Cover Page
Cover Page - shares | 6 Months Ended | |
Jun. 30, 2020 | Aug. 05, 2020 | |
Cover [Abstract] | ||
Document Type | 10-Q | |
Document Quarterly Report | true | |
Document Period End Date | Jun. 30, 2020 | |
Document Transition Report | false | |
Entity File Number | 001-33876 | |
Entity Registrant Name | ATHERSYS, INC / NEW | |
Entity Incorporation, State or Country Code | DE | |
Entity Tax Identification Number | 20-4864095 | |
Entity Address, Address Line One | 3201 Carnegie Avenue, | |
Entity Address, City or Town | Cleveland, | |
Entity Address, State or Province | OH | |
Entity Address, Postal Zip Code | 44115-2634 | |
City Area Code | 216 | |
Local Phone Number | 431-9900 | |
Title of 12(b) Security | Common Stock, par value $0.001 per share | |
Trading Symbol | ATHX | |
Security Exchange Name | NASDAQ | |
Entity Current Reporting Status | Yes | |
Entity Interactive Data Current | Yes | |
Entity Filer Category | Accelerated Filer | |
Entity Small Business | true | |
Entity Emerging Growth Company | false | |
Entity Shell Company | false | |
Entity Common Stock, Shares Outstanding | 197,403,562 | |
Amendment Flag | false | |
Document Fiscal Year Focus | 2020 | |
Document Fiscal Period Focus | Q2 | |
Entity Central Index Key | 0001368148 | |
Current Fiscal Year End Date | --12-31 |
Condensed Consolidated Balance
Condensed Consolidated Balance Sheets - USD ($) $ in Thousands | Jun. 30, 2020 | Dec. 31, 2019 |
Current assets: | ||
Cash and cash equivalents | $ 80,707 | $ 35,041 |
Prepaid expenses and other | 1,071 | 1,168 |
Total current assets | 81,898 | 37,171 |
Equipment, net | 3,163 | 2,882 |
Deposits and other | 1,375 | 1,613 |
Total assets | 86,436 | 41,666 |
Current liabilities: | ||
Accrued compensation and related benefits | 1,066 | 773 |
Accrued clinical trial related costs | 750 | 1,160 |
Accrued expenses and other | 1,592 | 723 |
Total current liabilities | 16,872 | 12,837 |
Other long-term liabilities | 48 | 220 |
Stockholders’ equity: | ||
Preferred stock, at stated value; 10,000,000 shares authorized, and no shares issued and outstanding at June 30, 2020 and December 31, 2019 | 0 | 0 |
Common stock, $0.001 par value; 300,000,000 shares authorized, and 197,008,562 and 159,791,585 shares issued and outstanding at June 30, 2020 and December 31, 2019, respectively | 197 | 160 |
Additional paid-in capital | 515,621 | 440,735 |
Accumulated deficit | (451,640) | (417,624) |
Total stockholders’ equity | 64,178 | 23,271 |
Total liabilities and stockholders’ equity | 86,436 | 41,666 |
Consolidated entity excluding, related party | ||
Current assets: | ||
Accounts receivable | 24 | 17 |
Current liabilities: | ||
Accounts payable | 12,331 | 9,048 |
Healios | ||
Current assets: | ||
Accounts receivable | 96 | 945 |
Current liabilities: | ||
Accounts payable | 1,068 | 1,068 |
Deferred revenue - Healios | 65 | 65 |
Advance from Healios | $ 5,338 | $ 5,338 |
Condensed Consolidated Balanc_2
Condensed Consolidated Balance Sheets (Parenthetical) - $ / shares | Jun. 30, 2020 | Dec. 31, 2019 |
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) | 197,008,562 | 159,791,585 |
Common stock, shares outstanding (in shares) | 197,008,562 | 159,791,585 |
Condensed Consolidated Statemen
Condensed Consolidated Statements of Operations and Comprehensive Loss - USD ($) shares in Thousands, $ in Thousands | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2020 | Jun. 30, 2019 | Jun. 30, 2020 | Jun. 30, 2019 | |
Revenues | ||||
Revenues | $ 84 | $ 4,262 | $ 84 | $ 5,707 |
Costs and expenses | ||||
Research and development | 13,767 | 11,139 | 25,862 | 22,554 |
General and administrative | 4,432 | 2,867 | 7,906 | 5,973 |
Depreciation | 222 | 157 | 412 | 341 |
Total costs and expenses | 18,421 | 14,163 | 34,180 | 28,868 |
Loss from operations | (18,337) | (9,901) | (34,096) | (23,161) |
Other income (expense), net | (35) | 213 | 80 | 517 |
Net loss and comprehensive loss | $ (18,372) | $ (9,688) | $ (34,016) | $ (22,644) |
Net loss per share, basic and diluted (in dollars per share) | $ (0.10) | $ (0.06) | $ (0.19) | $ (0.15) |
Weighted average shares outstanding, basic and diluted (in shares) | 191,317 | 150,163 | 177,016 | 148,075 |
Grant revenue | ||||
Revenues | ||||
Revenues | $ 7 | $ 69 | $ 7 | $ 73 |
Healios | Contract revenue | ||||
Revenues | ||||
Revenues | $ 77 | $ 4,193 | $ 77 | $ 5,634 |
Condensed Consolidated Statem_2
Condensed Consolidated Statements of Stockholders' Equity - USD ($) $ in Thousands | Total | Preferred Stock | Common Stock | Stock Subscription Receivable | Additional Paid-in Capital | Accumulated Deficit | Healios | HealiosCommon Stock | HealiosStock Subscription Receivable | HealiosAdditional Paid-in Capital | Consolidated entity excluding, related party | Consolidated entity excluding, related partyCommon Stock | Consolidated entity excluding, related partyAdditional Paid-in Capital |
