Cabaletta Bio(CABA)2025-03-31 11:03Financial Position - As of December 31, 2024, Cabaletta Bio reported unaudited cash and cash equivalents of $164 million, expected to fund operations into the first half of 2026[4]. Clinical Development - 21 patients have been enrolled across 44 actively recruiting clinical sites in the RESET clinical development program as of December 31, 2024[11]. - The first patient has been enrolled in the RESET-PV trial, evaluating rese-cel without preconditioning in patients with pemphigus vulgaris[11]. - The first juvenile myositis clinical site in the RESET-Myositis trial is now open and actively recruiting[16]. Clinical Outcomes - In the first 10 patients dosed with rese-cel, 90% experienced no cytokine release syndrome (CRS) or grade 1 CRS, and 90% experienced no immune effector cell-associated neurotoxicity syndrome (ICANS)[11]. Regulatory Affairs - Cabaletta plans to meet with the FDA regarding registrational trial designs for rese-cel in the first half of 2025[12]. - The FDA has granted Fast Track Designation to rese-cel for the treatment of relapsing and progressive forms of multiple sclerosis (MS)[16]. Manufacturing and Supply Chain - Cabaletta has expanded its CDMO agreement with Lonza to supply rese-cel clinical product under current Good Manufacturing Practices by the second half of 2025[16]. - Cabaletta is advancing a whole blood manufacturing program as a potential replacement for apheresis and seeks to align with the FDA on this strategy[17]. Future Plans - The company aims to present new and updated clinical and translational data on rese-cel throughout 2025[13].