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Share Name | Share Symbol | Market | Type |
---|---|---|---|
Rexahn Pharmaceuticals, Inc. | AMEX:RNN | AMEX | Ordinary Share |
Price Change | % Change | Share Price | High Price | Low Price | Open Price | Shares Traded | Last Trade | |
---|---|---|---|---|---|---|---|---|
0.00 | 0.00% | 5.24 | 0.00 | 01:00:00 |
Delaware
|
11-3516358
|
|
(State or other jurisdiction of incorporation or organization)
|
(I.R.S. Employer Identification Number)
|
Title of Each Class
|
Name of Each Exchange On Which Registered
|
|
Common Stock, $0.0001 par value per share
|
NYSE MKT
|
Large Accelerated Filer
|
☐
|
Accelerated Filer
|
☑
|
Non-Accelerated Filer
|
☐
|
Smaller reporting company
|
☐
|
(Do not check if a smaller reporting company)
|
Class
|
Outstanding as of February 24, 2017
|
|
Common Stock, $0.0001 par value per share
|
237,443
,785
shares
|
· |
our understandings and beliefs regarding the role of certain biological mechanisms and processes in cancer;
|
· |
our drug candidates being in early stages of development, including in pre-clinical development;
|
· |
our ability to initially develop drug candidates for orphan indications to reduce the time-to-market and take advantage of certain incentives provided by the U.S. Food and Drug Administration;
|
· |
our ability to transition from our initial focus on developing drug candidates for orphan indications to candidates for more highly prevalent indications;
|
· |
our ability to successfully and timely complete clinical trials for our drug candidates in clinical development;
|
· |
uncertainties related to the timing, results and analyses related to our drug candidates in pre-clinical development;
|
· |
our ability to obtain the necessary U.S. and international regulatory approvals for our drug candidates;
|
· |
our reliance on third-party contract research organizations and other investigators and collaborators for certain research and development services;
|
· |
our ability to maintain or engage third-party manufacturers to manufacture, supply, store and distribute supplies of our drug candidates for our clinical trials;
|
· |
our ability to form strategic alliances and partnerships with pharmaceutical companies and other partners for sales and marketing of certain of our product candidates;
|
· |
demand for and market acceptance of our drug candidates;
|
· |
the scope and validity of our intellectual property protection for our drug candidates and our ability to develop our candidates without infringing the intellectual property rights of others;
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· |
our lack of profitability and the need for additional capital to operate our business; and
|
· |
other risks and uncertainties, including those set forth herein under the caption “Risk Factors” and those detailed from time to time in our filings with the Securities and Exchange Commission.
|
Page
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||
PART I
|
1
|
|
Item 1
|
1
|
|
Item 1A
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24
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Item 1B
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43
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Item 2
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43
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Item 3
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43
|
|
Item 4
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43
|
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PART II
|
44
|
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Item 5
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44
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Item 6
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46
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Item 7
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47
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Item 7A
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59
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Item 8
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59
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Item 9
|
60
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Item 9A
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60
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Item 9B
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64
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PART III
|
||
Item 10
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65
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Item 11
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65
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Item 12
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65
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Item 13
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65
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Item 14
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65
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Item 15
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66
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67
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· |
RX-3117
is a small molecule nucleoside compound with an anti-metabolite mechanism of action, and we believe it has therapeutic potential in a broad range of cancers, including pancreatic, bladder, colon, and lung cancer. We completed an exploratory Phase I clinical study of RX-3117 that showed a level of oral bioavailability of RX-3117 in humans. In this trial, RX-3117 appeared to be safe and well tolerated with a predictable pharmacokinetic profile for an orally administered agent, with preliminary evidence of single agent activity. We are currently conducting a Phase IIa clinical trial of RX-3117 in patients with relapsed or refractory pancreatic cancer, and a Phase IIa clinical trial in patients with advanced muscle-invasive bladder cancer. RX-3117 has received “orphan drug designation” from the U.S. Food and Drug Administration (“FDA”) for pancreatic cancer. Orphan drug designation provides tax incentives for clinical research and a waiver from user fees under certain circumstances. In addition, an orphan drug generally receives seven years of exclusivity after approval for a designated use, during which time, the FDA generally cannot approve another product with the same active moiety for the same indication.
|
· |
Supinoxin
, or RX-5902, is a potential first-in-class small molecule inhibitor of phosphorylated-p68, a protein that we believe plays a key role in cancer cell growth, progression and metastasis through its interaction with beta-catenin. Phosphorylated p68, which is highly expressed in cancer cells, but not in normal cells, results in up-regulation of cancer-related genes and a subsequent proliferation of cancer cells and tumor growth. Supinoxin selectively blocks phosphorylated p68, thereby decreasing the proliferation or growth of cancer cells in preclinical models. We have evaluated Supinoxin in a Phase I dose escalation study in patients with a diverse range of metastatic, treatment-refractory tumors, including breast, ovarian, colorectal, and neuro-endocrine tumors. In February, 2017, we initiated a Phase IIa clinical study of Supinoxin in patients with metastatic triple negative breast cancer (“TNBC”).
|
· |
Archexin
is a potential best-in-class, potent inhibitor of the protein kinase Akt-1, which we believe plays a critical role in cancer cell proliferation, survival, angiogenesis, metastasis and drug resistance. Archexin has received orphan drug designation from the FDA for renal cell carcinoma (“RCC”), glioblastoma, ovarian cancer, stomach cancer and pancreatic cancer. We have completed a pilot Phase IIa clinical trial of Archexin for the treatment of pancreatic cancer. We are currently conducting a Phase IIa proof-of-concept clinical trial of Archexin in patients with metastatic renal cell carcinoma who have failed first line treatment to evaluate its safety and efficacy in combination with AFINITOR® (everolimus).
|
· |
Long-term management of cancers
: Surgery, radiation therapy or chemotherapy may not result in long-term remission, although surgery and radiation therapies are considered effective methods for some cancers. There is a need for more effective drugs and adjuvant therapies to treat relapsed and refractory cancers.
|
· |
Multi-drug resistance
: Multi-drug resistance is a major obstacle to effectively treating various cancers with chemotherapy.
|
· |
Debilitating toxicity by chemotherapy
:
Chemotherapy as a mainstay of cancer treatment can induce severe adverse reactions and toxicities, adversely affecting quality of life or life itself.
|
· |
Expedited Regulatory or Commercialization Pathways
. Drugs for life-threatening diseases such as cancer are often candidates for fast track designation, breakthrough therapy designation, priority review and accelerated approval, each of which may lead to approval sooner than would otherwise be the case.
|
· |
Favorable Environment for Formulary Access and Reimbursement
. We believe cancer drugs with proven efficacy would gain rapid market uptake, formulary listing and third-party payor reimbursement. Drugs with orphan designations are generally reimbursed by third-party payors because there are few, if any, alternatives.
|
· |
Low Marketing Costs
. We believe the marketing of new drugs to oncologists can be accomplished with a smaller sales force and lower related costs than a sales force that markets widely to primary care physicians and general practitioners.
|
· |
developing drugs;
|
· |
undertaking pre-clinical testing and human clinical trials;
|
· |
obtaining FDA and other regulatory approvals of drugs;
|
· |
formulating and manufacturing drugs; and
|
· |
launching, marketing and selling drugs.
|
· |
The federal Anti-Kickback Law, which prohibits, among other things, knowingly or willingly offering, paying, soliciting or receiving remuneration, directly or indirectly, in cash or in kind, to induce or reward the purchasing, leasing, ordering or arranging for or recommending the purchase, lease or order of any health care items or service for which payment may be made, in whole or in part, by federal healthcare programs such as Medicare and Medicaid. This statute has been interpreted to apply to arrangements between pharmaceutical companies on one hand and prescribers, purchasers and formulary managers on the other. Further, the Affordable Care Act clarified among other things that liability may be established under the federal Anti-Kickback Law without proving actual knowledge of the statute or specific intent to violate it. In addition, the Affordable Care Act amended the Social Security Act to provide that the government may assert that a claim including items or services resulting from a violation of the federal Anti-Kickback Law constitutes a false or fraudulent claim for purposes of the federal civil False Claims Act. Although there are a number of statutory exemptions and regulatory safe harbors to the federal Anti-Kickback Law protecting certain common business arrangements and activities from prosecution or regulatory sanctions, the exemptions and safe harbors are drawn narrowly, and practices that do not fit squarely within an exemption or safe harbor, or for which no exception or safe harbor is available, may be subject to scrutiny;
|
· |
The federal civil False Claims Act, which prohibits, among other things, individuals or entities from knowingly presenting, or causing to be presented, a false or fraudulent claim for payment of government funds or knowingly making, using or causing to be made or used, a false record or statement material to an obligation to pay money to the government or knowingly concealing or knowingly and improperly avoiding, decreasing or concealing an obligation to pay money to the federal government. Many pharmaceutical and other healthcare companies have been investigated and have reached substantial financial settlements with the federal government under the civil False Claims Act for a variety of alleged improper marketing activities, including: providing free product to customers with the expectation that the customers would bill federal programs for the product; providing sham consulting fees, grants, free travel and other benefits to physicians to induce them to prescribe the company’s products; and inflating prices reported to private price publication services, which are used to set drug payment rates under government healthcare programs. In addition, in recent years the government has pursued civil False Claims Act cases against a number of pharmaceutical companies for causing false claims to be submitted as a result of the marketing of their products for unapproved, and thus non-reimbursable, uses. Pharmaceutical and other healthcare companies also are subject to other federal false claim laws, including, among others, federal criminal healthcare fraud and false statement statutes that extend to non-government health benefit programs;
|
· |
Analogous state laws and regulations, such as state anti-kickback and false claims laws, may apply to items or services reimbursed under Medicaid and other state programs or, in several states, apply regardless of the payor. Some state laws also require pharmaceutical companies to report expenses relating to the marketing and promotion of pharmaceutical products and to report gifts and payments to certain healthcare providers in the states. Other states prohibit providing meals to prescribers or other marketing related activities. In addition, California, Connecticut, Nevada and Massachusetts require pharmaceutical companies to implement compliance programs or marketing codes of conduct.
