Cabaletta Bio Reports $35.9 Million Net Loss in Q1 2025, Driven by Increased R&D Expenses

Cabaletta Bio, Inc. reported a net loss of $35.9 million for the first quarter of 2025, compared to a net loss of $25.0 million for the same period in 2024, reflecting an increase in operating expenses driven by higher research and development costs. Total operating expenses rose to $37.1 million, up from $28.0 million year-over-year. The company’s research and development expenses increased to $29.0 million, primarily due to costs associated with clinical trials for its lead product candidate, rese-cel, and an increase in personnel costs. The company’s cash and cash equivalents stood at $131.8 million as of March 31, 2025, down from $163.9 million at the end of 2024.

Cabaletta's financial performance indicates a significant increase in losses, attributed to expanded clinical trial activities and increased staffing to support its product development pipeline. The company has incurred an accumulated deficit of $385.0 million since its inception. The increase in operating expenses is expected to continue as the company advances its clinical trials and seeks regulatory approvals for its product candidates, which include therapies for autoimmune diseases.

Strategically, Cabaletta has made notable progress in its clinical development programs. The company has received Fast Track Designation from the FDA for rese-cel, which is designed to treat systemic lupus erythematosus and other autoimmune conditions. The company is actively enrolling patients in multiple clinical trials, including the RESET-SLE and RESET-Myositis trials, and has expanded its manufacturing partnerships with Minaris Advanced Therapies and Oxford Biomedica to support its clinical development needs.

Operationally, Cabaletta has reported a total of 44 patients enrolled and 23 patients dosed across its clinical trials as of May 9, 2025. The company is also focused on enhancing its manufacturing capabilities, with plans to establish its own facility in the future. However, the reliance on third-party manufacturers for critical components of its product candidates poses risks, including potential delays in production and supply chain disruptions.

Looking ahead, Cabaletta has expressed substantial doubt about its ability to continue as a going concern without additional funding. The company anticipates needing to raise significant capital to support its ongoing operations and clinical development efforts. The management has indicated that it will pursue various financing options, including equity offerings and collaborations, to secure the necessary funds to continue its operations into the first half of 2026.