Document and Entity Information
Document and Entity Information - shares | 6 Months Ended | |
Jun. 30, 2017 | Aug. 04, 2017 | |
Document And Entity Information [Abstract] | ||
Document Type | 10-Q | |
Amendment Flag | false | |
Document Period End Date | Jun. 30, 2017 | |
Document Fiscal Year Focus | 2,017 | |
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 | 113,911,309 |
Condensed Consolidated Balance
Condensed Consolidated Balance Sheets - USD ($) $ in Thousands | Jun. 30, 2017 | Dec. 31, 2016 |
Current assets: | ||
Cash and cash equivalents | $ 28,594 | $ 14,753 |
Accounts and other receivables | 608 | 598 |
Prepaid expenses and other | 920 | 929 |
Total current assets | 30,122 | 16,280 |
Equipment, net | 2,410 | 2,605 |
Deferred tax assets | 191 | 175 |
Total assets | 32,723 | 19,060 |
Current liabilities: | ||
Accounts payable | 4,936 | 4,761 |
Accrued compensation and related benefits | 726 | 1,190 |
Accrued clinical trial costs | 204 | 389 |
Accrued expenses | 339 | 535 |
Deferred revenue | 503 | |
Total current liabilities | 6,708 | 6,875 |
Warrant liabilities | 0 | 1,004 |
Stockholders' equity: | ||
Preferred stock, at stated value; 10,000,000 shares authorized, and no shares issued and outstanding at June 30, 2017 and December 31, 2016 | ||
Common stock, $0.001 par value; 300,000,000 and 150,000,000 shares authorized at June 30, 2017 and December 31, 2016, respectively, and 113,059,889 and 86,629,302 shares issued and outstanding at June 30, 2017 and December 31, 2016, respectively | 113 | 87 |
Additional paid-in capital | 356,189 | 329,373 |
Accumulated deficit | (330,287) | (318,279) |
Total stockholders' equity | 26,015 | 11,181 |
Total liabilities and stockholders' equity | $ 32,723 | $ 19,060 |
Condensed Consolidated Balance3
Condensed Consolidated Balance Sheets (Parenthetical) - $ / shares | Jun. 30, 2017 | Dec. 31, 2016 |
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 | 300,000,000 | 150,000,000 |
Common stock, shares issued | 113,059,889 | 86,629,302 |
Common stock, shares outstanding | 113,059,889 | 86,629,302 |
Condensed Consolidated Statemen
Condensed Consolidated Statements of Operations and Comprehensive Loss - USD ($) $ in Thousands | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2017 | Jun. 30, 2016 | Jun. 30, 2017 | Jun. 30, 2016 | |
Revenues | ||||
Contract revenue | $ 449 | $ 136 | $ 1,709 | $ 15,260 |
Grant revenue | 220 | 459 | 430 | 793 |
Total revenues | 669 | 595 | 2,139 | 16,053 |
Costs and expenses | ||||
Research and development | 4,633 | 5,824 | 10,266 | 12,487 |
General and administrative | 2,207 | 1,985 | 4,278 | 4,001 |
Depreciation | 167 | 67 | 331 | 134 |
Total costs and expenses | 7,007 | 7,876 | 14,875 | 16,622 |
Loss from operations | (6,338) | (7,281) | (12,736) | (569) |
Income (expense) from change in fair value of warrants, net | 301 | 728 | (1,880) | |
Other income, net | 58 | 11 | 84 | 221 |
Loss before income taxes | (6,280) | (6,969) | (11,924) | (2,228) |
Income tax benefit | 13 | 13 | 26 | 22 |
Net loss and comprehensive loss | $ (6,267) | $ (6,956) | $ (11,898) | $ (2,206) |
Net loss per share, basic | $ (0.06) | $ (0.08) | $ (0.11) | $ (0.03) |
Weighted average shares outstanding, basic | 111,819,655 | 84,341,401 | 106,960,354 | 84,061,257 |
Net loss per share, diluted | $ (0.06) | $ (0.08) | $ (0.11) | $ (0.03) |
Weighted average shares outstanding, diluted | 111,819,655 | 85,416,506 | 106,960,354 | 84,061,257 |
Condensed Consolidated Stateme5
Condensed Consolidated Statements of Cash Flows - USD ($) $ in Thousands | 6 Months Ended | |
Jun. 30, 2017 | Jun. 30, 2016 | |
Operating activities | ||
Net loss | $ (11,898) | $ (2,206) |
Adjustments to reconcile net loss to net cash (used in) provided by operating activities: | ||
Depreciation | 331 | 134 |
Gain from forgiveness of note payable | (190) | |
Stock-based compensation | 1,418 | 1,430 |
Change in fair value of warrant liabilities | (728) | 1,880 |
Amortization of premium of available-for-sale-securities | 16 | |
Changes in operating assets and liabilities: | ||
Accounts receivable | (10) | (287) |
Prepaid expenses and other assets | (7) | (580) |
Accounts payable and accrued expenses | (670) | 900 |
Deferred revenue | 503 | (245) |
Net cash (used in) provided by operating activities | (11,061) | 852 |
Investing activities | ||
Purchases of available-for-sale securities | (10,203) | |
Purchases of equipment | (136) | (503) |