|
· |
The federal Physician Payment Sunshine Act, being implemented as the Open Payments Program, requires certain pharmaceutical manufacturers to engage in extensive tracking of payments and other transfers of value to physicians and teaching hospitals, and to submit such data to the Centers for Medicare and Medicaid Services (“CMS”), which will then make all of this data publicly available on the CMS website. Pharmaceutical manufacturers with products for which payment is available under Medicare, Medicaid or the State Children’s Health Insurance Program are required to track reportable payments and must submit a report to CMS on or before the 90th day of each calendar year disclosing reportable payments made in the previous calendar year. Failure to comply with the reporting obligations may result in civil monetary penalties;
|
· |
The federal Foreign Corrupt Practices Act of 1997 and other similar anti-bribery laws in other jurisdictions generally prohibit companies and their intermediaries from providing money or anything of value to officials of foreign governments, foreign political parties, or international organizations with the intent to obtain or retain business or seek a business advantage. Recently, there has been a substantial increase in anti-bribery law enforcement activity by U.S. regulators, with more frequent and aggressive investigations and enforcement proceedings by both the Department of Justice and the U.S. Securities and Exchange Commission (the “SEC”). Violations of United States or foreign laws or regulations could result in the imposition of substantial fines, interruptions of business, loss of supplier, vendor or other third-party relationships, termination of necessary licenses and permits and other legal or equitable sanctions. Other internal or government investigations or legal or regulatory proceedings, including lawsuits brought by private litigants, may also follow as a consequence.
|
· |
continued pre-clinical development and clinical trials for our current and new drug candidates;
|
· |
finding suitable partners to help us research, develop and commercialize new drug candidates;
|
· |
efforts to seek regulatory approvals for our drug candidates;
|
· |
implementing additional internal systems and infrastructure;
|
· |
in-licensing additional technologies to develop; and
|
· |
hiring additional personnel or entering into relationships with third parties to perform functions that we are unable to perform on our own.
|
· |
conducting pre-clinical and clinical trials;
|
· |
participating in regulatory approval processes;
|
· |
formulating and manufacturing products; and
|
· |
conducting sales and marketing activities.
|
· |
a limited availability of market quotations for our securities;
|
· |
a determination that the Common Stock is a “penny stock,” which will require brokers trading in the Common Stock to adhere to more stringent rules and possibly result in a reduced level of trading activity in the secondary trading market for our securities;
|
· |
a limited amount of news and little or no analyst coverage for the Company;
|
· |
the Company would no longer qualify for exemptions from state securities registration requirements, which may require us to comply with applicable state securities laws; and
|
· |
a decreased ability to issue additional securities (including pursuant to short-form registration statements on Form S-3) or obtain additional financing in the future.
|
· |
delay or failure in reaching agreement with the FDA or a foreign regulatory authority on the design of a given trial, or in obtaining authorization to commence a trial;
|
· |
delay or failure in reaching agreement on acceptable terms with prospective contract research organizations and clinical trial sites;
|
· |
delay or failure in obtaining approval of
an IRB
to conduct a clinical trial at a given site;
|
· |
withdrawal of clinical trial sites from our clinical trials as a result of changing standards of care of the ineligibility of a site to participate;
|
· |
delay or failure in recruiting and enrolling study subjects;
|
· |
delay or failure in having subjects complete a clinical trial or return for post-treatment follow up;
|
· |
clinical sites or investigators deviating from trial protocol, failing to conduct the trial in accordance with applicable regulatory requirements, or dropping out of a trial;
|
· |
inability to identify and maintain a sufficient number of trial sites;
|
· |
failure of third-party clinical trial managers to meet their contractual obligations or deadlines;
|
· |
the need to modify a study protocol;
|
· |
unforeseen safety issues;
|
· |
emergence of dosing issues;
|
· |
lack of effectiveness during clinical trials;
|
· |
change in the standard of care of the indication being studied;
|
· |
reliance on third-party suppliers for the clinical trial supply of drug candidates;
|
· |
inability to monitor patients adequately during or after treatment;
|
· |
lack of sufficient funding to finance the clinical trials; and
|
· |
changes in governmental regulations or administrative action.
|
· |
disagreement with the design or implementation of our clinical trials;
|
· |
failure to demonstrate to the authority’s satisfaction that the product candidate is safe and effective for the proposed indication;
|
· |
failure of clinical trials to meet the level of statistical significance required for approval;
|
· |
failure to demonstrate that the product’s benefits outweigh its risks;
|
· |
disagreement with our interpretation of pre-clinical or clinical data; and
|
· |
inadequacies in the manufacturing facilities or processes of third-party manufacturers.
|
· |
awareness of a drug’s availability and benefits;
|
· |
perceptions by members of the health care community, including physicians, about the safety and effectiveness of our drugs;
|
· |
pharmacological benefit and cost-effectiveness of our products relative to competing products;
|
· |
availability of reimbursement for our products from government or other third-party payors;
|
· |
effectiveness of marketing and distribution efforts by us and our licensees and distributors, if any; and
|
· |
the price at which we sell our products.
|
· |
the federal Anti-Kickback Law prohibits persons from, among other things, knowingly and willfully soliciting, offering, receiving or providing remuneration, directly or indirectly, in cash or in kind, to induce or reward, or in return for, the referral of an individual for the furnishing or arranging for the furnishing, or the purchase, lease or order, or arranging for or recommending purchase, lease or order, any good or service for which payment may be made under a federal healthcare program such as Medicare and Medicaid;
|
· |
the federal civil False Claims Act imposes penalties, including through civil whistleblower or qui tam actions, against individuals or entities for, among other things, knowingly presenting, or causing to be presented, to the federal government, claims for payment that are false or fraudulent or making a false statement material to an obligation to pay money to the government or knowingly concealing or knowingly and improperly avoiding, decreasing, or concealing an obligation to pay money to the federal government;
|
· |
the federal Health Insurance Portability and Accountability Act of 1996, or HIPAA, imposes criminal liability for knowingly and willfully executing a scheme to defraud any healthcare benefit program, knowingly and willfully embezzling or stealing from a health care benefit program, willfully obstructing a criminal investigation of a health care offense, or knowingly and willfully making false statements relating to healthcare matters;
|
· |
HIPAA, as amended by the Health Information Technology for Economic and Clinical Health Act of 2009 and its implementing regulations, also imposes obligations on certain covered entity health care providers, health plans and health care clearinghouses as well as their business associates that perform certain services involving the use or disclosure of individually identifiable health information, including mandatory contractual terms, with respect to safeguarding the privacy, security and transmission of individually identifiable health information;
|
· |
the federal Open Payments program, created under Section 6002 of the Affordable Care Act and its implementing regulations, requires manufacturers of drugs, devices, biologics and medical supplies for which payment is available under Medicare, Medicaid or the Children’s Health Insurance Program (with certain exceptions) to report annually to the CMS information related to “payments or other transfers of value” made to physicians (defined to include doctors, dentists, optometrists, podiatrists and chiropractors) and teaching hospitals, and applicable manufacturers and applicable group purchasing organizations to report annually CMS ownership and investment interests held by physicians (as defined above) and their immediate family members; and
|
· |
analogous state and foreign laws and regulations, such as state anti-kickback and false claims laws, which may apply to sales or marketing arrangements and claims involving healthcare items or services reimbursed by non-governmental third-party payors, including private insurers; state and foreign laws that require pharmaceutical companies to comply with the pharmaceutical industry’s voluntary compliance guidelines and the relevant compliance guidance promulgated by the federal government or otherwise restrict payments that may be made to certain healthcare providers; state and foreign laws that require drug manufacturers to report information related to payments and other transfers of value to physicians and other healthcare providers or marketing expenditures; and state and foreign laws that govern the privacy and security of health information in certain circumstances, many of which differ from each other in significant ways and often are not preempted by HIPAA, thus complicating compliance efforts.
|
· |
developing drugs;
|
· |
undertaking pre-clinical testing and human clinical trials;
|
· |
obtaining FDA and other regulatory approvals of drugs;
|
· |
formulating and manufacturing drugs; and
|
· |
launching, marketing and selling drugs.
