Cover Page
Cover Page - shares | 9 Months Ended | |
Sep. 30, 2022 | Nov. 07, 2022 | |
Cover [Abstract] | ||
Document Type | 10-Q | |
Document Quarterly Report | true | |
Document Period End Date | Sep. 30, 2022 | |
Document Transition Report | false | |
Entity File Number | 001-33876 | |
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 $0.001 per share | |
Trading Symbol | ATHX | |
Security Exchange Name | NASDAQ | |
Entity Current Reporting Status | Yes | |
Entity Interactive Data Current | Yes | |
Entity Filer Category | Non-accelerated Filer | |
Entity Small Business | true | |
Entity Emerging Growth Company | false | |
Entity Shell Company | false | |
Entity Common Stock, Shares Outstanding | 12,933,736 | |
Amendment Flag | false | |
Document Fiscal Year Focus | 2022 | |
Document Fiscal Period Focus | Q3 | |
Entity Registrant Name | ATHERSYS, INC / NEW | |
Entity Central Index Key | 0001368148 | |
Current Fiscal Year End Date | --12-31 |
Condensed Consolidated Balance
Condensed Consolidated Balance Sheets - USD ($) $ in Thousands | Sep. 30, 2022 | Dec. 31, 2021 |
Current assets: | ||
Cash and cash equivalents | $ 13,782 | $ 37,407 |
Prepaid clinical trial costs | 4,889 | 2,861 |
Prepaid expenses and other | 1,417 | 1,345 |
Total current assets | 20,748 | 46,027 |
Operating right-of-use assets, net | 8,131 | 8,960 |
Property and equipment, net | 5,438 | 3,692 |
Deposits and other | 1,226 | 1,505 |
Total assets | 35,543 | 60,184 |
Current liabilities: | ||
Operating lease liabilities, current | 845 | 1,011 |
Accrued compensation and related benefits | 1,553 | 4,133 |
Accrued clinical trial related costs | 4,094 | 3,773 |
Accrued expenses and other | 1,108 | 704 |
Total current liabilities | 38,729 | 29,861 |
Operating lease liabilities, non-current | 8,109 | 8,755 |
Other long-term liabilities | 119 | 0 |
Stockholders’ equity: | ||
Preferred stock, at stated value; 10,000,000 shares authorized, and no shares issued and outstanding at September 30, 2022 and December 31, 2021 | 0 | 0 |
Common stock, $0.001 par value; 600,000,000 shares authorized with 12,933,736 and 9,713,767 shares issued and outstanding at September 30, 2022 and December 31, 2021, respectively | 13 | 10 |
Additional paid-in capital | 626,251 | 599,703 |
Accumulated deficit | (642,877) | (583,344) |
Total stockholders’ equity (deficit) | (16,613) | 16,369 |
Total liabilities and stockholders’ equity | 35,543 | 60,184 |
Consolidated entity, excluding related party | ||
Current liabilities: | ||
Accounts payable | 29,182 | 15,781 |
Healios | ||
Current assets: | ||
Accounts receivable from Healios | 660 | 1,414 |
Unbilled accounts receivable from Healios | 0 | 3,000 |
Current liabilities: | ||
Accounts payable to Healios | 0 | 1,119 |
Deferred revenue - Healios | 0 | 3,340 |
Warrant liability | 1,947 | 0 |
Advance from Healios | $ 5,199 | $ 5,199 |
Condensed Consolidated Balanc_2
Condensed Consolidated Balance Sheets (Parenthetical) - $ / shares | Sep. 30, 2022 | Dec. 31, 2021 |
Stockholders’ equity: | ||
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) | 600,000,000 | 600,000,000 |
Common stock, shares issued (in shares) | 12,933,736 | 9,713,767 |
Common stock, shares outstanding (in shares) | 12,933,736 | 9,713,767 |
Condensed Consolidated Statemen
Condensed Consolidated Statements of Operations and Comprehensive Loss - USD ($) shares in Thousands, $ in Thousands | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2022 | Sep. 30, 2021 | Sep. 30, 2022 | Sep. 30, 2021 | |
Revenues | ||||
Total revenues | $ 65 | $ 4,792 | $ 5,294 | $ 4,792 |
Costs and expenses | ||||
Research and development | 12,424 | 17,162 | 54,162 | 52,361 |
General and administrative | 3,737 | 3,632 | 12,999 | 16,627 |
Depreciation | 617 | 220 | 1,482 | 1,187 |
Total costs and expenses | 16,778 | 21,014 | 68,643 | 70,175 |
Loss from operations | (16,713) | (16,222) | (63,349) | (65,383) |
Other income, net | 3,044 | 45 | 3,816 | 139 |
Net loss | (13,669) | (16,177) | (59,533) | (65,244) |
Net and comprehensive loss | $ (13,669) | $ (16,177) | $ (59,533) | $ (65,244) |
Net loss per share, basic (in dollars per share) | $ (1.15) | $ (1.76) | $ (5.58) | $ (7.41) |
Net loss per share, diluted (in dollars per share) | $ (1.15) | $ (1.76) | $ (5.58) | $ (7.41) |
Weighted average shares outstanding, basic (in shares) | 11,855 | 9,169 | 10,676 | 8,801 |
Weighted average shares outstanding, diluted (in shares) | 11,855 | 9,169 | 10,676 | 8,801 |
Healios | ||||
Revenues | ||||
Contract revenue from Healios | $ 65 | $ 4,792 | $ 5,294 | $ 4,792 |
Condensed Consolidated Statem_2
Condensed Consolidated Statements of Stockholders' Equity - USD ($) $ in Thousands | Total | Consolidated entity, excluding related party | Preferred Stock | Common Stock | Common Stock Consolidated entity, excluding related party | Additional Paid-in Capital | Additional Paid-in Capital Consolidated entity, excluding related party | Accumulated Deficit |
Preferred stock shares, beginning balance (in shares) at Dec. 31, 2020 | 0 | |||||||
Beginning balance at Dec. 31, 2020 | $ 31,362 | $ 0 | $ 8 | $ 527,743 | $ (496,389) | |||
Common stock, beginning balance (in shares) at Dec. 31, 2020 | 8,078,943 | |||||||
Increase (Decrease) in Stockholders' Equity [Roll Forward] | ||||||||
Stock-based compensation | 3,903 | 3,903 | ||||||
Issuance of common stock (in shares) | 608,000 | |||||||
Issuance of common stock | $ 30,495 | $ 1 | $ 30,494 | |||||
Issuance of common stock under equity compensation plan (in shares) | 17,517 | |||||||
Issuance of common stock under equity compensation plan | (611) | (611) | ||||||
Net and comprehensive loss | (26,468) | (26,468) | ||||||
Preferred stock shares, ending balance (in shares) at Mar. 31, 2021 | 0 | |||||||
Ending balance at Mar. 31, 2021 | 38,681 | $ 0 | $ 9 | 561,529 | (522,857) | |||
Common stock, ending balance (in shares) at Mar. 31, 2021 | 8,704,460 | |||||||
Preferred stock shares, beginning balance (in shares) at Dec. 31, 2020 | 0 | |||||||
Beginning balance at Dec. 31, 2020 | 31,362 | $ 0 | $ 8 | 527,743 | (496,389) | |||
Common stock, beginning balance (in shares) at Dec. 31, 2020 | 8,078,943 | |||||||
Increase (Decrease) in Stockholders' Equity [Roll Forward] | ||||||||
Net and comprehensive loss | (65,244) | |||||||
Preferred stock shares, ending balance (in shares) at Sep. 30, 2021 | 0 | |||||||
Ending balance at Sep. 30, 2021 | 29,347 | $ 0 | $ 9 | 590,971 | (561,633) | |||
Common stock, ending balance (in shares) at Sep. 30, 2021 | 9,409,209 | |||||||
Preferred stock shares, beginning balance (in shares) at Mar. 31, 2021 | 0 | |||||||
Beginning balance at Mar. 31, 2021 | 38,681 | $ 0 | $ 9 | 561,529 | (522,857) | |||
Common stock, beginning balance (in shares) at Mar. 31, 2021 | 8,704,460 | |||||||
Increase (Decrease) in Stockholders' Equity [Roll Forward] | ||||||||
Stock-based compensation | 1,788 | 1,788 | ||||||
Issuance of common stock (in shares) | 340,000 | |||||||
Issuance of common stock | 13,292 | $ 0 | 13,292 | |||||
Issuance of common stock under equity compensation plan (in shares) | 5,743 | |||||||
Issuance of common stock under equity compensation plan | (116) | (116) | ||||||
Net and comprehensive loss | (22,599) | (22,599) | ||||||
Preferred stock shares, ending balance (in shares) at Jun. 30, 2021 | 0 | |||||||
Ending balance at Jun. 30, 2021 | 31,046 | $ 0 | $ 9 | 576,493 | (545,456) | |||
Common stock, ending balance (in shares) at Jun. 30, 2021 | 9,050,203 | |||||||
Increase (Decrease) in Stockholders' Equity [Roll Forward] | ||||||||
Stock-based compensation | 1,407 | 1,407 | ||||||
Issuance of common stock (in shares) | 354,000 | |||||||
Issuance of common stock | 13,157 | $ 0 | 13,157 | |||||
Issuance of common stock under equity compensation plan (in shares) | 5,006 | |||||||
