Cabaletta Bio recently released its latest Form 10-Q. The Philadelphia-based company is a clinical-stage biotechnology firm focused on engineered T cell therapies for autoimmune diseases, with resecabtagene autoleucel as its lead candidate and two other programs in development, DSG3-CAART and MuSK-CAART. It also maintains research and manufacturing collaborations with academic and industry partners, including the University of Pennsylvania, the Children’s Hospital of Philadelphia, Nanjing IASO Biotherapeutics, Oxford Biomedica, Autolus Holdings, and WuXi Advanced Therapies.
In Item 2, Management’s Discussion and Analysis, Cabaletta says it is pursuing a late-stage CARTA platform intended to produce deep B-cell depletion after a single infusion, with the goal of restoring immune tolerance in autoimmune disease. The company says rese-cel is being studied across multiple RESET trials in rheumatology, neurology, and dermatology, including cohorts in myositis, systemic sclerosis, lupus, and pemphigus vulgaris, and that it is evaluating both standard preconditioning and preconditioning-free dosing.
Cabaletta highlighted clinical data presented at EULAR 2026 from 52 evaluable patients with myositis, lupus, and systemic sclerosis. It said patients were generally able to stop immunomodulators or remain on low-dose steroids while showing improvement in disease activity, and that updated safety data covered the first 63 patients treated with rese-cel plus preconditioning across four RESET trials.
In myositis, Cabaletta said the adult disease subtypes under study affect about 80,000 patients in the U.S., with roughly 16,000 to 20,000 potentially eligible for rese-cel. The company reported that 80% of the 10 DM and ASyS patients with data available as of April 16, 2026 would have met the registrational endpoint, while 83% of DM patients and 75% of ASyS patients achieved immunomodulator-free moderate-to-major responses at 16 weeks. Cabaletta also said 100% of the 17 patients in the myositis dataset experienced either no CRS or only transient fever, and no ICANS was observed.
The company said it initiated enrollment in a registrational DM/ASyS cohort in December 2025, with a planned size of 17 patients and a 16-week primary endpoint. It expects topline data in mid-2027 and a potential BLA submission in the second half of 2027.
For systemic sclerosis, Cabaletta said the disease affects about 90,000 U.S. patients. In the Phase 1/2 trial, 83% of six patients achieved rCRISS-25 and 67% achieved rCRISS-50 at 36 weeks, while patients with interstitial lung disease showed a median 7.5% improvement in percent predicted FVC among those with 36 weeks of follow-up. The company said it plans to start a single-arm registrational study of about 25 patients in the fourth quarter of 2026.
In lupus, Cabaletta said SLE affects up to 320,000 patients in the U.S., with lupus nephritis affecting about 30% to 40% of those patients. It reported that in preconditioning cohorts, 75% of 18 patients achieved DORIS while remaining off immunomodulators, and that in the PC-free lupus study the first two patients suggested the lowest dose may be a threshold dose, with one patient showing deep B-cell depletion and the other about a 90% reduction in peripheral B cells. The market has reacted to these announcements by moving the company's shares -1.93% to a price of $2.795. Check out the company's full 10-Q submission here.