Net cash used in investing activities | (136) | (10,706) |
Financing activities | ||
Proceeds from issuance of common stock, net | 23,270 | 874 |
Shares retained for withholding tax payments on stock-based awards | (93) | (327) |
Proceeds from exercise of warrants | 1,861 | 117 |
Net cash provided by financing activities | 25,038 | 664 |
Increase (decrease) in cash and cash equivalents | 13,841 | (9,190) |
Cash and cash equivalents at beginning of the period | 14,753 | 23,027 |
Cash and cash equivalents at end of the period | $ 28,594 | $ 13,837 |
Background and Basis of Present
Background and Basis of Presentation | 6 Months Ended |
Jun. 30, 2017 | |
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. We incurred losses since our inception in 1995 and had an accumulated deficit of $330 million at June 30, 2017. We will require substantial additional capital to continue our research and development programs, including progressing our clinical product candidates to commercialization and preparing for commercial-scale manufacturing. At June 30, 2017, we had available cash and cash equivalents of $28.6 million, and we believe that these funds, used to execute our existing operating plans, are sufficient to meet our obligations as they come due for a period of at least twelve months from the date of the issuance of these unaudited condensed consolidated financial statements. In the longer term, we will make use of available cash, but will have to continue to generate additional capital to meet our needs through new and existing collaborations and related license fees and milestones, the sale of equity securities from time to time, including through our equity purchase agreement with Aspire Capital Fund LLC (“Aspire Capital”), grant-funding opportunities, deferring certain discretionary costs and staging certain development costs, as needed. 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 S-X. 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. |
Recently Issued Accounting Stan
Recently Issued Accounting Standards | 6 Months Ended |
Jun. 30, 2017 | |
Accounting Changes and Error Corrections [Abstract] | |
Recently Issued Accounting Standards | 2. Recently Issued Accounting Standards In March 2016, the Financial Accounting Standards Board (“FASB”) issued Accounting Standards Update (“ASU”) 2016-09, Compensation - Stock Compensation - Improvements to Employee Share-Based Payment Accounting 2016-09”), 2016-09, In February 2016, the FASB issued ASU 2016-02, Leases (Topic 842) 2016-02”), right-of-use 2016-02 2016-02. In May 2014, the FASB issued ASU No. 2014-09, Revenue from Contracts with Customers (Topic 606) 2014-09”). 2014-09 2015-14, 2014-09 2014-09 one-for-one 2014-09 |
Net Loss per Share
Net Loss per Share | 6 Months Ended |
Jun. 30, 2017 | |
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 Three months ended Six months ended June 30, 2017 2016 2017 2016 Numerator: Net loss attributable to common stockholders, basic $ (6,267 ) $ (6,956 ) $ (11,898 ) $ (2,206 ) Less: income from change in fair value of warrants — (203 ) — — Net loss attributable to common stockholders used to calculate diluted net loss per share $ (6,267 ) $ (7,159 ) $ (11,898 ) $ (2,206 ) Denominator: Weighted-average shares outstanding, basic 111,820 84,341 106,960 84,061 Potentially dilutive common shares outstanding related to warrants — 1,076 — — Weighted-average shares used to calculate diluted net loss per share 111,820 85,417 106,960 84,061 Basic earnings per share $ (0.06 ) $ (0.08 ) $ (0.11 ) $ (0.03 ) Dilutive earnings per share $ (0.06 ) $ (0.08 ) $ (0.11 ) $ (0.03 ) We have outstanding stock-based awards and have had warrants that were 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, 2017 2016 2017 2016 Stock-based awards 11,031,006 11,212,175 11,031,006 11,212,175 Warrants — 1,500,000 — 3,438,527 Total 11,031,006 12,712,175 11,031,006 14,650,702 |
Financial Instruments
Financial Instruments | 6 Months Ended |
Jun. 30, 2017 | |
