Document and Entity Information
Document and Entity Information - USD ($) $ in Millions | 12 Months Ended | ||
Dec. 31, 2023 | Mar. 08, 2024 | Jun. 30, 2023 | |
Cover [Abstract] | |||
Document Type | 10-K | ||
Amendment Flag | false | ||
Document Period End Date | Dec. 31, 2023 | ||
Document Fiscal Year Focus | 2023 | ||
Document Fiscal Period Focus | FY | ||
Trading Symbol | ALVR | ||
Entity Registrant Name | ALLOVIR, INC. | ||
Entity Central Index Key | 0001754068 | ||
Entity Well-known Seasoned Issuer | No | ||
Entity Voluntary Filers | No | ||
Entity Current Reporting Status | Yes | ||
Entity Interactive Data Current | Yes | ||
Current Fiscal Year End Date | --12-31 | ||
Document Annual Report | true | ||
Document Transition Report | false | ||
Entity Filer Category | Non-accelerated Filer | ||
Entity Small Business | true | ||
Entity Emerging Growth Company | true | ||
Entity Ex Transition Period | false | ||
ICFR Auditor Attestation Flag | false | ||
Entity Shell Company | false | ||
Entity Public Float | $ 265.4 | ||
Entity Common Stock, Shares Outstanding | 114,869,175 | ||
Security12b Title | Common Stock, par value $0.0001 per share | ||
Security Exchange Name | NASDAQ | ||
Entity File Number | 001-39409 | ||
Entity Incorporation State Country Code | DE | ||
Entity Tax Identification Number | 83-1971007 | ||
Entity Address Address Line1 | 1100 Winter Street | ||
Entity Address City Or Town | Waltham | ||
Entity Address State Or Province | MA | ||
Entity Address Postal Zip Code | 02451 | ||
City Area Code | 617 | ||
Local Phone Number | 433-2605 | ||
Document Financial Statement Error Correction Flag | false | ||
Documents Incorporated by Reference | Portions of the Proxy Statement for the registrant’s 2024 Annual Meeting of Stockholders, or the Proxy Statement, which the Registrant intends to file pursuant to Regulation 14A with the Securities and Exchange Commission not later than 120 days after the Registrant’s fiscal year end of December 31, 2023 , are incorporated by reference into Part III of this Annual Report on Form 10-K. | ||
Auditor Firm ID | 34 | ||
Auditor Name | Deloitte & Touche LLP | ||
Auditor Location | Boston, MA, USA |
CONSOLIDATED BALANCE SHEETS
CONSOLIDATED BALANCE SHEETS - USD ($) $ in Thousands | Dec. 31, 2023 | Dec. 31, 2022 |
Current assets: | ||
Cash and cash equivalents | $ 90,121 | $ 106,092 |
Short-term investments | 93,822 | 127,703 |
Interest receivable | 206 | 157 |
Prepaid expenses and other current assets | 3,486 | 7,100 |
Prepaid expenses to related party | 2,000 | |
Total current assets | 187,635 | 243,052 |
Restricted cash | 852 | 852 |
Other assets | 122 | 612 |
Property and equipment, net | 930 | |
Operating lease right-of-use assets | 2,187 | 31,633 |
Total assets | 190,796 | 277,079 |
Current liabilities: | ||
Accounts payable | 6,761 | 3,004 |
Accrued expenses | 10,086 | 13,985 |
Income tax payable | 128 | |
Operating lease liability, current | 10,781 | 7,165 |
Total current liabilities | 28,367 | 24,338 |
Operating lease liability, long term | 16,648 | 28,222 |
Total liabilities | 45,015 | 52,560 |
Stockholders' equity: | ||
Preferred stock, $0.0001 par value: 10,000,000 shares authorized at December 31, 2023 and December 31, 2022, respectively; 0 shares issued and outstanding at December 31, 2023 and December 31, 2022, respectively; | ||
Common stock, $0.0001 par value: 300,000,000 and 150,000,000 shares authorized at December 31, 2023 and Decembe 31, 2022 respectively; 114,153,538 and 93,268,069 shares issued at December 31, 2023 and Decembe 31, 2022, respectively; and 114,148,991 and 93,093,243 shares outstanding at December 31, 2023 and December 31, 2022, respectively | 11 | 9 |
Additional paid-in capital | 802,025 | 690,753 |
Accumulated other comprehensive loss | (62) | (468) |
Accumulated deficit | (656,193) | (465,775) |
Total stockholders' equity | 145,781 | 224,519 |
Total liabilities and stockholders' equity | 190,796 | 277,079 |
Related Party | ||
Current liabilities: | ||
Amount due to related party | $ 739 | $ 56 |
CONSOLIDATED BALANCE SHEETS (Pa
CONSOLIDATED BALANCE SHEETS (Parenthetical) - $ / shares | Dec. 31, 2023 | Dec. 31, 2022 |
Statement of Financial Position [Abstract] | ||
Preferred stock, par or stated value per share | $ 0.0001 | $ 0.0001 |
Preferred stock, shares authorized | 10,000,000 | 10,000,000 |
Preferred stock, shares issued | 0 | 0 |
Preferred stock, shares outstanding | 0 | 0 |
Common stock, par value | $ 0.0001 | $ 0.0001 |
Common stock, shares authorized | 300,000,000 | 150,000,000 |
Common stock, shares issued | 114,153,538 | 93,268,069 |
Common stock, shares outstanding | 114,148,991 | 93,093,243 |
CONSOLIDATED STATEMENTS OF OPER
CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2023 | Dec. 31, 2022 | |
Operating expenses: | ||
Research and development | $ 133,070 | $ 118,870 |
General and administrative | 48,261 | 52,332 |
Impairment costs | 18,570 | |
Total operating expenses | 199,901 | 171,202 |
Loss from operations | (199,901) | (171,202) |
Total other income (loss), net: | ||
Interest income | 5,734 | 1,876 |
Other income (loss), net | 3,623 | 351 |
Loss before income taxes | (190,544) | (168,975) |
Income tax benefit | (126) | (265) |
Net loss | $ (190,418) | $ (168,710) |
Net loss per share - basic | $ (1.83) | $ (2.2) |
Net loss per share - diluted | $ (1.83) | $ (2.2) |
Weighted-average common shares outstanding - basic | 104,057,220 | 76,654,856 |
Weighted-average common shares outstanding - diluted | 104,057,220 | 76,654,856 |
Comprehensive loss: | ||
Net Income (Loss) | $ (190,418) | $ (168,710) |
Other comprehensive income (loss), net of tax: | ||
Unrealized gain (loss) on available-for-sale securities | 406 | (313) |
Total other comprehensive (income) loss | 406 | (313) |
Comprehensive loss | $ (190,012) | $ (169,023) |
CONSOLIDATED STATEMENTS OF CHAN
CONSOLIDATED STATEMENTS OF CHANGES IN STOCKHOLDERS' EQUITY - USD ($) $ in Thousands | Total | Common Stock | Additional Paid-In Capital | Accumulated Other Comprehensive (Loss) Income | Accumulated Deficit |
Balance at Dec. 31, 2021 | $ 225,266 | $ 7 | $ 522,479 | $ (155) | $ (297,065) |
Balance, Shares at Dec. 31, 2021 | 63,565,886 | ||||
Stock-based compensation | 41,315 | 41,315 | |||
Issuance of common stock, upon vesting of restricted stock, Shares | 1,912,210 | ||||
Purchase of common stock under the 2020 Employee Stock Purchase Plan | 536 | 536 | |||
Purchase of common stock under the 2020 employee stock purchase plan, Shares | 157,052 | ||||
Issuance of common stock in public offering, net of underwriting discounts, commissions and offering costs and registered direct offering, net of issuance costs | 126,425 | $ 2 | 126,423 | ||
Issuance of common stock in public offering, net of underwriting discounts, commissions and offering costs and registered direct offering, net of issuance costs, Shares | 27,458,095 | ||||
Unrealized gain (loss) on available-for-sale securities | (313) | (313) | |||
Net Income (Loss) | (168,710) | (168,710) | |||
Balance at Dec. 31, 2022 | 224,519 | $ 9 | 690,753 | (468) | (465,775) |
Balance, Shares at Dec. 31, 2022 | 93,093,243 | ||||
Stock-based compensation | 40,779 | 40,779 | |||
Issuance of common stock, upon vesting of restricted stock, Shares | 921,505 | ||||
Purchase of common stock under the 2020 Employee Stock Purchase Plan | 326 | 326 | |||
Purchase of common stock under the 2020 employee stock purchase plan, Shares | 134,243 | ||||
Issuance of common stock in public offering, net of underwriting discounts, commissions and offering costs and registered direct offering, net of issuance costs | 70,169 | $ 2 | 70,167 | ||
Issuance of common stock in public offering, net of underwriting discounts, commissions and offering costs and registered direct offering, net of issuance costs, Shares | 20,000,000 | ||||
Unrealized gain (loss) on available-for-sale securities | 406 | 406 | |||
Net Income (Loss) | (190,418) | (190,418) | |||
Balance at Dec. 31, 2023 | $ 145,781 | $ 11 | $ 802,025 | $ (62) | $ (656,193) |
Balance, Shares at Dec. 31, 2023 | 114,148,991 |
CONSOLIDATED STATEMENTS OF CH_2
CONSOLIDATED STATEMENTS OF CHANGES IN STOCKHOLDERS' EQUITY (Parenthetical) $ in Millions | 12 Months Ended |
Dec. 31, 2022 USD ($) | |
Issuance costs | $ 0.2 |
CONSOLIDATED STATEMENTS OF CASH
CONSOLIDATED STATEMENTS OF CASH FLOWS - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2023 | Dec. 31, 2022 | |
Cash flows from operating activities | ||
Net loss | $ (190,418) | $ (168,710) |
Adjustments to reconcile net loss to net cash used in operating activities: | ||
Depreciation and amortization | 398 | 723 |
Non-cash lease expense | 7,893 | 1,842 |
Impairment costs | 18,570 | |
Accretion of short-term investment discounts | (3,698) | (1,076) |
Stock-based compensation expense | 40,779 | 41,315 |
Changes in operating assets and liabilities: | ||
Interest receivable | (49) | (107) |
Prepaid expenses and other current assets and prepaid expenses to related party | 5,614 | (3,028) |
Other assets | (900) | 490 |
Income tax payable | (128) | (879) |
Accounts payable, accrued expenses, other liabilities and amount due to related party | (2,512) | (12,622) |
Net cash used in operating activities | (124,451) | (142,052) |
Cash flows from investing activities | ||
Purchase of short-term investments | (125,827) | (228,806) |
Maturities of short-term investments | 163,812 | 148,328 |
Net cash provided by (used in) investing activities | 37,985 | (80,478) |
Cash flows from financing activities | ||
Proceeds from issuance of common stock in public offering, net of underwriting discounts, commissions and offering costs | 70,169 | |
Proceeds from issuance of common stock in registered direct offering, net of issuance costs | 126,425 | |
Proceeds from issuance of stock under the 2020 Employee Stock Purchase Plan | 326 | 536 |
Net cash provided by financing activities | 70,495 | 126,961 |
Net decrease in cash, cash equivalents, and restricted cash | (15,971) | (95,569) |
Cash, cash equivalents, and restricted cash at beginning of period | 106,944 | 202,513 |
Cash, cash equivalents, and restricted cash at end of period | 90,973 | 106,944 |
Non-cash investing and financing activities | ||
Unrealized gain (loss) on available-for-sale securities | 406 | (313) |
Right-of-use assets obtained in exchange for operating lease liability | 14,717 | |
Reduction of right-of-use asset due to modification and remeasurement | (4,904) | (5,506) |
Purchase of property and equipment included in AP and accrued expenses | 104 | |
Supplemental disclosure of cash flows | ||
Income taxes paid, net of refunds | 220 | 613 |
Cash and cash equivalents | 90,121 | 106,092 |
Restricted cash | 852 | 852 |
Total cash, cash equivalents, and restricted cash | $ 90,973 | $ 106,944 |
Pay vs Performance Disclosure
Pay vs Performance Disclosure - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2023 | Dec. 31, 2022 | |
Pay vs Performance Disclosure | ||
Net Income (Loss) | $ (190,418) | $ (168,710) |
Insider Trading Arrangements
Insider Trading Arrangements | 3 Months Ended |
Dec. 31, 2023 | |
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 |
Rule 10b51 Arr Modified Flag | false |
Non Rule 10b51 Arr Modified Flag | false |
Nature of the Business
Nature of the Business | 12 Months Ended |
Dec. 31, 2023 | |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | |
Nature of the Business | 1. Nature of the Business AlloVir, Inc. (“AlloVir” or “the Company”, formerly known as ViraCyte, Inc.) is a cell therapy company developing highly innovative allogeneic T cell therapies to treat and prevent devastating viral diseases. The Company’s innovative and proprietary virus-specific T cell, or VST, therapy platform allows AlloVir to generate off-the-shelf VSTs designed to restore immunity in patients with T cell deficiencies who are at risk from the life-threatening consequences of viral diseases. There is an urgent medical need for therapies to treat a large number of patients suffering from viral diseases who currently have limited or no treatment options. The Company’s platform includes three innovative, allogeneic, off-the-shelf VST therapy candidates targeting 11 different devastating viruses. The Company’s lead product candidate, posoleucel (previously referred to as Viralym-M or ALVR105), is a multi-VST therapy that targets six viruses: adenovirus, or AdV, BK virus, or BKV, cytomegalovirus, or CMV, Epstein-Barr virus, or EBV, human herpesvirus 6, or HHV-6 and JC virus, or JCV. In December 2023, the Company announced the discontinuation of three Phase 3 registrational trials of posoleucel following separate, pre-planned Data Safety Monitoring Board, or DSMB, futility analyses that concluded the studies were unlikely to meet their primary endpoints. Specifically, the Company discontinued a multicenter, randomized, double-blind, placebo-controlled Phase 3 trial comparing posoleucel to placebo for the prevention of infection or disease due to AdV, BKV, CMV, EBV, HHV-6, or JCV in high-risk adult and pediatric patients after undergoing an allogeneic hematopoietic stem cell transplant. The Company also discontinued two multicenter, randomized, double-blind, placebo-controlled Phase 3 trials of posoleucel – one for the treatment of virus-associated hemorrhagic cystitis and the second for the treatment of adenovirus infection – both after allogeneic hematopoietic cell transplant. In December 2023, the Company also announced that it would review the detailed datasets from those Phase 3 trials and launch a comprehensive review of strategic alternatives focused on maximizing stockholder value, including, but not limited to, a merger, sale, divestiture of assets, licensing, or other strategic transaction. The Company expects to devote substantial time and resources to exploring strategic alternatives that the board of directors believes will maximize stockholder value. Despite devoting significant efforts to identify and evaluate potential strategic alternatives, there can be no assurance that this strategic review process will result in us pursuing any transaction or that any transaction, if pursued, will be completed on attractive terms or at all. The Company has not set a timetable for completion of this strategic review process, and the board of directors has not approved a definitive course of action. Additionally, there can be no assurances that any particular course of action, business arrangement or transaction, or series of transactions, will be pursued, successfully consummated or lead to increased stockholder value, or that the Company will make any cash distributions to our stockholders. In connection with the evaluation of strategic alternatives and in order maximize capital preservation, the Company has implemented a plan to reduce our workforce by approximately 95 %. This workforce reduction plan was approved in January 2024, and will take place primarily during the first quarter of 2024 and is expected to be substantially completed by April 15, 2024. The Company’s pipeline includes additional investigational VST therapies that may benefit high-risk individuals. ALVR106 is the Company’s second off-the-shelf, multi-VST product candidate targeting devastating respiratory diseases caused by human metapneumovirus, or hMPV, influenza, parainfluenza virus, or PIV and respiratory syncytial virus, or RSV. A Phase 1b/2 POC clinical study of ALVR106 has completed enrollment of patients in Part A of the trial. The Company has paused development of ALVR106, including discontinuing the trial pending the outcome of the Company's review of strategic alternatives. In the preclinical space, preclinical and IND-enabling studies of ALVR107 to treat and cure HBV were completed in 2022 to support advancement into a POC study. Clinical development of ALVR107 has been paused pending the outcome of the Company’s review of strategic alternatives. Going Concern In accordance with Accounting Standards Update (“ASU”) 2014-15, Disclosure of Uncertainties about an Entity’s Ability to Continue as a Going Concern (Subtopic 205-40) , the Company has evaluated whether there are conditions and events, considered in the aggregate, that raise substantial doubt about the Company’s ability to continue as a going concern within one year after the date the consolidated financial statements are issued. Since its inception and until recently, the Company devoted substantially all of its resources to recruiting personnel, developing its technology platform and advancing its pipeline of product candidates through discovery, preclinical and clinical trials, acquiring and manufacturing clinical trial materials and maintaining and building its intellectual property portfolio. The Company is subject to risks and uncertainties common to early-stage companies in the biotechnology industry, including, but not limited to, success of clinical trials, development by competitors of new technological innovations, dependence on key personnel, protection of proprietary technology, compliance with government regulations and the ability to secure additional capital to fund operations. Should the Company resume development of its product candidates, the product candidates will require significant additional research and development efforts, including preclinical and clinical testing and regulatory approval, prior to commercialization. Through December 31, 2023, the Company has funded its operations primarily with proceeds received from the sale of common stock, research grants, and from the sale of preferred stock. The Company has incurred recurring losses since its inception, including net losses attributable to common stockholders of $ 190.4 million for the year ended December 31, 2023 and $ 168.7 million for the year ended December 31, 2022. In addition, at December 31, 2023, the Company had an accumulated deficit of $ 656.2 million. The Company expects to continue to generate operating losses for the foreseeable future. The Company has incurred and expects to continue to incur costs and expenditures in connection with the process of evaluating strategic alternatives. There can be no assurance, however, that the Company will be able to successfully consummate any particular strategic transaction. The process of evaluating strategic options has been and may continue to be costly, time-consuming and complex and the Company may incur significant costs related to this continued evaluation, such as legal, accounting and advisory fees and expenses and other related charges. Based on current projections, the Company believes that its $ 183.9 million of cash, cash equivalents and short-term investments held at December 31, 2023 will be sufficient to fund planned operations for at least twelve months from the date that these consolidated financial statements are available to be issued. However, due to the consideration of certain qualitative factors, including the discontinuation of all clinical trials and research activities, as well as the Company's workforce reduction plan, management has concluded there is substantial doubt regarding the Company's ability to continue as a going concern for more than twelve months from the date that the consolidated financial statements are available to be issued. These consolidated financial statements do not include any adjustments that might result from the outcome of this uncertainty. Should the Company resume the development of product candidates, it would need to obtain substantial additional funding in connection with continuing operations, particularly as the Company resumes its preclinical activities and clinical trials for its product candidates. There can be no assurance that the Company will be able to obtain sufficient capital to cover its costs on acceptable terms, if at all. ElevateBio, LLC - Related Party On September 17, 2018, the Company executed a Series A2 Preferred Stock Purchase Agreement ("Series A2 Agreement"), with ElevateBio, LLC ("ElevateBio") and ElevateBio was a purchaser in our registered direct offering in July 2022. ElevateBio, through its diverse platform of technologies to support cell and gene therapy products and expertise, provides drug development and manufacturing services. As a result of ElevateBio’s purchase of our Series A2 Preferred Stock, which converted to common stock upon completion of our IPO, and as a result of ElevateBio’s participation in the July 2022 registered direct offering, ElevateBio acquired an ownership interest in the Company. The Chief Financial Officer of ElevateBio currently serves in a similar management role with AlloVir. In May 2021, Diana M. Brainard, M.D. succeeded David Hallal, ElevateBio’s Chief Executive Officer, as the Company’s Chief Executive Officer. Mr. Hallal currently serves as Executive Chairman of the Company’s board of directors. In addition to Mr. Hallal and Mr. Sinha, Morana Jovan-Embiricos, a director of the Company’s board of directors, also serves as a director of the board of directors of ElevateBio. |
