Document and Entity Information
Document and Entity Information - shares | 9 Months Ended | |
Sep. 30, 2015 | Nov. 01, 2015 | |
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 | Sep. 30, 2015 | |
Document Fiscal Period Focus | Q3 | |
Document Fiscal Year Focus | 2,015 | |
Amendment Flag | false | |
Current Fiscal Year End Date | --12-31 | |
Entity Filer Category | Accelerated Filer | |
Entity Common Stock, Shares Outstanding | 39,875,405 |
CONSOLIDATED BALANCE SHEETS
CONSOLIDATED BALANCE SHEETS - USD ($) $ in Thousands | Sep. 30, 2015 | Dec. 31, 2014 |
Current assets: | ||
Cash and cash equivalents | $ 55,762 | $ 2,639 |
Accounts receivable | 983 | |
Prepaid expenses and other current assets | 374 | $ 383 |
Total current assets | 57,119 | 3,022 |
Property and equipment - net | 335 | 468 |
TOTAL | 57,454 | 3,490 |
Current liabilities: | ||
Accounts payable | 7,021 | 2,232 |
Accrued clinical expenses | 1,707 | 1,239 |
Accrued liabilities | 324 | 211 |
Accrued payroll and related costs | 1,135 | $ 1,069 |
Deferred revenue - current | $ 1,957 | |
Other current liabilities | $ 1,000 | |
Total current liabilities | $ 12,144 | 5,751 |
Total liabilities | $ 12,144 | $ 5,751 |
Commitments and Contingencies (Note 6) | ||
Stockholders' equity (deficit): | ||
Common stock, $0.001 par value, 100,000,000 shares authorized; 39,875,405 and 23,005,209 shares issued and outstanding as of September 30, 2015 and December 31, 2014, respectively | $ 40 | $ 23 |
Additional paid-in capital | 389,962 | 314,527 |
Accumulated deficit | (344,692) | (316,811) |
Total stockholders' equity (deficit) | 45,310 | (2,261) |
TOTAL | $ 57,454 | $ 3,490 |
CONSOLIDATED BALANCE SHEETS (Pa
CONSOLIDATED BALANCE SHEETS (Parenthetical) - $ / shares | Sep. 30, 2015 | Dec. 31, 2014 |
CONSOLIDATED BALANCE SHEETS [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 | 39,875,405 | 23,005,209 |
Common stock, shares outstanding | 39,875,405 | 23,005,209 |
CONSOLIDATED STATEMENTS OF OPER
CONSOLIDATED STATEMENTS OF OPERATIONS - USD ($) $ in Thousands | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2015 | Sep. 30, 2014 | Sep. 30, 2015 | Sep. 30, 2014 | |
REVENUES: | ||||
License revenue | $ 548 | $ 743 | ||
Collaborative revenue | 185 | 524 | ||
Total revenues | 733 | 1,267 | ||
OPERATING EXPENSES: | ||||
Research and development | 10,359 | $ 5,268 | 24,893 | $ 16,312 |
General and administrative | 2,091 | $ 1,419 | 5,694 | $ 4,849 |
Research award | (367) | (1,467) | ||
Total operating expenses | 12,083 | $ 6,687 | 29,120 | $ 21,161 |
LOSS FROM OPERATIONS | (11,350) | (6,687) | (27,853) | (21,161) |
OTHER INCOME (EXPENSE): | ||||
Other income (expense) | $ 24 | (14) | $ (28) | (93) |
Interest expense | (286) | (905) | ||
Total other income (expense) | $ 24 | (300) | $ (28) | (998) |
NET LOSS | $ (11,326) | $ (6,987) | $ (27,881) | $ (22,159) |
Net loss per share - basic and diluted | $ (0.29) | $ (0.31) | $ (0.81) | $ (1.03) |
Weighted-average number of shares used in per common share calculation - basic and diluted | 39,241,738 | 22,747,308 | 34,260,866 | 21,459,516 |
CONSOLIDATED STATEMENTS OF CASH
CONSOLIDATED STATEMENTS OF CASH FLOWS - USD ($) $ in Thousands | 9 Months Ended | |
Sep. 30, 2015 | Sep. 30, 2014 | |
CASH FLOW FROM OPERATING ACTIVITIES: | ||
Net loss | $ (27,881) | $ (22,159) |
Adjustments to reconcile net loss to net cash used in operating activities: | ||
Depreciation | 213 | 277 |
Stock-based compensation expense | $ 2,495 | 1,702 |
Amortization of discount and deferred interest on notes payable | 59 | |
Amortization of debt issuance costs | $ 96 | |
Changes in assets and liabilities: | ||
Accounts receivable | $ (983) | |
Prepaid expenses and other assets | 9 | $ 69 |
Accounts payable | 4,789 | (149) |
Accrued clinical expenses | 468 | 432 |
Accrued liabilities | 113 | 54 |
Accrued payroll and related costs | 66 | $ 254 |
Deferred revenue | (743) | |
Net cash used in operating activities | (21,454) | $ (19,365) |
INVESTING ACTIVITIES: | ||
Property and equipment purchases | $ (80) | |
Decrease in restricted cash | $ 8,640 | |
Net cash provided by (used in) investing activities | $ (80) | 8,640 |
FINANCING ACTIVITIES: | ||
Principal payment against note payable | (10,782) | |
Proceeds from issuance of common stock, net of offering costs | $ 65,378 | $ 10,117 |
Proceeds from issuance of common stock to collaborative partner | 9,000 | |
Proceeds from issuance of common stock pursuant to exercise of stock options | 279 | $ 4 |
Net cash provided by financing activities | 74,657 | (661) |
NET INCREASE (DECREASE) IN CASH AND CASH EQUIVALENTS | 53,123 | (11,386) |
CASH AND CASH EQUIVALENTS - Beginning of period | 2,639 | 25,946 |
CASH AND CASH EQUIVALENTS - End of period | $ 55,762 | 14,560 |
Non-cash financing activities: | ||
Interest Paid | $ 579 |
ORGANIZATION AND SIGNIFICANT AC
ORGANIZATION AND SIGNIFICANT ACCOUNTING POLICIES | 9 Months Ended |
Sep. 30, 2015 | |
