Cabaletta Bio Reports $45.1 Million Net Loss in Q2 2025 Amid Increased R&D Expenses

Cabaletta Bio, Inc. reported significant financial results for the second quarter of 2025, with total operating expenses reaching $45.9 million, a 51.7% increase from $30.3 million in the same period last year. The company's net loss for the quarter was $45.1 million, compared to a loss of $27.6 million in Q2 2024. For the first half of 2025, the net loss totaled $81.1 million, up from $52.6 million in the prior year. The increase in losses is attributed to higher research and development expenses, which rose to $37.6 million from $23.4 million year-over-year, driven by expanded clinical trial activities and increased manufacturing costs.

Cabaletta's cash and cash equivalents stood at $145.6 million as of June 30, 2025, down from $164.0 million at the end of 2024. The company has incurred an accumulated deficit of $430.2 million since its inception. The increase in operating expenses is primarily due to a $7.8 million rise in manufacturing costs and a $3.8 million increase in clinical trial expenses, reflecting the company's ongoing commitment to advancing its product candidates, particularly rese-cel, through clinical trials.

Strategically, Cabaletta has made significant progress in its clinical development programs. The company is actively enrolling patients in multiple Phase 1/2 clinical trials for its lead product candidate, rese-cel, which is designed to treat various autoimmune diseases. The FDA has granted Fast Track Designation for rese-cel in several indications, including systemic lupus erythematosus and myositis. Additionally, the company has entered into key manufacturing agreements with Minaris Advanced Therapies and Lonza Houston to support the global clinical development of rese-cel.

Cabaletta's operational metrics indicate a focus on expanding its clinical trial footprint and enhancing manufacturing capabilities. The company has increased its employee headcount to support its growth, with personnel costs rising significantly. As of June 30, 2025, the company had 91.5 million shares of common stock outstanding, following a financing round in June 2025 that raised approximately $93.6 million. This financing included the issuance of common stock and warrants, which will help fund ongoing research and development activities.

Looking ahead, Cabaletta anticipates continued operating losses as it invests in the development of its product candidates. The company has expressed substantial doubt about its ability to continue as a going concern without securing additional funding, which it plans to pursue through equity offerings and potential collaborations. The management's outlook emphasizes the need for ongoing capital to support clinical trials and operational expenses, with expectations of increased research and development costs as the company advances its clinical programs.