Document and Entity Information
Document and Entity Information - USD ($) $ in Millions | 12 Months Ended | ||
Dec. 31, 2018 | Mar. 07, 2019 | Jun. 29, 2018 | |
Document And Entity Information [Abstract] | |||
Document Type | 10-K | ||
Amendment Flag | false | ||
Document Period End Date | Dec. 31, 2018 | ||
Document Fiscal Year Focus | 2018 | ||
Document Fiscal Period Focus | FY | ||
Trading Symbol | ATHX | ||
Entity Registrant Name | ATHERSYS, INC / NEW | ||
Entity Central Index Key | 0001368148 | ||
Current Fiscal Year End Date | --12-31 | ||
Entity Well-known Seasoned Issuer | No | ||
Entity Current Reporting Status | Yes | ||
Entity Voluntary Filers | No | ||
Entity Filer Category | Accelerated Filer | ||
Entity Emerging Growth Company | false | ||
Entity Small Business | true | ||
Entity Shell Company | false | ||
Entity Common Stock, Shares Outstanding | 146,842,739 | ||
Entity Public Float | $ 245.4 |
Consolidated Balance Sheets
Consolidated Balance Sheets - USD ($) | Dec. 31, 2018 | Dec. 31, 2017 |
Current assets: | ||
Cash and cash equivalents | $ 51,059,000 | $ 29,316,000 |
Accounts receivable | 262,000 | 586,000 |
Prepaid expenses and other | 1,791,000 | 1,135,000 |
Total current assets | 57,840,000 | 31,190,000 |
Equipment, net | 3,002,000 | 2,206,000 |
Deposits and other | 888,000 | 197,000 |
Total assets | 61,730,000 | 33,593,000 |
Current liabilities: | ||
Accounts payable | 9,163,000 | 4,469,000 |
Accrued compensation and related benefits | 1,901,000 | 1,065,000 |
Accrued clinical trial related costs | 1,276,000 | 1,453,000 |
Accrued expenses | 461,000 | 425,000 |
Accrued license fee expense | 0 | 1,900,000 |
Deferred revenue - Healios | 0 | 250,000 |
Total current liabilities | 15,475,000 | 10,083,000 |
Stockholders’ equity: | ||
Preferred stock, at stated value; 10,000,000 shares authorized, and no shares issued and outstanding at December 31, 2018 and 2017 | 0 | 0 |
Common stock, $0.001 par value; 300,000,000 shares authorized; 144,292,739 and 122,077,453 shares issued and outstanding at December 31, 2018 and 2017, respectively | 144,000 | 122,000 |
Additional paid-in capital | 416,014,000 | 373,884,000 |
Accumulated deficit | (373,042,000) | (350,630,000) |
Total stockholders’ equity | 43,116,000 | 23,376,000 |
Total liabilities and stockholders’ equity | 61,730,000 | 33,593,000 |
Healios License Agreement | ||
Current assets: | ||
Accounts receivable | 1,108,000 | 153,000 |
Unbilled accounts receivable from Healios | 3,620,000 | 0 |
Current liabilities: | ||
Deposit from Healios | 2,000,000 | 0 |
Deferred revenue - Healios | 674,000 | 521,000 |
Advance from Healios | $ 3,139,000 | $ 134,000 |
Consolidated Balance Sheets (Pa
Consolidated Balance Sheets (Parenthetical) - $ / shares | Dec. 31, 2018 | Dec. 31, 2017 |
Statement of Financial Position [Abstract] | ||
Preferred stock, shares authorized (in shares) | 10,000,000 | 10,000,000 |
Preferred stock, shares issued (in shares) | 0 | 0 |
Preferred stock, shares outstanding (in shares) | 0 | 0 |
Common stock, par value (in dollars per share) | $ 0.001 | $ 0.001 |
Common stock, shares authorized (in shares) | 300,000,000 | 300,000,000 |
Common stock, shares issued (in shares) | 144,292,739 | 122,077,453 |
Common stock, shares outstanding (in shares) | 144,292,739 | 122,077,453 |
Consolidated Statements of Oper
Consolidated Statements of Operations and Comprehensive Loss - USD ($) shares in Thousands, $ in Thousands | 12 Months Ended | ||
Dec. 31, 2018 | Dec. 31, 2017 | Dec. 31, 2016 | |
Revenues | |||
Revenues | $ 24,291 | $ 3,708 | $ 17,347 |
Costs and expenses | |||
Research and development (including stock compensation expense of $1,609, $1,232 and $1,192 in 2018, 2017 and 2016, respectively) | 38,656 | 27,841 | 24,838 |
General and administrative (including stock compensation expense of $2,240, $1,812 and $1,676 in 2018, 2017 and 2016, respectively) | 10,442 | 8,466 | 7,835 |
Depreciation | 855 | 684 | 382 |
Total costs and expenses | 49,953 | 36,991 | 33,055 |
Gain from insurance proceeds, net | 617 | 0 | 682 |
Loss from operations | (25,045) | (33,283) | (15,026) |
Income (expense) from change in fair value of warrants, net | 0 | 728 | (557) |
Other income, net | 762 | 314 | 209 |
Loss before income taxes | (24,283) | (32,241) | (15,374) |
Income tax benefit | 0 | 0 | 37 |
Net loss and comprehensive loss | $ (24,283) | $ (32,241) | $ (15,337) |
Net loss per common share, basic and diluted (in dollars per share) | $ (0.18) | $ (0.29) | $ (0.18) |
Weighted average shares outstanding, basic and diluted (in shares) | 136,641 | 112,053 | 84,715 |
Royalty and other contract revenue | |||
Revenues | |||
Revenues | $ 1,461 | $ 1,925 | $ 0 |
Grant revenue | |||
Revenues | |||
Revenues | 554 | 865 | 1,109 |
Healios License Agreement | Contract revenue from Healios | |||
Revenues | |||
Revenues | $ 22,276 | $ 918 | $ 16,238 |
Consolidated Statements of Op_2
Consolidated Statements of Operations and Comprehensive Loss (Parenthetical) - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2018 | Dec. 31, 2017 | Dec. 31, 2016 | |
Research and Development | |||
Stock compensation expense | $ 1,609 | $ 1,232 | $ 1,192 |
General and Administrative | |||
Stock compensation expense | $ 2,240 | $ 1,812 | $ 1,676 |
Consolidated Statements of Stoc
Consolidated Statements of Stockholders' Equity - USD ($) $ in Thousands | Total | Preferred Stock | Common Stock | Additional Paid-in Capital | Accumulated Deficit | Healios License Agreement | Healios License AgreementCommon Stock | Healios License AgreementAdditional Paid-in Capital |
Preferred stock shares, beginning balance (in shares) at Dec. 31, 2015 | 0 | |||||||
Common stock, beginning balance (in shares) at Dec. 31, 2015 | 83,720,154 | |||||||
Beginning balance at Dec. 31, 2015 | $ 19,724 | $ 0 | $ 84 | $ 322,582 | $ (302,942) | |||
Stock-based compensation | 2,868 | 2,868 | ||||||
Issuance of common stock from warrant exercises (in shares) | 161,366 | |||||||
Issuance of common stock from warrant exercises | 163 | 163 | ||||||
Issuance of common stock, net of issuance costs (in shares) | 2,191,418 | |||||||
Issuance of common stock, net of issuance costs | 4,230 | $ 2 | 4,228 | |||||
Issuance of common stock under equity compensation plans (in shares) | 556,364 | |||||||
Issuance of common stock under equity compensation plans | (467) | $ 1 | (468) | |||||
Net and comprehensive loss | (15,337) | (15,337) | ||||||
Preferred stock shares, ending balance (in shares) at Dec. 31, 2016 | 0 | |||||||
Common stock, ending balance (in shares) at Dec. 31, 2016 | 86,629,302 | |||||||
Ending balance at Dec. 31, 2016 | 11,181 | $ 0 | $ 87 | 329,373 | (318,279) | |||
Cumulative effect of accounting change | (110) | (110) | ||||||
Stock-based compensation | 3,154 | 3,154 | ||||||
Issuance of common stock from warrant exercises (in shares) | 1,843,363 | |||||||
Issuance of common stock from warrant exercises | 1,862 | $ 2 | 1,860 | |||||
Issuance of common stock, net of issuance costs (in shares) | 33,172,300 | |||||||
Issuance of common stock, net of issuance costs | 39,813 | $ 33 | 39,780 | |||||
Issuance of common stock under equity compensation plans (in shares) | 432,488 | |||||||
Issuance of common stock under equity compensation plans | (283) | (283) | ||||||
Net and comprehensive loss | $ (32,241) | (32,241) | ||||||
Preferred stock shares, ending balance (in shares) at Dec. 31, 2017 | 0 | 0 | ||||||
Common stock, ending balance (in shares) at Dec. 31, 2017 | 122,077,453 | 122,077,453 | ||||||
Ending balance at Dec. 31, 2017 | $ 23,376 | $ 0 | $ 122 | 373,884 | (350,630) | |||
Cumulative effect of accounting change | 1,871 | 1,871 | ||||||
Stock-based compensation | 3,849 | 3,849 | ||||||
Issuance of warrant to Healios at fair value | 1,080 | 1,080 | ||||||
Issuance of common stock, net of issuance costs (in shares) | 9,658,582 | 12,000,000 | ||||||
Issuance of common stock, net of issuance costs | $ 16,628 | $ 9 | 16,619 | $ 20,995 | $ 12 | $ 20,983 | ||
Issuance of common stock under equity compensation plans (in shares) | 5,120,464 | 556,704 | ||||||
Issuance of common stock under equity compensation plans | $ (400) | $ 1 | (401) | |||||
Net and comprehensive loss | $ (24,283) | (24,283) | ||||||
Preferred stock shares, ending balance (in shares) at Dec. 31, 2018 | 0 | 0 | ||||||
Common stock, ending balance (in shares) at Dec. 31, 2018 | 144,292,739 | 144,292,739 | ||||||
Ending balance at Dec. 31, 2018 | $ 43,116 | $ 0 | $ 144 | $ 416,014 | $ (373,042) |
Consolidated Statements of Cash
Consolidated Statements of Cash Flows - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2018 | Dec. 31, 2017 | Dec. 31, 2016 | |
Operating activities | |||
Net loss | $ (24,283) | $ (32,241) | $ (15,337) |
Adjustments to reconcile net loss to net cash used in operating activities: | |||
Depreciation | 855 | 684 | 382 |
Gain from forgiveness of note payable | 0 | 0 | (190) |
Stock-based compensation | 3,849 | 3,044 | 2,868 |
Discount on revenue from issuance of warrant | 1,080 | 0 | 0 |
Other | 0 | (22) | 2 |
Stock–based patent license and settlement expense | 315 | 3,150 | 0 |
Gain from insurance proceeds, net | (617) | 0 | (682) |
Change in fair value of warrant liabilities | 0 | (728) | 557 |
Changes in operating assets and liabilities: | |||
Accounts receivable | 324 | 12 | (237) |
Prepaid expenses and other | (1,346) | (206) | (462) |
Accounts payable and accrued expenses | 4,269 | 1,537 | 2,413 |
Advances and deposits from Healios | 4,889 | 134 | 0 |
Deferred revenue | (250) | 771 | (245) |
Net cash used in operating activities | (13,350) | (24,018) | (10,931) |
Investing activities | |||
Purchase of available-for-sale securities | 0 | 0 | (16,343) |
Sales of available-for-sale securities | 0 | 0 | 16,305 |
Proceeds from insurance, net | 617 | 0 | 682 |
Purchases of equipment | (1,532) | (285) | (1,711) |
Net cash used in investing activities | (915) | (285) | (1,067) |
Financing activities | |||
Proceeds from issuance of common stock, net | 15,415 | 37,287 | 4,028 |
Proceeds from exercise of warrants | 0 | 1,862 | 163 |
Shares retained for withholding tax payments on stock-based awards | (402) | (283) | (467) |
Net cash provided by financing activities | 36,008 | 38,866 | 3,724 |
Increase (decrease) in cash and cash equivalents | 21,743 | 14,563 | (8,274) |
Cash and cash equivalents at beginning of year | 29,316 | 14,753 | 23,027 |
Cash and cash equivalents at end of year | 51,059 | 29,316 | 14,753 |
Healios License Agreement | |||
Changes in operating assets and liabilities: | |||
Accounts receivable | (4,545) | (153) | 0 |
Deferred revenue | (2,110) | 0 | 0 |
Financing activities | |||
Proceeds from issuance of common stock, net | $ 20,995 | $ 0 | $ 0 |
Background
Background | 12 Months Ended |
Dec. 31, 2018 | |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | |
Background | Background We are an international biotechnology company focused in the field of regenerative medicine and operate in one business segment. Our operations consist of research, preclinical development and clinical development activities, and our most advanced program is in Phase 3 clinical development. We have incurred losses since our inception in 1995 and had an accumulated deficit of $373.0 million at December 31, 2018 . We will require additional capital to continue our research and development programs, including progressing our clinical product candidates to commercialization and preparing for commercial-scale manufacturing and sales. At December 31, 2018 , we had available cash and cash equivalents of $51.1 million . We believe that these funds, expected cash receipts primarily attributed to our collaboration with HEALIOS K.K. (“Healios”) and proceeds from our equity facility are sufficient to meet our obligations as they come due at least for a period of twelve months from the date of the issuance of these consolidated financial statements. In the longer term, we 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 facility, grant-funding opportunities, deferring certain discretionary costs and staging certain development costs, as needed. |
Accounting Policies
Accounting Policies | 12 Months Ended |
Dec. 31, 2018 | |
Accounting Policies [Abstract] | |
Accounting Policies | B. Accounting Policies Principles of Consolidation The consolidated financial statements include our accounts and results of operations and those of our wholly-owned subsidiaries. All intercompany accounts and transactions have been eliminated in consolidation. Reclassifications Certain reclassifications have been made to the 2017 and 2016 consolidated financial statements to separately disclose transactions and balances related to Healios to conform to the 2018 presentation. Revenue Recognition Our license and collaboration agreements may contain multiple elements, including license and technology access fees, research and development funding, product supply revenue, service revenue, cost-sharing, milestones and royalties. As further described below, on January 1, 2018, we adopted Accounting Standards Update (“ASU”) No. 2014-09, Revenue from Contracts with Customers (“Topic 606”), to account for revenue. The deliverables under our arrangements are evaluated under Topic 606 which requires an entity to recognize revenue in a manner that depicts the transfer of promised goods or services to customers in an amount that reflects the consideration to which the entity expects to be entitled in exchange for those goods or services. Milestone Payments Topic 606 does not contain guidance specific to milestone payments, but rather requires potential milestone payments to be considered in accordance with the overall model of Topic 606. As a result, revenues from contingent milestone payments are recognized based on an assessment of the probability of milestone achievement and the likelihood of a significant reversal of such milestone revenue at each reporting date. This assessment may result in recognizing milestone revenue before the milestone event has been achieved. Since the milestones in the Healios arrangement are generally related to development and commercial milestone achievement by Healios, we have not included any of the Healios milestones in the estimated transaction price of the Healios arrangement, since they would be constrained, as a significant reversal of revenue could result in future periods. Other than for our collaboration with Healios that has remaining deliverables, as of the date of adoption of Topic 606 on January 1, 2018, we had recognized the full amount of license fees under our collaboration agreements as contract revenue under the prior guidance associated with multiple-element arrangements, since the performance periods for our multiple element arrangements had concluded. The events triggering any future contingent milestone payments from these arrangements were determined to be non-substantive and revenue will be recognized in the period that the triggering event occurs, and the remaining potential commercial milestones will be recognized when earned. Grant Revenue Grant revenue, which is not within the scope of Topic 606 for our grant arrangements, consists of funding under cost reimbursement programs primarily from federal and non-profit foundation sources for qualified research and development activities performed by us, and as such, are not based on estimates that are susceptible to change. Such amounts are invoiced and recorded as revenue as grant-funded activities are performed, with any advance funding recorded as deferred revenue until the activities are performed. Royalty Revenue We generate royalty revenue from the sale of licensed products by our licensees. Royalty revenue is recognized upon the later to occur of (i) achievement of the collaborator’s underlying sales and (ii) satisfaction of any performance obligation(s) related to these sales, in each case assuming the license to our intellectual property is deemed to be the predominant item to which the sales-based royalties relate. Unbilled Accounts Receivable We record amounts that are due to us under contractual arrangements for which invoicing has not yet occurred if our performance has concluded for the billable activity, and we have the unconditional right to the consideration, but such amounts have not yet been billed. At December 31, 2018, unbilled accounts receivable from Healios was $3.6 million , which includes $2.5 million of license fees that were paid to us by Healios in the first quarter of 2019 related to the expansion of our arrangement described in Note E . The remainder of the unbilled accounts receivable on the consolidated balance sheets at December 31, 2018 relates to manufacturing technology transfer services performed that were not yet billed to Healios. Contractual Right to Consideration and Deferred Revenue Amounts included in deferred revenue or contract assets are determined at the contract level, and for our Healios arrangement, such amounts are included in a contract asset or liability depending on the overall status of the arrangement. Amounts received from customers or collaborators in advance of our performance of services or other deliverables are included in deferred revenue, while amounts for performance of services or other deliverables before customer payment is received or due are included in contract assets, with those amounts that are unconditional being included in either accounts receivable or unbilled accounts receivable. Grant proceeds received in advance of our performance under the grant is included in deferred revenue. Generally, deferred revenue and contract assets or liabilities are classified as current assets or obligations, as opposed to non-current. Deposit from Healios Included in the deposit from Healios at December 31, 2018 is a $2.0 million payment received from Healios to extend the period of its exclusive right to negotiate for an option to expand its license to develop and commercialize certain disease indications in China. These nonrefundable proceeds will either be applied to Healios' option fee for the China license or be creditable against potential milestone payments under the existing Healios licenses. Advances from Healios The clinical trial supply agreement with