ORGANIZATION AND SIGNIFICANT ACCOUNTING POLICIES [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 and blisibimod. The Company licensed liprotamase from Eli Lilly & Co (Eli Lilly) in July 2014. Liprotamase is a novel non-porcine investigational Pancreatic Enzyme Replacement Therapy (PERT) intended for the treatment of patients with Exocrine Pancreatic Insufficiency (EPI), often seen in patients with cystic fibrosis and other conditions. The Company licensed blisibimod from Amgen, Inc. (Amgen) in December 2007. Blisibimod targets B-cell activating factor or (BAFF) which has been shown to be elevated in a variety of B-cell mediated autoimmune diseases, including systemic lupus erythematosus (SLE), or lupus, Immunoglobulin A nephropathy, or IgA nephropathy, lupus nephritis, and others. 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 , reimbursement for certain research and development expenses from a collaborative partner, and research award from Cystic Fibrosis Foundation Therapeutics Incorporated ("CFFT") . As of the date of this report, the Company anticipates its existing cash, and access to additional cash through an equity purchase agreement with Lincoln Park Capital (LPC) and an at-the-market Sales A greement with Cowen & Company, LLC (Cowen) 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 expenditures 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 conduct new trials in the development of its product candidates; such financing may not be available on terms favorable to the Company, if at all. The Company plans to meet its capital requirements primarily through issuances of equity securities, debt financing, potential partnerships 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, 2014, filed with the SEC on March 16, 2015. 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 nine months ended September 30 , 2015 are not necessarily indicative of the results to be expected for the year ending December 31, 2015 or for any other period. The consolidated balance sheet as of December 31, 2014 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. Significant Accounting Policies Beginning in 2015, the Company established a policy to account for income and related accounts receivable balances owed to the Company from its collaborative partner, Zenyaku and a research award from Cystic Fibrosis Foundation Therapeutics Inc. (CFFT). Our collaboration with Zenyaku provides for various types of payments to us, including development milestones, sales milestone s , royalty and reimbursement for a portion of our internal and external cost s . All payments from Zenyaku are nonrefundable. The collaborative arrangement is on a best-efforts basis, does not require scientific achievement as a performance obligation and provides for payment to be made when costs are incurred or the services are performed. We recognize a contingent milestone payment as revenue in its entirety upon our achievement of a substantive milestone if the consideration earned from the achievement of the milestone (i) is consistent with performance required to achieve the milestone or the increase in value to the delivered item, (ii) relates solely to past performance and (iii) is reasonable relative to all of the other deliverables and payments within the arrangement. Funds received from the CFFT pursuant to a research award are recorded as an offset to Operating Expenses when payments under the award become contractually due. There have been no other changes to the Company's significant accounting policies for the nine months ended September 30, 2015 as compared to the significant accounting policies described in the Company's Annual Report on Form 10-K for the fiscal year ended December 31, 2014. 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, stock-based compensation, allocation of consideration to various elements under multiple-element collaboration arrangement s and recognition of revenue. 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. |
COLLABORATIVE AGREEMENT
COLLABORATIVE AGREEMENT | 9 Months Ended |
Sep. 30, 2015 | |
COLLABORATIVE AGREEMENT [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). Upon termination of the Zenyaku Agreement on January 7, 2016, the Company will regain full rights of blisibimod in Japan. Under the terms of the Zenyaku Agreement, the Company has the right to receive an upfront and forgivable loan of $ 7.0 22.0 15.0 1.3 11.0 15.0 9.0 2.0 4.0 100 25 The Company's deliverables under the Zenyaku Agreement include the delivery of rights to and license for blisibimod in Japan and performance of research and development activities under a joint development plan. The delivered license did not have standalone value at the inception of the arrangement due to the Company's proprietary expertise with respect to the licensed compound and related ongoing developmental participation under the collaboration agreement, which is required for Zenyaku to fully realize the value from the delivered license. Therefore, the fees received related to the license were recorded as deferred revenue and are recognized over the estimated performance period under the agreement, which is