Delaware
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11-3516358
|
|
(State or other jurisdiction of incorporation or organization)
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(I.R.S. Employer Identification Number)
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Title of Each Class
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Name of Each Exchange On Which Registered
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Common Stock, $0.0001 par value per share
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NYSE American
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Large Accelerated Filer
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☐
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Accelerated Filer
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☑
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Non-Accelerated Filer
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☐
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Smaller reporting company
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☐
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(Do not check if a smaller reporting company)
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Emerging growth company
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☐
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Class
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Outstanding as of March 9, 2018
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Common Stock, $0.0001 par value per share
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31,744,439 shares
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· |
our understandings and beliefs regarding the role of certain biological mechanisms and processes in cancer;
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· |
our drug candidates being in early stages of development, including in pre-clinical development;
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· |
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;
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our ability to transition from our initial focus on developing drug candidates for orphan indications to candidates for more highly prevalent indications;
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· |
our ability to successfully and timely complete clinical trials for our drug candidates in clinical development;
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uncertainties related to the timing, results and analyses related to our drug candidates in pre-clinical development;
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· |
our ability to obtain the necessary U.S. and international regulatory approvals for our drug candidates;
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our reliance on third-party contract research organizations and other investigators and collaborators for certain research and development services;
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our ability to maintain or engage third-party manufacturers to manufacture, supply, store and distribute supplies of our drug candidates for our clinical trials;
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our ability to form strategic alliances and partnerships with pharmaceutical companies and other partners for sales and marketing of certain of our product candidates;
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demand for and market acceptance of our drug candidates;
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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
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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.
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Page
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PART I
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1
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Item 1
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1
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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
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Item 4
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43
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PART II
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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
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60
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Item 9A
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60
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Item 9B
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62
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PART III
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63 | ||
Item 10
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63
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Item 11
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63
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Item 12
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63
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Item 13
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63
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Item 14
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63
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Item 15
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64
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Item 16
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64
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69
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· |
RX-3117
is a novel, oral, small molecule nucleoside compound. Once intracellularly activated (phosphorylated) by the enzyme UCK2, it is incorporated into the DNA or RNA of cells and inhibits both DNA and RNA synthesis, which induces apoptotic cell death of tumor cells. Because UCK2 is overexpressed in multiple human tumors, but has a very limited presence in normal tissues, RX-3117 offers the potential for a targeted anti-cancer therapy with an improved efficacy and safety profile, and we believe it has therapeutic potential in a broad range of cancers, including pancreatic, bladder, colon, and lung cancer. In January 2018, we reported final data from a Phase 2a clinical trial of RX-3117 in patients with relapsed or refractory metastatic pancreatic cancer. In this trial, encouraging progression free survival and evidence of tumor shrinkage were observed in patients with metastatic pancreatic cancer that was resistant to gemcitabine and who had failed on multiple prior treatments. RX-3117 is currently the subject of a Phase 2a clinical trial in combination with Abraxane® (paclitaxel protein-bound) in patients newly diagnosed with metastatic pancreatic cancer. In February 2018, updated safety and efficacy data from the ongoing Phase 2a clinical trial of RX-3117 in advanced urothelial (bladder) cancer were reported. In this trial, encouraging progression free survival and evidence of tumor shrinkage were observed in patients with advanced bladder cancer who had failed on multiple prior treatments including immunotherapy and gemcitabine. RX-3117 has received “orphan drug designation” from the U.S. Food and Drug Administration (“FDA”) and from the European Commission (“EC”) for pancreatic cancer. Orphan drug designation in the U.S. 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 in the U.S. 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.
|
· |
RX-5902 (Supinoxin) 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. RX-5902 selectively blocks the interaction of phosphorylated p68 with beta-catenin, thereby decreasing the proliferation or growth of cancer cells in preclinical models. In addition, multiple pre-clinical models suggest that RX-5902 enhances the efficacy of immunotherapy. We have evaluated RX-5902 in a Phase 1 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 2a clinical study of RX-5902 in patients with metastatic triple negative breast cancer (“TNBC”).
|
· |
RX-0201 (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. RX-0201 is the subject of a research and development collaboration with Zhejiang Haichang Biotechnology Co., Ltd. (“Haichang”) for the development of RX-0201 to conduct certain pre-clinical and clinical activities through completion of a Phase 2a proof-of-concept clinical trial in hepatocellular carcinoma (“HCC”) and pursuant to which the parties will share any downstream licensing fees and royalties paid by third parties in connection with the further development and commercialization of RX-0201 for the treatment of HCC. RX-0201 has received orphan drug designation from the FDA for renal cell carcinoma (“RCC”), glioblastoma, ovarian cancer, stomach cancer and pancreatic cancer. In February 2018, in response to the changing treatment landscape for metastatic RCC over the past two years with the approval of new therapies by the FDA, we announced plans to discontinue the internally funded programs of RX-0201 and ceased enrolling patients in a Phase 2a proof-of-concept clinical trial of RX-0201 in patients with metastatic renal cell carcinoma.
|
· |
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.
|
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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.
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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.
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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.
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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;
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undertaking pre-clinical testing and human clinical trials;
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· |
obtaining FDA and other regulatory approvals of drugs;
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formulating and manufacturing drugs; and
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launching, marketing and selling drugs.
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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;
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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;
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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.
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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;
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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.
