Core Viewpoint - Cabaletta Bio, Inc. has initiated an underwritten public offering of its common stock and accompanying warrants, aiming to raise capital for its clinical-stage biotechnology operations focused on autoimmune diseases [1][2]. Group 1: Offering Details - The public offering includes shares of common stock and pre-funded warrants, with an option for underwriters to purchase an additional 15% of the offering [1][2]. - The offering is expected to close around June 12, 2025, subject to market conditions and customary closing conditions [2]. Group 2: Company Overview - Cabaletta Bio is a clinical-stage biotechnology company dedicated to developing curative targeted cell therapies for autoimmune diseases [5]. - The company’s CABA™ platform employs two strategies to advance engineered T cell therapies, with a focus on the CARTA strategy and its lead investigational therapy, rese-cel [5]. - Rese-cel is currently being evaluated in the RESET™ clinical development program, which spans multiple therapeutic areas including rheumatology, neurology, and dermatology [5].

Core Insights - Cabaletta Bio, Inc. announced promising clinical data from its ongoing RESET clinical trials for autoimmune diseases, highlighting the potential of rese-cel to provide drug-free, symptom-free lives for patients [1][2][6] Clinical Trial Results - In the RESET-Myositis trial, 7 out of 8 patients achieved clinically meaningful total improvement scores (TIS) while off all immunomodulators and steroids, with 4 patients experiencing grade 1 cytokine release syndrome (CRS) [1][2][3] - All systemic lupus erythematosus (SLE) patients without nephropathy achieved remission as per DORIS criteria, with 7 out of 7 patients responding clinically while off immunomodulators and glucocorticoids [1][2] - Both patients in the RESET-SSc trial showed significant improvements in modified Rodnan Skin Score (mRSS) after discontinuing immunomodulatory drugs, with one patient meeting the revised Composite Response Index in Systemic Sclerosis (CRISS) criteria [1][8] Safety Profile - Among 18 patients with follow-up of 4 weeks or more, 94% experienced no CRS or only Grade 1 CRS, and 89% had no immune effector cell-associated neurotoxicity syndrome (ICANS) [1][2] - In the RESET-SLE trial, 2 out of 8 patients experienced grade 1 CRS, and one ICANS event was reported [3][8] Regulatory and Development Plans - Cabaletta plans to initiate enrollment in two registrational myositis cohorts in 2025 and has scheduled discussions with the FDA regarding registrational pathways for SLE/LN in 3Q25, scleroderma in 4Q25, and myasthenia gravis in 1H26 [1][9] - The RESET clinical trial program is accelerating, with 51 patients actively enrolled across over 65 clinical sites as of May 30, 2025 [1][2][6] Company Overview - Cabaletta Bio is focused on developing curative targeted cell therapies for autoimmune diseases, with rese-cel being a key investigational therapy designed to deplete CD19-positive B cells [5][6] - The company aims to change treatment paradigms for autoimmune diseases through its innovative CARTA platform, which includes multiple disease-specific clinical trials [5][6]

Core Insights - Cabaletta Bio, Inc. is a clinical-stage biotechnology company focused on developing curative targeted cell therapies for autoimmune diseases [3] - The company will participate in a fireside chat at the Jefferies Global Healthcare Conference on June 4, 2025 [1] - The lead strategy, CARTA, is centered on the investigational therapy rese-cel, which is currently in the RESET clinical development program [3] Company Overview - Cabaletta Bio is dedicated to advancing engineered T cell therapies that may provide deep and durable, potentially curative treatments for a variety of autoimmune diseases [3] - The company is headquartered in Philadelphia, PA, and has a comprehensive platform that includes two complementary strategies for therapy development [3] - Rese-cel is a fully human CD19-CAR T cell therapy that contains 4-1BB and is being evaluated across multiple therapeutic areas, including rheumatology, neurology, and dermatology [3]