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Cabaletta Bio, Inc., a clinical-stage biotechnology company, focuses on the discovery and development of engineered T cell therapies for patients with B cell-mediated autoimmune diseases. Its proprietary technology utilizes chimeric autoantibody receptor (CAAR) T cells that are designed to selectively bind and eliminate B cells, which produce disease-causing autoantibodies or pathogenic B cells. The company's lead product candidate is DSG3-CAART, which is in Phase I clinical trial for the treatment of mucosal pemphigus vulgaris, an autoimmune blistering skin disease, and Hemophilia A with Factor VIII alloantibodies. Its product candidate pipeline also includes MuSK-CAART, a preclinical stage product to treat a subset of patients with myasthenia gravis; FVIII-CAART, a discovery stage product to treat a subset of patients with Hemophilia A; and DSG3/1-CAART, a discovery stage product for the treatment of mucocutaneous pemphigus vulgaris. It has a collaboration with the University of Pennsylvania; and research agreement with The Regents of the University of California. The company was formerly known as Tycho Therapeutics, Inc. and changed its name to Cabaletta Bio, Inc. in August 2018. Cabaletta Bio, Inc. was incorporated in 2017 and is headquartered in Philadelphia, Pennsylvania.

Cabaletta Bio, Inc.

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RESE-CEL DATA PRESENTED AT MULTIPLE MEDICAL MEETINGS DEMONSTRATED POTENTIALLY TRANSFORMATIVE, DRUG-FREE CLINICAL RESPONSES WITH A FAVORABLE SAFETY PROFILE FOR AUTOIMMUNE PATIENTS SUPPORTING OUTPATIENT USE ALL MYOSITIS PATIENTS IN THE PHASE 1/2 DM/ASYS COHORT WITH SUFFICIENT FOLLOW-UP WHO WOULD HAVE MET KEY CRITERIA FOR THE REGISTRATIONAL COHORT MET THE REGISTRATIONAL, 16-WEEK PRIMARY ENDPOINT PLANNED BLA SUBMISSION FOR RESE-CEL IN 2027 BASED ON 14-PATIENT, SINGLE-ARM DM/ASYS REGISTRATIONAL COHORT INITIATING ENROLLMENT THIS QUARTER WITHIN THE RESET-MYOSITIS TRIAL FDA ALIGNMENT ON ADDITIONAL REGISTRATIONAL COHORT DESIGNS FOR RESET-SSC AND RESET-SLE ANTICIPATED BY YEAR-END 2025 PHILADELPHIA, NOV. 10, 2025 (GLOBE NEWSWIRE) -- CABALETTA BIO, INC. (NASDAQ: CABA), A CLINICAL-STAGE BIOTECHNOLOGY COMPANY FOCUSED ON DEVELOPING AND LAUNCHING THE FIRST CURATIVE TARGETED CELL THERAPIES DESIGNED SPECIFICALLY FOR PATIENTS WITH AUTOIMMUNE DISEASES, TODAY REPORTED FINANCIAL RESULTS FOR THE THIRD QUARTER ENDED SEPTEMBER 30, 2025, AND PROVIDED A BUSINESS UPDATE. OUR TEAM CONTINUED TO EXECUTE WITH DISCIPLINE AND PRECISION TO EXTEND OUR LEADERSHIP THROUGH THE RESET CLINICAL DEVELOPMENT PROGRAM.

CABALETTA BIO REPORTS THIRD QUARTER 2025 FINANCIAL RESULTS AND PROVIDES BUSINESS UPDATE

PHILADELPHIA, NOV. 04, 2025 (GLOBE NEWSWIRE) -- CABALETTA BIO, INC. (NASDAQ: CABA), A CLINICAL-STAGE BIOTECHNOLOGY COMPANY FOCUSED ON DEVELOPING AND LAUNCHING THE FIRST CURATIVE TARGETED CELL THERAPIES DESIGNED SPECIFICALLY FOR PATIENTS WITH AUTOIMMUNE DISEASES, TODAY ANNOUNCED THAT THE COMPANY WILL PARTICIPATE IN THE FOLLOWING UPCOMING INVESTOR CONFERENCES IN NOVEMBER AND DECEMBER:

CABALETTA BIO TO PARTICIPATE IN UPCOMING INVESTOR CONFERENCES IN NOVEMBER AND DECEMBER

 ALL MYOSITIS PATIENTS IN THE PHASE 1/2 DM/ASYS COHORT WITH SUFFICIENT FOLLOW-UP WHO MET KEY REGISTRATIONAL INCLUSION CRITERIA EXCEEDED THE REGISTRATIONAL PRIMARY ENDPOINT, DEMONSTRATING MAJOR TIS RESPONSES WITH NO IMMUNOMODULATORS   MYOSITIS REGISTRATIONAL TRIAL BEING INITIATED THIS QUARTER WITH A PLANNED COHORT OF 14 DM/ASYS PATIENTS AND A 16-WEEK PRIMARY ENDPOINT  MODERATE OR MAJOR TIS WHILE OFF IMMUNOMODULATORS AND ON NO OR LOW-DOSE STEROIDS  CONSISTENT WITH FDA ALIGNMENT ON KEY TRIAL PARAMETERS   ALL SYSTEMIC SCLEROSIS PATIENTS WITH SUFFICIENT FOLLOW-UP DEMONSTRATED ONGOING, TRANSFORMATIVE CLINICAL RESPONSES OFF ALL IMMUNOMODULATORS AND STEROIDS   SEVEN OF 8 LUPUS PATIENTS WITH SUFFICIENT FOLLOW-UP ACHIEVED DORIS OR RENAL RESPONSE; RESET-SLE TRIAL EXPANDING TO INCLUDE A NO PRECONDITIONING COHORT WITH INITIAL CLINICAL DATA EXPECTED IN 2026   76 PATIENTS ENROLLED AT 77 CLINICAL TRIAL SITES GLOBALLY AS OF OCTOBER 24, 2025  PHILADELPHIA, OCT. 27, 2025 (GLOBE NEWSWIRE) -- CABALETTA BIO, INC. (NASDAQ: CABA), A CLINICAL-STAGE BIOTECHNOLOGY COMPANY FOCUSED ON DEVELOPING AND LAUNCHING THE FIRST CURATIVE TARGETED CELL THERAPIES DESIGNED SPECIFICALLY FOR PATIENTS WITH AUTOIMMUNE DISEASES, TODAY ANNOUNCED POSITIVE CLINICAL DATA AND DEVELOPMENT UPDATES ACROSS THE RESET-MYOSITIS, RESET-SSC AND RESET-SLE TRIALS EVALUATING RESE-CEL (RESECABTAGENE AUTOLEUCEL, FORMERLY KNOWN AS CABA-201). THESE DATA ARE BEING PRESENTED IN MULTIPLE ORAL AND POSTER PRESENTATIONS AT THE ONGOING AMERICAN COLLEGE OF RHEUMATOLOGY (ACR) CONVERGENCE 2025, WHICH IS BEING HELD AT THE MCCORMICK PLACE CONVENTION CENTER IN CHICAGO, ILLINOIS, FROM OCTOBER 24-29, 2025.

Cabaletta Bio, Inc.

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