Cover Page
Cover Page - shares | 9 Months Ended | |
Sep. 30, 2021 | Nov. 10, 2021 | |
Cover [Abstract] | ||
Document Type | 10-Q | |
Document Quarterly Report | true | |
Document Period End Date | Sep. 30, 2021 | |
Document Transition Report | false | |
Entity File Number | 001-33876 | |
Entity Registrant Name | ATHERSYS, INC / NEW | |
Entity Incorporation, State or Country Code | DE | |
Entity Tax Identification Number | 20-4864095 | |
Entity Address, Address Line One | 3201 Carnegie Avenue, | |
Entity Address, City or Town | Cleveland, | |
Entity Address, State or Province | OH | |
Entity Address, Postal Zip Code | 44115-2634 | |
City Area Code | 216 | |
Local Phone Number | 431-9900 | |
Title of 12(b) Security | Common Stock, par value $0.001 per share | |
Trading Symbol | ATHX | |
Security Exchange Name | NASDAQ | |
Entity Current Reporting Status | Yes | |
Entity Interactive Data Current | Yes | |
Entity Filer Category | Non-accelerated Filer | |
Entity Small Business | true | |
Entity Emerging Growth Company | false | |
Entity Shell Company | false | |
Entity Common Stock, Shares Outstanding | 235,235,247 | |
Amendment Flag | false | |
Document Fiscal Year Focus | 2021 | |
Document Fiscal Period Focus | Q3 | |
Entity Central Index Key | 0001368148 | |
Current Fiscal Year End Date | --12-31 |
Condensed Consolidated Balance
Condensed Consolidated Balance Sheets - USD ($) $ in Thousands | Sep. 30, 2021 | Dec. 31, 2020 |
Current assets: | ||
Cash and cash equivalents | $ 49,671 | $ 51,546 |
Prepaid expenses and other | 2,066 | 2,926 |
Total current assets | 58,137 | 54,561 |
Operating right-of-use assets, net | 8,828 | 648 |
Property and equipment, net | 3,613 | 3,155 |
Deposits and other | 1,511 | 1,350 |
Total assets | 72,089 | 59,714 |
Current liabilities: | ||
Operating lease liabilities, current | 835 | 480 |
Accrued compensation and related benefits | 3,434 | 1,779 |
Accrued clinical trial related costs | 3,660 | 6,870 |
Accrued expenses and other | 577 | 718 |
Total current liabilities | 27,680 | 22,954 |
Operating lease liabilities, non-current | 8,744 | 197 |
Stockholders’ equity: | ||
Preferred stock, at stated value; 10,000,000 shares authorized, and no shares issued and outstanding at September 30, 2021 and December 31, 2020 | 0 | 0 |
Common stock, $0.001 par value; 600,000,000 shares authorized, and 235,230,247 issued and outstanding at September 30, 2021 and 300,000,000 shares authorized, and 201,973,582 shares issued and outstanding at December 31, 2020 | 235 | 202 |
Additional paid-in capital | 590,745 | 527,549 |
Accumulated deficit | (561,633) | (496,389) |
Total stockholders’ equity | 29,347 | 31,362 |
Total liabilities and stockholders’ equity | 72,089 | 59,714 |
Consolidated entity, excluding related party | ||
Current liabilities: | ||
Accounts payable | 17,080 | 11,337 |
Healios | ||
Current assets: | ||
Accounts receivable from Healios | 3,400 | 89 |
Unbilled accounts receivable from Healios | 3,000 | 0 |
Current liabilities: | ||
Accounts payable to Healios | 0 | 1,705 |
Deferred revenue - Healios | 2,094 | 65 |
Accounts payable to Healios, non-current | 1,119 | 0 |
Advance from Healios | $ 5,199 | $ 5,201 |
Condensed Consolidated Balanc_2
Condensed Consolidated Balance Sheets (Parenthetical) - $ / shares | Sep. 30, 2021 | Dec. 31, 2020 |
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 | 300,000,000 |
Common stock, shares issued (in shares) | 235,230,247 | 201,973,582 |
Common stock, shares outstanding (in shares) | 235,230,247 | 201,973,582 |
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, 2021 | Sep. 30, 2020 | Sep. 30, 2021 | Sep. 30, 2020 | |
Revenues [Abstract] | ||||
Grant revenue | $ 0 | $ 1 | $ 0 | $ 8 |
Total revenues | 4,792 | 86 | 4,792 | 170 |
Costs and expenses | ||||
Research and development | 17,162 | 18,471 | 52,361 | 44,333 |
General and administrative | 3,632 | 3,700 | 16,627 | 11,606 |
Depreciation | 220 | 233 | 1,187 | 645 |
Total costs and expenses | 21,014 | 22,404 | 70,175 | 56,584 |
Loss from operations | (16,222) | (22,318) | (65,383) | (56,414) |
Other income (expense), net | 45 | (225) | 139 | (145) |
Net loss and comprehensive loss | $ (16,177) | $ (22,543) | $ (65,244) | $ (56,559) |
Net loss per share, basic (in dollars per share) | $ (0.07) | $ (0.11) | $ (0.30) | $ (0.31) |
Net loss per share, diluted (in dollars per share) | $ (0.07) | $ (0.11) | $ (0.30) | $ (0.31) |
Weighted average shares outstanding, basic (in shares) | 229,218 | 197,343 | 220,025 | 183,841 |
Weighted average shares outstanding, diluted (in shares) | 229,218 | 197,343 | 220,025 | 183,841 |
Healios | ||||
Revenues [Abstract] | ||||
Contract revenue from Healios | $ 4,792 | $ 85 | $ 4,792 | $ 162 |
Condensed Consolidated Statem_2
Condensed Consolidated Statements of Stockholders' Equity - USD ($) $ in Thousands | Total | Preferred Stock | Common Stock | Stock Subscription Receivable | Additional Paid-in Capital | Accumulated Deficit | Consolidated entity, excluding related party | Consolidated entity, excluding related partyCommon Stock | Consolidated entity, excluding related partyAdditional Paid-in Capital | Healios | HealiosCommon Stock | HealiosStock Subscription Receivable | HealiosAdditional Paid-in Capital |
Preferred stock shares, beginning balance (in shares) at Dec. 31, 2019 | 0 | ||||||||||||
Beginning balance at Dec. 31, 2019 | $ 23,271 | $ 0 | $ 160 | $ 0 | $ 440,735 | $ (417,624) | |||||||
Common stock, beginning balance (in shares) at Dec. 31, 2019 | 159,791,585 | ||||||||||||
Stock-based compensation | 1,280 | 1,280 | |||||||||||
Stock subscription receivable from Healios warrant exercise (in shares) | 4,000,000 | ||||||||||||
Stock subscription receivable from Healios warrant exercise | $ 0 | $ 4 | $ (7,040) | $ 7,036 | |||||||||