Summary of Significant Accounti
Summary of Significant Accounting Policies | 12 Months Ended |
Dec. 31, 2023 | |
Accounting Policies [Abstract] | |
Summary of Significant Accounting Policies | 2. Summary of Significant Accounting Policies Basis of Presentation and Consolidation The accompanying consolidated financial statements have been prepared in accordance with accounting principles generally accepted in the United States (“U.S. GAAP”). The consolidated financial statements include the Company’s accounts and those of its wholly-owned subsidiaries. All intercompany accounts, transactions and balances have been eliminated in consolidation. Segment Information Operating segments are defined as components of an enterprise for which separate and discrete information is available for evaluation by the chief operating decision-maker in deciding how to allocate resources and assess performance. The Company has one operating segment. The Company’s singular focus is the research, development and commercialization of off-the-shelf VST therapies to prevent and treat severe viral-associated diseases. The Company’s chief operating decision maker, its Chief Executive Officer, manages the Company’s operations on a consolidated basis for the purpose of allocating resources. All of the Company’s long-lived assets are held in the United States. Use of Estimates The preparation of financial statements in conformity with U.S. GAAP requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities and disclosure of contingent assets and liabilities at the date of the financial statements and the reported amounts of expenses during the reporting period. Changes in estimates and assumptions are reflected in reported results in the period in which they become known. Actual results could differ from those estimates. Cash and Cash Equivalents Cash and cash equivalents are short-term, highly liquid investments with original maturities of three months or less at the date of purchase. Investments qualifying as cash equivalents primarily consist of money market funds, corporate bonds and commercial paper. Short-Term Investments Short-term investments consist of U.S. treasury securities and corporate bonds classified as available-for-sale that have maturities of less than one year . Available-for-sale securities are carried at fair value, with the unrealized gains and losses reported in other comprehensive income (loss) until realized. The amortized cost of debt securities in this category is adjusted for amortization of premiums and accretion of discounts to maturity. Such amortization or accretion is included in "other income (loss), net". Realized gains and losses are determined using the specific identification method and are included in "other income (loss), net". Restricted Cash Cash accounts with any type of restriction are classified as restricted cash. The Company has restricted cash deposits with a bank, which serve as collateral for a letter of credit issued to the landlord of the Company’s leased Waltham facility for a security deposit. The Company classified this amount as non-current restricted cash in the accompanying consolidated balance sheet at December 31, 2023 and 2022 . Property and Equipment, Net The Company records property and equipment at cost and recognizes depreciation using the straight-line method over the estimated useful lives of the respective assets , as follows: Asset category Estimated useful life Computer equipment 3 years Laboratory equipment 5 years The Company periodically evaluates whether events and circumstances have occurred that may warrant revision of the estimated useful life of property and equipment. Expenditures for repairs and maintenance of assets are expensed as incurred. Upon retirement or sale, the cost of assets disposed and the corresponding accumulated depreciation are removed from the related accounts and any resulting gain or loss is reflected in the results of operations. Construction in progress is not depreciated until it is placed in service. Property and equipment to be disposed of are carried at fair value less costs to sell. Impairment of Long-Lived Assets The Company accounts for long-lived assets in accordance with ASC Topic 360, Property, Plant, and Equipment (“ASC 360”). ASC 360 requires companies to: (i) recognize an impairment loss only if the carrying amount of a long-lived asset is not recoverable based on its undiscounted future cash flows and (ii) measure an impairment loss as the difference between the carrying amount and the fair value of the asset. The Company tests long-lived assets to be held and used, including right-of-use assets and property and equipment, for impairment whenever events or changes in circumstances indicate that the carrying amount of assets or asset groups may not be fully recoverable. Determination of recoverability is based on an estimate of undiscounted future cash flows resulting from the use of the asset and its eventual disposition. In the event that such cash flows are not expected to be sufficient to recover the carrying amount of the assets, the assets are written-down to their fair values. See Note 5 and Note 6 for impairment costs recognized during the years ended December 31, 2023 and 2022 . Fair Value Measurements ASC Topic 820, Fair Value Measurement (“ASC 820”), establishes a fair value hierarchy for instruments measured at fair value that distinguishes between assumptions based on market data (observable inputs) and the Company’s own assumptions (unobservable inputs). Observable inputs are inputs that market participants would use in pricing the asset or liability based on market data obtained from sources independent of the Company. Unobservable inputs are inputs that reflect the Company’s assumptions about the inputs that market participants would use in pricing the asset or liability and are developed based on the best information available in the circumstances. ASC 820 identifies fair value as the exchange price, or exit price, representing the amount that would be received to sell an asset or paid to transfer a liability in an orderly transaction between market participants. As a basis for considering market participant assumptions in fair value measurements, ASC 820 establishes a three-tier fair value hierarchy that distinguishes among the following: • Level 1 – Valuations based on unadjusted quoted prices in active markets for identical assets or liabilities that the Company has the ability to access. • Level 2 – Valuations based on quoted prices for similar assets or liabilities in active markets, quoted prices for identical or similar assets or liabilities in markets that are not active and models for which all significant inputs are observable, either directly or indirectly. • Level 3 – Valuations based on inputs that are unobservable and significant to the overall fair value measurement. To the extent that the valuation is based on models or inputs that are less observable or unobservable in the market, the determination of fair value requires more judgment. Accordingly, the degree of judgment exercised by the Company in determining fair value is greatest for instruments categorized in Level 3. A financial instrument’s level within the fair value hierarchy is based on the lowest level of any input that is significant to the fair value measurement. The Company’s financial instruments include cash equivalents, short-term investments, prepaid expenses and other current assets, prepaid expenses to related party, accounts payable, amount due to related party and accrued expenses. Certain of the Company’s financial assets, including cash equivalents and short-term investments, have been initially valued at the transaction price, and subsequently revalued at the end of each reporting period, utilizing third-party pricing services or other observable market data. The pricing services utilize industry standard valuation models and observable market inputs to determine value. Other financial instruments, including prepaid expenses and other current assets, prepaid expenses to related party, accounts payable, amount due to related party and accrued expenses, are carried at cost, which approximate fair value due to the short duration and term to maturity. Deferred Offering Costs The Company capitalizes certain legal, professional accounting and other third-party fees that are directly associated with in-process equity financings as deferred offering costs until such financings are consummated. After consummation of the equity financing, these costs are presented in the consolidated balance sheets as a direct reduction from the carrying amount of the respective equity instrument issued. Should an in-process equity financing be abandoned, the deferred offering costs will be expensed immediately as a charge to operating expenses in the consolidated statements of operations and comprehensive loss. At December 31, 2023 and 2022 , the Company had no deferred offering costs. Cloud Computing Arrangements The Company capitalizes certain implementation costs for internal-use software incurred in a cloud computing agreement that is a service contract. Eligible costs associated with cloud computing arrangements, such as the implementation costs incurred to develop or obtain software business applications used in the normal course of business, are capitalized in accordance with ASC 350. Capitalization ceases at the point the software is substantially complete and ready for its intended use, and after all substantial testing is completed. Amortization is recorded on a straight-line basis over the expected useful life of three years of the internal-use software cost in the same line item in the statement of operations and comprehensive loss as the expense for fees for the associated cloud computing arrangement. Amortization expense associated with the Company's cloud computing arrangements has been recognized in the amount of $ 0.5 million during the years ended December 31, 2023 and 2022 . As a result of the December 2023 announcement of the discontinuation of the Company’s three Phase 3 registrational trials and a comprehensive review of strategic alternatives, an impairment loss of $ 1.4 million was recognized during the year ended December 31, 2023 for implementation costs associated with cloud computing arrangements that are no longer probable of being implemented. Other Income (Loss), Net The Company records interest expense, investment amortization and accretion of discounts and premiums on short-term investments and foreign exchange gains and losses in “other income (loss), net” when incurred. Research and Development Costs Research and development costs are charged to expense as incurred. Research and development expenses are comprised of costs incurred in performing research and development activities, including personnel-related costs, stock-based compensation, facilities, research-related overhead, clinical trial costs, contracted services, research-related manufacturing, license fees and other external costs. The Company accounts for nonrefundable advance payments for goods and services that will be used in future research and development activities as expenses when the services have been performed or when the goods have been received. Accrued Research and Development Expenses The Company has entered into various research and development contracts. The payments under these contracts are recorded as research and development expenses as incurred. The Company records accrued liabilities for estimated ongoing research costs. When evaluating the adequacy of the accrued liabilities, the Company analyzes progress of the studies, including the phase or completion of events, invoices received and contracted costs. Judgements and estimates are made in determining the accrued balances at the end of any reporting period. Actual results could differ from the Company’s estimates. The Company’s historical accrual estimates have not been materially different from the actual costs. Stock-Based Compensation Expense The Company grants restricted stock and stock options to employees, consultants and directors. The Company recognizes stock-based compensation cost for awards with performance conditions if and when it concludes that it is probable that the performance conditions will be achieved. For awards with only a service condition, the Company expenses stock-based compensation on a straight-line basis over the requisite employee service period or for grants issued with performance conditions, on a graded-vesting basis over the requisite employee service period. Awards for employees and non-employees are accounted for similarly. The Company records stock-based compensation expense associated with grants of restricted stock and stock options in the consolidated statements of operations and comprehensive loss based on their estimated fair value at the date of the grant. The Company classifies stock-based compensation expense in its consolidated statements of operations and comprehensive loss in the same manner in which the grantee’s payroll costs are classified or in which the grantee’s service payments are classified. Forfeitures are accounted for as they occur. The fair value of each stock option grant is estimated on the date of grant using the Black‑Scholes option pricing model. The fair value of the Company’s common stock is determined based on the quoted market price of common stock. The Company also lacks company‑specific historical and implied volatility information for its stock. The Company estimates its expected stock price volatility based on the historical volatility of publicly traded peer companies and expects to continue to do so until such time as it has adequate historical data regarding the volatility of its own traded stock price. The expected term of the Company’s stock options has been determined utilizing the “simplified” method. The “simplified” method estimates the expected term of stock options as the mid‑point between the weighted average time to vesting and the contractual maturity. The risk‑free interest rate is determined by reference to the U.S. Treasury yield curve in effect at the time of grant of the award for time periods approximately equal to the expected term of the award. There is no expected dividend yield since the Company has never paid cash dividends on common stock and does not expect to pay any cash dividends in the foreseeable future. Net Loss per Share Basic and diluted net loss per share is determined by dividing net loss by the weighted‑average common stock outstanding during the period. Since we have incurred operating losses for all periods presented, outstanding stock options and unvested restricted common stock have been excluded from the calculation because their effects would be anti‑dilutive. Therefore, the weighted‑average shares used to calculate both basic and diluted loss per share are the same. Income Taxes The Company accounts for income taxes under the asset and liability method in accordance with ASC 740, Income Taxes . Under this method, deferred tax assets and liabilities are recognized for the estimated future tax consequences attributable to differences between financial statement carrying amounts of existing assets and liabilities and their respective tax bases. Deferred tax assets and liabilities are measured using enacted rates in effect for the year in which these temporary differences are expected to be recovered or settled. Valuation allowances are provided if based on the weight of available evidence, it is more likely than not that some or all of the deferred tax assets will not be realized. Management believes that it is more likely than not that all deferred tax assets will not be realized. The Company recognizes liabilities for potential tax payments to various tax authorities related to uncertain tax positions. The liabilities are based on a determination of whether and how much of a tax benefit taken by the Company in its tax filing is more likely than not to be realized following resolution of any potential contingencies present related to the tax benefit. Potential interest and penalties associated with such uncertain tax positions, if any, are recorded as components of income tax expense. The Company assesses its income tax positions and records tax benefits for all years subject to examination based upon management’s evaluation of the facts, circumstances and information available as of the reporting date. For those tax positions where it is more likely than not that a tax benefit will be sustained, the Company records the largest amount of tax benefit with a greater than 50 percent likelihood of being realized upon ultimate settlement with a taxing authority having full knowledge of all relevant information. For those income tax positions where it is not more likely than not that a tax benefit will be sustained, the Company does not recognize a tax benefit in the consolidated financial statements. Concentration of Credit Risk and Off-Balance Sheet Risk Financial instruments that subject the Company to credit risk consist primarily of cash, cash equivalents, restricted cash and short-term investments. Periodically, the Company maintains deposits in accredited financial institutions in excess of federally insured limits. The Company deposits its cash in financial institutions that it believes have high credit quality and have not experienced any losses on such accounts and does not believe it is exposed to any unusual credit risk beyond the normal credit risk associated with commercial banking relationships. Such deposits have and will continue to exceed federally insured limits. The Company has not experienced any losses on its cash deposits. At December 31, 2023 and 2022 , the Company had no off-balance sheet risk. Foreign Exchange The functional currency for all subsidiaries is the U.S. Dollar (“USD”). Transactions in foreign currencies are remeasured into the functional currency of the relevant subsidiaries at the exchange rate in effect at the date of the transaction. Any monetary assets and liabilities arising from these transactions are translated into the functional currency at exchange rates in effect at the balance sheet date or on settlement. Resulting gains and losses are recorded in "other income (loss), net" within the consolidated statements of operations and comprehensive loss. Comprehensive Loss Comprehensive loss is defined as a change in equity of a business enterprise during a period, resulting from transactions from non-owner sources. Comprehensive loss includes net loss and certain changes in stockholder’s deficit that are excluded from net loss. The Company's comprehensive loss includes unrealized gains (losses) on available-for-sale securities during the year ended December 31, 2023 and 2022 . Leases In accordance with ASC Topic 842, Lease Accounting , at the inception of an arrangement, the Company determines whether the arrangement is or contains a lease. Leases with a term greater than one year are recognized on the consolidated balance sheet as a right-of-use (“ROU”) asset and current and non-current lease liabilities, as applicable. The Company has made an accounting policy election, known as the short-term lease recognition exemption, which allows the Company to not recognize ROU assets and lease liabilities that arise from short-term leases (12 months or less) for any class of underlying asset. Options to renew or options to cancel a lease are not included in the Company’s assessment unless there is reasonable certainty that the Company will renew or will not cancel, respectively. Operating lease liabilities and their corresponding ROU assets are recorded based on the present value of future lease payments over the expected remaining lease term. Lease cost for operating leases is