Document and Entity Information
Document and Entity Information - shares | 6 Months Ended | |
Jun. 30, 2016 | Jul. 31, 2016 | |
Document And Entity Information [Abstract] | ||
Entity Registrant Name | Anthera Pharmaceuticals Inc | |
Entity Central Index Key | 1,316,175 | |
Document Type | 10-Q | |
Document Period End Date | Jun. 30, 2016 | |
Document Fiscal Period Focus | Q2 | |
Document Fiscal Year Focus | 2,016 | |
Amendment Flag | false | |
Current Fiscal Year End Date | --12-31 | |
Entity Filer Category | Accelerated Filer | |
Entity Common Stock, Shares Outstanding | 41,427,352 |
CONSOLIDATED BALANCE SHEETS
CONSOLIDATED BALANCE SHEETS - USD ($) $ in Thousands | Jun. 30, 2016 | Dec. 31, 2015 | [1] |
Current assets: | |||
Cash and cash equivalents | $ 28,500 | $ 46,951 | |
Accounts receivable | 261 | 326 | |
Prepaid expenses and other current assets | 1,178 | 585 | |
Total current assets | 29,939 | 47,862 | |
Property and equipment - net | 778 | 263 | |
TOTAL | 30,717 | 48,125 | |
Current liabilities: | |||
Accounts payable | 4,228 | 5,259 | |
Accrued clinical expenses | 4,199 | 1,377 | |
Accrued liabilities | 449 | 98 | |
Accrued payroll and related costs | 1,305 | 1,596 | |
Deferred revenue - current | 138 | ||
Total current liabilities | 10,181 | 8,468 | |
Total liabilities | 10,181 | 8,468 | |
Commitments and Contingencies (Note 6) | |||
Stockholders' equity: | |||
Common stock, $0.001 par value, 100,000,000 shares authorized; 41,285,033 and 40,004,037 shares issued and outstanding as of June 30, 2016 and December 31, 2015, respectively | 41 | 40 | |
Additional paid-in capital | 398,586 | 391,648 | |
Accumulated deficit | (378,091) | (352,031) | |
Total stockholders' equity | 20,536 | 39,657 | |
TOTAL | $ 30,717 | $ 48,125 | |
[1] | Derived from audited Financial Statements. |
CONSOLIDATED BALANCE SHEETS (Pa
CONSOLIDATED BALANCE SHEETS (Parenthetical) - $ / shares | Jun. 30, 2016 | Dec. 31, 2015 |
Statement of Financial Position [Abstract] | ||
Common stock, par value per share | $ 0.001 | $ 0.001 |
Common stock, shares authorized | 100,000,000 | 100,000,000 |
Common stock, shares issued | 41,285,033 | 40,004,037 |
Common stock, shares outstanding | 41,285,033 | 40,004,037 |
CONSOLIDATED STATEMENTS OF OPER
CONSOLIDATED STATEMENTS OF OPERATIONS - USD ($) $ in Thousands | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2016 | Jun. 30, 2015 | Jun. 30, 2016 | Jun. 30, 2015 | |
REVENUES: | ||||
License fee revenue | $ 146 | $ 139 | $ 195 | |
Collaborative revenue | 143 | 6 | 339 | |
Total revenues | 289 | 145 | 534 | |
OPERATING EXPENSE: | ||||
Research and development | 11,966 | 8,539 | 21,590 | 14,534 |
General and administrative | 2,576 | 1,696 | 4,814 | 3,603 |
Research award | (261) | (1,100) | (261) | (1,100) |
Total operating expenses | 14,281 | 9,135 | 26,143 | 17,037 |
LOSS FROM OPERATIONS | (14,281) | (8,846) | (25,998) | (16,503) |
OTHER INCOME (EXPENSE): | ||||
Other income (expense) | (53) | (49) | (62) | (52) |
NET LOSS | $ (14,334) | $ (8,895) | $ (26,060) | $ (16,555) |
Net loss per share - Basic and diluted | $ (0.35) | $ (0.25) | $ (0.64) | $ (0.52) |
Weighted-average number of shares used in per common share calculation - basic and diluted | 41,032,544 | 35,817,794 | 40,541,219 | 31,729,152 |
CONSOLIDATED STATEMENTS OF CASH
CONSOLIDATED STATEMENTS OF CASH FLOWS - USD ($) $ in Thousands | 6 Months Ended | ||
Jun. 30, 2016 | Jun. 30, 2015 | ||
CASH FLOW FROM OPERATING ACTIVITIES: | |||
Net loss | $ (26,060) | $ (16,555) | |
Adjustments to reconcile net loss to net cash used in operating activities: | |||
Depreciation | 146 | 140 | |
Stock-based compensation expense | 2,557 | 1,183 | |
Changes in assets and liabilities: | |||
Accounts receivable | 65 | (551) | |
Prepaid expenses and other assets | (593) | (275) | |
Accounts payable | (1,031) | 3,049 | |
Accrued clinical expenses | 2,822 | 385 | |
Accrued liabilities | 352 | 76 | |
Accrued payroll and related costs | (151) | (9) | |
Deferred revenue | (138) | (195) | |
Net cash used in operating activities | (22,031) | (12,752) | |
INVESTING ACTIVITIES: | |||
Property and equipment purchases | (662) | (80) | |
Net cash used in investing activities | (662) | (80) | |
FINANCING ACTIVITIES: | |||
Proceeds from issuance of common stock, net of offering costs | 3,947 | 38,469 | |
Proceeds from issuance of common stock to Zenyaku Kogyo Co., Ltd. | 7,000 | ||
Proceeds from issuance of common stock pursuant to exercise of stock options | 295 | 179 | |
Net cash provided by financing activities | 4,242 | 45,648 | |
NET INCREASE (DECREASE) IN CASH AND CASH EQUIVALENTS | (18,451) | 32,816 | |
CASH AND CASH EQUIVALENTS - Beginning of period | 46,951 | [1] | 2,639 |
CASH AND CASH EQUIVALENTS - End of period | 28,500 | 35,455 | |
Non-cash financing activities: | |||
Issuance of common stock in the form of a waiver of a fee otherwise payable to Amgen under the Amgen Agreement | 1,000 | ||
Issuance of common stock as a commitment fee pursuant to an equity purchase agreement | $ 76 | $ 60 | |
[1] | Derived from audited Financial Statements. |
ORGANIZATION AND SIGNIFICANT AC
ORGANIZATION AND SIGNIFICANT ACCOUNTING POLICIES | 6 Months Ended |
Jun. 30, 2016 | |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | |
ORGANIZATION AND SIGNIFICANT ACCOUNTING POLICIES | 1. ORGANIZATION AND SIGNIFICANT ACCOUNTING POLICIES Organization Anthera Pharmaceuticals, Inc. (the “Company” or “Anthera”) is a biopharmaceutical company focused on advancing the development and commercialization of innovative medicines that benefit patients with unmet medical needs. The Company currently has two compounds in development, liprotamase, also known as Sollpura™, Liquidity and Need for Additional Capital The Company’s planned principal operations are acquiring product and technology rights, raising capital and performing research and development activities. The Company is currently conducting research and development activities to treat autoimmune diseases and EPI. The Company’s activities are subject to significant risks and uncertainties. Successful completion of the Company’s development programs and, ultimately, the attainment of profitable operations are dependent on future events, including, among other things, its ability to access potential markets; secure financing; develop a customer base; attract, retain and motivate qualified personnel; and develop strategic alliances. Since inception in 2004, the Company has funded its operations through equity offerings, private placements of convertible debt, debt financing, equity investment and cost reimbursement from a former collaborative partner, Zenyaku Kogyo Co., Ltd (“Zenyaku”), and a research award from Cystic Fibrosis Foundation Therapeutics Incorporated ("CFFT"). On April 21, 2016, the Company entered into an At Market Issuance Sales Agreement (“ATM Agreement”) with H.C. Wainwright & Co., LLC (“H.C. Wainwright”) to create an at-the-market equity program under which the Company from time to time may offer and sell shares of its common stock, par value $0.001 per share, having an aggregate offering price of up to $25.0 million through H.C. Wainwright, as agent. On April 27, 2016, the Company amended an existing equity purchase agreement with Lincoln Park Capital Fund, LLC (“LPC”), pursuant to which the Company has the right, but not the obligation, to sell to LPC up to an aggregate of $15.0 million in shares of common stock by March 2017. As of the date of this report, the Company anticipates its existing