Document and Entity Information
Document and Entity Information - USD ($) | 12 Months Ended | ||
Dec. 31, 2022 | Mar. 29, 2023 | Jun. 30, 2022 | |
Cover [Abstract] | |||
Document Type | 10-K | ||
Amendment Flag | false | ||
Document Period End Date | Dec. 31, 2022 | ||
Document Fiscal Year Focus | 2022 | ||
Document Fiscal Period Focus | FY | ||
Trading Symbol | ELDN | ||
Entity Registrant Name | ELEDON PHARMACEUTICALS, INC. | ||
Entity Central Index Key | 0001404281 | ||
Current Fiscal Year End Date | --12-31 | ||
Entity Well-known Seasoned Issuer | No | ||
Entity Current Reporting Status | Yes | ||
Entity Interactive Data Current | Yes | ||
Entity Voluntary Filers | No | ||
Entity Filer Category | Non-accelerated Filer | ||
Entity Small Business | true | ||
Entity Shell Company | false | ||
Entity Emerging Growth Company | false | ||
Entity File Number | 001-36620 | ||
Entity Tax Identification Number | 20-1000967 | ||
Entity Address, Address Line One | 19900 MacArthur Boulevard | ||
Entity Address, Address Line Two | Suite 550 | ||
Entity Address, City or Town | Irvine | ||
Entity Address, State or Province | CA | ||
Entity Address, Postal Zip Code | 92612 | ||
City Area Code | (949) | ||
Local Phone Number | 238-8090 | ||
Entity Incorporation, State or Country Code | DE | ||
Document Annual Report | true | ||
Document Transition Report | false | ||
ICFR Auditor Attestation Flag | false | ||
Title of 12(b) Security | Common Stock, $0.001 par value | ||
Security Exchange Name | NASDAQ | ||
Entity Common Stock, Shares Outstanding | 13,776,788 | ||
Entity Public Float | $ 33,518,551 | ||
Auditor Firm ID | 170 | ||
Auditor Name | KMJ Corbin & Company LLP | ||
Auditor Location | Irvine, California | ||
Documents Incorporated by Reference | Portions of the registrant’s definitive proxy statement for its 2023 Annual Meeting of Stockholders, which the registrant intends to file pursuant to Regulation 14A with the Securities and Exchange Commission not later than 120 days after the registrant’s fiscal year end December 31, 2022 , are incorporated by reference into Items 10, 11, 12, 13 and 14 of Part III of this Annual Report on Form 10-K. |
Consolidated Balance Sheets
Consolidated Balance Sheets - USD ($) $ in Thousands | Dec. 31, 2022 | Dec. 31, 2021 |
Current assets: | ||
Cash and cash equivalents | $ 56,409 | $ 84,833 |
Prepaid expenses and other current assets | 3,109 | 3,513 |
Total current assets | 59,518 | 88,346 |
Operating lease asset, net | 739 | 768 |
Goodwill | 0 | 48,648 |
In-process research and development | 32,386 | 32,386 |
Other assets | 150 | 400 |
Total assets | 92,793 | 170,548 |
Current liabilities: | ||
Accounts payable | 2,200 | 1,813 |
Current operating lease liability | 363 | 369 |
Accrued expenses and other liabilities | 3,912 | 2,219 |
Total current liabilities | 6,475 | 4,401 |
Deferred tax liability | 1,752 | 1,752 |
Non-current operating lease liability | 383 | 400 |
Total liabilities | 8,610 | 6,553 |
Commitments and contingencies (Note 6) | ||
Stockholders’ equity: | ||
Common stock, $0.001 par value, 200,000,000 shares authorized at December 31, 2022 and 2021; 13,776,788 and 14,306,788 shares issued and outstanding at December 31, 2022 and 2021, respectively | 14 | 14 |
Additional paid-in capital | 287,034 | 278,880 |
Accumulated deficit | (202,865) | (114,899) |
Total stockholders’ equity | 84,183 | 163,995 |
Total liabilities and stockholders’ equity | 92,793 | 170,548 |
Series X1 Non-voting Convertible Preferred Stock [Member] | ||
Stockholders’ equity: | ||
Preferred stock, value | ||
Series X Non-voting Convertible Preferred Stock [Member] | ||
Stockholders’ equity: | ||
Preferred stock, value |
Consolidated Balance Sheets (Pa
Consolidated Balance Sheets (Parenthetical) - $ / shares | Dec. 31, 2022 | Dec. 31, 2021 |
Preferred stock, par value | $ 0.001 | $ 0.001 |
Preferred stock, shares authorized | 5,000,000 | 5,000,000 |
Common stock, par value | $ 0.001 | $ 0.001 |
Common stock, shares authorized | 200,000,000 | 200,000,000 |
Common stock, shares issued | 13,776,788 | 14,306,788 |
Common stock, shares outstanding | 13,776,788 | 14,306,788 |
Series X1 Non-voting Convertible Preferred Stock [Member] | ||
Preferred stock, par value | $ 0.001 | $ 0.001 |
Preferred stock, shares authorized | 515,000 | 515,000 |
Preferred stock, shares issued | 117,970 | 108,070 |
Preferred stock, shares outstanding | 117,970 | 108,070 |
Series X Non-voting Convertible Preferred Stock [Member] | ||
Preferred stock, par value | $ 0.001 | $ 0.001 |
Preferred stock, shares authorized | 10,000 | 10,000 |
Preferred stock, shares issued | 6,204 | 6,204 |
Preferred stock, shares outstanding | 6,204 | 6,204 |
Consolidated Statements of Oper
Consolidated Statements of Operations and Comprehensive Loss - USD ($) | 12 Months Ended | |
Dec. 31, 2022 | Dec. 31, 2021 | |
Operating expenses | ||
Research and development | $ 27,080,000 | $ 23,735,000 |
General and administrative | 12,700,000 | 13,132,000 |
Goodwill impairment | 48,648,000 | 0 |
Total operating expenses | 88,428,000 | 36,867,000 |
Loss from operations | (88,428,000) | (36,867,000) |
Other income, net | 462,000 | 7,000 |
Loss before income tax benefit | (87,966,000) | (36,860,000) |
Income tax benefit | 0 | 2,354,000 |
Net loss and comprehensive loss | $ (87,966,000) | $ (34,506,000) |
Net loss per share, basic | $ (6.16) | $ (2.33) |
Net loss per share, diluted | $ (6.16) | $ (2.33) |
Weighted-average common shares outstanding, basic | 14,285,254 | 14,819,582 |
Weighted-average common shares outstanding, diluted | 14,285,254 | 14,819,582 |
Consolidated Statements of Stoc
Consolidated Statements of Stockholders' Equity - USD ($) $ in Thousands | Total | Common Stock [Member] | Additional Paid-In Capital [Member] | Accumulated Deficit [Member] | Series X1 Non-voting Convertible Preferred Stock [Member] | Series X Non Voting Convertible Preferred Stock |
Beginning Balance, Shares at Dec. 31, 2020 | $ 190,596 | $ 15 | $ 270,974 | $ (80,393) | ||
Beginning Balance at Dec. 31, 2020 | 15,160,397 | 108,070 | ||||
Cancellation of common stock in connection with exchange for preferred stock, Shares | (344,666) | 6,204 | ||||
Cancellation of common stock in connection with exchange for warrants | $ (1) | 1 | ||||
Cancellation of common stock in connection with exchange for warrants, Shares | (509,117) | |||||
Stock-based compensation | 7,904 | 7,904 | ||||
Stock options exercised | 1 | 1 | ||||
Stock options exercised, Shares | 174 | |||||
Net loss and other comprehensive loss | (34,506) | (34,506) | ||||
Ending Balance at Dec. 31, 2021 | 163,995 | $ 14 | 278,880 | (114,899) | ||
Ending Balance, Shares at Dec. 31, 2021 | 14,306,788 | 108,070 | 6,204 | |||
Issuance of common stock in connection with vesting of restricted stock units | 20,000 | |||||
Cancellation of common stock in connection with exchange for preferred stock | 1 | 1 | ||||
Cancellation of common stock in connection with exchange for preferred stock, Shares | (550,000) | 9,900 | ||||
Stock-based compensation | 8,153 | 8,153 | ||||
Net loss and other comprehensive loss | (87,966) | (87,966) | ||||
Ending Balance at Dec. 31, 2022 | $ 84,183 | $ 14 | $ 287,034 | $ (202,865) | ||
Ending Balance, Shares at Dec. 31, 2022 | 13,776,788 | 117,970 | 6,204 |
Consolidated Statements of Cash
Consolidated Statements of Cash Flows - USD ($) | 12 Months Ended | |
Dec. 31, 2022 | Dec. 31, 2021 | |
Operating activities | ||
Net loss | $ (87,966,000) | $ (34,506,000) |
Adjustments to reconcile net loss to net cash used in operating activities: | ||
Amortization of operating lease asset | 373,000 | 195,000 |
Impairment charge | 48,648,000 | 0 |
Stock-based compensation | 8,153,000 | 7,904,000 |
Deferred income taxes | (2,354,000) | |
Changes in operating assets and liabilities: | ||
Prepaid expenses and other assets | 654,000 | (2,095,000) |
Accounts payable and accrued expenses | 2,081,000 | 2,143,000 |
Operating lease liability | (367,000) | (200,000) |
Net cash used in operating activities | (28,424,000) | (28,913,000) |
Financing activities | ||
Proceeds from exercise of stock options | 1,000 | |
Payment of offering costs in connection with PIPE transaction | (450,000) | |
Net cash used in financing activities | (449,000) | |
Net change in cash and cash equivalents | (28,424,000) | (29,362,000) |
Cash and cash equivalents at beginning of year | 84,833,000 | 114,195,000 |
Cash and cash equivalents at end of year | 56,409,000 | 84,833,000 |
Supplemental disclosure of non-cash investing and financing activities | ||
Increase in operating lease asset and liability due to new and modified operating leases | 344,000 | 825,000 |
Common stock exchange for warrants | $ 1,000 | |
Common stock exchanged for X1 non-voting convertible preferred stock | $ 1,000 |
Description of Business
Description of Business | 12 Months Ended |
Dec. 31, 2022 | |
Accounting Policies [Abstract] | |
Description of Business | Note 1. Description of Business Eledon Pharmaceuticals, Inc. (formerly Novus Therapeutics, Inc.) is a clinical stage biopharmaceutical company focused on developing life-changing, targeted medicines for persons living with an autoimmune disease, requiring an organ or cell-based transplant, or living with amyotrophic lateral sclerosis (“ALS”). Unless otherwise indicated, references to the terms “Eledon,” “our,” “us,” “we”, or the “Company” refer to Eledon Pharmaceuticals, Inc. and its wholly owned subsidiaries, on a consolidated basis. The Company’s lead compound in development is tegoprubart, an anti-CD40L antibody with high affinity for CD40 ligand, a well-validated biological target with broad therapeutic potential. On September 14, 2020 , Eledon acquired Anelixis Therapeutics, Inc. (“Anelixis”), a privately held clinical stage biotechnology company developing a next generation anti-CD40L antibody as a potential treatment for organ and cellular transplantation, autoimmune diseases, and neurodegenerative diseases. The Company maintains its corporate headquarters in Irvine, California and has research and development facilities in Burlington, Massachusetts. |
Going Concern and Management's
Going Concern and Management's Plans | 12 Months Ended |
Dec. 31, 2022 | |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | |
Going Concern and Management's Plans | Note 2. Going Concern and Management’s Plans The accompanying consolidated financial statements have been prepared under the assumption the Company will continue to operate as a going concern, which contemplates the realization of assets and the settlement of liabilities in the normal course of business. The consolidated financial statements do not include any adjustments to reflect the possible future effects on the recoverability and classification of assets or the amounts of liabilities that may result from uncertainty related to the Company’s ability to continue as a going concern. The Company had a net loss of $ 88.0 million and an accumulated deficit of $ 202.9 million as of December 31, 2022, as a result of incurring losses since our inception. Due to continuing research and development activities, the Company expects to continue to incur net losses into the foreseeable future. The Company has financed operations primarily by net proceeds from the sale of preferred and common stock and warrants. The Company’s ability to raise additional capital in the equity and debt markets is dependent on a number of factors, including, but not limited to, the market demand for the Company’s common stock, which itself is subject to a number of development and business risks and uncertainties, as well as the uncertainty that the Company would be able to raise such additional capital at a price or on terms that are favorable to the Company. If the Company issues equity or convertible debt securities to raise additional funding, its existing stockholders may experience dilution, it may incur significant financing costs, and the new equity or convertible debt securities may have rights, preferences and privileges senior to those of its existing stockholders. If the Company issues debt securities to raise additional funding, it would incur additional debt service obligations, it could become subject to additional restrictions limiting its ability to operate its business, and it may be required to further encumber its assets. As of December 31, 2022, the Company had cash and cash equivalents of approximately $ 56.4 million, consisting of readily available cash and cash equivalents in bank accounts. Management believes that the Company does not have sufficient capital resources to sustain operations through at least the next twelve months from the date of this filing. The Company plans to seek to address this condition by raising additional capital to finance its operations, although the availability of, and the Company’s access to such financing is not assured. Accordingly, management believes that there is substantial doubt regarding the Company’s ability to continue operating as a going concern through at least the next twelve months from the date of this filing. |
Summary of Significant Accounti
Summary of Significant Accounting Policies | 12 Months Ended |
Dec. 31, 2022 | |
Accounting Policies [Abstract] | |
Summary of Significant Accounting Policies | Note 3. Summary of Significant Accounting Policies Basis of Presentation and Principles of Consolidation The consolidated financial statements are prepared in accordance with accounting principles generally accepted in the United States (“GAAP”). Eledon, a Delaware corporation, owns 100 % of the issued and outstanding common stock or other ownership interest in Anelixis Therapeutics, LLC, a Delaware limited liability company, and Otic Pharma, Ltd., a private limited company organized under the laws of the State of Israel (“Otic”). Otic owns 100 % of the issued and outstanding common stock or other ownership interest in its U.S. subsidiary, Otic Pharma, Inc. The functional currency of the Company’s foreign subsidiary is the U.S. Dollar; however, certain expenses, assets and liabilities are transacted at the local currency. These transactions are translated from the local currency into U.S. Dollars at exchange rates during or at the end of the reporting period. The activities of the Company’s foreign subsidiary are not significant to the consolidated financial statements. All significant intercompany accounts and transactions among the entities have been eliminated in consolidation. Use of Estimates The preparation of the Company’s consolidated financial statements in conformity with GAAP requires management to make informed estimates and assumptions that affect the reported amounts of assets, liabilities and expenses and the disclosure of contingent assets and liabilities in the Company’s consolidated financial statements and accompanying notes. The most significant estimates in the Company’s consolidated financial statements relate to stock-based compensation, accruals for liabilities, impairment of long-lived assets, including goodwill, and other matters that affect the consolidated financial statements and related disclosures. Actual results could differ materially from those estimates under different assumptions or conditions and the differences may be material to the consolidated financial statements. Cash and Cash Equivalents Cash represents cash deposits held at financial institutions. The Company considers all liquid investments purchased with an original maturity of three months or less and that can be liquidated without prior notice or penalty to be cash equivalents. The carrying value of cash equivalents approximates their fair value due to the short-term maturities of these instruments. Cash equivalents are held for the purpose of meeting short-term liquidity requirements, rather than for investment purposes. The Company had $ 