Healios was amended in July 2017 to clarify a cost-sharing arrangement associated with our supply of clinical product for Healios' ischemic stroke trial in Japan. The proceeds from Healios for clinical supply that relate specifically to the cost-sharing arrangement may (i) result in a decrease in the amount we receive from Healios upon the achievement of certain milestones and an increase to a commercial milestone, or (ii) be repaid at our election. While the amendment to the supply agreement resulted in a revision to the terms associated with the product supply, namely the cost of product supply, the revision did not affect any of the performance obligations under the overall arrangement. The proceeds from Healios that relate specifically to the cost-sharing arrangement for Healios’ ischemic stroke study in Japan are recognized as a non-current advance from Healios until the related milestones are achieved or such amounts are repaid to Healios at our election. No revenue has been recognized yet related to this advance. Effect of Adoption of Topic 606 We adopted Topic 606 utilizing the modified retrospective transition method applied to contracts that were not complete as of January 1, 2018. We evaluated all of our arrangements on a contract-by-contract basis, identifying all of the performance obligations, including those that are contingent. For our contracts with customers that contain multiple performance obligations, we account for the individual performance obligations separately when they are both capable of being distinct, whereby the customer can benefit from the service either on its own or together with other resources that are readily available from third parties or from us, and are distinct in the context of the contract, whereby the transfer of the services is separately identifiable from other promises in the contract. Under the new standard, we assessed whether licenses granted under our collaboration and license agreements were distinct in the context of the agreement from other performance obligations and functional when granted. After considering the relative selling prices of the contract elements and the allocation of revenue thereto, we recognized a cumulative effect adjustment of $1.9 million as an adjustment to the opening balance of our accumulated deficit primarily related to a contract asset since the revenue permitted to be recognized at inception was not limited to the cash proceeds received as of that time, which was a requirement of the previous guidance. We concluded that the new guidance resulted in revisions to accounting for our arrangement with Healios, only, since our other collaborations had no remaining performance obligations and potential contingent receipts would be constrained. The adoption of ASC 606 primarily resulted in the acceleration of revenue as of December 31, 2017, which in turn reduced our existing deferred tax asset for net operating loss carryforwards. As we have provided a full valuation allowance against our deferred tax assets, this impact was offset by a corresponding reduction to the valuation allowance. Our performance obligations and methods used for determining the relative selling prices and transaction prices of the Healios contract elements is further discussed in Note E . As noted above, our arrangement with Healios was the only collaboration that was impacted by the adoption of Topic 606. Notes E and F further describe our arrangement with Healios, including subsequent modifications to the original collaboration. For contracts that were modified prior to January 1, 2018, we aggregated the effect of those modifications when identifying the satisfied and unsatisfied performance obligations and determining the transaction price to be allocated. We applied the practical expedient under Topic 606 and reflected the aggregate effect of all modifications at January 1, 2018. The components of the cumulative effect of the changes made to our consolidated January 1, 2018 balance sheet for the adoption of Topic 606 were as follows (in thousands): Balance at December 31, 2017 Adjustments Due to Topic 606 Balance at January 1, 2018 Assets Accounts receivable - Healios $ 153 $ 30 $ 183 Contractual right to consideration from Healios — 1,436 1,436 Liabilities Deferred revenue - Healios (521 ) 521 — Advance from Healios (134 ) (116 ) (250 ) Stockholders' Equity Accumulated deficit $ (350,630 ) $ 1,871 $ (348,759 ) In accordance with the new revenue recognition requirements, the disclosure of the impact of adoption on our consolidated balance sheet as of December 31, 2018 and statement of operations for the twelve-month period ended December 31, 2018 was as follows (in thousands, except per share data): As of December 31, 2018 As Reported Balances without Adoption of Topic 606 Effect of Change Assets Unbilled accounts receivable from Healios $ 3,620 $ — $ 3,620 Liabilities Deferred revenue - Healios (674 ) (2,154 ) 1,480 Stockholders' Equity Accumulated deficit $ (373,042 ) $ (378,142 ) $ (5,100 ) Twelve months ended December 31, 2018 As Reported Balances without Adoption of Topic 606 Effect of Change Revenues Contract revenues from Healios $ 22,276 $ 19,047 $ 3,229 Net loss (24,283 ) (27,512 ) (3,229 ) Net loss per common share Basic and diluted $ (0.18 ) $ (0.20 ) $ 0.02 The adoption of Topic 606 had no impact on our total cash flows from operations. Cash and Cash Equivalents We consider all highly liquid investments with a maturity of three months or less when purchased to be cash equivalents. Cash equivalents are primarily invested in money market funds. The carrying amount of our cash equivalents approximates fair value due to the short maturity of the investments. Cash used in investing activities excluded $0.1 million of accrued capital expenditures in both 2018 and 2016. Investments in Available-for-Sale Securities We determine the appropriate classification of investment securities, if any, at the time of purchase and re-evaluate such designation as of each balance sheet date. Our investments, if any, typically consist of United States government obligations, United States government-backed municipal bonds and bank certificates of deposit, which are classified as available-for-sale and are valued based on market prices for similar assets using third party certified pricing sources. Available-for-sale securities are carried at fair value, with the unrealized gains and losses, net of applicable tax, reported as a component of accumulated other comprehensive income (loss). The amortized cost of debt securities is adjusted for amortization of premiums and accretion of discounts to maturity. Such amortization or accretion is included in interest income. The cost of securities sold is based on the specific identification method. Interest earned on securities classified as available-for-sale is included in interest income. At December 31, 2018 , we had no available-for-sale securities, and realized gains and losses for each of the three years in the period ended December 31, 2018 on available-for-sale securities were insignificant. Research and Development Research and development expenditures, which consist primarily of costs associated with clinical trials, preclinical research, product manufacturing and process development for manufacturing, personnel, legal fees resulting from intellectual property application and maintenance processes, and laboratory supply and reagent costs, including direct and allocated overhead expenses, are charged to expense as incurred. Clinical Trial Costs Clinical trial costs are accrued based on work performed by outside contractors that manage and perform the trials, and those that manufacture the investigational product. We obtain initial estimates of total costs based on enrollment of subjects, trial duration, project management estimates, manufacturing estimates, patient treatment costs and other activities. Actual costs may be charged to us and recognized as the tasks are completed by the contractor or, alternatively, may be invoiced in accordance with agreed-upon payment schedules and recognized based on estimates of work completed to date. Accrued clinical trial costs may be subject to revisions as clinical trials progress, and any revisions are recorded in the period in which the facts that give rise to the revisions become known. Royalty Payments and Sublicense Fees We are required to make royalty payments to certain parties based on our product sales under license agreements. No royalties were recorded during the three-year period ended December 31, 2018 , since we have not yet generated sales revenue. We are also required to record sublicense fees from time-to-time in connection with license fees from collaborators and clinical and commercial milestone achievement, of which $0.6 million and $0.3 million were recorded as research and development expenses in the Consolidated Statements of Operations in the years ended December 31, 2018 and 2016 , respectively. Long-Lived Assets Equipment is stated at acquired cost less accumulated depreciation. Laboratory and office equipment are depreciated on the straight-line basis over the estimated useful lives ( three to ten years ). Leasehold improvements are amortized over the shorter of the lease term or estimated useful life. Long-lived assets are evaluated for impairment when events or changes in circumstances indicate that the carrying amount of the asset or related group of assets may not be recoverable. If the expected future undiscounted cash flows are less than the carrying amount of the asset, an impairment loss is recognized at that time. Measurement of impairment may be based upon appraisal, market value of similar assets or discounted cash flows. Proceeds from Insurance In 2016, our facility sustained flood damage representing both an unusual and infrequent event, and we recognized a net insurance recovery gain of $0.7 million in 2016 that was reported as a separate component of our loss from operations. An additional $0.6 million of insurance proceeds, net of associated expenses, were received in 2018, concluding the insurance claim. Proceeds from insurance settlements, except for those directly related to investing or financing activities, were recognized as cash inflows from operating activities. 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. Patent Costs and Rights Costs of applying for, prosecuting and maintaining patents and patent rights are expensed as incurred. We have filed for broad intellectual property protection on our proprietary technologies and have numerous United States and international patents and patent applications related to our technologies. Warrants We account for common stock warrants as either liabilities or as equity instruments depending on the specific terms of the warrant agreements. Generally, warrants are classified as liabilities, as opposed to equity, if the agreement includes the potential for a cash settlement or an adjustment to the exercise price, and warrant liabilities are recorded at their fair values at each balance sheet date. We classify these warrant liabilities on the consolidated balance sheet as non-current liabilities. 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 warrants are reflected in the consolidated statement of operations as income or expense from change in fair value of warrants. We had no warrant liabilities at December 31, 2018 and 2017, since certain warrants that were classified as liabilities expired during 2017. Refer to Note F for a warrant issued in 2018 to Healios (the “Healios Warrant”), which is accounted for as an equity instrument. Concentration of Credit Risk Our accounts receivable are generally comprised of amounts due from collaborators and granting authorities and are subject to concentration of credit risk due to the absence of a large number of customers. At December 31, 2018 , the majority of our accounts receivable are due from Healios. We do not typically require collateral from our customers. Use of Estimates The preparation of financial statements in conformity with accounting principles generally accepted in the United States requires management to make estimates and assumptions that affect the amounts reported in the financial statements and accompanying notes. Actual results could differ from those estimates. Stock-Based Compensation We recognize stock-based compensation expense on the straight-line method and use a Black-Scholes option-pricing model to estimate the fair value of option awards. The expected term of options granted represent the period of time that option grants are expected to be outstanding. We use the “simplified” method to calculate the expected life of option grants given our limited history of exercise activity and determine volatility by using our historical stock volatility. The fair value of our restricted stock units are equal to the closing price of our common stock on the date of grant and is expensed over the vesting period on a straight-line basis. Estimates of fair value are not intended to predict actual future events or the value ultimately realized by persons that receive equity awards. Options may be exercised for cash or by a cashless exercise that is permitted under certain conditions. In the event of a cashless exercise, we retain the number of shares equivalent to the exercise cost based on the market value at the time of exercise and issue the net number of shares to the holder. We recognize income tax benefits and deficiencies as income tax expense or benefit in the consolidated statement of operations and the tax effects of exercised or vested awards are treated as discrete items in the reporting period in which they occur. We also recognize excess tax benefits regardless of whether the benefit reduces taxes payable in the current period. Excess tax benefits are classified along with other income tax cash flows as an operating activity in the consolidated statement of cash flows. In regards to forfeitures, we account for them when they occur following the adoption of ASU 2016-09, Compensation - Stock Compensation - Improvements to Employee Share-Based Payment Accounting, in 2017. All of the aforementioned estimates and assumptions are evaluated on a quarterly basis and may change as facts and circumstances warrant. Changes in these assumptions can materially affect the estimate of the fair value of our share-based payments and the related amount recognized in our financial statements. Annual stock-based awards to employees typically vest over a four -year period, although the 2018 awards vest over a three -year period, have an exercise price equal to the fair market value of a share of common stock on the grant date and have a contractual term of 10 years. The following weighted-average input assumptions were used in determining the fair value of the Company’s stock options: December 31, 2018 2017 2016 Volatility 70.8 % 71.2 % 70.3 % Risk-free interest rate 2.8 % 2.0 % 1.5 % Expected life of option 6.0 years 6.2 years 6.2 years Expected dividend yield 0.0 % 0.0 % 0.0 % Income Taxes Deferred tax liabilities and assets are determined based on the differences between the financial reporting and tax basis of assets and liabilities and are measured using the tax rate and laws currently in effect. We evaluate our deferred income taxes to determine if a valuation allowance should be established against the deferred tax assets or if the valuation allowance should be reduced based on consideration of all available evidence, both positive and negative, using a “more likely than not” standard. We had no liability for uncertain income tax positions as of December 31, 2018 and 2017 . Our policy is to recognize potential accrued interest and penalties related to the liability for uncertain tax benefits, if applicable, in income tax expense. Net operating loss and credit carryforwards since inception remain open to examination by taxing authorities, and will for a period post utilization. Refer to Note H regarding recent tax reform. 