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continued pre-clinical development and clinical trials for our current and new drug candidates;
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· |
finding and maintaining suitable partnerships to help us research, develop and commercialize drug candidates;
|
· |
efforts to seek regulatory approvals for our drug candidates;
|
· |
implementing additional internal systems and infrastructure;
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· |
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.
|
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conducting pre-clinical and clinical trials;
|
· |
participating in regulatory approval processes;
|
· |
formulating and manufacturing products; and
|
· |
conducting sales and marketing activities.
|
· |
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 CROs 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, including as a result of changing standards of care or 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 trial results 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;
|
· |
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 and its implementing regulations also impose 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. Potential manufacturers of any product candidate that is approved will be subject to FDA compliance inspections and any new manufacturer would have to be qualified to produce our products;
|
· |
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.
|
Market for Common Equity, Related Stockholder Matters and Issuer Purchases of Equity Securities.
|
Period
|
High ($)
|
Low ($)
|
||||||
2016
|
||||||||
First Quarter
|
4.25
|
2.60
|
||||||
Second Quarter
|
3.42
|
2.40
|
||||||
Third Quarter
|
2.80
|
2.02
|
||||||
Fourth Quarter
|
2.29
|
1.27
|
||||||
2017
|
||||||||
First Quarter
|
5.62
|
1.36
|
||||||
Second Quarter
|
7.10
|
2.80
|
||||||
Third Quarter
|
3.06
|
1.70
|
||||||
Fourth Quarter
|
3.19
|
1.69
|
|
For the Year Ended December 31,
|
|||||||||||||||||||
Statement of Operations Data:
|
2017
|
2016
|
2015
|
2014
|
2013
|
|||||||||||||||
Revenues
|
$
|
-
|
$
|
-
|
$
|
-
|
$
|
-
|
$
|
-
|
||||||||||
Expenses:
|
||||||||||||||||||||
General and administrative
|
6,639,421
|
6,324,236
|
6,115,210
|
6,253,328
|
4,725,699
|
|||||||||||||||
Research and development
|
10,715,296
|
10,089,149
|
12,148,226
|
7,015,901
|
3,253,139
|
|||||||||||||||
Total expenses
|
17,354,717
|
16,413,385
|
18,263,436
|
13,269,229
|
7,978,838
|
|||||||||||||||
Loss from operations
|
(17,354,717
|
)
|
(16,413,385
|
)
|
(18,263,436
|
)
|
(13,269,229
|
)
|
(7,978,838
|
)
|
||||||||||
Other Income (Expense), net
|
(7,939,786
|
)
|
7,106,040
|
3,878,880
|
(5,252,372
|
)
|
(1,520,586
|
)
|
||||||||||||
Net Loss
|
$
|
(25,294,503
|
)
|
$
|
(9,307,345
|
)
|
$
|
(14,384,556
|
)
|
$
|
(18,521,601
|
)
|
$
|
(9,499,424
|
)
|
|||||
Net Loss per share, basic and diluted
|
$
|
(0.92
|
)
|
$
|
(0.43
|
)
|
$
|
(0.79
|
)
|
$
|
(1.05
|
)
|
$
|
(0.74
|
)
|
|||||
Weighted average shares outstanding, basic and diluted
|
27,390,527
|
21,744,740
|
18,238,822
|
17,610,697
|
12,864,929
|
|||||||||||||||
|
||||||||||||||||||||
|
As of December 31,
|
|||||||||||||||||||
Balance Sheet Data:
|
2017
|
2016
|
2015
|
2014
|
2013
|
|||||||||||||||
Cash, Cash Equivalents, and Marketable Securities
|
$
|
26,831,095
|
$
|
20,315,580
|
$
|
23,439,526
|
$
|
32,698,296
|
$
|
18,788,031
|
||||||||||
Working Capital
(1)
|
$
|
24,901,710
|
$
|
19,041,597
|
$
|
22,000,046
|
$
|
30,970,020
|
$
|
18,361,438
|
||||||||||
Total Assets
|
$
|
28,287,881
|
$
|
21,043,532
|
$
|
24,805,029
|
$
|
33,533,060
|
$
|
19,556,498
|
||||||||||
Warrant Liabilities
|
$
|
7,853,635
|
$
|
1,573,366
|
$
|
2,739,163
|
$
|
3,768,351
|
$
|
5,034,058
|
||||||||||
Accumulated Deficit
|
$
|
(140,318,712
|
)
|
$
|
(115,024,209
|
)
|
$
|
(105,716,864
|
)
|
$
|
(91,332,308
|
)
|
$
|
(72,810,707
|
)
|
|||||
Total Stockholders' Equity
|
$
|
16,768,596
|
$
|
17,058,462
|
$
|
18,775,548
|
$
|
26,580,491
|
$
|
12,625,488
|
||||||||||
Common shares outstanding
|
31,725,114
|
23,736,878
|
19,741,378
|
17,825,331
|
14,671,772
|
(1) |
Working Capital defined as current assets less current liabilities
|
· |
CROs and investigative sites in connection with clinical studies;
|
· |
vendors in connection with product manufacturing, development, and distribution of clinical supplies; and
|
· |
vendors in connection with preclinical development activities.
|
For the Year Ended December 31,
|
||||||||
2017
|
2016
|
|||||||
Clinical Candidates:
|
||||||||
RX-3117
|
$
|
4,559,200
|
$
|
2,290,000
|
||||
RX-5902
|
2,019,700
|
2,230,800
|
||||||
RX-0201
|
535,700
|
1,573,800
|
||||||
Preclinical, Personnel and Overhead
|
3,600,696
|
3,994,549
|
||||||
Total Research and Development Expenses
|
$
|
10,715,296
|
$
|
10,089,149
|
For the Year Ended December 31,
|
||||||||
2016
|
2015
|
|||||||
Clinical Candidates:
|
||||||||
RX-3117
|
$
|
2,290,000
|
$
|
4,062,000
|
||||
RX-5902
|
2,230,800
|
2,839,000
|
||||||
RX-0201
|
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,
|
||||||||||||
2017
|
2016
|
2015
|
||||||||||
Net Cash Used in Operating Activities
|
$
|
(15,420,055
|
)
|
$
|
(13,227,101
|
)
|
$
|
(17,351,950
|
)
|
|||
Net Cash (Used In) Provided by Investing Activities
|
(9,372,778
|
)
|
4,483,911
|
9,554,394
|
||||||||
Net Cash Provided by Financing Activities
|
22,113,514
|
10,122,223
|
8,170,751
|
|||||||||
Net (Decrease) Increase in Cash and Cash Equivalents
|
$
|
(2,679,319
|
)
|
$
|
1,379,033
|
$
|
373,195
|
Total
|
Less than 1
year
|
1 -3 Years
|
3-5 Years
|
More than 5
years
|
||||||||||||||||
Operating Leases
|
$
|
489,822
|
$
|
279,274
|
$
|
210,548
|
$
|
-
|
$
|
-
|
· |
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.