Issuance of common stock (in shares) | 6,825,000 | ||||||||||||
Issuance of common stock | 10,250 | $ 7 | 10,243 | ||||||||||
Issuance of common stock under equity compensation plan (in shares) | 153,504 | ||||||||||||
Issuance of common stock under equity compensation plan | (149) | (149) | |||||||||||
Net comprehensive loss | (15,644) | (15,644) | |||||||||||
Preferred stock shares, ending balance (in shares) at Mar. 31, 2020 | 0 | ||||||||||||
Ending balance at Mar. 31, 2020 | 19,008 | $ 0 | $ 171 | (7,040) | 459,145 | (433,268) | |||||||
Common stock, ending balance (in shares) at Mar. 31, 2020 | 170,770,089 | ||||||||||||
Preferred stock shares, beginning balance (in shares) at Dec. 31, 2019 | 0 | ||||||||||||
Beginning balance at Dec. 31, 2019 | 23,271 | $ 0 | $ 160 | 0 | 440,735 | (417,624) | |||||||
Common stock, beginning balance (in shares) at Dec. 31, 2019 | 159,791,585 | ||||||||||||
Net comprehensive loss | (56,559) | ||||||||||||
Preferred stock shares, ending balance (in shares) at Sep. 30, 2020 | 0 | ||||||||||||
Ending balance at Sep. 30, 2020 | 44,162 | $ 0 | $ 198 | 0 | 518,147 | (474,183) | |||||||
Common stock, ending balance (in shares) at Sep. 30, 2020 | 197,585,732 | ||||||||||||
Preferred stock shares, beginning balance (in shares) at Mar. 31, 2020 | 0 | ||||||||||||
Beginning balance at Mar. 31, 2020 | 19,008 | $ 0 | $ 171 | (7,040) | 459,145 | (433,268) | |||||||
Common stock, beginning balance (in shares) at Mar. 31, 2020 | 170,770,089 | ||||||||||||
Stock-based compensation | 2,579 | 2,579 | |||||||||||
Stock subscription receivable from Healios warrant exercise | 7,040 | $ 7,040 | |||||||||||
Issuance of common stock (in shares) | 25,587,500 | 310,526 | |||||||||||
Issuance of common stock | $ 53,691 | $ 26 | $ 53,665 | $ 534 | $ 534 | ||||||||
Issuance of common stock under equity compensation plan (in shares) | 340,447 | ||||||||||||
Issuance of common stock under equity compensation plan | (302) | (302) | |||||||||||
Net comprehensive loss | (18,372) | (18,372) | |||||||||||
Preferred stock shares, ending balance (in shares) at Jun. 30, 2020 | 0 | ||||||||||||
Ending balance at Jun. 30, 2020 | 64,178 | $ 0 | $ 197 | 0 | 515,621 | (451,640) | |||||||
Common stock, ending balance (in shares) at Jun. 30, 2020 | 197,008,562 | ||||||||||||
Stock-based compensation | 1,651 | 1,651 | |||||||||||
Issuance of common stock (in shares) | 395,000 | ||||||||||||
Issuance of common stock | 1,095 | $ 1 | 1,094 | ||||||||||
Issuance of common stock under equity compensation plan (in shares) | 182,170 | ||||||||||||
Issuance of common stock under equity compensation plan | (219) | (219) | |||||||||||
Net comprehensive loss | (22,543) | (22,543) | |||||||||||
Preferred stock shares, ending balance (in shares) at Sep. 30, 2020 | 0 | ||||||||||||
Ending balance at Sep. 30, 2020 | $ 44,162 | $ 0 | $ 198 | $ 0 | 518,147 | (474,183) | |||||||
Common stock, ending balance (in shares) at Sep. 30, 2020 | 197,585,732 | ||||||||||||
Preferred stock shares, beginning balance (in shares) at Dec. 31, 2020 | 0 | 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 | 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, 2020 | 0 | 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 | 201,973,582 | |||||||||||
Net comprehensive loss | $ (65,244) | ||||||||||||
Preferred stock shares, ending balance (in shares) at Sep. 30, 2021 | 0 | 0 | |||||||||||
Ending balance at Sep. 30, 2021 | $ 29,347 | $ 0 | $ 235 | 590,745 | (561,633) | ||||||||
Common stock, ending balance (in shares) at Sep. 30, 2021 | 235,230,247 | 235,230,247 | |||||||||||
Preferred stock shares, beginning balance (in shares) at Mar. 31, 2021 | 0 | ||||||||||||
Beginning balance at Mar. 31, 2021 | $ 38,681 | $ 0 | $ 218 | 561,320 | (522,857) | ||||||||
Common stock, beginning balance (in shares) at Mar. 31, 2021 | 217,611,507 | ||||||||||||
Stock-based compensation | 1,788 | 1,788 | |||||||||||
Issuance of common stock (in shares) | 8,500,000 | ||||||||||||
Issuance of common stock | 13,292 | $ 8 | 13,284 | ||||||||||
Issuance of common stock under equity compensation plan (in shares) | 143,586 | ||||||||||||
Issuance of common stock under equity compensation plan | (116) | (116) | |||||||||||
Net 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 | $ 226 | 576,276 | (545,456) | ||||||||
Common stock, ending balance (in shares) at Jun. 30, 2021 | 226,255,093 | ||||||||||||
Stock-based compensation | 1,407 | 1,407 | |||||||||||
Issuance of common stock (in shares) | 8,850,000 | ||||||||||||
Issuance of common stock | 13,157 | $ 9 | 13,148 | ||||||||||
Issuance of common stock under equity compensation plan (in shares) | 125,154 | ||||||||||||
Issuance of common stock under equity compensation plan | (86) | (86) | |||||||||||
Net comprehensive loss | $ (16,177) | (16,177) | |||||||||||
Preferred stock shares, ending balance (in shares) at Sep. 30, 2021 | 0 | 0 | |||||||||||
Ending balance at Sep. 30, 2021 | $ 29,347 | $ 0 | $ 235 | $ 590,745 | $ (561,633) | ||||||||
Common stock, ending balance (in shares) at Sep. 30, 2021 | 235,230,247 | 235,230,247 |
Condensed Consolidated Statem_3
Condensed Consolidated Statements of Cash Flows - USD ($) $ in Thousands | 9 Months Ended | |
Sep. 30, 2021 | Sep. 30, 2020 | |
Operating activities | ||
Net loss | $ (65,244) | $ (56,559) |
Adjustments to reconcile net loss to net cash used in operating activities: | ||
Depreciation | 1,187 | 645 |
Stock-based compensation | 7,098 | 5,510 |
Operating right-of-use assets, net | 232 | 9 |
Changes in operating assets and liabilities: | ||
Prepaid expenses, deposits and other | 699 | (1,161) |
Net cash used in operating activities | (56,851) | (44,535) |
Investing activities | ||
