Document and Entity Information
Document and Entity Information - shares | 3 Months Ended | |
Mar. 31, 2024 | May 09, 2024 | |
Cover [Abstract] | ||
Document Type | 10-Q | |
Amendment Flag | false | |
Document Period End Date | Mar. 31, 2024 | |
Document Fiscal Period Focus | Q1 | |
Document Fiscal Year Focus | 2024 | |
Current Fiscal Year End Date | --12-31 | |
Entity Registrant Name | IO Biotech, Inc. | |
Entity Central Index Key | 0001865494 | |
Entity File Number | 001-41008 | |
Entity Tax Identification Number | 87-0909276 | |
Entity Incorporation, State or Country Code | DE | |
Entity Address, Address Line One | Ole Maaløes Vej 3 | |
Entity Address, City or Town | Copenhagen N | |
Entity Address, Country | DK | |
Entity Address, Postal Zip Code | DK-2200 | |
City Area Code | +45 | |
Local Phone Number | 7070 2980 | |
Title of each class | Common Stock, par value $0.001 per share | |
Trading Symbol(s) | IOBT | |
Name of each exchange on which registered | NASDAQ | |
Entity Current Reporting Status | Yes | |
Entity Interactive Data Current | Yes | |
Entity Filer Category | Non-accelerated Filer | |
Entity Small Business | true | |
Entity Emerging Growth Company | true | |
Entity Ex Transition Period | false | |
Entity Shell Company | false | |
Entity Common Stock, Shares Outstanding | 65,880,914 | |
Document Quarterly Report | true | |
Document Transition Report | false |
Consolidated Balance Sheets (Un
Consolidated Balance Sheets (Unaudited) - USD ($) $ in Thousands | Mar. 31, 2024 | Dec. 31, 2023 |
Current assets | ||
Cash and cash equivalents | $ 117,982 | $ 143,193 |
Prepaid expenses and other current assets | 6,146 | 4,062 |
Total current assets | 124,128 | 147,255 |
Restricted cash | 268 | 268 |
Property and equipment, net | 788 | 847 |
Right of use lease asset | 2,092 | 2,259 |
Other non-current assets | 883 | 89 |
Total non-current assets | 4,031 | 3,463 |
Total assets | 128,159 | 150,718 |
Current liabilities | ||
Accounts payable | 3,840 | 3,878 |
Lease liability - current | 666 | 655 |
Accrued expenses and other current liabilities | 6,537 | 11,184 |
Total current liabilities | 11,043 | 15,717 |
Lease liability - noncurrent | 1,650 | 1,839 |
Total non-current liabilities | 1,650 | 1,839 |
Total liabilities | 12,693 | 17,556 |
Commitments and contingencies (Note 9) | ||
Stockholders' equity | ||
Preferred stock, par value of $0.001 per share; 5,000,000 shares authorized, no shares issued and outstanding as of March 31, 2024 and December 31, 2023 | ||
Common stock, par value of $0.001 per share; 300,000,000 shares authorized at March 31, 2024 and December 31, 2023; 65,880,914 shares issued and outstanding as of March 31, 2024 and December 31, 2023, respectively | 66 | 66 |
Additional paid-in capital | 408,154 | 406,587 |
Accumulated deficit | (283,279) | (263,822) |
Accumulated other comprehensive loss | (9,475) | (9,669) |
Total stockholders' equity | 115,466 | 133,162 |
Total liabilities and stockholders' equity | $ 128,159 | $ 150,718 |
Consolidated Balance Sheets (_2
Consolidated Balance Sheets (Unaudited) (Parenthetical) - $ / shares | Mar. 31, 2024 | Dec. 31, 2023 |
Preferred stock, par value | $ 0.001 | $ 0.001 |
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 | $ 0.001 | $ 0.001 |
Common stock, shares authorized | 300,000,000 | 300,000,000 |
Common stock, shares issued | 65,880,914 | 65,880,914 |
Common stock, shares outstanding | 65,880,914 | 65,880,914 |
Consolidated Statements of Oper
Consolidated Statements of Operations and Comprehensive Loss (Unaudited) - USD ($) $ in Thousands | 3 Months Ended | |
Mar. 31, 2024 | Mar. 31, 2023 | |
Operating expenses | ||
Research and development | $ 14,311 | $ 11,900 |
General and administrative | 5,886 | 6,024 |
Total operating expenses | 20,197 | 17,924 |
Loss from operations | (20,197) | (17,924) |
Other income (expense) | ||
Currency exchange (loss) gain, net | (462) | 258 |
Interest income | 1,617 | 1,028 |
Total other income | 1,155 | 1,286 |
Loss before income tax expense | (19,042) | (16,638) |
Income tax expense | 415 | 406 |
Net loss | (19,457) | (17,044) |
Net loss attributable to common shareholders | $ (19,457) | $ (17,044) |
Net loss per common share, basic | $ (0.3) | $ (0.59) |
Net loss per common share, diluted | $ (0.3) | $ (0.59) |
Weighted-average number of shares used in computing net loss per common share, basic | 65,880,914 | 28,815,267 |
Weighted-average number of shares used in computing net loss per common share, diluted | 65,880,914 | 28,815,267 |
Other comprehensive loss | ||
Net loss | $ (19,457) | $ (17,044) |
Foreign currency translation | 194 | 517 |
Total comprehensive loss | $ (19,263) | $ (16,527) |
Consolidated Statements of Stoc
Consolidated Statements of Stockholders' Equity (Unaudited) - USD ($) $ in Thousands | Total | Common Stock | Additional Paid-In Capital | Accumulated Other Comprehensive Loss | Accumulated Deficit |
Balance at Dec. 31, 2022 | $ 138,854 | $ 29 | $ 326,705 | $ (10,141) | $ (177,739) |
Balance, shares at Dec. 31, 2022 | 28,815,267 | ||||
Equity-based compensation | 1,888 | 1,888 | |||
Foreign currency translation | 517 | 517 | |||
Net loss | (17,044) | (17,044) | |||
Balance at Mar. 31, 2023 | 124,215 | $ 29 | 328,593 | (9,624) | (194,783) |
Balance, shares at Mar. 31, 2023 | 28,815,267 | ||||
Balance at Dec. 31, 2022 | 138,854 | $ 29 | 326,705 | (10,141) | (177,739) |
Balance, shares at Dec. 31, 2022 | 28,815,267 | ||||
Net loss | (86,100) | ||||
Balance at Dec. 31, 2023 | 133,162 | $ 66 | 406,587 | (9,669) | (263,822) |
Balance, shares at Dec. 31, 2023 | 65,880,914 | ||||
Equity-based compensation | 1,567 | 1,567 | |||
Foreign currency translation | 194 | 194 | |||
Net loss | (19,457) | (19,457) | |||
Balance at Mar. 31, 2024 | $ 115,466 | $ 66 | $ 408,154 | $ (9,475) | $ (283,279) |
Balance, shares at Mar. 31, 2024 | 65,880,914 |
Consolidated Statements of Cash
Consolidated Statements of Cash Flows (Unaudited) - USD ($) $ in Thousands | 3 Months Ended | |
Mar. 31, 2024 | Mar. 31, 2023 | |
Cash flows from operating activities | ||
Net loss | $ (19,457) | $ (17,044) |
Adjustment to reconcile net loss to net cash used in operating activities | ||
Depreciation | 62 | 47 |
Equity-based compensation | 1,567 | 1,888 |
Amortization of right of use lease asset | 149 | 127 |
Foreign currency loss (gain) | 462 | (258) |
Changes in operating assets and liabilities | ||
Prepaid expenses and other current assets | (2,083) | 1,890 |
Other non-current assets | (792) | (792) |
Accounts payable | (38) | 256 |
Lease liability | (155) | (185) |
Accrued expenses and other current liabilities | (4,647) | (619) |
Net cash used in operating activities | (24,932) | (14,690) |
Cash flows from investing activities | ||
Purchase of property and equipment | (11) | (148) |
Net cash used in investing activities | (11) | (148) |
Cash flows from financing activities | ||
Net decrease in cash, cash equivalents and restricted cash | (24,943) | (14,838) |
Effect of exchange rate changes on cash, cash equivalents and restricted cash | (268) | 775 |
Cash, cash equivalents and restricted cash, beginning of period | 143,461 | 142,858 |
Cash, cash equivalents and restricted cash, end of period | 118,250 | 128,795 |
Components of cash, cash equivalents, and restricted cash | ||
Cash and cash equivalents | 117,982 | 128,527 |
Restricted cash | 268 | 268 |
Total cash, cash equivalents and restricted cash | $ 118,250 | $ 128,795 |
Description of Business, Organi
Description of Business, Organization and Liquidity | 3 Months Ended |
Mar. 31, 2024 | |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | |
Description of Business, Organization and Liquidity | 1. Description of Business, Organization and Liquidity Business IO Biotech, Inc. is a clinical-stage biopharmaceutical company developing novel, immune-modulating therapeutic cancer vaccines based on our T-win® platform. As used in these financial statements, unless the context otherwise requires, references to the “Company,” “we,” “us,” and “our” refer to IO Biotech, Inc. and its subsidiaries. Corporate Reorganization IO Biotech ApS was incorporated in Denmark in December 2014. In November 2021, we completed a corporate reorganization (the “Corporate Reorganization”) whereby IO Biotech ApS became a wholly-owned subsidiary of the Company. In connection with the corporate reorganization, each issued and outstanding Class A ordinary share ($ 0.16 par value) was exchanged on a one-for-one basis into shares of common stock of the Company ($ 0.001 par value). Each Class B and Class C preference share of IO Biotech ApS was exchanged on a one-for-one basis into shares of Class B and Class C preferred stock of the Company. IO Bio US, Inc., a wholly owned subsidiary of IO Biotech ApS, was incorporated in Delaware in May 2021. IO Biotech Limited, a wholly owned subsidiary of IO Biotech ApS, was incorporated in the UK in August 2021. In November 2021, the Company engaged in a series of transactions, referred to collectively as the Corporate Reorganization. As a result of the Corporate Reorganization, IO Biotech ApS became a wholly-owned subsidiary of IO Biotech, Inc. IO Biotech, Inc. is a holding company formed in October 2021, which, prior to our initial public offering (“IPO”), had nominal assets and no liabilities, contingencies, or commitments, and which has not conducted any operations prior to our IPO other than acquiring the entire issued and outstanding stock of IO Biotech ApS. The Company, IO Biotech ApS, and the holders of all of the issued and outstanding equity interests of IO Biotech ApS have entered into a Share Contribution and Exchange Agreement, dated as of October 29, 2021, pursuant to which the Corporate Reorganization was effected. IPO