Document and Entity Information
Document and Entity Information - shares | 6 Months Ended | |
Jun. 30, 2016 | Aug. 04, 2016 | |
Document And Entity Information [Abstract] | ||
Document Type | 10-Q | |
Amendment Flag | false | |
Document Period End Date | Jun. 30, 2016 | |
Document Fiscal Year Focus | 2,016 | |
Document Fiscal Period Focus | Q2 | |
Trading Symbol | ATHX | |
Entity Registrant Name | ATHERSYS, INC / NEW | |
Entity Central Index Key | 1,368,148 | |
Current Fiscal Year End Date | --12-31 | |
Entity Filer Category | Accelerated Filer | |
Entity Common Stock, Shares Outstanding | 84,982,125 |
Condensed Consolidated Balance
Condensed Consolidated Balance Sheets - USD ($) $ in Thousands | Jun. 30, 2016 | Dec. 31, 2015 |
Current assets: | ||
Cash and cash equivalents | $ 13,837 | $ 23,027 |
Available-for-sale securities | 10,187 | |
Accounts and other receivables | 648 | 361 |
Prepaid expenses and other | 999 | 429 |
Total current assets | 25,671 | 23,817 |
Equipment, net | 2,028 | 1,135 |
Deferred tax assets | 187 | 177 |
Total assets | 27,886 | 25,129 |
Current liabilities: | ||
Accounts payable | 4,170 | 2,702 |
Accrued compensation and related benefits | 712 | 1,024 |
Accrued clinical trial costs | 234 | 82 |
Accrued expenses | 629 | 513 |
Deferred revenue | 245 | |
Note payable | 190 | |
Total current liabilities | 5,745 | 4,756 |
Warrant liabilities | 2,369 | 649 |
Stockholders' equity: | ||
Preferred stock, at stated value; 10,000,000 shares authorized, and no shares issued and outstanding at June 30, 2016 and December 31, 2015 | ||
Common stock, $0.001 par value; 150,000,000 shares authorized, and 84,597,601 and 83,720,154 shares issued and outstanding at June 30, 2016 and December 31, 2015, respectively | 85 | 84 |
Additional paid-in capital | 324,834 | 322,582 |
Accumulated deficit | (305,147) | (302,942) |
Total stockholders' equity | 19,772 | 19,724 |
Total liabilities and stockholders' equity | $ 27,886 | $ 25,129 |
Condensed Consolidated Balance3
Condensed Consolidated Balance Sheets (Parenthetical) - $ / shares | Jun. 30, 2016 | Dec. 31, 2015 |
Statement of Financial Position [Abstract] | ||
Preferred stock, shares authorized | 10,000,000 | 10,000,000 |
Preferred stock, shares issued | 0 | 0 |
Preferred stock, shares outstanding | 0 | 0 |
Common stock, par value | $ 0.001 | $ 0.001 |
Common stock, shares authorized | 150,000,000 | 150,000,000 |
Common stock, shares issued | 84,597,601 | 83,720,154 |
Common stock, shares outstanding | 84,597,601 | 83,720,154 |
Condensed Consolidated Statemen
Condensed Consolidated Statements of Operations and Comprehensive Loss - USD ($) $ in Thousands | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2016 | Jun. 30, 2015 | Jun. 30, 2016 | Jun. 30, 2015 | |
Revenues | ||||
Contract revenue | $ 136 | $ 49 | $ 15,260 | $ 155 |
Grant revenue | 459 | 167 | 793 | 792 |
Total revenues | 595 | 216 | 16,053 | 947 |
Costs and expenses | ||||
Research and development | 5,824 | 5,261 | 12,487 | 10,928 |
General and administrative | 1,985 | 1,924 | 4,001 | 3,810 |
Depreciation | 67 | 65 | 134 | 136 |
Total costs and expenses | 7,876 | 7,250 | 16,622 | 14,874 |
Loss from operations | (7,281) | (7,034) | (569) | (13,927) |
Income (expense) from change in fair value of warrants, net | 301 | 5,957 | (1,880) | 354 |
Other income, net | 11 | 25 | 221 | 39 |
Loss before income taxes | (6,969) | (1,052) | (2,228) | (13,534) |
Income tax benefit | 13 | 17 | 22 | 17 |
Net loss and comprehensive loss | $ (6,956) | $ (1,035) | $ (2,206) | $ (13,517) |
Net loss per share, basic | $ (0.08) | $ (0.01) | $ (0.03) | $ (0.17) |
Weighted average shares outstanding, basic | 84,341,401 | 82,843,739 | 84,061,257 | 81,022,337 |
Net loss per share, diluted | $ (0.08) | $ (0.05) | $ (0.03) | $ (0.17) |
Weighted average shares outstanding, diluted | 85,416,506 | 83,562,405 | 84,061,257 | 81,022,337 |
Condensed Consolidated Stateme5
Condensed Consolidated Statements of Cash Flows - USD ($) $ in Thousands | 6 Months Ended | |
Jun. 30, 2016 | Jun. 30, 2015 | |
Operating activities | ||
Net loss | $ (2,206) | $ (13,517) |
Adjustments to reconcile net loss to net cash provided by (used in) operating activities: | ||
Depreciation | 134 | 136 |
Income from forgiveness of note payable | (190) | |
Stock-based compensation | 1,430 | 1,456 |
Change in fair value of warrant liabilities | 1,880 | (354) |
Amortization of premium of available-for-sale-securities | 16 | |
Changes in operating assets and liabilities: | ||
Accounts receivable | (287) | (1,688) |
Prepaid expenses and other assets | (580) | 87 |
Accounts payable and accrued expenses | 900 | (769) |
Deferred revenue | (245) | 9,925 |
Net cash provided by (used in) operating activities | 852 | (4,724) |
Investing activities | ||
Purchases of available-for-sale securities | (10,203) | |
Purchases of equipment | (503) | (73) |
Net cash used in investing activities | (10,706) | (73) |
Financing activities | ||
Proceeds from issuance of common stock, net | 874 | 10,371 |
Purchase of treasury stock | (327) | (331) |
Proceeds from exercise of warrants | 117 | 976 |
Net cash provided by financing activities | 664 | 11,016 |
(Decrease) increase in cash and cash equivalents | (9,190) | 6,219 |
Cash and cash equivalents at beginning of the period | 23,027 | 26,127 |
Cash and cash equivalents at end of the period | $ 13,837 | $ 32,346 |
Background and Basis of Present
Background and Basis of Presentation | 6 Months Ended |
Jun. 30, 2016 | |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | |
