Cover Page
Cover Page - shares | 6 Months Ended | |
Jun. 30, 2023 | Aug. 09, 2023 | |
Cover [Abstract] | ||
Document Type | 10-Q | |
Document Quarterly Report | true | |
Document Period End Date | Jun. 30, 2023 | |
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 $0.001 per share | |
Trading Symbol | ATHX | |
Security Exchange Name | NASDAQ | |
Entity Current Reporting Status | Yes | |
Entity Interactive Data Current | Yes | |
Entity Filer Category | Non-accelerated Filer | |
Entity Small Business | true | |
Entity Emerging Growth Company | false | |
Entity Shell Company | false | |
Entity Common Stock, Shares Outstanding | 22,501,410 | |
Amendment Flag | false | |
Document Fiscal Year Focus | 2023 | |
Document Fiscal Period Focus | Q2 | |
Entity Registrant Name | ATHERSYS, INC / NEW | |
Entity Central Index Key | 0001368148 | |
Current Fiscal Year End Date | --12-31 |
Condensed Consolidated Balance
Condensed Consolidated Balance Sheets - USD ($) $ in Thousands | Jun. 30, 2023 | Dec. 31, 2022 |
Current assets: | ||
Cash and cash equivalents | $ 1,803 | $ 9,038 |
Prepaid clinical trial costs | 0 | 2,747 |
Prepaid expenses and other | 1,225 | 1,034 |
Total current assets | 3,692 | 13,535 |
Operating right-of-use assets, net | 38 | 7,846 |
Property and equipment, net | 4,633 | 4,214 |
Deposits and other | 2,114 | 2,136 |
Total assets | 10,477 | 27,731 |
Current liabilities: | ||
Accounts payable | 8,701 | 27,765 |
Operating lease liabilities, current | 8,390 | 746 |
Accrued compensation and related benefits | 419 | 1,090 |
Accrued clinical trial related costs | 364 | 7,231 |
Accrued expenses and other | 1,321 | 1,078 |
Note Payable | 15,640 | 0 |
Warrant liability | 0 | 534 |
Total current liabilities | 42,697 | 38,444 |
Operating lease liabilities, non-current | 0 | 7,939 |
Stockholders’ equity: | ||
Preferred stock, at stated value; 10,000,000 shares authorized, and no shares issued and outstanding at June 30, 2023 and December 31, 2022 | 0 | 0 |
Common stock, $0.001 par value; 600,000,000 shares authorized with 21,833,847 and 17,986,147 shares issued and outstanding at June 30, 2023 and December 31, 2022, respectively | 21 | 18 |
Additional paid-in capital | 639,173 | 632,009 |
Accumulated deficit | (676,613) | (655,878) |
Total stockholders’ equity (deficit) | (37,419) | (23,851) |
Total liabilities and stockholders’ equity | 10,477 | 27,731 |
Deferred Accounts Payable To Supplier | 7,862 | 0 |
Healios | ||
Current assets: | ||
Accounts receivable from Healios | 664 | 716 |
Current liabilities: | ||
Advance from Healios | $ 5,199 | $ 5,199 |
Condensed Consolidated Balanc_2
Condensed Consolidated Balance Sheets (Parenthetical) - $ / shares | Jun. 30, 2023 | Dec. 31, 2022 |
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) | 21,833,847 | 17,986,147 |
Common stock, shares outstanding (in shares) | 21,833,847 | 17,986,147 |
Condensed Consolidated Statemen
Condensed Consolidated Statements of Operations and Comprehensive Loss - USD ($) shares in Thousands, $ in Thousands | 3 Months Ended | 6 Months Ended | |||
Jun. 30, 2023 | Jun. 30, 2022 | Jun. 30, 2023 | Jun. 30, 2022 | ||
Revenues | |||||
Contract revenue from Healios | $ 49 | $ 2,316 | $ 49 | $ 5,228 | |
Total revenues | 49 | 2,316 | 49 | 5,228 | |
Costs and expenses | |||||
Research and development | 10,649 | 20,794 | 15,116 | 41,738 | |
General and administrative | 2,345 | 5,162 | 5,160 | 9,261 | |
Depreciation | 43 | 618 | 95 | 865 | |
Total costs and expenses | 13,037 | 26,574 | 20,371 | 51,864 | |
Loss from operations | (12,988) | (24,258) | (20,322) | (46,636) | |
Other (expense) income, net | [1] | 64 | 610 | (413) | 772 |
Net loss | (12,924) | (23,648) | (20,735) | (45,864) | |
Comprehensive loss | $ (12,924) | $ (23,648) | $ (20,735) | $ (45,864) | |
Net loss per share, basic (in dollars per share) | $ (0.62) | $ (2.28) | $ (1.06) | $ (4.55) | |
Net loss per share, diluted (in dollars per share) | $ (0.62) | $ (2.28) | $ (1.06) | $ (4.55) | |
Weighted average shares outstanding, basic (in shares) | 20,700 | 10,383 | 19,502 | 10,077 | |
Weighted average shares outstanding, diluted (in shares) | 20,700 | 10,383 | 19,502 | 10,077 | |
[1]See Footnote 10 for components of other (expense) income, net |
Condensed Consolidated Statem_2
Condensed Consolidated Statements of Stockholders’ Equity - USD ($) $ in Thousands | Total | Preferred Stock | Common Stock | Additional Paid-in Capital | Accumulated Deficit | ||
Preferred stock shares, beginning balance (in shares) at Dec. 31, 2021 | 0 | ||||||
Beginning balance at Dec. 31, 2021 | $ 16,369 | $ 0 | $ 10 | $ 599,703 | $ (583,344) | ||
Common stock, beginning balance (in shares) at Dec. 31, 2021 | [1] | 9,713,767 | |||||
Increase (Decrease) in Stockholders' Equity [Roll Forward] | |||||||
Stock-based compensation | 1,410 | 1,410 | |||||
Issuance of common stock (in shares) | [1] | 129,333 | |||||
Issuance of common stock | 4,803 | 4,803 | |||||
Issuance of common stock under equity compensation plan (in shares) | [1] | 148,611 | |||||
Issuance of common stock under equity compensation plan | (58) | (58) | |||||
Net loss | (22,216) | (22,216) | |||||
Comprehensive loss | (22,216) | (22,216) | |||||
Preferred stock shares, ending balance (in shares) at Mar. 31, 2022 | 0 | ||||||
Ending balance at Mar. 31, 2022 | 308 | $ 0 | $ 10 | 605,858 | (605,560) | ||
Common stock, ending balance (in shares) at Mar. 31, 2022 | [1] | 9,991,711 | |||||
Preferred stock shares, beginning balance (in shares) at Dec. 31, 2021 | 0 | ||||||
Beginning balance at Dec. 31, 2021 | 16,369 | $ 0 | $ 10 | 599,703 | (583,344) | ||
Common stock, beginning balance (in shares) at Dec. 31, 2021 | [1] | 9,713,767 | |||||
Increase (Decrease) in Stockholders' Equity [Roll Forward] | |||||||
Net loss | (45,864) | ||||||
Comprehensive loss | (45,864) | ||||||
Preferred stock shares, ending balance (in shares) at Jun. 30, 2022 | 0 | ||||||
Ending balance at Jun. 30, 2022 | (11,737) | $ 0 | $ 11 | 617,460 | (629,208) | ||
Common stock, ending balance (in shares) at Jun. 30, 2022 | [1] | 11,004,390 | |||||
Preferred stock shares, beginning balance (in shares) at Mar. 31, 2022 | 0 | ||||||
Beginning balance at Mar. 31, 2022 | 308 | $ 0 | $ 10 | 605,858 | (605,560) | ||
Common stock, beginning balance (in shares) at Mar. 31, 2022 | [1] | 9,991,711 | |||||
Increase (Decrease) in Stockholders' Equity [Roll Forward] | |||||||
Stock-based compensation | 1,945 | 1,945 | |||||
Issuance of common stock (in shares) | [1] | 784,724 | |||||
Issuance of common stock | 9,698 | $ 1 | 9,697 | ||||
Issuance of common stock under equity compensation plan (in shares) | [1] | 227,955 | |||||
Issuance of common stock under equity compensation plan | (40) | (40) | |||||
Net loss | (23,648) | ||||||
Comprehensive loss | (23,648) | (23,648) | |||||
Preferred stock shares, ending balance (in shares) at Jun. 30, 2022 | 0 | ||||||
Ending balance at Jun. 30, 2022 | $ (11,737) | $ 0 | $ 11 | 617,460 | (629,208) | ||
Common stock, ending balance (in shares) at Jun. 30, 2022 | [1] | 11,004,390 | |||||
Preferred stock shares, beginning balance (in shares) at Dec. 31, 2022 | 0 | 0 | |||||
Beginning balance at Dec. 31, 2022 | $ (23,851) | $ 0 | $ 18 | 632,009 | (655,878) | ||
Common stock, beginning balance (in shares) at Dec. 31, 2022 | 17,986,147 | 17,986,147 | [1] | ||||
Increase (Decrease) in Stockholders' Equity [Roll Forward] | |||||||
Stock-based compensation | $ 707 | 707 | |||||
Stock Issue- warrant exercise (in shares) | [1] | 344,170 | |||||
Issuance of common stock under equity compensation plan (in shares) | [1] | 118,172 | |||||
Issuance of common stock under equity compensation plan | (56) | (56) | |||||
Net loss | (7,811) | (7,811) | |||||
Comprehensive loss | (7,811) | (7,811) | |||||
Preferred stock shares, ending balance (in shares) at Mar. 31, 2023 | 0 | ||||||
Ending balance at Mar. 31, 2023 | $ (31,011) | $ 0 | $ 18 | 632,660 | (663,689) | ||
Common stock, ending balance (in shares) at Mar. 31, 2023 | [1] | 18,448,489 | |||||
Preferred stock shares, beginning balance (in shares) at Dec. 31, 2022 | 0 | 0 | |||||
Beginning balance at Dec. 31, 2022 | $ (23,851) | $ 0 | $ 18 | 632,009 | (655,878) | ||
Common stock, beginning balance (in shares) at Dec. 31, 2022 | 17,986,147 | 17,986,147 | [1] | ||||
Increase (Decrease) in Stockholders' Equity [Roll Forward] | |||||||
Net loss | $ (20,735) | ||||||
Comprehensive loss | $ (20,735) | ||||||
Preferred stock shares, ending balance (in shares) at Jun. 30, 2023 | 0 | 0 | |||||
Ending balance at Jun. 30, 2023 | $ (37,419) | $ 0 | $ 21 | 639,173 | (676,613) | ||
Common stock, ending balance (in shares) at Jun. 30, 2023 | 21,833,847 | 21,833,847 | [1] | ||||
Preferred stock shares, beginning balance (in shares) at Mar. 31, 2023 | 0 | ||||||
Beginning balance at Mar. 31, 2023 | $ (31,011) | $ 0 | $ 18 | 632,660 | (663,689) | ||
Common stock, beginning balance (in shares) at Mar. 31, 2023 | [1] | 18,448,489 | |||||
Increase (Decrease) in Stockholders' Equity [Roll Forward] | |||||||
Stock-based compensation | 568 | 568 | |||||
Stock Issue- warrant exercise (in shares) | 813,000 | ||||||
Stock Issue- warrant exercise | 0 | $ 1 | (1) | ||||
Issuance of common stock (in shares) | [1] | 2,315,000 | |||||
Issuance of common stock | 3,338 | $ 2 | 3,336 | ||||
Reclass of warrant liability to additional paid-in capital upon exercise | [2] | 2,685 | 2,685 | ||||
Issuance of common stock under equity compensation plan (in shares) | [1] | 257,358 | |||||
Issuance of common stock under equity compensation plan | (75) | (75) | |||||
Net loss | (12,924) | ||||||
Comprehensive loss | $ (12,924) | (12,924) | |||||
Preferred stock shares, ending balance (in shares) at Jun. 30, 2023 | 0 | 0 | |||||
Ending balance at Jun. 30, 2023 | $ (37,419) | $ 0 | $ 21 | $ 639,173 | $ (676,613) | ||
Common stock, ending balance (in shares) at Jun. 30, 2023 | 21,833,847 | 21,833,847 | [1] | ||||
[1]Reflects the 1-for-25 reverse stock split that became effective August 26, 2022. Refer to Note 1, “Background and Basis of Presentation.”[2]Warrant reclassification (Footnote 9 Fair Value Measurements) |
Condensed Consolidated Statem_3
Condensed Consolidated Statements of Stockholders’ Equity (Parenthetical) | Aug. 26, 2022 |
Statement of Stockholders' Equity [Abstract] | |
Reverse stock split, conversion ratio | 0.04 |
Condensed Consolidated Statem_4
Condensed Consolidated Statements of Cash Flows - USD ($) $ in Thousands | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2023 | Jun. 30, 2022 | Jun. 30, 2023 | Jun. 30, 2022 | |
Operating activities | ||||
Net loss | $ (12,924) | $ (23,648) | $ (20,735) | $ (45,864) |
Adjustments to reconcile net loss to net cash used in operating activities: | ||||
Depreciation | 43 | 618 | 95 | 865 |
Gain on debt extinguishment | (2,612) | 0 | (2,612) | 0 |
Loss from impairment of assets | 7,545 | 4,931 | ||
Stock-based compensation | 1,275 | 3,355 | ||
Discount On Revenue From Issuance Of Warrant | 185 | 0 | ||
