Cartesian Therapeutics Q2 2024 Financial Results and Business Update

Cartesian Therapeutics, Inc., a clinical-stage biotech firm specializing in mRNA cell therapy for autoimmune diseases, has disclosed significant advancements and financial results for the second quarter of 2024. Dr. Carsten Brunn, President and CEO, emphasized that the past quarter was pivotal for Cartesian, demonstrating the clinical differentiation of their innovative mRNA platform. The company's lead product, Descartes-08, has shown promising outcomes in various trials, supporting its efficacy in treating autoimmune diseases.

In July 2024, Cartesian revealed positive topline results from a Phase 2b trial of Descartes-08 in patients with generalized myasthenia gravis (MG). The trial met its primary endpoint, with 71% of patients showing a 5-point or greater improvement in MG Composite (MGC) score at Month 3, compared to 25% in the placebo group. Patients who reached four-month and six-month assessments demonstrated significant and durable improvements in their MGC severity scores. Descartes-08 also exhibited a favorable safety profile, supporting its outpatient administration without the need for preconditioning chemotherapy. An End-of-Phase 2 meeting with the FDA is planned by the end of 2024 to review trial data and discuss the initiation of a Phase 3 clinical trial in MG.

The company also dosed the first patient in a Phase 2 clinical trial of Descartes-08 for systemic lupus erythematosus (SLE) in July 2024. This trial aims to evaluate the safety, tolerability, and clinical activity of Descartes-08 without preconditioning chemotherapy. SLE is a chronic autoimmune disease affecting multiple organ systems and impacting approximately 1.5 million people in the U.S. Cartesian anticipates that the mechanism of action of Descartes-08 could provide clinical benefits for SLE patients.

Looking ahead, Cartesian plans to file an Investigational New Drug (IND) application for Descartes-08 in pediatric autoimmune disease indications by the end of 2024. The proposed basket trial will focus on pediatric neurological and rheumatological autoimmune diseases with high unmet medical needs. The favorable safety profile observed in adult patients treated with Descartes-08 without lymphodepleting chemotherapy could be advantageous for pediatric treatments.

In addition to Descartes-08, Cartesian is progressing with Descartes-15, a next-generation autologous anti-BCMA mRNA CAR-T product. The company expects to dose the first patient in a Phase 1 trial for multiple myeloma in the latter half of 2024. Following this, Descartes-15 will be assessed in autoimmune indications. Preclinical studies have shown that Descartes-15 achieves a ten-fold increase in CAR expression and selective target-specific killing relative to Descartes-08.

From a corporate perspective, Cartesian completed a $130 million private placement equity financing in July 2024. The funds will support the development of Descartes-08 in MG, specifically covering manufacturing costs for a Phase 3 trial and early commercial activities in preparation for a potential launch. The proceeds will also advance Cartesian's autoimmune pipeline, including Descartes-08 for SLE and Descartes-15, and support a planned basket trial for pediatric indications.

Operationally, the company is enhancing its process development and manufacturing capabilities to improve production yields. In July 2024, Kemal Malik, MBBS, joined the Board of Directors, bringing extensive regulatory and clinical expertise to the company.

For the second quarter of 2024, Cartesian reported cash, cash equivalents, and restricted cash of approximately $88.9 million as of June 30, 2024. Research and development expenses decreased to $12.7 million for the quarter, compared to $17.8 million in the same period in 2023, primarily due to a reduction in headcount and lower contract license and milestone payments. General and administrative expenses increased to $7.0 million from $6.1 million. The company achieved a net income of $13.8 million for the quarter, compared to a net loss of $11.4 million in the second quarter of 2023.

Cartesian Therapeutics continues to advance its innovative mRNA cell therapy platform, aiming to provide new treatment options for autoimmune diseases with high unmet needs.