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. At June 30, 2017, we had no financial assets or liabilities measured at fair value on a recurring basis. At December 31, 2016, we had warrant liabilities of $1,004,000 that represented Level 3 liabilities under the hierarchy. As of March 31, 2017, these warrants were either exercised or expired, and we no longer have any outstanding warrants. 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 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 was estimated using the expected volatility based on our historical volatility and is determined using probability weighted-average assumptions, when appropriate. A roll-forward of fair value measurements using significant unobservable inputs (Level 3) for the warrant liabilities is as follows (in thousands): Six months ended Balance January 1, 2017 $ 1,004 Settlements from exercises (276 ) Gain included in income from change in fair value of warrants (728 ) Balance June 30, 2017 $ — Other In February 2016, a $190,000 loan and accrued interest related to regionally-funded preclinical work was forgiven according to its terms based on the achievement of certain milestones, and the forgiveness was recognized as other income. |
Insurance Recovery
Insurance Recovery | 6 Months Ended |
Jun. 30, 2017 | |
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 over 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 were replaced at replacement cost. Insurance recovery proceeds were 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. Ultimately, as of December 31, 2016, the net insurance recovery gain amounted to $682,000. Since the majority of the damage from the flood was to fully-depreciated leasehold improvements, the amount of losses were less than the amount of the insurance proceeds received. No such insurance recoveries were recognized in the six-month |
Collaborative Arrangements and
Collaborative Arrangements and Revenue Recognition | 6 Months Ended |
Jun. 30, 2017 | |
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 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 non-creditable 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) 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 the 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. 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. In January 2017, we signed a clinical trial supply agreement for the manufacturing of investigational product for Healios for its Japan clinical study, the terms of which were consistent with the license agreement. Other In January 2017, we received an option fee related to an agreement that was entered into in December 2016 with a global leader in the animal health business segment to evaluate our cell therapy technology for application in an animal health area. Under the terms of the agreement, we received the payment in exchange for an exclusive period to evaluate our cell therapy technology with an option to negotiate for a license for the development and commercialization of the technology for the animal health area. The option fee is recorded as deferred revenue at June 30, 2017 since the performance obligation of granting a license has not occurred. If the option is exercised, we will include the option fee in the overall consideration for the license arrangement, to be evaluated at that time. If the option is not exercised, the option fee will be recognized as revenue at that time since there will be no more performance obligations. The evaluation of our technology for this application is currently ongoing. Under our agreement with RTI Surgical, Inc. to develop and commercialize biologic implants using our technology for certain orthopedic applications in the bone graft substitutes market, we are eligible to receive cash payments upon the successful achievement of certain commercial milestones. The first commercial milestone was achieved in the first quarter of 2017, with a payment in the amount of $1.0 million, which we received in April 2017. In addition, we continue to receive tiered royalties on worldwide commercial sales of implants using our technologies based on a royalty rate starting in the mid-single mid-teens. |
Stock-based Compensation
Stock-based Compensation | 6 Months Ended |
Jun. 30, 2017 | |
Disclosure of Compensation Related Costs, Share-based Payments [Abstract] | |