the product development period. Although the Zenyaku Agreement does not provide a contractually stated price for the rights to blisibimod, the Company determined the Premium Purchase Price to be paid by Zenyaku for its equity investment in Anthera represents consideration for the rights to blisibimod and are record ed in deferred revenue as shares are issued to Zenyaku at the Premium Purchase Price. The Company periodically review s and, if necessary, revise s the estimated periods of performance of its collaboration with Zenyaku. Fees for the performance of sponsored research and development activities and services are not refundable. Therefore, the Company recognize s all FTE reimbursement collaborative revenue as such services are rendered. Reimbursement for certain development costs are recorded as a reduction to research and development expense in the period in which such reimbursement becomes due in accordance with ASC 808 Collaborative Arrangements , subtopic ASC 808-10-45. As a result of the Termination Notice received from Zenyaku in September 2015, the Company changed the amortization period of its deferred revenue to correspond with the shorten ed collaboration period with Zenyaku. The effect of this change in estimate was a $ 370,000 three and nine month periods ended September 30, 2015. The effect on both basic and diluted earnings per share was a decrease of $ 0.01 The change in estimate is anticipated to increase our license fee revenue by $ 2.0 5 . As of September 30, 2015, the deferred revenue of approximately $ 2.0 t. During the three months ended September 30, 2015, the Company recorded revenue of $ 733 ,000 , which was comprised of $ 548 ,000 for the amortization of the Premium Purchase Price and $ 1 8 5 ,000 for the reimbursement of FTEs, respectively. During the nine months ended September 30, 2015, the Company recorded revenue of $ 1.3 , which was comprised of $ 743 ,000 for the amortization of the Premium Purchase Price and $ 524 ,000 for the reimbursement of FTEs, respectively. In addition, during the three and nine months ended September 30, 2015, the Company recorded $ 417 ,000 and $ 1.3 , respectively, as reduction to research and development expenses in connection with the reimbursement of qualifying costs under the collaboration agreement. |
RESEARCH AWARD
RESEARCH AWARD | 9 Months Ended |
Sep. 30, 2015 | |
RESEARCH AWARD [Abstract] | |
RESEARCH AWARD | 3. RESEARCH AWARD In March 2015, the Company received a research award of up to $ 3 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 Anthera 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 Anthera, CFFT grants to Anthera a non-exclusive, transferrable, sublicensable , worldwide rights and license under all of CFFT's rights in such CFFT Know-How to assist Anthera 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 For the three and nine months ended September 30, 2015, the Company recognized $ 0.4 and $ 1.5 million of research award as a reduction to operating expense, respectively, from CFFT in connection with achieving certain milestones specified in the award agreement and included these amounts as part of operating expense. As of September 30, 2015, there is $ 1.5 million remaining under the research award. |
NET LOSS PER SHARE
NET LOSS PER SHARE | 9 Months Ended |
Sep. 30, 2015 | |
NET LOSS 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 September 30, Nine Months Ended September 30, 2015 2014 2015 2014 Net loss per share Numerator Net loss $ (11,326 ) $ (6,987 ) $ (27,881 ) $ (22,159 ) Denominator Weighted average common shares outstanding 39,241,738 22,747,308 34,260,866 21,459,516 Basic and diluted net loss per share $ (0.29 ) $ (0.31 ) $ (0.81 ) $ (1.03 ) 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: Three and Nine Months Ended September 30, 2015 2014 Options to purchase common stock 4,282,356 2,089,437 Warrants to purchase common stock 40,178 630,367 Restricted Stock Units 937 1,874 Total 4,323,471 2,721,678 |
FAIR VALUE OF FINANCIAL INSTRUM
FAIR VALUE OF FINANCIAL INSTRUMENTS | 9 Months Ended |
Sep. 30, 2015 | |
FAIR VALUE OF FINANCIAL INSTRUMENTS [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 Valuations are based on quoted prices in active markets for identical assets or liabilities and readily accessible by us at the reporting date. Examples of assets and liabilities utilizing Level 1 inputs are certain money market funds, U.S. Treasuries and trading securities with quoted prices on active markets. Level 2 Valuations based on inputs other than the quoted prices in active markets that are observable either directly or indirectly in active markets. Examples of assets and liabilities utilizing Level 2 inputs are U.S. government agency bonds, corporate bonds, commercial paper, certificates of deposit and over-the- counter derivatives. Level 3 Valuations based on unobservable inputs in which there are little or no market data, which require us to develop our own assumptions. 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 September 30, 2015 and December 31, 2014 (in thousands): September 30, 2015 Estimated Fair Value Level 1 Level 2 Level 3 Money market funds $ 55,586 $ 55,586 $ $ December 31, 2014 Estimated Fair Value Level 1 Level 2 Level 3 Money market funds $ 2,354 $ 2,354 $ $ There were no transfers between Level 1, Level 2 or Level 3 for the three and nine months ended September 30, 2015 and 2014. |
