Cabaletta Bio (NASDAQ:CABA) today reported financial results for the fourth quarter and full year ended December 31, 2025, providing a definitive timeline for the regulatory submission of its lead product candidate.
The company expects to submit a Biologics License Application (BLA) in 2027 for rese-cel (CABA-201) to treat myositis.
This filing will be supported by a registrational cohort of 17 patients, marking a significant transition from early-stage clinical exploration to a formal pathway for commercial approval in the autoimmune sector.
Operational efficiency remains a primary theme for the 2026 fiscal year.
Cabaletta confirmed that it is on track to integrate automated manufacturing through its partnership with Cellares in the first half of 2026.
This transition is intended to scale production and improve the consistency of rese-cel as the clinical program expands.
Furthermore, the company anticipates releasing data in the first half of 2026 regarding a "no-preconditioning" regimen, which could potentially eliminate the need for intensive chemotherapy before cell infusion—a move that would significantly lower the barrier for patient adoption in autoimmune indications.
Financial results for 2025 reflect the intensive investment required for these late-stage preparations.
Research and development expenses reached $142.7 million for the full year.
Cabaletta ended December with $133.6 million in cash and short-term investments, which was bolstered by an additional $30 million raised shortly after the year-end.
This capital position is expected to support the company’s current operational plan into the fourth quarter of 2026.