Purchases of equipment | (1,154) | (735) |
Net cash used in investing activities | (1,154) | (735) |
Financing activities | ||
Shares retained for withholding tax payments on stock-based awards | (814) | (670) |
Net cash provided by financing activities | 56,130 | 71,940 |
(Decrease) Increase in cash and cash equivalents | (1,875) | 26,670 |
Cash and cash equivalents at beginning of the period | 51,546 | 35,041 |
Cash and cash equivalents at end of the period | 49,671 | 61,711 |
Non-cash investing activities: | ||
Right-of-use assets obtained in exchange for lease liabilities | 9,162 | 0 |
Consolidated entity, excluding related party | ||
Changes in operating assets and liabilities: | ||
Accounts receivable | 0 | 17 |
Accounts payable, accrued expenses and other | 4,047 | 6,200 |
Financing activities | ||
Proceeds from issuance of common stock, net of issuance cost | 56,944 | 65,036 |
Healios | ||
Changes in operating assets and liabilities: | ||
Accounts receivable from Healios - billed and unbilled | (6,311) | 804 |
Accounts payable to Healios | (586) | 137 |
Deferred revenue - Healios | 2,029 | 0 |
Advance from Healios | (2) | (137) |
Financing activities | ||
Proceeds from issuance of common stock, net of issuance cost | 0 | 534 |
Proceeds from exercise of warrants - Healios | $ 0 | $ 7,040 |
Background and Basis of Present
Background and Basis of Presentation | 9 Months Ended |
Sep. 30, 2021 | |
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 have incurred losses since our inception in 1995 and had an accumulated deficit of $561.6 million at September 30, 2021, and we will not commence sales of our clinical product candidates until they receive regulatory approval for commercialization. We will require significant additional capital to continue our research and development programs, including progressing our clinical product candidates to potential commercialization and preparing for commercial-scale manufacturing and sales. At September 30, 2021, we had available cash and cash equivalents of $49.7 million. We believe that our existing cash balance, available proceeds from our existing equity facility, our ability to defer certain spending and potential deferrals and delays in certain non-core programs will enable us to meet our obligations as they come due at least for a period of twelve months from the date of the issuance of these unaudited condensed consolidated financial statements. Importantly, upcoming clinical trial results from the TREASURE study, conducted by our collaborator in Japan, HEALIOS K.K. (“Healios”) and our MASTERS-2 study, both evaluating MultiStem (invimestrocel) cell therapy for the treatment of ischemic stroke, may 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 outcome of these clinical trials, we may accelerate, defer or stage the timing of certain programs. In the longer term, we will have to continue to generate additional capital to meet our needs until we generate positive cash flow 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 their related license fees, milestones and potential royalties, 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”) to optimize and better align the collaboration structure to drive therapeutic reach and commercial success in Japan for the MultiStem product following potential regulatory approval. 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 5 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 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. Lease Agreement On January 4, 2021, we entered into an operating lease agreement to lease approximately 214,000 square feet of warehouse and office space. The initial lease term is approximately ten years and includes five renewal options with terms of five years each. The lease commenced on May 1, 2021, upon us taking control of the warehouse and office space on that date. Base annual rent for the first year is approximately $1.3 million with 2.0% annual rent escalators. As of the lease commencement date, the right-of-use asset and corresponding operating lease liability was approximately $9.2 million, which represented the present value of remaining lease payments over the initial lease term, using an incremental borrowing rate of 9.0%. The terms of the lease agreement also include an allowance in the amount of $0.7 million for the cost of construction of office and laboratory space expected to be completed in the fourth quarter of 2021. We are also obligated to pay certain variable expenses separately from the base rent, including utilities, real estate taxes and common area maintenance. Such costs are considered non-lease components and have been excluded from the calculation of the right-of-use asset and corresponding operating lease liability and are being expensed in the period they are incurred. 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 $2.8 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 resigned from his position as the Company’s Chief Executive Officer and Chairman of the Board. In connection with his resignation, 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 September 30, 2021, we recorded a liability in the amount of $0.5 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, 2020. The accompanying financial statements have been prepared in accordance with U.S. generally accepted accounting principles (“GAAP”) for interim financial information and Regulation S-X. Accordingly, since they are interim statements, the accompanying financial statements do not include all of the information and notes required by GAAP for complete financial statements. The accompanying financial statements reflect all adjustments, consisting of normal recurring adjustments and disclosures that are, in the opinion of management, necessary for a fair presentation of financial position and results of operations for the interim periods presented. Interim results are not necessarily indicative of results for a full year. Use of Estimates: The preparation of financial statements in conformity with GAAP requires management to make estimates and assumptions that affect the amounts reported in the financial statements and accompanying notes. Our critical accounting policies, estimates and assumptions are described in “Management’s Discussion and Analysis of Financial Condition and Results of Operations,” which is included in this Quarterly Report on Form 10-Q. |