cash, and access to additional cash through the ATM Agreement with H.C. Wainwright and an equity purchase agreement with LPC will be sufficient to fund its near term liquidity needs for at least the next 12 months. To fully execute its business plan, the Company will need to complete certain research and development activities and clinical studies. Further, the Company’s product candidates will require regulatory approval prior to commercialization. These activities may span many years and require substantial capital to complete and may ultimately be unsuccessful. Any delays in completing these activities could adversely impact the Company. The Company will need substantial additional financing to continue development of its product candidates, obtain regulatory approvals, and prepare for commercial readiness if the clinical trials are successful; such financing may not be available on terms favorable to the Company, if at all. If adequate funds are not available, the Company may be required to delay, reduce the scope of, or eliminate one or more of its clinical trials. The Company plans to meet its capital requirements primarily through future partnerships, issuances of equity securities, debt financing, and in the longer term, revenue from product sales. Failure to generate revenue or raise additional capital would adversely affect the Company’s ability to achieve its intended business objectives. Basis of Presentation The accompanying unaudited Condensed Consolidated Financial Statements have been prepared pursuant to the rules and regulations of the Securities and Exchange Commission (“SEC”) for Quarterly Reports on Form 10-Q and do not contain all of the information and footnotes required by U.S. generally accepted accounting principles (“U.S. GAAP”) for complete financial statements. The accompanying unaudited Condensed Consolidated financial statements and notes thereto should be read in conjunction with the audited consolidated financial statements and notes thereto included in the Company’s Annual Report on Form 10-K for the year ended December 31, 2015, filed with the SEC on March 14, 2016. In the opinion of management, the accompanying unaudited Condensed Consolidated financial statements reflect all adjustments, which include only normal recurring adjustments necessary to present fairly the Company’s interim consolidated financial information. The results for the three and six months ended June 30, 2016 are not necessarily indicative of the results to be expected for the year ending December 31, 2016 or for any other period. The consolidated balance sheet as of December 31, 2015 has been derived from the audited financial statements as of that date but it does not include all of the information and notes required by U.S. GAAP. The Company has evaluated events and transactions subsequent to the balance sheet date and has disclosed all events or transactions that occurred subsequent to the balance sheet date but prior to filing this Quarterly Report on Form 10-Q that would require recognition or disclosure in the unaudited Condensed Consolidated Financial Statements. Use of Estimates The preparation of these condensed consolidated financial statements in conformity with U.S. GAAP requires us to make estimates and judgments that affect the reported amounts of assets, liabilities, expenses and related disclosures. On an ongoing basis, management evaluates its estimates, including critical accounting policies or estimates related to clinical trial accruals, tax provision, and stock-based compensation. The Company bases its estimates on historical experience and on various other market specific and other relevant assumptions that it believes to be reasonable under the circumstances, the results of which form the basis for making judgments about the carrying values of assets and liabilities that are not readily apparent from other sources. Actual results may differ significantly from these estimates. Recent Accounting Pronouncements In September 2014, the Financial Accounting Standards Board (“FASB”) issued Accounting Standards Update No. 2014-15, Presentation of Financial Statements - Going Concern (Subtopic 205-40): Disclosure of Uncertainties about an Entity’s Ability to Continue as Going Concern (“ASU 2014-15”). ASU 2014-15 defines when and how companies are required to disclose going concern uncertainties, which must be evaluated each interim and annual period. Specifically, the ASU requires management to determine whether substantial doubt exists regarding the entity’s going concern presumption. Substantial doubt about an entity’s ability to continue as a going concern exists when relevant conditions and events, considered in the aggregate, indicate that it is probable that the entity will be unable to meet its obligations as they become within one year after the financial statements are issued (or available to be issued). If substantial doubt exists, certain disclosures are required; the extent of those disclosures depends on an evaluation of management’s plans (if any) to mitigate the going concern uncertainty. The guidance is effective for fiscal years ending after December 15, 2016 and for interim periods thereafter. The Company does not expect the adoption of this guidance to materially affect its consolidated financial statements. In November 2015, the FASB issued guidance on the classification of deferred taxes, Accounting Standards Update No. 20154-17 (“ASU 2015-17”), Balance Sheet Classification of Deferred Taxes. ASU 2015-17 eliminates the guidance in Topic 740, Income Taxes, that required an entity to separate deferred tax liabilities and assets between current and noncurrent amounts in a classified balance sheet. The amendments require that all deferred tax liabilities and assets of the same tax jurisdiction or a tax filing group, as well as any related valuation allowance, be offset and presented as a single amount in a classified balance sheet. The amendments are effective for public business entities for fiscal years, and for interim periods within those fiscal years, beginning after December 15, 2016. Early adoption is permitted as of the beginning of any interim period or annual reporting period. The Company does not expect the adoption of this guidance to materially affect its consolidated financial statements. In February 2016, the FASB issued ASU No. 2016-02 Leases (Topic 842). ASU 2016-02 impacts any entity that enters into a lease with some specified scope exceptions. The guidance updates and supersedes Topic 840, Leases. For public entities, ASU 2016-02 is effective for fiscal years, and interim periods with those years, beginning after December 15, 2018, and early adoption is permitted. The Company does not expect the adoption of this standard to materially affect its consolidated financial statements. In March 2016, the FASB issued ASU No. 2016-09, Compensation—Stock Compensation (Topic 718). This standard makes several modifications to Topic 718 related to the accounting for forfeitures, employer tax withholding on share-based compensation and the financial statement presentation of excess tax benefits or deficiencies. ASU 2016-09 also clarifies the statement of cash flows presentation for certain components of share-based awards. The standard is effective for interim and annual reporting periods beginning after December 15, 2016, although early adoption is permitted. The adoption of ASU 2015-17 is not expected to have a significant impact on the Company’s consolidated financial position or results of operations. |