Preferred stock shares, beginning balance (in shares) at Dec. 31, 2018 | 0 | ||||||||||||
Common stock, beginning balance (in shares) at Dec. 31, 2018 | 144,292,739 | ||||||||||||
Beginning balance at Dec. 31, 2018 | $ 43,116 | $ 0 | $ 144 | $ 416,014 | $ (373,042) | ||||||||
Stock-based compensation | 1,090 | 1,090 | |||||||||||
Issuance of common stock, net of issuance cost (in shares) | 3,825,000 | ||||||||||||
Issuance of common stock, net of issuance cost | $ 5,607 | $ 4 | $ 5,603 | ||||||||||
Issuance of common stock under equity compensation plan (in shares) | 158,494 | ||||||||||||
Issuance of common stock under equity compensation plan | (69) | (69) | |||||||||||
Net comprehensive income (loss) | (12,956) | (12,956) | |||||||||||
Preferred stock shares, ending balance (in shares) at Mar. 31, 2019 | 0 | ||||||||||||
Common stock, ending balance (in shares) at Mar. 31, 2019 | 148,276,233 | ||||||||||||
Ending balance at Mar. 31, 2019 | 36,788 | $ 0 | $ 148 | 422,638 | (385,998) | ||||||||
Preferred stock shares, beginning balance (in shares) at Dec. 31, 2018 | 0 | ||||||||||||
Common stock, beginning balance (in shares) at Dec. 31, 2018 | 144,292,739 | ||||||||||||
Beginning balance at Dec. 31, 2018 | 43,116 | $ 0 | $ 144 | 416,014 | (373,042) | ||||||||
Net comprehensive income (loss) | (22,644) | ||||||||||||
Preferred stock shares, ending balance (in shares) at Jun. 30, 2019 | 0 | ||||||||||||
Common stock, ending balance (in shares) at Jun. 30, 2019 | 151,777,751 | ||||||||||||
Ending balance at Jun. 30, 2019 | 33,251 | $ 0 | $ 152 | 428,785 | (395,686) | ||||||||
Preferred stock shares, beginning balance (in shares) at Mar. 31, 2019 | 0 | ||||||||||||
Common stock, beginning balance (in shares) at Mar. 31, 2019 | 148,276,233 | ||||||||||||
Beginning balance at Mar. 31, 2019 | 36,788 | $ 0 | $ 148 | 422,638 | (385,998) | ||||||||
Stock-based compensation | 1,152 | 1,152 | |||||||||||
Issuance of common stock, net of issuance cost (in shares) | 3,350,000 | ||||||||||||
Issuance of common stock, net of issuance cost | 5,106 | $ 4 | 5,102 | ||||||||||
Issuance of common stock under equity compensation plan (in shares) | 151,518 | ||||||||||||
Issuance of common stock under equity compensation plan | (107) | (107) | |||||||||||
Net comprehensive income (loss) | (9,688) | (9,688) | |||||||||||
Preferred stock shares, ending balance (in shares) at Jun. 30, 2019 | 0 | ||||||||||||
Common stock, ending balance (in shares) at Jun. 30, 2019 | 151,777,751 | ||||||||||||
Ending balance at Jun. 30, 2019 | $ 33,251 | $ 0 | $ 152 | 428,785 | (395,686) | ||||||||
Preferred stock shares, beginning balance (in shares) at Dec. 31, 2019 | 0 | 0 | |||||||||||
Common stock, beginning balance (in shares) at Dec. 31, 2019 | 159,791,585 | 159,791,585 | |||||||||||
Beginning balance at Dec. 31, 2019 | $ 23,271 | $ 0 | $ 160 | $ 0 | 440,735 | (417,624) | |||||||
Stock-based compensation | 1,280 | 1,280 | |||||||||||
Stock subscription receivable from Healios warrant exercise (in shares) | 4,000,000 | ||||||||||||
Stock subscription receivable from Healios warrant exercise | $ 0 | $ 4 | $ (7,040) | $ 7,036 | |||||||||
Issuance of common stock, net of issuance cost (in shares) | 6,825,000 | ||||||||||||
Issuance of common stock, net of issuance cost | 10,250 | $ 7 | 10,243 | ||||||||||
Issuance of common stock under equity compensation plan (in shares) | 153,504 | ||||||||||||
Issuance of common stock under equity compensation plan | (149) | (149) | |||||||||||
Net comprehensive income (loss) | (15,644) | (15,644) | |||||||||||
Preferred stock shares, ending balance (in shares) at Mar. 31, 2020 | 0 | ||||||||||||
Common stock, ending balance (in shares) at Mar. 31, 2020 | 170,770,089 | ||||||||||||
Ending balance at Mar. 31, 2020 | $ 19,008 | $ 0 | $ 171 | (7,040) | 459,145 | (433,268) | |||||||
Preferred stock shares, beginning balance (in shares) at Dec. 31, 2019 | 0 | 0 | |||||||||||
Common stock, beginning balance (in shares) at Dec. 31, 2019 | 159,791,585 | 159,791,585 | |||||||||||
Beginning balance at Dec. 31, 2019 | $ 23,271 | $ 0 | $ 160 | 0 | 440,735 | (417,624) | |||||||
Net comprehensive income (loss) | $ (34,016) | ||||||||||||
Preferred stock shares, ending balance (in shares) at Jun. 30, 2020 | 0 | 0 | |||||||||||
Common stock, ending balance (in shares) at Jun. 30, 2020 | 197,008,562 | 197,008,562 | |||||||||||
Ending balance at Jun. 30, 2020 | $ 64,178 | $ 0 | $ 197 | 0 | 515,621 | (451,640) | |||||||
Preferred stock shares, beginning balance (in shares) at Mar. 31, 2020 | 0 | ||||||||||||
Common stock, beginning balance (in shares) at Mar. 31, 2020 | 170,770,089 | ||||||||||||
Beginning balance at Mar. 31, 2020 | 19,008 | $ 0 | $ 171 | (7,040) | 459,145 | (433,268) | |||||||
Stock-based compensation | 2,579 | 2,579 | |||||||||||
