Cabaletta Bio(US:CABA) Globenewswire·2025-08-07 11:30Core Insights - Cabaletta Bio is advancing its investigational CAR-T cell therapy, rese-cel, with plans for a Biologics License Application (BLA) submission for myositis anticipated in 2027 following FDA alignment on registrational pathways [1][11] - The company has successfully enrolled five disease-specific cohorts in the RESET™ clinical development program, with ongoing expansion phase enrollment [1][4] - Recent clinical data presented at the EULAR 2025 Congress indicate strong therapeutic potential for rese-cel, with nearly all patients off immunomodulatory medications and steroids [1][4] Clinical Development - Rese-cel is designed to treat autoimmune diseases by transiently depleting CD19-positive cells, aiming for durable clinical responses without chronic therapy [3] - Enrollment in two open-label, single-arm registrational myositis cohorts is set to begin in the second half of 2025, each consisting of approximately 15 patients [4][11] - Upcoming presentations will include complete Phase 1/2 data from the RESET-Myositis trial and initial data from RESET-PV and RESET-MG trials [4] Regulatory - The FDA has aligned with Cabaletta on key design elements for registrational cohorts in the RESET-Myositis trial, which includes patients with dermatomyositis and antisynthetase syndrome [11] - Additional regulatory discussions are planned for the RESET-SLE and RESET-SSc trials in late 2025 and early 2026 [11] Financial Overview - Cabaletta closed a $100 million public offering to support late clinical-stage development and extended its cash runway into the second half of 2026 [1][7] - For Q2 2025, research and development expenses were $37.6 million, up from $23.4 million in Q2 2024, while general and administrative expenses rose to $8.3 million from $6.9 million [12][17] - As of June 30, 2025, the company reported cash, cash equivalents, and short-term investments of $194.7 million, an increase from $164.0 million at the end of 2024 [12][19]