COMMITMENTS AND CONTINGENCIES
COMMITMENTS AND CONTINGENCIES | 9 Months Ended |
Sep. 30, 2015 | |
COMMITMENTS AND CONTINGENCIES [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 expense on rent payments are classified as deferred rent liability and included in the accrued liabilities on the balance sheet. In November 2013, the Company renewed its facility lease for an additional three years beginning October 2014 and ending 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 33.0 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 the number of shares of its common stock equal to $ 1.0 The Company accrued $ 1.0 The Company issued 420,751 2.3767 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 $ 33.5 9.5 September 30, 2015. In addition, after sales of the licensed products exceed an aggregate of $ 100.0 In March 2015, the Company received a research award of up to $ 3 The Company is obligated to pay royalties to CFFT as follows: i) a one-time royalty in an amount equal to five times the 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 Due to the inherent risk associated with drug development the Company has not accrued any obligation for the period ended September 30, 2015. |
STOCKHOLDERS' EQUITY
STOCKHOLDERS' EQUITY | 9 Months Ended |
Sep. 30, 2015 | |
STOCKHOLDERS' EQUITY [Abstract] | |
STOCKHOLDERS' EQUITY | 7. STOCKHOLDERS' EQUITY Preferred Stock The Company's Fifth Amended and Restated Certificate of Incorporation designates 5,000,000 There were no preferred shares issued or outstanding as of September 30, 2015. Warrants In March 2011, the Company issued a seven-year warrant to purchase 40,178 48.00 September 30, 2015, the warrant remained outstanding and exercisable. On September 24, 2015, unexercised warrants to purchase 516,660 Common Stock In April 2013, the Company filed a universal shelf registration statement with the SEC on Form S-3 (File No. 333-187780) for the proposed offering from time to time of up to $ 100.0 1.2 The Company has a s ales a greement with Cowen for an at-the-market offering under which the Company from time to time may offer and sell up to an aggregate of $ 25.0 in shares of common stock through Cowen, as placement agent. As of September 30, 2015, there is a balance of $ 3.7 sales a greement. No sales of common stock have been made under the sales agreement in the quarter ended September 30, 2015. The Company has an equity purchase agreement with Lincoln Park Capital Fund, LLC (LPC), pursuant to which the Company has the right, but not obligation, to sell to LPC up to an aggregate $ 6.0 million in shares of common stock over a period of two years. No sales of common stock have been made under the p urchase agreement as of September 30, 2015 , which will expire in March 2017 . Equity Issuance In January 2015, the Company issued 2,795,895 of common stock to Zenyaku pursuant to a stock purchase agreement for cash proceeds of $ 7.0 . In August 2015, the Company issued an additional 150,9 1 7 shares of common stock to Zenyaku for cash proceeds of $ 2.0 million. In January 2015, the Company issued 420,751 in exchange for a waiver of a fee otherwise payable to Amgen by the Company under an amendment to the Amgen Agreement . In the first quarter of 2015, the Company sold 3,125,662 11.5 In March 2015, the Company sold 6,388,889 4.50 26.9 In July 2015, the Company sold 3,833,334 7.50 26. 9 million. The Company intends to use all net proceeds from its sale of common stock for clinical research and development and general corporate purposes. |
SHARE-BASED COMPENSATION PLANS
SHARE-BASED COMPENSATION PLANS | 9 Months Ended |
Sep. 30, 2015 | |
SHARE-BASED COMPENSATION PLANS [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 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 June 2014 and May 2015, the Company's shareholders approved an additional 500,000 1,790,818 of its common stock for issuance of awards under the 2013 Plan, respectively. Of the shares of common stock reserved for issuance under the 2013 Plan, no more than 750,000 100 10 four 110 five 6,250,000 The terms of awards granted during the three and nine months ended September 30, 2015 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, 2014. The following table summarizes stock option activity for the nine months ended September 30, 2015 (in thousands except share and per share information): Number of Options Weighted-AverageExercisePrice Weighted-AverageRemainingContractualLife in Years AggregateIntrinsicValue Balance at December 31, 2014 3,021,969 $ 3.67 8.92 $ - Granted 1,359,499 $ 7.16 Exercised (43,343 ) $ 4.65 Cancelled and expired (19,379 $ 4.69 Forfeited (36,390 $ 3.19 Balance at March 