Stock subscription receivable from Healios warrant exercise | 7,040 | $ 7,040 | |||||||||||
Issuance of common stock, net of issuance cost (in shares) | 310,526 | 25,587,500 | |||||||||||
Issuance of common stock, net of issuance cost | $ 534 | $ 534 | $ 53,691 | $ 26 | $ 53,665 | ||||||||
Issuance of common stock under equity compensation plan (in shares) | 340,447 | ||||||||||||
Issuance of common stock under equity compensation plan | (302) | (302) | |||||||||||
Net comprehensive income (loss) | $ (18,372) | (18,372) | |||||||||||
Preferred stock shares, ending balance (in shares) at Jun. 30, 2020 | 0 | 0 | |||||||||||
Common stock, ending balance (in shares) at Jun. 30, 2020 | 197,008,562 | 197,008,562 | |||||||||||
Ending balance at Jun. 30, 2020 | $ 64,178 | $ 0 | $ 197 | $ 0 | $ 515,621 | $ (451,640) |
Condensed Consolidated Statem_3
Condensed Consolidated Statements of Cash Flows - USD ($) $ in Thousands | 6 Months Ended | |
Jun. 30, 2020 | Jun. 30, 2019 | |
Operating activities | ||
Net loss | $ (34,016) | $ (22,644) |
Adjustments to reconcile net loss to net cash used in operating activities: | ||
Depreciation | 412 | 341 |
Stock-based compensation | 3,859 | 2,242 |
Changes in operating assets and liabilities: | ||
Prepaid expenses, deposits and other | 336 | 677 |
Accounts payable and accrued expenses | 3,720 | 1,192 |
Net cash used in operating activities | (24,847) | (16,959) |
Investing activities | ||
Purchases of equipment | (551) | (400) |
Net cash used in investing activities | (551) | (400) |
Financing activities | ||
Shares retained for withholding tax payments on stock-based awards | (451) | (176) |
Net cash provided by financing activities | 71,064 | 10,537 |
Increase (decrease) in cash and cash equivalents | 45,666 | (6,822) |
Cash and cash equivalents at beginning of the period | 35,041 | 51,059 |
Cash and cash equivalents at end of the period | 80,707 | 44,237 |
Consolidated entity excluding, related party | ||
Changes in operating assets and liabilities: | ||
Accounts receivable | (7) | 182 |
Financing activities | ||
Proceeds from issuance of common stock, net of issuance cost | 63,941 | 10,713 |
Healios | ||
Changes in operating assets and liabilities: | ||
Accounts receivable | 849 | 1,820 |
Deferred revenue - Healios | 0 | (672) |
Advances and deposits from Healios | 0 | (97) |
Financing activities | ||
Proceeds from issuance of common stock, net of issuance cost | 534 | 0 |
Proceeds from exercise of warrant | $ 7,040 | $ 0 |
Background and Basis of Present
Background and Basis of Presentation | 6 Months Ended |
Jun. 30, 2020 | |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | |
Background and Basis of Presentation | Background and Basis of Presentation 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 $451.6 million at June 30, 2020, and we will not commence sales of our clinical product candidates until they receive regulatory approval for commercialization. We will require significant 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 June 30, 2020, we had available cash and cash equivalents of $80.7 million. In April 2020, we completed an underwritten public offering of common stock, generating net proceeds of approximately $53.7 million. Also, in March 2020, HEALIOS K.K. (“Healios”), our collaborator in Japan, elected to exercise its warrant in full, and we generated proceeds of approximately $7.0 million, which were received in April 2020. We believe that these recent proceeds combined with our cash on hand, certain cash receipts, proceeds from the equity facility, potential delays in non-core programs and our ability to defer certain spending will enable us to meet our obligations as they come due at least for a period of twelve months from the date of the issuance of these unaudited condensed consolidated financial statements. We expect that our near-term milestones and clinical trial results, including the results of Healios’ clinical trials, may have a significant impact on our ability to access capital from the equity capital markets. Depending on the outcome of these milestones and clinical trial results, we may accelerate, defer or stage the timing of certain programs until we become cash flow positive from the sales of our clinical products, if they are approved for marketing. In the longer term, we will have to continue to generate additional capital to meet our needs until we would become cash flow positive as a result of the sales our clinical products, if they are approved for marketing. Such capital would come from new and existing collaborations and the related license fees, milestones and potential royalties, monetization of other assets, and/or the sale of equity securities from time to time including through our equity facility and grant-funding opportunities. The accompanying unaudited