Cover Page
Cover Page - shares | 3 Months Ended | |
Mar. 31, 2022 | Apr. 29, 2022 | |
Cover [Abstract] | ||
Document Type | 10-Q | |
Document Quarterly Report | true | |
Document Period End Date | Mar. 31, 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 $0.001 per share | |
Trading Symbol | ATHX | |
Security Exchange Name | NASDAQ | |
Entity Current Reporting Status | Yes | |
Entity Interactive Data Current | Yes | |
Entity Filer Category | Non-accelerated Filer | |
Entity Small Business | true | |
Entity Emerging Growth Company | false | |
Entity Shell Company | false | |
Entity Common Stock, Shares Outstanding | 251,967,791 | |
Amendment Flag | false | |
Document Fiscal Year Focus | 2022 | |
Document Fiscal Period Focus | Q1 | |
Entity Registrant Name | ATHERSYS, INC / NEW | |
Entity Central Index Key | 0001368148 | |
Current Fiscal Year End Date | --12-31 |
Condensed Consolidated Balance
Condensed Consolidated Balance Sheets - USD ($) $ in Thousands | Mar. 31, 2022 | Dec. 31, 2021 |
Current assets: | ||
Cash and cash equivalents | $ 21,797 | $ 37,407 |
Prepaid expenses and other | 4,661 | 4,206 |
Total current assets | 31,101 | 46,027 |
Operating right-of-use assets, net | 8,707 | 8,960 |
Property and equipment, net | 3,631 | 3,692 |
Deposits and other | 1,520 | 1,505 |
Total assets | 44,959 | 60,184 |
Current liabilities: | ||
Operating lease liabilities, current | 1,031 | 1,011 |
Accrued compensation and related benefits | 3,345 | 4,133 |
Accrued clinical trial related costs | 5,770 | 3,773 |
Accrued expenses and other | 727 | 704 |
Total current liabilities | 30,965 | 29,861 |
Operating lease liabilities, non-current | 8,488 | 8,755 |
Stockholders’ equity: | ||
Preferred stock, at stated value; 10,000,000 shares authorized, and no shares issued and outstanding at March 31, 2022 and December 31, 2021 | 0 | 0 |
Common stock, $0.001 par value; 600,000,000 shares authorized with 249,792,791 and 242,844,180 shares issued and outstanding at March 31, 2022 and December 31, 2021, respectively | 250 | 243 |
Additional paid-in capital | 605,617 | 599,470 |
Accumulated deficit | (605,560) | (583,344) |
Total stockholders’ equity | 307 | 16,369 |
Total liabilities and stockholders’ equity | 44,959 | 60,184 |
Consolidated entity, excluding related party | ||
Current liabilities: | ||
Accounts payable | 16,771 | 15,781 |
Healios | ||
Current assets: | ||
Accounts receivable from Healios | 1,643 | 1,414 |
Unbilled accounts receivable from Healios | 3,000 | 3,000 |
Current liabilities: | ||
Accounts payable to Healios | 1,119 | 1,119 |
Deferred revenue - Healios | 2,202 | 3,340 |
Advance from Healios | $ 5,199 | $ 5,199 |
Condensed Consolidated Balanc_2
Condensed Consolidated Balance Sheets (Parenthetical) - $ / shares | Mar. 31, 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) | 249,792,791 | 242,844,180 |
Common stock, shares outstanding (in shares) | 249,792,791 | 242,844,180 |
Condensed Consolidated Statemen
Condensed Consolidated Statements of Operations and Comprehensive Loss - USD ($) shares in Thousands, $ in Thousands | 3 Months Ended | |
Mar. 31, 2022 | Mar. 31, 2021 | |
Revenues | ||
Total revenues | $ 2,912 | $ 0 |
Costs and expenses | ||
Research and development | 20,944 | 17,508 |
General and administrative | 4,099 | 8,837 |
Depreciation | 247 | 244 |
Total costs and expenses | 25,290 | 26,589 |
Loss from operations | (22,378) | (26,589) |
Other income, net | 162 | 121 |
Net loss and comprehensive loss | $ (22,216) | $ (26,468) |
Net loss per share, basic (in dollars per share) | $ (0.09) | $ (0.13) |
Net loss per share, diluted (in dollars per share) | $ (0.09) | $ (0.13) |
Weighted average shares outstanding, basic (in shares) | 244,197 | 208,192 |
Weighted average shares outstanding, diluted (in shares) | 244,197 | 208,192 |
Healios | ||
Revenues | ||
Contract revenue from Healios | $ 2,912 | $ 0 |
Condensed Consolidated Statem_2
Condensed Consolidated Statements of Stockholders' Equity - USD ($) $ in Thousands | Total | Preferred Stock | Common Stock | Additional Paid-in Capital | Accumulated Deficit | 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, 2020 | 0 | |||||||
Beginning balance at Dec. 31, 2020 | $ 31,362 | $ 0 | $ 202 | $ 527,549 | $ (496,389) | |||
Common stock, beginning balance (in shares) at Dec. 31, 2020 | 201,973,582 | |||||||
Stock-based compensation | 3,903 | 3,903 | ||||||
Issuance of common stock (in shares) | 15,200,000 | |||||||
Issuance of common stock | $ 30,495 | $ 15 | $ 30,480 | |||||
