Attached files

file filename
EX-31.2 - EX-31.2 - PLx Pharma Inc.a15-12131_1ex31d2.htm
EX-32.2 - EX-32.2 - PLx Pharma Inc.a15-12131_1ex32d2.htm
EX-32.1 - EX-32.1 - PLx Pharma Inc.a15-12131_1ex32d1.htm
EX-31.1 - EX-31.1 - PLx Pharma Inc.a15-12131_1ex31d1.htm
XML - IDEA: XBRL DOCUMENT - PLx Pharma Inc.R9999.htm

Table of Contents

 

 

 

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

 

FORM 10-Q

 

(Mark One)

 

x      Quarterly Report PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934

 

For the quarterly period ended June 30, 2015

 

or

 

o         TRANSITION REPORT PURSUANT TO 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

 

46-4995704

(State or Other Jurisdiction of
Incorporation or Organization)

 

(I.R.S. Employer
Identification No.)

 

61 Broadway, 19th Floor
New York, NY

 

10006

(Address of Principal Executive
Offices)

 

(Zip Code)

 

(212) 269-2834

(Registrant’s Telephone Number, Including Area Code)

 

 

(Former Name, Former Address and Former Fiscal Year, if Changed Since Last Report)

 

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.  x Yes  No o

 

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

 

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.

 

Large accelerated filer o

 

Accelerated filer o

 

 

 

Non-accelerated filer o  (Do not check if a smaller reporting company)

 

Smaller reporting company x

 

Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act).  o Yes  x No

 

APPLICABLE ONLY TO ISSUERS INVOLVED IN BANKRUPTCY

PROCEEDINGS DURING THE PRECEDING FIVE YEARS:

 

Indicate by check mark whether the registrant has filed all documents and reports required to be filed by Sections 12, 13 or 15(d) of the Securities Exchange Act of 1934 subsequent to the distribution of securities under a plan confirmed by a court.  o  Yes  o

 

APPLICABLE ONLY TO CORPORATE ISSUERS:

 

Indicate the number of shares outstanding of each of the issuer’s classes of common stock, as of August 12, 2015:   10,301,114

 

 

 




Table of Contents

 

PART I - FINANCIAL INFORMATION

 

ITEM 1.  FINANCIAL STATEMENTS

 

The accompanying condensed financial statements have been prepared by the Company and are unaudited.  In the opinion of management, all adjustments (consisting of normal recurring adjustments) necessary to state fairly the Company’s financial position as of June 30, 2015, the results of operations for the three and six months ended June 30, 2015 and 2014, and the cash flows for the six months ended June 30, 2015 and 2014 have been made.  Certain information and footnote disclosures normally included in financial statements prepared in accordance with accounting principles generally accepted in the United States of America have been condensed or omitted.  It is suggested that these condensed financial statements be read in conjunction with the audited annual financial statements and notes thereto included in the Company’s Annual Report for the year ended December 31, 2014 on Form 10-K, filed with the United States Securities Exchange Commission on March 23, 2015.  The results of operations for the quarterly period ended June 30, 2015 are not necessarily indicative of the operating results for the full year.

 

3



Table of Contents

 

DIPEXIUM PHARMACEUTICALS, INC.

CONDENSED BALANCE SHEETS

 

 

 

June 30,

 

December 31,

 

 

 

2015

 

2014

 

 

 

(unaudited)

 

(Note 1)

 

ASSETS

 

 

 

 

 

 

 

 

 

 

 

CURRENT ASSETS

 

 

 

 

 

Cash

 

$

28,689,258

 

$

27,040,325

 

Short-term Investments

 

11,991,949

 

 

Prepaid Expenses

 

229,547

 

120,128

 

TOTAL CURRENT ASSETS

 

40,910,754

 

27,160,453

 

 

 

 

 

 

 

 

 

 

 

 

 

OTHER ASSETS

 

 

 

 

 

Security Deposit

 

49,385

 

49,385

 

TOTAL OTHER ASSETS

 

49,385

 

49,385

 

 

 

 

 

 

 

TOTAL ASSETS

 

$

40,960,139

 

$

27,209,838

 

 

 

 

 

 

 

LIABILITIES AND SHAREHOLDERS’ EQUITY

 

 

 

 

 

 

 

 

 

 

 

CURRENT LIABILITIES

 

 

 

 

 

Accounts Payable and Accrued Expenses

 

$

1,169,156

 

$

1,260,598

 

TOTAL LIABILITIES

 

1,169,156

 

1,260,598

 

 

 

 

 

 

 

COMMITMENTS AND CONTINGENCIES

 

 

 

 

 

 

 

 

 

 

 

SHAREHOLDERS’ EQUITY

 

 

 

 

 

Common Stock: $.001 par value, 30,000,000 shares authorized, 10,269,507 and 8,538,329

 

 

 

 

 

shares issued and outstanding at June 30, 2015 and December 31, 2014, respectively

 

10,269

 

8,538

 

Additional paid-in capital

 

70,318,604

 

48,259,451

 

Accumulated deficit

 

(30,537,890

)

(22,318,749

)

TOTAL SHAREHOLDER’S EQUITY

 

39,790,983

 

25,949,240

 

 

 

 

 

 

 

TOTAL LIABILITIES AND SHAREHOLDERS’ EQUITY

 

$

40,960,139

 

$

27,209,838

 

 

The accompanying notes are an integral part of these condensed financial statements.

 

4



Table of Contents

 

DIPEXIUM PHARMACEUTICALS, INC.

CONDENSED STATEMENTS OF OPERATIONS

(Unaudited)

 

 

 

Three Months Ended June 30,

 

Six Months Ended June 30,

 

 

 

2015

 

2014

 

2015

 

2014

 

REVENUES

 

$

 

$

 

$

 

$

 

 

 

 

 

 

 

 

 

 

 

EXPENSES

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

OPERATING EXPENSES

 

 

 

 

 

 

 

 

 

Research and Development Expenses

 

2,290,266

 

2,592,917

 

3,999,665

 

4,409,607

 

General and Administrative Expenses

 

1,744,257

 

1,327,567

 

4,222,684

 

2,054,716

 

 

 

 

 

 

 

 

 

 

 

TOTAL OPERATING EXPENSES

 

4,034,523

 

3,920,484

 

8,222,349

 

6,464,323

 

 

 

 

 

 

 

 

 

 

 

LOSS FROM OPERATIONS

 

(4,034,523

)

(3,920,484

)

(8,222,349

)

(6,464,323

)

 

 

 

 

 

 

 

 

 

 

Interest Income

 

2,615

 

371

 

3,208

 

371

 

 

 

 

 

 

 

 

 

 

 

NET LOSS

 

$

(4,031,908

)

$

(3,920,113

)

$

(8,219,141

)

$

(6,463,952

)

 

 

 

 

 

 

 

 

 

 

LOSS PER SHARE

 

 

 

 

 

 

 

 

 

Basic and diluted net loss per common share

 

$

(0.47

)

$

(0.46

)

 $(0.96

)

$

(0.90

)

 

 

 

 

 

 

 

 

 

 

Weighted average common shares/units outstanding basic and diluted

 

8,584,554

 

8,537,877

 

8,568,441

 

7,151,252

 

 

The accompanying notes are an integral part of these condensed financial statements.

 

5



Table of Contents

 

DIPEXIUM PHARMACEUTICALS, INC.

