Document and Entity Information
Document and Entity Information - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2023 | Jun. 30, 2023 | |
Cover [Abstract] | ||
Document Type | 10-K | |
Amendment Flag | false | |
Document Annual Report | true | |
Document Transition Report | false | |
Document Period End Date | Dec. 31, 2023 | |
Document Fiscal Year Focus | 2023 | |
Document Fiscal Period Focus | FY | |
Entity Registrant Name | INOZYME PHARMA, INC. | |
Entity Central Index Key | 0001693011 | |
Entity Incorporation, State or Country Code | DE | |
Entity File Number | 001-39397 | |
Entity Tax Identification Number | 38-4024528 | |
Entity Address, Address Line One | 321 Summer Street | |
Entity Address, Address Line Two | Suite 400 | |
Entity Address, City or Town | Boston | |
Entity Address, State or Province | MA | |
Entity Address, Postal Zip Code | 02210 | |
City Area Code | 857 | |
Local Phone Number | 330-4340 | |
Title of 12(b) Security | Common stock, par value $0.0001 per share | |
Trading Symbol | INZY | |
Security Exchange Name | NASDAQ | |
Current Fiscal Year End Date | --12-31 | |
Entity Well-known Seasoned Issuer | No | |
Entity Voluntary Filers | No | |
Entity Current Reporting Status | Yes | |
Entity Interactive Data Current | Yes | |
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 | |
Document Financial Statement Error Correction [Flag] | false | |
Entity Shell Company | false | |
Entity Public Float | $ 199,465,749 | |
Documents Incorporated by Reference | The registrant intends to file a definitive proxy statement pursuant to Regulation 14A within 120 days of the end of the fiscal year ended December 31, 2023 . Portions of such definitive proxy statement are incorporated by reference into Part III of this Annual Report on Form 10-K. | |
Auditor Firm ID | 42 | |
Auditor Location | Boston, Massachusetts | |
Auditor Name | Ernst & Young LLP |
CONSOLIDATED BALANCE SHEETS
CONSOLIDATED BALANCE SHEETS - USD ($) $ in Thousands | Dec. 31, 2023 | Dec. 31, 2022 |
Current assets: | ||
Cash and cash equivalents | $ 34,588 | $ 32,915 |
Short-term investments | 154,001 | 94,951 |
Prepaid expenses and other current assets | 7,661 | 3,527 |
Total current assets | 196,250 | 131,393 |
Property and equipment, net | 1,466 | 2,018 |
Right-of-use assets | 1,126 | 1,620 |
Restricted Cash, Noncurrent | 311 | 354 |
Prepaid expenses, net of current portion | 1,694 | 3,810 |
Total assets | 200,847 | 139,195 |
Current liabilities: | ||
Accounts payable | 1,166 | 2,544 |
Accrued expenses | 12,610 | 11,355 |
Operating lease liabilities | 910 | 816 |
Total current liabilities | 14,686 | 14,715 |
Operating lease liabilities, net of current portion | 913 | 1,823 |
Long term debt, net | 44,769 | 4,139 |
Other long term liabilities | 0 | 124 |
Total liabilities | 60,368 | 20,801 |
Commitments and contingencies (Note 7) | ||
Stockholders' equity | ||
Preferred Stock, $0.0001 par value - 5,000,000 shares authorized at December 31, 2023 and December 31, 2022; No shares issued and outstanding at December 31, 2023 or December 31, 2022 | 0 | 0 |
Common Stock, $0.0001 par value - 200,000,000 shares authorized at December 31, 2023 and December 31, 2022; 61,768,771 shares issued and outstanding at December 31, 2023 and 40,394,363 shares issued and outstanding at December 31, 2022 | 6 | 4 |
Additional paid in-capital | 426,362 | 333,356 |
Accumulated other comprehensive (loss) income | 41 | (205) |
Accumulated deficit | (285,930) | (214,761) |
Total stockholders' equity | 140,479 | 118,394 |
Total liabilities and stockholders' equity | $ 200,847 | $ 139,195 |
CONSOLIDATED BALANCE SHEETS (Pa
CONSOLIDATED BALANCE SHEETS (Parenthetical) - $ / shares | Dec. 31, 2023 | Dec. 31, 2022 |
Preferred stock, par value | $ 0.0001 | $ 0.0001 |
Preferred stock, shares authorized | 5,000,000 | 5,000,000 |
Preferred stock, shares issued | 0 | 0 |
Preferred stock, shares outstanding | 0 | 0 |
Common stock, par value | $ 0.0001 | $ 0.0001 |
Common stock, shares authorized | 200,000,000 | 200,000,000 |
Common stock, shares issued | 61,768,771 | 40,394,363 |
Common stock, shares outstanding | 61,768,771 | 40,394,363 |
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 | $ 54,847 | $ 47,849 |
General and administrative | 20,798 | 20,826 |
Total operating expenses | 75,645 | 68,675 |
Loss from operations | (75,645) | (68,675) |
Other income (expense): | ||
Interest income | 7,837 | 2,195 |
Interest expense | (3,333) | (262) |
Other expense, net | (28) | (319) |
Other income, net | 4,476 | 1,614 |
Net loss | (71,169) | (67,061) |
Other comprehensive income (loss): | ||
Unrealized (losses) on available-for-sale securities | 264 | (198) |
Foreign currency translation adjustment | (18) | (25) |
Total other comprehensive income (loss) | 246 | (223) |
Comprehensive loss | (70,923) | (67,284) |
Net Income (Loss) | $ (71,169) | $ (67,061) |
Net loss per share attributable to common stockholder - basic | $ (1.37) | $ (1.78) |
Net loss per share attributable to common stockholders- diluted | $ (1.37) | $ (1.78) |
Weighted-average common shares outstanding - basic | 51,839,131 | 37,763,168 |
Weighted-average common shares outstanding - diluted | 51,839,131 | 37,763,168 |
CONSOLIDATED STATEMENTS OF STOC
CONSOLIDATED STATEMENTS OF STOCKHOLDERS' EQUITY (DEFICIT) - USD ($) $ in Thousands | Total | Common Stock | Additional Paid-in Capital | Accumulated Other Comprehensive Income (Loss) | Accumulated Deficit |
Balance at Dec. 31, 2021 | $ 109,268 | $ 2 | $ 256,948 | $ 18 | $ (147,700) |
Balance, shares at Dec. 31, 2021 | 23,668,747 | ||||
Initial public offering, net of issuance costs, shares | 16,276,987 | ||||
Stock-based compensation | 7,672 | 7,672 | |||
Exercise of stock options | 359 | 359 | |||
Exercise of stock options, shares | 210,977 | ||||
Issuance of common stock, net of issuance costs | 56,137 | $ 2 | 56,135 | ||
Issuance of common stock, net of issuance costs, Share | 16,276,987 | ||||
Issuance of pre-funded warrants, net of issuance costs | 12,150 | 12,150 | |||
Exercise of pre-funded warrants, shares | 197,240 | ||||
Stock Issued During Period, Shares, Employee Stock Purchase Plans | 40,412 | ||||
Shares purchased in Employee Stock Purchase Plan | 92 | 92 | |||
Comprehensive income: | |||||
Unrealized loss on investments | (198) | (198) | |||
Foreign currency translation adjustment | (25) | (25) | |||
Net loss | (67,061) | (67,061) | |||
Balance at Dec. 31, 2022 | 118,394 | $ 4 | 333,356 | (205) | (214,761) |
Balance, shares at Dec. 31, 2022 | 40,394,363 | ||||
Initial public offering, net of issuance costs, shares | 14,375,000 | ||||
Stock-based compensation | 7,037 | 7,037 | |||
Exercise of stock options | $ 117 | $ 1 | 116 | ||
Exercise of stock options, shares | 43,209 | 43,209 | |||
Shares issued in at-the-market offering | $ 21,236 | $ 1 | 21,235 | ||
Shares issued in at-the-market offering, share | 3,553,995 | ||||
Issuance of common stock, net of issuance costs, Share | 14,375,000 | ||||
Issuance of pre-funded warrants, net of issuance costs | 64,412 | 64,412 | |||
Exercise of pre-funded warrants, shares | 3,325,644 | ||||
Stock Issued During Period, Shares, Employee Stock Purchase Plans | 76,560 | ||||
Shares purchased in Employee Stock Purchase Plan | 206 | 206 | |||
Comprehensive income: | |||||
Unrealized loss on investments | 264 | (264) | |||
Foreign currency translation adjustment | (18) | (18) | |||
Net loss | (71,169) | (71,169) | |||
Balance at Dec. 31, 2023 | $ 140,479 | $ 6 | $ 426,362 | $ 41 | $ (285,930) |
Balance, shares at Dec. 31, 2023 | 61,768,771 |
CONSOLIDATED STATEMENTS OF CASH
CONSOLIDATED STATEMENTS OF CASH FLOWS - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2023 | Dec. 31, 2022 | |
Operating activities | ||
Net loss | $ (71,169) | $ (67,061) |
Adjustments to reconcile net loss to net cash used in operating activities: | ||
Depreciation expense | 833 | 744 |
Loss on disposal of fixed assets | 20 | 17 |
Stock-based compensation expense | 7,037 | 7,672 |
Amortization of premiums and discounts on marketable securities | (5,438) | (1,671) |
Reduction in the carrying value of right-of-use assets | 494 | 433 |
Non-cash interest expense and amortization of debt issuance costs | 630 | 93 |
Changes in operating assets and liabilities: | ||
Prepaid expenses and other current assets | (4,134) | 14 |
Accounts payable | (1,378) | 150 |
Accrued expenses | 1,255 | 2,857 |
Operating lease liabilities | (816) | (732) |
Prepaid expenses - noncurrent | 2,115 | (401) |
Other Long term liabilities | (124) | 124 |
Net cash used in operating activities | (70,675) | (57,761) |
Investing activities | ||
Purchases of marketable securities | (269,330) | (151,993) |
Maturities of marketable securities | 215,982 | 147,000 |
Purchases of property and equipment | (298) | (410) |
Net cash (used in) provided by investing activities | (53,646) | (5,403) |
Financing activities | ||
Net proceeds from issuance of common stock | 85,647 | 56,137 |
Net proceeds from issuance of pre-funded warrants | 0 | 12,150 |
Net proceeds from issuance of long-term debt | 40,000 | 4,050 |
Proceeds from exercise of stock options | 116 | 359 |
Proceeds from issuance of common stock for cash under employee stock purchase plan | 206 | 92 |
Net cash provided by financing activities | 125,969 | 72,788 |
Net increase in cash, cash equivalents, and restricted cash | 1,648 | 9,624 |
Effect of foreign currency exchange rate in cash | (18) | (25) |
Cash, cash equivalents and restricted cash at beginning of period | 33,269 | 23,670 |
Cash, cash equivalents and restricted cash at end of period | 34,899 | 33,269 |
Supplemental cash flow information: | ||
Cash and cash equivalents | 34,588 | 32,915 |
Restricted cash | 311 | 354 |
Cash, cash equivalents and restricted cash at end of period | 34,899 | 33,269 |
Property and equipment unpaid at end of period | 0 | 14 |
Cash paid for interest | $ (2,347) | $ (170) |
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) | $ (71,169) | $ (67,061) |
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 |
Organization and Basis of Prese
Organization and Basis of Presentation | 12 Months Ended |
Dec. 31, 2023 | |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | |
Organization and Basis of Presentation | 1. Organization and Basis of Presentation Inozyme Pharma, Inc. (the “Company”) is a clinical-stage rare disease biopharmaceutical company developing novel therapeutics for the treatment of diseases impacting the vasculature, soft tissue, and skeleton. Through the Company’s in-depth understanding of a key biological pathway, the Company is pursuing the development of therapeutics that address pathologic mineralization and intimal proliferation to improve the underlying causes of these debilitating diseases. It is well established that low levels of plasma pyrophosphate drive pathologic mineralization and low levels of adenosine drive intimal proliferation in a number of rare diseases. The Company is initially focused on developing a novel therapy to treat for ENPP1 Deficiency, ABCC6 Deficiency, and calciphylaxis. The Company’s lead product candidate, INZ-701, is a soluble, recombinant, or genetically engineered, fusion protein that is designed to metabolize extracellular adenosine triphosphate to generate plasma pyrophosphate and adenosine monophosphate, which can be processed to phosphate and adenosine. This process is central to the regulation of calcium deposition throughout the body and is further associated with the inhibition of intimal proliferation, or narrowing and obstruction of blood vessels. Basis of Presentation The accompanying consolidated financial statements have been prepared in conformity with accounting principles generally accepted in the United States of America (“U.S. GAAP”). Any reference in these notes to applicable guidance is meant to refer to the authoritative U.S. GAAP as found in the Accounting Standards Codification (“ASC”) and Accounting Standards Update (“ASU”) of the Financial Accounting Standards Board (“FASB”). Liquidity, Capital Resources, and Going Concern Since the Company’s incorporation in 2017 and through December 31, 2023, the Company has devoted substantially all of its efforts to raising capital, building infrastructure, developing intellectual property and conducting research and development. The Company incurred net losses of $ 71.2 million and $ 67.1 million in the years ended December 31, 2023 and 2022, respectively, and had an accumulated deficit of $ 285.9 million as of December 31, 2023. The Company had cash, cash equivalents, and short-term investments of $ 188.6 million as of December 31, 2023. Because of the numerous risks and uncertainties associated with product development, the Company is unable to predict the timing or amount of increased expenses or when or if the Company will be able to achieve or maintain profitability. Even if the Company is able to generate revenue from product sales, the Company may not become profitable. If the Company fails to become profitable or is unable to sustain profitability on a continuing basis, then the Company may be unable to continue its operations at planned levels and be forced to reduce or terminate its operations. The accompanying consolidated financial statements have been prepared on the basis of continuity of operations, realization of assets, and the satisfaction of liabilities and commitments in the ordinary course of business. The Company has incurred recurring losses and negative cash flows from operations since inception and has primarily funded its operations with proceeds from the issuance of convertible preferred stock, offerings of common stock and pre-funded warrants, and its loan and security agreement (the "Loan Agreement") with K2 HealthVentures LLC (see Note 8). The Company expects its operating losses and negative operating cash flows to continue into the foreseeable future as it continues to expand its research and development efforts. The Company believes that its cash, cash equivalents, and short-term investments as of December 31, 2023 will be sufficient to fund its cash flow requirements for at least 12 months from the date of filing this Annual Report on Form 10-K. Management’s expectations with respect to its ability to fund current and long-term planned operations are based on estimates that are subject to risks and uncertainties. The Company will need additional funding to support its planned operating activities. However, there is no guarantee that any financing opportunities will be executed on favorable terms, or at all, and some could be dilutive to existing stockholders. If the Company is unable to obtain additional funding, it would be forced to delay, reduce or eliminate some or all of its research and development programs, portfolio expansion, or commercialization efforts, which could adversely affect its business prospects. |
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 Principles of Consolidation The accompanying consolidated financial statements include the accounts of the Company and its wholly owned subsidiaries, Inozyme Securities Corp., which is a Massachusetts subsidiary created to buy, sell, and hold securities; Inozyme Ireland Limited; and Inozyme Pharma Switzerland GmbH. All intercompany transactions and balances have been eliminated. Use of Estimates The preparation of the Company’s financial statements 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. Estimates and judgments are based on historical information and other market-specific or various relevant assumptions, including, in certain circumstances, future projections that management believes to be reasonable under the circumstances. Actual results could differ materially from estimates. Significant estimates and assumptions are used for, but not limited to the accruals for research and development expenses. The Company evaluates its estimates and assumptions on an ongoing basis. All revisions to accounting estimates are recognized in the period in which the estimates are revised and in any future periods affected. Concentration of Credit Risk, Significant Suppliers, and Off-Balance Sheet Risk Financial instruments that potentially subject the Company to significant concentrations of credit risk consist primarily of cash, cash equivalents, and short-term investments and, from time to time, long-term investments. The Company maintains deposits in federally insured financial institutions in excess of federally insured limits and limits its exposure to credit risk by placing its cash with high credit quality financial institutions. The Company’s investments are composed of U.S. Treasury and U.S. government agency debt securities and commercial paper of corporations. The Company mitigates credit risk by maintaining a diversified portfolio and limiting the amount of investment exposure as to institution, maturity, and investment type. The Company is dependent on third-party manufacturers and contract research organizations ("CROs") to supply product candidates and provide services for research and development activities in its programs. In particular, the Company relies and expects to continue to rely on a small number of manufacturers to supply it with its requirements for the active pharmaceutical ingredients and formulated drugs related to these programs. The Company also relies on CROs to conduct its clinical trials. The Company’s programs could be adversely affected if a third-party manufacturer or a CRO is unable to successfully carry out their contractual obligations or meet expected deadlines. If a third-party manufacturer or a CRO needs to be replaced, the Company may not be able to complete its program development on its anticipated timelines and the Company may incur additional expenses as a result, which could be significant. The Company has no significant off-balance sheet risk such as foreign exchange contracts, option contracts, or other foreign hedging arrangements. Cash and Cash Equivalents The Company considers all highly liquid investments with original maturities of three months or less at the date of purchase to be cash equivalents. Cash and cash equivalents include cash in readily available checking accounts, money market accounts, and