Background and Basis of Presentation | 1. Background and Basis of Presentation We are an international biotechnology company that is focused primarily in the field of regenerative medicine and operate in one business segment. Our operations consist primarily of research and product development activities. The accompanying unaudited condensed consolidated financial statements should be read in conjunction with the audited financial statements and notes thereto included in our Annual Report on Form 10-K for the year ended December 31, 2015. The accompanying financial statements have been prepared in accordance with U.S. generally accepted accounting principles (“GAAP”) for interim financial information and Article 10 of Regulation S-X. Accordingly, since they are interim statements, the accompanying financial statements do not include all of the information and notes required by GAAP for complete financial statements. The accompanying financial statements reflect all adjustments, consisting of normal recurring adjustments, that are, in the opinion of management, necessary for a fair presentation of financial position and results of operations for the interim periods presented. Interim results are not necessarily indicative of results for a full year. The preparation of financial statements in conformity with GAAP requires management to make estimates and assumptions that affect the amounts reported in the financial statements and accompanying notes. Our critical accounting policies, estimates and assumptions are described in “Management’s Discussion and Analysis of Financial Condition and Results of Operations,” which is included below in this Quarterly Report on Form 10-Q. Certain prior year amounts have been reclassified to conform with current year presentations. |
Recently Issued Accounting Stan
Recently Issued Accounting Standards | 6 Months Ended |
Jun. 30, 2016 | |
Accounting Changes and Error Corrections [Abstract] | |
Recently Issued Accounting Standards | Recently Issued Accounting Standards In November 2015, the Financial Accounting Standards Board (“FASB”) issued Accounting Standards Update (“ASU”) 2015-17, Balance Sheet Classification of Deferred Taxes In May 2014, the FASB issued ASU No. 2014-09, Revenue from Contracts with Customers (Topic 606) In August 2014, the FASB issued ASU 2014-15, Presentation of Financial Statements - Going Concern, Disclosure of Uncertainties about an Entity’s Ability to Continue as a Going Concern In February 2016, the FASB issued ASU 2016-02, Leases (Topic 842) In March 2016, the FASB issued ASU 2016-09, Compensation - Stock Compensation - Improvements to Employee Share-Based Payment Accounting |
Net Loss per Share
Net Loss per Share | 6 Months Ended |
Jun. 30, 2016 | |
Earnings Per Share [Abstract] | |
Net Loss per Share | 3. Net Loss per Share Basic and diluted net loss per share have been computed using the weighted-average number of shares of common stock outstanding during the period. The table below reconciles the net loss and the number of shares used to calculate basic and diluted net loss per share for the three- and six-month periods ended June 30, 2016 and 2015, in thousands, except per share data. Three months ended Six months ended June 30, 2016 2015 2016 2015 Numerator: Net loss attributable to common stockholders, basic $ (6,956 ) $ (1,035 ) $ (2,206 ) $ (13,517 ) Less: income from change in fair value of warrants (203 ) (3,074 ) — — Net loss attributable to common stockholders used to calculate diluted net loss per share $ (7,159 ) $ (4,109 ) $ (2,206 ) $ (13,517 ) Denominator: Weighted-average shares outstanding, basic 84,341 82,844 84,061 81,022 Potentially dilutive common shares outstanding: Warrants 1,076 718 — — Weighted-average shares used to calculate diluted net loss per share 85,417 83,562 84,061 81,022 Basic earnings per share $ (0.08 ) $ (0.01 ) $ (0.03 ) $ (0.17 ) Dilutive earnings per share $ (0.08 ) $ (0.05 ) $ (0.03 ) $ (0.17 ) We have outstanding stock-based awards and warrants that are not used in the calculation of diluted net loss per share because to do so would be antidilutive. The following instruments were excluded from the calculation of diluted net loss per share because their effects would be antidilutive: Three months ended June 30, Six months ended June 30, 2016 2015 2016 2015 Stock-based awards 11,212,175 9,295,631 11,212,175 9,295,631 Warrants 1,500,000 2,810,000 3,438,527 4,864,893 Total 12,712,175 12,105,631 14,650,702 14,160,524 |
Financial Instruments
Financial Instruments | 6 Months Ended |
Jun. 30, 2016 | |
Investments, All Other Investments [Abstract] | |
Financial Instruments | 4. Financial Instruments Fair Value Measurements We classify the inputs used to measure fair value into the following hierarchy: Level 1 Unadjusted quoted prices in active markets for identical assets or liabilities. Level 2 Unadjusted quoted prices in active markets for similar assets or liabilities, or unadjusted quoted prices for identical or similar assets or liabilities in markets that are not active, or inputs other than quoted prices that are observable for the asset or liability. Level 3 Unobservable inputs for the asset or liability. The following table provides a summary of the financial assets and liabilities measured at fair value on a recurring basis as of June 30, 2016 (in thousands): Fair Value Measurements at June 30, 2016 Using Description Balance as of Quoted Prices in Active Significant Other Significant Unobservable Assets: Available-for-sale securities: U.S. government-backed municipal bonds $ 1,856 $ — $ 1,856 $ — Bank certificates of deposit, FDIC-insured $ 8,331 $ — $ 8,331 $ — Total available-for-sale securities $ 10,187 $ — $ 10,187 $ — Liabilities: Warrant liabilities $ 2,369 $ — $ — $ 2,369 We review and reassess the fair value hierarchy classifications on a quarterly basis. Changes from one quarter to the next related to the observability of inputs in a fair value measurement may result in a reclassification between fair value hierarchy levels. There were no reclassifications for all periods presented. The estimated fair value of our U.S. government-backed municipal bonds, representing a level 2 fair value measure, is based on market pricing for similar assets using third party certified pricing sources. The estimated fair value of our FDIC-insured bank certificates of deposit, representing a level 2 fair value measure, is based on third party calculated pricing, taking into