Cabaletta Bio Inc 2026年季度报告

(Mark One)☒QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGEACT OF 1934 For the quarterly period ended March 31, 2026 OR CABALETTA BIO, INC. (Exact Name of Registrant as Specified in its Charter) Indicate by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of theSecurities Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required tofile such reports), and (2) has been subject to such filing requirements for the past 90 days.Yes☒No☐ Indicate by check mark whether the registrant has submitted electronically every Interactive Data File required to besubmitted pursuant to Rule 405 of Regulation S-T (§232.405 of this chapter) during the preceding 12 months (or for such shorterperiod that the registrant was required to submit such files).Yes☒No☐ Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer,smaller reporting company, or an emerging growth company. See the definitions of “large accelerated filer,” “accelerated filer,”“smaller reporting company,” and “emerging growth company” in Rule 12b-2 of the Exchange Act. Large accelerated filer☐Non-accelerated filer☒Emerging growthcompany☐ If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transitionperiod for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the ExchangeAct.☐ Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act).Yes☐No☒ As of May 7, 2026, the registrant had 163,054,796 shares of common stock, $0.00001 par value per share, outstanding. Table of Contents PagePART I.FINANCIAL INFORMATION4Item 1.Financial Statements (Unaudited)4Condensed Consolidated Balance Sheets4Condensed Consolidated Statements of Operations and Comprehensive Loss5Condensed Consolidated Statements of Stockholders’ Equity6Condensed Consolidated Statements of Cash Flows8Notes to Unaudited Condensed Consolidated Financial Statements9Item 2.Management’s Discussion and Analysis of Financial Condition and Results of Operations23Item 3.Quantitative and Qualitative Disclosures About Market Risk35Item 4.Controls and Procedures35PART II.OTHER INFORMATION36Item 1.Legal Proceedings36Item 1A.Risk Factors36Item 2.Unregistered Sales of Equity Securities, Use of Proceeds and Issuer Purchases of EquitySecurities99Item 3.Defaults Upon Senior Securities99Item 4.Mine Safety Disclosures99Item 5.Other Information99Item 6.Exhibits100Signatures101 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 sinceour inception, and anticipate that we will continue to incur significant losses for the foreseeable future.•We are highly dependent on our relationships with Minaris Advanced Therapies, LLC, or Minaris (f/k/aWuXi Advanced Therapies, Inc) and/or Lonza Houston Inc., or Lonza, and/or Cellares Corporation, orCellares, for our current manufacturing needs for our Phase 1/2 RESET, or Restoring Self-Tolerance,clinical trials for resecabtagene autoleucel, or rese-cel (formerly referred to as CABA-201), and ifmanufacturing capacity at any of these manufacturing partners is reduced or otherwise delayed orlimited, including due to legislative action, or if we, Minaris, Lonza, Cellares or any third-partymanufacturers encounter difficulties in manufacturing our product candidates, this could adverselyimpact the supply of product candidates for and enrollment in our trials.•We are reliant on intellectual property licensed to us by Nanjing IASO Biotherapeutics Co., Ltd., orIASO, and termination of this license agreement would result in the loss of significant rights, whichwould have a material adverse effect on our business.•If we are unable to obtain and maintain sufficient intellectual property protection for our currentproduct candidates and technologies or any future product candidates, we may not be able to competeeffectively in our markets.•We will need to raise substantial additional funding before we can expect to complete development ofany of our product candidates or generate any revenues from product sales.•Our limited operating history may make it difficult for you to evaluate the success of our business todate and to assess our future viability.•If we are unable to successfully develop our current programs into a portfolio of product candidates, orexperience significant delays in doing so, we may not realize the full commercial potential of ourcurrent and future product candidates.•If we encounter difficulties enrolling patients in our RESETTMclinical trials for rese-cel or futureclinical trials, these clinical development activities could be delayed or otherwise adversely affected.•If we are unable to advance our pr