In November 2021, we completed our IPO, selling an aggregate of 8,222,500 shares of common stock at a price to the public of $ 14.00 per share, including 1,072,500 shares of common stock sold pursuant to the underwriters’ exercise of their option to purchase additional shares of common stock. We received net proceeds from the IPO, after deducting underwriting discounts and commissions and other offering costs of $ 103.3 million. Immediately prior to the consummation of the IPO, all outstanding shares of our Class A ordinary shares and Class B and Class C convertible preference shares were converted into 20,592,413 shares of common stock. Upon the closing of the IPO on November 9, 2021, a total of 28,815,267 shares of common stock were issued and outstanding. Our common stock began trading on the Nasdaq Global Market on November 5, 2021 under the symbol “IOBT.” On November 9, 2021, we amended and restated the certificate of incorporation of IO Biotech, Inc. to authorize the issuance of 300,000,000 shares of common stock and 5,000,000 shares of preferred stock. The shares of preferred stock are currently undesignated. August 2023 Private Placement On August 9, 2023, the Company completed a private placement transaction (the “Private Placement”), pursuant to which we sold an aggregate of 37,065,647 shares of the Company’s common stock, par value $ 0.001 per share, and 37,065,647 warrants to purchase up to 37,065,647 shares of common stock (the “Warrants”) to certain institutional investors and existing shareholders (the “Purchasers”). Each Purchaser’s Warrant is exercisable for a number of shares of common stock equal to one hundred percent of the aggregate number of shares of common stock purchased by such Purchaser. The purchase price per share of common stock and Warrant was $ 2.025 (the “Purchase Price”). The Company received net proceeds from the Private Placement, after deducting $ 3.2 million in underwriting discounts and commissions and other offering costs, of $ 71.9 million. Refer to Note 10, "Stockholders' Equity" in the accompanying notes to our unaudited consolidated financial statements for the period ended March 31, 2024 for additional information on the Private Placement. At-The-Market Equity Program On February 15, 2023, we filed a new prospectus supplement with the U.S. Securities and Exchange Commission (the “SEC”) with respect to the offer and sale of shares of our Common Stock, with an aggregate offering price of up to $ 19.5 million, establishing an at-the-market equity program. We also entered into a common stock sales agreement, dated February 15, 2023 (the “Sales Agreement”) by and between the Company and Cowen and Company, LLC for shares with an aggregate offering price of up to $ 75.0 million, through which we may, from time to time, sell shares through Cowen and Company, LLC, acting as agent and/or principal. Any shares offered and sold through the at-the-market equity program will be issued pursuant to the Company’s Registration Statement on Form S-3 (File No. 333-269569), which was declared effective on February 10, 2023, the prospectus supplement related to the offering that forms a part of the registration statement, and any applicable prospectus supplements that may form a part of the registration statement in the future. The aggregate market value of shares eligible for sale under the prospectus supplement and under the Sales Agreement will be subject to the limitations of General Instruction I.B.6 of Form S-3, to the extent required under such instruction. We have no t issued any shares pursuant to our at-the-market equity program as of March 31, 2024. Risks and Uncertainties We are subject to risks common to companies in the biotechnology industry including, but not limited to, new technological innovations, protection of proprietary technology, dependence on key personnel, compliance with government regulations and the need to obtain additional financing. Product candidates currently under development will require significant additional research and development efforts, including extensive preclinical and clinical testing and regulatory approval, prior to commercialization. These efforts require significant amounts of additional capital, adequate personnel infrastructure and extensive compliance reporting capabilities. Our product candidates are in preclinical research and clinical development. There can be no assurance that our research and development will be successfully completed, that adequate protection for our intellectual property will be obtained, that any products developed will obtain necessary government regulatory approval or that any approved products will be commercially viable. Even if our product development efforts are successful, it is uncertain when, if ever, we will generate significant revenue from product sales. We operate in an environment of rapid change in technology and substantial competition from pharmaceutical and biotechnology companies. In addition, we are dependent upon the services of our employees and consultants. Liquidity Considerations and Going Concern Basis of Accounting Since inception, we have devoted substantially all of our efforts to business planning, conducting research and development, recruiting management and technical staff, and raising capital. We have financed our operations primarily through the issuance of convertible preference shares, convertible notes, our IPO and the Private Placement. Our continued discovery and development of product candidates will require significant additional research and development efforts, including extensive preclinical and clinical testing and regulatory approval prior to commercialization. These efforts require significant amounts of additional capital, adequate personnel and infrastructure and extensive compliance-reporting capabilities. Even if product development efforts are successful, it is uncertain when, if ever, we will realize significant revenue from product sales. As of March 31, 2024, we had an accumulated deficit of $ 283.3 million. We have incurred losses and negative cash flows from operations since inception, including net losses of $ 19.5 million and $ 86.1 million for the three months ended March 31, 2024 and the year ended December 31, 2023, respectively. We expect that our operating losses and negative cash flows will continue for the foreseeable future as we continue to develop our product candidates. We currently expect that our cash and cash equivalents of $ 118.0 million as of March 31, 2024 will be sufficient to fund our operating expenses and capital requirements for at least 12 months from the date the financial statements are issued. On this basis, the consolidated financial statements are prepared on a going concern basis of accounting. However, additional funding will be necessary to fund future discovery research, preclinical and clinical activities. We will seek additional funding through public financings, debt financings, collaboration agreements, strategic alliances and licensing arrangements. Although we have been successful in raising capital in the past, there is no assurance that we will be successful in obtaining such additional financing on acceptable terms, or at all, and we may not be able to enter into collaborations or other arrangements. If we are unable to obtain funding, we could be forced to delay, reduce or eliminate our research and development programs, product portfolio expansion or commercialization efforts, which could adversely affect our business prospects, even our ability to continue operations. |
Summary of Significant Accounti
Summary of Significant Accounting Policies | 3 Months Ended |
Mar. 31, 2024 | |
Accounting Policies [Abstract] | |
Summary of Significant Accounting Policies | 2. Summary of Significant Accounting Policies There have been no changes to the significant accounting policies disclosed in Note 2 to the Company’s annual financial statements for the years ended December 31, 2023 and 2022 included in its Annual Report on Form 10-K filed with the SEC. Unaudited Financial Information The accompanying unaudited interim consolidated financial statements included herein have been prepared in conformity with generally accepted accounting principles in the United States of America ("U.S. GAAP"), and pursuant to the rules and regulations of the SEC. In the Company’s opinion, the information furnished herein reflects all adjustments, all of which are of a normal and recurring nature and necessary for a fair presentation of the financial position and results of operations for the reported interim periods. The Company considers events or transactions that occur after the balance sheet date but before the financial statements are issued to provide additional evidence relative to certain estimates or to identify matters that require additional disclosure. The results of operations for interim periods are not necessarily indicative of results to be expected for the full year or any other interim period. Unaudited interim financial statements and footnotes should be read in conjunction with the audited financial statements and footnotes included in the Company’s Annual Report filed on Form 10-K for the fiscal year ended December 31, 2023 . Recently Adopted Accounting Standards In August 2020, the FASB issued ASU No. 2020-06, Debt—Debt with Conversion and Other Options (Subtopic 470-20) and Derivatives and Hedging Contracts in Entity's Own Equity (Subtopic 815-40): Accounting for Convertible Instruments and Contracts in an Entity’s Own Equity . ASU 2020-06 will simplify the accounting for convertible instruments by reducing the number of accounting models for convertible debt instruments and