|
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
.
|
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.
|
|
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.
|
|
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.
|
|
Fifth Amendment to Lease Agreement, dated as of April 13, 2017, by and between Rexahn Pharmaceuticals, Inc. and SG Plaza Holdings, LLC, filed as Exhibit 10.2 to the Company’s Quarterly Report on Form 10-Q for the quarterly period ended June 30, 2017, is incorporated herein by reference.
|
|
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.
|
|
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, 2013, is incorporated herein by reference.
|
|
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 15, 2014, is incorporated herein by reference.
|
|
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.
|
|
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.
|
|
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.
|
|
Form of Securities Purchase Agreement, dated as of June 6, 2017, 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 June 7, 2017, is incorporated herein by reference.
|
Form of Securities Purchase Agreement, dated as of October 13, 2017, 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 13, 2017, 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
|
REXAHN PHARMACEUTICALS, INC.
|
|||
By:
|
/s/ Douglas J. Swirsky
|
||
Douglas J. Swirsky
|
|||
Chief Financial Officer and President
|
Name
|
Title
|
Date
|
|
/s/ Peter D. Suzdak*
|
Chief Executive Officer and
|
March 9, 2018
|
|
Peter Suzdak
|
Director (Principal Executive Officer)
|
||
/s/ Douglas J. Swirsky
|
Chief Financial Officer and
|
March 9, 2018
|
|
Douglas J. Swirsky
|
President (Principal Financial and Accounting Officer)
|
||
/s/ Peter Brandt*
|
Chairman
|
March 9, 2018
|
|
Peter Brandt
|
|||
/s/ Charles Beever*
|
Director
|
March 9, 2018
|
|
Charles Beever
|
|||
/s/ Kwang Soo Cheong*
|
Director
|
March 9, 2018
|
|
Kwang Soo Cheong
|
|||
/s/ Mark Carthy*
|
Director
|
March 9, 2018
|
|
Mark Carthy
|
|||
/s/ Richard J. Rodgers*
|
Director
|
March 9, 2018
|
|
Richard J. Rodgers
|
December 31, 2017
|
December 31, 2016
|
|||||||
ASSETS
|
||||||||
Current Assets:
|
||||||||
Cash and cash equivalents
|
$
|
8,899,154
|
$
|
11,578,473
|
||||
Marketable securities
|
17,931,941
|
8,737,107
|
||||||
Prepaid expenses and other current assets
|
1,304,541
|
608,517
|
||||||
Total Current Assets
|
28,135,636
|
20,924,097
|
||||||
Security Deposits
|
30,785
|
30,785
|
||||||
Equipment, Net
|
121,460
|
88,650
|
||||||
Total Assets
|
$
|
28,287,881
|
$
|
21,043,532
|
||||
LIABILITIES AND STOCKHOLDERS’ EQUITY
|
||||||||
Current Liabilities:
|
||||||||
Accounts payable and accrued expenses
|
$
|
3,233,926
|
$
|
1,882,500
|
||||
Deferred Research and Development Arrangement
|
375,000
|
450,000
|
||||||
Other Liabilities
|
56,724
|
79,204
|
||||||
Warrant Liabilities
|
7,853,635
|
1,573,366
|
||||||
Total Liabilities
|
11,519,285
|
3,985,070
|
||||||
Commitments and Contingencies
(note 15)
|
||||||||
Stockholders’ Equity:
|
||||||||
Preferred stock, par value $0.0001, 10,000,000 authorized shares, none issued and outstanding
|
-
|
-
|
||||||
Common stock, par value $0.0001, 50,000,000 authorized shares, 31,725,114 and 23,736,878 issued and outstanding
|
3,173
|
2,374
|
||||||
Additional paid-in capital
|
157,141,021
|
132,086,419
|
||||||
Accumulated other comprehensive loss
|
(56,886
|
)
|
(6,122
|
)
|
||||
Accumulated deficit
|
(140,318,712
|
)
|
(115,024,209
|
)
|
||||
Total Stockholders’ Equity
|
16,768,596
|
17,058,462
|
||||||
Total Liabilities and Stockholders’ Equity
|
$
|
28,287,881
|
$
|
21,043,532
|
For the Year Ended December 31,
|
||||||||||||
2017
|
2016
|
2015
|
||||||||||
Revenues:
|
$
|
-
|
$
|
-
|
$
|
-
|
||||||
Expenses:
|
||||||||||||
General and administrative
|
6,639,421
|
6,324,236
|
6,115,210
|
|||||||||
Research and development
|
10,715,296
|
10,089,149
|
12,148,226
|
|||||||||
Total Expenses
|
17,354,717
|
16,413,385
|
18,263,436
|