|
· |
We may be unable to contract with third-party manufacturers on acceptable terms, or at all, because the number of potential manufacturers is limited and potential manufacturers are subject to FDA approval. FDA approval requires testing and compliance inspections. In addition, any new manufacturer would have to be qualified and approved to produce our products after receipt of FDA approval, if any;
|
· |
Our third-party manufacturers might be unable to formulate and manufacture our drugs in the volume and of the quality required to meet our clinical and commercial needs, if any;
|
· |
Our third-party manufacturers may not perform as agreed or may not remain in the contract manufacturing business for the time required to supply our clinical trials through completion or to successfully produce, store and distribute our commercial products, if approved;
|
· |
Drug manufacturers are subject to ongoing periodic unannounced inspection by the FDA and other government agencies to ensure compliance with cGMP and other government regulations and corresponding foreign standards. We do not have control over third-party manufacturers’ compliance with these regulations and standards, but we may ultimately be responsible for any of their failures;
|
· |
If any third-party manufacturer makes improvements in the manufacturing process for our products, we may not own, or may have to share, the intellectual property rights to such improvements; and
|
· |
A third-party manufacturer may gain knowledge from working with us that could be used to supply one of our competitors with a product that competes with ours.
|
· |
the degree and range of protection any patents will afford us against competitors, including whether third parties find ways to invalidate or otherwise circumvent our licensed patents;
|
· |
if and when patents will issue in the United States or any other country;
|
· |
whether or not others will obtain patents claiming aspects similar to those covered by our licensed patents and patent applications;
|
· |
whether we will need to initiate litigation or administrative proceedings to protect our intellectual property rights, which may be costly whether we win or lose;
|
· |
whether any of our patents will be challenged by our competitors alleging invalidity or unenforceability and, if opposed or litigated, the outcome of any administrative or court action as to patent validity, enforceability or scope;
|
· |
whether a competitor will develop a similar compound that is outside the scope of protection afforded by a patent or whether the patent scope is inherent in the claims modified due to interpretation of claim scope by a court;
|
· |
whether there were activities previously undertaken by a licensor that could limit the scope, validity or enforceability of licensed patents and intellectual property; or
|
· |
whether a competitor will assert infringement of its patents or intellectual property, whether or not meritorious, and what the outcome of any related litigation or challenge may be.
|
· |
obtain licenses, which may not be available on commercially reasonable terms, if at all;
|
· |
redesign our products or processes to avoid infringement;
|
· |
stop using the subject matter claimed in patents held by others, which could cause us to lose the use of one or more of our drug candidates;
|
· |
pay damages; or
|
· |
defend litigation or administrative proceedings that may be costly whether we win or lose and that could result in a substantial diversion of our management resources.
|
· |
the announcement of new products or product enhancements by us or our competitors;
|
· |
changes in our relationships with our licensors or other strategic partners;
|
· |
developments concerning intellectual property rights and regulatory approvals;
|
· |
variations in our and our competitors’ results of operations;
|
· |
changes in earnings estimates or recommendations by securities analysts;
|
· |
changes in the structure of healthcare payment systems; and
|
· |
developments and market conditions in the pharmaceutical and biotechnology industries.
|
Item 5. |
Market for Common Equity, Related Stockholder Matters and Issuer Purchases of Equity Securities.
|
Period
|
High ($)
|
Low ($)
|
||||||
2015
|
||||||||
First Quarter
|
0.96
|
0.69
|
||||||
Second Quarter
|
0.81
|
0.60
|
||||||
Third Quarter
|
0.66
|
0.48
|
||||||
Fourth Quarter
|
0.53
|
0.35
|
||||||
2016
|
||||||||
First Quarter
|
0.42
|
0.26
|
||||||
Second Quarter
|
0.34
|
0.24
|
||||||
Third Quarter
|
0.28
|
0.20
|
||||||
Fourth Quarter
|
0.23
|
0.13
|
For the Year Ended December 31,
|
||||||||||||||||||||
Statement of Operations Data:
|
2016
|
2015
|
2014
|
2013
|
2012
|
|||||||||||||||
Revenues
|
$
|
-
|
$
|
-
|
$
|
-
|
$
|
-
|
$
|
-
|
||||||||||
Expenses:
|
||||||||||||||||||||
General and administrative
|
6,324,236
|
6,115,210
|
6,253,328
|
4,725,699
|
3,186,634
|
|||||||||||||||
Research and development
|
10,089,149
|
12,148,226
|
7,015,901
|
3,253,139
|
3,392,896
|
|||||||||||||||
Total expenses
|
16,413,385
|
18,263,436
|
13,269,229
|
7,978,838
|
6,579,530
|
|||||||||||||||
Loss from operations
|
(16,413,385
|
)
|
(18,263,436
|
)
|
(13,269,229
|
)
|
(7,978,838
|
)
|
(6,579,530
|
)
|
||||||||||
Other Income (Expense), net
|
7,106,040
|
3,878,880
|
(5,252,372
|
)
|
(1,520,586
|
)
|
352,860
|
|||||||||||||
Net Loss
|
$
|
(9,307,345
|
)
|
$
|
(14,384,556
|
)
|
$
|
(18,521,601
|
)
|
$
|
(9,499,424
|
)
|
$
|
(6,226,670
|
)
|
|||||
Net Loss per share, basic and diluted
|
$
|
(0.04
|
)
|
$
|
(0.08
|
)
|
$
|
(0.11
|
)
|
$
|
(0.07
|
)
|
$
|
(0.06
|
)
|
|||||
Weighted average shares outstanding, basic and diluted
|
217,447,405
|
182,388,226
|
176,106,981
|
128,649,303
|
97,138,233
|
As of December 31,
|
||||||||||||||||||||
Balance Sheet Data:
|
2016
|
2015
|
2014
|
2013
|
2012
|
|||||||||||||||
Cash, Cash Equivalents, and Marketable Securities
|
$
|
20,315,580
|
$
|
23,439,526
|
$
|
32,698,296
|
$
|
18,788,031
|
$
|
13,586,543
|
||||||||||
Working Capital
|
$
|
19,041,597
|
$
|
22,000,046
|
$
|
30,970,020
|
$
|
18,361,438
|
$
|
12,923,514
|
||||||||||
Total Assets
|
$
|
21,043,532
|
$
|
24,805,029
|
$
|
33,533,060
|
$
|
19,556,498
|
$
|
14,919,308
|
||||||||||
Warrant Liabilities
|
$
|
1,573,366
|
$
|
2,739,163
|
$
|
3,768,351
|
$
|
5,034,058
|
$
|
2,842,065
|
||||||||||
Accumulated Deficit
|
$
|
(115,024,209
|
)
|
$
|
(105,716,864
|
)
|
$
|
(91,332,308
|
)
|
$
|
(72,810,707
|
)
|
$
|
(63,311,283
|
)
|
|||||
Total Stockholders' Equity
|
$
|
17,058,462
|
$
|
18,775,548
|
$
|
26,580,491
|
$
|
12,625,488
|
$
|
9,533,989
|
||||||||||
Common shares outstanding
|
237,368,785
|
197,413,785
|
178,253,318
|
146,717,795
|
119,428,989
|
· |
Contract Research Organizations (“CROs”) and investigative sites in connection with clinical studies;
|
· |
Vendors related to product manufacturing, development, and distribution of clinical supplies; and
|
· |
Vendors in connection with preclinical development activities.
|
For the Year Ended December 31,
|
||||||||
2016
|
2015
|
|||||||
Clinical Candidates:
|
||||||||
RX-3117
|
$
|
2,290,000
|
$
|
4,062,000
|
||||
Supinoxin
|
2,230,800
|
2,839,000
|
||||||
Archexin
|
1,573,800
|
1,547,000
|
||||||
Preclinical, Personnel and Overhead
|
3,994,549
|
3,700,226
|
||||||
Total Research and Development Expenses
|
$
|
10,089,149
|
$
|
12,148,226
|
|
For the Year Ended December 31,
|
|||||||
|
2015
|
2014
|
||||||
Clinical Candidates:
|
||||||||
RX-3117
|
$
|
4,062,000
|
$
|
1,897,000
|
||||
Supinoxin
|
2,839,000
|
1,351,000
|
||||||
Archexin
|
1,547,000
|
1,215,000
|
||||||
|
||||||||
Preclinical, Personnel and Overhead
|
3,700,226
|
2,552,901
|
||||||
|
||||||||
Total Research and Development Expenses
|
$
|
12,148,226
|
$
|
7,015,901
|
For the Year Ended December 31,
|
||||||||||||
2016
|
2015
|
2014
|
||||||||||
Net Cash Used in Operating Activities
|
$
|
(13,227,101
|
)
|
$
|
(17,351,950
|
)
|
$
|
(11,041,211
|
)
|
|||
Net Cash Provided by (Used In) Investing Activities
|
4,483,911
|
9,554,394
|
(22,661,045
|
)
|
||||||||
Net Cash Provided by Financing Activities
|
10,122,223
|
8,170,751
|
24,840,470
|
|||||||||
Net Increase (Decrease) in Cash and Cash Equivalents
|
$
|
1,379,033
|
$
|
373,195
|
$
|
(8,861,786
|
)
|
Total
|
Less than 1
year
|
1 -3 Years
|
3-5 Years
|
More than 5
years
|
||||||||||||||||
Operating Leases
|
$
|
677,077
|
$
|
255,731
|
$
|
386,878
|
$
|
34,468
|
$
|
-
|
· |
the progress of our product development activities;
|
· |
the number and scope of our product development programs;
|
· |
the progress of our pre-clinical and clinical trial activities;
|
· |
the progress of the development efforts of parties with whom we have entered into collaboration agreements;
|
· |
our ability to maintain current collaboration programs and to establish new collaboration arrangements;
|
· |
the costs involved in prosecuting and enforcing patent claims and other intellectual property rights; and
|
· |
the costs and timing of regulatory approvals.
