Cabaletta Bio Reports Fourth Quarter and Full Year 2025 Financial Results and Provides Business Update

Core Insights - Cabaletta Bio is advancing its investigational CAR T cell therapy, rese-cel, targeting autoimmune diseases, with a Biologics License Application (BLA) submission planned for 2027 based on a 17-patient cohort study in myositis [1][3] - The company is implementing an automated manufacturing process using Cellares' Cell Shuttle, which could enable production for thousands of patients annually with reduced costs [1][3] - Initial clinical data from trials involving rese-cel with no preconditioning are expected in the first half of 2026, with durability data to follow later in the year [2][7] Clinical Development - Rese-cel is designed to reset the immune system by depleting CD19-positive cells through a single weight-based infusion, aiming for durable clinical responses without chronic therapy [3][5] - The RESET clinical program includes multiple trials across various autoimmune diseases, with pivotal trial designs for systemic lupus erythematosus (SLE) and lupus nephritis (LN) announced, each involving approximately 25 patients [1][3] - The registrational cohort for dermatomyositis and antisynthetase syndrome is currently enrolling, with a primary endpoint focused on improvement while off immunomodulators [3][7] Financial Performance - For the fourth quarter of 2025, research and development expenses were $36.2 million, up from $25.5 million in the same quarter of 2024, while general and administrative expenses were $6.4 million, down from $8.3 million [4][10] - The total net loss for the year ended December 31, 2025, was $167.9 million, compared to a net loss of $115.9 million in 2024 [10] - As of December 31, 2025, the company had cash and equivalents of $133.6 million, a decrease from $164.0 million in 2024, but has since raised an additional $30 million [11][10] Upcoming Milestones - Initial clinical experience with rese-cel manufactured by Cellares is expected in the first half of 2026, which will confirm Good Manufacturing Practice readiness [3][7] - Complete Phase 1/2 data from the RESET-SLE, RESET-SSc, and RESET-MG trials are anticipated to be presented in the first half of 2026, supporting discussions with the FDA on potential registrational pathways [7][3] - The company plans to announce additional clinical data from the RESET trials throughout 2026, including updates on registrational designs for various indications [7][8]