|||||||||
Loss from Operations
|
(17,354,717
|
)
|
(16,413,385
|
)
|
(18,263,436
|
)
|
||||||
Other Income (Expense)
|
||||||||||||
Interest income
|
207,003
|
118,565
|
103,269
|
|||||||||
Mediation settlement
|
-
|
1,770,658
|
-
|
|||||||||
Unrealized (loss) gain on fair value of warrants
|
(7,594,162
|
)
|
5,529,907
|
3,986,727
|
||||||||
Financing expense
|
(552,627
|
)
|
(313,090
|
)
|
(211,116
|
)
|
||||||
Total Other Income (Expense)
|
(7,939,786
|
)
|
7,106,040
|
3,878,880
|
||||||||
Net Loss Before Provision for Income Taxes
|
(25,294,503
|
)
|
(9,307,345
|
)
|
(14,384,556
|
)
|
||||||
Provision for income taxes
|
-
|
-
|
-
|
|||||||||
Net Loss
|
$
|
(25,294,503
|
)
|
$
|
(9,307,345
|
)
|
$
|
(14,384,556
|
)
|
|||
Net loss per share, basic and diluted
|
$
|
(0.92
|
)
|
$
|
(0.43
|
)
|
$
|
(0.79
|
)
|
|||
Weighted average number of shares outstanding, basic and diluted
|
27,390,527
|
21,744,740
|
18,238,822
|
For the Year Ended December 31,
|
||||||||||||
2017
|
2016
|
2015
|
||||||||||
Net Loss
|
$
|
(25,294,503
|
)
|
$
|
(9,307,345
|
)
|
$
|
(14,384,556
|
)
|
|||
Unrealized (loss) gain on available-for-sale securities
|
(50,764
|
)
|
11,919
|
15,606
|
||||||||
Comprehensive Loss
|
$
|
(25,345,267
|
)
|
$
|
(9,295,426
|
)
|
$
|
(14,368,950
|
)
|
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, 2015
|
17,836,652
|
$
|
1,784
|
$
|
118,073,072
|
$
|
(91,332,308
|
)
|
11,321
|
$
|
(128,410
|
)
|
$
|
(33,647
|
)
|
$
|
26,580,491
|
|||||||||||||||
Issuance of common stock and units
|
1,807,374
|
181
|
5,249,892
|
-
|
-
|
-
|
-
|
5,250,073
|
||||||||||||||||||||||||
Stock issuance costs
|
-
|
-
|
(566,065
|
)
|
-
|
-
|
-
|
-
|
(566,065
|
)
|
||||||||||||||||||||||
Common stock issued in exchange for services
|
15,000
|
2
|
101,998
|
-
|
-
|
-
|
-
|
102,000
|
||||||||||||||||||||||||
Stock options exercised
|
88,943
|
9
|
708,608
|
-
|
-
|
-
|
-
|
708,617
|
||||||||||||||||||||||||
Stock warrants exercised
|
4,730
|
-
|
31,703
|
-
|
-
|
-
|
-
|
31,703
|
||||||||||||||||||||||||
Stock-based compensation
|
-
|
-
|
1,037,679
|
-
|
-
|
-
|
-
|
1,037,679
|
||||||||||||||||||||||||
Retirement of treasury stock
|
(11,321
|
)
|
(1
|
)
|
(128,409
|
)
|
-
|
(11,321
|
)
|
128,410
|
-
|
-
|
||||||||||||||||||||
Net loss
|
-
|
-
|
-
|
(14,384,556
|
)
|
-
|
-
|
-
|
(14,384,556
|
)
|
||||||||||||||||||||||
Other comprehensive income
|
-
|
-
|
-
|
-
|
-
|
-
|
15,606
|
15,606
|
||||||||||||||||||||||||
Balances at December 31, 2015
|
19,741,378
|
$
|
1,975
|
$
|
124,508,478
|
$
|
(105,716,864
|
)
|
-
|
$
|
-
|
$
|
(18,041
|
)
|
$
|
18,775,548
|
||||||||||||||||
Issuance of common stock and units
|
3,962,500
|
396
|
6,908,562
|
-
|
-
|
-
|
-
|
6,908,958
|
||||||||||||||||||||||||
Stock issuance costs
|
-
|
-
|
(837,755
|
)
|
-
|
-
|
-
|
-
|
(837,755
|
)
|
||||||||||||||||||||||
Common stock issued in exchange for services
|
33,000
|
3
|
97,646
|
-
|
-
|
-
|
-
|
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
|
23,736,878
|
$
|
2,374
|
$
|
132,086,419
|
$
|
(115,024,209
|
)
|
-
|
$
|
-
|
$
|
(6,122
|
)
|
$
|
17,058,462
|
||||||||||||||||
Issuance of common stock and units
|
6,295,613
|
630
|
11,965,753
|
-
|
-
|
-
|
-
|
11,966,383
|
||||||||||||||||||||||||
Stock issuance costs
|
-
|
-
|
(1,470,536
|
)
|
-
|
-
|
-
|
-
|
(1,470,536
|
)
|
||||||||||||||||||||||
Common stock issued in exchange for services
|
15,000
|
2
|
31,198
|
-
|
-
|
-
|
-
|
31,200
|
||||||||||||||||||||||||
Stock-based compensation
|
-
|
-
|
1,044,167
|
-
|
-
|
-
|
-
|
1,044,167
|
||||||||||||||||||||||||
Stock options exercised
|
25,000
|
2
|
77,498
|
-
|
-
|
-
|
-
|
77,500
|
||||||||||||||||||||||||
Stock warrants exercised
|
1,652,623
|
165
|
13,406,522
|
-
|
-
|
-
|
-
|
13,406,687
|
||||||||||||||||||||||||
Net loss
|
-
|
-
|
-
|
(25,294,503
|
)
|
-
|
-
|
-
|
(25,294,503
|
)
|
||||||||||||||||||||||
Other comprehensive loss
|
-
|
-
|
-
|
-
|
-
|
-
|
(50,764
|
)
|
(50,764
|
)
|
||||||||||||||||||||||
Balances at December 31, 2017
|
31,725,114
|
$
|
3,173
|
$
|
157,141,021
|
$
|
(140,318,712
|
)