|
· |
Pertain to the maintenance of records that, in reasonable detail, accurately and fairly reflect the transactions and the dispositions of our assets;
|
· |
Provide reasonable assurance that transactions are recorded as necessary to permit preparation of financial statements in accordance with generally accepted accounting principles, and that our receipts and expenditures are being made only in accordance with authorization of our management and the board of directors; and
|
· |
Provide reasonable assurance regarding prevention or timely detection of unauthorized acquisition, use, or disposition of our assets that could have a material effect on the financial statements.
|
Item 12. |
Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters.
|
(a) |
The following documents are filed as a part of this Annual Report:
|
(b) |
See
the accompanying Index to Exhibits filed as a part of this Annual Report.
|
(c) |
Other schedules are not applicable.
|
REXAHN PHARMACEUTICALS, INC. | |||
|
By:
|
/s/ Peter D. Suzdak | |
Peter D. Suzdak | |||
Chief Executive Officer |
Name
|
Title
|
Date
|
||
/s/ Peter D. Suzdak*
|
Chief Executive Officer and
|
February 24, 2017
|
||
Peter Suzdak
|
Director (Principal Executive Officer)
|
|||
/s/ Tae Heum Jeong*
|
Chief Financial Officer, and
|
February 24, 2017
|
||
Tae Heum Jeong
|
Secretary (Principal Financial and Accounting Officer)
|
|||
/s/ Peter Brandt*
|
Chairman
|
February 24, 2017
|
||
Peter Brandt
|
||||
/s/ Chang H. Ahn*
|
Director
|
February 24, 2017
|
||
Chang H. Ahn
|
||||
/s/ Charles Beever*
|
Director
|
February 24, 2017
|
||
Charles Beever
|
||||
/s/ Kwang Soo Cheong*
|
Director
|
February 24, 2017
|
||
Kwang Soo Cheong
|
||||
/s/ Mark Carthy*
|
Director
|
February 24, 2017
|
||
Mark Carthy
|
||||
/s/ Richard J. Rodgers*
|
Director
|
February 24, 2017
|
||
Richard J. Rodgers
|
December 31, 2016
|
December 31, 2015
|
|||||||
ASSETS
|
||||||||
Current Assets:
|
||||||||
Cash and cash equivalents
|
$
|
11,578,473
|
$
|
10,199,440
|
||||
Marketable securities
|
8,737,107
|
13,240,086
|
||||||
Prepaid expenses and other current assets
|
608,517
|
1,221,818
|
||||||
Total Current Assets
|
20,924,097
|
24,661,344
|
||||||
Security Deposits
|
30,785
|
30,785
|
||||||
Equipment, Net
|
88,650
|
112,900
|
||||||
Total Assets
|
$
|
21,043,532
|
$
|
24,805,029
|
||||
LIABILITIES AND STOCKHOLDERS’ EQUITY
|
||||||||
Current Liabilities:
|
||||||||
Accounts payable and accrued expenses
|
$
|
1,882,500
|
$
|
2,661,298
|
||||
Deferred Research and Development Arrangement
|
450,000
|
525,000
|
||||||
Other Liabilities
|
79,204
|
104,020
|
||||||
Warrant Liabilities
|
1,573,366
|
2,739,163
|
||||||
Total Liabilities
|
3,985,070
|
6,029,481
|
||||||
Commitments and Contingencies
(note 15)
|
||||||||
Stockholders’ Equity:
|
||||||||
Preferred stock, par value $0.0001, 100,000,000 authorized shares, none issued and outstanding
|
-
|
-
|
||||||
Common stock, par value $0.0001, 500,000,000 authorized shares, 237,368,785 and 197,413,785 issued and outstanding
|
23,737
|
19,741
|
||||||
Additional paid-in capital
|
132,065,056
|
124,490,712
|
||||||
Accumulated other comprehensive loss
|
(6,122
|
)
|
(18,041
|
)
|
||||
Accumulated deficit
|
(115,024,209
|
)
|
(105,716,864
|
)
|
||||
Total Stockholders’ Equity
|
17,058,462
|
18,775,548
|
||||||
Total Liabilities and Stockholders’ Equity
|
$
|
21,043,532
|
$
|
24,805,029
|
For the Year Ended December 31,
|
||||||||||||
2016
|
2015
|
2014
|
||||||||||
Revenues:
|
$
|
-
|
$
|
-
|
$
|
-
|
||||||
Expenses:
|
||||||||||||
General and administrative
|
6,324,236
|
6,115,210
|
6,253,328
|
|||||||||
Research and development
|
10,089,149
|
12,148,226
|
7,015,901
|
|||||||||
Total Expenses
|
16,413,385
|
18,263,436
|
13,269,229
|
|||||||||
Loss from Operations
|
(16,413,385
|
)
|
(18,263,436
|
)
|
(13,269,229
|
)
|
||||||
Other Income (Expense)
|
||||||||||||
Interest income
|
118,565
|
103,269
|
133,907
|
|||||||||
Mediation settlement
|
1,770,658
|
-
|
-
|
|||||||||
Unrealized gain (loss) on fair value of warrants
|
5,529,907
|
3,986,727
|
(5,180,107
|
)
|
||||||||
Financing expense
|
(313,090
|
)
|
(211,116
|
)
|
(206,172
|
)
|
||||||
Total Other Income (Expense)
|
7,106,040
|
3,878,880
|
(5,252,372
|
)
|
||||||||
Net Loss Before Provision for Income Taxes
|
(9,307,345
|
)
|
(14,384,556
|
)
|
(18,521,601
|
)
|
||||||
Provision for income taxes
|
-
|
-
|
-
|
|||||||||
Net Loss
|
$
|
(9,307,345
|
)
|
$
|
(14,384,556
|
)
|
$
|
(18,521,601
|
)
|
|||
Net loss per share, basic and diluted
|
$
|
(0.04
|
)
|
$
|
(0.08
|
)
|
$
|
(0.11
|
)
|
|||
Weighted average number of shares outstanding, basic and diluted
|
217,447,405
|
182,388,226
|
176,106,981
|
For the Year Ended December 31,
|
||||||||||||
2016
|
2015
|
2014
|
||||||||||
Net Loss
|
$
|
(9,307,345
|
)
|
$
|
(14,384,556
|
)
|
$
|
(18,521,601
|
)
|
|||
Unrealized gain (loss) on available-for-sale securities
|
11,919
|
15,606
|
(33,647
|
)
|
||||||||
Comprehensive Loss
|
$
|
(9,295,426
|
)
|
$
|
(14,368,950
|
)
|
$
|
(18,555,248
|
)
|
Common Stock
|
Treasury Stock
|
|||||||||||||||||||||||||||||||
Number of
Shares
|
Amount
|
Additional
Paid-in
Capital
|
Accumulated
Deficit
|
Number
of Shares
|
Amount
|
Accumulated
Other
Comprehensive
Loss
|
Total
Stockholders'
Equity
|
|||||||||||||||||||||||||
Balances at January 1, 2014
|
146,732,000
|
$
|
14,673
|
$
|
85,449,932
|
$
|
(72,810,707
|
)
|
14,205
|
$
|
(28,410
|
)
|
$
|
-
|
$
|
12,625,488
|
||||||||||||||||
Issuance of common stock and units
|
19,047,620
|
1,905
|
16,306,667
|
-
|
-
|
-
|
-
|
16,308,572
|
||||||||||||||||||||||||
Stock issuance costs
|
-
|
-
|
(1,159,582
|
)
|
-
|
-
|
-
|
-
|
(1,159,582
|
)
|
||||||||||||||||||||||
Common stock issued in exchange for services
|
400,000
|
40
|
408,960
|
-
|
-
|
-
|
-
|
409,000
|
||||||||||||||||||||||||
Stock options exercised
|
448,693
|
45
|
358,910
|
-
|
-
|
-
|
-
|
358,955
|
||||||||||||||||||||||||
Shares surrendered for net stock option exercise
|
-
|
-
|
-
|
-
|
99,010
|
(100,000
|
)
|
-
|
(100,000
|
)
|
||||||||||||||||||||||
Stock warrants exercised
|
11,738,220
|
1,174
|
16,083,337
|
-
|
-
|
-
|
-
|
16,084,511
|
||||||||||||||||||||||||
Stock-based compensation
|
-
|
-
|
608,795
|
-
|
-
|
-
|
-
|
608,795
|
||||||||||||||||||||||||
Net loss
|
-
|
-
|
-
|
(18,521,601
|
)
|
-
|
-
|
-
|
(18,521,601
|
)
|
||||||||||||||||||||||
Other comprehensive loss
|
-
|
-