COLLABORATIVE AGREEMENT
COLLABORATIVE AGREEMENT | 6 Months Ended |
Jun. 30, 2016 | |
Business Combinations [Abstract] | |
COLLABORATIVE AGREEMENT | 2. COLLABORATIVE AGREEMENT In December 2014, the Company entered into an exclusive license agreement with Zenyaku (“Zenyaku Agreement”) for the development and commercialization of blisibimod in Japan and potentially other countries throughout Asia, while the Company retained full development and commercialization rights of blisibimod for all other global territories including North America and the European Union. In September 2015, Zenyaku provided the Company a notice of its intent to terminate the Zenyaku Agreement, effective January 7, 2016 (“Termination Notice”). As a result of the Termination Notice, the Company changed the amortization period of its deferred revenue and has fully amortized its deferred revenue as of January 7, 2016. |
RESEARCH AWARD
RESEARCH AWARD | 6 Months Ended |
Jun. 30, 2016 | |
Research and Development [Abstract] | |
RESEARCH AWARD | 3. RESEARCH AWARD In March 2015, the Company received a research award of up to $3 million from the CFFT for the Company's development of liprotamase. The Company retains the right to develop and commercialize liprotamase and will owe royalties to CFFT on net sales of any drug candidate approved and commercialized under the collaboration. The funding is to be disbursed by CFFT to the Company upon the Company’s achievement of milestones specified in the award agreement. At its discretion, the Company may choose to fund a particular stage of the liprotamase development plan without CFFT funds. Any CFFT funds not expended on the development program of liprotamase must be returned to CFFT and, upon such return, the amounts of such returned funds will not be included as part of the research award for the purpose of calculating royalties or other amounts owed by the Company to CFFT. To the extent CFFT provides or makes available any information, expertise, know-how or other intellectual property related to cystic fibrosis or the treatment, prevention or cure there-of (“CFFT Know-How”) to the Company, CFFT grants to the Company a non-exclusive, transferrable, sublicensable, worldwide rights and license under all of CFFT’s rights in such CFFT Know-How to assist the Company to research, develop, commercialize, make or have made, use, sell, have sold, offer for sale, import, export and otherwise exploit the product. In consideration for CFFT’s research award and any licenses of intellectual property granted by CFFT, the Company agrees to pay royalties to CFFT as follows: i) a one-time royalty in an amount equal to five times the actual award, payable in three installments between the first and second anniversaries of the first commercial sale of a product; ii) a one-time royalty in an amount equal to the actual award after net product sales reaches $100 million; and iii) in the event of a license, sale or other transfer of the product or a change of control transaction prior to the commercial sale of the product, a milestone payment equal to three times the actual award. For the three and six months ended June 30, 2016 and 2015, the Company recognized approximately $0.3 million and $1.1 million, respectively, from CFFT in connection with achieving certain milestones specified in the award agreement and included it as part of operating expense. As of June 30, 2016, there was $100,000 remaining under the research award. |
NET LOSS PER SHARE
NET LOSS PER SHARE | 6 Months Ended |
Jun. 30, 2016 | |
Earnings Per Share [Abstract] | |
NET LOSS PER SHARE | 4. NET LOSS PER SHARE Basic net loss attributable to common stockholders per share is computed by dividing income available to common stockholders (the numerator) by the weighted-average number of common shares outstanding (the denominator) during the period. Shares issued during the period and shares reacquired during the period are weighted for the portion of the period that they were outstanding. The computation of diluted Earnings Per Share, or EPS, is similar to the computation of basic EPS except that the denominator is increased to include the number of additional common shares that would have been outstanding if the dilutive potential common shares had been issued. The following table summarizes the Company’s calculation of net loss per common share (in thousands except share and per share amounts): Three Months Ended June 30, Six Months Ended June 30, 2016 2015 2016 2015 Net loss per share Numerator Net loss $ (14,334 ) $ (8,895 ) $ (26,060 ) $ (16,555 ) Denominator Weighted average common shares outstanding 41,032,544 35,817,794 40,541,219 31,729,152 Basic and diluted net loss per share $ (0.35 ) $ (0.25 ) $ (0.64 ) $ (0.52 ) As the Company incurred net losses for all of the periods presented, the following outstanding potentially dilutive securities were excluded from the computation of diluted net loss per share, as the effect of including them would have been antidilutive: As of June 30, 2016 2015 Options to purchase common stock 5,880,160 3,482,848 Warrants to purchase common stock 40,178 556,838 Restricted Stock Units — 937 Total 5,920,338 4,040,623 |
FAIR VALUE OF FINANCIAL INSTRUM
FAIR VALUE OF FINANCIAL INSTRUMENTS | 6 Months Ended |
Jun. 30, 2016 | |
Fair Value Disclosures [Abstract] | |
FAIR VALUE OF FINANCIAL INSTRUMENTS | 5. FAIR VALUE OF FINANCIAL INSTRUMENTS Pursuant to the accounting guidance for fair value measurement and its subsequent updates, fair value is defined as the price that would be received to sell an asset or paid to transfer a liability (i.e., the “exit price”) in an orderly transaction between market participants at the measurement date. The accounting guidance establishes a hierarchy for inputs used in measuring fair value that minimizes the use of unobservable inputs by requiring the use of observable market data when available. Observable inputs are inputs that market participants would use in pricing the asset or liability based on active market data. Unobservable inputs are inputs that reflect the assumptions market participants would use in pricing the asset or liability based on the best information available in the circumstances The fair value hierarchy is broken down into the three input levels summarized below: • Level 1 • Level 2 • Level 3 The following tables present the Company’s fair value hierarchy for all its financial assets (including those in cash and cash equivalents), in thousands, by major security type measured at fair value on a recurring basis as of June 30, 2016 and December 31, 2015 (in thousands): June 30, 2016 Estimated Level 1 Level 2 Level 3 Money market funds $ 24,773 $ 24,773 $ — $ — December 31, 2015 Estimated Level 1 Level 2 Level 3 Money market funds $ 45,156 $ 45,156 $ — $ — There were no transfers between Level 1, Level 2 or Level 3 for the six months ended June 30, 2016 and year-ended 2015. |
COMMITMENTS AND CONTINGENCIES
COMMITMENTS AND CONTINGENCIES | 6 Months Ended |
Jun. 30, 2016 | |
Commitments and Contingencies Disclosure [Abstract] | |