Recently Issued Accounting Stan
Recently Issued Accounting Standards | 9 Months Ended |
Sep. 30, 2021 | |
Accounting Policies [Abstract] | |
Recently Issued Accounting Standards | Recently Issued Accounting Standards In December 2019, the Financial Accounting Standards Board (the “FASB”) issued Accounting Standards Update (“ASU”) 2019-12, Income Taxes (Topic 740) - Simplifying the Accounting for Income Taxes , which simplifies the accounting for income taxes by removing certain exceptions to the general principles in Topic 740. This ASU is effective for fiscal years beginning after December 15, 2020. We adopted this ASU prospectively on January 1, 2021, and the adoption of this ASU did not have a material impact on our condensed consolidated financial statements and disclosures. In June 2016, the FASB issued 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, 2021 | |
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 10,000,000 shares of our common stock that were issued to Healios in August 2021. The warrants are not yet exercisable according to their terms. Refer to Note 7 for additional details. The following instruments (in thousands) were excluded from the calculation of diluted net loss per share because their effects would be anti-dilutive: Three months ended Nine months ended 2021 2020 2021 2020 Stock-based awards 25,189 20,585 25,189 20,585 Healios warrants – see Note 7 10,000 — 10,000 — Total 35,189 20,585 35,189 20,585 |
Property and Equipment, net
Property and Equipment, net | 9 Months Ended |
Sep. 30, 2021 | |
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 $ 8,946 $ 9,225 Office equipment and leasehold improvements 3,895 3,336 Process development equipment not yet in service 650 294 13,491 12,855 Accumulated depreciation (9,878) (9,700) $ 3,613 $ 3,155 |
Collaborative Arrangements and
Collaborative Arrangements and Revenue Recognition | 9 Months Ended |
Sep. 30, 2021 | |
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 by June 2022 and $5.0 million upon 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 connection with the execution of the Framework Agreement, the Cooperation Agreement was amended to extend certain customary standstill provisions until the conclusion of our 2023 annual meeting of stockholders. 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 at an exercise price at a premium to the then-current market price and exercisable for 60 days following regulatory approval for ARDS and ischemic stroke, respectively. 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, 2021, 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 7 regarding the 2021 Warrants issued to Healios in connection with the Framework Agreement, as well as Healios’ exercise, in March 2020, of its warrant that was issued in 2018 and its exercise of a right to participate in certain equity transactions in May 2020. Healios Revenue Recognition At the inception of the Healios arrangement and again each time that the arrangement is modified, all material performance obligations are identified, which currently include one performance obligation for services necessary for regulatory approvals, manufacturing readiness, and commercial launch in Japan. It was determined that the performance obligation encompassed by the Framework Agreement is separate and distinct within the context of the contract. We determined the transaction price includes estimated payments for reimbursable services to be performed and the milestone payment due no later than 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 are being performed, which are expected to be completed in the first quarter of 2022. The remaining transaction price for the performance obligation that was not yet delivered is $4.2 million at September 30, 2021. During the three and nine months ended September 30, 2021, we recognized approximately $4.3 million of revenue associated with this performance obligation. We recognized revenue of approximately $0.5 million for the three and nine months ended September 30, 2021, and no revenue for the three and nine months ended September 30, 2020 from performance obligations satisfied in previous periods. Unbilled Accounts Receivable We record amounts that are due to us under contractual arrangements and for which we have the unconditional right to consideration. At September 30, 2021, the unbilled accounts receivable from Healios was $3.0 million, which represents a milestone payment owed to us under the Framework Agreement. Deferred Revenue - Healios Amounts included in deferred revenue are determined at the contract level, and for our Healios collaboration, such amounts are considered a contract liability. Amounts received or owed to us from customers or collaborators in advance of our performance of services or other deliverables are included in deferred revenue, with those amounts that are unconditional being included in either accounts receivable from Healios or unbilled accounts receivable from Healios. During the three and nine months ended September 30, 2021, revenue recognized from contract liabilities as of