certain marketable securities. Cash is carried at cost, which approximates its fair value. Cash equivalents are carried at fair market value. Restricted Cash Restricted cash is composed of amounts held to collateralize the letters of credit related to the Company’s lease arrangements. Restricted cash is classified as either current or non-current based on the terms of the underlying lease arrangement. Short-Term and Long-Term Investments The Company classifies its investments as available-for-sale and records such assets at estimated fair value on the balance sheet, with unrealized gains and losses on marketable securities, if any, reported as a component of accumulated other comprehensive (loss) income. Realized gains and losses are calculated based on the specific-identification method and are recorded as a component of interest income. There have been no realized gains and losses for the years ended December 31, 2023 and 2022. The Company periodically reviews available-for-sale securities for other-than-temporary declines in fair value below the cost basis whenever events or changes in circumstances indicate the carrying amount of an asset may not be recoverable. Marketable securities with a maturity date of one year or less from the balance sheet date are classified by the Company as short-term investments. Marketable securities with a maturity date of greater than one year from the balance sheet date are classified as long-term investments and are available to fund operations as needed. As of December 31, 2023 , the Company did no t have any long-term investments. In accordance with the Company’s investment policy, at the time of purchase, the final maturity of each security within the portfolio shall not exceed 18 months and the weighted average maturity of the portfolio will be no greater than 12 months. Property and Equipment Property and equipment are stated at cost, less accumulated depreciation. Depreciation is calculated using the straight-line method over the estimated useful lives of the assets. Leasehold improvements are amortized over the shorter of the lease term or the estimated useful life of the related asset. The estimated useful lives of the Company’s property and equipment are as follows: Estimated Useful Life (In Years) Laboratory equipment and manufacturing equipment 5 Furniture and fixtures 5 Computer equipment 3 Leasehold improvements Lesser of asset life or lease term Impairment of Long-lived Assets As required under the applicable accounting guidance, the Company periodically reevaluates the original assumptions and rationale used in the establishment of the carrying value and estimated lives of all of its long-lived assets, including property and equipment. The Company reviews long-lived assets for impairment whenever events or changes in circumstances indicate that the carrying amount of the assets may not be recoverable. An impairment loss is recognized when the total of estimated future undiscounted cash flows, expected to result from the use of the asset and its eventual disposition, are less than its carrying amount. Impairment, if any, would be assessed using discounted cash flows or other appropriate measures of fair value. There were no impairments for the years ended December 31, 2023 and 2022 . Accrued Research and Development Costs The Company records accrued liabilities for estimated costs of research and development activities conducted by service providers for sponsored research, preclinical studies, clinical operations, and contract manufacturing activities based upon the estimated amount of services provided but not yet invoiced and includes these costs in accrued expenses in the accompanying consolidated balance sheets and within research and development expense in the accompanying consolidated statements of operations and comprehensive loss. The Company accrues for these costs based on factors such as estimates of the work completed and in accordance with agreements established with service providers. The Company makes significant judgments and estimates in determining the accrued liabilities balance in each reporting period. As actual costs become known, the Company adjusts its accrued liabilities. The Company has not experienced any material differences between accrued costs and actual costs incurred since its inception. Research and Development Costs Research and development costs are expensed as incurred. Research and development costs consist of direct and indirect internal costs related to specific projects as well as fees paid to other entities that conduct certain research and development activities on the Company’s behalf. Patent Costs The Company expenses all costs as incurred in connection with patent applications, including direct application fees, and the legal and consulting expenses related to making such applications, and such costs are included in general and administrative expenses within the Company’s consolidated statements of operations and comprehensive loss. Stock-Based Compensation Stock-based compensation expense represents the cost of the grant date fair value of employee and non-employee stock option grants recognized over the requisite service period of the awards on a straight-line basis. For service-based awards that are subject to graded vesting, the Company has elected to recognize compensation expense on a straight-line basis. The Company has elected to recognize forfeitures as they occur. Income Taxes Income taxes have been accounted for using the asset and liability method. Under the asset and liability method, deferred tax assets and liabilities are recognized for the future tax consequences attributable to differences between the financial carrying amounts of existing assets and liabilities and their respective tax bases and operating loss and tax credit carryforwards. Deferred tax assets and liabilities are measured using enacted tax rates applicable to taxable income in the years in which those temporary differences are expected to be recovered or settled. The effect on deferred tax assets and liabilities of a change in tax rates is recognized in the period that includes the enactment date. A valuation allowance against deferred tax assets is recorded if, based upon the weight of all available evidence, it is more likely than not that some or all of the deferred tax assets will not be realized. The Company accounts for income taxes in accordance with authoritative accounting guidance which states the impact of an uncertain income tax position is recognized at the largest amount that is “more likely than not” to be sustained upon audit by the relevant taxing authority. There are no unrecognized tax benefits included in the Company’s consolidated balance sheets at December 31, 2023 or 2022 . The Company’s policy is to recognize interest and penalties related to income tax matters in income tax expense. The Company has no t recognized any interest or penalties in its consolidated statements of operations and comprehensive loss since inception. Leases The Company determines if an arrangement is a lease at contract inception based on the facts and circumstances present in the arrangement. If a lease is identified in an arrangement, the Company recognizes a right-of-use asset and liability on its balance sheet and determines whether the lease should be classified as a finance or operating lease. Short-term leases, or leases that have a lease term of 12 months or less at the commencement date are excluded from this treatment and are recognized on a straight-line basis over the term of the lease. Additionally, the Company does not separate lease and non-lease components for all leases. A lease qualifies as a finance lease if any of the following criteria are met at the inception of the lease: (i) there is a transfer of ownership of the leased asset to the Company by the end of the lease term, (ii) the Company holds an option to purchase the leased asset that it is reasonably certain to exercise, (iii) the lease term is for a major part of the remaining economic life of the leased asset, (iv) the present value of the sum of lease payments equals or exceeds substantially all of the fair value of the leased asset, (v) the nature of the leased asset is specialized to the point that it is expected to provide the lessor no alternative use at the end of the lease term. All other leases are recorded as operating leases. Finance and operating lease assets and liabilities are recognized at the lease commencement date based on the present value of the lease payments over the lease term using the discount rate implicit in the lease. If the rate implicit is not readily determinable, the Company utilizes an estimate of its incremental borrowing rate at the lease commencement date. Operating lease assets are further adjusted for prepaid or accrued lease payments. Operating lease payments are expensed using the straight-line method as an operating expense over the lease term. Finance lease assets are amortized to depreciation expense using the straight-line method over the shorter of the useful life of the related asset or the lease term. Finance lease payments are bifurcated into (i) a portion that is recorded as imputed interest expense and (ii) a portion that reduces the finance liability associated with the lease. The Company did no t have any finance leases recorded on its consolidated balance sheet as of December 31, 2023 and 2022 . Deferred Issuance Costs The Company capitalizes certain legal, professional accounting, and other third-party fees that are directly associated with in-process equity financings as deferred issuance costs until such financings are consummated. After consummation of such an equity financing, these costs are recorded as a reduction of the proceeds generated as a result of the offering. Should a planned equity financing be abandoned, the deferred issuance costs would be expensed immediately as a charge to operating expenses in the consolidated statements of operations and comprehensive loss. The Company did no t have any deferred issuance costs recorded at December 31, 2023 or December 31, 2022 . Net Loss Per Share Basic net loss per share attributable to common stockholders is computed by dividing the net loss attributable to common stockholders by the weighted-average number of shares of common stock and pre-funded warrants outstanding during the period, without consideration for potentially dilutive securities. Diluted net loss per share is computed by dividing the net loss attributable to common stockholders by the weighted-average number of shares of common stock and pre-funded warrants and potentially dilutive securities outstanding during the period determined using the treasury-stock and if-converted methods. The Company has generated a net loss in all periods presented; therefore, the basic and diluted net loss per share attributable to common stockholders are the same as the inclusion of the potentially dilutive securities would be anti-dilutive. Segments Operating segments are defined as components of an entity for which separate financial information is available and that is regularly reviewed by the Chief Operating Decision Maker (“CODM”) in deciding how to allocate resources to an individual segment and in assessing performance. The Company’s CODM is its Chief Executive Officer. The Company has determined it operates in a single operating segment and has one reportable segment. All long-lived assets of the Company reside in the United States. Comprehensive Loss The Company is required to report all components of comprehensive loss, including net loss, in the financial statements in the period in which they are recognized. Comprehensive loss is defined as the change in equity during a period from transactions and other events and circumstances from non-owner sources. Comprehensive loss consists of the Company’s net loss, unrealized gains and losses on the Company’s investments, and foreign currency translation adjustments and is presented within the consolidated statements of operations and comprehensive loss. Foreign Currency Transactions The Company maintains foreign bank accounts denominated in euros and Swiss francs and enters into transactions which are denominated in various currencies. Foreign currency transactions are initially recorded by the Company using the exchange rates prevailing at the date of the transaction. At the balance sheet date, recorded monetary balances denominated in foreign currencies are adjusted to U.S. dollars using the period-end rates of exchange. Exchange gains and losses arising from the translation of foreign currency items are included in other expense, net in the consolidated statements of operations and comprehensive loss. Fair Value Measurements The Company categorizes its assets and liabilities measured at fair value in accordance with the authoritative accounting guidance that establishes a consistent framework for measuring fair value, and expands disclosures for each major asset and liability category measured at fair value on either a recurring or nonrecurring basis. Fair value is defined as the 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 such, fair value is a market-based measurement that should be determined based on assumptions that market participants would use in pricing an asset or liability. As a basis for considering such assumptions, the guidance establishes a three-tier fair value hierarchy, which prioritizes the inputs used in measuring fair value as follows: • Level 1 – Unadjusted quoted prices in active markets that are accessible at the measurement date for identical assets or liabilities; • Level 2 – Quoted prices for similar assets and liabilities in active markets, quoted prices in markets that are not active, or inputs which are observable, either directly or indirectly, for substantially the full term of the asset or liability; or • Level 3 – Prices or valuation techniques that require inputs that are both significant to the fair value measurement and unobservable (i.e., supported by little or no market activity). Emerging Growth Company Status The Company is an “emerging growth company” (“EGC”) as defined in the Jumpstart Our Business Startups Act of 2012 (the “JOBS Act”), and the Company may take advantage of certain exemptions from various reporting requirements that are applicable to other public companies that are not EGCs. As an EGC, the Company can elect to take advantage of the extended transition period afforded by the JOBS Act for the implementation of new or revised accounting standards. The Company has elected to use the extended transition period for complying with new or revised accounting standards, and as a result of this election, the Company’s consolidated financial statements may not be comparable to companies that comply with public company FASB standards’ effective dates. The Company will remain an EGC until December 31, 2025, although if the market value of the Company’s common stock that is held by non-affiliates exceeds $ 700 million as of any June 30 before that time or if the Company has annual gross revenues of $ 1.235 billion or more in any fiscal year, the Company would cease to be an EGC as of December 31 of the applicable year. The Company would also cease to be an EGC if it issued more than $ 1 billion of non-convertible debt over a three-year period. Debt and Debt Issuance Costs Debt issuance costs are presented on the consolidated balance sheet as a direct deduction from the related debt liability. Debt issuance costs represent legal and other direct costs incurred in connection with the Company’s term loan under the Loan Agreement. These costs are amortized as a non-cash component of interest expense using the effective interest method over the term of the loan. Any final payments are included in the cash flows to determine the effective interest rate and are recognized using the effective interest method over the term of the loan. Warrants The Company determines the accounting classification of warrants that are issued, as either liability or equity, by first assessing whether the warrants meet liability classification in accordance with ASC 480-10, Accounting for Certain Financial Instruments with Characteristics of Both Liabilities and Equity , and then in accordance with ASC 815-40, Accounting for Derivative Financial Instruments Indexed to, and Potentially Settled in, a Company’s Own Stock . Under ASC 480-10, warrants are considered liability classified if the warrants are mandatorily redeemable, obligate the issuer to settle the warrants or the underlying shares by paying cash or other assets, or must or may require settlement by issuing variable number of shares. If warrants do not meet liability classification under ASC 480-10, the Company assesses the requirements under ASC 815-40, which states that contracts that require or may require the issuer to settle the contract for cash are liabilities recorded at fair value, irrespective of the likelihood of the transaction occurring that triggers the net cash settlement feature. If the warrants do not require liability classification under ASC 815-40, in order to conclude equity classification, the Company assesses whether the warrants are indexed to its common stock and whether the warrants are classified as equity under ASC 815-40 or other applicable U.S. GAAP. After all relevant assessments are made, the Company concludes whether the warrants are classified as liability or equity. Liability classified warrants are required to be accounted for at fair value both on the date of issuance and on subsequent accounting period ending dates, with all changes in fair value after the issuance date recorded in the statements of operations as a gain or loss. Equity classified warrants are accounted for at fair value on the issuance date with no changes in fair value recognized after the issuance date. |
Recent Accounting Pronouncement
Recent Accounting Pronouncements | 12 Months Ended |
Dec. 31, 2023 | |
Accounting Changes and Error Corrections [Abstract] | |
