PHILADELPHIA, November 10, 2025 — Leads & Copy — Cabaletta Bio, Inc. (Nasdaq: CABA), a clinical-stage biotechnology company, has released its financial results for the third quarter ended September 30, 2025, along with a business update, highlighting promising developments in its autoimmune disease therapies.
The company’s lead CARTA (Chimeric Antigen Receptor T cells for Autoimmunity) strategy focuses on rese-cel (resecabtagene autoleucel, formerly CABA-201), an investigational autologous CAR T-cell therapy engineered with a fully human CD19 binder and a 4-1BB co-stimulatory domain. Rese-cel is designed to treat autoimmune diseases by transiently depleting CD19-positive cells, aiming for durable clinical responses without chronic therapy.
Cabaletta is evaluating rese-cel in the RESET (REstoring SElf-Tolerance) clinical development program, which includes trials across rheumatology, neurology, and dermatology.
At medical meetings in October 2025, Cabaletta presented encouraging data from 32 patients treated with rese-cel in myositis, systemic sclerosis, lupus, and myasthenia gravis. The data included full Phase 1/2 results from RESET-Myositis and preliminary data from RESET-SSc, RESET-SLE, and RESET-MG™ trials, highlighting the potential for transformative, drug-free responses with a favorable safety profile supporting outpatient use.
At the 2025 European Society of Gene & Cell Therapy Annual Congress, Cabaletta presented initial data from the RESET-PV™ trial evaluating a low dose of rese-cel without preconditioning in patients with pemphigus vulgaris, demonstrating complete B cell depletion in 2 of 3 patients along with early clinical responses with a generally well-tolerated profile. Based on these data, Cabaletta is expanding patient enrollment in the RESET-PV trial at the current dose, with the potential to evaluate higher doses, as warranted. In addition, Cabaletta is incorporating a new dose-escalation cohort in the RESET-SLE trial to evaluate rese-cel without preconditioning given the clinical responses observed in lupus following complete B cell depletion after administration of rese-cel with preconditioning.
Consistent with prior alignment with the FDA, the company is aligned on a dermatomyositis (DM) and antisynthetase syndrome (ASyS) registrational cohort with a 16-week primary endpoint. All patients with sufficient follow-up in the Phase 1/2 DM/ASyS cohort who would have met key criteria for the registrational cohort met the registrational primary endpoint.
The company projects submitting a Biologics License Application (BLA) for rese-cel in myositis in 2027, based on data from the DM/ASyS cohort. Cabaletta plans to present clinical data from the RESET trials throughout 2026, including a poster presentation at the 67th American Society of Hematology Annual Meeting and Exposition on December 6, 2025.
The EMA granted PRIME (PRIority Medicines) scheme access for rese-cel to treat myositis, offering early support to optimize data generation and enable accelerated assessment of medicines applications. The FDA granted Regenerative Medicine Advanced Therapy (RMAT) designation for SLE and lupus nephritis and Fast Track Designation for generalized myasthenia gravis.
Cabaletta expects to align with the FDA on key registrational design elements for the RESET-SSc and RESET-SLE trials by year-end 2025, and for the RESET-MG trial in the first half of 2026, with potential enrollment in registrational cohorts in 2026.
In October 2025, Steve Gavel was appointed Chief Commercial Officer, bringing CAR T experience from Legend Biotech. He will lead global commercial strategy for rese-cel and future pipeline opportunities.
Third Quarter 2025 Financial Results:
- Research and development expenses: $39.8 million (Q3 2025) vs. $26.3 million (Q3 2024)
- General and administrative expenses: $6.8 million (Q3 2025), consistent with Q3 2024
- Cash, cash equivalents, and short-term investments: $159.9 million (September 30, 2025) vs. $164.0 million (December 31, 2024)
Cabaletta expects its cash position will fund operations into the second half of 2026.
Anup Marda, Chief Financial Officer, can be contacted at investors@cabalettabio.com.
Source: Cabaletta Bio