|
-
|
-
|
-
|
-
|
(33,647
|
)
|
(33,647
|
)
|
||||||||||||||||||||||
Balances at December 31, 2014
|
178,366,533
|
$
|
17,837
|
$
|
118,057,019
|
$
|
(91,332,308
|
)
|
113,215
|
$
|
(128,410
|
)
|
$
|
(33,647
|
)
|
$
|
26,580,491
|
|||||||||||||||
Issuance of common stock and units
|
18,073,739
|
1,807
|
5,248,266
|
-
|
-
|
-
|
-
|
5,250,073
|
||||||||||||||||||||||||
Stock issuance costs
|
-
|
-
|
(566,065
|
)
|
-
|
-
|
-
|
-
|
(566,065
|
)
|
||||||||||||||||||||||
Common stock issued in exchange for services
|
150,000
|
15
|
101,985
|
-
|
-
|
-
|
-
|
102,000
|
||||||||||||||||||||||||
Stock options exercised
|
889,428
|
89
|
708,528
|
-
|
-
|
-
|
-
|
708,617
|
||||||||||||||||||||||||
Stock warrants exercised
|
47,300
|
4
|
31,699
|
-
|
-
|
-
|
-
|
31,703
|
||||||||||||||||||||||||
Stock-based compensation
|
-
|
-
|
1,037,679
|
-
|
-
|
-
|
-
|
1,037,679
|
||||||||||||||||||||||||
Retirement of treasury stock
|
(113,215
|
)
|
(11
|
)
|
(128,399
|
)
|
(113,215
|
)
|
128,410
|
-
|
-
|
|||||||||||||||||||||
Net loss
|
-
|
-
|
-
|
(14,384,556
|
)
|
-
|
-
|
-
|
(14,384,556
|
)
|
||||||||||||||||||||||
Other comprehensive income
|
-
|
-
|
-
|
-
|
-
|
-
|
15,606
|
15,606
|
||||||||||||||||||||||||
Balances at December 31, 2015
|
197,413,785
|
$
|
19,741
|
$
|
124,490,712
|
$
|
(105,716,864
|
)
|
-
|
$
|
-
|
$
|
(18,041
|
)
|
$
|
18,775,548
|
||||||||||||||||
Issuance of common stock and units
|
39,625,000
|
3,963
|
6,904,995
|
-
|
-
|
-
|
-
|
6,908,958
|
||||||||||||||||||||||||
Stock issuance costs
|
-
|
-
|
(837,755
|
)
|
-
|
-
|
-
|
-
|
(837,755
|
)
|
||||||||||||||||||||||
Common stock issued in exchange for services
|
330,000
|
33
|
97,616
|
-
|
-
|
-
|
-
|
97,649
|
||||||||||||||||||||||||
Stock-based compensation
|
-
|
-
|
1,409,488
|
-
|
-
|
-
|
-
|
1,409,488
|
||||||||||||||||||||||||
Net loss
|
-
|
-
|
-
|
(9,307,345
|
)
|
-
|
-
|
-
|
(9,307,345
|
)
|
||||||||||||||||||||||
Other comprehensive income
|
-
|
-
|
-
|
-
|
-
|
-
|
11,919
|
11,919
|
||||||||||||||||||||||||
Balances at
December 31, 2016
|
237,368,785
|
$
|
23,737
|
$
|
132,065,056
|
$
|
(115,024,209
|
)
|
-
|
$
|
-
|
$
|
(6,122
|
)
|
$
|
17,058,462
|
For the Year Ended December 31,
|
||||||||||||
2016
|
2015
|
2014
|
||||||||||
Cash Flows from Operating Activities:
|
||||||||||||
Net loss
|
$
|
(9,307,345
|
)
|
$
|
(14,384,556
|
)
|
(18,521,601
|
)
|
||||
Adjustments to reconcile net loss to net cash used in operating activities:
|
||||||||||||
Compensatory stock
|
97,649
|
102,000
|
409,000
|
|||||||||
Depreciation and amortization
|
32,916
|
27,498
|
28,325
|
|||||||||
Amortization of premiums and discounts on marketable securities, net
|
22,321
|
30,875
|
10,228
|
|||||||||
Stock-based compensation
|
1,409,488
|
1,037,679
|
608,795
|
|||||||||
Amortization of deferred research and development arrangements
|
(75,000
|
)
|
(75,000
|
)
|
(233,630
|
)
|
||||||
Unrealized (gain) loss on fair value of warrants
|
(5,529,907
|
)
|
(3,986,727
|
)
|
5,180,107
|
|||||||
Financing expense
|
313,090
|
211,116
|
206,172
|
|||||||||
Amortization of deferred lease incentive
|
(12,443
|
)
|
(12,443
|
)
|
(12,443
|
)
|
||||||
Deferred lease expenses
|
(12,373
|
)
|
(8,492
|
)
|
7,834
|
|||||||
Changes in assets and liabilities:
|
||||||||||||
Prepaid expenses and other assets
|
613,301
|
(495,935
|
)
|
(249,503
|
)
|
|||||||
Accounts payable and accrued expenses
|
(778,798
|
)
|
202,035
|
1,525,505
|
||||||||
Net Cash Used in Operating Activities
|
(13,227,101
|
)
|
(17,351,950
|
)
|
(11,041,211
|
)
|
||||||
Cash Flows from Investing Activities:
|
||||||||||||
Restricted cash equivalents
|
-
|
-
|
196,130
|
|||||||||
Purchase of equipment
|
(8,666
|
)
|
(62,302
|
)
|
(41,249
|
)
|
||||||
Purchase of marketable securities
|
(8,747,423
|
)
|
(7,908,304
|
)
|
(26,075,926
|
)
|
||||||
Redemption of marketable securities
|
13,240,000
|
17,525,000
|
3,260,000
|
|||||||||
Net Cash Provided by (Used in) Investing Activities
|
4,483,911
|
9,554,394
|
(22,661,045
|
)
|
||||||||
Cash Flows from Financing Activities:
|
||||||||||||
Issuance of common stock and units, net of issuance costs
|
10,122,223
|
7,439,809
|
18,634,247
|
|||||||||
Proceeds from exercise of stock options
|
-
|
708,617
|
258,955
|
|||||||||
Proceeds from exercise of stock warrants
|
-
|
22,325
|
5,947,268
|
|||||||||
Net Cash Provided by Financing Activities
|
10,122,223
|
8,170,751
|
24,840,470
|
|||||||||
Net Increase (Decrease) in Cash and Cash Equivalents
|
1,379,033
|
373,195
|
(8,861,786
|
)
|
||||||||
Cash and Cash Equivalents – beginning of period
|
10,199,440
|
9,826,245
|
18,688,031
|
|||||||||
Cash and Cash Equivalents - end of period
|
$
|
11,578,473
|
$
|
10,199,440
|
9,826,245
|
|||||||
Supplemental Cash Flow Information
|
||||||||||||
Non-cash financing and investing activities:
|
||||||||||||
Warrants issued
|
$
|
4,364,110
|
$
|
2,966,917
|
3,691,429
|
|||||||
Warrant liability extinguishment from exercise of warrants
|
$
|
-
|
$
|
9,378
|
10,137,243
|
|||||||
Shares withheld for net stock option exercise
|
$
|
-
|
$
|
-
|
100,000
|
|||||||
Retirement of treasury stock
|
$
|
-
|
$
|
128,410
|
-
|
1.
|
Operations and Organization
|
2. |
Summary of Significant Accounting Policies
|
3.
|
Marketable Securities
|
December 31, 2016
|
||||||||||||||||
Cost
Basis
|
Gross
Unrealized
Gains
|
Gross
Unrealized
Losses
|
Fair
Value
|
|||||||||||||
Certificates of Deposit
|
$
|
720,000
|
$
|
197
|
$
|
-
|
$
|
720,197
|
||||||||
Commercial Paper
|
3,987,424
|
-
|
(1,684
|
)
|
3,985,740
|
|||||||||||
Corporate Bonds
|
4,035,805
|
-
|
(4,635
|
)
|
4,031,170
|
|||||||||||
Total Marketable Securities
|
$
|
8,743,229
|
$
|
197
|
$
|
(6,319
|
)
|
$
|
8,737,107
|
December 31, 2015
|
||||||||||||||||
Cost
Basis
|
Gross
Unrealized
Gains
|
Gross
Unrealized
Losses
|
Fair
Value
|
|||||||||||||
Certificates of Deposit
|
$
|
6,240,000
|
$
|
571
|
$
|
(5,575
|
)
|
$
|
6,234,996
|
|||||||
Commercial Paper
|
2,981,307
|
-
|
(3,737
|
)
|
2,977,570
|
|||||||||||
Corporate Bonds
|
4,036,820
|
-
|
(9,300
|
)
|
4,027,520
|
|||||||||||
Total Marketable Securities
|
$
|
13,258,127
|
$
|
571
|
$
|
(18,612
|
)
|
$
|
13,240,086
|
4.
|
Prepaid Expenses and Other Current Assets
|
December 31,
2016
|
December 31,
2015
|
|||||||
Deposits on contracts
|
$
|
179,476
|
$
|
501,170
|
||||
Prepaid expenses and other current assets
|
429,041
|
720,648
|
||||||
$
|
608,517
|
$
|
1,221,818
|
5.