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. For each reporting period in which we have outstanding warrants, we evaluate the income from such warrant liabilities and consider whether it results in a potentially dilutive effect to net loss per share. There were no such dilutive effects from warrant liabilities for each of the periods ended December 31, 2018, 2017 and 2016. We have outstanding options, restricted stock units and outstanding 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: Years ended December 31, 2018 2017 2016 Stock options 10,955,508 8,919,113 9,236,228 Restricted stock units 1,656,688 1,648,986 1,201,159 Warrants, including Healios Warrant 18,500,000 — 1,893,527 31,112,196 10,568,099 12,330,914 Recently Issued Accounting Standards In August 2018, the Financial Accounting Standards Board (“FASB”) issued ASU 2018-15, Intangibles-Goodwill and Other-Internal-Use Software: Customer’s Accounting for Implementation Costs Incurred in a Cloud Computing Arrangement that is a Service Contract (“ASU 2018-15”). ASU 2018-15 requires implementation costs incurred by customers in cloud computing arrangements (i.e., hosting arrangements) to be capitalized under the same premises of authoritative guidance for internal-use software and deferred over the noncancellable term of the cloud computing arrangements plus any option renewal periods that are reasonably certain to be exercised by the customer or for which the exercise is controlled by the service provider. The guidance is effective for the annual and interim periods beginning after December 15, 2019, with early adoption permitted. We have outstanding cloud computing arrangements and continue to incur costs that we believe may be required to be capitalized under ASU 2018-15, including those related to our 2018 implementation of a new enterprise resource planning system. We are currently evaluating the potential impact of adoption of this standard on our consolidated financial statements and we do not intend to early adopt. In August 2018, the FASB issued ASU 2018-13, Fair Value Measurements (“Topic 820”): Disclosure Framework - Changes to the Disclosure Requirements for Fair Value Measurement , which adds, modifies and removes several disclosure requirements relative to the three levels of inputs used to measure fair value in accordance with Topic 820, Fair Value Measurement . This guidance is effective for fiscal years beginning after December 15, 2019, including interim periods within that fiscal year. Early adoption is permitted. We are currently assessing the effect that this ASU will have on our disclosures. In February 2016, the FASB issued ASU 2016-02, Leases (“Topic 842”), which requires lessees to put most leases with a term greater than 12 months on their balance sheets, but recognize expenses on their statement of operations in a manner similar to current accounting practice. Under the guidance, lessees initially recognize a lease liability for the obligation to make lease payments and a right-of-use (“ROU”) asset for the right to use the underlying asset for the lease term. The lease liability is measured at the present value of the lease payments over the lease term. The ROU asset is measured at the lease liability amount, adjusted for lease prepayments, lease incentives received and the lessee’s initial direct costs. The guidance is effective for the annual and interim periods beginning after December 15, 2018. We adopted Topic 842 effective January 1, 2019. We will elect the ‘package of practical expedients’ and will not reassess our prior conclusions about lease identification, lease classification and initial direct costs. We will also elect the short-term lease recognition exemption for all leases that qualify and will not recognize right-of-use assets or lease liabilities for those leases. Based on contracts in place at December 31, 2018, we expect our ROU asset and lease liability recorded will be approximately 2% of our total assets and do not expect the standard to have a material effect on our cash flows or results of operations. In June 2018, the FASB issued ASU 2018-07, Compensation - Stock Compensation (“Topic 718”), Improvements to Nonemployee Share-Based Payment Accounting. This aligns the measurement and classification guidance for share-based payments to nonemployees with that for employees, with certain exceptions. It also expands the scope of Topic 718 to include share-based payments granted to nonemployees in exchange for goods or services used or consumed in the entity's own operations. We have elected to early adopt this guidance which did not materially impact our consolidated financial statements. In August 2018, the Securities and Exchange Commission (“SEC”) issued the final rule under SEC Release No. 33-10532, Disclosure Update and Simplification , that amends certain of its disclosure requirements that have become redundant, duplicative, overlapping, outdated or superseded. The amendments include replacing the requirement to disclose the high and low trading prices of entity's ordinary shares with a requirement to disclose the ticker symbol of its shares. Additionally, the final rule extends to interim periods the annual disclosure requirement of presenting changes in each caption of stockholders' equity and the amount of dividends per share. These disclosures are required to be provided for the current and comparative year-to-date interim periods. We have adopted all relevant disclosure requirements in our annual report on Form 10-K for the year ended December 31, 2018. In November 2018, the FASB issued ASU 2018-18, Collaborative Arrangements (“Topic 808”): Clarifying the Interaction between Topic 808 and Topic 606 . The amendments in this update make targeted improvements to generally accepted accounting principles (“GAAP”) for collaborative arrangements as follows: clarify that certain transactions between collaborative arrangement participants should be accounted for as revenue under Topic 606 when the collaborative arrangement participant is a customer in the context of a unit of account. In those situations, all the guidance in Topic 606 should be applied, including recognition, measurement, presentation, and disclosure requirements; add unit-of-account guidance in Topic 808 to align with the guidance in Topic 606 (that is, a distinct good or service) when an entity is assessing whether the collaborative arrangement or a part of the arrangement is within the scope of Topic 606; and require that in a transaction with a collaborative arrangement participant that is not directly related to sales to third parties, presenting the transaction together with revenue recognized under Topic 606 is precluded if the collaborative arrangement participant is not a customer. The provisions of ASU 2018-18 are effective for years beginning after December 15, 2019, with early adoption permitted. We are currently evaluating the impact of this clarifying guidance. |
Equipment
Equipment | 12 Months Ended |
Dec. 31, 2018 | |
Property, Plant and Equipment [Abstract] | |
Equipment | Equipment December 31, Equipment consists of (in thousands): 2018 2017 Laboratory equipment $ 7,444 $ 6,262 Office equipment and leasehold improvements 3,043 3,039 Process development equipment not yet in service 822 363 11,309 9,664 Accumulated depreciation (8,307 ) (7,458 ) $ 3,002 $ 2,206 In 2017 , we disposed of approximately $0.8 million of obsolete laboratory equipment, office equipment and leasehold improvements, all of which were fully depreciated. |
Financial Instruments
Financial Instruments | 12 Months Ended |
Dec. 31, 2018 | |
Fair Value Disclosures [Abstract] | |
Financial Instruments | 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 December 31, 2018 , we had no financial assets or liabilities measured at fair value on a recurring basis. The Healios Warrant that was issued in March 2018 was measured at fair value on a nonrecurring basis and is a Level 3 equity instrument under the hierarchy. Refer to Note F regarding its valuation. Financing Arrangements We lease office and laboratory space under operating leases. The lease for our corporate offices and laboratories began in 2000 and currently expires in March 2021, with options to renew annually through March 2024. Our rent is $267,000 per year and our rental rate has not changed since the lease inception in 2000. We also lease office and laboratory space for our Belgian subsidiary, which expires in July 2020 (we renewed the lease for an additional term in March 2019). This lease includes options to renew annually through July 2022 and annual rent expense is approximately $196,000 , subject to adjustments based on an inflationary index. Rent expense is recognized on a straight-line basis over the minimum lease term. Aggregate rent expense was approximately $493,000 , $477,000 and $465,000 in 2018 , 2017 and 2016 , respectively. The future annual minimum lease commitments at December 31, 2018 are approximately $393,000 for 2019 , $297,000 for 2020 , and $ 90,000 for 2021 . Refer to Note B regarding our adoption of ASU 2016-02 in January 2019 to account for our leases. We paid no interest during the three years ended December 31, 2018 . |
Collaborative Arrangements and
Collaborative Arrangements and Revenue Recognition | 12 Months Ended |
Dec. 31, 2018 | |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | |
Collaborative Arrangements and Revenue Recognition | Collaborative Arrangements and Revenue Recognition Healios Collaboration In 2016, we entered into a license agreement (the “First License Agreement”) with Healios to develop and commercialize MultiStem cell therapy for ischemic stroke in Japan and to provide Healios with access to our proprietary MAPC technology for use in Healios' “organ bud” program, initially for transplantation to treat liver disease or dysfunction. Under the terms of the First License Agreement, Healios also obtained a right 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 at that time included acute respiratory distress syndrome (“ARDS”) and another indication in the orthopedic area, and all indications for the “organ bud” program. In accordance with the First License Agreement, in addition to potential royalties and milestones, we received a nonrefundable up-front cash payment of $15 million , and if expanded at Healios’ election, Healios would pay an additional $10 million cash payment. Healios exercised its option to expand the collaboration in June 2018, as described below. Under the collaboration, Healios is responsible for the development and commercialization of the MultiStem product in the licensed territories, and we provide manufacturing services to Healios, currently comprising the supply of product for its clinical trials and the transfer of technology to a contract manufacturer in Japan to produce product for Healios. We receive payments for these products and services provided to Healios. In 2017, we signed a clinical trial supply agreement for delivering the planned manufacturing services for Healios’ clinical trial in Japan treating ischemic stroke patients. The clinical trial supply agreement was amended later that year to clarify the operational elements, terms and cost-sharing arrangement associated with our supply of clinical material and certain adjustments to potential milestone payments related to the clinical product supply for Healios’ TREASURE study in Japan. Healios’ cost-share payments may be creditable against milestone payments that may become due under the First License Agreement and a sales milestone would be increased, or such payments may be repaid by us at our election. Services to Healios under the clinical trial supply agreement are ongoing. Also in 2017, we entered into a technology transfer services agreement with Healios, in which Healios provides financial support to establish a contract manufacturer in Japan to produce product for Healios. At that time, we also amended the First License Agreement to confer to Healios a limited license to manufacture MultiStem in the event that we are acquired by a third-party. Services to Healios under the technology transfer services agreement are ongoing. In March 2018, we entered into a letter of intent (“LOI”), with Healios outlining the terms for a potential expansion of the relationship with Healios beyond that contemplated by the First License Agreement, to include, among other things, the exercise of its option to license the ARDS field in Japan and organ buds for all organ diseases, a worldwide exclusive license for use of MultiStem product to treat certain ophthalmological indications, and an exclusive option to a license to develop and commercialize certain MultiStem treatments in China. In connection with the LOI, in March 2018, Healios purchased 12,000,000 shares of our common stock and the Healios Warrant for $21.1 million , or approximately $1.76 per share. In June 2018, Healios exercised its option to expand the collaboration to include ARDS and expand organ bud as contemplated by the First License Agreement, and entered into the Collaboration Expansion Agreement (“CEA”) that included new license agreements and rights that further broadened the collaboration. Under the CEA, Healios (i) expanded its First License Agreement to include ARDS in Japan, expanded the organ bud license to include all transplantation indications, and terminated Healios’ right to include a designated orthopedic indication per the First License Agreement; (ii) obtained a worldwide exclusive license, or the Ophthalmology License Agreement, for use of MultiStem product to treat certain ophthalmological indications; (iii) obtained an exclusive license in Japan (“the Combination Product License Agreement”), for use of the MultiStem product to treat diseases of the liver, kidney, pancreas and intestinal tissue through local administration of MultiStem in combination with iPSC-derived cells; (iv) obtained an exclusive, time-limited right of first negotiation (“ROFN Period”) to enter into an option for a license to develop and commercialize certain MultiStem treatments in China; and (v) an option for an additional non-therapeutic technology license. For all indications, Healios is responsible for the costs of clinical development in its licensed territories, and we provide manufacturing services to Healios. For the rights granted to Healios under the CEA, Healios paid us a nonrefundable, up-front cash payment of $10.0 million to exercise its option to license ARDS and expand its license for organ bud, as contemplated by the First License Agreement, and paid an additional $10.0 million for the new license rights, which has been paid in full in four quarterly installment payments of $2.5 million . The payments were received in the second, third and fourth quarters of 2018 with the final payment received in the first quarter of 2019. Healios may elect to credit up to $10.0 million against milestone payments that may become due under the First License Agreement, as expanded to include ARDS, with limitations on amounts that may be credited to earlier milestone payments versus later milestone payments. For each of the ischemic stroke indication and the ARDS indication, we may receive success-based regulatory filing and approval and sales milestones aggregating up to $225 million in aggregate for each indication, subject to potential milestone credits. Milestone payments are non-refundable and non-creditable towards future royalties or any other payment due from Healios. We may 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. For standalone products sold by Healios under the Ophthalmology License Agreement, we are entitled to receive success-based regulatory filing and approval and sales milestones aggregating up to $135.6 million and tiered royalties on net product sales in the single digits depending on net sales levels. For the combination products under the Ophthalmology License Agreement, we will be entitled to receive a low single-digit royalty, but no milestone payments. Under the Combination Product License Agreement, we are entitled to receive a low single-digit royalty on net sales of the combination product treatments, but no milestone payments. For the “organ bud” product, we are entitled to receive a fractional royalty percentage on net sales of the “organ bud” products; and we have a time-limited right of first negotiation for commercialization of an “organ bud” product in North America. Under the CEA, the ROFN Period with respect to the option for a license in China was initially to expire on September 1, 2018, but was extended to June 30, 2019 in exchange for a $2.0 million payment from Healios that we received in December 2018. Furthermore, Healios may make an additional payment of $3.0 million to extend the ROFN Period for another six months through December 31, 2019. All such extension payments would be creditable against the option fee payable by Healios upon execution of a China option agreement if entered into, or Healios may apply the extension payment amounts as credits against any potential milestone payments under the current licenses, subject to certain limitations. In connection with the entry into the CEA, we amended the terms of the Healios Warrant as addressed in Note F. Healios Revenue Recognition At the inception of the Healios arrangement and again each time that the arrangement has been modified, all material performance obligations were identified, which include (i) licenses to our technology, (ii) product supply services, and (iii) services to transfer technology to a contract manufacturer on Healios’ behalf. It was determined that these performance obligations were both capable of being distinct and distinct within the context of the contract. We develop assumptions that require judgment to determine the standalone selling price in order to account for our collaborative agreements, as these assumptions typically include probabilities of obtaining marketing approval for the product candidates, estimated timing of commercialization, estimated future cash flows from potential product sales of our product candidates, estimating the cost and markup of providing product supply and technical services, and appropriate discount rates. In order to determine the transaction price, in addition to the fixed payments, we estimate the amount of variable consideration utilizing the expected value or most likely amount method, depending on the facts and circumstances relative to the contract, and the estimates for variable consideration are reassessed each reporting period. We constrain, or reduce, the estimates of variable consideration if it is probable that a significant reversal of previously recognized revenue could occur throughout the life of the contract, and both the likelihood and magnitude of a potential reversal of revenue are taken into consideration. At inception and upon each modification date, once the estimated transaction price is established, amounts are allocated to each separate performance obligation on a relative standalone selling price basis. These performance obligations include any remaining, undelivered elements at the time of modifications and any new elements from a modification to the arrangement if the conditions are not met for being treated as a separate agreement. Following the June 2018 modification, the specific performance obligations that had been delivered included the licenses, and the performance obligations that were not yet fully delivered included clinical product manufacturing services and technology transfer services that we provide to a contract manufacturer in Japan. In the third quarter of 2018, an additional modification was executed to add clinical product manufacturing services for Healios’ planned ARDS study, which resulted in a new performance obligation, creating a modification to the arrangement and remeasurement of the transaction and standalone selling prices for the undelivered elements on the modification date. For performance obligations satisfied over time, we apply an appropriate method of measuring progress each reporting period and, if necessary, adjust the estimates of performance and the related revenue recognition. Our technology transfer services are satisfied over time, and we recognize revenue in proportion to the contractual services provided. For performance obligations satisfied at a point in