Recent Accounting Pronouncements | 3. Recent Accounting Pronouncements From time to time, new accounting pronouncements are issued by the FASB or other standard setting bodies that are adopted by the Company as of the specified effective date. Unless otherwise discussed, the Company believes that the impact of recently issued standards that are not yet effective will not have a material impact on its financial position or results of operations upon adoption. Recently Adopted Accounting Standard In June 2016, the FASB issued ASU No. 2016-13, Financial Instruments-Credit Losses (“Topic 326”): Measurement of Credit Losses on Financial Instruments. ASU 2016-13 and its subsequent related updates establish a new forward-looking “expected loss model” that requires entities to estimate current expected credit losses on accounts receivable and financial instruments by using all practical and relevant information. The Company adopted this standard effective January 1, 2023. There was no impact to the Company's financial statements upon adoption. |
Balance Sheet Details
Balance Sheet Details | 12 Months Ended |
Dec. 31, 2023 | |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | |
Balance Sheet Details | 4. Balance Sheet Details Short-term investments consisted of the following (dollar amounts in thousands): December 31, 2023 Description Maturity Amortized Gross Gross Estimated U.S. Treasury securities 1 year or less $ 80,160 $ 59 $ ( 1 ) $ 80,218 U.S. government agency debt securities 1 year or less 73,774 17 ( 8 ) 73,783 $ 153,934 $ 76 $ ( 9 ) $ 154,001 December 31, 2022 Description Maturity Amortized Gross Gross Estimated Commercial paper 1 year or less $ 78,451 $ 4 $ ( 119 ) $ 78,336 U.S. Treasury securities 1 year or less 16,698 — ( 83 ) 16,615 $ 95,149 $ 4 $ ( 202 ) $ 94,951 The Company concluded that the declines in market value of available-for-sale securities were temporary in nature and did not consider any of the investments to be other-than-temporarily impaired. In accordance with its investment policy, the Company invests in investment grade securities with high credit quality issuers, and generally limits the amount of credit exposure to any one issuer. The Company evaluates securities for other-than-temporary impairment at the end of each reporting period. Impairment is evaluated considering numerous factors, and their relative significance varies depending on the situation. Factors considered include the length of time and extent to which fair value has been less than the cost basis, the financial condition and near-term prospects of the issuer, and the Company’s intent and ability to hold the investment to allow for an anticipated recovery in fair value. Furthermore, the aggregate of individual unrealized losses that had been outstanding for 12 months or less was not significant as of December 31, 2023 and December 31, 2022. The Company does not intend to sell these investments and it is not more likely than not that the Company will be required to sell the investments before a recovery of their amortized cost bases, which may be maturity. The Company also believes that it will be able to collect both principal and interest amounts due at maturity. Prepaid expenses and other current assets consisted of the following (dollar amounts in thousands): At December 31, 2023 At December 31, 2022 Interest receivable $ 385 $ 115 Prepaid insurance 1,067 1,293 Prepaid research studies 5,339 1,397 Prepaid other 870 722 Total $ 7,661 $ 3,527 Property and equipment consisted of the following (dollar amounts in thousands): At December 31, 2023 At December 31, 2022 Laboratory equipment and manufacturing equipment $ 947 $ 805 Furniture and fixtures 284 258 Computer equipment 491 558 Leasehold improvements 2,157 2,129 3,879 3,750 Less accumulated depreciation ( 2,413 ) ( 1,732 ) Total $ 1,466 $ 2,018 Depreciation expense for the years ended December 31, 2023 and 2022 totaled $ 0.8 million and $ 0.7 million, respectively. Accrued expenses consisted of the following (dollar amounts in thousands): At December 31, 2023 At December 31, 2022 Payroll and related liabilities $ 3,838 $ 3,229 Other professional fees 1,377 1,310 Clinical expenses 3,595 3,986 Research and development costs 2,917 2,345 Other 883 485 Total $ 12,610 $ 11,355 |
Fair Value Measurement
Fair Value Measurement | 12 Months Ended |
Dec. 31, 2023 | |
Fair Value Disclosures [Abstract] | |
Fair Value Measurement | 5. Fair Value Measurement The following tables represent the Company’s financial assets measured at fair value on a recurring basis and indicate the level of fair value hierarchy utilized to determine such fair values (in thousands): Fair Value Measurements at Reporting Date Description December 31, 2023 Quoted Significant Significant Assets: Money market funds (included in cash and cash $ 33,830 $ 33,830 $ — $ — U.S. government agency debt securities 73,783 — 73,783 — U.S. Treasury securities 80,218 80,218 — — Total assets $ 187,831 $ 114,048 $ 73,783 $ — Fair Value Measurements at Reporting Date Description December 31, Quoted Significant Significant Assets: Money market funds (included in cash and cash $ 26,587 $ 26,587 $ — $ — Commercial paper 78,336 — 78,336 — U.S. Treasury securities 16,615 16,615 — — Total assets $ 121,538 $ 43,202 $ 78,336 $ — There have been no transfers between fair value levels during the years ended December 31, 2023 and December 31, 2022 . |
License and Sponsored Research
License and Sponsored Research Agreements | 12 Months Ended |
Dec. 31, 2023 | |
Research and Development [Abstract] | |
License and Sponsored Research Agreements | 6. License and Sponsored Research Agreements In January 2017, the Company entered into a license agreement with Yale University (“Yale”), which was amended in May 2020 and July 2020, under which the Company licensed certain intellectual property related to ectonucleotide pyrophosphatase/phosphodiesterase enzymes that is the basis for the Company’s INZ-701 development program. Pursuant to the license agreement, as partial upfront consideration, the Company made a payment of approximately $ 0.1 million to Yale, which amount reflected unreimbursed patent expenses incurred by Yale prior to the date of the license agreement. The Company is responsible for paying Yale an annual license maintenance fee in varying amounts throughout the term ranging from the low tens of thousands of dollars to the high tens of thousands of dollars. For the years ended December 31, 2023 and 2022, the Company incurred a total of $ 0.1 million and $ 0.1 million, respectively, in license maintenance fees to Yale. The Company is required to pay Yale up to $ 3.0 million, based on the achievement of a specified net product sales milestone or specified development and commercialization milestones, for each therapeutic and prophylactic licensed product developed. In January 2022, the Company paid Yale an approximately $ 0.3 million milestone payment following dosing of the first patient in Company’s Phase 1/2 clinical trial of INZ-701 in adult patients with ENPP1 Deficiency in November 2021. In March 2022, the Company paid Yale an approximately $ 0.3 million milestone payment following completion of the first cohort of the Company's Phase 1/2 clinical trial of INZ-701 in adult patients with ENPP1 Deficiency in January 2022. In addition, the Company is required to pay Yale an amount in the several hundreds of thousands of dollars, based on the achievement of a specified net product sales milestone or specified development and commercialization milestones, for each diagnostic licensed product developed. While the agreement remains in effect, the Company is required to pay Yale low single-digit percentage royalties on aggregate worldwide net sales of certain licensed products. Yale is guaranteed a minimum royalty payment amount (ranging in dollar amounts from the mid six figures to low seven figures) for each year after the first sale of a therapeutic or prophylactic licensed product that results in net sales. Yale is guaranteed a minimum royalty payment amount (ranging from the low tens of thousands of dollars to the mid tens of thousands of dollars) for each year after the first sale of a diagnostic licensed product that results in net sales. The Company must also pay Yale a percentage in the twenties of certain types of income it receives from sublicensees. The Company is also responsible for costs relating to the prosecution and maintenance of the licensed patents. Finally, subject to certain conditions, all payments due by the Company to Yale will be tripled following any patent challenge or challenge to a claim by Yale that a product is a licensed product under the agreement, made by the Company against Yale if Yale prevails in such challenge. In January 2017, the Company also entered into a corporate sponsored research agreement with Yale (the "Sponsored Research Agreement"), which was amended in February 2019, under which the Company agreed to provide research support funding in the aggregate amount of $ 2.4 million over the five-year period from contract inception through December 2021 . The Sponsored Research Agreement was amended in February 2022, under which the contract was extended through June 30, 2022 subject to the terms of the existing agreement. The Sponsored Research Agreement was amended again in May 2022, March 2023, and January 2024, such that the agreement now extends through December 2024, with approximately $ 0.3 million of Company-provided research support funding for the most recent extension. The aggregate amount of agreed upon research support funding under the Sponsored Research Agreement is $ 3.0 million. The Company recorded research and development expenses associated with this arrangement of $ 0.1 million in each of the years ended December 31, 2023 and 2022 , respectively. |
Commitments and Contingencies
Commitments and Contingencies | 12 Months Ended |
Dec. 31, 2023 | |
Commitments and Contingencies Disclosure [Abstract] | |
Commitments and Contingencies | 7. Commitments and Contingencies Operating Leases The Company held the following significant operating leases of office and laboratory space as of December 31, 2023: • An operating lease for 8,499 square feet of office space in Boston, Massachusetts that expires in 2025 , with an option to extend the term for five years . Exercise of the option was determined not to be reasonably certain and thus was not included in the operating lease liability on the consolidated balance sheet as of December 31, 2023 or 2022; and • An operating lease for 6,244 square feet of laboratory space in Boston, Massachusetts that expires in 2025 , with an option to extend the term for five years . Exercise of the option was determined not to be reasonably certain and thus was not included in the operating lease liability on the consolidated balance sheet as of December 31, 2023 or 2022. Both leases are subject to yearly rent escalations. In connection with the Company’s leases of office space and laboratory space, the Company provided security deposits to the landlords in the form of letters of credit totaling $ 0.3 million as of December 31, 2023. The cash collateralizing the letters of credit is included in restricted cash in the accompanying balance sheets as of December 31, 2023 and December 31, 2022. At December 31, 2023 , the weighted average incremental borrowing rate and the weighted average remaining lease term for the operating leases held by the Company were 8 % and 1.9 years, respectively. During the year ended December 31, 2023, cash paid for amounts included for the measurement of lease liabilities was $ 0.7 million and the Company recorded operating lease expense of $ 0.9 million. During the year ended December 31, 2022 , cash paid for amounts included for the measurement of lease liabilities was $ 0.9 million and the Company recorded operating lease expense of $ 0.7 million. Future lease payments under non-cancelable leases as of December 31, 2023 are as follows (dollar amounts in thousands): Year Ending December 31, 2024 $ 1,016 2025 944 $ 1,960 The Company did not have any finance leases recorded on its consolidated balance sheet as of December 31, 2023 and 2022. Indemnification Agreements In the ordinary course of business, the Company may provide indemnification of varying scope and terms to vendors, lessors, business partners and other parties with respect to certain matters arising out of the relationship between such parties and the Company. In addition, the Company has entered into indemnification agreements with members of its board of directors and senior management that will require the Company, among other things, to indemnify them against certain liabilities that may arise by reason of their status or service as directors or officers. To date, the Company has not incurred any material costs as a result of such indemnifications. The Company is not aware of any claims under indemnification arrangements, and it has not accrued any liabilities related to such obligations as of December 31, 2023 or December 31, 2022. Legal Proceedings The Company is not currently a party to any material legal proceedings. At each reporting date, the Company evaluates whether or not a potential loss amount or a potential range of loss is probable and reasonably estimable under the provisions of the authoritative guidance that addresses accounting for contingencies. The Company expenses the costs related to its legal proceedings as they are incurred. No such costs have been incurred during the years ended December 31, 2023 and 2022 . |
Convertible Debt
Convertible Debt | 12 Months Ended |
Dec. 31, 2023 | |
Debt Disclosure [Abstract] | |
Debt Disclosure [Text Block] | 8. Convertible Debt Loan Agreement with K2 HealthVentures LLC On July 25, 2022, the Company, as borrower, entered into the Loan Agreement with K2 HealthVentures LLC (“K2HV”, together with any other lender from time to time, the “Lenders”), K2HV, as administrative agent for the Lenders, and Ankura Trust Company, LLC, as collateral agent for the Lenders. The Loan Agreement provides up to $ 70.0 million principal in term loans, subject to certain customary conditions. The Company received $ 5.0 million from the first tranche commitment upon closing. The first tranche commitment contained an additional $ 20.0 million available to be drawn at the Company’s option through March 31, 2023. The Company elected to borrow the remaining $ 20.0 million in February 2023. Two subsequent tranche commitments totaling $ 20.0 million in the aggregate were available to be drawn at the Company’s option during certain availability periods, subject to the achievement of certain clinical and regulatory milestones relating to INZ-701. The Company elected to borrow $ 7.5 million under the second tranche commitment in June 2023 and elected to borrow $ 12.5 million under the third tranche commitment in December 2023. A fourth tranche commitment of $ 25.0 million may be made available to be drawn down at the Company’s option through August 31, 2025, subject to use of proceeds limitations and Lender's consent at its discretion. The fourth tranche commitment is subject to an additional 0.75 % facility fee. As of December 31, 2023 , a total of $ 25.0 million of borrowing capacity remained available under the Loan Agreement, subject to the terms and conditions set forth therein. As security for its obligations under the Loan Agreement, the Company granted the Lenders a first priority security interest on substantially all of the Company’s assets (other than intellectual property), subject to certain exceptions. The term loan matures on August 1, 2026 , and the Company is obligated to make interest only payments for the first 36 months and then interest and equal principal payments through the maturity date. The term loan bears a variable interest rate equal to the greater of (i) 7.85 %, and (ii) the sum of (A) the prime rate last quoted in The Wall Street Journal (or a comparable replacement rate if The Wall Street Journal ceases to quote such rate) and (B) 3.85 %; provided that the interest rate cannot exceed 9.60% . The interest rate as of December 31, 2023 was 9.60 %. The Company has the option to prepay all, but not less than, the outstanding principal balance and all accrued and unpaid interest with respect to the principal balance being repaid of the term loans, subject to a prepayment premium to which the Lenders are entitled. The prepayment fee is 3 % prior to the second anniversary of the July 25, 2022 funding date, 2 % after the second anniversary but prior to the third anniversary of the funding date, and 1 % thereafter if prior to the maturity date. Upon final payment or prepayment of the loans, the Company must pay a final payment equal to 6.25 % of the loans borrowed ("Final Fee"), which is being accrued as interest expense over the term of the loan using the effective interest method. The Lenders may elect, prior to the full repayment of the term loans, to convert up to $ 5.0 million of outstanding principal of the term loans into shares of the Company’s common stock, at a conversion price of $ 6.21 per share, subject to customary adjustments and 9.99 % and 19.99 % beneficial ownership limitations. The Company determined that the embedded conversion option was not required to be separated from the term loan. The embedded conversion option met the derivative accounting scope exception since the embedded conversion option is indexed to the Company’s own common stock and qualifies for classification within stockholders’ equity. The Loan Agreement contains customary representations and warranties, events of default and affirmative and negative covenants, including covenants that limit or restrict the Company’s ability to, among other things, dispose of assets, make changes to the Company’s business, management, ownership or business locations, merge or consolidate, incur additional indebtedness, incur additional liens, pay dividends or other distributions or repurchase equity, make investments, and enter into certain transactions with affiliates, in each case subject to certain exceptions. Upon the occurrence of an event of default, a default interest rate of an additional 5.00 % per annum may be applied to the outstanding loan balances, and the Lender may declare all outstanding obligations immediately due and payable and exercise all of its rights and remedies as set forth in the Loan Agreement and under applicable law. As of December 31, 2023, the Company was in compliance with all covenants under the Loan Agreement. Subject to certain conditions, the Company granted the Lenders the right, prior to repayment of the term loans, to invest up to $ 5.0 million in the aggregate in future offerings of common stock, convertible preferred stock or other equity securities of the Company that are broadly marketed and offered to multiple investors, on the same terms, conditions and pricing afforded to others participating in any such financing. The Company incurred debt issuance costs of $ 0.5 million in connection with the term loan. In addition, at the time of closing the Company paid to the Lenders a facility fee of $ 0.4 million, as well as $ 0.1 million of other expenses incurred by the Lenders and reimbursed by the Company ("Lender Expenses"). At December 31, 2023, the carrying value of the Loan Agreement approximates the fair value of the term loan, considering that it bears interest that is similar to prevailing market rates. The following table summarizes the impact of the term loan on the Company’s consolidated balance sheet at December 31, 2023: December 31, 2023 (in thousands) Gross proceeds $ 45,000 Unamortized debt issuance costs ( 231 ) Carrying value $ 44,769 Future principal payments, which include the Final Fee, in connection with the Loan Agreement as of December 31, 2023 are as follows (dollar amounts in thousands): Fiscal Year 2024 — 2025 14,508 2026 33,305 Total $ 47,813 |