COMMITMENTS AND CONTINGENCIES | 6 COMMITMENTS AND CONTINGENCIES Leases The Company leases its main operating facility in Hayward, California. The lease is for approximately 14,000 square feet and the lease agreement will expire in September 2017. Other Commitments In December 2007, the Company and Amgen entered into a worldwide, exclusive license agreement (the “Amgen Agreement”) to develop and commercialize blisibimod in any indication, including for the treatment of systemic lupus erythematosus (“lupus”). Under the terms of the Amgen Agreement, the Company paid a nonrefundable, upfront license fee of $6.0 million. As there was no future alternative use for the technology, the Company expensed the license fee in research and development expenses during 2007. Under the terms of the Amgen Agreement, the Company is obligated to make additional milestone payments to Amgen of up to $33.0 million upon the achievement of certain development and regulatory milestones. The Company is also obligated to pay tiered royalties on future net sales of products, ranging from the high single digits to the low double digits, which are developed and approved as set forth in the Amgen Agreement. The Company’s royalty obligations as to a particular licensed product will be payable, on a country-by-country and licensed product-by-licensed product basis, for the longer of (a) the date of expiration of the last to expire valid claim within the licensed patents that covers the manufacture, use or sale, offer to sell, or import of such licensed product by the Company or a sublicense in such country or (b) 10 years after the first commercial sale of the applicable licensed product in the applicable country. In connection with the collaborative arrangement with Zenyaku pursuant to the Zenyaku Agreement, the Company amended the Amgen Agreement in November 2014 to (i) adjust certain royalty and milestone payment obligations payable to Amgen in light of the collaboration between Anthera and Zenyaku and (ii) provide that the sublicense granted by Anthera to Zenyaku shall survive the termination of the Amgen Agreement. Under this amendment, Anthera also agreed to grant Amgen that number of shares of its common stock equal to $1.0 million divided by the volume weighted average price of the Company’s common stock for 20 trading days prior to issuance. The Company issued 420,751 shares of common stock to Amgen at $2.3767 per share on January 28, 2015, pursuant to a subscription agreement with Amgen, with the On July 11, 2014, the Company and Eli Lilly and Company (“Eli Lilly”) entered into a worldwide, exclusive license agreement (the “Lilly Agreement”), to develop and commercialize liprotamase, a Phase 3 novel investigational Pancreatic Enzyme Replacement Therapy (“PERT”), for the treatment of patients with Exocrine Pancreatic Insufficiency, or EPI, often seen in patients with cystic fibrosis and other conditions. Under the terms of the Lilly Agreement, the Company was not required to make any up-front payment but is obligated to make milestone payments of up to up to $33.5 million for capsule products and $9.5 million for reformulated products upon the achievement of certain regulatory and commercial sales milestones, none of which have been achieved as of June 30, 2016. In addition, after sales of the licensed products exceed an aggregate of $100.0 million in the United States, the Company is obligated to pay tiered royalties on future net sales of products, ranging from the single digits to the mid-teens, that are developed and approved as defined in the Lilly Agreement. The Company’s royalty obligations as to a particular licensed product will be payable, on a licensed product-by-licensed product basis, for the longer of (a) the date of expiration of the last to expire valid claim within the licensed patents that covers the manufacture, use or sale, offer to sell, or import of such licensed product by the Company or a sublicense in such country, or (b) 12 years after the first commercial sale of the applicable licensed product in the applicable country. See Note 3 – “Research Award” for discussion of commitments and contingencies associated with the research award received from the CFFT. |
STOCKHOLDERS' EQUITY
STOCKHOLDERS' EQUITY | 6 Months Ended |
Jun. 30, 2016 | |
Stockholders' Equity Note [Abstract] | |
STOCKHOLDERS' EQUITY | 7. STOCKHOLDERS’ EQUITY Preferred Stock The Company’s Fifth Amended and Restated Certificate of Incorporation designates 5,000,000 shares of the Company’s capital stock as undesignated preferred stock. There were no preferred shares issued or outstanding as of June 30, 2016. Common Stock On March 14, 2016, the Company filed a universal shelf registration statement with the SEC on Form S-3 (File No. 333-210166) for the proposed offering from time to time of up to $100.0 million of its securities, including common stock, preferred stock, debt securities and/or warrants. As of the date of this report, there is a balance of $60.6 million available for future issuance. On November 15, 2013, the Company entered into an at-the-market sales agreement (the “Cowen ATM Agreement”) with Cowen and Company, LLC (“Cowen”) under which the Company from time to time was able to offer and sell shares of its common stock, par value $0.001 per share, having an aggregate offering price of up to $25.0 million through Cowen, as agent. For the three and six months ended June 30, 2016, the Company sold $1.6 million and $2.5 million, respectively, in shares of common stock pursuant to the Cowen ATM Agreement. The Cowen ATM Agreement was terminated on April 21, 2016. On April 21, 2016, the Company entered into an at-the-market sales agreement with H.C. Wainwright (the “H.C. Wainwright ATM Agreement”) under which the Company from time to time may offer and sell shares of its common stock, par value $0.001 per share, having an aggregate offering price of up to $25.0 million through H.C. Wainwright, as agent. For the three and six months ended June 30, 2016, the Company sold $0.7 million in shares of common stock pursuant to the H.C. Wainwright ATM Agreement, leaving a balance of $24.3 million available for future sale pursuant to the H.C. Wainwright ATM Agreement as of June 30, 2016. On March 12, 2015, the Company executed an equity purchase agreement with LPC, pursuant to which the Company has the right, but not the obligation, to sell to LPC up to an aggregate of $10.0 million in shares of common stock over a period of two years. In July 2015, the Company amended the equity purchase agreement to reduce the amount available for purchase to $6.0 million. On April 27, 2016, the Company amended the equity purchase agreement and increased the amount of common stock available for purchase to $15.0 million. For the three and six months ended June 30, 2016, the Company sold approximately $0.2 million and $1.0 million in shares of common stock, respectively, pursuant to the equity purchase agreement, leaving a balance of $14.0 million available for future sales as of June 30, 2016. Warrants In March 2011, the Company issued a seven-year warrant to purchase 40,178 shares of the Company’s common stock at an exercise price of $48.00 per share. The warrant was immediately exercisable and expires in March 2018. As of June 30, 2016, the warrant remained outstanding and exercisable. |
SHARE-BASED COMPENSATION PLANS
SHARE-BASED COMPENSATION PLANS | 6 Months Ended |
Jun. 30, 2016 | |
Compensation and Retirement Disclosure [Abstract] | |
