Document_and_Entity_Informatio
Document and Entity Information | 3 Months Ended | |
Mar. 31, 2015 | 13-May-15 | |
Document and Entity Information | ||
Entity Registrant Name | Dipexium Pharmaceuticals, Inc. | |
Entity Central Index Key | 1497504 | |
Document Type | 10-Q | |
Document Period End Date | 31-Mar-15 | |
Amendment Flag | FALSE | |
Current Fiscal Year End Date | -19 | |
Entity Current Reporting Status | Yes | |
Entity Filer Category | Smaller Reporting Company | |
Entity Common Stock, Shares Outstanding | 8,566,047 | |
Document Fiscal Year Focus | 2015 | |
Document Fiscal Period Focus | Q1 |
CONDENSED_BALANCE_SHEETS
CONDENSED BALANCE SHEETS (USD $) | Mar. 31, 2015 | Dec. 31, 2014 |
CURRENT ASSETS | ||
Cash | $23,999,419 | $27,040,325 |
Prepaid Expenses | 133,421 | 120,128 |
TOTAL CURRENT ASSETS | 24,132,840 | 27,160,453 |
OTHER ASSETS | ||
Security Deposit | 49,385 | 49,385 |
TOTAL OTHER ASSETS | 49,385 | 49,385 |
TOTAL ASSETS | 24,182,225 | 27,209,838 |
CURRENT LIABILITIES | ||
Accounts Payable and Accrued Expenses | 697,674 | 1,260,598 |
TOTAL LIABILITIES | 697,674 | 1,260,598 |
COMMITMENTS AND CONTINGENCIES | ||
SHAREHOLDERS' EQUITY | ||
Common Stock : $.001 par value, 30,000,000 shares authorized, 8,564,675 and 8,538,329 shares issued and outstanding at March 31,2015 and December 31, 2014, respectively | 8,564 | 8,538 |
Additional paid-in capital | 49,981,969 | 48,259,451 |
Accumulated deficit | -26,505,982 | -22,318,749 |
TOTAL SHAREHOLDERS' EQUITY | 23,484,551 | 25,949,240 |
TOTAL LIABILITIES AND SHAREHOLDERS' EQUITY | $24,182,225 | $27,209,838 |
CONDENSED_BALANCE_SHEETS_Paren
CONDENSED BALANCE SHEETS (Parenthetical) (USD $) | Mar. 31, 2015 | Dec. 31, 2014 |
CONDENSED BALANCE SHEETS | ||
Common Stock, par value (in dollars per share) | $0.00 | $0.00 |
Common Stock, shares authorized | 30,000,000 | 30,000,000 |
Common Stock, shares issued | 8,564,675 | 8,538,329 |
Common Stock, shares outstanding | 8,564,675 | 8,538,329 |
CONDENSED_STATEMENTS_OF_OPERAT
CONDENSED STATEMENTS OF OPERATIONS (USD $) | 3 Months Ended | |
Mar. 31, 2015 | Mar. 31, 2014 | |
OPERATING EXPENSES | ||
Research and Development Expenses | $1,709,398 | $1,816,690 |
General and Administrative Expenses | 2,477,835 | 727,149 |
TOTAL OPERATING EXPENSES | 4,187,233 | 2,543,839 |
LOSS FROM OPERATIONS | -4,187,233 | -2,543,839 |
NET LOSS | ($4,187,233) | ($2,543,839) |
LOSS PER SHARE | ||
Basic and diluted net loss per common share/units (in dollars per share) | ($0.49) | ($0.44) |
Weighted average common shares/units outstanding basic and diluted (in shares) | 8,552,150 | 5,749,220 |
CONDENSED_STATEMENTS_OF_CHANGE
CONDENSED STATEMENTS OF CHANGES IN MEMBERS' & SHAREHOLDERS' EQUITY (USD $) | Common Stock | Additional paid-capital | Accumulated Deficit | Total |
Balance (in shares) at Dec. 31, 2014 | 8,538,329 | 8,538,329 | ||
Balance at Dec. 31, 2014 | $8,538 | $48,259,451 | ($22,318,749) | $25,949,240 |
Increase (Decrease) in Stockholders' Equity | ||||
Share Based Payments to Vendors | 12 | 78,822 | 78,834 | |
Share Based Payments to Vendors (in units) | 12,346 | |||
Share-Based Compensation | 14 | 1,643,696 | 1,643,710 | |
Share-Based Compensation (in shares) | 14,000 | |||
Net Loss | -4,187,233 | -4,187,233 | ||
Balance (in shares) at Mar. 31, 2015 | 8,564,675 | 8,564,675 | ||
Balance at Mar. 31, 2015 | $8,564 | $49,981,969 | ($26,505,982) | $23,484,551 |
CONDENSED_STATEMENTS_OF_CASH_F
CONDENSED STATEMENTS OF CASH FLOWS (USD $) | 3 Months Ended | |
Mar. 31, 2015 | Mar. 31, 2014 | |
Operating Activities: | ||
Net Loss | ($4,187,233) | ($2,543,839) |
Adjustments to reconcile net loss to net cash used in operating activities: | ||
Share Based Compensation | 1,643,710 | 95,960 |