condensed consolidated financial statements should be read in conjunction with the audited financial statements and notes thereto included in our Annual Report on Form 10-K for the year ended December 31, 2019. The accompanying financial statements have been prepared in accordance with U.S. generally accepted accounting principles (“GAAP”) for interim financial information and Regulation S-X. Accordingly, since they are interim statements, the accompanying financial statements do not include all of the information and notes required by GAAP for complete financial statements. The accompanying financial statements reflect all adjustments, consisting of normal recurring adjustments and disclosures that are, in the opinion of management, necessary for a fair presentation of financial position and results of operations for the interim periods presented. Interim results are not necessarily indicative of results for a full year. Use of Estimates: The preparation of financial statements in conformity with GAAP requires management to make estimates and assumptions that affect the amounts reported in the financial statements and accompanying notes. Our critical accounting policies, estimates and assumptions are described in “Management’s Discussion and Analysis of Financial Condition and Results of Operations,” which is included in this Quarterly Report on Form 10-Q. |
Recently Issued Accounting Stan
Recently Issued Accounting Standards | 6 Months Ended |
Jun. 30, 2020 | |
Accounting Policies [Abstract] | |
Recently Issued Accounting Standards | Recently Issued Accounting Standards In June 2016, the Financial Accounting Standards Board (“FASB”) issued Accounting Standards Update (“ASU”) 2016-13, Financial Instruments-Credit Losses (Topic 326): Measurement of Credit Losses on Financial Instruments (“ASU 2016-13”) . This ASU replaces the incurred loss impairment methodology in current GAAP with a methodology that reflects expected credit losses and requires consideration of a broader range of reasonable and supportable information to inform credit loss estimates. Subsequent to issuing ASU 2016-13, the FASB issued ASU 2019-10, Financial Instruments - Credit Losses (Topic 326): Effective Dates , delaying the effective date for smaller reporting companies until January 2023. We are currently evaluating the potential impact of adoption of this standard on our condensed consolidated financial statements and disclosures, and we do not intend to early adopt. In August 2018, the 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 non-cancellable term of the cloud computing arrangement plus any optional renewal periods reasonably certain to be exercised by the customer or for which exercise is controlled by the provider. ASU 2018-15 is effective for annual and interim periods beginning after December 15, 2019. The amendments in ASU 2018-15 should be applied either retrospectively or prospectively to all implementation costs incurred after the date of adoption. We adopted this standard on a prospective basis effective January 1, 2020 and the adoption of this standard had no impact on our condensed consolidated financial statements. In November 2018, the FASB issued ASU 2018-18, Collaborative Arrangements (Topic 808): Clarifying the Interaction between Topic 808 and Topic 606 (“ASU 2018-18”) . The amendments in this update: (i) 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, and in those situations, all the guidance in Topic 606 should be applied, including recognition, measurement, presentation and disclosure requirements; (ii) 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 (iii) 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. We have adopted the standard effective January 1, 2020 prospectively, which had no impact on our condensed consolidated financial statements. In December 2019, the FASB issued ASU 2019-12, Income Taxes (Topic 740) : Simplifying the Accounting for Income Taxes. The ASU simplifies the accounting for income taxes, changes the accounting for certain income tax transactions, and other minor changes. This guidance is effective for fiscal years beginning after December 15, 2020, including interim periods, with early adoption permitted. We are currently assessing the impact that this ASU will have on our condensed consolidated financial statements and disclosures. |
Net Loss per Share
Net Loss per Share | 6 Months Ended |
Jun. 30, 2020 | |
Earnings Per Share [Abstract] | |
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. We have outstanding stock-based awards that are not used in the calculation of diluted net loss per share because to do so would be anti-dilutive. The following instruments (in thousands) were excluded from the calculation of diluted net loss per share because their effects would be antidilutive: Three months ended Six months ended 2020 2019 2020 2019 Stock-based awards 21,061 16,791 21,061 16,791 Healios warrant – see Note 6 — 4,000 — 4,000 Total 21,061 20,791 21,061 20,791 |