Stockholders' Equity
Stockholders' Equity | 12 Months Ended |
Dec. 31, 2023 | |
Stockholders' Equity Note [Abstract] | |
Stockholders' Equity | 9. Stockholders’ Equity July 2023 Underwritten Offering On July 27, 2023, the Company entered into an underwriting agreement with BofA Securities, Inc., Cowen and Company, LLC and Piper Sandler & Co., as representatives of the several underwriters named therein (collectively, the “Underwriters”), relating to an underwritten public offering of 14,375,000 shares of the Company's common stock, which included 1,875,000 shares issued upon the exercise in full by the underwriters of their option to purchase additional shares (the "July 2023 Shares"). The closing of the offering took place on August 1, 2023. All of the July 2023 Shares were sold by the Company. The offering price of the July 2023 Shares was $ 4.80 per share. Net proceeds from the sale and issuance of the July 2023 Shares were approximately $ 64.4 million, after deducting underwriting discounts and commissions and offering expenses. April 2022 Underwritten Offering On August 11, 2021, the Company filed a universal shelf registration statement on Form S-3, which was declared effective on August 23, 2021, (the "Registration Statement"). Under the Registration Statement, the Company may offer and sell up to $ 200.0 million of a variety of securities, including common stock, preferred stock, depositary shares, debt securities, warrants, subscription rights or units from time to time pursuant to one or more offerings at prices and terms to be determined at the time of the sale. On April 14, 2022, the Company entered into an underwriting agreement with Jefferies LLC and Cowen and Company, LLC, relating to an underwritten offering under the Registration Statement of 16,276,987 shares of the Company’s common stock (the "Shares") and, in lieu of common stock to certain investors, pre-funded warrants to purchase 3,523,013 shares of common stock. The closing of the offering took place on April 19, 2022. The offering price of the Shares was $ 3.69 per share and the offering price of the pre-funded warrants was $ 3.6899 per share underlying each pre-funded warrant. Warrants must be exercised by means of a cashless exercise. Net proceeds from the offering were approximately $ 68.3 million, after deducting underwriting discounts and commissions and offering expenses. On June 10, 2022, the Company and each holder of the pre-funded warrants entered into amended and restated pre-funded warrants solely to eliminate the seven-year expiration date of the pre-funded warrants. Each amended and restated pre-funded warrant is now exercisable for $ 0.0001 per share of common stock from the original date of issuance until the date the pre-funded warrant is exercised in full. All other terms of the pre-funded warrants remain unchanged. The pre-funded warrants contain standard adjustment provisions if certain corporate events were to happen. The pre-funded warrants are classified as a component of permanent equity and were recorded at the issuance date using a relative fair value allocation method. The pre-funded warrants are equity classified because they are freestanding financial instruments that are legally detachable and separately exercisable from the equity instruments, are immediately exercisable, do not embody an obligation for the Company to repurchase its shares, and permit the holders to receive a fixed number of shares of common stock upon exercise. In addition, such pre-funded warrants do not provide any guarantee of value or return. As of December 31, 2022, 197,251 pre-funded warrants had been exercised by means of cashless exercise in exchange for the issuance of 197,240 shares of the Company's common stock. As of December 31, 2023, the remaining 3,325,762 pre-funded warrants had been exercised by means of cashless exercise in exchange for the issuance of 3,325,644 shares of the Company's common stock. Open Market Sale Agreement In connection with the filing of the Registration Statement on August 11, 2021, the Company entered into an Open Market Sale Agreement with Jefferies LLC, as sales agent, pursuant to which the Company may offer and sell shares of its common stock with an aggregate offering price of up to $ 50.0 million under an “at-the-market” offering program. As of December 31, 2023 , the Company sold 3,553,995 shares of its common stock pursuant to the Open Market Sale Agreement for aggregate net proceeds of $ 21.2 million. Equity Incentive Plans In January 2017, the Company’s board of directors and stockholders adopted the 2017 Equity Incentive Plan, which was amended and restated in July 2017, (as so amended and restated, the “2017 Plan”), which provided for the grant of incentive stock options, non-statutory stock options, stock appreciation rights, restricted stock awards, restricted stock unit awards and other stock awards. The maximum number of shares of common stock that were authorized for issuance under the 2017 Plan was 2,730,496 . On July 17, 2020, the Company’s stockholders approved the 2020 Stock Incentive Plan (the “2020 Plan”), which became effective on July 23, 2020. The 2020 Plan provides for the grant of incentive stock options, non-statutory stock options, stock appreciation rights, restricted stock awards, restricted stock units, and other stock-based awards. The number of shares of the Company’s common stock reserved for issuance under the 2020 Plan was 1,588,315 shares, plus the 426,065 shares of common stock remaining available for issuance under the 2017 Plan as of July 23, 2020. The number of shares reserved under the 2020 Plan will be annually increased on each January 1 through January 1, 2030 by the lower of (i) 4 % of the number of shares of common stock outstanding on the first day of such fiscal year and (ii) an amount determined by the Company’s board of directors. As of the effective date of the 2020 Plan, no further awards will be made under the 2017 Plan. Any options or awards outstanding under the 2017 Plan are governed by their existing terms. The shares of the Company’s common stock subject to outstanding awards under the 2017 Plan that expire, terminate, or are otherwise surrendered, cancelled, forfeited, or repurchased by the Company at their original issuance price pursuant to a contractual repurchase right will be added back to the shares of common stock available for issuance under the 2020 Plan. No more than 1,588,315 shares of the Company’s common stock may be granted subject to incentive stock options under the 2020 Plan. On January 1, 2024 and 2023, the number of shares of common stock reserved under the 2020 Plan was increased by 2,470,750 shares and 1,615,774 shares, respectively. On February 27, 2023, the Company's board of directors adopted the 2023 Inducement Stock Incentive Plan (the "Inducement Plan"). The Inducement Plan provides for the grant of non-statutory stock options, stock appreciation rights, restricted stock awards, restricted stock units, and other stock-based awards to persons who (a) were not previously an employee or director or (b) are commencing employment with the Company following a bona fide period of non-employment, in either case, as an inducement material to such person ’s entry into employment with the Company and in accordance with the requirements of the Nasdaq Stock Market Rule 5635(c)(4). As of December 31, 2023, the maximum number of shares of the Company's common stock reserved for issuance under the Inducement Plan is 1,000,000 shares. For the years ended December 31, 2023 and 2022, the Company recognized stock-based compensation expense of $ 7.0 million and $ 7.7 million, respectively. The fair value of shares vested for the years ended December 31, 2023 and 2022 was $ 7.6 million and $ 9.0 million, respectively. Stock Options The following table summarizes stock option activity under the Company’s equity incentive plans since December 31, 2022: Options Weighted- Weighted- Aggregate (in years) (in thousands) Outstanding at December 31, 2022 4,687,811 $ 8.53 8.06 $ 18 Granted 3,019,590 4.53 Exercised ( 43,209 ) 2.70 Forfeited ( 627,526 ) 10.43 Outstanding at December 31, 2023 7,036,666 $ 6.68 7.71 $ 4,615 Exercisable at December 31, 2023 3,370,210 $ 8.05 6.37 $ 3,007 Vested and expected to vest at December 31, 2023 7,036,666 $ 6.68 7.71 $ 4,615 (1) The aggregate intrinsic value of stock 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 Company’s common stock. The weighted average grant date fair value of stock options granted in the years ended December 31, 2023 and 2022 was $ 3.47 per share and $ 3.45 per share, respectively. The aggregate intrinsic value of stock options exercised during the years ended December 31, 2023 and 2022 was $ 0.1 million and $ 0.5 million, respectively. The total unrecognized compensation cost related to outstanding employee option awards as of December 31, 2023 was $ 11.6 million and is expected to be recognized over a weighted average period of 2.8 years. For purposes of calculating stock-based compensation expense, the Company estimates the fair value of stock options using the Black-Scholes option-pricing model. This model incorporates various assumptions, including the expected volatility, expected term, and interest rates. The underlying assumptions used to value stock options granted to participants using the Black-Scholes option-pricing were as follows: Years Ended December 31, 2023 2022 Risk-free interest rate range 3.36 % to 4.67 % 1.59 % to 4.30 % Dividend yield 0 % 0 % Expected term of options (years) 5.5 to 6.48 5.08 to 6.48 Volatility rate range 87.26 % to 89.67 % 84.50 % to 87.15 % Expected Term – The expected term of stock options represents the weighted average period the stock options are expected to be outstanding. The Company uses the simplified method for estimating the expected term, which calculates the expected term as the average time-to-vesting and the contractual life of the options for stock options issued to participants. Expected Volatility – Due to the Company’s limited operating history and lack of company-specific historical or implied volatility, the expected volatility assumption was determined by examining the historical volatilities of a group of industry peers whose share prices are publicly available. The Company expects to continue using this approach until such time as it has adequate historical data regarding the volatility of its own traded stock price. Risk-Free Interest Rate – The risk-free rate assumption is based on U.S. Treasury instruments, the terms of which were consistent with the expected term of the Company’s stock options. Expected Dividend – The expected dividend assumption is based on the Company’s history and expectation of dividend payouts. The Company has not paid any dividends to date and does not intend to pay dividends. Fair Value of Common Stock – Following the Company's initial public offering, the fair value of the Company’s common stock has been determined based on the closing price of the Company’s common stock on the Nasdaq Global Select Market on the grant date, with consideration of whether there is material nonpublic information that could impact that estimated fair value when it is released. RSUs Activity related to restricted stock units ("RSUs") for the year ended December 31, 2023 is summarized in the table below: Number of Shares Outstanding as of January 1, 2023 — Granted 100,000 Canceled / Forfeited — Vested / Settled — Outstanding as of December 31, 2023 100,000 The weighted-average grant date fair value of RSUs granted in the year ended December 31, 2023 was $ 5.73 per share. The total unrecognized compensation cost related to outstanding RSUs as of December 31, 2023 was $ 0.5 million and is expected to be recognized over a weighted-average period of 3.2 years. Employee Stock Purchase Plan On July 17, 2020, the Company’s stockholders approved the 2020 Employee Stock Purchase Plan (the “ESPP”), which became effective on July 23, 2020. The ESPP initially provided participating employees with the opportunity to purchase up to an aggregate of 198,539 shares of the Company’s common stock. The number of shares of common stock reserved for issuance under the ESPP will increase each January 1 through January 1, 2031, in an amount equal to the lowest of (1) 397,079 shares of the Company’s common stock, (2) 1 % of the number of shares of the Company’s common stock outstanding on the first day of such fiscal year, and (3) an amount determined by the Company’s board of directors. On January 1, 2024 and 2023, the number of shares of common stock reserved under the ESPP was increased by 397,079 shares and 397,079 shares, respectively. The Company activated its first six month offering period under the ESPP on April 1, 2022. As of December 31, 2023, 116,972 shares have been purchased by employees under the ESPP. |
Income Taxes
Income Taxes | 12 Months Ended |
Dec. 31, 2023 | |
Income Tax Disclosure [Abstract] | |
Income Tax | 10. Income Taxes During the years ended December 31, 2023 and 2022, the Company recorded pre-tax net losses of $ 71.2 million and $ 67.1 million, respectively. Since it maintains a full valuation allowance on its deferred tax assets, the Company did no t record an income tax provision for the years ended December 31, 2023 and 2022. A reconciliation of the U.S. federal statutory income tax rate to the Company’s effective income tax rate is as follows: Year Ended December 31, 2023 2022 Federal income tax at statutory rate 21.0 % 21.0 % Permanent differences ( 1.0 ) ( 1.6 ) State income tax, net of federal benefit 8.1 5.4 Federal and state research and development tax credits 9.1 5.5 Valuation allowance ( 37.2 ) ( 30.3 ) Effective income tax rate — % — % Deferred taxes are recognized for temporary differences between the bases of assets and liabilities for financial statement and income tax purposes. The significant components of the Company’s deferred tax assets as of December 31, 2023 and 2022 are composed of the following (dollar amounts in thousands): December 31, 2023 2022 Deferred tax assets: Net operating losses $ 42,999 $ 36,144 Research and development credits 16,903 9,220 Stock options 1,930 1,604 Accrued expenses 916 758 Amortization 3,759 3,899 Lease liability 499 688 Capitalized research and experimental expenditures 21,959 10,467 Other 351 297 Gross deferred tax assets 89,316 63,077 Less: Valuation allowance ( 88,906 ) ( 62,468 ) Net deferred tax assets 410 609 Deferred tax liabilities: Depreciation of fixed assets ( 64 ) ( 184 ) Right of use assets ( 308 ) ( 422 ) Other ( 38 ) ( 3 ) Gross deferred tax liabilities ( 410 ) ( 609 ) Non-current net deferred tax assets (liabilities) — — As of December 31, 2023, the Company had gross federal net operating loss carryforwards ("NOLs") of $ 164.5 million, which may be available to offset future taxable income. Of the federal NOLs, $ 5.6 million expire in 2037 and $ 158.9 million do not expire. As of December 31, 2023, the Company had gross state NOLs of $ 135.6 million, which may be available to offset future taxable income and which begin to expire in 2037 . As required by FASB ASC Topic 740, Income Taxes , management of the Company has evaluated the positive and negative evidence bearing upon the realizability of its deferred tax assets, which are composed principally of capitalized research and experimental ("R&E") expenditures, NOLs, and research and development credits. Under the applicable accounting standards, management has considered the Company’s history of losses and concluded that it is more likely than not that the Company will not recognize the benefits of federal and state deferred tax assets. Accordingly, a full valuation allowance of $ 88.9 million and $ 62.5 million has been established at December 31, 2023 and December 31, 2022, respectively. The increase in the valuation allowance of $ 26.4 million during 2023 was primarily due to increases in capitalized R&E expenditures, NOLs, and research and development credits generated by the Company. The Company also has federal and state research and development credit carryforwards totaling $ 17.3 million as of December 31, 2023 . The federal research and development credit carryforwards will begin to expire in 2038 , unless previously utilized. The state research and development credit carryforwards will begin to expire in 2032 , unless previously utilized. The Company has generated research and development credits but has not conducted a study to document the qualified activity. This study may