Share Based Payments to Vendors | 78,834 | 380,200 |
(Increase) / Decrease In: | ||
Prepaid Expenses | -13,293 | -170,470 |
Accounts Payable and Accrued Expenses | -562,924 | -13,128 |
Net Cash Used In Operating Activities | -3,040,906 | -2,251,277 |
Financing Activities: | ||
Proceeds from issuance of Common Stock, net of issuance costs | 34,455,669 | |
Net Cash Provided By Financing Activities | 34,455,669 | |
Net Increase (Decrease) In Cash | -3,040,906 | 32,204,392 |
Cash at Beginning of Year | 27,040,325 | 3,861,145 |
Cash at End of Year | $23,999,419 | $36,065,537 |
NATURE_OF_OPERATIONS
NATURE OF OPERATIONS | 3 Months Ended |
Mar. 31, 2015 | |
NATURE OF OPERATIONS | |
NATURE OF OPERATIONS | |
NOTE 1 — NATURE OF OPERATIONS | |
Business: | |
Dipexium Pharmaceuticals, Inc. (the “Company”), a Delaware corporation, formerly Dipexium Pharmaceuticals, LLC, is a biopharmaceutical company addressing the need for new antibiotics to treat infectious diseases. The Company was formed on January 14, 2010. The Company is a late-stage pharmaceutical company focused on the development and commercialization of Locilex® (pexiganan cream 0.8%). | |
On March 18, 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 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. As of March 31, 2015, the Company had a cash balance of approximately $24.0 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 into the second half of 2016. Furthermore, 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, 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 March 31, 2015, the results of operations and cash flows for the three months ended March 31, 2015 and 2014. The December 31, 2014 balance sheet included herein was derived from the audited financial statements, but may not include all disclosures including notes required by GAAP for complete financial statements. | |
SUMMARY_OF_SIGNIFICANT_ACCOUNT
SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES | 3 Months Ended |
Mar. 31, 2015 | |
SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES | |
SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES | |
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. | |
Concentration of Credit Risk | |
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 amount of $1,709,398 and $1,816,690 for the three months ended March 31, 2015 and 2014, respectively. | |
Although the Company manages the conduct of its clinical trials, it relies on third parties to conduct 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. | |
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 months ended March 31, 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 March 31, 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. | |
ACCOUNTS_PAYABLE_AND_ACCRUED_E
ACCOUNTS PAYABLE AND ACCRUED EXPENSES | 3 Months Ended | |||||||
Mar. 31, 2015 | ||||||||
ACCOUNTS PAYABLE AND ACCRUED EXPENSES | ||||||||
ACCOUNTS PAYABLE AND ACCRUED EXPENSES | ||||||||
NOTE 3 - ACCOUNTS PAYABLE AND ACCRUED EXPENSES | ||||||||
Accounts payable and accrued expenses at March 31, 2015 and December 31, 2014 were as follows: | ||||||||
March 31, 2015 | December 31, 2014 | |||||||
Accrued compensation expense | $ | 31,460 | $ | 511,769 | ||||
Accrued research and development | 576,599 | 641,997 | ||||||
Accrued professional fees | 30,075 | 23,901 | ||||||
Other accounts payable and accrued expenses | 59,540 | 82,931 | ||||||
Totals | $ | 697,674 | $ | 1,260,598 | ||||
ISSUANCE_OF_MEMBERSHIP_INTERES
ISSUANCE OF MEMBERSHIP INTERESTS and COMMON STOCK | 3 Months Ended |
Mar. 31, 2015 | |
ISSUANCE OF MEMBERSHIP INTERESTS and COMMON STOCK | |
ISSUANCE OF MEMBERSHIP INTERESTS and COMMON STOCK | |