Change in fair value of Note Payables | 640 | 0 | 640 | 0 |
Change in fair value of warrant liabilities | 1,522 | 0 | 2,151 | 0 |
Changes in operating assets and liabilities: | ||||
Accounts receivable from Healios - billed and unbilled | 52 | 820 | ||
Prepaid expenses, deposits and other | 66 | 307 | ||
Accounts payable, accrued expenses and other | 787 | 2,320 | ||
Deferred revenue - Healios | 0 | (3,340) | ||
Net cash used in operating activities | (10,551) | (36,606) | ||
Investing activities | ||||
Proceeds from the sale of equipment | 105 | 0 | ||
Purchases of equipment | 0 | (1,825) | ||
Net cash used in investing activities | 105 | (1,825) | ||
Financing activities | ||||
Proceeds from issuance of common stock, net of issuance cost | 3,342 | 14,500 | ||
Shares retained for withholding tax payments on stock-based awards | (131) | (98) | ||
Net cash provided by financing activities | 3,211 | 14,402 | ||
Decrease in cash and cash equivalents | (7,235) | (24,029) | ||
Cash and cash equivalents at beginning of the period | 9,038 | 37,407 | ||
Cash and cash equivalents at end of the period | $ 1,803 | $ 13,378 | $ 1,803 | $ 13,378 |
Background and Basis of Present
Background and Basis of Presentation | 6 Months Ended |
Jun. 30, 2023 | |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | |
Background and Basis of Presentation | Background and Basis of Presentation Organization Athersys, Inc., including its consolidated subsidiaries (collectively, “we,” “us,” “our,” “Athersys,” and the “Company”), is a biotechnology company focused in the field of regenerative medicine and operates in one business segment. Our operations consist of research, clinical development activities, manufacturing and manufacturing process development activities, and our most advanced program is in a pivotal Phase 3 clinical trial for the treatment of ischemic stroke. Basis of Presentation The accompanying unaudited condensed consolidated financial statements should be read in conjunction with the audited financial statements and notes thereto included in our Annual Report on Form 10-K for the year ended December 31, 2022, filed with the SEC on April 3, 2023. The accompanying financial statements have been prepared in accordance with U.S. generally accepted accounting principles (“GAAP”) for interim financial information and Regulation S-X. Accordingly, since they are interim statements, the accompanying financial statements do not include all of the information and notes required by GAAP for complete financial statements. The accompanying financial statements reflect all adjustments, consisting of normal recurring adjustments and disclosures that are, in the opinion of management, necessary for a fair presentation of financial position and results of operations for the interim periods presented. Interim results are not necessarily indicative of results for a full year. The preparation of financial statements in conformity with GAAP requires management to make estimates and assumptions that affect the amounts reported in the financial statements and accompanying notes. Our critical accounting policies, estimates and assumptions are described in “Management’s Discussion and Analysis of Financial Condition and Results of Operations,” which is included in this Quarterly Report on Form 10-Q in Part I, Item 2. Reverse Stock Split On August 26, 2022, the Company amended its Certificate of Incorporation to implement a 1-for-25 reverse stock split of its common stock. The reverse stock split did not cause an adjustment to the par value or the authorized shares of the common stock. As a result of the reverse stock split, the Company adjusted the share amounts under its employee equity incentive plans, inducement awards and common stock warrant agreements with third parties. All disclosures of common shares and per common share data in the accompanying interim financial statements and related notes reflect the reverse stock split for all periods presented. |
Going Concern
Going Concern | 6 Months Ended |
Jun. 30, 2023 | |
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 June 30, 2023, we had cash and cash equivalents of $1.8 million. We will need substantial additional funding to develop our MultiStem product candidate and to continue our operations. Significant additional capital will be required to continue our research and development programs, including progressing our clinical product candidates to potential commercialization and preparing for commercial-scale manufacturing and sales. If we are unable to obtain adequate financing, we likely would have to file for protection under the bankruptcy laws to continue to pursue potential transactions and conduct a wind down of our Company. If we decide to dissolve and liquidate our assets or to seek protection under the bankruptcy laws, it is unclear to what extent we will be able to pay our obligations, and, accordingly, it is further unclear whether and to what extent any resources will be available for distributions to stockholders. For the foreseeable future, our ability to continue our operations is dependent upon the ability to obtain additional funding through public or private equity offerings, debt financings, collaborations and/or licensing arrangements. However, there can be no assurance that we will be able to obtain such funding on terms acceptable to us, on a timely basis or at all, particularly in light of our current stock price and liquidity. If we are unable to obtain funding, we may be required to further delay, reduce or eliminate our MultiStem product candidate approval and commercialization efforts, which would adversely affect our business prospects, and we likely will be unable to continue operations. Additionally, our ability to make timely payments on obligations to the supplier we have entered into the Forbearance Agreement, discussed in more detail below, is dependent on future capital raise. The supplier has the right to call the full amount of the debt due |
Accounting Standards Adopted
Accounting Standards Adopted | 6 Months Ended |
Jun. 30, 2023 | |
Accounting Policies [Abstract] | |
Accounting Standards Adopted | Accounting Standards 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 , delaying the effective date for smaller reporting companies until January 2023. The impact of adoption of this standard did not have a material impact on the consolidated financial statements and disclosures. |
Net Loss per Share
Net Loss per Share | 6 Months Ended |
Jun. 30, 2023 | |
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. As of June 30, 2023, we have outstanding options, restricted stock units and warrants that were not used in the calculation of diluted net loss per share because to do so would be anti-dilutive. As of June 30, 2023, we had warrants outstanding to purchase an aggregate of 400,000 shares of our common stock that were issued to HEALIOS K.K. (“Healios”) in August 2021 and are not yet exercisable according to their terms. Additionally, as of June 30, 2023, we had outstanding warrants to purchase 1,920,000, 2,000,000, 9,109,090, and 3,685,000 shares of our common stock that were issued in August 2022, September 2022, November 2022, and April 2023, respectively. Additionally, we had shares related to the convertible note that have been excluded from the calculation, as these would be anti-dilutive. The following instruments were excluded from the calculation of diluted net loss per share because their effect would be anti-dilutive. Three months ended Six months ended 2023 2022 2023 2022 Stock options 1,132,606 1,224,505 1,132,606 1,224,505 Restricted stock units 525,239 69,765 525,239 69,765 Convertible Note - refer to Note 11 11,538,461 — 11,538,461 — Warrants - refer to Note 8 17,114,090 400,000 17,114,090 400,000 Total 30,310,396 1,694,270 30,310,396 1,694,270 |
Property and Equipment, net
Property and Equipment, net | 6 Months Ended |
Jun. 30, 2023 | |
Property, Plant and Equipment [Abstract] | |
Property and Equipment, net | Property and Equipment, net For the periods ended Property and equipment consists of (in thousands): June 30, December 31, Laboratory equipment $ 7,224 $ 7,576 Office equipment and leasehold improvements 3,933 3,934 Equipment not yet in service 2,911 2,313 14,068 13,823 Accumulated depreciation and amortization (9,435) (9,609) $ 4,633 $ 4,214 Long-lived assets are evaluated for impairment when events or changes in circumstances indicate that the carrying amount of the asset or related group of assets may not be recoverable. In June 2022, we announced a restructuring plan (the “Plan”) of our organization with the intention of significantly reducing expenses, conserving cash, improving the focus of the Company’s activities and becoming more attractive to potential financial and strategic partners. The Plan included a significant reduction in our workforce and changes to our management team. The Plan also includes the reduction of our internal research function, the decommissioning of certain equipment and pausing our manufacturing and process development efforts toward commercializing our MultiStem product candidate. As a result of these actions, during 2022, we recorded impairment charges of approximately $7.2 million to adjust the carrying amount of certain equipment assets to the estimated market value of similar assets. As part of the Plan, we have disposed of gross assets of approximately $0.4 million with accumulated depreciation of $0.3 million, for a gain of approximately $0.1 million for the six months ended June 30, 2023. We had no disposals for the period ended June 30, 2022, but as part of the Plan we did reduce the useful lives of equipment resulting in additional depreciation of $0.4 million. |
Collaborative Arrangements and
Collaborative Arrangements and Revenue Recognition | 6 Months Ended |
Jun. 30, 2023 | |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | |
Collaborative Arrangements and Revenue Recognition | Collaborative Arrangements and Revenue Recognition Healios Collaboration We have a licensing agreement with Healios to primarily develop and commercialize our cell therapy technologies for certain disease indications in Japan, pursuant to which we received nonrefundable license fee payments and are entitled to royalties on net sales. We also have the right to receive development and commercial milestone payments from Healios, subject to certain potential credits that have been negotiated from time-to-time and are associated with modifications to the arrangement. Healios is responsible for the development and commercialization of the licensed products in the licensed territory, and we provide certain services to Healios for which we are paid. In February 2021, the Company, Healios, and Dr. Tadahisa Kagimoto entered into a Cooperation Agreement, or the Cooperation agreement, which established Director Nominations and Related Agreements and established the Standstill Provisions. In August 2021, the Company and Healios entered into a Comprehensive Framework Agreement for Commercial Manufacturing and Ongoing Support, or the Framework Agreement, which provided for clarification under and modified the existing agreements between the parties. It also provided Healios with deferral of certain milestone payments. Under the Framework Agreement, the Company was entitled to payments for reimbursable services of which $0.7 million and $0.6 million which are included in accounts receivable from Healios at June 30, 2023 and June 30, 2022, respectively. In addition, under the Framework Agreement, the Company was entitled to a $3.0 million milestone payment from Healios and was obligated to pay Healios $1.1 million by December 31, 2022. In September 2022, we received $1.9 million from Healios, which represents the milestone payment net of amounts owed to Healios. Additionally, to assist Healios with the advancement of its ischemic stroke and acute respiratory distress syndrome (“ARDS”) programs in Japan, in September 2022, we granted to Healios, subject to the terms of the licensing agreement, a non-exclusive license to make and have made MultiStem for the treatment of ischemic stroke and ARDS worldwide solely for import for use in Japan. 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. In August 2021, we also issued two warrants (together, the “2021 Warrants”) to Healios in connection with the Framework Agreement to purchase up to a total of 400,000 shares of our common stock. The 2021 Warrants are being accounted for as consideration paid or payable to a customer according to Topic 606, Revenue from Contracts with Customers , and Topic 718, Compensation Stock Compensation , under which the recognition of such equity instruments is required at the time that the underlying performance conditions become probable or are satisfied. As of June 30, 2023, 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, “Stockholders’ Equity and Warrants”, for further information. Healios has alleged that we are in material breach of our Framework Agreement for, among other things, not meeting our supply obligations and cooperation and assistance obligations. We strongly disagree with Healios’ allegations and will continue to work with Healios to try to resolve this dispute. However, there can be no assurance that we will be able to resolve this dispute without legal proceedings. Healios Revenue Recognition At the inception of the Healios arrangement and again each time that the arrangement has been modified, all material performance obligations were identified, which include (i) licenses to our technology, (ii) product supply services, and (iii) manufacturing services provided on Healios’ behalf. Under the Framework Agreement, it was determined there was one performance obligation for services necessary for regulatory approvals, manufacturing readiness, and commercial launch in Japan. We determined the transaction price included estimated payments for reimbursable services to be performed by us for Healios and the $3.0 million milestone payment. We allocated the total transaction price to this one performance obligation. We began recognizing revenue in the third quarter of 2021 as the services were being performed. At June 30, 2023, the services related to this performance obligation are largely complete and consist of minimal close-out activities which are immaterial. During the three months ended June 30, 2023, we recognized no revenue associated with this performance obligation, compared to $2.3 million for three months ended June 30, 2022. We recognized no revenue for three months ended June 30, 2023 and June 30, 2022 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 Advance from Healios In 2017, we amended the clinical trial supply agreement for the manufacturing of clinical product for TREASURE to clarify a cost-sharing arrangement. The proceeds from Healios that relate specifically to the cost-sharing arrangement may either (i) result in a reduction in the proceeds we receive from Healios upon the achievement of two potential milestones and an increase to a commercial milestone under the license agreement for stroke or (ii) be repaid to Healios at our election, as defined. The cost-sharing proceeds received are recognized in advance from Healios on the unaudited condensed consolidated balance sheets until the earlier of the milestones being achieved or such amounts being repaid to Healios at our election, at which time the culmination of the earnings process or the repayment will be complete. Disaggregation of Revenues We recognize product supply revenue at a point in time upon delivery, as defined in the applicable product supply contracts, while service revenue is recognized when earned over time. The following table presents our contract revenues disaggregated by timing of revenue recognition (in thousands): Three months ended Three months ended Point in Over Time Point in Over Time Contract Revenue from Healios Product supply revenue $ 49 $ — $ — $ — Service revenue — — — 2,316 Total disaggregated revenues $ 49 $ — $ — $ 2,316 Six months ended Six months ended Point in Over Time Point in Over Time Contract Revenue from Healios Product supply revenue $ 49 $ — $ — $ — Service revenue — — — 5,228 Total disaggregated revenues $ 49 $ — $ — $ 5,228 |
Stock-Based Compensation
Stock-Based Compensation | 6 Months Ended |
Jun. 30, 2023 | |
Share-Based Payment Arrangement [Abstract] | |
Stock-Based Compensation | Stock-Based CompensationOur 2019 Equity and Incentive Compensation Plan (the “EICP”) authorized at inception, an aggregate of approximately 1,700,000 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. As of June 30, 2023, a total of 961,333 shares (including 11,289 shares related to an expired incentive plan) of common stock have been issued under our equity incentive plans.As of June 30, 2023, a total of 84,103 shares were available for issuance under our EICP, and stock-based awards representing 1,228,345 (including 21,092 shares related to an expired incentive plan) of common stock were outstanding. Additionally, inducement stock options granted outside of our equity incentive plans to purchase 429,500 shares of common stock were outstanding at June 30, 2023. For the three months ended June 30, 2023 and 2022, stock-based compensation expense was approximately $0.6 million and $1.9 million, respectively. At June 30, 2023, total unrecognized estimated compensation cost related to unvested stock-based awards was approximately $3.8 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 | 6 Months Ended |
Jun. 30, 2023 | |
Equity [Abstract] | |
Stockholders’ Equity and Warrants | Stockholders’ Equity and Warrants At June 30, 2023 and June 30, 2022, we had 600,000,000 shares of common stock and 10,000,000 shares of undesignated preferred stock authorized. No shares of preferred stock have been issued as of June 30, 2023 and 2022. August 2022 Securities Purchase Agreement On August 15, 2022, the Company entered into a placement agency agreement with A.G.P./Alliance Global Partners (“A.G.P.”), pursuant to which A.G.P. agreed to serve as exclusive placement agent for the issuance and sale of common stock and warrants. A.G.P. received a placement fee of approximately $0.8 million and approximately $0.1 million for the reimbursement of expenses. On August 15, 2022, the Company entered into a securities purchase agreement (the “August 2022 Purchase Agreement”) with an investor, pursuant to which the Company agreed to issue and sell, in a registered direct offering, (i) an aggregate of 1,200,000 shares of the Company’s common stock, (ii) pre-funded warrants (the “August 2022 Pre-Funded Warrants”) exercisable for an aggregate of 720,000 shares of common stock and (iii) warrants (the “August 2022 Common Warrants”) exercisable for an aggregate of 1,920,000 shares of common stock, in combinations of one share of common stock or one August 2022 Pre-Funded Warrant and one August 2022 Common Warrant for a combined purchase price of $6.25 (less $0.0025 for any August 2022 Pre-Funded Warrant). Subject to certain ownership limitations, under the terms of the August 2022 Purchase Agreement, the August 2022 Pre-Funded Warrants were exercisable upon issuance, and the August 2022 Common Warrants were exercisable upon the six-month anniversary of issuance for a five-year period. Under the August 2022 Purchase Agreement, each August 2022 Pre-Funded Warrant was exercisable for one share of common stock at a price per share of $0.0025 and each August 2022 Common Warrant was exercisable for one share of common stock at a price per share of $6.385. The offering closed on August 17, 2022 and the Company received net proceeds of approximately $11.0 million, after giving effect to the payment of placement fees and expenses. On August 29, 2022, the August 2022 Pre-Funded Warrants were exercised in full and re-measured to fair value. Upon remeasurement and exercise, we recorded a gain of $0.8 million to adjust the warrant liability associated with the August 2022 Pre-Funded Warrants to fair value and reclassified the $3.8 million warrant liability to additional paid-in capital. The fair value adjustment is recorded in other income, net on the condensed consolidated statement of operations and comprehensive loss. Pursuant to the August 2022 Purchase Agreement, in the event the Company proposes a future offering to sell shares of common stock during the twelve months following the closing date, the investor has the right to participate in each offering in an amount up to 30.0%. On September 22, 2022, the Company entered into an amendment to the August 2022 Purchase Agreement (the “August 2022 Purchase Agreement Amendment”) with the investor to, among other things, (i) amend the August 2022 Common Warrants to be exercisable for a seven-year period after the six-month anniversary of the closing date, (ii) reduce the standstill period, (iii) reduce the term and the amount of the participation right, and (iv) require the investor, subject to certain conditions, to participate in future offerings to sell certain securities to investors primarily for capital raising purposes. On September 22, 2022, in consideration of the August 2022 Purchase Agreement Amendment, and without receiving any cash proceeds, the Company issued to the investor additional warrants exercisable for 2,000,000 shares of common stock (the “September Warrants”) at a price of $6.385 for a seven-year period after the six-month anniversary of the date of issuance thereof. The Company has assessed the August 2022 Pre-Funded Warrants, the August 2022 Common Warrants and the September Warrants (collectively, the “Warrants”) for appropriate equity or liability classification pursuant to the Company’s accounting policy as described in Note C, in the notes to consolidated financial statements in our Annual Report on Form 10-K for the year ended December 31, 2022. The Warrants contain a provision pursuant to which the warrant holder has the option to receive