9.3 million in cash equivalents at December 31, 2022 and 2021 . Fair Value Measurements Financial assets and liabilities are recorded at fair value. The Company measures the fair value of certain of its financial instruments on a recurring basis. A fair value hierarchy is used to rank the quality and reliability of the information used to determine fair values. Financial assets and liabilities carried at fair value will be classified and disclosed in one of the following three categories: Level 1—Quoted prices (unadjusted) in active markets for identical assets and liabilities. Level 2—Inputs other than Level 1 that are observable, either directly or indirectly, such as unadjusted quoted prices for similar assets and liabilities, unadjusted quoted prices in the markets that are not active, or other inputs that are observable or can be corroborated by observable market data for substantially the full term of the assets or liabilities. Level 3—Unobservable inputs that are supported by little or no market activity and that are significant to the fair value of the assets or liabilities. There have been no transfers of assets for liabilities between these fair value measurement classifications during the periods presented. The Company had no financial instruments, assets or liabilities measured at fair value on a recurring basis as of December 31, 2022 and 2021 . Concentration of Credit Risk and Other Risks and Uncertainties As of December 31, 2022 and 2021, all of the Company’s long-lived assets were located in the United States. Financial instruments that are subject to concentration of credit risk consist primarily of cash equivalents. The Company’s policy is to invest cash in institutional money market funds to limit the amount of credit exposure. At times, the Company maintains cash equivalents in short‑term money market funds and it has not experienced any losses on its cash equivalents. The Company’s products will require approval from the U.S. Food and Drug Administration (“FDA”) and foreign regulatory agencies before commercial sales can commence. There can be no assurance that its products will receive any of these required approvals. The denial or delay of such approvals may impact the Company’s business in the future. In addition, after the approval by the FDA, there is still an ongoing risk of adverse events that did not appear during the product approval process. The Company is subject to risks common to companies in the pharmaceutical industry, including, but not limited to, new technological innovations, clinical development risk, establishment of appropriate commercial partnerships, protection of proprietary technology, compliance with government and environmental regulations, uncertainty of market acceptance of products, product liability, the volatility of its stock price and the need to obtain additional financing. Our facilities and equipment, including those of our suppliers and vendors, may be affected by natural or man-made disasters. Our administrative office is based in Irvine, California and we manage all our research and development activities through third parties that are located throughout the world. We have taken precautions to safeguard our facilities, equipment and systems, including insurance, health and safety protocols, and off-site storage of computer data. However, our facilities and systems, as well as those of our third-party suppliers and vendors, may be vulnerable to earthquakes, fire, storm, public health or similar emergencies, power loss, telecommunications failures, physical and software break-ins, software viruses and similar events which could cause substantial delays in our operations, damage or destroy our equipment or inventory, and cause us to incur additional expenses and delay research and development activities. In addition, the insurance coverage we maintain may not be adequate to cover our losses in any circumstance and may not continue to be available to use on acceptable terms, or at all. Reportable Segments Operating segments under GAAP are defined as components of an enterprise about which separate financial information is available that is evaluated regularly by the Chief Operating Decision Maker (“CODM”), or decision-making group, in deciding how to allocate resources and in assessing performance. The CODM is the Company’s Chief Executive Officer and the Company has determined that it operates in one business segment, which is the development of products for therapeutic medicines selectively targeting critical pathways associated with the underlying molecular pathogenesis for patients with severe inflammation and autoimmune diseases. Goodwill Goodwill represents the difference between the consideration transferred and the fair value of the net assets acquired under the acquisition method of accounting. Goodwill is not amortized but is evaluated for impairment as of December 31 of each year or if indicators of impairment exist that would, more likely than not, reduce the fair value from its carrying amount. The Company performs its goodwill impairment analysis at the reporting unit level, which aligns with the Company’s reporting structure and availability of discrete financial information. The Company performs its annual impairment analysis by either comparing the reporting unit’s estimated fair value to its carrying amount or doing a qualitative assessment of a reporting unit’s fair value from the last quantitative assessment to determine if there is potential impairment. The Company may do a qualitative assessment when the results of the previous quantitative test indicated the reporting unit’s estimated fair value was significantly in excess of the carrying value of its net assets and it does not believe there have been significant changes in the reporting unit’s operations that would significantly decrease its estimated fair value or significantly increase its net assets. If a quantitative assessment is performed, the evaluation includes management estimates of cash flow projections based on internal future projections and/or use of a market approach by looking at market values of comparable companies. Key assumptions for these projections include revenue growth, future gross and operating margin growth, and its weighted cost of capital and terminal growth rates. The revenue and margin growth is based on increased sales of new products as the Company maintains investments in research and development. Additional assumed value creators may include increased efficiencies from capital spending. The resulting cash flows are discounted using a weighted average cost of capital. Operating mechanisms and requirements to ensure that growth and efficiency assumptions will ultimately be realized are also considered in the evaluation, including timing and probability of regulatory approvals for Company products to be commercialized. The Company’s market capitalization is also considered as a part of its analysis. The Company’s annual evaluation for impairment of goodwill consists of one reporting unit. In accordance with the Company’s policy, the Company completed its annual evaluation for impairment as of December 31, 2022 using the quantitative assessment, utilizing the market approach and due to declining market conditions, determined that the fair value of the reporting unit was below its carrying value. As a result, the Company recognized $ 48.6 million of goodwill impairment, reducing the goodwill balance to zero. No impairment was recorded for the year ended December 31, 2021 . Long-Lived Assets Property and equipment are recorded at cost. Depreciation is computed using the straight-line method over the estimated useful lives of the respective assets. Additions, major renewals and improvements are capitalized and repair and maintenance costs are charged to expense as incurred. Leasehold improvements are amortized over the remaining life of the initial lease term or the estimated useful lives of the assets, whichever is shorter. The Company reviews property and equipment for impairment whenever events or changes in circumstances indicate that the carrying value of an asset may not be recoverable. An impairment loss would be recognized when estimated future undiscounted cash flows relating to the asset are less than its carrying amount. An impairment loss is measured as the amount by which the carrying amount of an asset exceeds its fair value. Significant management judgment is required in the forecast of future operating results that are used in the preparation of expected cash flows. No impairments of long-lived assets have been identified during the years presented. In-Process Research and Development The fair value of in-process research and development (“IPR&D”) acquired through a business combination is capitalized as an indefinite-lived intangible asset until the completion or abandonment of the related research and development activities. When the related research and development is completed, the asset will be assigned a useful life and amortized. The fair value of an IPR&D intangible asset is determined using the replacement cost method. This method involves arriving at an asset’s value by reference to the present-day cost, in an arms-length transaction, of replacing that asset with a similar asset in a similar condition. Research and Development Expenses Research and development expenses include personnel and facility-related expenses, outside contracted services including clinical trial costs, manufacturing and process development costs, research costs and other consulting services and non-cash stock-based compensation. Research and development costs are expensed as incurred. Amounts due under contracts with third parties may be either fixed fee or fee for service, and may include upfront payments, monthly payments and payments upon the completion of milestones or receipt of deliverables. Non-refundable advance payments under agreements are capitalized and expensed as the related goods are delivered or services are performed. The Company’s contracts with third parties to perform various clinical trial activities in the on-going development of potential products. The financial terms of these agreements are subject to negotiation, vary from contract to contract and may result in uneven payment flows to its vendors. Payments under the contracts depend on factors such as the achievement of certain events, successful enrollment of patients, and completion of portions of the clinical trial or similar conditions. The Company’s accrual for clinical trials is based on estimates of the services received and efforts expended pursuant to contracts with clinical trial centers and clinical research organizations. These contracts may be terminated by the Company upon written notice and the Company is generally only liable for actual effort expended by the organizations to the date of termination, although in certain instances the Company may be further responsible for termination fees and penalties. The Company estimates its research and development expenses and the related accrual as of each balance sheet date based on the facts and circumstances known to the Company at that time. There have been no material adjustments to the Company’s prior period accrued estimates for clinical trial activities through December 31, 2022 . Net Loss Per Share Basic net loss per common share is calculated by dividing the net loss attributable to common stockholders by the weighted-average number of common shares outstanding during the period, without consideration for potentially dilutive securities. Diluted net loss per share is computed by dividing the net loss attributable to common stockholders by the weighted-average number of common shares and potentially dilutive securities outstanding for the period determined using the treasury-stock and if-converted methods. For purposes of the diluted net loss per share calculation, preferred stock, and stock options and warrants are considered to be potentially dilutive securities and are excluded from the calculation of diluted net loss per share because their effect would be anti-dilutive. Therefore, basic and diluted net loss per share was the same for the periods presented due to the Company’s net loss position. Basic weighted average shares outstanding for the years ended December 31, 2022 and 2021 include 509,117 shares underlying warrants to purchase common shares. As the shares underlying these warrants can be issued for little consideration (an exercise price per share equal to $ 0.001 per share), these shares are deemed to be issued for purposes of basic earnings per share. Year Ended 2022 2021 (In thousands, except share and per share data) Net loss $ ( 87,966 ) $ ( 34,506 ) Net loss per share, basic and diluted $ ( 6.16 ) $ ( 2.33 ) Weighted-average number of common shares 14,285,254 14,819,582 The computation of diluted earnings per share excludes stock options, warrants, and restricted stock units that are anti-dilutive. For the year ended December 31, 2022 , common share equivalents of 8,139,155 shares were anti-dilutive. For the year ended December 31, 2021 , common share equivalents of 1,087,174 shares were anti-dilutive. Stock-Based Compensation The Company recognizes compensation expense for all stock-based awards based on the grant-date estimated fair value. The fair value of stock options is determined using the Black-Scholes option pricing model, using assumptions that are subjective and require significant judgment and estimation by management. The fair value of stock options is determined using the Black-Scholes option pricing model, using assumptions which are subjective and require significant judgment and estimation by management. The risk-free rate assumption was based on observed yields from governmental zero-coupon bonds with an equivalent term. The expected volatility assumption was based on historical volatilities of a group of comparable industry companies whose share prices are publicly available. The peer group was developed based on companies in the pharmaceutical industry. The expected term of stock options represents the weighted-average period that the stock options are expected to be outstanding. Because the Company does not have historical exercise behavior, the Company determined the expected life assumption using the simplified method for stock options granted to employees, which is an average of the options ordinary vesting period and the contractual term. For stock options granted to the Company’s board of directors (the “Board”), the Company determined the expected life assumption using the simplified method as the starting point with an average period of twelve ( 12 ) months added to take into account for the extended range of time of 12 to 18 months vested stock options granted to Board members may be exercised upon termination. The expected dividend assumption was based on the Company’s history and expectation of dividend payouts. The Company has not paid and does not expect to pay dividends at any time in the foreseeable future. The Company recognizes forfeitures on an actual basis and as such did not estimate forfeitures to calculate stock-based compensation. Restricted Stock Units (“RSU”) are measured and recognized based on the quoted market price of our common stock on the date of grant. In March 2020, the Board approved an increase of 28,816 shares issuable under the 2014 Stock Incentive Plan (the “2014 Plan”) and 7,204 shares issuable under the 2014 Employee Stock Purchase Plan (the “ESPP”). On December 18, 2020, the Company held the Special Meeting, whereby the Company’s stockholders approved the 2020 Long Term Incentive Plan (the “2020 Plan”). The aggregate number of shares of stock available for issuance under the 2020 Plan will initially be 4,860,000 shares of common stock, which