CABA-201 is designed to deeply and transiently deplete CD19-positive cells following a one-time infusion, which may enable an "immune system reset" with the potential for durable remission without chronic therapy in patients with autoimmune diseases. Cabaletta is evaluating CABA-201 in multiple autoimmune conditions within five disease-specific company sponsored INDs including myositis (idiopathic inflammatory myopathy, or IIM), systemic lupus erythematosus (SLE), systemic sclerosis (SSc), generalized myast ...

FORM 10-Q Title of each class Symbol(s) Name of each exchange on which registered Common Stock, par value $0.00001 per share CABA The Nasdaq Global Select Market Indicate by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter 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 ☒ ...

Exhibit 99.1 – No CRS or ICANS of any grade observed during the 28-day DLT observation window for either of the first patients dosed with CABA-201 in the RESET-Myositis™ and RESET-SLE™ trials – PHILADELPHIA, May 15, 2024 – 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 first quarter ended March 31, 202 ...

Title of each classTrading Symbol(s) Name of each exchange on which registered Common Stock, par value $0.00001 per share CABA The 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 of the Securities Act. Yes ☒ No ☐ Indicate by check mark if the registrant is not required to file reports pursuant to Section 13 or Section 15(d) of the Act. Yes ☐ No ☒ Indicate by check mar ...

– First patient dosed with CABA-201 in the RESET™ (REstoring SElf-Tolerance) clinical trial program – – Initial clinical data from each of the first patients in the RESET-Myositis™ and RESET-SLE™ trials anticipated in 1H24; longer term follow-up on these and additional patients to be reported in 2H24 – – RESET-SSc™ (systemic sclerosis) and RESET-MG™ trials initial clinical data anticipated to be reported in 2H24 – – Rare Pediatric Disease designation granted by FDA for CABA-201 in juvenile dermatomyositis – ...

PHILADELPHIA, March 20, 2024 (GLOBE NEWSWIRE) -- Cabaletta Bio, Inc. (NASDAQ:CABA), a clinical-stage biotechnology company focused on developing and launching the first curative targeted cell therapies for patients with autoimmune diseases, today announced that the U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation (ODD) to CABA-201, a 4-1BB-containing fully human CD19-CAR T cell investigational therapy, for the treatment of systemic sclerosis (SSc). CABA-201 is in development as a ...

PHILADELPHIA, Feb. 01, 2024 (GLOBE NEWSWIRE) -- Cabaletta Bio, Inc. (NASDAQ:CABA), a clinical-stage biotechnology company focused on developing and launching the first curative targeted cell therapies for patients with autoimmune diseases, today announced that the U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation (ODD) to CABA-201, a 4-1BB-containing fully human CD19-CAR T cell investigational therapy, for the treatment of idiopathic inflammatory myopathies (IIM, or myositis). CABA ...

Tanjim Hasan Tamim/iStock via Getty Images Cabaletta Bio (NASDAQ:CABA) fast making headway with its lead asset CABA-201 for the treatment of patients with autoimmune disorders. This is a CD-19 CAR-T therapy being used for the treatment of patients with lupus nephritis [SLE of the kidney] and non-renal SLE as well. What makes this company unique would be its approach of attaching a 4-1BB co-stimulatory domain to the drug to enhance efficacy. The main form of the technology is known as Chimeric Antigen Re ...

2019 Employee Stock Purchase Plan 20 In December 2021, we entered into a Licence and Supply agreement, or LSA, with Oxford Biomedica (UK) Limited, or Oxford, wherein the LSA grants us a non-exclusive license to Oxford's LentiVector® platform for its application in our DSG3-CAART program and puts in place a multi-year vector supply agreement. Under the terms of the agreement, we were required to pay Oxford an upfront fee, as well as costs associated with initial vector manufacturing activities for a total co ...

1 • the potential advantages of our proprietary Cabaletta Approach for B cell Ablation platform, called our CABA TM platform, and our product candidates; • our ability to obtain funding for our operations, including funding necessary to initiate and complete our DesCAARTes TM trial, our MusCAARTes TMtrial, our planned clinical trial of CABA-201 and our ongoing preclinical studies of other product candidates; • the potential achievement of milestones and receipt of payments under our collaborations; • our ab ...