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 dated January 2014, pursuant to which RRD International, LLC will continue to provide certain strategic product development services to the Company for an additional six month term. These product development services include the development, 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). Terms of services to be provided after June 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. The Company recorded research and development expense relating to this agreement of $303,834, including the cash payments and stock issuance, for the three months ended March 31, 2015. | |
SHAREBASED_COMPENSATION_and_ST
SHARE-BASED COMPENSATION and STOCK OPTIONS | 3 Months Ended | ||||||
Mar. 31, 2015 | |||||||
SHARE-BASED COMPENSATION and STOCK OPTIONS | |||||||
SHARE-BASED COMPENSATION and STOCK OPTIONS | |||||||
NOTE 5 — SHARE-BASED COMPENSATION and STOCK OPTIONS | |||||||
The Company granted restricted Class A Membership Interests awards to board members in exchange for services. These membership interests awards were originally scheduled to vest over a period of 3 or 4 years, with the first year beginning on the date the member joined the board. Accelerated vesting will occur 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 March 31, 2015 and 2014, respectively. | |||||||
The following table summarizes the non-vested Class A Membership Interests at March 31, 2015 giving effect to the corporate conversion and the associated activity for the year ended December 31, 2014 and the three months ended March 31, 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 March 31, 2015 | 28,000 | ||||||
In December 2013, 1,000 Membership Interests were issued to a member of board of directors which vested February 2014. | |||||||
As of March 31, 2015, there was $195,833 of total unrecognized compensation cost related to these awards. That cost is expected to be recognized over a weighted average period of 2.0 years. | |||||||
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 four of its 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, an 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: | |||||||
Three Months Ended | Three Months Ended | ||||||
March 31, 2015 | March 31, 2014 | ||||||
Expected term | 4.6 years | 4.2 years | |||||
Volatility | 60.20% | 59.60% | |||||
Dividend yield | 0% | 0% | |||||
Risk free interest rate | 1.31% | 1.22% | |||||
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: | |||||||
Three Months Ended | Weighted Average | ||||||
March 31, 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 March 31, 2015 and 2014 was $1,618,710 and $58,460, respectively. The total compensation expense not yet recognized as of March 31, 2015 was $4,030,224. The weighted average vesting period over which the total compensation expense will be recorded related to unvested options not yet recognized as of March 31, 2015 was approximately 1.9 years. The weighted average grant date fair value is $6.27. The intrinsic value of the stock options as of March 31, 2015 was $598,642, with a remaining weighted average contractual life of 6.14 years. | |||||||
SHAREBASED_PAYMENTS_TO_VENDORS
SHARE-BASED PAYMENTS TO VENDORS | 3 Months Ended |
Mar. 31, 2015 | |
SHARE-BASED PAYMENTS TO VENDORS | |
SHARE-BASED PAYMENTS TO VENDORS | |
NOTE 6 — SHARE-BASED PAYMENTS TO VENDORS | |
In January 2014, the Company entered into a Product Development Agreement with RRD International, LLC, pursuant to which RRD International, LLC 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 development, 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 International, LLC 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 International, LLC dated January 2014, pursuant to which RRD International, LLC 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 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). Terms of services to be provided after June 2015, if any, will be negotiated at a later date. | |
