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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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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 PRESENTS POSITIVE CLINICAL DATA AND DEVELOPMENT UPDATES FOR RESE-CEL AT ACR CONVERGENCE 2025

 GAVEL BRINGS HIGHLY RELEVANT CAR T EXPERIENCE FROM LEGEND BIOTECH WHERE HE LED THE LAUNCH AND COMMERCIALIZATION OF CARVYKTI FROM 2018 UNTIL 2025  PHILADELPHIA, OCT. 14, 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 THE APPOINTMENT OF STEVE GAVEL AS CHIEF COMMERCIAL OFFICER, EFFECTIVE IMMEDIATELY. IN HIS ROLE, MR.

CABALETTA BIO ANNOUNCES APPOINTMENT OF STEVE GAVEL AS CHIEF COMMERCIAL OFFICER AND AWARD OF INDUCEMENT GRANT

 COMPLETE B CELL DEPLETION, RAPID REDUCTION IN AUTOANTIBODIES AND NEAR-COMPLETE RESOLUTION OF CLINICAL SYMPTOMS IN TWO OF THREE REFRACTORY PATIENTS; ALL THREE PATIENTS REMAINED OFF IMMUNOMODULATORS SINCE INFUSION AND ARE OFF OR TAPERING STEROIDS AS OF THE DATA CUT-OFF 

CABALETTA BIO PRESENTS FIRST RESE-CEL DATA WITH NO PRECONDITIONING DEMONSTRATING BIOLOGIC ACTIVITY AND EARLY CLINICAL RESPONSES AT THE 2025 ESGCT ANNUAL CONGRESS

 REGISTRATIONAL COHORT ENROLLMENT IN RESET-MYOSITIS TRIAL ON TRACK TO START IN 2H25 WITH ANTICIPATED 2027 BLA SUBMISSION FOR RESE-CEL IN MYOSITIS 

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

PHILADELPHIA, JUNE 11, 2025 (GLOBE NEWSWIRE) -- CABALETTA BIO, INC. (CABALETTA OR THE COMPANY) (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, ANNOUNCED TODAY THE PRICING OF AN UNDERWRITTEN PUBLIC OFFERING CONSISTING OF (I) 39,200,000 SHARES OF ITS COMMON STOCK AND ACCOMPANYING WARRANTS TO PURCHASE AN AGGREGATE OF 39,200,000 SHARES OF COMMON STOCK (OR PRE-FUNDED WARRANTS IN LIEU THEREOF) AND (II) IN LIEU OF COMMON STOCK, TO CERTAIN INVESTORS, PRE-FUNDED WARRANTS TO PURCHASE AN AGGREGATE OF UP TO 10,800,000 SHARES OF ITS COMMON STOCK AND ACCOMPANYING WARRANTS TO PURCHASE AN AGGREGATE OF 10,800,000 SHARES OF COMMON STOCK (OR PRE-FUNDED WARRANTS IN LIEU THEREOF), AT AN EXERCISE PRICE OF $0.00001 PER PRE-FUNDED WARRANT. CABALETTA ALSO GRANTED THE UNDERWRITERS A 30-DAY OPTION TO PURCHASE UP TO AN ADDITIONAL 15,000,000 SHARES OF COMMON STOCK AND/OR WARRANTS AT THE PUBLIC OFFERING PRICE, LESS UNDERWRITING DISCOUNTS AND COMMISSIONS. THE COMMON STOCK AND PRE-FUNDED WARRANTS ARE BEING SOLD IN COMBINATION WITH AN ACCOMPANYING WARRANT TO PURCHASE ONE SHARE OF COMMON STOCK (OR A PRE-FUNDED WARRANT IN LIEU THEREOF) ISSUED FOR EACH SHARE OF COMMON STOCK OR PRE-FUNDED WARRANT SOLD. THE ACCOMPANYING WARRANT HAS AN EXERCISE PRICE OF $2.50 PER SHARE, IS IMMEDIATELY EXERCISABLE FROM THE DATE OF ISSUANCE AND WILL EXPIRE FIFTEEN MONTHS FROM THE DATE OF ISSUANCE. THE COMBINED OFFERING PRICE OF EACH SHARE OF COMMON STOCK AND ACCOMPANYING COMMON STOCK WARRANT IS $2.00. THE COMBINED OFFERING PRICE OF EACH PRE-FUNDED WARRANT AND ACCOMPANYING COMMON STOCK WARRANT IS $1.99999.

CABALETTA BIO ANNOUNCES PRICING OF PUBLIC OFFERING OF SECURITIES

PHILADELPHIA, JUNE 11, 2025 (GLOBE NEWSWIRE) -- CABALETTA BIO, INC. (CABALETTA OR THE COMPANY) (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, ANNOUNCED THAT IT HAS COMMENCED AN UNDERWRITTEN PUBLIC OFFERING OF SHARES OF ITS COMMON STOCK AND ACCOMPANYING WARRANTS TO PURCHASE SHARES OF ITS COMMON STOCK (OR PRE-FUNDED WARRANTS IN LIEU THEREOF) AND, IN LIEU OF COMMON STOCK, TO CERTAIN INVESTORS, PRE-FUNDED WARRANTS TO PURCHASE SHARES OF ITS COMMON STOCK AND ACCOMPANYING WARRANTS TO PURCHASE SHARES OF ITS COMMON STOCK (OR PRE-FUNDED WARRANTS IN LIEU THEREOF). CABALETTA ALSO INTENDS TO GRANT THE UNDERWRITERS A 30-DAY OPTION TO PURCHASE UP TO AN ADDITIONAL FIFTEEN PERCENT (15%) OF THE SHARES OF COMMON STOCK AND WARRANTS OFFERED IN THE PUBLIC OFFERING. ALL OF THE SHARES, PRE-FUNDED WARRANTS AND ACCOMPANYING COMMON STOCK WARRANTS TO BE SOLD IN THE PROPOSED OFFERING ARE TO BE SOLD BY CABALETTA.