consideration amortization and constant yield principles. The estimated fair value of warrants accounted for as liabilities, representing a level 3 fair value measure, was determined on the issuance date and subsequently marked to market at each financial reporting date. We use the Black-Scholes valuation model to value the warrant liabilities at fair value. The fair value is estimated using the expected volatility based on our historical volatility. The fair value of the warrants is determined using probability weighted-average assumptions, when appropriate. The following inputs were used at June 30, 2016: Expected Volatility Risk-Free Interest Rate Expected Life Warrants with one year or less remaining term 62.22% – 79.52% 0.20% – 0.36% 0.04 – 0.70 year A roll-forward of fair value measurements using significant unobservable inputs (Level 3) for the warrants is as follows (in thousands): Three months Six months ended Balance April 1, 2016 $ 2,830 Balance January 1, 2016 $ 649 Settlements from exercise (160 ) Settlements from exercise (160 ) Income for the period (301 ) Loss for the period 1,880 Balance June 30, 2016 $ 2,369 Balance June 30, 2016 $ 2,369 Investments The following is a summary of available-for-sale securities (in thousands) at June 30, 2016, and we had no available-for-sale securities at December 31, 2015: Cost or Gross Gross Estimated June 30, 2016: U.S. government-backed municipal bonds $ 1,856 $ — $ — $ 1,856 Bank certificates of deposit, FDIC-insured 8,331 — — 8,331 $ 10,187 $ — $ — $ 10,187 All of our available-for-sale securities are in U.S. government-backed municipal bonds and FDIC-insured bank certificates of deposit. We had no realized gains or losses during the first six months of 2016. Unrealized gains and losses on our available-for-sale securities are excluded from earnings and are reported as a separate component of stockholders’ equity within accumulated other comprehensive income until realized. When available-for-sale securities are sold in the future, the cost of the securities will be specifically identified and used to determine any realized gain or loss. There were no net unrealized gains or losses on available-for-sale securities as of June 30, 2016. All of our available-for-sale securities at June 30, 2016 have a contractual maturity of one year or less, and actual maturities may differ from contractual maturities because the issuers of the securities may have the right to repay the obligations without prepayment penalties. In January 2016, a $190,000 loan, including accrued interest, related to a 2012 local grant was forgiven according to its terms based on our achievement of certain milestones, and the forgiveness was recognized as other income in the consolidated statement of operations and comprehensive loss. |
Insurance Recovery
Insurance Recovery | 6 Months Ended |
Jun. 30, 2016 | |
Unusual or Infrequent Items, or Both [Abstract] | |
Insurance Recovery | 5. Insurance Recovery In May 2016, a flood caused damage to our primary facilities that required the reconstruction of certain laboratory space that will occur over the next several months. The damaged items included fully-depreciated leasehold improvements under an operating lease and laboratory supplies, all of which were covered by insurance and are being replaced at replacement cost. The expenses associated with the flood damage, e.g., removal, disposal, clean-up and insurance deductible, are recorded in operating results and recognized in the consolidated statement of operations and comprehensive loss. Insurance recovery proceeds have been recognized in the consolidated statement of operations and comprehensive loss as of June 30, 2016 to the extent of the losses recognized as of June 30, 2016, and include proceeds received subsequent to June 30, 2016. While we expect to receive additional insurance recovery proceeds, such amounts represent a gain contingency. Any further contingent gain on insurance proceeds that may be received in the future will be recognized when the contingency is resolved and the amount is realizable. |
Collaborative Arrangements and
Collaborative Arrangements and Revenue Recognition | 6 Months Ended |
Jun. 30, 2016 | |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | |
Collaborative Arrangements and Revenue Recognition | 6. Collaborative Arrangements and Revenue Recognition Healios On January 8, 2016, we entered into a license agreement (“Healios Agreement”) with HEALIOS K.K. (“Healios”) to develop and commercialize MultiStem cell therapy for ischemic stroke in Japan, and to provide Healios with access to Athersys’ proprietary MAPC technology for use in Healios’ “organ bud” program, initially for transplantation to treat liver disease or dysfunction. Under the Healios Agreement, Healios also obtained a right, at their option, to expand the scope of the collaboration to include the exclusive rights to develop and commercialize MultiStem for the treatment of two additional indications in Japan, which include acute respiratory distress syndrome (“ARDS”) and another indication in the orthopedic area, and to include all indications for the “organ bud” program. Healios will develop and commercialize the MultiStem product in Japan, and we will provide the manufactured product to Healios. Under the terms of the Healios Agreement, we received a nonrefundable, up-front cash payment of $15 million from Healios, the majority of which was received in January 2016. If Healios exercises its option to expand the collaboration, we will be entitled to receive a cash payment of $10 million. Healios may exercise its option to expand the collaboration prior to certain milestone dates that are expected to occur within the next two years. For the ischemic stroke indication, we may also receive additional success-based development, regulatory approval and sales milestones aggregating up to $225 million. Such amounts are non-refundable and non-creditable towards future royalties or any other payment due from