Stock-based Compensation | 7. Stock-based Compensation As of June 30, 2017, we have an equity incentive plan that authorizes 20,035,000 shares of common stock for awards to employees, directors and consultants. The equity incentive plan authorizes 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. In June 2017, a separate incentive plan with 1,465,000 authorized shares expired according to its terms, and 1,081,471 stock options remain outstanding under that plan that survive such expiration. In the three-month period ended June 30, 2017, we granted 2,498,480 stock options and 1,054,720 restricted stock units to our employees and directors pursuant to our annual incentive programs. As of June 30, 2017, a total of 3,795,247 shares of common stock have been issued under our equity incentive plans. As of June 30, 2017, a total of 6,400,968 shares of common stock were available for issuance under our current equity incentive plan, and stock-based awards to purchase 11,031,006 shares of common stock were outstanding under both the current and expired plans. For the three-month periods ended June 30, 2017 and 2016, stock-based compensation expense was approximately $729,000 and $722,000, respectively. At June 30, 2017, total unrecognized estimated compensation cost related to unvested stock-based awards was approximately $8.8 million, which is expected to be recognized by the end of 2021 using the straight-line method. |
Stockholders' Equity
Stockholders' Equity | 6 Months Ended |
Jun. 30, 2017 | |
Equity [Abstract] | |
Stockholders' Equity | 8. Stockholders’ Equity Charter Amendment In June 2017, we amended our certificate of incorporation to increase the number of authorized shares of common stock to 300,000,000, upon approval at our annual stockholders’ meeting. Other than the change to the number of authorized shares of common stock, there were no changes to the terms of our common stock. Equity Offering In February 2017, we completed a public offering generating net proceeds of approximately $20.9 million through the issuance of 22,772,300 shares of common stock at an offering price of $1.01 per share. Aspire Capital We currently have in place an equity purchase agreement with Aspire Capital that was entered into in December 2015 and 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 filed a registration statement for the resale of 16,600,000 shares of common stock in connection with the equity facility. During the three- and six-month |
Warrant Liabilities
Warrant Liabilities | 6 Months Ended |
Jun. 30, 2017 | |
Text Block [Abstract] | |
Warrant Liabilities | 9. Warrant Liabilities As of June 30, 2017, we had no warrants outstanding. All of our previously outstanding warrants were either exercised prior to expiration or expired in March 2017. We received proceeds of $1.9 million in the first quarter of 2017 from warrant exercises. Prior to their expiration, we accounted 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 were accounted for as liabilities and classified on the consolidated balance sheet as a non-current |
Income Taxes
Income Taxes | 6 Months Ended |
Jun. 30, 2017 | |
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. We recognize refundable tax benefits related to research and development credits associated with one of our foreign subsidiary. The utilization of net operating loss and tax credit carryforwards generated prior to October 2012 is substantially limited under Section 382 of the Internal Revenue Code of 1986, as amended, as a result of our October 2012 equity offering. We generated U.S. federal net operating loss carryforwards, research and development tax credits, and state and local net operating loss carryforwards since 2012. We will update our analysis under Section 382 prior to using these attributes. |
Recently Issued Accounting St16
Recently Issued Accounting Standards (Policies) | 6 Months Ended |
Jun. 30, 2017 | |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | |
Recently Issued Accounting Standards | Recently Issued Accounting Standards In March 2016, the Financial Accounting Standards Board (“FASB”) issued Accounting Standards Update (“ASU”) 2016-09, Compensation - Stock Compensation - Improvements to Employee Share-Based Payment Accounting 2016-09”), 2016-09, In February 2016, the FASB issued ASU 2016-02, Leases (Topic 842) 2016-02”), right-of-use 2016-02 2016-02. In May 2014, the FASB issued ASU No. 2014-09, Revenue from Contracts with Customers (Topic 606) 2014-09”). 2014-09 2015-14, 2014-09 2014-09 one-for-one 2014-09 |
Fair Value Measurements | 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. 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 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 was estimated using the expected volatility based on our historical volatility and is determined using probability weighted-average assumptions, when appropriate. |
Collaborative Arrangements | 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. |
