number of common stock sold |
|
|
|
|
|
|
10,000
|
|
78,000
|
122,000
|
|
|
Securities Purchase Agreements [Member] |
|
|
|
|
|
|
|
|
|
|
|
|
Class of Stock [Line Items] |
|
|
|
|
|
|
|
|
|
|
|
|
Principal issued |
$ 311,356
|
|
|
|
|
|
|
|
|
|
|
|
Principal amount |
310,000,000
|
|
|
|
|
|
|
|
|
|
|
|
Accrued interest |
1,356,000
|
|
|
|
|
|
|
|
|
|
|
|
Discount |
100,000,000
|
|
|
|
|
|
|
|
|
|
|
|
Net cash |
$ 588,644,000
|
|
|
|
|
|
|
|
|
|
|
|
Securities Purchase Agreements [Member] | Series B Convertible Preferred Stock [Member] | Ault Lending [Member] |
|
|
|
|
|
|
|
|
|
|
|
|
Class of Stock [Line Items] |
|
|
|
|
|
|
|
|
|
|
|
|
Number of shares purchase |
|
|
|
|
|
|
|
|
|
600,000
|
|
|
Termination loans description |
|
|
|
|
|
|
|
|
|
Ault
Lending has the right to purchase up to $2 million of Series B Convertible Preferred Stock, on or before March 31, 2024, and the
right to purchase up to $4 million of Series B Convertible Preferred Stock after March 31, 2024, but on or before March 31, 2025
(the “Termination Date”).
|
|
|
Series A Preferred Stock [Member] |
|
|
|
|
|
|
|
|
|
|
|
|
Class of Stock [Line Items] |
|
|
|
|
|
|
|
|
|
|
|
|
Preferred stock, shares authorized |
|
|
|
|
|
|
|
|
|
|
9,991,000
|
|
Preferred stock, par value (in dollars per share) |
|
|
|
|
|
|
|
|
|
|
$ 0.0001
|
$ 0.0001
|
Preferred stock shares designated |
|
|
|
|
|
|
|
|
|
|
3,000
|
3,000
|
Shares purchase price |
|
|
|
$ 200,000
|
$ 160,000
|
|
|
|
|
|
|
|
Number of common stock sold |
|
|
|
250
|
200
|
|
|
|
|
|
|
|
Converted shares |
|
|
3,196,825
|
|
|
|
|
|
|
|
|
|
Series A Preferred Stock [Member] | Securities Purchase Agreements [Member] |
|
|
|
|
|
|
|
|
|
|
|
|
Class of Stock [Line Items] |
|
|
|
|
|
|
|
|
|
|
|
|
Number of shares purchase |
|
2,500
|
|
|
|
|
|
|
|
|
|
|
Series B Preferred Stock [Member] |
|
|
|
|
|
|
|
|
|
|
|
|
Class of Stock [Line Items] |
|
|
|
|
|
|
|
|
|
|
|
|
Preferred stock, par value (in dollars per share) |
|
|
|
|
|
|
|
|
|
|
$ 0.0001
|
$ 0.0001
|
Preferred stock shares designated |
|
|
|
|
|
|
|
|
|
|
6,000
|
6,000
|
Exercise price |
|
|
|
|
|
|
$ 12.00
|
|
|
$ 12.00
|
|
|
Shares purchase price |
|
|
|
|
|
|
$ 100,000
|
$ 780,000
|
|
$ 1,220,000
|
|
|
Number of common stock sold |
|
|
|
|
|
|
100
|
|
780
|
1,220
|
|
|
Cancellations of cash advances |
|
|
|
|
|
|
|
|
|
$ 1,150,000
|
|
|
Subscription receivable |
|
|
|
|
|
|
|
|
|
$ 70,000
|
|
|
Common Stock [Member] | Securities Purchase Agreements [Member] |
|
|
|
|
|
|
|
|
|
|
|
|
Class of Stock [Line Items] |
|
|
|
|
|
|
|
|
|
|
|
|
Number of shares purchase |
80,000
|
|
|
|
|
120,000
|
|
|
|
|
|
|
Exercise price |
$ 12.50
|
|
|
|
|
$ 12.50
|
|
|
|
|
|
|
Shares purchase price |
$ 1,000,000.0
|
|
|
|
|
$ 1,500,000
|
|
|
|
|
|
|
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v3.24.2.u1
SUBSEQUENT EVENTS (Details Narrative) - USD ($)
|
1 Months Ended |
3 Months Ended |
|
Sep. 10, 2024 |
Aug. 21, 2024 |
Aug. 19, 2024 |
Jul. 31, 2024 |
Apr. 30, 2024 |
Exercise price |
|
$ 12.50
|
$ 12.50
|
$ 106.96
|
$ 67.45
|
Shares converted |
|
|
|
173,333
|
|
Series A Preferred Stock [Member] |
|
|
|
|
|
Number of stock sold |
|
250
|
200
|
|
|
Shares purchase price |
|
$ 200,000
|
$ 160,000
|
|
|
Total purchase price |
|
2,500,000
|
$ 2,000,000.0
|
|
|
Discount amount |
|
$ 100,000
|
|
|
|
Shares converted |
3,196,825
|
|
|
|
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