CONDENSED STATEMENTS OF CHANGES IN SHAREHOLDERS’ EQUITY

(Unaudited)

 

 

 

Common Stock

 

 

 

Accumulated

 

Total

 

 

 

Shares

 

Amount

 

Additional Paid-In Capital

 

Deficit

 

Shareholders’ Equity

 

Balance at December 31, 2014

 

8,538,329

 

$

8,538

 

$

48,259,451

 

$

(22,318,749

)

$

25,949,240

 

 

 

 

 

 

 

 

 

 

 

 

 

Share-Based payment to vendors

 

12,346

 

12

 

158,483

 

 

 

158,495

 

 

 

 

 

 

 

 

 

 

 

 

 

Share-Based compensation

 

14,000

 

14

 

2,187,762

 

 

 

2,187,776

 

 

 

 

 

 

 

 

 

 

 

 

 

Cashless Exercise of Warrants

 

2,832

 

3

 

(3

)

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Issuance of Common Stock, net of issuance costs

 

1,702,000

 

1,702

 

19,712,911

 

 

 

19,714,613

 

 

 

 

 

 

 

 

 

 

 

 

 

Net Loss

 

 

 

 

 

 

 

(8,219,141

)

(8,219,141

)

 

 

 

 

 

 

 

 

 

 

 

 

Balance at June 30, 2015 (unaudited)

 

10,269,507

 

$

10,269

 

$

70,318,604

 

$

(30,537,890

)

$

39,790,983

 

 

The accompanying notes are an integral part of these condensed financial statements.

 

6



Table of Contents

 

DIPEXIUM PHARMACEUTICALS, INC.

CONDENSED STATEMENTS OF CASH FLOWS

(Unaudited)

 

 

 

Six Months Ended June 30,

 

 

 

2015

 

2014

 

Operating Activities:

 

 

 

 

 

Net Loss

 

$

(8,219,141

)

$

(6,463,952

)

 

 

 

 

 

 

Adjustments to reconcile net loss to net cash used in operating activities:

 

 

 

 

 

Share-Based Compensation

 

2,187,776

 

554,085

 

Share-Based Payments to Vendors

 

158,495

 

438,602

 

Amortization of short-term investment interest income

 

(2,271

)

 

 

 

 

 

 

 

 

(Increase) / Decrease In:

 

 

 

 

 

Prepaid Expenses

 

(109,419

)

(119,120

)

Security Deposit

 

 

(49,385

)

Accounts Payable and Accrued Expenses

 

(247,493

)

(33,653

)

 

 

 

 

 

 

Net Cash Used In Operating Activities

 

(6,232,053

)

(5,673,423

)

 

 

 

 

 

 

Investing Activities:

 

 

 

 

 

Purchase of Short-term Investments

 

(11,989,678

)

 

 

 

 

 

 

 

Net Cash Used In Investing Activities

 

(11,989,678

)

 

 

 

 

 

 

 

Financing Activities:

 

 

 

 

 

Proceeds from issuance of Common Stock, net of issuance costs

 

19,870,664

 

34,455,669

 

 

 

 

 

 

 

Net Cash Provided By Financing Activities

 

19,870,664

 

34,455,669

 

 

 

 

 

 

 

Net Increase In Cash

 

1,648,933

 

28,782,246

 

 

 

 

 

 

 

Cash at Beginning of Period

 

27,040,325

 

3,861,145

 

 

 

 

 

 

 

Cash at End of Period

 

$

28,689,258

 

$

32,643,391

 

 

 

 

 

 

 

SUPPLEMENTAL DISCLOSURE:

 

 

 

 

 

NONCASH OPERATING ACTIVITY

 

 

 

 

 

Accrued financing issuance costs

 

$

156,051

 

$

 

 

The accompanying notes are an integral part of these condensed financial statements.

 

7



Table of Contents

 

DIPEXIUM PHARMACEUTICALS, INC.

NOTES TO THE UNAUDITED CONDENSED FINANCIAL STATEMENTS

 

NOTE 1 — NATURE OF OPERATIONS

 

Business:

 

Dipexium Pharmaceuticals, Inc. (the “Company”), a Delaware corporation, formerly Dipexium Pharmaceuticals, LLC, is a late stage pharmaceutical company focused on the development and commercialization of Locilex® (pexiganan cream 0.8%).  The Company was formed on January 14, 2010.

 

On March 12, 2014, the Company completed a corporate conversion from a limited liability company to a corporation in conjunction with an initial public offering (“IPO”) of common stock.  As a result of the corporate conversion, holders of the Class A Membership Interests and warrants in Dipexium Pharmaceuticals, LLC, became holders of common stock and warrants of Dipexium Pharmaceuticals, Inc.

 

The Company has experienced net losses and negative cash flows from operations since inception and expects these conditions to continue for the foreseeable future.  The Company has needed to raise capital from sales of its securities to sustain operations.  In March 2014, the Company completed an IPO of common stock with proceeds, net of issuance costs, of approximately $34.5 million.  In June 2015, the Company completed an additional public offering of common stock with net proceeds of approximately $19.7 million.  As of June 30, 2015, the Company had cash and short-term investments totaling approximately $40.7 million.  Based on the Company’s projected expenditures for 2015, management currently believes that its current cash balances should be sufficient to fund the Company’s operations through 2017.  However, if the Company’s assumptions underlying its estimated expenses prove to be wrong, it may have to raise additional capital sooner than anticipated.

 

There can be no assurance that the Company’s research and development will be successfully completed or that any Company product will be approved or commercially viable.  The Company is subject to risks common to companies in the biopharmaceutical industry including, but not limited to, dependence on collaborative arrangements, development by the Company or its competitors of new technological innovations, dependence on key personnel, protection of proprietary technology, development of sales and marketing infrastructure and compliance with Food and Drug Administration (“FDA”) and other governmental regulations and approval requirements.

 

Unaudited Condensed Interim Financial Data

 

The accompanying interim condensed financial statements are unaudited.  These unaudited condensed financial statements have been prepared in accordance with the rules and regulations of the United States Securities and Exchange Commission (“SEC”) for interim financial information.  Accordingly, they do not include all the information and footnotes required by Generally Accepted Accounting Principles (“GAAP”) for complete financial statements.  These unaudited interim condensed financial statements should be read in conjunction with the audited financial statements and accompanying notes for the year ended December 31, 2014.  The unaudited interim condensed financial statements have been prepared on the same basis as the annual financial statements included in the Company’s Annual Report for the year ended December 31, 2014, and, in the opinion of management, reflect all the adjustments (consisting of normal recurring adjustments) necessary to state fairly the Company’s financial position as of June 30, 2015, the results of operations for the three and six months ended June 30, 2015 and 2014, and the cash flows for the six months ended June 30, 2015 and 2014.  The December 31, 2014 balance sheet included herein was derived from the audited financial statements, but may not include all disclosures required by GAAP for complete financial statements.

 

NOTE 2 — SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES

 

Use of Estimates

 

The preparation of financial statements in conformity with GAAP requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities and disclosure of contingent assets and liabilities at the date of the financial statements and the reported amounts of expenses during the reporting period.  Actual results could differ from those estimates.

 

8



Table of Contents

 

DIPEXIUM PHARMACEUTICALS, INC.

NOTES TO THE UNAUDITED CONDENSED FINANCIAL STATEMENTS

 

Cash, Cash equivalents, and Short-Term Investments

 

The Company considers all highly-liquid instruments purchased with a maturity of three months or less to be cash equivalents.  Instruments with maturities greater than three months but less than twelve months are included in short-term investments.  The Company purchases United States Treasury bills with maturities ranging from six to twelve months which are classified as being held to maturity and are carried at amortized cost.  Securities classified as held to maturity securities are those securities that management has the intent and ability to hold to maturity.

 

The Company maintains its cash balance in one financial institution.  The balance is insured up to the maximum allowable by the Federal Deposit Insurance Company (“FDIC”).  The Company has not experienced any losses in such accounts and does not believe it is exposed to any significant risk of loss on cash.  At times, the cash balance may exceed the maximum limit of the FDIC.

