Cabaletta Bio Inc. reported its third quarter 2025 financial results and provided a business update. The company highlighted progress in its RESET™ clinical development program, including the presentation of rese-cel data at multiple medical meetings showing potentially transformative, drug-free clinical responses with a favorable safety profile for autoimmune patients. All myositis patients in the Phase 1/2 DM/ASyS cohort with sufficient follow-up who would have met key criteria for the registrational cohort achieved the 16-week primary endpoint. The company plans a BLA submission for rese-cel in 2027, based on a 14-patient, single-arm DM/ASyS registrational cohort, which is starting enrollment this quarter within the RESET-Myositis™ trial. FDA alignment on additional registrational cohort designs for RESET-SSc™ and RESET-SLE™ is anticipated by year-end 2025. For the three months ended September 30, 2025, research and development expenses were $39.8 million, compared to $26.3 million for the same period in 2024. General and administrative expenses were $6.8 million, unchanged from the same period in 2024. As of September 30, 2025, Cabaletta had cash, cash equivalents, and short-term investments of $159.9 million, compared to $164.0 million as of December 31, 2024. The company expects its cash position to fund its operating plan into the second half of 2026.
Disclaimer: This news brief was created by Public Technologies (PUBT) using generative artificial intelligence. While PUBT strives to provide accurate and timely information, this AI-generated content is for informational purposes only and should not be interpreted as financial, investment, or legal advice. Cabaletta Bio Inc. published the original content used to generate this news brief via EDGAR, the Electronic Data Gathering, Analysis, and Retrieval system operated by the U.S. Securities and Exchange Commission (Ref. ID: 0001193125-25-273272), on November 10, 2025, and is solely responsible for the information contained therein.
Comments