PHILADELPHIA, PA — Cabaletta Bio, Inc. (Nasdaq: CABA) reported third-quarter results and outlined major clinical and regulatory milestones that position its lead therapy, rese-cel, as a potential first-in-class CAR T treatment for multiple autoimmune diseases.
The company highlighted new data across several trials showing drug-free, durable responses and a favorable safety profile, strengthening confidence in rese-cel’s outpatient use potential. Rese-cel, an autologous CD19 CAR T construct, is engineered to temporarily deplete B cells with the aim of resetting the immune system without the need for chronic immunosuppression.
CEO Steven Nichtberger said rapid enrollment and consistent clinical signals across the RESET™ program demonstrate the therapy’s potential across a broad range of autoimmune indications. He pointed to early findings showing that a single, weight-based infusion may be effective even without preconditioning. “Our team continued to execute with discipline and precision to extend our leadership through the RESET clinical development program,” Nichtberger said.
Clinical Trials Move Toward Registration-Ready Designs
Cabaletta shared positive updates from 32 patients treated across four Phase 1/2 studies in myositis, systemic sclerosis, lupus, and myasthenia gravis. The company reported that all myositis patients in the Phase 1/2 dermatomyositis/antisynthetase syndrome cohort who met key entry criteria also met the 16-week primary endpoint planned for the registrational trial.
Enrollment for the 14-patient registrational DM/ASyS cohort is expected to begin this quarter, with a planned Biologics License Application (BLA) submission in 2027. Cabaletta also plans to present additional data from its RESET-SSc™, RESET-SLE™, and RESET-MG™ trials throughout 2026, including full Phase 1/2 datasets and new insights on rese-cel without preconditioning.
Early results from the RESET-PV™ pemphigus vulgaris study showed complete B-cell depletion in two of three low-dose, no-preconditioning patients. The company is expanding the cohort and evaluating a similar no-preconditioning strategy in lupus, supported by clinical responses observed in earlier SLE patients.
Regulatory Tailwinds Strengthen the Path Forward
The European Medicines Agency granted PRIME designation for rese-cel in myositis, offering the company accelerated support and potential for faster assessment in Europe. In the United States, the FDA granted RMAT designation for lupus and lupus nephritis and Fast Track designation for generalized myasthenia gravis.
Cabaletta expects FDA alignment on additional registrational cohort designs for systemic sclerosis and lupus by year-end and for myasthenia gravis in the first half of 2026, setting the stage for multiple potential registrational trial initiations next year.
Financials Reflect Heightened R&D Investment
Research and development expenses rose to $39.8 million in the quarter, up from $26.3 million a year earlier, driven by expanding clinical activity across the RESET platform. General and administrative costs remained steady at $6.8 million.
Cabaletta ended the quarter with $159.9 million in cash, cash equivalents, and short-term investments, a modest decrease from year-end. The company said its current cash position should fund operations into the second half of 2026.
Commercial Build-Out Begins
Cabaletta appointed Steve Gavel as Chief Commercial Officer in October, bringing CAR T commercialization experience from his tenure leading the launch of CARVYKTI®. He will oversee commercial planning for rese-cel and potential future indications.
With expanding clinical evidence, growing regulatory support, and early commercial infrastructure taking shape, Cabaletta enters 2026 with momentum — and rising expectations — as it pursues what could become one of the first broadly applicable CAR T therapies for autoimmune disease.
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