cash in the event there is a fundamental transaction (contractually defined to include various merger, acquisition or stock transfer activities). The Warrants met the definition of a derivative pursuant to ASC 815, Derivatives and Hedging and did not meet the derivative scope exception. As a result, the Warrants were initially recorded as liabilities and measured at fair value using the Black-Scholes valuation model. Issuance costs of $0.5 million were allocated to the Pre-Funded Warrants and Common Warrants and recorded in other income, net on the condensed consolidated statement of operations and comprehensive loss in the three ended September 30, 2022. The remaining issuance costs of $0.4 million were allocated to the common stock and recorded in additional paid-in capital. On April 17, 2023, the Company amended the August Warrants and the September Warrants to, among other things, reduce the exercise price to $0.96 per share with respect to 1,920,000 shares of common stock covered by the August Warrants and 1,760,000 shares of common stock covered by the September Warrants. As a result of the amended agreement, the August and September Warrants now meet the guidance for equity classification in accordance with ASC 815, Derivatives and Hedging. The warrants were adjusted to their fair value on April 17, 2023, inclusive of the change in exercise price and the change in fair value was recorded in other (expense) income, net and then the warrants were reclassified to additional paid-in-capital (APIC). During the three- and six-months ended June 30, 2023, the Company recognized other expense of $1.5 million and other expense of $2.2 million, respectively, for the fair value adjustment related to the warrant liabilities. November 2022 Securities Purchase Agreement On November 9, 2022, the Company entered into a placement agency agreement with A.G.P. pursuant to which A.G.P. agreed to serve as exclusive placement agent for the issuance and sale of common stock and warrants. A.G.P received a placement fee of approximately $0.4 million and approximately $0.1 million for the reimbursement of expenses. On November 9, 2022, the Company entered into a securities purchase agreement (the “November 2022 Purchase Agreement”) with investors, pursuant to which the Company agreed to issue and sell, in a public offering, (i) an aggregate of 3,927,275 shares of the Company’s common stock, (ii) pre-funded warrants (the “November 2022 Pre-Funded Warrants”) exercisable for an aggregate of 1,077,270 shares of common stock and (iii) warrants (the “November 2022 Common Warrants”) exercisable for an aggregate of 10,009,090 shares of common stock, in combinations of one share of common stock or one November 2022 Pre-Funded Warrant and two November 2022 Common Warrants for a combined purchase price of $1.10 (less $0.0001 for any November 2022 Pre-Funded Warrant). Subject to certain ownership limitations, under the terms of the November 2022 Purchase Agreement, the November 2022 Pre-Funded Warrants and November 2022 Common Warrants were exercisable upon issuance. Under the November 2022 Purchase Agreement, each November 2022 Pre-Funded Warrant was exercisable for one share of common stock at a price per share of $0.0001 and each November 2022 Common Warrant is exercisable for one share of common stock at a price per share of $1.10 for a five-year period after the date of issuance. The offering closed on November 10, 2022, and the Company received net proceeds of approximately $5.0 million, after giving effect to the payment of placement fees and expenses. The November 2022 Pre-Funded Warrants were exercised in full at the closing. The November 2022 Common Warrants meet the requirements to be classified as equity in accordance with ASC 815, Derivatives and Hedging. The November 2022 Common Warrants were recorded at their relative fair value at issuance in the stockholders’ equity section of the balance sheet. April 2023 Securities Purchase Agreement On April 18, 2023, the Company entered into a placement agency with A.G.P. pursuant to which A.G.P. agreed to serve as the exclusive placement agent for the issuance and sale of common stock and warrants. A.G.P. received a placement fee of approximately $0.2 million and approximately $0.1 million for the reimbursement of expenses. On April 18, 2023, the Company entered into a securities purchase agreement (the “April 2023 Purchase Agreement”) with investors, pursuant to which the Company agreed to issue and sell, in a registered direct offering, (i) an aggregate of 2,315,000 shares of the Company’s common stock and (ii) pre-funded warrants (the “April 2023 Pre-Funded Warrants”) exercisable for an aggregate of 1,370,000 shares of common stock, together with warrants (the “April 2023 Common Warrants”) exercisable for an aggregate of 3,685,000 shares of the Company’s common stock in a private placement, in combinations of one share or one April 2023 Pre-Funded Warrant and one April 2023 Common Warrant for a combined purchase price of $1.00. Subject to certain ownership limitations, the April 2023 Pre-Funded Warrants are exercisable upon issuance, and the April 2023 Common Warrants are exercisable upon the six-month anniversary of issuance. Each April 2023 Pre-Funded Warrant is exercisable for one share of common stock at a price per share of $0.0001 (as adjusted from time to time in accordance with the terms thereof) and does not expire. Each April 2023 Common Warrant is exercisable into one share of common stock at a price per share of $0.96 (as adjusted from time to time in accordance with the terms thereof) for a seven-year period after the six-month anniversary of the date of issuance. The offering closed on April 19, 2023, and the Company received net proceeds of approximately $3.4 million, after giving effect to the payment of placement fees and expenses. The April 2023 Common Warrants and 557,000 of the remaining outstanding April 2023 Pre-Funded Warrants meet the requirements to be classified as equity in accordance with ASC 815, Derivatives and Hedging. The April Common Warrants were recorded at their relative fair value at issuance in the stockholders’ equity section of the balance sheet. Healios 2021 Warrants In August 2021, we issued the 2021 Warrants to Healios to purchase up to an aggregate of 400,000 shares of our common stock. One of the 2021 Warrants is for the purchase of up to 120,000 shares at an exercise price of $45.00 per share, subject to specified increases, and generally is only exercisable within 60 days of receipt of either conditional or full marketing approval from the Pharmaceuticals and Medical Devices Agency in Japan (the “PMDA”) for the intravenous administration of MultiStem to treat patients who are suffering from acute respiratory distress syndrome. The other 2021 Warrant is for the purchase of up to 280,000 shares at an exercise price of $60.0 per share, subject to specified increases, and generally is only exercisable within 60 days of receipt of either conditional or full marketing approval from the PMDA for the intravenous administration of MultiStem to treat patients who are suffering from ischemic stroke. The 2021 Warrants may be terminated by us under certain conditions and have an exercise cap triggered at Healios’ ownership of 19.9% of our common stock. Equity Purchase Agreement We previously had equity purchase agreements in place since 2011 with Aspire Capital Fund, LLC (“Aspire Capital”) that provided us the ability to sell shares to Aspire Capital from time to time. On May 12, 2022, we entered into an agreement (the “2022 Equity Facility”) that included Aspire Capital’s commitment to purchase up to an aggregate of $100.0 million of shares of our common stock over a defined timeframe. The terms of the 2022 Equity Facility were similar to the previous equity facilities with Aspire Capital. Our prior equity facility that was entered into in June 2021, or 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 1,600,000 shares of our common stock in connection with the 2021 Equity Facility. Our prior equity facility that was entered into in 2019, that was fully utilized and terminated during the third quarter of 2021. On July 6, 2022, Aspire Capital terminated the 2022 Equity Facility. Aspire Capital had the right to terminate the 2022 Equity Facility at the time or any time after any of the Company’s then current executive officers ceased to be an executive officer or full-time employee of the Company, which right was triggered in connection with the departures of William Lehmann, former president and Chief Operating Officer, John Harrington, Former Executive Vice President and Chief Scientific Officer, and Ivor MacLeod, former Chief Financial Officer. During quarter ended June 30, 2022, we sold 1,003,560 shares to Aspire Capital at an average price of $9.67 per share. |
Fair Value Measurements
Fair Value Measurements | 6 Months Ended |
Jun. 30, 2023 | |
Fair Value Disclosures [Abstract] | |
Fair Value Measurements | Fair Value Measurements The carrying amounts of certain financial instruments, including cash and cash equivalents, accounts receivable, prepaid expenses and other current assets, accounts payable and accrued expenses approximate their respective fair values due to the short-term nature of such instruments. Liabilities Measured at Fair Value on a Recurring Basis The Company evaluates its financial assets and liabilities subject to fair value measurements on a recurring basis to determine the appropriate level in which to classify them for each reporting period. The requirement requires judgements to be made. Our Level 3 financial liabilities consist of the warrant liabilities and a convertible note payable for which there is no current market such that the determination of fair value requires judgement or estimation. Changes in fair value measurements categorized within Level 3 of the fair value hierarchy are analyzed each period based on changes in estimates or assumptions and recorded as appropriate. The Company uses the Black-Scholes option valuation model to value the Level 3 warrant liabilities at inception and on subsequent valuation dates. This model incorporates transaction detail such as the Company’s stock price, contractual terms, maturing, risk free rates as well as volatility. The unobservable input for the Level 3 warrant liabilities includes volatility, which is not significant to the fair value measurement of the warrant liabilities. A reconciliation of the beginning and ending balances for the warrant liabilities which are measured at fair value on a recurring basis using significant unobservable inputs (Level 3) is as follows (in thousands): Warrant Liabilities Balance December 31, 2022 $ (534) Fair Value Adjustment - March 31, 2023 (629) Balance March 31, 2023 (1,163) Fair Value Adjustment - April 18, 2023 (1,522) Reclassification to Additional paid in capital 2,685 Balance June 30, 2023 $ — The Company uses the Lattice Model to value the