|
-
|
$
|
-
|
$
|
(56,886
|
)
|
$
|
16,768,596
|
For the Year Ended December 31,
|
||||||||||||
2017
|
2016
|
2015
|
||||||||||
Cash Flows from Operating Activities:
|
||||||||||||
Net loss
|
$
|
(25,294,503
|
)
|
$
|
(9,307,345
|
)
|
$
|
(14,384,556
|
)
|
|||
Adjustments to reconcile net loss to net cash used in operating activities:
|
||||||||||||
Compensatory stock
|
31,200
|
97,649
|
102,000
|
|||||||||
Depreciation and amortization
|
42,358
|
32,916
|
27,498
|
|||||||||
Amortization of premiums and discounts on marketable securities, net
|
52,012
|
22,321
|
30,875
|
|||||||||
Stock-based compensation
|
1,044,167
|
1,409,488
|
1,037,679
|
|||||||||
Amortization of deferred research and development arrangement
|
(75,000
|
)
|
(75,000
|
)
|
(75,000
|
)
|
||||||
Unrealized loss (gain) on fair value of warrants
|
7,594,162
|
(5,529,907
|
)
|
(3,986,727
|
)
|
|||||||
Financing expense
|
552,627
|
313,090
|
211,116
|
|||||||||
Amortization of deferred lease incentive
|
(12,444
|
)
|
(12,443
|
)
|
(12,443
|
)
|
||||||
Deferred lease expenses
|
(10,036
|
)
|
(12,373
|
)
|
(8,492
|
)
|
||||||
Changes in assets and liabilities:
|
||||||||||||
Prepaid expenses and other assets
|
(696,024
|
)
|
613,301
|
(495,935
|
)
|
|||||||
Accounts payable and accrued expenses
|
1,351,426
|
(778,798
|
)
|
202,035
|
||||||||
Net Cash Used in Operating Activities
|
(15,420,055
|
)
|
(13,227,101
|
)
|
(17,351,950
|
)
|
||||||
Cash Flows from Investing Activities:
|
||||||||||||
Purchase of equipment
|
(75,168
|
)
|
(8,666
|
)
|
(62,302
|
)
|
||||||
Purchase of marketable securities
|
(21,017,610
|
)
|
(8,747,423
|
)
|
(7,908,304
|
)
|
||||||
Redemption of marketable securities
|
11,720,000
|
13,240,000
|
17,525,000
|
|||||||||
Net Cash (Used in) Provided by Investing Activities
|
(9,372,778
|
)
|
4,483,911
|
9,554,394
|
||||||||
Cash Flows from Financing Activities:
|
||||||||||||
Issuance of common stock and units, net of issuance costs
|
16,681,921
|
10,122,223
|
7,439,809
|
|||||||||
Proceeds from exercise of stock warrants
|
5,354,093
|
-
|
22,325
|
|||||||||
Proceeds from exercise of stock options
|
77,500
|
-
|
708,617
|
|||||||||
Net Cash Provided by Financing Activities
|
22,113,514
|
10,122,223
|
8,170,751
|
|||||||||
Net (Decrease) Increase in Cash and Cash Equivalents
|
(2,679,319
|
)
|
1,379,033
|
373,195
|
||||||||
Cash and Cash Equivalents – beginning of period
|
11,578,473
|
10,199,440
|
9,826,245
|
|||||||||
Cash and Cash Equivalents - end of period
|
$
|
8,899,154
|
$
|
11,578,473
|
$
|
10,199,440
|
||||||
Supplemental Cash Flow Information
|
||||||||||||
Non-cash financing and investing activities:
|
||||||||||||
Warrants issued
|
$
|
6,738,701
|
$
|
4,364,110
|
$
|
2,966,917
|
||||||
Warrant liability extinguishment from exercise of warrants
|
$
|
8,052,594
|
$
|
-
|
$
|
9,378
|
||||||
Retirement of treasury stock
|
$
|
-
|
$
|
-
|
$
|
128,410
|
1. |
Operations and Organization
|
2. |
Summary of Significant Accounting Policies
|
3.
|
Marketable Securities
|
December 31, 2017
|
||||||||||||||||
Cost
Basis
|
Gross
Unrealized
Gains
|
Gross
Unrealized
Losses
|
Fair
Value
|
|||||||||||||
Commercial Paper
|
$
|
3,241,005
|
$
|
-
|
$
|
(2,505
|
)
|
$
|
3,238,500
|
|||||||
Corporate Bonds
|
14,747,822
|
-
|
(54,381
|
)
|
14,693,441
|
|||||||||||
Total Marketable Securities
|
$
|
17,988,827
|
$
|
-
|
$
|
(56,886
|
)
|
$
|
17,931,941
|
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
|
Maturity
|
Cost Basis
|
Fair Value
|
||||||
Less than 1 year
|
$
|
11,981,457
|
$
|
11,955,101
|
||||
1 to 5 years
|
6,007,370
|
5,976,840
|
||||||
Total Marketable Securities
|
$
|
17,988,827
|
$
|
17,931,941
|
4. |
Prepaid Expenses and Other Current Assets
|
December 31,
2017
|
December 31,
2016
|
|||||||
Deposits on contracts
|
$
|
793,940
|
$
|
179,476
|
||||
Prepaid expenses and other current assets
|
510,601
|
429,041
|
||||||
$
|
1,304,541
|
$
|
608,517
|
5. |
Equipment, Net
|
December 31,
2017
|
December 31,
2016
|
|||||||
Furniture and fixtures
|
$
|
82,686
|
$
|
78,794
|
||||