 

Guaranteed Payments to Members

 

Guaranteed payments to members of the Company prior to the March 2014 corporate conversion, that were designated to represent reasonable compensation for services rendered, were accounted for as Company expenses rather than an allocation of the Company’s net income.

 

Research and Development

 

In accordance with Accounting Standards Codification (“ASC”) 730, “Accounting for Research and Development Costs”, the Company expenses research and development costs when incurred.  At times, the Company may make cash advances for research and development services.  These amounts are capitalized and expensed in the period the service is provided.  The Company incurred net research and development expenses in the amounts of $2,290,266 and $2,592,917 for the three months ended June 30, 2015 and 2014, respectively and $3,999,665 and $4,409,607 for the six months ended June 30, 2015 and 2014, respectively.

 

Although the Company manages the conduct of its clinical trials, it relies on third parties to conduct its clinical and preclinical studies and to provide services, including data management, statistical analysis and electronic compilation for clinical trials, as well as for the manufacture of clinical trial supplies. At the end of each reporting period, the Company compares the payments made to each service provider to the estimated progress towards completion of the related project. Factors that are considered in preparing these estimates include the number of subjects enrolled in studies, milestones achieved and other criteria related to the efforts of the vendors. These estimates are subject to change as additional information becomes available. Depending on the timing of payments to vendors and estimated services provided, the Company records net prepaid or accrued expenses related to these costs.

 

Share-Based Compensation

 

The Company accounts for the cost of services performed by officers and directors received in exchange for an award of Company membership interests, common stock, or stock options, based on the grant-date fair value of the award.  In accordance with ASC 718 “Stock Compensation”, the Company recognizes compensation expense, net of estimated forfeitures, on a straight-line basis over the service period.

 

Share-Based Payments to Vendors

 

The Company accounts for the cost of services performed by vendors in exchange for an award of Company membership interests or common stock based on the grant-date fair value of the award or fair value of the services rendered; whichever is more readily determinable and adjusted to fair value at each reporting date.  Such fair value is measured as of the earlier of the date the other party becomes committed to provide goods or services or the date performance by the other party is complete.  The Company recognizes the expense in the same period and in the same manner as if the Company had paid cash for the services.

 

9



Table of Contents

 

DIPEXIUM PHARMACEUTICALS, INC.

NOTES TO THE UNAUDITED CONDENSED FINANCIAL STATEMENTS

 

Income Taxes

 

Prior to the Company’s corporate conversion in March 2014, the Company was organized as a limited liability company.  As such, the Company was not a tax paying entity for Federal income tax purposes and, therefore, no income tax expense had been recorded in the financial statements.  Income or losses of the Company was passed through to members for inclusion in their respective income tax returns.

 

Subsequent to the corporate conversion in March 2014, the Company became a taxable entity.  As such, the Company recognizes deferred tax assets and liabilities for temporary differences between the financial reporting basis and the tax basis of the Company’s assets and liabilities and the expected benefits of net operating loss carryforwards. The impact of changes in tax rates and laws on deferred taxes, if any, applied during the years in which temporary differences are expected to be settled, is reflected in the financial statements in the period of enactment. The measurement of deferred tax assets is reduced, if necessary, if, based on weight of the evidence, it is more likely than not that some, or all, of the deferred tax assets will not be realized. The effect on deferred tax assets and liabilities of a change in tax rates is recognized in the period that such tax rate changes are enacted. The Company had no material amounts recorded for uncertain tax positions, interest or penalties in the accompanying financial statements. The Company currently estimates an annual effective tax rate of 0% as the Company incurred losses for the three and six months ended June 30, 2015 and is forecasting additional losses through year end, resulting in an estimated net loss for both financial statement and tax purposes.  Therefore, no Federal or state income tax expense has been recorded in the financial statements.

 

Based on the Company’s history of generating operating losses and its anticipation of operating losses continuing in the foreseeable future, the Company has determined that it would be more likely than not that the tax benefits from these net operating losses would not be realized and a full valuation allowance against all deferred tax assets has been recorded at December 31, 2014 and June 30, 2015.  In the event, the Company becomes profitable for a period of two or more years with future expectations at that time of profitability for future years prior to any significant change in its equity capitalization, the Company would have an opportunity to realize benefit from the deferred tax asset at such time in the future.

 

Fair value of financial instruments

 

The carrying amount of certain of the Company’s financial instruments including cash and accounts payable are shown at cost, which approximates fair value.  Short-term investments with maturities ranging from six to twelve months are classified as being held to maturity and are carried at amortized cost.  The age of gross unrealized gains and the fair value of related securities at June 30, 2015 were as follows:

 

 

 

Total (maturities within 12 months)

 

 

 

Amortized Cost

 

Unrealized Gains

 

Fair Value

 

Held to Maturity:

 

 

 

 

 

 

 

Debt Securities:

 

 

 

 

 

 

 

United States Government sponsored bonds

 

$

11,991,949

 

$

1,251

 

$

11,993,200

 

 

For the three and six months ended June 30, 2015, the amount of amortized interest income was $2,271.

 

NOTE 3 - ACCOUNTS PAYABLE AND ACCRUED EXPENSES

 

Accounts payable and accrued expenses at June 30, 2015 and December 31, 2014 were as follows:

 

 

 

June 30, 2015

 

December 31, 2014

 

Accrued compensation expense

 

$

196,785

 

$

511,769

 

Accrued research and development

 

684,685

 

641,997

 

Accrued professional fees

 

113,356

 

23,901

 

Accrued financing issuance costs

 

156,051

 

 

Other accounts payable and accrued expenses

 

18,279

 

82,931

 

Totals

 

$

1,169,156

 

$

1,260,598

 

 

10



Table of Contents

 

DIPEXIUM PHARMACEUTICALS, INC.

NOTES TO THE UNAUDITED CONDENSED FINANCIAL STATEMENTS

 

NOTE 4 — ISSUANCE OF MEMBERSHIP INTERESTS and COMMON STOCK

 

On March 18, 2014, the Company completed an IPO issuing 3,162,500 shares of common stock at a price of $12 per share, resulting in net proceeds of $34,455,669 after deducting underwriting discounts of $2,656,500 and offering costs $837,831.  The then outstanding Class A Membership Interests were converted to shares of common stock using a conversion ratio of 7 to 1, resulting in the conversion of 767,911 Class A Membership Interests into an aggregate of 5,375,377 shares of common stock.

 

In January 2015, the Company entered into a new amendment to the Product Development Agreement with RRD International, LLC (“RRD”) dated January 2014, pursuant to which RRD will continue to provide certain strategic product development services to the Company for an additional six month term. These product development services include management of the Company’s ongoing Phase 3 clinical trials, developing, planning and execution of a fully integrated product development strategy and implementation of that strategy either directly or with third party vendors. As consideration for services rendered, the Company has agreed to pay RRD International, LLC a total of $600,000, consisting of $450,000 in cash and $150,000 in restricted shares of the Company’s common stock (12,346 shares). The Company will recognize the costs incurred in connection with this agreement as research and development expenses as services are rendered.  The Company recorded research and development expense relating to this agreement of $304,661 and $608,495, including the cash payments and stock issuance, for the three and six months ended June 30, 2015, respectively.

 

On June 30, 2015, the Company completed a stock offering issuing 1,702,000 shares of common stock at a price of $12.50 per share, resulting in net proceeds of approximately $19.7 million after deducting underwriting discounts of $1.3 million and offering costs of approximately $0.3 million.