result in an adjustment to the Company’s research and development credit carryforwards; however, until a study is completed and any adjustment is known, no amounts are being presented as an uncertain tax position. A full valuation allowance has been provided against the Company’s research and development credits and, if an adjustment is required, this adjustment would be offset by an adjustment to the deferred tax asset established for the research and development credit carryforwards and the valuation allowance. Effective January 1, 2022, a provision of the Tax Cuts and Jobs Act ("TCJA") changed the treatment of R&E expenditures under Section 174 of the United States Internal Revenue Code (the "Internal Revenue Code"). Prior to the TCJA being effective, businesses have had the option of deducting Section 174 expenses in the year incurred or capitalizing and amortizing the costs over five years. The new TCJA provision, however, eliminates this option and requires Section 174 expenses associated with research conducted in the United States to be capitalized and amortized over a five-year period. For expenses associated with research outside of the United States, Section 174 expenses will be capitalized and amortized over a 15-year period. The Company’s ability to use its NOLs and tax credit carryforwards to offset taxable income is subject to restrictions under Sections 382 and 383 of the Internal Revenue Code. Under the Internal Revenue Code provisions, certain substantial changes in the Company’s ownership, including the sale of the Company or significant changes in ownership due to sales of equity, have limited and may limit in the future, the amount of NOLs which could be used annually to offset future taxable income. The Company has not yet conducted an analysis of ownership changes. The Company may also experience ownership changes in the future as a result of subsequent shifts in its stock ownership, some of which may be outside the Company’s control. As a result, the Company’s ability to use its pre-change NOLs to offset U.S. federal taxable income may be subject to limitations, which could potentially result in increased future tax liability to the Company. In addition, at the state level, there may be periods during which the use of NOLs is suspended or otherwise limited, which could accelerate or permanently increase state taxes owed. Under the TCJA, the use of federal NOLs arising in taxable years beginning after December 31, 2017 is limited to 80 % of current year taxable income and NOLs arising in taxable years ending after December 31, 2017 may not be carried back (though any such NOLs may be carried forward indefinitely). The Company establishes reserves for uncertain tax positions based on management’s assessment of exposures associated with tax positions taken on tax return filings. The tax reserves are analyzed periodically and adjustments are made as events occur that warrant adjustment to the reserves. The Company does not have any reserves for uncertain tax positions as of December 31, 2023 and any change in position would result in a change in the valuation allowance maintained against its net deferred tax assets. Interest and penalty charges, if any, related to unrecognized tax benefits are classified as income tax expense in the accompanying consolidated statements of operations and comprehensive loss. As of December 31, 2023 , the Company had no accrued interest related to uncertain tax positions. Since the Company is in a loss carryforward position, the Company is generally subject to examination by the U.S. federal, state, and local income tax authorities for all tax years in which a loss carryforward is available. |
Net Loss per Share
Net Loss per Share | 12 Months Ended |
Dec. 31, 2023 | |
Earnings Per Share [Abstract] | |
Net Loss per Share | 11. Net Loss per Share Net Loss per Share Attributable to Common Stockholders The following table sets forth the computation of basic and diluted net loss per share for the years ended December 31, 2023 and 2022 (in thousands, except share and per share amounts): Year Ended December 31, 2023 2022 Net loss attributable to common stockholders—basic and diluted $ ( 71,169 ) $ ( 67,061 ) Net loss per share attributable to common stockholders—basic and diluted $ ( 1.37 ) $ ( 1.78 ) Weighted-average common shares and pre-funded warrants outstanding—basic and diluted 51,839,131 37,763,168 The Company has generated a net loss in all periods presented; therefore, the basic and diluted net loss per share attributable to common stockholders are the same as the inclusion of the potentially dilutive securities would be anti-dilutive. Since the shares underlying the pre-funded warrants are issuable for nominal consideration, they are considered outstanding for both basic and diluted earnings per share from the date of issuance. The Company excluded the following potential dilutive securities, presented based on amounts outstanding at each period end, from the computation of diluted net loss per share attributable to common stockholders for the periods indicated: Year Ended December 31, 2023 2022 Options to purchase common stock 7,036,666 4,687,811 Unvested RSUs 100,000 — Total 7,136,666 4,687,811 |
Employee Benefit Plans
Employee Benefit Plans | 12 Months Ended |
Dec. 31, 2023 | |
Retirement Benefits [Abstract] | |
Employee Benefit Plans | 12. Employee Benefit Plans The Company established a defined contribution savings plan in 2018 for all eligible U.S. employees under Section 401(k) of the Internal Revenue Code. Employees can designate the investment of their 401(k) accounts into several mutual funds. Effective January 1, 2021, the Company implemented a matching policy under which the Company matches 50 % of an employee’s contributions to the 401(k) plan, up to a maximum of 6 % of the employee’s base salary and bonus paid during the year. For each of the years ended December 31, 2023 and 2022, the Company made employer contributions to the 401(k) plan of $ 0.3 million. |
Related Party Transactions
Related Party Transactions | 12 Months Ended |
Dec. 31, 2023 | |
Related Party Transactions [Abstract] | |
Related Party Transactions | 13. Related Party Transactions On May 6, 2021, the Company entered into an amended and restated consulting agreement (the “Consulting Agreement”) with Danforth Advisors, LLC (“Danforth”), pursuant to which Danforth, in addition to providing finance, accounting and administrative functions, provided interim chief financial officer services to the Company by Stephen J. DiPalma, Managing Director of Danforth. The Company paid Danforth an agreed upon hourly rate for such services and reimbursed Danforth for expenses. The Consulting Agreement could be terminated by the Company or Danforth with cause, upon 30 days prior written notice, and without cause, upon 60 days prior written notice. Mr. DiPalma ceased serving as the Company's interim chief financial officer on March 21, 2022 in connection with the appointment of Sanjay S. Subramanian as the Company's Chief Financial Officer ("CFO"). The Company incurred $ 0.4 million of expense for services provided by Danforth during the time Mr. DiPalma was the Company's interim CFO in 2022. In addition, on May 17, 2021, the Company granted Mr. DiPalma an option to purchase 15,000 shares of the Company’s common stock (the “Option”) under the Company’s 2020 Stock Incentive Plan at an exercise price of $ 15.90 . The shares underlying the Option vested in full in 2022. |
Summary of Significant Accoun_2
Summary of Significant Accounting Policies (Policies) | 12 Months Ended |
Dec. 31, 2023 | |
Accounting Policies [Abstract] | |
Basis of Presentation | Basis of Presentation The accompanying consolidated financial statements have been prepared in conformity with accounting principles generally accepted in the United States of America (“U.S. GAAP”). Any reference in these notes to applicable guidance is meant to refer to the authoritative U.S. GAAP as found in the Accounting Standards Codification (“ASC”) and Accounting Standards Update (“ASU”) of the Financial Accounting Standards Board (“FASB”). |
Principles of Consolidation | Principles of Consolidation The accompanying consolidated financial statements include the accounts of the Company and its wholly owned subsidiaries, Inozyme Securities Corp., which is a Massachusetts subsidiary created to buy, sell, and hold securities; Inozyme Ireland Limited; and Inozyme Pharma Switzerland GmbH. All intercompany transactions and balances have been eliminated. |
Use of Estimates | Use of Estimates The preparation of the Company’s financial statements 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. Estimates and judgments are based on historical information and other market-specific or various relevant assumptions, including, in certain circumstances, future projections that management believes to be reasonable under the circumstances. Actual results could differ materially from estimates. Significant estimates and assumptions are used for, but not limited to the accruals for research and development expenses. The Company evaluates its estimates and assumptions on an ongoing basis. All revisions to accounting estimates are recognized in the period in which the estimates are revised and in any future periods affected. |
Concentration of Credit Risk, Sigificant Suppliers, and Off-Balance Sheet Risk | Concentration of Credit Risk, Significant Suppliers, and Off-Balance Sheet Risk Financial instruments that potentially subject the Company to significant concentrations of credit risk consist primarily of cash, cash equivalents, and short-term investments and, from time to time, long-term investments. The Company maintains deposits in federally insured financial institutions in excess of federally insured limits and limits its exposure to credit risk by placing its cash with high credit quality financial institutions. The Company’s investments are composed of U.S. Treasury and U.S. government agency debt securities and commercial paper of corporations. The Company mitigates credit risk by maintaining a diversified portfolio and limiting the amount of investment exposure as to institution, maturity, and investment type. The Company is dependent on third-party manufacturers and contract research organizations ("CROs") to supply product candidates and provide services for research and development activities in its programs. In particular, the Company relies and expects to continue to rely on a small number of manufacturers to supply it with its requirements for the active pharmaceutical ingredients and formulated drugs related to these programs. The Company also relies on CROs to conduct its clinical trials. The Company’s programs could be adversely affected if a third-party manufacturer or a CRO is unable to successfully carry out their contractual obligations or meet expected deadlines. If a third-party manufacturer or a CRO needs to be replaced, the Company may not be able to complete its program development on its anticipated timelines and the Company may incur additional expenses as a result, which could be significant. The Company has no significant off-balance sheet risk such as foreign exchange contracts, option contracts, or other foreign hedging arrangements. |
Cash and Cash Equivalents | Cash and Cash Equivalents The Company considers all highly liquid investments with original maturities of three months or less at the date of purchase to be cash equivalents. Cash and cash equivalents include cash in readily available checking accounts, money market accounts, and certain marketable securities. Cash is carried at cost, which approximates its fair value. Cash equivalents are carried at fair market value. |
Restricted Cash | Restricted Cash Restricted cash is composed of amounts held to collateralize the letters of credit related to the Company’s lease arrangements. Restricted cash is classified as either current or non-current based on the terms of the underlying lease arrangement. |
Short-Term and Long-Term Investments | Short-Term and Long-Term Investments The Company classifies its investments as available-for-sale and records such assets at estimated fair value on the balance sheet, with unrealized gains and losses on marketable securities, if any, reported as a component of accumulated other comprehensive (loss) income. Realized gains and losses are calculated based on the specific-identification method and are recorded as a component of interest income. There have been no realized gains and losses for the years ended December 31, 2023 and 2022. The Company periodically reviews available-for-sale securities for other-than-temporary declines in fair value below the cost basis whenever events or changes in circumstances indicate the carrying amount of an asset may not be recoverable. Marketable securities with a maturity date of one year or less from the balance sheet date are classified by the Company as short-term investments. Marketable securities with a maturity date of greater than one year from the balance sheet date are classified as long-term investments and are available to fund operations as needed. As of December 31, 2023 , the Company did no t have any long-term investments. In accordance with the Company’s investment policy, at the time of purchase, the final maturity of each security within the portfolio shall not exceed 18 months and the weighted average maturity of the portfolio will be no greater than 12 months. |
Property and Equipment | Property and Equipment Property and equipment are stated at cost, less accumulated depreciation. Depreciation is calculated using the straight-line method over the estimated useful lives of the assets. Leasehold improvements are amortized over the shorter of the lease term or the estimated useful life of the related asset. The estimated useful lives of the Company’s property and equipment are as follows: Estimated Useful Life (In Years) Laboratory equipment and manufacturing equipment 5 Furniture and fixtures 5 Computer equipment 3 Leasehold improvements Lesser of asset life or lease term |
Impairment of Long-lived Assets | Impairment of Long-lived Assets As required under the applicable accounting guidance, the Company periodically reevaluates the original assumptions and rationale used in the establishment of the carrying value and estimated lives of all of its long-lived assets, including property and equipment. The Company reviews long-lived assets for impairment whenever events or changes in circumstances indicate that the carrying amount of the assets may not be recoverable. An impairment loss is recognized when the total of estimated future undiscounted cash flows, expected to result from the use of the asset and its eventual disposition, are less than its carrying amount. Impairment, if any, would be assessed using discounted cash flows or other appropriate measures of fair value. There were no impairments for the years ended December 31, 2023 and 2022 . |
Accrued Research and Development Costs | Accrued Research and Development Costs The Company records accrued liabilities for estimated costs of research and development activities conducted by service providers for sponsored research, preclinical studies, clinical operations, and contract manufacturing activities based upon the estimated amount of services provided but not yet invoiced and includes these costs in accrued expenses in the accompanying consolidated balance sheets and within research and development expense in the accompanying consolidated statements of operations and comprehensive loss. The Company accrues for these costs based on factors such as estimates of the work completed and in accordance with agreements established with service providers. The Company makes significant judgments and estimates in determining the accrued liabilities balance in each reporting period. As actual costs become known, the Company adjusts its accrued liabilities. The Company has not experienced any material differences between accrued costs and actual costs incurred since its inception. |
Research and Development Costs | Research and Development Costs Research and development costs are expensed as incurred. Research and development costs consist of direct and indirect internal costs related to specific projects as well as fees paid to other entities that conduct certain research and development activities on the Company’s behalf. |
Patent Costs | Patent Costs The Company expenses all costs as incurred in connection with patent applications, including direct application fees, and the legal and consulting expenses related to making such applications, and such costs are included in general and administrative expenses within the Company’s consolidated statements of operations and comprehensive loss. |
Stock-Based Compensation | Stock-Based Compensation Stock-based compensation expense represents the cost of the grant date fair value of employee and non-employee stock option grants recognized over the requisite service period of the awards on a straight-line basis. For service-based awards that are subject to graded vesting, the Company has elected to recognize compensation expense on a straight-line basis. The Company has elected to recognize forfeitures as they occur. |
IncomeTaxes | Income Taxes Income taxes have been accounted for using the asset and liability method. Under the asset and liability method, deferred tax assets and liabilities are recognized for the future tax consequences attributable to differences between the financial carrying amounts of existing assets and liabilities and their respective tax bases and operating loss and tax credit carryforwards. Deferred tax assets and liabilities are measured using enacted tax rates applicable to taxable income in the years in which those temporary differences are expected to be recovered or settled. The effect on deferred tax assets and liabilities of a change in tax rates is recognized in the period that includes the enactment date. A valuation allowance against deferred tax assets is recorded if, based upon the weight of all available evidence, it is more likely than not that some or all of the deferred tax assets will not be realized. The Company accounts for income taxes in accordance with authoritative accounting guidance which states the impact of an uncertain income tax position is recognized at the largest amount that is “more likely than not” to be sustained upon audit by the relevant taxing authority. There are no unrecognized tax benefits included in the Company’s consolidated balance sheets at December 31, 2023 or 2022 . The Company’s policy is to recognize interest and penalties related to income tax matters in income tax expense. The Company has no t recognized any interest or penalties in its consolidated statements of operations and comprehensive loss since inception. |