Issuance of common stock under equity compensation plan | (86) | (86) | ||||||
Net and comprehensive loss | (16,177) | (16,177) | ||||||
Preferred stock shares, ending balance (in shares) at Sep. 30, 2021 | 0 | |||||||
Ending balance at Sep. 30, 2021 | $ 29,347 | $ 0 | $ 9 | 590,971 | (561,633) | |||
Common stock, ending balance (in shares) at Sep. 30, 2021 | 9,409,209 | |||||||
Preferred stock shares, beginning balance (in shares) at Dec. 31, 2021 | 0 | 0 | ||||||
Beginning balance at Dec. 31, 2021 | $ 16,369 | $ 0 | $ 10 | 599,703 | (583,344) | |||
Common stock, beginning balance (in shares) at Dec. 31, 2021 | 9,713,767 | 9,713,767 | ||||||
Increase (Decrease) in Stockholders' Equity [Roll Forward] | ||||||||
Stock-based compensation | $ 1,410 | 1,410 | ||||||
Issuance of common stock (in shares) | 272,000 | |||||||
Issuance of common stock | 4,802 | $ 0 | 4,802 | |||||
Issuance of common stock under equity compensation plan (in shares) | 5,944 | |||||||
Issuance of common stock under equity compensation plan | (58) | (58) | ||||||
Net and comprehensive loss | (22,216) | (22,216) | ||||||
Preferred stock shares, ending balance (in shares) at Mar. 31, 2022 | 0 | |||||||
Ending balance at Mar. 31, 2022 | $ 307 | $ 0 | $ 10 | 605,857 | (605,560) | |||
Common stock, ending balance (in shares) at Mar. 31, 2022 | 9,991,711 | |||||||
Preferred stock shares, beginning balance (in shares) at Dec. 31, 2021 | 0 | 0 | ||||||
Beginning balance at Dec. 31, 2021 | $ 16,369 | $ 0 | $ 10 | 599,703 | (583,344) | |||
Common stock, beginning balance (in shares) at Dec. 31, 2021 | 9,713,767 | 9,713,767 | ||||||
Increase (Decrease) in Stockholders' Equity [Roll Forward] | ||||||||
Net and comprehensive loss | $ (59,533) | |||||||
Preferred stock shares, ending balance (in shares) at Sep. 30, 2022 | 0 | 0 | ||||||
Ending balance at Sep. 30, 2022 | $ (16,613) | $ 0 | $ 13 | 626,251 | (642,877) | |||
Common stock, ending balance (in shares) at Sep. 30, 2022 | 12,933,736 | 12,933,736 | ||||||
Preferred stock shares, beginning balance (in shares) at Mar. 31, 2022 | 0 | |||||||
Beginning balance at Mar. 31, 2022 | $ 307 | $ 0 | $ 10 | 605,857 | (605,560) | |||
Common stock, beginning balance (in shares) at Mar. 31, 2022 | 9,991,711 | |||||||
Increase (Decrease) in Stockholders' Equity [Roll Forward] | ||||||||
Stock-based compensation | 1,945 | 1,945 | ||||||
Issuance of common stock (in shares) | 1,003,560 | |||||||
Issuance of common stock | 9,698 | $ 1 | 9,697 | |||||
Issuance of common stock under equity compensation plan (in shares) | 9,119 | |||||||
Issuance of common stock under equity compensation plan | (40) | (40) | ||||||
Net and comprehensive loss | (23,648) | (23,648) | ||||||
Preferred stock shares, ending balance (in shares) at Jun. 30, 2022 | 0 | |||||||
Ending balance at Jun. 30, 2022 | (11,738) | $ 0 | $ 11 | 617,459 | (629,208) | |||
Common stock, ending balance (in shares) at Jun. 30, 2022 | 11,004,390 | |||||||
Increase (Decrease) in Stockholders' Equity [Roll Forward] | ||||||||
Stock-based compensation | 2,001 | 2,001 | ||||||
Issuance of common stock (in shares) | 1,200,000 | |||||||
Issuance of common stock | 4,593 | $ 1 | 4,592 | |||||
Pre-funded warrant exercise (in shares) | 720,000 | |||||||
Pre-funded warrant exercise | $ 2,233 | $ 1 | $ 2,232 | |||||
Issuance of common stock under equity compensation plan (in shares) | 9,346 | |||||||
Issuance of common stock under equity compensation plan | (33) | (33) | ||||||
Net and comprehensive loss | $ (13,669) | (13,669) | ||||||
Preferred stock shares, ending balance (in shares) at Sep. 30, 2022 | 0 | 0 | ||||||
Ending balance at Sep. 30, 2022 | $ (16,613) | $ 0 | $ 13 | $ 626,251 | $ (642,877) | |||
Common stock, ending balance (in shares) at Sep. 30, 2022 | 12,933,736 | 12,933,736 |
Condensed Consolidated Statem_3
Condensed Consolidated Statements of Cash Flows - USD ($) $ in Thousands | 9 Months Ended | |
Sep. 30, 2022 | Sep. 30, 2021 | |
Operating activities | ||
Net loss | $ (59,533) | $ (65,244) |
Adjustments to reconcile net loss to net cash used in operating activities: | ||
Depreciation | 1,482 | 1,187 |
Loss from impairment of assets | 5,435 | 0 |
Stock-based compensation | 5,356 | 7,098 |
Operating right-of-use assets, net | 0 | 232 |
Gain on sale of assets | (11) | 0 |
Change in fair value of warrant liabilities | (2,784) | 0 |
Issuance costs allocated to warrant liabilities | 560 | |
Changes in operating assets and liabilities: | ||
Accounts receivable from Healios - billed and unbilled | 3,754 | (6,311) |
Prepaid expenses, deposits and other | (1,262) | 699 |
Accounts payable, accrued expenses and other | 4,472 | 4,047 |
Accounts payable to Healios | (1,119) | (586) |
Deferred revenue - Healios | (3,340) | 2,029 |
Advance from Healios | 0 | (2) |
Net cash used in operating activities | (46,990) | (56,851) |
Investing activities | ||
Proceeds from the sale of equipment | 41 | 0 |
Purchases of equipment | (2,044) | (1,154) |
Net cash used in investing activities | (2,003) | (1,154) |
Financing activities | ||
Proceeds from issuance of common stock, net of issuance cost | 14,500 | 56,944 |
Proceeds from the issuance of common stock and warrants, net of issuance cost | 10,997 | 0 |
Proceeds from the exercise of pre-funded warrants | 2 | 0 |
Shares retained for withholding tax payments on stock-based awards | (131) | (814) |
Net cash provided by financing activities | 25,368 | 56,130 |
Decrease in cash and cash equivalents | (23,625) | (1,875) |
Cash and cash equivalents at beginning of the period | 37,407 | 51,546 |
Cash and cash equivalents at end of the period | 13,782 | 49,671 |
Noncash financing activities | ||
Issuance of warrants | 413 | 0 |
Reclass of warrant liability to additional paid-in capital upon exercise | $ 2,231 | $ 0 |
Background and Basis of Present
Background and Basis of Presentation | 9 Months Ended |
Sep. 30, 2022 | |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | |
Background and Basis of Presentation | Background and Basis of Presentation Organization Athersys, Inc., including its consolidated subsidiaries (collectively, “we,” “us,” “our,” “Athersys,” and the “Company”), is a biotechnology company focused in the field of regenerative medicine and operates in one business segment. Our operations consist of research, clinical development activities, manufacturing and manufacturing process development activities, and our most advanced program is in a pivotal Phase 3 clinical trial for the treatment of ischemic stroke. Basis of Presentation 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, 2021. 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. 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. Reverse stock split On August 26, 2022, the Company amended its Certificate of Incorporation to implement a 1-for-25 reverse stock split of its common stock. The reverse stock split did not cause an adjustment to the par value or the authorized shares of the common stock. As a result of the reverse stock split, the Company adjusted the share amounts under its employee equity incentive plans, inducement awards and common stock warrant agreements with third parties. All disclosures of common shares and per common share data in the accompanying interim financial statements and related notes reflect the reverse stock split for all periods presented. |
Going Concern
Going Concern | 9 Months Ended |
Sep. 30, 2022 | |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | |
Going Concern | Going Concern We have prepared our unaudited condensed consolidated financial statements on a going concern basis, which assumes that we will realize our assets and satisfy our liabilities in the normal course of business. However, we have incurred net losses since our inception in 1995 and have negative operating cash flows. These factors, among others, raise substantial doubt about our ability to continue as a going concern within one year after the date that these financial statements are issued. The accompanying unaudited condensed consolidated financial statements do not include any adjustments to reflect the possible future effect on the recoverability and classification of assets or the amounts and classification of liabilities that may result from the outcome of the uncertainty concerning our ability to continue as a going concern. At September 30, 2022, we had cash and cash equivalents of $13.8 million. We will need substantial additional funding to develop our MultiStem product candidate and to continue our operations. To conserve cash, we have been delaying payments to most of our suppliers and service providers. In the near term, we will need to obtain significant capital through public or private equity offerings, debt financings, collaborations and licensing arrangements or other sources to continue to fund our operations. However, there can be no assurance that we will be able to obtain adequate funding on terms acceptable to us, on a timely basis or at all, particularly in light of our current stock price and liquidity. If we are unable to obtain funding, we may be required to further delay, reduce or eliminate our MultiStem product candidate approval efforts, which could adversely affect our business prospects, and we may be unable to continue operations. Adequate additional financing may not be available to us on acceptable terms, or at all. There can be no assurance that we will be able to out-license our MultiStem product candidate on a timely basis or on terms that are favorable to us, or at all. Our failure to raise capital through financing or a license as and when needed would have a negative impact on our financial condition and our ability to pursue our business strategy. We could be forced to discontinue the development of our MultiStem |
Accounting Standards Not Yet Ad
Accounting Standards Not Yet Adopted | 9 Months Ended |
Sep. 30, 2022 | |
Accounting Policies [Abstract] | |
Accounting Standards Not Yet Adopted | Accounting Standards Not Yet Adopted In June 2016, the Financial Accounting Standards Board (“FASB”) issued Accounting Standard Update (“ASU”) 2016-13, Measurement of Credit Losses on Financial Instruments (Topic 326) . 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 |
Net Loss per Share
Net Loss per Share | 9 Months Ended |
Sep. 30, 2022 | |
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 our 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. We have two warrants outstanding to purchase an aggregate of 400,000 shares of our common stock that were issued to HEALIOS K.K. (“Healios”) in August 2021 and are not yet exercisable according to their terms, and we have warrants outstanding to purchase an aggregate of 3,920,000 shares of our common stock that were issued in the third quarter of 2022. Refer to Note 8 for additional information. The following instruments were excluded from the calculation of diluted net loss per share because their effect would be anti-dilutive. Three months ended Nine months ended 2022 2021 2022 2021 Stock-based awards 1,393,231 1,007,597 1,393,231 1,007,597 Warrants - refer to Note 8 3,920,000 400,000 4,320,000 400,000 Total 5,313,231 1,407,597 5,713,231 1,407,597 |
Property and Equipment, net
Property and Equipment, net | 9 Months Ended |
Sep. 30, 2022 | |
Property, Plant and Equipment [Abstract] | |
Property and Equipment, net | Property and Equipment, net For the periods ended Property and equipment consists of (in thousands): September 30, December 31, Laboratory equipment $ 8,326 $ 9,352 Office equipment and leasehold improvements 4,071 4,000 Equipment and leasehold improvements not yet in service 3,497 458 15,894 13,810 Accumulated depreciation and amortization (10,456) (10,118) $ 5,438 $ 3,692 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. In June 2022, we announced a restructuring of our organization, with the intention of significantly reducing expenses, conserving cash, improving the focus of the Company’s activities and becoming more attractive to potential financial and strategic partners. This restructuring plan (the “Plan”) included a significant reduction in our workforce and changes to our management team. The Plan also includes the reduction of our internal research function, decommissioning certain equipment and pausing our manufacturing and process development efforts toward commercializing our MultiStem product candidate. As a result of these actions, we recorded an impairment charge of approximately $5.4 million to adjust the carrying amount of certain equipment assets to the estimated market value of similar assets. The impairment charge is included in research and development costs and expenses on the condensed consolidated statements of operations and comprehensive loss for the nine months ended September 30, 2022. |
Collaborative Arrangements and
Collaborative Arrangements and Revenue Recognition | 9 Months Ended |
Sep. 30, 2022 | |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | |
Collaborative Arrangements and Revenue Recognition | Collaborative Arrangements and Revenue Recognition Healios Collaboration We have a licensing agreement 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 territory, and we provide certain services to Healios for which we are paid. In August 2021, the Company and Healios entered into the Framework Agreement, which provides for clarification under and modifies the existing agreements between the parties. It also provides Healios with deferral of certain milestone payments during the expensive initial commercial launch period. Under the Framework Agreement, the Company was entitled to payments for reimbursable services of which $0.7 million are included in accounts receivable from Healios at September 30, 2022. In addition, under the Framework Agreement, the Company was entitled to a $3.0 million milestone payment from Healios and was obligated to pay Healios $1.1 million by December 31, 2022. In September 2022, we received $1.9 million from Healios, which represents the milestone payment net of amounts owed to Healios. Additionally, to assist Healios with the advancement of its ischemic stroke and acute respiratory distress syndrome (“ARDS”) programs in Japan, in September 2022, we granted to Healios, subject to the terms of the licensing agreement, a non-exclusive license to make and have made MultiStem for the treatment of ischemic stroke and ARDS worldwide solely for import into Japan for use in Japan. In August 2021, we also issued two warrants (together, the “2021 Warrants”) to Healios in connection with the Framework Agreement to purchase up to a total of 400,000 shares of our common stock. The 2021 Warrants are being accounted for as consideration paid or payable to a customer according to Topic 606, Revenue from Contracts with Customers , and Topic 718, Compensation Stock Compensation , under which the recognition of such equity instruments is required at the time that the underlying performance conditions become probable or are satisfied. As of September 30, 2022, the 2021 Warrants have not been recorded as the underlying performance conditions have not been satisfied and are not yet considered probable. Refer to Note 8 for further information. Healios recently alleged that we are in material breach of our Framework Agreement for, among other things, not meeting our supply obligations and cooperation and assistance obligations. We strongly disagree with Healios’ allegations and no loss has been accrued as a loss is not probable. We will continue to work with Healios to try to resolve this dispute. 