 

NOTE 5 — SHARE-BASED COMPENSATION and STOCK OPTIONS

 

Prior to the corporate conversion in March 2014, the Company granted awards of restricted Class A Membership Interests to board members in exchange for services.  These membership interests awards were originally scheduled to vest over a period of either 3 or 4 years, with the first year beginning on the date the member joined the board.  In each case, these membership interests involved accelerated vesting upon a change of control or other business combination.  The fair value of the membership interests granted was equal to the per-membership interest value of the most recent private placement ($50 per membership interest).  Total compensation expense in the amount of $25,000 and $37,500 has been recorded as director fees for the three months ended June 30, 2015 and 2014, respectively, and $50,000 and $75,000 for the six months ended June 30, 2015 and 2014, respectively.

 

The following table summarizes the non-vested Class A Membership Interests at June 30, 2015 giving effect to the corporate conversion and the associated activity for the year ended December 31, 2014 and the six months ended June 30, 2015:

 

 

 

Class A

 

 

 

Membership Interests

 

 

 

converted to Common Stock 7:1 ratio

 

Nonvested at January 1, 2014

 

77,000

 

Granted

 

 

Forfeited

 

(21,000

)

Vested

 

(14,000

)

Nonvested at December 31, 2014

 

42,000

 

Granted

 

 

Forfeited

 

 

Vested

 

(14,000

)

Nonvested at June 30, 2015

 

28,000

 

 

In December 2013, 1,000 Membership Interests were issued to a member of the board of directors which vested in February 2014.

 

As of June 30, 2015, there was $170,833 of total unrecognized compensation cost related to these awards. That cost is expected to be recognized over a weighted average period of 1.75 years.

 

11



Table of Contents

 

DIPEXIUM PHARMACEUTICALS, INC.

NOTES TO THE UNAUDITED CONDENSED FINANCIAL STATEMENTS

 

In November 2013, the board of directors adopted the 2013 Equity Incentive Plan.  The plan became effective as of the completion of the corporate conversion and the closing of the IPO.  The Equity Incentive Plan reserves an aggregate number of common shares equal to 20% of the issued and outstanding common stock.  The purpose of the plan is to attract and retain directors, officers, and employees whose services are considered valuable to the Company.

 

In March 2014, effective at the closing of the Company’s IPO, the Company granted stock options to purchase 853,787 common shares (10% of the common stock outstanding) to its four executives.  The options were issued pursuant to the 2013 Equity Incentive Plan at an exercise price of $13.93 and vest over thirty-six (36) equal monthly installments.  In April 2014, a new employee received 7,500 stock options at an exercise price of $10.46 vesting over a three (3) year period.

 

In January 2015, the Company granted stock options to purchase 251,000 common shares to its five employees, outside directors, and certain non-employee consultants.  The options were issued pursuant to the 2013 Equity Incentive Plan at an exercise price of $11.35, with one-half of the options vesting upon issuance and the balance vesting evenly over the subsequent 24 months. A portion of the January stock option grant, 35,000 options, was granted to non-employees for services rendered.  As such, the Company expensed $353,150, the entire portion of those grants, at the grant date.

 

Compensation expense associated with these awards is recognized over the vesting period based on the fair value of the option at the grant date determined based on the Black-Scholes model. Option valuation models require the input of highly subjective assumptions including the expected price volatility.  The Company’s employee stock options have characteristics significantly different from those of traded options, and changes in the subjective input assumptions can materially affect the fair value estimate.

 

Because there is no public market for the Company’s stock options and very little historical experience with the Company’s stock, similar public companies were used for comparison and expectations as to the price volatility assumptions required for fair value computation using the Black-Scholes methodology.

 

The Company determined the fair value of the option awards using the Black-Scholes option pricing model and the following weighted average assumptions:

 

 

 

Six Months Ended

 

Six Months Ended

 

 

 

June 30, 2015

 

June 30, 2014

 

Expected term

 

4.6 years

 

4.3 years

 

Volatility

 

60.2

%

59.6

%

Dividend yield

 

0

%

0

%

Risk free interest rate

 

1.31

%

1.23

%

 

ASC 718 requires stock compensation expense to be recorded net of estimated forfeitures.  The Company currently estimates there will be no forfeitures of options.

 

A summary of the Company’s stock option activity is as follows:

 

 

 

Six Months Ended

 

Weighted Average

 

 

 

June 30, 2015

 

Exercise Price

 

Outstanding at the beginning of the period

 

861,287

 

$

13.90

 

Granted

 

251,000

 

$

11.35

 

Forfeited

 

 

 

 

Outstanding and expected to vest at the end of the period

 

1,112,287

 

$

13.32

 

 

Compensation expense relating to options for the three months ended June 30, 2015 and 2014 was $519,066 and $420,625, respectively, and $2,137,776 and $479,085 for the six months ended June 30, 2015 and 2014, respectively.  The total compensation expense not yet recognized as of June 30, 2015 was $3,511,159.  The weighted average vesting period over which the total compensation expense will be recorded related to unvested options not yet recognized as of June 30, 2015 was approximately 1.7 years. The weighted average grant date fair value is $6.27. The intrinsic value of the stock options as of June 30, 2015 was $360,820, with a remaining weighted average contractual life of 5.9 years.

 

12



Table of Contents

 

DIPEXIUM PHARMACEUTICALS, INC.

NOTES TO THE UNAUDITED CONDENSED FINANCIAL STATEMENTS

 

NOTE 6 — SHARE-BASED PAYMENTS TO VENDORS

 

In January 2014, the Company entered into a Product Development Agreement with RRD International, LLC (“RRD”), pursuant to which RRD provides certain strategic product development services to the Company during the term of the agreement which was calendar year 2014.  These product development services include the management of the Company’s ongoing Phase 3 clinical trials, developing, planning and execution of a fully integrated product development strategy and implementation of that strategy either directly or with third party vendors.  As consideration for services rendered, the Company agreed to pay RRD partially in cash and by issuing 7,604 of the Company’s Class A Membership Interests.  The Company expensed the fair value of the Class A Membership Interests, $50 per Class A Membership Interest, based on the most recent private placement.

 

In January 2015, the Company entered into a new amendment to the Product Development Agreement with RRD dated January 2014, pursuant to which RRD will continue to provide certain strategic product development services to the Company for an additional six month term.  As consideration for services rendered, the Company has agreed to pay RRD a total of $600,000, consisting of $450,000 in cash and $150,000 in restricted shares of the Company’s common stock (12,346 shares).

 

In July 2015, the Company entered into two new amendments to the Product Development Agreement with RRD (originally dated January 2014) pursuant to which RRD will continue to provide the strategic product development services described above.  Please see Note 12 “Subsequent Events” below.

 

NOTE 7 — LEASE OF OFFICE SPACE

 

Effective May 2014, the Company entered into a sublease agreement for office space with current monthly payments of $12,717.  The term of the sublease ends on March 30, 2016 with inflationary escalations in 2015 and the first three months of 2016.  Total minimum sublease payments for the remaining term of the sublease from July 1, 2015 to March 30, 2016 are $115,596.

 

NOTE 8 — LEGAL MATTERS

 

The Company and its two original executives were three of some 30 defendants in a lawsuit filed by a former stockholder of Genaera Corporation, which was the predecessor of the Genaera Liquidating Trust, the party from which the Company purchased the worldwide rights to pexiganan, the active ingredient of the Product Locilex ™ on April 8, 2010. The complaint was filed on June 8, 2012 in the United States District Court for the Eastern District of Pennsylvania (Civil Action No. 12-3265) by Alan W. Schmidt, individually and on behalf of former Genaera Corporation shareholders. Among others, the suit was filed against the Company, as well as John A. Skolas and Argyce LCC, who were responsible for the administration of the Trust and who sold pexiganan to the Company via a public auction. The defendants listed in the complaint included several individuals and companies formerly associated with Genaera Corporation, the Trust and/or Argyce LLC. Also included in the defendant group were several other pharmaceutical companies that were involved in acquiring the former drug-related assets of the Genaera Corporation.