Office and computer equipment
|
171,724
|
113,932
|
||||||
Lab equipment
|
445,134
|
431,650
|
||||||
Leasehold improvements
|
133,762
|
133,762
|
||||||
Total equipment
|
833,306
|
758,138
|
||||||
Less: Accumulated depreciation and amortization
|
(711,846
|
)
|
(669,488
|
)
|
||||
Net carrying amount
|
$
|
121,460
|
$
|
88,650
|
6. |
Accounts Payable and Accrued Expenses
|
December 31,
2017
|
December 31,
2016
|
|||||||
Trade payables
|
$
|
895,638
|
$
|
430,013
|
||||
Accrued expenses
|
95,416
|
141,190
|
||||||
Accrued research and development contract costs
|
1,435,109
|
499,889
|
||||||
Payroll liabilities
|
807,763
|
811,408
|
||||||
$
|
3,233,926
|
$
|
1,882,500
|
7. |
Deferred Research and Development Arrangements
|
8. |
Other Liabilities
|
December 31,
2017
|
December 31,
2016
|
|||||||
Deferred lease incentive
|
$
|
154,660
|
$
|
154,660
|
||||
Less accumulated amortization
|
(135,995
|
)
|
(123,551
|
)
|
||||
Balance
|
$
|
18,665
|
$
|
31,109
|
9. |
Net Loss per Common Share
|
10. |
Common Stock
|
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
|
Gross Proceeds:
|
$
|
10,000,003
|
||
Allocated to warrant liabilities
|
3,673,168
|
|||
Allocated to common stock and additional paid-in capital
|
6,326,835
|
|||
Total allocated gross proceeds:
|
$
|
10,000,003
|
Gross Proceeds:
|
$
|
8,000,007
|
||
Allocated to warrant liabilities
|
2,360,459
|
|||
Allocated to common stock and additional paid-in capital
|
5,639,548
|
|||
Total allocated gross proceeds:
|
$
|
8,000,007
|
For the Year Ended December 31,
|
||||||||||||
2017
|
2016
|
2015
|
||||||||||
Compensatory shares issued
|
15,000
|
33,000
|
15,000
|
|||||||||
Aggregate market value
|
$
|
31,200
|
$
|
97,649
|
$
|
102,000
|
For the Year Ended December 31,
|
||||||||||||
2017
|
2016
|
2015
|
||||||||||
Stock Option Exercises
|
||||||||||||
Number of shares issued
|
25,000
|
-
|
88,943
|
|||||||||
Total cash received
|
$
|
77,500
|
$
|
-
|
$
|
708,617
|
||||||
Stock Warrant Exercises
|
||||||||||||
Number of shares issued
|
1,652,623
|
-
|
4,730
|
|||||||||
Total cash received
|
$
|
5,354,093
|
$
|
-
|
$
|
22,325
|
11. |
Stock-Based Compensation
|
For the Year Ended December 31,
|
||||||||||||
2017
|
2016
|
2015
|
||||||||||
Statement of operations line item:
|
||||||||||||
General and administrative
|
$
|
765,726
|
$
|
905,911
|
$
|
665,063
|
||||||
Research and development
|
278,441
|
503,577
|
372,616
|
|||||||||
Total
|
$
|
1,044,167
|
$
|
1,409,488
|
$
|
1,037,679
|
Year Ended December 31,
|
||||||||||||
2017
|
2016
|
2015
|
||||||||||
Black-Scholes assumptions
|
||||||||||||
Expected dividend yield
|
0
|
%
|
0
|
%
|
0
|
%
|
||||||
Expected volatility
|
69-79
|
%
|
31-75
|
%
|
72-80
|
%
|
||||||
Risk-free interest rate
|
1.7-2.0
|
%
|
0.8-1.4
|
%
|
1.2-1.7
|
%
|
||||||
Expected term (in years)
|
5.5-6 years
|
2-6 years
|
5-6 years
|
Number of
Options
|
Weighted
Average
Exercise
Price
|
Weighted Average
Remaining
Contractual Term
|
Aggregate
Intrinsic
Value
|
||||||||||
Outstanding, January 1, 2017
|
1,690,037
|
$
|
6.20
|
7.3 years
|
$
|
-
|
|||||||
Granted
|
483,260
|
$
|
2.37
|
||||||||||
Exercised
|
(25,000
|
)
|
$
|
3.10
|
|||||||||
Expired
|
(20,000
|
)
|
$
|
16.18
|
|||||||||
Cancelled
|
(314,066
|
)
|
$
|
4.97
|
|||||||||
Outstanding, December 31, 2017
|
1,814,231
|
$
|
5.33
|
7.1 years
|
$
|
53,883
|
|||||||
Exercisable, December 31, 2017
|
1,086,688
|
$
|
6.50
|
6.2 years
|
$
|
321
|
2017
|
||||||||
Number of Options
|
Weighted Average Fair
Value at Grant Date
|
|||||||
Unvested at January 1, 2017
|
897,123
|
$
|
3.21
|
|||||
Granted
|
483,260
|
$
|
1.53
|
|||||
Vested
|
(489,235
|
)
|
$
|
3.11
|
||||
Cancelled
|
(163,605
|
)
|
$
|
2.25
|
||||
Unvested at December 31, 2017
|
727,543
|
$
|
2.39
|
Number of RSUs
|
Weighted
Average Grant
Date Fair Value
|
|||||||
Outstanding, January 1, 2017
|
-
|
$
|
-
|
|||||
Granted
|
62,300
|
$
|
1.84
|
|||||
Vested and Released
|
-
|
$
|
-
|
|||||
Cancelled
|
(15,000
|
)
|
$
|
1.84
|
||||
Outstanding, December 31, 2017
|
47,300
|
$
|
1.84
|
12.