LEASE_OF_OFFICE_SPACE
LEASE OF OFFICE SPACE | 3 Months Ended |
Mar. 31, 2015 | |
LEASE OF OFFICE SPACE | |
LEASE OF OFFICE SPACE | |
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 is $153,747. | |
LEGAL_MATTERS
LEGAL MATTERS | 3 Months Ended |
Mar. 31, 2015 | |
LEGAL MATTERS | |
LEGAL MATTERS | |
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 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 await Plaintiff’s response. The Company anticipates hearing on these motions in late summer. 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. | |
RELATED_PARTY_TRANSACTIONS
RELATED PARTY TRANSACTIONS | 3 Months Ended |
Mar. 31, 2015 | |
RELATED PARTY TRANSACTIONS | |
RELATED PARTY TRANSACTIONS | |
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 and $22,500 in fees to Aumoe for the three months ended March 31, 2015 and 2014, respectively, which were recorded in general and administrative expenses. | |
NET_LOSS_PER_SHARE
NET LOSS PER SHARE | 3 Months Ended |
Mar. 31, 2015 | |
NET LOSS PER SHARE | |
NET LOSS PER SHARE | |
NOTE 10 — NET LOSS PER SHARE | |
Basic and diluted net loss per common share for the three months ended March 31, 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 31,500 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 18, 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. | |
RECENT_ACCOUNTING_PRONOUNCEMEN
RECENT ACCOUNTING PRONOUNCEMENTS | 3 Months Ended |
Mar. 31, 2015 | |
RECENT ACCOUNTING PRONOUNCEMENTS | |
RECENT ACCOUNTING PRONOUNCEMENTS | |
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. | |
SUMMARY_OF_SIGNIFICANT_ACCOUNT1
SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES (Policies) | 3 Months Ended |
Mar. 31, 2015 | |
SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES | |
Use of Estimates | |
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. | |
Concentration of Credit Risk | |
Concentration of Credit Risk | |
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 | |
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 | |
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 amount of $1,709,398 and $1,816,690 for the three months ended March 31, 2015 and 2014, respectively. | |
Although the Company manages the conduct of its clinical trials, it relies on third parties to conduct 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 | |
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 | |
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. | |
Income Taxes | |
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 months ended March 31, 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 March 31, 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. | |
ACCOUNTS_PAYABLE_AND_ACCRUED_E1
ACCOUNTS PAYABLE AND ACCRUED EXPENSES (Tables) | 3 Months Ended | |||||||
Mar. 31, 2015 | ||||||||
ACCOUNTS PAYABLE AND ACCRUED EXPENSES | ||||||||
Schedule of accounts payable and accrued expenses | ||||||||
March 31, 2015 | December 31, 2014 | |||||||
Accrued compensation expense | $ | 31,460 | $ | 511,769 | ||||
Accrued research and development | 576,599 | 641,997 | ||||||
Accrued professional fees | 30,075 | 23,901 | ||||||
Other accounts payable and accrued expenses | 59,540 | 82,931 | ||||||
Totals | $ | 697,674 | $ | 1,260,598 | ||||
SHAREBASED_COMPENSATION_and_ST1
SHARE-BASED COMPENSATION and STOCK OPTIONS (Tables) | 3 Months Ended | ||||||
Mar. 31, 2015 | |||||||