Healios. We will also receive tiered royalties on net product sales, starting in the low double-digits and increasing incrementally into the high teens, depending on net sales levels. Additionally, we will receive payments for product supplied to Healios for ischemic stroke. If Healios exercises the option to expand the collaboration to include ARDS and another indication in the orthopedic area, we would be entitled to receive royalties from product sales and success-based development, regulatory approval and sales milestones, as well as payments for product supply related to the additional indications covered by the option. For the “organ bud” product, we are entitled to receive a fractional royalty percentage on net sales of the “organ bud” products and will receive payments for manufactured product supplied to Healios under a manufacturing supply agreement. Additionally, we have a right of first negotiation for commercialization of an “organ bud” product in North America, with such right expiring on the later of (i) the date five years from the effective date of the Healios Agreement and (ii) 30 days after authorization to initiate clinical studies on an “organ bud” product under the first investigational new drug application or equivalent in Japan, North America or the European Union. The Healios Agreement will expire automatically when there are no remaining intellectual property rights subject to the license. Additionally, Healios may terminate the Healios Agreement under certain circumstances, including for material breach and without cause upon advance written notice. We may terminate the Healios Agreement if there is an uncured material breach of the agreement by Healios. In the event that Healios does not move the program forward, the development and commercialization rights would revert to us. To determine the appropriate accounting for the license agreement, we evaluated the Healios Agreement and related facts and circumstances, focusing in particular on the rights and obligations of the arrangement. We have determined that our obligations under the Healios Agreement represent multiple deliverables. For deliverables with standalone value, our policy is to account for these as separate units of accounting. We allocate the overall consideration of the arrangement that is fixed and determinable, excluding consideration that is contingent upon future deliverables, to the separate units of accounting based on estimated selling prices (as defined in ASC 605-25) of each deliverable. Given Healios’ ability to sublicense under the Healios Agreement and its ability to conduct the ongoing development efforts, we concluded that the license had stand-alone value at the inception of the arrangement and would be treated as a separate unit of accounting, noting that there was no general right of return associated with the license. Further, the preclinical and clinical manufacturing services and certain near-term regulatory advisory services that will be provided to Healios under the Healios Agreement had been determined to have stand-alone value and considered separate units of accounting. We were unable to establish vendor-specific objective evidence of selling price or third-party evidence for either the license or the services, and thus, instead, allocated the arrangement consideration between the license and the services based on their relative selling prices using a best estimate of selling price (“BESP”). We developed the BESP of the license using a probability weighted, discounted cash flow analysis using the income approach, taking into consideration market assumptions including the estimated development and commercialization timeline, data regarding patient population, discount rate related to our industry, and probability of success using market data for both our industry and therapeutic field. We estimated the BESP of the manufacturing services and certain near-term regulatory advisory services using actual historical experience and best estimates of the cost of obtaining these services at arm’s length from a third-party provider, including an estimated mark-up. As a result of the analysis, we allocated $15 million to the license, which represents the amount of consideration that is allocable pursuant to the relative selling price and is not contingent upon delivery of additional items under the Healios Agreement. The license was delivered and recognized as revenue in January 2016. Other contingent deliverables that were not accounted for at the inception of the arrangement, and will not be accounted for until the contingency is resolved, included the potential expansion of the collaboration to include additional indications, and the milestones that are not substantive since they are dependent on the activities of Healios. Further, the Healios arrangement contemplates our providing manufacturing services for commercial product supply, the terms of which are not defined and are to be agreed upon in the future under a separate supply agreement. Upon the removal of the contingencies associated with each of the potential contingent deliverables, including the expansion fee, milestone payments and/or commercial product supply, we will reevaluate the overall arrangement, including the estimated selling prices and the allocation of the overall consideration of the arrangement, with any changes in estimates accounted for on a prospective basis. Chugai In October 2015, we and Chugai Pharmaceutical Co. Ltd. (“Chugai”) agreed to terminate the License Agreement (the “Chugai Agreement”), dated February 28, 2015, between the parties, as a result of an inability to reach an agreement on the modification of the financial terms of the Chugai Agreement and on the development strategy, as proposed by Chugai, of our MultiStem ® Under the Chugai Agreement, we received a non-refundable, up-front cash payment of $10 million from Chugai, of which approximately $2.0 million was temporarily withheld by Japan taxing authorities