convertible preferred stock. Limiting the accounting models results in fewer embedded conversion features being separately recognized from the host contract as compared with current U.S. GAAP. Convertible instruments that continue to be subject to separation models are (i) those with embedded conversion features that are not clearly and closely related to the host contract, that meet the definition of a derivative, and that do not qualify for a scope exception from derivative accounting and (ii) convertible debt instruments issued with substantial premiums for which the premiums are recorded as paid-in capital. ASU 2020-06 also amends the guidance for the derivatives scope exception for contracts in an entity’s own equity to reduce form-over-substance-based accounting conclusions. ASU 2020-06 will be effective for us beginning after December 15, 2023. The Company has adopted the standard effective January 1, 2024 . The adoption of the standard has no t had a material impact on our financial statements or financial statement disclosures. Recently Issued Accounting Standards In October 2023, the FASB issued ASU 2023-06, Accounting Standards Update 2023-06—Disclosure Improvements: Codification Amendments in Response to the SEC’s Disclosure Update and Simplification Initiative. ASU 2023-06 will eliminate disclosure requirements that are redundant, duplicative, overlapping, outdated, or superseded as a result of subsequent changes to SEC disclosure requirements, U.S. GAAP or technology. ASU 2023-06 is intended to better align U.S. GAAP requirements with those of the SEC and to facilitate the application of U.S. GAAP. The disclosure requirements would apply prospectively in the financial statements. ASU 2023-06 will be effective for us on the date on which the SEC’s removal of that related disclosure requirement from Regulation S-X or Regulation S-K becomes effective, if we are already subject to the SEC’s current disclosure requirements. For those current disclosure requirements we are not subject to, ASU 2023-06 will become effective two years after the date of such removal by the SEC. We are currently assessing the impact adoption of ASU 2023-06 will have on our financial statements and disclosures. In November 2023, the FASB issued ASU 2023-07, Segment Reporting (Topic 280): Improvements to Reportable Segment Disclosures. ASU 2023-07 will improve reportable segment disclosure requirements, primarily through enhanced disclosures about significant segment expenses. ASU 2023-07 will also enhance interim disclosure requirements, clarify circumstances in which an entity can disclose multiple segment measures of profit or loss, provide new segment disclosure requirements for entities with a single reportable segment and contain other disclosure requirements. The enhanced segment disclosure requirements apply retrospectively to all prior periods presented in the financial statements. ASU 2023-07 will be effective for us in the annual periods beginning after December 15, 2023, and interim periods within fiscal years beginning after December 15, 2024. We are currently assessing the impact adoption of ASU 2023-07 will have on our financial statements and disclosures, but do not expect a material impact on the financial statements or disclosures. In December 2023, the FASB issued ASU 2023-09, Income Taxes (Topic 740): Improvements to Income Tax Disclosures. ASU 2023-09 will require disclosure of additional information in specified categories with respect to the reconciliation of the effective tax rate to the statutory rate (the rate reconciliation) for federal, state and foreign income taxes. ASU 2023-09 will also require information pertaining to taxes paid (net of refunds received) to be disaggregated for federal, state and foreign taxes and further disaggregated for specific jurisdictions to the extent the related amounts exceed a quantitative threshold. ASU 2023-09 will be effective for us in the annual periods beginning after December 15, 2025. Early adoption is permitted for annual financial statements that have not yet been issued or made available for issuance. We are currently assessing the impact adoption of ASU 2020-06 will have on our financial statements and disclosures. Other than the items noted above, there have been no new accounting pronouncements not yet effective or adopted in the current year that we believe have a significant impact, or potential significant impact, to our unaudited interim consolidated financial statements. |
Fair Value Measurements
Fair Value Measurements | 3 Months Ended |
Mar. 31, 2024 | |
Fair Value Disclosures [Abstract] | |
Fair Value Measurements | 3. Fair Value Measurements The following table presents information about our financial assets and liabilities measured at fair value on a recurring basis and indicate the level of the fair value hierarchy utilized to determine such fair values (in thousands): March 31, 2024 Total Level 1 Level 2 Level 3 Assets Money market funds (1) $ 100,815 $ 100,815 $ — $ — Total assets measured at fair value $ 100,815 $ 100,815 $ — $ — December 31, 2023 Total Level 1 Level 2 Level 3 Assets Money market funds (1) $ 131,613 $ 131,613 $ — $ — Total assets measured at fair value $ 131,613 $ 131,613 $ — $ — (1) Money market funds with maturities of 90 days or less at the date of purchase are included within cash and cash equivalents in the accompanying consolidated balance sheets and are recognized at fair value. As of March 31, 2024 and December 31, 2023, the Company only held Level 1 financial instruments. There were no transfers among Level 1, Level 2 or Level 3 categories in the three months ended March 31, 2024 and the year ended December 31, 2023 . |
License and Collaboration Agree
License and Collaboration Agreements | 3 Months Ended |
Mar. 31, 2024 | |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | |
License and Collaboration Agreements | 4. License and Collaboration Agreements In February 2018, we entered into a clinical collaboration with MSD International GmbH (“MSDIG”) to evaluate IO102 in combination with KEYTRUDA® (“pembrolizumab”) in first-line treatment of patients with metastatic non-small cell lung cancer. Under the terms of the collaboration with MSDIG, we will conduct an international Phase 1/2 study to evaluate a combination therapy of IO102 and KEYTRUDA®. We will sponsor the clinical trial and MSDIG will provide KEYTRUDA® to be used in the clinical trial free of charge. We and MSDIG will be responsible for our own internal costs and expenses to support the study and we shall bear all other costs associated with conducting the study, including costs of providing IO102 for use in the study. The rights to the data from the clinical trial will be shared by us and MSDIG and we will maintain global commercial rights to IO102. In September 2021, we entered into a clinical collaboration with MSDIG and MSD International Business GmbH (“MSDIB”), another affiliate of Merck (collectively, “MSD”) to evaluate IO102-IO103 in combination with KEYTRUDA® versus KEYTRUDA® alone in treatment of patients with metastatic (advanced) melanoma. Under the terms of the collaboration with MSD, we are conducting an international Phase 3 study to evaluate a combination therapy of IO102-IO103 and KEYTRUDA®. We are the sponsor of the clinical trial and MSD will provide KEYTRUDA® to be used in the clinical trial free of charge. We and MSD are responsible for our own internal costs and expenses to support the study and we will bear all other costs associated with conducting the study, including costs of providing IO102-IO103 for use in the study. The rights to the data from the clinical trial will be shared by us and MSD and we will maintain global commercial rights to IO102-IO103. In December 2021, we entered into a clinical collaboration with MSD to evaluate IO102-IO103 in combination with KEYTRUDA® in previously untreated patients with three different tumor types— metastatic non-small cell lung cancer (“NSCLC”), squamous cell carcinoma of the head and neck (“SCCHN”), and urothelial bladder cancer (“UBC”). Under the terms of the collaboration with MSD, we are conducting an international Phase 2 study to evaluate a combination therapy of IO102-IO103 and KEYTRUDA®. We are the sponsor of the clinical trial and MSD will provide KEYTRUDA® to be used in the clinical trial free of charge. We and MSD are responsible for our own internal costs and expenses to support the study and we will bear all other costs associated with conducting the study, including costs of providing IO102-IO103 for use in the study. The rights to the data from the clinical trial will be shared by us and MSD and we will maintain global commercial rights to IO102-IO103. In November 2022, we entered into a clinical collaboration with MSD to evaluate IO102-IO103 in combination with KEYTRUDA® as a neo-adjuvant/adjuvant therapy for patients with metastatic melanoma and SCCHN. Under the terms of the collaboration with MSD, we will conduct an international Phase 2 study to evaluate a combination therapy of IO102-IO103 and KEYTRUDA®. We will sponsor the clinical trial and MSD will provide KEYTRUDA® to be used in the clinical trial free of charge. We and MSD will be responsible for our own internal costs and expenses to support the study and we shall bear all other costs associated with conducting the study, including costs of providing IO102-IO103 for use in the study. The rights to the data from the clinical trial will be shared by us and MSD and we will maintain global commercial rights to IO102-IO103. |
Prepaid Expenses and Other Curr
Prepaid Expenses and Other Current Assets | 3 Months Ended |
Mar. 31, 2024 | |
Deferred Costs, Capitalized, Prepaid, and Other Assets Disclosure [Abstract] | |