Issuance of common stock under equity compensation plan (in shares) | 437,925 | |||||||
Issuance of common stock under equity compensation plan | (611) | $ 1 | (612) | |||||
Net 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 | $ 218 | 561,320 | (522,857) | |||
Common stock, ending balance (in shares) at Mar. 31, 2021 | 217,611,507 | |||||||
Preferred stock shares, beginning balance (in shares) at Dec. 31, 2021 | 0 | 0 | ||||||
Beginning balance at Dec. 31, 2021 | $ 16,369 | $ 0 | $ 243 | 599,470 | (583,344) | |||
Common stock, beginning balance (in shares) at Dec. 31, 2021 | 242,844,180 | 242,844,180 | ||||||
Stock-based compensation | $ 1,410 | 1,410 | ||||||
Issuance of common stock (in shares) | 6,800,000 | |||||||
Issuance of common stock | $ 4,802 | $ 7 | $ 4,795 | |||||
Issuance of common stock under equity compensation plan (in shares) | 148,611 | |||||||
Issuance of common stock under equity compensation plan | (58) | $ 0 | (58) | |||||
Net comprehensive loss | $ (22,216) | (22,216) | ||||||
Preferred stock shares, ending balance (in shares) at Mar. 31, 2022 | 0 | 0 | ||||||
Ending balance at Mar. 31, 2022 | $ 307 | $ 0 | $ 250 | $ 605,617 | $ (605,560) | |||
Common stock, ending balance (in shares) at Mar. 31, 2022 | 249,792,791 | 249,792,791 |
Condensed Consolidated Statem_3
Condensed Consolidated Statements of Cash Flows - USD ($) $ in Thousands | 3 Months Ended | |
Mar. 31, 2022 | Mar. 31, 2021 | |
Operating activities | ||
Net loss | $ (22,216) | $ (26,468) |
Adjustments to reconcile net loss to net cash used in operating activities: | ||
Depreciation | 247 | 244 |
Stock-based compensation | 1,410 | 3,903 |
Changes in operating assets and liabilities: | ||
Prepaid expenses, deposits and other | (217) | (45) |
Net cash used in operating activities | (20,168) | (17,093) |
Investing activities | ||
Purchases of equipment | (186) | (114) |
Net cash used in investing activities | (186) | (114) |
Financing activities | ||
Shares retained for withholding tax payments on stock-based awards | (58) | (622) |
Net cash provided by financing activities | 4,744 | 29,884 |
(Decrease) Increase in cash and cash equivalents | (15,610) | 12,677 |
Cash and cash equivalents at beginning of the period | 37,407 | 51,546 |
Cash and cash equivalents at end of the period | 21,797 | 64,223 |
Consolidated entity, excluding related party | ||
Changes in operating assets and liabilities: | ||
Accounts payable, accrued expenses and other | 1,975 | 5,273 |
Financing activities | ||
Proceeds from issuance of common stock, net | 4,802 | 30,506 |
Healios | ||
Changes in operating assets and liabilities: | ||
Accounts receivable from Healios - billed and unbilled | (229) | 0 |
Deferred revenue - Healios | $ (1,138) | $ 0 |
Background and Basis of Present
Background and Basis of Presentation | 3 Months Ended |
Mar. 31, 2022 | |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | |
Background and Basis of Presentation | Background and Basis of Presentation Background 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. We expect that the results of the TREASURE study, the clinical trial of our partner in Japan, HEALIOS K.K. (“Healios”), followed by the results of our MASTERS-2 clinical trial, will have a significant impact, favorable or unfavorable, on our ability to access capital from potential third-party commercial partners or the equity capital markets. Depending on the nature of these results, we may accelerate or may delay certain programs. In the long term, we will have to continue to generate additional capital to meet our needs until we become cash flow positive as a result of the sales of 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 and the sale of equity securities from time to time including through our equity facility and grant-funding opportunities. Healios Framework Agreement On August 5, 2021, we expanded our partnership with Healios by entering into the Comprehensive Framework Agreement for Commercial Manufacturing and Ongoing Support (the “Framework Agreement”). The Framework Agreement provides for planned investment by Healios in certain manufacturing preparation activities. We have agreed to defer certain milestone payments and potentially adjust royalty payments during the initial commercial launch period. Refer to Note 6 for additional information on the Framework Agreement. On February 16, 2021, the Company, Healios and Dr. Hardy TS Kagimoto, the Chairman and Chief Executive Officer of Healios and a member of the Company’s board of directors (the “Board”), entered into a cooperation