|
Warrants
|
2017
|
2016
|
|||||||||||||||
Number of
warrants
|
Weighted
average exercise
price
|
Number of
warrants
|
Weighted average
exercise price
|
|||||||||||||
Balance, January 1
|
5,452,691
|
$
|
4.92
|
2,649,199
|
$
|
7.97
|
||||||||||
Issued during the period
|
3,525,543
|
$
|
3.42
|
3,194,000
|
$
|
3.47
|
||||||||||
Exercised during the period
|
(1,861,195
|
)
|
$
|
3.51
|
-
|
$
|
-
|
|||||||||
Expired during the period
|
(17,430
|
)
|
$
|
4.72
|
(390,508
|
)
|
$
|
13.72
|
||||||||
Balance, December 31
|
7,099,609
|
$
|
4.55
|
5,452,691
|
$
|
4.92
|
Fair Value as of:
|
||||||||
Warrant Issuance:
|
December 31, 2017
|
December 31, 2016
|
||||||
December 2012 Investor Warrants
|
$
|
-
|
$
|
49
|
||||
July 2013 Investor Warrants
|
8,762
|
2,060
|
||||||
October 2013 Investor Warrants
|
26,288
|
3,708
|
||||||
January 2014 Investor Warrants
|
29,257
|
714
|
||||||
November 2015 Investor Warrants
|
1,260,050
|
260,500
|
||||||
November 2015 Placement Agent Warrants
|
2,936
|
13,542
|
||||||
March 2016 Investor Warrants
|
697,554
|
358,945
|
||||||
March 2016 Placement Agent Warrants
|
-
|
21,320
|
||||||
September 2016 Investor Warrants
|
1,054,083
|
854,640
|
||||||
September 2016 Placement Agent Warrants
|
-
|
57,888
|
||||||
June 2017 Investor Warrants
|
1,981,864
|
-
|
||||||
June 2017 Placement Agent Warrants
|
221,591
|
-
|
||||||
October 2017 Investor Warrants
|
2,305,552
|
-
|
||||||
October 2017 Placement Agent Warrants
|
265,698
|
-
|
||||||
Total:
|
$
|
7,853,635
|
$
|
1,573,366
|
Number of Shares indexed as of:
|
||||||||
Warrant Issuance
|
December 31, 2017
|
December 31, 2016
|
||||||
December 2012 Investor Warrants
|
-
|
17,430
|
||||||
July 2013 Investor Warrants
|
200,000
|
200,000
|
||||||
October 2013 Investor Warrants
|
231,732
|
231,732
|
||||||
January 2014 Investor Warrants
|
476,193
|
476,193
|
||||||
November 2015 Investor Warrants
|
1,250,001
|
1,250,001
|
||||||
November 2015 Placement Agent Warrants
|
3,334
|
83,335
|
||||||
March 2016 Investor Warrants
|
607,806
|
1,171,875
|
||||||
March 2016 Placement Agent Warrants
|
-
|
78,125
|
||||||
September 2016 Investor Warrants
|
805,000
|
1,800,000
|
||||||
September 2016 Placement Agent Warrants
|
-
|
144,000
|
||||||
June 2017 Investor Warrants
|
1,515,152
|
-
|
||||||
June 2017 Placement Agent Warrants
|
181,818
|
-
|
||||||
October 2017 Investor Warrants
|
1,632,654
|
-
|
||||||
October 2017 Placement Agent Warrants
|
195,919
|
-
|
||||||
Total:
|
7,099,609
|
5,452,691
|
December 31, 2017
|
December 31, 2016
|
|||||||
Trading market prices
|
$
|
2.02
|
$
|
1.40
|
||||
Estimated future volatility
|
104
|
%
|
104
|
%
|
||||
Dividend
|
-
|
-
|
||||||
Estimated future risk-free rate
|
2.14-2.45
|
%
|
1.06-2.44
|
%
|
||||
Equivalent volatility
|
85-104
|
%
|
51-60
|
%
|
||||
Equivalent risk-free rate
|
1.30-1.89
|
%
|
0.59-1.25
|
%
|
For the Year Ended December 31,
|
||||||||||||
2017
|
2016
|
2015
|
||||||||||
Expired Warrants
|
$
|
-
|
$
|
2,590
|
$
|
458,439
|
||||||
December 2012 Investor Warrants
|
49
|
9,769
|
70,856
|
|||||||||
July 2013 Investor Warrants
|
(6,702
|
)
|
119,360
|
666,894
|
||||||||
October 2013 Investor Warrants
|
(22,580
|
)
|
165,641
|
780,407
|
||||||||
January 2014 Investor Warrants
|
(28,543
|
)
|
130,762
|
1,347,724
|
||||||||
November 2015 Investor Warrants
|
(999,550
|
)
|
1,908,875
|
623,125
|
||||||||
November 2015 Placement Agent Warrants
|
(365,748
|
)
|
121,593
|
39,282
|
||||||||
March 2016 Investor Warrants
|
(2,708,163
|
)
|
2,060,977
|
-
|
||||||||
March 2016 Placement Agent Warrants
|
(351,899
|
)
|
134,617
|
-
|
||||||||
September 2016 Investor Warrants
|
(4,571,872
|
)
|
816,480
|
-
|
||||||||
September 2016 Placement Agent Warrants
|
(503,150
|
)
|
59,243
|
-
|
||||||||
June 2017 Investor Warrants
|
1,691,304
|
-
|
-
|
|||||||||
June 2017 Placement Agent Warrants
|
212,729
|
-
|
-
|
|||||||||
October 2017 Investor Warrants
|
54,907
|
-
|
-
|
|||||||||
October 2017 Placement Agent Warrants
|
5,056
|
-
|
-
|
|||||||||
Total:
|
$
|
(7,594,162
|
)
|
$
|
5,529,907
|
$
|
3,986,727
|
13. |
Mediation Settlement
|
14. |
Income Taxes
|
December 31,
2017
|
December 31,
2016
|
|||||||
Net Operating Loss Carryforwards
|
$
|
35,805,000
|
$
|
43,526,000
|
||||
Stock Compensation Expense
|
1,458,000
|
1,968,000
|
||||||
Book tax differences on assets and liabilities
|
365,000
|
547,000
|
||||||
Valuation Allowance
|
(37,628,000
|
)
|
(46,041,000
|
)
|
||||
Net Deferred Tax Assets
|
$
|
-
|
$
|
-
|
15. |
Commitments and Contingencies
|
a) |
The Company has contracted with various vendors for research and development services, with terms that 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, 2017, the total estimated cost to complete these agreements was approximately $
11,110,000
. 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, 2017, the milestone has not occurred.
|
c) |
Office Space Lease
|
For the year ending December 31:
|
2018
|
$
|
279,274
|
||
|
2019 |
176,080
|
|||
2020
|
34,468
|
||||
|
Total
|
$
|
489,822
|
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 $123,145, $113,204, and $121,519, for the years ended December 31, 2017, 2016 and 2015 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. The agreement requires the Company to make payments to the University of Maryland if any products from the licensed delivery platform achieve development milestones. As of December 31, 2017, 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, 2017, 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.