 

The complaint alleged, among other things, the Company and its two executives aided and abetted a breach of fiduciary duty alleged to have been committed by the former director and officers of Genaera Corporation before it was approved for dissolution by its shareholders and also Argyce, LLC, the trustee of the Liquidating Trust. Plaintiff claims that the Company and its executives aided and abetted a breach of the duties of the board of directors and the trustee under common law and under a certain trust agreement allegedly signed between Argyce, LLC, as the trustee, and the Liquidating Trust. With regard to the claims made against the Company and two executives, the plaintiff alleged, in pertinent part, that the Company’s acquisition of the pexiganan rights was for alleged inadequate consideration, and that the Company and its management aided and abetted a breach of fiduciary duty by the Genaera Corporation defendants who were formerly associated with Genaera Corporation and/or the Trust.

 

The Company and its two executives filed a motion to dismiss the complaint within the prescribed time period. All of the other defendants in this litigation also filed motions to dismiss, and a court order granted each and every motion to dismiss, with prejudice, without leave to refile, on August 12, 2013 based on the argument that Plaintiff’s claims were time barred. Plaintiff appealed the dismissal to the United States Third Circuit Court of Appeals seeking reversal of the dismissal. On October 17, 2014, the Third Circuit Appellate Court, in a 2-1 decision with a strong dissenting opinion, reversed the trial court’s dismissal of Plaintiff’s claims based on the expiration of the applicable statutes of limitation. In a 2-1 decision, the Third Circuit held that more information was necessary to determine when Plaintiff should have been on notice of his claims to determine the applicability of the discovery rule, which could

 

13



Table of Contents

 

DIPEXIUM PHARMACEUTICALS, INC.

NOTES TO THE UNAUDITED CONDENSED FINANCIAL STATEMENTS

 

serve to extend the time frame in which Plaintiff could bring his claims. Due to the strong dissent, all Defendants filed the necessary documents requesting a petition for rehearing en banc, by the majority of the Third Circuit justices who are in active service. The Third Circuit denied the request for en banc hearing and remanded this case to District Court.

 

This matter has now been remanded to District Court and all Defendants have again moved to dismiss the complaint for reasons other than being time barred.  The Company and the executives move for dismissal based on Plaintiff’s inability to make a case for aiding and abetting a breach of fiduciary duty because there was no underlying breach and such an aiding and abetting claim requires an element of knowing participation in the fiduciary breach which cannot be established by Plaintiff.  Defendants have filed their moving papers, and the Plaintiff responded in July 2015.  The District Court has ordered a hearing on this which is expected to occur in September 2015.  The Company intends to vigorously defend Plaintiff’s claims on the factual record, which it believes will prove that the Company is not liable to the Plaintiff in any regard.

 

NOTE 9 — RELATED PARTY TRANSACTIONS

 

The individual employed as the Company’s Vice President, Finance and Corporate Development as of the closing of the initial public offering, is the owner of Aumoe Partners, LLC (“Aumoe”), which was engaged in January 2012 to perform certain financial advisory services.

 

The Company incurred $0 in fees to Aumoe for both three month periods ended June 30, 2015 and 2014, respectively, and $0 and $22,500 for the six months ended June 30, 2015 and 2014, respectively, which were recorded in general and administrative expenses.

 

NOTE 10 — NET LOSS PER SHARE

 

Basic and diluted net loss per common share for the three and six months ended June 30, 2015 and 2014 was determined by dividing net loss by the weighted average common shares outstanding during the period.  The Company’s potentially dilutive shares, which include 1,112,287 of stock options, 28,000 unvested common shares, and 24,500 warrants, have not been included in the computation of diluted net loss per share for all periods as the result would be antidilutive.  On March 12, 2014, the Company completed a corporate conversion from a limited liability company to a corporation (the “Conversion”).  Accordingly, the outstanding Class A Membership Interests were converted to shares of common stock using a conversion ratio of 7 to 1, resulting in the conversion of its 767,911 Class A Membership Interests into an aggregate of 5,375,377 shares of common stock.  The effects of this Conversion on the Company’s net loss per share have been reflected for all periods presented retroactively.

 

NOTE 11 — RECENT ACCOUNTING PRONOUNCEMENTS

 

In August 2014, the Financial Accounting Standards Board issued Accounting Standards Update 2014-15, Presentation of Financial Statements—Going Concern, which requires management of an entity to evaluate whether there are conditions or events, considered in the aggregate, that raise substantial doubt about the entity’s ability to continue as a going concern within one year after the date that the financial statements are issued or available to be issued. This update will become effective beginning January 1, 2017, with early adoption permitted. The Company is currently evaluating the provisions of this amendment.

 

NOTE 12 — SUBSEQUENT EVENTS

 

In July 2015, the Company entered into two new amendments to the Product Development Agreement with RRD dated January 2014, pursuant to which RRD will continue to provide certain strategic product development services to the Company for an additional six month term.  These services include management of the Company’s ongoing Phase 3 clinical trials, developing, planning, and execution of a fully integrated product development strategy and implementation of that strategy either directly or with third party vendors.  The services also include activities to support the initiation and the preparation of the New Drug Application (“NDA”) Amendment.  As consideration for the services rendered, the Company has agreed to pay RRD approximately $1.7 million, consisting of approximately $1.27 million in cash and approximately $423,000 in restricted common stock (31,607 shares).  Terms of the services to be provided after December 2015, if any, will be negotiated at a later date.  The Company will recognize the costs incurred in connection with this agreement as research and development expenses as services are rendered.

 

14



Table of Contents

 

ITEM 2.  MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS

 

FORWARD-LOOKING STATEMENT NOTICE

 

This Form 10-Q contains certain forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995.  For this purpose, any statements contained in this Form 10-Q that are not statements of historical fact may be deemed to be forward-looking statements.  Without limiting the foregoing, words such as “may,” “will,” “expect,” “believe,” “anticipate,” “estimate” or “continue” or comparable terminology are intended to identify forward-looking statements.  These statements by their nature involve substantial risks and uncertainties, and actual results may differ materially depending on a variety of factors, many of which are not within our control.  These factors include but are not limited to economic conditions generally and in the industries in which we may participate; competition within our chosen industry, including competition from much larger competitors; technological advances and failure to successfully develop business relationships.  Unless the context indicates otherwise, as used in this report, the terms “Dipexium,” “we,” “us,” “our,” “our company” and “our business” refer, prior to the corporate conversion discussed herein, to Dipexium Pharmaceuticals, LLC, and after the corporate conversion to Dipexium Pharmaceuticals, Inc.

 

Description of Business

 

Dipexium Pharmaceuticals, LLC (“Dipexium LLC”) was incorporated under the laws of the State of Delaware in January 2010. In March 2014, we effected a corporate conversion pursuant to which we succeeded to the business of Dipexium LLC and the holders of membership interests of Dipexium LLC became our stockholders.

 

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 $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 in both the United States and Europe for the regulatory approval of Locilex®.  We have reached agreement with the FDA through a special protocol assessment (or SPA) for our Phase 3 program which is actively enrolling patients at up to 70 clinical trial centers in the U.S. We intend to complete enrollment in the OneStep-1 and OneStep-2, our two pivotal Phase 3, double blind, placebo-controlled superiority studies, in the second half of 2015.  We also 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 our new drug application (or NDA) for Locilex® to the FDA soon thereafter. We expect to receive a response from the FDA within six months of our NDA submission.

 

In Europe, we received formal clinical and regulatory guidance from the European Medicines Agency (or EMA) in May 2015.  Based on this formal guidance, if the data from our Phase 3 studies are favorable, we anticipate filing a marketing authorization application (or MAA) for approval in Europe under the centralized process soon after the NDA submission to the FDA with related European approval anticipated in late 2017 or early 2018.