31, 2015 4,282,356 $ 4.77 8.69 $ 8,977 Exercisable at September 30, 2015 1,531,798 $ 4.53 8.04 $ 3,155 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 September 30, 2015, there was $ 9.5 million of total unrecognized compensation expense related to stock options and is expected to be amortize d on a straight-line basis over a weighted-average remaining period of 2.59 years . The assumptions used in the Black-Scholes option-pricing model to value stock options are as follows: Three Months Ended September 30, Nine Months Ended September 30, 2015 2014 2015 2014 Expected Volatility 94 % 86 % 94 % 92 % Dividend Yield 0 % 0 % 0 % 0 % Risk-Free Interest Rate 1.74 % 1.09 % 1.69 % 1.24 % Expected Term (years) 6.02 3.50 5.92 3.84 Weighted-average fair value per option $ 7.29 $ 1.46 $ 5.46 $ 1.86 Prior to March 31, 2015, the expected volatility was determined using the volatility of a representative industry peer group. Effective April 1, 2015, the Company determined expected volatility based on a blend of the historical volatility of its stock since becoming a public entity and the volatility of a representative industry peer group. Restricted Stock Units The Company grants restricted stock unit awards (RSUs) under its 2013 Plan and 2010 Plan, as determined by the Company's compensation committee. The RSUs granted represent a right to receive shares of common stock at a future date determined in accordance with the participant's award agreement. An exercise price and monetary payment are not required for receipt of RSUs or the shares issued in settlement of the award. Instead, consideration is furnished in the form of the participant's services to the Company. Recipients of RSUs granted from the 2010 Plan are permitted to net share settle in excess of the minimum statutory withholding amount for taxes and therefore, in accordance with guidance issued by the FASB, RSUs granted from the 2010 Plan are classified as liability with the subsequent change in fair value being recorded as expense. The unsettled RSUs are re-measured at each reporting date and will continue to be re-measured until they are fully vested in approximately 0. 13 years. As of September 30, 2015, the liability related to the unsettled awards was not significant. Recipients of RSUs granted from the 2013 Plan are not permitted to net share settle in excess of the minimum statutory withholding amount for taxes and therefore, in accordance with guidance issued by the FASB. RSUs granted from the 2013 Plan are classified as equity and the fair values of the awards are recognized on a straight-line basis over the vesting term of the awards. Substantially all of the RSUs vest over four There were no outstanding RSUs granted from the 2013 Plan as of September 30, 2015. 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 1 31,250 On January 1, 2015, 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 15 For the offering period from January 1, 2015 to June 30, 2015, the Company issued 52,069 78,000 Three Months Ended September 30, Nine Months Ended September 30, 2015 2014 2015 2014 Expected Volatility 109 % 41 % 65 % 41 % Dividend Yield 0 % 0 % 0 % 0 % Risk-Free Interest Rate 0.09 % 0.05 % 0.07 % 0.05 % 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 September 30, Nine Months Ended September 30, 2015 2014 2015 2014 Research and development $ 583 $ 131 $ 1,025 $ 672 General and administrative 729 279 1,470 1,030 Total stock-based compensation $ 1,312 $ 410 $ 2,495 $ 1,702 |
ORGANIZATION AND SIGNIFICANT 14
ORGANIZATION AND SIGNIFICANT ACCOUNTING POLICIES (Policies) | 9 Months Ended |
Sep. 30, 2015 | |
SUMMARY OF SIGNIFICANT 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 and blisibimod. The Company licensed liprotamase from Eli Lilly & Co (Eli Lilly) in July 2014. Liprotamase is a novel non-porcine investigational Pancreatic Enzyme Replacement Therapy (PERT) intended for the treatment of patients with Exocrine Pancreatic Insufficiency (EPI), often seen in patients with cystic fibrosis and other conditions. The Company licensed blisibimod from Amgen, Inc. (Amgen) in December 2007. Blisibimod targets B-cell activating factor or (BAFF) which has been shown to be elevated in a variety of B-cell mediated autoimmune diseases, including systemic lupus erythematosus (SLE), or lupus, Immunoglobulin A nephropathy, or IgA nephropathy, lupus nephritis, and others. |
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 , reimbursement for certain research and development expenses from a collaborative partner, and research award from Cystic Fibrosis Foundation Therapeutics Incorporated ("CFFT") . As of the date of this report, the Company anticipates its existing cash, and access to additional cash through an equity purchase agreement with Lincoln Park Capital (LPC) and an at-the-market Sales A greement with Cowen & Company, LLC (Cowen) 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 expenditures 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 conduct new trials in the development of its product candidates; such financing may not be available on terms favorable to the Company, if at all. The Company plans to meet its capital requirements primarily through issuances of equity securities, debt financing, potential partnerships 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, 2014, filed with the SEC on March 16, 2015. 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 nine months ended September 30 , 2015 are not necessarily indicative of the results to be expected for the year ending December 31, 2015 or for any other period. The consolidated balance sheet as of December 31, 2014 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. |
