Cabaletta Bio Inc 2024年度报告

Title of each classTradingSymbol(s)Name of each exchange on whichregisteredCommon Stock, par value $0.00001 pershareCABAThe Nasdaq Global Select Market Securities registered pursuant to Section 12(g) of the Act: None Indicate by check mark if the registrant is a well-known seasoned issuer, as defined in Rule 405 ofthe Securities Act. Yes☐No☒ Indicate by check mark if the registrant is not required to file reports pursuant to Section 13 orSection 15(d) of the Act. Yes☐No☒ Indicate by check mark whether the registrant: (1) has filed all reports required to be filed by Section13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for suchshorter period that the registrant was required to file such reports), and (2) has been subject to suchfiling requirements for the past 90 days.Yes☒No☐ Indicate by check mark whether the registrant has submitted electronically every Interactive DataFile required to be submitted pursuant to Rule 405 of Regulation S-T (§232.405 of this chapter)during the preceding 12 months (or for such shorter period that the registrant was required to submitsuch files).Yes☒No☐ Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, a smaller reporting company, or an emerging growth company. See the definitionsof “large accelerated filer,” “accelerated filer,” “smaller reporting company,” and “emerging growthcompany” in Rule 12b-2 of the Exchange Act. Large acceleratedfiler☐.Non-acceleratedfiler☒ If an emerging growth company, indicate by check mark if the registrant has elected not to use theextended transition period for complying with any new or revised financial accounting standardsprovided pursuant to Section 13(a) of the Exchange Act.☐ Indicate by check mark whether the registrant has filed a report on and attestation to itsmanagement’s assessment of the effectiveness of its internal control over financial reporting underSection 404(b) of the Sarbanes-Oxley Act (15 U.S.C. 7262(b)) by the registered public accountingfirm that prepared or issued its audit report.☐ If securities are registered pursuant to Section 12(b) of the Act, indicate by check mark whether thefinancial statements of the registrant included in the filing reflect the correction of an error to previously issued financial statements.☐ Indicate by check mark whether any of those error corrections are restatements that required arecovery analysis of incentive-based compensation received by any of the registrant’s executiveofficers during the relevant recovery period pursuant to §240.10D-1(b).☐ Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of theAct). Yes☐No☒ As of June 30, 2024 (the last business day of the registrant's most recently completed second fiscalquarter), the aggregate market value of the registrant's common stock held by non-affiliates wasapproximately $350million based on the last reported sale price of the registrant's common stock onthe Nasdaq Global Select Market on June 30, 2024. The number of shares of registrant’s Common Stock outstanding as of March 27, 2025 was50,743,101. Table of Contents PARTI 4Item1.Business4Item1A.Risk Factors36Item1B.Unresolved Staff Comments93Item1C.Cybersecurity94Item2.Properties94Item3.Legal Proceedings94Item4.Mine Safety Disclosures94 PARTII Item 5.Market for Registrant’s Common Equity, Related StockholderMatters and Issuer Purchases of Equity Securities95Item6.Reserved95Item7.Management’s Discussion and Analysis of Financial Conditionand Results of Operations96Item7A.Quantitative and Qualitative Disclosures About Market Risk110Item8.Consolidated Financial Statements and Supplementary Data110Item9.Changes in and Disagreements With Accountants on Accountingand Financial Disclosure110Item9A.Controls and Procedures111Item9B.Other Information112Item9C.Disclosure Regarding Foreign Jurisdictions that PreventInspections112 PARTIII Item10.Directors, Executive Officers and Corporate Governance113Item11.Executive Compensation120Item12.Security Ownership of Certain Beneficial Owners andManagement and Related Stockholder Matters128Item13.Certain Relationships and Related Transactions, and DirectorIndependence131Item14.Principal Accounting Fees and Services133 PARTIV134Item15.Exhibits, Consolidated Financial Statement Schedules134Item16Form 10-K Summary134Signatures139 Summary of the Material and Other Risks Associated with Our Business •We are a clinical-stage company with a limited operating history, have incurred significant lossessince our inception, and anticipate that we will continue to incur significant losses for theforeseeable future.•We are highly dependent on our relationships with University of Pennsylvania, or Penn, and/orWuXi Advanced Therapies, Inc., or WuXi, for our current manufacturing needs for our Phase 1/2RESETTM, or Restoring Self-Tolerance, clinical trials for resecabtagene autoleucel (rese-cel,formerly