agreement (the “Cooperation Agreement”). The Cooperation Agreement provided for the parties’ cooperation on certain commercial matters, including a commitment to work in good faith to finalize negotiations on all aspects of their supply, manufacturing, information provision and regulatory support relationship. The Cooperation Agreement also provided for, among related matters, the dismissal with prejudice of the complaint filed by Dr. Kagimoto against the Company seeking the inspection of the Company’s books and records in the Court of Chancery of the State of Delaware on November 21, 2020 (the “Section 220 Litigation”). Pursuant to the Cooperation Agreement, in April 2021, the Company reimbursed Healios and Dr. Kagimoto for reasonable out-of-pocket fees and expenses, including legal expenses, incurred in connection with the Section 220 Litigation, which were not to exceed $0.5 million in the aggregate. In April 2022, the Company received an insurance reimbursement of $0.4 million for legal costs incurred in connection with the Section 220 Litigation. In connection with the execution of the Framework Agreement, certain issues as contemplated by the Cooperation Agreement were resolved and the Cooperation Agreement was amended to extend certain customary standstill provisions until the conclusion of our 2023 annual meeting of stockholders. Retention Program In the first quarter of 2021, we entered into retention letter agreements (“Retention Agreements”) with our executive officers and certain other employees in leadership positions. Each Retention Agreement provides for, among other things, a cash retention bonus and a stock option award, each with vesting tied to continued employment. The cash retention bonuses generally represent a percentage of the employee’s annual compensation and generally vest in full if employed on May 1, 2022. The stock option awards generally vest one-third on May 1, 2022 with the remainder vesting on May 1, 2023 and include a provision for accelerated vesting upon termination without cause. The total stock compensation expense related to the stock option awards is approximately $2.7 million and is being expensed ratably over the vesting period. In April 2021, we expanded the retention program to all then-current employees of the Company, providing for a cash retention bonus with vesting also tied to continued employment through May 1, 2022. The total cash retention bonus is approximately $2.5 million, which is being expensed ratably over the respective vesting periods. Chief Executive Officer Separation Letter Agreement Effective February 15, 2021, Dr. Gil Van Bokkelen was terminated from his position as the Company’s Chief Executive Officer and Chairman of the Board. In connection with his cessation of service, the Company and Dr. Van Bokkelen entered into a separation letter agreement (the “Separation Letter”) entitling him to severance payments and benefits with an aggregate value of approximately $1.0 million payable in installments over an 18-month period, and providing for a total lump sum payment of approximately $0.2 million. At March 31, 2022, we recorded a liability in the amount of $0.2 million, which represents the remaining installments payable to Dr. Van Bokkelen. The lump sum payment was made to Dr. Van Bokkelen in March 2021. The related expense is recorded in general and administrative expense on the unaudited condensed consolidated statements of operations and comprehensive loss. The terms of the Separation Letter also provide for the accelerated vesting of Dr. Van Bokkelen’s outstanding restricted stock units (“RSUs”) and the modification of his stock option awards by providing for accelerated vesting of his unvested stock options and the extension of time during which certain vested stock options can be exercised. In the first quarter of 2021, following the evaluation of the modification, we recorded stock compensation expense of approximately $1.4 million related to the accelerated vesting of Dr. Van Bokkelen’s stock options and $0.9 million related to the accelerated vesting of his RSUs. 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. |
Going Concern
Going Concern | 3 Months Ended |
Mar. 31, 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 March 31, 2022, we had cash and cash equivalents of $21.8 million. We will require significant additional capital to continue our research and development programs, including progressing our clinical product candidates to potential commercialization and preparing for commercial-scale manufacturing and sales. We expect that the results of the TREASURE study, followed by the results of our MASTERS-2 clinical trial, will have a significant impact, favorable or unfavorable, on our ability to access capital from potential third-party commercial partners or the equity capital markets. |