Significant Accounting Policies | Significant Accounting Policies Beginning in 2015, the Company established a policy to account for income and related accounts receivable balances owed to the Company from its collaborative partner, Zenyaku and a research award from Cystic Fibrosis Foundation Therapeutics Inc. (CFFT). Our collaboration with Zenyaku provides for various types of payments to us, including development milestones, sales milestone s , royalty and reimbursement for a portion of our internal and external cost s . All payments from Zenyaku are nonrefundable. The collaborative arrangement is on a best-efforts basis, does not require scientific achievement as a performance obligation and provides for payment to be made when costs are incurred or the services are performed. We recognize a contingent milestone payment as revenue in its entirety upon our achievement of a substantive milestone if the consideration earned from the achievement of the milestone (i) is consistent with performance required to achieve the milestone or the increase in value to the delivered item, (ii) relates solely to past performance and (iii) is reasonable relative to all of the other deliverables and payments within the arrangement. Funds received from the CFFT pursuant to a research award are recorded as an offset to Operating Expenses when payments under the award become contractually due. There have been no other changes to the Company's significant accounting policies for the nine months ended September 30, 2015 as compared to the significant accounting policies described in the Company's Annual Report on Form 10-K for the fiscal year ended December 31, 2014. |
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, stock-based compensation, allocation of consideration to various elements under multiple-element collaboration arrangement s and recognition of revenue. 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. |
NET LOSS PER SHARE (Tables)
NET LOSS PER SHARE (Tables) | 9 Months Ended |
Sep. 30, 2015 | |
NET LOSS PER SHARE [Abstract] | |
Schedule of Calculation of Net Loss Per Common Share | Three Months Ended September 30, Nine Months Ended September 30, 2015 2014 2015 2014 Net loss per share Numerator Net loss $ (11,326 ) $ (6,987 ) $ (27,881 ) $ (22,159 ) Denominator Weighted average common shares outstanding 39,241,738 22,747,308 34,260,866 21,459,516 Basic and diluted net loss per share $ (0.29 ) $ (0.31 ) $ (0.81 ) $ (1.03 ) |
Schedule of Antidilutive Securities | Three and Nine Months Ended September 30, 2015 2014 Options to purchase common stock 4,282,356 2,089,437 Warrants to purchase common stock 40,178 630,367 Restricted Stock Units 937 1,874 Total 4,323,471 2,721,678 |
FAIR VALUE OF FINANCIAL INSTR16
FAIR VALUE OF FINANCIAL INSTRUMENTS (Tables) | 9 Months Ended |
Sep. 30, 2015 | |
FAIR VALUE OF FINANCIAL INSTRUMENTS [Abstract] | |
Schedule of Financial Assets Measured at Fair Value on a Recurring Basis | September 30, 2015 Estimated Fair Value Level 1 Level 2 Level 3 Money market funds $ 55,586 $ 55,586 $ $ December 31, 2014 Estimated Fair Value Level 1 Level 2 Level 3 Money market funds $ 2,354 $ 2,354 $ $ |
SHARE-BASED COMPENSATION PLANS
SHARE-BASED COMPENSATION PLANS (Tables) | 9 Months Ended |
Sep. 30, 2015 | |
SHARE-BASED COMPENSATION PLANS [Abstract] | |
Summary of Option Activity | Number of Options Weighted-AverageExercisePrice Weighted-AverageRemainingContractualLife in Years AggregateIntrinsicValue Balance at December 31, 2014 3,021,969 $ 3.67 8.92 $ - Granted 1,359,499 $ 7.16 Exercised (43,343 ) $ 4.65 Cancelled and expired (19,379 $ 4.69 Forfeited (36,390 $ 3.19 Balance at March 31, 2015 4,282,356 $ 4.77 8.69 $ 8,977 Exercisable at September 30, 2015 1,531,798 $ 4.53 8.04 $ 3,155 |
Schedule of Stock-Based Compensation Expense | Three Months Ended September 30, Nine Months Ended September 30, 2015 2014 2015 2014 Research and development $ 583 $ 131 $ 1,025 $ 672 General and administrative 729 279 1,470 1,030 Total stock-based compensation $ 1,312 $ 410 $ 2,495 $ 1,702 |
Stock Option Plans [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 September 30, Nine Months Ended September 30, 2015 2014 2015 2014 Expected Volatility 94 % 86 % 94 % 92 % Dividend Yield 0 % 0 % 0 % 0 % Risk-Free Interest Rate 1.74 % 1.09 % 1.69 % 1.24 % Expected Term (years) 6.02 3.50 5.92 3.84 Weighted-average fair value per option $ 7.29 $ 1.46 $ 5.46 $ 1.86 |