time (i.e., product supply), we recognize revenue upon delivery. The remaining transaction price for the performance obligations that were not yet delivered amounted to $3.6 million at December 31, 2018, which is expected to be recognized within one year as the goods and services are delivered. At December 31, 2018, the contract liability included in deferred revenue - Healios on the consolidated balance sheets, is properly classified as a current liability since the rights to consideration are expected to be satisfied, in all material respects, within one year. We included as a reduction of the transaction price of the licenses granted in the June 2018 expansion, the value of a portion of the Healios Warrant that was issued in March 2018 in connection with the then-proposed expansion under a letter of intent. Under the agreements in the June 2018 expansion that included an amendment to the Healios Warrant, 4,000,000 shares (“Warrant Shares”) became exercisable, and as a result, $1.1 million of the $5.3 million initial warrant valuation was recorded in June 2018 as a reduction of revenue. In accordance with the June 2018 amendment to the Healios Warrant, the remaining 16,000,000 shares would not be exercisable until the execution of an option for a license in China, and the remaining $4.2 million of the Healios Warrant was reversed against additional paid-in-capital. See Note F. Also, see Note B regarding our revenue recognition policies. Advance from Healios In 2017, we amended the clinical trial supply agreement for the manufacturing of investigational product for Healios for its Japan stroke clinical study to clarify a cost-sharing arrangement. The proceeds from Healios that relate specifically to the cost-sharing arrangement may either (i) result in a reduction in the proceeds we receive from Healios upon the achievement of two potential milestones and an increase to a commercial milestone under the First License Agreement for stroke, or (ii) be repaid to Healios at our election, as defined. The cost-sharing proceeds received are recognized on the balance sheet as a non-current advance from customer until the related milestone is achieved, unless such amounts are repaid to Healios at our election, at which time, the culmination of the earnings process will be complete and revenue will be recognized. Other Collaborators Under our 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, we have been receiving royalties on worldwide commercial sales of implants using our technologies and cash payments upon the achievement of certain commercial milestones. No milestone revenues have been received in 2018, and we received a commercial milestone payment of $1.0 million in 2017. However, RTI has announced that it will cease distribution of its bone graft product that utilizes our technology, and we expect royalty proceeds to cease. In 2017, we received a $0.3 million option fee from an animal health company in exchange for an exclusive period to evaluate our technology with an option to negotiate for a license to the technology for an animal health area. The nonrefundable option fee was initially recorded as deferred revenue and was recognized in the second quarter of 2018 as the agreement had expired. Disaggregation of Revenues We recognize license-related amounts, including upfront payments, exclusivity fees, additional disease indication fees, and development, regulatory and sales-based milestones, at a point in time when earned. Similarly, product supply revenue is recognized at a point in time, while service revenue is recognized when earned over time. The following table presents our contract revenues disaggregated by timing of revenue recognition and excludes royalty revenue (in thousands): Twelve months ended December 31, 2018 Point in Time Over Time Contract revenue from Healios: License fee revenue $ 17,682 $ — Product supply revenue 1,445 — Service revenue — 3,149 Other contract revenue 251 — Total disaggregated revenues $ 19,378 $ 3,149 |
Capitalization and Warrant Inst
Capitalization and Warrant Instruments | 12 Months Ended |
Dec. 31, 2018 | |
Equity [Abstract] | |
Capitalization and Warrant Instruments | Capitalization and Warrant Instruments Capitalization At December 31, 2018 and December 31, 2017, we had 300 million shares of common stock and 10.0 million shares of undesignated preferred stock authorized. No shares of preferred stock have been issued as of December 31, 2018 . 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. The following shares, in thousands, of common stock were reserved for future issuance: December 31 2018 2017 Stock-based compensation plans 16,096 16,952 Healios Warrants to purchase common stock 18,500 — Shares issuable upon patent milestone — 500 34,596 17,452 Proceeds from warrant exercises were $1.9 million and $0.2 million in 2017 and 2016 , respectively. Equity Issuance - Healios In March 2018, Healios purchased 12,000,000 shares of our common stock for $21.1 million , or approximately $1.76 per share, and the Healios Warrant to purchase up to an additional 20,000,000 shares. In connection with this investment, we entered into an Investor Rights Agreement that governs certain rights of Healios and us relating to Healios’ ownership of our common stock. The Investor Rights Agreement provides for customary standstill and voting obligations, transfer restrictions and registration rights for Healios. Additionally, we agree to provide notice to Healios of certain equity issuances and to allow Healios to participate in certain issuances in order maintain its proportionate ownership of our common stock as of the time of such issuance. We further agreed that during such time as Healios beneficially owns more than 5.0% but less than 15.0% of our outstanding common stock, our Board of Directors (the “Board”) will nominate a Healios nominee suitable to us to become a member of the Board, and during such time as Healios beneficially owns 15.0% or more of our outstanding common stock, our Board will nominate two suitable Healios nominees to become members of the Board, at each annual election of directors. Healios nominated an individual to the Board, who was elected at the 2018 annual stockholders’ meeting. As a result of Healios’ investment, Healios became a related party, and the transactions with Healios are separately identified within these financial statements as related party transactions. The value of the Healios Warrant was considered as an element of compensation in the transaction price of the Healios collaboration expansion. The Healios Warrant originally would not become effective until the expansion as contemplated under the LOI became effective in June 2018 and the first payment was made under the expansion. Upon entering into the CEA, the Healios Warrant became exercisable with respect to 4,000,000 Warrant Shares. These Warrant Shares are exercisable at the greater of $1.76 and the Reference Price (which is generally 110% of the average closing price per share of the Company’s common stock for the ten trading days ending on the trading day immediately preceding the date the Warrant is exercised). The remaining 16,000,000 shares underlying the Healios Warrant will become exercisable only if Healios agrees to execute an option for a license in China. As of December 31, 2018, 1,500,000 of the 16,000,000 shares underlying the Healios Warrant will no longer be exercisable according to the terms of the Healios Warrant. Other Healios Warrant terms include a general expiration date in September 2020 , as defined, fixed and floating exercise price mechanisms, and an exercise cap triggered at Healios’ ownership of 19.9% of our common stock. The Healios Warrant may be terminated by us under certain conditions. We evaluated the various terms of the Healios Warrant and concluded that it is accounted for as an equity instrument at inception and $5.3 million was computed as the best estimate of the fair value of the Healios Warrant at the time of issuance in March 2018. The fair value was computed using a Monte Carlo simulation model that included probability-weighted estimates of potential milestone points in time that could impact the value of the Healios Warrant during its term. The fair value was recorded as additional paid-in capital in the first quarter of 2018, with the offset being included in other asset related to Healios, and the asset would be included as an element of compensation in the transaction price upon the expansion proposed in March 2018 under the LOI. Upon the modification of the Healios Warrant in June 2018 in connection with the expansion of the collaboration, we reassessed the fair value of the Healios Warrant immediately before and after the modification using the same valuation methodology providing for no incremental fair value to be recorded. The value of the 4,000,000 tranche of Warrant Shares that became effective upon the June 2018 expansion of $1.1 million was recorded as a reduction to the revenue recognized for the delivered licenses in June 2018. See Note E . However, since the June 2018 expansion agreements made the 16,000,000 shares underlying the Healios Warrant contingent on entering into an option for a license in China, we considered the ability to apply the $4.2 million value of such warrant shares as an element of compensation to be constrained. Therefore, the remaining asset was reversed against additional paid-in-capital. Equity Purchase Agreement We have had equity purchase agreements in place since 2011 with Aspire Capital Fund LLC (“Aspire Capital”) that provide us the ability to sell shares to Aspire Capital from time to time, as appropriate. The current agreement with Aspire Capital was entered into in February 2018 and includes Aspire Capital’s commitment to purchase up to an aggregate of $100.0 million of shares of our common stock over a three -year period. The terms of the 2018 equity facility are similar to the previous arrangements, and we issued 450,000 shares of our common stock to Aspire Capital as a commitment fee in February 2018 and filed a registration statement for the resale of 24,700,000 shares of common stock in connection with the new equity facility. Also in connection with this equity facility, in February 2018, Aspire Capital invested $1.0 million in us at $2.00 per share of common stock. During the years ended December 31, 2018 , 2017 and 2016 , we sold 8,708,582 , 9,400,000 , and 2,191,418 shares, respectively, to Aspire Capital at average prices of $1.78 , $1.75 and $1.84 per share, respectively. As of February 28, 2019, we had approximately 18.1 million shares remaining to sell to Aspire Capital under the 2018 agreement. License Agreement and Settlement In October 2017, we entered into an agreement to settle longstanding intellectual property disagreements with a third party. As part of the agreement, we were granted a worldwide, non-exclusive license, with the right to sublicense, to the other party’s patents and applications that were at the core of the intellectual property dispute, for use related to the treatment or prevention of disease or conditions using cells. In return, we agreed not to enforce our intellectual property rights against the party with respect to certain patent claims, nor to further challenge the patentability or validity of certain applications or patents. Upon execution of the license and settlement agreement in 2017, we paid $0.5 million and issued 1,000,000 shares of our common stock with a fair value of $2.3 million . In 2018, in accordance with the agreement, we paid an additional $1.0 million and we issued 500,000 additional shares of our common stock related to a patent issuance. This contingent obligation to issue 500,000 shares of common stock was originally recorded in accrued license fee expense on the consolidated balance sheets at December 31, 2017 at a fair value of $0.9 million . The actual issuance of the 500,000 shares in May 2018 was recorded at an actual fair value of $1.2 million , resulting in $0.3 million of additional paid-in-capital and research and development expense in 2018. There will be no royalty, milestone or other payments due to the third party associated with the development and commercialization of our cell therapy products. Our payment obligations are concluded. |
Stock-Based Compensation
Stock-Based Compensation | 12 Months Ended |
Dec. 31, 2018 | |
Disclosure of Compensation Related Costs, Share-based Payments [Abstract] | |
Stock-Based Compensation | Stock-Based Compensation We have a long-term incentive plan (“LTIP”) that has an aggregate of 20,035,000 authorized shares of common stock for awards to employees, directors and consultants. The LTIP provides for 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 December 31, 2018 , a total of 5,120,464 shares (including 250,579 shares related to an expired incentive plan) of common stock have been issued under our equity incentive plans. As of December 31, 2018 , a total of 3,483,912 shares were available for issuance under our LTIP, and stock-based awards to purchase 12,612,196 shares (including 930,993 shares related to the expired incentive plan) of common stock were outstanding. We recognized $3.8 million , $3.0 million and $2.9 million of stock-based compensation expense in 2018 , 2017 and 2016 , respectively. Stock Options The weighted average fair value of options granted in 2018 , 2017 and 2016 was $1.46 , $0.95 and $1.35 per share, respectively. The total fair value of options vested during 2018 , 2017 and 2016 was $2.5 million , $2.0 million and $1.7 million , respectively. The total intrinsic value of options exercised during the years ended December 31, 2018, 2017 and 2016 was not significant. At December 31, 2018 , total unrecognized estimated compensation cost related to unvested stock options was approximately $5.3 million , which is expected to be recognized by the end of 2022 using the straight-line method. The weighted average contractual life of unvested options at December 31, 2018 was 8.7 years . The aggregate intrinsic value of fully vested option shares and option shares expected to vest as of December 31, 2018 was $0.2 million . A summary of our stock option activity and related information is as follows: Number of Options Weighted Average Exercise Price Outstanding January 1, 2016 7,052,642 $ 3.05 Granted 2,840,000 2.13 Exercised (164,827 ) 1.56 Forfeited / Expired (491,587 ) 3.57 Outstanding December 31, 2016 9,236,228 2.76 Granted 2,596,480 1.47 Exercised (136,056 ) 1.50 Forfeited / Expired (2,777,539 ) 4.76 Outstanding December 31, 2017 8,919,113 1.78 Granted 2,434,732 2.26 Exercised (112,484 ) 1.57 Forfeited / Expired (285,853 ) 2.62 Outstanding December 31, 2018 10,955,508 $ 1.87 Vested during 2018 2,045,058 $ 1.83 Vested and exercisable at December 31, 2018 6,630,228 $ 1.83 December 31, 2018 Options Outstanding Options Vested and Exercisable Exercise Price Number of Options Weighted Average Remaining Contractual Life Weighted Average Exercise Price Number of Options Weighted Average Remaining Contractual Life Weighted Average Exercise Price $1.01 – $1.71 5,634,994 6.7 years $ 1.50 4,058,842 4.4 years $ 1.52 $1.81 – $2.31 5,031,451 8.3 years $ 2.19 2,287,573 3.4 years $ 2.14 $2.45 – $5.28 289,063 2.1 years $ 3.53 283,813 2.1 years $ 3.55 10,955,508 6,630,228 Restricted Stock Units A summary of our restricted stock unit activity and related information is as follows: Number of Restricted Stock Units Weighted Average Fair Value Outstanding January 1, 2016 1,069,100 $ 1.55 Granted 933,552 2.19 Vested-common stock issued (732,720 ) 1.71 Forfeited / Expired (68,773 ) 1.90 Outstanding December 31, 2016 1,201,159 1.92 Granted 1,054,720 1.46 Vested-common stock issued (571,118 ) 1.75 Forfeited / Expired (35,775 ) 1.82 Outstanding December 31, 2017 1,648,986 1.69 Granted 787,968 2.31 Vested-common stock issued (741,424 ) 1.81 Forfeited / Expired (38,842 ) 1.74 Outstanding December 31, 2018 1,656,688 $ 1.93 Vested/Issued cumulative at December 31, 2018 4,569,865 $ 1.73 The total fair value of restricted stock units vested during 2018 , 2017 and 2016 was $1.3 million , $1.0 million and $1.3 million , respectively. At December 31, 2018 , total unrecognized estimated compensation cost related to unvested restricted stock units was approximately $3.1 million , which is expected to be recognized by the end of 2021 using the straight-line method. |
Income Taxes
Income Taxes | 12 Months Ended |
Dec. 31, 2018 | |
Income Tax Disclosure [Abstract] | |