Level 3 note payable liabilities at inception and for subsequent valuation dates. This model incorporates transaction detail such as the term of the note, the nominal value of the note at inception, the coupon rate of the note, the conversion price of the note, the Company’s stock price, risk-free rate and implied bond yield as well as volatility. The unobservable input for the Level 3 note payable includes volatility and implied bond yield, which are significant to the fair value measurement of the note payable. The Company’s stock is publicly traded and is readily determinable. The risk-free interest rate is based on the U.S. Treasury yield for a period consistent with the expected term of the Note. We determine volatility by using our historical stock volatility. The implied bond yield is based on the required rate of return for mezzanine financing for similar companies. The following weighted-average input assumptions were used in determining the fair value of the note at inception and as of June 30, 2023. Volatility was 49.5% on May 17, 2023, and 50.6% on June 30, 2023, and the implied bond yield was 18.9% on May 17, 2023, and 19.6% on June 30, 2023 A reconciliation of the beginning and ending balances for the note payable which are measured at fair value on a recurring basis using significant unobservable inputs (Level 3) is as follows (in thousands): Note Payable Accrued Interest Total Fair Value Balance March 31, 2023 $ — $ — $ — Initial Transaction Fair Value - May 17 $15,000 — 15,000 Accrued Paid-in-Kind (PIK) Interest as of June 30, 2023 — 185 185 Fair Value Adjustment - June 30, 2023 640 — 640 Balance June 30, 2023 15,640 185 $ 15,825 |
Other Income and Expenses
Other Income and Expenses | 6 Months Ended |
Jun. 30, 2023 | |
Other Income and Expenses [Abstract] | |
Other Income and Expense | Other Income and Expense Other (expense) income consists of loss from extinguishment of debt, interest expense, foreign exchange gain/(loss), fair value change from warrants, gain/(loss) on disposal of assets and other. Three months ended Six months ended 2023 2022 2023 2022 Gain/(Loss) from extinguishment of debt $ 2,612 $ — $ 2,612 $ — Change in fair value - note payable (640) — (640) — Interest expense (366) (6) (376) (14) Foreign exchange gain/(loss) (80) 117 (178) 284 Fair value change - warrants (1,522) — (2,151) — Gain/(Loss) on disposal of assets — — 146 — Other 60 499 174 502 $ 64 $ 610 $ (413) $ 772 |
Forbearance Agreement and Conve
Forbearance Agreement and Convertible Note | 6 Months Ended |
Jun. 30, 2023 | |
Debt Disclosure [Abstract] | |
Forbearance Agreement and Convertible Note | Forbearance Agreement and Convertible Note On May 17, 2023, the Company entered into a Forbearance, Restructuring and Settlement Agreement (the “Forbearance Agreement”) with a supplier, which amends certain supply agreements between the Company and the supplier. The Forbearance Agreement provides that the supplier agrees to forbear from exercising rights and remedies available as a result of existing overdue amounts under existing agreements, so long as the Company pays to the supplier an aggregate of $11.8 million in deferred accounts payable, in monthly payments of $0.25 million, commencing in October 2023. Pursuant to the terms of the Forbearance Agreement, the Company also issued a convertible promissory note to the supplier in the principal amount of $15.0 million (the “Note”). The Company accounted for the restructuring as an extinguishment and recorded the new liabilities at fair value of $7.9 million for the deferred accounts payable and $15.0 million for the Note. The Company recorded a gain on extinguishment of $2.6 million as a result of the restructuring. The Note bears interest at a rate of 10.0% per annum, which shall be capitalized and added to the principal amount semi-annually on January 1 and July 1, commencing on July 1, 2023, and must be repaid in full, including accrued and unpaid interest thereunder, on (or before, subject to certain conditions) May 17, 2026 (the “Maturity Date”). The Note provides for customary events of default, including nonpayment, failure to comply with covenants or other agreements in the Note, certain events of bankruptcy and an adverse judgment for payment of $3.0 million or more (each, an “Event of Default”). Upon and during the continuance of any Event of Default, the rate of interest shall increase to 14%. The obligations under the Note are guaranteed by certain of the Company’s existing subsidiaries. Subject to a beneficial ownership limitation of 19.99% of the Company’s outstanding common stock and any shareholder approval requirements, the supplier may elect, at its sole discretion, to convert any outstanding principal and interest on the Note into shares of common stock of the Company at a conversion price of $1.30 per share (subject to adjustment as provided under the Note), which amounts to 11,538,461 convertible shares, at any time after the 18-month anniversary of the date of issuance of the Note (or upon an Event of Default) until the total outstanding balance of the Note is paid. The Company has elected the fair value option under ASC 825-10-25 to measure the Note at fair value at inception and in subsequent periods, with changes in fair value reported in earnings. The Note is eligible for the fair value option as it is a permissible instrument within the scope of ASC 825-10-15. The Company incurred debt issuance costs (legal fees) of $16,679 which were expensed at issuance. The fair value of the Note on June 30, 2023 was $15.8 million and the change in fair value of $0.8 million was reported in other (expense) income, net, with $0.2 million being recorded as Paid-in-Kind interest and the remaining $0.6 million being the fair value adjustment, increasing the interest expense and note payable balance. See a reconciliation of the change in fair value of the Note in Note 9, “Fair Value Measurements”. The Note is an unsecured obligation. The Note is unconditionally and irrevocably guaranteed by certain guarantors. If an Event of Default occurs under points (1) through (6) below, the holder of the Note may request for acceleration of maturity of 100% of the Note principal. Upon the request for acceleration of maturity, the Note principal will be due immediately. If an Event of Default occurs under clause (4) and (5) below, 100% of the principal amount of the Note will be automatically and immediately due and payable to the holder of the note. An Event of Default is defined in the Agreement as any of the following: 1. Company defaults in the payment of principal, accrued and unpaid interest or any other amounts owing under the Note 2. Any representation or warranty made by the Company proves to have been false 3. The Company defaults in the performance of, or fails to comply with, any other terms, provision, condition, covenant or agreement contained in the Note 4. Company files for bankruptcy 5. Court appoints a custodian, receiver, trustee or other officer for dissolution, winding-up, or liquation of the Company 6. One or more judgments for payment of money in excess of $3 million shall be rendered against the Company |
Restructuring Charges
Restructuring Charges | 6 Months Ended |
Jun. 30, 2023 | |
Restructuring and Related Activities [Abstract] | |
Restructuring Charges | Restructuring Charges In June 2022, we announced a restructuring of our organization (the “Plan”), including an approximate 70% reduction in our workforce. As part of the Plan, we also announced changes to our executive team. Mr. Lehmann left the Company on May 31, 2022. Dr. Harrington and Mr. Macleod left the Company on June 30, 2022. The Company’s restructuring efforts are intended to preserve cash and reduce operating expenses going forward. In addition to the workforce reductions, the Company’s restructuring efforts include the reduction of our internal research function, the decommissioning of certain equipment and pausing our manufacturing and process development efforts toward commercializing our MultiStem product candidate. The following table sets forth certain details associated with the restructuring charges incurred in the three months ended June 30, 2023 and the obligations recorded for the expenses associated with the Plan (in thousands). It is anticipated the Plan will be completed by the end of 2023. Balances Cash Balances March 31, 2023 Charges (payments) June 30, 2023 Employee severance and benefits 565 $ — (251) $ 314 Legal and professional fees 27 16 (16) 27 Other 15 — (15) — $ 607 $ 16 $ (282) $ 341 The current portion of our restructuring accrual is included in accrued compensation and related benefits and accounts payable and there is no long-term portion of our restructuring accrual. Restructuring charges are recorded general and administrative costs and expenses for the three months ended June 30, 2023. |
Income Taxes
Income Taxes | 6 Months Ended |
Jun. 30, 2023 | |
Income Tax Disclosure [Abstract] | |
Income Taxes | Income Taxes We 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 generated prior to October 2012 under Section 382 of the Internal Revenue Code of 1986, as amended. Utilization of some of the federal and state net operating loss and tax credit carryforwards generated after October 2012 may be subject to additional annual limitations due to the “change in ownership” provisions of the IRC and similar state provisions. The annual limitations may result in the expiration of net operating losses and credits before utilization. The Company has not performed a Section 382 study subsequent to October 2012 as of June 30, 2023. We will update our analysis under Section 382 prior to using these attributes. |
Subsequent Event
Subsequent Event | 6 Months Ended |
Jun. 30, 2023 | |
Subsequent Events [Abstract] | |