Collaborative Arrangements and
Collaborative Arrangements and Revenue Recognition | 6 Months Ended |
Jun. 30, 2020 | |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | |
Collaborative Arrangements and Revenue Recognition | Collaborative Arrangements and Revenue Recognition Healios Collaboration We have a licensing collaboration with Healios to primarily develop and commercialize our cell therapy technologies for certain disease indications in Japan, pursuant to which we received nonrefundable license fee payments and are entitled to royalties on net sales. We also have the right to receive development and commercial milestone payments from Healios, subject to certain potential credits that have been negotiated from time-to-time and are associated with modifications to the arrangement. Healios is responsible for the development and commercialization of the licensed products in the licensed territories, and we provide certain services to Healios for which we are paid. Refer to Note 6 regarding Healios’ exercise of a warrant in March 2020 and its exercise of a right to participate in certain equity transactions in May 2020. Healios Revenue Recognition At the inception of the Healios arrangement and again each time that the arrangement is modified, all material performance obligations are identified, which currently 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 are separate and distinct within the context of the contract. We determine the standalone selling price of each performance obligation and the related transaction price, taking into account variable consideration using the expected value or most likely amount method and reassessing our estimates 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. The remaining transaction price for the performance obligations that were not yet delivered is not significant at June 30, 2020. At June 30, 2020, the contract liability, included in Deferred Revenue - Healios on the unaudited condensed 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. Advance from Healios Certain clinical product supply services that were concluded in 2019 involved a cost-sharing arrangement, the proceeds from which 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 license agreement for stroke or (ii) be repaid to Healios at our election, as defined. The cost-sharing proceeds received are recognized in advance from Healios on the unaudited condensed consolidated balance sheets until the earlier of the milestones being achieved or such amounts being repaid to Healios at our election, at which time, the culmination of the earnings process or the repayment will be complete. Disaggregation of Revenues We recognize license-related amounts, including upfront payments, exclusivity fees, additional disease indication fees and milestones at a point in time when earned. Similarly, product supply revenue is recognized at a point in time upon delivery, as defined in the applicable product supply contracts, while service revenue (e.g., technology transfer) is recognized when earned over time in proportion to the contractual services provided. 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. The following table presents our contract revenues disaggregated by timing of revenue recognition (in thousands): Three months ended Three months ended Point in Over Time Point in Over Time Contract Revenue from Healios License fee revenue $ — $ — $ 1,624 $ — Product supply revenue 77 — 905 — Service revenue — — — 1,664 Total disaggregated revenues $ 77 $ — $ 2,529 $ 1,664 |
Stock-based Compensation
Stock-based Compensation | 6 Months Ended |
Jun. 30, 2020 | |
Share-based Payment Arrangement [Abstract] | |
Stock-based Compensation | Stock-based Compensation Our 2019 Equity and Incentive Compensation Plan (the “EICP”) authorized at inception an aggregate of approximately 18,500,000 shares of common stock for awards to employees, directors and consultants. Under the EICP, in the three-month period ended June 30, 2020, we granted 3,594,984 stock options and 1,453,671 restricted stock units to our employees, primarily in connection with our annual incentive programs. The EICP authorizes the issuance of stock-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. Also, in the first quarter of 2020, we awarded inducement stock options to purchase 1,000,000 shares of our common stock. As of June 30, 2020, a total of 9,108,743 shares were available for issuance under our EICP, and stock-based awards to purchase 20,060,708 shares of common stock were outstanding under our current and former equity incentive plans, and inducement awards granted outside of our equity incentive plans to purchase 1,000,000 shares of common stock were outstanding. For the three-month periods ended June 30, 2020 and 2019, stock-based compensation expense was approximately $2.6 million and $1.2 million, respectively. At June 30, 2020, total unrecognized estimated compensation cost related to unvested stock-based awards was approximately $18.3 million, which is expected to be recognized by the end of 2024 using the straight-line method. |