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 one performance obligation for services necessary for regulatory approvals, manufacturing readiness, and commercial launch in Japan. At the inception of the Healios arrangement, we determined the transaction price included estimated payments for reimbursable services to be performed by us for Healios and the $3.0 million milestone payment. We allocated the total transaction price to this one performance obligation. We began recognizing this revenue beginning in the third quarter of 2021 as the services were being performed. At September 30, 2022, the services related to this performance obligation are largely complete, and we expect the remaining services, which consist of minimal close-out activities, to be completed by the end of 2022. During the three months ended September 30, 2022 and 2021, we recognized revenue associated with this performance obligation of approximately $0.1 million and $4.3 million, respectively. We recognized no revenue for the three and nine months ended September 30, 2022, and revenue of approximately $0.5 million for the three and nine months ended September 30, 2021 from performance obligations satisfied in previous periods. Accounts receivable from Healios Accounts receivable from Healios are related to our contracts and are recorded when the right to consideration is unconditional at the amount that management expects to collect. Accounts receivable from Healios do not bear interest if paid when contractually due, and payments are generally due within thirty Unbilled Accounts Receivable Unbilled accounts receivable from Healios represent amounts due to us under contractual arrangements and for which we have an unconditional right to consideration, but for which we have not yet invoiced Healios. At September 30, 2022, we had no unbilled accounts receivable from Healios. Deferred Revenue - Healios Amounts included in deferred revenue - Healios are considered a contract liability. During the nine months ended September 30, 2022 revenue recognized from contract liabilities as of the beginning of the respective period was $2.8 million. No revenue was recognized from contract liabilities during the nine months ended September 30, 2021. Advance from Healios In 2017, we amended the clinical trial supply agreement for the manufacturing of clinical product for TREASURE 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 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 product supply revenue at a point in time upon delivery, as defined in the applicable product supply contracts, while service revenue is recognized when earned over time. 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 Product supply revenue $ — $ — $ 283 $ — Service revenue — 65 — 4,509 Total disaggregated revenues $ — $ 65 $ 283 $ 4,509 Nine months ended Nine months ended Point in Over Time Point in Over Time Contract Revenue from Healios Product supply revenue $ — $ — $ 283 $ — Service revenue — 5,294 — 4,509 Total disaggregated revenues $ — $ 5,294 $ 283 $ 4,509 |
Stock-Based Compensation
Stock-Based Compensation | 9 Months Ended |
Sep. 30, 2022 | |
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 740,000 shares of our common stock for awards to employees, directors and consultants. The EICP authorizes the issuance of stock-based compensation in the form of stock options, stock appreciation rights, restricted stock, restricted stock units (“RSUs”) , performance shares and units, and other stock-based awards. Under the EICP, in the three months ended September 30, 2022, we granted 59,772 RSUs and 128,168 stock options to our employees and members of our Board of Directors (the “Board”). On July 28, 2022, the stockholders of the Company approved the amendment and restatement of the Athersys, Inc. 2019 Equity and Incentive Compensation Plan (the “Amended EICP”). The Amended EICP continues to provide stock-based compensation as described above. Subject to adjustment, an additional 840,000 shares of Company common stock are available for awards under the Amended EICP. As an inducement to Mr. Camardo’s acceptance of employment with the Company, Mr. Camardo was granted an initial equity award (the “Inducement Award”) to purchase 400,000 shares of our common stock at a per share exercise price of $21.50. With regard to 160,000 shares, vesting of the Inducement Award will occur over a four-year period, with 25% of such portion of the award generally vesting on the first anniversary of the grant date and the remainder generally vesting monthly in substantially equal installments over the remaining 36 months. With regard to 240,000 shares, vesting of the Inducement Award will generally occur upon achievement of certain Company milestones. The Inducement Award has up to a 10-year term. On June 17, 2022, the Board appointed Ms. Maia Hansen as the Company’s Chief Operating Officer. To reflect her level of responsibility and leadership in the Company, and in connection with her promotion, Ms. Hansen received grants of 2,000 stock options and 1,333 RSUs. In addition, in recognition of continued service, in the second quarter of 2022, we granted stock options and RSUs to all then-current employees who would continue to be employed with the Company after June 30, 2022. All stock options and RSUs granted in the second quarter of 2022 generally vest one-half one year from the grant date and the remaining one-half vesting two years from the grant date. |
Stockholders_ Equity and Warran
Stockholders’ Equity and Warrants | 9 Months Ended |
Sep. 30, 2022 | |
Equity [Abstract] | |
Stockholders’ Equity and Warrants | 8. Stockholders’ Equity and Warrants Securities Purchase Agreement On August 15, 2022, the Company entered into a placement agency agreement with A.G.P./Alliance Global Partners (“A.G.P.”) pursuant to which A.G.P. agreed to serve as exclusive placement agent for the issuance and sale of common stock and warrants. A.G.P received a placement fee of approximately $0.8 million and approximately $0.1 million for the reimbursement of expenses. On August 15, 2022, the Company entered into a securities purchase agreement (the “Purchase Agreement”) with an investor, pursuant to which the Company agreed to issue and sell, in a registered direct offering, (i) an aggregate of 1,200,000 shares of the Company’s common stock (“Common Stock”), par value $0.001 per share, (ii) pre-funded warrants (“Pre-Funded Warrants”) exercisable for an aggregate of 720,000 shares of Common Stock and (iii) warrants (“Common Warrants”) exercisable for an aggregate of 1,920,000 shares of Common Stock, in combinations of one share of Common Stock or one Pre-Funded Warrant and one Common Warrant for a combined purchase price of $6.250 (less $0.0025 for any Pre-Funded Warrant). Subject to certain ownership limitations, under the terms of the Purchase Agreement, the Pre-Funded Warrants were exercisable upon issuance, and the Common Warrants were exercisable upon the six-month anniversary of issuance for a five-year period. Under the Purchase Agreement, each Pre-Funded Warrant was exercisable for one share of Common Stock at a price per share of $0.0025 and each Common Warrant was exercisable into one share of Common Stock at a price per share of $6.385. The offering closed on August 17, 2022 (the “Closing Date”) and the Company received net proceeds of approximately $11.0 million, after giving effect to the payment of placement fees and expenses. On August 29, 2022, the Pre-Funded Warrants were exercised in full and re-measured to fair value. Upon remeasurement and exercise, we recorded a gain of $0.8 million to adjust the warrant liability associated with the Pre-Funded Warrants to fair value and reclassified the $2.2 million warrant liability to additional paid-in capital. The fair value adjustment is recorded