represented approximately 15 % of the total issued and outstanding shares of the Company’s common stock as of the record date of the Special Meeting (calculated on an as-converted basis and without regard to the potential application of beneficial ownership conversion limitations on the preferred stock) and may be increased by the number of shares under the 2014 Plan that expire, terminate or are otherwise surrendered, cancelled, forfeited or repurchased by the Company. Based on projected utilization rates, the Board currently intends that the initial shares under the 2020 Plan will be sufficient to fund the Company’s equity compensation needs for approximately three years from the date of the Special Meeting. The 2014 Plan was closed to new grants following the approval of the 2020 Plan, and therefore, there were no shares reserved for issuance under the 2014 Plan as of December 31, 2022 . The number of shares reserved for issuance under the 2020 Plan and ESPP was 3,126,608 and 24,077 shares, respectively, as of December 31, 2022 . Income Taxes Significant judgment is required in determining the Company’s provision for income taxes, deferred tax assets and liabilities and the valuation allowance recorded against net deferred tax assets. We assess the likelihood that deferred tax assets will be recovered as deductions from future taxable income. The evaluation of the need for a valuation allowance is performed on a jurisdiction-by-jurisdiction basis and includes a review of all available positive and negative evidence. Factors reviewed include projections of pre-tax book income for the foreseeable future, determination of cumulative pre-tax book income after permanent differences, earnings history, and reliability of forecasting. We have provided a valuation allowance on our deferred tax assets as of December 31, 2022 and 2021 because we believe it is more likely than not that a majority of our deferred tax assets will not be realized as of this date. The Company evaluates the accounting for uncertainty in income tax recognized in its consolidated financial statements and determines whether it is more likely than not that a tax position will be sustained upon examination by the appropriate taxing authorities before any part of the benefit is recorded in its consolidated financial statements. For those tax positions where it is “not more likely than not” that a tax benefit will be sustained, no tax benefit is recognized. Where applicable, associated interest and penalties are also recorded. The Company has not accrued any liabilities for any such uncertain tax positions as of December 31, 2022 and 2021. The Company is subject to U.S. federal and state tax authority examinations for all the years since inception due to net operating loss and tax credit carryforwards. The net operating losses and tax credits are subject to adjustment until the statute closes on the year the attributes are ultimately utilized. The Company’s income tax returns are based on calculations and assumptions that are subject to examination by the Internal Revenue Service and other tax authorities. In addition, the calculation of the Company’s tax liabilities involves dealing with uncertainties in the application of complex tax regulations. The Company recognizes liabilities for uncertain tax positions based on a two-step process. The first step is to evaluate the tax position for recognition by determining if the weight of available evidence indicates that it is more likely than not that the position will be sustained on audit, including resolution of related appeals or processes, if any. The second step is to measure the tax benefit as the largest amount that is more than 50 % likely of being realized upon settlement. While the Company believes it has appropriate support for the positions taken on its tax returns, the Company regularly assesses the potential outcomes of examinations by tax authorities in determining the adequacy of its provision for income taxes. The Company continually assesses the likelihood and amount of potential revisions and adjusts the income tax provision, income taxes payable and deferred taxes in the period in which the facts that give rise to a revision become known. For additional information, see Note 7. Income Taxes. Recently Adopted Accounting Pronouncements No new accounting pronouncement issued or effective during the fiscal period had or is expected to have a material impact on the Company’s consolidated financial statements or disclosures. |
Prepaid Expenses Other Assets A
Prepaid Expenses Other Assets Accrued Expenses and Other Liabilities | 12 Months Ended |
Dec. 31, 2022 | |
Prepaid Expenses Other Assets Accrued Expenses And Other Liabilities [Abstract] | |
Prepaid Expenses, Other Assets, Accrued Expenses and Other Liabilities | Note 4. Prepaid Expenses, Other Assets, Accrued Expenses and Other Liabilities Prepaid expenses and other current assets consisted of the following as of December 31, 2022 and 2021 (in thousands): December 31, 2022 2021 Prepaid insurance $ 823 $ 1,344 Prepaid clinical 2,115 2,039 Prepaid other 143 96 Other current assets 28 34 Total prepaid expenses and other current assets $ 3,109 $ 3,513 Accrued expenses and other liabilities consisted of the following as of December 31, 2022 and 2021 (in thousands): December 31, 2022 2021 Accrued compensation and related expenses $ 1,909 $ 1,411 Accrued severance — 104 Accrued clinical 1,826 454 Accrued professional services 65 167 Accrued other 112 83 Total accrued expenses and other liabilities $ 3,912 $ 2,219 |
Goodwill
Goodwill | 12 Months Ended |
Dec. 31, 2022 | |
Goodwill and Intangible Assets Disclosure [Abstract] | |
Goodwill | Note 5. Goodwill In 2022, the Company determined that the sustained decrease in our market capitalization constituted an indicator of impairment and as a result, a quantitative goodwill impairment test, utilizing the market approach, determined that the fair value of the reporting unit was below its carrying value and the goodwill was fully impaired. The Company recorded an impairment of $ 48.6 million for the year ended December 31, 2022 for the full write-down of the goodwill recorded as part of the acquisition of Anelixis. Total Balance as of January 1, 2021 $ 48,648 Impairments — Balance as of December 31, 2021 $ 48,648 Impairments ( 48,648 ) Balance as of December 31, 2022 $ — |
Commitments and Contingencies
Commitments and Contingencies | 12 Months Ended |
Dec. 31, 2022 | |
Commitments and Contingencies Disclosure [Abstract] | |
Commitments and Contingencies | Note 6. Commitments and Contingencies Operating Leases The Company leases office space under various operating leases. Total rent expense for all operating leases in the consolidated statements of operations and comprehensive loss was approximately $ 0.3 million and $ 0.3 million for the years ended December 31, 2022 and 2021, respectively. The Company has an operating lease for 5,197 square feet of office space in Irvine, California, which was set to expire on December 31, 2022 . On August 12, 2022, the Company extended the term of the lease through December 31, 2024 , by amending the office lease effective January 1, 2023 . On November 4, 2021, the Company entered into an operating lease for 6,138 square feet of office space in Burlington, Massachusetts, that expires on November 20, 2024 . The Company determines if a contract contains a lease at inception. Our office leases have remaining term of approximately two years and do not include options to extend the leases for additional periods. Operating lease assets and liabilities are recognized at the lease commencement date. Operating lease liabilities represent the present value of lease payments not yet paid. Operating lease assets represent our right to use an underlying asset and are based upon the operating lease liabilities as adjusted for prepayments or accrued lease payments, initial direct costs, lease incentives, and impairment of operating lease assets. To determine the present value of lease payments not yet paid, we estimate incremental secured borrowing rates corresponding to the maturities of the leases. As we have no outstanding debt nor committed credit facilities, secured or otherwise, we estimate this rate based on prevailing financial market conditions, comparable company and credit analysis, and management’s judgment. Our leases contain rent escalations over the lease term. We recognize expense for these leases on a straight-line basis over the lease term. Additionally, tenant incentives used to fund leasehold improvements are recognized when earned and reduce our right-of-use asset related to the lease. These are amortized through the right-of-use asset as reductions of expense over the lease term. Our lease agreements do not contain any material residual value guarantees or material restrictive covenants. While we do not currently have any lease agreement with lease and non-lease components, we elected to account for lease and non-lease components as separate components. We have elected the short-term lease recognition exemption for all applicable classes of underlying assets. Short-term disclosures include only those leases with a term greater than one month and 12 months or less, and expense is recognized on a straight-line basis over the lease term. Leases with an initial term of 12 months or less, that do not include an option to purchase the underlying asset that we are reasonably certain to exercise, are not recorded on the consolidated balance sheet. The components of lease expense were as follows (in thousands): Year Ended 2022 2021 Operating lease cost (a) $ 403 $ 283 (a) Includes variable operating lease expenses, which are immaterial. Other information related to leases was as follows (in thousands, except lease term and discount rate): Year Ended 2022 2021 Supplemental Cash Flows Information Cash paid for amounts included in the measurement of lease liability: Operating cash flows from operating lease $ 387 $ 208 Operating lease asset obtained in exchange for lease liability: Operating lease $ 344 $ 825 Remaining lease term Operating lease 1.95 years 2.41 years Discount rate Operating lease 2.49 % 3.00 % Future payments under noncancelable operating leases having initial or remaining terms of one year or more are as follows for the succeeding fiscal year and thereafter (in thousands): Year Ended 2022 2023 378 2024 388 Total minimum lease payments 766 Less imputed interest ( 20 ) Present value of lease liabilities 746 Less current portion of operating lease liability ( 363 ) Non-current operating lease liability $ 383 Grants and Licenses ALS Therapy Development Foundation, Inc. License Agreement In May 2015, Anelixis executed a License Agreement (the “Agreement”), which is an exclusive patent rights agreement with ALS Therapy Development Foundation, Inc. (“ALS TDI”) for certain patents and “know-how” of ALS TDI. This agreement continues until the licensee terminates the agreement with ninety days written notice. The Agreement requires license fees payable to ALS TDI, subject to the achievement of certain milestones and other conditions. The first and second milestones of the Agreement are the dosing of the first subjects in a first toxicity study in non-human primates and the dosing of the first patient in a Phase I Clinical Trial, respectively. Both of these milestones were achieved as of December 31, 2018 and 2017. The fee due for the achievement of these milestones was $ 1.0 million each. During 2018 and 2017, Anelixis issued $ 1.0 million worth of its common stock in lieu of making a cash payment. There were no milestones achieved during 2022 and 2021. The Agreement was amended and restated in February 2020, and a first amendment to the restated license agreement was executed in September 2020. As amended in September 2020, the remaining milestone payments for a first licensed product total $ 6.0 million. In the event that the Company develops a second licensed product, the Company is obligated to pay up to $ 2.5 million in additional milestone payments. In addition to the milestone payments, the Company is required to pay ALS TDI an amended annual license maintenance fee of $ 0.1 million beginning on the earlier of January 1, 2022, the Company’s first sublicense, or change in control, as defined in the Agreement. The Company made the first $ 0.1 million annual license maintenance fee in 2022. Furthermore, the Company shall pay ALS TDI fees based on reaching certain levels of annual net sales of any product produced with the patent rights. A royalty in the low single digits will be due on aggregate net sales. Upon the first calendar year of reaching $ 500.0 million in aggregate net sales, the Company shall pay ALS TDI a one-time milestone payment of $ 15.0 million. Upon the first calendar year of reaching $ 1.0 billion in aggregate net sales, the Company is obligated to pay ALS TDI a one-time milestone payment of $ 30.0 million. Lonza Sales AG Inc. License Agreement In September 2018, Anelixis executed a License Agreement (the “Lonza Agreement”), which is a manufacturing know-how rights agreement with Lonza Sales AG Inc. (“Lonza”) for the use of certain processes and know-how related to the manufacture of tegoprubart. The Lonza Agreement continues until the later of the last Valid Claim (as defined therein) or ten years from the First Commercial Sale of tegoprubart, as defined and subject to the conditions therein. A royalty in the low single digits will be due on aggregate net sales of tegoprubart that is manufactured by Lonza or any other third-party or licensee. eGenesis, Inc. Collaboration Agreement In September 2022, and subsequently amended in January 2023, Eledon executed a collaborative research agreement with eGenesis, Inc. (the “eGenesis Agreement”), under which eGenesis will gain access to tegoprubart for eGenesis’ ongoing preclinical research and development xenotransplant studies of human-compatible organs and cells for the treatment of organ failure. eGenesis will pay Eledon for supplies of tegoprubart based on the number of study days per animal needed for the eGenesis preclinical xenotransplant studies. The eGenesis agreement continues until September 2025, unless terminated earlier by either party. Israeli Innovation Authority Grant From 2012 through 2015, the Company received grants in the amount of approximately $ 0.5 million from the Israeli Innovation Authority (previously the Office of Chief Scientist) of the Israeli Ministry of Economy and Industry designated for investments in research and development. The grants are linked to the U.S. dollar and bear annual interest of LIBOR. The grants are to be repaid as royalties from sales of the products developed by the Company from their investments in research and development. Because the Company has not yet earned revenues related to these investments and cannot estimate potential royalties, no liabilities related to these grants have been recorded as of each period presented. Repayment of the grant is contingent upon the successful completion of the Company’s research and development programs and generating sales. The Company has no obligation to repay these grants, if the research and development program fails, is unsuccessful or aborted or if no sales are generated. The Company had not yet generated sales as of December 31, 2022; therefore, no liability was recorded for the repayment in the accompanying consolidated financial statements. Legal Matters The Company and its subsidiaries are not a party to or the subject of any claim or lawsuit that individually or in the aggregate is anticipated to have a material adverse effect on the Company’s results of operations, financial condition or cash flows. Indemnifications In the normal course of business, the Company enters into contracts and agreements that contain a variety of representations and warranties and provide for general indemnification. The Company’s exposure under these agreements is unknown because it involves future claims that may be made against the Company but have not yet been made. To date, the Company has not paid any claims or been required to defend any action related to its indemnification obligations. However, the Company may record charges in the future because of these indemnification obligations. No amounts associated with such indemnifications have been recorded to date. Contingencies From time to time, the Company may have certain contingent liabilities that arise in the ordinary course of business activities. The Company accrues a liability for such matters when it is probable that future expenditures will be made and such expenditures can be reasonably estimated. There have been no contingent liabilities requiring accrual at December 31, 2022 and 2021 . |
