PHILADELPHIA, PA — Cabaletta Bio Inc. (Nasdaq: CABA) recently reported fourth-quarter and full-year 2025 results and said it is advancing clinical development of its rese-cel cell therapy program for autoimmune diseases, with a regulatory filing targeted for 2027, the company announced.
The company said a registrational cohort in its RESET-Myositis trial is enrolling approximately 17 patients and could support a Biologics License Application submission for rese-cel in myositis.
Cabaletta also reported progress in trials evaluating rese-cel without preconditioning, with initial data from its RESET-SLE trial expected in the first half of 2026 and additional durability data from RESET-SLE and RESET-PV trials anticipated throughout 2026.
The company said it is testing automated manufacturing of rese-cel using Cellares’ Cell Shuttle platform, with initial clinical data expected in the first half of 2026.
Cabaletta outlined plans for additional pivotal trials, including single-arm studies of about 25 patients each in systemic lupus erythematosus and lupus nephritis, with further trial design updates expected in 2026.
Complete Phase 1/2 data from multiple trials, including RESET-SLE, RESET-SSc, and RESET-MG, are expected in the first half of 2026.
Research and development expenses were $142.7 million for 2025, compared to $97.2 million in 2024, while general and administrative expenses were $29.6 million, compared to $27.9 million the prior year.
The company reported cash, cash equivalents, and short-term investments of $133.6 million as of December 31, 2025, down from $164.0 million a year earlier.
Cabaletta said it raised an additional $30.0 million in early 2026 and expects its current cash position to fund operations into the fourth quarter of 2026.
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