Accounting Standards Not Yet Ad
Accounting Standards Not Yet Adopted | 3 Months Ended |
Mar. 31, 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 | 3 Months Ended |
Mar. 31, 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. Stock-based awards of approximately 28,355,351 and 21,788,078 for the three months ended March 31, 2022 and 2021, respectively, were excluded from the calculation of diluted net loss per share because their effects would be antidilutive. We have two warrants outstanding to purchase an aggregate of 10,000,000 shares of our common stock that were issued to Healios in August 2021 and are excluded from the calculation of diluted net loss per share, as the underlying performance condition associated with each warrant has not been satisfied and is not yet considered probable by the end of the reporting period. Refer to Note 8 for additional information. |
Property and Equipment, net
Property and Equipment, net | 3 Months Ended |
Mar. 31, 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): March 31, December 31, Laboratory equipment $ 9,535 $ 9,352 Office equipment and leasehold improvements 4,000 4,000 Equipment and leasehold improvements not yet in service 433 458 13,968 13,810 Accumulated depreciation and amortization (10,337) (10,118) $ 3,631 $ 3,692 |
Collaborative Arrangements and
Collaborative Arrangements and Revenue Recognition | 3 Months Ended |
Mar. 31, 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 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. 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 and reframes our collaboration to set the stage for productive efforts as Healios and our collaboration move towards commercialization of MultiStem in Japan. It also provides Healios with deferral of certain milestone payments during the expensive initial commercial launch period. We will be entitled to new milestone payments in the amount of $3.0 million in June 2022 and $5.0 million upon the successful completion of certain commercial manufacturing activities. Additionally, accounts payable to Healios have been reduced to $1.1 million and are due on or before December 31, 2022. 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 10,000,000 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 March 31, 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 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. We determined the transaction price includes estimated payments for reimbursable services to be performed by us for Healios and the $3.0 million milestone payment due in June 2022. 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. We expect the services to be completed by the end of 2022. During our evaluation of variable consideration in the first quarter of 2022, we decreased our estimated transaction price due to changes in the estimated cost of the reimbursable services. The remaining transaction price for the performance obligation that was not yet satisfied is approximately $1.4 million at March 31, 2022. During the three months ended March 31, 2022, we recognized approximately $2.8 million of revenue associated with this performance obligation. We recognized no revenue for the three months ended March 31, 2022, and March 31, 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 which we have not yet invoiced Healios. At March 31, 2022, the unbilled accounts receivable from Healios was $3.0 million, which represents a milestone payment owed to us under the Framework Agreement for which we are entitled to receive payment in June 2022. Deferred Revenue - Healios Amounts included in deferred revenue - Healios on the condensed consolidated balance sheets are considered a contract liability. During the three months ended March 31, 2022, revenue recognized from contract liabilities as of the beginning of the respective period was $1.1 million. No revenue was recognized from contract liabilities during the three months ended March 31, 2021. At March 31, 2022, the contract liability included in deferred revenue - Healios is classified as a current liability because the rights to consideration are expected to be satisfied, in all material respects, within one year. 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 service revenue 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 Service revenue — 2,912 — — Total disaggregated revenues $ — $ 2,912 $ — $ — |