Income Taxes | Income Taxes At December 31, 2018 , we had U.S. federal net operating loss and research and development tax credit carryforwards of approximately $151.4 million and $10.0 million , respectively. Such operating losses and tax credits may be used to reduce future taxable income and tax liabilities and will expire at various dates between 2032 and 2038 . Additionally, as of December 31, 2018, we had federal net operating loss carryforwards generated after 2017 of $ 16.8 million that have an indefinite life, but with usage limited to 80% of taxable income in any given year. We also had foreign net operating loss carryforwards of approximately $21.6 million . Such foreign net operating loss carryforwards do not expire. We also had state and city net operating loss carryforwards aggregating approximately $65.5 million . Such state and city net operating loss carryforwards may be used to reduce future taxable income and tax liabilities and will expire at various dates between 2019 and 2038 . The utilization of net operating loss and tax credit carryforwards generated prior to October 2012 (the “Section 382 Limited Attributes”) is substantially limited under Section 382 of the Internal Revenue Code of 1986, as amended, (the “IRC”). We generated U.S. federal net operating loss carryforwards of $116.8 million , research and development tax credits of $10.0 million , and state and local net operating loss carryforwards of $65.3 million since 2012. We will update our analysis under Section 382 prior to using these attributes. A reconciliation of the federal statutory income tax rate to our effective tax rate is as follows: Percent of Income before Income Taxes 2018 2017 Statutory federal income tax rate 21.0 % 34.0 % State income taxes - net of federal tax benefit 0.9 % 0.8 % Other permanent differences (3.7 )% (5.5 )% Valuation allowances (29.2 )% 24.1 % Federal rate change — % (57.9 )% Research and development - U.S. 11.0 % 4.5 % Research and development - Foreign — % — % Effective tax rate for the year — % — % Significant components of our deferred tax assets are as follows (in thousands): December 31, 2018 2017 Net operating loss carryforwards $ 38,813 $ 35,409 Research and development credit carryforwards 9,979 7,301 Compensation expense 1,552 652 Other 1,166 1,467 Total deferred tax assets 51,510 44,829 Valuation allowance for deferred tax assets (51,510 ) (44,829 ) Net deferred tax assets $ — $ — Because of our cumulative losses, substantially all of the deferred tax assets have been fully offset by a valuation allowance. We have not paid income taxes for the three-year period ended December 31, 2018 . In December 2017, the U.S. federal government enacted legislation commonly referred to as the “Tax Cuts and Jobs Act” (the “TCJA”). The TCJA made widespread changes to the IRC, including, among other items, a reduction in the federal corporate tax rate from 35% to 21% , effective January 1, 2018. The TCJA also eliminated alternative minimum tax and the 20-year carryforward limitation for net operating losses incurred after December 31, 2017, and imposes a limit on the usage of net operating losses incurred after such date equal to 80% of taxable income in any given year. The 80% usage limit will not have an economic impact on us until our current net operating losses are either utilized or expire. The carrying value of our deferred tax assets and liabilities is determined by the enacted U.S. corporate income tax rate. Consequently, any changes in the U.S. corporate income tax rate impacts the carrying value of our deferred tax assets and liabilities. The Deemed Repatriation Transition Tax (“Transition Tax”) is a tax on previously untaxed accumulated and current earnings and profit (“E&P”) of certain of our foreign subsidiaries. To determine the amount of Transition Tax, a company must determine, in addition to other factors, the amount of post-1986 E&P of the relevant foreign subsidiaries as well as the amount of non-U.S. income tax paid on such earnings. We have an overall foreign E&P deficit and accordingly have not recorded any Transition Tax obligation as of December 31, 2018 . As of December 31, 2018, we have completed the accounting for all the impacts of the TCJA. We continue to evaluate the impacts of the TCJA and will consider additional guidance from the U.S. Treasury Department, Internal Revenue Service or other standard-setting bodies. However, no additional adjustments were recorded by us during the measurement period in 2018 as permitted by SEC Staff Accounting Bulletin 118, Income Tax Accounting Implications of the Tax Cuts and Jobs Act . |
Profit Sharing and 401(k) Plan
Profit Sharing and 401(k) Plan | 12 Months Ended |
Dec. 31, 2018 | |
Postemployment Benefits [Abstract] | |
Profit Sharing and 401(k) Plan | Profit Sharing and 401(k) Plan We have a profit sharing and 401(k) plan that covers substantially all employees and allows for discretionary contributions by us. We make employer contributions to this plan, and the expense was approximately $0.5 million , $0.3 million and $0.3 million in 2018 , 2017 and 2016 , respectively. |
Quarterly Financial Data (unaud
Quarterly Financial Data (unaudited) | 12 Months Ended |
Dec. 31, 2018 | |
Quarterly Financial Information Disclosure [Abstract] | |
Quarterly Financial Data (unaudited) | Quarterly Financial Data (unaudited) The following table presents quarterly data for the years ended December 31, 2018 and 2017 , in thousands, except per share data: 2018 First Quarter Second Quarter Third Quarter Fourth Quarter Full Year Revenues (1) $ 1,066 $ 19,391 $ 2,321 $ 1,513 $ 24,291 Income (loss) from operations (10,262 ) 6,745 (9,976 ) (11,552 ) (25,045 ) Net income (loss) (10,155 ) 6,933 (9,740 ) (11,321 ) (24,283 ) Basic and diluted net loss per common share $ (0.08 ) $ 0.05 $ (0.07 ) $ (0.08 ) $ (0.18 ) 2017 First Quarter Second Quarter Third Quarter Fourth Quarter Full Year Revenues (1) $ 1,470 $ 669 $ 399 $ 1,170 $ 3,708 Loss from operations (6,398 ) (6,338 ) (7,332 ) (13,215 ) (33,283 ) Net loss (5,631 ) (6,267 ) (7,243 ) (13,100 ) (32,241 ) Basic and diluted net loss per common share (2) $ (0.06 ) $ (0.06 ) $ (0.06 ) $ (0.11 ) $ (0.29 ) (1) We adopted Topic 606 effective January 1, 2018 as further described in Note B to the consolidated financial statements. As a result, the recognized revenue in 2018 is not accounted for on the same basis as the prior years and is not comparable largely due to the timing of revenue recognition. (2) Due to the effect of quarterly changes to outstanding shares of common stock and weightings, the annual loss per share will not necessarily equal the sum of the respective quarters. |
Schedule II - Valuation and Qua
Schedule II - Valuation and Qualifying Accounts | 12 Months Ended |
Dec. 31, 2018 | |
SEC Schedule, 12-09, Valuation and Qualifying Accounts [Abstract] | |
Schedule II - Valuation and Qualifying Accounts | Schedule II – Valuation and Qualifying Accounts (In thousands) Balance at Beginning of Year Additions Deductions Balance at End of Year Year Ended December 31, 2018 Deducted from asset accounts: Tax valuation allowances $ 44,829 $ 6,681 $ — $ 51,510 (A) Total 2018 $ 44,829 $ 6,681 $ — $ 51,510 Year Ended December 31, 2017 Deducted from asset accounts: Allowance for doubtful accounts-note receivable $ 376 $ — $ (376 ) $ 0 (B) Tax valuation allowances 54,772 — (9,943 ) 44,829 (A) Total 2017 $ 55,148 $ — $ (10,319 ) $ 44,829 Year Ended December 31, 2016 Deducted from asset accounts: Allowance for doubtful accounts-note receivable $ 363 $ 13 $ — $ 376 (B) Tax valuation allowances 48,921 5,851 — 54,772 (A) Total 2016 $ 49,284 $ 5,864 $ — $ 55,148 (A) – Substantially all of our deferred tax assets are offset by valuation allowances. (B) – Reserve on note receivable that was fully-reserved. We wrote-off the note in 2017. |
Accounting Policies (Policies)
Accounting Policies (Policies) | 12 Months Ended |
Dec. 31, 2018 | |
Accounting Policies [Abstract] | |
Principles of Consolidation | Principles of Consolidation The consolidated financial statements include our accounts and results of operations and those of our wholly-owned subsidiaries. All intercompany accounts and transactions have been eliminated in consolidation. |
Reclassifications | Reclassifications Certain reclassifications have been made to the 2017 and 2016 consolidated financial statements to separately disclose transactions and balances related to Healios to conform to the 2018 presentation. |
Revenue Recognition | Revenue Recognition Our license and collaboration agreements may contain multiple elements, including license and technology access fees, research and development funding, product supply revenue, service revenue, cost-sharing, milestones and royalties. As further described below, on January 1, 2018, we adopted Accounting Standards Update (“ASU”) No. 2014-09, Revenue from Contracts with Customers (“Topic 606”), to account for revenue. The deliverables under our arrangements are evaluated under Topic 606 which requires an entity to recognize revenue in a manner that depicts the transfer of promised goods or services to customers in an amount that reflects the consideration to which the entity expects to be entitled in exchange for those goods or services. Milestone Payments Topic 606 does not contain guidance specific to milestone payments, but rather requires potential milestone payments to be considered in accordance with the overall model of Topic 606. As a result, revenues from contingent milestone payments are recognized based on an assessment of the probability of milestone achievement and the likelihood of a significant reversal of such milestone revenue at each reporting date. This assessment may result in recognizing milestone revenue before the milestone event has been achieved. Since the milestones in the Healios arrangement are generally related to development and commercial milestone achievement by Healios, we have not included any of the Healios milestones in the estimated transaction price of the Healios arrangement, since they would be constrained, as a significant reversal of revenue could result in future periods. Other than for our collaboration with Healios that has remaining deliverables, as of the date of adoption of Topic 606 on January 1, 2018, we had recognized the full amount of license fees under our collaboration agreements as contract revenue under the prior guidance associated with multiple-element arrangements, since the performance periods for our multiple element arrangements had concluded. The events triggering any future contingent milestone payments from these arrangements were determined to be non-substantive and revenue will be recognized in the period that the triggering event occurs, and the remaining potential commercial milestones will be recognized when earned. Grant Revenue Grant revenue, which is not within the scope of Topic 606 for our grant arrangements, consists of funding under cost reimbursement programs primarily from federal and non-profit foundation sources for qualified research and development activities performed by us, and as such, are not based on estimates that are susceptible to change. Such amounts are invoiced and recorded as revenue as grant-funded activities are performed, with any advance funding recorded as deferred revenue until the activities are performed. Royalty Revenue We generate royalty revenue from the sale of licensed products by our licensees. Royalty revenue is recognized upon the later to occur of (i) achievement of the collaborator’s underlying sales and (ii) satisfaction of any performance obligation(s) related to these sales, in each case assuming the license to our intellectual property is deemed to be the predominant item to which the sales-based royalties relate. Unbilled Accounts Receivable We record amounts that are due to us under contractual arrangements for which invoicing has not yet occurred if our performance has concluded for the billable activity, and we have the unconditional right to the consideration, but such amounts have not yet been billed. At December 31, 2018, unbilled accounts receivable from Healios was $3.6 million , which includes $2.5 million of license fees that were paid to us by Healios in the first quarter of 2019 related to the expansion of our arrangement described in Note E . The remainder of the unbilled accounts receivable on the consolidated balance sheets at December 31, 2018 relates to manufacturing technology transfer services performed that were not yet billed to Healios. Contractual Right to Consideration and Deferred Revenue Amounts included in deferred revenue or contract assets are determined at the contract level, and for our Healios arrangement, such amounts are included in a contract asset or liability depending on the overall status of the arrangement. Amounts received from customers or collaborators in advance of our performance of services or other deliverables are included in deferred revenue, while amounts for performance of services or other deliverables before customer payment is received or due are included in contract assets, with those amounts that are unconditional being included in either accounts receivable or unbilled accounts receivable. Grant proceeds received in advance of our performance under the grant is included in deferred revenue. Generally, deferred revenue and contract assets or liabilities are classified as current assets or obligations, as opposed to non-current. Deposit from Healios Included in the deposit from Healios at December 31, 2018 is a $2.0 million payment received from Healios to extend the period of its exclusive right to negotiate for an option to expand its license to develop and commercialize certain disease indications in China. These nonrefundable proceeds will either be applied to Healios' option fee for the China license or be creditable against potential milestone payments under the existing Healios licenses. Advances from Healios The clinical trial supply agreement with Healios was amended in July 2017 to clarify a cost-sharing arrangement associated with our supply of clinical product for Healios' ischemic stroke trial in Japan. The proceeds from Healios for clinical supply that relate specifically to the cost-sharing arrangement may (i) result in a decrease in the amount we receive from Healios upon the achievement of certain milestones and an increase to a commercial milestone, or (ii) be repaid at our election. While the amendment to the supply agreement resulted in a revision to the terms associated with the product supply, namely the cost of product supply, the revision did not affect any of the performance obligations under the overall arrangement. The proceeds from Healios that relate specifically to the cost-sharing arrangement for Healios’ ischemic stroke study in Japan are recognized as a non-current advance from Healios until the related milestones are achieved or such amounts are repaid to Healios at our election. No revenue has been recognized yet related to this advance. Effect of Adoption of Topic 606 We adopted Topic 606 utilizing the modified retrospective transition method applied to contracts that were not complete as of January 1, 2018. We evaluated all of our arrangements on a contract-by-contract basis, identifying all of the performance obligations, including those that are contingent. For our contracts with customers that contain multiple performance obligations, we account for the individual performance obligations separately when they are both capable of being distinct, whereby the customer can benefit from the service either on its own or together with other resources that are readily available from third parties or from us, and are distinct in the context of the contract, whereby the transfer of the services is separately identifiable from other promises in the contract. Under the new standard, we assessed whether licenses granted under our collaboration and license agreements were distinct in the context of the agreement from other performance obligations and functional when granted. After considering the relative selling prices of the contract elements and the allocation of revenue thereto, we recognized a cumulative effect adjustment of $1.9 million as an adjustment to the opening balance of our accumulated deficit primarily related to a contract asset since the revenue permitted to be recognized at inception was not limited to the cash proceeds received as of that time, which was a requirement of the previous guidance. We concluded that the new guidance resulted in revisions to accounting for our arrangement with Healios, only, since our other collaborations had no remaining performance obligations and potential contingent receipts would be constrained. The adoption of ASC 606 primarily resulted in the acceleration of revenue as of December 31, 2017, which in turn reduced our existing deferred tax asset for net operating loss carryforwards. As we have provided a full valuation allowance against our deferred tax assets, this impact was offset by a corresponding reduction to the valuation allowance. Our performance obligations and methods used for determining the relative selling prices and transaction prices of the Healios contract elements is further discussed in Note E . As noted above, our arrangement with Healios was the only collaboration that was impacted by the adoption of Topic 606. Notes E and F further describe our arrangement with Healios, including subsequent modifications to the original collaboration. For contracts that were modified prior to January 1, 2018, we aggregated the effect of those modifications when identifying the satisfied and unsatisfied performance obligations and determining the transaction price to be allocated. We applied the practical expedient under Topic 606 and reflected the aggregate effect of all modifications at January 1, 2018. |
Cash and Cash Equivalents | Cash and Cash Equivalents We consider all highly liquid investments with a maturity of three months or less when purchased to be cash equivalents. Cash equivalents are primarily invested in money market funds. The carrying amount of our cash equivalents approximates fair value due to the short maturity of the investments. |
Investments in Available-for-Sale Securities | Investments in Available-for-Sale Securities We determine the appropriate classification of investment securities, if any, at the time of purchase and re-evaluate such designation as of each balance sheet date. Our investments, if any, typically consist of United States government obligations, United States government-backed municipal bonds and bank certificates of deposit, which are classified as available-for-sale and are valued based on market prices for similar assets using third party certified pricing sources. Available-for-sale securities are carried at fair value, with the unrealized gains and losses, net of applicable tax, reported as a component of accumulated other comprehensive income (loss). The amortized cost of debt securities is adjusted for amortization of premiums and accretion of discounts to maturity. Such amortization or accretion is included in interest income. The cost of securities sold is based on the specific identification method. Interest earned on securities classified as available-for-sale is included in interest income. |
Research and Development | Research and Development Research and development expenditures, which consist primarily of costs associated with clinical trials, preclinical research, product manufacturing and process development for manufacturing, personnel, legal fees resulting from intellectual property application and maintenance processes, and laboratory supply and reagent costs, including direct and allocated overhead expenses, are charged to expense as incurred. |