SHARE-BASED COMPENSATION PLANS | 8. SHARE-BASED COMPENSATION PLANS 2013 Plan On March 25, 2013, the Company’s board of directors adopted the 2013 Stock Option and Incentive Plan (the “2013 Plan”), which was also approved by the Company’s stockholders at its annual general meeting on May 16, 2013. The Company initially reserved 1,750,000 shares of its common stock for the issuance of awards under the 2013 Plan, plus all shares remaining available for grant under the Company’s 2010 Stock Option and Incentive Plan (the “2010 Plan”), plus any additional shares returned under the 2010 Plan or 2013 Plan as a result of the cancellation, forfeiture or other termination (other than by exercise) of awards issued pursuant to the 2010 Plan or 2013 Plan, subject in all cases to adjustment including reorganization, recapitalization, reclassification, stock dividend, stock split, reverse stock split or other similar change in the Company’s capital stock. In May 2015, the Company’s shareholders approved an additional 1,790,818 shares of its common stock for issuance under the 2013 Plan. In April 2016, the Company’s shareholders approved an additional 1,600,000 shares of its common stock for issuance under the 2013 Plan. Of the shares of common stock reserved for issuance under the 2013 Plan, no more than 750,000 shares will be issued to any individual participant as incentive options, non-qualified options or stock appreciation rights during any calendar year. The 2013 Plan permits the granting of incentive and non-statutory stock options, restricted and unrestricted stock awards, restricted stock units, stock appreciation rights, performance share awards, cash-based awards and dividend equivalent rights to eligible employees, directors and consultants. The option exercise price of an option granted under the 2013 Plan may not be less than 100% of the fair market value of a share of the Company’s common stock on the date the stock option is granted. Options granted under the 2013 Plan have a maximum term of 10 years and generally vest over four years. In addition, in the case of certain large stockholders, the minimum exercise price of incentive options must equal 110% of fair market value on the date of grant and the maximum term is limited to five years. Subject to overall Plan limitations, the maximum aggregate number of shares of common stock that may be issued in the form of incentive options shall not exceed 6,250,000 shares of common stock. The 2013 Plan does not allow the option holders to exercise their options prior to vesting. The terms of awards granted during the three and six months ended June 30, 2016 and the method for determining the grant date fair value of the awards were consistent with those described in the financial statements included in the Company’s Annual Report on Form 10-K for the year ended December 31, 2015. The following table summarizes stock option activity for the six months ended June 30, 2016 (in thousands except share and per share information): Number of Options Weighted- Average Exercise Price Weighted- Average Remaining Contractual Life in Years Aggregate Intrinsic Value Balance at December 31, 2015 4,255,981 $ 4.78 8.44 $ 4,323 Granted 2,180,322 $ 3.55 Exercised (111,765 ) $ 2.21 Cancelled and expired (354,378 ) $ 4.53 Forfeited (90,000 ) $ 9.48 Balance at June 30, 2016 5,880,160 $ 4.32 8.10 $ 1,551 Exercisable at June 30, 2016 2,478,736 $ 4.56 6.61 $ 713 The intrinsic value of stock options represents the difference between the exercise price of stock options and the market price of our stock on that day for all in-the-money options. As of June 30, 2016, there was $10.2 million of total unrecognized compensation expense related to stock options and is expected to be amortized on a straight-line basis over a weighted-average remaining period of 2.76 years. The assumptions used in the Black-Scholes option-pricing model to value stock options are as follows: Three Months Ended June 30, Six Months Ended June 30, 2016 2015 2016 2015 Expected Volatility 98 % 97 % 98 % 95 % Dividend Yield 0 % 0 % 0 % 0 % Risk-Free Interest Rate 1.32 % 1.52 % 1.49 % 1.63 % Expected Term (years) 5.86 5.59 5.92 5.76 Weighted-average fair value per option $ 2.74 $ 4.18 $ 2.69 $ 3.02 Fair value of awards vested $ 894 $ 398 $ 2,978 $ 1,711 2010 Employee Stock Purchase Plan (“ESPP”) Effective July 2010, under the terms of the ESPP, eligible employees of the Company may authorize the Company to deduct amounts from their compensation, which amounts are used to enable the employees to purchase shares of the Company’s common stock. The Company initially reserved 12,500 shares of common stock for issuance thereunder on January 1, 2011, and on each January 1 thereafter, the number of shares of stock reserved and available for issuance under the Plan shall be cumulatively increased by the lesser of (i) one percent (1%) of the number of shares of common stock issued and outstanding on the immediately preceding December 31 or (ii) 31,250 shares of common stock. On January 1, 2016, in accordance with the ESPP’s annual increase provisions, the authorized shares in the ESPP increased by 31,250. The purchase price per share is 85% of the fair market value of the common stock as of the first date or the ending date of the applicable semi-annual purchase period, whichever is less (the “Look-Back Provision”). The 15% discount and the Look-Back Provision make the ESPP compensatory. The Black-Scholes option pricing model was used to value the employee stock purchase rights. The assumptions used in the Black-Scholes option-pricing model to value the employee stock purchase rights are as follows: Three Months Ended June 30, Six Months Ended June 30, 2016 2015 2016 2015 Expected Volatility 88 % 52 % 88 % 52 % Dividend Yield 0 % 0 % 0 % 0 % Risk-Free Interest Rate 0.24 % 0.06 % 0.24 % 0.06 % Expected Term (years) 0.50 0.50 0.50 0.50 Stock-Based Compensation Expense Total stock-based compensation expense, including expense recorded for the ESPP, was as follows (in thousands): Three Months Ended June 30, Six Months Ended June 30, 2016 2015 2016 2015 Research and development $ 448 $ 240 876 $ 442 General and administrative 991 440 1,681 741 Total stock-based compensation $ 1,439 $ 680 $ 2,557 $ 1,183 |
ORGANIZATION AND SIGNIFICANT 14
ORGANIZATION AND SIGNIFICANT ACCOUNTING POLICIES (Policies) | 6 Months Ended |
Jun. 30, 2016 | |
Accounting Policies [Abstract] | |
Organization | Organization Anthera Pharmaceuticals, Inc. (the “Company” or “Anthera”) is a biopharmaceutical company focused on advancing the development and commercialization of innovative medicines that benefit patients with unmet medical needs. The Company currently has two compounds in development, liprotamase, also known as Sollpura™, |