Leases | Leases The Company determines if an arrangement is a lease at contract inception based on the facts and circumstances present in the arrangement. If a lease is identified in an arrangement, the Company recognizes a right-of-use asset and liability on its balance sheet and determines whether the lease should be classified as a finance or operating lease. Short-term leases, or leases that have a lease term of 12 months or less at the commencement date are excluded from this treatment and are recognized on a straight-line basis over the term of the lease. Additionally, the Company does not separate lease and non-lease components for all leases. A lease qualifies as a finance lease if any of the following criteria are met at the inception of the lease: (i) there is a transfer of ownership of the leased asset to the Company by the end of the lease term, (ii) the Company holds an option to purchase the leased asset that it is reasonably certain to exercise, (iii) the lease term is for a major part of the remaining economic life of the leased asset, (iv) the present value of the sum of lease payments equals or exceeds substantially all of the fair value of the leased asset, (v) the nature of the leased asset is specialized to the point that it is expected to provide the lessor no alternative use at the end of the lease term. All other leases are recorded as operating leases. Finance and operating lease assets and liabilities are recognized at the lease commencement date based on the present value of the lease payments over the lease term using the discount rate implicit in the lease. If the rate implicit is not readily determinable, the Company utilizes an estimate of its incremental borrowing rate at the lease commencement date. Operating lease assets are further adjusted for prepaid or accrued lease payments. Operating lease payments are expensed using the straight-line method as an operating expense over the lease term. Finance lease assets are amortized to depreciation expense using the straight-line method over the shorter of the useful life of the related asset or the lease term. Finance lease payments are bifurcated into (i) a portion that is recorded as imputed interest expense and (ii) a portion that reduces the finance liability associated with the lease. The Company did no t have any finance leases recorded on its consolidated balance sheet as of December 31, 2023 and 2022 . |
Deferred Issuance Costs | Deferred Issuance Costs The Company capitalizes certain legal, professional accounting, and other third-party fees that are directly associated with in-process equity financings as deferred issuance costs until such financings are consummated. After consummation of such an equity financing, these costs are recorded as a reduction of the proceeds generated as a result of the offering. Should a planned equity financing be abandoned, the deferred issuance costs would be expensed immediately as a charge to operating expenses in the consolidated statements of operations and comprehensive loss. The Company did no t have any deferred issuance costs recorded at December 31, 2023 or December 31, 2022 . |
Net Loss Per Share | Net Loss Per Share Basic net loss per share attributable to common stockholders is computed by dividing the net loss attributable to common stockholders by the weighted-average number of shares of common stock and pre-funded warrants outstanding during the period, without consideration for potentially dilutive securities. Diluted net loss per share is computed by dividing the net loss attributable to common stockholders by the weighted-average number of shares of common stock and pre-funded warrants and potentially dilutive securities outstanding during the period determined using the treasury-stock and if-converted methods. The Company has generated a net loss in all periods presented; therefore, the basic and diluted net loss per share attributable to common stockholders are the same as the inclusion of the potentially dilutive securities would be anti-dilutive. |
Segments | Segments Operating segments are defined as components of an entity for which separate financial information is available and that is regularly reviewed by the Chief Operating Decision Maker (“CODM”) in deciding how to allocate resources to an individual segment and in assessing performance. The Company’s CODM is its Chief Executive Officer. The Company has determined it operates in a single operating segment and has one reportable segment. All long-lived assets of the Company reside in the United States. |
Comprehensive Loss | Comprehensive Loss The Company is required to report all components of comprehensive loss, including net loss, in the financial statements in the period in which they are recognized. Comprehensive loss is defined as the change in equity during a period from transactions and other events and circumstances from non-owner sources. Comprehensive loss consists of the Company’s net loss, unrealized gains and losses on the Company’s investments, and foreign currency translation adjustments and is presented within the consolidated statements of operations and comprehensive loss. |
Foreign Currency Transactions | Foreign Currency Transactions The Company maintains foreign bank accounts denominated in euros and Swiss francs and enters into transactions which are denominated in various currencies. Foreign currency transactions are initially recorded by the Company using the exchange rates prevailing at the date of the transaction. At the balance sheet date, recorded monetary balances denominated in foreign currencies are adjusted to U.S. dollars using the period-end rates of exchange. Exchange gains and losses arising from the translation of foreign currency items are included in other expense, net in the consolidated statements of operations and comprehensive loss. |
Fair Value Measurements | Fair Value Measurements The Company categorizes its assets and liabilities measured at fair value in accordance with the authoritative accounting guidance that establishes a consistent framework for measuring fair value, and expands disclosures for each major asset and liability category measured at fair value on either a recurring or nonrecurring basis. Fair value is defined as the 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 such, fair value is a market-based measurement that should be determined based on assumptions that market participants would use in pricing an asset or liability. As a basis for considering such assumptions, the guidance establishes a three-tier fair value hierarchy, which prioritizes the inputs used in measuring fair value as follows: • Level 1 – Unadjusted quoted prices in active markets that are accessible at the measurement date for identical assets or liabilities; • Level 2 – Quoted prices for similar assets and liabilities in active markets, quoted prices in markets that are not active, or inputs which are observable, either directly or indirectly, for substantially the full term of the asset or liability; or • Level 3 – Prices or valuation techniques that require inputs that are both significant to the fair value measurement and unobservable (i.e., supported by little or no market activity). |
Emerging Growth Company Status | Emerging Growth Company Status The Company is an “emerging growth company” (“EGC”) as defined in the Jumpstart Our Business Startups Act of 2012 (the “JOBS Act”), and the Company may take advantage of certain exemptions from various reporting requirements that are applicable to other public companies that are not EGCs. As an EGC, the Company can elect to take advantage of the extended transition period afforded by the JOBS Act for the implementation of new or revised accounting standards. The Company has elected to use the extended transition period for complying with new or revised accounting standards, and as a result of this election, the Company’s consolidated financial statements may not be comparable to companies that comply with public company FASB standards’ effective dates. The Company will remain an EGC until December 31, 2025, although if the market value of the Company’s common stock that is held by non-affiliates exceeds $ 700 million as of any June 30 before that time or if the Company has annual gross revenues of $ 1.235 billion or more in any fiscal year, the Company would cease to be an EGC as of December 31 of the applicable year. The Company would also cease to be an EGC if it issued more than $ 1 billion of non-convertible debt over a three-year period. |
Debt and Debt Issuance Costs | Debt and Debt Issuance Costs Debt issuance costs are presented on the consolidated balance sheet as a direct deduction from the related debt liability. Debt issuance costs represent legal and other direct costs incurred in connection with the Company’s term loan under the Loan Agreement. These costs are amortized as a non-cash component of interest expense using the effective interest method over the term of the loan. Any final payments are included in the cash flows to determine the effective interest rate and are recognized using the effective interest method over the term of the loan. |
Warrants | Warrants The Company determines the accounting classification of warrants that are issued, as either liability or equity, by first assessing whether the warrants meet liability classification in accordance with ASC 480-10, Accounting for Certain Financial Instruments with Characteristics of Both Liabilities and Equity , and then in accordance with ASC 815-40, Accounting for Derivative Financial Instruments Indexed to, and Potentially Settled in, a Company’s Own Stock . Under ASC 480-10, warrants are considered liability classified if the warrants are mandatorily redeemable, obligate the issuer to settle the warrants or the underlying shares by paying cash or other assets, or must or may require settlement by issuing variable number of shares. If warrants do not meet liability classification under ASC 480-10, the Company assesses the requirements under ASC 815-40, which states that contracts that require or may require the issuer to settle the contract for cash are liabilities recorded at fair value, irrespective of the likelihood of the transaction occurring that triggers the net cash settlement feature. If the warrants do not require liability classification under ASC 815-40, in order to conclude equity classification, the Company assesses whether the warrants are indexed to its common stock and whether the warrants are classified as equity under ASC 815-40 or other applicable U.S. GAAP. After all relevant assessments are made, the Company concludes whether the warrants are classified as liability or equity. Liability classified warrants are required to be accounted for at fair value both on the date of issuance and on subsequent accounting period ending dates, with all changes in fair value after the issuance date recorded in the statements of operations as a gain or loss. Equity classified warrants are accounted for at fair value on the issuance date with no changes in fair value recognized after the issuance date. |
Recently Issued and Adopted Accounting Standards | Recently Adopted Accounting Standard In June 2016, the FASB issued ASU No. 2016-13, Financial Instruments-Credit Losses (“Topic 326”): Measurement of Credit Losses on Financial Instruments. ASU 2016-13 and its subsequent related updates establish a new forward-looking “expected loss model” that requires entities to estimate current expected credit losses on accounts receivable and financial instruments by using all practical and relevant information. The Company adopted this standard effective January 1, 2023. There was no impact to the Company's financial statements upon adoption. |
Summary of Significant Accoun_3
Summary of Significant Accounting Policies (Tables) | 12 Months Ended |
Dec. 31, 2023 | |
Accounting Policies [Abstract] | |
Schedule of Estimated Useful Lives of Property and Equipment | The estimated useful lives of the Company’s property and equipment are as follows: Estimated Useful Life (In Years) Laboratory equipment and manufacturing equipment 5 Furniture and fixtures 5 Computer equipment 3 Leasehold improvements Lesser of asset life or lease term |
Balance Sheet Details (Tables)
Balance Sheet Details (Tables) | 12 Months Ended |
Dec. 31, 2023 | |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | |
Schedule of Short-Term Investments | Short-term investments consisted of the following (dollar amounts in thousands): December 31, 2023 Description Maturity Amortized Gross Gross Estimated U.S. Treasury securities 1 year or less $ 80,160 $ 59 $ ( 1 ) $ 80,218 U.S. government agency debt securities 1 year or less 73,774 17 ( 8 ) 73,783 $ 153,934 $ 76 $ ( 9 ) $ 154,001 December 31, 2022 Description Maturity Amortized Gross Gross Estimated Commercial paper 1 year or less $ 78,451 $ 4 $ ( 119 ) $ 78,336 U.S. Treasury securities 1 year or less 16,698 — ( 83 ) 16,615 $ 95,149 $ 4 $ ( 202 ) $ 94,951 |
Schedule of Prepaid Expenses and Other Current Assets | Prepaid expenses and other current assets consisted of the following (dollar amounts in thousands): At December 31, 2023 At December 31, 2022 Interest receivable $ 385 $ 115 Prepaid insurance 1,067 1,293 Prepaid research studies 5,339 1,397 Prepaid other 870 722 Total $ 7,661 $ 3,527 |
Schedule of Property and Equipment | Property and equipment consisted of the following (dollar amounts in thousands): At December 31, 2023 At December 31, 2022 Laboratory equipment and manufacturing equipment $ 947 $ 805 Furniture and fixtures 284 258 Computer equipment 491 558 Leasehold improvements 2,157 2,129 3,879 3,750 Less accumulated depreciation ( 2,413 ) ( 1,732 ) Total $ 1,466 $ 2,018 |
Schedule of Accrued Expenses | Accrued expenses consisted of the following (dollar amounts in thousands): At December 31, 2023 At December 31, 2022 Payroll and related liabilities $ 3,838 $ 3,229 Other professional fees 1,377 1,310 Clinical expenses 3,595 3,986 Research and development costs 2,917 2,345 Other 883 485 Total $ 12,610 $ 11,355 |
Fair Value Measurement (Tables)
Fair Value Measurement (Tables) | 12 Months Ended |
Dec. 31, 2023 | |
Fair Value Disclosures [Abstract] | |
Summary of Financial Assets Measured at Fair Value | The following tables represent the Company’s financial assets measured at fair value on a recurring basis and indicate the level of fair value hierarchy utilized to determine such fair values (in thousands): Fair Value Measurements at Reporting Date Description December 31, 2023 Quoted Significant Significant Assets: Money market funds (included in cash and cash $ 33,830 $ 33,830 $ — $ — U.S. government agency debt securities 73,783 — 73,783 — U.S. Treasury securities 80,218 80,218 — — Total assets $ 187,831 $ 114,048 $ 73,783 $ — Fair Value Measurements at Reporting Date Description December 31, Quoted Significant Significant Assets: Money market funds (included in cash and cash $ 26,587 $ 26,587 $ — $ — Commercial paper 78,336 — 78,336 — U.S. Treasury securities 16,615 16,615 — — Total assets $ 121,538 $ 43,202 $ 78,336 $ — |
Commitments and Contingencies (
Commitments and Contingencies (Tables) | 12 Months Ended |
Dec. 31, 2023 | |
Commitments and Contingencies Disclosure [Abstract] | |
Schedule of Future Lease Payments Under Non-Cancelable Leases | Future lease payments under non-cancelable leases as of December 31, 2023 are as follows (dollar amounts in thousands): Year Ending December 31, 2024 $ 1,016 2025 944 $ 1,960 |
Convertible Debt (Tables)
Convertible Debt (Tables) | 12 Months Ended |
Dec. 31, 2023 | |
Debt Disclosure [Abstract] | |
Summarizes of Impact of Term Loan | The following table summarizes the impact of the term loan on the Company’s consolidated balance sheet at December 31, 2023: December 31, 2023 (in thousands) Gross proceeds $ 45,000 Unamortized debt issuance costs ( 231 ) Carrying value $ 44,769 |
Future Principal Payment of Loan Agreement | Future principal payments, which include the Final Fee, in connection with the Loan Agreement as of December 31, 2023 are as follows (dollar amounts in thousands): Fiscal Year 2024 — 2025 14,508 2026 33,305 Total $ 47,813 |
Stockholders' Equity (Tables)
Stockholders' Equity (Tables) | 12 Months Ended |
Dec. 31, 2023 | |
Stockholders' Equity Note [Abstract] | |
Summary of Stock Option Activity Under Equity Incentive Plans | The following table summarizes stock option activity under the Company’s equity incentive plans since December 31, 2022: Options Weighted- Weighted- Aggregate (in years) (in thousands) Outstanding at December 31, 2022 4,687,811 $ 8.53 8.06 $ 18 Granted 3,019,590 4.53 Exercised ( 43,209 ) 2.70 Forfeited ( 627,526 ) 10.43 Outstanding at December 31, 2023 7,036,666 $ 6.68 7.71 $ 4,615 Exercisable at December 31, 2023 3,370,210 $ 8.05 6.37 $ 3,007 Vested and expected to vest at December 31, 2023 7,036,666 $ 6.68 7.71 $ 4,615 (1) The aggregate intrinsic value of stock 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 Company’s common stock. |
Summary of Assumptions Used to Value Stock Options Granted Using Black-Scholes Option-Pricing | The underlying assumptions used to value stock options granted to participants using the Black-Scholes option-pricing were as follows: Years Ended December 31, 2023 2022 Risk-free interest rate range 3.36 % to 4.67 % 1.59 % to 4.30 % Dividend yield 0 % 0 % Expected term of options (years) 5.5 to 6.48 5.08 to 6.48 Volatility rate range 87.26 % to 89.67 % 84.50 % to 87.15 % |
