Cabaletta Bio Reports Third Quarter 2025 Financial Results and Provides Business Update

Core Insights - Cabaletta Bio, Inc. is advancing its investigational CAR T cell therapy, rese-cel, showing promising drug-free clinical responses in autoimmune diseases with a favorable safety profile [1][4][9] - The company plans to submit a Biologics License Application (BLA) for rese-cel in 2027, based on data from a 14-patient registrational cohort in the RESET-Myositis trial [1][5] - Recent operational highlights include rapid enrollment in clinical trials and positive data presentations across multiple autoimmune diseases, including myositis, systemic sclerosis, lupus, and myasthenia gravis [2][4] Clinical Development - Rese-cel is designed to transiently deplete CD19-positive cells to reset the immune system, aiming for durable clinical responses without chronic therapy [3][4] - Positive clinical data from 32 patients across four autoimmune trials were presented, indicating the potential for transformative, drug-free responses [4] - Initial data from the RESET-PV trial showed complete B cell depletion in 2 of 3 patients treated with a low dose of rese-cel without preconditioning, leading to plans for expanded enrollment [4][5] Regulatory Updates - The European Medicines Agency (EMA) granted PRIME access for rese-cel for myositis, while the FDA awarded RMAT and Fast Track designations for systemic lupus erythematosus and generalized myasthenia gravis [9] - The company anticipates alignment with the FDA on registrational cohort designs for RESET-SSc and RESET-SLE trials by the end of 2025 [9] Financial Performance - For Q3 2025, research and development expenses were $39.8 million, up from $26.3 million in Q3 2024, while general and administrative expenses remained stable at $6.8 million [10][16] - The net loss for Q3 2025 was $44.9 million, compared to a net loss of $30.6 million in Q3 2024 [10][16] - As of September 30, 2025, the company had cash and equivalents of $159.9 million, expected to fund operations into the second half of 2026 [10][18] Corporate Updates - Steve Gavel was appointed Chief Commercial Officer in October 2025, bringing experience from Legend Biotech to lead global commercial strategy for rese-cel [7]