Document and Entity Information
Document and Entity Information - shares | 6 Months Ended | |
Jun. 30, 2024 | Aug. 14, 2024 | |
Document Information [Line Items] | ||
Document Type | 10-Q | |
Amendment Flag | false | |
Document Period End Date | Jun. 30, 2024 | |
Document Fiscal Year Focus | 2024 | |
Document Fiscal Period Focus | Q2 | |
Trading Symbol | ELDN | |
Entity Registrant Name | ELEDON PHARMACEUTICALS, INC. | |
Entity Central Index Key | 0001404281 | |
Entity Current Reporting Status | Yes | |
Current Fiscal Year End Date | --12-31 | |
Entity Filer Category | Non-accelerated Filer | |
Entity Small Business | true | |
Entity Shell Company | false | |
Entity Emerging Growth Company | false | |
Entity Common Stock, Shares Outstanding | 39,655,702 | |
Entity File Number | 001-36620 | |
Entity Tax Identification Number | 20-1000967 | |
Entity Address, Address Line One | 19800 MacArthur Blvd | |
Entity Address, Address Line Two | Suite 250 | |
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 | |
Document Quarterly Report | true | |
Document Transition Report | false | |
Entity Incorporation, State or Country Code | DE | |
Title of 12(b) Security | Common Stock, $0.001 par value | |
Security Exchange Name | NASDAQ | |
Entity Interactive Data Current | Yes |
Condensed Consolidated Balance
Condensed Consolidated Balance Sheets - USD ($) $ in Thousands | Jun. 30, 2024 | Dec. 31, 2023 |
Current assets: | ||
Cash and cash equivalents | $ 26,039 | $ 4,612 |
Short-term investments | 57,571 | 46,490 |
Prepaid expenses and other current assets | 3,611 | 5,027 |
Total current assets | 87,221 | 56,129 |
Operating lease asset, net | 621 | 365 |
In-process research and development | 32,386 | 32,386 |
Other assets | 255 | 186 |
Total assets | 120,483 | 89,066 |
Current liabilities: | ||
Accounts payable | 2,148 | 967 |
Current operating lease liabilities | 269 | 383 |
Accrued expenses and other liabilities | 3,608 | 2,545 |
Total current liabilities | 6,025 | 3,895 |
Deferred tax liabilities | 1,752 | 1,752 |
Non-current operating lease liabilities | 386 | |
Warrant liabilities | 120,821 | 76,211 |
Total liabilities | 128,984 | 81,858 |
Commitments and contingencies (Note 8) | ||
Stockholders' equity (deficit): | ||
Common stock, $0.001 par value, 200,000,000 shares authorized at June 30, 2024 and December 31, 2023; 38,506,614 and 24,213,130 shares issued and outstanding at June 30, 2024 and December 31, 2023, respectively | 39 | 24 |
Additional paid-in capital | 379,400 | 326,586 |
Accumulated deficit | (387,940) | (319,402) |
Total stockholders’ equity | (8,501) | 7,208 |
Total liabilities and stockholders' equity (deficit) | 120,483 | 89,066 |
Series X1 Non-voting Convertible Preferred Stock [Member] | ||
Stockholders' equity (deficit): | ||
Preferred stock, value | ||
Series X Non-voting Convertible Preferred Stock [Member] | ||
Stockholders' equity (deficit): | ||
Preferred stock, value |
Condensed Consolidated Balanc_2
Condensed Consolidated Balance Sheets (Parenthetical) - $ / shares | Jun. 30, 2024 | Dec. 31, 2023 |
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 | 38,506,614 | 24,213,130 |
Common stock, shares outstanding | 38,506,614 | 24,213,130 |
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 | 110,086 | 110,086 |
Preferred stock, shares outstanding | 110,086 | 110,086 |
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 | 4,422 | 4,422 |
Preferred stock, shares outstanding | 4,422 | 4,422 |
Condensed Consolidated Statemen
Condensed Consolidated Statements of Operations and Comprehensive Loss - USD ($) $ in Thousands | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2024 | Jun. 30, 2023 | Jun. 30, 2024 | Jun. 30, 2023 | |
Operating expenses | ||||
Research and development | $ 10,106 | $ 7,201 | $ 17,516 | $ 15,314 |
General and administrative | 4,396 | 3,153 | 7,855 | 6,150 |
Total operating expenses | 14,502 | 10,354 | 25,371 | 21,464 |
Loss from operations | (14,502) | (10,354) | (25,371) | (21,464) |
Other income, net | 869 | 775 | 1,443 | 1,113 |
Change in fair value of warrant liabilities and fair value of financial instruments issued in excess of proceeds | (31,274) | (56,181) | (44,610) | (56,181) |
Net loss and comprehensive loss | $ (44,907) | $ (65,760) | $ (68,538) | $ (76,532) |
Net loss per share, Basic | $ (1.06) | $ (2.74) | $ (1.9) | $ (3.99) |
Net loss per share, Diluted | $ (1.06) | $ (2.74) | $ (1.9) | $ (3.99) |
Weighted-average common shares outstanding, Basic | 42,278,411 | 24,006,549 | 36,133,906 | 19,173,080 |
Weighted Average Number of Shares Outstanding, Diluted | 42,278,411 | 24,006,549 | 36,133,906 | 19,173,080 |
Condensed Consolidated Statem_2
Condensed Consolidated Statements of Stockholders' Equity (Deficit) - 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 [Member] |
Beginning Balance at Dec. 31, 2022 | $ 84,183 | $ 14 | $ 287,034 | $ (202,865) | ||
Beginning Balance, Shares at Dec. 31, 2022 | 13,776,788 | 117,970 | 6,204 | |||
Stock-based compensation | 1,381 | 1,381 | ||||
Net loss and comprehensive loss | (10,772) | (10,772) | ||||
Ending Balance at Mar. 31, 2023 | 74,792 | $ 14 | 288,415 | (213,637) | ||
Ending Balance, Shares at Mar. 31, 2023 | 13,776,788 | 117,970 | 6,204 | |||
Beginning Balance at Dec. 31, 2022 | 84,183 | $ 14 | 287,034 | (202,865) | ||
Beginning Balance, Shares at Dec. 31, 2022 | 13,776,788 | 117,970 | 6,204 | |||
Net loss and comprehensive loss | (76,532) | |||||
Ending Balance at Jun. 30, 2023 | 43,768 | $ 23 | 323,142 | (279,397) | ||
Ending Balance, Shares at Jun. 30, 2023 | 23,043,933 | 110,086 | 4,422 | |||
Beginning Balance at Mar. 31, 2023 | 74,792 | $ 14 | 288,415 | (213,637) | ||
Beginning Balance, Shares at Mar. 31, 2023 | 13,776,788 | 117,970 | 6,204 | |||
Issuance of common stock and pre-funded warrants in connection with Securities Purchase Agreement, net of issuance costs, Shares | 8,730,168 | |||||
Issuance of common stock and pre-funded warrants in connection with Securities Purchase Agreement, net of issuance costs, Value | 33,017 | $ 9 | 33,008 | |||
Issuance of common stock in connection with conversion of X non-voting convertible preferred stock, Shares | 99,000 | (1,782) | ||||
Issuance of common stock in connection with conversion of X1 non-voting convertible preferred stock, Shares | 437,977 | (7,884) | ||||
Issuance of common stock in connection with conversion of X1 non-voting convertible preferred stock, Value | (1) | |||||
Stock-based compensation | 1,720 | 1,720 | ||||
Net loss and comprehensive loss | (65,760) | (65,760) | ||||
Ending Balance at Jun. 30, 2023 | 43,768 | $ 23 | 323,142 | (279,397) | ||
Ending Balance, Shares at Jun. 30, 2023 | 23,043,933 | 110,086 | 4,422 | |||
Beginning Balance at Dec. 31, 2023 | 7,208 | $ 24 | 326,586 | (319,402) | ||
Beginning Balance, Shares at Dec. 31, 2023 | 24,213,130 | 110,086 | 4,422 | |||
Issuance of common stock in connection with exercise of pre-funded warrants, Shares | 600,000 | |||||
Issuance of common stock in connection with exercise of pre-funded warrants, Value | 1 | $ 1 | ||||
Stock-based compensation | 1,694 | 1,694 | ||||
Net loss and comprehensive loss | (23,631) | (23,631) | ||||
Ending Balance at Mar. 31, 2024 | (14,728) | $ 25 | 328,280 | (343,033) | ||
Ending Balance, Shares at Mar. 31, 2024 | 24,813,130 | 110,086 | 4,422 | |||
Beginning Balance at Dec. 31, 2023 | 7,208 | $ 24 | 326,586 | (319,402) | ||
Beginning Balance, Shares at Dec. 31, 2023 | 24,213,130 | 110,086 | 4,422 | |||
Net loss and comprehensive loss | (68,538) | |||||
Ending Balance at Jun. 30, 2024 | (8,501) | $ 39 | 379,400 | (387,940) | ||
Ending Balance, Shares at Jun. 30, 2024 | 38,506,614 | 110,086 | 4,422 | |||
Beginning Balance at Mar. 31, 2024 | (14,728) | $ 25 | 328,280 | (343,033) | ||
Beginning Balance, Shares at Mar. 31, 2024 | 24,813,130 | 110,086 | 4,422 | |||
Issuance of common stock and pre-funded warrants in connection with Securities Purchase Agreement, net of issuance costs, Shares | 13,110,484 | |||||
Issuance of common stock and pre-funded warrants in connection with Securities Purchase Agreement, net of issuance costs, Value | 48,070 | $ 13 | 48,057 | |||
Issuance of common stock in connection with exercise of pre-funded warrants, Shares | 583,000 | |||||
Issuance of common stock in connection with exercise of pre-funded warrants, Value | 1 | $ 1 | ||||
Stock-based compensation | 3,063 | 3,063 | ||||
Net loss and comprehensive loss | (44,907) | (44,907) | ||||
Ending Balance at Jun. 30, 2024 | $ (8,501) | $ 39 | $ 379,400 | $ (387,940) | ||
Ending Balance, Shares at Jun. 30, 2024 | 38,506,614 | 110,086 | 4,422 |
Condensed Consolidated Statem_3
Condensed Consolidated Statements of Cash Flows - USD ($) $ in Thousands | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2024 | Jun. 30, 2023 | Jun. 30, 2024 | Jun. 30, 2023 | |
Cash flows used in operating activities: | ||||
Net loss | $ (44,907) | $ (65,760) | $ (68,538) | $ (76,532) |
Adjustments to reconcile net loss to net cash used in operating activities: | ||||
Gain on lease termination | (10) | |||
Amortization of operating lease asset | 192 | 186 | ||
Accretion on investment discounts | (951) | (97) | ||
Stock-based compensation | 3,063 | 1,720 | 4,757 | 3,101 |
Change in fair value of warrant liabilities and fair value of financial instruments issued in excess of proceeds | 31,274 | 56,181 | 44,610 | 56,181 |
Changes in operating assets and liabilities: | ||||
Prepaid expenses and other assets | 1,347 | 791 | ||
Accounts payable, accrued expenses and other liabilities | 2,244 | (1,603) | ||
Operating lease liabilities | (166) | (172) | ||
Net cash used in operating activities | (16,515) | (18,145) | ||
Cash flows from investing activities: | ||||
Purchase of available-for-sale short-term investments | (49,230) | (30,334) | ||
Proceeds from maturities of available-for-sale short-term investments | 39,100 | |||
Net cash used in investing activities | (10,130) | (30,334) | ||
Cash flows from financing activities: | ||||
Proceeds from issuances of common stock and pre-funded warrants, net | 48,072 | 33,017 | ||
Net cash provided by financing activities | 48,072 | 33,017 | ||
Net change in cash and cash equivalents | 21,427 | (15,462) | ||
Cash and cash equivalents at beginning of period | 4,612 | 56,409 | ||
Cash and cash equivalents at end of period | $ 26,039 | $ 40,947 | 26,039 | 40,947 |
Noncash activities: | ||||
Common stock exchanged for X and X1 non-voting convertible preferred stock | $ 1 | |||
Increase in operating lease asset and liability due to new lease | $ 448 |
Pay vs Performance Disclosure
Pay vs Performance Disclosure - USD ($) $ in Thousands | 3 Months Ended | 6 Months Ended | ||||
Jun. 30, 2024 | Mar. 31, 2024 | Jun. 30, 2023 | Mar. 31, 2023 | Jun. 30, 2024 | Jun. 30, 2023 | |
Pay vs Performance Disclosure | ||||||
Net Income (Loss) | $ (44,907) | $ (23,631) | $ (65,760) | $ (10,772) | $ (68,538) | $ (76,532) |
Insider Trading Arrangements
Insider Trading Arrangements | 6 Months Ended |
Jun. 30, 2024 | |
Trading Arrangements, by Individual | |
Rule 10b5-1 Arrangement Adopted | false |
Non-Rule 10b5-1 Arrangement Adopted | false |
Rule 10b5-1 Arrangement Terminated | false |
Non-Rule 10b5-1 Arrangement Terminated | false |
Description of Business
Description of Business | 6 Months Ended |
Jun. 30, 2024 | |
Accounting Policies [Abstract] | |
Description of Business | Note 1. Description of Business Eledon Pharmaceuticals, Inc. is a clinical stage biotechnology company using its immunology expertise in targeting the CD40 Ligand (“CD40L”, or “CD154”) pathway to develop therapies to protect transplanted organs and prevent rejection, and to treat amyotrophic lateral sclerosis (“ALS”). The Company’s lead compound in development is tegoprubart, an IgG1, anti-CD40L antibody with high affinity for the CD40 Ligand, a well-validated biological target that we believe has broad therapeutic potential. 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. 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. Restatement of Previously Issued Financial Statements In the course of preparing the Company’s Condensed Consolidated Financial Statements as of and for the three and six months ended June 30, 2024, the Company determined that the Common Warrants and the Subsequent Closing Warrants (See Note 9) do not meet the conditions to be classified as equity instruments under ASC 815-40, “Derivatives and Hedging — Contracts in Entity’s Own Equity,” (“ASC 815-40”) and must instead be recorded as liabilities on the Company’s consolidated balance sheet at their fair value and remeasured at fair value for each subsequent reporting period. As a result, the Company determined that a correction was necessary with respect to the Company’s reporting and recording of the fair value of the Common Warrants and the Subsequent Closing Warrants. Certain prior period financial statements and financial information are presented herein as restated. See Note 13 for further information. |
Going Concern and Management's
Going Concern and Management's Plans | 6 Months Ended |
Jun. 30, 2024 | |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | |
Going Concern and Management's Plans | Note 2. Going Concern and Management’s Plans The accompanying condensed 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 condensed 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 $ 68.5 million for the six months ended June 30, 2024 , negative cash flows from operations of $ 16.5 million and an accumulated deficit of $ 387.9 million as of June 30, 2024, as a result of incurring losses since its inception. The Company expects to continue to incur net losses into the foreseeable future in connection with its ongoing activities, particularly as the Company expands its clinical program with tegoprubart, continues the research and development of, and seeks marketing approval for, its product candidates. In addition, if the Company obtains marketing approval for any of its product candidates, the Company expects to incur significant commercialization expenses related to product sales, marketing, manufacturing and distribution. The Company has financed operations primarily by net proceeds from the sale of preferred and common stock and warrants. On April 28, 2023, the Company entered into a Securities Purchase Agreement (the “2023 Securities Purchase Agreement”) with certain institutional and accredited investors, pursuant to which the Company agreed to issue and sell to the investors in a private placement (the “2023 Private Placement”) shares of common stock and warrants in a series of three potential closings. On May 5, 2023, the initial closing occurred and the Company received $ 35.0 million, in exchange for 8,730,168 shares of common stock, pre-funded warrants to purchase 6,421,350 shares of common stock and additional common stock warrants to purchase 15,151,518 shares of common stock (or pre-funded warrants in lieu thereof). As described in Note 12, on July 8, 2024, the Company completed the sale of 909,088 shares of its common stock, $ 0.001 par value share, pursuant to a second closing under the 2023 Securities Purchase Agreement (the "Second Closing"). The sale resulted in gross proceeds to the Company of approximately $ 2.1 million, or net proceeds of approximately $ 2.0 million after deducting offering costs. Effective with this sale, the Company is no longer obliged to sell, and investors are no longer obliged to purchase, additional shares of the Company's common stock in the Second Closing. The Company may receive up to an additional $ 58.3 million in tranche financing in a third closing, (the “Third