PHILADELPHIA, PA — Cabaletta Bio, Inc. (Nasdaq: CABA) has announced its financial results for the fourth quarter and full year 2024, along with significant updates across its clinical programs. The company, known for its pioneering approach to engineering T cell therapies for autoimmune diseases, outlined key advancements in its RESET clinical development program and ongoing preparations for a potential registrational trial.
Promising Developments in the RESET Clinical Programs
Cabaletta continues to make strides with rese-cel (resecabtagene autoleucel), its autologous, engineered T cell product designed for a range of autoimmune disorders. By March 14, 2025, the company reported enrolling 33 patients across 56 active clinical trial sites in the U.S. and Europe, averaging approximately one patient per week since presenting promising data from the RESET program at the ACR Convergence in late 2024.
The company plans to meet with the FDA in the first half of 2025 to align on registrational trial designs for rese-cel in myositis, a condition affecting roughly 70,000 people in the U.S. “We are looking forward to meeting with the FDA to align on registrational trial designs… leveraging our emerging clinical data and our efficient development strategy,” said Steven Nichtberger, M.D., Chief Executive Officer of Cabaletta.
Additional clinical updates include the expansion of Cabaletta’s trials into previously untapped areas such as juvenile myositis, and advancements in lupus nephritis, systemic sclerosis, and generalized myasthenia gravis. Notably, three out of four systemic lupus erythematosus (SLE) patients achieved clinical remission in the RESET-SLE trial, while early results in pulmonary and dermatological cohorts have shown encouraging improvements in disease markers.
Advancements in Manufacturing and Partnerships
Cabaletta reported significant progress in its manufacturing capabilities, further bolstered by partnerships. The company concluded a Technology Adoption Program with Cellares, providing access to the Cell Shuttle™, an automated manufacturing platform, for clinical and potential commercial use if rese-cel gains regulatory approval. Additionally, Cabaletta expanded its agreement with Lonza, aiming to bolster the production of clinical products as patient enrollment accelerates and trials progress toward registrational phases.
Upcoming Data Presentations
Cabaletta has scheduled three oral presentations at the EULAR 2025 Congress in June, where it will unveil data from the RESET-Myositis, RESET-SLE, and RESET-SSc trials. These will provide an opportunity to showcase the clinical and translational impact of rese-cel to the broader research community.
Financial Highlights
Cabaletta reported research and development expenses of $25.5 million for Q4 2024, up from $17.4 million the year prior. Full-year R&D expenses reached $97.2 million, reflecting significant investment in expanding clinical capabilities and trial enrollment. General and administrative expenses also rose to $8.3 million in Q4, compared to $5.7 million in Q4 2023, and $27.9 million for the full year.
The company ended 2024 with $164 million in cash and equivalents, positioning it to continue funding operations into the first half of 2026. CEO Steven Nichtberger noted that the financial outlook reflects Cabaletta’s focus on advancing its clinical pipeline while maintaining operational efficiency.
Looking Ahead
With a robust pipeline, strong data, and strategic operational partnerships, Cabaletta Bio is poised for a pivotal year in 2025. From its planned FDA meetings to its anticipated data presentations, the company is moving closer to its goal of transforming the treatment landscape for autoimmune diseases.
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