PHILADELPHIA, August 7, 2025 — Leads & Copy — Cabaletta Bio, Inc. (Nasdaq: CABA) reported its second quarter financial results and provided a business update. The clinical-stage biotechnology company is focused on developing and launching curative targeted cell therapies for autoimmune diseases. Registrational cohort enrollment in the RESET-Myositis™ trial is on track to start in the second half of 2025, with an anticipated 2027 BLA submission for rese-cel in myositis.
Five disease-specific cohorts are fully enrolled in the RESET™ clinical development program from over 70 clinical sites as of July 31, 2025, with expansion phase enrollment continuing. FDA meetings are anticipated in the third quarter of 2025 for lupus, the fourth quarter of 2025 for systemic sclerosis, and the first half of 2026 for myasthenia gravis to align on the next wave of registrational cohorts for rese-cel.
Rese-cel clinical data presented at the EULAR 2025 Congress reinforce compelling clinical responses with nearly all patients off immunomodulatory medications and steroids; favorable risk-benefit profile observed across myositis, lupus and systemic sclerosis patients. Cabaletta closed a $100 million public offering to support late clinical-stage development and commercial readiness activities for rese-cel; cash runway extended into the second half of 2026.
Steven Nichtberger, M.D., Chief Executive Officer of Cabaletta, said the company achieved significant progress advancing rese-cel in the first half of 2025, including aligning with the FDA on a registrational pathway for rese-cel in myositis to support an anticipated 2027 first BLA submission.
Anup Marda, Chief Financial Officer, investors@cabalettabio.com
Source: Cabaletta Bio