Royalties | 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. |
Revenue Recognition | 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) |
Warrant Liabilities | We accounted 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 were accounted for as liabilities and classified on the consolidated balance sheet as a non-current |
Net Loss per Share (Tables)
Net Loss per Share (Tables) | 6 Months Ended |
Jun. 30, 2017 | |
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 Three months ended Six months ended June 30, 2017 2016 2017 2016 Numerator: Net loss attributable to common stockholders, basic $ (6,267 ) $ (6,956 ) $ (11,898 ) $ (2,206 ) Less: income from change in fair value of warrants — (203 ) — — Net loss attributable to common stockholders used to calculate diluted net loss per share $ (6,267 ) $ (7,159 ) $ (11,898 ) $ (2,206 ) Denominator: Weighted-average shares outstanding, basic 111,820 84,341 106,960 84,061 Potentially dilutive common shares outstanding related to warrants — 1,076 — — Weighted-average shares used to calculate diluted net loss per share 111,820 85,417 106,960 84,061 Basic earnings per share $ (0.06 ) $ (0.08 ) $ (0.11 ) $ (0.03 ) Dilutive earnings per share $ (0.06 ) $ (0.08 ) $ (0.11 ) $ (0.03 ) |
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, 2017 2016 2017 2016 Stock-based awards 11,031,006 11,212,175 11,031,006 11,212,175 Warrants — 1,500,000 — 3,438,527 Total 11,031,006 12,712,175 11,031,006 14,650,702 |
Financial Instruments (Tables)
Financial Instruments (Tables) | 6 Months Ended |
Jun. 30, 2017 | |
Investments, All Other Investments [Abstract] | |
Roll-Forward of Fair Value Measurements Using Significant Unobservable Inputs (Level 3) for Warrant Liabilities | A roll-forward of fair value measurements using significant unobservable inputs (Level 3) for the warrant liabilities is as follows (in thousands): Six months ended Balance January 1, 2017 $ 1,004 Settlements from exercises (276 ) Gain included in income from change in fair value of warrants (728 ) Balance June 30, 2017 $ — |
Background and Basis of Prese19
Background and Basis of Presentation - Additional Information (Detail) $ in Thousands | 6 Months Ended | |||
Jun. 30, 2017USD ($)Segment | Dec. 31, 2016USD ($) | Jun. 30, 2016USD ($) | Dec. 31, 2015USD ($) | |
Accounting Policies [Abstract] | ||||
Number of business segments | Segment | 1 | |||
Accumulated deficit | $ (330,287) | $ (318,279) | ||
Cash and cash equivalents | $ 28,594 | $ 14,753 | $ 13,837 | $ 23,027 |
Recently Issued Accounting St20
Recently Issued Accounting Standards - Additional Information (Detail) $ in Millions | Jan. 01, 2017USD ($) | Jun. 30, 2017Facility |
Accounting Policies [Abstract] | ||
Accumulated deficit recognized due to adoption of new accounting policy | $ | $ 0.1 | |
Number of operating leases facilities that need to be evaluated under the ASU 2016-02 | Facility | 2 |
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, 2017 | Jun. 30, 2016 | Jun. 30, 2017 | Jun. 30, 2016 | |
Numerator: | ||||
Net loss attributable to common stockholders, basic | $ (6,267) | $ (6,956) | $ (11,898) | $ (2,206) |
Less: income from change in fair value of warrants | (203) | |||
Net loss attributable to common stockholders used to calculate diluted net loss per share | $ (6,267) | $ (7,159) | $ (11,898) | $ (2,206) |
Denominator: | ||||
Weighted-average shares outstanding, basic | 111,819,655 | 84,341,401 | 106,960,354 | 84,061,257 |
Potentially dilutive common shares outstanding related to warrants | 1,076,000 | |||
Weighted-average shares used to calculate diluted net loss per share | 111,819,655 | 85,416,506 | 106,960,354 | 84,061,257 |
Basic earnings per share | $ (0.06) | $ (0.08) | $ (0.11) | $ (0.03) |
Dilutive earnings per share | $ (0.06) | $ (0.08) | $ (0.11) | $ (0.03) |
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, 2017 | Jun. 30, 2016 | Jun. 30, 2017 | Jun. 30, 2016 | |
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||||
Total | 11,031,006 | 12,712,175 | 11,031,006 | 14,650,702 |
Stock - Based Awards [Member] | ||||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||||
Total | 11,031,006 | 11,212,175 | 11,031,006 | 11,212,175 |
Warrants [Member] | ||||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||||
Total | 1,500,000 | 3,438,527 |
Financial Instruments - Additio
Financial Instruments - Additional Information (Detail) - USD ($) | Jun. 30, 2017 | Mar. 31, 2017 | Dec. 31, 2016 | Feb. 29, 2016 |