recognized on a straight-line basis over the lease term as an operating expense. Certain adjustments to the ROU asset may be required for items such as lease prepayments or incentives received. The interest rate implicit in lease contracts is typically not readily determinable. As a result, the Company utilizes its incremental borrowing rate, which reflects the fixed rate at which the Company could borrow on a collateralized basis the amount of the lease payments in the same currency, for a similar term, in a similar economic environment. The Company has elected to account for the lease and non-lease components together for all existing classes of underlying assets. Subsequent Events The Company evaluates events occurring after the date of our accompanying consolidated balance sheets for potential recognition or disclosure in our consolidated financial statements. The Company did not identify any material subsequent events requiring adjustment to our accompanying consolidated financial statements (recognized subsequent events). Those items requiring disclosure (unrecognized subsequent events) in the consolidated financial statements have been disclosed accordingly. Refer to Note 16 for further details. Recent Accounting Pronouncements From time to time, new accounting pronouncements are issued by the Financial Accounting Standards Board (“FASB”), or other standard setting bodies and adopted by the Company as of the specified effective date. Unless otherwise discussed, the impact of recently issued standards that are not yet effective will not have a material impact on the Company’s consolidated financial statements upon adoption. Under the Jumpstart Our Business Startups Act of 2012, as amended (the “JOBS Act”), the Company meets the definition of an emerging growth company and has elected the extended transition period for complying with certain new or revised accounting standards pursuant to Section 107(b) of the JOBS Act. Recently Adopted Accounting Pronouncements In June 2016, the FASB issued ASU No. 2016-13, Financial Instruments—Credit Losses (Topic 326): Measurement of Credit Losses on Financial Instruments , or ASU 2016-13, which requires the measurement and recognition of expected credit losses for financial assets held at amortized cost. ASU 2016-13 replaces the existing incurred loss impairment model with an expected loss model. It also eliminates the concept of other-than-temporary impairment and requires credit losses related to available-for-sale debt securities to be recorded through an allowance for credit losses rather than as a reduction in the amortized cost basis of the securities. These changes may result in earlier recognition of credit losses. The Company adopted ASU 2016-13 on January 1, 2023 . The adoption of ASU 2016-13 did not have a material impact on the Company’s consolidated financial statements and related disclosures. Recently Issued Accounting Pronouncements Not Yet Adopted In November 2023, the FASB issued ASU 2023-07, Segment Reporting (Topic 280): Improvements to Reportable Segment Disclosures , which requires disclosure of incremental segment information on an interim and annual basis. This ASU is effective for fiscal years beginning after December 15, 2023, and interim periods within fiscal periods beginning after December 15, 2024, and requires retrospective application to all prior periods presented in the financial statements. The adoption of this standard is not expected to have a material impact on the Company’s consolidated financial statements and related disclosures. In December 2023, the FASB issued ASU 2023-09, Income Taxes (Topic 740): Improvements to Income Tax Disclosures , which requires public entities, on an annual basis, to provide disclosure of specific categories in the rate reconciliation, as well as disclosure of income taxes paid disaggregated by jurisdiction. This ASU is effective for fiscal years beginning after December 15, 2024, with early adoption permitted. The adoption of this standard is not expected to have a material impact on the Company’s consolidated financial statements and related disclosures. |
Short-Term Investments
Short-Term Investments | 12 Months Ended |
Dec. 31, 2023 | |
Investments, Debt and Equity Securities [Abstract] | |
Short-Term Investments | 3. Short-Term Investments The following tables summarize the amortized cost and estimated fair value of the Company’s U.S. government treasury securities and marketable securities, which are considered to be available-for-sale investments and are included in short-term investments on the consolidated balance sheets: December 31, 2023 (in thousands) Amortized Unrealized Unrealized Fair U.S. government treasury securities $ 93,749 $ 73 $ — $ 93,822 Totals $ 93,749 $ 73 $ — $ 93,822 December 31, 2022 (in thousands) Amortized Unrealized Unrealized Fair U.S. government treasury securities $ 99,288 $ 1 $ ( 253 ) $ 99,036 Marketable securities: Corporate and agency bonds 28,748 3 ( 84 ) 28,667 Totals $ 128,036 $ 4 $ ( 337 ) $ 127,703 Certain short-term debt securities with original maturities of less than three months are included in cash and cash equivalents on the consolidated balance sheets and are not included in the tables above. The Company holds debt securities of companies with high credit quality and has determined that there was no material change in the credit risk of any of its debt securities. At December 31, 2023 and 2022 , all investments had contractual maturities within one year. |
Fair Value Measurements
Fair Value Measurements | 12 Months Ended |
Dec. 31, 2023 | |
Fair Value Disclosures [Abstract] | |
Fair Value Measurements | 4. Fair Value Measurements The following tables present information about the Company’s financial assets measured at fair value on a recurring basis: December 31, 2023 (in thousands) Level 1 Level 2 Level 3 Total Cash equivalents: Money market fund $ 23,854 $ — $ — $ 23,854 Totals $ 23,854 $ — $ — $ 23,854 Short-term investments: U.S. government treasury securities $ 93,822 $ — $ — $ 93,822 Totals $ 93,822 $ — $ — $ 93,822 December 31, 2022 (in thousands) Level 1 Level 2 Level 3 Total Cash equivalents: Money market fund $ 32,641 $ — $ — $ 32,641 Totals $ 32,641 $ — $ — $ 32,641 Short-term investments: U.S. government treasury securities $ 99,036 $ — $ — $ 99,036 Marketable securities: Corporate and agency bonds — 28,667 — 28,667 Totals $ 99,036 $ 28,667 $ — $ 127,703 During the years ended December 31, 2023 and 2022, there were no transfers between levels. The Company classifies its money market fund and U.S. government treasury securities as Level 1 assets under the fair value hierarchy, as these assets have been valued using quoted market prices in active markets without any valuation adjustment. The Company classifies its marketable securities as Level 2 assets under the fair value hierarchy, as these assets have pricing inputs that are other than quoted prices in active markets, which are either directly or indirectly observable as of the reporting date, and fair value is determined using models or other valuation methodologies. The carrying amounts of prepaid expenses and other current assets, prepaid expenses to related party, accounts payable, amount due to related party and accrued expenses approximate their fair values due to the short-term nature of these assets and liabilities. |
Leases
Leases | 12 Months Ended |
Dec. 31, 2023 | |
Leases [Abstract] | |
Leases | 5. Leases Operating leases Development and Manufacturing Services Agreement ("DMS Agreement") with Third-Party Supplier In October 2022, the Company entered into a Statement of Work ("SOW") under the DMS Agreement (the "2022 SOW under the DMS Agreement") with a third-party supplier. The 2022 SOW under the DMS Agreement contained an embedded lease for a dedicated manufacturing suite for the manufacture of AlloVir’s products at the facility because the Company directs how and for what purpose the suite is used and obtains substantially all of the economic benefit of the suite. At inception of the lease, it was determined that, in exchange for this dedicated manufacturing suite, AlloVir will pay the supplier a monthly fixed suite utilization fee, fixed batch payments and other related fixed costs, totaling $ 16.3 million over the 2.25 year lease term ending in December 2024 . As part of the arrangement, there were also variable costs for materials, non-fixed batch payments, testing, storage, knowledge and tech transfer and other common area maintenance fees that were not included in the measurement of the lease liability. The lease of the facility was determined to be classified as an operating lease and commenced in October 2022, the point at which the suite was substantially complete and available for use by the Company. Accordingly, at inception, the Company recorded a right-of-use asset and lease liability of $ 14.7 million. In December 2023, the Company issued a notice of termination of the DMS Agreement effective June 2024, or 190 days from the third-party supplier’ s receipt of the notice. Management concluded that the notice of termination constituted a lease reassessment under ASC 842 as the Company was granted the option of such termination at the onset of the DMS Agreement and it was previously determined to be reasonably certain of not being exercised. As a result, the remaining lease term was shortened and the Company recorded a $ 4.9 million reduction to the right-of-use asset and lease liability in December 2023. In February 2024, the Company entered into a new SOW that terminated the 2022 SOW under the DMS Agreement (see Note 16). Waltham Leases In September 2021, the Company entered into a lease agreement with BP Bay Colony LLC and a sublease with AMAG Pharmaceuticals Inc. for the lease of property in Waltham, Massachusetts (collectively, the "Waltham leases"). The space identified under the Waltham leases is intended for general office space, research and development, laboratory use, and light manufacturing. The Waltham leases are classified as operating leases and commenced in September 2021 . At the inception date, the Company recorded a ROU asset and lease liability of $ 6.0 million for the lease and a ROU asset and lease liability of $ 17.3 million for the sublease based on a July 30, 2030 end date for the Waltham leases. As part of the arrangement, there were also variable costs for common area maintenance fees that were not included in the measurement of the lease liability. The agreement also provided a $ 3.1 million tenant improvement allowance. The Company utilized $ 0.9 million of the tenant improvement allowance. The Company has the option to renew the leased space for an additional one time period of five years with written notice from the Company. As of December 31, 2023 , the Company has no reasonable certainty that this option to extend will be exercised. Impairment of Lease Right-of-Use Assets As a result of the December 2023 announcement of the discontinuation of the Company's three Phase 3 registrational trials, a comprehensive review of strategic alternatives, and the December 2023 notice of termination of the DMS Agreement, the Company determined that there was a triggering event for impairment. The Company determined that the operating lease right-of-use assets were not recoverable as the carrying value exceeded the anticipated future cash flows on an undiscounted basis. To measure the impairment, the Company determined the fair value of the operating lease right-of-use assets based on estimated subleasing scenarios, which represent the highest and best use of the right-of-use assets. This fair value assessment utilized market participant assumptions, including the anticipated amount and timing of potential sublease payments using current real estate trends and market conditions. As a result, an impairment charge was calculated by reducing the carrying amount of the operating lease right-of-use assets to their estimated fair value, which was determined by discounting the estimated future cash flows by applying a rate that a market participant would require in assuming the risks associated with those cash flows. During the year ended December 31, 2023 , the Company recorded an impairment loss of $ 16.6 million to the operating lease right-of-use assets. As of December 31, 2023 , the remaining right-of-use asset balance is $ 2.2 million, which relates to the Waltham leases. Maturities of operating lease liabilities at December 31, 2023 are as follows (in thousands): 2024 11,842 2025 3,219 2026 3,298 2027 3,376 2028 3,455 Thereafter 5,824 Total lease payments 31,014 Less: interest 3,585 Total lease liability $ 27,429 Lease liability – current $ 10,781 Lease liability – long-term $ 16,648 Total lease costs were $ 9.7 million and $ 6.6 million for the years ended December 31, 2023 and 2022 , respectively. Cash paid for operating leases was $ 4.8 million and $ 4.8 million for the year ended December 31, 2023 and 2022 , respectively. The Company’s total variable lease costs, such as materials, non-fixed batch payments, testing, storage, knowledge and tech transfer, and other common area maintenance fees, related to the operating leases was $ 0.9 million and $ 3.7 million for the years ended December 31, 2023 and 2022 , respectively. The weighted average remaining lease term is 4.70 years and 6.93 years at December 31, 2023 and 2022 , respectively. The weighted average discount rate is 5.95 % and 6.23 % at December 31, 2023 and 2022 , respectively. |
Property and Equipment, Net
Property and Equipment, Net | 12 Months Ended |
Dec. 31, 2023 | |
Property, Plant and Equipment [Abstract] | |
Property and Equipment, Net | 6. Property and Equipment, Net Property and equipment, net consisted of the following: December 31, (in thousands) 2023 2022 Laboratory equipment $ 1,483 $ 1,395 Computer equipment 435 435 Construction-in-progress — 104 Total property and equipment 1,918 1,934 Less: accumulated depreciation and impairment ( 1,918 ) ( 1,004 ) Property and equipment, net $ — $ 930 Depreciation expense was $ 0.4 million and $ 0.7 million for the years ended December 31, 2023 and 2022 , respectively. As a result of the December 2023 announcement of the discontinuation of the Company’s three Phase 3 registrational trials and a comprehensive review of strategic alternatives, an impairment loss of $ 0.5 million w as recognized on property and equipment during the year ended December 31, 2023. |
Accrued Expenses
Accrued Expenses | 12 Months Ended |
Dec. 31, 2023 | |
Payables and Accruals [Abstract] | |
Accrued Expenses | 7. Accrued Expenses Accrued expenses consisted of the following: December 31, (in thousands) 2023 2022 Employee compensation and benefits $ 3,809 $ 6,416 Professional fees 435 559 Research and development 2,442 5,678 Process development and manufacturing costs 2,367 504 Other 1,033 828 Total accrued expenses $ 10,086 $ 13,985 |
Sponsored Research, Collaborati
Sponsored Research, Collaboration and License Agreements | 12 Months Ended |
Dec. 31, 2023 | |
Research and Development [Abstract] | |
Sponsored Research, Collaboration and License Agreements | 8. Sponsored Research, Collaboration and License Agreements Amended and Restated Exclusive License Agreement with BCM In June 2017, the Company signed a License Agreement (the “License Agreement”) with BCM, whereby the Company acquired a royalty-bearing, worldwide, exclusive license to BCM’s rights in Subject Technology and related patent rights in the field of viral infection. In May 2020, the Company amended and restated the License Agreement (the “A&R License Agreement”), pursuant to which the Company obtained (a) an exclusive worldwide license, with the right to sublicense, under certain patent rights and other intellectual property rights of BCM, to make, have made, use, market, sell, offer to sell, lease, import and export products in a particular field, except that such license is non-exclusive within a particular subfield, and in addition with respect to certain patent rights such license is limited to two particular subfields, and (b) an exclusive, worldwide sublicense, with the right to further sublicense, under all patent rights and other intellectual property rights that are exclusively licensed to BCM by a certain third party licensor, to make, have made, use, market, sell, offer to sell, lease, import and export products in the same field. The Company’s rights are subject to the rights of the U.S. government and certain rights retained by BCM. Unless earlier terminated, the A&R License Agreement will expire on a country-by-country basis with respect to a product upon the later of (a) the expiration of the last to expire valid claim of a patent or patent application covering such product in such country or (b) 10 years after the first commercial sale of such product in such country. The Company may terminate the A&R License Agreement in its entirety at any time for convenience upon a certain number of days’ written notice. BCM may terminate the A&R License Agreement in its entirety for the Company’s uncured material default. BCM maintains control of all filing, prosecution and maintenance of its patent rights licensed by the Company, and the Company is responsible for all related costs and expenses during the term of the agreement. The Company also reimbursed BCM for costs and expenses (including reasonable legal fees and expenses) incurred prior to the effective date of the agreement with respect to the filing, prosecution and maintenance of the patent rights licensed by the Company. If BCM licenses the patent rights licensed by the Company to third parties for additional fields of use, the Company’s responsibility for patent related costs and expenses will be reduced on a pro-rata basis. Under the A&R License Agreement, the Company must use commercially reasonable efforts to develop and commercialize one or more products in certain countries. As partial consideration for the rights conveyed by BCM under the original agreement executed in June 2017, the Company paid BCM a non-refundable license fee of $ 250,000 . During the term of the A&R License Agreement, the Company is obligated to pay BCM a non-refundable annual license maintenance fee, but beginning with the fifth year after the original agreement date, license maintenance fees are fully creditable against royalty revenue due in the applicable year. The Company is required to pay certain milestone payments upon the achievement of specified clinical, regulatory, and sales milestones. In the event that the Company is able to successfully develop, launch and commercialize a product under the A&R License Agreement, total milestone payments could exceed $ 40.0 million. BCM is also eligible to receive tiered royalties at percentage rates ranging from less than 1 % to the low single-digits, on net sales of any products that are commercialized by the Company or its sublicensees that incorporate, utilize or are made with the use of, the intellectual property licensed by the Company. To the extent the Company sublicenses its license rights under the A&R License Agreement, BCM would be eligible to receive tiered sublicense income at percentage rates in the mid-single to low double-digits. In November 2020, the Company also entered into the First Amendment (the “License Amendment”) to the A&R License Agreement. Under the License Amendment, the Company assumed responsibility from BCM for the filing, prosecution and maintenance of the patent rights licensed by the Company from BCM under the A&R License Agreement that are in common with the License Agreement. Further, BCM also transferred to the Company the right of enforcement against third parties for any suspected infringement of any claims in such patent rights or misuse, misappropriation, theft or breach of confidence of other proprietary rights. Exclusive License Agreement with BCM In November 2020, the Company signed a second License Agreement (the “Second License Agreement) with BCM, whereby the Company acquired a royalty-bearing, worldwide, exclusive license to BCM’s rights in Subject Technology and related patent rights outside the field of viral infection (all fields other than those covered by the A&R License Agreement). Unless earlier terminated, the Second License Agreement will expire on a country-by-country basis with respect to a product upon the later of (a) the expiration of the last to expire valid