Closing”), subject to the satisfaction or waiver of specified conditions, including achieving specified clinical development milestones, volume weighted average share price levels and trading volume conditions, and an additional $ 45.5 million assuming the exercise of all common stock warrants issued in the initial closing of the 2023 Private Placement. See Note 9. “Stockholders’ Equity (Deficit)” for further information regarding the 2023 Private Placement. On May 6, 2024, the Company entered into a Securities Purchase Agreement (the “2024 Securities Purchase Agreement”) with certain institutional and accredited investors, pursuant to which the Company agreed to issue and sell to the investors in a private placement (the “2024 Private Placement”) an aggregate of 13,110,484 shares (the “2024 Shares”) of the Company’s common stock, $ 0.001 par value per share (the “Common Stock”) at a price of $ 2.37 per share, and pre-funded warrants (the “2024 Pre-Funded Warrants”) at a price of $ 2.369 per underlying share, which are exercisable to purchase 7,989,516 shar es of common stock at an exercise price of $ 0.001 per share. The 2024 Private Placement resulted in gross proceeds to the Company of $ 50.0 million, or net proceeds of approximately $ 48.1 million after deducting offering costs . Due to the contingent nature of the exercise of the common stock warrants and the Third Closing, accounting principles generally accepted in the United States of America (“GAAP”) requires the Company to exclude them from its going concern analysis. If these events do not occur or the Company is unable to raise additional capital or is unable to do so on acceptable terms, it will be forced to significantly alter its business strategy, substantially curtail its current operations, or liquidate and cease operations altogether. As of June 30, 2024, the Company had cash and cash equivalents and short-term investments of approximately $ 83.6 million. However, in view of the Company’s expectation to incur significant losses for the foreseeable future and uncertainty with regard to the timing and amount of expenditures for progression of continued development, the Company will be required to raise additional capital to finance its operation. However, the availability of, and the Company’s access, to such resources is not assured. Accordingly, management believes that there is substantial doubt about regarding the Company’s ability to continue operating as a going concern for a year from the date these financial statements are issued. |
Summary of Significant Accounti
Summary of Significant Accounting Policies | 6 Months Ended |
Jun. 30, 2024 | |
Accounting Policies [Abstract] | |
Summary of Significant Accounting Policies | Note 3. Summary of Significant Accounting Policies Basis of Presentation The accompanying unaudited condensed consolidated financial statements have been prepared in accordance with GAAP and Article 8 of Regulation S-X requirements as set forth by the Securities and Exchange Commission (“SEC”) for interim financial information and reflect all adjustments and disclosures, which are, in the opinion of management, of a normal and recurring nature, and considered necessary for a fair presentation of the financial information contained herein. Pursuant to these rules and regulations, the unaudited condensed consolidated financial statements do not include all information and notes necessary for a complete presentation of results of operations and comprehensive loss, financial position, and cash flows in conformity with GAAP. The accompanying unaudited condensed consolidated financial statements and notes should be read in conjunction with the audited consolidated financial statements and accompanying notes of Eledon for the year ended December 31, 2023 included in the Company’s Annual Report on Form 10-K filed by the Company with the SEC on March 28, 2024, as amended on each of April 26, 2024 and August 19, 2024 (together, the “Amended Form 10-K”). The results of operations and comprehensive loss for the three and six months ended June 30, 2024 are not necessarily indicative of results expected for the full fiscal year or any other future period. Principles of Consolidation 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 condensed consolidated financial statements. All significant intercompany accounts and transactions among the entities have been eliminated from the condensed consolidated financial statements. 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 expense, warrant liabilities, the fair value of right-of-use assets and liabilities, accruals for liabilities, impairment of long-lived assets, and other matters that affect the consolidated financial statements and related disclosures. Management bases its estimates on historical experience and on various other market-specific and relevant assumptions that management believes to be reasonable under the circumstances. Actual results could differ materially from those estimates under different assumptions or conditions and the differences may be material to the consolidated financial statements. Concentration of Credit Risk Financial instruments which potentially subject the Company to significant concentration of credit risk consists of cash, cash equivalents and short-term investments. The Company maintains deposits in federally insured institutions in excess of federally insured limits and invests in short-term investments with the primary objective of seeking to preserve principal, achieve liquidity requirements and safeguard invested funds. We believe that the Company is not exposed to significant credit risk due to the financial position of the depository institution in which those deposits are held and the nature, including the credit ratings, of our cash equivalents and short-term investments, but we have not eliminated all credit risk. Cash and Cash Equivalents The Company considers all highly liquid investments with original maturities of three months or less when purchased to be cash equivalents. Cash and cash equivalents include cash in readily available checking accounts, money market funds, U.S. government securities and U.S. government agency securities. The carrying amounts reported in the unaudited condensed consolidated balance sheets for cash and cash equivalents are valued at cost, which approximates their fair value due to the short-term maturities of these investments. Risks and Uncertainties As of June 30, 2024 and December 31, 2023, all of the Company’s long-lived assets were located in the United States. 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. The Company's facilities and equipment, including those of the Company's suppliers and vendors, may be affected by natural or man-made disasters. The Company's administrative office is based in Irvine, California and the Company manages all its research and development activities through third parties that are located throughout the world. The Company has taken precautions to safeguard its facilities, equipment and systems, including insurance, health and safety protocols, and off-site storage of computer data. However, the Company's facilities and systems, as well as those of its 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 its operations, damage or destroy its equipment or inventory, and cause the Company to incur additional expenses and delay research and development activities. In addition, the insurance coverage the Company maintains may not be adequate to cover its losses in any circumstance and may not continue to be available to use on acceptable terms, or at all. In-Process Research and Development The fair values of in-process research and development (“IPR&D”) projects acquired in a business combination that are not complete are capitalized and accounted for as indefinite-lived intangible assets until completion or abandonment of the related research and development (“R&D”) efforts. Upon successful completion of the project, the capitalized amount is amortized over its estimated useful life. If a project is abandoned, all remaining capitalized amounts are written off immediately. Major risks and uncertainties are often associated with IPR&D projects because we are required to obtain regulatory approvals before marketing the resulting products. Such approvals require completing clinical trials that demonstrate a product candidate is safe and effective. Consequently, the eventual realized value of the acquired IPR&D project may vary from its fair value at the date of acquisition, and IPR&D impairment charges may occur in future periods. Capitalized IPR&D projects are tested for impairment annually and whenever events or changes in circumstances indicate that the carrying amount may not be recoverable. We consider various factors for potential impairment, including the current legal and regulatory environment and the competitive landscape. Adverse clinical trial results, significant delays in obtaining marketing approval, the inability to bring a product to market and the introduction or advancement of competitors’ products could result in partial or full impairment of the related intangible assets. 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 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 during the three and six months ended June 30, 2024 . Recently Adopted Accounting Pronouncements In December 2023, the Financial Accounting Standards Board (“FASB”) issued Accounting Standards Update (“A SU”) No. 2023-09 , Income Taxes (Topic 740): Improvements to Income Tax Disclosures. This update requires disaggregated information about a reporting entity’s effective tax rate reconciliation as well as information on income taxes paid. ASU No. 2023-09 is effective for public entities with annual periods beginning after December 15, 2024, with early adoption permitted. The Company is currently evaluating the impact of this guidance on its consolidated financial statements. In November 2023, the FASB issued ASU No. 2023-07 , Segment Reporting (Topic 280): Improvements to Reportable Segment Disclosures. This update requires public entities to disclose information about their reportable segments’ significant expenses and other segment items on an interim and annual basis. Public entities with a single reportable segment are required to apply the disclosure requirements in ASU 2023-07, as well as all existing segment disclosures and reconciliation requirements in ASC 280, on an interim and annual basis. ASU 2023-07 is effective for fiscal years beginning after December 15, 2023 and for interim periods beginning after December 15, 2024, with early adoptions permitted. The Company is currently evaluating the impact of this guidance on its consolidated financial statements. Other recent accounting pronouncements issued by the FASB (including its Emerging Issues Task Force), the American Institute of Certified Public Accountants, and the SEC did not, or are not believed by management to, have a material impact on the Company’s present or future financial position, results of operations or cash flows. Warrant Liabilities The Company accounts for issued warrants either as a liability or equity in accordance with ASC 815-40, Derivatives and Hedging — Contracts in Entity’s Own Equity (“ASC 815-40”). Under ASC 815-40, contracts that may require settlement for cash are liabilities, regardless of the probability of the occurrence of the triggering event. Liability-classified warrants are measured at fair value on the issuance date and at the end of each reporting period. Any change in the fair value of the warrants after the issuance date is recorded in the condensed consolidated statements of operations and comprehensive loss as a gain or loss. If warrants do not require liability classification under ASC 815-40, in order to conclude warrants should be classified as equity, the Company assesses whether the warrants are indexed to its common stock and whether the warrants are classified as equity under ASC 815-40 or other applicable GAAP standard. Equity-classified warrants are accounted for at fair value on the issuance date with no changes in fair value recognized after the issuance date. |
Short-Term Investments
Short-Term Investments | 6 Months Ended |
Jun. 30, 2024 | |
Investments, Debt and Equity Securities [Abstract] | |
Short-Term Investments | Note 4. Short-Term Investments The objectives of the Company’s investment policy are to preserve principal, meet the Company's liquidity requirements and safeguard invested funds. Short-term investments consist of U.S. government securities and U.S. government agency securities. The Company has classified these investments as available-for-sale securities, as the sale of such investments may be required prior to maturity to implement management strategies, and therefore has classified all investments with maturity dates beyond three months at the date of purchase as current assets in the accompanying unaudited condensed consolidated balance sheets. Any premium or discount arising at purchase is amortized and/or accreted to interest income as an adjustment to yield using the straight-line method over the life of the instrument. The amortized cost of available-for-sale securities is adjusted for amortization of premiums and accretion of discounts to maturity. Investments are reported at their estimated fair value. Unrealized gains and losses are included in accumulated other comprehensive loss as a component of stockholders' equity until realized. The following is a summary of short-term investments, which were classified as available-for-sale securities as of June 30, 2024 and December 31, 2023 (in thousands): June 30, 2024 December 31, 2023 Amortized Cost Fair Value Amortized Cost Fair Value U.S. government securities $ 47,837 $ 47,837 $ 33,213 $ 33,213 U.S. government agency securities 9,734 9,734 13,277 13,277 Total short-term investments $ 57,571 $ 57,571 $ 46,490 $ 46,490 All of the Company's available-for-sale securities have a stated maturity of less than one year. |
Fair Value Measurements
Fair Value Measurements | 6 Months Ended |
Jun. 30, 2024 | |
Text Block [Abstract] | |
