PHILADELPHIA, PA — Cabaletta Bio, Inc. (Nasdaq: CABA) reported second-quarter financial results and provided a detailed business update, emphasizing progress toward a 2027 Biologics License Application (BLA) submission for its lead candidate, rese-cel, in myositis.
The company confirmed that enrollment in registrational cohorts for its RESET-Myositis™ trial remains on track to begin in the second half of 2025, following alignment with the U.S. Food and Drug Administration (FDA) on key trial design elements. Cabaletta aims to file its first BLA for rese-cel in 2027, contingent on success in either of two independent cohorts: one for dermatomyositis and antisynthetase syndrome, and the other for immune-mediated necrotizing myopathy (IMNM).
Rese-cel, an autologous CD19-targeted CAR-T therapy, is designed to reset the immune system in autoimmune diseases without the need for chronic treatment. Recent clinical data from the RESET™ trials presented at the EULAR 2025 Congress showed robust B cell depletion and durable clinical responses across myositis, lupus, and systemic sclerosis, with most patients off steroids and immunosuppressants.
Five disease-specific cohorts in the RESET program are now fully enrolled across more than 70 clinical sites. Enrollment continues in expansion phases, while further regulatory discussions with the FDA are expected in the coming quarters for lupus, systemic sclerosis, and myasthenia gravis.
Cabaletta is also preparing to release additional clinical data later this year, including full Phase 1/2 results from RESET-Myositis and early findings from RESET-PV™, which evaluates rese-cel without pre-conditioning in pemphigus vulgaris patients.
The company closed a $100 million public offering in June, bolstering its cash reserves to $194.7 million as of June 30, 2025. Management anticipates this capital will support operations into the second half of 2026.
Research and development expenses rose to $37.6 million in the second quarter, up from $23.4 million a year earlier, driven by increased trial activity. General and administrative expenses were $8.3 million, compared to $6.9 million in Q2 2024.
CEO Dr. Steven Nichtberger noted that strong early data and regulatory momentum are positioning the company for long-term success: “We achieved significant progress advancing rese-cel in the first half of 2025,” he said, citing upcoming milestones and the initiation of late-stage trials as key drivers.
Cabaletta also reported advancements in its manufacturing capabilities, including technology transfers to Lonza and Oxford Biomedica, to support future commercial supply.
As its pipeline matures, Cabaletta is building toward broader clinical and commercial readiness in the autoimmune space, with rese-cel at the center of its strategy.
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