and was refunded in September 2015. The $10 million upfront payment from Chugai was recorded as deferred revenue since we had concluded that the license grant did not have standalone value (as defined in ASC 605-25) at the inception of the arrangement. In connection with the termination and the parties having no further obligations under the Chugai Agreement, we recognized the $10 million upfront payment from Chugai as revenue in October 2015. RTI Surgical, Inc. In 2010, we entered into an agreement with RTI Surgical, Inc. (“RTI”) to develop and commercialize biologic implants using our technology for certain orthopedic applications in the bone graft substitutes market on an exclusive basis. Under the terms of the agreement, we received a non-refundable license fee in installments and performed certain services that were concluded in 2012, and we are eligible to receive cash payments upon the successful achievement of certain commercial milestones. We evaluated the nature of the events triggering these contingent payments and concluded that these events are substantive and that revenue will be recognized in the period in which each underlying triggering event occurs. No milestone revenue has been recognized to date. In addition, we began receiving in 2014 tiered royalties on worldwide commercial sales of implants using our technologies based on a royalty rate starting in the mid-single digits and increasing into the mid-teens. Any royalties may be subject to a reduction if third-party payments for intellectual property rights are necessary or commercially desirable to permit the manufacture or sale of the product. |
Stock-based Compensation
Stock-based Compensation | 6 Months Ended |
Jun. 30, 2016 | |
Disclosure of Compensation Related Costs, Share-based Payments [Abstract] | |
Stock-based Compensation | 7. Stock-based Compensation We have two equity incentive plans that authorize an aggregate of 21,500,000 shares of common stock for awards to employees, directors and consultants, which includes an amendment approved by our stockholders and made to the primary plan in June 2016 to increase the shares of common stock available to awards. In the three-month period ended June 30, 2016, we granted 2,403,792 stock options and 931,760 restricted stock units to our employees and directors pursuant to our annual incentive programs. These equity incentive plans authorize the issuance of equity-based compensation in the form of stock options, stock appreciation rights, restricted stock, restricted stock units, performance shares and units, and other stock-based awards. As of June 30, 2016, a total of 3,226,266 shares of common stock have been issued under our equity incentive plans as vested restricted stock units or exercised stock options. As of June 30, 2016, a total of 7,061,559 shares of common stock were available for issuance under our equity incentive plans, and stock-based awards to purchase 11,212,175 shares of common stock were outstanding. For the three-month periods ended June 30, 2016 and 2015, stock-based compensation expense was approximately $722,000 and $705,000, respectively. At June 30, 2016, total unrecognized estimated compensation cost related to unvested stock-based awards was approximately $8.1 million, which is expected to be recognized by the end of 2020 using the straight-line method. |
Issuance of Common Stock and Wa
Issuance of Common Stock and Warrants | 6 Months Ended |
Jun. 30, 2016 | |
Equity [Abstract] | |
Issuance of Common Stock and Warrants | 8. Issuance of Common Stock and Warrants Aspire Capital We currently have in place an equity purchase agreement with Aspire Capital Fund, LLC (“Aspire Capital”) that was entered into in December 2015, and which provides that Aspire Capital is committed to purchase shares of our common stock up to an aggregate amount of $30.0 million over a three-year term, subject to our election to sell any such shares. We had previously entered into similar equity purchase agreements with Aspire Capital in 2011 and 2013 with purchase commitments of $20 million and $25 million, respectively. Under the current equity facility, we issued 250,000 shares of our common stock to Aspire Capital as a commitment fee in December 2015, which are accounted for as a cost of the offering, and we filed a registration statement for the resale of 16,600,000 shares of common stock in connection with the equity facility. During the second quarter of 2016, we sold 200,000 shares to Aspire Capital under the current equity purchase agreement at an average price of $2.25 per share, generating aggregate proceeds of $449,000, and during the six-month period ended June 30, 2016, we sold 400,000 shares of common stock at an average price of $2.19 per share, generating aggregate proceeds of $877,000. Warrants As of June 30, 2016, we had the following outstanding warrants to purchase shares of common stock: Number of Underlying Shares Exercise Price Expiration 1,938,527 $ 1.01 March 14, 2017 1,500,000 $ 4.50 July 15, 2016 3,438,527 During the three-month period ending June 30, 2016, warrants to purchase 116,366 shares of common stock were exercised. |
Warrant Liabilities
Warrant Liabilities | 6 Months Ended |
Jun. 30, 2016 | |
Text Block [Abstract] | |