Prepaid Expenses and Other Current Assets | 5. Prepaid Expenses and Other Current Assets Prepaid expenses and other current assets consist of the following (in thousands): March 31, December 31, Prepaid contract research and development costs $ 2,833 — Insurance 967 1,352 Research and development tax credit receivable 796 814 Prepaid income taxes 526 829 Value-added tax refund receivable 113 313 Other 911 754 Total prepaid expenses and other current assets $ 6,146 $ 4,062 |
Property and Equipment, Net
Property and Equipment, Net | 3 Months Ended |
Mar. 31, 2024 | |
Property, Plant and Equipment [Abstract] | |
Property and Equipment, Net | 6. Property and Equipment, Net Property and equipment, net consist of the following (in thousands): March 31, December 31, Laboratory equipment $ 829 $ 836 Office furniture 236 238 Computer hardware 115 103 Less: accumulated depreciation ( 392 ) ( 330 ) Total property and equipment, net $ 788 $ 847 For the three months ended March 31, 2024 and 2023, the Company recognized $ 0.1 million and $ 0.05 million , respectively, of depreciation expense in the consolidated statements of operations. |
Accrued Expenses and Other Curr
Accrued Expenses and Other Current Liabilities | 3 Months Ended |
Mar. 31, 2024 | |
Payables and Accruals [Abstract] | |
Accrued Expenses and Other Current Liabilities | 7. Accrued Expenses and Other Current Liabilities Accrued expenses and other current liabilities consist of the following (in thousands): March 31, December 31, Accrued contract research and development costs $ 3,841 $ 6,153 Professional fees 582 243 Employee compensation costs 1,538 4,225 Other liabilities 576 563 Total accrued expenses and other current liabilities $ 6,537 $ 11,184 |
Leases
Leases | 3 Months Ended |
Mar. 31, 2024 | |
Leases [Abstract] | |
Leases | 8. Leases As of March 31, 2024 , the Company is party to five operating leases for laboratory and office space. The Company’s finance leases are immaterial both individually and in the aggregate. In the consolidated balance sheet as of March 31, 2024, the Company has a right-of-use lease asset (“ROU”) balance of $ 2.1 million and a current and non-current lease liability of $ 0.7 million and $ 1.7 million, respectively, relating to the ROU lease asset. The balance of both the ROU lease asset and the lease liabilities primarily consists of future payments under the Company’s office and laboratory space leased in New York, New York, Rockville, Maryland and Copenhagen, Denmark. The Company is party to an operating lease in Copenhagen, Denmark for office space that commenced in March 2021 with the initial term set to expire in January 2025. Base rent for this initial lease was $ 0.1 million annually. The Company amended its operating lease in Copenhagen, Denmark on September 1, 2022 with a new term set to expire in December 2027. The base rent for the amended lease is $ 0.2 million annually. The Company is also party to an operating lease in Copenhagen, Denmark for laboratory space that commenced in January 2023 with the term set to expire in December 2027. The base rent for the lease is $ 0.04 million annually. The Company is party to an operating lease in New York, New York for office space that commenced in October 2021 with the initial term set to expire in January 2027. Base rent for this lease is $ 0.2 million annually. The Company is party to an operating lease in Rockville, Maryland for office and laboratory space that commenced in December 2021 with the initial term set to expire in May 2027. Base rent for this lease is $ 0.3 million annually. The Company is party to an immaterial operating lease in Newport, United Kingdom that commenced in June 2023. Rent expense for each of the three months ended March 31, 2024 and 2023 was $ 0.2 million , respectively. Quantitative information regarding the Company’s leases for the three months ended March 31, 2024 and 2023 is as follows (in thousands): Three Months Ended Three Months Ended Lease Cost March 31, 2024 March 31, 2023 Operating lease cost $ 184 $ 206 Operating cash flows paid for amounts included in the measurement of lease liabilities $ 193 $ 175 Operating lease liabilities arising from obtaining right-of-use assets $ — $ 165 Remaining average lease term (years) 3.2 4.3 Weighted average discount rate 6.3 % 6.5 % Future lease payments (undiscounted) under noncancelable leases are as follows at March 31, 2024 (in thousands): Future Lease Payments Amount Remainder of 2024 $ 591 2025 787 2026 793 2027 397 2028 — Thereafter — Total $ 2,568 The Company’s leases do not provide an explicit rate. Therefore, the Company used its incremental borrowing rate based on the information available at commencement date in determining the present value of lease payments. The Company used the incremental borrowing rate on January 1, 2022 for operating leases that commenced prior to that date, which is the rate incurred to borrow on a collateralized basis over a similar term an amount equal to the lease payments in a similar economic environment. |
Commitments and Contingencies
Commitments and Contingencies | 3 Months Ended |
Mar. 31, 2024 | |
Commitments and Contingencies Disclosure [Abstract] | |
Commitments and Contingencies | 9. Commitments and Contingencies Legal Proceedings From time to time, we may be party to litigation arising in the ordinary course of business. We were not subject to any material legal proceedings during the three months ended March 31, 2024 and the year ended December 31, 2023, and, to our knowledge, no material legal proceedings are currently pending or threatened. Contractual Obligations and Commitments We enter into contracts in the ordinary course of business with third-party service providers for clinical trials, preclinical research studies and testing, manufacturing and other services and products for operating purposes. These contracts generally provide for termination upon notice of 30 to 90 days, and therefore, we believe that our noncancelable obligations under these agreements are not material and we cannot reasonably estimate whether they will occur. However, in the event of a termination of any contracts with CROs or other institutions and with respect to active patients enrolled in our clinical trials, we may be financially obligated for a period beyond the contractual termination notice periods. We may also enter into additional research, manufacturing, supplier, lease and other agreements in the future, which may require up-front payments and even long-term commitments of cash. Indemnification Agreements We enter into certain types of contracts that contingently require us to indemnify various parties against claims from third parties. These contracts primarily relate to procurement, service, consultancy or license agreements under which we may be required to indemnify vendors, service providers or licensees for certain claims, including claims that may be brought against them arising from our acts or omissions with respect to our products, technology, intellectual property or services. The Company, as permitted under Delaware law and in accordance with its amended and restated certificate of incorporation and amended and restated bylaws and pursuant to indemnification agreements with certain of its officers and directors, indemnifies its officers and directors for certain events or occurrences, subject to certain limits, which the officer or director is or was serving at the Company’s request in such capacity. At the 2023 Annual Meeting of Stockholders, the Company’s stockholders approved an amendment to, and the Company subsequently amended, its amended and restated certificate of incorporation to extend the indemnification of officers pursuant to recent amendments to the General Corporation Law of the State of Delaware. From time to time, we may receive indemnification claims under existing contracts in the normal course of business. In the event that one or more of these matters were to result in a claim against us, an adverse outcome, including a judgment or settlement, may cause a material adverse effect on our future business, operating results or financial condition. It is not possible to estimate the maximum amount potentially payable under these contracts since we have no history of prior indemnification claims and the unique facts and circumstances involved in each particular claim will be determinative. |
Stockholders' Equity
Stockholders' Equity | 3 Months Ended |
Mar. 31, 2024 | |
Class of Stock Disclosures [Abstract] | |