SHARE-BASED COMPENSATION and STOCK OPTIONS | |||||||
Summary of the non-vested Class A Membership Interests which were converted to Common Stock at a conversion ratio of seven to one, and the associated activity | |||||||
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 March 31, 2015 | 28,000 | ||||||
Schedule of weighted average assumptions used in determining the fair value of the option awards using the Black-Scholes option pricing model | |||||||
Three Months Ended | Three Months Ended | ||||||
March 31, 2015 | March 31, 2014 | ||||||
Expected term | 4.6 years | 4.2 years | |||||
Volatility | 60.20% | 59.60% | |||||
Dividend yield | 0% | 0% | |||||
Risk free interest rate | 1.31% | 1.22% | |||||
Summary of stock option activity | |||||||
Three Months Ended | Weighted Average | ||||||
March 31, 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 | ||||
NATURE_OF_OPERATIONS_Details
NATURE OF OPERATIONS (Details) (USD $) | 0 Months Ended | 3 Months Ended | ||
Mar. 18, 2014 | Mar. 31, 2014 | Mar. 31, 2015 | Dec. 31, 2014 | |
NATURE OF OPERATIONS | ||||
Proceeds from initial public offering of common stock, net of transaction costs | $34,455,669 | $34,455,669 | ||
Cash balance | $23,999,419 | $27,040,325 |
SUMMARY_OF_SIGNIFICANT_ACCOUNT2
SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES (Details) (USD $) | 3 Months Ended | |
Mar. 31, 2015 | Mar. 31, 2014 | |
item | ||
Concentration of Credit Risk | ||
Number of financial institutions in which the entity maintains its cash balance | 1 | |
Research and Development | ||
Net research and development expenses | $1,709,398 | $1,816,690 |
Federal Income Taxes | ||
Income tax expense | 0 | |
Estimated annual effective tax rate (as a percent) | 0.00% | |
Current federal income tax expense | 0 | |
Current state income tax expense | $0 |
ACCOUNTS_PAYABLE_AND_ACCRUED_E2
ACCOUNTS PAYABLE AND ACCRUED EXPENSES (Details) (USD $) | Mar. 31, 2015 | Dec. 31, 2014 |
ACCOUNTS PAYABLE AND ACCRUED EXPENSES | ||
Accrued compensation expense | $31,460 | $511,769 |
Accrued research and development | 576,599 | 641,997 |
Accrued professional fees | 30,075 | 23,901 |
Other accounts payable and accrued expenses | 59,540 | 82,931 |
Total | $697,674 | $1,260,598 |
ISSUANCE_OF_MEMBERSHIP_INTERES1
ISSUANCE OF MEMBERSHIP INTERESTS and COMMON STOCK (Details) (USD $) | 0 Months Ended | 3 Months Ended | 1 Months Ended | |||
Mar. 18, 2014 | Mar. 31, 2015 | Mar. 31, 2014 | Jan. 31, 2015 | Jan. 31, 2014 | Dec. 31, 2014 | |
Issuance of membership interests and common stock | ||||||
Conversion ratio | 7 | |||||
Shares of common stock issued in IPO | 3,162,500 | |||||
Share price of common stock (in dollars per share) | $12 | |||||
Net proceeds from IPO | $34,455,669 | $34,455,669 | ||||
Underwriting discounts | 2,656,500 | |||||
Offering costs | 837,831 | |||||
Shares of common stock issued upon conversion of membership interests | 5,375,377 | |||||
Common Stock, Shares, Issued | 8,564,675 | 8,538,329 | ||||
Research and Development Expenses | 1,709,398 | 1,816,690 | ||||
RRD International, LLC | ||||||
Issuance of membership interests and common stock | ||||||
Term of services | 6 months | |||||
Total product development expense | 600,000 | |||||
Cash portion | 450,000 | |||||
Consulting expense | 150,000 | |||||
Share Based Payments to Vendors (in units) | 12,346 | |||||
Research and Development Expenses | $303,834 | |||||
Class A Membership Interests | ||||||
Issuance of membership interests and common stock | ||||||
Conversion ratio | 7 | |||||
Membership interests converted into shares of common stock | 767,911 | |||||
Class A Membership Interests | RRD International, LLC | ||||||
Issuance of membership interests and common stock | ||||||