CABALETTA BIO ANNOUNCES PROPOSED PUBLIC OFFERING OF SECURITIES

 7 OF 8 MYOSITIS PATIENTS ACHIEVED CLINICALLY MEANINGFUL TIS RESPONSES AFTER DISCONTINUATION OF ALL IMMUNOMODULATORS, WHILE OFF OR ACTIVELY TAPERING STEROIDS; RESPONSES WERE SUSTAINED THROUGHOUT THE FOLLOW-UP PERIOD IN ALL RESPONDING PATIENTS 

CABALETTA BIO ANNOUNCES NEW RESE-CEL SAFETY AND EFFICACY DATA IN PATIENTS WITH MYOSITIS, LUPUS AND SCLERODERMA TO BE PRESENTED AT THE EULAR 2025 CONGRESS

PHILADELPHIA, MAY 29, 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 A FIRESIDE CHAT AT THE JEFFERIES GLOBAL HEALTHCARE CONFERENCE ON WEDNESDAY, JUNE 4, 2025, AT 11:05 A.M. ET IN NEW YORK, NY.

CABALETTA BIO TO PARTICIPATE IN THE JEFFERIES GLOBAL HEALTHCARE CONFERENCE

 TWO SUBTYPE SPECIFIC COHORTS WITH ~15 PATIENTS EACH ADDED TO THE ONGOING RESET-MYOSITISTRIAL   RMAT DESIGNATION GRANTED FOR RESE-CEL IN MYOSITIS, WHICH IS A DISABLING, MULTI-SYSTEM AUTOIMMUNE DISEASE AFFECTING APPROXIMATELY 80,000 U.S. PATIENTS WITH NO APPROVED TREATMENTS OTHER THAN MONTHLY IVIG   MULTIPLE PHASE 1/2 DISEASE COHORTS FULLY ENROLLED ACROSS THE RESET CLINICAL DEVELOPMENT PROGRAM; 44 PATIENTS ENROLLED AND 23 PATIENTS DOSED AS OF MAY 9, 2025   SLE AND LN REGISTRATIONAL DISCUSSIONS WITH FDA ANTICIPATED IN 3Q25; SYSTEMIC SCLEROSIS REGISTRATIONAL DISCUSSIONS WITH FDA ANTICIPATED IN 4Q25   NEW CLINICAL DATA ON RESE-CEL IN MYOSITIS, SLE / LN AND SYSTEMIC SCLEROSIS TO BE PRESENTED IN THREE ORAL SESSIONS AT THE EULAR 2025 CONGRESS IN JUNE  PHILADELPHIA, MAY 15, 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 PLANS FOR AN ANTICIPATED 2027 RESE-CEL BLA SUBMISSION FOLLOWING A RECENT U.S. FOOD AND DRUG ADMINISTRATION (FDA) MEETING ON A PROPOSED REGISTRATIONAL COHORT DESIGN FOR THE RESET-MYOSITIS TRIAL OF RESE-CEL (RESECABTAGENE AUTOLEUCEL, FORMERLY KNOWN AS CABA-201). MYOSITIS IS A SEVERE, DISABLING, AND POTENTIALLY LIFE-THREATENING MULTI-SYSTEM DISEASE THAT AFFECTS APPROXIMATELY 80,000 PATIENTS IN THE U.S. WITH A THREE-FOLD INCREASED MORTALITY RISK PRIMARILY DUE TO INTERSTITIAL LUNG DISEASE, CARDIOVASCULAR DISEASE AND AN INCREASED RISK OF CANCER.

CABALETTA BIO ANNOUNCES 2027 RESE-CEL BLA SUBMISSION ANTICIPATED IN MYOSITIS FOLLOWING RECENT FDA ALIGNMENT ON REGISTRATIONAL COHORTS

 FDA MEETING TO ALIGN ON MYOSITIS REGISTRATIONAL TRIAL DESIGNS FOR RESE-CEL IN 1H25 ON TRACK   ENROLLING APPROXIMATELY ONE PATIENT PER WEEK ACROSS THE RESET CLINICAL DEVELOPMENT PROGRAM SINCE ACR CONVERGENCE PRESENTATION IN NOVEMBER 2024 WITH 33 PATIENTS ENROLLED ACROSS 56 ACTIVE CLINICAL TRIAL SITES IN THE U.S. & EUROPE AS OF MARCH 14, 2025   CLINICAL AND TRANSLATIONAL DATA ON RESE-CEL TO BE PRESENTED IN THREE ORAL PRESENTATIONS AT THE EULAR 2025 CONGRESS IN JUNE   OPERATIONAL RUNWAY INTO 1H26 WITH CASH AND CASH EQUIVALENTS OF $164.0 MILLION AS OF DECEMBER 31, 2024  PHILADELPHIA, MARCH 31, 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 FOURTH QUARTER AND FULL YEAR ENDED DECEMBER 31, 2024, AND PROVIDED A BUSINESS UPDATE. WE ARE LOOKING FORWARD TO MEETING WITH THE FDA TO ALIGN ON REGISTRATIONAL TRIAL DESIGNS IN MYOSITIS, WHICH AFFECTS APPROXIMATELY 70,000 PATIENTS IN THE U.S., BY LEVERAGING OUR EMERGING CLINICAL DATA AND OUR EFFICIENT DEVELOPMENT STRATEGY.

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