in other income, net on the condensed consolidated statement of operations and comprehensive loss. The Purchase Agreement contains certain restrictions that prohibit the Company from issuing its Common Stock in certain transactions for a period of 180 days following the Closing Date (the “Standstill Period”). Additionally, in the event the Company proposes a future offering to sell shares of Common Stock during the twelve months following the Closing Date, the investor has the right to participate in each offering in an amount up to 30.0 percent (the “Participation Right”). On September 22, 2022, the Company entered into an amendment to the Purchase Agreement (the “Purchase Agreement Amendment”) with the investor to, among other things, (i) amend the Common Warrants to be exercisable for a seven-year period after the six-month anniversary of the Closing Date, (ii) reduce the Standstill Period to 150 days following the Closing Date, (iii) reduce the term and the amount of the Participation Right to six months following the Closing Date and 20.0 percent in the aggregate of certain offered securities, and (iv) require the investor, subject to certain conditions, to participate in future offerings to sell certain securities to investors primarily for capital raising purposes during the six months following the Closing Date. On September 22, 2022, in consideration of the Purchase Agreement Amendment, and without receiving any cash proceeds, the Company issued to the investor additional warrants exercisable for 2,000,000 shares of Common Stock (the ‘New Warrants”) at a price of $6.385 for a seven-year period after the six-month anniversary of the date of issuance thereof. The Company has assessed the Pre-Funded Warrants, the Common Warrants and the New Warrants (collectively, the “Warrants”) for appropriate equity or liability classification pursuant to the Company’s accounting policy as described in Note C, in our Annual Report on Form 10-K. The Warrants contain a provision pursuant to which the warrant holder has the option to receive cash in the event there is a fundamental transaction (contractually defined to include various merger, acquisition or stock transfer activities). The Warrants meet the definition of a derivative pursuant to ASC 815 , Derivatives and Hedging and do not meet the derivative scope exception. As a result, the Warrants were initially recorded as liabilities and measured at fair value using the Black-Scholes valuation model. Issuance costs of $0.5 million were allocated to the Pre-Funded Warrants and Common Warrants and recorded in other income, net on the condensed consolidated statement of operations and comprehensive loss in the three and nine months ended September 30, 2022. The remaining issuance costs of $0.4 million were al1ocated to the Common Stock and recorded in additional paid-in capital. During the three and nine months ended September 30, 2022, the Company recognized a net gain of $2.8 million for the fair value adjustment related to the warrant liabilities, which includes a charge of $0.4 million recorded upon issuance of the New Warrants. As of September 30, 2022, the fair value of the warrant liabilities was $1.9 million. Equity Purchase Agreement We previously had equity purchase agreements in place since 2011 with Aspire Capital Fund, LLC (“Aspire Capital”) that provided us the ability to sell shares to Aspire Capital from time to time. On May 12, 2022, we entered into an agreement (the “2022 Equity Facility”) that included Aspire Capital’s commitment to purchase up to an aggregate of $100.0 million of shares of our common stock over a defined timeframe. The terms of the 2022 Equity Facility were similar to the previous equity facilities with Aspire Capital. Our prior equity facility that was entered into in 2021 (the “2021 Equity Facility”) was fully utilized and terminated during the second quarter of 2022. On July 6, 2022, Aspire Capital terminated the 2022 Equity Facility. Aspire Capital had the right to terminate the 2022 Equity Facility at the time or any time after any of the Company’s then current executive officers ceased to be an executive officer or full-time employee of the Company, which right was triggered in connection with the departures of Mr. William Lehmann, former president and Chief Operating Officer, Dr. Harrington, former Executive Vice President and Chief Scientific Officer, and Mr. MacLeod, former Chief Financial Officer. During the quarter ended September 30, 2022, we sold no shares of our common stock to Aspire Capital. During the quarter ended September 30, 2021, we sold 354,000 shares of our common stock to Aspire Capital at an average price of $37.19 per share. Healios 2021 Warrants In August 2021, we issued the 2021 Warrants to Healios to purchase up to an aggregate of 400,000 shares of our common stock. One of the 2021 Warrants is for the purchase of up to 120,000 shares at an exercise price of $45.0 per share, subject to specified increases, and generally is only exercisable within 60 days of receipt of either conditional or full marketing approval from the Pharmaceuticals and Medical Devices Agency in Japan (the “PMDA”) for the intravenous administration of MultiStem to treat patients who are suffering from acute respiratory distress syndrome. The other 2021 Warrant is for the purchase of up to 280,000 shares at an exercise price of $60.0 per share, subject to specified increases, and generally is only exercisable within 60 days of receipt of either conditional or full marketing approval from the PMDA for the intravenous administration of MultiStem to treat patients who are suffering from ischemic stroke. The 2021 Warrants may be terminated by us under certain conditions and have an exercise cap triggered at Healios’ ownership of 19.9% of our common stock. Increase Shares of Authorized Common Stock |
Fair Value Measurements
Fair Value Measurements | 9 Months Ended |
Sep. 30, 2022 | |
Fair Value Disclosures [Abstract] | |
Fair Value Measurements | Fair Value Measurements The carrying amounts of certain financial instruments, including cash and cash equivalents, accounts receivable, prepaid expenses and other current assets, accounts payable and accrued expenses approximate their respective fair values due to the short-term nature of such instruments. Liabilities Measured at Fair Value on a Recurring Basis The Company evaluates its financial assets and liabilities subject to fair value measurements on a recurring basis to determine the appropriate level in which to classify them for each reporting period. The requirement requires judgements to be made. Level 3 financial liabilities consist of the warrant liabilities for which there is no current market such that the determination of fair value requires judgement or estimation. Changes in fair value measurements categorized within Level 3 of the fair value hierarchy are analyzed each period based on changes in estimates or assumptions and recorded as appropriate. The Company uses the Black-Scholes option valuation model to value the Level 3 warrant liabilities at inception and on subsequent valuation dates. This model incorporates transaction detail such as the Company’s stock price, contractual terms, maturing, risk free rates as well as volatility. The unobservable input for the Level 3 warrant liabilities includes volatility, which is not significant to the fair value measurement of the warrant liabilities. A reconciliation of the beginning and ending balances for the warrant liabilities which are measured at fair value on a recurring basis using significant unobservable inputs (Level 3) is as follows (in thousands): Warrant Liabilities Balance December 31, 2021 $ — August 2022 Issuance Pre-Funded Warrants 3,022 August 2022 Issuance Common Warrants 3,940 Adjustment to fair value Pre-Funded Warrants (791) Exercise Pre-Funded Warrants (2,231) September 2022 Issuance New Warrants 413 Adjustment to fair value Common Warrants and New Warrants (2,406) Balance September 30, 2022 $ 1,947 |