Subsequent Event | Subsequent Events Nasdaq Notices Market Value Standard Compliance On October 14, 2022, we received a written notice (the “October 2022 Notice”) from the Listing Qualifications Department of The Nasdaq Stock Market LLC (“Nasdaq”) that we are not in compliance with the requirement to maintain a minimum market value of listed securities of $35 million, as set forth in Nasdaq Listing Rule 5550(b)(2) (the “Market Value Standard”) because the market value of the common stock was below $35 million for 30 consecutive business days. The October 2022 Notice provided that, in accordance with Nasdaq Listing Rule 5810(c)(3)(C), we had a period of 180 calendar days from the date of the October 2022 Notice, or until April 12, 2023, to regain compliance under the Market Value Standard. On April 13, 2023, we received notice from Nasdaq that we had not regained compliance with the Market Value Standard. On April 14, 2023, we filed our request for a hearing, which was held before the Nasdaq Hearing Panel (the “Panel”) on May 18, 2023. On June 26, 2023, the Panel notified us that it had granted our request for an exception through September 15, 2023, to the continued listing requirements, subject to our demonstrating compliance with the Market Value Standard by September 15, 2023. In accordance with the Market Value Standard and Nasdaq Listing Rule 5810(c)(3)(C), compliance with the Market Value Standard may be achieved if at any time during the compliance period the market value of the listed securities closes at a value of at least $35 million for a minimum of ten consecutive business days. The Panel noted that it reserves the right to reconsider the terms of this exception based on any event, condition or circumstance that exists or develops that would, in the opinion of the Panel, make continued listing of our securities on Nasdaq inadvisable or unwarranted. In addition, the Nasdaq Listing and Hearing Review Council may, on its own motion, determine to review any Panel decision within 45 calendar days after issuance of the written decision. There can be no assurance that we will be able to regain compliance under the Market Value Standard, or will otherwise be in compliance with other Nasdaq listing criteria. While we are exercising diligent efforts to maintain the listing of our common stock on The Nasdaq Capital Market, there can be no assurance that we will be able to regain or maintain compliance with Nasdaq listing criteria. Minimum Closing Bid Price Compliance On July 28, 2023, the Company received a written notice (the “July 2023 Notice”) from Nasdaq that the Company is not in compliance with the requirement to maintain a minimum closing bid price of $1.00 per share, as set forth in Nasdaq Listing Rule 5550(a)(2) (the “Bid Price Requirement”), because the closing bid price of the Company’s common stock was below $1.00 per share for 30 consecutive business days for the period of June 14, 2023 through July 27, 2023. The July 2023 Notice does not impact the listing of the Company’s common stock on The Nasdaq Capital Market at this time. The July 2023 Notice provided that, in accordance with Nasdaq Listing Rule 5810(c)(3)(A), the Company has a period of 180 calendar days from the date of the July 2023 Notice, or until January 24, 2024, to regain compliance with the Bid Price Requirement. During this period, the Company’s common stock will continue to trade on The Nasdaq Capital Market. If at any time before January 24, 2024, the bid price of the Company’s common stock closes at or above $1.00 per share for a minimum of ten consecutive trading days, Nasdaq will provide written notification that the Company has achieved compliance with the Bid Price Requirement and the matter will be closed. However, under Nasdaq Listing Rule 5810(c)(3)(A), Nasdaq may exercise its discretion to extend this ten day period as discussed in Rule 5810(c)(3)(H). The Company is considering all available options to regain compliance with the Bid Price Requirement. However, there can be no assurance that the Company will be able to regain compliance with the rule or will otherwise be in compliance with other Nasdaq listing criteria. In the event the Company does not regain compliance by January 24, 2024, the Company may be eligible for an additional 180 calendar day compliance period to demonstrate compliance with the Bid Price Requirement. To qualify for the additional 180-day period, the Company will be required to meet the continued listing requirements for market value of publicly held shares and all other initial listing standards (with the exception of the Bid Price Requirement). In addition, the Company will need to provide written notice to Nasdaq of its intention to cure the deficiency during the second compliance period by effecting a reverse stock split, if necessary. If the Company does not qualify for the second compliance period or fails to regain compliance during the second 180-day period, then Nasdaq will notify the Company that its common stock is subject to delisting. At that time, the Company may appeal the delisting determination to a Nasdaq Hearings Panel. Healios Update On August 9, 2023, ABT Holding Company, a wholly-owned subsidiary of Athersys, Inc. (together, the “ABT/ATHX”), entered into a Memorandum of Understanding (“MOU”) with HEALIOS, K.K. (“Healios”), which memorializes the terms between the ABT/ATHX and Healios regarding consultation services that ABT/ATHX agreed to provide Healios as it explores its effort to join and participate in the Company’s ongoing MASTERS-2 Study, a 300 patient Phase 3 clinical trial for the treatment of ischemic stroke using MultiStem (the “ Masters-2 Trial ”). |
Accounting Standards Adopted (P
Accounting Standards Adopted (Policies) | 6 Months Ended |
Jun. 30, 2023 | |
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, 2022, filed with the SEC on April 3, 2023. 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 in Part I, Item 2. |
Accounting Standards Adopted | Accounting Standards 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 , delaying the effective date for smaller reporting companies until January 2023. The impact of adoption of this standard did not have a material impact on the consolidated financial statements and disclosures. |
Net Loss per Share (Tables)
Net Loss per Share (Tables) | 6 Months Ended |
Jun. 30, 2023 | |
Earnings Per Share [Abstract] | |
Schedule of Instruments Excluded from Calculation of Diluted Net Loss Per Share | The following instruments were excluded from the calculation of diluted net loss per share because their effect would be anti-dilutive. Three months ended Six months ended 2023 2022 2023 2022 Stock options 1,132,606 1,224,505 1,132,606 1,224,505 Restricted stock units 525,239 69,765 525,239 69,765 Convertible Note - refer to Note 11 11,538,461 — 11,538,461 — Warrants - refer to Note 8 17,114,090 400,000 17,114,090 400,000 Total 30,310,396 1,694,270 30,310,396 1,694,270 |
Property and Equipment, net (Ta
Property and Equipment, net (Tables) | 6 Months Ended |
Jun. 30, 2023 | |
Property, Plant and Equipment [Abstract] | |
Schedule of Property and Equipment, net | For the periods ended Property and equipment consists of (in thousands): June 30, December 31, Laboratory equipment $ 7,224 $ 7,576 Office equipment and leasehold improvements 3,933 3,934 Equipment not yet in service 2,911 2,313 14,068 13,823 Accumulated depreciation and amortization (9,435) (9,609) $ 4,633 $ 4,214 |
Collaborative Arrangements an_2
Collaborative Arrangements and Revenue Recognition (Tables) | 6 Months Ended |
Jun. 30, 2023 | |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | |
Schedule of Contract Revenues Disaggregated by Timing of Revenue Recognition | The following table presents our contract revenues disaggregated by timing of revenue recognition (in thousands): Three months ended Three months ended Point in Over Time Point in Over Time Contract Revenue from Healios Product supply revenue $ 49 $ — $ — $ — Service revenue — — — 2,316 Total disaggregated revenues $ 49 $ — $ — $ 2,316 Six months ended Six months ended Point in Over Time Point in Over Time Contract Revenue from Healios Product supply revenue $ 49 $ — $ — $ — Service revenue — — — 5,228 Total disaggregated revenues $ 49 $ — $ — $ 5,228 |
Fair Value Measurements (Tables
Fair Value Measurements (Tables) | 6 Months Ended |
Jun. 30, 2023 | |
Fair Value Disclosures [Abstract] | |
Schedule of Liabilities Measured at Fair Value on Recurring Basis Using Significant Unobservable Inputs | A reconciliation of the beginning and ending balances for the warrant liabilities which are measured at fair value on a recurring basis using significant unobservable inputs (Level 3) is as follows (in thousands): Warrant Liabilities Balance December 31, 2022 $ (534) Fair Value Adjustment - March 31, 2023 (629) Balance March 31, 2023 (1,163) Fair Value Adjustment - April 18, 2023 (1,522) Reclassification to Additional paid in capital 2,685 Balance June 30, 2023 $ — A reconciliation of the beginning and ending balances for the note payable which are measured at fair value on a recurring basis using significant unobservable inputs (Level 3) is as follows (in thousands): Note Payable Accrued Interest Total Fair Value Balance March 31, 2023 $ — $ — $ — Initial Transaction Fair Value - May 17 $15,000 — 15,000 Accrued Paid-in-Kind (PIK) Interest as of June 30, 2023 — 185 185 Fair Value Adjustment - June 30, 2023 640 — 640 Balance June 30, 2023 15,640 185 $ 15,825 |
Other Income and Expenses (Tabl
Other Income and Expenses (Tables) | 6 Months Ended |
Jun. 30, 2023 | |
Other Income and Expenses [Abstract] | |
Schedule of Other Income and Expense | Other (expense) income consists of loss from extinguishment of debt, interest expense, foreign exchange gain/(loss), fair value change from warrants, gain/(loss) on disposal of assets and other. Three months ended Six months ended 2023 2022 2023 2022 Gain/(Loss) from extinguishment of debt $ 2,612 $ — $ 2,612 $ — Change in fair value - note payable (640) — (640) — Interest expense (366) (6) (376) (14) Foreign exchange gain/(loss) (80) 117 (178) 284 Fair value change - warrants (1,522) — (2,151) — Gain/(Loss) on disposal of assets — — 146 — Other 60 499 174 502 $ 64 $ 610 $ (413) $ 772 |
Restructuring Charges (Tables)
Restructuring Charges (Tables) | 6 Months Ended |
Jun. 30, 2023 | |
Restructuring and Related Activities [Abstract] | |
Schedule of Restructuring Reserve by Type of Expenses | The following table sets forth certain details associated with the restructuring charges incurred in the three months ended June 30, 2023 and the obligations recorded for the expenses associated with the Plan (in thousands). It is anticipated the Plan will be completed by the end of 2023. Balances Cash Balances March 31, 2023 Charges (payments) June 30, 2023 Employee severance and benefits 565 $ — (251) $ 314 Legal and professional fees 27 16 (16) 27 Other 15 — (15) — $ 607 $ 16 $ (282) $ 341 |
Background and Basis of Prese_2
Background and Basis of Presentation (Details) | 6 Months Ended | |
Aug. 26, 2022 | Jun. 30, 2023 segment | |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | ||
Number of business segments | 1 | |
Reverse stock split, conversion ratio | 0.04 |
Going Concern (Details)
Going Concern (Details) - USD ($) $ in Thousands | Jun. 30, 2023 | Dec. 31, 2022 |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | ||
Cash and cash equivalents | $ 1,803 | $ 9,038 |
Net Loss per Share - Additional
Net Loss per Share - Additional Information (Details) - shares | Apr. 30, 2023 | Nov. 30, 2022 | Sep. 30, 2022 | Aug. 31, 2022 | Aug. 31, 2021 |
Healios Framework Agreement | |||||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | |||||
Shares called by warrants (in shares) | 3,685,000 | 9,109,090 | 2,000,000 | 1,920,000 | 400,000 |
Net Loss per Share - Instrument
Net Loss per Share - Instruments Excluded from Calculation of Diluted Net Loss Per Share (Details) - shares | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2023 | Jun. 30, 2022 | Jun. 30, 2023 | Jun. 30, 2022 | |
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||||