 

Plan of Operation

 

Our primary objective is to establish Locilex® as the standard of care to treat patients with Mild DFI. The key elements of our strategy are as follows:

 

· Complete the Phase 3 program for Locilex®.  As a result of our SPA for Locilex®, we believe the U.S. clinical pathway for Locilex® is clear. Working with our key third party vendors, we commenced our Phase 3 program in the third quarter of 2014 and, based upon the advice of our scientific vendors, we anticipate completing enrollment in the second half of 2015.

 

· Obtain FDA approval of Locilex® for Mild DFI.  If our Phase 3 trials meet their primary endpoint, we plan to submit our NDA for Locilex®.

 

15



Table of Contents

 

· Commercially launch Locilex® in the U.S.  We plan to utilize a small specialty sales force to launch Locilex®, if it is approved, in the U.S., initially targeting podiatrists and potentially expanding to other specialty healthcare providers.

 

· Expand Locilex®’s FDA-approved uses.  If we are able to obtain FDA approval in Mild DFI, we will consider seeking additional FDA approvals that will enable us to expand the Locilex® label to include patients with Moderate DFI and certain other mild or moderate skin and skin structure infections in superficial wounds.

 

· Commercialize Locilex® in Europe.  We received formal clinical and regulatory guidance from the European Medicine Agency (EMA) in May 2015.  Based upon the EMA guidance, we anticipate filing a MAA in the European Union under the centralized process in 2016 at or shortly after our intended submission of the NDA to the FDA in the United States provided that we receive favorable efficacy, safety, and microbiology data upon completion of our Phase 3 program in the United States.

 

We will rely on our strong management team, board of directors and scientific advisors to execute our strategy. The individuals on our management team, board of directors and scientific advisors will contribute their significant business development, finance, and regulatory experience to the development and commercialization of Locilex®.

 

Drug Development Strategy

 

We are conducting concurrently two pivotal Phase 3 clinical trials of Locilex® for the treatment of Mild DFI. The trials are referred to as OneStep-1 and OneStep-2.

 

We have an SPA with the FDA relating to the trial design for our Phase 3 studies. The SPA calls for us to conduct two placebo-controlled pivotal Phase 3 studies, but does not require us to demonstrate equivalence to oral antibiotics. Enrollment has commenced in these two pivotal Phase 3 studies and we expect to complete enrollment in the second half of 2015. Both trials will be randomized, placebo-controlled double blind, multi-center trials in 180 evaluable patients in each trial.  These trials are designed to establish the superiority of Locilex® over placebo-cream in the treatment of Mild DFI.

 

We are conducting the OneStep-1 and OneStep-2 trials at up to 70 clinical sites in the U.S. The primary endpoint of the trials will be clinical success, defined as resolution of infection per the clinical judgment of each treating physician using the 2012 Infectious Diseases Society of America Clinical Practice Guideline for the Diagnosis and Treatment of Diabetic Foot Infections.  Microbiological success, defined as complete microbiological response, will be assessed as one of the secondary endpoints. All of the primary and secondary endpoints will be assessed for each patient on the 28th day following entry into the study.  Furthermore, the FDA has agreed that data from the Locilex® arm of the two prior Phase 3 non-inferiority studies conducted by Locilex®’s prior sponsor can be used to supplement our safety database.

 

We completed our Phase 1 skin irritation study in Q2 2014 and reported top line data in Q3 2014.  We also completed our Phase 1 skin sensitization study in Q4 2014 and reported top line data in Q1 2015.

 

Research Pharmaceutical Services, Inc. (a division of PRA International) is the contract research organization conducting our Phase 3 studies for Locilex®. This work is being performed under the auspices of RRD International, LLC, which is managing all aspects of our scientific, clinical and regulatory development.

 

We are a late-stage pharmaceutical company and have never generated revenue. Currently we do not have a stable recurring source of revenues sufficient to cover our operating costs. We incurred net losses of $4.0 million and $8.2 million for the three and six months ended June 30, 2015, respectively.

 

Opportunities, Challenges and Risks

 

Our business and ability to execute our business strategy are subject to a number of risks and challenges including, without limitation, the following:

 

· We are heavily dependent on attaining regulatory approval for and, if approved, successfully commercializing Locilex®. Locilex® is our only product candidate. As such, all of our resources and efforts have been and are expected for the foreseeable future to be dedicated to the development and commercialization of Locilex®. As such, we are subject to the risk of dependency on this sole product, and if our efforts fail to gain FDA or other regulatory approvals for Locilex® (for example, for use in treating mild or moderate skin and skin structure infections in superficial wounds), our viability would be materially impacted unless we were able to develop or acquire other product candidates.

 

· The regulatory approval process for Locilex® may be lengthy and is inherently unpredictable. Although we anticipate certain time frames for our regulatory pathway for Locilex®, the approval process of the FDA and comparable foreign

 

16



Table of Contents

 

regulatory authorities may be lengthy and time consuming. The process also is inherently unpredictable, and if we are ultimately unable to obtain regulatory approval for Locilex®, our business will be substantially harmed.

 

· Manufacturing issues may prevent Locilex® from receiving regulatory approval.  Although we believe that we have successfully worked with our third-party vendors to resolve the manufacturing issues encountered by Locilex®’s prior sponsor and previously identified by the FDA, to the extent that such issues are not resolved, regulatory approval for Locilex® may be delayed or withheld, and we may not be able to meet the developmental milestones necessary to continue our business.

 

· Even if Locilex® is approved, the market may not accept it as a viable treatment option. Even if Locilex® is approved, there is a risk that it may not be accepted in the marketplace for a variety of reasons. If we are unable to generate revenue from sales of Locilex®, our business will be substantially harmed.

 

Results of Operations

 

Three Months Ended June 30, 2015 Compared to the Three Months Ended June 30, 2014

 

Summary Table

 

The following table presents a summary of the changes in our results of operations for the three months ended June 30, 2015 compared with the three months ended June 30, 2014:

 

 

 

Three Months Ended
June 30,

 

Percentage

 

 

 

2015

 

2014

 

Increase (Decrease)

 

 

 

(in thousands)

 

 

 

Research and Development Expenses

 

$

2,290

 

$

2,593

 

(12

)%

General and Administrative Expenses

 

$

1,745

 

$

1,327

 

31

%

Total Operating Expenses

 

$

4,035

 

$

3,920

 

3

%

Interest Income

 

$

3

 

$

 

 

Net Loss

 

$

4,032

 

$

3,920

 

3

%

 

Research and Development Expenses

 

Research and development expenses were $2.3 million for the three months ended June 30, 2015, and $2.6 million for the three months ended June 30, 2014, a decrease of $0.3 million. Research and development expenses decreased slightly due to the higher manufacturing related expenses in 2014 for the commencement of the clinical trial.

 

General and Administrative Expenses

 

General and administrative expenses were $1.7 million for the three months ended June 30, 2015, and $1.3 million for the three months ended June 30, 2014, an increase of $0.4 million. The increase in general and administrative expenses is attributable to an increase of $0.2 in professional and administrative related costs, $0.1 million for stock-based compensation related expenses, and a $0.1 million increase in conference related expenses.

 

Net Loss

 

Net loss was $4.0 million for the three months ended June 30, 2015, compared to $3.9 million for the three months ended June 30, 2014, an increase of $0.1 million, primarily due to a $0.4 million increase in general and administrative expenses, offset by $0.3 million decrease in research and development expenses due to the reasons stated above.