Fair Value Measurements | Note 5. Fair Value Measurements Financial assets and liabilities are recorded at fair value. The Company classifies fair value measurements using a three-level hierarchy that prioritizes the inputs used to measure fair value. This hierarchy requires entities to maximize the use of observable inputs and minimize the use of unobservable inputs. The three levels of inputs used to measure fair value are as follows: • Level 1—Quoted market prices (unadjusted) in active markets for identical assets and liabilities. • Level 2—Observable inputs other than quoted market prices included in Level 1, such as quoted market prices for markets that are not active or other inputs that are observable or can be corroborated by observable market data. • 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, including certain pricing models, discounted cash flow methodologies and similar techniques that use significant unobservable inputs. These fair values are obtained from independent pricing services which utilize Level 1 and Level 2 inputs. Financial Assets The following table summarizes the Company's financial asset instruments measured at fair value on a recurring basis as of June 30, 2024 and December 31, 2023 (in thousands). Included within cash and cash equivalents on the unaudited condensed consolidated balance sheets, but excluded from the fair value hierarchy table, are cash deposits held at financial institutions. June 30, 2024 Level 1 Level 2 Level 3 Total Assets: Cash equivalents: Money market funds $ 3,949 $ — $ — $ 3,949 U.S. government securities 21,230 — — 21,230 Total cash equivalents $ 25,179 $ — $ — $ 25,179 Short-term investments: U.S. government securities $ — $ 47,837 $ — $ 47,837 U.S. government agency securities — 9,734 — 9,734 Total short-term investments $ — $ 57,571 $ — $ 57,571 Total financial assets $ 25,179 $ 57,571 $ — $ 82,750 December 31, 2023 Level 1 Level 2 Level 3 Total Assets: Cash equivalents: Money market funds $ 4,246 $ — $ — $ 4,246 Total cash equivalents $ 4,246 $ — $ — $ 4,246 Short-term investments: U.S. government securities $ — $ 33,213 $ — $ 33,213 U.S. government agency securities — 13,277 — 13,277 Total short-term investments $ — $ 46,490 $ — $ 46,490 Total financial assets $ 4,246 $ 46,490 $ — $ 50,736 Warrant Liabilities The following table summarizes the Company's warrant liabilities (see Note 9) measured at fair value on a recurring basis as of June 30, 2024 and December 31, 2023 (in thousands) and was based on significant inputs not observable in the market, which represents a Level 3 measurement within the fair value hierarchy. June 30, 2024 Level 1 Level 2 Level 3 Total Warrant liabilities $ — $ — $ 120,821 $ 120,821 December 31, 2023 Level 1 Level 2 Level 3 Total Warrant liabilities $ — $ — $ 76,211 $ 76,211 The following table provides a roll-forward of the aggregate fair value of the warrant liability categorized with Level 3 inputs: Warrants Balance as of December 31, 2023 $ 76,211 Change in fair value of warrant liabilities 44,610 Balance as of June 30, 2024 $ 120,821 The change in fair value of warrant liabilities and fair value of financial instruments issued in excess of proceeds of $ 44.6 mill ion was recorded in the condensed consolidated statement of operations and comprehensive loss for the six months ended June 30, 2024 . |
Prepaid Expenses and Other Curr
Prepaid Expenses and Other Current Assets | 6 Months Ended |
Jun. 30, 2024 | |
Prepaid Expense and Other Assets, Current [Abstract] | |
Prepaid Expenses and Other Current Assets | Note 6. Prepaid Expenses and Other Current Assets Prepaid expenses and other current assets consisted of the following as of June 30, 2024 and December 31, 2023 (in thousands): June 30, December 31, 2024 2023 Prepaid clinical $ 2,907 $ 4,128 Prepaid insurance 260 624 Prepaid other 287 185 Other current assets 157 90 Total prepaid expenses and other current assets $ 3,611 $ 5,027 |
Accrued Expenses and Other Liab
Accrued Expenses and Other Liabilities | 6 Months Ended |
Jun. 30, 2024 | |
Payables and Accruals [Abstract] | |
Accrued Expenses and Other Liabilities | Note 7. Accrued Expenses and Other Liabilities Accrued expenses and other liabilities consisted of the following as of June 30, 2024 and December 31, 2023 (in thousands): June 30, December 31, 2024 2023 Accrued compensation and related expenses $ 1,561 $ 2,003 Accrued clinical 1,248 451 Accrued professional services 94 47 Accrued other 705 44 Total accrued expenses and other liabilities $ 3,608 $ 2,545 Included in other accrued expenses and other liabilities, as of June 30, 2024 are advance deposits from certain institutional and accredited investors for the sale of common stock pursuant to the Second Closing. See Note 12. Subsequent Events for additional information. |
Commitments and Contingencies
Commitments and Contingencies | 6 Months Ended |
Jun. 30, 2024 | |
Commitments and Contingencies Disclosure [Abstract] | |
Commitments and Contingencies | Note 8. Commitments and Contingencies Operating Leases The Company leases office space under various operating leases. Total rent expense for all operating leases in the accompanying condensed consolidated statements of operations and comprehensive loss was $ 0.1 million for each of the three months ended June 30, 2024 and 2023 and $ 0.2 million for each of the six months ended June 30, 2024 and 2023. On April 19, 2024, the Company entered into a 38-month operating lease for 5,817 square feet of office space in Irvine, California, that expires on June 30, 2027 (the “Lease Agreement”). On April 19, 2024, in conjunction with the Lease Agreement, the Company terminated an existing operating lease for 5,197 square feet of office space in Irvine, California, that was set to expire on December 31, 2024 . On April 19, 2024, the effective date of the Lease Agreement, the Company recognized additional net ROU assets and lease liabilities in the amount of $ 0.5 million. 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 a remaining term of approximately 3 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 condensed consolidated balance sheet. The components of lease expense were as follows (in thousands): For the Six Months 2024 2023 Operating lease cost (a) $ 203 $ 199 (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): For the Six Months 2024 2023 Supplemental Cash Flows Information Cash paid for amounts included in the measurement of lease liabilities: Operating cash flows from operating leases $ 114 $ 181 Weighted-average remaining lease term Operating leases 1.67 years 1.45 years Discount rate Operating leases 2.12 % 2.49 % All noncancelable operating leases have remaining terms of less than one year . Future payments for these noncancelable operating leases for the remainder of the current fiscal year are as follows (in thousands): June 30, 2024 2024 (remainder of) $ 185 2025 191 2026 197 2027 100 Total minimum lease payments 673 Less imputed interest ( 18 ) Present value of lease liabilities 655 Less current portion of operating lease liabilities ( 269 ) Non-current operating lease liabilities $ 386 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 the six months ended June 30, 2024 or 2023. 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 has made a $ 0.1 million annual license maintenance fee each year since 2022. Furthermore, the Company is required to 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 will be required to 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 non-exclusive 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. 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 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. Management is not aware of any contingent liabilities requiring accrual at June 30, 2024. |
Stockholders' Equity
Stockholders' Equity | 6 Months Ended |
Jun. 30, 2024 | |
Equity [Abstract] | |
Stockholders' Equity | Note 9. Stockholders’ Equity Preferred Stock The Company has 5,000,000 authorized shares of preferred stock with a par value of $ 0.001 per share: • Series X 1 non-voting convertible preferred stock, 515,000 shares designated; 110,086 shares issued and outstanding, respectively, at each of June 30, 2024 and December 31, 2023; and • Series X non-voting convertible preferred stock, 10,000 shares designated; 4,422 shares issued and outstanding, respectively, at each of June 30, 2024 and December 31, 2023. Each share of the Series X 1 or X non-voting convertible preferred stock (the “Preferred Stock”) is convertible into 55.5556 shares of common stock, at the option of the holder at any time, subject to certain limitations, including, that the holder will be prohibited from converting the Preferred Stock into common stock if, as a result of such conversion, the holder, together with its affiliates, would beneficially own a number of shares of common stock above a conversion blocker, which is initially set at 9.99 % or 9.9 % of the total common stock then issued and outstanding immediately following the conversion of such shares of Series X Preferred Stock or Series X 1 Preferred Stock, respectively. The holder of the Preferred Stock is entitled to receive dividends on shares of the Preferred Stock equal (on an as-if-converted-to-common-stock basis and without regard to any beneficial ownership limitations) to and in the same form as dividends actually paid on shares of the common stock. No other dividends will be paid on shares of the Preferred Stock. In the event of any liquidation, dissolution or winding up, the holder of the Preferred Stock will be entitled to receive out of the assets, whether capital or surplus, the same amount that a holder of common stock would receive if the Preferred Stock were fully converted to common stock, which amounts shall be paid pari passu with all holders of common stock. Shares of the Preferred Stock will generally have no voting rights, except as required by law and except that consent of a majority of the holders of either series of outstanding Preferred Stock will be required to amend the terms of such series. 2021 Equity Distribution Agreement On March 31, 2021, the Company filed a registration statement on Form S-3 containing a prospectus and prospectus supplement under which the Company may offer and sell up to $ 75.0 million in shares of its common stock, from time to time, pursuant to an open market sale agreement with Jefferies 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 June 30, 2024 , the Company was permitted to sell up to $ 33.5 million of shares of common stock pursuant to the ATM Program under the SEC’s “baby shelf rules. ” 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. Through June 30, 2024 , no shares of common stock had been sold under the ATM program. The Form S-3 registration statement pursuant to which the ATM Program was registered expired in May 2024 and no shares of common stock were able to be sold under the ATM Program after that date. 2023 Securities Purchase Agreement On April 28, 2023, the Company entered into the 2023 Securities Purchase Agreement with certain investors, pursuant to which the Company agreed to issue and sell to the investors in the 2023 Private Placement (i) in an initial closing, (a) an aggregate of 15,151,518 shares (the “Shares”) of the Company’s common stock, $ 0.001 par value per share, or pre-funded warrants in lieu thereof (the “Pre-Funded Warrants”), and (b) common stock warrants exercisable into an aggregate of 15,151,518 shares of common stock (or Pre-Funded Warrants in lieu thereof) (the “Common Warrants” and, together with the Pre-Funded Warrants, the “Warrants”); (ii) in the Second Closing , upon the satisfaction or waiver of specified conditions set forth in the 2023 Securities Purchase Agreement, an aggregate of 20,202,024 shares of common stock (or Pre-Funded Warrants); and (iii) in the Third Closing , upon the satisfaction or waiver of specified conditions set forth in the 2023 Securities Purchase Agreement, an aggregate of 25,252,530 shares of common stock (or Pre-Funded Warrants), in each case subject to customary adjustments as provided in the 2023 Securities Purchase Agreement, Pre-Funded Warrant or Common Warrant, as applicable. Each Common Warrant has an exercise price of $ 3.00 per share and expires five years after issuance. The Pre-Funded Warrants are exercisable immediately and until exercised in full, with an exercise price of $ 0.001 per share. The Pre-Funded Warrants and Common Warrants are subject to specified beneficial ownership limitations, which are generally set at 9.99 % of the total common stock then issued and outstanding immediately following the exercise of such warrants, and provided that any beneficial ownership limitation may not exceed 19.99 % unless otherwise permitted. The Shares, the Warrants, and the shares of common stock issuable upon the exercise of the Warrants, have not been registered under the Securities Act of 1933, as amended, and were offered pursuant to the exemption from registration provided in Section 4(a)(2) under the Securities Act of 1933, as amended, and Rule 506(b) promulgated thereunder. On May 5, 2023, the initial closing occurred and the Company received $ 35.0 million, or net proceeds of approximately $ 33.0 million after deducting offering costs, in exchange for 8,730,168 shares of common stock and Pre-Funded Warrants to purchase 6,421,350 shares of common stock. As described in Note 12, on July 8, 2024, the Second Closing occurred and the Company received gross proceeds of $ 2.1 million, or net proceeds of approximately $ 2.0 million after deducting offering costs, in exchange for 909,088 shares of common stock. The Company may receive an additional $ 58.3 million upon sale of the shares to be issued in the Third Closing, subject to the satisfaction or waiver of specified conditions, including clinical development milestones and volume weighted average share price levels and trading volume conditions, and an additional $ 45.5 million assuming the exercise of all Common Warrants issued in the initial closing of the 2023 Private Placement. In connection with the 2023 Private Placement, the Company filed on May 18, 2023, a registration statement on Form S-3 (“Registration Statement”) with the SEC to register for resale the Shares and the shares of common stock issuable upon the exercise of the Warrants. The Registration Statement became effective on June 2, 2023. In August 2024, the Company concluded that the Common Warrants, and the potential issuance of Pre-Funded Warrants in lieu of additional shares of common stock in the Second and Third Closings (the “Subsequent Closing Warrants”) do not meet the conditions to be classified as equity instruments under ASC 815-40 and must instead be recorded as liabilities on the Company’s consolidated balance sheets at their fair value and remeasured at fair value for each subsequent reporting period. The valuation of the Common Warrants and the Subsequent Closing Warrants is adjusted to fair value (Level 3) at each balance sheet date until the Common Warrants and the Subsequent Closing Warrants are settled or expired. The following table presents the assumptions used in the Black-Scholes option pricing model to determine the fair value of stock options granted as of June 30, 2024 as follows: June 30, 2024 December 31, 2023 Risk-free interest rate 4.33 % 3.84 % - 3.88 % Expected volatility 91.90 % - 97.15 % 89.08 % - 94.28 % Expected term (in years) 4.0 - 5.5 4.5 - 6.0 Share price $ 2.64 $ 1.80 2024 Securities Purchase Agreement On May 6, 2024, the Company entered into a Securities Purchase Agreement (the “2024 Securities Purchase Agreement”) (see Note 9) with certain institutional and accredited investors, pursuant to which the Company agreed to issue and sell to the investors in a private placement (the “2024 Private Placement”) an aggregate of 13,110,484 shares (the “2024 Shares”) of the Company’s common stock, $ 0.001 par value per share at a price of $ 2.37 per share, and pre-funded warrants (the “2024 Pre-Funded Warrants”) at a price of $ 2.369 per underlying share, which are exercisable to purchase 7,989,516 shar es of common stock at an exercise price of $ 0.001 per share. The 2024 Pre-Funded Warrants were issued in lieu of shares of common stock and are exercisable immediately and until exercised in full. The 2024 Pre-Funded Warrants are subject to specified beneficial ownership limitations (equal to 4.99 % or 9.99 % as determined by holder of each such warrant) of the total common stock then issued and outstanding immediately following the exercise of such warrants, and provided that any beneficial ownership limitation may not exceed 19.99 % unless otherwise permitted. The 2024 Pre-Funded Warrants were classified as a component of permanent stockholders’ equity within additional paid-in-capital. The 2024 Pre-Funded Warrants are equity classified because they are freestanding financial instruments that are legally detachable and separately exercisable from the equity instruments, are immediately exercisable, do not embody an obligation for the Company to repurchase its shares, permit the holders to receive a fixed number of common shares upon exercise, are indexed to the Company’s common stock and meet the equity classification criteria. In addition, the 2024 Pre-Funded Warrants do not provide any guarantee of value or return. The 2024 Private Placement resulted in gross proceeds to the Company of $ 50.0 million, or net proceeds of approximately $ 48.1 million after deducting offering costs . The Company intends to use the net proceeds from the 2024 Private Placement to fund pre-commercial activities for its products and general corporate purposes. In connection with the 2024 Private Placement, the Company filed on May 24, 2024, a registration statement on Form S-3 (“Registration Statement”) with the SEC to register for resale the Shares and the shares of common stock issuable upon the exercise of the Warrants. The Registration Statement became effective on June 5, 2024. 