Summary of Activity Related to Restricted Stock Units ("RSUs") | Activity related to restricted stock units ("RSUs") for the year ended December 31, 2023 is summarized in the table below: Number of Shares Outstanding as of January 1, 2023 — Granted 100,000 Canceled / Forfeited — Vested / Settled — Outstanding as of December 31, 2023 100,000 |
Income Taxes (Tables)
Income Taxes (Tables) | 12 Months Ended |
Dec. 31, 2023 | |
Income Tax Disclosure [Abstract] | |
Schedule of Reconciliation of U.S. Federal Statutory Income Tax Rate to Effective Income Tax Rate | A reconciliation of the U.S. federal statutory income tax rate to the Company’s effective income tax rate is as follows: Year Ended December 31, 2023 2022 Federal income tax at statutory rate 21.0 % 21.0 % Permanent differences ( 1.0 ) ( 1.6 ) State income tax, net of federal benefit 8.1 5.4 Federal and state research and development tax credits 9.1 5.5 Valuation allowance ( 37.2 ) ( 30.3 ) Effective income tax rate — % — % |
Significant Components of Deferred Tax Assets | The significant components of the Company’s deferred tax assets as of December 31, 2023 and 2022 are composed of the following (dollar amounts in thousands): December 31, 2023 2022 Deferred tax assets: Net operating losses $ 42,999 $ 36,144 Research and development credits 16,903 9,220 Stock options 1,930 1,604 Accrued expenses 916 758 Amortization 3,759 3,899 Lease liability 499 688 Capitalized research and experimental expenditures 21,959 10,467 Other 351 297 Gross deferred tax assets 89,316 63,077 Less: Valuation allowance ( 88,906 ) ( 62,468 ) Net deferred tax assets 410 609 Deferred tax liabilities: Depreciation of fixed assets ( 64 ) ( 184 ) Right of use assets ( 308 ) ( 422 ) Other ( 38 ) ( 3 ) Gross deferred tax liabilities ( 410 ) ( 609 ) Non-current net deferred tax assets (liabilities) — — |
Net Loss per Share (Tables)
Net Loss per Share (Tables) | 12 Months Ended |
Dec. 31, 2023 | |
Earnings Per Share [Abstract] | |
Schedule of Net Loss Per Share, Basic and Diluted | The following table sets forth the computation of basic and diluted net loss per share for the years ended December 31, 2023 and 2022 (in thousands, except share and per share amounts): Year Ended December 31, 2023 2022 Net loss attributable to common stockholders—basic and diluted $ ( 71,169 ) $ ( 67,061 ) Net loss per share attributable to common stockholders—basic and diluted $ ( 1.37 ) $ ( 1.78 ) Weighted-average common shares and pre-funded warrants outstanding—basic and diluted 51,839,131 37,763,168 |
Schedule of Potential Dilutive Securities from Computation of Diluted Net Loss Per Share Attributable to Common Stockholders | The Company excluded the following potential dilutive securities, presented based on amounts outstanding at each period end, from the computation of diluted net loss per share attributable to common stockholders for the periods indicated: Year Ended December 31, 2023 2022 Options to purchase common stock 7,036,666 4,687,811 Unvested RSUs 100,000 — Total 7,136,666 4,687,811 |
Organization and Basis of Pre_2
Organization and Basis of Presentation - Additional Information (Details) $ in Thousands | 12 Months Ended | ||
Jul. 17, 2020 | Dec. 31, 2023 USD ($) | Dec. 31, 2022 USD ($) | |
Subsidiary, Sale of Stock [Line Items] | |||
Reverse stock split of common stock | 0.1338 | ||
Net proceeds issuance of common stock, deducting underwriting discounts and commissions | $ 85,647 | $ 56,137 | |
Net loss | 71,169 | 67,061 | |
Accumulated deficit | 285,930 | $ 214,761 | |
Cash and cash equivalents and short term investments | $ 188,600 |
Summary of Significant Accoun_4
Summary of Significant Accounting Policies - Additional Information (Details) $ in Thousands | 12 Months Ended | |||
Dec. 31, 2023 USD ($) Segment | Dec. 31, 2022 USD ($) | Dec. 31, 2021 USD ($) | Jun. 30, 2021 USD ($) | |
Off-balance sheet concentrations of credit risk description | The Company has no significant off-balance sheet risk such as foreign exchange contracts, option contracts, or other foreign hedging arrangements. | |||
Off-balance sheet concentrations of credit risk | $ 0 | |||
Realized gain and losses on investments as available-for-sale | 0 | $ 0 | ||
Impairments of long-lived assets | $ 0 | 0 | ||
Unrecognized tax benefits | 0 | $ 0 | ||
Number of operating segments | Segment | 1 | |||
Number of reportable segments | Segment | 1 | |||
Issuance period of non-convertible debt cease to be EGC | 3 years | |||
Long-term investments | $ 0 | |||
Debt securities held-to-maturity | 12 months | |||
Income tax penalties and interest expense | 0 | |||
Finance lease | 0 | $ 0 | ||
Deferred issuance costs | $ 0 | $ 0 | ||
Minimum | ||||
Market value of common stock held by non-affiliates cease to be EGC | $ 700,000 | |||
Annual gross revenues cease to be EGC | 1,235,000 | |||
Issuance of non-convertible debt cease to be EGC | $ 1,000,000 | |||
Maximum | ||||
Debt securities held-to-maturity | 18 months |
Summary of Significant Accoun_5
Summary of Significant Accounting Policies - Schedule of Estimated Useful Lives of Property and Equipment (Details) | Dec. 31, 2023 |
Laboratory Equipment and Manufacturing Equipment | |
Property, Plant and Equipment [Line Items] | |
Estimated Useful Life (In Years) | 5 years |
Furniture and Fixtures | |
Property, Plant and Equipment [Line Items] | |
Estimated Useful Life (In Years) | 5 years |
Computer Equipment and Software | |
Property, Plant and Equipment [Line Items] | |
Estimated Useful Life (In Years) | 3 years |
Leasehold Improvements | |
Property, Plant and Equipment [Line Items] | |
Property, Plant, and Equipment, Useful Life, Term, Description [Extensible Enumeration] | Property, Plant and Equipment, Net |
Recent Accounting Pronounceme_2
Recent Accounting Pronouncements - Additional Information (Details) - USD ($) $ in Thousands | 12 Months Ended | |||
Dec. 31, 2021 | Dec. 31, 2023 | Dec. 31, 2022 | Jan. 01, 2022 | |
New Accounting Pronouncements Or Change In Accounting Principle [Line Items] | ||||
Change in accounting principle, accounting standards update, adopted | true | |||
Right-of-use assets | $ 1,126 | $ 1,620 | ||
Operating lease liabilities | 700 | 900 | ||
Accumulated deficit | $ (285,930) | $ (214,761) | ||
Change in accounting principle, accounting standards update, immaterial effect | true | |||
Accounting Standards Update [Extensible Enumeration] | us-gaap:AccountingStandardsUpdate201912Member | |||
ASU 2016-02 | ||||
New Accounting Pronouncements Or Change In Accounting Principle [Line Items] | ||||
Change in accounting principle, accounting standards update, adopted | true |
Balance Sheet Details - Schedul
Balance Sheet Details - Schedule of Short-Term Investments (Details) - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2023 | Dec. 31, 2022 | |
Schedule Of Available For Sale Securities [Line Items] | ||
Amortized Costs | $ 153,934 | $ 95,149 |
Gross Unrealized Gains | 76 | 4 |
Gross Unrealized Losses | (9) | (202) |
Estimated Fair Value | $ 154,001 | $ 94,951 |
Commercial Paper | ||
Schedule Of Available For Sale Securities [Line Items] | ||
Maturity | 1 year or less | |
Amortized Costs | $ 78,451 | |
Gross Unrealized Gains | 4 | |
Gross Unrealized Losses | (119) | |
Estimated Fair Value | $ 78,336 | |
U.S. Treasury Securities | ||
Schedule Of Available For Sale Securities [Line Items] | ||
Maturity | 1 year or less | 1 year or less |
Amortized Costs | $ 80,160 | $ 16,698 |
Gross Unrealized Gains | 59 | 0 |
Gross Unrealized Losses | (1) | (83) |
Estimated Fair Value | $ 80,218 | $ 16,615 |
U.S. Government Agency Debt Securities | ||
Schedule Of Available For Sale Securities [Line Items] | ||
Maturity | 1 year or less | |
Amortized Costs | $ 73,774 | |
Gross Unrealized Gains | 17 | |
Gross Unrealized Losses | (8) | |
Estimated Fair Value | $ 73,783 |
Balance Sheet Details - Additio
Balance Sheet Details - Additional Information (Details) - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2023 | Dec. 31, 2022 | |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | ||
Long-term investments | $ 0 | |
Depreciation expense | $ 800 | $ 700 |
Balance Sheet Details - Sched_2
Balance Sheet Details - Schedule of Long-Term Investments (Details) - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2023 | Dec. 31, 2022 | |
Schedule Of Available For Sale Securities [Line Items] | ||
Amortized Costs | $ 153,934 | $ 95,149 |
Gross Unrealized Gains | 76 | 4 |
Gross Unrealized Losses | (9) | (202) |
Estimated Fair Value | $ 154,001 | $ 94,951 |
U.S. Treasury Securities | ||
Schedule Of Available For Sale Securities [Line Items] | ||
Maturity | 1 year or less | 1 year or less |
Amortized Costs | $ 80,160 | $ 16,698 |
Gross Unrealized Gains | 59 | 0 |
Gross Unrealized Losses | (1) | (83) |
Estimated Fair Value | $ 80,218 | $ 16,615 |
U.S. Government Agency Debt Securities | ||
Schedule Of Available For Sale Securities [Line Items] | ||
Maturity | 1 year or less | |
Amortized Costs | $ 73,774 | |
Gross Unrealized Gains | 17 | |
Gross Unrealized Losses | (8) | |
Estimated Fair Value | $ 73,783 |
Balance Sheet Details - Sched_3
Balance Sheet Details - Schedule of Prepaid Expenses and Other Current Assets (Details) - USD ($) $ in Thousands | Dec. 31, 2023 | Dec. 31, 2022 |
Deferred Costs, Capitalized, Prepaid, and Other Assets Disclosure [Abstract] | ||
Interest receivable | $ 385 | $ 115 |
Prepaid insurance | 1,067 | 1,293 |
Prepaid research studies | 5,339 | 1,397 |
Prepaid other | 870 | 722 |
Total | $ 7,661 | $ 3,527 |
Balance Sheet Details - Sched_4
Balance Sheet Details - Schedule of Noncurrent Prepaid Expenses (Details) - USD ($) $ in Thousands | Dec. 31, 2023 | Dec. 31, 2022 |
Payables and Accruals [Abstract] | ||
Prepaid expenses - noncurrent | $ 1,694 | $ 3,810 |
Balance Sheet Details - Sched_5
Balance Sheet Details - Schedule of Property and Equipment (Details) - USD ($) $ in Thousands | Dec. 31, 2023 | Dec. 31, 2022 |
Property Plant And Equipment [Line Items] | ||
Property and equipment, gross | $ 3,879 | $ 3,750 |
Less accumulated depreciation | (2,413) | (1,732) |
Total | 1,466 | 2,018 |
Laboratory Equipment and Manufacturing Equipment | ||
Property Plant And Equipment [Line Items] | ||
Property and equipment, gross | 947 | 805 |
Furniture and Fixtures | ||
Property Plant And Equipment [Line Items] | ||
Property and equipment, gross | 284 | 258 |
Computer Equipment and Software | ||
Property Plant And Equipment [Line Items] | ||
Property and equipment, gross | 491 | 558 |
Leasehold Improvements | ||
Property Plant And Equipment [Line Items] | ||
Property and equipment, gross | $ 2,157 | $ 2,129 |
Balance Sheet Details - Sched_6
Balance Sheet Details - Schedule of Accrued Expenses (Details) - USD ($) $ in Thousands | Dec. 31, 2023 | Dec. 31, 2022 |
Payables and Accruals [Abstract] | ||
Payroll and related liabilities | $ 3,838 | $ 3,229 |
Other professional fees | 1,377 | 1,310 |
Clinical expenses | 3,595 | 3,986 |
Research and development costs | 2,917 | 2,345 |
Other | 883 | 485 |
Total | $ 12,610 | $ 11,355 |
Fair Value Measurement - Summar
Fair Value Measurement - Summary of Financial Assets Measured at Fair Value (Details) - Recurring - USD ($) $ in Thousands | Dec. 31, 2023 | Dec. 31, 2022 |
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | ||
Assets fair value disclosure | $ 187,831 | $ 121,538 |
Money Market Funds | ||
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | ||
Cash and cash equivalents fair value disclosure | 33,830 | 26,587 |
Commercial Paper | ||
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | ||
Assets fair value disclosure | 78,336 | |
Quoted Prices in Active Markets for Identical Assets (Level 1) | ||
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | ||
Assets fair value disclosure | 114,048 | 43,202 |
Quoted Prices in Active Markets for Identical Assets (Level 1) | Money Market Funds | ||
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | ||
Cash and cash equivalents fair value disclosure | 33,830 | 26,587 |
Quoted Prices in Active Markets for Identical Assets (Level 1) | Commercial Paper | ||
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | ||
Assets fair value disclosure | 0 | |
Significant Other Observable Inputs (Level 2) | ||
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | ||
Assets fair value disclosure | 73,783 | 78,336 |
Significant Other Observable Inputs (Level 2) | Money Market Funds | ||
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | ||
Cash and cash equivalents fair value disclosure | 0 | 0 |
Significant Other Observable Inputs (Level 2) | Commercial Paper | ||
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | ||
Assets fair value disclosure | 78,336 | |
Significant Unobservable Inputs (Level 3) | ||
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | ||
Assets fair value disclosure | 0 | 0 |
Significant Unobservable Inputs (Level 3) | Money Market Funds | ||
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | ||
Cash and cash equivalents fair value disclosure | 0 | 0 |
Significant Unobservable Inputs (Level 3) | Commercial Paper | ||
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | ||
Assets fair value disclosure | 0 | |
U.S. Treasury Securities | ||
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | ||
Assets fair value disclosure | 80,218 | 16,615 |
U.S. Treasury Securities | Quoted Prices in Active Markets for Identical Assets (Level 1) | ||
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | ||
Assets fair value disclosure | 80,218 | 16,615 |
U.S. Treasury Securities | Significant Other Observable Inputs (Level 2) | ||
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | ||
Assets fair value disclosure | 0 | 0 |
U.S. Treasury Securities | Significant Unobservable Inputs (Level 3) | ||
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | ||
Assets fair value disclosure | 0 | $ 0 |
U.S. Government Agency Debt Securities | ||
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | ||
Assets fair value disclosure | 73,783 | |
U.S. Government Agency Debt Securities | Quoted Prices in Active Markets for Identical Assets (Level 1) | ||
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | ||
Assets fair value disclosure | 0 | |
U.S. Government Agency Debt Securities | Significant Other Observable Inputs (Level 2) | ||
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | ||
Assets fair value disclosure | 73,783 | |
U.S. Government Agency Debt Securities | Significant Unobservable Inputs (Level 3) | ||
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | ||
Assets fair value disclosure | $ 0 |
Fair Value Measurement - Additi
Fair Value Measurement - Additional Information (Details) - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2023 | Dec. 31, 2022 | |
Fair Value Disclosures [Abstract] | ||
Fair value measurement with unobservable inputs reconciliation recurring basis asset transfers into level 3 | $ 0 | $ 0 |
Fair value measurement with unobservable inputs reconciliation recurring basis asset transfers out of level 3 | $ 0 | $ 0 |
License and Sponsored Researc_2
License and Sponsored Research Agreements - Additional Information (Details) - USD ($) $ in Thousands | 1 Months Ended | 12 Months Ended | |||||
Feb. 28, 2019 | Dec. 31, 2023 | Dec. 31, 2022 | May 31, 2023 | Mar. 31, 2022 | Nov. 30, 2021 | Feb. 01, 2019 | |
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | |||||||
Research support funding amount | $ 3,000 | ||||||
Research support funding expiration year | 2021-12 | ||||||
Research and development expenses | $ 54,847 | $ 47,849 | |||||
Yale | |||||||
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | |||||||
Partial upfront consideration payment under license agreement | 100 | ||||||
Milestone payment upon achievement of certain milestones | 3,000 | $ 300 | $ 300 | ||||
Yale | Sponsored Research Agreement | |||||||
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | |||||||
Research support funding amount | $ 300 | $ 2,400 | |||||
Research support funding period | 5 years | ||||||
Research and development expenses | 100 | 100 | |||||
Yale | License | |||||||
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | |||||||
Maintenance fees | $ 100 | $ 100 |
Commitments and Contingencies -
Commitments and Contingencies - Additional Information (Details) | 12 Months Ended | ||
Dec. 31, 2023 USD ($) ft² | Dec. 31, 2022 USD ($) | Jan. 01, 2022 | |
Lessee Lease Description [Line Items] | |||
Change in accounting principle, accounting standards update, adopted | true | ||
Weighted average incremental borrowing rate for operating leases | 8% | ||
Weighted average remaining lease term for operating leases | 1 year 10 months 24 days | ||
Right-of-use assets | $ 1,126,000 | $ 1,620,000 | |
Operating lease liabilities | 700,000 | 900,000 | |
Operating lease expense | 900,000 | 700,000 | |
Costs related to legal proceedings | 0 | $ 0 | |
Restricted Cash | Letters of Credit | |||
Lessee Lease Description [Line Items] | |||
Security deposits | $ 300,000 | ||
Office Space | Boston, Massachusetts | |||
Lessee Lease Description [Line Items] | |||
Area of leased space | ft² | 8,499 | ||
Lessee operating lease expiration year | 2025 | ||
Lessee, Operating Lease, Existence of Option to Extend [true false] | true | ||
Lessee operating lease option to extend description | option to extend the term for five years. | ||
Operating lease renewal term | 5 years | ||
Laboratory Space | Boston, Massachusetts | |||
Lessee Lease Description [Line Items] | |||
Area of leased space | ft² | 6,244 | ||
Lessee operating lease expiration year | 2025 | ||
Lessee, Operating Lease, Existence of Option to Extend [true false] | true | ||
Lessee operating lease option to extend description | option to extend the term for five years. | ||
Operating lease renewal term | 5 years | ||
ASU 2016-02 | |||
Lessee Lease Description [Line Items] | |||
Change in accounting principle, accounting standards update, adopted | true |
Commitments and Contingencies_2
Commitments and Contingencies - Schedule of Future Lease Payments Under Non-Cancelable Leases (Details) $ in Thousands | Dec. 31, 2023 USD ($) |
Commitments and Contingencies Disclosure [Abstract] | |
2024 | $ 1,016 |
2025 | 944 |
Operating lease liability, Total | $ 1,960 |
