PHILADELPHIA, PA — Cabaletta Bio, Inc. (Nasdaq: CABA) reported first-quarter financial results and outlined plans to advance its autoimmune disease cell therapy program toward potential regulatory filings, while expanding manufacturing capacity and extending its projected cash runway into mid-2027.
The Philadelphia-based biotechnology company is advancing rese-cel, its investigational CAR-T therapy for autoimmune diseases, through a registrational trial in myositis while preparing additional late-stage development plans in systemic sclerosis and myasthenia gravis.
Cabaletta also reported clinical data presented at the American Society of Gene & Cell Therapy annual meeting showing drug-free responses in some pemphigus vulgaris patients treated without preconditioning chemotherapy. Two of four patients in the lowest-dose cohort achieved clinical responses through six months of follow-up, according to the company.
“Later this quarter, we expect to announce initial data from the lowest dose cohort of lupus patients dosed without preconditioning,” Chief Executive Officer Steven Nichtberger said.
The company separately highlighted progress in manufacturing automation through a recently announced 10-year commercial supply agreement with Cellares. The deal is intended to support large-scale commercial production of rese-cel using automated manufacturing systems capable of producing thousands of batches annually.
Nichtberger said the company believes the Cellares agreement gives Cabaletta the potential to produce rese-cel “for thousands of patients per year” with limited capital investment.
Rese-cel, formally known as resecabtagene autoleucel, is being studied across multiple autoimmune indications through Cabaletta’s RESET clinical development program. The therapy is designed to reset the immune system by depleting CD19-positive B cells after patients discontinue immunomodulatory treatments.
Enrollment continues in the company’s 17-patient RESET-Myositis registrational cohort evaluating dermatomyositis and antisynthetase syndrome patients. Cabaletta expects successful data from the study to support its first planned Biologics License Application submission for rese-cel in 2027.
The company also presented complete Phase 1/2 data from its RESET-MG study at the American Academy of Neurology annual meeting in April. Among evaluable patients, Cabaletta reported predictable CAR-T expansion and B-cell depletion, while several patients experienced clinically meaningful improvement in daily living measures after stopping immunomodulators.
Cabaletta plans additional scientific presentations at the European Alliance of Associations for Rheumatology Congress in London in June, including updated data from lupus, myositis and systemic sclerosis studies.
Separately, the company appointed Francisco Ramírez-Valle, senior vice president of immunology research at Eli Lilly and Company (NYSE: LLY), to its scientific advisory board.
Earlier this month, Cabaletta closed a $150 million registered direct offering backed by investors including Bain Capital Life Sciences, Adage Capital Management, Cormorant Asset Management and Eli Lilly.
Research and development expenses rose to $37.4 million during the quarter ended March 31, from $29.0 million a year earlier, reflecting increased clinical and manufacturing activity.
General and administrative expenses declined to $6.9 million from $8.1 million in the prior-year period.
Cabaletta reported cash, cash equivalents and short-term investments totaling $116.6 million as of March 31, compared with $133.6 million at the end of 2025. The company expects existing cash combined with proceeds from the May financing to fund operations into mid-2027.
Additional information about upcoming presentations and investor events is available at www.cabalettabio.com.
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