Stock-based Compensation
Stock-based Compensation | 3 Months Ended |
Mar. 31, 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 18,500,000 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, performance shares and units, and other stock-based awards. Under the EICP, in the three months ended March 31, 2022, we granted 33,400 stock options and no RSUs to our employees. On February 14, 2022, Daniel Camardo was named the Company’s Chief Executive Officer. As an inducement to Mr. Camardo’s acceptance of employment with us, Mr. Camardo was granted an initial equity award (the “Inducement Award”) to purchase 10,000,000 shares of our common stock at a per share exercise price of $0.86. With regard to 4,000,000 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 6,000,000 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. As of March 31, 2022, a total of 3,628,308 shares were available for issuance under the EICP, and stock-based awards representing 23,355,351 shares of our common stock were outstanding under our current and former equity incentive plans, and inducement awards granted outside of our equity incentive plans to purchase 11,000,000 shares of our common stock were outstanding. For the three months ended March 31, 2022 and 2021, stock-based compensation expense was approximately $1.4 million and $3.9 million, respectively. At March 31, 2022, total unrecognized estimated compensation cost related to unvested stock-based awards was approximately $12.7 million, which is expected to be recognized by the end of 2026 using the straight-line method. |
Stockholders_ Equity and Warran
Stockholders’ Equity and Warrants | 3 Months Ended |
Mar. 31, 2022 | |
Equity [Abstract] | |
Stockholders’ Equity and Warrants | Stockholders’ Equity and Warrants Equity Purchase Agreement We have had equity purchase agreements in place since 2011 with 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 in June 2021 (the “2021 Equity Facility”) and includes 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 2021 Equity Facility are similar to the previous equity facilities with Aspire Capital, and we filed a registration statement for the resale of 40,000,000 shares of our common stock in connection with the 2021 Equity Facility. Our prior equity facility that was entered into in November 2019 was fully utilized and terminated during the third quarter of 2021. We sold 6,800,000 shares to Aspire Capital at an average price of $0.71 per share in the first quarter of 2022, generating proceeds of $4.8 million. We sold 15,200,000 shares to Aspire Capital at an average price of $2.01 per share in the first quarter of 2021, generating proceeds of $30.5 million. Healios 2021 Warrants In August 2021, we issued the 2021 Warrants to Healios to purchase up to an aggregate of 10,000,000 shares of our common stock. One of the 2021 Warrants is for the purchase of up to 3,000,000 shares at an exercise price of $1.80 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 7,000,000 shares at an exercise price of $2.40 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 |
Income Taxes
Income Taxes | 3 Months Ended |
Mar. 31, 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. |
Accounting Standards Not Yet _2
Accounting Standards Not Yet Adopted (Policies) | 3 Months Ended |
Mar. 31, 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 | 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 |
Property and Equipment, net (Ta
Property and Equipment, net (Tables) | 3 Months Ended |
Mar. 31, 2022 | |
Property, Plant and Equipment [Abstract] | |
Schedule of Property and Equipment, net | For the periods ended Property and equipment consists of (in thousands): March 31, December 31, Laboratory equipment $ 9,535 $ 9,352 Office equipment and leasehold improvements 4,000 4,000 Equipment and leasehold improvements not yet in service 433 458 13,968 13,810 Accumulated depreciation and amortization (10,337) (10,118) $ 3,631 $ 3,692 |
Collaborative Arrangements an_2
Collaborative Arrangements and Revenue Recognition (Tables) | 3 Months Ended |
Mar. 31, 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 Service revenue — 2,912 — — Total disaggregated revenues $ — $ 2,912 $ — $ — |
Background and Basis of Prese_2