Warrant Liabilities | 9. Warrant Liabilities We account for common stock warrants as either liabilities or as equity instruments depending on the specific terms of the warrant agreement. Registered common stock warrants that could require cash settlement are accounted for as liabilities. We classify these warrant liabilities on the consolidated balance sheet as a non-current liability. The warrant liabilities are revalued at fair value at each balance sheet date subsequent to the initial issuance. Changes in the fair market value of the warrant are reflected in the consolidated statement of operations as income (expense) from change in fair value of warrants. The warrants that we issued in the January 2014 registered direct offering contain a provision for a cash payment in the event that the shares are not delivered to the holder within two trading days. The cash payment equals $10 per day per $2,000 of warrant shares for each day late. The warrants we issued in the March 2012 private placement contain a provision for net cash settlement in the event that there is a fundamental transaction (e.g., merger, sale of substantially all assets, tender offer, or share exchange). If a fundamental transaction occurs in which the consideration issued consists of all cash or stock in a non-public company, then the warrant holder has the option to receive cash equal to a Black Scholes value of the remaining unexercised portion of the warrant. Further, the March 2012 warrants include price protection in the event we sell stock below the exercise price, as defined. The warrants have been classified as liabilities, as opposed to equity, due to the potential adjustment to the exercise price that could result upon late delivery of the shares or potential cash settlement upon the occurrence of certain events as described above, and are recorded at their fair values at each balance sheet date. |
Income Taxes
Income Taxes | 6 Months Ended |
Jun. 30, 2016 | |
Income Tax Disclosure [Abstract] | |
Income Taxes | 10. Income Taxes We have U.S. federal net operating loss and research and development tax credit carryforwards, as well as state and city net operating loss carryforwards, which may be used to reduce future taxable income and tax liabilities. We also have foreign net operating loss and tax credit carryforwards, and the foreign net operating losses do not expire. Substantially all of our deferred tax assets have been fully offset by a valuation allowance due to our cumulative losses. As a result of our October 2012 equity offering, the utilization of our net operating loss and tax credit carryforwards generated prior to October 2012 is substantially limited under Section 382 of the Internal Revenue Code. U.S. federal net operating loss carryforwards, research and development tax credits, and state and local net operating loss carryforwards generated after October 2012, as well as foreign net operating loss carryforwards and foreign tax credits, are not subject to annual limitations. We recognize refundable tax benefits related to research and development credits associated with one of our foreign subsidiaries. |
Recently Issued Accounting St16
Recently Issued Accounting Standards (Policies) | 6 Months Ended |
Jun. 30, 2016 | |
Accounting Changes and Error Corrections [Abstract] | |
Recently Issued Accounting Standards | 2. Recently Issued Accounting Standards In November 2015, the Financial Accounting Standards Board (“FASB”) issued Accounting Standards Update (“ASU”) 2015-17, Balance Sheet Classification of Deferred Taxes In May 2014, the FASB issued ASU No. 2014-09, Revenue from Contracts with Customers (Topic 606) In August 2014, the FASB issued ASU 2014-15, Presentation of Financial Statements - Going Concern, Disclosure of Uncertainties about an Entity’s Ability to Continue as a Going Concern In February 2016, the FASB issued ASU 2016-02, Leases (Topic 842) In March 2016, the FASB issued ASU 2016-09, Compensation - Stock Compensation - Improvements to Employee Share-Based Payment Accounting |
Net Loss per Share (Tables)
Net Loss per Share (Tables) | 6 Months Ended |
Jun. 30, 2016 | |
Earnings Per Share [Abstract] | |
Net Loss and Number of Shares Used to Calculate Basic and Diluted Net Loss Per Share | The table below reconciles the net loss and the number of shares used to calculate basic and diluted net loss per share for the three- and six-month periods ended June 30, 2016 and 2015, in thousands, except per share data. Three months ended Six months ended June 30, 2016 2015 2016 2015 Numerator: Net loss attributable to common stockholders, basic $ (6,956 ) $ (1,035 ) $ (2,206 ) $ (13,517 ) Less: income from change in fair value of warrants (203 ) (3,074 ) — — Net loss attributable to common stockholders used to calculate diluted net loss per share $ (7,159 ) $ (4,109 ) $ (2,206 ) $ (13,517 ) Denominator: Weighted-average shares outstanding, basic 84,341 82,844 84,061 81,022 Potentially dilutive common shares outstanding: Warrants 1,076 718 — — Weighted-average shares used to calculate diluted net loss per share 85,417 83,562 84,061 81,022 Basic earnings per share $ (0.08 ) $ (0.01 ) $ (0.03 ) $ (0.17 ) Dilutive earnings per share $ (0.08 ) $ (0.05 ) $ (0.03 ) $ (0.17 ) |
Instruments Excluded from Calculation of Diluted Net Loss Per Share | The following instruments were excluded from the calculation of diluted net loss per share because their effects would be antidilutive: Three months ended June 30, Six months ended June 30, 2016 2015 2016 2015 Stock-based awards 11,212,175 9,295,631 11,212,175 9,295,631 Warrants 1,500,000 2,810,000 3,438,527 4,864,893 Total 12,712,175 12,105,631 14,650,702 14,160,524 |
Financial Instruments (Tables)
Financial Instruments (Tables) | 6 Months Ended |
Jun. 30, 2016 | |
Investments, All Other Investments [Abstract] | |
Summary of Financial Assets and Liabilities Measured at Fair Value on Recurring Basis | The following table provides a summary of the financial assets and liabilities measured at fair value on a recurring basis as of June 30, 2016 (in thousands): Fair Value Measurements at June 30, 2016 Using Description Balance as of Quoted Prices in Active Significant Other Significant Unobservable Assets: Available-for-sale securities: U.S. government-backed municipal bonds $ 1,856 $ — $ 1,856 $ — Bank certificates of deposit, FDIC-insured $ 8,331 $ — $ 8,331 $ — Total available-for-sale securities $ 10,187 $ — $ 10,187 $ — Liabilities: Warrant liabilities $ 2,369 $ — $ — $ 2,369 |
Fair Value of Warrants Based on Historical Volatilities | The following inputs were used at June 30, 2016: Expected Volatility Risk-Free Interest Rate Expected Life Warrants with one year or less remaining term 62.22% – 79.52% 0.20% – 0.36% 0.04 – 0.70 year |