claim of a patent or patent application covering such product in such country or (b) 10 years after the first commercial sale of such product in such country, provided that the Second License Agreement shall not expire later than March 25, 2040. The Company may terminate the Second License Agreement in its entirety at any time for convenience upon a certain number of days’ written notice. BCM may terminate the Second License Agreement in its entirety for the Company’s uncured material default. Under the Second License Agreement, BCM transferred to the Company control of all filing, prosecution and maintenance of the patent rights licensed by the Company, and the Company is responsible for all related costs and expenses during the term of the Second License Agreement. BCM also transferred to the Company the right of enforcement against third parties for any suspected infringement of any claims in the patent rights or misuse, misappropriation, theft or breach of confidence of other proprietary rights. The Company also reimbursed BCM for costs and expenses (including reasonable legal fees and expenses) incurred prior to the effective date of the Second License Agreement with respect to the filing, prosecution and maintenance of the patent rights licensed by the Company, to the extent not already paid by the Company under the A&R License Agreement. Under the Second License Agreement, the Company must use commercially reasonable efforts to develop and commercialize one or more products in certain countries. As partial consideration for the rights conveyed by BCM under the Second License Agreement, the Company paid BCM a non-refundable license fee of $ 125,000 . During the term of the Second License Agreement, the Company is obligated to pay BCM a non-refundable annual license maintenance fee of (a) $ 20,000 for the first through fourth anniversary of the effective date of the Second License Agreement, and (b) $ 40,000 for the fifth anniversary of the effective date and continuing thereafter, but beginning with the fifth year, license maintenance fees are fully creditable against royalty revenue due in the applicable year. The Company is required to pay certain milestone payments upon the achievement of specified clinical, regulatory, and sales milestones. In the event that the Company is able to successfully develop, launch and commercialize multiple products under the Second License Agreement, total milestone payments could exceed $ 30.0 million. BCM is also eligible to receive tiered royalties at percentage rates ranging from less than 1 % to the low single-digits, on net sales of any products that are commercialized by the Company or its sublicensees that incorporate, utilize or are made with the use of, the intellectual property licensed by the Company. To the extent the Company sublicenses its license rights under the Second License Agreement, BCM would be eligible to receive tiered sublicense income at percentage rates in the mid-single to low double-digits. Collaboration Agreement with BCM In November 2020, the Company entered into a Research Collaboration Agreement (the “Research Agreement”) with BCM, under which the Company agreed to pay BCM for performing certain research activities under the direction of Dr. Ann Leen commencing on January 1, 2021 and continuing for a three-year period thereafter. The Research Agreement requires the Company to make payments to BCM totaling approximately $ 6.0 million over the term of the Research Agreement. In August 2023, the Research Agreement was extended for an additional year, expiring December 31, 2024. Collectively under the agreements above and for services provided by BCM the Company paid $ 2.0 million and $ 2.5 million during the years ended December 31, 2023 and 2022, respectively, and the payments were classified in research and development expense in the consolidated statements of operations and comprehensive loss. CPRIT Grant In August 2017, the Company was awarded a grant (the “CPRIT Grant”) from the Cancer Prevention and Research Institute of Texas (“CPRIT”). The CPRIT Grant required that the Company grant CPRIT a non-commercial license to technology developed under the grant and pay CPRIT a share of revenue on sales of commercial products developed using CPRIT funds equal to low single digits of revenue until such time as CPRIT has been paid an aggregate amount equal to 400 % of the grant award proceeds. No royalty payments were made under this license agreement during the years ended December 31, 2023 and 2022, respectively. Redeemable Preferred Stock Redemption Agreement In September 2018, the Company entered into a redeemable preferred stock redemption agreement, or Redemption Agreement, to redeem shares of our Series A1 convertible preferred stock held by certain investors, including executive officer Ann Leen, director and former executive officer Juan Vera and entities affiliated with director, Malcolm Brenner and former director, John Wilson (or their affiliates). Pursuant to the Redemption Agreement, for a period of 20 years from the date of the first commercial sale of Viralym-M (now posoleucel), the Company is obligated to make earnout payments to such investors on at least an annual basis. The earnout payments will be 10 % of net sales of Viralym-M, which number will be reduced to a high single-digit percentage if certain events occur. Specifically, royalties due to third parties for the sale of Viralym-M are subtracted from the earnout payments due to the investors. Further, if the investors receive at least $ 50,000,000 in earnout payments from AlloVir during the three-year period after the first commercial sale of Viralym-M, the earnout payment percentage will be reduced. |
Stockholder's Equity
Stockholder's Equity | 12 Months Ended |
Dec. 31, 2023 | |
Equity [Abstract] | |
Stockholder's Equity | 9. Stockholder’s Equity On May 15, 2023, the Company filed a certificate of amendment to its amended and restated certificate of incorporation authorizing the Company to issue up to 300,000,000 shares of common stock at a par value of $ 0.0001 per share and 10,000,000 shares of preferred stock at a par value of $ 0.0001 per share. There were no shares of preferred stock issued or outstanding at December 31, 2023 and 2022. On June 21, 2023, the Company entered into an underwriting agreement with J.P. Morgan Securities LLC, Morgan Stanley & Co. LLC and BoFA Securities, Inc., as the representatives of the several underwriters (the “Underwriters”) relating to an underwritten public offering of 20,000,000 shares of its common stock at a public offering price of $ 3.75 per share, resulting in net proceeds of $ 70.2 million after deducting underwriting discounts and commissions of $ 4.5 million and offering costs of $ 0.3 million. Under the terms of the underwriting agreement, the Company granted the Underwriters an option, exercisable for 30 days, to purchase up to an additional 3,000,000 shares of its common stock at the same price per share as the shares, less underwriting discounts and commissions. On July 21, 2023 , the Underwriters option expired. On July 26, 2022, the Company entered into the Securities Purchase Agreement with certain investors for aggregate net proceeds of $ 126.4 million after deducting issuance costs of $ 0.2 million. Pursuant to the terms of the Securities Purchase Agreement, the Company agreed to issue and sell to the investors in a registered direct offering an aggregate of 27,458,095 shares of the Company's common stock, par value $ 0.0001 per share (the "Shares") at a purchase price of $ 4.61 per Share (the "Offering"). The Offering was made without an underwriter or a placement agent, and therefore, there were no underwriting discounts or commissions in connection with the offering. The following is a summary of the rights and privileges of the holders of the Company’s common stock at December 31, 2023 and 2022: Voting Rights The holders of the common stock are entitled to one vote for each share of common stock held at all meetings of stockholders (and written actions in lieu of meetings), and there are not any cumulative voting rights. The number of authorized shares of common stock may be increased or decreased by the affirmative vote of the holders of shares of capital stock of the Company; however, the issuance of common stock may be subject to the vote of the holders of one or more series of preferred stock that may be required by terms of the Third Amended and Restated Certificate of Incorporation. Dividends Subject to preferences that may be applicable to any then-outstanding preferred stock, holders of common stock are entitled to receive ratably those dividends, if any, as may be declared from time to time by the Board out of legally available funds. At December 31, 2023 , no cash dividends have been declared or paid. Liquidation Preference In the event of a liquidation, dissolution or winding up, holders of common stock will be entitled to share ratably in the net assets legally available for distribution to stockholders after the payment of all debts and other liabilities and the satisfaction of any liquidation preference granted to the then-outstanding shares of preferred stock. Rights and Preferences Holders of common stock have no preemptive, conversion or subscription rights and there are no redemption or sinking fund provisions applicable to the common stock. The rights, preferences and privileges of the holders of common stock are subject to, and may be adversely affected by, the rights of the holders of shares of any series of preferred stock that the Company may designate in the future. The Company has reserved shares of common stock for issuance as follows: December 31, 2023 2022 Unvested restricted stock 3,254,863 2,239,106 Options to purchase common stock 10,439,751 7,922,797 Stock available for grant under the 2020 Stock Option and Grant Plan 4,182,461 4,253,680 Stock available for issuance under the 2020 Employee Stock Purchase Plan 480,059 454,302 Total 18,357,134 14,869,885 |
Stock-Based Compensation
Stock-Based Compensation | 12 Months Ended |
Dec. 31, 2023 | |
Share-Based Payment Arrangement [Abstract] | |
Stock-Based Compensation | 10. Stock-Based Compensation Stock-Based Compensation Expense Stock-based compensation expense was as follows: Years Ended December 31, (in thousands) 2023 2022 Research and development $ 13,167 $ 14,014 General and administrative 27,612 27,301 Total stock-based compensation expense $ 40,779 $ 41,315 2018 Equity Incentive Plan The Company’s 2018 Plan provided for the Company to issue restricted stock, restricted stock units, incentive stock options, and non-statutory stock options and other stock-based awards to employees, officers, members of the Board, consultants and advisors of the Company. The 2018 Plan was most recently amended in July 2020. The awards granted under this plan generally vest over a four-year period and have a 10-year contractual term. At December 31, 2023 , there was an aggregate of 64,042 shares of common stock issuable upon the exercise of outstanding options under the 2018 Plan and 6,616,772 shares of restricted common stock granted under the 2018 plan. No shares remain available for future issuance under the 2018 Plan. Any options or awards outstanding under the 2018 Plan remain outstanding and effective. 2020 Stock Option and Grant Plan On July 2, 2020, the Company’s Board of Directors adopted and in July 2020 the stockholders approved the 2020 Stock Option and Grant Plan (the “2020 Plan”) which became effective on July 28, 2020, the date immediately prior to the date on which the registration statement related to the IPO was declared effective, and as a result no further awards were made under the 2018 Plan thereafter. Initially, the aggregate number of shares of our common stock that may be issued pursuant to stock awards under the 2020 Plan was 8,008,734 shares. The number of shares of our common stock reserved for issuance under the 2020 Plan shall be cumulatively increased on January 1, 2021 and each January 1 thereafter by 5 % of the total number of shares of our common stock outstanding on December 31 of the preceding calendar year or a lesser number of shares determined by our board of directors. Unless our board of directors elects not to increase the number of shares available for future grant each year, our stockholders may experience additional dilution, which could cause our stock price to fall. On January 1, 2023, 4,663,403 shares were added to the number of available shares under the 2020 Plan. The awards granted under this plan generally vest over a four-year period and have a 10-year contractual term. At December 31, 2023 , there were an aggregate of 10,375,709 shares of common stock issuable upon the exercise of outstanding options under the 2020 Plan and 5,356,510 shares of restricted common stock granted under the 2020 Plan. There is an aggregate of 4,182,461 shares reserved for future issuance under the 2020 Plan. Restricted Common Stock The following table summarizes restricted common stock activity for the year ended December 31, 2023: Shares Weighted Unvested at January 1, 2023 2,239,106 $ 13.75 Granted 2,279,994 6.02 Forfeited ( 342,732 ) 11.46 Vested ( 921,505 ) 13.24 Unvested at December 31, 2023 3,254,863 $ 8.73 At December 31, 2023 , there was $ 23.6 million of unrecognized stock-based compensation cost related to the restricted stock, which is expected to be recognized over a weighted average period of 2.20 years. The total fair value of restricted stock vested was $ 3.6 million and $ 14.2 million for the year ended December 31, 2023 and 2022, respectively. Stock Options The following table summarizes stock option activity (in thousands, except share and per share data): Shares Weighted Weighted Aggregate Options outstanding at January 1, 2023 7,922,797 $ 17.81 8.3 $ 786 Granted 3,779,342 6.24 — 57 Exercised — — — — Forfeited ( 1,262,388 ) 16.25 — 82 Options outstanding at December 31, 2023 10,439,751 $ 13.81 7.9 $ — Options vested and exercisable at December 31, 2023 4,534,147 $ 18.86 7.2 $ — The aggregate intrinsic value of options is calculated as the difference between the exercise price of the stock options and the fair value of the Company’s common stock for those stock options that had exercise prices lower than the fair value of the common stock as of the end of the period. The weighted average grant-date fair value of stock options granted during the year ended December 31, 2023 and 2022 was $ 4.88 per share and $ 5.61 per share, respectively. At December 31, 2023 , there was $ 36.9 million of unrecognized stock-based compensation expense related to unvested stock options, which is being recognized over a period of 1.92 years. The fair value was estimated on the date of grant using the Black-Scholes option-pricing model, with the following weighted-average assumptions: Years Ended December 31, 2023 2022 Expected term (in years) 6.11 6.07 Expected volatility 94 % 90 % Risk-free interest rate 3.52 % 2.00 % Expected dividend yield — — Fair value of common stock $ 6.24 $ 7.48 2020 Employee Stock Purchase Plan In July 2020, the 2020 Employee Stock Purchase Plan (the “2020 ESPP”) was adopted by the Board of Directors and approved by the stockholders. The purpose of the 2020 ESPP is to provide eligible employees of the Company and other designated companies, with opportunities to purchase shares of the Company’s common stock, par value $ 0.0001 per share. Initially, 611,354 shares of common stock in the aggregate were approved and reserved for this purpose. The number of shares of common stock reserved and available for issuance under the 2020 ESPP shall be cumulatively increased on January 1, 2021 and each January 1 thereafter by the least of (i) 1,222,707 shares of common stock, (ii) 1 % of the number of shares of common stock issued and outstanding on the immediately preceding December 31, and (iii) such number of shares of common stock as determined by the Administrator. On January 1, 2023, 160,000 shares were added to the number of available shares under the ESPP. At December 31, 2023 , there was an aggregate of 480,059 shares reserved for future issuance under the ESPP. The ESPP allows eligible employees to authorize payroll deductions of up to 15 % of their base salary or wages up to $ 25,000 annually to be applied toward the purchase of shares of the Company's common stock on the last trading day of the offering period. Participating employees will purchase shares of the Company's common stock at a discount of up to 15 % on the lesser of the closing price of the Company's common stock on the NASDAQ Global Market (i) on the first trading day of the offering period or (ii) the last day of any offering period. The Company utilizes the Black Scholes option pricing model to compute the fair market value of the shares and compensation expense is recognized over the offering period. Six-month offering periods commence each January 1 and July 1 during the term of the plan, with the administrator having the right to establish different offering periods. Participation in the ESPP is voluntary. Eligible employees become participants in the ESPP by enrolling in the plan and authorizing payroll deductions. At the end of each offering period, accumulated payroll deductions are used to purchase the Company’s shares at the discounted price. The Company makes no contributions to the ESPP. A participant may withdraw from the ESPP or suspend contributions to the ESPP. If the participant elects to withdraw during an offering period, all contributions are refunded as soon as administratively practicable. If a participant elects to withdraw or suspend contributions, they will not be able to re-enroll in the current offering but may elect to participate in future offerings. The ESPP purchases only whole shares of the Company’s common stock. The Company issued 134,243 common shares under the ESPP during the year ended December 31, 2023 , at an average price per share of $ 2.43 . Cash received from purchases under the ESPP for the year ended December 31, 2023 and 2022 was $ 0.3 million and $ 0.5 million, respectively. The Company recognized $ 0.3 million and $ 0.2 million of compensation expense for the ESPP during the year ended December 31, 2023 and 2022 , respectively. |
Income Taxes
Income Taxes | 12 Months Ended |
Dec. 31, 2023 | |
Income Tax Disclosure [Abstract] | |