Income Taxes
Income Taxes | 12 Months Ended |
Dec. 31, 2022 | |
Income Tax Disclosure [Abstract] | |
Income Taxes | Note 7. Income Taxes Loss before income taxes are as follows (in thousands): Year Ended 2022 2021 Losses before income taxes: U.S. $ ( 88,159 ) $ ( 37,055 ) Non-U.S. 193 195 Total $ ( 87,966 ) $ ( 36,860 ) The provision (benefit) for income taxes are as follows (in thousands): Year Ended 2022 2021 Current: Federal $ — $ — State — — Foreign — — — — Deferred: Federal — ( 2,746 ) State — 392 Foreign — — — ( 2,354 ) Provision (benefit) for income taxes $ — $ ( 2,354 ) The Company is subject to income taxes under U.S. tax laws. The Company is subject to an Israeli corporate tax rate of 23 % in 2020 and thereafter. The Company was subject to a blended U.S. tax rate (federal as well as state corporate tax) of 21 % in 2022 and 2021. Significant judgment is required in determining the Company’s provision for income taxes, deferred tax assets and liabilities and the valuation allowance recorded against net deferred tax assets. Deferred tax assets and liabilities are determined using the enacted tax rates in effect for the years in which those tax assets are expected to be realized. A valuation allowance is established when it is more likely than not the future realization of all or some of the deferred tax assets will not be achieved. The evaluation of the need for a valuation allowance is performed on a jurisdiction-by-jurisdiction basis, and includes a review of all available positive and negative evidence. Factors reviewed include projections of pre-tax book income for the foreseeable future, determination of cumulative pre-tax book income after permanent differences, earnings history, and reliability of forecasting. Based on its review, the Company concluded that it was more likely than not that they would not realize the benefit of a portion of its deferred tax assets in the future. This conclusion was based on historical and projected operating performance, as well as the Company’s expectation that its operations will not generate sufficient taxable income in future periods to realize the tax benefits associated with the deferred tax assets within the statutory carryover periods. Therefore, the Company has a valuation allowance on its deferred tax assets as of December 31, 2022. The Company will continue to assess the need for a valuation allowance on its deferred tax assets by evaluating both positive and negative evidence that may exist. Any adjustment to the net deferred tax asset valuation allowance would be recorded in the statement of operations for the period that the adjustment is determined to be required. A reconciliation of the U.S. federal statutory income tax rate to the Company’s effective income tax rate is as follows (in thousands): Year Ended 2022 2021 Statutory Federal income tax rate $ ( 18,473 ) $ ( 7,741 ) State income taxes, net of Federal tax benefits ( 2,678 ) ( 445 ) Tax credits ( 1,046 ) ( 651 ) Stock-based compensation 986 651 Permanent items 3 2 State rate differential 274 235 NOL true-up ( 337 ) ( 991 ) Other 114 146 Goodwill impairment 11,697 — Change in valuation allowance 9,460 6,440 Total provision (benefit) for income taxes $ — $ ( 2,354 ) Significant components of the Company’s deferred tax assets and liabilities as of December 31, 2022 and 2021 consisted of the following (in thousands): Year Ended 2022 2021 Net operating loss carryforwards $ 15,230 $ 12,531 Research and development tax credits 2,294 1,356 Accruals and reserves 452 296 Research expenditures 5,264 — Stock-based compensation 2,874 1,867 Depreciation and amortization 1,595 1,713 Lease liability 179 171 Total deferred tax assets 27,888 17,934 Right-of-use asset ( 178 ) ( 171 ) Acquired IPR&D ( 7,787 ) ( 7,192 ) Total deferred tax liabilities ( 7,965 ) ( 7,363 ) Less: valuation allowance ( 21,675 ) ( 12,323 ) Net deferred tax liabilities $ ( 1,752 ) $ ( 1,752 ) The following table reconciles the beginning and ending amounts of unrecognized tax benefits for the years presented (in thousands): Year Ended 2022 2021 Gross unrecognized tax benefits at the beginning of the year $ 1,469 $ 764 Additions from tax positions taken in the current year 914 712 Additions from tax positions taken in prior years 281 — Reductions from tax positions taken in prior years — ( 7 ) Gross unrecognized tax benefits at the end of the year $ 2,664 $ 1,469 The deferred income tax assets have been offset by a valuation allowance, as realization is dependent on future earnings, if any, the timing and amount of which are uncertain. The net valuation allowance increased by $ 9.4 million from December 31, 2021 to December 31, 2022. The net valuation allowance increased by $ 6.4 million from December 31, 2020 to December 31, 2021. The Company’s accounting for deferred taxes involves the evaluation of a number of factors concerning the realizability of its net deferred tax assets. The Company primarily considered such factors as its history of operating losses, the nature of the Company’s deferred tax assets, and the timing, likelihood, and amount, if any, of future taxable income during the periods in which those temporary differences and carryforwards become deductible. At present, the Company does not believe that it is more likely than not that the deferred tax assets will be realized; accordingly, a valuation allowance has been established. As of December 31, 2022 and 2021 , the Company had federal net operating loss carryforwards of approximately $ 56.8 million and $ 46.9 million, respectively, available to reduce future taxable income. As of December 31, 2022 and 2021 , the Company also has state net operating loss carryforwards of $ 25.0 million and $ 15.0 million, respectively. Both the federal and state net operating loss carryforwards incurred before 2018 begin expiring in 2035 , if not utilized. The federal net operating losses incurred since 2018 of $ 56.0 million do not expire. The state net operating losses begin to expire in 2035 . As of December 31, 2022 and 2021 , the Company had Israeli net operating losses of $ 7.9 , which carryforward indefinitely. As of December 31, 2022 and 2021 , the Company had federal research and development tax credit carryforwards of approximately $ 2.4 million and $ 1.9 million, respectively. If not utilized, the carryforwards will begin expiring in 2036 . As of December 31, 2022 and 2021 , the Company has state research and development credit carryforwards or approximately $ 1.2 million and $ 1.1 million, respectively, which will begin expiring in 2030 if not utilized . Pursuant to Internal Revenue Code (“IRC) Sections 382 and 383, annual use of the Company’s net operating loss and research and development credit carryforwards may be limited in the event a cumulative change in ownership of more than 50 % occurs within a three-year period. The Company has not completed an IRC Section 382/383 analysis regarding the limitation of net operating loss and research and development credit carryforwards. Due to the existence of the valuation allowance, future changes in the Company’s unrecognized tax benefits will not impact the Company’s effective tax rate. The Company’s ability to use its remaining net operating loss and tax credit carryforwards may be further limited if the Company experiences a Section 382 ownership change in connection with future changes in our stock ownership. In the United States, the Company files income tax returns in the U.S. Federal jurisdiction, California and Massachusetts. The Company’s tax years for 2018 and forward are subject to examination by the Federal and California tax authorities due to the carryforward of unutilized net operating losses and research and development credits. The Company’s policy is to recognize interest expense and penalties related to income tax matters as a component of income tax expense. There was no accrued interest and penalties associated with uncertain tax positions as of December 31, 2022 and 2021 . The Company has no t recorded any interest or penalties in 2022 or 2021. |
Stockholders' Equity
Stockholders' Equity | 12 Months Ended |
Dec. 31, 2022 | |
Equity [Abstract] | |
Stockholders' Equity | Note 8. Stockholders’ Equity December 2020 Exchange Agreements On December 31, 2020, the Company entered into an exchange agreement (the “Series X Exchange Agreement”) with Biotechnology Value Fund, L.P., Biotechnology Value Fund II, L.P., Biotechnology Value Trading Fund OS, L.P. , MSI BVF SPV, L.L.C. (collectively, the “BVF Exchanging Stockholders”) and Cormorant Global Healthcare Master Fund, LP (together with the BVF Exchanging Stockholders, the “Series X Exchanging Stockholders”), pursuant to which the Series X Exchanging Stockholders exchanged (the “Series X Exchange”) 344,666 shares of the Company’s common stock for 6,203.98 shares of Series X Convertible Preferred Stock. In addition, on December 31, 2020 the Company entered into an exchange agreement (the “Warrant Exchange Agreement,” and together with the Series X Exchange Agreement, the “Exchange Agreements”) with the BVF Exchanging Stockholders, pursuant to which the BVF Exchanging Stockholders exchanged (the “Warrant Exchange,” and together with the Series X Exchange, “the Exchanges”) 509,117 shares of the Common Stock for one or more pre-funded warrants to purchase an aggregate of 509,117 shares of the Common Stock at a nominal exercise price (the “Warrants”). The Company recorded the shares of Series X Preferred Stock and Warrants issuable as preferred stock and warrant subscriptions at December 31, 2020, since the physical settlement of the Exchanges was made on January 5, 2021, whereby the transfer agent recorded the exchange of common stock for the issuance of preferred stock and warrants. September 2021 Warrant Exchange Agreement On September 21, 2021, the Company issued warrants exercisable for 298,692 shares of common stock in exchange for warrants exercisable for 5,376.456 shares of Series X 1 Preferred Stock previously issued as part of the Anelixis merger. These Series X 1 Preferred Stock warrants were replaced by Eledon for the outstanding warrants issued by Anelixis that were not settled upon completion of the merger. January 2022 Exchange Agreement On January 11, 2022, the Company entered into an exchange agreement (the “Series X 1 Exchange Agreement”) with Biotechnology Value Fund, L.P., Biotechnology Value Fund II, L.P., Biotechnology Value Trading Fund OS, L.P., MSI BVF SPV, L.L.C. (collectively, the “BVF Exchanging Stockholders”), pursuant to which the Series X 1 Exchanging Stockholders exchanged (the “Series X 1 Exchange”) 550,000 shares of the Company’s common stock for 9,899.99 shares of Series X 1 Non-Voting Convertible Preferred Stock. Common Stock Warrants As of December 31, 2022 , 1,145,631 warrants were exercisable into common stock (after rounding for fractional shares and subject to beneficial ownership conversion blockers). The shares of common stock underlying the registered direct and private placement warrants are registered for offer and sale under the Securities Act of 1933, as amended (the “Securities Act”), pursuant to the Company’s effective registration statements on Forms S-1. The following table shows the warrants to purchase common stock activity: Rollforward of Warrant Activity Registered direct warrants, placement agent Private placement warrants Private placement warrants, placement agent Warrants exchanged for common stock Warrants exchanged for Series X 1 preferred stock Total Balance as of December 31, 2021 9,581 319,064 9,177 509,117 298,692 1,145,631 Issued — — — — — — Exercised — — — — — — Cancelled/Expired — — — — — — Balance as of December 31, 2022 9,581 319,064 9,177 509,117 298,692 1,145,631 Series X 1 Preferred Stock Warrants As of December 31, 2022 , 50,207.419 warrants were exercisable into Series X 1 Preferred Stock which are convertible into 2,789,301 shares of common stock (after rounding for fractional shares and subject to beneficial ownership conversion blockers). The following table shows the warrants to purchase Series X 1 Convertible Preferred Stock activity: Rollforward of Warrant Activity Warrants assumed and Total Balance as of December 31, 2021 50,207.419 50,207.419 Assumed and replaced — — Exercised — — Cancelled/Expired — — Balance as of December 31, 2022 50,207.419 50,207.419 2021 Equity Distribution Agreement On March 31, 2021, the Company filed a registration statement on Form S-3 containing a prospectus and prospectus supplement (the "Prospectus") under which the Company may offer and sell up to $ 75 million in shares of its common stock, from time to time, pursuant to an open market sale agreement with Jeffries LLC and by any method deemed to be an “at the market offering” as defined in Rule 415(a)(4) promulgated under the Securities Act of 1933 (the “ATM Program”). Pursuant to the “baby shelf rules” promulgated by the SEC, if the Company’s public float is less than $ 75.0 million as of specified measurement periods, the number of shares of common stock that may be offered and sold by the Company under a Form S-3 registration statement, including pursuant to the ATM Program, in any twelve-month period is limited to an aggregate amount that does not exceed one-third of the Company’s public float. As of December 31, 2022 , due to the SEC’s “baby shelf rules,” the Company was permitted to sell up to $ 10.5 million of shares of common stock pursuant to the ATM Program. The Company will remain subject to the “baby shelf rules” under the Form S-3 registration statement until such time as its public float exceeds $ 75.0 million. During the years ended December 31, 2022 and 2021 , no shares were sold under the Prospectus. |
Stock-Based Compensation
Stock-Based Compensation | 12 Months Ended |
Dec. 31, 2022 | |
Share-Based Payment Arrangement [Abstract] | |