2023 Conversion Agreement of Non-Voting Convertible Preferred Stock On May 16, 2023, Cormorant Global Healthcare Master Fund LP provided notice to convert (i) 1,782 shares of Series X Non-Voting Convertible Preferred Stock for 99,000 shares of common stock in accordance with the Certificate of Designation of Preferences, Rights and Limitations of the Series X Non-Voting Convertible Preferred Stock, and (ii) 7,883.586 shares of Series X 1 Non-Voting Convertible Preferred Stock for 437,977 shares of common stock in accordance with the Certificate of Designation of Preferences, Rights and Limitations of the Series X 1 Non-Voting Convertible Preferred Stock. The conversion was completed on May 23, 2023. Exercise of Pre-Funded Warrants from 2023 Securities Purchase Agreement On July 10, 2023, Armistice Capital Master Fund Ltd. (the “Exercising Stockholder”) exercised Pre-Funded Warrants to purchase 501,197 shares of common stock at an exercise price of $ 0.001 per share, which were issued in conjunction with the 2023 Securities Purchase Agreement. On July 14, 2023, the Company issued 501,197 shares of common stock to the Exercising Stockholder in accordance with such exercise. On November 2, 2023, the Exercising Stockholder exercised Pre-Funded Warrants to purchase 653,000 shares of common stock at an exercise price of $ 0.001 per share, which were issued in conjunction with the 2023 Securities Purchase Agreement. On November 6, 2023, the Company issued 653,000 shares of common stock to the Exercising Stockholder in accordance with such exercise. On January 30, 2024, the Exercising Stockholder exercised Pre-Funded Warrants to purchase 600,000 shares of common stock at an exercise price of $ 0.001 per share, which were issued in conjunction with the 2023 Securities Purchase Agreement. On January 30, 2024, the Company issued 600,000 shares of common stock to the Exercising Stockholder in accordance with such exercise. On May 7, 2024, the Exercising Stockholder exercised Pre-Funded Warrants to purchase 583,000 shares of common stock at an exercise price of $ 0.001 per share, which were issued in conjunction with the 2023 Securities Purchase Agreement. On May 9, 2024, the Company issued 583,000 shares of common stock to the Exercising Stockholder in accordance with such exercise. Common Stock Warrants As of June 30, 2024 , there were 28,361,237 warrants exercisable into common stock (after rounding for fractional shares and subject to beneficial ownership limitations). The following table shows the warrants to purchase common stock activity: Roll-Forward of Warrant Activity Common Stock Warrants Pre-Funded Warrants All Other Warrants Total Balance as of December 31, 2023 15,151,518 5,776,270 636,514 21,564,302 Issued — 7,989,516 — 7,989,516 Exercised — ( 1,183,000 ) — ( 1,183,000 ) Cancelled/Expired — — ( 9,581 ) ( 9,581 ) Balance as of June 30, 2024 15,151,518 12,582,786 626,933 28,361,237 Preferred Stock Warrants As of June 30, 2024 , there were 50,207.419 warrants exercisable into Series X 1 Non-Voting Convertible Preferred Stock, which are convertible into 2,789,301 shares of common stock (after rounding for fractional shares and subject to beneficial ownership conversion limitations). Roll-Forward of Series X 1 Non-Voting Convertible Preferred Warrant Activity Total Balance as of December 31, 2023 50,207.419 Issued — Exercised — Balance as of June 30, 2024 50,207.419 |
Stock-based Compensation
Stock-based Compensation | 6 Months Ended |
Jun. 30, 2024 | |
Share-Based Payment Arrangement [Abstract] | |
Stock-Based Compensation | Note 10. 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 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 the extended range of time of 12 to 18 months that 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 (“RSUs”) are measured and recognized based on the quoted market price of our common stock on the date of grant. As described in Note 12, on July 10, 2024, the Company held its Annual Meeting of Stockholders (the “Annual Meeting”). At the Annual Meeting, the Company’s stockholders approved an amendment to the Company's 2020 Long Term Incentive Plan (the “2020 Plan”). The 2020 Plan, as amended, (i) reflects an increase in the limit on the aggregate number of shares of the Company’s common stock that may be delivered pursuant to all awards granted under the 2020 Incentive Plan by an additional 3,500,000 shares so that the new aggregate share limit under the 2020 Plan is 17,960,000 shares, and (ii) extends the date through which the Company may grant new awards under the 2020 Plan from November 15, 2030 to April 28, 2034. On May 1, 2023, the Company issued stock option awards to its employees with both time-based and performance-based vesting requirements, totaling 7,381,857 stock options, with 1,476,372 of the granted stock options subject to the Company’s customary time-based vesting schedule. The remaining 5,905,485 stock options granted are subject to both customary time-based vesting requirements and performance-based vesting requirements that are based on the same clinical development milestones applicable to the Second and Third Closings of the 2023 Private Placement as specified in the 2023 Securities Purchase Agreement. In December 2023, the Company amended the performance-based vesting requirements with its named executive officers and other employees that upon the Second Closing and Third Closing, a full or prorated amount of each closing installment shall vest based on the percentage of funding received relative to the total funding opportunity represented by the investors’ Second Closing and Third Closing subscription amounts. On June 13, 2024, the performance-based vesting requirement based on the milestones applicable to the Second Closing were satisfied, and 1,980,952 stock options were granted. The 2014 Plan was closed to new grants following the initial approval of the 2020 Plan, and therefore, there were no shares reserved for issuance under the 2014 Plan as of June 30, 2024 . The number of shares reserved for issuance under the 2020 Plan and ESPP was 2,988,117 and 24,077 shares, respectively, as of June 30, 2024. Total stock-based compensation expense was recognized in our condensed consolidated statements of operations and comprehensive loss as follows (in thousands): For the Three Months For the Six Months 2024 2023 2024 2023 Research and development $ 816 $ 455 $ 1,166 $ 852 General and administrative 2,247 1,265 3,591 2,249 Total stock-based compensation $ 3,063 $ 1,720 $ 4,757 $ 3,101 |
Net Loss Per Share
Net Loss Per Share | 6 Months Ended |
Jun. 30, 2024 | |
Earnings Per Share [Abstract] | |
Net Loss Per Share | Note 11. 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, incentive stock options, restricted stock units 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 three and six months ended June 30, 2024 and 2023 include 12,582,786 and 6,930,467 , reflectively, shares underlying pre-funded warrants to purchase common shares. As the shares underlying these pre-funded 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. For the Three Months For the Six Months 2024 2023 2024 2023 (In thousands, except share and per share data) (As Restated) (As Restated) Net loss used in the calculation of basic and diluted loss per share $ ( 44,907 ) $ ( 65,760 ) $ ( 68,538 ) $ ( 76,532 ) Net loss per share, basic and diluted $ ( 1.06 ) $ ( 2.74 ) $ ( 1.90 ) $ ( 3.99 ) Weighted-average number of common shares, basic and diluted 42,278,411 24,006,549 36,133,906 19,173,080 The computation of diluted earnings per share exclude s incentive stock options, restricted stock units and warrants that are anti-dilutive. The following table provides a summary as of June 30, 2024 and 2023 of common share equivalents that were excluded because their inclusion would have been anti-dilutive. For the Six Months 2024 2023 Stock options outstanding and other equity awards 15,223,757 6,686,360 Common and preferred warrants outstanding 18,567,751 18,577,332 Total 33,791,508 25,263,692 |
Subsequent Events
Subsequent Events | 3 Months Ended |
Mar. 31, 2024 | |
Subsequent Events [Abstract] | |
Subsequent Events | Note 12. Subsequent Events Second Closing of 2023 Securities Purchase Agreement On July 8, 2024, the Company completed the sale of 909,088 shares of its common stock, $ 0.001 par value share, pursuant to the Second Closing under the 2023 Securities Purchase Agreement. The sale resulted in gross proceeds to the Company of approximately $ 2.1 million or net proceeds of approximately $ 2.0 million after deducting offering costs. This sale resulted in a $ 43.9 million reduction to warrant liabilities and a $ 43.9 million change in fair value of warrant liabilities and fair value of financial instruments issued in excess of proceeds on the condensed consolidated statement of operations. Amendment to the 2020 Long Term Incentive Plan On July 10, 2024, the Company held its Annual Meeting and the Company's stockholders approved an amendment to the 2020 Plan. The 2020 Plan, as amended, (i) reflects an increase in the limit on the aggregate number of shares of the Company's common stock that may be delivered pursuant to all awards granted under the 2020 Plan by an additional 3,500,000 shares so that the new aggregate share limit under the 2020 Plan is 17,960,000 shares, and (ii) extends the date through which the Company may grant new awards under the 2020 Plan from April 26, 2033 to May 28, 2034. Exercise of Pre-Funded Warrants Issued Pursuant to 2023 Securities Purchase Agreement On July 11, 2024, the Exercising Stockholder, exercised Pre-Funded Warrants to purchase 240,000 shares of common stock at an exercise price of $ 0.001 per share, which were issued in conjunction with the 2023 Securities Purchase Agreement. The Company issued 240,000 shares of common stock to the Exercising Stockholder in accordance with such exercise. |
Restatement of Previously Issue
Restatement of Previously Issued Consolidated Financial Statements | 6 Months Ended |
Jun. 30, 2024 | |
Prior Period Adjustment [Abstract] | |
Restatement of Previously Issued Consolidated Financial Statements | Note 13. Restatement of Previously Issued Consolidated Financial Statements In the course of preparing the Company’s Condensed Consolidated Financial Statements as of and for the three and six months ended June 30, 2024, the Company determined that a correction was necessary with respect to the Company’s reporting and recording of the fair value of the Common Warrants and the Subsequent Closing Warrants, issuable by the Company in the Second and Third Closing contingent upon the satisfaction or waiver of certain specified conditions set forth therein (See Note 9). The Company has historically reported the Common Warrants and Subsequent Closing Warrants as equity instruments, because (i) of the respective holders’ ability to settle the Common Warrants and Subsequent Closing Warrants by issuance of a fixed number of shares of common stock or Pre-funded Warrants and (ii) the Common Warrants and Subsequent Closing Warrants contain a fixed exercise price and contain no cash settlement obligation. However, in the course of preparing the Company’s Condensed Consolidated Financial Statements as of and for the three and six months ended June 30, 2024, management of the Company concluded that the Common Warrants and the Subsequent Closing Warrants do not meet the conditions to be classified as equity instruments under ASC 815-40, and must instead be recorded as liabilities on the Company’s balance sheet at their fair value and remeasured at fair value for each subsequent reporting period, with the initial fair value and fair value of financial instruments issued in excess of proceeds and any change in fair value recorded in the condensed consolidated statements of operations and comprehensive income as a gain or loss. Management prepared a quantitative and qualitative analysis of the errors in accordance with the U.S. SEC Staff's Accounting Bulletin Nos. 99 and 108, Materiality, and concluded the impact of the errors are material to the Company's previously reported interim unaudited condensed consolidated financial statements as of and for the three and six months ended June 30, 2023. As a result, the Company has restated its Condensed Consolidated Balance Sheet, Condensed Consolidated Statement of Operations and Comprehensive Loss, Condensed Consolidated Statement of Stockholders' Equity, and Condensed Consolidated Statement of Cash Flows as of and for the three and six months ended June 30, 2023. The restatement includes adjustments to Change in fair value of warrant liabilities and fair value of financial instruments issued in excess of proceeds, Additional paid-in capital, and Accumulated Deficit. The impact of the correction of the misstatements is summarized below (in thousands): As of June 30, 2023 Corrected Condensed Consolidated Balance Sheets (Unaudited) As Previously Reported Restatement Impact As Restated Warrant liabilities — 56,181 56,181 Total liabilities 6,836 56,181 63,017 Common stock 23 — 23 Additional paid-in capital 323,142 — 323,142 Accumulated deficit ( 223,216 ) ( 56,181 ) ( 279,397 ) Total Stockholders' Equity $ 99,949 $ ( 56,181 ) $ 43,768 For the Three Months Ended For the Six Months Ended Corrected Condensed Consolidated Statements of Operations and Comprehensive Loss (Unaudited) As Restatement As As Restatement As Change in fair value of warrant liabilities and fair value of financial instruments issued in excess of proceeds — ( 56,181 ) ( 56,181 ) — ( 56,181 ) ( 56,181 ) Net loss and comprehensive loss $ ( 9,579 ) $ ( 56,181 ) $ ( 65,760 ) $ ( 20,351 ) $ ( 56,181 ) $ ( 76,532 ) Net loss per share, basic and diluted $ ( 0.40 ) $ ( 2.34 ) $ ( 2.74 ) $ ( 1.06 ) $ ( 2.93 ) $ ( 3.99 ) For the Six Months Ended June 30, 2023 Accumulated Deficit Total Stockholders' Equity Corrected Condensed Consolidated Statements of Stockholders' Equity (Unaudited) As Restatement As As Restatement As Balance as of December 31, 2022 $ ( 202,865 ) $ — $ ( 202,865 ) $ 84,183 $ — $ 84,183 Stock-based compensation — — — 1,381 — 1,381 Net loss and comprehensive loss ( 10,772 ) — ( 10,772 ) ( 10,772 ) — ( 10,772 ) Balance as of March 31, 2023 $ ( 213,637 ) $ — $ ( 213,637 ) $ 74,792 $ — $ 74,792 Issuance of common stock and pre-funded warrants in connection with Securities Purchase Agreement, net of issuance costs — — — 33,017 — 33,017 Stock-based compensation — — — 1,720 — 1,720 Net loss and comprehensive loss ( 9,579 ) ( 56,181 ) ( 65,760 ) ( 9,579 ) ( 56,181 ) ( 65,760 ) Balance as of June 30, 2023 $ ( 223,216 ) $ ( 56,181 ) $ ( 279,397 ) $ 99,949 $ ( 56,181 ) $ 43,768 For the Six Months Ended June 30, 2023 Corrected Condensed Consolidated Statements of Cash Flows (Unaudited) As Previously Reported Restatement Impact As Restated Net loss $ ( 20,351 ) $ ( 56,181 ) $ ( 76,532 ) Change in fair value of warrant liabilities and fair value of financial instruments issued in excess of proceeds — 56,181 56,181 Net cash used in operating activities $ ( 18,145 ) $ — $ ( 18,145 ) |