Income Taxes | 11. Income Taxes Income (loss) before provision for income taxes consisted of the following: Years Ended December 31, (in thousands) 2023 2022 Federal ( 376,152 ) ( 113,389 ) Foreign 185,608 ( 55,586 ) Loss before provision for income taxes $ ( 190,544 ) $ ( 168,975 ) The provision for income taxes for the years ended December 31, 2023 and 2022 consisted of the following: Years Ended December 31, (in thousands) 2023 2022 Current income tax (benefit) expense: Federal $ ( 136 ) ( 246 ) State 10 ( 19 ) Foreign — — Total current income tax benefit ( 126 ) ( 265 ) Deferred income tax (benefit) expense: Federal — — State — — Foreign — — Total deferred income tax benefit — — Total income tax benefit $ ( 126 ) $ ( 265 ) The Company’s income tax benefit for the years ended December 31, 2023 and 2022 relating to federal, state and foreign tax jurisdictions differs from the amounts determined by applying the statutory federal income tax rate based on the following: Years Ended December 31, (in thousands) 2023 2022 Benefit at the federal rate $ ( 40,015 ) 21.0 % $ ( 35,472 ) 21.0 % Increase (decrease) resulting from: Foreign tax rate differential ( 15,783 ) 8.3 % 2,177 ( 1.3 )% State taxes, net of federal benefit ( 9,514 ) 5.0 % ( 1,603 ) 0.9 % Change in valuation allowance 98,714 ( 51.8 )% 35,406 ( 21.0 )% Intercompany note impairment ( 34,615 ) 18.2 % — — Tax credits ( 5,928 ) 3.1 % ( 6,992 ) 4.1 % Officer's compensation 177 ( 0.1 )% 695 ( 0.4 )% Stock compensation 4,564 ( 2.4 )% 4,637 ( 2.7 )% Impairment of intellectual property 3,003 ( 1.6 )% — — Permanent differences 79 0.0 % ( 182 ) 0.1 % Change in state tax law 384 ( 0.2 )% — — Other ( 1,192 ) 0.6 % 1,069 ( 0.6 )% Total income tax benefit $ ( 126 ) 0.1 % $ ( 265 ) 0.1 % In 2021, the Company transferred intellectual property rights between tax jurisdictions, resulting in a deferred tax asset on the basis difference in the intangible assets. In addition, in connection with the transfer of the intellectual property the Company recorded intercompany notes between the parties. In December 2023, the Company determined that the intellectual property intangible assets and intercompany notes were impaired resulting in the recognition of income or loss in the respective jurisdiction. Components of deferred income taxes consist of the following: December 31, (in thousands) 2023 2022 Deferred tax assets: Net operating loss carryforwards $ 54,081 $ 9,374 Tax credit carryforwards 19,378 12,374 Intangible assets — 25,537 Intercompany note impairment 64,087 Operating lease liabilities 6,348 8,074 Non-qualified stock compensation 15,435 12,017 Restricted stock compensation 680 235 Capitalization of R&D expenses 20,758 20,375 Other 676 1,661 Total deferred tax assets 181,443 89,647 Valuation allowance ( 180,943 ) ( 82,228 ) Net deferred tax assets $ 500 $ 7,419 Deferred tax liabilities: Operating lease right-of-use assets ( 506 ) ( 7,218 ) Depreciation 4 ( 186 ) Other 2 ( 15 ) Total deferred tax liabilities ( 500 ) ( 7,419 ) Net deferred tax asset (liability) $ — $ — The Company’s accounting for deferred taxes involves the evaluation of a number of factors concerning the realizability of its net deferred tax assets. The Company primarily considered such factors as its history of operating losses, the nature of the Company’s deferred tax assets, and the timing, likelihood and amount, if any, of future taxable income during the periods in which those temporary differences and carryforwards become deductible. At December 31, 2023 and 2022, the Company does not believe that it is more likely than not that the deferred tax assets will be realized; accordingly, a full valuation allowance has been established and no deferred tax asset is shown in the accompanying consolidated balance sheets. For the year ended December 31, 2023 , the valuation allowance for deferred tax assets increased by $ 98.7 million, which was principally due to increased deffered taxes for net operating losses and intercompany note impairment. For the year ended December 31, 2022 , the valuation allowance for deferred tax assets increased by $ 35.4 million, which was principally due to net operating losses, tax credits, tax basis generated from the intellectual property transfer, and U.S. research and development expense capitalization. At December 31, 2023 and 2022 , the Company had unused federal net operating loss carryforwards of $ 38.9 million and $ 0 , respectively. The federal net operating loss carryforwards have no expiration, and are limited in utilization to 80 % of taxable income. The CARES Act temporarily allows the Company to carryback net operating losses arising in 2018, 2019 and 2020 to the five prior tax years. In addition, net operating losses generated in these years could fully offset prior year taxable income without the 80 % of the taxable income limitation under the TCJA which was enacted on December 22, 2017. The Company has been generating losses since its inception, as such the net operating loss carryback provision under the CARES Act is not applicable to the Company. At December 31, 2023 and 2022 , the Company had unused state net operating loss carryforwards of $ 26.4 million and $ 3.6 million, respectively. The state net operating loss carryforwards expire in 2035. At December 31, 2023 and 2022 , the Company had unused foreign net operating loss carryforwards of $ 354.8 million and $ 72.9 million, respectively. The foreign net operating loss carryforwards have no expiration. At December 31, 2023 and 2022 , the Company had $ 11.7 million and $ 6.6 million of federal research and development tax credit carryforwards that may be available to offset future federal income taxes through 2040 . Additionally, at December 31, 2023 , the Company had a federal orphan drug credit (ODC) carryforward related to qualifying research of $ 6.0 million that will begin to expire in 2041 . At December 31, 2023 and 2022 , the Company also had $ 2.1 million and $ 1.3 million of research and development tax credit carryforwards that may be available to offset future state income taxes in the state of Massachusetts through 2035 . Utilization of net operating loss and research and development tax credit carryforwards may be subject to a substantial annual limitation under Section 382 of the Internal Revenue Code of 1986, as amended, due to ownership changes that have occurred previously or that could occur in the future. These ownership changes may limit the amount of net operating loss and research and development tax credit carryforwards that can be utilized annually to offset future taxable income and tax expense, respectively. The Company has completed several financings since its inception which may result in a change of control as defined in Section 382 of the Internal Revenue Code or could result in a change in control in the future. The Company complies with the provisions of ASC 740 in accounting for its uncertain tax positions. ASC 740 addresses the determination of whether tax benefits claimed or expected to be claimed on a tax return should be recorded in the consolidated financial statements. Under ASC 740, the Company may recognize the tax benefit from an uncertain tax position only if it is more likely that not that the tax position will be sustained on examination by the taxing authorities, based on the technical merits of the position. At December 31, 2023 and 2022 , the Company had no uncertain tax positions. The Company recognizes interest accrued related to unrecognized tax benefits and penalties in income tax expense. The Company had no accruals for interest and penalties at December 31, 2023 and 2022. The Company files tax returns as prescribed by the tax laws of the jurisdictions in which it operates. The statute of limitations for assessment by the Internal Revenue Service and state tax authorities remains open for the tax years December 31, 2020 through December 31, 2023 as the Company was incorporated in September 2018. There are currently no federal, state or foreign income tax audits in progress. The resolution of tax matters is not expected to have a material effect on the Company's consolidated financial statements. |
Net Loss per Share
Net Loss per Share | 12 Months Ended |
Dec. 31, 2023 | |
Earnings Per Share [Abstract] | |
Net Loss per Share | 12. Net Loss per Share The following table summarizes the computation of basic and diluted net loss per share attributable to common stockholders of the Company: Years Ended December 31, (in thousands, except share and per share data) 2023 2022 Numerator: Net loss – basic and diluted $ ( 190,418 ) $ ( 168,710 ) Denominator: Weighted-average common shares outstanding – basic and diluted 104,057,220 76,654,856 Net loss per share – basic and diluted $ ( 1.83 ) $ ( 2.20 ) Based on the amounts outstanding at December 31, 2023 and 2022, the Company excluded the following potential shares of common stock from the computation of diluted net loss per share attributable to common stockholders for the years ended December 31, 2023 and 2022, because including them would have had an anti-dilutive effect. Therefore, the weighted-average number of common shares outstanding used to calculate both basic and diluted net loss per share attributable to common stockholders is the same. Years Ended December 31, 2023 2022 Options to purchase common stock 10,439,751 7,922,797 Unvested restricted stock 3,254,863 2,239,106 |
Commitments and Contingencies
Commitments and Contingencies | 12 Months Ended |
Dec. 31, 2023 | |
Commitments and Contingencies Disclosure [Abstract] | |
Commitments and Contingencies | 13. Commitments and Contingencies Leases The Company entered into a lease agreement and a sublease agreement for the lease of property in Waltham, Massachusetts (see Note 5 and Note 16). Legal Proceedings From time to time, in the ordinary course of business, the Company is subject to litigation and regulatory examinations as well as information gathering requests, inquiries and investigations. On January 19, 2024, a purported stockholder of the Company filed a lawsuit, captioned Zerbato v. AlloVir, Inc. et al., No. 1:24-cv-10152 (D. Mass.), in Massachusetts federal court against the Company and two of its officers purportedly on behalf of a putative class of stockholders consisting of persons who purchased or otherwise acquired Company securities between March 22, 2022 and December 21, 2023, inclusive. The complaint purports to assert claims under Section 10(b) and 20(a) of the Securities Act of 1934, as amended, and the related regulations, alleging that the defendants made false and misleading statements and omissions to investors relating to the Company’s three Phase 3 studies of posoleucel. The complaint seeks, among other things, damages, prejudgment and post-judgment interest, and attorneys’ fees, expert fees and other costs. The Company intends to vigorously defend against the lawsuit. As the outcome is not presently determinable, any loss is neither probable nor reasonably estimable. Purchase and Other Obligations We enter into contracts in the normal course of business with CROs and other third-party vendors for clinical trials and testing and manufacturing services, which can contain purchase commitments or other noncancelable obligations. Most contracts do not contain minimum purchase commitments and are cancellable by us upon written notice. Payments due upon cancellation consist of payments for services provided or expenses incurred, including non-cancelable obligations of services provided up to one year after the date of cancellation. The amount and timing of such payments are not known. We may incur potential contingent payments upon our achievement of clinical, regulatory and commercial milestones, as applicable, or we may be required to make royalty payments under license and grant agreements we have entered into with various entities pursuant to which we have in-licensed certain intellectual property. Due to the uncertainty of the achievement and timing of the events requiring payment under these agreements, the amounts to be paid by us are not fixed or determinable at this time (see Note 8). |
Related Party Transactions
Related Party Transactions | 12 Months Ended |
Dec. 31, 2023 | |
Related Party Transactions [Abstract] | |
Related Party Transactions | 14. Related Party Transactions In March 2020, the Company entered into a Management and Administrative Services Agreement with ElevateBio Technologies, Inc. that provides for ongoing services to the Company in areas such as information technology, human resources and administration management, and facilities. The Company is billed monthly for such services at cost, with mark-up for profit on specific services, but including reasonable allocations of employee benefits, facilities and other direct or fairly allocated indirect costs that relate to the associates providing the services. The agreement has an initial term of five years and will automatically renew for successive one year terms, unless earlier terminated under the terms of the agreement. In May 2020, the Company entered into a Development and Manufacturing Services Agreement with ElevateBio BaseCamp, Inc. ("BaseCamp") pursuant to which BaseCamp provides products and services that are used in the Company's laboratory operations, including consulting services, project management services, quality control services and cGMP drug product manufacturing (see Note 5). The agreement will expire upon the later of (a) five years from the effective date of January 1, 2019 or (b) the completion of services under all work orders executed prior to the fifth anniversary of the effective date, unless earlier terminated under the terms of the agreement . In August 2022, the Company made a $ 2.0 million prepayment to BaseCamp for future services. The Company incurred $ 2.6 million and $ 3.5 million during the year ended December 31, 2023 and 2022, respectively, related to services provided to the Company by ElevateBio and affiliates. At December 31, 2023 and 2022 , the Company owed ElevateBio and affiliates $ 0.3 million and $ 0.1 million, respectively and had prepaid expenses with ElevateBio and affiliates of $ 0 and $ 2.0 million, respectively. In March 2023, the Company entered into a services agreement with Marker Therapeutics, Inc. (“Marker”) pursuant to which Marker provides development services to the Company. Juan Vera, a current director and former executive officer of the Company, is co-founder, director and chief executive officer of Marker. In June 2023, CellReady LLC ("CellReady") acquired certain manufacturing assets previously owned by Marker, and inherited the service agreement that Allovir previously maintained with Marker. The Company incurred $ 0.5 million during the year ended December 31, 2023, under the agreement. At December 31, 2023 , the Company owed CellReady $ 0.5 million. Members of the Company’s management and board of directors received consulting fees totaling $ 0.4 million and $ 0.5 million during the years ended December 31, 2023 and 2022 , respectively. |
Employee Benefit Plans
Employee Benefit Plans | 12 Months Ended |
Dec. 31, 2023 | |
Retirement Benefits [Abstract] | |
Employee Benefit Plans | 15. Employee Benefit Plans Effective January 1, 2019, the Company adopted a 401(k) Plan for its employees, which is designed to be qualified under Section 401(k) of the Internal Revenue Code. Eligible employees are permitted to contribute to the 401(k) Plan within statutory and 401(k) Plan limits. The Company made matching contributions of $ 0.9 million and $ 0.8 million for the years ended December 31, 2023 and 2022 , respectively. |
Subsequent Events
Subsequent Events | 12 Months Ended |
Dec. 31, 2023 | |
Subsequent Events [Abstract] | |
Subsequent Events | 16. Subsequent Events In January 2024, the board of directors approved a reduction in the Company's workforce by approximately 95 % of the Company's current employee base in order to reduce costs and preserve capital in light of the announcement on December 22, 2023 that the Company is discontinuing its three global Phase 3 posoleucel studies. This workforce reduction will take place primarily during the first quarter of 2024 and expected to be substantially completed by April 15, 2024. As a result of these actions, the Company expects to incur personnel-related restructuring charges, excluding bonuses accrued as of December 31, 2023, of approximately $ 10 million in connection with one-time employee termination cash expenditures, including severance and other benefits. The Company had previously granted certain of the terminated employees restricted stock units (“RSUs”) that vest in annual installments based on continued service to the Company, as well as options to purchase shares of the Company’s common stock that typically vest over a period of four years . In connection with the reduction in workforce, the Company agreed to accelerate the vesting of a portion of the RSUs that were unvested as of the employees’ termination dates. In February 2024, the Company entered into a new SOW ("2024 SOW under the DMS Agreement") that terminated the 2022 SOW under the DMS Agreement with a third-party supplier (see Note 5), resulting in a decrease in lease payments of $ 5.7 million in 2024. In Q1 2024, the Company paid all remaining lease obligations of $ 2.9 million. |
Summary of Significant Accoun_2
Summary of Significant Accounting Policies (Policies) | 12 Months Ended |
Dec. 31, 2023 | |
Accounting Policies [Abstract] | |
Basis of Presentation and Consolidation | Basis of Presentation and Consolidation The accompanying consolidated financial statements have been prepared in accordance with accounting principles generally accepted in the United States (“U.S. GAAP”). The consolidated financial statements include the Company’s accounts and those of its wholly-owned subsidiaries. All intercompany accounts, transactions and balances have been eliminated in consolidation. |
Segment Information | Segment Information Operating segments are defined as components of an enterprise for which separate and discrete information is available for evaluation by the chief operating decision-maker in deciding how to allocate resources and assess performance. The Company has one operating segment. The Company’s singular focus is the research, development and commercialization of off-the-shelf VST therapies to prevent and treat severe viral-associated diseases. The Company’s chief operating decision maker, its Chief Executive Officer, manages the Company’s operations on a consolidated basis for the purpose of allocating resources. All of the Company’s long-lived assets are held in the United States. |
Use of Estimates | Use of Estimates The preparation of financial statements in conformity with U.S. GAAP requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities and disclosure of contingent assets and liabilities at the date of the financial statements and the reported amounts of expenses during the reporting period. Changes in estimates and assumptions are reflected in reported results in the period in which they become known. Actual results could differ from those estimates. |
Cash and Cash Equivalents | Cash and Cash Equivalents Cash and cash equivalents are short-term, highly liquid investments with original maturities of three months or less at the date of purchase. Investments qualifying as cash equivalents primarily consist of money market funds, corporate bonds and commercial paper. |
Short-Term Investments | Short-Term Investments Short-term investments consist of U.S. treasury securities and corporate bonds classified as available-for-sale that have maturities of less than one year . Available-for-sale securities are carried at fair value, with the unrealized gains and losses reported in other comprehensive income (loss) until realized. The amortized cost of debt securities in this category is adjusted for amortization of premiums and accretion of discounts to maturity. Such amortization or accretion is included in "other income (loss), net". Realized gains and losses are determined using the specific identification method and are included in "other income (loss), net". |
Restricted Cash | Restricted Cash Cash accounts with any type of restriction are classified as restricted cash. The Company has restricted cash deposits with a bank, which serve as collateral for a letter of credit issued to the landlord of the Company’s leased Waltham facility for a security deposit. The Company classified this amount as non-current restricted cash in the accompanying consolidated balance sheet at December 31, 2023 and 2022 . |
Property and Equipment, Net | Property and Equipment, Net The Company records property and equipment at cost and recognizes depreciation using the straight-line method over the estimated useful lives of the respective assets , as follows: Asset category Estimated useful life Computer equipment 3 years Laboratory equipment 5 years The Company periodically evaluates whether events and circumstances have occurred that may warrant revision of the estimated useful life of property and equipment. Expenditures for repairs and maintenance of assets are expensed as incurred. Upon retirement or sale, the cost of assets disposed and the corresponding accumulated depreciation are removed from the related accounts and any resulting gain or loss is reflected in the results of operations. Construction in progress is not depreciated until it is placed in service. Property and equipment to be disposed of are carried at fair value less costs to sell. |
Impairment of Long-Lived Assets | Impairment of Long-Lived Assets The Company accounts for long-lived assets in accordance with ASC Topic 360, Property, Plant, and Equipment (“ASC 360”). ASC 360 requires companies to: (i) recognize an impairment loss only if the carrying amount of a long-lived asset is not recoverable based on its undiscounted future cash flows and (ii) measure an impairment loss as the difference between the carrying amount and the fair value of the asset. The Company tests long-lived assets to be held and used, including right-of-use assets and property and equipment, for impairment whenever events or changes in circumstances indicate that the carrying amount of assets or asset groups may not be fully recoverable. Determination of recoverability is based on an estimate of undiscounted future cash flows resulting from the use of the asset and its eventual disposition. In the event that such cash flows are not expected to be sufficient to recover the carrying amount of the assets, the assets are written-down to their fair values. See Note 5 and Note 6 for impairment costs recognized during the years ended December 31, 2023 and 2022 . |