Roll-Forward of Fair Value Measurements Using Significant Unobservable Inputs (Level 3) for Warrants | A roll-forward of fair value measurements using significant unobservable inputs (Level 3) for the warrants is as follows (in thousands): Three months Six months ended Balance April 1, 2016 $ 2,830 Balance January 1, 2016 $ 649 Settlements from exercise (160 ) Settlements from exercise (160 ) Income for the period (301 ) Loss for the period 1,880 Balance June 30, 2016 $ 2,369 Balance June 30, 2016 $ 2,369 |
Summary of Available for Sale Securities | The following is a summary of available-for-sale securities (in thousands) at June 30, 2016, and we had no available-for-sale securities at December 31, 2015: Cost or Gross Gross Estimated June 30, 2016: U.S. government-backed municipal bonds $ 1,856 $ — $ — $ 1,856 Bank certificates of deposit, FDIC-insured 8,331 — — 8,331 $ 10,187 $ — $ — $ 10,187 |
Issuance of Common Stock and 19
Issuance of Common Stock and Warrants (Tables) | 6 Months Ended |
Jun. 30, 2016 | |
Equity [Abstract] | |
Outstanding Warrants to Purchase Shares of Common Stock | As of June 30, 2016, we had the following outstanding warrants to purchase shares of common stock: Number of Underlying Shares Exercise Price Expiration 1,938,527 $ 1.01 March 14, 2017 1,500,000 $ 4.50 July 15, 2016 3,438,527 |
Background and Basis of Prese20
Background and Basis of Presentation - Additional Information (Detail) | 6 Months Ended |
Jun. 30, 2016Segment | |
Accounting Policies [Abstract] | |
Number of business segments | 1 |
Net Loss per Share - Net Loss a
Net Loss per Share - Net Loss and Number of Shares Used to Calculate Basic and Diluted Net Loss Per Share (Detail) - 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 attributable to common stockholders, basic | $ (6,956) | $ (1,035) | $ (2,206) | $ (13,517) |
Less: income from change in fair value of warrants | (203) | (3,074) | ||
Net loss attributable to common stockholders used to calculate diluted net loss per share | $ (7,159) | $ (4,109) | $ (2,206) | $ (13,517) |
Denominator: | ||||
Weighted-average shares outstanding, basic | 84,341,401 | 82,843,739 | 84,061,257 | 81,022,337 |
Potentially dilutive common shares outstanding: | ||||
Warrants | 1,076,000 | 718,000 | ||
Weighted-average shares used to calculate diluted net loss per share | 85,416,506 | 83,562,405 | 84,061,257 | 81,022,337 |
Basic earnings per share | $ (0.08) | $ (0.01) | $ (0.03) | $ (0.17) |
Dilutive earnings per share | $ (0.08) | $ (0.05) | $ (0.03) | $ (0.17) |
Net Loss per Share - Instrument
Net Loss per Share - Instruments Excluded from Calculation of Diluted Net Loss Per Share (Detail) - shares | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2016 | Jun. 30, 2015 | Jun. 30, 2016 | Jun. 30, 2015 | |
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||||
Total | 12,712,175 | 12,105,631 | 14,650,702 | 14,160,524 |
Stock-Based Awards [Member] | ||||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||||
Total | 11,212,175 | 9,295,631 | 11,212,175 | 9,295,631 |
Warrants [Member] | ||||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||||
Total | 1,500,000 | 2,810,000 | 3,438,527 | 4,864,893 |
Financial Instruments - Summary
Financial Instruments - Summary of Financial Assets and Liabilities Measured at Fair Value on Recurring Basis (Detail) - USD ($) $ in Thousands | Jun. 30, 2016 | Dec. 31, 2015 |
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Total available-for-sale securities | $ 10,187 | |
Warrant liabilities | 2,369 | $ 649 |
Fair Value Measurements, Recurring Basis [Member] | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Total available-for-sale securities | 10,187 | |
Warrant liabilities | 2,369 | |
Fair Value Measurements, Recurring Basis [Member] | U.S. Government-Backed Municipal Bonds [Member] | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Total available-for-sale securities | 1,856 | |
Fair Value Measurements, Recurring Basis [Member] | Bank Certificates of Deposit, FDIC-Insured [Member] | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Total available-for-sale securities | 8,331 | |
Fair Value Measurements, Recurring Basis [Member] | Significant Other Observable Inputs (Level 2) [Member] | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Total available-for-sale securities | 10,187 | |
Fair Value Measurements, Recurring Basis [Member] | Significant Other Observable Inputs (Level 2) [Member] | U.S. Government-Backed Municipal Bonds [Member] | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Total available-for-sale securities | 1,856 | |
Fair Value Measurements, Recurring Basis [Member] | Significant Other Observable Inputs (Level 2) [Member] | Bank Certificates of Deposit, FDIC-Insured [Member] | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Total available-for-sale securities | 8,331 | |
Fair Value Measurements, Recurring Basis [Member] | Significant Unobservable Inputs (Level 3) [Member] | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Warrant liabilities | $ 2,369 |
Financial Instruments - Fair Va
Financial Instruments - Fair Value of Warrants Based on Historical Volatilities (Detail) - Warrants With One Year or Less Remaining Term [Member] | 6 Months Ended |
Jun. 30, 2016 | |
Minimum [Member] | |
Class of Warrant or Right [Line Items] | |
Expected Volatility | 62.22% |
Risk-Free Interest Rate | 0.20% |
Expected Life | 15 days |
Maximum [Member] | |
Class of Warrant or Right [Line Items] | |
Expected Volatility | 79.52% |
Risk-Free Interest Rate | 0.36% |
Expected Life | 8 months 12 days |
Financial Instruments - Roll-Fo
Financial Instruments - Roll-Forward of Fair Value Measurements Using Significant Unobservable Inputs (Level 3) for Warrants (Detail) - Outstanding Warrants [Member] - USD ($) $ in Thousands | 3 Months Ended | 6 Months Ended |
Jun. 30, 2016 | Jun. 30, 2016 | |
Fair Value Measurements, Recurring and Nonrecurring, Valuation Techniques [Line Items] | ||
Beginning Balance | $ 2,830 | $ 649 |
