Cartesian Therapeutics Announces Q3 2024 Financial Results and Business Update

Cartesian Therapeutics, Inc., a biotechnology company specializing in mRNA cell therapy for autoimmune diseases, has disclosed its financial outcomes for the third quarter of 2024 and offered updates on its business and corporate activities. The company has made significant strides this year, focusing on its mission to enhance cell therapy's potential for treating autoimmune diseases.

Key highlights include the planned commencement of a Phase 3 trial for Descartes-08, Cartesian's leading product for myasthenia gravis (MG), in the first half of 2025. This follows promising discussions with the U.S. Food and Drug Administration (FDA). The company aims to present updated efficacy and safety data from its Phase 2b trial and details of the Phase 3 trial design by the end of the year. Descartes-08 has shown substantial effectiveness, with 71% of treated MG patients demonstrating significant improvement compared to 25% for placebo. Additionally, the therapy has a favorable safety profile, potentially allowing outpatient administration without requiring lymphodepleting chemotherapy.

In parallel with the MG program, Cartesian is progressing with a Phase 2 trial of Descartes-08 in patients with systemic lupus erythematosus (SLE), which began dosing the first patient in July 2024. The company also plans to file an investigational new drug (IND) application for a pediatric study of Descartes-08 by the end of the year. Descartes-08 has received Rare Pediatric Disease Designation from the FDA for treating juvenile dermatomyositis (JDM), an uncommon pediatric autoimmune disorder.

Moreover, Cartesian has initiated a Phase 1 trial for Descartes-15, another mRNA CAR-T product targeting B-cell maturation antigen (BCMA), designed for outpatient use without preconditioning chemotherapy. This trial, aimed at assessing safety and tolerability in patients with multiple myeloma, began dosing the first patient in September 2024.

Financially, Cartesian reported having approximately $220.9 million in cash, cash equivalents, and restricted cash as of September 30, 2024. This capital is expected to fund operations into mid-2027, covering the planned Phase 3 trial for Descartes-08 in MG, the expansion of the autoimmune pipeline, and the enhancement of manufacturing capabilities. Research and development expenses for the quarter ended September 30, 2024, were $11.4 million, a decrease from $13.0 million for the same period in 2023, attributed to lower clinical development costs. General and administrative expenses remained steady at $6.6 million.

In July 2024, Cartesian also completed a $130.0 million private placement equity financing, bolstering its financial position. Additionally, the company strengthened its board of directors with the appointment of Kemal Malik, MBBS, bringing extensive regulatory and clinical expertise.

Cartesian's lead product, Descartes-08, is an mRNA-engineered chimeric antigen receptor T-cell therapy (mRNA CAR-T) targeting BCMA, in advanced clinical stages for treating generalized MG and SLE. Unlike traditional DNA-based CAR-T therapies, mRNA CAR-T therapies are designed for outpatient administration without preconditioning chemotherapy, reducing the risk of genomic integration and potential cancerous transformation. Descartes-08 has been granted Orphan Drug Designation and Regenerative Medicine Advanced Therapy Designation by the FDA for treating MG, and Rare Pediatric Disease Designation for treating JDM.

Overall, Cartesian Therapeutics is advancing its innovative pipeline with significant regulatory and clinical progress, underpinned by robust financial health, aiming to revolutionize treatment options for patients with autoimmune diseases.