|
Warrant Liabilities
|
||||
Balance at January 1, 2017
|
$
|
1,573,366
|
||
Additions
|
6,738,701
|
|||
Unrealized losses, net
|
7,594,162
|
|||
Transfers out of level 3
|
(8,052,594
|
)
|
||
Balance at December 31, 2017
|
$
|
7,853,635
|
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
|
17. |
Select Quarterly Data (Unaudited)
|
2017
|
||||||||||||||||
For the Quarter Ended
|
||||||||||||||||
March 31
|
June 30
|
September 30
|
December 31
|
|||||||||||||
Revenues
|
$
|
-
|
$
|
-
|
$
|
-
|
$
|
-
|
||||||||
Expenses
|
3,953,241
|
4,283,925
|
4,219,322
|
4,898,229
|
||||||||||||
Loss from Operations
|
(3,953,241
|
)
|
(4,283,925
|
)
|
(4,219,322
|
)
|
(4,898,229
|
)
|
||||||||
Other Income (Expense), net
|
(17,657,783
|
)
|
5,230,981
|
3,181,250
|
1,305,766
|
|||||||||||
Net Income (Loss)
|
$
|
(21,611,024
|
)
|
$
|
947,056
|
$
|
(1,038,072
|
)
|
$
|
(3,592,463
|
)
|
|||||
Net Income (Loss) per share, basic
|
$
|
(0.91
|
)
|
$
|
0.04
|
$
|
(0.04
|
)
|
$
|
(0.12
|
)
|
|||||
Net Income (Loss) per share, diluted
|
$
|
(0.91
|
)
|
$
|
0.03
|
$
|
(0.04
|
)
|
$
|
(0.12
|
)
|
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
|
$
|
(0.20
|
)
|
$
|
(0.08
|
)
|
$
|
(0.13
|
)
|
$
|
(0.02
|
)
|
18. |
Subsequent Events
|
REXAHN PHARMACEUTICALS, INC.
|
|
By:
/s/ Peter Suzdak
|
|
Name: Peter Suzdak
|
|
Title: CEO
|
|
Date: December 11, 2017
|
|
Tae Heum (Ted) Jeong
|
|
/s/: Tae Heum (Ted) Jeong
|
|
Date: December 11, 2017
|
For the Year Ended December 31,
|
||||||||||||||||||||
Statement of Operations Data:
|
2017
|
2016
|
2015
|
2014
|
2013
|
|||||||||||||||
Earnings:
|
||||||||||||||||||||
Net loss
|
$
|
(25,295
|
)
|
$
|
(9,307
|
)
|
$
|
(14,385
|
)
|
$
|
(18,522
|
)
|
$
|
(9,499
|
)
|
|||||
Plus fixed charges
|
80
|
81
|
78
|
68
|
61
|
|||||||||||||||
Total loss to cover fixed charges
|
(25,215
|
)
|
(9,226
|
)
|
(14,307
|
)
|
(18,454
|
)
|
(9,438
|
)
|
||||||||||
Fixed Charges:
|
||||||||||||||||||||
Interest portion of rental expense (see below)
|
80
|
81
|
78
|
68
|
61
|
|||||||||||||||
Deficiency of earnings to cover fixed charges
|
(25,295
|
)
|
(9,307
|
)
|
(14,385
|
)
|
(18,522
|
)
|
(9,499
|
)
|
/s/ BAKER TILLY VIRCHOW KRAUSE, LLP
|
Wyomissing, Pennsylvania
|
March 9, 2018
|
Signature
|
Title
|
Date
|
/s/ Peter D. Suzdak
|
Chief Executive Officer and Director
|
March 6, 2018
|
Peter D. Suzdak
|
||
/s/ Douglas J. Swirsky
|
Chief Financial Officer and President
|
March 5, 2018
|
Douglas J. Swirsky
|
||
/s/ Peter Brandt
|
Chairman
|
March 7, 2018
|
Peter Brandt
|
||
/s/ Charles Beever
|
Director
|
March 6, 2018
|
Charles Beever
|
||
/s/ Kwang Soo Cheong
|
Director
|
March 6, 2018
|
Kwang Soo Cheong
|
||
/s/ Mark Carthy
|
Director
|
March 6, 2018
|
Mark Carthy
|
||
/s/ Richard J. Rodgers
|
Director
|
March 5, 2018
|
Richard J. Rodgers
|
1. |
I have reviewed this Annual Report on Form 10-K of Rexahn Pharmaceuticals, 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 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 annual 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 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: March 9, 2018
|
|
/s/ Peter D. Suzdak
|
|
Peter D. Suzdak
|
|
Chief Executive Officer
|
1. |
I have reviewed this Annual Report on Form 10-K of Rexahn Pharmaceuticals, 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 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 annual 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 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: March 9, 2018
|
/s/ Douglas J. Swirsky
|
Douglas J. Swirsky
|
Chief Financial Officer and President
|
(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 results of operations of the Company.
|
Dated: March 9, 2018
|
By:
|
/s/ Peter D. Suzdak
|
|
Peter D. Suzdak,
|
|||
Chief Executive Officer
|
*
|
This Certification is being furnished as required by Rule 13a-14(b) under the Securities Exchange Act of 1934 (the “Exchange Act”) and Section 1350 of Chapter 63 of Title 18 of the United States Code, and shall not be deemed “filed” for purposes of Section 18 of the Exchange Act or otherwise subject to the liability of that section. This Certification shall not be deemed to be incorporated by reference into any filing under the Securities Act of 1933 or the Exchange Act, except as otherwise stated in such filing.
|
(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 results of operations of the Company.
|
Dated: March 9, 2018
|
By:
|
/s/ Douglas J. Swirsky
|
|
Douglas J. Swirsky,
|
|||
Chief Financial Officer and President
|
*
|
This Certification is being furnished as required by Rule 13a-14(b) under the Securities Exchange Act of 1934 (the “Exchange Act”) and Section 1350 of Chapter 63 of Title 18 of the United States Code, and shall not be deemed “filed” for purposes of Section 18 of the Exchange Act or otherwise subject to the liability of that section. This Certification shall not be deemed to be incorporated by reference into any filing under the Securities Act of 1933 or the Exchange Act, except as otherwise stated in such filing.
|