Stockholders' Equity | 10. Stockholders' Equity Common and Preferred Stock Upon the closing of our IPO in November 2021, we filed an amended and restated certificate of incorporation, which authorized us to issue 300,000,000 shares of common stock and 5,000,000 shares of preferred stock. The shares of preferred stock are currently undesignated. Common stockholders are entitled to one vote for each share of common stock held at all meetings of stockholders and written actions in lieu of meetings. Common stockholders are entitled to receive dividends, if and when declared by the Company's board of directors (“Board”). No dividends have been declared or paid by us through March 31, 2024. The Private Placement On August 7, 2023, the Company entered into the Purchase Agreement, pursuant to which the Company agreed to sell and issue (i) 37,065,647 shares of the Company’s Common Stock, and (ii) 37,065,647 Warrants in the Private Placement. Each Purchaser’s Warrant is exercisable for a number of shares of Common Stock equal to one hundred percent of the aggregate number of shares of Common Stock purchased by such Purchaser. The Purchase Price for each Common Stock and Warrant was $ 2.025 per share. The Warrants are exercisable at an exercise price of $ 2.47 per share, subject to adjustment as set forth therein. The Warrants are exercisable until the earlier of (i) February 9, 2027, and (ii) one day prior to the closing of an acquisition, as defined in the Warrants. The Warrants may be exercised on a cashless basis if there is no effective registration statement registering the shares underlying the Warrants. The Private Placement closed on August 9, 2023. The Company received $ 75.1 million in gross proceeds from the Private Placement, before deducting offering expenses of $ 3.2 million. Of the total proceeds, legal entities of certain related parties contributed $ 33.4 million, and members of management contributed $ 0.2 million. The Company intends to use the net proceeds of $ 71.9 million from the Private Placement for general corporate purposes. The Warrants were classified as a component of permanent stockholders’ equity within additional paid-in-capital and were recorded at the issuance date using a relative fair value allocation method. The Warrants are equity classified because they are freestanding financial instruments that are legally detachable and separately exercisable from the equity instruments, are immediately exercisable, do not embody an obligation for the Company to repurchase its shares, permit the holders to receive a fixed number of common shares upon exercise, are indexed to the Company’s common stock and meet the equity classification criteria. In addition, such Warrants do not provide any guarantee of value or return. The Company valued the Warrants at issuance using the Black-Scholes valuation model and allocated proceeds from the sale proportionately to the Common Stock and Warrants, of which $ 29.6 million was allocated to the Warrants and recorded as a component of additional paid-in-capital. As of March 31, 2024 , the Company had 37,065,647 warrants issued and outstanding at an exercise price of $ 2.47 per share to purchase shares of the Company's common stock. In connection with the execution of the Purchase Agreement, the Company also entered into a registration rights agreement (the “Registration Rights Agreement”) with the Purchasers. Under the terms of the Registration Rights Agreement, the Company has filed the Registration Statement with the SEC to register for resale the Common Stock issued under the Purchase Agreement and the shares of Common Stock issuable upon conversion of the Warrants issued pursuant to the Purchase Agreement (the “Registrable Securities”), which Registration Statement was declared effective on September 8, 2023. The Company may be required to pay certain liquidated damages under the terms of the Registration Rights Agreement in the event sales cannot be made pursuant to the Registration Statement. As of March 31, 2024 and December 31, 2023, the Company had 65,880,914 common shares outstanding, respectively. |
Equity-Based Compensation
Equity-Based Compensation | 3 Months Ended |
Mar. 31, 2024 | |
Share-Based Payment Arrangement [Abstract] | |
Equity-Based Compensation | 11. Equity-Based Compensation 2021 Equity Incentive Plan In November 2021, our Board adopted, and our stockholders approved, the 2021 Equity Incentive Plan (“2021 Equity Plan”), which became effective on November 4, 2021. The 2021 Equity Plan provides for the grant of incentive stock options, non-statutory stock options, stock appreciation rights, awards of restricted stock, restricted stock units and other stock-based awards. The number of shares of our common stock reserved for issuance under the 2021 Equity Plan is equal to 2,496,934 , subject to an annual increase, to be added on the first day of each fiscal year, beginning with the fiscal year ending December 31, 2022 and continuing until, and including, the fiscal year ending December 31, 2031, equal to the lesser of (i) 4 % of the number of shares of common stock outstanding on the first day of such fiscal year or (ii) such other amount determined by our Board . As of March 31, 2024, we had 642,341 shares available for future grant under the 2021 Equity Plan. 2021 Employee Stock Purchase Plan In November 2021, our Board adopted and our stockholders approved the 2021 Employee Stock Purchase Plan (“2021 ESPP”), which became effective on November 4, 2021. The number of shares of our common stock reserved for issuance under the 2021 ESPP is equal to 257,272 , subject to an annual increase, to be added on the first day of each fiscal year, beginning January 1, 2023, equal to the lesser of (1) 1 % of the number of shares of common stock outstanding on the first day of such fiscal year; (2) 257,272 shares of our common stock; or (3) such other amount as determined by our Board. As of March 31, 2024, the Board had not yet approved any offerings under the 2021 ESPP. 2023 Inducement Award Plan In September 2023, our Board adopted the 2023 Inducement Award Plan (“2023 Inducement Plan”), which became effective on September 28, 2023. The 2023 Inducement Plan provides for the grant of non-statutory stock options, stock appreciation rights, awards of restricted stock, restricted stock units and other stock-based awards to eligible employees who satisfy the standards for inducement grants under Nasdaq Global Market rules. The number of shares of our common stock reserved for issuance under the 2023 Inducement Plan is equal to 1,976,427 . As of March 31, 2024 , there were 1,976,427 shares available for future grant under the 2023 Inducement Plan. The following table summarizes our stock options activity for the three months ended March 31, 2024: Number of Weighted- Weighted- Aggregate Outstanding, January 1, 2024 5,851,923 $ 7.20 8.4 $ 102 Granted 2,626,930 $ 1.65 — $ — Cancelled or forfeited ( 40,567 ) $ 6.24 — $ — Outstanding, March 31, 2024 8,438,286 $ 5.47 8.7 $ 292 Exercisable, March 31, 2024 2,483,730 $ 9.81 7.6 $ 5 Equity-Based Compensation All share-based awards granted are measured based on the fair value on the date of the grant and compensation expense is recognized with respect to those awards over the requisite service period, which is generally the vesting period of the respective award. Forfeitures related to equity-based compensation awards are recognized as they occur, and we reverse any previously recognized compensation cost associated with forfeited awards in the period the forfeiture occurs. As of March 31, 2024, there was $ 12.7 million of unrecognized compensation cost related to unvested stock-based compensation arrangements that is expected to be recognized over a weighted average period of 3.0 years. The fair values of the stock options granted during the period ended March 31, 2024 were estimated based on the Black-Scholes model, using the following assumptions: March 31, Expected volatility 87.3 % - 87.4 % Risk-free interest rate 4.2 % - 4.3 % Expected term (in years) 6.1 Expected dividend yield 0 % Equity-based compensation expense recorded as research and development and general and administrative expenses is as follows (in thousands): Three Months Ended March 31, 2024 2023 Research and development $ 613 $ 704 General and administrative 954 1,184 Total equity-based compensation $ 1,567 $ 1,888 We did no t recognize any tax benefits for stock-based compensation during the three months ended March 31, 2024 and 2023. |
Income Taxes
Income Taxes | 3 Months Ended |
Mar. 31, 2024 | |
Income Tax Disclosure [Abstract] | |
Income Taxes | 12. Income Taxes We are subject to taxes for earnings generated in multiple jurisdictions, both inside and outside of the United States and our tax expense is primarily affected by unrecognized tax benefits in Denmark due to the full valuation allowance. We recorded expense for income taxes of $ 0.4 million during the three months ended March 31, 2024 and 2023, respectively. We continue to maintain a full valuation allowance against all of our deferred tax assets in IO Biotech ApS, IO Bio US, Inc., a wholly-owned subsidiary of IO Biotech ApS that was incorporated in Delaware in May 2021, and IO Biotech, Inc. We have evaluated the positive and negative evidence involving our ability to realize our deferred tax assets. We have considered our history of cumulative net losses incurred since inception and our lack of any commercial products. We have concluded that it is more likely than not that we will not realize the benefits of our deferred tax assets in IO Biotech ApS, IO Bio US, Inc. and IO Biotech, Inc. We reevaluate the positive and negative evidence at each reporting period. |
Net Loss Per Share
Net Loss Per Share | 3 Months Ended |
Mar. 31, 2024 | |
Earnings Per Share [Abstract] | |
Net Loss Per Share | 13. Net Loss Per Share Basic and diluted net loss per common share is calculated as follows (in thousands except share and per share amounts): Three Months Ended 2024 2023 Net loss $ ( 19,457 ) $ ( 17,044 ) Net loss attributable to common shareholders $ ( 19,457 ) $ ( 17,044 ) Net loss per common share, basic and diluted $ ( 0.30 ) $ ( 0.59 ) Weighted-average number of shares used in computing net loss per common share, basic and diluted 65,880,914 28,815,267 The following outstanding potentially dilutive securities have been excluded from the calculation of diluted net loss per common share, as their effect is anti-dilutive: Three Months Ended 2024 2023 Stock options to purchase common stock 8,438,286 5,500,126 Warrants issued in Private Placement 37,065,647 — |
Subsequent Events
Subsequent Events | 3 Months Ended |
Mar. 31, 2024 | |
Subsequent Events [Abstract] | |
Subsequent Events | 14. Subsequent Events We have evaluated subsequent events through the date on which the consolidated financial statements were issued. The Company has concluded that no subsequent events have occurred that require disclosure to the consolidated financial statements. |