Background and Basis of Presentation - Additional Information (Details) $ in Millions | Feb. 16, 2021USD ($) | Feb. 15, 2021USD ($) | Apr. 30, 2022USD ($) | Mar. 31, 2022USD ($)segment | Mar. 31, 2021USD ($) | Apr. 30, 2021USD ($) |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | ||||||
Number of business segments | segment | 1 | |||||
Class of Stock [Line Items] | ||||||
Unrecognized compensation cost of unvested stock awards | $ 12.7 | |||||
Stock-based compensation expense | 1.4 | $ 3.9 | ||||
Former Chief Executive Officer | ||||||
Class of Stock [Line Items] | ||||||
Severance payments and benefits | $ 1 | |||||
Severance payments and benefits, period (in months) | 18 months | |||||
Lump sum payment | $ 0.2 | $ 0.2 | ||||
Former Chief Executive Officer | Stock Options | ||||||
Class of Stock [Line Items] | ||||||
Stock-based compensation expense | 1.4 | |||||
Former Chief Executive Officer | RSUs | ||||||
Class of Stock [Line Items] | ||||||
Stock-based compensation expense | 0.9 | |||||
Deferred Bonus | ||||||
Class of Stock [Line Items] | ||||||
Unrecognized compensation cost of unvested stock awards | $ 2.7 | |||||
Deferred Bonus | Tranche One | ||||||
Class of Stock [Line Items] | ||||||
Vesting percentage | 33.33% | |||||
Deferred Bonus | Tranche Two | ||||||
Class of Stock [Line Items] | ||||||
Vesting percentage | 66.67% | |||||
Deferred Bonus | Additional Employees | ||||||
Class of Stock [Line Items] | ||||||
Cash retention bonus granted | $ 2.5 | |||||
Section 220 Litigation | Pending Litigation | Subsequent Event | ||||||
Class of Stock [Line Items] | ||||||
Insurance reimbursement amount | $ 0.4 | |||||
Section 220 Litigation | Maximum | Pending Litigation | ||||||
Class of Stock [Line Items] | ||||||
Fees and expenses sought by plaintiff | $ 0.5 |
Going Concern (Details)
Going Concern (Details) - USD ($) $ in Thousands | 1 Months Ended | ||
Aug. 31, 2021 | Mar. 31, 2022 | Dec. 31, 2021 | |
Accounting Policies And General Information [Line Items] | |||
Cash and cash equivalents | $ 21,797 | $ 37,407 | |
Healios Framework Agreement | |||
Accounting Policies And General Information [Line Items] | |||
Potential revenue from milestones | $ 3,000 |
Net Loss per Share - Additional
Net Loss per Share - Additional Information (Details) - shares | 3 Months Ended | ||
Mar. 31, 2022 | Mar. 31, 2021 | Aug. 31, 2021 | |
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | |||
Shares called by warrants (in shares) | 10,000,000 | ||
Healios Framework Agreement | |||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | |||
Warrants outstanding (in shares) | 2 | ||
Shares called by warrants (in shares) | 10,000,000 | ||
Share-based Payment Arrangement | |||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | |||
Stock-based awards (in shares) | 28,355,351 | 21,788,078 |
Property and Equipment, net - S
Property and Equipment, net - Schedule of Property and Equipment, net (Details) - USD ($) $ in Thousands | Mar. 31, 2022 | Dec. 31, 2021 |
Property, Plant and Equipment [Line Items] | ||
Property and equipment, gross | $ 13,968 | $ 13,810 |
Accumulated depreciation and amortization | (10,337) | (10,118) |
Property and equipment, net | 3,631 | 3,692 |
Laboratory equipment | ||
Property, Plant and Equipment [Line Items] | ||
Property and equipment, gross | 9,535 | 9,352 |
Office equipment and leasehold improvements | ||
Property, Plant and Equipment [Line Items] | ||
Property and equipment, gross | 4,000 | 4,000 |
Equipment and leasehold improvements not yet in service | ||
Property, Plant and Equipment [Line Items] | ||
Property and equipment, gross | $ 433 | $ 458 |
Collaborative Arrangements an_3
Collaborative Arrangements and Revenue Recognition - Additional Information (Details) | 1 Months Ended | 3 Months Ended | 9 Months Ended | ||
Aug. 31, 2021USD ($)shares | Mar. 31, 2022USD ($)performanceObligation | Mar. 31, 2021USD ($) | Sep. 30, 2020milestone | Dec. 31, 2021performanceObligation | |
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | |||||
Shares called by warrants (in shares) | shares | 10,000,000 | ||||
Maximum | |||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | |||||
Accounts receivable, payments due within period of invoicing | 45 days | ||||
Minimum | |||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | |||||
Accounts receivable, payments due within period of invoicing | 30 days | ||||
Healios Framework Agreement | |||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | |||||
Potential revenue from milestones | $ 3,000,000 | ||||
Potential revenue from completion of certain manufacturing activities | 5,000,000 | ||||
Accounts payable to healios | $ 1,100,000 | ||||