the beginning of the respective period was $0.1 million. No revenue was recognized from contract liabilities during the three and nine months ended September 30, 2020. At September 30, 2021, the contract liability, included in deferred revenue - Healios on the unaudited condensed consolidated balance sheets, is classified as a current liability since the rights to consideration are expected to be satisfied, in all material respects, within one year. Advance from Healios Certain clinical product supply services that were concluded in 2019 involved a cost-sharing arrangement, the proceeds from which may either (i) result in a reduction in the proceeds we receive from Healios upon the achievement of two potential milestones and an increase to a commercial milestone under the license agreement for stroke or (ii) be repaid to Healios at our election, as defined. The cost-sharing proceeds received are recognized in advance from Healios on the unaudited condensed consolidated balance sheets until the earlier of the milestones being achieved or such amounts being repaid to Healios at our election, at which time the culmination of the earnings process or the repayment will be complete. Disaggregation of Revenues We recognize license-related amounts, including upfront payments, exclusivity fees, additional disease indication fees and milestones at a point in time when earned. Similarly, product supply revenue is recognized at a point in time upon delivery, as defined in the applicable product supply contracts, while service revenue (e.g., manufacturing readiness) is recognized when earned over time in proportion to the contractual services provided. For performance obligations satisfied over time, we apply an appropriate method of measuring progress each reporting period and, if necessary, adjust the estimates of performance and the related revenue recognition. The following table presents our contract revenues disaggregated by timing of revenue recognition (in thousands): Three months ended Three months ended Point in Over Time Point in Over Time Contract Revenue from Healios Product supply revenue $ 283 $ — $ 85 $ — Service revenue — 4,509 — — Total disaggregated revenues $ 283 $ 4,509 $ 85 $ — Nine months ended Nine months ended Point in Over Time Point in Over Time Contract Revenue from Healios Product supply revenue $ 283 $ — $ 162 $ — Service revenue — 4,509 — — Total disaggregated revenues $ 283 $ 4,509 $ 162 $ — |
Stock-based Compensation
Stock-based Compensation | 9 Months Ended |
Sep. 30, 2021 | |
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 September 30, 2021, we granted 162,653 stock options and RSUs to our employees. As of September 30, 2021, a total of 3,205,259 shares were available for issuance under the EICP, and stock-based awards representing 24,189,138 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 1,000,000 shares of our common stock were outstanding. For the three months ended September 30, 2021 and 2020, stock-based compensation expense was approximately $1.4 million and $1.7 million, respectively. For the nine months ended September 30, 2021 and 2020, stock-based compensation expense was approximately $7.1 million and $5.5 million, respectively. At September 30, 2021, total unrecognized estimated compensation cost related to unvested stock-based awards was approximately $13.9 million, which is expected to be recognized by the end of 2025 using the straight-line method. In June 2020, we modified stock option awards granted under the EICP and our prior equity plans for all then-current employees and directors by providing an extension to the period of time during which vested stock options can be exercised, first, for employees, following an employee’s voluntary termination of employment or the involuntary termination of the employee’s employment by the Company without cause (as defined with respect to the applicable options) and second, for directors, following a director’s death or voluntary termination of service with the Company, in each case following significant tenure with the Company. Upon modification, employees have post-employment exercise periods from three months up to a maximum of three years and directors have from eighteen months up to thirty months maximum, with the exercise periods increasing based on the applicable individual’s tenure. The modification was applied to all nonqualified stock option awards outstanding on the modification date and to those incentive stock options held by individuals who accepted the modification. Stock option awards issued post-modification include the extended exercise provisions as described in this paragraph. |
Stockholders' Equity
Stockholders' Equity | 9 Months Ended |
Sep. 30, 2021 | |
Equity [Abstract] | |
Stockholders' Equity | Stockholders’ Equity Equity Purchase Agreement We have had equity purchase agreements in place since 2011 with Aspire Capital Fund, LLC (“Aspire Capital”) that provide us the ability to sell shares to Aspire Capital from time to time. Currently, we have an agreement with Aspire Capital that was entered into 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 8,850,000 shares to Aspire Capital at an average price of $1.49 per share in the third quarter of 2021, generating proceeds of $13.2 million, and sold 32,550,000 shares to Aspire Capital at an average price of $1.75 per share during the nine months ended September 30, 2021, generating proceeds of $57.1 million. We sold 395,000 shares to Aspire Capital at an average price of $2.77 per share in the third quarter of 2020, generating proceeds of $1.1 million, and we sold 7,220,000 shares to Aspire Capital at an average price of $1.57 per share during the nine months ended September 30, 2020, generating proceeds of $11.3 million. Public Offering In April 2020, we completed an underwritten public offering of our common stock, generating gross proceeds of approximately $57.6 million and net proceeds of approximately $53.7 million through the issuance of 25,587,500 shares of our common stock at an offering price of $2.25 per share. 