Cabaletta Bio Inc 2025年度报告

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 such filing requirements for the past 90 days. Yes☒No☐ 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 topreviously 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, 2025 (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 $137 million based on the last reported sale price of the registrant's common stock onthe Nasdaq Global Select Market on June 30, 2025. The number of shares of registrant’s Common Stock outstanding as of March 19, 2026 was111,322,671. Table of Contents PARTI 5Item1.Business5Item1A.Risk Factors41Item1B.Unresolved Staff Comments115Item1C.Cybersecurity116Item2.Properties116Item3.Legal Proceedings116Item4.Mine Safety Disclosures116 PARTII Item5.Market for Registrant’s Common Equity, Related StockholderMatters and Issuer Purchases of Equity Securities117Item6.Reserved117Item7.Management’s Discussion and Analysis of Financial Conditionand Results of Operations118Item7A.Quantitative and Qualitative Disclosures About Market Risk133Item8.Consolidated Financial Statements and Supplementary Data133Item9.Changes in and Disagreements With Accountants on Accountingand Financial Disclosure133Item9A.Controls and Procedures134Item9B.Other Information136Item9C.Disclosure Regarding Foreign Jurisdictions that PreventInspections136 PartIII137ItemDirectors, Executive Officers and Corporate Governance 10.137Item11.Executive Compensation137Item12.Security Ownership of Certain Beneficial Owners andManagement and Related Stockholder Matters137Item13.Certain Relationships and Related Transactions, and DirectorIndependence137Item14.Principal Accounting Fees and Services137 PARTIV138Item15.Exhibits, Consolidated Financial Statement Schedules138Item16Form 10-K Summary138Signatures139 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 losses since our inception, and anticipatethat we will continue to incur significant losses for the foreseeablefuture.•We are highly dependent on our relationships with MinarisAdvanced Therapies, LLC, or Minaris (f/k/a WuXi AdvancedTherapies, Inc) and/or Lonza Houston Inc., or Lonza, and/orCellares Corporation, or Cellares, for our current manufacturingneeds for our Phase 1/2 RESET, or Restoring Self-Tolerance,clinical trials for resecabtagene autoleucel, or rese-cel (formerlyreferred to as CABA-201), and if manufacturing capacity at any ofthese manufacturing partners is reduced or otherwise delayed orlimited, including due to legislative action, or if we, Minaris, Lonza,Cellares or any third-party manufacturers encounter difficu