Stock-Based Compensation | Note 9. Stock-Based Compensation Stock Option Plans The Company has three stock compensation plans, the 2020 Stock Incentive Plan (the “2020 Plan”), the 2014 Stock Incentive Plan (the “2014 Plan”) and the 2007 Stock Incentive Plan (the “2007 Plan”). The 2020 Plan permits the Company to make grants of incentive stock options, non-statutory stock options, restricted stock, restricted stock units, stock appreciation rights and other stock-based awards to the Company’s employees, officers, directors, consultants and advisors; however, incentive stock options may only be granted to the Company’s employees. The number of shares initially reserved for issuance under the 2020 Plan was 4,860,000 shares of common stock and may be increased by the number of shares under the 2014 Plan that expire, terminate or are otherwise surrendered, cancelled, forfeited or repurchased by the Company. Options remain outstanding under the 2007, 2014 and the 2020 Plan. As of December 31, 2022 , there were 1,151 and 72,519 options outstanding under the 2007 Plan and 2014 Plan, respectively. Options granted under the 2007, 2014 and 2020 Plans generally expire ten years from the date of grant. The Company intends for the 2020 Plan to be its primary stock compensation plan in the future. As of December 31, 2022 , there were 1,733,392 options outstanding and 3,126,608 shares available to issue under the 2020 Plan. The 2014 Plan was closed to new grants following the approval of the 2020 Plan, and therefore, there were no shares reserved for issuance under the 2007 and 2014 Plan as of December 31, 2022. The following table summarizes all option activity under the 2007 Plan, 2014 Plan, 2020 Plan and inducement grants: Shares Weighted Weighted Aggregate (In years) Outstanding as of January 1, 2021 3,621,479 $ 10.63 8.9 $ — Granted 702,836 10.69 — — Options Assumed ( 174 ) 4.73 — — Forfeited / Canceled ( 110,164 ) 19.50 — — Outstanding as of December 31, 2021 4,213,977 $ 10.33 8.4 $ — Granted 1,267,700 3.81 — — Forfeited / Canceled ( 263,644 ) 12.12 — — Outstanding as of December 31, 2022 5,218,033 $ 8.69 8.1 $ — Options vested and expected to vest as of 5,218,033 $ 8.69 8.1 $ — Options exercisable as of December 31, 2022 3,076,338 $ 8.72 7.0 $ — As of December 31, 2022 , the range of exercise prices was between $ 2.45 and $ 2,147 for options outstanding. Intrinsic value is calculated as the difference between the exercise price of the underlying options and the fair value of the common stock for the options that had exercise prices that were lower than the fair value per share of the common stock on the date of exercise. There was no aggregate intrinsic value of options exercised during the year ended December 31, 2022. The following table presents the assumptions used in the Black-Scholes option pricing model to determine the fair value of stock options granted in the periods presented, as follows: Year Ended 2022 2021 Expected stock price volatility 81 % - 84 % 105 % - 110 % Risk-free interest rate 1.8 % - 4.2 % 1 % Expected life of option (in years) 6.25 - 6.50 6.25 - 6.75 Estimated dividend yield 0 % 0 % Restricted Stock Units The following table shows the RSU activity, as follows: Shares Weighted Aggregate Outstanding as of January 1, 2021 — $ — $ — Granted 20,000 5.07 — RSUs Vested — — — Forfeited / Canceled — — — Outstanding as of December 31, 2021 20,000 $ 5.07 $ — Granted 15,000 2.47 — RSUs Vested ( 20,000 ) 5.07 — Forfeited / Canceled — — — Outstanding as of December 31, 2022 15,000 $ 2.47 $ — RSUs vested and expected to vest as of 15,000 $ 2.47 $ — RSUs exercisable as of December 31, 2022 — $ — $ — Stock-based Compensation Expense Total compensation expense related to all of the Company’s stock-based awards for the years ended December 31, 2022 and 2021 was comprised of the following (in thousands): Year Ended 2022 2021 Stock-based compensation classified as: Research and development expense $ 3,230 $ 3,166 General and administrative expense 4,923 4,738 Total stock-based compensation expense $ 8,153 $ 7,904 As of December 31, 2022 , total unrecognized stock-based compensation expense related to non-vested equity awards was $ 10.5 million, which is expected to be recognized over an estimated weighted-average period of 2.5 years. |
Subsequent Events
Subsequent Events | 12 Months Ended |
Dec. 31, 2022 | |
Subsequent Events [Abstract] | |
Subsequent Events | Note 10. Subsequent Events The Company has evaluated events subsequent to December 31, 2022 through the filing date of this Annual Report on Form 10-K. Any material subsequent events that occurred during this time have been properly recognized or disclosed in the consolidated financial statements and accompanying notes. |
Summary of Significant Accoun_2
Summary of Significant Accounting Policies (Policies) | 12 Months Ended |
Dec. 31, 2022 | |
Accounting Policies [Abstract] | |
Basis of Presentation and Principles of Consolidation | Basis of Presentation and Principles of Consolidation The consolidated financial statements are prepared in accordance with accounting principles generally accepted in the United States (“GAAP”). Eledon, a Delaware corporation, owns 100 % of the issued and outstanding common stock or other ownership interest in Anelixis Therapeutics, LLC, a Delaware limited liability company, and Otic Pharma, Ltd., a private limited company organized under the laws of the State of Israel (“Otic”). Otic owns 100 % of the issued and outstanding common stock or other ownership interest in its U.S. subsidiary, Otic Pharma, Inc. The functional currency of the Company’s foreign subsidiary is the U.S. Dollar; however, certain expenses, assets and liabilities are transacted at the local currency. These transactions are translated from the local currency into U.S. Dollars at exchange rates during or at the end of the reporting period. The activities of the Company’s foreign subsidiary are not significant to the consolidated financial statements. All significant intercompany accounts and transactions among the entities have been eliminated in consolidation. |
Use of Estimates | Use of Estimates The preparation of the Company’s consolidated financial statements in conformity with GAAP requires management to make informed estimates and assumptions that affect the reported amounts of assets, liabilities and expenses and the disclosure of contingent assets and liabilities in the Company’s consolidated financial statements and accompanying notes. The most significant estimates in the Company’s consolidated financial statements relate to stock-based compensation, accruals for liabilities, impairment of long-lived assets, including goodwill, and other matters that affect the consolidated financial statements and related disclosures. Actual results could differ materially from those estimates under different assumptions or conditions and the differences may be material to the consolidated financial statements. |
Cash and Cash Equivalents | Cash and Cash Equivalents Cash represents cash deposits held at financial institutions. The Company considers all liquid investments purchased with an original maturity of three months or less and that can be liquidated without prior notice or penalty to be cash equivalents. The carrying value of cash equivalents approximates their fair value due to the short-term maturities of these instruments. Cash equivalents are held for the purpose of meeting short-term liquidity requirements, rather than for investment purposes. The Company had $ 9.3 million in cash equivalents at December 31, 2022 and 2021 . |
Fair Value Measurements | Fair Value Measurements Financial assets and liabilities are recorded at fair value. The Company measures the fair value of certain of its financial instruments on a recurring basis. A fair value hierarchy is used to rank the quality and reliability of the information used to determine fair values. Financial assets and liabilities carried at fair value will be classified and disclosed in one of the following three categories: Level 1—Quoted prices (unadjusted) in active markets for identical assets and liabilities. Level 2—Inputs other than Level 1 that are observable, either directly or indirectly, such as unadjusted quoted prices for similar assets and liabilities, unadjusted quoted prices in the markets that are not active, or other inputs that are observable or can be corroborated by observable market data for substantially the full term of the assets or liabilities. Level 3—Unobservable inputs that are supported by little or no market activity and that are significant to the fair value of the assets or liabilities. There have been no transfers of assets for liabilities between these fair value measurement classifications during the periods presented. The Company had no financial instruments, assets or liabilities measured at fair value on a recurring basis as of December 31, 2022 and 2021 . |
Concentration of Credit Risk and Other Risks and Uncertainties | Concentration of Credit Risk and Other Risks and Uncertainties As of December 31, 2022 and 2021, all of the Company’s long-lived assets were located in the United States. Financial instruments that are subject to concentration of credit risk consist primarily of cash equivalents. The Company’s policy is to invest cash in institutional money market funds to limit the amount of credit exposure. At times, the Company maintains cash equivalents in short‑term money market funds and it has not experienced any losses on its cash equivalents. The Company’s products will require approval from the U.S. Food and Drug Administration (“FDA”) and foreign regulatory agencies before commercial sales can commence. There can be no assurance that its products will receive any of these required approvals. The denial or delay of such approvals may impact the Company’s business in the future. In addition, after the approval by the FDA, there is still an ongoing risk of adverse events that did not appear during the product approval process. The Company is subject to risks common to companies in the pharmaceutical industry, including, but not limited to, new technological innovations, clinical development risk, establishment of appropriate commercial partnerships, protection of proprietary technology, compliance with government and environmental regulations, uncertainty of market acceptance of products, product liability, the volatility of its stock price and the need to obtain additional financing. Our facilities and equipment, including those of our suppliers and vendors, may be affected by natural or man-made disasters. Our administrative office is based in Irvine, California and we manage all our research and development activities through third parties that are located throughout the world. We have taken precautions to safeguard our facilities, equipment and systems, including insurance, health and safety protocols, and off-site storage of computer data. However, our facilities and systems, as well as those of our third-party suppliers and vendors, may be vulnerable to earthquakes, fire, storm, public health or similar emergencies, power loss, telecommunications failures, physical and software break-ins, software viruses and similar events which could cause substantial delays in our operations, damage or destroy our equipment or inventory, and cause us to incur additional expenses and delay research and development activities. In addition, the insurance coverage we maintain may not be adequate to cover our losses in any circumstance and may not continue to be available to use on acceptable terms, or at all. |
Reportable Segments | Reportable Segments Operating segments under GAAP are defined as components of an enterprise about which separate financial information is available that is evaluated regularly by the Chief Operating Decision Maker (“CODM”), or decision-making group, in deciding how to allocate resources and in assessing performance. The CODM is the Company’s Chief Executive Officer and the Company has determined that it operates in one business segment, which is the development of products for therapeutic medicines selectively targeting critical pathways associated with the underlying molecular pathogenesis for patients with severe inflammation and autoimmune diseases. |
Goodwill | Goodwill Goodwill represents the difference between the consideration transferred and the fair value of the net assets acquired under the acquisition method of accounting. Goodwill is not amortized but is evaluated for impairment as of December 31 of each year or if indicators of impairment exist that would, more likely than not, reduce the fair value from its carrying amount. The Company performs its goodwill impairment analysis at the reporting unit level, which aligns with the Company’s reporting structure and availability of discrete financial information. The Company performs its annual impairment analysis by either comparing the reporting unit’s estimated fair value to its carrying amount or doing a qualitative assessment of a reporting unit’s fair value from the last quantitative assessment to determine if there is potential impairment. The Company may do a qualitative assessment when the results of the previous quantitative test indicated the reporting unit’s estimated fair value was significantly in excess of the carrying value of its net assets and it does not believe there have been significant changes in the reporting unit’s operations that would significantly decrease its estimated fair value or significantly increase its net assets. If a quantitative assessment is performed, the evaluation includes management estimates of cash flow projections based on internal future projections and/or use of a market approach by looking at market values of comparable companies. Key assumptions for these projections include revenue growth, future gross and operating margin growth, and its weighted cost of capital and terminal growth rates. The revenue and margin growth is based on increased sales of new products as the Company maintains investments in research and development. Additional assumed value creators may include increased efficiencies from capital spending. The resulting cash flows are discounted using a weighted average cost of capital. Operating mechanisms and requirements to ensure that growth and efficiency assumptions will ultimately be realized are also considered in the evaluation, including timing and probability of regulatory approvals for Company products to be commercialized. The Company’s market capitalization is also considered as a part of its analysis. The Company’s annual evaluation for impairment of goodwill consists of one reporting unit. In accordance with the Company’s policy, the Company completed its annual evaluation for impairment as of December 31, 2022 using the quantitative assessment, utilizing the market approach and due to declining market conditions, determined that the fair value of the reporting unit was below its carrying value. As a result, the Company recognized $ 48.6 million of goodwill impairment, reducing the goodwill balance to zero. No impairment was recorded for the year ended December 31, 2021 . |
Long-Lived Assets | Long-Lived Assets Property and equipment are recorded at cost. Depreciation is computed using the straight-line method over the estimated useful lives of the respective assets. Additions, major renewals and improvements are capitalized and repair and maintenance costs are charged to expense as incurred. Leasehold improvements are amortized over the remaining life of the initial lease term or the estimated useful lives of the assets, whichever is shorter. The Company reviews property and equipment for impairment whenever events or changes in circumstances indicate that the carrying value of an asset may not be recoverable. An impairment loss would be recognized when estimated future undiscounted cash flows relating to the asset are less than its carrying amount. An impairment loss is measured as the amount by which the carrying amount of an asset exceeds its fair value. Significant management judgment is required in the forecast of future operating results that are used in the preparation of expected cash flows. No impairments of long-lived assets have been identified during the years presented. |
In-Process Research and Development | In-Process Research and Development The fair value of in-process research and development (“IPR&D”) acquired through a business combination is capitalized as an indefinite-lived intangible asset until the completion or abandonment of the related research and development activities. When the related research and development is completed, the asset will be assigned a useful life and amortized. The fair value of an IPR&D intangible asset is determined using the replacement cost method. This method involves arriving at an asset’s value by reference to the present-day cost, in an arms-length transaction, of replacing that asset with a similar asset in a similar condition. |