Fair Value Measurements | Fair Value Measurements ASC Topic 820, Fair Value Measurement (“ASC 820”), establishes a fair value hierarchy for instruments measured at fair value that distinguishes between assumptions based on market data (observable inputs) and the Company’s own assumptions (unobservable inputs). Observable inputs are inputs that market participants would use in pricing the asset or liability based on market data obtained from sources independent of the Company. Unobservable inputs are inputs that reflect the Company’s assumptions about the inputs that market participants would use in pricing the asset or liability and are developed based on the best information available in the circumstances. ASC 820 identifies fair value as the exchange price, or exit price, representing the amount that would be received to sell an asset or paid to transfer a liability in an orderly transaction between market participants. As a basis for considering market participant assumptions in fair value measurements, ASC 820 establishes a three-tier fair value hierarchy that distinguishes among the following: • Level 1 – Valuations based on unadjusted quoted prices in active markets for identical assets or liabilities that the Company has the ability to access. • Level 2 – Valuations based on quoted prices for similar assets or liabilities in active markets, quoted prices for identical or similar assets or liabilities in markets that are not active and models for which all significant inputs are observable, either directly or indirectly. • Level 3 – Valuations based on inputs that are unobservable and significant to the overall fair value measurement. To the extent that the valuation is based on models or inputs that are less observable or unobservable in the market, the determination of fair value requires more judgment. Accordingly, the degree of judgment exercised by the Company in determining fair value is greatest for instruments categorized in Level 3. A financial instrument’s level within the fair value hierarchy is based on the lowest level of any input that is significant to the fair value measurement. The Company’s financial instruments include cash equivalents, short-term investments, prepaid expenses and other current assets, prepaid expenses to related party, accounts payable, amount due to related party and accrued expenses. Certain of the Company’s financial assets, including cash equivalents and short-term investments, have been initially valued at the transaction price, and subsequently revalued at the end of each reporting period, utilizing third-party pricing services or other observable market data. The pricing services utilize industry standard valuation models and observable market inputs to determine value. Other financial instruments, including prepaid expenses and other current assets, prepaid expenses to related party, accounts payable, amount due to related party and accrued expenses, are carried at cost, which approximate fair value due to the short duration and term to maturity. |
Deferred Offering Costs | Deferred Offering Costs The Company capitalizes certain legal, professional accounting and other third-party fees that are directly associated with in-process equity financings as deferred offering costs until such financings are consummated. After consummation of the equity financing, these costs are presented in the consolidated balance sheets as a direct reduction from the carrying amount of the respective equity instrument issued. Should an in-process equity financing be abandoned, the deferred offering costs will be expensed immediately as a charge to operating expenses in the consolidated statements of operations and comprehensive loss. At December 31, 2023 and 2022 , the Company had no deferred offering costs. |
Cloud Computing Arrangements | Cloud Computing Arrangements The Company capitalizes certain implementation costs for internal-use software incurred in a cloud computing agreement that is a service contract. Eligible costs associated with cloud computing arrangements, such as the implementation costs incurred to develop or obtain software business applications used in the normal course of business, are capitalized in accordance with ASC 350. Capitalization ceases at the point the software is substantially complete and ready for its intended use, and after all substantial testing is completed. Amortization is recorded on a straight-line basis over the expected useful life of three years of the internal-use software cost in the same line item in the statement of operations and comprehensive loss as the expense for fees for the associated cloud computing arrangement. Amortization expense associated with the Company's cloud computing arrangements has been recognized in the amount of $ 0.5 million during the years ended December 31, 2023 and 2022 . As a result of the December 2023 announcement of the discontinuation of the Company’s three Phase 3 registrational trials and a comprehensive review of strategic alternatives, an impairment loss of $ 1.4 million was recognized during the year ended December 31, 2023 for implementation costs associated with cloud computing arrangements that are no longer probable of being implemented. |
Other Income (Loss), Net | Other Income (Loss), Net The Company records interest expense, investment amortization and accretion of discounts and premiums on short-term investments and foreign exchange gains and losses in “other income (loss), net” when incurred. |
Research and Development Costs | Research and Development Costs Research and development costs are charged to expense as incurred. Research and development expenses are comprised of costs incurred in performing research and development activities, including personnel-related costs, stock-based compensation, facilities, research-related overhead, clinical trial costs, contracted services, research-related manufacturing, license fees and other external costs. The Company accounts for nonrefundable advance payments for goods and services that will be used in future research and development activities as expenses when the services have been performed or when the goods have been received. |
Accrued Research and Development Expenses | Accrued Research and Development Expenses The Company has entered into various research and development contracts. The payments under these contracts are recorded as research and development expenses as incurred. The Company records accrued liabilities for estimated ongoing research costs. When evaluating the adequacy of the accrued liabilities, the Company analyzes progress of the studies, including the phase or completion of events, invoices received and contracted costs. Judgements and estimates are made in determining the accrued balances at the end of any reporting period. Actual results could differ from the Company’s estimates. The Company’s historical accrual estimates have not been materially different from the actual costs. |
Stock-Based Compensation Expense | Stock-Based Compensation Expense The Company grants restricted stock and stock options to employees, consultants and directors. The Company recognizes stock-based compensation cost for awards with performance conditions if and when it concludes that it is probable that the performance conditions will be achieved. For awards with only a service condition, the Company expenses stock-based compensation on a straight-line basis over the requisite employee service period or for grants issued with performance conditions, on a graded-vesting basis over the requisite employee service period. Awards for employees and non-employees are accounted for similarly. The Company records stock-based compensation expense associated with grants of restricted stock and stock options in the consolidated statements of operations and comprehensive loss based on their estimated fair value at the date of the grant. The Company classifies stock-based compensation expense in its consolidated statements of operations and comprehensive loss in the same manner in which the grantee’s payroll costs are classified or in which the grantee’s service payments are classified. Forfeitures are accounted for as they occur. The fair value of each stock option grant is estimated on the date of grant using the Black‑Scholes option pricing model. The fair value of the Company’s common stock is determined based on the quoted market price of common stock. The Company also lacks company‑specific historical and implied volatility information for its stock. The Company estimates its expected stock price volatility based on the historical volatility of publicly traded peer companies and expects to continue to do so until such time as it has adequate historical data regarding the volatility of its own traded stock price. The expected term of the Company’s stock options has been determined utilizing the “simplified” method. The “simplified” method estimates the expected term of stock options as the mid‑point between the weighted average time to vesting and the contractual maturity. The risk‑free interest rate is determined by reference to the U.S. Treasury yield curve in effect at the time of grant of the award for time periods approximately equal to the expected term of the award. There is no expected dividend yield since the Company has never paid cash dividends on common stock and does not expect to pay any cash dividends in the foreseeable future. |
Net Loss Per Share | Net Loss per Share Basic and diluted net loss per share is determined by dividing net loss by the weighted‑average common stock outstanding during the period. Since we have incurred operating losses for all periods presented, outstanding stock options and unvested restricted common stock have been excluded from the calculation because their effects would be anti‑dilutive. Therefore, the weighted‑average shares used to calculate both basic and diluted loss per share are the same. |
Income Taxes | Income Taxes The Company accounts for income taxes under the asset and liability method in accordance with ASC 740, Income Taxes . Under this method, deferred tax assets and liabilities are recognized for the estimated future tax consequences attributable to differences between financial statement carrying amounts of existing assets and liabilities and their respective tax bases. Deferred tax assets and liabilities are measured using enacted rates in effect for the year in which these temporary differences are expected to be recovered or settled. Valuation allowances are provided if based on the weight of available evidence, it is more likely than not that some or all of the deferred tax assets will not be realized. Management believes that it is more likely than not that all deferred tax assets will not be realized. The Company recognizes liabilities for potential tax payments to various tax authorities related to uncertain tax positions. The liabilities are based on a determination of whether and how much of a tax benefit taken by the Company in its tax filing is more likely than not to be realized following resolution of any potential contingencies present related to the tax benefit. Potential interest and penalties associated with such uncertain tax positions, if any, are recorded as components of income tax expense. The Company assesses its income tax positions and records tax benefits for all years subject to examination based upon management’s evaluation of the facts, circumstances and information available as of the reporting date. For those tax positions where it is more likely than not that a tax benefit will be sustained, the Company records the largest amount of tax benefit with a greater than 50 percent likelihood of being realized upon ultimate settlement with a taxing authority having full knowledge of all relevant information. For those income tax positions where it is not more likely than not that a tax benefit will be sustained, the Company does not recognize a tax benefit in the consolidated financial statements. |
Concentration of Credit Risk and Off-Balance Sheet Risk | Concentration of Credit Risk and Off-Balance Sheet Risk Financial instruments that subject the Company to credit risk consist primarily of cash, cash equivalents, restricted cash and short-term investments. Periodically, the Company maintains deposits in accredited financial institutions in excess of federally insured limits. The Company deposits its cash in financial institutions that it believes have high credit quality and have not experienced any losses on such accounts and does not believe it is exposed to any unusual credit risk beyond the normal credit risk associated with commercial banking relationships. Such deposits have and will continue to exceed federally insured limits. The Company has not experienced any losses on its cash deposits. At December 31, 2023 and 2022 , the Company had no off-balance sheet risk. |
Foreign Exchange | Foreign Exchange The functional currency for all subsidiaries is the U.S. Dollar (“USD”). Transactions in foreign currencies are remeasured into the functional currency of the relevant subsidiaries at the exchange rate in effect at the date of the transaction. Any monetary assets and liabilities arising from these transactions are translated into the functional currency at exchange rates in effect at the balance sheet date or on settlement. Resulting gains and losses are recorded in "other income (loss), net" within the consolidated statements of operations and comprehensive loss. |
Comprehensive Loss | Comprehensive Loss Comprehensive loss is defined as a change in equity of a business enterprise during a period, resulting from transactions from non-owner sources. Comprehensive loss includes net loss and certain changes in stockholder’s deficit that are excluded from net loss. The Company's comprehensive loss includes unrealized gains (losses) on available-for-sale securities during the year ended December 31, 2023 and 2022 . |
Leases | Leases In accordance with ASC Topic 842, Lease Accounting , at the inception of an arrangement, the Company determines whether the arrangement is or contains a lease. Leases with a term greater than one year are recognized on the consolidated balance sheet as a right-of-use (“ROU”) asset and current and non-current lease liabilities, as applicable. The Company has made an accounting policy election, known as the short-term lease recognition exemption, which allows the Company to not recognize ROU assets and lease liabilities that arise from short-term leases (12 months or less) for any class of underlying asset. Options to renew or options to cancel a lease are not included in the Company’s assessment unless there is reasonable certainty that the Company will renew or will not cancel, respectively. Operating lease liabilities and their corresponding ROU assets are recorded based on the present value of future lease payments over the expected remaining lease term. Lease cost for operating leases is recognized on a straight-line basis over the lease term as an operating expense. Certain adjustments to the ROU asset may be required for items such as lease prepayments or incentives received. The interest rate implicit in lease contracts is typically not readily determinable. As a result, the Company utilizes its incremental borrowing rate, which reflects the fixed rate at which the Company could borrow on a collateralized basis the amount of the lease payments in the same currency, for a similar term, in a similar economic environment. The Company has elected to account for the lease and non-lease components together for all existing classes of underlying assets. |
Subsequent Events | Subsequent Events The Company evaluates events occurring after the date of our accompanying consolidated balance sheets for potential recognition or disclosure in our consolidated financial statements. The Company did not identify any material subsequent events requiring adjustment to our accompanying consolidated financial statements (recognized subsequent events). Those items requiring disclosure (unrecognized subsequent events) in the consolidated financial statements have been disclosed accordingly. Refer to Note 16 for further details. |
Recent Accounting Pronouncements | Recent Accounting Pronouncements From time to time, new accounting pronouncements are issued by the Financial Accounting Standards Board (“FASB”), or other standard setting bodies and adopted by the Company as of the specified effective date. Unless otherwise discussed, the impact of recently issued standards that are not yet effective will not have a material impact on the Company’s consolidated financial statements upon adoption. Under the Jumpstart Our Business Startups Act of 2012, as amended (the “JOBS Act”), the Company meets the definition of an emerging growth company and has elected the extended transition period for complying with certain new or revised accounting standards pursuant to Section 107(b) of the JOBS Act. |
Recently Adopted Accounting Pronouncements | Recently Adopted Accounting Pronouncements In June 2016, the FASB issued ASU No. 2016-13, Financial Instruments—Credit Losses (Topic 326): Measurement of Credit Losses on Financial Instruments , or ASU 2016-13, which requires the measurement and recognition of expected credit losses for financial assets held at amortized cost. ASU 2016-13 replaces the existing incurred loss impairment model with an expected loss model. It also eliminates the concept of other-than-temporary impairment and requires credit losses related to available-for-sale debt securities to be recorded through an allowance for credit losses rather than as a reduction in the amortized cost basis of the securities. These changes may result in earlier recognition of credit losses. The Company adopted ASU 2016-13 on January 1, 2023 . The adoption of ASU 2016-13 did not have a material impact on the Company’s consolidated financial statements and related disclosures. |
Recently Issued Accounting Pronouncements Not Yet Adopted | Recently Issued Accounting Pronouncements Not Yet Adopted In November 2023, the FASB issued ASU 2023-07, Segment Reporting (Topic 280): Improvements to Reportable Segment Disclosures , which requires disclosure of incremental segment information on an interim and annual basis. This ASU is effective for fiscal years beginning after December 15, 2023, and interim periods within fiscal periods beginning after December 15, 2024, and requires retrospective application to all prior periods presented in the financial statements. The adoption of this standard is not expected to have a material impact on the Company’s consolidated financial statements and related disclosures. In December 2023, the FASB issued ASU 2023-09, Income Taxes (Topic 740): Improvements to Income Tax Disclosures , which requires public entities, on an annual basis, to provide disclosure of specific categories in the rate reconciliation, as well as disclosure of income taxes paid disaggregated by jurisdiction. This ASU is effective for fiscal years beginning after December 15, 2024, with early adoption permitted. The adoption of this standard is not expected to have a material impact on the Company’s consolidated financial statements and related disclosures. |
Summary of Significant Accoun_3
Summary of Significant Accounting Policies (Tables) | 12 Months Ended |
Dec. 31, 2023 | |
Accounting Policies [Abstract] | |
Schedule of Estimated Useful Life | The Company records property and equipment at cost and recognizes depreciation using the straight-line method over the estimated useful lives of the respective assets , as follows: Asset category Estimated useful life Computer equipment 3 years Laboratory equipment 5 years |
Short-Term Investments (Tables)
Short-Term Investments (Tables) | 12 Months Ended |
Dec. 31, 2023 | |
Investments, Debt and Equity Securities [Abstract] | |