 

17



Table of Contents

 

Six Months Ended June 30, 2015 Compared to the Six Months Ended June 30, 2014

 

Summary Table

 

The following table presents a summary of the changes in our results of operations for the six months ended June 30, 2015 compared with the six months ended June 30, 2014:

 

 

 

Six Months Ended
June 30,

 

Percentage

 

 

 

2015

 

2014

 

Increase (Decrease)

 

 

 

(in thousands)

 

 

 

Research and Development Expenses

 

$

4,000

 

$

4,410

 

(9

)%

General and Administrative Expenses

 

$

4,222

 

$

2,054

 

105

%

Total Operating Expenses

 

$

8,222

 

$

6,464

 

27

%

Interest Income

 

$

3

 

$

 

 

Net Loss

 

$

8,219

 

$

6,464

 

27

%

 

Research and Development Expenses

 

Research and development expenses were $4.0 million for the six months ended June 30, 2015, and $4.4 million for the six months ended June 30, 2014, a decrease of $0.4 million. Research and development expenses decreased slightly due to the large contractual and manufacturing expenses in 2014 for the commencement of the clinical trial work.

 

General and Administrative Expenses

 

General and administrative expenses were $4.2 million for the six months ended June 30, 2015, and $2.1 million for the six months ended June 30, 2014, an increase of $2.1 million. The increase in general and administrative expenses is primarily attributable to an increase of $1.7 million for stock-based compensation related expenses and a $0.4 million increase in professional and administrative related expenses.

 

Net Loss

 

Net loss was $8.2 million for the six months ended June 30, 2015, compared to $6.5 million for the six months ended June 30, 2014, an increase of $1.7 million, primarily due to a $2.1 million increase in general and administrative expenses, offset by $0.4 million decrease in research and development expenses due to the reasons stated above.

 

Liquidity and Capital Resources

 

Overview

 

We have generated no revenue from operations and we have incurred cumulative losses of approximately $30.5 million since inception. We have funded our operations primarily from equity issuances and a Federal government grant under the Qualified Therapeutic Discovery Act. We received net cash proceeds of approximately $9.7 million from equity financings closed between July 2010 and November 2013. All of those equity financings were consummated at $50 per Class A membership interest ($7.14 on a post-conversion basis) with 50% warrant coverage at 120% of the issue price or $60 per interest ($8.57 on a post-conversion basis). On March 18, 2014, we closed an initial public offering of 3,162,500 shares of our common stock at a public offering price of $12.00 per share. Gross proceeds raised by us in the offering were approximately $38.0 million, and net proceeds to us were approximately $34.5 million.

 

On June 30, 2015, the Company completed a stock offering issuing 1,702,000 shares of common stock at a price of $12.50 per share, resulting in net proceeds of $19.7 million after deducting underwriting discounts of $1.3 million and offering costs of approximately $0.3 million.

 

We believe that we have sufficient cash to fund our operations through 2017.

 

18



Table of Contents

 

As of June 30, 2015, we had working capital of approximately $39.7 million, consisting primarily of $40.7 million of cash and short-term investments, offset by $1.2 million of accounts payable and accrued expenses.

 

The following tables sets forth selected cash flow information for the periods indicated:

 

 

 

For the six months ended
June 30,

 

 

 

2015

 

2014

 

 

 

(in thousands)

 

Net cash used in operating activities

 

$

(6,232

)

$

(5,673

)

Net cash used in investing activities

 

(11,990

)

 

Net cash provided by financing activities

 

19,871

 

34,455

 

Net increase in cash

 

$

1,649

 

$

28,782

 

 

Net Cash Used in Operating Activities

 

Net cash used in operating activities was $6.2 million for the six months ended June 30, 2015.  The net loss for this period was greater than the net cash used in operating activities by $1.9 million, which was primarily attributable to $2.2 million of share-based compensation offset by a $0.3 million decrease in accounts payable and accrued expenses.

 

Net cash used in operating activities was $5.7 million for the six months ended June 30, 2014. The net loss for this period was greater than the net cash used in operating activities by $0.8 million, which was primarily attributable to $1.0 million of share-based compensation offset by an increase in prepaid expenses and other assets of $0.2 million.

 

Net Cash Used in Investing Activities

 

Net cash used in investing activities for the six months ended June 30, 2015 was $11.9 million, which was attributable to the Company’s investment in United States Treasury Bills.

 

Net Cash Provided by Financing Activities

 

Net cash provided by financing activities for the six months ended June 30, 2015 was $19.9 million, which was attributable to the net proceeds from the Company’s June 30, 2015 public offering.

 

Net cash provided by financing activities for the six months ended June 30, 2014 was $34.5 million, which was attributable to the net proceeds from the Company’s initial public offering.

 

Contractual Obligations

 

Effective May 2014, the Company entered into a sublease agreement for office space with current monthly payments of $12,717.  The term of the sublease is 23 months with inflationary escalations in 2015 and the first three months of 2016.  Total minimum sublease payments for the remaining term of the sublease are $115,596.

 

19



Table of Contents

 

Recent Accounting Pronouncements

 

In August 2014, the FASB issued Accounting Standards Update 2014-15, Presentation of Financial Statements—Going Concern, which requires management of an entity to evaluate whether there are conditions or events, considered in the aggregate, that raise substantial doubt about the entity’s ability to continue as a going concern within one year after the date that the financial statements are issued or available to be issued. This update will become effective beginning January 1, 2017, with early adoption permitted.  The Company is currently evaluating the provisions of this amendment.

 

Critical Accounting Policies and Estimates

 

On April 5, 2012, the JOBS Act was signed into law. The JOBS Act contains provisions that, among other things, reduce certain reporting requirements for qualifying public companies. As an “emerging growth company,” we may, under Section 7(a)(2)(B) of the Securities Act of 1933 (or Securities Act), delay adoption of new or revised accounting standards applicable to public companies until such standards would otherwise apply to private companies. We may take advantage of this extended transition period until the first to occur of the date that we (i) are no longer an “emerging growth company” or (ii) affirmatively and irrevocably opt out of this extended transition period. We have elected to take advantage of the benefits of this extended transition period. Our financial statements may therefore not be comparable to those of companies that comply with such new or revised accounting standards. Until the date that we are no longer an “emerging growth company” or affirmatively and irrevocably opt out of the exemption provided by Securities Act Section 7(a)(2)(B), upon issuance of a new or revised accounting standard that applies to our financial statements and that has a different effective date for public and private companies, we will disclose the date on which adoption is required for non-emerging growth companies and the date on which we will adopt the recently issued accounting standard. Our management’s discussion and analysis of our financial condition and results of operations is based on our financial statements, which have been prepared in accordance with accounting principles generally accepted in the United States, or GAAP. The preparation of these financial statements requires us to make estimates and judgments that affect the reported amounts of assets, liabilities and expenses. On an ongoing basis, we evaluate these estimates and judgments, including those described below. We base our estimates on our historical experience and on various other assumptions that we believe to be reasonable under the circumstances. These estimates and assumptions form the basis for making judgments about the carrying values of assets and liabilities that are not readily apparent from other sources. Actual results and experiences may differ materially from these estimates.

 

Share-Based Compensation

 

We account for the cost of services performed by employees and directors received in exchange for common stock, or stock options, based upon the grant date fair value of the award. In accordance with the Accounting Standards Codification, we recognize compensation expense, net of estimated forfeitures, on a straight-line basis over the vesting period.

 

We account for the cost of services performed by vendors in exchange for an award of membership interests or common stock based upon the grant date fair value of the award or fair value of the services rendered, whichever is more readily determinable. In accordance with the Accounting Standards Codification, we recognize the expense in the same period and in the same manner as if we had paid cash for the services.

 

Off-Balance Sheet Arrangements

 

We did not have, during the periods presented, and we are currently not party to, any off-balance sheet arrangements.

 

Seasonality

 

We do not have a seasonal business cycle. Our operating results are generally derived evenly throughout the calendar year.