Stockholders' Equity
Stockholders' Equity | 6 Months Ended |
Jun. 30, 2020 | |
Equity [Abstract] | |
Stockholders' Equity | Stockholders’ Equity Public Offering In April 2020, we completed an underwritten public offering of common stock, generating gross proceeds of approximately $57.6 million and net proceeds of approximately $53.7 million through the issuance of 25,587,500 shares of common stock at an offering price of $2.25 per share. 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. Currently, we have an agreement with Aspire Capital that was entered into on November 5, 2019 and includes Aspire Capital’s commitment to purchase up to an aggregate of $100.0 million shares of our common stock over a defined timeframe. The terms of the 2019 equity facility are similar to the previous equity facilities with Aspire Capital, and we issued 350,000 shares of our common stock to Aspire Capital as a commitment fee in November 2019 and filed a registration statement for the resale of 31,000,000 shares of common stock in connection with the equity facility. Our prior equity facility that was entered into in February 2018 was fully utilized and terminated during the first quarter of 2020. There were no sales to Aspire Capital in the second quarter of 2020, and we sold 6,825,000 shares to Aspire Capital at an average price of $1.50 per share in the first quarter of 2020, generating proceeds of $10.2 million. We sold 3,350,000 shares to Aspire Capital at an average price of $1.52 per share in the second quarter of 2019, generating proceeds of $5.1 million and we sold 7,175,000 shares to Aspire Capital at an average price of $1.49 per share during the six months ended June 30, 2019, generating proceeds of $10.7 million. Healios Warrant In March 2020, Healios elected to exercise its warrant in full, and we issued 4,000,000 shares of our common stock at an exercise price equal to the reference price of $1.76 per share, as defined in the warrant. Proceeds of approximately $7.0 million were received in April 2020 in accordance with the terms of the warrant. Healios Investor Rights Agreement |
Income Taxes
Income Taxes | 6 Months Ended |
Jun. 30, 2020 | |
Income Tax Disclosure [Abstract] | |
Income Taxes | Income TaxesWe have United States (“U.S.”) federal net operating loss and research and development tax credit carryforwards, as well as state and city net operating loss carryforwards, which may be used to reduce future taxable income and tax liabilities. We also have foreign net operating loss and tax credit carryforwards, and the foreign net operating loss carryforwards do not expire. All of our deferred tax assets have been fully offset by a valuation allowance due to our cumulative losses. 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. Also, there are significant limitations on our ability to utilize our net operating loss and tax credit carryforwards under Section 382 of the Internal Revenue Code of 1986, as amended. |
Recently Issued Accounting St_2
Recently Issued Accounting Standards (Policies) | 6 Months Ended |
Jun. 30, 2020 | |
Accounting Policies [Abstract] | |
Recently Issued Accounting Standards | In June 2016, the Financial Accounting Standards Board (“FASB”) issued Accounting Standards Update (“ASU”) 2016-13, Financial Instruments-Credit Losses (Topic 326): Measurement of Credit Losses on Financial Instruments (“ASU 2016-13”) . This ASU replaces the incurred loss impairment methodology in current GAAP with a methodology that reflects expected credit losses and requires consideration of a broader range of reasonable and supportable information to inform credit loss estimates. Subsequent to issuing ASU 2016-13, the FASB issued ASU 2019-10, Financial Instruments - Credit Losses (Topic 326): Effective Dates , delaying the effective date for smaller reporting companies until January 2023. We are currently evaluating the potential impact of adoption of this standard on our condensed consolidated financial statements and disclosures, and we do not intend to early adopt. In August 2018, the 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 non-cancellable term of the cloud computing arrangement plus any optional renewal periods reasonably certain to be exercised by the customer or for which exercise is controlled by the provider. ASU 2018-15 is effective for annual and interim periods beginning after December 15, 2019. The amendments in