Liquidity and Need for Additional Capital | Liquidity and Need for Additional Capital The Company’s planned principal operations are acquiring product and technology rights, raising capital and performing research and development activities. The Company is currently conducting research and development activities to treat autoimmune diseases and EPI. The Company’s activities are subject to significant risks and uncertainties. Successful completion of the Company’s development programs and, ultimately, the attainment of profitable operations are dependent on future events, including, among other things, its ability to access potential markets; secure financing; develop a customer base; attract, retain and motivate qualified personnel; and develop strategic alliances. Since inception in 2004, the Company has funded its operations through equity offerings, private placements of convertible debt, debt financing, equity investment and cost reimbursement from a former collaborative partner, Zenyaku Kogyo Co., Ltd (“Zenyaku”), and a research award from Cystic Fibrosis Foundation Therapeutics Incorporated ("CFFT"). On April 21, 2016, the Company entered into an At Market Issuance Sales Agreement (“ATM Agreement”) with H.C. Wainwright & Co., LLC (“H.C. Wainwright”) to create an at-the-market equity program under which the Company from time to time may offer and sell shares of its common stock, par value $0.001 per share, having an aggregate offering price of up to $25.0 million through H.C. Wainwright, as agent. On April 27, 2016, the Company amended an existing equity purchase agreement with Lincoln Park Capital Fund, LLC (“LPC”), pursuant to which the Company has the right, but not the obligation, to sell to LPC up to an aggregate of $15.0 million in shares of common stock by March 2017. As of the date of this report, the Company anticipates its existing cash, and access to additional cash through the ATM Agreement with H.C. Wainwright and an equity purchase agreement with LPC will be sufficient to fund its near term liquidity needs for at least the next 12 months. To fully execute its business plan, the Company will need to complete certain research and development activities and clinical studies. Further, the Company’s product candidates will require regulatory approval prior to commercialization. These activities may span many years and require substantial capital to complete and may ultimately be unsuccessful. Any delays in completing these activities could adversely impact the Company. The Company will need substantial additional financing to continue development of its product candidates, obtain regulatory approvals, and prepare for commercial readiness if the clinical trials are successful; such financing may not be available on terms favorable to the Company, if at all. If adequate funds are not available, the Company may be required to delay, reduce the scope of, or eliminate one or more of its clinical trials. The Company plans to meet its capital requirements primarily through future partnerships, issuances of equity securities, debt financing, and in the longer term, revenue from product sales. Failure to generate revenue or raise additional capital would adversely affect the Company’s ability to achieve its intended business objectives. |
Basis of Presentation | Basis of Presentation The accompanying unaudited Condensed Consolidated Financial Statements have been prepared pursuant to the rules and regulations of the Securities and Exchange Commission (“SEC”) for Quarterly Reports on Form 10-Q and do not contain all of the information and footnotes required by U.S. generally accepted accounting principles (“U.S. GAAP”) for complete financial statements. The accompanying unaudited Condensed Consolidated financial statements and notes thereto should be read in conjunction with the audited consolidated financial statements and notes thereto included in the Company’s Annual Report on Form 10-K for the year ended December 31, 2015, filed with the SEC on March 14, 2016. In the opinion of management, the accompanying unaudited Condensed Consolidated financial statements reflect all adjustments, which include only normal recurring adjustments necessary to present fairly the Company’s interim consolidated financial information. The results for the three and six months ended June 30, 2016 are not necessarily indicative of the results to be expected for the year ending December 31, 2016 or for any other period. The consolidated balance sheet as of December 31, 2015 has been derived from the audited financial statements as of that date but it does not include all of the information and notes required by U.S. GAAP. The Company has evaluated events and transactions subsequent to the balance sheet date and has disclosed all events or transactions that occurred subsequent to the balance sheet date but prior to filing this Quarterly Report on Form 10-Q that would require recognition or disclosure in the unaudited Condensed Consolidated Financial Statements. |
Use of Estimates | Use of Estimates The preparation of these condensed consolidated financial statements in conformity with U.S. GAAP requires us to make estimates and judgments that affect the reported amounts of assets, liabilities, expenses and related disclosures. On an ongoing basis, management evaluates its estimates, including critical accounting policies or estimates related to clinical trial accruals, tax provision, and stock-based compensation. The Company bases its estimates on historical experience and on various other market specific and other relevant assumptions that it believes to be reasonable under the circumstances, the results of which form the basis for making judgments about the carrying values of assets and liabilities that are not readily apparent from other sources. Actual results may differ significantly from these estimates. |
Recent Accounting Pronouncements | Recent Accounting Pronouncements In September 2014, the Financial Accounting Standards Board (“FASB”) issued Accounting Standards Update No. 2014-15, Presentation of Financial Statements - Going Concern (Subtopic 205-40): Disclosure of Uncertainties about an Entity’s Ability to Continue as Going Concern (“ASU 2014-15”). ASU 2014-15 defines when and how companies are required to disclose going concern uncertainties, which must be evaluated each interim and annual period. Specifically, the ASU requires management to determine whether substantial doubt exists regarding the entity’s going concern presumption. Substantial doubt about an entity’s ability to continue as a going concern exists when relevant conditions and events, considered in the aggregate, indicate that it is probable that the entity will be unable to meet its obligations as they become within one year after the financial statements are issued (or available to be issued). If substantial doubt exists, certain disclosures are required; the extent of those disclosures depends on an evaluation of management’s plans (if any) to mitigate the going concern uncertainty. The guidance is effective for fiscal years ending after December 15, 2016 and for interim periods thereafter. The Company does not expect the adoption of this guidance to materially affect its consolidated financial statements. In November 2015, the FASB issued guidance on the classification of deferred taxes, Accounting Standards Update No. 20154-17 (“ASU 2015-17”), Balance Sheet Classification of Deferred Taxes. ASU 2015-17 eliminates the guidance in Topic 740, Income Taxes, that required an entity to separate deferred tax liabilities and assets between current and noncurrent amounts in a classified balance sheet. The amendments require that all deferred tax liabilities and assets of the same tax jurisdiction or a tax filing group, as well as any related valuation allowance, be offset and presented as a single amount in a classified balance sheet. The amendments are effective for public business entities for fiscal years, and for interim periods within those fiscal years, beginning after December 15, 2016. Early adoption is permitted as of the beginning of any interim period or annual reporting period. The Company does not expect the adoption of this guidance to materially affect its consolidated financial statements. In February 2016, the FASB issued ASU No. 2016-02 Leases (Topic 842). ASU 2016-02 impacts any entity that enters into a lease with some specified scope exceptions. The guidance updates and supersedes Topic 840, Leases. For public entities, ASU 2016-02 is effective for fiscal years, and interim periods with those years, beginning after December 15, 2018, and early adoption is permitted. The Company does not expect the adoption of this standard to materially affect its consolidated financial statements. In March 2016, the FASB issued ASU No. 2016-09, Compensation—Stock Compensation (Topic 718). This standard makes several modifications to Topic 718 related to the accounting for forfeitures, employer tax withholding on share-based compensation and the financial statement presentation of excess tax benefits or deficiencies. ASU 2016-09 also clarifies the statement of cash flows presentation for certain components of share-based awards. The standard is effective for interim and annual reporting periods beginning after December 15, 2016, although early adoption is permitted. The adoption of ASU 2015-17 is not expected to have a significant impact on the Company’s consolidated financial position or results of operations. |