Clinical Trial Costs | Clinical Trial Costs Clinical trial costs are accrued based on work performed by outside contractors that manage and perform the trials, and those that manufacture the investigational product. We obtain initial estimates of total costs based on enrollment of subjects, trial duration, project management estimates, manufacturing estimates, patient treatment costs and other activities. Actual costs may be charged to us and recognized as the tasks are completed by the contractor or, alternatively, may be invoiced in accordance with agreed-upon payment schedules and recognized based on estimates of work completed to date. Accrued clinical trial costs may be subject to revisions as clinical trials progress, and any revisions are recorded in the period in which the facts that give rise to the revisions become known. |
Royalty Payments and Sublicense Fees | Royalty Payments and Sublicense Fees We are required to make royalty payments to certain parties based on our product sales under license agreements. No royalties were recorded during the three-year period ended December 31, 2018 , since we have not yet generated sales revenue. We are also required to record sublicense fees from time-to-time in connection with license fees from collaborators and clinical and commercial milestone achievement, of which $0.6 million and $0.3 million were recorded as research and development expenses in the Consolidated Statements of Operations in the years ended December 31, 2018 and 2016 , respectively. |
Long-Lived Assets | Long-Lived Assets Equipment is stated at acquired cost less accumulated depreciation. Laboratory and office equipment are depreciated on the straight-line basis over the estimated useful lives ( three to ten years ). Leasehold improvements are amortized over the shorter of the lease term or estimated useful life. Long-lived assets are evaluated for impairment when events or changes in circumstances indicate that the carrying amount of the asset or related group of assets may not be recoverable. If the expected future undiscounted cash flows are less than the carrying amount of the asset, an impairment loss is recognized at that time. Measurement of impairment may be based upon appraisal, market value of similar assets or discounted cash flows. |
Proceeds from Insurance | Proceeds from Insurance In 2016, our facility sustained flood damage representing both an unusual and infrequent event, and we recognized a net insurance recovery gain of $0.7 million in 2016 that was reported as a separate component of our loss from operations. An additional $0.6 million of insurance proceeds, net of associated expenses, were received in 2018, concluding the insurance claim. Proceeds from insurance settlements, except for those directly related to investing or financing activities, were recognized as cash inflows from operating activities. 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. |
Patent Costs and Rights | Patent Costs and Rights Costs of applying for, prosecuting and maintaining patents and patent rights are expensed as incurred. We have filed for broad intellectual property protection on our proprietary technologies and have numerous United States and international patents and patent applications related to our technologies. |
Warrants | Warrants We account for common stock warrants as either liabilities or as equity instruments depending on the specific terms of the warrant agreements. Generally, warrants are classified as liabilities, as opposed to equity, if the agreement includes the potential for a cash settlement or an adjustment to the exercise price, and warrant liabilities are recorded at their fair values at each balance sheet date. We classify these warrant liabilities on the consolidated balance sheet as non-current liabilities. 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 warrants are reflected in the consolidated statement of operations as income or expense from change in fair value of warrants. |
Concentration of Credit Risk | Concentration of Credit Risk Our accounts receivable are generally comprised of amounts due from collaborators and granting authorities and are subject to concentration of credit risk due to the absence of a large number of customers. At December 31, 2018 , the majority of our accounts receivable are due from Healios. We do not typically require collateral from our customers. |
Use of Estimates | Use of Estimates The preparation of financial statements in conformity with accounting principles generally accepted in the United States requires management to make estimates and assumptions that affect the amounts reported in the financial statements and accompanying notes. Actual results could differ from those estimates. |
Stock-Based Compensation | Stock-Based Compensation We recognize stock-based compensation expense on the straight-line method and use a Black-Scholes option-pricing model to estimate the fair value of option awards. The expected term of options granted represent the period of time that option grants are expected to be outstanding. We use the “simplified” method to calculate the expected life of option grants given our limited history of exercise activity and determine volatility by using our historical stock volatility. The fair value of our restricted stock units are equal to the closing price of our common stock on the date of grant and is expensed over the vesting period on a straight-line basis. Estimates of fair value are not intended to predict actual future events or the value ultimately realized by persons that receive equity awards. Options may be exercised for cash or by a cashless exercise that is permitted under certain conditions. In the event of a cashless exercise, we retain the number of shares equivalent to the exercise cost based on the market value at the time of exercise and issue the net number of shares to the holder. We recognize income tax benefits and deficiencies as income tax expense or benefit in the consolidated statement of operations and the tax effects of exercised or vested awards are treated as discrete items in the reporting period in which they occur. We also recognize excess tax benefits regardless of whether the benefit reduces taxes payable in the current period. Excess tax benefits are classified along with other income tax cash flows as an operating activity in the consolidated statement of cash flows. In regards to forfeitures, we account for them when they occur following the adoption of ASU 2016-09, Compensation - Stock Compensation - Improvements to Employee Share-Based Payment Accounting, in 2017. All of the aforementioned estimates and assumptions are evaluated on a quarterly basis and may change as facts and circumstances warrant. Changes in these assumptions can materially affect the estimate of the fair value of our share-based payments and the related amount recognized in our financial statements. Annual stock-based awards to employees typically vest over a four -year period, although the 2018 awards vest over a three -year period, have an exercise price equal to the fair market value of a share of common stock on the grant date and have a contractual term of 10 years. |
Income Taxes | Income Taxes Deferred tax liabilities and assets are determined based on the differences between the financial reporting and tax basis of assets and liabilities and are measured using the tax rate and laws currently in effect. We evaluate our deferred income taxes to determine if a valuation allowance should be established against the deferred tax assets or if the valuation allowance should be reduced based on consideration of all available evidence, both positive and negative, using a “more likely than not” standard. We had no liability for uncertain income tax positions as of December 31, 2018 and 2017 . Our policy is to recognize potential accrued interest and penalties related to the liability for uncertain tax benefits, if applicable, in income tax expense. Net operating loss and credit carryforwards since inception remain open to examination by taxing authorities, and will for a period post utilization. Refer to Note H regarding recent tax reform. |
Net Loss per Share | 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. |
Recently Issued Accounting Standards | Recently Issued Accounting Standards In August 2018, the Financial Accounting Standards Board (“FASB”) issued ASU 2018-15, Intangibles-Goodwill and Other-Internal-Use Software: Customer’s Accounting for Implementation Costs Incurred in a Cloud Computing Arrangement that is a Service Contract (“ASU 2018-15”). ASU 2018-15 requires implementation costs incurred by customers in cloud computing arrangements (i.e., hosting arrangements) to be capitalized under the same premises of authoritative guidance for internal-use software and deferred over the noncancellable term of the cloud computing arrangements plus any option renewal periods that are reasonably certain to be exercised by the customer or for which the exercise is controlled by the service provider. The guidance is effective for the annual and interim periods beginning after December 15, 2019, with early adoption permitted. We have outstanding cloud computing arrangements and continue to incur costs that we believe may be required to be capitalized under ASU 2018-15, including those related to our 2018 implementation of a new enterprise resource planning system. We are currently evaluating the potential impact of adoption of this standard on our consolidated financial statements and we do not intend to early adopt. In August 2018, the FASB issued ASU 2018-13, Fair Value Measurements (“Topic 820”): Disclosure Framework - Changes to the Disclosure Requirements for Fair Value Measurement , which adds, modifies and removes several disclosure requirements relative to the three levels of inputs used to measure fair value in accordance with Topic 820, Fair Value Measurement . This guidance is effective for fiscal years beginning after December 15, 2019, including interim periods within that fiscal year. Early adoption is permitted. We are currently assessing the effect that this ASU will have on our disclosures. In February 2016, the FASB issued ASU 2016-02, Leases (“Topic 842”), which requires lessees to put most leases with a term greater than 12 months on their balance sheets, but recognize expenses on their statement of operations in a manner similar to current accounting practice. Under the guidance, lessees initially recognize a lease liability for the obligation to make lease payments and a right-of-use (“ROU”) asset for the right to use the underlying asset for the lease term. The lease liability is measured at the present value of the lease payments over the lease term. The ROU asset is measured at the lease liability amount, adjusted for lease prepayments, lease incentives received and the lessee’s initial direct costs. The guidance is effective for the annual and interim periods beginning after December 15, 2018. We adopted Topic 842 effective January 1, 2019. We will elect the ‘package of practical expedients’ and will not reassess our prior conclusions about lease identification, lease classification and initial direct costs. We will also elect the short-term lease recognition exemption for all leases that qualify and will not recognize right-of-use assets or lease liabilities for those leases. Based on contracts in place at December 31, 2018, we expect our ROU asset and lease liability recorded will be approximately 2% of our total assets and do not expect the standard to have a material effect on our cash flows or results of operations. In June 2018, the FASB issued ASU 2018-07, Compensation - Stock Compensation (“Topic 718”), Improvements to Nonemployee Share-Based Payment Accounting. This aligns the measurement and classification guidance for share-based payments to nonemployees with that for employees, with certain exceptions. It also expands the scope of Topic 718 to include share-based payments granted to nonemployees in exchange for goods or services used or consumed in the entity's own operations. We have elected to early adopt this guidance which did not materially impact our consolidated financial statements. In August 2018, the Securities and Exchange Commission (“SEC”) issued the final rule under SEC Release No. 33-10532, Disclosure Update and Simplification , that amends certain of its disclosure requirements that have become redundant, duplicative, overlapping, outdated or superseded. The amendments include replacing the requirement to disclose the high and low trading prices of entity's ordinary shares with a requirement to disclose the ticker symbol of its shares. Additionally, the final rule extends to interim periods the annual disclosure requirement of presenting changes in each caption of stockholders' equity and the amount of dividends per share. These disclosures are required to be provided for the current and comparative year-to-date interim periods. We have adopted all relevant disclosure requirements in our annual report on Form 10-K for the year ended December 31, 2018. In November 2018, the FASB issued ASU 2018-18, Collaborative Arrangements (“Topic 808”): Clarifying the Interaction between Topic 808 and Topic 606 . The amendments in this update make targeted improvements to generally accepted accounting principles (“GAAP”) for collaborative arrangements as follows: clarify that certain transactions between collaborative arrangement participants should be accounted for as revenue under Topic 606 when the collaborative arrangement participant is a customer in the context of a unit of account. In those situations, all the guidance in Topic 606 should be applied, including recognition, measurement, presentation, and disclosure requirements; add unit-of-account guidance in Topic 808 to align with the guidance in Topic 606 (that is, a distinct good or service) when an entity is assessing whether the collaborative arrangement or a part of the arrangement is within the scope of Topic 606; and require that in a transaction with a collaborative arrangement participant that is not directly related to sales to third parties, presenting the transaction together with revenue recognized under Topic 606 is precluded if the collaborative arrangement participant is not a customer. The provisions of ASU 2018-18 are effective for years beginning after December 15, 2019, with early adoption permitted. We are currently evaluating the impact of this clarifying guidance. |
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. At December 31, 2018 , we had no financial assets or liabilities measured at fair value on a recurring basis. The Healios Warrant that was issued in March 2018 was measured at fair value on a nonrecurring basis and is a Level 3 equity instrument under the hierarchy. Refer to Note F regarding its valuation. |
Accounting Policies (Tables)
Accounting Policies (Tables) | 12 Months Ended |
Dec. 31, 2018 | |
Accounting Policies [Abstract] | |
Schedule of Effects From the Adoption of Topic 606 | The components of the cumulative effect of the changes made to our consolidated January 1, 2018 balance sheet for the adoption of Topic 606 were as follows (in thousands): Balance at December 31, 2017 Adjustments Due to Topic 606 Balance at January 1, 2018 Assets Accounts receivable - Healios $ 153 $ 30 $ 183 Contractual right to consideration from Healios — 1,436 1,436 Liabilities Deferred revenue - Healios (521 ) 521 — Advance from Healios (134 ) (116 ) (250 ) Stockholders' Equity Accumulated deficit $ (350,630 ) $ 1,871 $ (348,759 ) In accordance with the new revenue recognition requirements, the disclosure of the impact of adoption on our consolidated balance sheet as of December 31, 2018 and statement of operations for the twelve-month period ended December 31, 2018 was as follows (in thousands, except per share data): As of December 31, 2018 As Reported Balances without Adoption of Topic 606 Effect of Change Assets Unbilled accounts receivable from Healios $ 3,620 $ — $ 3,620 Liabilities Deferred revenue - Healios (674 ) (2,154 ) 1,480 Stockholders' Equity Accumulated deficit $ (373,042 ) $ (378,142 ) $ (5,100 ) Twelve months ended December 31, 2018 As Reported Balances without Adoption of Topic 606 Effect of Change Revenues Contract revenues from Healios $ 22,276 $ 19,047 $ 3,229 Net loss (24,283 ) (27,512 ) (3,229 ) Net loss per common share Basic and diluted $ (0.18 ) $ (0.20 ) $ 0.02 |
Fair Value of Stock-Based Compensation Awards | The following weighted-average input assumptions were used in determining the fair value of the Company’s stock options: December 31, 2018 2017 2016 Volatility 70.8 % 71.2 % 70.3 % Risk-free interest rate 2.8 % 2.0 % 1.5 % Expected life of option 6.0 years 6.2 years 6.2 years Expected dividend yield 0.0 % 0.0 % 0.0 % |
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: Years ended December 31, 2018 2017 2016 Stock options 10,955,508 8,919,113 9,236,228 Restricted stock units 1,656,688 1,648,986 1,201,159 Warrants, including Healios Warrant 18,500,000 — 1,893,527 31,112,196 10,568,099 12,330,914 |
Equipment (Tables)
Equipment (Tables) | 12 Months Ended |
Dec. 31, 2018 | |
Property, Plant and Equipment [Abstract] | |
Equipment | December 31, Equipment consists of (in thousands): 2018 2017 Laboratory equipment $ 7,444 $ 6,262 Office equipment and leasehold improvements 3,043 3,039 Process development equipment not yet in service 822 363 11,309 9,664 Accumulated depreciation (8,307 ) (7,458 ) $ 3,002 $ 2,206 |
Collaborative Arrangements an_2
Collaborative Arrangements and Revenue Recognition (Tables) | 12 Months Ended |
Dec. 31, 2018 | |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | |
Disaggregation of Revenue | The following table presents our contract revenues disaggregated by timing of revenue recognition and excludes royalty revenue (in thousands): Twelve months ended December 31, 2018 Point in Time Over Time Contract revenue from Healios: License fee revenue $ 17,682 $ — Product supply revenue 1,445 — Service revenue — 3,149 Other contract revenue 251 — Total disaggregated revenues $ 19,378 $ 3,149 |
Capitalization and Warrant In_2
Capitalization and Warrant Instruments (Tables) | 12 Months Ended |
Dec. 31, 2018 | |
Equity [Abstract] | |