Summary of Significant Accoun_2
Summary of Significant Accounting Policies (Policies) | 3 Months Ended |
Mar. 31, 2024 | |
Accounting Policies [Abstract] | |
Unaudited Financial Information | Unaudited Financial Information The accompanying unaudited interim consolidated financial statements included herein have been prepared in conformity with generally accepted accounting principles in the United States of America ("U.S. GAAP"), and pursuant to the rules and regulations of the SEC. In the Company’s opinion, the information furnished herein reflects all adjustments, all of which are of a normal and recurring nature and necessary for a fair presentation of the financial position and results of operations for the reported interim periods. The Company considers events or transactions that occur after the balance sheet date but before the financial statements are issued to provide additional evidence relative to certain estimates or to identify matters that require additional disclosure. The results of operations for interim periods are not necessarily indicative of results to be expected for the full year or any other interim period. Unaudited interim financial statements and footnotes should be read in conjunction with the audited financial statements and footnotes included in the Company’s Annual Report filed on Form 10-K for the fiscal year ended December 31, 2023 . |
Recently Adopted Accounting Standards and Recently Issued Accounting Standards | Recently Adopted Accounting Standards In August 2020, the FASB issued ASU No. 2020-06, Debt—Debt with Conversion and Other Options (Subtopic 470-20) and Derivatives and Hedging Contracts in Entity's Own Equity (Subtopic 815-40): Accounting for Convertible Instruments and Contracts in an Entity’s Own Equity . ASU 2020-06 will simplify the accounting for convertible instruments by reducing the number of accounting models for convertible debt instruments and convertible preferred stock. Limiting the accounting models results in fewer embedded conversion features being separately recognized from the host contract as compared with current U.S. GAAP. Convertible instruments that continue to be subject to separation models are (i) those with embedded conversion features that are not clearly and closely related to the host contract, that meet the definition of a derivative, and that do not qualify for a scope exception from derivative accounting and (ii) convertible debt instruments issued with substantial premiums for which the premiums are recorded as paid-in capital. ASU 2020-06 also amends the guidance for the derivatives scope exception for contracts in an entity’s own equity to reduce form-over-substance-based accounting conclusions. ASU 2020-06 will be effective for us beginning after December 15, 2023. The Company has adopted the standard effective January 1, 2024 . The adoption of the standard has no t had a material impact on our financial statements or financial statement disclosures. Recently Issued Accounting Standards In October 2023, the FASB issued ASU 2023-06, Accounting Standards Update 2023-06—Disclosure Improvements: Codification Amendments in Response to the SEC’s Disclosure Update and Simplification Initiative. ASU 2023-06 will eliminate disclosure requirements that are redundant, duplicative, overlapping, outdated, or superseded as a result of subsequent changes to SEC disclosure requirements, U.S. GAAP or technology. ASU 2023-06 is intended to better align U.S. GAAP requirements with those of the SEC and to facilitate the application of U.S. GAAP. The disclosure requirements would apply prospectively in the financial statements. ASU 2023-06 will be effective for us on the date on which the SEC’s removal of that related disclosure requirement from Regulation S-X or Regulation S-K becomes effective, if we are already subject to the SEC’s current disclosure requirements. For those current disclosure requirements we are not subject to, ASU 2023-06 will become effective two years after the date of such removal by the SEC. We are currently assessing the impact adoption of ASU 2023-06 will have on our financial statements and disclosures. In November 2023, the FASB issued ASU 2023-07, Segment Reporting (Topic 280): Improvements to Reportable Segment Disclosures. ASU 2023-07 will improve reportable segment disclosure requirements, primarily through enhanced disclosures about significant segment expenses. ASU 2023-07 will also enhance interim disclosure requirements, clarify circumstances in which an entity can disclose multiple segment measures of profit or loss, provide new segment disclosure requirements for entities with a single reportable segment and contain other disclosure requirements. The enhanced segment disclosure requirements apply retrospectively to all prior periods presented in the financial statements. ASU 2023-07 will be effective for us in the annual periods beginning after December 15, 2023, and interim periods within fiscal years beginning after December 15, 2024. We are currently assessing the impact adoption of ASU 2023-07 will have on our financial statements and disclosures, but do not expect a material impact on the financial statements or disclosures. In December 2023, the FASB issued ASU 2023-09, Income Taxes (Topic 740): Improvements to Income Tax Disclosures. ASU 2023-09 will require disclosure of additional information in specified categories with respect to the reconciliation of the effective tax rate to the statutory rate (the rate reconciliation) for federal, state and foreign income taxes. ASU 2023-09 will also require information pertaining to taxes paid (net of refunds received) to be disaggregated for federal, state and foreign taxes and further disaggregated for specific jurisdictions to the extent the related amounts exceed a quantitative threshold. ASU 2023-09 will be effective for us in the annual periods beginning after December 15, 2025. Early adoption is permitted for annual financial statements that have not yet been issued or made available for issuance. We are currently assessing the impact adoption of ASU 2020-06 will have on our financial statements and disclosures. Other than the items noted above, there have been no new accounting pronouncements not yet effective or adopted in the current year that we believe have a significant impact, or potential significant impact, to our unaudited interim consolidated financial statements. |
Fair Value Measurements (Tables
Fair Value Measurements (Tables) | 3 Months Ended |
Mar. 31, 2024 | |
Fair Value Disclosures [Abstract] | |
Summary of Assets Measured at Fair Value | The following table presents information about our financial assets and liabilities measured at fair value on a recurring basis and indicate the level of the fair value hierarchy utilized to determine such fair values (in thousands): March 31, 2024 Total Level 1 Level 2 Level 3 Assets Money market funds (1) $ 100,815 $ 100,815 $ — $ — Total assets measured at fair value $ 100,815 $ 100,815 $ — $ — December 31, 2023 Total Level 1 Level 2 Level 3 Assets Money market funds (1) $ 131,613 $ 131,613 $ — $ — Total assets measured at fair value $ 131,613 $ 131,613 $ — $ — (1) Money market funds with maturities of 90 days or less at the date of purchase are included within cash and cash equivalents in the accompanying consolidated balance sheets and are recognized at fair value. |
Prepaid Expenses and Other Cu_2
Prepaid Expenses and Other Current Assets (Tables) | 3 Months Ended |
Mar. 31, 2024 | |
Deferred Costs, Capitalized, Prepaid, and Other Assets Disclosure [Abstract] | |
Summary of Prepaid Expenses and Other Current Assets | Prepaid expenses and other current assets consist of the following (in thousands): March 31, December 31, Prepaid contract research and development costs $ 2,833 — Insurance 967 1,352 Research and development tax credit receivable 796 814 Prepaid income taxes 526 829 Value-added tax refund receivable 113 313 Other 911 754 Total prepaid expenses and other current assets $ 6,146 $ 4,062 |
Property and Equipment, Net (Ta
Property and Equipment, Net (Tables) | 3 Months Ended |
Mar. 31, 2024 | |
Property, Plant and Equipment [Abstract] | |
Schedule of Property and Equipment, Net | Property and equipment, net consist of the following (in thousands): March 31, December 31, Laboratory equipment $ 829 $ 836 Office furniture 236 238 Computer hardware 115 103 Less: accumulated depreciation ( 392 ) ( 330 ) Total property and equipment, net $ 788 $ 847 |
Accrued Expenses and Other Cu_2
Accrued Expenses and Other Current Liabilities (Tables) | 3 Months Ended |
Mar. 31, 2024 | |
Payables and Accruals [Abstract] | |
Summary of Accrued Expenses and Other Current Liabilities | Accrued expenses and other current liabilities consist of the following (in thousands): March 31, December 31, Accrued contract research and development costs $ 3,841 $ 6,153 Professional fees 582 243 Employee compensation costs 1,538 4,225 Other liabilities 576 563 Total accrued expenses and other current liabilities $ 6,537 $ 11,184 |
Leases (Tables)
Leases (Tables) | 3 Months Ended |
Mar. 31, 2024 | |
Leases [Abstract] | |
Schedule of Quantitative Information Regarding Leases | Quantitative information regarding the Company’s leases for the three months ended March 31, 2024 and 2023 is as follows (in thousands): Three Months Ended Three Months Ended Lease Cost March 31, 2024 March 31, 2023 Operating lease cost $ 184 $ 206 Operating cash flows paid for amounts included in the measurement of lease liabilities $ 193 $ 175 Operating lease liabilities arising from obtaining right-of-use assets $ — $ 165 Remaining average lease term (years) 3.2 4.3 Weighted average discount rate 6.3 % 6.5 % |