Settlements from exercise | (160) | (160) |
(Income) loss for the period | (301) | 1,880 |
Ending Balance | $ 2,369 | $ 2,369 |
Financial Instruments - Additio
Financial Instruments - Additional Information (Detail) - USD ($) | 6 Months Ended | ||
Jun. 30, 2016 | Jan. 31, 2016 | Dec. 31, 2015 | |
Fair Value Disclosures [Abstract] | |||
Available-for-sale securities | $ 10,187,000 | $ 0 | |
Realized gains (losses) on available-for-sale securities | 0 | ||
Unrealized gains (losses) on available-for-sale securities | $ 0 | ||
Non current note payable | $ 190,000 |
Financial Instruments - Summa27
Financial Instruments - Summary of Available for Sale Securities (Detail) - USD ($) | 6 Months Ended | |
Jun. 30, 2016 | Dec. 31, 2015 | |
Schedule of Available-for-sale Securities [Line Items] | ||
Cost or Amortized Cost | $ 10,187,000 | |
Gross Unrealized Losses | 0 | |
Gross Unrealized Gains | 0 | |
Estimated Fair Value | 10,187,000 | $ 0 |
U.S. Government-Backed Municipal Bonds [Member] | ||
Schedule of Available-for-sale Securities [Line Items] | ||
Cost or Amortized Cost | 1,856,000 | |
Gross Unrealized Losses | 0 | |
Gross Unrealized Gains | 0 | |
Estimated Fair Value | 1,856,000 | |
Bank Certificates of Deposit, FDIC-Insured [Member] | ||
Schedule of Available-for-sale Securities [Line Items] | ||
Cost or Amortized Cost | 8,331,000 | |
Gross Unrealized Losses | 0 | |
Gross Unrealized Gains | 0 | |
Estimated Fair Value | $ 8,331,000 |
Collaborative Arrangements an28
Collaborative Arrangements and Revenue Recognition - Additional Information (Detail) - USD ($) | 1 Months Ended | 6 Months Ended | |||
Jan. 31, 2016 | Sep. 30, 2015 | Jun. 30, 2016 | Oct. 31, 2015 | Feb. 28, 2015 | |
RTI Surgical Inc [Member] | |||||
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | |||||
Commercial milestone revenue | $ 0 | ||||
Healios License Agreement [Member] | |||||
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | |||||
Up-front cash payment received | 15,000,000 | ||||
Potential near-term payment received | $ 10,000,000 | ||||
Collaborative expansion period | 2 years | ||||
License revenue | $ 15,000,000 | ||||
Healios License Agreement [Member] | Regulatory and Sales Milestones [Member] | |||||
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | |||||
Commercial milestone revenue | $ 225,000,000 | ||||
Chugai Collaboration [Member] | |||||
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | |||||
Up-front cash payment received | $ 10,000,000 | $ 10,000,000 | $ 10,000,000 | ||
National Tax Agency, Japan [Member] | Chugai Collaboration [Member] | |||||
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | |||||
Cash withheld by tax authorities refunded | $ 2,000,000 |
Stock-Based Compensation - Addi
Stock-Based Compensation - Additional Information (Detail) $ in Thousands | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2016USD ($)shares | Jun. 30, 2015USD ($) | Jun. 30, 2016USD ($)Plansshares | Jun. 30, 2015USD ($) | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||
Number of incentive plans | Plans | 2 | |||
Common stock authorized for equity incentive plans | 21,500,000 | 21,500,000 | ||
Common stock shares issued | 3,226,266 | |||
Stock options granted | 2,403,792 | |||
Shares available for issuance | 7,061,559 | 7,061,559 | ||
Shares of common stock outstanding | 11,212,175 | 11,212,175 | ||
Stock-based compensation expense | $ | $ 722,000 | $ 705,000 | $ 1,430 | $ 1,456 |
Total unrecognized estimated compensation cost | $ | $ 8,100 | $ 8,100 | ||
Restricted Stock Units (RSUs) [Member] | ||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||
Restricted stock units granted | 931,760 |
Issuance of Common Stock and 30
Issuance of Common Stock and Warrants - Additional Information (Detail) - USD ($) | 3 Months Ended | 6 Months Ended | 12 Months Ended | ||
Jun. 30, 2016 | Jun. 30, 2016 | Dec. 31, 2013 | Dec. 31, 2011 | Dec. 31, 2015 | |
Class of Warrant or Right [Line Items] | |||||
Warrants issued to purchase common stock | 116,366 | 116,366 | |||
Aspire [Member] | |||||
Class of Warrant or Right [Line Items] | |||||
Equity purchase agreement, value | $ 30,000,000 | $ 25,000,000 | $ 20,000,000 | ||
Equity purchase agreement, term | 3 years | ||||
Common stock issued as commitment fees | 250,000 | ||||
Common stock registered for resale | 16,600,000 | 16,600,000 | |||
Aspire [Member] | Common Stock [Member] | |||||
Class of Warrant or Right [Line Items] | |||||
Issuance of common stock, new issues | 200,000 | 400,000 | |||
Sale of additional shares at an average price | $ 2.25 | $ 2.19 | |||
Issuance of common stock, new issues | $ 449,000 | $ 877,000 |
Issuance of Common Stock and 31
Issuance of Common Stock and Warrants - Outstanding Warrants to Purchase Shares of Common Stock (Detail) | 6 Months Ended |
Jun. 30, 2016$ / sharesshares | |
Class of Warrant or Right [Line Items] | |
Number of Underlying Shares | 3,438,527 |
March 14, 2017 [Member] | |
Class of Warrant or Right [Line Items] | |
Number of Underlying Shares | 1,938,527 |
Exercise Price | $ / shares | $ 1.01 |
Expiration | Mar. 14, 2017 |
July 15, 2016 [Member] | |
Class of Warrant or Right [Line Items] | |
Number of Underlying Shares | 1,500,000 |
Exercise Price | $ / shares | $ 4.50 |
Expiration | Jul. 15, 2016 |
Warrant Liabilities - Additiona
Warrant Liabilities - Additional Information (Detail) | 6 Months Ended |
Jun. 30, 2016USD ($) | |
Equity [Abstract] | |
Terms of issuance of warrant demanding cash payments | The warrants that we issued in the January 2014 registered direct offering contain a provision for a cash payment in the event that the shares are not delivered to the holder within two trading days. The cash payment equals $10 per day per $2,000 of warrant shares for each day late. |
Number of trading days to deliver shares under warrants provision | 2 days |
Value of warrants considered for cash payment for late delivery of shares | $ 2,000 |
Cash payment per day for warrants shares not delivered as per provision | $ 10 |