ASU 2018-15 should be applied either retrospectively or prospectively to all implementation costs incurred after the date of adoption. We adopted this standard on a prospective basis effective January 1, 2020 and the adoption of this standard had no impact on our condensed consolidated financial statements. In November 2018, the FASB issued ASU 2018-18, Collaborative Arrangements (Topic 808): Clarifying the Interaction between Topic 808 and Topic 606 (“ASU 2018-18”) . The amendments in this update: (i) 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, and in those situations, all the guidance in Topic 606 should be applied, including recognition, measurement, presentation and disclosure requirements; (ii) 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 (iii) 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. We have adopted the standard effective January 1, 2020 prospectively, which had no impact on our condensed consolidated financial statements. In December 2019, the FASB issued ASU 2019-12, Income Taxes (Topic 740) : Simplifying the Accounting for Income Taxes. The ASU simplifies the accounting for income taxes, changes the accounting for certain income tax transactions, and other minor changes. This guidance is effective for fiscal years beginning after December 15, 2020, including interim periods, with early adoption permitted. We are currently assessing the impact that this ASU will have on our condensed consolidated financial statements and disclosures. |
Net Loss per Share (Tables)
Net Loss per Share (Tables) | 6 Months Ended |
Jun. 30, 2020 | |
Earnings Per Share [Abstract] | |
Instruments Excluded from Calculation of Diluted Net Loss Per Share | The following instruments (in thousands) were excluded from the calculation of diluted net loss per share because their effects would be antidilutive: Three months ended Six months ended 2020 2019 2020 2019 Stock-based awards 21,061 16,791 21,061 16,791 Healios warrant – see Note 6 — 4,000 — 4,000 Total 21,061 20,791 21,061 20,791 |
Collaborative Arrangements an_2
Collaborative Arrangements and Revenue Recognition (Tables) | 6 Months Ended |
Jun. 30, 2020 | |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | |
Disaggregation of Revenue | The following table presents our contract revenues disaggregated by timing of revenue recognition (in thousands): Three months ended Three months ended Point in Over Time Point in Over Time Contract Revenue from Healios License fee revenue $ — $ — $ 1,624 $ — Product supply revenue 77 — 905 — Service revenue — — — 1,664 Total disaggregated revenues $ 77 $ — $ 2,529 $ 1,664 Six months ended Six months ended Point in Over Time Point in Time Over Time Contract Revenue from Healios License fee revenue $ — $ — $ 1,624 $ — Product supply revenue 77 — 1,871 — Service revenue — — — 2,139 Total disaggregated revenues $ 77 $ — $ 3,495 $ 2,139 |
Background and Basis of Prese_2
Background and Basis of Presentation - Additional Information (Details) $ in Thousands | 1 Months Ended | 6 Months Ended | |
Apr. 30, 2020USD ($) | Jun. 30, 2020USD ($)Segment | Dec. 31, 2019USD ($) | |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | |||
Number of business segments | Segment | 1 | ||
Accumulated deficit | $ 451,640 | $ 417,624 | |
Cash and cash equivalents | $ 80,707 | $ 35,041 | |
Public Stock Offering | |||
Class of Stock [Line Items] | |||
Net proceeds from public offering | $ 53,700 | ||
Healios | |||
Class of Stock [Line Items] | |||
Proceeds from exercise of warrant | $ 7,000 |
Net Loss per Share - Instrument
Net Loss per Share - Instruments Excluded from Calculation of Diluted Net Loss Per Share (Details) - shares shares in Thousands | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2020 | Jun. 30, 2019 | Jun. 30, 2020 | Jun. 30, 2019 | |
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||||
Total | 21,061 | 20,791 | 21,061 | 20,791 |
Stock-based awards | ||||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||||
Total | 21,061 | 16,791 | 21,061 | 16,791 |
Healios | Healios Warrant | ||||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||||
Total | 0 | 4,000 | 0 | 4,000 |
Collaborative Arrangements an_3
Collaborative Arrangements and Revenue Recognition - Additional Information (Details) | 12 Months Ended |
Dec. 31, 2019Milestone | |
Regulatory and sales milestones | Healios | |
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | |
Number of future milestones achieved | 2 |
Collaborative Arrangements an_4
Collaborative Arrangements and Revenue Recognition - Summary of Revenues Disaggregated by Recognition at Point in Time and Over Time (Details) - USD ($) $ in Thousands | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2020 | Jun. 30, 2019 | Jun. 30, 2020 | Jun. 30, 2019 | |
Point in Time | ||||
Disaggregation of Revenue [Line Items] | ||||