Research and Development Expenses | Research and Development Expenses Research and development expenses include personnel and facility-related expenses, outside contracted services including clinical trial costs, manufacturing and process development costs, research costs and other consulting services and non-cash stock-based compensation. Research and development costs are expensed as incurred. Amounts due under contracts with third parties may be either fixed fee or fee for service, and may include upfront payments, monthly payments and payments upon the completion of milestones or receipt of deliverables. Non-refundable advance payments under agreements are capitalized and expensed as the related goods are delivered or services are performed. The Company’s contracts with third parties to perform various clinical trial activities in the on-going development of potential products. The financial terms of these agreements are subject to negotiation, vary from contract to contract and may result in uneven payment flows to its vendors. Payments under the contracts depend on factors such as the achievement of certain events, successful enrollment of patients, and completion of portions of the clinical trial or similar conditions. The Company’s accrual for clinical trials is based on estimates of the services received and efforts expended pursuant to contracts with clinical trial centers and clinical research organizations. These contracts may be terminated by the Company upon written notice and the Company is generally only liable for actual effort expended by the organizations to the date of termination, although in certain instances the Company may be further responsible for termination fees and penalties. The Company estimates its research and development expenses and the related accrual as of each balance sheet date based on the facts and circumstances known to the Company at that time. There have been no material adjustments to the Company’s prior period accrued estimates for clinical trial activities through December 31, 2022 . |
Net Loss Per Share | Net Loss Per Share Basic net loss per common share is calculated by dividing the net loss attributable to common stockholders by the weighted-average number of common shares outstanding during the period, without consideration for potentially dilutive securities. Diluted net loss per share is computed by dividing the net loss attributable to common stockholders by the weighted-average number of common shares and potentially dilutive securities outstanding for the period determined using the treasury-stock and if-converted methods. For purposes of the diluted net loss per share calculation, preferred stock, and stock options and warrants are considered to be potentially dilutive securities and are excluded from the calculation of diluted net loss per share because their effect would be anti-dilutive. Therefore, basic and diluted net loss per share was the same for the periods presented due to the Company’s net loss position. Basic weighted average shares outstanding for the years ended December 31, 2022 and 2021 include 509,117 shares underlying warrants to purchase common shares. As the shares underlying these warrants can be issued for little consideration (an exercise price per share equal to $ 0.001 per share), these shares are deemed to be issued for purposes of basic earnings per share. Year Ended 2022 2021 (In thousands, except share and per share data) Net loss $ ( 87,966 ) $ ( 34,506 ) Net loss per share, basic and diluted $ ( 6.16 ) $ ( 2.33 ) Weighted-average number of common shares 14,285,254 14,819,582 The computation of diluted earnings per share excludes stock options, warrants, and restricted stock units that are anti-dilutive. For the year ended December 31, 2022 , common share equivalents of 8,139,155 shares were anti-dilutive. For the year ended December 31, 2021 , common share equivalents of 1,087,174 shares were anti-dilutive. |
Stock-Based Compensation | Stock-Based Compensation The Company recognizes compensation expense for all stock-based awards based on the grant-date estimated fair value. The fair value of stock options is determined using the Black-Scholes option pricing model, using assumptions that are subjective and require significant judgment and estimation by management. The fair value of stock options is determined using the Black-Scholes option pricing model, using assumptions which are subjective and require significant judgment and estimation by management. The risk-free rate assumption was based on observed yields from governmental zero-coupon bonds with an equivalent term. The expected volatility assumption was based on historical volatilities of a group of comparable industry companies whose share prices are publicly available. The peer group was developed based on companies in the pharmaceutical industry. The expected term of stock options represents the weighted-average period that the stock options are expected to be outstanding. Because the Company does not have historical exercise behavior, the Company determined the expected life assumption using the simplified method for stock options granted to employees, which is an average of the options ordinary vesting period and the contractual term. For stock options granted to the Company’s board of directors (the “Board”), the Company determined the expected life assumption using the simplified method as the starting point with an average period of twelve ( 12 ) months added to take into account for the extended range of time of 12 to 18 months vested stock options granted to Board members may be exercised upon termination. The expected dividend assumption was based on the Company’s history and expectation of dividend payouts. The Company has not paid and does not expect to pay dividends at any time in the foreseeable future. The Company recognizes forfeitures on an actual basis and as such did not estimate forfeitures to calculate stock-based compensation. Restricted Stock Units (“RSU”) are measured and recognized based on the quoted market price of our common stock on the date of grant. In March 2020, the Board approved an increase of 28,816 shares issuable under the 2014 Stock Incentive Plan (the “2014 Plan”) and 7,204 shares issuable under the 2014 Employee Stock Purchase Plan (the “ESPP”). On December 18, 2020, the Company held the Special Meeting, whereby the Company’s stockholders approved the 2020 Long Term Incentive Plan (the “2020 Plan”). The aggregate number of shares of stock available for issuance under the 2020 Plan will initially be 4,860,000 shares of common stock, which represented approximately 15 % of the total issued and outstanding shares of the Company’s common stock as of the record date of the Special Meeting (calculated on an as-converted basis and without regard to the potential application of beneficial ownership conversion limitations on the preferred stock) and may be increased by the number of shares under the 2014 Plan that expire, terminate or are otherwise surrendered, cancelled, forfeited or repurchased by the Company. Based on projected utilization rates, the Board currently intends that the initial shares under the 2020 Plan will be sufficient to fund the Company’s equity compensation needs for approximately three years from the date of the Special Meeting. The 2014 Plan was closed to new grants following the approval of the 2020 Plan, and therefore, there were no shares reserved for issuance under the 2014 Plan as of December 31, 2022 . The number of shares reserved for issuance under the 2020 Plan and ESPP was 3,126,608 and 24,077 shares, respectively, as of December 31, 2022 . |
Income Taxes | Income Taxes Significant judgment is required in determining the Company’s provision for income taxes, deferred tax assets and liabilities and the valuation allowance recorded against net deferred tax assets. We assess the likelihood that deferred tax assets will be recovered as deductions from future taxable income. The evaluation of the need for a valuation allowance is performed on a jurisdiction-by-jurisdiction basis and includes a review of all available positive and negative evidence. Factors reviewed include projections of pre-tax book income for the foreseeable future, determination of cumulative pre-tax book income after permanent differences, earnings history, and reliability of forecasting. We have provided a valuation allowance on our deferred tax assets as of December 31, 2022 and 2021 because we believe it is more likely than not that a majority of our deferred tax assets will not be realized as of this date. The Company evaluates the accounting for uncertainty in income tax recognized in its consolidated financial statements and determines whether it is more likely than not that a tax position will be sustained upon examination by the appropriate taxing authorities before any part of the benefit is recorded in its consolidated financial statements. For those tax positions where it is “not more likely than not” that a tax benefit will be sustained, no tax benefit is recognized. Where applicable, associated interest and penalties are also recorded. The Company has not accrued any liabilities for any such uncertain tax positions as of December 31, 2022 and 2021. The Company is subject to U.S. federal and state tax authority examinations for all the years since inception due to net operating loss and tax credit carryforwards. The net operating losses and tax credits are subject to adjustment until the statute closes on the year the attributes are ultimately utilized. The Company’s income tax returns are based on calculations and assumptions that are subject to examination by the Internal Revenue Service and other tax authorities. In addition, the calculation of the Company’s tax liabilities involves dealing with uncertainties in the application of complex tax regulations. The Company recognizes liabilities for uncertain tax positions based on a two-step process. The first step is to evaluate the tax position for recognition by determining if the weight of available evidence indicates that it is more likely than not that the position will be sustained on audit, including resolution of related appeals or processes, if any. The second step is to measure the tax benefit as the largest amount that is more than 50 % likely of being realized upon settlement. While the Company believes it has appropriate support for the positions taken on its tax returns, the Company regularly assesses the potential outcomes of examinations by tax authorities in determining the adequacy of its provision for income taxes. The Company continually assesses the likelihood and amount of potential revisions and adjusts the income tax provision, income taxes payable and deferred taxes in the period in which the facts that give rise to a revision become known. For additional information, see Note 7. Income Taxes. |
Recently Issued or Adopted Accounting Pronouncements | Recently Adopted Accounting Pronouncements No new accounting pronouncement issued or effective during the fiscal period had or is expected to have a material impact on the Company’s consolidated financial statements or disclosures. |
Summary of Significant Accoun_3
Summary of Significant Accounting Policies (Tables) | 12 Months Ended |
Dec. 31, 2022 | |
Accounting Policies [Abstract] | |
Schedule of Common Share Equivalents Included from Computation of Net Loss Per Share | As the shares underlying these warrants can be issued for little consideration (an exercise price per share equal to $ 0.001 per share), these shares are deemed to be issued for purposes of basic earnings per share. Year Ended 2022 2021 (In thousands, except share and per share data) Net loss $ ( 87,966 ) $ ( 34,506 ) Net loss per share, basic and diluted $ ( 6.16 ) $ ( 2.33 ) Weighted-average number of common shares 14,285,254 14,819,582 |
Prepaid Expenses Other Assets_2
Prepaid Expenses Other Assets Accrued Expenses and Other Liabilities (Tables) | 12 Months Ended |
Dec. 31, 2022 | |
Prepaid Expenses Other Assets Accrued Expenses And Other Liabilities [Abstract] | |
Prepaid Expenses and Other Current Assets | Prepaid expenses and other current assets consisted of the following as of December 31, 2022 and 2021 (in thousands): December 31, 2022 2021 Prepaid insurance $ 823 $ 1,344 Prepaid clinical 2,115 2,039 Prepaid other 143 96 Other current assets 28 34 Total prepaid expenses and other current assets $ 3,109 $ 3,513 |
Schedule of Accrued Expenses and Other Liabilities | Accrued expenses and other liabilities consisted of the following as of December 31, 2022 and 2021 (in thousands): December 31, 2022 2021 Accrued compensation and related expenses $ 1,909 $ 1,411 Accrued severance — 104 Accrued clinical 1,826 454 Accrued professional services 65 167 Accrued other 112 83 Total accrued expenses and other liabilities $ 3,912 $ 2,219 |
Goodwill (Tables)
Goodwill (Tables) | 12 Months Ended |
Dec. 31, 2022 | |
Goodwill and Intangible Assets Disclosure [Abstract] | |
Schedule of Goodwill | Total Balance as of January 1, 2021 $ 48,648 Impairments — Balance as of December 31, 2021 $ 48,648 Impairments ( 48,648 ) Balance as of December 31, 2022 $ — |
Commitments and Contingencies (
Commitments and Contingencies (Tables) | 12 Months Ended |
Dec. 31, 2022 | |
Commitments and Contingencies Disclosure [Abstract] | |
Components of Lease Expense | The components of lease expense were as follows (in thousands): Year Ended 2022 2021 Operating lease cost (a) $ 403 $ 283 (a) Includes variable operating lease expenses, which are immaterial. |
Schedule of Other Information Related to Leases | Other information related to leases was as follows (in thousands, except lease term and discount rate): Year Ended 2022 2021 Supplemental Cash Flows Information Cash paid for amounts included in the measurement of lease liability: Operating cash flows from operating lease $ 387 $ 208 Operating lease asset obtained in exchange for lease liability: Operating lease $ 344 $ 825 Remaining lease term Operating lease 1.95 years 2.41 years Discount rate Operating lease 2.49 % 3.00 % |
Schedule of Future Payments Under Noncancelable Operating Leases | Future payments under noncancelable operating leases having initial or remaining terms of one year or more are as follows for the succeeding fiscal year and thereafter (in thousands): Year Ended 2022 2023 378 2024 388 Total minimum lease payments 766 Less imputed interest ( 20 ) Present value of lease liabilities 746 Less current portion of operating lease liability ( 363 ) Non-current operating lease liability $ 383 |
Income Taxes (Tables)
Income Taxes (Tables) | 12 Months Ended |
Dec. 31, 2022 | |
Income Tax Disclosure [Abstract] | |
Summary of Loss Before Income Taxes | Loss before income taxes are as follows (in thousands): Year Ended 2022 2021 Losses before income taxes: U.S. $ ( 88,159 ) $ ( 37,055 ) Non-U.S. 193 195 Total $ ( 87,966 ) $ ( 36,860 ) |
Summary of Provision (Benefit) for Income Taxes | The provision (benefit) for income taxes are as follows (in thousands): Year Ended 2022 2021 Current: Federal $ — $ — State — — Foreign — — — — Deferred: Federal — ( 2,746 ) State — 392 Foreign — — — ( 2,354 ) Provision (benefit) for income taxes $ — $ ( 2,354 ) |
Reconciliation of U.S. Federal Statutory Income Tax Rate | A reconciliation of the U.S. federal statutory income tax rate to the Company’s effective income tax rate is as follows (in thousands): Year Ended 2022 2021 Statutory Federal income tax rate $ ( 18,473 ) $ ( 7,741 ) State income taxes, net of Federal tax benefits ( 2,678 ) ( 445 ) Tax credits ( 1,046 ) ( 651 ) Stock-based compensation 986 651 Permanent items 3 2 State rate differential 274 235 NOL true-up ( 337 ) ( 991 ) Other 114 146 Goodwill impairment 11,697 — Change in valuation allowance 9,460 6,440 Total provision (benefit) for income taxes $ — $ ( 2,354 ) |