|
Equipment, Net
|
December 31,
2016
|
December 31,
2015
|
|||||||
Furniture and fixtures
|
$
|
78,794
|
$
|
78,794
|
||||
Office and computer equipment
|
113,932
|
105,266
|
||||||
Lab equipment
|
431,650
|
431,650
|
||||||
Leasehold improvements
|
133,762
|
133,762
|
||||||
Total equipment
|
758,138
|
749,472
|
||||||
Less: Accumulated depreciation and amortization
|
(669,488
|
)
|
(636,572
|
)
|
||||
Net carrying amount
|
$
|
88,650
|
$
|
112,900
|
6. |
Accounts Payable and Accrued Expenses
|
December 31,
2016
|
December 31,
2015
|
|||||||
Trade payables
|
$
|
430,013
|
$
|
774,543
|
||||
Accrued expenses
|
141,190
|
92,752
|
||||||
Accrued research and development contract costs
|
499,889
|
1,515,151
|
||||||
Payroll liabilities
|
811,408
|
278,852
|
||||||
$
|
1,882,500
|
$
|
2,661,298
|
7.
|
Deferred Research and Development Arrangements
|
8.
|
Other Liabilities
|
|
December 31,
2016
|
|
December 31,
2015
|
|||||
Deferred lease incentive
|
$
|
154,660
|
$
|
154,660
|
||||
Less accumulated amortization
|
(123,551
|
)
|
(111,108
|
)
|
||||
Balance
|
$
|
31,109
|
$
|
43,552
|
9. |
Net Loss per Common Share
|
10. |
Common Stock
|
Gross Proceeds:
|
$
|
20,000,001
|
||
Allocated to warrant liabilities:
|
3,691,429
|
|||
Allocated to common stock and additional paid-in capital
|
16,308,572
|
|||
Total allocated gross proceeds:
|
$
|
20,000,001
|
Gross Proceeds:
|
$
|
7,000,000
|
||
Allocated to warrant liabilities:
|
2,792,500
|
|||
Allocated to common stock and additional paid-in capital
|
4,207,500
|
|||
Total allocated gross proceeds:
|
$
|
7,000,000
|
Gross Proceeds:
|
$
|
5,000,000
|
||
Allocated to warrant liabilities:
|
2,419,922
|
|||
Allocated to common stock and additional paid-in capital
|
2,580,078
|
|||
Total allocated gross proceeds:
|
$
|
5,000,000
|
Gross Proceeds:
|
$
|
6,000,000
|
||
Allocated to warrant liabilities:
|
1,671,120
|
|||
Allocated to common stock and additional paid-in capital
|
4,328,880
|
|||
Total allocated gross proceeds:
|
$
|
6,000,000
|
For the Year Ended December 31,
|
||||||||||||
2016
|
2015
|
2014
|
||||||||||
Compensatory shares issued
|
330,000
|
150,000
|
400,000
|
|||||||||
Aggregate market value
|
$
|
97,649
|
$
|
102,000
|
$
|
409,000
|
For the Year Ended December 31,
|
||||||||||||
2016
|
2015
|
2014
|
||||||||||
Stock Option Exercises
|
||||||||||||
Number of shares issued
|
-
|
889,428
|
448,693
|
|||||||||
Total cash received
|
$
|
-
|
$
|
708,617
|
$
|
258,955
|
||||||
Stock Warrant Exercises
|
||||||||||||
Number of shares issued
|
-
|
47,300
|
11,738,220
|
|||||||||
Total cash received
|
$
|
-
|
$
|
22,325
|
$
|
5,947,268
|
11.
|
Stock-Based Compensation
|
For the Year Ended December 31,
|
||||||||||||
2016
|
2015
|
2014
|
||||||||||
Statement of operations line item:
|
||||||||||||
General and administrative
|
$
|
905,911
|
$
|
665,063
|
$
|
457,128
|
||||||
Research and development
|
503,577
|
372,616
|
151,667
|
|||||||||
Total
|
$
|
1,409,488
|
$
|
1,037,679
|
$
|
608,795
|
Year Ended December 31,
|
||||||||||||
2016
|
2015
|
2014
|
||||||||||
Black-Scholes assumptions
|
||||||||||||
Expected dividend yield
|
0
|
%
|
0
|
%
|
0
|
%
|
||||||
Expected volatility
|
31-75
|
%
|
72-80
|
%
|
92-96
|
%
|
||||||
Risk free interest rate
|
0.8-1.4
|
%
|
1.2-1.7
|
%
|
1.5-1.8
|
%
|
||||||
Expected term (in years)
|
2-6 years
|
5-6 years
|
5 years
|
Number of
Options
|
Weighted
Average
Exercise
Price
|
Weighted Average
Remaining
Contractual Term
|
Aggregate
Intrinsic
Value
|
||||||||||
Outstanding, January 1, 2016
|
12,590,982
|
$
|
0.83
|
6.8 years
|
$
|
26,500
|
|||||||
Granted
|
5,926,391
|
0.31
|
|||||||||||
Exercised
|
-
|
-
|
|||||||||||
Expired
|
(730,000
|
)
|
1.37
|
||||||||||
Cancelled
|
(886,958
|
)
|
0.89
|
||||||||||
Outstanding, December 31, 2016
|
16,900,415
|
$
|
0.62
|
7.3 years
|
$
|
-
|
|||||||
Exercisable, December 31, 2016
|
7,929,179
|
$
|
0.78
|
5.8 years
|
$
|
-
|
2016
|
||||||||
Number of Options
|
Weighted Average Fair
Value at Grant Date
|
|||||||
Unvested at January 1, 2016
|
5,888,432
|
$
|
0.51
|
|||||
Granted
|
5,926,391
|
$
|
0.20
|
|||||
Vested
|
(2,625,254
|
)
|
$
|
0.46
|
||||
Cancelled
|
(218,333
|
)
|
$
|
0.41
|
||||
Unvested at December 31, 2016
|
8,971,236
|
$
|
0.32
|
12.
|
Warrants
|
2016
|
2015
|
|||||||||||||||
Number of
warrants
|
Weighted
average exercise
price
|
Number of
warrants
|
Weighted average
exercise price
|
|||||||||||||
Balance, January 1
|
26,491,904
|
$
|
0.80
|
13,205,871
|
$
|
1.07
|
||||||||||
Issued during the period
|
31,940,000
|
$
|
0.35
|
13,333,333
|
$
|
0.53
|
||||||||||
Exercised during the period
|
-
|
$
|
-
|
(47,300
|
)
|
$
|
0.47
|
|||||||||
Expired during the period
|
(3,905,057
|
)
|
$
|
1.37
|
-
|
$
|
-
|
|||||||||
Balance, December 31
|
54,526,847
|
$
|
0.49
|
26,491,904
|
$
|
0.80
|
Fair Value as of:
|
||||||||
Warrant Issuance:
|
December 31, 2016
|
December 31, 2015
|
||||||
Expired Warrants
|
$
|
-
|
$
|
2,590
|
||||
December 2012 Investor Warrants
|
49
|
9,818
|
||||||
July 2013 Investor Warrants
|
2,060
|
121,420
|
||||||
October 2013 Investor Warrants
|
3,708
|
169,349
|
||||||
January 2014 Investor Warrants
|
714
|
131,476
|
||||||
November 2015 Investor Warrants
|
260,500
|
2,169,375
|
||||||
November 2015 Placement Agent Warrants
|
13,542
|
135,135
|
||||||
March 2016 Investor Warrants
|
358,945
|
-
|
||||||
March 2016 Placement Agent Warrants
|
21,320
|
-
|
||||||
September 2016 Investor Warrants
|
854,640
|
-
|
||||||
September 2016 Placement Agent Warrants
|
57,888
|
-
|
||||||
Total:
|
$
|
1,573,366
|
$
|
2,739,163
|
Number of Shares indexed as of:
|
||||||||
Warrant Issuance
|
December 31, 2016
|
December 31, 2015
|
||||||
Expired Warrants
|
-
|
3,905,057
|
||||||
December 2012 Investor Warrants
|
174,300
|
174,300
|
||||||
July 2013 Investor Warrants
|
2,000,000
|
2,000,000
|
||||||
October 2013 Investor Warrants
|
2,317,309
|
2,317,309
|
||||||
January 2014 Investor Warrants
|
4,761,905
|
4,761,905
|
||||||
November 2015 Investor Warrants
|
12,500,000
|
12,500,000
|
||||||
November 2015 Placement Agent Warrants
|
833,333
|
833,333
|
||||||
March 2016 Investor Warrants
|
11,718,750
|
-
|
||||||
March 2016 Placement Agent Warrants
|
781,250
|
-
|
||||||
September 2016 Investor Warrants
|
18,000,000
|
-
|
||||||
September 2016 Placement Agent Warrants
|
1,440,000
|
-
|
||||||
Total:
|
54,526,847
|
26,491,904
|
December 31, 2016
|
December 31, 2015
|
|||||||
Trading market prices
|
$
|
0.14
|
$
|
0.36
|
||||
Estimated future volatility
|
104
|
%
|
105
|
%
|
||||
Dividend
|
-
|
-
|
||||||
Estimated future risk-free rate
|
1.06-2.44
|
%
|
0.82-2.38
|
%
|
||||
Equivalent volatility
|
51-60
|
%
|
44-65
|
%
|
||||
Equivalent risk-free rate
|
0.59-1.25
|
%
|
0.22-1.11
|
%
|
For the Year Ended December 31,
|
||||||||||||
2016
|
2015
|
2014
|
||||||||||
Expired Warrants
|
$
|
2,590
|
$
|
458,439
|
$
|
(1,059,400
|
)
|
|||||
December 2012 Investor Warrants
|
9,769
|
70,856
|
(4,120,103
|
)
|
||||||||
July 2013 Investor Warrants
|
119,360
|
666,894
|
(1,272,731
|
)
|
||||||||
October 2013 Investor Warrants
|
165,641
|
780,407
|
(940,100
|
)
|
||||||||
January 2014 Investor Warrants
|
130,762
|
1,347,724
|
2,212,227
|
|||||||||
November 2015 Investor Warrants
|
1,908,875
|
623,125
|
-
|
|||||||||
November 2015 Placement Agent Warrants
|
121,593
|
39,282
|
-
|
|||||||||
March 2016 Investor Warrants
|
2,060,977
|
-
|
-
|
|||||||||
March 2016 Placement Agent Warrants
|
134,617
|
-
|
-
|
|||||||||
September 2016 Investor Warrants
|
816,480
|
-
|
-
|
|||||||||
September 2016 Placement Agent Warrants
|
59,243
|
-
|
-
|
|||||||||
Total:
|
$
|
5,529,907
|
$
|
3,986,727
|
$
|
(5,180,107
|
)
|
13.