Revenues | $ 77 | $ 2,529 | $ 77 | $ 3,495 |
Over Time | ||||
Disaggregation of Revenue [Line Items] | ||||
Revenues | 0 | 1,664 | 0 | 2,139 |
Healios | Point in Time | License fee revenue | ||||
Disaggregation of Revenue [Line Items] | ||||
Revenues | 0 | 1,624 | 0 | 1,624 |
Healios | Point in Time | Product supply revenue | ||||
Disaggregation of Revenue [Line Items] | ||||
Revenues | 77 | 905 | 77 | 1,871 |
Healios | Point in Time | Service revenue | ||||
Disaggregation of Revenue [Line Items] | ||||
Revenues | 0 | 0 | 0 | 0 |
Healios | Over Time | License fee revenue | ||||
Disaggregation of Revenue [Line Items] | ||||
Revenues | 0 | 0 | 0 | 0 |
Healios | Over Time | Product supply revenue | ||||
Disaggregation of Revenue [Line Items] | ||||
Revenues | 0 | 0 | 0 | 0 |
Healios | Over Time | Service revenue | ||||
Disaggregation of Revenue [Line Items] | ||||
Revenues | $ 0 | $ 1,664 | $ 0 | $ 2,139 |
Stock-Based Compensation - Addi
Stock-Based Compensation - Additional Information (Details) - USD ($) $ in Millions | 1 Months Ended | 3 Months Ended | ||
Jun. 30, 2020 | Jun. 30, 2020 | Mar. 31, 2020 | Jun. 30, 2019 | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||
Common stock authorized for equity incentive plan (in shares) | 18,500,000 | 18,500,000 | ||
Stock options granted (in shares) | 3,594,984 | |||
Shares purchased for award (in shares) | 1,000,000 | |||
Shares available for issuance (in shares) | 9,108,743 | 9,108,743 | ||
Stock-based compensation expense | $ 2.6 | $ 1.2 | ||
Unrecognized compensation cost of unvested stock awards | $ 18.3 | $ 18.3 | ||
Restricted Stock Units | ||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||
Restricted stock units granted (in shares) | 1,453,671 | |||
2019 Equity And Incentive Compensation Plan | ||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||
Shares of common stock outstanding (in shares) | 20,060,708 | 20,060,708 | ||
2019 Equity And Incentive Compensation Plan | Employees | Minimum | ||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||
Post-employment exercise period (in years and months) | 6 months | |||
2019 Equity And Incentive Compensation Plan | Employees | Maximum | ||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||
Post-employment exercise period (in years and months) | 3 years | |||
2019 Equity And Incentive Compensation Plan | Directors | Minimum | ||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||
Post-employment exercise period (in years and months) | 24 months | |||
2019 Equity And Incentive Compensation Plan | Directors | Maximum | ||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||
Post-employment exercise period (in years and months) | 30 months | |||
Inducement Awards Plan | ||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||
Shares of common stock outstanding (in shares) | 1,000,000 | 1,000,000 | ||
2019 Equity And Incentive Compensation Plan, Modification | ||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||
Stock-based compensation expense | $ 1.2 | |||
Unrecognized compensation cost of unvested stock awards | $ 0.5 | $ 0.5 |
Stockholders' Equity - Addition
Stockholders' Equity - Additional Information (Details) - USD ($) | Nov. 05, 2019 | May 31, 2020 | Apr. 30, 2020 | Mar. 31, 2020 | Jun. 30, 2020 | Mar. 31, 2020 | Jun. 30, 2019 | Jun. 30, 2019 | Nov. 30, 2019 |
Public Stock Offering | |||||||||
Class of Stock [Line Items] | |||||||||
Gross proceeds from public offering | $ 57,600,000 | ||||||||
Consideration received from sale of stock | $ 53,700,000 | ||||||||
Shares issued and sold (in shares) | 25,587,500 | ||||||||
Offering price (in dollars per share) | $ 2.25 | ||||||||
Aspire Capital | |||||||||
Class of Stock [Line Items] | |||||||||
Equity purchase agreement, value | $ 100,000,000 | ||||||||
Common stock issued as commitment fees (in shares) | 350,000 | ||||||||
Common stock registered for resale (in shares) | 31,000,000 | ||||||||
Net proceeds from sales of common stock | $ 10,200,000 | $ 5,100,000 | $ 10,700,000 | ||||||
Aspire Capital | Common Stock | |||||||||
Class of Stock [Line Items] | |||||||||
Issuance of common stock, new issues (in shares) | 0 | 6,825,000 | 3,350,000 | 7,175,000 | |||||
Sale of additional shares at an average price (in dollars per share) | $ 1.50 | $ 1.52 | $ 1.49 | ||||||
Healios | |||||||||
Class of Stock [Line Items] | |||||||||
Common stock issued upon exercise of warrant (in shares) | 4,000,000 | ||||||||
Common stock issued, price per share (in dollars per share) | $ 1.76 | ||||||||
Proceeds from exercise of warrant | $ 7,000,000 | ||||||||
Healios | Securities Purchase Agreement | |||||||||
Class of Stock [Line Items] | |||||||||
Consideration received from sale of stock | $ 534,105 | ||||||||
Shares issued and sold (in shares) | 310,526 | ||||||||
Offering price (in dollars per share) | $ 1.72 |