 

ITEM 3.  QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK.

 

Not required by smaller reporting companies.

 

ITEM 4.  CONTROLS AND PROCEDURES.

 

Evaluation of Disclosure Controls and Procedures.  We carried out an evaluation, under the supervision and with the participation of our management, including our principal executive officer and principal financial officer, of the effectiveness of the design and operation of our disclosure controls and procedures, as defined in Rules 13a-15(e) and 15d-15(e) under the Securities Exchange Act of 1934, as amended (the ‘‘Exchange Act’’). Disclosure controls and procedures include, without limitation, controls and procedures designed to ensure that information required to be disclosed by an issuer in the reports that it files or submits under the Exchange Act is accumulated and communicated to the issuer’s management, including its principal executive and principal financial officers, or persons performing similar functions, as appropriate to allow timely decisions regarding required disclosure. Based upon our evaluation, our principal executive officer and principal financial officer concluded that our disclosure controls and procedures are effective as of June 30, 2015, in ensuring that material information that we are required to disclose in reports that we file or submit under the Exchange Act is recorded, processed, summarized and reported within the time periods specified in the Securities and Exchange Commission rules and forms.

 

Changes in Internal Control over Financial Reporting.  There were no changes in our system of internal controls over financial reporting during the period covered by this report that have materially affected, or are reasonably likely to materially affect, our internal control over financial reporting.

 

20



Table of Contents

 

PART II — OTHER INFORMATION

 

ITEM 1.  LEGAL PROCEEDINGS

 

The Company and its two original executives were three of some 30 defendants in a lawsuit filed by a former stockholder of Genaera Corporation, which was the predecessor of the Genaera Liquidating Trust, the party from which the Company purchased the worldwide rights to pexiganan, the active ingredient of the Product Locilex ™ on April 8, 2010. The complaint was filed on June 8, 2012 in the United States District Court for the Eastern District of Pennsylvania (Civil Action No. 12-3265) by Alan W. Schmidt, individually and on behalf of former Genaera Corporation shareholders. Among others, the suit was filed against the Company, as well as John A. Skolas and Argyce LCC, who were responsible for the administration of the Trust and who sold pexiganan to the Company via a public auction. The defendants listed in the complaint included several individuals and companies formerly associated with Genaera Corporation, the Trust and/or Argyce LLC. Also included in the defendant group were several other pharmaceutical companies that were involved in acquiring the former drug-related assets of the Genaera Corporation.

 

The complaint alleged, among other things, the Company and its two executives aided and abetted a breach of fiduciary duty alleged to have been committed by the former director and officers of Genaera Corporation before it was approved for dissolution by its shareholders and also Argyce, LLC, the trustee of the Liquidating Trust. Plaintiff claims that the Company and its executives aided and abetted a breach of the duties of the board of directors and the trustee under common law and under a certain trust agreement allegedly signed between Argyce, LLC, as the trustee, and the Liquidating Trust. With regard to the claims made against the Company and two executives, the plaintiff alleged, in pertinent part, that the Company’s acquisition of the pexiganan rights was for alleged inadequate consideration, and that the Company and its management aided and abetted a breach of fiduciary duty by the Genaera Corporation defendants who were formerly associated with Genaera Corporation and/or the Trust.

 

The Company and its two executives filed a motion to dismiss the complaint within the prescribed time period. All of the other defendants in this litigation also filed motions to dismiss, and a court order granted each and every motion to dismiss, with prejudice, without leave to refile, on August 12, 2013 based on the argument that Plaintiff’s claims were time barred. Plaintiff appealed the dismissal to the United States Third Circuit Court of Appeals seeking reversal of the dismissal. On October 17, 2014, the Third Circuit Appellate Court, in a 2-1 decision with a strong dissenting opinion, reversed the trial court’s dismissal of Plaintiff’s claims based on the expiration of the applicable statutes of limitation. In a 2-1 decision, the Third Circuit held that more information was necessary to determine when Plaintiff should have been on notice of his claims to determine the applicability of the discovery rule, which could serve to extend the time frame in which Plaintiff could bring his claims. Due to the strong dissent, all Defendants filed the necessary documents requesting a petition for rehearing en banc, by the majority of the Third Circuit justices who are in active service. The Third Circuit denied the request for en banc hearing and remanded this case to District Court.

 

This matter has now been remanded to District Court and all Defendants have again moved to dismiss the complaint for reasons other than being time barred.  The Company and the executives move for dismissal based on Plaintiff’s inability to make a case for aiding and abetting a breach of fiduciary duty because there was no underlying breach and such an aiding and abetting claim requires an element of knowing participation in the fiduciary breach which cannot be established by Plaintiff.  Defendants have filed their moving papers, and Plaintiff responded in July 2015.  The District Court has ordered a hearing on this which is expected to occur in September 2015.  The Company intends to vigorously defend Plaintiff’s claims on the factual record, which it believes will prove that the Company is not liable to the Plaintiff in any regard.

 

21



Table of Contents

 

ITEM 1A.  RISK FACTORS

 

Not Applicable to a smaller reporting company.

 

ITEM 2. UNREGISTERED SALES OF EQUITY SECURITIES AND USE OF PROCEEDS.

 

None

 

ITEM 3. DEFAULTS UPON SENIOR SECURITIES.

 

None

 

ITEM 4. MINE SAFETY DISCLOSURES

 

Not Applicable.

 

ITEM 5. OTHER INFORMATION.

 

None

 

ITEM 6. EXHIBITS

 

Copies of the following documents are included as exhibits to this report pursuant to Item 601 of Regulation S-K.

 

Exhibit
No.

 

Title of Document

 

Location

 

 

 

 

 

31.1

 

Certification of the Principal Executive Officer pursuant to Section 302 of the Sarbanes-Oxley Act of 2002

 

Attached

31.2

 

Certification of the Principal Financial and Accounting Officer pursuant to Section 302 of the Sarbanes-Oxley Act of 2002

 

Attached

32.1

 

Certification of the Principal Executive Officer pursuant to U.S.C. Section 1350 as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002*

 

Attached

32.2

 

Certification of the Principal Financial and Accounting Officer pursuant to U.S.C. Section 1350 as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002*

 

Attached

 

 

 

 

 

101.INS

 

X XBRL Instance Document

 

Attached

 

 

 

 

 

101.SCH

 

X XBRL Taxonomy Extension Schema Document

 

Attached

 

 

 

 

 

101.CAL

 

X XBRL Taxonomy Calculation Linkbase Document

 

Attached

 

 

 

 

 

101.DEF

 

X XBRL Taxonomy Extension Definition Linkbase Document

 

Attached

 

 

 

 

 

101.LAB

 

X XBRL Taxonomy Label Linkbase Document

 

Attached

 

 

 

 

 

101.PRE

 

X XBRL Taxonomy Presentation Linkbase Document

 

Attached

 


* The Exhibit attached to this Form 10-Q shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934 (the “Exchange Act”) or otherwise subject to liability under that section, nor shall it be deemed incorporated by reference in any filing under the Securities Act of 1933, as amended, or the Exchange Act, except as expressly set forth by specific reference in such filing.

 

22



Table of Contents

 

SIGNATURES

 

Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned thereunto duly authorized.

 

 

DIPEXIUM PHARMACEUTICALS, INC.

Date: August 12, 2015

 

 

 

 

 

 

By:

/s/ David P. Luci

 

 

David P. Luci

 

 

President and Chief Executive
Officer (Duly Authorized Officer, and
Principal Executive Officer)

 

 

 

 

By:

/s/ Robert G. Shawah

 

 

Robert G. Shawah

 

 

Chief Accounting Officer and Treasurer
(Duly Authorized Officer and Principal
Financial and Accounting Officer)

 

23