NET LOSS PER SHARE (Tables)
NET LOSS PER SHARE (Tables) | 6 Months Ended |
Jun. 30, 2016 | |
Earnings Per Share [Abstract] | |
Schedule of Calculation of Net Loss Per Common Share | Three Months Ended June 30, Six Months Ended June 30, 2016 2015 2016 2015 Net loss per share Numerator Net loss $ (14,334 ) $ (8,895 ) $ (26,060 ) $ (16,555 ) Denominator Weighted average common shares outstanding 41,032,544 35,817,794 40,541,219 31,729,152 Basic and diluted net loss per share $ (0.35 ) $ (0.25 ) $ (0.64 ) $ (0.52 ) |
Schedule of Antidilutive Securities | As of June 30, 2016 2015 Options to purchase common stock 5,880,160 3,482,848 Warrants to purchase common stock 40,178 556,838 Restricted Stock Units — 937 Total 5,920,338 4,040,623 |
FAIR VALUE OF FINANCIAL INSTR16
FAIR VALUE OF FINANCIAL INSTRUMENTS (Tables) | 6 Months Ended |
Jun. 30, 2016 | |
Fair Value Disclosures [Abstract] | |
Schedule of Financial Assets Measured at Fair Value on a Recurring Basis | June 30, 2016 Estimated Level 1 Level 2 Level 3 Money market funds $ 24,773 $ 24,773 $ — $ — December 31, 2015 Estimated Level 1 Level 2 Level 3 Money market funds $ 45,156 $ 45,156 $ — $ — |
SHARE-BASED COMPENSATION PLANS
SHARE-BASED COMPENSATION PLANS (Tables) | 6 Months Ended |
Jun. 30, 2016 | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |
Summary of Option Activity | Number of Options Weighted- Average Exercise Price Weighted- Average Remaining Contractual Life in Years Aggregate Intrinsic Value Balance at December 31, 2015 4,255,981 $ 4.78 8.44 $ 4,323 Granted 2,180,322 $ 3.55 Exercised (111,765 ) $ 2.21 Cancelled and expired (354,378 ) $ 4.53 Forfeited (90,000 ) $ 9.48 Balance at June 30, 2016 5,880,160 $ 4.32 8.10 $ 1,551 Exercisable at June 30, 2016 2,478,736 $ 4.56 6.61 $ 713 |
Schedule of Stock-Based Compensation Expense | Three Months Ended June 30, Six Months Ended June 30, 2016 2015 2016 2015 Research and development $ 448 $ 240 876 $ 442 General and administrative 991 440 1,681 741 Total stock-based compensation $ 1,439 $ 680 $ 2,557 $ 1,183 |
Employee Stock Option [Member] | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |
Summary of Fair Value Assumptions for Stock Options and Stock Purchase Rights | Three Months Ended June 30, Six Months Ended June 30, 2016 2015 2016 2015 Expected Volatility 98 % 97 % 98 % 95 % Dividend Yield 0 % 0 % 0 % 0 % Risk-Free Interest Rate 1.32 % 1.52 % 1.49 % 1.63 % Expected Term (years) 5.86 5.59 5.92 5.76 Weighted-average fair value per option $ 2.74 $ 4.18 $ 2.69 $ 3.02 Fair value of awards vested $ 894 $ 398 $ 2,978 $ 1,711 |
Employee Stock Purchase Plan [Member] | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |
Summary of Fair Value Assumptions for Stock Options and Stock Purchase Rights | Three Months Ended June 30, Six Months Ended June 30, 2016 2015 2016 2015 Expected Volatility 88 % 52 % 88 % 52 % Dividend Yield 0 % 0 % 0 % 0 % Risk-Free Interest Rate 0.24 % 0.06 % 0.24 % 0.06 % Expected Term (years) 0.50 0.50 0.50 0.50 |
ORGANIZATION AND SIGNIFICANT 18
ORGANIZATION AND SIGNIFICANT ACCOUNTING POLICIES (Details) - USD ($) $ / shares in Units, $ in Thousands | Jun. 30, 2016 | Apr. 27, 2016 | Apr. 21, 2016 | Dec. 31, 2015 |
Accounting Policies [Abstract] | ||||
Common stock, par value per share | $ 0.001 | $ 0.001 | $ 0.001 | |
Maximum proceeds pursuant to security agreement | $ 15,000 | $ 25,000 |
RESEARCH AWARD (Details)
RESEARCH AWARD (Details) - USD ($) $ in Thousands | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2016 | Jun. 30, 2015 | Jun. 30, 2016 | Jun. 30, 2015 | |
Research and Development [Abstract] | ||||
Research award amount | $ 3,000 | $ 3,000 | ||
Royalty threshold amount | 100,000 | 100,000 | ||
Remaining research award | 100 | 100 | ||
Research award | $ (261) | $ (1,100) | $ (261) | $ (1,100) |
NET LOSS PER SHARE (Schedule of
NET LOSS PER SHARE (Schedule of Calculation of Net Loss Per Common Share) (Details) - USD ($) $ / shares in Units, $ in Thousands | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2016 | Jun. 30, 2015 | Jun. 30, 2016 | Jun. 30, 2015 | |
Numerator | ||||
Net loss | $ (14,334) | $ (8,895) | $ (26,060) | $ (16,555) |
Denominator | ||||
Weighted average common shares oustanding | 41,032,544 | 35,817,794 | 40,541,219 | 31,729,152 |
Basic and diluted net loss per share | $ (0.35) | $ (0.25) | $ (0.64) | $ (0.52) |
NET LOSS PER SHARE (Schedule 21
NET LOSS PER SHARE (Schedule of Antidilutive Securities) (Details) - shares | 6 Months Ended | |
Jun. 30, 2016 | Jun. 30, 2015 | |
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||
Anti-dilutive common share equivalents outstanding | 5,920,338 | 4,040,623 |
Employee Stock Option [Member] | ||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||
Anti-dilutive common share equivalents outstanding | 5,880,160 | 3,482,848 |
Warrant [Member] | ||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||
Anti-dilutive common share equivalents outstanding | 40,178 | 556,838 |
Restricted Stock Units [Member] | ||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||
Anti-dilutive common share equivalents outstanding | 937 |
FAIR VALUE OF FINANCIAL INSTR22
FAIR VALUE OF FINANCIAL INSTRUMENTS (Details) - Money Market Funds [Member] - USD ($) $ in Thousands | Jun. 30, 2016 | Dec. 31, 2015 |
Estimated Fair Value [Member] | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Assets measured on a recurring basis | $ 24,773 | $ 45,156 |
Level 1 [Member] | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Assets measured on a recurring basis | 24,773 | 45,156 |
Level 2 [Member] | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Assets measured on a recurring basis | ||
Level 3 [Member] | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Assets measured on a recurring basis |
COMMITMENTS AND CONTINGENCIES (
COMMITMENTS AND CONTINGENCIES (Details) $ / shares in Units, $ in Millions | 6 Months Ended | 12 Months Ended |
Jun. 30, 2016USD ($)ft²$ / sharesshares | Dec. 31, 2007USD ($) | |
Loss Contingencies [Line Items] | ||
Square footage of operating facility, in square feet | ft² | 14,000 | |
Amgen Inc [Member] | ||
Loss Contingencies [Line Items] | ||
Number of shares issued under collaborative arrangement | shares | 420,751 | |
Share issue price | $ / shares | $ 2.3767 | |
Value of shares granted divided by weighted average price of common stock | $ 1 | |
Amgen Inc [Member] | Collaborative Arrangement [Member] | ||
Loss Contingencies [Line Items] | ||
License initiation fees | $ 6 | |
Amgen Inc [Member] | Maximum [Member] | ||
Loss Contingencies [Line Items] | ||