Fair Value Measurements, Recurring and Nonrecurring, Valuation Techniques [Line Items] | ||||
Financial assets measured at fair value on recurring basis | $ 0 | |||
Financial liabilities measured at fair value on recurring basis | 0 | |||
Warrant liabilities | $ 0 | $ 1,004,000 | ||
Non current note payable | $ 190,000 | |||
Fair Value Measurements, Recurring Basis [Member] | Significant Unobservable Inputs (Level 3) [Member] | ||||
Fair Value Measurements, Recurring and Nonrecurring, Valuation Techniques [Line Items] | ||||
Warrant liabilities | $ 0 | $ 1,004,000 |
Financial Instruments - Roll-Fo
Financial Instruments - Roll-Forward of Fair Value Measurements Using Significant Unobservable Inputs (Level 3) for Warrant Liabilities (Detail) - Outstanding Warrants [Member] $ in Thousands | 6 Months Ended |
Jun. 30, 2017USD ($) | |
Fair Value Measurements, Recurring and Nonrecurring, Valuation Techniques [Line Items] | |
Beginning Balance | $ 1,004 |
Settlements from exercises | (276) |
Gain included in income from change in fair value of warrants | $ (728) |
Insurance Recovery - Additional
Insurance Recovery - Additional Information (Detail) - USD ($) | 6 Months Ended | 12 Months Ended |
Jun. 30, 2017 | Dec. 31, 2016 | |
Insurance [Abstract] | ||
Gain from insurance proceeds, net | $ 0 | $ 682,000 |
Collaborative Arrangement and R
Collaborative Arrangement and Revenue Recognition - Additional Information (Detail) $ in Millions | 6 Months Ended |
Jun. 30, 2017USD ($) | |
Healios License Agreement [Member] | |
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | |
Up-front cash payment received | $ 15 |
Potential near-term payment received | $ 10 |
Collaborative expansion period | 2 years |
License revenue | $ 15 |
Healios License Agreement [Member] | Regulatory and Sales Milestones [Member] | |
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | |
Commercial milestone revenue | 225 |
RTI Surgical Inc [Member] | |
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | |
Commercial milestone revenue | $ 1 |
Stock-Based Compensation - Addi
Stock-Based Compensation - Additional Information (Detail) - USD ($) $ in Thousands | 1 Months Ended | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2017 | Jun. 30, 2017 | Jun. 30, 2016 | Jun. 30, 2017 | Jun. 30, 2016 | |
Disclosure of Compensation Related Costs, Share-based Payments [Abstract] | |||||
Common stock authorized for equity incentive plans | 20,035,000 | 20,035,000 | 20,035,000 | ||
Stock option expired | 1,465,000 | ||||
Stock option outstanding | 1,081,471 | ||||
Stock options granted | 2,498,480 | ||||
Restricted stock units granted | 1,054,720 | ||||
Common stock shares issued | 3,795,247 | ||||
Shares available for issuance | 6,400,968 | 6,400,968 | 6,400,968 | ||
Shares of common stock outstanding | 11,031,006 | 11,031,006 | 11,031,006 | ||
Stock-based compensation expense | $ 729 | $ 722 | $ 1,418 | $ 1,430 | |
Total unrecognized estimated compensation cost | $ 8,800 | $ 8,800 | $ 8,800 |
Stockholders' Equity - Addition
Stockholders' Equity - Additional Information (Detail) - USD ($) $ / shares in Units, $ in Thousands | 1 Months Ended | 3 Months Ended | 6 Months Ended | |||
Feb. 28, 2017 | Jun. 30, 2017 | Mar. 31, 2017 | Jun. 30, 2017 | Jun. 30, 2016 | Dec. 31, 2016 | |
Class of Stock [Line Items] | ||||||
Common stock, shares authorized | 300,000,000 | 300,000,000 | 150,000,000 | |||
Proceeds from common stock issued in public offerings | $ 20,900 | $ 23,270 | $ 23,270 | $ 874 | ||
Common stock share issued in public offering | 22,772,300 | |||||
Common stock offering price | $ 1.01 | |||||
Common stock registered for resale | 16,600,000 | 16,600,000 | ||||
Aspire [Member] | ||||||
Class of Stock [Line Items] | ||||||
Equity purchase agreement, value | $ 30,000 | |||||
Equity purchase agreement, term | 3 years | |||||
Aspire [Member] | Common Stock [Member] | ||||||
Class of Stock [Line Items] | ||||||
Common stock share issued in public offering | 1,650,000 | 0 | 1,650,000 | |||
Sale of additional shares at an average price | $ 1.45 | $ 1.45 |
Warrant Liabilities - Additiona
Warrant Liabilities - Additional Information (Detail) - USD ($) $ in Thousands | 3 Months Ended | 6 Months Ended | ||
Mar. 31, 2017 | Jun. 30, 2017 | Jun. 30, 2016 | Dec. 31, 2016 | |
Equity [Abstract] | ||||
Warrants outstanding | $ 0 | $ 1,004 | ||
Proceeds from warrant exercises | $ 1,900 | $ 1,861 | $ 117 |