Schedule of Future Lease Payments (Undiscounted) under Noncancelable Leases | Future lease payments (undiscounted) under noncancelable leases are as follows at March 31, 2024 (in thousands): Future Lease Payments Amount Remainder of 2024 $ 591 2025 787 2026 793 2027 397 2028 — Thereafter — Total $ 2,568 |
Equity-Based Compensation (Tabl
Equity-Based Compensation (Tables) | 3 Months Ended |
Mar. 31, 2024 | |
Share-Based Payment Arrangement [Abstract] | |
Schedule of Stock Options Activity | The following table summarizes our stock options activity for the three months ended March 31, 2024: Number of Weighted- Weighted- Aggregate Outstanding, January 1, 2024 5,851,923 $ 7.20 8.4 $ 102 Granted 2,626,930 $ 1.65 — $ — Cancelled or forfeited ( 40,567 ) $ 6.24 — $ — Outstanding, March 31, 2024 8,438,286 $ 5.47 8.7 $ 292 Exercisable, March 31, 2024 2,483,730 $ 9.81 7.6 $ 5 |
Summary of Assumptions for Estimated Fair Value of Options | The fair values of the stock options granted during the period ended March 31, 2024 were estimated based on the Black-Scholes model, using the following assumptions: March 31, Expected volatility 87.3 % - 87.4 % Risk-free interest rate 4.2 % - 4.3 % Expected term (in years) 6.1 Expected dividend yield 0 % |
Schedule of Equity-based Compensation Expense | Equity-based compensation expense recorded as research and development and general and administrative expenses is as follows (in thousands): Three Months Ended March 31, 2024 2023 Research and development $ 613 $ 704 General and administrative 954 1,184 Total equity-based compensation $ 1,567 $ 1,888 |
Net Loss Per Share (Table)
Net Loss Per Share (Table) | 3 Months Ended |
Mar. 31, 2024 | |
Earnings Per Share [Abstract] | |
Schedule of Earnings Per Share, Basic and Diluted | Basic and diluted net loss per common share is calculated as follows (in thousands except share and per share amounts): Three Months Ended 2024 2023 Net loss $ ( 19,457 ) $ ( 17,044 ) Net loss attributable to common shareholders $ ( 19,457 ) $ ( 17,044 ) Net loss per common share, basic and diluted $ ( 0.30 ) $ ( 0.59 ) Weighted-average number of shares used in computing net loss per common share, basic and diluted 65,880,914 28,815,267 |
Schedule of Potentially Dilutive Securities Excluded from Calculation of Diluted Net Loss per Share | The following outstanding potentially dilutive securities have been excluded from the calculation of diluted net loss per common share, as their effect is anti-dilutive: Three Months Ended 2024 2023 Stock options to purchase common stock 8,438,286 5,500,126 Warrants issued in Private Placement 37,065,647 — |
Description of Business, Orga_2
Description of Business, Organization and Liquidity - Additional Information (Details) - USD ($) | 1 Months Ended | 3 Months Ended | 12 Months Ended | ||||
Aug. 09, 2023 | Nov. 30, 2021 | Mar. 31, 2024 | Mar. 31, 2023 | Dec. 31, 2023 | Feb. 15, 2023 | Nov. 09, 2021 | |
Description Of Business Organization And Liquidity [Line Items] | |||||||
Common stock, par value | $ 0.001 | $ 0.001 | |||||
Accumulated deficit | $ (283,279,000) | $ (263,822,000) | |||||
Net losses | (19,457,000) | $ (17,044,000) | (86,100,000) | ||||
Cash and cash equivalents | $ 117,982,000 | $ 128,527,000 | $ 143,193,000 | ||||
Net proceeds from IPO, after deducting underwriting discounts, commissions and offering costs | $ 103,300,000 | ||||||
Convertible preference share issued upon conversion | 20,592,413 | ||||||
Common stock shares issued | 65,880,914 | 65,880,914 | 28,815,267 | ||||
Common stock shares outstanding | 65,880,914 | 65,880,914 | 28,815,267 | ||||
Common stock shares authorized | 300,000,000 | 300,000,000 | 300,000,000 | ||||
Preferred stock shares authorized | 5,000,000 | 5,000,000 | |||||
Proceeds from private placement | $ 71,900,000 | ||||||
Class A Ordinary Shares | |||||||
Description Of Business Organization And Liquidity [Line Items] | |||||||
Common stock, par value | $ 0.16 | ||||||
Common stock conversion basis | one-for-one | ||||||
Class B Preference Shares | |||||||
Description Of Business Organization And Liquidity [Line Items] | |||||||
Common stock, par value | $ 0.001 | ||||||
Common stock conversion basis | one-for-one | ||||||
Class C Preference Shares | |||||||
Description Of Business Organization And Liquidity [Line Items] | |||||||
Common stock, par value | $ 0.001 | ||||||
Common stock conversion basis | one-for-one | ||||||
Undesignated Preferred Stock | |||||||
Description Of Business Organization And Liquidity [Line Items] | |||||||
Preferred stock shares authorized | 5,000,000 | ||||||
Underwriters | |||||||
Description Of Business Organization And Liquidity [Line Items] | |||||||
Shares issued | 1,072,500 | ||||||
IPO | |||||||
Description Of Business Organization And Liquidity [Line Items] | |||||||
Shares issued | 8,222,500 | ||||||
Common stock shares sold, price per share | $ 14 | ||||||
At-The-Market Equity Program | |||||||
Description Of Business Organization And Liquidity [Line Items] | |||||||
Shares issued | 0 | ||||||
Common stock, maximum aggregate offering price | $ 19,500,000 | ||||||
At-The-Market Equity Program | Sales Agreement | |||||||
Description Of Business Organization And Liquidity [Line Items] | |||||||
Common stock, maximum aggregate offering price | $ 75,000,000 | ||||||
Private Placement | |||||||
Description Of Business Organization And Liquidity [Line Items] | |||||||
Common stock, par value | $ 0.001 | ||||||
Shares issued | 37,065,647 | ||||||
Warrants Issued | 37,065,647 | ||||||
Purchase price per share of common stock and warrant | $ 2.025 | ||||||
Offering expenses | $ 3,200,000 | ||||||
Private Placement | Maximum | Common Stock | |||||||
Description Of Business Organization And Liquidity [Line Items] | |||||||
Shares issued | 37,065,647 |
Summary of Significant Accoun_3
Summary of Significant Accounting Policies - Additional Information (Details) | 3 Months Ended |
Mar. 31, 2024 | |
Accounting Policies [Abstract] | |
Change in accounting principle, accounting standards update, adopted [true false] | true |
Change in accounting principle, accounting standards update, adoption date | Jan. 01, 2024 |
Change in accounting principle, accounting standards update, immaterial effect [true false] | true |
Accounting standards update [extensible enumeration] | us-gaap:AccountingStandardsUpdate202006Member |
Fair Value Measurements - Summa
Fair Value Measurements - Summary of Assets Measured at Fair Value (Details) - Recurring - USD ($) $ in Thousands | Mar. 31, 2024 | Dec. 31, 2023 |
Assets | ||
Total assets measured at fair value | $ 100,815 | $ 131,613 |
Money Market Funds | ||
Assets | ||
Total assets measured at fair value | 100,815 | 131,613 |
Level 1 | ||
Assets | ||
Total assets measured at fair value | 100,815 | 131,613 |
Level 1 | Money Market Funds | ||
Assets | ||
Total assets measured at fair value | $ 100,815 | $ 131,613 |
Fair Value Measurements - Addit
Fair Value Measurements - Additional Information (Details) - USD ($) | 3 Months Ended | 12 Months Ended |
Mar. 31, 2024 | Dec. 31, 2023 | |
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | ||
Fair Value, Liabilities, Level 1 to Level 2 Transfers, Amount | $ 0 | $ 0 |
Fair Value, Liabilities, Level 2 to Level 1 Transfers, Amount | 0 | 0 |
Transfers into Level 3 | 0 | 0 |
Transfers out of Level 3 | $ 0 | $ 0 |
Prepaid Expenses and Other Cu_3
Prepaid Expenses and Other Current Assets - Summary of Prepaid Expenses and Other Current Assets (Details) - USD ($) $ in Thousands | Mar. 31, 2024 | Dec. 31, 2023 |
Deferred Costs, Capitalized, Prepaid, and Other Assets Disclosure [Abstract] | ||
Prepaid contract research and development costs | $ 2,833 | |
Insurance | 967 | $ 1,352 |
Research and development tax credit receivable | 796 | 814 |
Prepaid income taxes | 526 | 829 |
Value-added tax refund receivable | 113 | 313 |
Other | 911 | 754 |
Total prepaid expenses and other current assets | $ 6,146 | $ 4,062 |
Property and Equipment, Net - S
Property and Equipment, Net - Schedule of Property and Equipment, Net (Details) - USD ($) $ in Thousands | Mar. 31, 2024 | Dec. 31, 2023 |
Property, Plant and Equipment [Line Items] | ||
Less: accumulated depreciation | $ (392) | $ (330) |
Total property and equipment, net | 788 | 847 |
Laboratory equipment | ||
Property, Plant and Equipment [Line Items] | ||
Property and equipment, gross | 829 | 836 |
Office furniture | ||
Property, Plant and Equipment [Line Items] | ||
Property and equipment, gross | 236 | 238 |
Computer hardware | ||
Property, Plant and Equipment [Line Items] | ||
Property and equipment, gross | $ 115 | $ 103 |
Property and Equipment, Net - A
Property and Equipment, Net - Additional Information (Details) - USD ($) $ in Thousands | 3 Months Ended | |
Mar. 31, 2024 | Mar. 31, 2023 | |
Property, Plant and Equipment [Abstract] | ||
Depreciation expense | $ 100 | $ 50 |
Accrued Expenses and Other Cu_3
Accrued Expenses and Other Current Liabilities - Summary of Accrued Expenses and Other Current Liabilities (Details) - USD ($) $ in Thousands | Mar. 31, 2024 | Dec. 31, 2023 |
Payables and Accruals [Abstract] | ||
Accrued contract research and development costs | $ 3,841 | $ 6,153 |
Professional fees | 582 | 243 |
Employee compensation costs | 1,538 | 4,225 |
Other liabilities | 576 | 563 |
Total accrued expenses and other current liabilities | $ 6,537 | $ 11,184 |
Leases - Additional Information
Leases - Additional Information (Details) $ in Thousands | 3 Months Ended | ||
Mar. 31, 2024 USD ($) Lease | Mar. 31, 2023 USD ($) | Dec. 31, 2023 USD ($) | |
Lessee, Lease, Description [Line Items] | |||