|
Mediation Settlement
|
14.
|
Income Taxes
|
December 31,
2016
|
December 31,
2015
|
|||||||
Net Operating Loss Carryforwards
|
$
|
43,526,000
|
$
|
38,592,000
|
||||
Stock Compensation Expense
|
1,968,000
|
1,891,000
|
||||||
Book tax differences on assets and liabilities
|
547,000
|
380,000
|
||||||
Valuation Allowance
|
(46,041,000
|
)
|
(40,863,000
|
)
|
||||
Net Deferred Tax Assets
|
$
|
-
|
$
|
-
|
15.
|
Commitments and Contingencies
|
a) |
The Company has contracted with various vendors for research and development services, the terms which require payments over the term of the agreements, usually ranging from two to 36 months. The costs to be incurred are estimated and are subject to revision. As of December 31, 2016, the total estimated cost to complete these agreements was approximately $
4,960,000
.
All of these agreements may be terminated by either party upon appropriate notice as stipulated in the respective agreements.
|
b) |
On June 22, 2009, the Company entered into a License Agreement with Korea Research Institute of Chemical Technology (“KRICT”) to acquire the rights to all intellectual property related to quinoxaline-piperazine derivatives that were synthesized under a Joint Research Agreement. The initial license fee was $100,000, all of which was paid as of December 31, 2009. The agreement with KRICT calls for a one-time milestone payment of $1,000,000 within 30 days after the first achievement of marketing approval of the first commercial product arising out of or in connection with the use of KRICT’s intellectual properties. As of December 31, 2016, the milestone has not occurred.
|
c) |
Office Space Lease
|
On June 7, 2013, the Company signed the first amendment to its commercial lease agreement for 5,466 square feet of office space in Rockville, Maryland. Under the lease agreement, the Company pays its allocable portion of real estate taxes and common area operating charges.
|
On July 26, 2014 the Company entered into the second amendment to the lease agreement. According to the terms of this amendment, the Company leased an additional 1,637 square feet of office space, beginning on September 1, 2014 and ending on August 31, 2015. The Company subsequently renewed the lease for this space for additional one-year terms, beginning on September 1, 2015 and 2016.
|
Rent paid under the Company’s lease during the years ended December 31, 2016, 2015, and 2014 was $205,324, $202,529 and $155,057, respectively.
|
Prior Laboratory Lease
|
On August 26, 2014 and June 24, 2013, the Company signed one-year renewals to use laboratory space commencing on July 1, 2014 and 2013, respectively. The lease required monthly rental payments of $4,554. Rent paid under the Company’s lease during the years ended December 31, 2015, and 2014 was $
27,324 and
$
54,648
, respectively
.
|
Current Laboratory Lease
|
On April 20, 2015, the Company signed a five-year lease agreement for 2,552 square feet of laboratory space commencing on July 1, 2015 and ending on June 30, 2020. Under the lease agreement, the Company pays its allocable portion of real estate taxes and common area operating charges. Rent paid under this lease during the years ended December 31, 2016 and 2015 was $62,167 and $30,624, respectively.
|
For the year ending December 31:
|
2017
|
255,731
|
|||
2018
|
233,923
|
||||
2019
|
152,955
|
||||
2020
|
34,468
|
||||
Total
|
$
|
677,077
|
d) |
The Company has established a 401(k) plan for its employees. The Company has elected to match 100% of the first 3% of an employee’s compensation plus 50% of an additional 2% of the employee’s deferral. Expense related to this matching contribution aggregated to $113,204, $121,519 and $91,241 for the years ended December 31, 2016, 2015 and 2014 respectively.
|
e) |
In July 2013, the Company entered into an exclusive license agreement with the University of Maryland, Baltimore for a novel drug delivery platform, Nano-Polymer Drug Conjugate Systems. RX-21101 is the Company’s first drug candidate utilizing this platform. The agreement requires the Company to make payments to the University of Maryland if RX-21101 or any products from the licensed delivery platform achieve development milestones. As of December 31, 2016, no development milestones have occurred.
|
f) |
In October 2013, the Company signed an exclusive license agreement with the Ohio State Innovation Foundation, for a novel oligonucleotide drug delivery platform, Lipid-Coated Albumin Nanoparticle. The agreement requires the Company to make payments to the Ohio State Innovation Foundation or any products from the licensed delivery platform achieve development milestones. As of December 31, 2016, no development milestones have occurred.
|
16.
|
Fair Value Measurements
|
Level 1 Inputs
|
—
|
Unadjusted quoted prices in active markets for identical assets or liabilities that are accessible by the Company;
|
||
Level 2 Inputs
|
—
|
Quoted prices in markets that are not active or financial instruments for which all significant inputs are observable, either directly or indirectly;
|
||
Level 3 Inputs
|
—
|
Unobservable inputs for the asset or liability including significant assumptions of the Company and other market participants.
|
Fair Value Measurements at December 31, 2016
|
||||||||||||||||
Total
|
Level 1
|
Level 2
|
Level 3
|
|||||||||||||
Assets:
|
||||||||||||||||
Certificates of Deposit
|
$
|
720,197
|
$
|
-
|
$
|
720,197
|
$
|
-
|
||||||||
Commercial Paper
|
3,985,740
|
-
|
3,985,740
|
-
|
||||||||||||
Corporate Bonds
|
4,031,170
|
-
|
4,031,170
|
-
|
||||||||||||
Total Assets:
|
$
|
8,737,107
|
$
|
-
|
$
|
8,737,107
|
$
|
-
|
||||||||
Liabilities:
|
||||||||||||||||
Warrant Liabilities
|
$
|
1,573,366
|
-
|
-
|
$
|
1,573,366
|
Fair Value Measurements at December 31, 2015
|
||||||||||||||||
Total
|
Level 1
|
Level 2
|
Level 3
|
|||||||||||||
Assets:
|
||||||||||||||||
Certificates of Deposit
|
$
|
6,234,996
|
$
|
-
|
$
|
6,234,996
|
$
|
-
|
||||||||
Commercial Paper
|
2,977,570
|
-
|
2,977,570
|
-
|
||||||||||||
Corporate Bonds
|
4,027,520
|
-
|
4,027,520
|
-
|
||||||||||||
Total Assets:
|
$
|
13,240,086
|
$
|
-
|
$
|
13,240,086
|
$
|
-
|
||||||||
Liabilities:
|
||||||||||||||||
Warrant Liabilities
|
$
|
2,739,163
|
-
|
-
|
$
|
2,739,163
|
Warrant Liabilities | ||||
Balance at January 1, 2016
|
$
|
2,739,163
|
||
Additions
|
4,364,110
|
|||
Unrealized gains, net
|
(5,529,907
|
)
|
||
Transfers out of level 3
|
-
|
|||
Balance at December 31, 2016
|
$
|
1,573,366
|
Warrant Liabilities | ||||
Balance at January 1, 2015
|
$
|
3,768,351
|
||
Additions
|
2,966,917
|
|||
Unrealized gains, net
|
(3,986,727
|
)
|
||
Transfers out of level 3
|
(9,378
|
)
|
||
Balance at December 31, 2015
|
$
|
2,739,163
|
17.
