Exhibit 99.1
Cabaletta Bio Reports Fourth Quarter and Full Year 2025 Financial Results and Provides Business Update
Rese-cel myositis BLA submission on track for 2027 based on a 17-patient, single arm registrational cohort design, including an outpatient dosing option
No-preconditioning program enrolling in lupus and PV; anticipating initial RESET-SLE data in 1H26 and durability data from the RESET-SLE and RESET-PV® trials throughout 2026
Automated manufacturing of rese-cel with Cellares’ Cell Shuttle underway in the RESET clinical program, offering the potential to produce rese-cel for thousands of patients per year with minimal capital investment
Pivotal trial designs announced for SLE and LN single arm cohorts, each with ~25 patients; on track to announce SSc design in 1H26; FDA registrational design discussions and no preconditioning data will inform pivotal plans across the rese-cel program
Complete Phase 1/2 data to be presented in 1H26 from the RESET-SSc, RESET-SLE and RESET-MG trials evaluating rese-cel with preconditioning
PHILADELPHIA, March 23, 2026 -- Cabaletta Bio, Inc. (Nasdaq: CABA), a late-stage clinical biotechnology company focused on developing and launching the first curative targeted cell therapies designed specifically for patients with autoimmune diseases, today reported financial results for the fourth quarter and full year ended December 31, 2025, and provided a business update.
“As we advance our core clinical programs for rese-cel with preconditioning and standard manufacturing, we have meaningfully advanced two potentially transformative innovations: rese-cel with no preconditioning and automated manufacturing using the Cellares Cell Shuttle. Clinical data on both innovations are on track to be shared in the first half of this year with durability data to follow later this year. Clinical data currently suggest that rese-cel offers a competitive profile that may reliably deliver an immune reset following a single, weight-based infusion with a safety profile that facilitates outpatient delivery with – or potentially without – preconditioning,” said Steven Nichtberger, M.D., Chief Executive Officer of Cabaletta.
Recent Operational Highlights and Upcoming Anticipated Milestones
Rese-cel: Rese-cel (resecabtagene autoleucel) is an investigational, autologous CAR T cell therapy engineered with a fully human CD19 binder and a 4-1BB co-stimulatory domain, designed specifically for the treatment of autoimmune diseases. Administered as a single, weight-based infusion, rese-cel has demonstrated the ability to transiently, reliably and deeply deplete CD19-positive cells, with the goal of resetting the immune system and achieving durable clinical responses without the need for chronic therapy. Cabaletta is evaluating rese-cel in the RESET (REstoring SElf-Tolerance) clinical development program, which includes multiple