Cartesian Therapeutics Q1 2024 Financial Results and Business Update

Cartesian Therapeutics, Inc., a biotechnology firm specializing in mRNA cell therapies for autoimmune diseases, has announced notable advancements and financial results for the first quarter of 2024. The company is progressing with its lead product, Descartes-08, an mRNA CAR-T cell therapy for myasthenia gravis (MG) and other autoimmune conditions. Topline data from a Phase 2b trial of Descartes-08 in MG patients is anticipated by mid-2024. Additionally, the company plans to dose the first patient in a Phase 2 trial for systemic lupus erythematosus (SLE) by the second quarter of 2024 and initiate further Phase 2 studies for other autoimmune indications in the second half of the year.

Descartes-08 is designed using novel mRNA-engineered CAR-T technology, which allows for outpatient administration without the need for preconditioning chemotherapy. This therapy targets B cell maturation antigen (BCMA) and has shown promise as a first-in-class treatment for autoimmune diseases.

Cartesian is also moving forward with Descartes-15, another mRNA CAR-T product designed for multiple myeloma. The company is preparing for a Phase 1 dose escalation trial to evaluate its safety and tolerability, with plans to explore its potential for treating autoimmune conditions subsequently.

The company has been granted Orphan Drug Designation by the FDA for Descartes-08 in the treatment of MG. Previous clinical studies have shown positive, long-term follow-up results, which will be presented at the 27th Annual Meeting of the American Society of Gene and Cell Therapy.

In terms of infrastructure, Cartesian announced the transition to new corporate headquarters in Frederick, Maryland. This facility will enhance their in-house cGMP manufacturing capabilities for both clinical and commercial supply of their mRNA cell therapy candidates. The expansion to approximately 27,000 square feet provides state-of-the-art manufacturing and laboratory space, supporting late-stage clinical and commercial production.

Financially, Cartesian reported approximately $104.8 million in cash, cash equivalents, and restricted cash as of March 31, 2024. This capital is projected to fund operations through the second half of 2026, including the Phase 3 trial of Descartes-08 in MG. The company’s research and development expenses for the quarter were $9.7 million, down from $18.6 million the previous year, due to strategic reprioritization. General and administrative expenses increased to $9.5 million from $5.7 million, primarily due to professional fees related to a merger in November 2023. The net loss for the quarter was reported at $(56.8) million, compared to $(21.7) million for the same period in 2023.

Cartesian's transition to new headquarters aligns with their goal of maintaining control over product quality and production. The company believes this move will optimize manufacturing processes, enabling the production of safe, cost-effective mRNA cell therapy candidates.

Cartesian Therapeutics continues to focus on the development of innovative mRNA cell therapies for autoimmune diseases, with Descartes-08 and Descartes-15 leading their clinical pipeline. The company is committed to expanding the reach of cell therapy and addressing unmet medical needs in the treatment of autoimmune conditions.