Cabaletta Bio Outlines Strategic Priorities and Anticipated Key Milestones for 2025

Core Insights - Cabaletta Bio is advancing its investigational therapy rese-cel for autoimmune diseases, with plans to meet the FDA in the first half of 2025 to align on registrational trial designs based on emerging clinical data and increased patient enrollment [1][4][10] Recent Pipeline and Operational Progress - As of December 31, 2024, 21 patients have been enrolled across 44 active clinical sites in the U.S. and Europe within the RESET clinical development program [3] - Among the first 10 patients dosed with rese-cel, 90% experienced either no cytokine release syndrome (CRS) or grade 1 CRS, and 90% experienced no immune effector cell-associated neurotoxicity syndrome (ICANS) [3] - The first patient has been enrolled in the RESET-PV trial, which evaluates rese-cel without preconditioning [3] - The first juvenile myositis clinical site in the RESET-Myositis trial is now open and actively recruiting [3] - The FDA has cleared the IND application for rese-cel for the RESET-MS trial in multiple sclerosis, granting it Fast Track Designation [3] Strategic Priorities and Anticipated Key Milestones for 2025 - The company aims to gain alignment with the FDA on a path to registration for rese-cel, leveraging indication-specific trials to advance registrational programs [4] - Key priorities include enrolling patients and completing dosing in multiple disease-specific cohorts across the RESET clinical development program [5] - The company plans to present new and updated clinical and translational data on rese-cel throughout 2025 [5] Financial Guidance - Cabaletta ended Q4 2024 with unaudited cash and cash equivalents of $164 million, which is expected to fund its updated operating plan into the first half of 2026 [7] About the RESET-MS Trial - The RESET-MS trial is a Phase 1/2 open-label, dose escalation study evaluating rese-cel in subjects with relapsing and progressive forms of multiple sclerosis [8] About rese-cel - Rese-cel is a 4-1BB-containing fully human CD19-CAR T cell investigational therapy designed to transiently deplete all CD19-positive cells, potentially resetting the immune system for patients with autoimmune diseases [9][13]