Cabaletta Bio Reports $115.9 Million Net Loss for 2024, Highlights FDA Approvals and Clinical Developments

Cabaletta Bio, Inc., a clinical-stage biotechnology company focused on engineered T-cell therapies for autoimmune diseases, reported a net loss of $115.9 million for the year ended December 31, 2024, compared to a net loss of $67.7 million in 2023. This increase is primarily attributable to a $41.8 million rise in total operating expenses, driven by increased research and development costs ($41.8 million increase) and general and administrative expenses ($8.7 million increase). The increase in research and development expenses reflects higher personnel costs, clinical trial costs, and manufacturing costs, partially offset by a decrease in intellectual property licensing fees.

Significant developments during the year included the FDA clearance of five Investigational New Drug (IND) applications for resecabtagene autoleucel (rese-cel) across various autoimmune indications (SLE, myositis, systemic sclerosis, gMG, and MS), as well as Fast Track designations for rese-cel in several of these indications. The company also announced initial clinical data from the first two patients dosed with rese-cel, showing complete B-cell depletion and improvements in disease measures. However, a subsequent dose-limiting toxicity event in a lupus nephritis patient led to protocol modifications to enhance patient safety. Further, the company expanded its manufacturing partnerships with Lonza and Cellares, aiming to improve scalability and reduce costs.

As of December 31, 2024, Cabaletta employed 164 people, 135 of whom were involved in research and development. The company's clinical trial program, encompassing the RESET™ trials for multiple autoimmune diseases, had 33 patients enrolled across 56 active clinical sites in the U.S. and Europe as of March 14, 2025. Updated clinical data presented at the American College of Rheumatology Convergence 2024 conference showed compelling clinical responses in lupus and myositis patients.

Cabaletta's financial outlook indicates continued losses for the foreseeable future, with significant additional funding required to complete clinical trials and commercialize any approved product candidates. The company anticipates that its existing cash and cash equivalents will fund operations into the first half of 2026, but acknowledges substantial doubt about its ability to continue as a going concern beyond that timeframe without securing additional funding. The company plans to pursue additional funding through equity offerings, debt financings, or other strategic arrangements. The company's financial statements do not include adjustments that might result from the uncertainty surrounding its ability to continue as a going concern.