Summary of Significant Accoun_2
Summary of Significant Accounting Policies (Policies) | 6 Months Ended |
Jun. 30, 2024 | |
Accounting Policies [Abstract] | |
Basis of Presentation | Basis of Presentation The accompanying unaudited condensed consolidated financial statements have been prepared in accordance with GAAP and Article 8 of Regulation S-X requirements as set forth by the Securities and Exchange Commission (“SEC”) for interim financial information and reflect all adjustments and disclosures, which are, in the opinion of management, of a normal and recurring nature, and considered necessary for a fair presentation of the financial information contained herein. Pursuant to these rules and regulations, the unaudited condensed consolidated financial statements do not include all information and notes necessary for a complete presentation of results of operations and comprehensive loss, financial position, and cash flows in conformity with GAAP. The accompanying unaudited condensed consolidated financial statements and notes should be read in conjunction with the audited consolidated financial statements and accompanying notes of Eledon for the year ended December 31, 2023 included in the Company’s Annual Report on Form 10-K filed by the Company with the SEC on March 28, 2024, as amended on each of April 26, 2024 and August 19, 2024 (together, the “Amended Form 10-K”). The results of operations and comprehensive loss for the three and six months ended June 30, 2024 are not necessarily indicative of results expected for the full fiscal year or any other future period. |
Principles of Consolidation | Principles of Consolidation 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 condensed consolidated financial statements. All significant intercompany accounts and transactions among the entities have been eliminated from the condensed consolidated financial statements. |
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 expense, warrant liabilities, the fair value of right-of-use assets and liabilities, accruals for liabilities, impairment of long-lived assets, and other matters that affect the consolidated financial statements and related disclosures. Management bases its estimates on historical experience and on various other market-specific and relevant assumptions that management believes to be reasonable under the circumstances. Actual results could differ materially from those estimates under different assumptions or conditions and the differences may be material to the consolidated financial statements. |
Concentration of Credit Risk | Concentration of Credit Risk Financial instruments which potentially subject the Company to significant concentration of credit risk consists of cash, cash equivalents and short-term investments. The Company maintains deposits in federally insured institutions in excess of federally insured limits and invests in short-term investments with the primary objective of seeking to preserve principal, achieve liquidity requirements and safeguard invested funds. We believe that the Company is not exposed to significant credit risk due to the financial position of the depository institution in which those deposits are held and the nature, including the credit ratings, of our cash equivalents and short-term investments, but we have not eliminated all credit risk. |
Cash and Cash Equivalents | Cash and Cash Equivalents The Company considers all highly liquid investments with original maturities of three months or less when purchased to be cash equivalents. Cash and cash equivalents include cash in readily available checking accounts, money market funds, U.S. government securities and U.S. government agency securities. The carrying amounts reported in the unaudited condensed consolidated balance sheets for cash and cash equivalents are valued at cost, which approximates their fair value due to the short-term maturities of these investments. |
Risks and Uncertainties | Risks and Uncertainties As of June 30, 2024 and December 31, 2023, all of the Company’s long-lived assets were located in the United States. 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. The Company's facilities and equipment, including those of the Company's suppliers and vendors, may be affected by natural or man-made disasters. The Company's administrative office is based in Irvine, California and the Company manages all its research and development activities through third parties that are located throughout the world. The Company has taken precautions to safeguard its facilities, equipment and systems, including insurance, health and safety protocols, and off-site storage of computer data. However, the Company's facilities and systems, as well as those of its 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 its operations, damage or destroy its equipment or inventory, and cause the Company to incur additional expenses and delay research and development activities. In addition, the insurance coverage the Company maintains may not be adequate to cover its losses in any circumstance and may not continue to be available to use on acceptable terms, or at all. |
In-Process Research and Development | In-Process Research and Development The fair values of in-process research and development (“IPR&D”) projects acquired in a business combination that are not complete are capitalized and accounted for as indefinite-lived intangible assets until completion or abandonment of the related research and development (“R&D”) efforts. Upon successful completion of the project, the capitalized amount is amortized over its estimated useful life. If a project is abandoned, all remaining capitalized amounts are written off immediately. Major risks and uncertainties are often associated with IPR&D projects because we are required to obtain regulatory approvals before marketing the resulting products. Such approvals require completing clinical trials that demonstrate a product candidate is safe and effective. Consequently, the eventual realized value of the acquired IPR&D project may vary from its fair value at the date of acquisition, and IPR&D impairment charges may occur in future periods. Capitalized IPR&D projects are tested for impairment annually and whenever events or changes in circumstances indicate that the carrying amount may not be recoverable. We consider various factors for potential impairment, including the current legal and regulatory environment and the competitive landscape. Adverse clinical trial results, significant delays in obtaining marketing approval, the inability to bring a product to market and the introduction or advancement of competitors’ products could result in partial or full impairment of the related intangible assets. |
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 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 during the three and six months ended June 30, 2024 . |
Recently Adopted Accounting Pronouncements | Recently Adopted Accounting Pronouncements In December 2023, the Financial Accounting Standards Board (“FASB”) issued Accounting Standards Update (“A SU”) No. 2023-09 , Income Taxes (Topic 740): Improvements to Income Tax Disclosures. This update requires disaggregated information about a reporting entity’s effective tax rate reconciliation as well as information on income taxes paid. ASU No. 2023-09 is effective for public entities with annual periods beginning after December 15, 2024, with early adoption permitted. The Company is currently evaluating the impact of this guidance on its consolidated financial statements. In November 2023, the FASB issued ASU No. 2023-07 , Segment Reporting (Topic 280): Improvements to Reportable Segment Disclosures. This update requires public entities to disclose information about their reportable segments’ significant expenses and other segment items on an interim and annual basis. Public entities with a single reportable segment are required to apply the disclosure requirements in ASU 2023-07, as well as all existing segment disclosures and reconciliation requirements in ASC 280, on an interim and annual basis. ASU 2023-07 is effective for fiscal years beginning after December 15, 2023 and for interim periods beginning after December 15, 2024, with early adoptions permitted. The Company is currently evaluating the impact of this guidance on its consolidated financial statements. Other recent accounting pronouncements issued by the FASB (including its Emerging Issues Task Force), the American Institute of Certified Public Accountants, and the SEC did not, or are not believed by management to, have a material impact on the Company’s present or future financial position, results of operations or cash flows. |
Warrant Liabilities | Warrant Liabilities The Company accounts for issued warrants either as a liability or equity in accordance with ASC 815-40, Derivatives and Hedging — Contracts in Entity’s Own Equity (“ASC 815-40”). Under ASC 815-40, contracts that may require settlement for cash are liabilities, regardless of the probability of the occurrence of the triggering event. Liability-classified warrants are measured at fair value on the issuance date and at the end of each reporting period. Any change in the fair value of the warrants after the issuance date is recorded in the condensed consolidated statements of operations and comprehensive loss as a gain or loss. If warrants do not require liability classification under ASC 815-40, in order to conclude warrants should be classified as equity, the Company assesses whether the warrants are indexed to its common stock and whether the warrants are classified as equity under ASC 815-40 or other applicable GAAP standard. Equity-classified warrants are accounted for at fair value on the issuance date with no changes in fair value recognized after the issuance date. |
Short-Term Investments (Tables)
Short-Term Investments (Tables) | 6 Months Ended |
Jun. 30, 2024 | |
Investments, Debt and Equity Securities [Abstract] | |
Summary of Short-term Investments Classified as Available-for-sale Securities | The following is a summary of short-term investments, which were classified as available-for-sale securities as of June 30, 2024 and December 31, 2023 (in thousands): June 30, 2024 December 31, 2023 Amortized Cost Fair Value Amortized Cost Fair Value U.S. government securities $ 47,837 $ 47,837 $ 33,213 $ 33,213 U.S. government agency securities 9,734 9,734 13,277 13,277 Total short-term investments $ 57,571 $ 57,571 $ 46,490 $ 46,490 |
Fair Value Measurements (Tables
Fair Value Measurements (Tables) | 6 Months Ended |
Jun. 30, 2024 | |
Table Text Block Supplement [Abstract] | |
Financial Instruments Measured At Fair Value On A Recurring Basis | The following table summarizes the Company's financial asset instruments measured at fair value on a recurring basis as of June 30, 2024 and December 31, 2023 (in thousands). Included within cash and cash equivalents on the unaudited condensed consolidated balance sheets, but excluded from the fair value hierarchy table, are cash deposits held at financial institutions. June 30, 2024 Level 1 Level 2 Level 3 Total Assets: Cash equivalents: Money market funds $ 3,949 $ — $ — $ 3,949 U.S. government securities 21,230 — — 21,230 Total cash equivalents $ 25,179 $ — $ — $ 25,179 Short-term investments: U.S. government securities $ — $ 47,837 $ — $ 47,837 U.S. government agency securities — 9,734 — 9,734 Total short-term investments $ — $ 57,571 $ — $ 57,571 Total financial assets $ 25,179 $ 57,571 $ — $ 82,750 December 31, 2023 Level 1 Level 2 Level 3 Total Assets: Cash equivalents: Money market funds $ 4,246 $ — $ — $ 4,246 Total cash equivalents $ 4,246 $ — $ — $ 4,246 Short-term investments: U.S. government securities $ — $ 33,213 $ — $ 33,213 U.S. government agency securities — 13,277 — 13,277 Total short-term investments $ — $ 46,490 $ — $ 46,490 Total financial assets $ 4,246 $ 46,490 $ — $ 50,736 |
Summary of Warrant Liabilities Measured at Fair Value on a Recurring Basis | The following table summarizes the Company's warrant liabilities (see Note 9) measured at fair value on a recurring basis as of June 30, 2024 and December 31, 2023 (in thousands) and was based on significant inputs not observable in the market, which represents a Level 3 measurement within the fair value hierarchy. June 30, 2024 Level 1 Level 2 Level 3 Total Warrant liabilities $ — $ — $ 120,821 $ 120,821 December 31, 2023 Level 1 Level 2 Level 3 Total Warrant liabilities $ — $ — $ 76,211 $ 76,211 |
Schedule of Aggregate Fair Values of Warrant Liability | The following table provides a roll-forward of the aggregate fair value of the warrant liability categorized with Level 3 inputs: Warrants Balance as of December 31, 2023 $ 76,211 Change in fair value of warrant liabilities 44,610 Balance as of June 30, 2024 $ 120,821 The change in fair value of warrant liabilities and fair value of financial instruments issued in excess of proceeds of $ 44.6 mill ion was recorded in the condensed consolidated statement of operations and comprehensive loss for the six months ended June 30, 2024 . |
Prepaid Expenses and Other Cu_2
Prepaid Expenses and Other Current Assets (Tables) | 6 Months Ended |
Jun. 30, 2024 | |
Prepaid Expense and Other Assets, Current [Abstract] | |
Prepaid Expenses and Other Current Assets | Prepaid expenses and other current assets consisted of the following as of June 30, 2024 and December 31, 2023 (in thousands): June 30, December 31, 2024 2023 Prepaid clinical $ 2,907 $ 4,128 Prepaid insurance 260 624 Prepaid other 287 185 Other current assets 157 90 Total prepaid expenses and other current assets $ 3,611 $ 5,027 |
Accrued Expenses and Other Li_2
Accrued Expenses and Other Liabilities (Tables) | 6 Months Ended |
Jun. 30, 2024 | |
Payables and Accruals [Abstract] | |
Schedule of Accrued Expenses and Other Liabilities | Accrued expenses and other liabilities consisted of the following as of June 30, 2024 and December 31, 2023 (in thousands): June 30, December 31, 2024 2023 Accrued compensation and related expenses $ 1,561 $ 2,003 Accrued clinical 1,248 451 Accrued professional services 94 47 Accrued other 705 44 Total accrued expenses and other liabilities $ 3,608 $ 2,545 Included in other accrued expenses and other liabilities, as of June 30, 2024 are advance deposits from certain institutional and accredited investors for the sale of common stock pursuant to the Second Closing. See Note 12. Subsequent Events for additional information. |
Commitments and Contingencies (
Commitments and Contingencies (Tables) | 6 Months Ended |
Jun. 30, 2024 | |
Commitments and Contingencies Disclosure [Abstract] | |
Components of Lease Expense | The components of lease expense were as follows (in thousands): For the Six Months 2024 2023 Operating lease cost (a) $ 203 $ 199 (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): For the Six Months 2024 2023 Supplemental Cash Flows Information Cash paid for amounts included in the measurement of lease liabilities: Operating cash flows from operating leases $ 114 $ 181 Weighted-average remaining lease term Operating leases 1.67 years 1.45 years Discount rate Operating leases 2.12 % 2.49 % |