Common Stock Shares Reserved for Future Issuance | The following shares, in thousands, of common stock were reserved for future issuance: December 31 2018 2017 Stock-based compensation plans 16,096 16,952 Healios Warrants to purchase common stock 18,500 — Shares issuable upon patent milestone — 500 34,596 17,452 |
Stock-Based Compensation (Table
Stock-Based Compensation (Tables) | 12 Months Ended |
Dec. 31, 2018 | |
Disclosure of Compensation Related Costs, Share-based Payments [Abstract] | |
Summary of Stock Option Activity and Related Information | A summary of our stock option activity and related information is as follows: Number of Options Weighted Average Exercise Price Outstanding January 1, 2016 7,052,642 $ 3.05 Granted 2,840,000 2.13 Exercised (164,827 ) 1.56 Forfeited / Expired (491,587 ) 3.57 Outstanding December 31, 2016 9,236,228 2.76 Granted 2,596,480 1.47 Exercised (136,056 ) 1.50 Forfeited / Expired (2,777,539 ) 4.76 Outstanding December 31, 2017 8,919,113 1.78 Granted 2,434,732 2.26 Exercised (112,484 ) 1.57 Forfeited / Expired (285,853 ) 2.62 Outstanding December 31, 2018 10,955,508 $ 1.87 Vested during 2018 2,045,058 $ 1.83 Vested and exercisable at December 31, 2018 6,630,228 $ 1.83 |
Summarizes Information Concerning Options Outstanding and Options Vested and Exercisable | December 31, 2018 Options Outstanding Options Vested and Exercisable Exercise Price Number of Options Weighted Average Remaining Contractual Life Weighted Average Exercise Price Number of Options Weighted Average Remaining Contractual Life Weighted Average Exercise Price $1.01 – $1.71 5,634,994 6.7 years $ 1.50 4,058,842 4.4 years $ 1.52 $1.81 – $2.31 5,031,451 8.3 years $ 2.19 2,287,573 3.4 years $ 2.14 $2.45 – $5.28 289,063 2.1 years $ 3.53 283,813 2.1 years $ 3.55 10,955,508 6,630,228 |
Summary of Restricted Stock Unit Activity and Related Information | A summary of our restricted stock unit activity and related information is as follows: Number of Restricted Stock Units Weighted Average Fair Value Outstanding January 1, 2016 1,069,100 $ 1.55 Granted 933,552 2.19 Vested-common stock issued (732,720 ) 1.71 Forfeited / Expired (68,773 ) 1.90 Outstanding December 31, 2016 1,201,159 1.92 Granted 1,054,720 1.46 Vested-common stock issued (571,118 ) 1.75 Forfeited / Expired (35,775 ) 1.82 Outstanding December 31, 2017 1,648,986 1.69 Granted 787,968 2.31 Vested-common stock issued (741,424 ) 1.81 Forfeited / Expired (38,842 ) 1.74 Outstanding December 31, 2018 1,656,688 $ 1.93 Vested/Issued cumulative at December 31, 2018 4,569,865 $ 1.73 |
Income Taxes (Tables)
Income Taxes (Tables) | 12 Months Ended |
Dec. 31, 2018 | |
Income Tax Disclosure [Abstract] | |
Schedule of Reconciliation of Federal Statutory Income Tax Rate to Effective Tax Rate | A reconciliation of the federal statutory income tax rate to our effective tax rate is as follows: Percent of Income before Income Taxes 2018 2017 Statutory federal income tax rate 21.0 % 34.0 % State income taxes - net of federal tax benefit 0.9 % 0.8 % Other permanent differences (3.7 )% (5.5 )% Valuation allowances (29.2 )% 24.1 % Federal rate change — % (57.9 )% Research and development - U.S. 11.0 % 4.5 % Research and development - Foreign — % — % Effective tax rate for the year — % — % |
Components of Deferred Tax Assets | Significant components of our deferred tax assets are as follows (in thousands): December 31, 2018 2017 Net operating loss carryforwards $ 38,813 $ 35,409 Research and development credit carryforwards 9,979 7,301 Compensation expense 1,552 652 Other 1,166 1,467 Total deferred tax assets 51,510 44,829 Valuation allowance for deferred tax assets (51,510 ) (44,829 ) Net deferred tax assets $ — $ — |
Quarterly Financial Data (una_2
Quarterly Financial Data (unaudited) (Tables) | 12 Months Ended |
Dec. 31, 2018 | |
Quarterly Financial Information Disclosure [Abstract] | |
Quarterly Financial Data | The following table presents quarterly data for the years ended December 31, 2018 and 2017 , in thousands, except per share data: 2018 First Quarter Second Quarter Third Quarter Fourth Quarter Full Year Revenues (1) $ 1,066 $ 19,391 $ 2,321 $ 1,513 $ 24,291 Income (loss) from operations (10,262 ) 6,745 (9,976 ) (11,552 ) (25,045 ) Net income (loss) (10,155 ) 6,933 (9,740 ) (11,321 ) (24,283 ) Basic and diluted net loss per common share $ (0.08 ) $ 0.05 $ (0.07 ) $ (0.08 ) $ (0.18 ) 2017 First Quarter Second Quarter Third Quarter Fourth Quarter Full Year Revenues (1) $ 1,470 $ 669 $ 399 $ 1,170 $ 3,708 Loss from operations (6,398 ) (6,338 ) (7,332 ) (13,215 ) (33,283 ) Net loss (5,631 ) (6,267 ) (7,243 ) (13,100 ) (32,241 ) Basic and diluted net loss per common share (2) $ (0.06 ) $ (0.06 ) $ (0.06 ) $ (0.11 ) $ (0.29 ) (1) We adopted Topic 606 effective January 1, 2018 as further described in Note B to the consolidated financial statements. As a result, the recognized revenue in 2018 is not accounted for on the same basis as the prior years and is not comparable largely due to the timing of revenue recognition. (2) Due to the effect of quarterly changes to outstanding shares of common stock and weightings, the annual loss per share will not necessarily equal the sum of the respective quarters. |
Background - Additional Informa
Background - Additional Information (Detail) $ in Thousands | 12 Months Ended | ||||
Dec. 31, 2018USD ($)Segment | Jan. 01, 2018USD ($) | Dec. 31, 2017USD ($) | Dec. 31, 2016USD ($) | Dec. 31, 2015USD ($) | |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | |||||
Number of business segments | Segment | 1 | ||||
Accumulated deficit | $ 373,042 | $ 348,759 | $ 350,630 | ||
Cash and cash equivalents | $ 51,059 | $ 29,316 | $ 14,753 | $ 23,027 |
Accounting Policies - Additiona
Accounting Policies - Additional Information (Details) - USD ($) | Jan. 01, 2019 | Dec. 31, 2018 | Dec. 31, 2017 | Dec. 31, 2016 | Jan. 01, 2018 |
Significant Accounting Policies [Line Items] | |||||
Revenue recognized related to the advance from Healios | $ 0 | ||||
Accrued capital expenditures | 100,000 | $ 100,000 | |||
Available for sale securities | 0 | $ 0 | 0 | ||
Realized gains and losses | 0 | 0 | 0 | ||
Payments for royalties | 0 | 0 | 0 | ||
Sublicense fees | 600,000 | 300,000 | |||
Gain from insurance proceeds, net | 617,000 | 0 | 682,000 | ||
Warrant liabilities | $ 0 | 0 | |||
Contractual term | 10 years | ||||
Liability for uncertain income tax | $ 0 | 0 | |||
Dilutive effects from warrant liabilities | 0 | 0 | $ 0 | ||
Healios License Agreement | |||||
Significant Accounting Policies [Line Items] | |||||
Unbilled accounts receivable from Healios | 3,620,000 | 0 | |||
Deposit from Healios | $ 2,000,000 | $ 0 | |||
Minimum | |||||
Significant Accounting Policies [Line Items] | |||||
Estimated useful life of long-lived assets | 3 years | ||||
Annual stock-based awards vesting period | 3 years | ||||
Maximum | |||||
Significant Accounting Policies [Line Items] | |||||
Estimated useful life of long-lived assets | 10 years | ||||
Annual stock-based awards vesting period | 4 years | ||||
License | Healios License Agreement | |||||
Significant Accounting Policies [Line Items] | |||||
Unbilled accounts receivable from Healios | $ 2,500,000 | ||||
Retained Earnings | ASU 2014-09 | |||||
Significant Accounting Policies [Line Items] | |||||
Cumulative effect adjustment recognized | $ 1,900,000 | ||||
Forecast | Subsequent Event | ASU 2016-02 | |||||
Significant Accounting Policies [Line Items] | |||||
Percentage of total assets (less than) | 2.00% |
Accounting Policies - Modified
Accounting Policies - Modified Retrospective Effect - Consolidated Balance Sheet (Details) - USD ($) | Dec. 31, 2018 | Jan. 01, 2018 | Dec. 31, 2017 |
New Accounting Pronouncements or Change in Accounting Principle [Line Items] | |||
Accounts receivable - Healios | $ 262,000 | $ 586,000 | |
Deferred revenue - Healios | 0 | (250,000) | |
Accumulated deficit | (373,042,000) | $ (348,759,000) | (350,630,000) |
Healios License Agreement | |||
New Accounting Pronouncements or Change in Accounting Principle [Line Items] | |||
Accounts receivable - Healios | 1,108,000 | 183,000 | 153,000 |
Contractual right to consideration from Healios | 1,436,000 | ||
Deferred revenue - Healios | (674,000) | 0 | (521,000) |
Advance from Healios | (3,139,000) | (250,000) | (134,000) |
Balances without Adoption of Topic 606 | |||
New Accounting Pronouncements or Change in Accounting Principle [Line Items] | |||
Accumulated deficit | (378,142,000) | (350,630,000) | |
Balances without Adoption of Topic 606 | Healios License Agreement | |||
New Accounting Pronouncements or Change in Accounting Principle [Line Items] | |||
Accounts receivable - Healios | 153,000 | ||
Contractual right to consideration from Healios | 0 | ||
Deferred revenue - Healios | (2,154,000) | (521,000) | |
Advance from Healios | $ (134,000) | ||
Adjustments Due to Topic 606 | ASU 2014-09 | |||
New Accounting Pronouncements or Change in Accounting Principle [Line Items] | |||
Accumulated deficit | (5,100,000) | 1,871,000 | |
Adjustments Due to Topic 606 | ASU 2014-09 | Healios License Agreement | |||
New Accounting Pronouncements or Change in Accounting Principle [Line Items] | |||
Accounts receivable - Healios | 30,000 | ||
Contractual right to consideration from Healios | 1,436,000 | ||
Deferred revenue - Healios | $ 1,480,000 | 521,000 | |
Advance from Healios | $ (116,000) |
Accounting Policies - Modifie_2
Accounting Policies - Modified Retrospective Effect - Consolidated Balance Sheet Cumulative Effect (Details) - USD ($) | Dec. 31, 2018 | Jan. 01, 2018 | Dec. 31, 2017 |
Revenue, Initial Application Period Cumulative Effect Transition [Line Items] | |||
Deferred revenue - Healios | $ 0 | $ (250,000) | |
Accumulated deficit | (373,042,000) | $ (348,759,000) | (350,630,000) |
Balances without Adoption of Topic 606 | |||
Revenue, Initial Application Period Cumulative Effect Transition [Line Items] | |||
Accumulated deficit | (378,142,000) | (350,630,000) | |
Effect of Change | ASU 2014-09 | |||
Revenue, Initial Application Period Cumulative Effect Transition [Line Items] | |||
Accumulated deficit | (5,100,000) | 1,871,000 | |
Healios License Agreement | |||
Revenue, Initial Application Period Cumulative Effect Transition [Line Items] | |||
Unbilled accounts receivable from Healios | 3,620,000 | 0 | |
Deferred revenue - Healios | (674,000) | 0 | (521,000) |
Healios License Agreement | Balances without Adoption of Topic 606 | |||
Revenue, Initial Application Period Cumulative Effect Transition [Line Items] | |||
Unbilled accounts receivable from Healios | 0 | ||
Deferred revenue - Healios | (2,154,000) | $ (521,000) | |
Healios License Agreement | Effect of Change | ASU 2014-09 | |||
Revenue, Initial Application Period Cumulative Effect Transition [Line Items] | |||
Unbilled accounts receivable from Healios | 3,620,000 | ||
Deferred revenue - Healios | $ 1,480,000 | $ 521,000 |
Accounting Policies - Modifie_3
Accounting Policies - Modified Retrospective Effect - Consolidated Statements of Operations (Details) - USD ($) $ / shares in Units, $ in Thousands | 3 Months Ended | 12 Months Ended | |||||||||
Dec. 31, 2018 | Sep. 30, 2018 | Jun. 30, 2018 | Mar. 31, 2018 | Dec. 31, 2017 | Sep. 30, 2017 | Jun. 30, 2017 | Mar. 31, 2017 | Dec. 31, 2018 | Dec. 31, 2017 | Dec. 31, 2016 | |
Revenue, Initial Application Period Cumulative Effect Transition [Line Items] | |||||||||||
Net loss | $ (11,321) | $ (9,740) | $ 6,933 | $ (10,155) | $ (13,100) | $ (7,243) | $ (6,267) | $ (5,631) | $ (24,283) | $ (32,241) | $ (15,337) |
Net loss per common share, basic and diluted (in dollars per share) | $ (0.08) | $ (0.07) | $ 0.05 | $ (0.08) | $ (0.11) | $ (0.06) | $ (0.06) | $ (0.06) | $ (0.18) | $ (0.29) | $ (0.18) |
Balances without Adoption of Topic 606 | |||||||||||
Revenue, Initial Application Period Cumulative Effect Transition [Line Items] | |||||||||||
Net loss | $ (27,512) | ||||||||||
Net loss per common share, basic and diluted (in dollars per share) | $ (0.20) | ||||||||||
Effect of Change | ASU 2014-09 | |||||||||||
Revenue, Initial Application Period Cumulative Effect Transition [Line Items] | |||||||||||
Net loss | $ (3,229) | ||||||||||
Net loss per common share, basic and diluted (in dollars per share) | $ 0.02 | ||||||||||
Healios License Agreement | Contract revenues from Healios | |||||||||||
Revenue, Initial Application Period Cumulative Effect Transition [Line Items] | |||||||||||
Contract revenues from Healios | $ 22,276 | $ 918 | $ 16,238 | ||||||||
Healios License Agreement | Contract revenues from Healios | Balances without Adoption of Topic 606 | |||||||||||
Revenue, Initial Application Period Cumulative Effect Transition [Line Items] | |||||||||||
Contract revenues from Healios | 19,047 | ||||||||||
Healios License Agreement | Contract revenues from Healios | Effect of Change | ASU 2014-09 | |||||||||||
Revenue, Initial Application Period Cumulative Effect Transition [Line Items] | |||||||||||
Contract revenues from Healios | $ 3,229 |
Accounting Policies - Fair Valu
Accounting Policies - Fair Value of Stock-Based Compensation Awards (Details) | 12 Months Ended | ||
Dec. 31, 2018 | Dec. 31, 2017 | Dec. 31, 2016 | |
Accounting Policies [Abstract] | |||
Volatility | 70.80% | 71.20% | 70.30% |
Risk-free interest rate | 2.80% | 2.00% | 1.50% |
Expected life of option | 6 years | 6 years 2 months 12 days | 6 years 2 months 12 days |
Expected dividend yield | 0.00% | 0.00% | 0.00% |
Accounting Policies - Instrumen
Accounting Policies - Instruments Excluded from Calculation of Diluted Net Loss Per Share (Details) - shares | 12 Months Ended | ||
Dec. 31, 2018 | Dec. 31, 2017 | Dec. 31, 2016 | |
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | |||
Total | 31,112,196 | 10,568,099 | 12,330,914 |
Stock options | |||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | |||
Total | 10,955,508 | 8,919,113 | 9,236,228 |
Restricted stock units | |||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | |||
Total | 1,656,688 | 1,648,986 | 1,201,159 |
Warrants, including Healios Warrant | |||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | |||
Total | 18,500,000 | 0 | 1,893,527 |
Equipment - Equipment (Details)
Equipment - Equipment (Details) - USD ($) $ in Thousands | Dec. 31, 2018 | Dec. 31, 2017 |
Property, Plant and Equipment [Line Items] | ||
Equipment, gross | $ 11,309 | $ 9,664 |
Accumulated depreciation | (8,307) | (7,458) |
Equipment, net | 3,002 | 2,206 |
Laboratory equipment | ||
Property, Plant and Equipment [Line Items] | ||
Equipment, gross | 7,444 | 6,262 |
Office equipment and leasehold improvements | ||
Property, Plant and Equipment [Line Items] | ||
Equipment, gross | 3,043 | 3,039 |
Process development equipment not yet in service | ||
Property, Plant and Equipment [Line Items] | ||
Equipment, gross | $ 822 | $ 363 |
Equipment - Additional Informat
Equipment - Additional Information (Details) $ in Millions | 12 Months Ended |
Dec. 31, 2017USD ($) | |
Property, Plant and Equipment [Abstract] | |
Disposal of obsolete equipment | $ 0.8 |
Financial Instruments - Additio
Financial Instruments - Additional Information (Detail) - USD ($) | 12 Months Ended | ||
Dec. 31, 2018 | Dec. 31, 2017 | Dec. 31, 2016 | |
Fair Value Measurement Inputs and Valuation Techniques [Line Items] | |||
Rent | $ 267,000 | ||
Aggregate rent expense | 493,000 | $ 477,000 | $ 465,000 |
Future annual minimum lease commitments for 2019 | 393,000 | ||
Future annual minimum lease commitments for 2020 | 297,000 | ||
Future annual minimum lease commitments for 2021 | 90,000 | ||
Interest paid | 0 | $ 0 | $ 0 |
Belgium | |||
Fair Value Measurement Inputs and Valuation Techniques [Line Items] | |||
Rent | 196,000 | ||
Fair Value Measurements, Recurring Basis | |||
Fair Value Measurement Inputs and Valuation Techniques [Line Items] | |||
Financial assets measured at fair value on recurring basis | 0 | ||
Financial liabilities measured at fair value on recurring basis | $ 0 |
Collaborative Arrangements an_3
Collaborative Arrangements and Revenue Recognition - Additional Information (Details) | 1 Months Ended | 12 Months Ended | ||||||
Dec. 31, 2018USD ($)shares | Jun. 30, 2018USD ($)$ / sharesshares | Mar. 31, 2018USD ($)$ / sharesshares | Feb. 28, 2017shares | Dec. 31, 2019USD ($) | Dec. 31, 2018USD ($)Installmentshares | Dec. 31, 2017USD ($)Milestone | Dec. 31, 2016USD ($) | |
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | ||||||||
Common stock share issued in public offering (in shares) | shares | 22,772,300 | |||||||
Shares of common stock issued, value | $ 16,628,000 | $ 39,813,000 | $ 4,230,000 | |||||
Transaction price expected to be recognized | $ 3,600,000 | 3,600,000 | ||||||
Number of first warrant shares (in shares) | shares | 4,000,000 | |||||||
Healios License Agreement | ||||||||
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | ||||||||
Upfront cash payments received | 15,000,000 | |||||||
Potential payment for rights to additional indications including ARDS | $ 10,000,000 | |||||||
Common stock share issued in public offering (in shares) | shares | 12,000,000 | |||||||
Shares of common stock issued, value | $ 21,100,000 | 20,995,000 | ||||||
Common stock issued, price per share (in dollars per share) | $ / shares | $ 1.76 | $ 1.76 | ||||||
Potential near-term payment received | 2,000,000 | 10,000,000 | ||||||
Additional payment from Healios | $ 10,000,000 | |||||||
License and services revenue payment number of installments | Installment | 4 | |||||||
License and services revenue payment installment amount due per quarter | $ 2,500,000 | $ 2,500,000 | ||||||
Expected credit to future milestone payment | $ 10,000,000 | |||||||
Fair value of the warrant | $ 4,200,000 | $ 5,300,000 | ||||||
Remaining exercisable warrants (in shares) | shares | 16,000,000 | 16,000,000 | 16,000,000 | |||||
Healios License Agreement | Regulatory and Sales Milestones | ||||||||
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | ||||||||
Potential revenue from approvals and milestones | $ 225,000,000 | |||||||
Number of future milestones achieved | Milestone | 2 | |||||||
Healios License Agreement | Forecast | ||||||||
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | ||||||||
Additional payment from Healios | $ 3,000,000 | |||||||