Summary of Amortized Cost and Estimated Fair Value of Marketable Securities | The following tables summarize the amortized cost and estimated fair value of the Company’s U.S. government treasury securities and marketable securities, which are considered to be available-for-sale investments and are included in short-term investments on the consolidated balance sheets: December 31, 2023 (in thousands) Amortized Unrealized Unrealized Fair U.S. government treasury securities $ 93,749 $ 73 $ — $ 93,822 Totals $ 93,749 $ 73 $ — $ 93,822 December 31, 2022 (in thousands) Amortized Unrealized Unrealized Fair U.S. government treasury securities $ 99,288 $ 1 $ ( 253 ) $ 99,036 Marketable securities: Corporate and agency bonds 28,748 3 ( 84 ) 28,667 Totals $ 128,036 $ 4 $ ( 337 ) $ 127,703 |
Fair Value Measurements (Tables
Fair Value Measurements (Tables) | 12 Months Ended |
Dec. 31, 2023 | |
Fair Value Disclosures [Abstract] | |
Summary of Financial Assets and Liabilities Measured at Fair Value on Recurring Basis | The following tables present information about the Company’s financial assets measured at fair value on a recurring basis: December 31, 2023 (in thousands) Level 1 Level 2 Level 3 Total Cash equivalents: Money market fund $ 23,854 $ — $ — $ 23,854 Totals $ 23,854 $ — $ — $ 23,854 Short-term investments: U.S. government treasury securities $ 93,822 $ — $ — $ 93,822 Totals $ 93,822 $ — $ — $ 93,822 December 31, 2022 (in thousands) Level 1 Level 2 Level 3 Total Cash equivalents: Money market fund $ 32,641 $ — $ — $ 32,641 Totals $ 32,641 $ — $ — $ 32,641 Short-term investments: U.S. government treasury securities $ 99,036 $ — $ — $ 99,036 Marketable securities: Corporate and agency bonds — 28,667 — 28,667 Totals $ 99,036 $ 28,667 $ — $ 127,703 |
Leases (Tables)
Leases (Tables) | 12 Months Ended |
Dec. 31, 2023 | |
Leases [Abstract] | |
Summary of Maturities Operating Leases Liabilities | Maturities of operating lease liabilities at December 31, 2023 are as follows (in thousands): 2024 11,842 2025 3,219 2026 3,298 2027 3,376 2028 3,455 Thereafter 5,824 Total lease payments 31,014 Less: interest 3,585 Total lease liability $ 27,429 Lease liability – current $ 10,781 Lease liability – long-term $ 16,648 |
Property and Equipment, Net (Ta
Property and Equipment, Net (Tables) | 12 Months Ended |
Dec. 31, 2023 | |
Property, Plant and Equipment [Abstract] | |
Schedule of Property and Equipment, Net | Property and equipment, net consisted of the following: December 31, (in thousands) 2023 2022 Laboratory equipment $ 1,483 $ 1,395 Computer equipment 435 435 Construction-in-progress — 104 Total property and equipment 1,918 1,934 Less: accumulated depreciation and impairment ( 1,918 ) ( 1,004 ) Property and equipment, net $ — $ 930 |
Accrued Expenses (Tables)
Accrued Expenses (Tables) | 12 Months Ended |
Dec. 31, 2023 | |
Payables and Accruals [Abstract] | |
Schedule of Accrued Expenses | Accrued expenses consisted of the following: December 31, (in thousands) 2023 2022 Employee compensation and benefits $ 3,809 $ 6,416 Professional fees 435 559 Research and development 2,442 5,678 Process development and manufacturing costs 2,367 504 Other 1,033 828 Total accrued expenses $ 10,086 $ 13,985 |
Stockholder's Equity (Tables)
Stockholder's Equity (Tables) | 12 Months Ended |
Dec. 31, 2023 | |
Equity [Abstract] | |
Schedule of Reserved Shares of Common Stock for Issuance | The Company has reserved shares of common stock for issuance as follows: December 31, 2023 2022 Unvested restricted stock 3,254,863 2,239,106 Options to purchase common stock 10,439,751 7,922,797 Stock available for grant under the 2020 Stock Option and Grant Plan 4,182,461 4,253,680 Stock available for issuance under the 2020 Employee Stock Purchase Plan 480,059 454,302 Total 18,357,134 14,869,885 |
Stock-Based Compensation (Table
Stock-Based Compensation (Tables) | 12 Months Ended |
Dec. 31, 2023 | |
Share-Based Payment Arrangement [Abstract] | |
Schedule of Stock-based Compensation Expense | Stock-based compensation expense was as follows: Years Ended December 31, (in thousands) 2023 2022 Research and development $ 13,167 $ 14,014 General and administrative 27,612 27,301 Total stock-based compensation expense $ 40,779 $ 41,315 |
Summary of Restricted Common Stock Activity | The following table summarizes restricted common stock activity for the year ended December 31, 2023: Shares Weighted Unvested at January 1, 2023 2,239,106 $ 13.75 Granted 2,279,994 6.02 Forfeited ( 342,732 ) 11.46 Vested ( 921,505 ) 13.24 Unvested at December 31, 2023 3,254,863 $ 8.73 |
Summary of Stock Option Activity | The following table summarizes stock option activity (in thousands, except share and per share data): Shares Weighted Weighted Aggregate Options outstanding at January 1, 2023 7,922,797 $ 17.81 8.3 $ 786 Granted 3,779,342 6.24 — 57 Exercised — — — — Forfeited ( 1,262,388 ) 16.25 — 82 Options outstanding at December 31, 2023 10,439,751 $ 13.81 7.9 $ — Options vested and exercisable at December 31, 2023 4,534,147 $ 18.86 7.2 $ — |
Schedule of Estimated Fair Value Weighted-Average Assumptions Using Black-Scholes Option-Pricing Model | The fair value was estimated on the date of grant using the Black-Scholes option-pricing model, with the following weighted-average assumptions: Years Ended December 31, 2023 2022 Expected term (in years) 6.11 6.07 Expected volatility 94 % 90 % Risk-free interest rate 3.52 % 2.00 % Expected dividend yield — — Fair value of common stock $ 6.24 $ 7.48 |
Income Taxes (Tables)
Income Taxes (Tables) | 12 Months Ended |
Dec. 31, 2023 | |
Income Tax Disclosure [Abstract] | |
Summary of Income (Loss) Before Provision for Income Taxes | Income (loss) before provision for income taxes consisted of the following: Years Ended December 31, (in thousands) 2023 2022 Federal ( 376,152 ) ( 113,389 ) Foreign 185,608 ( 55,586 ) Loss before provision for income taxes $ ( 190,544 ) $ ( 168,975 ) |
Schedule of Provision for Income Taxes | The provision for income taxes for the years ended December 31, 2023 and 2022 consisted of the following: Years Ended December 31, (in thousands) 2023 2022 Current income tax (benefit) expense: Federal $ ( 136 ) ( 246 ) State 10 ( 19 ) Foreign — — Total current income tax benefit ( 126 ) ( 265 ) Deferred income tax (benefit) expense: Federal — — State — — Foreign — — Total deferred income tax benefit — — Total income tax benefit $ ( 126 ) $ ( 265 ) |
Schedule of Income Tax (Benefit) Expense Reconciliation | The Company’s income tax benefit for the years ended December 31, 2023 and 2022 relating to federal, state and foreign tax jurisdictions differs from the amounts determined by applying the statutory federal income tax rate based on the following: Years Ended December 31, (in thousands) 2023 2022 Benefit at the federal rate $ ( 40,015 ) 21.0 % $ ( 35,472 ) 21.0 % Increase (decrease) resulting from: Foreign tax rate differential ( 15,783 ) 8.3 % 2,177 ( 1.3 )% State taxes, net of federal benefit ( 9,514 ) 5.0 % ( 1,603 ) 0.9 % Change in valuation allowance 98,714 ( 51.8 )% 35,406 ( 21.0 )% Intercompany note impairment ( 34,615 ) 18.2 % — — Tax credits ( 5,928 ) 3.1 % ( 6,992 ) 4.1 % Officer's compensation 177 ( 0.1 )% 695 ( 0.4 )% Stock compensation 4,564 ( 2.4 )% 4,637 ( 2.7 )% Impairment of intellectual property 3,003 ( 1.6 )% — — Permanent differences 79 0.0 % ( 182 ) 0.1 % Change in state tax law 384 ( 0.2 )% — — Other ( 1,192 ) 0.6 % 1,069 ( 0.6 )% Total income tax benefit $ ( 126 ) 0.1 % $ ( 265 ) 0.1 % In 2021, the Company transferred intellectual property rights between tax jurisdictions, resulting in a deferred tax asset on the basis difference in the intangible assets. In addition, in connection with the transfer of the intellectual property the Company recorded intercompany notes between the parties. In December 2023, the Company determined that the intellectual property intangible assets and intercompany notes were impaired resulting in the recognition of income or loss in the respective jurisdiction. |
Summary of Components of Deferred Income Taxes | Components of deferred income taxes consist of the following: December 31, (in thousands) 2023 2022 Deferred tax assets: Net operating loss carryforwards $ 54,081 $ 9,374 Tax credit carryforwards 19,378 12,374 Intangible assets — 25,537 Intercompany note impairment 64,087 Operating lease liabilities 6,348 8,074 Non-qualified stock compensation 15,435 12,017 Restricted stock compensation 680 235 Capitalization of R&D expenses 20,758 20,375 Other 676 1,661 Total deferred tax assets 181,443 89,647 Valuation allowance ( 180,943 ) ( 82,228 ) Net deferred tax assets $ 500 $ 7,419 Deferred tax liabilities: Operating lease right-of-use assets ( 506 ) ( 7,218 ) Depreciation 4 ( 186 ) Other 2 ( 15 ) Total deferred tax liabilities ( 500 ) ( 7,419 ) Net deferred tax asset (liability) $ — $ — |
Net Loss per Share (Tables)
Net Loss per Share (Tables) | 12 Months Ended |
Dec. 31, 2023 | |
Earnings Per Share [Abstract] | |
Computation Of Basic And Diluted Net Loss Per Share Attributable To Common Stockholders | The following table summarizes the computation of basic and diluted net loss per share attributable to common stockholders of the Company: Years Ended December 31, (in thousands, except share and per share data) 2023 2022 Numerator: Net loss – basic and diluted $ ( 190,418 ) $ ( 168,710 ) Denominator: Weighted-average common shares outstanding – basic and diluted 104,057,220 76,654,856 Net loss per share – basic and diluted $ ( 1.83 ) $ ( 2.20 ) |
Potential Dilutive Securities Excluded From Computation Of Diluted Net Loss Per Share Attributable To Common Stockholders | Based on the amounts outstanding at December 31, 2023 and 2022, the Company excluded the following potential shares of common stock from the computation of diluted net loss per share attributable to common stockholders for the years ended December 31, 2023 and 2022, because including them would have had an anti-dilutive effect. Therefore, the weighted-average number of common shares outstanding used to calculate both basic and diluted net loss per share attributable to common stockholders is the same. Years Ended December 31, 2023 2022 Options to purchase common stock 10,439,751 7,922,797 Unvested restricted stock 3,254,863 2,239,106 |
Nature of the Business - Additi
Nature of the Business - Additional Information (Details) - USD ($) $ in Thousands | 1 Months Ended | 12 Months Ended | |
Jan. 31, 2024 | Dec. 31, 2023 | Dec. 31, 2022 | |
Net losses attributable to common stockholders | $ (190,418) | $ (168,710) | |
Accumulated deficit | (656,193) | $ (465,775) | |
Cash, cash equivalents and short-term investments | $ 183,900 | ||
Subsequent Event | |||
Percentage of workforce reduction | 95% |
Summary of Significant Accoun_4
Summary of Significant Accounting Policies - Additional Information (Details) | 12 Months Ended | |
Dec. 31, 2023 USD ($) Segment | Dec. 31, 2022 USD ($) | |
Summary Of Significant Accounting Policies [Line Items] | ||
Number of operating segment | Segment | 1 | |
Cash and cash equivalents maturity period | 3 months | |
Short-term investments maturity period | 1 year | |
Property, plant and equipment, valuation basis | cost | |
Property, plant and equipment, depreciation methods | us-gaap:UsefulLifeTermOfLeaseMember | |
Impairment losses on long-lived assets | $ 500,000 | |
Deferred offering costs | 0 | $ 0 |
Amortization expense for cloud computing arrangements | $ 500,000 | $ 500,000 |
Impairment, Intangible Asset, Finite-Lived, Statement of Income or Comprehensive Income [Extensible Enumeration] | Asset Impairment Charges | |
Expected dividend yield | 0% | 0% |
Off-balance sheet risk description | At December 31, 2023 and 2022, the Company had no off-balance sheet risk. | |
ASU 2016-13 | ||
Summary Of Significant Accounting Policies [Line Items] | ||
Change in Accounting Principle, Accounting Standards Update, Adopted [true false] | true | |
Change in Accounting Principle, Accounting Standards Update, Adoption Date | Jan. 01, 2023 | |
Change in Accounting Principle, Accounting Standards Update, Immaterial Effect [true false] | true | |
Internal-use Software | ||
Summary Of Significant Accounting Policies [Line Items] | ||
Expected useful life | 3 years | |
Impairment loss implementation costs | $ 1,400,000 |
Summary of Significant Accoun_5
Summary of Significant Accounting Policies - Schedule of Estimated Useful Life (Details) | Dec. 31, 2023 |
Computer Equipment | |
Summary Of Significant Accounting Policies [Line Items] | |
Estimated useful life | 3 years |
Laboratory Equipment | |
Summary Of Significant Accounting Policies [Line Items] | |
Estimated useful life | 5 years |
Short-Term Investments - Summar
Short-Term Investments - Summary of Amortized Cost and Estimated Fair Value of Marketable Securities (Details) - USD ($) $ in Thousands | Dec. 31, 2023 | Dec. 31, 2022 |
Schedule Of Available For Sale Securities [Line Items] | ||
Amortized Cost | $ 93,749 | $ 128,036 |
Unrealized Gains | 73 | 4 |
Unrealized Losses | (337) | |
Fair Value | 93,822 | 127,703 |
U.S. Government Treasury Securities | ||
Schedule Of Available For Sale Securities [Line Items] | ||
Amortized Cost | 93,749 | 99,288 |
Unrealized Gains | 73 | 1 |
Unrealized Losses | (253) | |
Fair Value | $ 93,822 | 99,036 |
Corporate and Agency Bonds | ||
Schedule Of Available For Sale Securities [Line Items] | ||
Amortized Cost | 28,748 | |
Unrealized Gains | 3 | |
Unrealized Losses | (84) | |
Fair Value | $ 28,667 |
Fair Value Measurements - Summa
Fair Value Measurements - Summary of Financial Assets and Liabilities Measured at Fair Value On Recurring Basis (Details) - USD ($) $ in Thousands | Dec. 31, 2023 | Dec. 31, 2022 |
Cash equivalents: | ||
Cash equivalents | $ 23,854 | $ 32,641 |
Short-term investments: | ||
Short-term investments | 93,822 | 127,703 |
Corporate and Agency Bonds | ||
Short-term investments: | ||
Short-term investments | 28,667 | |
Money Market Fund | ||
Cash equivalents: | ||
Cash equivalents | 23,854 | 32,641 |
U.S. Government Treasury Securities | ||
Short-term investments: | ||
Short-term investments | 93,822 | 99,036 |
Level 1 | ||
Cash equivalents: | ||
Cash equivalents | 23,854 | 32,641 |
Short-term investments: | ||
Short-term investments | 93,822 | 99,036 |
Level 1 | Money Market Fund | ||
Cash equivalents: | ||
Cash equivalents | 23,854 | 32,641 |
Level 1 | U.S. Government Treasury Securities | ||
Short-term investments: | ||
Short-term investments | $ 93,822 | 99,036 |
Level 2 | ||
Short-term investments: | ||
Short-term investments | 28,667 | |
Level 2 | Corporate and Agency Bonds | ||
Short-term investments: | ||
Short-term investments | $ 28,667 |
Leases - Additional Information
Leases - Additional Information (Details) - USD ($) $ in Thousands | 1 Months Ended | 12 Months Ended | |||
Dec. 31, 2023 | Oct. 31, 2022 | Sep. 30, 2021 | Dec. 31, 2023 | Dec. 31, 2022 | |
Leases [Line Items] | |||||
ROU asset | $ 2,187 | $ 2,187 | $ 31,633 | ||
Lease liability | 27,429 | 27,429 | |||
Remaining right-of-use asset balance | $ 2,200 | 2,200 | |||
Operating lease costs | 9,700 | 6,600 | |||
Cash paid for operating lease | 4,800 | 4,800 | |||
Variable lease costs | $ 900 | $ 3,700 | |||
Operating lease, weighted average remaining lease term | 4 years 8 months 12 days | 4 years 8 months 12 days | 6 years 11 months 4 days | ||
Operating lease, weighted average discount rate, percent | 5.95% | 5.95% | 6.23% | ||
Impairment loss to operating lease right-of-use assets | $ 16,600 | ||||
Waltham Leases | |||||
Leases [Line Items] | |||||
Expiration date | Jul. 30, 2030 | ||||
Operating lease, existence of option to extend | true | ||||
Lease, option to extend | The Company has the option to renew the leased space for an additional one time period of five years with written notice from the Company. As of December 31, 2023, the Company has no reasonable certainty that this option to extend will be exercised. | ||||
Lease commencement month and year | 2021-09 | ||||
Additional one time lease period | 5 years | ||||
Tenant improvement allowance to be reimbursed | $ 900 | $ 3,100 | $ 900 | ||
New Lease Agreement with BP Bay Colony LLC | |||||
Leases [Line Items] | |||||
ROU asset | 6,000 | ||||
Lease liability | 6,000 | ||||
Sublease with AMAG Pharmaceuticals | |||||
Leases [Line Items] | |||||
ROU asset | 17,300 | ||||
Lease liability | $ 17,300 | ||||
2022 SOW Under the DMS Agreement | |||||
Leases [Line Items] | |||||
Lease expiration month and year | 2024-12 | ||||
ROU asset | $ 14,700 | ||||
Lease liability | 14,700 | ||||
Reduction to right-of-use asset and lease liability | $ 4,900 | ||||
Utilization fee | $ 16,300 | ||||
Lessee operating lease, lease term including renewal option | 2 years 3 months |
Leases - Summary of Operating L
Leases - Summary of Operating Lease Liabilities (Details) - USD ($) $ in Thousands | Dec. 31, 2023 | Dec. 31, 2022 |
Leases [Abstract] | ||
2024 | $ 11,842 | |
2025 | 3,219 | |
2026 | 3,298 | |
2027 | 3,376 | |
2028 | 3,455 | |
Thereafter | 5,824 | |
Total lease payments | 31,014 | |
Less: interest | 3,585 | |
Total lease liability | 27,429 | |
Lease liability – current | 10,781 | $ 7,165 |
Lease liability – long-term | $ 16,648 | $ 28,222 |
Property and Equipment, Net - S
Property and Equipment, Net - Schedule of Property and Equipment, Net (Details) - USD ($) $ in Thousands | Dec. 31, 2023 | Dec. 31, 2022 |
Property Plant And Equipment [Line Items] | ||
Total property and equipment | $ 1,918 | $ 1,934 |
Less: accumulated depreciation and impairment | (1,918) | (1,004) |
Property and equipment, net | 930 | |
Laboratory equipment | ||
Property Plant And Equipment [Line Items] | ||
Total property and equipment | 1,483 | 1,395 |
Computer equipment | ||
Property Plant And Equipment [Line Items] | ||
Total property and equipment | $ 435 | 435 |
Construction-in-Progress | ||
Property Plant And Equipment [Line Items] | ||
Total property and equipment | $ 104 |
Property and Equipment, Net - A
Property and Equipment, Net - Additional Information (Details) - USD ($) $ in Millions | 12 Months Ended | |
Dec. 31, 2023 | Dec. 31, 2022 | |
Property, Plant and Equipment [Abstract] | ||
Depreciation expenses | $ 0.4 | $ 0.7 |
Impairment loss | $ 0.5 | |
Impairment, Long-Lived Asset, Held-for-Use, Statement of Income or Comprehensive Income [Extensible Enumeration] | Asset Impairment Charges |
Accrued Expenses - Schedule of
Accrued Expenses - Schedule of Accrued Expenses (Details) - USD ($) $ in Thousands | Dec. 31, 2023 | Dec. 31, 2022 |
Payables and Accruals [Abstract] | ||
Employee compensation and benefits | $ 3,809 | $ 6,416 |
Professional fees | 435 | 559 |
Research and development | 2,442 | 5,678 |
Process development and manufacturing costs | 2,367 | 504 |
Other | 1,033 | 828 |
Total accrued expenses | $ 10,086 | $ 13,985 |
Sponsored Research, Collabora_2
Sponsored Research, Collaboration and License Agreements - Additional Information (Details) - USD ($) | 1 Months Ended | 12 Months Ended | |||
Nov. 30, 2020 | Sep. 30, 2018 | Jun. 30, 2017 | Dec. 31, 2023 | Dec. 31, 2022 | |
Sponsored Research, Collaboration and License Agreements [Line Items] | |||||
Research and development expense | $ 133,070,000 | $ 118,870,000 | |||
CPRIT | License agreement terms | |||||
Sponsored Research, Collaboration and License Agreements [Line Items] | |||||
Maximum paid percentage of grant award proceeds until which revenue share is payable | 400% | ||||
Royalty payments | $ 0 | 0 | |||
A&R License Agreement | BCM | |||||
Sponsored Research, Collaboration and License Agreements [Line Items] | |||||
Non-refundable license fee payments | $ 250,000 | ||||
Milestone payments | $ 40,000,000 | ||||
Minimum percentage of eligible to receive tiered royalties | 1% | ||||
Second License Agreement | BCM | |||||
Sponsored Research, Collaboration and License Agreements [Line Items] | |||||
Non-refundable license fee payments | $ 125,000 | ||||
Milestone payments | $ 30,000,000 | ||||
Minimum percentage of eligible to receive tiered royalties | 1% | ||||
Non-refundable license fee payments, first year through fourth anniversary of effective date | $ 20,000 | ||||
Non-refundable license fee payments fifth anniversary of effective date and continuing thereafter | 40,000 | ||||
Research Agreement | BCM | |||||
Sponsored Research, Collaboration and License Agreements [Line Items] | |||||
Agreement for research activities, term | 3 years | ||||
Total research activities performing fees, over the term | $ 6,000,000 | ||||
Collective Agreements | BCM | |||||
Sponsored Research, Collaboration and License Agreements [Line Items] | |||||