Schedule of Future Payments Under Noncancelable Operating Leases | All noncancelable operating leases have remaining terms of less than one year . Future payments for these noncancelable operating leases for the remainder of the current fiscal year are as follows (in thousands): June 30, 2024 2024 (remainder of) $ 185 2025 191 2026 197 2027 100 Total minimum lease payments 673 Less imputed interest ( 18 ) Present value of lease liabilities 655 Less current portion of operating lease liabilities ( 269 ) Non-current operating lease liabilities $ 386 |
Stockholders' Equity (Tables)
Stockholders' Equity (Tables) | 6 Months Ended |
Jun. 30, 2024 | |
Class Of Stock [Line Items] | |
Schedule of Assumptions Used in Black-Scholes Option Pricing Model to Determine 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 as of June 30, 2024 as follows: June 30, 2024 December 31, 2023 Risk-free interest rate 4.33 % 3.84 % - 3.88 % Expected volatility 91.90 % - 97.15 % 89.08 % - 94.28 % Expected term (in years) 4.0 - 5.5 4.5 - 6.0 Share price $ 2.64 $ 1.80 |
Common Stock Warrants [Member] | |
Class Of Stock [Line Items] | |
Schedule of Warrant Activity | The following table shows the warrants to purchase common stock activity: Roll-Forward of Warrant Activity Common Stock Warrants Pre-Funded Warrants All Other Warrants Total Balance as of December 31, 2023 15,151,518 5,776,270 636,514 21,564,302 Issued — 7,989,516 — 7,989,516 Exercised — ( 1,183,000 ) — ( 1,183,000 ) Cancelled/Expired — — ( 9,581 ) ( 9,581 ) Balance as of June 30, 2024 15,151,518 12,582,786 626,933 28,361,237 |
Preferred Stock Warrants [Member] | |
Class Of Stock [Line Items] | |
Schedule of Warrant Activity | As of June 30, 2024 , there were 50,207.419 warrants exercisable into Series X 1 Non-Voting Convertible Preferred Stock, which are convertible into 2,789,301 shares of common stock (after rounding for fractional shares and subject to beneficial ownership conversion limitations). Roll-Forward of Series X 1 Non-Voting Convertible Preferred Warrant Activity Total Balance as of December 31, 2023 50,207.419 Issued — Exercised — Balance as of June 30, 2024 50,207.419 |
Stock-Based Compensation (Table
Stock-Based Compensation (Tables) | 6 Months Ended |
Jun. 30, 2024 | |
Share-Based Payment Arrangement [Abstract] | |
Schedule of Stock-Based Compensation Expense Recognized | Total stock-based compensation expense was recognized in our condensed consolidated statements of operations and comprehensive loss as follows (in thousands): For the Three Months For the Six Months 2024 2023 2024 2023 Research and development $ 816 $ 455 $ 1,166 $ 852 General and administrative 2,247 1,265 3,591 2,249 Total stock-based compensation $ 3,063 $ 1,720 $ 4,757 $ 3,101 |
Net Loss Per Share (Tables)
Net Loss Per Share (Tables) | 6 Months Ended |
Jun. 30, 2024 | |
Earnings Per Share [Abstract] | |
Schedule of Common Share Equivalents Included from Computation of Net Loss Per Share | basic and diluted net loss per share was the same for the periods presented due to the Company’s net loss position. For the Three Months For the Six Months 2024 2023 2024 2023 (In thousands, except share and per share data) (As Restated) (As Restated) Net loss used in the calculation of basic and diluted loss per share $ ( 44,907 ) $ ( 65,760 ) $ ( 68,538 ) $ ( 76,532 ) Net loss per share, basic and diluted $ ( 1.06 ) $ ( 2.74 ) $ ( 1.90 ) $ ( 3.99 ) Weighted-average number of common shares, basic and diluted 42,278,411 24,006,549 36,133,906 19,173,080 |
Summary of Common Share Equivalents were excluded because the Inclusion is Anti-dilutive | The computation of diluted earnings per share exclude s incentive stock options, restricted stock units and warrants that are anti-dilutive. The following table provides a summary as of June 30, 2024 and 2023 of common share equivalents that were excluded because their inclusion would have been anti-dilutive. For the Six Months 2024 2023 Stock options outstanding and other equity awards 15,223,757 6,686,360 Common and preferred warrants outstanding 18,567,751 18,577,332 Total 33,791,508 25,263,692 |
Restatement of Previously Iss_2
Restatement of Previously Issued Consolidated Financial Statements (Tables) | 6 Months Ended |
Jun. 30, 2024 | |
Prior Period Adjustment [Abstract] | |
Summary of Impact of Correction of Misstatements | The impact of the correction of the misstatements is summarized below (in thousands): As of June 30, 2023 Corrected Condensed Consolidated Balance Sheets (Unaudited) As Previously Reported Restatement Impact As Restated Warrant liabilities — 56,181 56,181 Total liabilities 6,836 56,181 63,017 Common stock 23 — 23 Additional paid-in capital 323,142 — 323,142 Accumulated deficit ( 223,216 ) ( 56,181 ) ( 279,397 ) Total Stockholders' Equity $ 99,949 $ ( 56,181 ) $ 43,768 For the Three Months Ended For the Six Months Ended Corrected Condensed Consolidated Statements of Operations and Comprehensive Loss (Unaudited) As Restatement As As Restatement As Change in fair value of warrant liabilities and fair value of financial instruments issued in excess of proceeds — ( 56,181 ) ( 56,181 ) — ( 56,181 ) ( 56,181 ) Net loss and comprehensive loss $ ( 9,579 ) $ ( 56,181 ) $ ( 65,760 ) $ ( 20,351 ) $ ( 56,181 ) $ ( 76,532 ) Net loss per share, basic and diluted $ ( 0.40 ) $ ( 2.34 ) $ ( 2.74 ) $ ( 1.06 ) $ ( 2.93 ) $ ( 3.99 ) For the Six Months Ended June 30, 2023 Accumulated Deficit Total Stockholders' Equity Corrected Condensed Consolidated Statements of Stockholders' Equity (Unaudited) As Restatement As As Restatement As Balance as of December 31, 2022 $ ( 202,865 ) $ — $ ( 202,865 ) $ 84,183 $ — $ 84,183 Stock-based compensation — — — 1,381 — 1,381 Net loss and comprehensive loss ( 10,772 ) — ( 10,772 ) ( 10,772 ) — ( 10,772 ) Balance as of March 31, 2023 $ ( 213,637 ) $ — $ ( 213,637 ) $ 74,792 $ — $ 74,792 Issuance of common stock and pre-funded warrants in connection with Securities Purchase Agreement, net of issuance costs — — — 33,017 — 33,017 Stock-based compensation — — — 1,720 — 1,720 Net loss and comprehensive loss ( 9,579 ) ( 56,181 ) ( 65,760 ) ( 9,579 ) ( 56,181 ) ( 65,760 ) Balance as of June 30, 2023 $ ( 223,216 ) $ ( 56,181 ) $ ( 279,397 ) $ 99,949 $ ( 56,181 ) $ 43,768 For the Six Months Ended June 30, 2023 Corrected Condensed Consolidated Statements of Cash Flows (Unaudited) As Previously Reported Restatement Impact As Restated Net loss $ ( 20,351 ) $ ( 56,181 ) $ ( 76,532 ) Change in fair value of warrant liabilities and fair value of financial instruments issued in excess of proceeds — 56,181 56,181 Net cash used in operating activities $ ( 18,145 ) $ — $ ( 18,145 ) |
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 ($) $ / shares in Units, $ in Thousands | 3 Months Ended | 6 Months Ended | |||||||||
Jul. 08, 2024 | May 06, 2024 | May 05, 2023 | Jun. 30, 2024 | Mar. 31, 2024 | Jun. 30, 2023 | Mar. 31, 2023 | Jun. 30, 2024 | Jun. 30, 2023 | Dec. 31, 2023 | Apr. 28, 2023 | |
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | |||||||||||
Net loss | $ (44,907) | $ (23,631) | $ (65,760) | $ (10,772) | $ (68,538) | $ (76,532) | |||||
Net cash used in Operating Activities | 16,515 | 18,145 | |||||||||
Accumulated deficit | (387,940) | $ (279,397) | (387,940) | $ (279,397) | $ (319,402) | ||||||
Cash and cash equivalents and short-term investments | $ 83,600 | $ 83,600 | |||||||||
Common stock, shares issued | 38,506,614 | 38,506,614 | 24,213,130 | ||||||||
Common stock, par value | $ 0.001 | $ 0.001 | $ 0.001 | ||||||||
Accredited Investor [Member] | Private Placement [Member] | |||||||||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | |||||||||||
Warrant exercise price | $ 3 | ||||||||||
Accredited Investor [Member] | Private Placement [Member] | Pre-funded Warrants [Member] | |||||||||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | |||||||||||
Warrant exercise price | $ 0.001 | ||||||||||
Securities Purchase Agreement Initial Closing [Member] | Private Placement [Member] | |||||||||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | |||||||||||
Common warrants issued | $ 35,000 | ||||||||||
Securities Purchase Agreement Initial Closing [Member] | Private Placement [Member] | Pre-funded Warrants [Member] | |||||||||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | |||||||||||
Common stock, shares issued | 6,421,350 | ||||||||||
Securities Purchase Agreement Initial Closing [Member] | Accredited Investor [Member] | Private Placement [Member] | |||||||||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | |||||||||||
Common warrants issued | $ 45,500 | ||||||||||
Common stock, shares issued | 8,730,168 | 15,151,518 | |||||||||
Common stock, par value | $ 0.001 | ||||||||||
Common stock warrants to purchase common stock shares | 15,151,518 | 15,151,518 | |||||||||
Securities Purchase Agreement Second Closing [Member] | Private Placement [Member] | Subsequent Event [Member] | |||||||||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | |||||||||||
Common stock, shares issued | 909,088 | ||||||||||
Common stock, par value | $ 0.001 | ||||||||||
Proceeds from Issuance of Common Stock | $ 2,100 | ||||||||||
Net proceeds after deducting offering costs | $ 2,000 | ||||||||||
Securities Purchase Agreement Second Closing [Member] | Accredited Investor [Member] | Private Placement [Member] | |||||||||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | |||||||||||
Common stock, shares issued | 20,202,024 | ||||||||||
Securities Purchase Agreement Second and Third Closing [Member] | Accredited Investor [Member] | Private Placement [Member] | |||||||||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | |||||||||||
Common warrants issued | $ 58,300 | ||||||||||
Securities Purchase Agreement [Member] | Accredited Investor [Member] | Private Placement [Member] | |||||||||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | |||||||||||
Common stock, shares issued | 13,110,484 | ||||||||||
Common stock, par value | $ 0.001 | ||||||||||
Stock price per share | $ 2.37 | ||||||||||
Gross proceeds | $ 50,000 | ||||||||||
Net proceeds after deducting offering costs | $ 48,100 | ||||||||||
Securities Purchase Agreement [Member] | Accredited Investor [Member] | Private Placement [Member] | Pre-funded Warrants [Member] | |||||||||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | |||||||||||
Common stock warrants to purchase common stock shares | 7,989,516 | ||||||||||
Stock price per share | $ 2.369 | ||||||||||
Warrant exercise price | $ 0.001 |
Summary of Significant Accoun_3
Summary of Significant Accounting Policies - Additional Information (Detail) | 6 Months Ended |
Jun. 30, 2024 | |
Summary Of Significant Accounting Policies [Line Items] | |
Cash, cash equivalents and restricted cash, maturity period | three months or less |
Accounting Standards Update 2023-09 [Member] | |
Summary Of Significant Accounting Policies [Line Items] | |
Change in accounting principle, accounting standards update, adopted | true |
Accounting Standards Update 2023-07 [Member] | |
Summary Of Significant Accounting Policies [Line Items] | |
Change in accounting principle, accounting standards update, adopted | true |
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% |
Short-Term Investments - Summar
Short-Term Investments - Summary of Short-term Investments Classified as Available-for-sale Securities (Detail) - USD ($) $ in Thousands | Jun. 30, 2024 | Dec. 31, 2023 |
Debt Securities, Available-for-Sale [Line Items] | ||
Amortized Cost | $ 57,571 | $ 46,490 |
Fair Value | 57,571 | 46,490 |
U.S. Government Securities [Member] | ||
Debt Securities, Available-for-Sale [Line Items] | ||
Amortized Cost | 47,837 | 33,213 |
Fair Value | 47,837 | 33,213 |
U.S. Government Agency Securities [Member] | ||
Debt Securities, Available-for-Sale [Line Items] | ||
Amortized Cost | 9,734 | 13,277 |
Fair Value | $ 9,734 | $ 13,277 |
Fair Value Measurements - Sched
Fair Value Measurements - Schedule of Financial Instruments Measured At Fair Value On A Recurring Basis (Detail) - Fair Value, Recurring [Member] - USD ($) $ in Thousands | Jun. 30, 2024 | Dec. 31, 2023 |
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Total cash equivalents | $ 25,179 | $ 4,246 |
Total short-term investments | 57,571 | 46,490 |
Total financial assets | 82,750 | 50,736 |
Money Market Funds [Member] | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Total cash equivalents | 3,949 | 4,246 |
U.S. Government Securities [Member] | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Total cash equivalents | 21,230 | |
Total short-term investments | 47,837 | 33,213 |
U.S. Government Agency Securities [Member] | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Total short-term investments | 9,734 | 13,277 |
Fair Value, Inputs, Level 1 [Member] | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Total cash equivalents | 25,179 | 4,246 |
Total financial assets | 25,179 | 4,246 |
Fair Value, Inputs, Level 1 [Member] | Money Market Funds [Member] | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Total cash equivalents | 3,949 | 4,246 |
Fair Value, Inputs, Level 1 [Member] | U.S. Government Securities [Member] | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Total cash equivalents | 21,230 | |
Fair Value, Inputs, Level 2 [Member] | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Total short-term investments | 57,571 | 46,490 |
Total financial assets | 57,571 | 46,490 |
Fair Value, Inputs, Level 2 [Member] | U.S. Government Securities [Member] | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Total short-term investments | 47,837 | 33,213 |
Fair Value, Inputs, Level 2 [Member] | U.S. Government Agency Securities [Member] | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Total short-term investments | $ 9,734 | $ 13,277 |
Fair Value Measurements - Summa
Fair Value Measurements - Summary of Warrant Liabilities Measured at Fair value on a Recurring Basis (Details) - Fair Value, Recurring [Member] - Warrant Liabilities [Member] - USD ($) $ in Thousands | Jun. 30, 2024 | Dec. 31, 2023 |
Fair Value, Liabilities Measured on Recurring Basis, Unobservable Input Reconciliation [Line Items] | ||
Liabilities measured at fair value | $ 120,821 | $ 76,211 |
Fair Value Inputs, Level 3 [Member] | ||
Fair Value, Liabilities Measured on Recurring Basis, Unobservable Input Reconciliation [Line Items] | ||
Liabilities measured at fair value | $ 120,821 | $ 76,211 |
Fair Value Measurements - Sch_2
Fair Value Measurements - Schedule of Aggregate Fair Value of Warrant Liability (Details) - Fair Value, Recurring [Member] - Warrant [Member] $ in Thousands | 6 Months Ended |
Jun. 30, 2024 USD ($) | |
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | |
Balance as of December 31, 2023 | $ 76,211 |
Change in fair value of warrant liabilities | 44,610 |
Balance as of June 30, 2024 | $ 120,821 |
Fair Value Measurements - Addit
Fair Value Measurements - Additional Information (Details) - USD ($) $ in Thousands | 3 Months Ended | 6 Months Ended | |||
Jun. 30, 2024 | Jun. 30, 2023 | Jun. 30, 2024 | Jun. 30, 2023 | Dec. 31, 2023 | |
Class of Stock [Line Items] | |||||
Change in fair value of warrant liabilities and fair value of financial instruments issued in excess of proceeds | $ 31,274 | $ 56,181 | $ 44,610 | $ 56,181 | |
Warrant liabilities | $ 120,821 | $ 56,181 | $ 120,821 | $ 56,181 | $ 76,211 |
Prepaid Expenses and Other Cu_3
Prepaid Expenses and Other Current Assets - Prepaid Expenses and Other Current Assets (Detail) - USD ($) $ in Thousands | Jun. 30, 2024 | Dec. 31, 2023 |
Prepaid Expense and Other Assets, Current [Abstract] | ||
Prepaid clinical | $ 2,907 | $ 4,128 |