Convertible Debt (Additional In
Convertible Debt (Additional Information) (Details) - USD ($) $ / shares in Units, $ in Thousands | 12 Months Ended | |||
Jul. 25, 2022 | Dec. 31, 2023 | Jun. 30, 2023 | Dec. 31, 2022 | |
Debt Instrument [Line Items] | ||||
Long term debt, net | $ 44,769 | $ 4,139 | ||
Additional facility fee | 5% | |||
Payment description for debt | the Company is obligated to make interest only payments for the first 36 months and then interest and equal principal payments through the maturity date. The term loan bears a variable interest rate equal to the greater of (i) 7.85%, and (ii) the sum of (A) the prime rate last quoted in The Wall Street Journal (or a comparable replacement rate if The Wall Street Journal ceases to quote such rate) and (B) 3.85%; provided that the interest rate cannot exceed 9.60% | |||
Annual rate of interest for the debt | 7.85 | 9.60 | ||
Additional Interest rate for debt instrument | 3.85% | |||
Prepayment of loans | 6.25% | |||
Term Loan | ||||
Debt Instrument [Line Items] | ||||
Debt issuance cost | $ 500 | |||
Lenders facility fee | 400 | |||
Lenders reimbursed amount | $ 100 | |||
Tranche Two | ||||
Debt Instrument [Line Items] | ||||
Prepayment fee percentage | 2% | |||
Tranche Four | ||||
Debt Instrument [Line Items] | ||||
Prepayment fee percentage | 1% | |||
K2HV | ||||
Debt Instrument [Line Items] | ||||
Long term debt, net | $ 70,000 | $ 25,000 | ||
Loan maturity date | Aug. 01, 2026 | |||
Debt instrument conversion price | $ 6.21 | |||
Customary percentage | 9.99% | |||
Beneficial ownership limitation percentage | 19.99% | |||
K2HV | Maximum | ||||
Debt Instrument [Line Items] | ||||
Debt instrument, amount converted to common stock upon lender's choice | $ 5,000 | |||
Future offerings of common stock | 5,000 | |||
K2HV | Tranche One | ||||
Debt Instrument [Line Items] | ||||
Long term debt, net | 5,000 | |||
Additional loan amount | $ 20,000 | |||
Prepayment fee percentage | 3% | |||
K2HV | Tranche Two | ||||
Debt Instrument [Line Items] | ||||
Long term debt, net | $ 20,000 | $ 7,500 | $ 12,500 | |
K2HV | Tranche Four | ||||
Debt Instrument [Line Items] | ||||
Long term debt, net | $ 25,000 | |||
Additional facility fee | 0.75% |
Convertible Debt - Summarizes o
Convertible Debt - Summarizes of Impact of Term Loan (Details) - USD ($) $ in Thousands | Dec. 31, 2023 | Dec. 31, 2022 |
Debt Disclosure [Abstract] | ||
Gross proceeds | $ 45,000 | |
Unamortized debt issuance costs | (231) | |
Carrying value | $ 44,769 | $ 4,139 |
Convertible Debt - Future Princ
Convertible Debt - Future Principal Payment (Details) - USD ($) $ in Thousands | Dec. 31, 2023 | Dec. 31, 2022 |
Debt Instrument [Line Items] | ||
Total | $ 44,769 | $ 4,139 |
K2 Loan Agreement [Member] | ||
Debt Instrument [Line Items] | ||
2024 | 0 | |
2025 | 14,508 | |
2026 | 33,305 | |
Total | $ 47,813 |
Stockholders' Equity - Addition
Stockholders' Equity - Additional Information (Details) - USD ($) $ / shares in Units, $ in Millions | 12 Months Ended | |||||||||||
Jul. 27, 2023 | Apr. 14, 2022 | May 17, 2021 | Jul. 23, 2020 | Dec. 31, 2023 | Dec. 31, 2022 | Jan. 01, 2024 | Jan. 01, 2023 | Jun. 10, 2022 | Aug. 11, 2021 | Jul. 31, 2020 | Jul. 17, 2020 | |
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||||||||||||
Additional shares issued | 1,875,000 | |||||||||||
Pre-funded warrant exercisable price | $ 0.0001 | |||||||||||
Common stock, shares issued | 61,768,771 | 40,394,363 | ||||||||||
Preferred stock, shares outstanding | 0 | 0 | ||||||||||
Common stock, shares authorized | 200,000,000 | 200,000,000 | ||||||||||
Preferred stock, shares authorized | 5,000,000 | 5,000,000 | ||||||||||
Plan description | On July 17, 2020, the Company’s stockholders approved the 2020 Stock Incentive Plan (the “2020 Plan”), which became effective on July 23, 2020. The 2020 Plan provides for the grant of incentive stock options, non-statutory stock options, stock appreciation rights, restricted stock awards, restricted stock units, and other stock-based awards. The number of shares of the Company’s common stock reserved for issuance under the 2020 Plan | |||||||||||
Granted | 15,000 | 3,019,590 | ||||||||||
Weighted-average exercise price of options granted | $ 15.9 | $ 4.53 | ||||||||||
Total unrecognized compensation cost related to outstanding employee awards | $ 11.6 | |||||||||||
Total unrecognized compensation cost related to outstanding employee awards, expected to be recognized over a weighted-average period | 2 years 9 months 18 days | |||||||||||
Share based compensation options to purchase number of common stock | 7,036,666 | 4,687,811 | ||||||||||
Fair value of shares vested | $ 7.6 | $ 9 | ||||||||||
Stock-based compensation expense | $ 7 | $ 7.7 | ||||||||||
2020 Stock Incentive Plan | ||||||||||||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||||||||||||
Common stock reserved for issuance | 1,588,315 | 1,615,774 | ||||||||||
Number of common stock reserved for issuance increase percentage on stock outstanding | 4% | |||||||||||
2020 Stock Incentive Plan | Subsequent Event | ||||||||||||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||||||||||||
Common stock reserved for issuance | 2,470,750 | |||||||||||
2017 Stock Incentive Plan | ||||||||||||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||||||||||||
Common stock reserved for issuance | 426,065 | |||||||||||
2017 Equity Incentive Plan | ||||||||||||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||||||||||||
Number of shares authorized for issuance | 2,730,496 | |||||||||||
Number of awards available for issuance | 0 | |||||||||||
2020 Employee Stock Purchase Plan | ||||||||||||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||||||||||||
Common stock reserved for issuance | 116,972 | 397,079 | ||||||||||
Number of common stock reserved for issuance increase percentage on stock outstanding | 1% | |||||||||||
Plan description | The number of shares of common stock reserved for issuance under the ESPP will increase each January 1 through January 1, 2031, in an amount equal to the lowest of (1) 397,079 shares of the Company’s common stock, (2) 1% of the number of shares of the Company’s common stock outstanding on the first day of such fiscal year, and (3) an amount determined by the Company’s board of directors. | |||||||||||
Share based compensation options to purchase number of common stock | 198,539 | |||||||||||
Increase in additional number of shares to be issued | 397,079 | |||||||||||
2020 Employee Stock Purchase Plan | Subsequent Event | ||||||||||||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||||||||||||
Common stock reserved for issuance | 397,079 | |||||||||||
Inducement Plan | ||||||||||||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||||||||||||
Common stock reserved for issuance | 1,000,000 | |||||||||||
Employee Stock Option | ||||||||||||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||||||||||||
Weighted-average grant date fair value of options granted | $ 3.47 | $ 3.45 | ||||||||||
Aggregate intrinsic value of stock options exercised | $ 0.1 | $ 0.5 | ||||||||||
RSUs | ||||||||||||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||||||||||||
Granted | 100,000 | |||||||||||
Weighted-average grant date fair value of options granted | $ 5.73 | |||||||||||
Total unrecognized compensation cost related to outstanding employee awards | $ 0.5 | |||||||||||
Employee Service ShareBased Compensation Nonvested Awards Total Compensation Cost Not Yet Recognized Period ForRecognition 2 | 3 years 2 months 12 days | |||||||||||
Share based compensation options to purchase number of common stock | 100,000 | 0 | ||||||||||
Pre-funded Warrants | ||||||||||||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||||||||||||
Pre-funded warrant exercisable price | $ 3,325,762 | $ 197,251 | ||||||||||
Number of shares authorized for issuance | 3,325,644 | 197,240 | ||||||||||
Bofa Securities Inc | ||||||||||||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||||||||||||
Offering price | $ 4.8 | |||||||||||
Net proceeds from the offering | $ 64.4 | |||||||||||
Bofa Securities Inc | Underwriting Agreement | ||||||||||||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||||||||||||
Initial public offering, net of issuance costs, shares | 14,375,000 | |||||||||||
Jefferies LLC | ||||||||||||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||||||||||||
Underwritten offering | 16,276,987 | |||||||||||
Offering price | $ 3.69 | |||||||||||
Net proceeds from the offering | $ 68.3 | |||||||||||
Sale of Stock, Number of Shares Issued in Transaction | 3,553,995 | |||||||||||
Proceeds from Issuance or Sale of Equity, Total | $ 21.2 | |||||||||||
Jefferies LLC | Maximum | ||||||||||||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||||||||||||
Offer and sell | $ 200 | |||||||||||
Aggregate offering price | $ 50 | |||||||||||
Jefferies LLC | Pre-funded Warrants | ||||||||||||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||||||||||||
Class of warrant purchases | 3,523,013 | |||||||||||
Offering price | $ 3.6899 |
Stockholders' Equity - Summary
Stockholders' Equity - Summary of Stock Option Activity Under Equity Incentive Plans (Details) - USD ($) $ / shares in Units, $ in Thousands | 12 Months Ended | |||
May 17, 2021 | Dec. 31, 2023 | Dec. 31, 2022 | ||
Stockholders' Equity Note [Abstract] | ||||
Options Outstanding, Beginning Balance | 4,687,811 | |||
Options Outstanding, Granted | 15,000 | 3,019,590 | ||
Options Outstanding, Exercised | (43,209) | |||
Options Outstanding, Forfeited | (627,526) | |||
Options Outstanding, Ending Balance | 7,036,666 | 4,687,811 | ||
Options Outstanding, Exercisable | 3,370,210 | |||
Options Outstanding, Vested and expected to vest | 7,036,666 | |||
Weighted Average Exercise Price, Outstanding, Beginning Balance | $ 8.53 | |||
Weighted Average Exercise Price, Granted | $ 15.9 | 4.53 | ||
Weighted Average Exercise Price, Exercised | 2.7 | |||
Weighted Average Exercise Price, Forfeited | 10.43 | |||
Weighted Average Exercise Price, Outstanding, Ending Balance | 6.68 | $ 8.53 | ||
Weighted Average Exercise Price, Exercisable | 8.05 | |||
Weighted Average Exercise Price, Vested and expected to vest | $ 6.68 | |||
Weighted Average Remaining Contractual Term (in years), Outstanding | 7 years 8 months 15 days | 8 years 21 days | ||
Weighted Average Remaining Contractual Term (in years), Exercisable | 6 years 4 months 13 days | |||
Weighted Average Remaining Contractual Term (in years), Vested and expected to vest | 7 years 8 months 15 days | |||
Aggregate Intrinsic Value, Outstanding | [1] | $ 4,615 | $ 18 | |
Aggregate Intrinsic Value, Exercisable | [1] | 3,007 | ||
Aggregate Intrinsic Value, Vested and expected to vest | [1] | $ 4,615 | ||
[1] The aggregate intrinsic value of stock 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 Company’s common stock. |
Stockholders' Equity - Summar_2
Stockholders' Equity - Summary of Assumptions Used to Value Stock Options Granted to Employees using Black-Scholes Option-Pricing (Details) | 12 Months Ended | |
Dec. 31, 2023 | Dec. 31, 2022 | |
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||
Risk-free interest rate range, minimum | 3.36% | 1.59% |
Risk-free interest rate range, maximum | 4.67% | 4.30% |
Dividend yield | 0% | 0% |
Volatility rate range, minimum | 87.26% | 84.50% |
Volatility rate range, maximum | 89.67% | 87.15% |
Minimum | ||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||
Expected term of options (years) | 5 years 6 months | 5 years 29 days |
Maximum | ||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||
Expected term of options (years) | 6 years 5 months 23 days | 6 years 5 months 23 days |
Stockholders' Equity - Summar_3
Stockholders' Equity - Summary of Activity related to restricted stock units ("RSUs") (Details) - shares | 12 Months Ended | |
May 17, 2021 | Dec. 31, 2023 | |
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] | ||
Options Outstanding, Beginning Balance | 4,687,811 | |
Granted | 15,000 | 3,019,590 |
Canceled / Forfeited | 627,526 | |
Options Outstanding, Ending Balance | 7,036,666 | |
RSUs | ||
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] | ||
Options Outstanding, Beginning Balance | 0 | |
Granted | 100,000 | |
Canceled / Forfeited | 0 | |
Vested / Settled | 0 | |
Options Outstanding, Ending Balance | 100,000 |
Stockholders' Equity - Summar_4
Stockholders' Equity - Summary of Total Compensation Cost Recognized in Statements of Operations (Details) - USD ($) $ in Millions | 12 Months Ended | |
Dec. 31, 2023 | Dec. 31, 2022 | |
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||
Total | $ 7 | $ 7.7 |
Income Taxes - Additional Infor
Income Taxes - Additional Information (Details) - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2023 | Dec. 31, 2022 | Mar. 27, 2020 | |
Operating Loss Carryforwards [Line Items] | |||
Net loss | $ 71,169 | $ 67,061 | |
Income tax benefit | 0 | 0 | |
Deferred tax assets, valuation allowance | 88,906 | $ 62,468 | |
Deferred tax assets, increase in valuation allowance | 26,400 | ||
Tax cuts and jobs act federal net operating loss | 80% | ||
Federal | |||
Operating Loss Carryforwards [Line Items] | |||
Gross operating loss carryforwards | 164,500 | ||
Operating loss carryforwards with expiration period | 5,600 | ||
Operating loss carryforwards with no expiration period | $ 158,900 | ||
Operating loss carryforwards expiration year | 2037 | ||
Federal | Research and Development | |||
Operating Loss Carryforwards [Line Items] | |||
Credit carryforward, expiration year | 2038 | ||
State | |||
Operating Loss Carryforwards [Line Items] | |||
Gross operating loss carryforwards | $ 135,600 | ||
Operating loss carryforwards expiration year | 2037 | ||
State | Research and Development | |||
Operating Loss Carryforwards [Line Items] | |||
Credit carryforward, expiration year | 2032 | ||
Federal and State | Research and Development | |||
Operating Loss Carryforwards [Line Items] | |||
Credit carryforwards | $ 17,300 |
Income Taxes - Schedule of Reco
Income Taxes - Schedule of Reconciliation of U.S. Federal Statutory Income Tax Rate to Effective Inc (Details) | 12 Months Ended | |
Dec. 31, 2023 | Dec. 31, 2022 | |
Income Tax Disclosure [Abstract] | ||
Federal income tax at statutory rate | 21% | 21% |
Permanent differences | (1.00%) | (1.60%) |
State income tax, net of federal benefit | 8.10% | 5.40% |
Federal and state research and development tax credits | 9.10% | 5.50% |
Valuation allowance | (37.20%) | (30.30%) |
Effective income tax rate | 0% | 0% |
Income Taxes - Significant Comp
Income Taxes - Significant Components of Deferred Tax Assets (Details) - USD ($) $ in Thousands | Dec. 31, 2023 | Dec. 31, 2022 |
Deferred tax assets: | ||
Net operating losses | $ 42,999 | $ 36,144 |
Research and development credits | 16,903 | 9,220 |
Stock options | 1,930 | 1,604 |
Accrued expenses | 916 | 758 |
Amortization | 3,759 | 3,899 |
Lease liability | 499 | 688 |
Capitalized research and experimental expenditures | 21,959 | 10,467 |
Other | 351 | 297 |
Gross deferred tax assets | 89,316 | 63,077 |
Less: Valuation allowance | (88,906) | (62,468) |
Net deferred tax assets | 410 | 609 |
Deferred tax liabilities: | ||
Depreciation of fixed assets | (64) | (184) |
Right of use assets | (308) | (422) |
Others | (38) | (3) |
Gross deferred tax liabilities | (410) | (609) |
Non-current net deferred tax assets (liabilities) | $ 0 | $ 0 |
Net Loss per Share - Schedule o
Net Loss per Share - Schedule of Net Loss Per Share, Basic and Diluted (Details) - USD ($) $ / shares in Units, $ in Thousands | 12 Months Ended | |
Dec. 31, 2023 | Dec. 31, 2022 | |
Earnings Per Share [Abstract] | ||
Net Income (Loss) | $ (71,169) | $ (67,061) |
Net loss per share attributable to common stockholders- basic | $ (1.37) | $ (1.78) |
Net loss per share attributable to common stockholders- diluted | $ (1.37) | $ (1.78) |
Weighted-average common shares and pre-funded warrants outstanding - basic | 51,839,131 | 37,763,168 |
Weighted-average common shares and pre-funded warrants outstanding - diluted | 51,839,131 | 37,763,168 |
Net Loss per Share - Schedule_2
Net Loss per Share - Schedule of Potential Dilutive Securities from Computation of Diluted Net Loss Per Share Attributable to Common Stockholders (Details) - shares | 12 Months Ended | ||
Dec. 31, 2023 | Dec. 31, 2022 | Dec. 31, 2021 | |
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | |||
Antidilutive shares excluded from computation of earnings per share | 7,136,666 | 4,687,811 | |
Employee Stock Option | |||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | |||
Antidilutive shares excluded from computation of earnings per share | 7,036,666 | 4,687,811 | |
Unvested RSUs | |||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | |||
Antidilutive shares excluded from computation of earnings per share | 100,000 | 0 |
Employee Benefit Plans - Additi
Employee Benefit Plans - Additional Information (Details) - USD ($) $ in Millions | 12 Months Ended | ||
Jan. 01, 2021 | Dec. 31, 2023 | Dec. 31, 2022 | |
Defined Contribution Plan Disclosure [Line Items] | |||
Employer matching contribution, percentage of match | 50% | ||
Employer contribution amount | $ 0.3 | $ 0.3 | |
Maximum | |||
Defined Contribution Plan Disclosure [Line Items] | |||
Employer matching contribution, percentage of employees base salary and bonus paid | 6% |
Related Party Transactions (Add
Related Party Transactions (Additional Information) (Details) - USD ($) $ / shares in Units, $ in Millions | 12 Months Ended | ||
May 17, 2021 | May 06, 2021 | Dec. 31, 2023 | |
Related Party Transaction [Line Items] | |||
Management Fee Expense | $ 0.4 | ||
Options Outstanding, Granted | 15,000 | 3,019,590 | |
Weighted Average Exercise Price, Granted | $ 15.9 | $ 4.53 | |
30 Days prior written notice | |||
Related Party Transaction [Line Items] | |||
Fair Value, Investments, Entities that Calculate Net Asset Value Per Share, Investment Redemption, Notice Period | 30 days | ||
60 Days prior written notice | |||
Related Party Transaction [Line Items] | |||
Fair Value, Investments, Entities that Calculate Net Asset Value Per Share, Investment Redemption, Notice Period | 60 days |