Restructuring Charges
Restructuring Charges | 9 Months Ended |
Sep. 30, 2022 | |
Restructuring and Related Activities [Abstract] | |
Restructuring Charges | Restructuring Charges In June 2022, we announced a restructuring of our organization, including an approximate 70% reduction in our workforce. As part of the Plan we also announced changes to our executive team. Mr. Lehmann left the Company on May 31, 2022. Dr. Harrington and Mr. Macleod left the Company on June 30, 2022. The Company’s restructuring efforts are intended to preserve cash and reduce operating expenses going forward. In addition to the workforce reductions, the Company’s restructuring efforts include the reduction of our internal research function, the decommissioning of certain equipment and pausing our manufacturing and process development efforts toward commercializing our MultiStem product candidate. We are attempting to negotiate payment terms with our primary contract manufacturing organization responsible for the manufacture of Multistem. The following table sets forth certain details associated with the restructuring charges incurred in the three and nine months ended September 30, 2022 and the obligations recorded for the expenses associated with the Plan (in thousands). It is anticipated the Plan will be completed by mid-2023. Balances Cash Balances January 1, 2022 Charges (payments) September 30, 2022 Employee severance and benefits $ — $ 2,538 $ (1,114) $ 1,424 Legal and professional fees — 197 (162) 35 Other — 15 — 15 $ — $ 2,750 $ (1,276) $ 1,474 Balances Cash Balances June 30, 2022 Charges (payments) September 30, 2022 Employee severance and benefits $ 2,248 $ — $ (824) $ 1,424 Legal and professional fees 162 35 (162) 35 Other 15 0 — 15 $ 2,425 $ 35 $ (986) $ 1,474 The current portion of our restructuring accrual is included in accrued compensation and related benefits and accounts payable and the long-term portion of our restructuring accrual is included in other liabilities. Restructuring charges of $1.5 million and $1.3 million are included in research and development costs and expenses and general and administrative costs and expenses, respectively, for the nine months ended September 30, 2022. |
Income Taxes
Income Taxes | 9 Months Ended |
Sep. 30, 2022 | |
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. Substantially 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. |
Subsequent Event
Subsequent Event | 9 Months Ended |
Sep. 30, 2022 | |
Subsequent Events [Abstract] | |
Subsequent Event | Subsequent EventOn November 10, 2022 the Company completed a public offering of 5,004,545 shares of common stock and warrants to purchase 10,009,090 shares of common stock at a combined price of $1.10 per share and accompanying warrants for aggregate gross proceeds of approximately $5.5 million, before deducting placement agent fees and other offering expenses. The warrants have an exercise price of $1.10 per share, are exercisable immediately following the date of issuance and will expire five years from the date of issuance. |
Accounting Standards Not Yet _2
Accounting Standards Not Yet Adopted (Policies) | 9 Months Ended |
Sep. 30, 2022 | |
Accounting Policies [Abstract] | |
Basis of Presentation | Basis of Presentation 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, 2021. 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 Standards | Accounting Standards Not Yet Adopted In June 2016, the Financial Accounting Standards Board (“FASB”) issued Accounting Standard Update (“ASU”) 2016-13, Measurement of Credit Losses on Financial Instruments (Topic 326) . 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 |
Net Loss per Share (Tables)
Net Loss per Share (Tables) | 9 Months Ended |
Sep. 30, 2022 | |
Earnings Per Share [Abstract] | |
Schedule of 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 effect would be anti-dilutive. Three months ended Nine months ended 2022 2021 2022 2021 Stock-based awards 1,393,231 1,007,597 1,393,231 1,007,597 Warrants - refer to Note 8 3,920,000 400,000 4,320,000 400,000 Total 5,313,231 1,407,597 5,713,231 1,407,597 |
Property and Equipment, net (Ta
Property and Equipment, net (Tables) | 9 Months Ended |
Sep. 30, 2022 | |
Property, Plant and Equipment [Abstract] | |
Schedule of Property and Equipment, net | For the periods ended Property and equipment consists of (in thousands): September 30, December 31, Laboratory equipment $ 8,326 $ 9,352 Office equipment and leasehold improvements 4,071 4,000 Equipment and leasehold improvements not yet in service 3,497 458 15,894 13,810 Accumulated depreciation and amortization (10,456) (10,118) $ 5,438 $ 3,692 |
Collaborative Arrangements an_2
Collaborative Arrangements and Revenue Recognition (Tables) | 9 Months Ended |
Sep. 30, 2022 | |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | |
Schedule of Contract Revenues Disaggregated by Timing of 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 Product supply revenue $ — $ — $ 283 $ — Service revenue — 65 — 4,509 Total disaggregated revenues $ — $ 65 $ 283 $ 4,509 Nine months ended Nine months ended Point in Over Time Point in Over Time Contract Revenue from Healios Product supply revenue $ — $ — $ 283 $ — Service revenue — 5,294 — 4,509 Total disaggregated revenues $ — $ 5,294 $ 283 $ 4,509 |
Fair Value Measurements (Tables
Fair Value Measurements (Tables) | 9 Months Ended |
Sep. 30, 2022 | |
Fair Value Disclosures [Abstract] | |
Schedule of Warrant Liabilities Measured at Fair Value on Recurring Basis Using Significant Unobservable Inputs | A reconciliation of the beginning and ending balances for the warrant liabilities which are measured at fair value on a recurring basis using significant unobservable inputs (Level 3) is as follows (in thousands): Warrant Liabilities Balance December 31, 2021 $ — August 2022 Issuance Pre-Funded Warrants 3,022 August 2022 Issuance Common Warrants 3,940 Adjustment to fair value Pre-Funded Warrants (791) Exercise Pre-Funded Warrants (2,231) September 2022 Issuance New Warrants 413 Adjustment to fair value Common Warrants and New Warrants (2,406) Balance September 30, 2022 $ 1,947 |
Restructuring Charges (Tables)
Restructuring Charges (Tables) | 9 Months Ended |
Sep. 30, 2022 | |
Restructuring and Related Activities [Abstract] | |
Schedule of Restructuring Reserve by Type of Expenses | The following table sets forth certain details associated with the restructuring charges incurred in the three and nine months ended September 30, 2022 and the obligations recorded for the expenses associated with the Plan (in thousands). It is anticipated the Plan will be completed by mid-2023. Balances Cash Balances January 1, 2022 Charges (payments) September 30, 2022 Employee severance and benefits $ — $ 2,538 $ (1,114) $ 1,424 Legal and professional fees — 197 (162) 35 Other — 15 — 15 $ — $ 2,750 $ (1,276) $ 1,474 Balances Cash Balances June 30, 2022 Charges (payments) September 30, 2022 Employee severance and benefits $ 2,248 $ — $ (824) $ 1,424 Legal and professional fees 162 35 (162) 35 Other 15 0 — 15 $ 2,425 $ 35 $ (986) $ 1,474 |
Background and Basis of Prese_2
Background and Basis of Presentation (Details) | 9 Months Ended | |
Aug. 26, 2022 | Sep. 30, 2022 segment | |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | ||
Number of business segments | 1 | |
Reverse stock split, conversion ratio | 0.04 |
Going Concern (Details)
Going Concern (Details) - USD ($) $ in Thousands | Sep. 30, 2022 | Dec. 31, 2021 |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | ||
Cash and cash equivalents | $ 13,782 | $ 37,407 |