Rent expense | $ 200 | $ 200 | |
Number of operating leases | Lease | 5 | ||
Right of use lease asset | $ 2,092 | $ 2,259 | |
Operating lease liability, current | 666 | 655 | |
Operating lease, liability, non-current | 1,650 | $ 1,839 | |
Office and Laboratory | Denmark | |||
Lessee, Lease, Description [Line Items] | |||
Operating lease amended base rent | 200 | ||
Office and Laboratory | New York, NY | |||
Lessee, Lease, Description [Line Items] | |||
Operating lease annual base rent | 200 | ||
Office and Laboratory | Maryland | |||
Lessee, Lease, Description [Line Items] | |||
Operating lease annual base rent | 300 | ||
Office | Denmark | |||
Lessee, Lease, Description [Line Items] | |||
Operating lease annual base rent | 100 | ||
Laboratory | Denmark | |||
Lessee, Lease, Description [Line Items] | |||
Operating lease annual base rent | $ 40 |
Leases - Schedule of Quantitati
Leases - Schedule of Quantitative information Regarding Leases (Details) - USD ($) $ in Thousands | 3 Months Ended | |
Mar. 31, 2024 | Mar. 31, 2023 | |
Lessee, Lease, Description [Line Items] | ||
Operating lease cost | $ 184 | $ 206 |
Operating cash flows paid for amounts included in the measurement of lease liabilities | 193 | 175 |
Operating lease liabilities arising from obtaining right-of-use assets | $ 0 | $ 165 |
Remaining average lease term (years) | 3 years 2 months 12 days | 4 years 3 months 18 days |
Weighted average discount rate | 6.30% | 6.50% |
Leases - Schedule of Future Lea
Leases - Schedule of Future Lease Payments (Undiscounted) under Noncancelable Leases (Details) $ in Thousands | Mar. 31, 2024 USD ($) |
Lessee, Operating Lease, Liability, to be Paid, Fiscal Year Maturity [Abstract] | |
Remainder of 2024 | $ 591 |
2025 | 787 |
2026 | 793 |
2027 | 397 |
2028 | 0 |
Thereafter | 0 |
Total | $ 2,568 |
Commitments and Contingencies -
Commitments and Contingencies - Additional Information (Details) | 3 Months Ended |
Mar. 31, 2024 | |
Minimum | |
Other Commitments [Line Items] | |
Contractual obligations termination notice period | 30 days |
Maximum | |
Other Commitments [Line Items] | |
Contractual obligations termination notice period | 90 days |
Stockholders' Equity - Addition
Stockholders' Equity - Additional Information (Details) | 3 Months Ended | ||||
Aug. 09, 2023 USD ($) $ / shares shares | Aug. 07, 2023 $ / shares shares | Mar. 31, 2024 USD ($) Vote $ / shares shares | Dec. 31, 2023 shares | Nov. 09, 2021 shares | |
Subsidiary, Sale of Stock [Line Items] | |||||
Common stock shares authorized | shares | 300,000,000 | 300,000,000 | 300,000,000 | ||
Preferred stock, shares authorized | shares | 5,000,000 | 5,000,000 | |||
Number of votes per share | Vote | 1 | ||||
Common stock shares outstanding | shares | 65,880,914 | 65,880,914 | 28,815,267 | ||
Proceeds from private placement | $ 71,900,000 | ||||
Private Placement | |||||
Subsidiary, Sale of Stock [Line Items] | |||||
Shares issued | shares | 37,065,647 | ||||
Warrants issued | shares | 37,065,647 | ||||
Purchase price per share of common stock and warrant | $ / shares | $ 2.025 | ||||
Offering expenses | $ 3,200,000 | ||||
Private Placement | Securities Purchase Agreement | |||||
Subsidiary, Sale of Stock [Line Items] | |||||
Warrants issued | shares | 37,065,647 | 37,065,647 | |||
Purchase price per share of common stock and warrant | $ / shares | $ 2.025 | ||||
Proceeds from private placement | 75,100,000 | ||||
Purchase Price of Common Stock and Warrants | $ / shares | $ 2.47 | $ 2.47 | |||
Net Proceeds From Issuance Of Private Placement | 71,900,000 | ||||
Offering expenses | 3,200,000 | ||||
Proceeds from Issuance of Warrants | $ 29,600,000 | ||||
Private Placement | Securities Purchase Agreement | Management | |||||
Subsidiary, Sale of Stock [Line Items] | |||||
Proceeds from private placement | 200,000 | ||||
Private Placement | Securities Purchase Agreement | Related Party | |||||
Subsidiary, Sale of Stock [Line Items] | |||||
Proceeds from private placement | $ 33,400,000 | ||||
Common Stock | Private Placement | Securities Purchase Agreement | |||||
Subsidiary, Sale of Stock [Line Items] | |||||
Shares issued | shares | 37,065,647 | ||||
Undesignated Preferred Stock | |||||
Subsidiary, Sale of Stock [Line Items] | |||||
Preferred stock, shares authorized | shares | 5,000,000 | ||||
Dividend Declared | |||||
Subsidiary, Sale of Stock [Line Items] | |||||
Dividends | 0 | ||||
Dividend Paid | |||||
Subsidiary, Sale of Stock [Line Items] | |||||
Dividends | $ 0 |
Equity-Based Compensation - Add
Equity-Based Compensation - Additional Information (Details) - USD ($) | 3 Months Ended | ||
Nov. 04, 2021 | Mar. 31, 2024 | Mar. 31, 2023 | |
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | |||
Unrecognized compensation cost | $ 12,700,000 | ||
Unrecognized compensation cost, recognition period | 3 years | ||
Tax benefits for stock-based compensation | $ 0 | $ 0 | |
2021 Equity Incentive Plan | |||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | |||
Number of warrants available for future grant | 642,341 | ||
Common stock reserved for issuance | 2,496,934 | ||
Maximum percentage of shares that may be issued under the plan as a proportion of outstanding capital stock | 4% | ||
2021 Employee Stock Purchase Plan | |||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | |||
Common stock reserved for issuance | 257,272 | ||
2021 Employee Stock Purchase Plan | Maximum | |||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | |||
Maximum percentage of shares that may be issued under the plan as a proportion of outstanding capital stock | 1% | ||
2023 Inducement Incentive Plan | |||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | |||
Number of warrants available for future grant | 1,976,427 | ||
Common stock reserved for issuance | 1,976,427 |
Equity-Based Compensation - Sch
Equity-Based Compensation - Schedule of Stock Options Activity (Details) - Warrant - USD ($) $ / shares in Units, $ in Thousands | 3 Months Ended | 12 Months Ended |
Mar. 31, 2024 | Dec. 31, 2023 | |
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] | ||
Number of Warrants, Beginning balance | 5,851,923 | |
Number of Warrants, Granted | 2,626,930 | |
Number of Warrants, Cancelled or forfeited | (40,567) | |
Number of Warrants, Ending balance | 8,438,286 | 5,851,923 |
Number of Warrants, Exercisable | 2,483,730 | |
Weighted-average exercise price per share, Beginning balance | $ 7.2 | |
Weighted-average exercise price per share, Granted | 1.65 | |
Weighted-average exercise price per share, Cancelled or forfeited | 6.24 | |
Weighted-average exercise price per share, Ending balance | 5.47 | $ 7.2 |
Weighted-average exercise price per share, Exercisable | $ 9.81 | |
Weighted-average remaining contractual term (in years), Outstanding | 8 years 8 months 12 days | 8 years 4 months 24 days |
Weighted-average remaining contractual term (in years), Exercisable | 7 years 7 months 6 days | |
Aggregate intrinsic value, Outstanding | $ 292 | $ 102 |
Aggregate intrinsic value, Exercisable | $ 5 |
Equity-Based Compensation - Sum
Equity-Based Compensation - Summary of Assumptions for Estimated Fair Value of Options (Details) | 3 Months Ended |
Mar. 31, 2024 | |
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] | |
Expected volatility minimum | 87.30% |
Expected volatility maximum | 87.40% |
Risk-free interest rate minimum | 4.20% |
Risk-free interest rate maximum | 4.30% |
Expected term (in years) | 6 years 1 month 6 days |
Expected dividend yield | 0% |
Equity-Based Compensation - S_2
Equity-Based Compensation - Schedule of Equity-based Compensation Expense (Details) - USD ($) $ in Thousands | 3 Months Ended | |
Mar. 31, 2024 | Mar. 31, 2023 | |
Employee Service Share Based Compensation Allocation Of Recognized Period Costs [Line Items] | ||
Total equity-based compensation | $ 1,567 | $ 1,888 |
Research and Development Expense | ||
Employee Service Share Based Compensation Allocation Of Recognized Period Costs [Line Items] | ||
Total equity-based compensation | 613 | 704 |
General and Administrative Expense | ||
Employee Service Share Based Compensation Allocation Of Recognized Period Costs [Line Items] | ||
Total equity-based compensation | $ 954 | $ 1,184 |
Income Taxes - Additional Infor
Income Taxes - Additional Information (Details) - USD ($) $ in Thousands | 3 Months Ended | |
Mar. 31, 2024 | Mar. 31, 2023 | |
Income Tax Disclosure [Abstract] | ||
Income taxes expense | $ 415 | $ 406 |
Net Loss Per Share - Basic and
Net Loss Per Share - Basic and Diluted Net Loss Per Ordinary Share (Details) - USD ($) $ / shares in Units, $ in Thousands | 3 Months Ended | 12 Months Ended | |
Mar. 31, 2024 | Mar. 31, 2023 | Dec. 31, 2023 | |
Earnings Per Share [Abstract] | |||
Net loss | $ (19,457) | $ (17,044) | $ (86,100) |
Net loss attributable to common shareholders | $ (19,457) | $ (17,044) | |
Net loss per common share, basic | $ (0.3) | $ (0.59) | |
Net loss per common share, diluted | $ (0.3) | $ (0.59) | |
Weighted-average number of shares used in computing net loss per common share, basic | 65,880,914 | 28,815,267 | |
Weighted-average number of shares used in computing net loss per common share, diluted | 65,880,914 | 28,815,267 |
Net Loss Per Share - Schedule o
Net Loss Per Share - Schedule of Potentially Dilutive Securities Excluded from Calculation of Diluted Net Loss per Share (Details) - shares | 3 Months Ended | |
Mar. 31, 2024 | Mar. 31, 2023 | |
Stock Options to Purchase Common Stock | ||
Earnings Per Share Basic [Line Items] | ||
Outstanding potentially dilutive securities | 8,438,286 | 5,500,126 |
Warrants Issued in Private Placement | ||
Earnings Per Share Basic [Line Items] | ||
Outstanding potentially dilutive securities | 37,065,647 |