Share Based Payments to Vendors (in units) | 7,604 |
SHAREBASED_COMPENSATION_and_ST2
SHARE-BASED COMPENSATION and STOCK OPTIONS (Details) (USD $) | 1 Months Ended | 3 Months Ended | 12 Months Ended | |
Dec. 31, 2013 | Mar. 31, 2015 | Mar. 31, 2014 | Dec. 31, 2014 | |
Restricted Class A Membership Interests awards | ||||
Share-based compensation and stock options | ||||
Fair value of the membership interests granted (in dollars per share) | $50 | |||
Total compensation expense recorded as director fees | $25,000 | $37,500 | ||
Additional disclosures | ||||
Number of Membership Interests issued but not vested | 1,000 | |||
Restricted Class A Membership Interests awards | Minimum | ||||
Share-based compensation and stock options | ||||
Vesting period | 3 years | |||
Restricted Class A Membership Interests awards | Maximum | ||||
Share-based compensation and stock options | ||||
Vesting period | 4 years | |||
Non-vested Class A Membership Interests awards converted to Common Stock awards | ||||
Non-vested Class A Membership interests converted to common stock at a conversion ratio and the associated activity | ||||
Nonvested at the beginning of the period (in shares) | 42,000 | 77,000 | 77,000 | |
Forfeited (in shares) | -21,000 | |||
Vested (in shares) | -14,000 | -14,000 | ||
Nonvested at the end of the period (in shares) | 28,000 | 42,000 | ||
Additional disclosures | ||||
Total unrecognized compensation cost | $195,833 | |||
Weighted average period over which total unrecognized compensation cost is expected to be recognized | 2 years |
SHAREBASED_COMPENSATION_and_ST3
SHARE-BASED COMPENSATION and STOCK OPTIONS (Details 2) (USD $) | 1 Months Ended | 3 Months Ended | ||||
Jan. 31, 2015 | Apr. 30, 2014 | Mar. 31, 2014 | Nov. 30, 2013 | Mar. 31, 2015 | Mar. 31, 2014 | |
item | ||||||
Company's stock option activity | ||||||
Outstanding at the beginning of the year (in shares) | 861,287 | 861,287 | ||||
Granted (in shares) | 251,000 | |||||
Outstanding at the end of the year (in shares) | 1,112,287 | |||||
Weighted Average Exercise Price | ||||||
Outstanding at the beginning of the period (in dollars per share) | $13.90 | $13.90 | ||||
Grant price (in dollars per share) | $11.35 | |||||
Outstanding at the end of the period (in dollars per share) | $13.32 | |||||
Exercise price (in dollars per share) | $13.32 | |||||
Employee stock options | ||||||
Share-based compensation and stock options | ||||||
Percentage of the issued and outstanding common stock reserved under the Equity Incentive Plan | 20.00% | |||||
Awards granted as percentage of common stock outstanding | 10.00% | |||||
Number of executives to whom awards are granted | 4 | |||||
Number of equal monthly installments in which awards issued under the 2013 Equity Incentive Plan will vest | 36 | |||||
Weighted average assumptions used in determining the fair value of the option awards using the Black-Scholes option pricing model | ||||||
Expected term | 4 years 7 months 6 days | 4 years 2 months 12 days | ||||
Volatility (as a percent) | 60.20% | 59.60% | ||||
Dividend yield (as a percent) | 0.00% | 0.00% | ||||
Risk free interest rate (as a percent) | 1.31% | 1.22% | ||||
Weighted average grant date fair value (in dollars per share) | $6.27 | |||||
Company's stock option activity | ||||||
Outstanding at the beginning of the year (in shares) | 853,787 | |||||
Granted (in shares) | 251,000 | 7,500 | ||||
Outstanding at the end of the year (in shares) | 853,787 | 853,787 | ||||
Weighted Average Exercise Price | ||||||
Outstanding at the beginning of the period (in dollars per share) | $13.93 | |||||
Grant price (in dollars per share) | $11.35 | |||||