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. Healios 2018 Warrant In March 2018, we issued to Healios a warrant to purchase up to 20,000,000 shares of our common stock (the “2018 Warrant”). Based upon the terms of the 2018 Warrant, it was no longer exercisable for up to 16,000,000 warrant shares. In March 2020, Healios elected to exercise the 2018 Warrant in full, and we issued 4,000,000 shares of our common stock at an exercise price equal to the reference price of $1.76 per share, as defined in the 2018 Warrant. Proceeds of approximately $7.0 million were received in April 2020 in accordance with the terms of the 2018 Warrant. Healios Investor Rights Agreement In March 2018, we entered into an investor rights agreement (the “Investor Rights Agreement”) with Healios that governs certain of our and Healios’ rights relating to its ownership of our common stock. Under the Investor Rights Agreement, Healios is permitted to participate in certain equity issuances as a means to maintain its proportionate ownership of our common stock as of the time of such issuance. In May 2020, we entered into a purchase agreement with Healios, providing for Healios to purchase shares of our common stock in connection with certain equity issuances to Aspire Capital. Healios purchased 310,526 shares of our common stock at $1.72 per share for an aggregate purchase price of $0.5 million, in accordance with the terms of the Investor Rights Agreement. In connection with the Framework Agreement, Healios agreed to terminate its existing right under the Investor Rights Agreement to nominate two nominees for election to the Board, if Healios beneficially owned 15.0% or more of our outstanding shares of common stock. Healios retains the right to appoint one nominee for election to the Board if Healios beneficially owns 5.0% or more of our outstanding shares of common stock. Increase Shares of Authorized Common Stock |
Income Taxes
Income Taxes | 9 Months Ended |
Sep. 30, 2021 | |
Income Tax Disclosure [Abstract] | |
Income Taxes | Income TaxesWe have United States (“U.S.”) federal net operating loss and research and development tax credit carryforwards, as well as state and city net operating loss carryforwards, which may be used to reduce future taxable income and tax liabilities. We also have foreign net operating loss and tax credit carryforwards, and the foreign net operating loss carryforwards do not expire. All of our deferred tax assets have been fully offset by a valuation allowance due to our cumulative losses. The carrying value of our deferred tax assets and liabilities is determined by the enacted U.S. corporate income tax rate. Consequently, any changes in the U.S. corporate income tax rate impacts the carrying value of our deferred tax assets and liabilities. Also, there are significant limitations on our ability to utilize our net operating loss and tax credit carryforwards under Section 382 of the Internal Revenue Code of 1986, as amended. |
Recently Issued Accounting St_2
Recently Issued Accounting Standards (Policies) | 9 Months Ended |
Sep. 30, 2021 | |
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, 2020. 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 | Recently Issued Accounting Standards In December 2019, the Financial Accounting Standards Board (the “FASB”) issued Accounting Standards Update (“ASU”) 2019-12, Income Taxes (Topic 740) - Simplifying the Accounting for Income Taxes , which simplifies the accounting for income taxes by removing certain exceptions to the general principles in Topic 740. This ASU is effective for fiscal years beginning after December 15, 2020. We adopted this ASU prospectively on January 1, 2021, and the adoption of this ASU did not have a material impact on our condensed consolidated financial statements and disclosures. In June 2016, the FASB issued 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, 2021 | |
Earnings Per Share [Abstract] | |
Schedule of Instruments Excluded from Calculation of Diluted Net Loss Per Share | The following instruments (in thousands) were excluded from the calculation of diluted net loss per share because their effects would be anti-dilutive: Three months ended Nine months ended 2021 2020 2021 2020 Stock-based awards 25,189 20,585 25,189 20,585 Healios warrants – see Note 7 10,000 — 10,000 — Total 35,189 20,585 35,189 20,585 |
Property and Equipment, net (Ta
Property and Equipment, net (Tables) | 9 Months Ended |
Sep. 30, 2021 | |
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 $ 8,946 $ 9,225 Office equipment and leasehold improvements 3,895 3,336 Process development equipment not yet in service 650 294 13,491 12,855 Accumulated depreciation (9,878) (9,700) $ 3,613 $ 3,155 |
Revenue Recognition and Deferre
Revenue Recognition and Deferred Revenue (Tables) | 9 Months Ended |
Sep. 30, 2021 | |
Revenue Recognition and Deferred Revenue [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 $ — $ 85 $ — Service revenue — 4,509 — — Total disaggregated revenues $ 283 $ 4,509 $ 85 $ — Nine months ended Nine months ended Point in Over Time Point in Over Time Contract Revenue from Healios Product supply revenue $ 283 $ — $ 162 $ — Service revenue — 4,509 — — Total disaggregated revenues $ 283 $ 4,509 $ 162 $ — |
Background and Basis of Prese_2
