Cabaletta Bio

Cabaletta Bio announced an underwritten public offering of common stock and warrants on June 11, 2025, with expected closing on June 12, 2025.

• Cellares has successfully completed a Technology Adoption Program with Cabaletta Bio, demonstrating their Cell Shuttle platform can automate and scale manufacturing of rese-cel, a CAR-T therapy for autoimmune diseases including myositis, scleroderma, and lupus nephritis. • The company has also formed a strategic partnership with the University of Wisconsin School of Medicine and Public Health to automate production of a CRISPR-edited GD2 CAR-T therapy for solid tumors, addressing manufacturing bottlenecks in clinical development. • Cellares' Integrated Development and Manufacturing Organization (IDMO) Smart Factories in the US, Europe, and Japan aim to reduce manufacturing costs by up to 50% while increasing production capacity tenfold compared to conventional CDMOs.

Clinical trials demonstrate significant efficacy of rese-cel across multiple autoimmune conditions, with three SLE patients achieving DORIS remission and successful discontinuation of immunosuppressants and steroids.

• Cabaletta Bio has received FDA clearance to proceed with RESET-MS trial, testing their B-cell-targeting CAR T-cell therapy rese-cel in relapsing and progressive multiple sclerosis patients. • The innovative cell therapy, rese-cel (formerly CABA-201), aims to reset the immune system by targeting CD19-positive B-cells, potentially offering a curative approach for autoimmune diseases. • The trial will enroll adults aged 18-60 with either relapsing MS who experienced recent relapses or progressive MS patients showing worsening disability, following specific preconditioning treatment.

Cabaletta Bio will present updated clinical data on rese-cel at upcoming scientific meetings in February 2025, showcasing its potential in autoimmune diseases.

• A phase 1/2 study of CD19 CAR-T therapy in autoimmune diseases, including lupus, myositis, and systemic sclerosis, demonstrates significant clinical responses. • The CASTLE study reports minimal toxicities, with low-grade cytokine release syndrome and no major hematotoxicities or neurotoxicity observed in patients. • Cabaletta Bio's CABA-201 shows potential for immunosuppressant-free clinical responses in refractory autoimmune diseases, with ongoing trials and planned FDA meetings. • Next-generation manufacturing processes for CAR-T therapies, like that used for CC-97540, offer faster production times and require fewer cells for infusion.

• Cabaletta Bio's RESET program, featuring CABA-201, is actively enrolling patients across multiple clinical trials targeting autoimmune diseases like myositis, SLE, and SSc. • The company has expanded its clinical trial program into Europe, securing EMA approval for the RESET-SLE trial, and is actively recruiting at 40 U.S. sites. • Cabaletta Bio anticipates a meeting with the FDA in 2025 to discuss program designs for CABA-201, a cell therapy aimed at resetting the immune system in autoimmune disorders. • With $183.0 million in cash reserves as of September 30, 2024, Cabaletta Bio expects to fund operations into the first half of 2026, supporting ongoing clinical development and strategic expansion.

• Cabaletta Bio reported clinical data from RESET-Myositis™, RESET-SLE™, and initial data from RESET-SSc™ trials at ACR Convergence 2024, showcasing CABA-201's potential in autoimmune disease treatment. • Sixteen patients have been enrolled, with ten dosed across the RESET™ clinical development program, and 40 U.S. clinical sites are actively recruiting patients for CABA-201 trials. • Cabaletta anticipates a meeting with the FDA in 2025 to discuss potential registrational program designs for CABA-201, pending data outcomes. • EMA has authorized clinical trials for CABA-201 in Europe for lupus, expanding the clinical development program internationally.

• Cabaletta Bio reports 40 active U.S. clinical sites recruiting for its RESET trials, with 16 patients enrolled and 10 dosed as of November 12. • The company received EMA CTA authorization for CABA-201 in lupus, facilitating expansion into Europe and broadening the clinical development program. • Clinical data from RESET-Myositis, RESET-SLE, and initial RESET-SSc trials will be presented at ACR Convergence 2024, highlighting potential efficacy. • Cabaletta Bio's cash position stands at $183.0 million as of September 30, 2024, expected to fund operations into the first half of 2026.

• Cabaletta Bio will present new clinical data on CABA-201, a CD19-CAR T cell therapy, at the ACR Convergence 2024 in Washington, D.C. • The presentations will cover the safety and efficacy of CABA-201 in patients with immune-mediated necrotizing myopathy and systemic lupus erythematosus. • Correlative studies of CABA-201 in myositis and SLE will also be presented, offering insights into the therapy's mechanism of action. • CABA-201 is being evaluated across multiple autoimmune conditions, holding promise for durable remission without chronic therapy.