Additional milestone payments upon the achievement of certain development and regulatory milestones | 33 | |
Eli Lilly [Member] | Maximum [Member] | ||
Loss Contingencies [Line Items] | ||
Additional milestone payments upon the achievement of certain development and regulatory milestones for capsule products | 33.5 | |
Additional milestone payments upon the achievement of certain development and regulatory milestones for reformulated products | 9.5 | |
Royalty obligation, sales amount | $ 100 |
STOCKHOLDERS' EQUITY (Details)
STOCKHOLDERS' EQUITY (Details) - USD ($) $ / shares in Units, $ in Thousands | 1 Months Ended | 3 Months Ended | 6 Months Ended | ||||||||||
Jun. 30, 2016 | Apr. 27, 2016 | Mar. 14, 2016 | Jul. 31, 2015 | Mar. 12, 2015 | Apr. 30, 2013 | Jun. 30, 2016 | Jun. 30, 2016 | Jun. 30, 2015 | Apr. 21, 2016 | Dec. 31, 2015 | Nov. 15, 2013 | Jun. 30, 2011 | |
Class of Stock [Line Items] | |||||||||||||
Exercise price of warrants | $ 48 | ||||||||||||
Proceeds from issuance of common stock | $ 3,947 | $ 38,469 | |||||||||||
Maximum amount of shares of common stock, preferred stock, debt securities and/or warrants that may be issued under a shelf registration statement | $ 100,000 | ||||||||||||
Number of shares called by warrant(s) | 40,178 | ||||||||||||
Preferred stock, shares authorized | 5,000,000 | 5,000,000 | 5,000,000 | ||||||||||
Maximum proceeds pursuant to security agreement | $ 15,000 | $ 25,000 | |||||||||||
Common stock, par value per share | $ 0.001 | $ 0.001 | $ 0.001 | $ 0.001 | $ 0.001 | ||||||||
Second Shelf Registration [Member] | |||||||||||||
Class of Stock [Line Items] | |||||||||||||
Maximum amount of shares of common stock, preferred stock, debt securities and/or warrants that may be issued under a shelf registration statement | $ 60,600 | $ 100,000 | |||||||||||
Lincoln Park Capital Fund [Member] | |||||||||||||
Class of Stock [Line Items] | |||||||||||||
Proceeds from issuance of common stock | $ 200 | $ 1,000 | |||||||||||
Equity purchase agreement, authorized amount of equity authorized for sale | $ 15,000 | $ 6,000 | $ 10,000 | ||||||||||
Equity agreement, amount remaining for future sale | 14,000 | 14,000 | 14,000 | ||||||||||
Cowen [Member] | |||||||||||||
Class of Stock [Line Items] | |||||||||||||
Proceeds from issuance of common stock | 1,600 | 2,500 | |||||||||||
Maximum proceeds pursuant to security agreement | $ 25,000 | ||||||||||||
Common stock, par value per share | $ 0.001 | ||||||||||||
Wainwright [Member] | |||||||||||||
Class of Stock [Line Items] | |||||||||||||
Proceeds from issuance of common stock | 700 | 700 | |||||||||||
Equity agreement, amount remaining for future sale | $ 24,300 | $ 24,300 | $ 24,300 |
SHARE-BASED COMPENSATION PLAN25
SHARE-BASED COMPENSATION PLANS (Narrative) (Details) - USD ($) $ in Millions | 1 Months Ended | 6 Months Ended | |
Apr. 30, 2016 | May 31, 2015 | Jun. 30, 2016 | |
2013 Plan [Member] | |||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||
Additional shares authorized | 1,600,000 | 1,790,818 | |
Share-based compensation, shares authorized under plan | 1,750,000 | ||
Purchase price as percentage of fair market value of common stock | 100.00% | ||
Maximum term for options granted under the plan | 10 years | ||
Maximum shares allowed to be issued per individual | 750,000 | ||
Vesting period | 4 years | ||
Maximum shares allowed to be issued as incentive options | 6,250,000 | ||
2013 Plan [Member] | Stockholder Group One [Member] | |||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||
Purchase price as percentage of fair market value of common stock | 110.00% | ||
Maximum term for options granted under the plan | 5 years | ||
Employee Stock [Member] | |||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||
Share-based compensation, shares authorized under plan | 12,500 | ||
Maximum number of shares of common stock by which the number of shares of stock reserved and available for grant shall be cumulatively increased | 31,250 | ||
Purchase price as percentage of fair market value of common stock | 85.00% | ||
Discount percentage on issuance of stock | 15.00% | ||
Percentage of the number of shares of common stock by which the number of shares available for sale shall be increased | 1.00% | ||
Employee Stock [Member] | 2013 Plan [Member] | |||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||
Unrecognized compensation cost | $ 10.2 | ||
Unrecognized compensation cost, period of recognition | 2 years 9 months 4 days |
SHARE-BASED COMPENSATION PLAN26
SHARE-BASED COMPENSATION PLANS (Summary of Option Activity) (Details) - USD ($) $ / shares in Units, $ in Thousands | 6 Months Ended | 12 Months Ended |
Jun. 30, 2016 | Dec. 31, 2015 | |
Number of Options | ||
Balance at December 31, 2015 | 4,255,981 | |
Granted | 2,180,322 | |
Exercised | (111,765) | |
Cancelled and expired | (354,378) | |
Forfeited | (90,000) | |
Balance at June 30, 2016 | 5,880,160 | 4,255,981 |
Exercisable at June 30, 2016 | 2,478,736 | |
Weighted-Average Exercise Price | ||
Balance at December 31, 2015 | $ 4.78 | |
Granted | 3.55 | |
Exercised | 2.21 | |
Cancelled and expired | 4.53 | |
Forfeited | 9.48 | |
Balance at June 30, 2016 | 4.32 | $ 4.78 |
Exercisable at June 30, 2016 | $ 4.56 | |
Weighted-Average Remaining Contractual Life in Years | ||
Outstanding | 8 years 1 month 6 days | 8 years 5 months 8 days |
Exercisable at June 30, 2016 | 6 years 7 months 10 days | |
Aggregate Intrinsic Value | ||
Balance at December 31, 2015 | $ 4,323 | |
Balance at June 30, 2016 | 1,551 | $ 4,323 |
Exercisable at June 30, 2016 | $ 713 |
SHARE-BASED COMPENSATION PLAN27
SHARE-BASED COMPENSATION PLANS (Summary of Fair Value Assumptions for Stock Options and Stock Purchase Rights) (Details) - USD ($) | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2016 | Jun. 30, 2015 | Jun. 30, 2016 | Jun. 30, 2015 | |
Employee Stock Option [Member] | ||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||
Expected Volatility | 98.00% | 97.00% | 98.00% | 95.00% |
Dividend Yield | 0.00% | 0.00% | 0.00% | 0.00% |
Risk-Free Interest Rate | 1.32% | 1.52% | 1.49% | 1.63% |
Expected Term | 5 years 10 months 10 days | 5 years 7 months 2 days | 5 years 11 months 1 day | 5 years 9 months 4 days |
Weighted-average fair value per option | $ 2.74 | $ 4.18 | $ 2.69 | $ 3.02 |
Fair value of awards vested | $ 89,400 | $ 39,800 | $ 297,800 | $ 171,100 |
Employee Stock Purchase Plan [Member] | ||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||
Expected Volatility | 88.00% | 52.00% | 88.00% | 52.00% |
Dividend Yield | 0.00% | 0.00% | 0.00% | 0.00% |
Risk-Free Interest Rate | 0.24% | 0.06% | 0.24% | 0.06% |
Expected Term | 6 months | 6 months | 6 months | 6 months |
SHARE-BASED COMPENSATION PLAN28
SHARE-BASED COMPENSATION PLANS (Schedule of Stock-Based Compensation Expense) (Details) - USD ($) $ in Thousands | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2016 | Jun. 30, 2015 | Jun. 30, 2016 | Jun. 30, 2015 | |
Share-based Compensation Arrangement by Share-based Payment Award, Compensation Cost [Line Items] | ||||
Total stock-based compensation | $ 1,439 | $ 680 | $ 2,557 | $ 1,183 |
Research and Development [Member] | ||||
Share-based Compensation Arrangement by Share-based Payment Award, Compensation Cost [Line Items] | ||||
Total stock-based compensation | 448 | 240 | 876 | 442 |
General and Administrative [Member] | ||||
Share-based Compensation Arrangement by Share-based Payment Award, Compensation Cost [Line Items] | ||||
Total stock-based compensation | $ 991 | $ 440 | $ 1,681 | $ 741 |