Annual report [Section 13 and 15(d), not S-K Item 405]

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DIPEXIUM PHARMACEUTICALS, INC. FINANCIAL STATEMENTS TABLE OF CONTENTS

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UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549



FORM 10-K



(Mark One)

ý


Annual Report Under Section 13 Or 15(d) Of The Securities Exchange Act Of 1934

For the fiscal year ended December 31, 2015

or

o


Transition Report Under Section 13 Or 15(d) Of The Securities Exchange Act Of 1934

For the transition period from            to

COMMISSION FILE NUMBER: 001-36351

DIPEXIUM PHARMACEUTICALS, INC.
(Exact name of registrant as specified in its charter)

Delaware
(State or other jurisdiction of
incorporation or organization)
46-4995704
(I.R.S. Employer
Identification No.)

14 Wall Street, 3rd Floor
New York, NY, 10005
(Address of principal executive offices)(Zip Code)

(212) 269-2834
Registrant's telephone number, including area code

Indicate by check mark if the registrant is a well-known seasoned issuer, as defined in Rule 405 of the Securities Act. Yes o No ý

Indicate by check mark if the registrant is not required to file reports pursuant to Section 13 or Section 15(d) of the Exchange Act. Yes o No ý

Indicate by check mark whether the registrant: (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days. Yes ý No o

Indicate by check mark whether the registrant has submitted electronically and posted on its corporate website, if any, every Interactive Date File required to be submitted and posted pursuant to Rule 405 of Regulation S-T (Section 232.405 of the chapter) during the preceding 12 months (or for such shorter period that the registrant was required to submit and post such files). Yes ý No o

Indicate by check mark if disclosure of delinquent filers pursuant to Item 405 of Regulation S-K is not contained herein, and will not be contained, to the best of registrant's knowledge, in definitive proxy or information statements incorporated by reference in Part III of this Form 10-K or any amendment to this Form 10-K. ý

Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, or a smaller reporting company. See the definitions of "large accelerated filer," "accelerated filer" and "smaller reporting company" in Rule 12b-2 of the Exchange Act. (Check one):

Large accelerated filer o Accelerated filer o Non-accelerated filer o
(Do not check if a
smaller reporting company)
Smaller reporting company ý

Indicate by check mark whether the registrant is a shell company (as defined in Rule 126-2 of the act): Yes o No ý

The aggregate market value of voting stock held by nonaffiliates of the registrant as of June 30, 2015, the last business day of the registrant's most recently completed second fiscal quarter, based on the closing price of the common stock on the NASDAQ stock exchange on June 30, 2015 was $77,568,188.

As of March 21, 2016, 10,351,613 shares of common stock, $0.001 par value per share, were outstanding.

DOCUMENTS INCORPORATED BY REFERENCE:

Portions of our Proxy Statement for the Annual Meeting of Shareholders to be held on May 24, 2016, are incorporated by reference in Items 10, 11, 12, 13 and 14 of Part III.


Table of Contents


Table of Contents



Page


PART I


Item 1.

Business


3

Item 1A.

Risk Factors

25

Item 1B.

Unresolved Staff Comments

51

Item 2.

Properties

51

Item 3.

Legal Proceedings

52

Item 4.

Mine Safety Disclosures

53

PART II

Item 5.

Market for Registrant's Common Equity, Related Stockholder Matters and Issuer Purchases of Equity Securities


53

Item 6.

Selected Financial Data

54

Item 7.

Management's Discussion and Analysis of Financial Condition and Results of Operations

54

Item 7A.

Quantitative and Qualitative Disclosures About Market Risk

62

Item 8.

Financial Statements and Supplementary Data

62

Item 9.

Changes in and Disagreements with Accountants on Accounting and Financial Disclosure

62

Item 9A.

Controls and Procedures

63

Item 9B.

Other Information

63

PART III

Item 10.

Directors, Executive Officers and Corporate Governance


63

Item 11.

Executive Compensation

65

Item 12.

Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters

65

Item 13.

Certain Relationships and Related Transactions and Director Independence

66

Item 14.

Principal Accountant Fees and Services

66

PART IV

Item 15.

Financial Statement Schedules, Exhibits


66

Signatures

70

1


Table of Contents


CAUTIONARY NOTE REGARDING FORWARD-LOOKING STATEMENTS

We are including the following cautionary statement in this Annual Report on Form 10-K to make applicable and take advantage of the safe harbor provisions of the Private Securities Litigation Reform Act of 1995 for any forward-looking statements made by, or on behalf of us. With the exception of historical matters, the matters discussed in this Annual Report on Form 10-K are forward-looking statements (as defined in Section 21E of the Exchange Act) that involve risks and uncertainties that could cause actual results to differ materially from projected results. Accordingly, investors should not place undue reliance on forward-looking statements as a prediction of actual results. The forward-looking statements may include projections and estimates concerning the timing and success of specific projects and our future production, revenues, income and capital spending. When we use the words "believe," "intend," "expect," "may," "should," "anticipate," "could," "estimate," "plan," "predict," "project," or their negatives, or other similar expressions, the statements which include those words are usually forward-looking statements. When we describe strategy that involves risks or uncertainties, we are making forward-looking statements. The forward-looking statements in this Annual Report on Form 10-K speak only as of the date of this Annual Report on Form 10-K; we disclaim any obligation to update these statements unless required by securities law, and we caution you not to rely on them unduly. We have based these forward-looking statements on our current expectations and assumptions about future events. While our management considers these expectations and assumptions to be reasonable, they are inherently subject to significant business, economic, competitive, regulatory and other risks, contingencies and uncertainties, most of which are difficult to predict and many of which are beyond our control. These risks, contingencies and uncertainties relate to, among other matters, the following:

    •
    risks and uncertainties associated with our research and development activities, including our clinical trials;

    •
    our dependence on Locilex® as our only product;

    •
    our ability to raise capital when needed;

    •
    the timing of and our ability to achieve U.S. or international regulatory approvals for Locilex® or any other product candidates we may develop;

    •
    our dependence on others to conduct clinical research of, and to manufacture and market, Locilex®;

    •
    the terms of future licensing arrangements, and whether we can enter into such arrangements at all;

    •
    risks associated with the timing and receipt of licensing and milestone revenues, if any;

    •
    our ability to gain market acceptance for Locilex® or any other product candidates we may develop;

    •
    our ability to maintain or protect the validity of our patents and other intellectual property, including in connection with pending or future litigation against us;

    •
    our ability to secure registration for our current and future patent applications;

    •
    our ability to extend our licensed composition of matter patent No. 5,912,231 under the Hatch-Waxman Act with the cooperation of Scripps;

    •
    our estimates of the size of the prospective markets in which we may offer Locilex®;

    •
    our ability to continue as a going concern;

    •
    our expectations regarding minimizing our development risk;

    •
    our ability to establish new relationships and maintain current relationships;

    •
    our ability to attract and retain key personnel; and

    •
    acceptance of our business model by investors.

2


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PART I

Item 1.    Business.

Overview

We are a late stage pharmaceutical company focused on the development and commercialization of Locilex® (pexiganan cream 0.8%), a novel, first-in-class, broad spectrum, topical antibiotic. Locilex® is a chemically synthesized, 22-amino acid peptide isolated from the skin of the African Clawed Frog. Its novel mechanism of action kills microbial targets by disrupting the bacterial cell membrane; a process known as cell membrane permeability. Locilex® is initially being targeted for the treatment of mild infections of diabetic foot ulcers (or Mild DFI). In 2011, the market for diabetic foot infection therapeutics worldwide was approximately $1.46 billion. Our primary objective is to establish Locilex® as the standard of care for the treatment of patients with Mild DFI. Thereafter, our growth strategy includes potentially expanding the indications for Locilex® to include moderate infections of diabetic foot ulcers (or Moderate DFI) and certain other mild or moderate skin and skin structure infections in superficial wounds.

We believe that we have a clear clinical and regulatory pathway with the potential for United States Food and Drug Administration (or FDA) approval of Locilex® by the second half of 2017. We are conducting two pivotal Phase 3 clinical trials in the United States under the auspicies of our special protocol assessment (or SPA) agreement with the FDA on our Phase 3 program. We intend to complete enrollment in these two pivotal Phase 3, double blind, placebo-controlled superiority studies in the first half of 2016. We successfully conducted two separate Phase 1 skin irritation and skin sensitization studies and we reported data on the first of these two Phase 1 studies in Q3 2014 and reported data on the second Phase 1 study in Q1 2015. If the data from our Phase 3 studies are sufficient to meet the primary endpoint, we expect to submit a new drug application (or NDA) amendment for Locilex® to the FDA and European Medicines Agency (EMA) soon thereafter. We expect to receive a response from the FDA within six months of our NDA amendment submission. In Europe, we anticipate receiving a response from EMA within ten months of submitting a marketing authorization application to the EMA under the centralized process.

According to the Infectious Disease Society of America (or IDSA), diabetic foot infections (or DFI) may be classified by their clinical severity as mild, moderate, or severe. 47% of DFI patients first present to a treating physician in the mild stage of infection, 34% of DFI patients first present at the moderate stage and 18% of DFI patients first present at the severe stage. At the mild stage, patients can typically be treated on an outpatient basis and amputation risk is minimal (2% to 3% in Mild DFI). When not managed effectively, the potential for Mild DFI to progress to a limb- or life-threatening infection increases dramatically. Published research suggests amputation rates increase in Moderate DFI and severe infections of diabetic foot ulcers (or Severe DFI) to approximately 45% and 75%, respectively. Similarly, the hospitalization rate for Mild DFI patients is approximately 10%, increasing in Moderate DFI and Severe DFI to approximately 55% and 85%, respectively. Thus, DFIs are a major cause of patient morbidity, a substantial burden to the healthcare system, and a source of high financial costs.

Systemic antibiotics currently prescribed off-label to treat Mild DFI generate resistant pathogens which create infections that are more difficult to treat. Such antibiotics are also associated with toxic side effects in patients who typically have some degree of compromised liver and kidney function. We believe that a topical preparation like Locilex®, which is locally administered on the open wound and skin, offers significant advantages over systemic treatments. As a topical antibiotic, Locilex® affects only the area to which it is applied, and unlike most systemic antibiotics, it does not spread to the entire

The above information was disclosed in a filing to the SEC. To see the filing, click here.

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