Warrants issued (in shares) | shares | 2 | ||||
Shares called by warrants (in shares) | shares | 10,000,000 | ||||
Number of material performance obligations | performanceObligation | 1 | 1 | |||
Remaining transaction price for the performance obligations that were not yet delivered | $ 1,400,000 | ||||
Revenue recognized | 2,800,000 | ||||
Revenue recognized from performance obligations satisfied in previous periods | 0 | $ 0 | |||
Unbilled accounts receivable from Healios | 3,000,000 | ||||
Healios | |||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | |||||
Revenue recognized | $ 1,100,000 | $ 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 | |
Mar. 31, 2022 | Mar. 31, 2021 | |
Point in Time | ||
Disaggregation of Revenue [Line Items] | ||
Total disaggregated revenues | $ 0 | $ 0 |
Point in Time | Service revenue | ||
Disaggregation of Revenue [Line Items] | ||
Total disaggregated revenues | 0 | 0 |
Over Time | ||
Disaggregation of Revenue [Line Items] | ||
Total disaggregated revenues | 2,912 | 0 |
Over Time | Service revenue | ||
Disaggregation of Revenue [Line Items] | ||
Total disaggregated revenues | $ 2,912 | $ 0 |
Stock-Based Compensation - Addi
Stock-Based Compensation - Additional Information (Details) - USD ($) $ / shares in Units, $ in Millions | Feb. 14, 2022 | Mar. 31, 2022 | Mar. 31, 2021 | Dec. 31, 2019 |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||
Stock options and RSUs granted (in shares) | 33,400 | |||
Shares available for issuance (in shares) | 3,628,308 | |||
Stock-based compensation expense | $ 1.4 | $ 3.9 | ||
Unrecognized compensation cost of unvested stock awards | $ 12.7 | |||
Chief Executive Officer | The Inducement Award | ||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||
Stock options granted (in shares) | 10,000,000 | |||
Award exercise price (in dollars per share) | $ 0.86 | |||
Award expiration period (in years) | 10 years | |||
Chief Executive Officer | The Inducement Award, Four-Year Vesting | ||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||
Stock options granted (in shares) | 4,000,000 | |||
Awards vesting period (in years) | 4 years | |||
Chief Executive Officer | The Inducement Award, Four-Year Vesting | Tranche One | ||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||
Vesting percentage | 25.00% | |||
Chief Executive Officer | The Inducement Award, Four-Year Vesting | Tranche Two | ||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||
Awards vesting period (in years) | 36 months | |||
Chief Executive Officer | The Inducement Award, Performance Based Vesting | ||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||
Stock options granted (in shares) | 6,000,000 | |||
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) | 18,500,000 | |||
Shares of common stock outstanding (in shares) | 23,355,351 | |||
Inducement Awards Plan | ||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||
Shares of common stock outstanding (in shares) | 11,000,000 |
Stockholders_ Equity and Warr_2
Stockholders’ Equity and Warrants - Additional Information (Details) - USD ($) $ / shares in Units, $ in Millions | 1 Months Ended | 3 Months Ended | ||||
Aug. 31, 2021 | Jun. 30, 2021 | Mar. 31, 2022 | Mar. 31, 2021 | Dec. 31, 2021 | May 31, 2021 | |
Class of Stock [Line Items] | ||||||
Shares called by warrants (in shares) | 10,000,000 | |||||
Common stock, shares authorized (in shares) | 600,000,000 | 600,000,000 | 600,000,000 | 300,000,000 | ||
Healios | ||||||
Class of Stock [Line Items] | ||||||
Ownership percentage in common stock for exercise cap to be triggered | 19.90% | |||||
Warrant One | ||||||
Class of Stock [Line Items] | ||||||
Shares called by warrants (in shares) | 3,000,000 | |||||
Exercise price of warrant (in dollars per share) | $ 1.80 | |||||
Exercise period (in days) | 60 days | |||||
Warrant Two | ||||||
Class of Stock [Line Items] | ||||||
Shares called by warrants (in shares) | 7,000,000 | |||||
Exercise price of warrant (in dollars per share) | $ 2.40 | |||||
Exercise period (in days) | 60 days | |||||
Aspire Capital | ||||||
Class of Stock [Line Items] | ||||||
Equity purchase agreement, value | $ 100 | |||||
Common stock registered for resale (in shares) | 40,000,000 | |||||
Net proceeds from sales of common stock | $ 4.8 | $ 30.5 | ||||
Aspire Capital | Common Stock | ||||||
Class of Stock [Line Items] | ||||||
Issuance of common stock, new issues (in shares) | 6,800,000 | 15,200,000 | ||||
Sale of additional shares at an average price (in dollars per share) | $ 0.71 | $ 2.01 |