Prepaid insurance | 260 | 624 |
Prepaid other | 287 | 185 |
Other current assets | 157 | 90 |
Total prepaid expenses and other current assets | $ 3,611 | $ 5,027 |
Accrued Expenses and Other Li_3
Accrued Expenses and Other Liabilities - Schedule of Accrued Expenses and Other Liabilities (Detail) - USD ($) $ in Thousands | Jun. 30, 2024 | Dec. 31, 2023 |
Accrued Liabilities and Other Liabilities [Abstract] | ||
Accrued compensation and related expenses | $ 1,561 | $ 2,003 |
Accrued clinical | 1,248 | 451 |
Accrued professional services | 94 | 47 |
Accrued other | 705 | 44 |
Total accrued expenses and other liabilities | $ 3,608 | $ 2,545 |
Commitments and Contingencies -
Commitments and Contingencies - Additional Information (Detail) | 3 Months Ended | 6 Months Ended | 12 Months Ended | |||||||||
Apr. 19, 2024 USD ($) ft² | Aug. 12, 2022 | Nov. 04, 2021 ft² | Jun. 30, 2024 USD ($) | Jun. 30, 2023 USD ($) | Jun. 30, 2024 USD ($) Milestone | Jun. 30, 2023 USD ($) Milestone | Dec. 31, 2023 USD ($) | Dec. 31, 2022 USD ($) ft² | Dec. 31, 2021 USD ($) | Dec. 31, 2018 USD ($) | Dec. 31, 2017 USD ($) | |
Other Commitments [Line Items] | ||||||||||||
Rental expense | $ 100,000 | $ 100,000 | $ 200,000 | $ 200,000 | ||||||||
ROU assets and lease liabilities | 621,000 | $ 621,000 | $ 365,000 | |||||||||
Remaining term of office lease | 3 years | |||||||||||
Debt outstanding | 0 | $ 0 | ||||||||||
Indemnification obligations amount | 0 | $ 0 | ||||||||||
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 | $ 6,000,000 | ||||||||||
Annual License Maintenance Fee | $ 100,000 | $ 100,000 | $ 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 | 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 | $ 30,000,000 | ||||||||||
Maximum [Member] | ||||||||||||
Other Commitments [Line Items] | ||||||||||||
Remaining term of office lease | 1 year | |||||||||||
Maximum [Member] | ALS Therapy Development Foundation, Inc. License Agreement [Member] | ||||||||||||
Other Commitments [Line Items] | ||||||||||||
Development and regulatory milestone payments | $ 2,500,000 | $ 2,500,000 | ||||||||||
Irvine, California [Member] | ||||||||||||
Other Commitments [Line Items] | ||||||||||||
Area of office space | ft² | 5,817 | 5,197 | ||||||||||
Operating lease, term of contract | 38 months | |||||||||||
Lease expiration date | Jun. 30, 2027 | Dec. 31, 2024 | ||||||||||
ROU assets and lease liabilities | $ 500,000 | |||||||||||
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 | 6 Months Ended | |
Jun. 30, 2024 | Jun. 30, 2023 | |
Commitments and Contingencies Disclosure [Abstract] | ||
Operating lease cost | $ 203 | $ 199 |
Commitments and Contingencies_3
Commitments and Contingencies - Schedule of Other Information Related to Leases (Detail) - USD ($) $ in Thousands | 6 Months Ended | |
Jun. 30, 2024 | Jun. 30, 2023 | |
Cash paid for amounts included in the measurement of lease liabilities: | ||
Operating cash flows from operating leases | $ 114 | $ 181 |
Weighted-average remaining lease term | ||
Operating leases | 1 year 8 months 1 day | 1 year 5 months 12 days |
Discount rate | ||
Operating leases | 2.12% | 2.49% |
Commitments and Contingencies_4
Commitments and Contingencies - Schedule of Future Payments Under Noncancelable Operating Leases (Detail) - USD ($) $ in Thousands | Jun. 30, 2024 | Dec. 31, 2023 |
Commitments and Contingencies Disclosure [Abstract] | ||
2024 (remainder of) | $ 185 | |
2025 | 191 | |
2026 | 197 | |
2027 | 100 | |
Total minimum lease payments | 673 | |
Less imputed interest | (18) | |
Present value of lease liabilities | 655 | |
Less current portion of operating lease liabilities | (269) | $ (383) |
Non-current operating lease liabilities | $ 386 |
Stockholders' Equity - Addition
Stockholders' Equity - Additional Information (Detail) - USD ($) | 6 Months Ended | |||||||||||||||||
Jul. 08, 2024 | May 06, 2024 | May 16, 2023 | May 05, 2023 | Apr. 28, 2023 | Mar. 31, 2021 | Jun. 30, 2024 | Jun. 30, 2023 | Jul. 11, 2024 | May 09, 2024 | May 07, 2024 | Mar. 31, 2024 | Jan. 30, 2024 | Dec. 31, 2023 | Nov. 06, 2023 | Nov. 02, 2023 | Jul. 14, 2023 | Jul. 10, 2023 | |
Class Of Stock [Line Items] | ||||||||||||||||||
Debt outstanding | $ 0 | |||||||||||||||||
Common stock, shares issued | 38,506,614 | 24,213,130 | ||||||||||||||||
Common stock par value | $ 0.001 | $ 0.001 | ||||||||||||||||
Net proceeds after deducting offering costs | $ 48,072,000 | $ 33,017,000 | ||||||||||||||||
Preferred stock, shares authorized | 5,000,000 | 5,000,000 | ||||||||||||||||
Preferred stock, par value | $ 0.001 | $ 0.001 | ||||||||||||||||
Armistice Capital Master Fund Ltd [Member] | Securities Purchase Agreement [Member] | ||||||||||||||||||
Class Of Stock [Line Items] | ||||||||||||||||||
Number of pre-funded warrants exercised for common stock | 583,000 | 600,000 | 653,000 | 501,197 | ||||||||||||||
Common stock, shares issued | 583,000 | 600,000 | 653,000 | 501,197 | ||||||||||||||
Warrant exercise price per share | $ 0.001 | $ 0.001 | $ 0.001 | $ 0.001 | ||||||||||||||
Armistice Capital Master Fund Ltd [Member] | Securities Purchase Agreement [Member] | Subsequent Event [Member] | ||||||||||||||||||
Class Of Stock [Line Items] | ||||||||||||||||||
Number of pre-funded warrants exercised for common stock | 240,000 | |||||||||||||||||
Common stock, shares issued | 240,000 | |||||||||||||||||
Warrant exercise price per share | $ 0.001 | |||||||||||||||||
Series X1 Preferred Stock [Member] | ||||||||||||||||||
Class Of Stock [Line Items] | ||||||||||||||||||
Warrants available for exercise | 50,207.419 | |||||||||||||||||
Shares of common stock issued upon conversion of each share of preferred stock | 2,789,301 | |||||||||||||||||
Series X1 Non-voting Convertible Preferred Stock [Member] | ||||||||||||||||||
Class Of Stock [Line Items] | ||||||||||||||||||
Preferred stock, shares authorized | 515,000 | 515,000 | ||||||||||||||||
Preferred stock, par value | $ 0.001 | $ 0.001 | ||||||||||||||||
Preferred stock, shares outstanding | 110,086 | 110,086 | ||||||||||||||||
Preferred stock, shares issued | 110,086 | 110,086 | ||||||||||||||||
Series X Non-Voting Convertible Preferred Stock [Member] | ||||||||||||||||||
Class Of Stock [Line Items] | ||||||||||||||||||
Preferred stock, shares authorized | 10,000 | |||||||||||||||||
Preferred stock, shares outstanding | 4,422 | 4,422 | ||||||||||||||||
Preferred stock, shares issued | 4,422 | 4,422 | ||||||||||||||||
Common Stock [Member] | ||||||||||||||||||
Class Of Stock [Line Items] | ||||||||||||||||||
Warrants available for exercise | 28,361,237 | 21,564,302 | ||||||||||||||||
Common Stock [Member] | Series X Non-Voting Convertible Preferred Stock [Member] | ||||||||||||||||||
Class Of Stock [Line Items] | ||||||||||||||||||
Shares of common stock issued upon conversion of each share of preferred stock | 55.5556 | |||||||||||||||||
Pre-funded Warrants [Member] | Accredited Investor [Member] | ||||||||||||||||||
Class Of Stock [Line Items] | ||||||||||||||||||
Class of Warrant Subject to Specified Beneficial Ownership Limitations Percentage | 9.99% | |||||||||||||||||
Common Stock Warrants [Member] | ||||||||||||||||||
Class Of Stock [Line Items] | ||||||||||||||||||
Warrants available for exercise | 15,151,518 | 15,151,518 | ||||||||||||||||
Common Stock Warrants [Member] | Accredited Investor [Member] | ||||||||||||||||||
Class Of Stock [Line Items] | ||||||||||||||||||
Class of Warrant Subject to Specified Beneficial Ownership Limitations Percentage | 9.99% | |||||||||||||||||
Private Placement Warrants [Member] | Accredited Investor [Member] | ||||||||||||||||||
Class Of Stock [Line Items] | ||||||||||||||||||
Warrant exercise price per share | $ 3 | |||||||||||||||||
Private Placement Warrants [Member] | Securities Purchase Agreement [Member] | Accredited Investor [Member] | ||||||||||||||||||
Class Of Stock [Line Items] | ||||||||||||||||||
Common stock, shares issued | 13,110,484 | |||||||||||||||||
Common stock par value | $ 0.001 | |||||||||||||||||
Stock price per share | $ 2.37 | |||||||||||||||||
Gross proceeds | $ 50,000,000 | |||||||||||||||||
Net proceeds after deducting offering costs | $ 48,100,000 | |||||||||||||||||
Private Placement Warrants [Member] | Securities Purchase Agreement Initial Closing [Member] | ||||||||||||||||||
Class Of Stock [Line Items] | ||||||||||||||||||
Common warrants issued | $ 35,000,000 | |||||||||||||||||
Net proceeds after deducting offering costs | $ 33,000,000 | |||||||||||||||||
Private Placement Warrants [Member] | Securities Purchase Agreement Initial Closing [Member] | Accredited Investor [Member] | ||||||||||||||||||
Class Of Stock [Line Items] | ||||||||||||||||||
Common stock, shares issued | 8,730,168 | 15,151,518 | ||||||||||||||||
Common stock par value | $ 0.001 | |||||||||||||||||
Common stock warrants exercisable | 15,151,518 | 15,151,518 | ||||||||||||||||
Common warrants issued | $ 45,500,000 | |||||||||||||||||
Private Placement Warrants [Member] | Securities Purchase Agreement Second Closing [Member] | Subsequent Event [Member] | ||||||||||||||||||
Class Of Stock [Line Items] | ||||||||||||||||||
Common stock, shares issued | 909,088 | |||||||||||||||||
Common stock par value | $ 0.001 | |||||||||||||||||
Proceeds from issuance of common stock | $ 2,100,000 | |||||||||||||||||
Net proceeds after deducting offering costs | $ 2,000,000 | |||||||||||||||||
Private Placement Warrants [Member] | Securities Purchase Agreement Second Closing [Member] | Accredited Investor [Member] | ||||||||||||||||||
Class Of Stock [Line Items] | ||||||||||||||||||
Common stock, shares issued | 20,202,024 | |||||||||||||||||
Private Placement Warrants [Member] | Securities Purchase Agreement Third Closing [Member] | Accredited Investor [Member] | ||||||||||||||||||
Class Of Stock [Line Items] | ||||||||||||||||||
Common stock, shares issued | 25,252,530 | |||||||||||||||||
Private Placement Warrants [Member] | Securities Purchase Agreement Second and Third Closing [Member] | Accredited Investor [Member] | ||||||||||||||||||
Class Of Stock [Line Items] | ||||||||||||||||||
Common warrants issued | $ 58,300,000 | |||||||||||||||||
Private Placement Warrants [Member] | Common Stock [Member] | Securities Purchase Agreement Initial Closing [Member] | ||||||||||||||||||
Class Of Stock [Line Items] | ||||||||||||||||||
Common stock, shares issued | 8,730,168 | |||||||||||||||||
Private Placement Warrants [Member] | Pre-funded Warrants [Member] | Accredited Investor [Member] | ||||||||||||||||||
Class Of Stock [Line Items] | ||||||||||||||||||
Warrant exercise price per share | $ 0.001 | |||||||||||||||||
Private Placement Warrants [Member] | Pre-funded Warrants [Member] | Securities Purchase Agreement [Member] | Accredited Investor [Member] | ||||||||||||||||||
Class Of Stock [Line Items] | ||||||||||||||||||
Stock price per share | $ 2.369 | |||||||||||||||||
Common stock warrants exercisable | 7,989,516 | |||||||||||||||||
Warrant exercise price per share | $ 0.001 | |||||||||||||||||
Private Placement Warrants [Member] | Pre-funded Warrants [Member] | Securities Purchase Agreement Initial Closing [Member] | ||||||||||||||||||
Class Of Stock [Line Items] | ||||||||||||||||||
Common stock, shares issued | 6,421,350 | |||||||||||||||||
Maximum [Member] | Common Stock [Member] | Series X Non-Voting Convertible Preferred Stock [Member] | ||||||||||||||||||
Class Of Stock [Line Items] | ||||||||||||||||||
Conversion of preferred stock, conversion blocker, percent | 9.99% | |||||||||||||||||
Maximum [Member] | Pre-funded Warrants [Member] | Accredited Investor [Member] | ||||||||||||||||||
Class Of Stock [Line Items] | ||||||||||||||||||
Class of Warrant Subject to Specified Beneficial Ownership Limitations Percentage | 9.99% | |||||||||||||||||
Class of Warrant Subject to Specified Beneficial Ownership Limitations Permitted Percentage | 19.99% | 19.99% | ||||||||||||||||
Maximum [Member] | Common Stock Warrants [Member] | Accredited Investor [Member] | ||||||||||||||||||
Class Of Stock [Line Items] | ||||||||||||||||||
Class of Warrant Subject to Specified Beneficial Ownership Limitations Permitted Percentage | 19.99% | |||||||||||||||||
Minimum [Member] | Common Stock [Member] | Series X Non-Voting Convertible Preferred Stock [Member] | ||||||||||||||||||
Class Of Stock [Line Items] | ||||||||||||||||||
Conversion of preferred stock, conversion blocker, percent | 9.90% | |||||||||||||||||
Minimum [Member] | Pre-funded Warrants [Member] | Accredited Investor [Member] | ||||||||||||||||||
Class Of Stock [Line Items] | ||||||||||||||||||
Class of Warrant Subject to Specified Beneficial Ownership Limitations Percentage | 4.99% | |||||||||||||||||
Jefferies LLC [Member] | ATM Program [Member] | ||||||||||||||||||
Class Of Stock [Line Items] | ||||||||||||||||||
Common stock number of shares issued | 0 | |||||||||||||||||
Equity distribution agreement maximum value of common shares issuable | $ 75,000,000 | |||||||||||||||||
Public float minimum balance to be maintained | $ 75,000,000 | $ 75,000,000 | ||||||||||||||||
Jefferies LLC [Member] | ATM Program [Member] | Common Stock [Member] | ||||||||||||||||||
Class Of Stock [Line Items] | ||||||||||||||||||
Common stock number of shares issued | 0 | |||||||||||||||||
Jefferies LLC [Member] | Maximum [Member] | ATM Program [Member] | ||||||||||||||||||
Class Of Stock [Line Items] | ||||||||||||||||||
Equity distribution agreement maximum value of common shares issuable | $ 33,500,000 | |||||||||||||||||
Cormorant Global Healthcare Master Fund LP [Member] | Series X1 Non-voting Convertible Preferred Stock [Member] | Conversion Agreement [Member] | ||||||||||||||||||
Class Of Stock [Line Items] | ||||||||||||||||||
Conversion of stock, shares converted | 7,883.586 | |||||||||||||||||
Cormorant Global Healthcare Master Fund LP [Member] | Series X Non-Voting Convertible Preferred Stock [Member] | Conversion Agreement [Member] | ||||||||||||||||||
Class Of Stock [Line Items] | ||||||||||||||||||
Conversion of stock, shares converted | 1,782 | |||||||||||||||||
Cormorant Global Healthcare Master Fund LP [Member] | Common Stock [Member] | Series X1 Non-voting Convertible Preferred Stock [Member] | Conversion Agreement [Member] | ||||||||||||||||||
Class Of Stock [Line Items] | ||||||||||||||||||
Conversion of stock, shares issued | 437,977 | |||||||||||||||||
Cormorant Global Healthcare Master Fund LP [Member] | Common Stock [Member] | Series X Non-Voting Convertible Preferred Stock [Member] | Conversion Agreement [Member] | ||||||||||||||||||
Class Of Stock [Line Items] | ||||||||||||||||||
Conversion of stock, shares issued | 99,000 |
Stockholders Equity - Schedule
Stockholders Equity - Schedule of Assumptions Used in Black-Scholes Option Pricing Model to Determine Fair Value of Stock Options Granted (Details) - $ / shares | 6 Months Ended | 12 Months Ended |
Jun. 30, 2024 | Dec. 31, 2023 | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Risk-free interest rate | 4.33% | |
Risk-free interest rate, Minimum | 3.84% | |
Risk-free interest rate, Maximum | 3.88% | |
Expected volatility , Minimum | 91.90% | 89.08% |
Expected volatility , Maximum | 97.15% | 94.28% |
Share Price | $ 2.64 | $ 1.8 |
Maximum [Member] | ||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Expected term (in years) | 5 years 6 months | 6 years |
Minimum [Member] | ||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Expected term (in years) | 4 years | 4 years 6 months |
Stockholders' Equity - Schedule
Stockholders' Equity - Schedule of Warrant Activity (Detail) | 6 Months Ended |
Jun. 30, 2024 shares | |