ESPP [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 September 30, Nine Months Ended September 30, 2015 2014 2015 2014 Expected Volatility 109 % 41 % 65 % 41 % Dividend Yield 0 % 0 % 0 % 0 % Risk-Free Interest Rate 0.09 % 0.05 % 0.07 % 0.05 % Expected Term (years) 0.50 0.50 0.50 0.50 |
COLLABORATIVE AGREEMENT (Detail
COLLABORATIVE AGREEMENT (Details) - USD ($) | 3 Months Ended | 9 Months Ended | |||
Sep. 30, 2015 | Sep. 30, 2014 | Sep. 30, 2015 | Sep. 30, 2014 | Dec. 31, 2014 | |
COLLABORATIVE AGREEMENT [Abstract] | |||||
Maximum loan amount | $ 7,000,000 | $ 7,000,000 | |||
Maximum milestone payments | 22,000,000 | 22,000,000 | |||
Maximum proceeds from common stock | 15,000,000 | 15,000,000 | |||
Amount exercised | 11,000,000 | ||||
Proceeds from issuance of stock | 9,000,000 | ||||
Amount outstanding | 2,000,000 | 2,000,000 | |||
Incremental equity investment | 4,000,000 | 4,000,000 | |||
Effect on amortization of deferred revenue | $ 370,000 | $ 370,000 | |||
Effect on basic and diluted earnings per share | $ (0.01) | $ (0.01) | |||
Expected revenue increase | $ 2,000,000 | $ 2,000,000 | |||
Deferred revenue - current | 1,957,000 | 1,957,000 | |||
License revenue | 548,000 | 743,000 | |||
Collaborative revenue | 185,000 | 524,000 | |||
Reduction to research and development | $ 417,000 | $ 1,300,000 | |||
Cost Inside Japan [Member] | |||||
Percentage of reimbursement cost | 100.00% | 100.00% | |||
Cost Outside Japan [Member] | |||||
Percentage of reimbursement cost | 25.00% | 25.00% |
RESEARCH AWARD (Details)
RESEARCH AWARD (Details) - USD ($) $ in Thousands | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2015 | Sep. 30, 2014 | Sep. 30, 2015 | Sep. 30, 2014 | |
RESEARCH AWARD [Abstract] | ||||
Research award amount | $ 3,000 | $ 3,000 | ||
Royalty threshold amount | 100,000 | 100,000 | ||
Research award | 367 | 1,467 | ||
Remaining research award | $ 1,500 | $ 1,500 |
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 | 9 Months Ended | ||
Sep. 30, 2015 | Sep. 30, 2014 | Sep. 30, 2015 | Sep. 30, 2014 | |
Numerator | ||||
Net loss | $ (11,326) | $ (6,987) | $ (27,881) | $ (22,159) |
Denominator | ||||
Weighted average common shares oustanding | 39,241,738 | 22,747,308 | 34,260,866 | 21,459,516 |
Basic and diluted net loss per share | $ (0.29) | $ (0.31) | $ (0.81) | $ (1.03) |
NET LOSS PER SHARE (Schedule 21
NET LOSS PER SHARE (Schedule of Antidilutive Securities) (Details) - shares | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2015 | Sep. 30, 2014 | Sep. 30, 2015 | Sep. 30, 2014 | |
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||||
Anti-dilutive common share equivalents outstanding | 4,323,471 | 2,721,678 | 4,323,471 | 2,721,678 |
Options to purchase common stock [Member] | ||||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||||
Anti-dilutive common share equivalents outstanding | 4,282,356 | 2,089,437 | 4,282,356 | 2,089,437 |
Warrants to purchase common stock [Member] | ||||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||||
Anti-dilutive common share equivalents outstanding | 40,178 | 630,367 | 40,178 | 630,367 |
Restricted Stock Units [Member] | ||||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||||
Anti-dilutive common share equivalents outstanding | 937 | 1,874 | 937 | 1,874 |
FAIR VALUE OF FINANCIAL INSTR22
FAIR VALUE OF FINANCIAL INSTRUMENTS (Details) - Money Market Funds [Member] - USD ($) $ in Thousands | Sep. 30, 2015 | Dec. 31, 2014 |
Estimated Fair Value [Member] | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Assets measured on a recurring basis | $ 55,586 | $ 2,354 |
Level 1 [Member] | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Assets measured on a recurring basis | $ 55,586 | $ 2,354 |
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 | 9 Months Ended | 12 Months Ended | |
Sep. 30, 2015USD ($)ft²$ / sharesshares | Dec. 31, 2007USD ($) | Dec. 31, 2014USD ($) | |
Loss Contingencies [Line Items] | |||
Square footage of operating facility, in square feet | ft² | 14,000 | ||
Research award amount | $ 3 | ||
Royalty obligation, sales amount | $ 100 | ||
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] | Maximum [Member] | |||
Loss Contingencies [Line Items] | |||
Additional milestone payments upon the achievement of certain development and regulatory milestones | 33 | ||
Amgen Inc. [Member] | License Agreement [Member] | |||
Loss Contingencies [Line Items] | |||
License initiation fees | $ 6 | ||
Accrued license costs current | $ 1 | ||
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 | 9 Months Ended | ||||||||
Aug. 31, 2015 | Jul. 31, 2015 | Mar. 31, 2015 | Jan. 31, 2015 | Nov. 30, 2013 | Apr. 30, 2013 | Sep. 30, 2010 | Mar. 31, 2015 | Sep. 30, 2015 | Sep. 30, 2014 | Mar. 31, 2011 | |
Class of Stock [Line Items] | |||||||||||
Issuance of common stock, shares | 3,833,334 | 6,388,889 | 516,660 | ||||||||
Issuance of stock, price per share | $ 7.50 | $ 4.50 | $ 4.50 | ||||||||
Proceeds from stock issuance | $ 11,500 | ||||||||||