Antidilutive securities excluded from computation of net loss per share (in shares) | 30,310,396 | 1,694,270 | 30,310,396 | 1,694,270 |
Stock options | ||||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||||
Antidilutive securities excluded from computation of net loss per share (in shares) | 1,132,606 | 1,224,505 | 1,132,606 | 1,224,505 |
Restricted stock units | ||||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||||
Antidilutive securities excluded from computation of net loss per share (in shares) | 525,239 | 69,765 | 525,239 | 69,765 |
Convertible Note | ||||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||||
Antidilutive securities excluded from computation of net loss per share (in shares) | 11,538,461 | 0 | 11,538,461 | 0 |
Warrants | ||||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||||
Antidilutive securities excluded from computation of net loss per share (in shares) | 17,114,090 | 400,000 | 17,114,090 | 400,000 |
Property and Equipment, net - S
Property and Equipment, net - Schedule of Property and Equipment, net (Details) - USD ($) $ in Thousands | Jun. 30, 2023 | Dec. 31, 2022 |
Property, Plant and Equipment [Line Items] | ||
Property and equipment, gross | $ 14,068 | $ 13,823 |
Accumulated depreciation and amortization | (9,435) | (9,609) |
Property and equipment, net | 4,633 | 4,214 |
Laboratory equipment | ||
Property, Plant and Equipment [Line Items] | ||
Property and equipment, gross | 7,224 | 7,576 |
Office equipment and leasehold improvements | ||
Property, Plant and Equipment [Line Items] | ||
Property and equipment, gross | 3,933 | 3,934 |
Equipment not yet in service | ||
Property, Plant and Equipment [Line Items] | ||
Property and equipment, gross | $ 2,911 | $ 2,313 |
Property and Equipment, net - A
Property and Equipment, net - Additional Information (Details) - USD ($) $ in Thousands | 3 Months Ended | 6 Months Ended | 12 Months Ended | ||
Jun. 30, 2023 | Jun. 30, 2022 | Jun. 30, 2023 | Jun. 30, 2022 | Dec. 31, 2022 | |
Property, Plant and Equipment [Abstract] | |||||
Loss from impairment of assets | $ 7,200 | ||||
Disposal of assets | $ 400 | $ 0 | |||
Accelerated depreciation | 300 | 400 | |||
Gain/(Loss) on disposal of assets | $ 0 | $ 0 | 146 | $ 0 | |
Lease right-of-use-asset impairment | $ 7,500 | $ 7,500 |
Collaborative Arrangements an_3
Collaborative Arrangements and Revenue Recognition - Additional Information (Details) | 1 Months Ended | 3 Months Ended | 12 Months Ended | ||||||
Sep. 30, 2022 USD ($) shares | Aug. 31, 2021 USD ($) shares | Jun. 30, 2023 USD ($) performanceObligation | Jun. 30, 2022 USD ($) | Dec. 31, 2017 milestone | Apr. 30, 2023 shares | Dec. 31, 2022 USD ($) | Nov. 30, 2022 shares | Aug. 31, 2022 shares | |
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | |||||||||
Number of performance obligation for services necessary for regulatory approvals | performanceObligation | 1 | ||||||||
Minimum | |||||||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | |||||||||
Accounts receivable, payments due within period of invoicing | 30 days | ||||||||
Maximum | |||||||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | |||||||||
Accounts receivable, payments due within period of invoicing | 45 days | ||||||||
Healios Framework Agreement | |||||||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | |||||||||
Accounts receivable from Healios | $ 700,000 | $ 600,000 | |||||||
Potential revenue from milestones | $ 3,000,000 | ||||||||
Milestones obligated to pay | $ 1,100,000 | ||||||||
Received milestones payment | $ 1,900,000 | ||||||||
Warrants issued (in shares) | shares | 2 | ||||||||
Shares called by warrants (in shares) | shares | 2,000,000 | 400,000 | 3,685,000 | 9,109,090 | 1,920,000 | ||||
Revenue recognized | 0 | 2,300,000 | |||||||
Revenue recognized from performance obligations satisfied in previous periods | $ 0 | $ 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) - USD ($) $ in Thousands | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2023 | Jun. 30, 2022 | Jun. 30, 2023 | Jun. 30, 2022 | |
Disaggregation of Revenue [Line Items] | ||||
Total disaggregated revenues | $ 49 | $ 2,316 | $ 49 | $ 5,228 |
Healios | Point in Time | ||||
Disaggregation of Revenue [Line Items] | ||||
Total disaggregated revenues | 49 | 0 | 49 | 0 |
Healios | Point in Time | Product supply revenue | ||||
Disaggregation of Revenue [Line Items] | ||||
Total disaggregated revenues | 0 | 0 | ||
Healios | Point in Time | Service revenue | ||||
Disaggregation of Revenue [Line Items] | ||||
Total disaggregated revenues | 0 | 0 | 0 | 0 |
Healios | Over Time | ||||
Disaggregation of Revenue [Line Items] | ||||
Total disaggregated revenues | 0 | 2,316 | 0 | 5,228 |
Healios | Over Time | Product supply revenue | ||||
Disaggregation of Revenue [Line Items] | ||||
Total disaggregated revenues | 0 | 0 | 0 | 0 |
Healios | Over Time | Service revenue | ||||
Disaggregation of Revenue [Line Items] | ||||
Total disaggregated revenues | $ 0 | $ 2,316 | $ 0 | $ 5,228 |
Stock-Based Compensation (Detai
Stock-Based Compensation (Details) - USD ($) $ in Millions | 3 Months Ended | 6 Months Ended | |
Jun. 30, 2023 | Jun. 30, 2022 | Jun. 30, 2023 | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||
Stock-based compensation expense | $ 0.6 | $ 1.9 | |
Unrecognized compensation cost of unvested stock awards | $ 3.8 | $ 3.8 | |
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) | 1,700,000 | 1,700,000 | |
Common stock shares issued (in shares) | 961,333 | ||
Shares available for issuance (in shares) | 84,103 | 84,103 | |
Shares of common stock outstanding (in shares) | 1,228,345 | 1,228,345 | |
Expired Incentive Plan | |||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||
Common stock shares issued (in shares) | 11,289 | ||
Shares of common stock outstanding (in shares) | 21,092 | 21,092 | |
Inducement Awards Plan | |||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||
Shares of common stock outstanding (in shares) | 429,500 | 429,500 |
Stockholders_ Equity and Warr_2
Stockholders’ Equity and Warrants (Details) - USD ($) $ / shares in Units, $ in Thousands | 1 Months Ended | 3 Months Ended | 6 Months Ended | |||||||||||||||
Apr. 18, 2023 | Apr. 17, 2023 | Nov. 09, 2022 | Sep. 22, 2022 | Aug. 29, 2022 | Aug. 17, 2022 | Aug. 15, 2022 | May 12, 2022 | Aug. 31, 2021 | Jun. 30, 2021 | Jun. 30, 2023 | Sep. 30, 2022 | Jun. 30, 2022 | Jun. 30, 2023 | Jun. 30, 2022 | Mar. 31, 2023 | Dec. 31, 2022 | ||
Class of Stock [Line Items] | ||||||||||||||||||
Common stock, shares authorized (in shares) | 600,000,000 | 600,000,000 | 600,000,000 | 600,000,000 | 600,000,000 | |||||||||||||
Preferred stock, shares authorized (in shares) | 10,000,000 | 10,000,000 | 10,000,000 | 10,000,000 | 10,000,000 | |||||||||||||
Preferred stock, shares issued (in shares) | 0 | 0 | 0 | 0 | 0 | |||||||||||||
Gain on change in fair value of warrants | $ (1,522) | $ 0 | $ (2,151) | $ 0 | ||||||||||||||
Reclass of warrant liability to additional paid-in capital upon exercise | [1] | 2,685 | ||||||||||||||||
Fair value of warrant liabilities | 15,825 | 15,825 | $ 0 | |||||||||||||||
Healios | ||||||||||||||||||
Class of Stock [Line Items] | ||||||||||||||||||
Warrant, exercise cap triggering percentage | 19.90% | |||||||||||||||||
Warrants | ||||||||||||||||||
Class of Stock [Line Items] | ||||||||||||||||||
Fair value of warrant liabilities | 0 | 0 | $ 1,163 | $ 534 | ||||||||||||||
August 2022 Common Warrant | ||||||||||||||||||
Class of Stock [Line Items] | ||||||||||||||||||
Shares issued and sold (in shares) | 1,920,000 | |||||||||||||||||
August 2022 Warrant | ||||||||||||||||||
Class of Stock [Line Items] | ||||||||||||||||||
Exercise price of warrant (in dollars per share) | $ 0.96 | |||||||||||||||||
September Warrants | ||||||||||||||||||
Class of Stock [Line Items] | ||||||||||||||||||
Shares issued and sold (in shares) | 1,760,000 | |||||||||||||||||
Pre-Funded Warrants and Common Warrants | ||||||||||||||||||
Class of Stock [Line Items] | ||||||||||||||||||
Gain on change in fair value of warrants | (1,500) | |||||||||||||||||
Issuance costs allocated to warrant liabilities | $ 500 | |||||||||||||||||
Warrant issuance costs allocated to equity | 400 | |||||||||||||||||
Pre-Funded Warrants and Common Warrants | Warrants | ||||||||||||||||||
Class of Stock [Line Items] | ||||||||||||||||||
Fair value of warrant liabilities | $ (2,200) | $ (2,200) | ||||||||||||||||
April 2023 Pre-Funded Warrants | ||||||||||||||||||
Class of Stock [Line Items] | ||||||||||||||||||
Warrants outstanding (in shares) | 557,000 | 557,000 | ||||||||||||||||
Healios | 2021 Warrants | ||||||||||||||||||
Class of Stock [Line Items] | ||||||||||||||||||
Shares called by warrants (in shares) | 400,000 | |||||||||||||||||
Healios | 2021 Warrant, Type One | ||||||||||||||||||
Class of Stock [Line Items] | ||||||||||||||||||
Exercise price of warrant (in dollars per share) | $ 45 | |||||||||||||||||
Warrants, exercisable period | 60 days | |||||||||||||||||
Shares called by warrants (in shares) | 120,000 | |||||||||||||||||
Healios | 2021 Warrant, Type Two | ||||||||||||||||||
Class of Stock [Line Items] | ||||||||||||||||||
Exercise price of warrant (in dollars per share) | $ 60 | |||||||||||||||||
Warrants, exercisable period | 60 days | |||||||||||||||||
Shares called by warrants (in shares) | 280,000 | |||||||||||||||||
Aspire Capital | ||||||||||||||||||
Class of Stock [Line Items] | ||||||||||||||||||
Shares issued and sold (in shares) | 1,003,560 | |||||||||||||||||
Offering price (in dollars per share) | $ 9.67 | $ 9.67 | ||||||||||||||||
Placement Agency Agreement With Alliance Global Partners | Alliance Global Partners | ||||||||||||||||||
Class of Stock [Line Items] | ||||||||||||||||||
Placement fee | $ 200 | $ 400 | $ 800 | |||||||||||||||
Placement fee reimbursement | $ 100 | $ 100 | $ 100 | |||||||||||||||
August 2022 Purchase Agreement | ||||||||||||||||||
Class of Stock [Line Items] | ||||||||||||||||||
Shares issued and sold (in shares) | 1,200,000 | |||||||||||||||||
Proceeds from the issuance of common stock and warrants, net of issuance cost | $ 11,000 | |||||||||||||||||
Participation right percentage | 30% | |||||||||||||||||
August 2022 Purchase Agreement | August 2022 Pre-Funded Warrants | ||||||||||||||||||
Class of Stock [Line Items] | ||||||||||||||||||
Shares issued and sold (in shares) | 720,000 | |||||||||||||||||
Number of shares called by each warrant (in shares) | 1 | |||||||||||||||||
Exercise price of warrant (in dollars per share) | $ 0.0025 | |||||||||||||||||
Gain on change in fair value of warrants | $ 800 | |||||||||||||||||
Reclass of warrant liability to additional paid-in capital upon exercise | $ 3,800 | |||||||||||||||||
August 2022 Purchase Agreement | August 2022 Common Warrant | ||||||||||||||||||
Class of Stock [Line Items] | ||||||||||||||||||
Shares issued and sold (in shares) | 1,920,000 | |||||||||||||||||
Number of shares called by each warrant (in shares) | 1 | |||||||||||||||||