Net Loss per Share - Additional
Net Loss per Share - Additional Information (Details) - Healios Framework Agreement - shares | Sep. 30, 2022 | Aug. 31, 2021 |
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||
Warrants outstanding (in shares) | 2 | |
Shares called by warrants (in shares) | 3,920,000 | 400,000 |
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 | 9 Months Ended | ||
Sep. 30, 2022 | Sep. 30, 2021 | Sep. 30, 2022 | Sep. 30, 2021 | |
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||||
Stock-based awards (in shares) | 5,313,231 | 1,407,597 | 5,713,231 | 1,407,597 |
Stock-based awards | ||||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||||
Stock-based awards (in shares) | 1,393,231 | 1,007,597 | 1,393,231 | 1,007,597 |
Warrants | ||||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||||
Stock-based awards (in shares) | 3,920,000 | 400,000 | 4,320,000 | 400,000 |
Property and Equipment, net - S
Property and Equipment, net - Schedule of Property and Equipment, net (Details) - USD ($) $ in Thousands | Sep. 30, 2022 | Dec. 31, 2021 |
Property, Plant and Equipment [Line Items] | ||
Property and equipment, gross | $ 15,894 | $ 13,810 |
Accumulated depreciation and amortization | (10,456) | (10,118) |
Property and equipment, net | 5,438 | 3,692 |
Laboratory equipment | ||
Property, Plant and Equipment [Line Items] | ||
Property and equipment, gross | 8,326 | 9,352 |
Office equipment and leasehold improvements | ||
Property, Plant and Equipment [Line Items] | ||
Property and equipment, gross | 4,071 | 4,000 |
Equipment and leasehold improvements not yet in service | ||
Property, Plant and Equipment [Line Items] | ||
Property and equipment, gross | $ 3,497 | $ 458 |
Property and Equipment, net - A
Property and Equipment, net - Additional Information (Details) - USD ($) $ in Thousands | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2022 | Sep. 30, 2021 | Sep. 30, 2022 | Sep. 30, 2021 | |
Property, Plant and Equipment [Abstract] | ||||
Impairment charge of equipment assets | $ 5,435 | $ 0 | ||
Accelerated depreciation | $ 500 | $ 500 | $ 900 |
Collaborative Arrangements an_3
Collaborative Arrangements and Revenue Recognition - Additional Information (Details) | 1 Months Ended | 3 Months Ended | 9 Months Ended | 12 Months Ended | |||
Sep. 30, 2022 USD ($) performanceObligation shares | Aug. 31, 2021 USD ($) shares | Sep. 30, 2022 USD ($) performanceObligation shares | Sep. 30, 2021 USD ($) | Sep. 30, 2022 USD ($) performanceObligation shares | Sep. 30, 2021 USD ($) | Dec. 31, 2017 milestone | |
Minimum | |||||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | |||||||
Accounts receivable, payments due within period of invoicing | 30 days | 30 days | 30 days | ||||
Maximum | |||||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | |||||||
Accounts receivable, payments due within period of invoicing | 45 days | 45 days | 45 days | ||||
Healios Framework Agreement | |||||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | |||||||
Accounts receivable from Healios | $ 700,000 | $ 700,000 | $ 700,000 | ||||
Potential revenue from milestones | $ 3,000,000 | ||||||
Milestones obligated to pay | 1,100,000 | $ 1,100,000 | $ 1,100,000 | ||||
Received milestones payment | $ 1,900,000 | ||||||
Warrants issued (in shares) | shares | 2 | ||||||
Shares called by warrants (in shares) | shares | 3,920,000 | 400,000 | 3,920,000 | 3,920,000 | |||
Number of material performance obligations | performanceObligation | 1 | 1 | 1 | ||||
Revenue recognized | $ 100,000 | $ 4,300,000 | |||||
Revenue recognized from performance obligations satisfied in previous periods | 0 | $ 500,000 | $ 0 | $ 500,000 | |||
Unbilled accounts receivable | $ 0 | $ 0 | 0 | ||||
Healios | |||||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | |||||||
Revenue recognized | $ 2,800,000 | $ 0 | |||||
Healios | Regulatory and sales milestones | |||||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | |||||||
Number of future milestones achieved | milestone | 2 |
Collaborative Arrangements an_4
Collaborative Arrangements and Revenue Recognition - Schedule of Contract Revenues Disaggregated by Timing of Revenue Recognition (Details) - Healios - USD ($) $ in Thousands | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2022 | Sep. 30, 2021 | Sep. 30, 2022 | Sep. 30, 2021 | |
Point in Time | ||||
Disaggregation of Revenue [Line Items] | ||||
Total disaggregated revenues | $ 0 | $ 283 | $ 0 | $ 283 |
Point in Time | Product supply revenue | ||||
Disaggregation of Revenue [Line Items] | ||||
Total disaggregated revenues | 0 | 283 | 0 | 283 |
Point in Time | Service revenue | ||||
Disaggregation of Revenue [Line Items] | ||||
Total disaggregated revenues | 0 | 0 | 0 | 0 |
Over Time | ||||
Disaggregation of Revenue [Line Items] | ||||
Total disaggregated revenues | 65 | 4,509 | 5,294 | 4,509 |
Over Time | Product supply revenue | ||||
Disaggregation of Revenue [Line Items] | ||||
Total disaggregated revenues | 0 | 0 | 0 | 0 |
Over Time | Service revenue | ||||
Disaggregation of Revenue [Line Items] | ||||
Total disaggregated revenues | $ 65 | $ 4,509 | $ 5,294 | $ 4,509 |
Stock-Based Compensation (Detai
Stock-Based Compensation (Details) - USD ($) $ / shares in Units, $ in Millions | 3 Months Ended | ||||||
Jul. 28, 2022 | Jun. 17, 2022 | Feb. 14, 2022 | Sep. 30, 2022 | Jun. 30, 2022 | Sep. 30, 2021 | Dec. 31, 2019 | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||||
Stock options granted (in shares) | 128,168 | ||||||
Shares available for issuance (in shares) | 893,551 | ||||||
Stock-based compensation expense | $ 2 | $ 1.4 | |||||
Unrecognized compensation cost of unvested stock awards | $ 5.6 | ||||||
Tranche One | |||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||||
Vesting percentage | 50% | ||||||
Tranche Two | |||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||||
Awards vesting period (in years) | 2 years | ||||||
Vesting percentage | 50% | ||||||
Chief Operating Officer | |||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||||
Stock options granted (in shares) | 2,000 | ||||||
RSUs | |||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||||
Restricted stock units granted (in shares) | 59,772 | ||||||
RSUs | Chief Operating Officer | |||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||||
Restricted stock units granted (in shares) | 1,333 | ||||||
The Inducement Award | Chief Executive Officer | |||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||||
Stock options granted (in shares) | 400,000 | ||||||
Award exercise price (in dollars per share) | $ 21.50 | ||||||
Award expiration period (in years) | 10 years | ||||||
The Inducement Award, Four-Year Vesting | Chief Executive Officer | |||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||||
Stock options granted (in shares) | 160,000 | ||||||
Awards vesting period (in years) | 4 years | ||||||
The Inducement Award, Four-Year Vesting | Chief Executive Officer | Tranche One | |||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||||
Vesting percentage | 25% | ||||||
The Inducement Award, Four-Year Vesting | Chief Executive Officer | Tranche Two | |||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||||
Awards vesting period (in years) | 36 months | ||||||
The Inducement Award, Performance Based Vesting | Chief Executive Officer | |||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||||
Stock options granted (in shares) | 240,000 | ||||||
2019 Equity And Incentive Compensation Plan | |||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||||
Common stock authorized for equity incentive plan (in shares) | 740,000 | ||||||
Amended Equity And Incentive Compensation Plan | |||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||||