Stock issued during period pursuant to purchase agreement, shares | 3,125,662 | ||||||||||
Exercise price of warrants | $ 48 | ||||||||||
Proceeds from issuance of common stock | $ 26,900 | $ 26,900 | $ 65,378 | $ 10,117 | |||||||
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 | $ 1,200 | |||||||||
Number of shares called by warrant(s) | 40,178 | ||||||||||
Preferred stock, shares authorized | 5,000,000 | ||||||||||
Lincoln Park Capital Fund [Member] | |||||||||||
Class of Stock [Line Items] | |||||||||||
Equity purchase agreement, authorized amount of equity authorized for sale | $ 6,000 | ||||||||||
Cowen [Member] | |||||||||||
Class of Stock [Line Items] | |||||||||||
Equity purchase agreement, authorized amount of equity authorized for sale | $ 25,000 | $ 3,700 | |||||||||
Amgen Inc [Member] | |||||||||||
Class of Stock [Line Items] | |||||||||||
Issuance of common stock, shares | 420,751 | ||||||||||
Zenyaku [Member] | |||||||||||
Class of Stock [Line Items] | |||||||||||
Issuance of common stock, shares | 150,917 | 2,795,895 | |||||||||
Proceeds from stock issuance | $ 2,000 | $ 7,000 |
SHARE-BASED COMPENSATION PLAN25
SHARE-BASED COMPENSATION PLANS (Narrative) (Details) - USD ($) | 1 Months Ended | 6 Months Ended | 9 Months Ended | |
May. 31, 2015 | Jun. 30, 2014 | Jun. 30, 2015 | Sep. 30, 2015 | |
Restricted Stock Units [Member] | ||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||
Vesting period | 4 years | |||
Unsettled Restricted Stock Units [Member] | ||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||
Vesting period | 1 month 17 days | |||
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% | |||
Unrecognized compensation cost | $ 9,500,000 | |||
Unrecognized compensation cost, period of recognition | 2 years 7 months 2 days | |||
ESPP, shares issued | 52,069 | |||
ESPP, gross proceeds | $ 78,000 | |||
2013 Plan [Member] | ||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||
Additional shares authorized | 1,790,818 | 500,000 | ||
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 | |||
Maximum shares allowed to be issued as incentive options | 6,250,000 | |||
Vesting period | 4 years | |||
2013 Plan [Member] | Specific cases of certain large stockholders [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 |
SHARE-BASED COMPENSATION PLAN26
SHARE-BASED COMPENSATION PLANS (Summary of Option Activity) (Details) - USD ($) $ / shares in Units, $ in Thousands | 9 Months Ended | 12 Months Ended |
Sep. 30, 2015 | Dec. 31, 2014 | |
Number of Options | ||
Balance at December 31, 2014 | 3,021,969 | |
Granted | 1,359,499 | |
Exercised | (43,343) | |
Cancelled and expired | (19,379) | |
Forfeited | (36,390) | |
Balance at September 30, 2015 | 4,282,356 | 3,021,969 |
Exercisable at September 30, 2015 | 1,531,798 | |
Weighted-Average Exercise Price | ||
Balance at December 31, 2014 | $ 3.67 | |
Granted | 7.16 | |
Exercised | 4.65 | |
Cancelled and expired | 4.69 | |
Forfeited | 3.19 | |
Balance at September 30, 2015 | 4.77 | $ 3.67 |
Exercisable at September 30, 2015 | $ 4.53 | |
Weighted-Average Remaining Contractual Life in Years | ||
Outstanding | 8 years 8 months 8 days | 8 years 11 months 1 day |
Exercisable at September 30, 2015 | 8 years 14 days | |
Aggregate Intrinsic Value | ||
Balance at December 31, 2014 | ||
Balance at September 30, 2015 | $ 8,977 | |
Exercisable at September 30, 2015 | $ 3,155 |
SHARE-BASED COMPENSATION PLAN27
SHARE-BASED COMPENSATION PLANS (Summary of Fair Value Assumptions for Stock Options and Stock Purchase Rights) (Details) - $ / shares | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2015 | Sep. 30, 2014 | Sep. 30, 2015 | Sep. 30, 2014 | |
Stock Option Plans [Member] | ||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||
Expected Volatility | 94.00% | 86.00% | 94.00% | 92.00% |
Dividend Yield | 0.00% | 0.00% | 0.00% | 0.00% |
Risk-Free Interest Rate | 1.74% | 1.09% | 1.69% | 1.24% |
Expected Term | 6 years 7 days | 3 years 6 months | 5 years 11 months 1 day | 3 years 10 months 2 days |
Weighted-average fair value per option | $ 7.29 | $ 1.46 | $ 5.46 | $ 1.86 |
ESPP [Member] | ||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||
Expected Volatility | 109.00% | 41.00% | 65.00% | 41.00% |
Dividend Yield | 0.00% | 0.00% | 0.00% | 0.00% |
Risk-Free Interest Rate | 0.09% | 0.05% | 0.07% | 0.05% |
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 | 9 Months Ended | ||
Sep. 30, 2015 | Sep. 30, 2014 | Sep. 30, 2015 | Sep. 30, 2014 | |
Employee Service Share-based Compensation, Allocation of Recognized Period Costs [Line Items] | ||||
Total stock-based compensation | $ 1,312 | $ 410 | $ 2,495 | $ 1,702 |
Research and Development [Member] | ||||
Employee Service Share-based Compensation, Allocation of Recognized Period Costs [Line Items] | ||||
Total stock-based compensation | 583 | 131 | 1,025 | 672 |
General and Administrative [Member] | ||||
Employee Service Share-based Compensation, Allocation of Recognized Period Costs [Line Items] | ||||
Total stock-based compensation | $ 729 | $ 279 | $ 1,470 | $ 1,030 |