Outstanding at the end of the period (in dollars per share) | $10.46 | $13.93 | $13.93 | |||
Employees | 5 | |||||
Vesting percentage upon issuance | 50.00% | |||||
Compensation expense | $1,618,710 | $58,460 | ||||
Total compensation expense not yet recognized | 4,030,224 | |||||
Weighted average vesting period over which the total compensation expense will be recorded | 1 year 10 months 24 days | |||||
Vesting period | 24 months | 3 years | ||||
Intrinsic value | 598,642 | |||||
Remaining weighted average contractual life | 6 years 1 month 21 days | |||||
Exercise price (in dollars per share) | $10.46 | $13.93 | $13.93 | |||
Non Employee Member | Employee stock options | ||||||
Company's stock option activity | ||||||
Granted (in shares) | 35,000 | |||||
Weighted Average Exercise Price | ||||||
Compensation expense | $353,150 |
SHAREBASED_PAYMENTS_TO_VENDORS1
SHARE-BASED PAYMENTS TO VENDORS (Details) (RRD International, LLC, USD $) | 1 Months Ended | |
Jan. 31, 2015 | Jan. 31, 2014 | |
Share-based payments to vendors | ||
Membership Interests granted (in units) | 12,346 | |
Term of services | 6 months | |
Total product development expense | $600,000 | |
Cash portion | 450,000 | |
Consulting expense | $150,000 | |
Class A Membership Interests | ||
Share-based payments to vendors | ||
Membership Interests granted (in units) | 7,604 | |
Value of recent private placement taken as fair value for the grant of the membership interests (in dollars per share) | $50 |
LEASE_OF_OFFICE_SPACE_Details
LEASE OF OFFICE SPACE (Details) (USD $) | 1 Months Ended | |
31-May-14 | Mar. 31, 2015 | |
LEASE OF OFFICE SPACE | ||
Monthly payments of lease under agreement | $12,717 | |
Total minimum sublease payments | $153,747 |
LEGAL_MATTERS_Details
LEGAL MATTERS (Details) (Lawsuit filed by a former stockholder of Genaera Corporation for breach of fiduciary duty) | 0 Months Ended |
Jun. 08, 2012 | |
item | |
Lawsuit filed by a former stockholder of Genaera Corporation for breach of fiduciary duty | |
Legal matters | |
Number of defendants represented by original executives | 2 |
Number of defendants represented by executives and the Company | 3 |
Number of defendants in a lawsuit | 30 |
RELATED_PARTY_TRANSACTIONS_Det
RELATED PARTY TRANSACTIONS (Details) (Aumoe, USD $) | 3 Months Ended | |
Mar. 31, 2015 | Mar. 31, 2014 | |
Aumoe | ||
Related party transactions | ||
Fees for services rendered by the related party | $0 | $22,500 |
NET_LOSS_PER_SHARE_Details
NET LOSS PER SHARE (Details) | 0 Months Ended | 3 Months Ended |
Mar. 18, 2014 | Mar. 31, 2015 | |
Proforma net loss per share | ||
Conversion ratio used to convert Class A Membership Interests on proforma basis to common shares to calculate the weighted average common shares | 7 | |
Shares of common stock issued upon conversion of membership interests | 5,375,377 | |
Class A Membership Interests | ||
Proforma net loss per share | ||
Conversion ratio used to convert Class A Membership Interests on proforma basis to common shares to calculate the weighted average common shares | 7 | |
Membership interests converted into shares of common stock | 767,911 | |
Stock options | ||
Proforma net loss per share | ||
Potentially dilutive shares not been included in the computation of diluted net loss per share as the result would be antidilutive | 1,112,287 | |
Warrants | ||
Proforma net loss per share | ||
Potentially dilutive shares not been included in the computation of diluted net loss per share as the result would be antidilutive | 31,500 | |
Unvested common shares | ||
Proforma net loss per share | ||
Potentially dilutive shares not been included in the computation of diluted net loss per share as the result would be antidilutive | 28,000 |