Background and Basis of Presentation - Additional Information (Details) $ in Thousands | Feb. 16, 2021USD ($) | Feb. 15, 2021USD ($) | Jan. 04, 2021USD ($)ft²renewalOption | Sep. 30, 2021USD ($) | Mar. 31, 2021USD ($) | Sep. 30, 2020USD ($) | Sep. 30, 2021USD ($)segment | Sep. 30, 2020USD ($) | May 01, 2021USD ($) | Apr. 30, 2021USD ($) | Dec. 31, 2020USD ($) |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | |||||||||||
Number of business segments | segment | 1 | ||||||||||
Accumulated deficit | $ 561,633 | $ 561,633 | $ 496,389 | ||||||||
Cash and cash equivalents | 49,671 | 49,671 | 51,546 | ||||||||
Class of Stock [Line Items] | |||||||||||
Right-of-use assets | 8,828 | 8,828 | $ 648 | ||||||||
Unrecognized compensation cost of unvested stock awards | 13,900 | 13,900 | |||||||||
Stock-based compensation expense | 1,400 | $ 1,700 | 7,100 | $ 5,500 | |||||||
Deferred Bonus | |||||||||||
Class of Stock [Line Items] | |||||||||||
Unrecognized compensation cost of unvested stock awards | $ 2,800 | ||||||||||
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% | ||||||||||
Building | |||||||||||
Class of Stock [Line Items] | |||||||||||
Number of square feet leased | ft² | 214,000 | ||||||||||
Lease term (in years) | 10 years | ||||||||||
Number of renewal options | renewalOption | 5 | ||||||||||
Renewal term (in years) | 5 years | ||||||||||
Payment due for base annual rent in first year | $ 1,300 | ||||||||||
Retention stock option award vesting rights (as a percent) | 2.00% | ||||||||||
Right-of-use assets | $ 9,200 | ||||||||||
Lease liabilities | $ 9,200 | ||||||||||
Borrowing rate | 9.00% | ||||||||||
Allowance | $ 700 | ||||||||||
Former Chief Executive Officer | |||||||||||
Class of Stock [Line Items] | |||||||||||
Severance payments and benefits | $ 1,000 | ||||||||||
Severance payments and benefits, period (in months) | 18 months | ||||||||||
Lump sum payment | $ 200 | $ 500 | $ 500 | ||||||||
Former Chief Executive Officer | Stock Options | |||||||||||
Class of Stock [Line Items] | |||||||||||
Stock-based compensation expense | $ 1,400 | ||||||||||
Former Chief Executive Officer | RSUs | |||||||||||
Class of Stock [Line Items] | |||||||||||
Stock-based compensation expense | $ 900 | ||||||||||
Additional Employees | Deferred Bonus | |||||||||||
Class of Stock [Line Items] | |||||||||||
Cash retention bonus granted | $ 2,500 | ||||||||||
Section 220 Litigation | Maximum | Pending Litigation | |||||||||||
Class of Stock [Line Items] | |||||||||||
Fees and expenses sought by plaintiff | $ 500 |
Net Loss per Share (Details)
Net Loss per Share (Details) - shares | 3 Months Ended | 9 Months Ended | ||||
Sep. 30, 2021 | Sep. 30, 2020 | Sep. 30, 2021 | Sep. 30, 2020 | Aug. 31, 2021 | Mar. 31, 2018 | |
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||||||
Shares called by warrants (in shares) | 10,000,000 | 20,000,000 | ||||
Total (in shares) | 35,189,000 | 20,585,000 | 35,189,000 | 20,585,000 | ||
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 | |||||
Stock-based awards | ||||||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||||||
Total (in shares) | 25,189,000 | 20,585,000 | 25,189,000 | 20,585,000 | ||
Healios warrants | Healios | ||||||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||||||
Total (in shares) | 10,000,000 | 0 | 10,000,000 | 0 |
Property and Equipment, net - S
Property and Equipment, net - Schedule of Property and Equipment, net (Details) - USD ($) $ in Thousands | Sep. 30, 2021 | Dec. 31, 2020 |
Property, Plant and Equipment [Line Items] | ||
Property and equipment, gross | $ 13,491 | $ 12,855 |
Accumulated depreciation | (9,878) | (9,700) |
Property and equipment, net | 3,613 | 3,155 |
Laboratory equipment | ||
Property, Plant and Equipment [Line Items] | ||
Property and equipment, gross | 8,946 | 9,225 |
Office equipment and leasehold improvements | ||
Property, Plant and Equipment [Line Items] | ||
Property and equipment, gross | 3,895 | 3,336 |
Process development equipment not yet in service | ||
Property, Plant and Equipment [Line Items] | ||
Property and equipment, gross | $ 650 | $ 294 |
Property and Equipment, net - A
Property and Equipment, net - Additional Information (Details) $ in Millions | 3 Months Ended |
Jun. 30, 2021USD ($) | |
Property, Plant and Equipment [Abstract] | |
Accelerated depreciation | $ 0.5 |
Collaborative Arrangements an_2
Collaborative Arrangements and Revenue Recognition - Additional Information (Details) $ in Millions | 1 Months Ended | 3 Months Ended | 9 Months Ended | ||||
Aug. 31, 2021USD ($)shares | Sep. 30, 2021USD ($)performanceObligation | Sep. 30, 2020USD ($) | Mar. 31, 2020milestone | Sep. 30, 2021USD ($)performanceObligation | Sep. 30, 2020USD ($) | Mar. 31, 2018shares | |
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | |||||||
Shares called by warrants (in shares) | shares | 10,000,000 | 20,000,000 | |||||
Healios Framework Agreement | |||||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | |||||||
Potential revenue from milestones | $ 3 | ||||||
Potential revenue from completion of certain manufacturing activities | 5 | ||||||
Accounts payable to Healios, non-current | $ 1.1 | ||||||
Warrants issued (in shares) | shares | 2 | ||||||
Shares called by warrants (in shares) | shares | 10,000,000 | ||||||
Warrants term (in days) | 60 days | ||||||
Number of material performance obligations | performanceObligation | 1 | 1 | |||||
Remaining transaction price for the performance obligations that were not yet delivered | $ 4.2 | $ 4.2 | |||||
Revenue recognized | 4.3 | 4.3 | |||||
Revenue recognized from performance obligations satisfied in previous periods | 0.5 | $ 0 | 0.5 | $ 0 | |||
Unbilled accounts receivable from Healios | 3 | 3 | |||||
Healios | |||||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | |||||||
Revenue recognized | $ 0.1 | $ 0 | $ 0.1 | $ 0 | |||