Healios License Agreement | License | ||||||||
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | ||||||||
Increase (decrease) in revenue | $ 1,100,000 | |||||||
Ophthalmology License Agreement | Regulatory and Sales Milestones | ||||||||
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | ||||||||
Potential revenue from approvals and milestones | 135,600,000 | |||||||
RTI Surgical Inc | ||||||||
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | ||||||||
Aggregated milestone revenue | $ 0 | $ 1,000,000 | ||||||
Animal health company agreement | ||||||||
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | ||||||||
Nonrefundable option fee | $ 300,000 |
Collaborative Arrangements an_4
Collaborative Arrangements and Revenue Recognition - Summary of Revenues Disaggregated by Recognition at Point in Time and Over Time (Details) $ in Thousands | 12 Months Ended |
Dec. 31, 2018USD ($) | |
Point in Time | |
Disaggregation of Revenue [Line Items] | |
Revenues | $ 19,378 |
Point in Time | Other contract revenue | |
Disaggregation of Revenue [Line Items] | |
Revenues | 251 |
Point in Time | Healios License Agreement | License fee revenue | |
Disaggregation of Revenue [Line Items] | |
Revenues | 17,682 |
Point in Time | Healios License Agreement | Product supply revenue | |
Disaggregation of Revenue [Line Items] | |
Revenues | 1,445 |
Point in Time | Healios License Agreement | Service revenue | |
Disaggregation of Revenue [Line Items] | |
Revenues | 0 |
Over Time | |
Disaggregation of Revenue [Line Items] | |
Revenues | 3,149 |
Over Time | Other contract revenue | |
Disaggregation of Revenue [Line Items] | |
Revenues | 0 |
Over Time | Healios License Agreement | License fee revenue | |
Disaggregation of Revenue [Line Items] | |
Revenues | 0 |
Over Time | Healios License Agreement | Product supply revenue | |
Disaggregation of Revenue [Line Items] | |
Revenues | 0 |
Over Time | Healios License Agreement | Service revenue | |
Disaggregation of Revenue [Line Items] | |
Revenues | $ 3,149 |
Capitalization and Warrant In_3
Capitalization and Warrant Instruments - Additional Information (Details) - USD ($) $ / shares in Units, $ in Thousands | 1 Months Ended | 12 Months Ended | ||||||||
Jun. 30, 2018 | May 31, 2018 | Mar. 31, 2018 | Feb. 28, 2018 | Oct. 31, 2017 | Feb. 28, 2017 | Dec. 31, 2018 | Dec. 31, 2017 | Dec. 31, 2016 | Feb. 28, 2019 | |
Class of Warrant or Right [Line Items] | ||||||||||
Common stock, shares authorized (in shares) | 300,000,000 | 300,000,000 | ||||||||
Preferred stock, shares authorized (in shares) | 10,000,000 | 10,000,000 | ||||||||
Preferred stock, shares issued (in shares) | 0 | 0 | ||||||||
Net proceeds through issuance of common stock | $ 15,415 | $ 37,287 | $ 4,028 | |||||||
Common stock share issued in public offering (in shares) | 22,772,300 | |||||||||
Common stock offering price (in dollars per share) | $ 1.01 | |||||||||
Proceeds from warrants exercise | 0 | 1,862 | 163 | |||||||
Shares of common stock issued, value | 16,628 | 39,813 | 4,230 | |||||||
Warrants exercised, percentage of average closing price per share for ten business days | 110.00% | |||||||||
Number of first warrant shares (in shares) | 4,000,000 | |||||||||
Discount on revenue from issuance of warrant | $ 1,100 | $ 1,080 | $ 0 | 0 | ||||||
Shares remaining for sale | 34,596,108 | 17,452,125 | ||||||||
Payment to acquire intellectual property rights | $ 500 | |||||||||
Additional shares issuable upon issuance of intellectual property rights (in shares) | 500,000 | 500,000 | ||||||||
Accrued License Fees | Cash Obligation | ||||||||||
Class of Warrant or Right [Line Items] | ||||||||||
Payment to acquire intellectual property rights | $ 1,000 | |||||||||
Intellectual Property | ||||||||||
Class of Warrant or Right [Line Items] | ||||||||||
Stock issued during period, shares, issued for intellectual property rights (in shares) | 1,000,000 | |||||||||
Stock issued during period, amount, issued for intellectual property rights | $ 2,300 | |||||||||
Increase in fair value of stock issued | $ 300 | |||||||||
Intellectual Property | Accrued License Fees | Contingent Obligation | ||||||||||
Class of Warrant or Right [Line Items] | ||||||||||
Stock issued during period, amount, issued for intellectual property rights | $ 900 | |||||||||
Healios License Agreement | ||||||||||
Class of Warrant or Right [Line Items] | ||||||||||
Net proceeds through issuance of common stock | $ 20,900 | 20,995 | $ 0 | $ 0 | ||||||
Common stock share issued in public offering (in shares) | 12,000,000 | |||||||||
Shares of common stock issued, value | $ 21,100 | $ 20,995 | ||||||||
Common stock issued, price per share (in dollars per share) | $ 1.76 | $ 1.76 | ||||||||
Warrants issued to purchase additional shares of common stock (in shares) | 20,000,000 | |||||||||
Minimum ownership percentage in outstanding common stock for board seat | 5.00% | |||||||||
Minimum ownership percentage in outstanding common stock for two board seats | 15.00% | |||||||||
Remaining exercisable warrants (in shares) | 16,000,000 | 16,000,000 | ||||||||
Expired warrants (in shares) | 1,500,000 | |||||||||
Maximum ownership percentage that Heallios is allowed own | 19.90% | |||||||||
Fair value of the warrant | $ 4,200 | $ 5,300 | ||||||||
Aspire Capital | ||||||||||
Class of Warrant or Right [Line Items] | ||||||||||
Net proceeds through issuance of common stock | $ 1,000 | |||||||||
Common stock share issued in public offering (in shares) | 8,708,582 | 9,400,000 | 2,191,418 | |||||||
Equity purchase agreement, value | $ 100,000 | |||||||||
Equity purchase agreement, term | 3 years | |||||||||
Common stock issued as commitment fees (in shares) | 450,000 | |||||||||
Common stock registered for resale (in shares) | 24,700,000 | |||||||||
Issuance of common stock per share (in dollars per share) | $ 2 | $ 1.78 | $ 1.75 | $ 1.84 | ||||||
Subsequent Event | Aspire Capital | 2018 Agreement | ||||||||||
Class of Warrant or Right [Line Items] | ||||||||||
Shares remaining for sale | 18,100,000 | |||||||||
Additional Paid-in Capital | ||||||||||
Class of Warrant or Right [Line Items] | ||||||||||
Shares of common stock issued, value | $ 16,619 | $ 39,780 | $ 4,228 | |||||||
Additional Paid-in Capital | Intellectual Property | ||||||||||
Class of Warrant or Right [Line Items] | ||||||||||
Stock issued during period, amount, issued for intellectual property rights | $ 1,200 | |||||||||
Additional Paid-in Capital | Healios License Agreement | ||||||||||
Class of Warrant or Right [Line Items] | ||||||||||
Shares of common stock issued, value | $ 20,983 |
Capitalization and Warrant In_4
Capitalization and Warrant Instruments - Common Stock Shares Reserved for Future Issuance (Details) - shares | Dec. 31, 2018 | Dec. 31, 2017 |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Common stock shares reserved for future issuance | 34,596,108 | 17,452,125 |
Stock-based compensation plans | ||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Common stock shares reserved for future issuance | 16,096,108 | 16,952,125 |
Healios Warrants to purchase common stock | ||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Common stock shares reserved for future issuance | 18,500,000 | 0 |
Shares issuable upon patent milestone | ||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Common stock shares reserved for future issuance | 0 | 500,000 |
Stock-Based Compensation - Addi
Stock-Based Compensation - Additional Information (Details) - USD ($) $ / shares in Units, $ in Thousands | 12 Months Ended | ||
Dec. 31, 2018 | Dec. 31, 2017 | Dec. 31, 2016 | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||
Common stock authorized for equity incentive plan (in shares) | 20,035,000 | ||
Common stock shares issued (in shares | 5,120,464 | ||
Shares available for issuance (in shares) | 3,483,912 | ||
Shares of common stock outstanding (in shares) | 12,612,196 | ||
Stock-based compensation expense | $ 3,849 | $ 3,044 | $ 2,868 |
Weighted average fair value of options granted (in dollars per share) | $ 1.46 | $ 0.95 | $ 1.35 |
Total fair value of options vested | $ 2,500 | $ 2,000 | $ 1,700 |
Total unrecognized estimated compensation cost | $ 5,300 | ||
Weighted average contractual life of unvested options | 8 years 8 months 12 days | ||
Aggregate intrinsic value of fully vested option shares | $ 200 | ||
Restricted stock vested | 1,300 | $ 1,000 | $ 1,300 |
Estimated compensation cost of unvested restricted stock | $ 3,100 | ||
Expired Incentive Plan | |||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||
Common stock shares issued (in shares | 250,579 | ||
Shares of common stock outstanding (in shares) | 930,993 |
Stock-Based Compensation - Summ
Stock-Based Compensation - Summary of Stock Option Activity and Related Information (Details) - $ / shares | 12 Months Ended | ||
Dec. 31, 2018 | Dec. 31, 2017 | Dec. 31, 2016 | |
Share-based Compensation Arrangement by Share-based Payment Award, Options, Outstanding [Roll Forward] | |||
Beginning Balance (in shares) | 8,919,113 | 9,236,228 | 7,052,642 |
Granted (in shares) | 2,434,732 | 2,596,480 | 2,840,000 |
Exercised (in shares) | (112,484) | (136,056) | (164,827) |
Forfeited / Expired (in shares) | (285,853) | (2,777,539) | (491,587) |
Ending Balance (in shares) | 10,955,508 | 8,919,113 | 9,236,228 |
Vested during 2018 (in shares) | 2,045,058 | ||
Vested and exercisable at December 31, 2018 (in shares) | 6,630,228 | ||
Share-based Compensation Arrangement by Share-based Payment Award, Options, Outstanding, Weighted Average Exercise Price [Abstract] | |||
Beginning Balance (in dollars per share) | $ 1.78 | $ 2.76 | $ 3.05 |
Granted (in dollars per share) | 2.26 | 1.47 | 2.13 |
Exercised (in dollars per share) | 1.57 | 1.50 | 1.56 |
Forfeited / Expired (in dollars per share) | 2.62 | 4.76 | 3.57 |
Ending Balance (in dollars per share) | 1.87 | $ 1.78 | $ 2.76 |
Vested during 2018 (in dollars per share) | 1.83 | ||
Vested and exercisable at December 31, 2018 (in dollars per share) | $ 1.83 |
Stock-Based Compensation - Su_2
Stock-Based Compensation - Summarizes Information Concerning Options Outstanding and Options Vested and Exercisable (Details) | 12 Months Ended |
Dec. 31, 2018$ / sharesshares | |
Share-based Compensation, Shares Authorized under Stock Option Plans, Exercise Price Range [Line Items] | |
Number of options (in shares) | shares | 10,955,508 |
Number of options (in shares) | shares | 6,630,228 |
$1.01 – $1.71 | |
Share-based Compensation, Shares Authorized under Stock Option Plans, Exercise Price Range [Line Items] | |
Exercise price lower range | $ 1.01 |
Exercise price upper range | $ 1.71 |
Number of options (in shares) | shares | 5,634,994 |
Weighted Average Remaining Contractual Life | 6 years 8 months 12 days |
Weighted average exercise price (in dollars per share) | $ 1.50 |
Number of options (in shares) | shares | 4,058,842 |
Weighted Average Remaining Contractual Life | 4 years 4 months 24 days |
Weighted average exercise price (in dollars per share) | $ 1.52 |
$1.81 – $2.31 | |
Share-based Compensation, Shares Authorized under Stock Option Plans, Exercise Price Range [Line Items] | |
Exercise price lower range | 1.81 |
Exercise price upper range | $ 2.31 |
Number of options (in shares) | shares | 5,031,451 |
Weighted Average Remaining Contractual Life | 8 years 3 months 18 days |
Weighted average exercise price (in dollars per share) | $ 2.19 |
Number of options (in shares) | shares | 2,287,573 |
Weighted Average Remaining Contractual Life | 3 years 4 months 24 days |
Weighted average exercise price (in dollars per share) | $ 2.14 |
$2.45 – $5.28 | |
Share-based Compensation, Shares Authorized under Stock Option Plans, Exercise Price Range [Line Items] | |
Exercise price lower range | 2.45 |
Exercise price upper range | $ 5.28 |
Number of options (in shares) | shares | 289,063 |
Weighted Average Remaining Contractual Life | 2 years 1 month 6 days |
Weighted average exercise price (in dollars per share) | $ 3.53 |
Number of options (in shares) | shares | 283,813 |
Weighted Average Remaining Contractual Life | 2 years 1 month 6 days |
Weighted average exercise price (in dollars per share) | $ 3.55 |
Stock-Based Compensation - Su_3
Stock-Based Compensation - Summary of Restricted Stock Unit Activity and Related Information (Details) - RSUs - $ / shares | 12 Months Ended | ||
Dec. 31, 2018 | Dec. 31, 2017 | Dec. 31, 2016 | |
Share-based Compensation Arrangement by Share-based Payment Award, Equity Instruments Other than Options, Nonvested, Number of Shares [Roll Forward] | |||
Beginning balance (in shares) | 1,648,986 | 1,201,159 | 1,069,100 |
Granted (in shares) | 787,968 | 1,054,720 | 933,552 |
Vested-common stock issued (in shares) | (741,424) | (571,118) | (732,720) |
Forfeited / Expired (in shares) | (38,842) | (35,775) | (68,773) |
Ending balance (in shares) | 1,656,688 | 1,648,986 | 1,201,159 |
Vested/Issued cumulative at period end (in shares) | 4,569,865 | ||
Share-based Compensation Arrangement by Share-based Payment Award, Equity Instruments Other than Options, Nonvested, Weighted Average Grant Date Fair Value [Abstract] | |||
Beginning Balance (in dollars per share) | $ 1.69 | $ 1.92 | $ 1.55 |
Granted (in dollars per share) | 2.31 | 1.46 | 2.19 |
Vested-common stock issued (in dollars per share) | 1.81 | 1.75 | 1.71 |
Forfeited / Expired (in dollars per share) | 1.74 | 1.82 | 1.90 |
Ending Balance (in dollars per share) | 1.93 | $ 1.69 | $ 1.92 |
Vested/Issued cumulative at period end (in dollars per share) | $ 1.73 |
Income Taxes - Additional Infor
Income Taxes - Additional Information (Details) - USD ($) | 12 Months Ended | ||
Dec. 31, 2018 | Dec. 31, 2017 | Dec. 31, 2016 | |
Income Taxes [Line Items] | |||
Income tax paid | $ 0 | $ 0 | $ 0 |
U.S. Federal | |||
Income Taxes [Line Items] | |||
Net operating loss carryforwards | 151,400,000 | ||
Research and development tax credit | 10,000,000 | ||
Foreign | |||
Income Taxes [Line Items] | |||
Net operating loss carryforwards | 21,600,000 | ||
State and City | |||
Income Taxes [Line Items] | |||
Net operating loss carryforwards | 65,500,000 | ||
Subject To Annual Limitations | U.S. Federal | |||
Income Taxes [Line Items] | |||
Net operating loss carryforwards | 16,800,000 | ||
Not Subject To Annual Limitations | U.S. Federal | |||
Income Taxes [Line Items] | |||
Net operating loss carryforwards | 116,800,000 | ||
Research and development tax credit | 10,000,000 | ||
Not Subject To Annual Limitations | State and City | |||
Income Taxes [Line Items] | |||
Net operating loss carryforwards | $ 65,300,000 |
Income Taxes - Schedule of Reco
Income Taxes - Schedule of Reconciliation of Federal Statutory Income Tax Rate to Effective Tax Rate (Details) | 12 Months Ended | |
Dec. 31, 2018 | Dec. 31, 2017 | |
Effective Income Tax Rate Reconciliation [Line Items] | ||
Statutory federal income tax rate | 21.00% | 34.00% |
State income taxes - net of federal tax benefit | 0.90% | 0.80% |
Other permanent differences | (3.70%) | (5.50%) |
Valuation allowances | (29.20%) | 24.10% |
Federal rate change | 0.00% | (57.90%) |
Effective tax rate for the year | 0.00% | 0.00% |
U.S. Federal | ||
Effective Income Tax Rate Reconciliation [Line Items] | ||
Research and development | 11.00% | 4.50% |
Foreign | ||
Effective Income Tax Rate Reconciliation [Line Items] | ||
Research and development | (0.00%) | (0.00%) |
Income Taxes - Components of De
Income Taxes - Components of Deferred Tax Assets (Details) - USD ($) $ in Thousands | Dec. 31, 2018 | Dec. 31, 2017 |
Income Tax Disclosure [Abstract] | ||
Net operating loss carryforwards | $ 38,813 | $ 35,409 |
Research and development credit carryforwards | 9,979 | 7,301 |
Compensation expense | 1,552 | 652 |
Other | 1,166 | 1,467 |
Total deferred tax assets | 51,510 | 44,829 |
Valuation allowance for deferred tax assets | (51,510) | (44,829) |
Net deferred tax assets | $ 0 | $ 0 |
Profit Sharing and 401(k) Plan
Profit Sharing and 401(k) Plan - Additional Information (Details) - USD ($) $ in Millions | 12 Months Ended | ||
Dec. 31, 2018 | Dec. 31, 2017 | Dec. 31, 2016 | |
Postemployment Benefits [Abstract] | |||
Employer contribution for profit sharing plan | $ 0.5 | $ 0.3 | $ 0.3 |
Quarterly Financial Data (una_3
Quarterly Financial Data (unaudited) (Details) - USD ($) $ / shares in Units, $ in Thousands | 3 Months Ended | 12 Months Ended | |||||||||
Dec. 31, 2018 | Sep. 30, 2018 | Jun. 30, 2018 | Mar. 31, 2018 | Dec. 31, 2017 | Sep. 30, 2017 | Jun. 30, 2017 | Mar. 31, 2017 | Dec. 31, 2018 | Dec. 31, 2017 | Dec. 31, 2016 | |
Quarterly Financial Information Disclosure [Abstract] | |||||||||||
Revenues | $ 1,513 | $ 2,321 | $ 19,391 | $ 1,066 | $ 1,170 | $ 399 | $ 669 | $ 1,470 | $ 24,291 | $ 3,708 | $ 17,347 |
Income (loss) from operations | (11,552) | (9,976) | 6,745 | (10,262) | (13,215) | (7,332) | (6,338) | (6,398) | (25,045) | (33,283) | (15,026) |
Net income (loss) | $ (11,321) | $ (9,740) | $ 6,933 | $ (10,155) | $ (13,100) | $ (7,243) | $ (6,267) | $ (5,631) | $ (24,283) | $ (32,241) | $ (15,337) |
Basic and diluted net loss per common share (in dollars per share) | $ (0.08) | $ (0.07) | $ 0.05 | $ (0.08) | $ (0.11) | $ (0.06) | $ (0.06) | $ (0.06) | $ (0.18) | $ (0.29) | $ (0.18) |
Valuation and Qualifying Accoun
Valuation and Qualifying Accounts (Details) - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2018 | Dec. 31, 2017 | Dec. 31, 2016 | |
SEC Schedule, 12-09, Movement in Valuation Allowances and Reserves [Roll Forward] | |||
Balance at Beginning of Year | $ 44,829 | $ 55,148 | $ 49,284 |
Additions | 6,681 | 0 | 5,864 |
Deductions | 0 | (10,319) | 0 |
Balance at End of Year | 51,510 | 44,829 | 55,148 |
Allowance for doubtful accounts-note receivable | |||
SEC Schedule, 12-09, Movement in Valuation Allowances and Reserves [Roll Forward] | |||
Balance at Beginning of Year | 0 | 376 | 363 |
Additions | 0 | 13 | |
Deductions | (376) | 0 | |
Balance at End of Year | 0 | 376 | |
Tax valuation allowances | |||
SEC Schedule, 12-09, Movement in Valuation Allowances and Reserves [Roll Forward] | |||
Balance at Beginning of Year | 44,829 | 54,772 | 48,921 |
Additions | 6,681 | 0 | 5,851 |
Deductions | 0 | (9,943) | 0 |
Balance at End of Year | $ 51,510 | $ 44,829 | $ 54,772 |