Research and development expense | $ 2,000,000 | $ 2,500,000 | |||
Redumption Agreement | |||||
Sponsored Research, Collaboration and License Agreements [Line Items] | |||||
Earnout payment as percentage of net sales | 10% | ||||
Earnout payment obligation for number of years from first commercial sale | 20 years | ||||
Minimum earnout payments received by investors for reduction of earnout payment | $ 50,000,000 | ||||
Period for reduction of earnout payment after first commercial sale | 3 years |
Stockholders Equity - Additiona
Stockholders Equity - Additional Information (Details) | 12 Months Ended | ||||
Jun. 21, 2023 USD ($) $ / shares shares | Jul. 26, 2022 USD ($) $ / shares shares | Dec. 31, 2023 USD ($) Vote $ / shares shares | Dec. 31, 2022 USD ($) $ / shares shares | May 15, 2023 $ / shares shares | |
Class Of Stock [Line Items] | |||||
Preferred stock, par or stated value per share | $ / shares | $ 0.0001 | $ 0.0001 | $ 0.0001 | ||
Preferred stock, shares authorized | shares | 10,000,000 | 10,000,000 | 10,000,000 | ||
Preferred stock, shares issued | shares | 0 | 0 | |||
Preferred stock, shares outstanding | shares | 0 | 0 | |||
Common stock, shares authorized | shares | 300,000,000 | 150,000,000 | 300,000,000 | ||
Common stock, par value | $ / shares | $ 0.0001 | $ 0.0001 | $ 0.0001 | ||
Proceeds from issuance of common stock | $ 126,425,000 | ||||
Number of votes per share | Vote | 1 | ||||
Common stock, voting rights | The holders of the common stock are entitled to one vote for each share of common stock held at all meetings of stockholders (and written actions in lieu of meetings), and there are not any cumulative voting rights. The number of authorized shares of common stock may be increased or decreased by the affirmative vote of the holders of shares of capital stock of the Company; however, the issuance of common stock may be subject to the vote of the holders of one or more series of preferred stock that may be required by terms of the Third Amended and Restated Certificate of Incorporation. | ||||
Cash dividends declared or paid | $ 0 | ||||
Underwriter | J.P. Morgan Securities LLC [Member] | |||||
Class Of Stock [Line Items] | |||||
Stock issued | shares | 20,000,000 | ||||
Offering price per share | $ / shares | $ 3.75 | ||||
Proceeds from issuance of common stock | $ 70,200,000 | ||||
Offering costs | $ 300,000 | ||||
Option to purchase additional number of shares | shares | 3,000,000 | ||||
Expiration of option to purchase additional number of shares | Jul. 21, 2023 | ||||
Underwriting discounts commissions | $ 4,500,000 | ||||
Securities Purchase Agreement | |||||
Class Of Stock [Line Items] | |||||
Common stock, par value | $ / shares | $ 0.0001 | ||||
Net proceeds with certain investors | $ 126,400,000 | ||||
Offering costs | $ 200,000 | ||||
Share issued to investors | shares | 27,458,095 | ||||
Underwriting discounts commissions | $ 0 | ||||
Offering price per share | $ / shares | $ 4.61 |
Stockholders Equity - Schedule
Stockholders Equity - Schedule of Reserved Shares of Common Stock for Issuance (Details) - shares | Dec. 31, 2023 | Dec. 31, 2022 | Jul. 31, 2020 |
Class Of Stock [Line Items] | |||
Reserved shares of common stock for issuance | 18,357,134 | 14,869,885 | |
2020 Employee Stock Purchase Plan | |||
Class Of Stock [Line Items] | |||
Reserved shares of common stock for issuance | 480,059 | 611,354 | |
Unvested Restricted Stock | |||
Class Of Stock [Line Items] | |||
Reserved shares of common stock for issuance | 3,254,863 | 2,239,106 | |
Option To Purchase Common Stock | |||
Class Of Stock [Line Items] | |||
Reserved shares of common stock for issuance | 10,439,751 | 7,922,797 | |
Stock Available For Grant | 2020 Stock Option and Grant Plan | |||
Class Of Stock [Line Items] | |||
Reserved shares of common stock for issuance | 4,182,461 | 4,253,680 | |
Stock Available For Issuance | 2020 Employee Stock Purchase Plan | |||
Class Of Stock [Line Items] | |||
Reserved shares of common stock for issuance | 480,059 | 454,302 |
Stock-Based Compensation - Sche
Stock-Based Compensation - Schedule of Stock-based Compensation Expense (Details) - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2023 | Dec. 31, 2022 | |
Employee Service Share Based Compensation Allocation Of Recognized Period Costs [Line Items] | ||
Stock-based compensation expense | $ 40,779 | $ 41,315 |
Research and Development | ||
Employee Service Share Based Compensation Allocation Of Recognized Period Costs [Line Items] | ||
Stock-based compensation expense | 13,167 | 14,014 |
General and Administrative | ||
Employee Service Share Based Compensation Allocation Of Recognized Period Costs [Line Items] | ||
Stock-based compensation expense | $ 27,612 | $ 27,301 |
Stock-Based Compensation - Addi
Stock-Based Compensation - Additional Information (Details) - USD ($) | 1 Months Ended | 12 Months Ended | |||||
Jan. 01, 2023 | Jan. 01, 2022 | Jul. 02, 2020 | Jul. 31, 2020 | Dec. 31, 2023 | Dec. 31, 2022 | May 15, 2023 | |
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | |||||||
Reserved shares of common stock for issuance | 18,357,134 | 14,869,885 | |||||
Common stock, par value | $ 0.0001 | $ 0.0001 | $ 0.0001 | ||||
Stock-based compensation expense | $ 40,779,000 | $ 41,315,000 | |||||
Restricted Common Stock | |||||||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | |||||||
Number of shares granted | 2,279,994 | ||||||
Unrecognized stock-based compensation cost | $ 23,600,000 | ||||||
Weighted average period of cost expected to be recognized | 2 years 2 months 12 days | ||||||
Total fair value of restricted stock vested | $ 3,600,000 | $ 14,200,000 | |||||
Employee Stock Option | |||||||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | |||||||
Weighted average period of cost expected to be recognized | 1 year 11 months 1 day | ||||||
Weighted average grant-date fair value of stock options granted | $ 4.88 | $ 5.61 | |||||
Unrecognized stock-based compensation expenses | $ 36,900,000 | ||||||
2018 Equity Incentive Plan | |||||||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | |||||||
Awards vesting period | 4 years | ||||||
Awards contractual term | 10 years | ||||||
Number of shares of common stock issuable upon exercise of outstanding options | 64,042 | ||||||
Reserved shares of common stock for issuance | 0 | ||||||
2018 Equity Incentive Plan | Restricted Common Stock | |||||||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | |||||||
Number of shares granted | 6,616,772 | ||||||
2020 Stock Option and Grant Plan | |||||||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | |||||||
Awards vesting period | 4 years | ||||||
Awards contractual term | 10 years | ||||||
Common stock authorized for issuance | 8,008,734 | ||||||
Cumulative increase in number shares reserved for issuance, percentage | 5% | ||||||
Shares added to number of available shares under plan | 4,663,403 | 160,000 | |||||
Common stock issuable upon exercise of outstanding options | 10,375,709 | ||||||
2020 Stock Option and Grant Plan | Restricted Common Stock | |||||||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | |||||||
Number of shares granted | 5,356,510 | ||||||
2020 Stock Option and Grant Plan | Stock Available For Grant | |||||||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | |||||||
Reserved shares of common stock for issuance | 4,182,461 | 4,253,680 | |||||
2020 Employee Stock Purchase Plan | |||||||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | |||||||
Reserved shares of common stock for issuance | 611,354 | 480,059 | |||||
Percentage of payroll deductions of base salary or wages | 15% | ||||||
Percentage of maximum discount on purchase of shares of common stock | 15% | ||||||
Offering period, description | (i) on the first trading day of the offering period or (ii) the last day of any offering period. The Company utilizes the Black Scholes option pricing model to compute the fair market value of the shares and compensation expense is recognized over the offering period. Six-month offering periods commence each January 1 and July 1 during the term of the plan, with the administrator having the right to establish different offering periods. | ||||||
Cumulative increase in number shares reserved for issuance, percentage | 1% | ||||||
Common stock, par value | $ 0.0001 | ||||||
Annual increase in number of shares reserved for issuance | 1,222,707 | ||||||
Purchase of common stock under the employee stock purchase plan | 134,243 | ||||||
Share issued, average price per share | $ 2.43 | ||||||
Cash received from purchases under the ESPP | $ 300,000 | $ 500,000 | |||||
Stock-based compensation expense | $ 300,000 | $ 200,000 | |||||
2020 Employee Stock Purchase Plan | Maximum | |||||||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | |||||||
Base salary or wages | $ 25,000 |
Stock-Based Compensation - Summ
Stock-Based Compensation - Summary of Restricted Common Stock Activity (Details) - Restricted Common Stock | 12 Months Ended |
Dec. 31, 2023 $ / shares shares | |
Number of Shares | |
Number of Shares, Unvested at January 1, 2023 | shares | 2,239,106 |
Number of Shares, Granted | shares | 2,279,994 |
Number of Shares, Forfeited | shares | (342,732) |
Number of Shares, Vested | shares | (921,505) |
Number of Shares, Unvested at December 31, 2023 | shares | 3,254,863 |
Weighted Average Grant Date Fair Value | |
Weighted Average Grant Date Fair Value, Unvested at January 1, 2023 | $ / shares | $ 13.75 |
Weighted Average Grant Date Fair Value, Granted | $ / shares | 6.02 |
Weighted Average Grant Date Fair Value, Forfeited | $ / shares | 11.46 |
Weighted Average Grant Date Fair Value, Vested | $ / shares | 13.24 |
Weighted Average Grant Date Fair Value, Unvested at December 31, 2023 | $ / shares | $ 8.73 |
Stock-Based Compensation - Su_2
Stock-Based Compensation - Summary of Stock Option Activity (Details) - USD ($) $ / shares in Units, $ in Thousands | 12 Months Ended | |
Dec. 31, 2023 | Dec. 31, 2022 | |
Share-Based Payment Arrangement [Abstract] | ||
Number of Options Outstanding, Beginning Balance | 7,922,797 | |
Number of Options, Granted | 3,779,342 | |
Number of Options, Forfeited | (1,262,388) | |
Number of Options Outstanding, Ending Balance | 10,439,751 | 7,922,797 |
Options vested and exercisable at December 31, 2023 | 4,534,147 | |
Weighted Average Exercise Price, Options outstanding at January 1, 2023 | $ 17.81 | |
Weighted Average Exercise Price, Granted | 6.24 | |
Weighted Average Exercise Price, Forfeited | 16.25 | |
Weighted Average Exercise Price, Options outstanding at December 31, 2023 | 13.81 | $ 17.81 |
Weighted Average Exercise Price, Options vested and exercisable at December 31, 2023 | $ 18.86 | |
Weighted Average Contractual Life, Options outstanding | 7 years 10 months 24 days | 8 years 3 months 18 days |
Weighted Average Contractual Life, Options vested and exercisable at December 31, 2023 | 7 years 2 months 12 days | |
Aggregate Intrinsic Value, Options outstanding at January 1, 2023 | $ 786 | |
Aggregate Intrinsic Value, Granted | 57 | |
Aggregate Intrinsic Value, Forfeited | $ 82 | |
Aggregate Intrinsic Value, Options outstanding at December 31, 2023 | $ 786 |
Stock-Based Compensation - Sc_2
Stock-Based Compensation - Schedule of Estimated Fair Value Weighted-Average Assumptions Using Black-Scholes Option-Pricing Model (Details) - $ / shares | 12 Months Ended | |
Dec. 31, 2023 | Dec. 31, 2022 | |
Share-Based Payment Arrangement [Abstract] | ||
Expected term (in years) | 6 years 1 month 9 days | 6 years 25 days |
Expected volatility | 94% | 90% |
Risk-free interest rate | 3.52% | 2% |
Expected dividend yield | 0% | 0% |
Fair value of common stock | $ 6.24 | $ 7.48 |
Income Taxes - Summary of Incom
Income Taxes - Summary of Income (Loss) Before Provision for Income Taxes (Details) - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2023 | Dec. 31, 2022 | |
Income Tax Disclosure [Abstract] | ||
Federal | $ (376,152) | $ (113,389) |
Foreign | 185,608 | (55,586) |
Loss before income taxes | $ (190,544) | $ (168,975) |
Income Taxes - Schedule of Prov
Income Taxes - Schedule of Provision for Income Taxes (Details) - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2023 | Dec. 31, 2022 | |
Current income tax (benefit) expense: | ||
Federal | $ (136) | $ (246) |
State | 10 | (19) |
Total current income tax (benefit) expense | (126) | (265) |
Deferred income tax (benefit) expense: | ||
Total income tax benefit | $ (126) | $ (265) |
Income Taxes - Schedule of Inco
Income Taxes - Schedule of Income Tax (Benefit) Expense Reconciliation (Details) - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2023 | Dec. 31, 2022 | |
Income Tax Disclosure [Abstract] | ||
Benefit at the federal rate | $ (40,015) | $ (35,472) |
Foreign tax rate differential | (15,783) | 2,177 |
State taxes, net of federal benefit | (9,514) | (1,603) |
Change in valuation allowance | 98,714 | 35,406 |
Intercompany note impairment | (34,615) | |
Tax credits | (5,928) | (6,992) |
Officer's compensation | 177 | 695 |
Stock compensation | 4,564 | 4,637 |
Impairment of intellectual property | 3,003 | |
Permanent differences | 79 | (182) |
Change in state tax law | 384 | |
Other | (1,192) | 1,069 |
Total income tax benefit | $ (126) | $ (265) |
Benefit at the federal rate | 21% | 21% |
Foreign tax rate differential | 8.30% | (1.30%) |
State taxes, net of federal benefit | 5% | 0.90% |
Change in valuation allowance | (51.80%) | (21.00%) |
Intercompany note impairment | 18.20% | |
Tax credits | 3.10% | 4.10% |
Officer's compensation | (0.10%) | (0.40%) |
Stock compensation | (2.40%) | (2.70%) |
Impairment of intellectual property | (1.60%) | |
Permanent differences | 0% | 0.10% |
Change in state tax law | (0.20%) | |
Other | 0.60% | (0.60%) |
Total income tax (benefit) expense | 0.10% | 0.10% |
Income Taxes - Summary of Compo
Income Taxes - Summary of Components of Deferred Income Taxes (Details) - USD ($) $ in Thousands | Dec. 31, 2023 | Dec. 31, 2022 |
Deferred tax assets: | ||
Net operating loss carryforwards | $ 54,081 | $ 9,374 |
Tax credit carryforwards | 19,378 | 12,374 |
Intangible Assets | 25,537 | |
Intercompany note impairment | 64,087 | |
Operating lease liabilities | 6,348 | 8,074 |
Non-qualified stock compensation | 15,435 | 12,017 |
Restricted stock compensation | 680 | 235 |
Capitalization of R&D expenses | 20,758 | 20,375 |
Other | 676 | 1,661 |
Total deferred tax assets | 181,443 | 89,647 |
Valuation allowance | (180,943) | (82,228) |
Net deferred tax assets | 500 | 7,419 |
Deferred tax liabilities: | ||
Operating lease right-of-use assets | (506) | (7,218) |
Depreciation | 4 | 186 |
Other | 2 | (15) |
Total deferred tax liabilities | $ (500) | $ (7,419) |
Income Taxes - Additional Infor
Income Taxes - Additional Information (Details) - USD ($) | 12 Months Ended | |
Dec. 31, 2023 | Dec. 31, 2022 | |
Income Taxes [Line Items] | ||
U.S. current income tax expense | $ (126,000) | $ (265,000) |
Increase in deferred tax assets valuation allowance | $ 98,714,000 | 35,406,000 |
Operating loss carryforwards carryback period | 5 years | |
Percentage of TCJA limitations on net operating loss carryforwards to taxable income | 80% | |
Uncertain tax positions | $ 0 | 0 |
Unrecognized tax benefits, interest and penalties accrued | $ 0 | 0 |
Net Operating Losses, Tax Credits | ||
Income Taxes [Line Items] | ||
Increase in deferred tax assets valuation allowance | 35,400,000 | |
Earliest Tax Year | ||
Income Taxes [Line Items] | ||
Open tax year | 2020 | |
Latest Tax Year | ||
Income Taxes [Line Items] | ||
Open tax year | 2023 | |
Federal | ||
Income Taxes [Line Items] | ||
Operating loss carryforwards | $ 38,900,000 | 0 |
Federal | Research and Development | ||
Income Taxes [Line Items] | ||
Tax credit carryforwards | $ 11,700,000 | 6,600,000 |
Tax credit carryforwards expiration year | 2040 | |
Federal | Orphan Drug Credit (ODC) | ||
Income Taxes [Line Items] | ||
Tax credit carryforwards | $ 6,000,000 | |
Tax credit carryforwards expiration year | 2041 | |
State | ||
Income Taxes [Line Items] | ||
Operating loss carryforwards | $ 26,400,000 | 3,600,000 |
State | Research and Development | ||
Income Taxes [Line Items] | ||
Tax credit carryforwards | $ 2,100,000 | 1,300,000 |
Tax credit carryforwards expiration year | 2035 | |
Foreign | ||
Income Taxes [Line Items] | ||
Operating loss carryforwards | $ 354,800,000 | $ 72,900,000 |
Net Loss per Share - Computatio
Net Loss per Share - Computation Of Basic And Diluted Net Loss Per Share Attributable To Common Stockholders (Details) - USD ($) $ / shares in Units, $ in Thousands | 12 Months Ended | |
Dec. 31, 2023 | Dec. 31, 2022 | |
Numerator: | ||
Net loss – basic and diluted | $ (190,418) | $ (168,710) |
Denominator: | ||
Weighted-average common shares outstanding - basic | 104,057,220 | 76,654,856 |
Weighted-average common shares outstanding - diluted | 104,057,220 | 76,654,856 |
Net loss per share - basic | $ (1.83) | $ (2.2) |
Net loss per share - diluted | $ (1.83) | $ (2.2) |
Net Loss per Share - Potential
Net Loss per Share - Potential Dilutive Securities Excluded From Computation Of Diluted Net Loss Per Share Attributable To Common Stockholders (Details) - shares | 12 Months Ended | |
Dec. 31, 2023 | Dec. 31, 2022 | |
Options To Purchase Common Stock | ||
Antidilutive Securities Excluded From Computation Of Earnings Per Share [Line Items] | ||
Antidilutive securities excluded from computation of earnings per share | 10,439,751 | 7,922,797 |
Unvested Restricted Stock | ||
Antidilutive Securities Excluded From Computation Of Earnings Per Share [Line Items] | ||
Antidilutive securities excluded from computation of earnings per share | 3,254,863 | 2,239,106 |
Related Party Transactions - Ad
Related Party Transactions - Additional Information (Details) - USD ($) $ in Millions | 12 Months Ended | ||
Dec. 31, 2023 | Dec. 31, 2022 | Aug. 31, 2022 | |
Related Party Transaction [Line Items] | |||
Consulting fees to members of management and board of directors | $ 0.4 | $ 0.5 | |
ElevateBio Technologies, Inc | Management and Administrative Services Agreement | |||
Related Party Transaction [Line Items] | |||
Lease expiration term | The agreement has an initial term of five years and will automatically renew for successive one year terms, unless earlier terminated under the terms of the agreement. | ||
BaseCamp | |||
Related Party Transaction [Line Items] | |||
Prepaid expenses | $ 2 | ||
BaseCamp | DMS Agreement | |||
Related Party Transaction [Line Items] | |||
Lease expiration term | The agreement will expire upon the later of (a) five years from the effective date of January 1, 2019 or (b) the completion of services under all work orders executed prior to the fifth anniversary of the effective date, unless earlier terminated under the terms of the agreement | ||
ElevateBio and Affiliates | |||
Related Party Transaction [Line Items] | |||
Prepaid expenses | $ 0 | 2 | |
Expenses related to services with related party | 2.6 | 3.5 | |
Amount due to related party | 0.3 | $ 0.1 | |
Marker Therapeutics, Inc. | |||
Related Party Transaction [Line Items] | |||
Costs incurred under agreement | $ 0.5 | ||
Cost of Revenue, Related Party, Type [Extensible Enumeration] | Related Party [Member] | ||
Amount due to related party | $ 0.5 |
Employee Benefit Plans - Additi
Employee Benefit Plans - Additional Information (Details) - USD ($) $ in Millions | 12 Months Ended | |
Dec. 31, 2023 | Dec. 31, 2022 | |
Retirement Benefits [Abstract] | ||
Matching contributions by employer | $ 0.9 | $ 0.8 |
Subsequent Events - Additional
Subsequent Events - Additional Information (Details) - USD ($) $ in Millions | 1 Months Ended | 3 Months Ended | 12 Months Ended | ||
Feb. 29, 2024 | Jan. 31, 2024 | Mar. 31, 2024 | Dec. 31, 2023 | Dec. 31, 2022 | |
Subsequent Event [Line Items] | |||||
Lease obligations remaining | $ 9.7 | $ 6.6 | |||
2024 SOW under the DMS Agreement | Forecast | |||||
Subsequent Event [Line Items] | |||||
Lease obligations remaining | $ 2.9 | ||||
Subsequent Event | |||||
Subsequent Event [Line Items] | |||||
Percentage of workforce reduction | 95% | ||||
Personnel-related restructuring charges | $ 10 | ||||
Subsequent Event | 2024 SOW under the DMS Agreement | |||||
Subsequent Event [Line Items] | |||||
Decrease in lease payments | $ 5.7 | ||||
Subsequent Event | Restricted Stock Units | |||||
Subsequent Event [Line Items] | |||||
Awards vesting period | 4 years |