Regulatory and sales milestones | Healios | |||||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | |||||||
Number of future milestones achieved | milestone | 2 |
Collaborative Arrangements an_3
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, 2021 | Sep. 30, 2020 | Sep. 30, 2021 | Sep. 30, 2020 | |
Point in Time | ||||
Disaggregation of Revenue [Line Items] | ||||
Total disaggregated revenues | $ 283 | $ 85 | $ 283,000 | $ 162 |
Point in Time | Product supply revenue | ||||
Disaggregation of Revenue [Line Items] | ||||
Total disaggregated revenues | 283 | 85 | 283,000 | 162 |
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 | 4,509 | 0 | 4,509,000 | 0 |
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 | $ 4,509 | $ 0 | $ 4,509,000 | $ 0 |
Stock-Based Compensation - Addi
Stock-Based Compensation - Additional Information (Details) - USD ($) $ in Millions | 1 Months Ended | 3 Months Ended | 9 Months Ended | |||
Jun. 30, 2020 | Sep. 30, 2021 | Sep. 30, 2020 | Jun. 30, 2020 | Sep. 30, 2021 | Sep. 30, 2020 | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||
Common stock authorized for equity incentive plan (in shares) | 18,500,000 | 18,500,000 | ||||
Stock options and RSUs granted (in shares) | 162,653 | |||||
Shares available for issuance (in shares) | 3,205,259 | 3,205,259 | ||||
Stock-based compensation expense | $ 1.4 | $ 1.7 | $ 7.1 | $ 5.5 | ||
Unrecognized compensation cost of unvested stock awards | $ 13.9 | $ 13.9 | ||||
2019 Equity And Incentive Compensation Plan | ||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||
Shares of common stock outstanding (in shares) | 24,189,138 | 24,189,138 | ||||
2019 Equity And Incentive Compensation Plan | Employees | Minimum | ||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||
Post-employment exercise period (in years and months) | 3 months | |||||
2019 Equity And Incentive Compensation Plan | Employees | Maximum | ||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||
Post-employment exercise period (in years and months) | 3 years | |||||
2019 Equity And Incentive Compensation Plan | Directors | Minimum | ||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||
Post-employment exercise period (in years and months) | 18 months | |||||
2019 Equity And Incentive Compensation Plan | Directors | Maximum | ||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||
Post-employment exercise period (in years and months) | 30 months | |||||
Inducement Awards Plan | ||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||
Shares of common stock outstanding (in shares) | 1,000,000 | 1,000,000 | ||||
2019 Equity And Incentive Compensation Plan, Modification | ||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||
Stock-based compensation expense | $ 1.2 | |||||
Unrecognized compensation cost of unvested stock awards | $ 0.5 | $ 0.5 |
Stockholders' Equity - Addition
Stockholders' Equity - Additional Information (Details) - USD ($) $ / shares in Units, $ in Millions | 1 Months Ended | 3 Months Ended | 9 Months Ended | ||||||||||||
Aug. 31, 2021 | Jun. 30, 2021 | May 31, 2020 | Apr. 30, 2020 | Mar. 31, 2020 | Sep. 30, 2021 | Jun. 30, 2021 | Mar. 31, 2021 | Sep. 30, 2020 | Mar. 31, 2020 | Sep. 30, 2021 | Sep. 30, 2020 | May 31, 2021 | Dec. 31, 2020 | Mar. 31, 2018 | |
Class of Stock [Line Items] | |||||||||||||||
Shares called by warrants (in shares) | 10,000,000 | 20,000,000 | |||||||||||||
Remaining exercisable warrants (in shares) | 16,000,000 | ||||||||||||||
Common stock, shares authorized (in shares) | 600,000,000 | 600,000,000 | 600,000,000 | 600,000,000 | 300,000,000 | 300,000,000 | |||||||||
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 | ||||||||||||||
Public Stock Offering | |||||||||||||||
Class of Stock [Line Items] | |||||||||||||||
Gross proceeds from public offering | $ 57.6 | ||||||||||||||
Consideration received from sale of stock | $ 53.7 | ||||||||||||||
Shares issued and sold (in shares) | 25,587,500 | ||||||||||||||
Offering price (in dollars per share) | $ 2.25 | ||||||||||||||
Common Stock | |||||||||||||||
Class of Stock [Line Items] | |||||||||||||||
Issuance of common stock, new issues (in shares) | 8,850,000 | 8,500,000 | 15,200,000 | 395,000 | 6,825,000 | ||||||||||
Aspire Capital | |||||||||||||||
Class of Stock [Line Items] | |||||||||||||||
Equity purchase agreement, value | $ 100 | ||||||||||||||
Common stock registered for resale (in shares) | 40,000,000 | 40,000,000 | |||||||||||||
Net proceeds from sales of common stock | $ 13.2 | $ 1.1 | $ 57.1 | $ 11.3 | |||||||||||
Aspire Capital | Common Stock | |||||||||||||||
Class of Stock [Line Items] | |||||||||||||||
Issuance of common stock, new issues (in shares) | 8,850,000 | 395,000 | 32,550,000 | 7,220,000 | |||||||||||
Sale of additional shares at an average price (in dollars per share) | $ 1.49 | $ 2.77 | $ 1.75 | $ 1.57 | |||||||||||
Healios | |||||||||||||||
Class of Stock [Line Items] | |||||||||||||||
Ownership percentage in common stock for exercise cap to be triggered | 19.90% | ||||||||||||||
Common stock issued upon exercise of warrant (in shares) | 4,000,000 | ||||||||||||||
Common stock issued, price per share (in dollars per share) | $ 1.76 | ||||||||||||||
Proceeds from exercise of warrants | $ 7 | ||||||||||||||
Minimum ownership percentage in outstanding common stock for two board seats | 15.00% | ||||||||||||||
Minimum ownership percentage in outstanding common stock for one board seat | 5.00% | ||||||||||||||
Healios | Securities Purchase Agreement | |||||||||||||||
Class of Stock [Line Items] | |||||||||||||||
Consideration received from sale of stock | $ 0.5 | ||||||||||||||
Shares issued and sold (in shares) | 310,526 | ||||||||||||||
Offering price (in dollars per share) | $ 1.72 |