Number of additional shares authorized (in shares) | 840,000 | ||||||
Equity Incentive Plans | |||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||||
Shares of common stock outstanding (in shares) | 963,731 | ||||||
Inducement Awards Plan | |||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||||
Shares of common stock outstanding (in shares) | 429,500 |
Stockholders_ Equity and Warr_2
Stockholders’ Equity and Warrants (Details) - USD ($) $ / shares in Units, $ in Thousands | 1 Months Ended | 3 Months Ended | 9 Months Ended | |||||||||
Sep. 22, 2022 | Aug. 29, 2022 | Aug. 15, 2022 | May 12, 2022 | Aug. 31, 2021 | Sep. 30, 2022 | Sep. 30, 2021 | Sep. 30, 2022 | Sep. 30, 2021 | Dec. 31, 2021 | Jun. 30, 2021 | May 31, 2021 | |
Class of Stock [Line Items] | ||||||||||||
Common stock, par value (in dollars per share) | $ 0.001 | $ 0.001 | $ 0.001 | $ 0.001 | ||||||||
Change in fair value of warrant liabilities | $ 2,800 | $ 2,784 | $ 0 | |||||||||
Issuance costs allocated to warrant liabilities | 560 | |||||||||||
Fair value of warrant liabilities | $ 1,900 | $ 1,900 | ||||||||||
Common stock, shares authorized (in shares) | 600,000,000 | 600,000,000 | 600,000,000 | 600,000,000 | 300,000,000 | |||||||
Healios | ||||||||||||
Class of Stock [Line Items] | ||||||||||||
Warrant, exercise cap triggering percentage | 19.90% | |||||||||||
New Warrants | ||||||||||||
Class of Stock [Line Items] | ||||||||||||
Change in fair value of warrant liabilities | $ 400 | $ 400 | ||||||||||
Pre-Funded Warrants and Common Warrants | ||||||||||||
Class of Stock [Line Items] | ||||||||||||
Issuance costs allocated to warrant liabilities | $ 500 | 500 | ||||||||||
Warrant issuance costs allocated to equity | $ 400 | |||||||||||
Healios | 2021 Warrants | ||||||||||||
Class of Stock [Line Items] | ||||||||||||
Shares called by warrants (in shares) | 400,000 | |||||||||||
Healios | 2021 Warrant, Type One | ||||||||||||
Class of Stock [Line Items] | ||||||||||||
Shares called by warrants (in shares) | 120,000 | |||||||||||
Exercise price of warrant (in dollars per share) | $ 45 | |||||||||||
Warrants, exercisable period | 60 days | |||||||||||
Healios | 2021 Warrant, Type Two | ||||||||||||
Class of Stock [Line Items] | ||||||||||||
Shares called by warrants (in shares) | 280,000 | |||||||||||
Exercise price of warrant (in dollars per share) | $ 60 | |||||||||||
Warrants, exercisable period | 60 days | |||||||||||
Placement Agency Agreement With Alliance Global Partners | Alliance Global Partners | ||||||||||||
Class of Stock [Line Items] | ||||||||||||
Placement fee | $ 800 | |||||||||||
Placement fee reimbursement | 100 | |||||||||||
Purchase Agreement | ||||||||||||
Class of Stock [Line Items] | ||||||||||||
Proceeds from the issuance of common stock and warrants, net of issuance cost | $ 11,000 | |||||||||||
Standstill period | 180 days | |||||||||||
Participation right percentage | 30% | |||||||||||
Purchase Agreement | Pre-Funded Warrants | ||||||||||||
Class of Stock [Line Items] | ||||||||||||
Shares issued in offering (in shares) | 720,000 | |||||||||||
Exercise price of warrant (in dollars per share) | $ 6.385 | |||||||||||
Exercise price of warrant, price difference (in dollars per share) | $ 0.0025 | |||||||||||
Change in fair value of warrant liabilities | $ (800) | |||||||||||
Reclass of warrant liability to additional paid-in capital upon exercise | $ 2,200 | |||||||||||
Purchase Agreement | Common Warrant | ||||||||||||
Class of Stock [Line Items] | ||||||||||||
Shares called by warrants (in shares) | 1,920,000 | |||||||||||
Exercise price of warrant (in dollars per share) | $ 6.250 | |||||||||||
Warrants, exercisable period | 6 months | |||||||||||
Warrants term | 5 years | |||||||||||
Purchase Agreement | Common Stock | ||||||||||||
Class of Stock [Line Items] | ||||||||||||
Shares issued in offering (in shares) | 1,200,000 | |||||||||||
Purchase Agreement Amendment | ||||||||||||
Class of Stock [Line Items] | ||||||||||||
Standstill period | 150 days | |||||||||||
Participation right percentage | 20% | |||||||||||
Purchase Agreement Amendment | Common Warrant | ||||||||||||
Class of Stock [Line Items] | ||||||||||||
Warrants, exercisable period | 6 months | |||||||||||
Warrants term | 7 years | |||||||||||
Purchase Agreement Amendment | New Warrants | ||||||||||||
Class of Stock [Line Items] | ||||||||||||
Shares called by warrants (in shares) | 2,000,000 | |||||||||||
Exercise price of warrant (in dollars per share) | $ 6.385 | |||||||||||
2022 Equity Facility | Aspire Capital | ||||||||||||
Class of Stock [Line Items] | ||||||||||||
Shares issued in offering (in shares) | 0 | 354,000 | ||||||||||
Number of shares committed to be purchased (in shares) | $ 100,000 | |||||||||||
Sale of stock, average price (in USD per share) | $ 37.19 |
Fair Value Measurements (Detail
Fair Value Measurements (Details) - Warrants $ in Thousands | 9 Months Ended |
Sep. 30, 2022 USD ($) | |
Fair Value, Liabilities Measured on Recurring Basis, Unobservable Input Reconciliation, Calculation [Roll Forward] | |
Beginning period | $ 0 |
Ending period | 1,947 |
Pre-Funded Warrants | |
Fair Value, Liabilities Measured on Recurring Basis, Unobservable Input Reconciliation, Calculation [Roll Forward] | |
Issuances | 3,022 |
Adjustment | (791) |
Settlements | (2,231) |
Common Warrant | |
Fair Value, Liabilities Measured on Recurring Basis, Unobservable Input Reconciliation, Calculation [Roll Forward] | |
Issuances | 3,940 |
New Warrants | |
Fair Value, Liabilities Measured on Recurring Basis, Unobservable Input Reconciliation, Calculation [Roll Forward] | |
Issuances | 413 |
Common Warrants and New Warrants | |
Fair Value, Liabilities Measured on Recurring Basis, Unobservable Input Reconciliation, Calculation [Roll Forward] | |
Settlements | $ (2,406) |
Restructuring Charges - Additio
Restructuring Charges - Additional Information (Details) - USD ($) $ in Thousands | 1 Months Ended | 3 Months Ended | 9 Months Ended |
Jun. 30, 2022 | Sep. 30, 2022 | Sep. 30, 2022 | |
Restructuring Cost and Reserve [Line Items] | |||
Percentage of reduction in workforce | 70% | ||
Restructuring charges | $ 35 | $ 2,750 | |
Research and Development Expense | |||
Restructuring Cost and Reserve [Line Items] | |||
Restructuring charges | 1,500 | ||
General and Administrative Expense | |||
Restructuring Cost and Reserve [Line Items] | |||
Restructuring charges | $ 1,300 |
Restructuring Charges - Schedul
Restructuring Charges - Schedule of Restructuring Reserve (Details) - USD ($) $ in Thousands | 3 Months Ended | 9 Months Ended |
Sep. 30, 2022 | Sep. 30, 2022 | |
Restructuring Reserve [Roll Forward] | ||
Beginning balance | $ 2,425 | $ 0 |
Charges | 35 | 2,750 |
Cash payments | (986) | (1,276) |
Ending balance | 1,474 | 1,474 |
Employee severance and benefits | ||
Restructuring Reserve [Roll Forward] | ||
Beginning balance | 2,248 | 0 |
Charges | 0 | 2,538 |
Cash payments | (824) | (1,114) |
Ending balance | 1,424 | 1,424 |
Legal and professional fees | ||
Restructuring Reserve [Roll Forward] | ||
Beginning balance | 162 | 0 |
Charges | 35 | 197 |
Cash payments | (162) | (162) |
Ending balance | 35 | 35 |
Other | ||
Restructuring Reserve [Roll Forward] | ||
Beginning balance | 15 | 0 |
Charges | 0 | 15 |
Cash payments | 0 | 0 |
Ending balance | $ 15 | $ 15 |
Subsequent Event (Details)
Subsequent Event (Details) - Subsequent Event $ / shares in Units, $ in Millions | Nov. 10, 2022 USD ($) $ / shares shares |
Subsequent Event [Line Items] | |
Shares issued in offering (in shares) | shares | 5,004,545 |
Shares called by warrants (in shares) | shares | 10,009,090 |
Offering price (in dollars per share) | $ / shares | $ 1.10 |
Exercise price of warrant (in dollars per share) | $ / shares | $ 1.10 |
Proceeds from public offering | $ | $ 5.5 |
Warrants term | 5 years |