Schedule of Significant Components Deferred Tax Assets and Liabilities | Significant components of the Company’s deferred tax assets and liabilities as of December 31, 2022 and 2021 consisted of the following (in thousands): Year Ended 2022 2021 Net operating loss carryforwards $ 15,230 $ 12,531 Research and development tax credits 2,294 1,356 Accruals and reserves 452 296 Research expenditures 5,264 — Stock-based compensation 2,874 1,867 Depreciation and amortization 1,595 1,713 Lease liability 179 171 Total deferred tax assets 27,888 17,934 Right-of-use asset ( 178 ) ( 171 ) Acquired IPR&D ( 7,787 ) ( 7,192 ) Total deferred tax liabilities ( 7,965 ) ( 7,363 ) Less: valuation allowance ( 21,675 ) ( 12,323 ) Net deferred tax liabilities $ ( 1,752 ) $ ( 1,752 ) |
Reconciliation of Beginning and Ending Amounts of Unrecognized Tax Benefits | The following table reconciles the beginning and ending amounts of unrecognized tax benefits for the years presented (in thousands): Year Ended 2022 2021 Gross unrecognized tax benefits at the beginning of the year $ 1,469 $ 764 Additions from tax positions taken in the current year 914 712 Additions from tax positions taken in prior years 281 — Reductions from tax positions taken in prior years — ( 7 ) Gross unrecognized tax benefits at the end of the year $ 2,664 $ 1,469 |
Stockholders' Equity (Tables)
Stockholders' Equity (Tables) | 12 Months Ended |
Dec. 31, 2022 | |
Common Stock Warrants [Member] | |
Class Of Stock [Line Items] | |
Schedule of Warrants to Purchase Common Stock Activity | The following table shows the warrants to purchase common stock activity: Rollforward of Warrant Activity Registered direct warrants, placement agent Private placement warrants Private placement warrants, placement agent Warrants exchanged for common stock Warrants exchanged for Series X 1 preferred stock Total Balance as of December 31, 2021 9,581 319,064 9,177 509,117 298,692 1,145,631 Issued — — — — — — Exercised — — — — — — Cancelled/Expired — — — — — — Balance as of December 31, 2022 9,581 319,064 9,177 509,117 298,692 1,145,631 |
Preferred Stock Warrants [Member] | |
Class Of Stock [Line Items] | |
Schedule of Warrants to Purchase Common Stock Activity | The following table shows the warrants to purchase Series X 1 Convertible Preferred Stock activity: Rollforward of Warrant Activity Warrants assumed and Total Balance as of December 31, 2021 50,207.419 50,207.419 Assumed and replaced — — Exercised — — Cancelled/Expired — — Balance as of December 31, 2022 50,207.419 50,207.419 |
Stock-Based Compensation (Table
Stock-Based Compensation (Tables) | 12 Months Ended |
Dec. 31, 2022 | |
Share-Based Payment Arrangement [Abstract] | |
Summary of All Option Activity Under 2007 Plan, 2014 Plan, 2020 Plan and Inducement Grants | The following table summarizes all option activity under the 2007 Plan, 2014 Plan, 2020 Plan and inducement grants: Shares Weighted Weighted Aggregate (In years) Outstanding as of January 1, 2021 3,621,479 $ 10.63 8.9 $ — Granted 702,836 10.69 — — Options Assumed ( 174 ) 4.73 — — Forfeited / Canceled ( 110,164 ) 19.50 — — Outstanding as of December 31, 2021 4,213,977 $ 10.33 8.4 $ — Granted 1,267,700 3.81 — — Forfeited / Canceled ( 263,644 ) 12.12 — — Outstanding as of December 31, 2022 5,218,033 $ 8.69 8.1 $ — Options vested and expected to vest as of 5,218,033 $ 8.69 8.1 $ — Options exercisable as of December 31, 2022 3,076,338 $ 8.72 7.0 $ — |
Schedule of Assumptions Used in Black-Scholes Option Pricing Model to Determine the Fair Value of Stock Options Granted | The following table presents the assumptions used in the Black-Scholes option pricing model to determine the fair value of stock options granted in the periods presented, as follows: Year Ended 2022 2021 Expected stock price volatility 81 % - 84 % 105 % - 110 % Risk-free interest rate 1.8 % - 4.2 % 1 % Expected life of option (in years) 6.25 - 6.50 6.25 - 6.75 Estimated dividend yield 0 % 0 % |
Summary of RSU Activity | The following table shows the RSU activity, as follows: Shares Weighted Aggregate Outstanding as of January 1, 2021 — $ — $ — Granted 20,000 5.07 — RSUs Vested — — — Forfeited / Canceled — — — Outstanding as of December 31, 2021 20,000 $ 5.07 $ — Granted 15,000 2.47 — RSUs Vested ( 20,000 ) 5.07 — Forfeited / Canceled — — — Outstanding as of December 31, 2022 15,000 $ 2.47 $ — RSUs vested and expected to vest as of 15,000 $ 2.47 $ — RSUs exercisable as of December 31, 2022 — $ — $ — |
Schedule of Stock-Based Compensation Expense Related to Stock-Based Awards | Total compensation expense related to all of the Company’s stock-based awards for the years ended December 31, 2022 and 2021 was comprised of the following (in thousands): Year Ended 2022 2021 Stock-based compensation classified as: Research and development expense $ 3,230 $ 3,166 General and administrative expense 4,923 4,738 Total stock-based compensation expense $ 8,153 $ 7,904 |
Description of Business - Addit
Description of Business - Additional Information (Detail) | Sep. 14, 2020 |
Anelixis [Member] | |
Description Of Business [Line Items] | |
Date of acquisition | Sep. 14, 2020 |
Going Concern and Management'_2
Going Concern and Management's Plans - Additional Information (Detail) - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2022 | Dec. 31, 2021 | |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | ||
Net loss | $ (87,966) | $ (34,506) |
Accumulated deficit | (202,865) | (114,899) |
Cash and cash equivalents | $ 56,409 | $ 84,833 |
Summary of Significant Accoun_4
Summary of Significant Accounting Policies - Additional Information (Detail) | 12 Months Ended | |||
Dec. 18, 2020 shares | Dec. 31, 2022 USD ($) Reporting_Unit Segment $ / shares shares | Dec. 31, 2021 USD ($) shares | Mar. 31, 2020 shares | |
Summary Of Significant Accounting Policies [Line Items] | ||||
Cash, cash equivalents and restricted cash, maturity period | three months or less | |||
Cash equivalents | $ 9,300,000 | $ 9,300,000 | ||
Financial assets transfers between level amount | 0 | 0 | ||
Financial liabilities transfers between level amount | $ 0 | 0 | ||
Number of operating business segments | Segment | 1 | |||
Number of reporting units | Reporting_Unit | 1 | |||
Impairment charge | $ 48,648,000 | 0 | ||
Impairments of long-lived assets | $ 0 | $ 0 | ||
Basic weighted average shares outstanding | shares | 14,285,254 | 14,819,582 | ||
Warrants exercise price | $ / shares | $ 0.001 | |||
Antidilutive securities excluded from computation of earnings per share, amount | shares | 8,139,155 | 1,087,174 | ||
Tax benefit | $ 0 | |||
Income tax examination, likelihood of settlement, description | The second step is to measure the tax benefit as the largest amount that is more than 50% likely of being realized upon settlement. | |||
Income tax examination, likelihood of settlement, percentage | 50% | |||
2014 Stock Incentive Plan [Member] | ||||
Summary Of Significant Accounting Policies [Line Items] | ||||
Increase in number of shares of common stock authorized for issuance | shares | 28,816 | |||
Common stock, number of shares initially reserved for issuance | shares | 0 | |||
Equity compensation period | 10 years | |||
2014 Employee Stock Purchase Plan [Member] | ||||
Summary Of Significant Accounting Policies [Line Items] | ||||
Increase in number of shares of common stock authorized for issuance | shares | 7,204 | |||
Common stock, number of shares initially reserved for issuance | shares | 24,077 | |||
2020 Plan [Member] | ||||
Summary Of Significant Accounting Policies [Line Items] | ||||
Common stock, number of shares initially reserved for issuance | shares | 4,860,000 | 3,126,608 | ||
Percentage of issued and outstanding shares of common stock | 15% | |||
Equity compensation period | 3 years | |||
Stock Options [Member] | Board of Directors [Member] | ||||
Summary Of Significant Accounting Policies [Line Items] | ||||
Expected life assumption using simplified method, description | For stock options granted to the Company’s board of directors (the “Board”), the Company determined the expected life assumption using the simplified method as the starting point with an average period of twelve (12) months added to take into account for the extended range of time of 12 to 18 months vested stock options granted to Board members may be exercised upon termination. | |||
Expected life assumption using simplified method | 12 months | |||
Fair Value, Measurements, Recurring [Member] | ||||
Summary Of Significant Accounting Policies [Line Items] | ||||
Assets measured at fair value | $ 0 | $ 0 | ||
Liabilities measured at fair value | $ 0 | $ 0 | ||
Maximum [Member] | ||||
Summary Of Significant Accounting Policies [Line Items] | ||||
Expected life assumption using simplified method | 6 years 6 months | 6 years 9 months | ||
Maximum [Member] | Stock Options [Member] | Board of Directors [Member] | ||||
Summary Of Significant Accounting Policies [Line Items] | ||||
Vesting period of stock options granted | 18 months | |||
Minimum [Member] | ||||
Summary Of Significant Accounting Policies [Line Items] | ||||
Expected life assumption using simplified method | 6 years 3 months | 6 years 3 months | ||
Minimum [Member] | Stock Options [Member] | Board of Directors [Member] | ||||
Summary Of Significant Accounting Policies [Line Items] | ||||
Vesting period of stock options granted | 12 months | |||
Warrants [Member] | ||||
Summary Of Significant Accounting Policies [Line Items] | ||||
Basic weighted average shares outstanding | shares | 509,117 | |||
Anelixis [Member] | ||||
Summary Of Significant Accounting Policies [Line Items] | ||||
Impairment charge | $ 48,600,000 | |||
Anelixis Therapeutics, LLC and Otic Pharma, Ltd. | ||||
Summary Of Significant Accounting Policies [Line Items] | ||||
Ownership interest percentage | 100% | |||
Otic Pharma, Inc. [Member] | ||||
Summary Of Significant Accounting Policies [Line Items] | ||||
Ownership interest percentage | 100% |
Summary of Significant Accoun_5
Summary of Significant Accounting Policies - Schedule of Common Share Equivalents Included from Computation of Net Loss Per Share (Detail) - USD ($) $ / shares in Units, $ in Thousands | 12 Months Ended | |
Dec. 31, 2022 | Dec. 31, 2021 | |
Earnings Per Share [Abstract] | ||
Net loss | $ (87,966) | $ (34,506) |
Net loss per share, basic | $ (6.16) | $ (2.33) |
Net loss per share, diluted | $ (6.16) | $ (2.33) |
Weighted-average number of common shares, basic | 14,285,254 | 14,819,582 |
Weighted-average number of common shares, diluted | 14,285,254 | 14,819,582 |
Prepaid Expenses Other Assets_3
Prepaid Expenses Other Assets Accrued Expenses and Other Liabilities - Prepaid Expenses and Other Current Assets (Detail) - USD ($) $ in Thousands | Dec. 31, 2022 | Dec. 31, 2021 |
Prepaid Expense and Other Assets, Current [Abstract] | ||
Prepaid insurance | $ 823 | $ 1,344 |
Prepaid clinical | 2,115 | 2,039 |
Prepaid other | 143 | 96 |
Other current assets | 28 | 34 |
Total prepaid expenses and other current assets | $ 3,109 | $ 3,513 |
Prepaid Expenses Other Assets_4
Prepaid Expenses Other Assets Accrued Expenses and Other Liabilities - Schedule of Accrued Expenses and Other Liabilities (Detail) - USD ($) $ in Thousands | Dec. 31, 2022 | Dec. 31, 2021 |
Accrued Liabilities and Other Liabilities [Abstract] | ||
Accrued compensation and related expenses | $ 1,909 | $ 1,411 |
Accrued severance | 104 | |
Accrued clinical | 1,826 | 454 |
Accrued professional services | 65 | 167 |
Accrued other | 112 | 83 |
Total accrued expenses and other liabilities | $ 3,912 | $ 2,219 |
Goodwill - Additional Informati
Goodwill - Additional Information (Detail) - USD ($) | 12 Months Ended | |
Dec. 31, 2022 | Dec. 31, 2021 | |
Goodwill [Line Items] | ||
Goodwill impairment | $ 48,648,000 | $ 0 |
Anelixis [Member] | ||
Goodwill [Line Items] | ||
Goodwill impairment | $ 48,600,000 |
Goodwill - Schedule of Goodwill
Goodwill - Schedule of Goodwill (Detail) - USD ($) | 12 Months Ended | |
Dec. 31, 2022 | Dec. 31, 2021 | |
Goodwill and Intangible Assets Disclosure [Abstract] | ||
Beginning balance | $ 48,648,000 | $ 48,648,000 |
Impairments | (48,648,000) | 0 |
Ending balance | $ 0 | $ 48,648,000 |
Commitments and Contingencies -
Commitments and Contingencies - Additional Information (Detail) | 12 Months Ended | ||||||
Aug. 12, 2022 | Nov. 04, 2021 ft² | Dec. 31, 2022 USD ($) ft² Milestone | Dec. 31, 2021 USD ($) Milestone | Dec. 31, 2018 USD ($) | Dec. 31, 2017 USD ($) | Dec. 31, 2015 USD ($) | |
Other Commitments [Line Items] | |||||||
Rental expense | $ 300,000 | $ 300,000 | |||||
Remaining term of office lease | 2 years | ||||||
Debt outstanding | $ 0 | ||||||
Indemnification obligations amount | 0 | ||||||
Contingent liabilities | $ 0 | $ 0 | |||||
Office of Chief Scientist of Israeli Ministry of Economy and Industry [Member] | |||||||
Other Commitments [Line Items] | |||||||
Grants received | $ 500,000 | ||||||
ALS Therapy Development Foundation, Inc. License Agreement [Member] | |||||||
Other Commitments [Line Items] | |||||||
Fee due for milestones achieved | $ 1,000,000 | $ 1,000,000 | |||||
Common stock issued in lieu of making a cash payment | $ 1,000,000 | $ 1,000,000 | |||||
Number of Milestones Achieved | Milestone | 0 | 0 | |||||
Remaining milestone payments for first licensed product | $ 6,000,000 | ||||||
Annual License Maintenance Fee | 100,000 | ||||||
ALS Therapy Development Foundation, Inc. License Agreement [Member] | Achievement of 500 Million Aggregate Sales [Member] | |||||||
Other Commitments [Line Items] | |||||||
Reaching of aggregate net sales | 500,000,000 | ||||||
Amount of one-time milestone payment | 15,000,000 | ||||||
ALS Therapy Development Foundation, Inc. License Agreement [Member] | Achievement of 1 Billion Aggregate Sales [Member] | |||||||
Other Commitments [Line Items] | |||||||
Reaching of aggregate net sales | 1,000,000,000 | ||||||
Amount of one-time milestone payment | 30,000,000 | ||||||
Maximum [Member] | ALS Therapy Development Foundation, Inc. License Agreement [Member] | |||||||
Other Commitments [Line Items] | |||||||
Development and regulatory milestone payments | $ 2,500,000 | ||||||
Irvine, California [Member] | |||||||
Other Commitments [Line Items] | |||||||
Area of office space | ft² | 5,197 | ||||||
Lease expiration date | Dec. 31, 2024 | Dec. 31, 2022 | |||||
Effective date of lease amendment | Jan. 01, 2023 | ||||||
Burlington, Massachusetts [Member] | |||||||
Other Commitments [Line Items] | |||||||
Area of office space | ft² | 6,138 | ||||||
Lease expiration date | Nov. 20, 2024 |
Commitments and Contingencies_2
Commitments and Contingencies - Components of Lease Expense (Detail) - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2022 | Dec. 31, 2021 | |
Commitments and Contingencies Disclosure [Abstract] | ||
Operating lease cost | $ 403 | $ 283 |
Commitments and Contingencies_3
Commitments and Contingencies - Schedule of Other Information Related to Leases (Detail) - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2022 | Dec. 31, 2021 | |
Cash paid for amounts included in the measurement of lease liability: | ||
Operating cash flows from operating lease | $ 387 | $ 208 |
Operating lease asset obtained in exchange for lease liability: | ||
Operating lease | $ 344 | $ 825 |
Remaining lease term | ||
Operating lease | 1 year 11 months 12 days | 2 years 4 months 28 days |
Discount rate | ||
Operating lease | 2.49% | 3% |
Commitments and Contingencies_4
Commitments and Contingencies - Schedule of Future Payments Under Noncancelable Operating Leases (Detail) - USD ($) $ in Thousands | Dec. 31, 2022 | Dec. 31, 2021 |
Commitments and Contingencies Disclosure [Abstract] | ||