Pre-funded Warrants [Member] | |
Class Of Warrant Or Right [Line Items] | |
Ending Balance | 12,582,786 |
All Other Warrants [Member] | |
Class Of Warrant Or Right [Line Items] | |
Ending Balance | 626,933 |
Common Stock Warrants [Member] | |
Class Of Warrant Or Right [Line Items] | |
Beginning Balance | 15,151,518 |
Issued | 0 |
Exercised | 0 |
Cancelled/Expired | 0 |
Ending Balance | 15,151,518 |
Common Stock Warrants [Member] | Pre-funded Warrants [Member] | |
Class Of Warrant Or Right [Line Items] | |
Beginning Balance | 5,776,270 |
Issued | 7,989,516 |
Exercised | (1,183,000) |
Cancelled/Expired | 0 |
Common Stock Warrants [Member] | All Other Warrants [Member] | |
Class Of Warrant Or Right [Line Items] | |
Beginning Balance | 636,514 |
Issued | 0 |
Exercised | 0 |
Cancelled/Expired | (9,581) |
Common Stock [Member] | |
Class Of Warrant Or Right [Line Items] | |
Beginning Balance | 21,564,302 |
Issued | 7,989,516 |
Exercised | (1,183,000) |
Cancelled/Expired | (9,581) |
Ending Balance | 28,361,237 |
Stockholders' Equity - Schedu_2
Stockholders' Equity - Schedule of Series X1 Convertible Preferred Stock Warrant Activity (Detail) - Preferred Stock Warrants [Member] | 6 Months Ended |
Jun. 30, 2024 shares | |
Class Of Warrant Or Right [Line Items] | |
Beginning Balance | 50,207.419 |
Issued | 0 |
Exercised | 0 |
Ending Balance | 50,207.419 |
Stock-Based Compensation - Addi
Stock-Based Compensation - Additional Information (Detail) - shares | 6 Months Ended | |||
Jul. 10, 2024 | Jun. 13, 2024 | May 01, 2023 | Jun. 30, 2024 | |
Time-based and Performance-based Vesting Requirements [Member] | ||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||
Stock options granted | 7,381,857 | |||
Stock options granted | 5,905,485 | |||
Time-based Vesting Requirements [Member] | ||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||
Stock options granted | 1,476,372 | |||
Performance-based Vesting Requirements [Member] | ||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||
Stock options granted | 1,980,952 | |||
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 | |||
2020 Long Term Incentive Plan [Member] | ||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||
Common stock, number of shares reserved for issuance | 2,988,117 | |||
2014 Employee Stock Purchase Plan [Member] | ||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||
Common stock, number of shares reserved for issuance | 24,077 | |||
Subsequent event | 2020 Long Term Incentive Plan [Member] | ||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||
Increased number of shares | 3,500,000 | |||
New aggregate share limit | 17,960,000 | |||
Employee Stock Option [Member] | Board of Directors [Member] | ||||
Share-based Compensation Arrangement by Share-based Payment Award [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 the extended range of time of 12 to 18 months that vested stock options granted to Board members may be exercised upon termination. | |||
Employee Stock Option [Member] | Board of Directors [Member] | Minimum [Member] | ||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||
Vesting period of stock options granted | 12 months | |||
Employee Stock Option [Member] | Board of Directors [Member] | Maximum [Member] | ||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||
Vesting period of stock options granted | 18 months |
Stock-Based Compensation - Sche
Stock-Based Compensation - Schedule of Stock-Based Compensation Expense Recognized (Detail) - USD ($) $ in Thousands | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2024 | Jun. 30, 2023 | Jun. 30, 2024 | Jun. 30, 2023 | |
Share-Based Payment Arrangement, Expensed and Capitalized, Amount [Line Items] | ||||
Stock-based compensation | $ 3,063 | $ 1,720 | $ 4,757 | $ 3,101 |
Research and Development [Member] | ||||
Share-Based Payment Arrangement, Expensed and Capitalized, Amount [Line Items] | ||||
Stock-based compensation | 816 | 455 | 1,166 | 852 |
General and Administrative [Member] | ||||
Share-Based Payment Arrangement, Expensed and Capitalized, Amount [Line Items] | ||||
Stock-based compensation | $ 2,247 | $ 1,265 | $ 3,591 | $ 2,249 |
Net Loss Per Share - Additional
Net Loss Per Share - Additional Information (Detail) - $ / shares | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2024 | Jun. 30, 2023 | Jun. 30, 2024 | Jun. 30, 2023 | |
Earnings Per Share, Basic, by Common Class, Including Two Class Method [Line Items] | ||||
Weighted-average common shares outstanding, Basic | 42,278,411 | 24,006,549 | 36,133,906 | 19,173,080 |
Pre-funded Warrants [Member] | ||||
Earnings Per Share, Basic, by Common Class, Including Two Class Method [Line Items] | ||||
Weighted-average common shares outstanding, Basic | 12,582,786 | 6,930,467 | 12,582,786 | 6,930,467 |
Warrant exercise price | $ 0.001 | $ 0.001 |
Net Loss Per Share - Schedule o
Net Loss Per Share - Schedule of Common Share Equivalents Included from Computation of Net Loss Per Share (Detail) - USD ($) $ / shares in Units, $ in Thousands | 3 Months Ended | 6 Months Ended | ||||
Jun. 30, 2024 | Mar. 31, 2024 | Jun. 30, 2023 | Mar. 31, 2023 | Jun. 30, 2024 | Jun. 30, 2023 | |
Earnings Per Share [Abstract] | ||||||
Net loss | $ (44,907) | $ (23,631) | $ (65,760) | $ (10,772) | $ (68,538) | $ (76,532) |
Net loss per share, basic | $ (1.06) | $ (2.74) | $ (1.9) | $ (3.99) | ||
Net loss per share, diluted | $ (1.06) | $ (2.74) | $ (1.9) | $ (3.99) | ||
Weighted-average number of common shares, basic | 42,278,411 | 24,006,549 | 36,133,906 | 19,173,080 | ||
Weighted-average number of common shares, diluted | 42,278,411 | 24,006,549 | 36,133,906 | 19,173,080 |
Net Loss Per Share - Summary of
Net Loss Per Share - Summary of Common Share Equivalents were excluded because the Inclusion is Anti-dilutive (Detail) - shares | 6 Months Ended | |
Jun. 30, 2024 | Jun. 30, 2023 | |
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||
Total | 33,791,508 | 25,263,692 |
Stock Options Outstanding and Other Equity Awards [Member] | ||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||
Total | 15,223,757 | 6,686,360 |
Common and Preferred Warrants Outstanding [Member] | ||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||
Total | 18,567,751 | 18,577,332 |
Subsequent Events - Additional
Subsequent Events - Additional Information (Details) - USD ($) $ / shares in Units, $ in Thousands | 3 Months Ended | 6 Months Ended | |||||||||||||
Jul. 10, 2024 | Jul. 08, 2024 | Jun. 30, 2024 | Jun. 30, 2023 | Jun. 30, 2024 | Jun. 30, 2023 | Jul. 11, 2024 | May 09, 2024 | May 07, 2024 | Jan. 30, 2024 | Dec. 31, 2023 | Nov. 06, 2023 | Nov. 02, 2023 | Jul. 14, 2023 | Jul. 10, 2023 | |
Subsequent Event [Line Items] | |||||||||||||||
Common stock, shares issued | 38,506,614 | 38,506,614 | 24,213,130 | ||||||||||||
Common stock, par value | $ 0.001 | $ 0.001 | $ 0.001 | ||||||||||||
Change in fair value of warrant liabilities and fair value of financial instruments issued in excess of proceeds | $ 31,274 | $ 56,181 | $ 44,610 | $ 56,181 | |||||||||||
Armistice Capital Master Fund Ltd [Member] | Securities Purchase Agreement [Member] | |||||||||||||||
Subsequent Event [Line Items] | |||||||||||||||
Common stock, shares issued | 583,000 | 600,000 | 653,000 | 501,197 | |||||||||||
Warrant exercise price | $ 0.001 | $ 0.001 | $ 0.001 | $ 0.001 | |||||||||||
Number of pre-funded warrants exercised for common stock | 583,000 | 600,000 | 653,000 | 501,197 | |||||||||||
Subsequent Event [Member] | Securities Purchase Agreement Second Closing [Member] | Private Placement [Member] | |||||||||||||||
Subsequent Event [Line Items] | |||||||||||||||
Common stock, shares issued | 909,088 | ||||||||||||||
Common stock, par value | $ 0.001 | ||||||||||||||
Proceeds from Issuance of Common Stock | $ 2,100 | ||||||||||||||
Net proceeds after deducting offering costs | 2,000 | ||||||||||||||
Change in fair value of warrant liabilities and fair value of financial instruments issued in excess of proceeds | 43,900 | ||||||||||||||
Reduction to warrant liabilities | $ 43,900 | ||||||||||||||
Subsequent Event [Member] | Amendment to the 2020 Long Term Incentive Plan [Member] | |||||||||||||||
Subsequent Event [Line Items] | |||||||||||||||
Increased number of shares | 3,500,000 | ||||||||||||||
New aggregate share limit | 17,960,000 | ||||||||||||||
Subsequent Event [Member] | Armistice Capital Master Fund Ltd [Member] | Securities Purchase Agreement [Member] | |||||||||||||||
Subsequent Event [Line Items] | |||||||||||||||
Common stock, shares issued | 240,000 | ||||||||||||||
Warrant exercise price | $ 0.001 | ||||||||||||||
Number of pre-funded warrants exercised for common stock | 240,000 |
Restatement of Previously Iss_3
Restatement of Previously Issued Consolidated Financial Statements - Summary of Impact of Correction of Misstatements - Corrected Condensed Consolidated Balance Sheets (Details) - USD ($) $ in Thousands | Jun. 30, 2024 | Mar. 31, 2024 | Dec. 31, 2023 | Jun. 30, 2023 | Mar. 31, 2023 | Dec. 31, 2022 |
Error Corrections and Prior Period Adjustments Restatement [Line Items] | ||||||
Warrant liabilities | $ 120,821 | $ 76,211 | $ 56,181 | |||
Total liabilities | 128,984 | 81,858 | 63,017 | |||
Common stock | 39 | 24 | 23 | |||
Additional paid-in capital | 379,400 | 326,586 | 323,142 | |||
Accumulated deficit | (387,940) | (319,402) | (279,397) | |||
Total stockholders' equity | $ (8,501) | $ (14,728) | $ 7,208 | 43,768 | $ 74,792 | $ 84,183 |
As Previously Reported [Member] | ||||||
Error Corrections and Prior Period Adjustments Restatement [Line Items] | ||||||
Total liabilities | 6,836 | |||||
Common stock | 23 | |||||
Additional paid-in capital | 323,142 | |||||
Accumulated deficit | (223,216) | |||||
Total stockholders' equity | 99,949 | $ 74,792 | $ 84,183 | |||
Restatement Impact [Member] | ||||||
Error Corrections and Prior Period Adjustments Restatement [Line Items] | ||||||
Warrant liabilities | 56,181 | |||||
Total liabilities | 56,181 | |||||
Accumulated deficit | (56,181) | |||||
Total stockholders' equity | $ (56,181) |
Restatement of Previously Iss_4
Restatement of Previously Issued Consolidated Financial Statements - Summary of Impact of Correction of Misstatements - Corrected Condensed Consolidated Statements of Operations and Comprehensive Loss (Details) - USD ($) $ / shares in Units, $ in Thousands | 3 Months Ended | 6 Months Ended | ||||
Jun. 30, 2024 | Mar. 31, 2024 | Jun. 30, 2023 | Mar. 31, 2023 | Jun. 30, 2024 | Jun. 30, 2023 | |
Error Corrections and Prior Period Adjustments Restatement [Line Items] | ||||||
Change in fair value of warrant liabilities and fair value of financial instruments issued in excess of proceeds | $ (31,274) | $ (56,181) | $ (44,610) | $ (56,181) | ||
Net loss and comprehensive loss | $ (44,907) | $ (23,631) | $ (65,760) | $ (10,772) | $ (68,538) | $ (76,532) |
Net loss per share, basic | $ (1.06) | $ (2.74) | $ (1.9) | $ (3.99) | ||
Net loss per share, diluted | $ (1.06) | $ (2.74) | $ (1.9) | $ (3.99) | ||
As Previously Reported [Member] | ||||||
Error Corrections and Prior Period Adjustments Restatement [Line Items] | ||||||
Net loss and comprehensive loss | $ (9,579) | $ (10,772) | $ (20,351) | |||
Net loss per share, basic | $ (0.4) | $ (1.06) | ||||
Net loss per share, diluted | $ (0.4) | $ (1.06) | ||||
Restatement Impact [Member] | ||||||
Error Corrections and Prior Period Adjustments Restatement [Line Items] | ||||||
Change in fair value of warrant liabilities and fair value of financial instruments issued in excess of proceeds | $ (56,181) | $ (56,181) | ||||
Net loss and comprehensive loss | $ (56,181) | $ (56,181) | ||||
Net loss per share, basic | $ (2.34) | $ (2.93) | ||||
Net loss per share, diluted | $ (2.34) | $ (2.93) |
Restatement of Previously Iss_5
Restatement of Previously Issued Consolidated Financial Statements - Summary of Impact of Correction of Misstatements - Corrected Condensed Consolidated Statements of Stockholders' Equity (Deficit) (Details) - USD ($) $ in Thousands | 3 Months Ended | 6 Months Ended | ||||
Jun. 30, 2024 | Mar. 31, 2024 | Jun. 30, 2023 | Mar. 31, 2023 | Jun. 30, 2024 | Jun. 30, 2023 | |
Error Corrections and Prior Period Adjustments Restatement [Line Items] | ||||||
Beginning Balance | $ (14,728) | $ 7,208 | $ 74,792 | $ 84,183 | $ 7,208 | $ 84,183 |
Issuance of common stock and pre-funded warrants in connection with Securities Purchase Agreement, net of issuance costs, Value | 48,070 | 33,017 | ||||
Stock-based compensation | 3,063 | 1,694 | 1,720 | 1,381 | ||
Net loss and comprehensive loss | (44,907) | (23,631) | (65,760) | (10,772) | (68,538) | (76,532) |
Ending Balance | (8,501) | (14,728) | 43,768 | 74,792 | (8,501) | 43,768 |
Accumulated Deficit [Member] | ||||||
Error Corrections and Prior Period Adjustments Restatement [Line Items] | ||||||
Beginning Balance | (343,033) | (319,402) | (213,637) | (202,865) | (319,402) | (202,865) |
Net loss and comprehensive loss | (44,907) | (23,631) | (65,760) | (10,772) | ||
Ending Balance | $ (387,940) | $ (343,033) | (279,397) | (213,637) | $ (387,940) | (279,397) |
As Previously Reported [Member] | ||||||
Error Corrections and Prior Period Adjustments Restatement [Line Items] | ||||||
Beginning Balance | 74,792 | 84,183 | 84,183 | |||
Issuance of common stock and pre-funded warrants in connection with Securities Purchase Agreement, net of issuance costs, Value | 33,017 | |||||
Stock-based compensation | 1,720 | 1,381 | ||||
Net loss and comprehensive loss | (9,579) | (10,772) | (20,351) | |||
Ending Balance | 99,949 | 74,792 | 99,949 | |||
As Previously Reported [Member] | Accumulated Deficit [Member] | ||||||
Error Corrections and Prior Period Adjustments Restatement [Line Items] | ||||||
Beginning Balance | (213,637) | (202,865) | (202,865) | |||
Net loss and comprehensive loss | (9,579) | (10,772) | ||||
Ending Balance | (223,216) | $ (213,637) | (223,216) | |||
Restatement Impact [Member] | ||||||
Error Corrections and Prior Period Adjustments Restatement [Line Items] | ||||||
Net loss and comprehensive loss | (56,181) | (56,181) | ||||
Ending Balance | (56,181) | (56,181) | ||||
Restatement Impact [Member] | Accumulated Deficit [Member] | ||||||
Error Corrections and Prior Period Adjustments Restatement [Line Items] | ||||||
Net loss and comprehensive loss | (56,181) | |||||
Ending Balance | $ (56,181) | $ (56,181) |
Restatement of Previously Iss_6
Restatement of Previously Issued Consolidated Financial Statements - Summary of Impact of Correction of Misstatements - Corrected Condensed Consolidated Statements of Cash Flows (Details) - USD ($) $ in Thousands | 3 Months Ended | 6 Months Ended | ||||
Jun. 30, 2024 | Mar. 31, 2024 | Jun. 30, 2023 | Mar. 31, 2023 | Jun. 30, 2024 | Jun. 30, 2023 | |
Error Corrections and Prior Period Adjustments Restatement [Line Items] | ||||||
Net loss | $ (44,907) | $ (23,631) | $ (65,760) | $ (10,772) | $ (68,538) | $ (76,532) |
Change in fair value of warrant liabilities and fair value of financial instruments issued in excess of proceeds | $ 31,274 | 56,181 | 44,610 | 56,181 | ||
Net cash used in operating activities | $ (16,515) | (18,145) | ||||
As Previously Reported [Member] | ||||||
Error Corrections and Prior Period Adjustments Restatement [Line Items] | ||||||
Net loss | (9,579) | $ (10,772) | (20,351) | |||
Net cash used in operating activities | (18,145) | |||||
Restatement Impact [Member] | ||||||
Error Corrections and Prior Period Adjustments Restatement [Line Items] | ||||||
Net loss | (56,181) | (56,181) | ||||
Change in fair value of warrant liabilities and fair value of financial instruments issued in excess of proceeds | $ 56,181 | $ 56,181 |