Exercise price of warrant (in dollars per share) | $ 6.385 | |||||||||||||||||
Warrants, exercisable period | 6 months | |||||||||||||||||
Warrants term | 5 years | |||||||||||||||||
August 2022 Purchase Agreement | August 2022 Warrant | ||||||||||||||||||
Class of Stock [Line Items] | ||||||||||||||||||
Exercise price of warrant (in dollars per share) | $ 6.25 | |||||||||||||||||
August 2022 Purchase Agreement | Common Stock | ||||||||||||||||||
Class of Stock [Line Items] | ||||||||||||||||||
Number of shares called by each warrant (in shares) | 1 | |||||||||||||||||
August 2022 Purchase Agreement | Common Stock | August 2022 Pre-Funded Warrants | ||||||||||||||||||
Class of Stock [Line Items] | ||||||||||||||||||
Number of shares called by each warrant (in shares) | 1 | |||||||||||||||||
August 2022 Purchase Agreement | Common Stock | August 2022 Common Warrant | ||||||||||||||||||
Class of Stock [Line Items] | ||||||||||||||||||
Number of shares called by each warrant (in shares) | 1 | |||||||||||||||||
August 2022 Purchase Agreement Amendment | August 2022 Common Warrant | ||||||||||||||||||
Class of Stock [Line Items] | ||||||||||||||||||
Warrants, exercisable period | 6 months | |||||||||||||||||
Warrants term | 7 years | |||||||||||||||||
August 2022 Purchase Agreement Amendment | September Warrants | ||||||||||||||||||
Class of Stock [Line Items] | ||||||||||||||||||
Exercise price of warrant (in dollars per share) | $ 6.385 | |||||||||||||||||
Warrants term | 7 years | |||||||||||||||||
Shares called by warrants (in shares) | 2,000,000 | |||||||||||||||||
November 2022 Purchase Agreement | ||||||||||||||||||
Class of Stock [Line Items] | ||||||||||||||||||
Shares issued and sold (in shares) | 3,927,275 | |||||||||||||||||
Proceeds from the issuance of common stock and warrants, net of issuance cost | $ 5,000 | |||||||||||||||||
November 2022 Purchase Agreement | November 2022 Pre-Funded Warrants | ||||||||||||||||||
Class of Stock [Line Items] | ||||||||||||||||||
Shares issued and sold (in shares) | 1,077,270 | |||||||||||||||||
Number of shares called by each warrant (in shares) | 1 | |||||||||||||||||
Exercise price of warrant, price difference (in dollars per share) | $ 0.0001 | |||||||||||||||||
November 2022 Purchase Agreement | November 2022 Common Warrants | ||||||||||||||||||
Class of Stock [Line Items] | ||||||||||||||||||
Shares issued and sold (in shares) | 10,009,090 | |||||||||||||||||
Number of shares called by each warrant (in shares) | 1 | |||||||||||||||||
Exercise price of warrant (in dollars per share) | $ 1.10 | |||||||||||||||||
Warrants term | 5 years | |||||||||||||||||
November 2022 Purchase Agreement | Common Stock | ||||||||||||||||||
Class of Stock [Line Items] | ||||||||||||||||||
Number of shares called by each warrant (in shares) | 1 | |||||||||||||||||
November 2022 Purchase Agreement | Common Stock | November 2022 Pre-Funded Warrants | ||||||||||||||||||
Class of Stock [Line Items] | ||||||||||||||||||
Number of shares called by each warrant (in shares) | 1 | |||||||||||||||||
November 2022 Purchase Agreement | Common Stock | November 2022 Common Warrants | ||||||||||||||||||
Class of Stock [Line Items] | ||||||||||||||||||
Number of shares called by each warrant (in shares) | 2 | |||||||||||||||||
April 2023 Purchase Agreement | ||||||||||||||||||
Class of Stock [Line Items] | ||||||||||||||||||
Shares issued and sold (in shares) | 2,315,000 | |||||||||||||||||
Exercise price of warrant (in dollars per share) | $ 1 | |||||||||||||||||
Proceeds from the issuance of common stock and warrants, net of issuance cost | $ 3,400 | |||||||||||||||||
April 2023 Purchase Agreement | April 2023 Pre-Funded Warrants | ||||||||||||||||||
Class of Stock [Line Items] | ||||||||||||||||||
Shares issued and sold (in shares) | 1,370,000 | |||||||||||||||||
Number of shares called by each warrant (in shares) | 1 | |||||||||||||||||
Exercise price of warrant (in dollars per share) | $ 0.0001 | |||||||||||||||||
April 2023 Purchase Agreement | April 2023 Common Warrants | ||||||||||||||||||
Class of Stock [Line Items] | ||||||||||||||||||
Shares issued and sold (in shares) | 3,685,000 | |||||||||||||||||
Number of shares called by each warrant (in shares) | 1 | |||||||||||||||||
Exercise price of warrant (in dollars per share) | $ 0.96 | |||||||||||||||||
Warrants, exercisable period | 6 months | |||||||||||||||||
Warrants term | 7 years | |||||||||||||||||
April 2023 Purchase Agreement | Common Stock | ||||||||||||||||||
Class of Stock [Line Items] | ||||||||||||||||||
Number of shares called by each warrant (in shares) | 1 | |||||||||||||||||
2022 Equity Facility | Aspire Capital | ||||||||||||||||||
Class of Stock [Line Items] | ||||||||||||||||||
Number of shares committed to be purchased (in shares) | $ 100,000 | |||||||||||||||||
2021 Equity Facility | Aspire Capital | ||||||||||||||||||
Class of Stock [Line Items] | ||||||||||||||||||
Number of shares committed to be purchased (in shares) | $ 100,000 | |||||||||||||||||
Common stock registered for resale (in shares) | 1,600,000 | |||||||||||||||||
[1]Warrant reclassification (Footnote 9 Fair Value Measurements) |
Fair Value Measurements - Recon
Fair Value Measurements - Reconciliation of Warrant Liabilities (Details) - USD ($) $ in Thousands | 3 Months Ended | |
Jun. 30, 2023 | Mar. 31, 2023 | |
Fair Value, Liabilities Measured on Recurring Basis, Unobservable Input Reconciliation, Calculation [Roll Forward] | ||
Beginning balance | $ 0 | |
Ending balance | (15,825) | $ 0 |
Warrants | ||
Fair Value, Liabilities Measured on Recurring Basis, Unobservable Input Reconciliation, Calculation [Roll Forward] | ||
Beginning balance | (1,163) | (534) |
Fair Value Adjustment | (1,522) | (629) |
Reclassification to Additional paid in capital | 2,685 | |
Ending balance | $ 0 | $ (1,163) |
Fair Value Measurements - Rec_2
Fair Value Measurements - Reconciliation of Notes Payable (Details) $ in Thousands | 3 Months Ended | |
Jun. 30, 2023 USD ($) | May 17, 2023 | |
Fair Value, Assets Measured on Recurring Basis, Unobservable Input Reconciliation [Line Items] | ||
Beginning period | $ 0 | |
Ending period | 15,825 | |
Notes Payable to Banks | ||
Fair Value, Assets Measured on Recurring Basis, Unobservable Input Reconciliation [Line Items] | ||
Beginning period | 0 | |
Initial Transaction Fair Value | 15,000 | |
Fair Value Adjustment | 640 | |
Ending period | $ 15,640 | |
Notes Payable to Banks | Measurement Input, Price Volatility | ||
Fair Value, Assets Measured on Recurring Basis, Unobservable Input Reconciliation [Line Items] | ||
Debt, measurement input | 0.506 | 0.495 |
Notes Payable to Banks | Measurement input, Bond Yield Rate | ||
Fair Value, Assets Measured on Recurring Basis, Unobservable Input Reconciliation [Line Items] | ||
Debt, measurement input | 0.196 | 0.189 |
Payment in Kind (PIK) Note | ||
Fair Value, Assets Measured on Recurring Basis, Unobservable Input Reconciliation [Line Items] | ||
Beginning period | $ 0 | |
Initial Transaction Fair Value | 185 | |
Ending period | $ 185 |
Other Income and Expenses (Deta
Other Income and Expenses (Details) - USD ($) $ in Thousands | 3 Months Ended | 6 Months Ended | |||
Jun. 30, 2023 | Jun. 30, 2022 | Jun. 30, 2023 | Jun. 30, 2022 | ||
Other Income and Expenses [Abstract] | |||||
Gain/(Loss) from extinguishment of debt | $ 2,612 | $ 0 | $ 2,612 | $ 0 | |
Change in fair value - note payable | (640) | 0 | (640) | 0 | |
Interest expense | (366) | (6) | (376) | (14) | |
Foreign exchange gain/(loss) | (80) | 117 | (178) | 284 | |
Fair value change - warrants | (1,522) | 0 | (2,151) | 0 | |
Gain/(Loss) on disposal of assets | 0 | 0 | 146 | 0 | |
Other | 60 | 499 | 174 | 502 | |
Other (expense) income, net | [1] | $ 64 | $ 610 | $ (413) | $ 772 |
[1]See Footnote 10 for components of other (expense) income, net |
Forbearance Agreement and Con_2
Forbearance Agreement and Convertible Note (Details) - USD ($) | 3 Months Ended | 6 Months Ended | |||
May 17, 2023 | Jun. 30, 2023 | Jun. 30, 2022 | Jun. 30, 2023 | Jun. 30, 2022 | |
Debt Instrument [Line Items] | |||||
Forbearance Agreement, deferred accounts payable | $ 11,800,000 | ||||
Forbearance Agreement, deferred accounts payable, monthly payments | 250,000 | ||||
Deferred accounts payable, fair value | $ 7,900,000 | ||||
Gain/(Loss) from extinguishment of debt | $ 2,612,000 | $ 0 | $ 2,612,000 | $ 0 | |
Fair value of the Notes | 15,800,000 | 15,800,000 | |||
Changes in fair value reported in earnings | 800,000 | ||||
Paid-in-Kind interest | 200,000 | ||||
Change in fair value of Note Payables | $ 640,000 | $ 0 | $ 640,000 | $ 0 | |
Forbearance Agreement, deferred accounts payable, payment term | 48 months | ||||
Forbearance Agreement, deferred accounts payable, cash payment not paid when due subject to interest rate | 10% | ||||
Forbearance Agreement, deferred accounts payable, cash payment due benchmark period | 60 days | ||||
Convertible Note | 10.0% Convertible Note Due May 17, 2026 | |||||
Debt Instrument [Line Items] | |||||
Debt, principal amount | $ 15,000,000 | ||||
Debt, interest rate | 10% | ||||
Debt, Event of Default, payment | $ 3,000,000 | ||||
Debt, Event of Default, interest rate | 14% | ||||
Convertible note, beneficial ownership limitation | 19.99% | ||||
Conversion price (in USD per share) | $ 1.30 | ||||
Convertible note, conversion period after date of issuance | 18 months | ||||
Debt issuance costs | $ 16,679 | ||||
Debt conversion, shares issued | 11,538,461 | ||||
Debt, Event of Default, percentage of principal for acceleration of maturity | 100% | ||||
Debt, Event of Default, percentage of principal automatically and immediately due | 100% | ||||
Debt, Event of Default, judgement payment rendered against the Company | $ 3,000,000 |
Restructuring Charges - Additio
Restructuring Charges - Additional Information (Details) | 1 Months Ended |
Jun. 30, 2022 | |
Restructuring and Related Activities [Abstract] | |
Percentage of reduction in workforce | 70% |
Restructuring Charges - Schedul
Restructuring Charges - Schedule of Restructuring Reserve (Details) $ in Thousands | 3 Months Ended |
Jun. 30, 2023 USD ($) | |
Restructuring Reserve [Roll Forward] | |
Beginning balance | $ 607 |
Charges | 16 |
Cash payments | (282) |
Ending balance | 341 |
Employee severance and benefits | |
Restructuring Reserve [Roll Forward] | |
Beginning balance | 565 |
Charges | 0 |
Cash payments | (251) |
Ending balance | 314 |
Legal and professional fees | |
Restructuring Reserve [Roll Forward] | |
Beginning balance | 27 |
Charges | 16 |
Cash payments | (16) |
Ending balance | 27 |
Other | |
Restructuring Reserve [Roll Forward] | |
Beginning balance | 15 |
Charges | 0 |
Cash payments | (15) |
Ending balance | $ 0 |
Subsequent Event (Details)
Subsequent Event (Details) - Subsequent Event $ in Thousands | Aug. 09, 2023 USD ($) | Aug. 07, 2023 patient |
Subsequent Event [Line Items] | ||
Number of patient in clinic trial | patient | 300 | |
Consulting services fees received | $ | $ 150 |