2023 | $ 378 | |
2024 | 388 | |
Total minimum lease payments | 766 | |
Less imputed interest | (20) | |
Present value of lease liabilities | 746 | |
Less current portion of operating lease liability | (363) | $ (369) |
Non-current operating lease liability | $ 383 | $ 400 |
Income Taxes - Summary of Loss
Income Taxes - Summary of Loss Before Income Taxes (Detail) - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2022 | Dec. 31, 2021 | |
Losses before income taxes: | ||
U.S. | $ (88,159) | $ (37,055) |
Non-U.S. | 193 | 195 |
Loss before income tax benefit | $ (87,966) | $ (36,860) |
Income Taxes - Summary of Provi
Income Taxes - Summary of Provision (Benefit) for Income Taxes (Detail) - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2022 | Dec. 31, 2021 | |
Deferred: | ||
Federal | $ (2,746) | |
State | 392 | |
Deferred income tax expense (benefit) | (2,354) | |
Provision (benefit) for income taxes | $ 0 | $ (2,354) |
Income Taxes - Additional Infor
Income Taxes - Additional Information (Detail) - USD ($) | 12 Months Ended | ||
Dec. 31, 2022 | Dec. 31, 2021 | Dec. 31, 2020 | |
Tax Credit Carryforward [Line Items] | |||
Federal Income tax rate | 21% | 21% | |
Net valuation allowance Increased (decreased) | $ 9,400,000 | $ 9,400,000 | $ 6,400,000 |
Research and development tax credit carryforwards for federal and state | $ 2,294,000 | 1,356,000 | |
Period for which cumulative change in ownership annual use net operating loss and research and development credit carryforwards | 3 years | ||
Accrued interest and penalties associated with uncertain tax positions | $ 0 | 0 | |
Interest or penalties recorded during the year | $ 0 | 0 | |
Minimum [Member] | |||
Tax Credit Carryforward [Line Items] | |||
Percentage of cumulative change in ownership | 50% | ||
Domestic Tax Authority [Member] | |||
Tax Credit Carryforward [Line Items] | |||
Federal net operating loss carryforwards | $ 56,800,000 | 46,900,000 | |
Net operating loss carryforward expiration period | 2035 | ||
Federal net operating loss carryforwards, not to expiration | $ 56,000,000 | ||
Research and development tax credit carryforwards for federal and state | $ 2,400,000 | 1,900,000 | |
Research and development tax credit carryforwards expiration period | 2036 | ||
State and Local Jurisdiction [Member] | |||
Tax Credit Carryforward [Line Items] | |||
State net operating loss carryforwards | $ 25,000,000 | 15,000,000 | |
Research and development tax credit carryforwards for federal and state | $ 1,200,000 | 1,100,000 | |
Research and development tax credit carryforwards expiration period | 2030 | ||
Research and development tax credit carryforwards expiration description | As of December 31, 2022 and 2021, the Company has state research and development credit carryforwards or approximately $1.2 million and $1.1 million, respectively, which will begin expiring in 2030 if not utilized | ||
Israeli Tax Authority [Member] | Foreign Country [Member] | |||
Tax Credit Carryforward [Line Items] | |||
Income tax rate | 23% | ||
Foreign operating losses carryforwards | $ 7,900,000 | $ 7,900,000 | |
California [Member] | State and Local Jurisdiction [Member] | |||
Tax Credit Carryforward [Line Items] | |||
Net operating loss carryforward expiration period | 2035 |
Income Taxes - Reconciliation o
Income Taxes - Reconciliation of U.S. Federal Statutory Income Tax Rate (Detail) - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2022 | Dec. 31, 2021 | |
Income Tax Disclosure [Abstract] | ||
Statutory Federal income tax rate | $ (18,473) | $ (7,741) |
State income taxes, net of Federal tax benefits | (2,678) | (445) |
Tax credits | (1,046) | (651) |
Stock-based compensation | 986 | 651 |
Permanent items | 3 | 2 |
State rate differential | 274 | 235 |
NOL true-up | (337) | (991) |
Other | 114 | 146 |
Goodwill impairment | 11,697 | |
Change in valuation allowance | 9,460 | 6,440 |
Provision (benefit) for income taxes | $ 0 | $ (2,354) |
Income Taxes - Schedule of Sign
Income Taxes - Schedule of Significant Components Deferred Tax Assets and Liabilities (Detail) - USD ($) $ in Thousands | Dec. 31, 2022 | Dec. 31, 2021 |
Income Tax Disclosure [Abstract] | ||
Net operating loss carryforwards | $ 15,230 | $ 12,531 |
Research and development tax credits | 2,294 | 1,356 |
Accruals and reserves | 452 | 296 |
Research expenditures | 5,264 | |
Stock-based compensation | 2,874 | 1,867 |
Depreciation and amortization | 1,595 | 1,713 |
Lease liability | 179 | 171 |
Total deferred tax assets | 27,888 | 17,934 |
Right-of-use asset | (178) | (171) |
Acquired IPR&D | (7,787) | (7,192) |
Total deferred tax liabilities | (7,965) | (7,363) |
Less: valuation allowance | (21,675) | (12,323) |
Net deferred tax liabilities | $ (1,752) | $ (1,752) |
Income Taxes - Reconciliation_2
Income Taxes - Reconciliation of Beginning and Ending Amounts of Unrecognized Tax Benefits (Detail) - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2022 | Dec. 31, 2021 | |
Income Tax Disclosure [Abstract] | ||
Gross unrecognized tax benefits at the beginning of the year | $ 1,469 | $ 764 |
Additions from tax positions taken in the current year | 914 | 712 |
Additions from tax positions taken in prior years | 281 | |
Reductions from tax positions taken in prior years | (7) | |
Gross unrecognized tax benefits at the end of the year | $ 2,664 | $ 1,469 |
Stockholders' Equity - Addition
Stockholders' Equity - Additional Information (Detail) - USD ($) $ / shares in Units, $ in Millions | 12 Months Ended | |||||
Jan. 11, 2022 | Sep. 21, 2021 | Dec. 31, 2022 | Dec. 31, 2021 | Dec. 31, 2020 | Mar. 31, 2021 | |
Class Of Stock [Line Items] | ||||||
Preferred stock, par value | $ 0.001 | $ 0.001 | ||||
Warrant exercise price per share | $ 0.001 | |||||
Common Stock [Member] | ||||||
Class Of Stock [Line Items] | ||||||
Warrants available for exercise | 1,145,631 | |||||
Series X1 Preferred Stock [Member] | ||||||
Class Of Stock [Line Items] | ||||||
Shares of common stock issued upon conversion of each share of preferred stock | 2,789,301 | |||||
Warrants available for exercise | 50,207.419 | |||||
Series X1 Non-voting Convertible Preferred Stock [Member] | ||||||
Class Of Stock [Line Items] | ||||||
Preferred stock, par value | $ 0.001 | $ 0.001 | ||||
Jeffries LLC [Member] | ATM Program [Member] | ||||||
Class Of Stock [Line Items] | ||||||
Common stock number of shares issued | 0 | 0 | ||||
Equity distribution agreement maximum value of common shares issuable | $ 75 | |||||
Public float minimum balance to be maintained | $ 75 | |||||
Jeffries LLC [Member] | Maximum [Member] | ATM Program [Member] | ||||||
Class Of Stock [Line Items] | ||||||
Equity distribution agreement maximum value of common shares issuable | $ 10.5 | |||||
Series X Exchange Agreement [Member] | BVF Exchanging Stockholders, Series X Exchanging Stockholders [Member] | Common Stock [Member] | ||||||
Class Of Stock [Line Items] | ||||||
Conversion of stock, shares converted | 344,666 | |||||
Series X Exchange Agreement [Member] | BVF Exchanging Stockholders, Series X Exchanging Stockholders [Member] | Series X Non-voting Convertible Preferred Stock [Member] | ||||||
Class Of Stock [Line Items] | ||||||
Conversion of stock, shares issued | 6,203.98 | |||||
Series X1 Exchange Agreement [Member] | BVF Exchanging Stockholders, Series X Exchanging Stockholders [Member] | Common Stock [Member] | ||||||
Class Of Stock [Line Items] | ||||||
Conversion of stock, shares converted | 550,000 | |||||
Series X1 Exchange Agreement [Member] | BVF Exchanging Stockholders, Series X Exchanging Stockholders [Member] | Series X1 Non-voting Convertible Preferred Stock [Member] | ||||||
Class Of Stock [Line Items] | ||||||
Conversion of stock, shares issued | 9,899.99 | |||||
Warrant Exchange Agreement and Exchange Agreements [Member] | BVF Exchanging Stockholders | Common Stock [Member] | ||||||
Class Of Stock [Line Items] | ||||||
Warrants to purchase common stock | 509,117 | |||||
September 2021 Warrant Exchange Agreement [Member] | Common Stock [Member] | ||||||
Class Of Stock [Line Items] | ||||||
Warrants issued | 298,692 | |||||
September 2021 Warrant Exchange Agreement [Member] | Series X1 Non-voting Convertible Preferred Stock [Member] | Common Stock [Member] | ||||||
Class Of Stock [Line Items] | ||||||
Warrants exercisable for exchange | 5,376.456 |
Stockholders' Equity - Schedule
Stockholders' Equity - Schedule of Warrants to Purchase Common Stock Activity (Detail) - Common Stock Warrants [Member] | 12 Months Ended |
Dec. 31, 2022 shares | |
Class Of Warrant Or Right [Line Items] | |
Beginning Balance | 1,145,631 |
Issued | 0 |
Exercised | 0 |
Cancelled/Expired | 0 |
Ending Balance | 1,145,631 |
Registered Direct Warrants, Placement Agent [Member] | |
Class Of Warrant Or Right [Line Items] | |
Beginning Balance | 9,581 |
Issued | 0 |
Exercised | 0 |
Cancelled/Expired | 0 |
Ending Balance | 9,581 |
Private Placement Warrants [Member] | |
Class Of Warrant Or Right [Line Items] | |
Beginning Balance | 319,064 |
Issued | 0 |
Exercised | 0 |
Cancelled/Expired | 0 |
Ending Balance | 319,064 |
Private Placement Warrants, Placement Agent [Member] | |
Class Of Warrant Or Right [Line Items] | |
Beginning Balance | 9,177 |
Issued | 0 |
Exercised | 0 |
Cancelled/Expired | 0 |
Ending Balance | 9,177 |
Warrants Exchanged for Common Stock [Member] | |
Class Of Warrant Or Right [Line Items] | |
Beginning Balance | 509,117 |
Issued | 0 |
Exercised | 0 |
Cancelled/Expired | 0 |
Ending Balance | 509,117 |
Warrants Exchanged for Series X1 Preferred Stock [Member] | |
Class Of Warrant Or Right [Line Items] | |
Beginning Balance | 298,692 |
Issued | 0 |
Exercised | 0 |
Cancelled/Expired | 0 |
Ending Balance | 298,692 |
Stockholders' Equity - Schedu_2
Stockholders' Equity - Schedule of Warrant to Purchase Series X1 Convertible Preferred Stock Activity (Detail) - Preferred Stock Warrants [Member] | 12 Months Ended |
Dec. 31, 2022 shares | |
Class Of Warrant Or Right [Line Items] | |
Beginning Balance | 50,207.419 |
Assumed and replaced | 0 |
Exercised | 0 |
Cancelled/Expired | 0 |
Ending Balance | 50,207.419 |
Warrants Assumed and Replaced in Acquisition [Member] | |
Class Of Warrant Or Right [Line Items] | |
Beginning Balance | 50,207.419 |
Assumed and replaced | 0 |
Exercised | 0 |
Cancelled/Expired | 0 |
Ending Balance | 50,207.419 |
Stock-Based Compensation - Addi
Stock-Based Compensation - Additional Information (Details) | 12 Months Ended | ||
Dec. 31, 2022 USD ($) Plan $ / shares shares | Dec. 31, 2021 USD ($) $ / shares shares | Dec. 31, 2020 $ / shares shares | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||
Number of stock compensation plans | Plan | 3 | ||
Number of options outstanding | 5,218,033 | 4,213,977 | 3,621,479 |
Range of exercise prices | $ / shares | $ 8.69 | $ 10.33 | $ 10.63 |
Aggregate intrinsic value of options exercised | $ | $ 0 | ||
Unrecognized stock-based compensation expense | $ | $ 10,500,000 | ||
Unrecognized stock-based compensation expense, recognized over estimated weighted average period | 2 years 6 months | ||
Stock-based compensation expense | $ | $ 8,153,000 | $ 7,904,000 | |
Minimum [Member] | |||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||
Range of exercise prices | $ / shares | $ 2.45 | ||
Maximum [Member] | |||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||
Range of exercise prices | $ / shares | $ 2,147 | ||
2020 Stock Incentive Plan [Member] | |||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||
Common stock, number of shares reserved for issuance | 4,860,000 | ||
Number of options outstanding | 1,733,392 | ||
Options granted, expiration period | 10 years | ||
Stock awards available for grant | 3,126,608 | ||
2014 Stock Incentive Plan [Member] | |||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||
Common stock, number of shares reserved for issuance | 0 | ||
Number of options outstanding | 72,519 | ||
Options granted, expiration period | 10 years | ||
2007 Stock Incentive Plan [Member] | |||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||
Number of options outstanding | 1,151 | ||
Options granted, expiration period | 10 years |
Stock-Based Compensation - Summ
Stock-Based Compensation - Summary of All Option Activity Under 2007 Plan, 2014 Plan, 2020 Plan and Inducement Grants (Details) - $ / shares | 12 Months Ended | ||
Dec. 31, 2022 | Dec. 31, 2021 | Dec. 31, 2020 | |
Shares Issuable Under Options | |||
Outstanding, beginning balance | 4,213,977 | 3,621,479 | |
Granted | 1,267,700 | 702,836 | |
Options Assumed | (174) | ||
Forfeited / Canceled | (263,644) | (110,164) | |
Outstanding, ending balance | 5,218,033 | 4,213,977 | 3,621,479 |
Options vested and expected to vest | 5,218,033 | ||
Options exercisable | 3,076,338 | ||
Weighted Average Exercise Price | |||
Outstanding, beginning balance | $ 10.33 | $ 10.63 | |
Granted | 3.81 | 10.69 | |
Options Assumed | 4.73 | ||
Forfeited / Canceled | 12.12 | 19.50 | |
Outstanding, ending balance | 8.69 | $ 10.33 | $ 10.63 |
Options vested and expected to vest | 8.69 | ||
Options exercisable | $ 8.72 | ||
Weighted Average Remaining Contractual Term (In years) | |||
Outstanding, balance | 8 years 1 month 6 days | 8 years 4 months 24 days | 8 years 10 months 24 days |
Options vested and expected to vest | 8 years 1 month 6 days | ||
Options exercisable | 7 years |
Stock-Based Compensation - Sche
Stock-Based Compensation - Schedule of Assumptions Used in Black-Scholes Option Pricing Model to Determine the Fair Value of Stock Options Granted (Detail) | 12 Months Ended | |
Dec. 31, 2022 | Dec. 31, 2021 | |
Employee Service Share Based Compensation Allocation Of Recognized Period Costs [Line Items] | ||
Expected stock price volatility, minimum | 81% | 105% |
Expected stock price volatility, maximum | 84% | 110% |
Risk-free interest rate, minimum | 1.80% | |
Risk-free interest rate | 1% | |
Risk-free interest rate, maximum | 4.20% | |
Estimated dividend yield | 0% | 0% |
Minimum [Member] | ||
Employee Service Share Based Compensation Allocation Of Recognized Period Costs [Line Items] | ||
Expected life of option (in years) | 6 years 3 months | 6 years 3 months |
Maximum [Member] | ||
Employee Service Share Based Compensation Allocation Of Recognized Period Costs [Line Items] | ||
Expected life of option (in years) | 6 years 6 months | 6 years 9 months |
Stock-Based Compensation - Su_2
Stock-Based Compensation - Summary of RSU Activity (Details) - $ / shares | 12 Months Ended | |
Dec. 31, 2022 | Dec. 31, 2021 | |
Shares Issuable Under RSUs | ||
Options exercisable | 3,076,338 | |
Weighted Average Exercise Price | ||
Options exercisable | $ 8.72 | |
RSU [Member] | ||
Shares Issuable Under RSUs | ||
Outstanding, beginning balance | 20,000 | |
Granted | 15,000 | 20,000 |
RSUs Vested | (20,000) | |
Outstanding, ending balance | 15,000 | 20,000 |
RSUs vested and expected to vest | 15,000 | |
Weighted Average Exercise Price | ||
Outstanding, beginning balance | $ 5.07 | |
Granted | 2.47 | $ 5.07 |
RSUs Vested | 5.07 | |
Outstanding, ending balance | 2.47 | $ 5.07 |
RSUs vested and expected to vest | $ 2.47 |
Stock-Based Compensation - Sc_2
Stock-Based Compensation - Schedule of Stock-Based Compensation Expense Related to Stock-Based Awards (Detail) - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2022 | Dec. 31, 2021 | |
Employee Service Share Based Compensation Allocation Of Recognized Period Costs [Line Items] | ||
Stock-based compensation expense | $ 8,153 | $ 7,904 |
Research and Development [Member] | ||
Employee Service Share Based Compensation Allocation Of Recognized Period Costs [Line Items] | ||
Stock-based compensation expense | 3,230 | 3,166 |
General and Administrative [Member] | ||
Employee Service Share Based Compensation Allocation Of Recognized Period Costs [Line Items] | ||
Stock-based compensation expense | $ 4,923 | $ 4,738 |