|
Select Quarterly Data (Unaudited)
|
2016
|
||||||||||||||||
For the Quarter Ended
|
||||||||||||||||
March 31
|
June 30
|
September 30
|
December 31
|
|||||||||||||
Revenues
|
$
|
-
|
$
|
-
|
$
|
-
|
$
|
-
|
||||||||
Expenses
|
4,863,981
|
3,912,782
|
3,717,575
|
3,919,047
|
||||||||||||
Loss from Operations
|
(4,863,981
|
)
|
(3,912,782
|
)
|
(3,717,575
|
)
|
(3,919,047
|
)
|
||||||||
Other Income, net
|
714,939
|
2,146,958
|
850,579
|
3,393,564
|
||||||||||||
Net Loss
|
$
|
(4,149,042
|
)
|
$
|
(1,765,824
|
)
|
$
|
(2,866,996
|
)
|
$
|
(525,483
|
)
|
||||
Net Loss per share, basic and diluted
|
$
|
(0.02
|
)
|
$
|
(0.01
|
)
|
$
|
(0.01
|
)
|
$
|
(0.00
|
)
|
2015
|
||||||||||||||||
For the Quarter Ended
|
||||||||||||||||
March 31
|
June 30
|
September 30
|
December 31
|
|||||||||||||
Revenues
|
$
|
-
|
$
|
-
|
$
|
-
|
$
|
-
|
||||||||
Expenses
|
4,417,708
|
4,819,940
|
4,658,555
|
4,367,233
|
||||||||||||
Loss from Operations
|
(4,417,708
|
)
|
(4,819,940
|
)
|
(4,658,555
|
)
|
(4,367,233
|
)
|
||||||||
Other Income, net
|
145,997
|
1,585,780
|
632,025
|
1,515,078
|
||||||||||||
Net Loss per share
|
$
|
(4,271,711
|
)
|
$
|
(3,234,160
|
)
|
$
|
(4,026,530
|
)
|
$
|
(2,852,155
|
)
|
||||
Net Loss per share, basic and diluted
|
$
|
(0.02
|
)
|
$
|
(0.02
|
)
|
$
|
(0.02
|
)
|
$
|
(0.02
|
)
|
18. |
Subsequent Events
|
*10.5
|
Form of Stock Option Grant Agreement under Rexahn Pharmaceuticals, Inc. 2013 Stock Option Plan filed as Exhibit 10.5 to the Company’s Annual Report on Form 10-K for the year ended December 31, 2015, filed on March 14, 2016, is incorporated herein by reference.
|
*10.6
|
Employment Agreement, dated as of September 9, 2010, by and between Rexahn Pharmaceuticals, Inc. and T. H. Jeong, filed as Exhibit 10.3 to the Company’s Current Report on Form 8-K filed on September 10, 2010, is incorporated herein by reference.
|
*10.7
|
Employment Agreement, dated as of February 4, 2013, by and between Rexahn Pharmaceuticals, Inc. and Peter Suzdak, filed as Exhibit 10.1 to the Company’s Current Report on Form 8-K filed on January 22, 2013, is incorporated herein by reference.
|
*10.8
|
Employment Agreement, dated as of March 25, 2013, by and between Rexahn Pharmaceuticals, Inc. and Chang H. Ahn, filed as Exhibit 10.1 to the Company’s Current Report on Form 8-K filed on March 29, 2013, is incorporated herein by reference.
|
*10.9
|
Employment Agreement, dated as of February 2, 2015, by and between Rexahn Pharmaceuticals, Inc. and Ely Benaim, M.D., filed as Exhibit 10.1 to the Company’s Current Report on Form 8-K filed on May 8, 2015, is incorporated herein by reference.
|
*10.10
|
Bonus Letter Agreement, dated as of August 2, 2016, by and between Rexahn Pharmaceuticals, Inc. and Ely Benaim, M.D., filed as Exhibit 10.2 to the Company’s Quarterly Report on Form 10-Q for the quarterly period ended June 30, 2016, is incorporated herein by reference.
|
*10.11
|
Employment Agreement, dated as of July 6, 2016, by and between Rexahn Pharmaceuticals, Inc. and Lisa Nolan, Ph.D., filed as Exhibit 10.2 to the Company’s Quarterly Report on Form 10-Q for the quarterly period ended September 30, 2016, is incorporated herein by reference.
|
10.12
|
Lease Agreement, dated June 5, 2009, by and between Rexahn Pharmaceuticals, Inc. and The Realty Associates Fund V, L.P., filed as Exhibit 10.4 to the Company’s Quarterly Report on Form 10-Q for the quarterly period ended June 30, 2009, is incorporated herein by reference.
|
10.13
|
First Amendment to Lease Agreement, dated as of June 7, 2013, by and between Rexahn Pharmaceuticals, Inc. and SG Plaza Holdings, LLC, filed as Exhibit 10.1 to the Company’s Quarterly Report on Form 10-Q for the quarterly period ended June 30, 2013, is incorporated herein by reference.
|
10.14
|
Second Amendment to Lease Agreement, dated as of July 26, 2014, by and between Rexahn Pharmaceuticals, Inc. and SG Plaza Holdings, LLC, filed as Exhibit 10.1 to the Company’s Quarterly Report on Form 10-Q for the quarterly period ended September 30, 2014, is incorporated herein by reference.
|
10.15
|
Third Amendment to Lease Agreement, dated as of May 6, 2015, by and between Rexahn Pharmaceuticals, Inc. and SG Plaza Holdings, LLC, filed as Exhibit 10.1 to the Company’s Quarterly Report on Form 10-Q for the quarterly period ended June 30, 2015, is incorporated herein by reference.
|
10.16
|
Fourth Amendment to Lease Agreement, dated as of April 4, 2016, by and between Rexahn Pharmaceuticals, Inc. and SG Plaza Holdings, LLC, filed as Exhibit 10.1 to the Company’s Quarterly Report on Form 10-Q for the quarterly period ended June 30, 2016, is incorporated herein by reference.
|
10.17
|
Research Collaboration Agreement on RX-0201 Clinical Development, dated as of February 6, 2003, filed as Exhibit 10.5 to the Company’s Annual Report on Form 10-K for the year ended December 31, 2005, is incorporated herein by reference.
|
10.18
|
Form of Securities Purchase Agreement, dated as of July 23, 2013, by and between Rexahn Pharmaceuticals, Inc. and the purchasers identified on the signature pages thereto, filed as Exhibit 10.1 to the Company’s Current Report on Form 8-K filed on July 24, 2013, is incorporated herein by reference.
|
10.19
|
Form of Securities Purchase Agreement, dated as of October 10, 2013, by and between Rexahn Pharmaceuticals, Inc. and the purchasers identified on the signature pages thereto, filed as Exhibit 10.1 to the Company’s Current Report on Form 8-K filed on October 16, 2014, is incorporated herein by reference.
|
10.20
|
Form of Securities Purchase Agreement, dated as of January 15, 2014, by and between Rexahn Pharmaceuticals, Inc. and the purchasers identified on the signature pages thereto, filed as Exhibit 10.1 to the Company’s Current Report on Form 8-K filed on January 21, 2014, is incorporated herein by reference.
|
10.21
|
Form of Securities Purchase Agreement, dated as of November 6, 2015, by and between Rexahn Pharmaceuticals, Inc. and the purchasers identified on the signature pages thereto, filed as Exhibit 10.1 to the Company’s Current Report on Form 8-K filed on November 6, 2015, is incorporated herein by reference.
|
10.22
|
Form of Securities Purchase Agreement, dated as of February 26, 2016, by and between Rexahn Pharmaceuticals, Inc. and the purchasers identified on the signature pages thereto, filed as Exhibit 10.1 to the Company’s Current Report on Form 8-K filed on February 26, 2016, is incorporated herein by reference.
|
10.23
|
Form of Securities Purchase Agreement, dated as of September 14, 2016, by and between Rexahn Pharmaceuticals, Inc. and the purchasers identified on the signature pages thereto, filed as Exhibit 10.1 to the Company’s Current Report on Form 8-K filed on September 14, 2016, is incorporated herein by reference.
|
10.24
|
At Market Issuance Sales Agreement, dated as of March 16, 2015, by and between Rexahn Pharmaceuticals, Inc. and MLV & Co. LLC, filed as Exhibit 10.18 to the Company’s Annual Report on Form 10-K for the year ended December 31, 2014, is incorporated herein by reference.
|
Statement Regarding the Computation of Ratio of Earnings to Combined Fixed Charges and Preferred Stock Dividends
|
|
Consent of Baker Tilly Virchow Krause, LLP, independent registered public accounting firm
|
|
Power of Attorney
|
|
Certification of Chief Executive Officer Pursuant to Rule 13a-14(a) or Rule 15d-14(a)
|
|
Certification of Chief Financial Officer Pursuant to Rule 13a-14(a) or Rule 15d-14(a)
|
|
Certification of Chief Executive Officer of Periodic Report Pursuant to 18 U.S.C. Section 1350
|
|
Certification of Chief Financial Officer of Periodic Report Pursuant to 18 U.S.C. Section 1350
|
|
101.INS
|
XBRL Instance Document
|
101.SCH
|
XBRL Taxonomy Extension Schema
|
101.CAL
|
XBRL Taxonomy Calculation Linkbase
|
101.DEF
|
XBRL Taxonomy Definition Linkbase
|
101.LAB
|
XBRL Taxonomy Label Linkbase
|
101.PRE
|
XBRL Taxonomy Presentation Linkbase
|
1 Year Rexahn Pharmaceuticals, Inc. Chart |
1 Month Rexahn Pharmaceuticals, Inc. Chart |
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