Cartesian Therapeutics, Inc. (NASDAQ:RNAC) (the "Company"), a clinical-stage biotechnology company pioneering cell therapy for autoimmune diseases, today announced that it has entered into an agreement with K2 HealthVentures LLC ("K2HV"), an alternative investment firm that provides flexible, long-term financing solutions in life sciences, to provide a credit facility of up to $150 million including an initial $50 million tranche. The proceeds from the initial tranche under the credit facility are expected to allow the Company to accelerate the ongoing investment in the commercial launch preparation activities for Descartes-08 in myasthenia gravis (MG) and myositis and to extend cash runway into 2028. The Company also announced progress across its pipeline, including updated timelines for all ongoing trials of Descartes-08, an autologous anti-B cell maturation antigen (BCMA) mRNA chimeric antigen receptor T-cell therapy (CAR-T).

"We are very excited to partner with K2 HealthVentures for this financing, which we expect to provide us with access to the additional capital necessary to help support our continued growth. With this additional financing, we believe we are now fully funded beyond anticipated timelines for achievement of three near-term clinical catalysts, including topline data from our Phase 3 AURORA trial in MG in the first quarter of 2027, data from our Phase 2 TRITON trial in myositis and data from our Phase 1/2 HELIOS trial in JDM," said Carsten Brunn, Ph.D., President and Chief Executive Officer of Cartesian. "Descartes-08 remains the only CAR-T in autoimmune disease that we are aware of that is designed for outpatient administration without preconditioning chemotherapy, and our prior data demonstrate deep and durable responses after a single course of therapy. We look forward to advancing Descartes-08 toward registration and commercial launch in MG."

Cash Runway and Credit Facility

Under the Company's credit facility with K2HV, the first $50 million term loan was funded upon signing of the agreement. The second $25 million term loan is expected to be available to be drawn between January 1, 2027 and December 1, 2027, subject to the Company's achievement of specified clinical and financing milestones and the third $25 million term loan is expected to be available to be drawn between January 1, 2028 and June 1, 2028, subject to the Company's achievement of specified approval and sales milestones. An additional $50 million tranche is available for draw at Cartesian's option subject K2 HealthVentures' discretion. Morgan Stanley served as sole structuring agent for the transaction.

The Company now anticipates current cash resources to support planned operations into 2028, including three clinical data readouts and accelerated investment in precommercial activities.

Multiple Clinical Catalysts Expected over the Next 12 Months

  • Phase 3 AURORA data in MG expected in 1Q27; biologics license application (BLA) filing planned for mid-2027
  • Phase 2 TRITON data in myositis expected in 1H27
  • Phase 1/2 HELIOS data in juvenile dermatomyositis (JDM) expected in 1H27

     

Phase 3 AURORA Trial in MG

  • The Company anticipates reporting topline data from the Phase 3 AURORA trial in the first quarter of 2027 with BLA filing planned for mid-2027.
  • The randomized, double-blind, placebo-controlled trial is designed to assess Descartes-08 versus placebo (1:1 randomization) administered as six once-weekly outpatient infusions without preconditioning chemotherapy in approximately 100 patients with acetylcholine receptor autoantibody positive (AChR Ab+) MG. The primary endpoint will assess the proportion of Descartes-08 participants with an improvement in MG Activities of Daily Living (MG-ADL) score of three points or more at Month 4 compared to placebo (a two-point reduction in MG-ADL is considered clinically meaningful).
  • In January 2026, the Company published a peer-reviewed journal article in Nature Medicine outlining the efficacy and safety data from the Phase 2b trial of Descartes-08 in participants with MG. After a single course of therapy, Descartes-08-treated participants were observed to sustain deep responses through long-term follow-up, with an average 4.8-point reduction in MG-ADL at Month 12. The deepest and most compelling sustained responses were observed in Descartes-08-treated participants who did not have prior exposure to biologic therapies, with an average 7.1-point reduction in MG-ADL and 57% of patients in this subgroup maintaining minimum symptom expression at Month 12. The safety profile of Descartes-08 was consistent with previously reported data and continues to support outpatient administration.

     

Phase 2 TRITON Trial in Myositis

  • Cartesian expects to evaluate clinical data from a subset of patients from the trial in the first half of 2027 to determine the path to a pivotal trial in these indications with significant unmet need.
  • The Phase 2 TRITON trial of Descartes-08 was initiated in April 2026, and enrollment continues to progress well. The randomized, double-blind, placebo-controlled trial in myositis is designed to assess Descartes-08 versus placebo (1:1 randomization) administered as six once-weekly outpatient infusions without preconditioning chemotherapy in patients with moderate to severe multi-refractory dermatomyositis and antisynthetase syndrome. The primary endpoint is expected to assess safety and efficacy of Descartes-08 compared to placebo added to standard of care in participants with myositis at Week 24.

Phase 1/2 HELIOS Trial in JDM

  • Clinical data from the Phase 1/2 HELIOS pediatric trial is expected in the first half of 2027.
  • The Phase 1/2 HELIOS trial of Descartes-08 in JDM was initiated in January 2026 and is designed to assess the safety, tolerability and efficacy of Descartes-08 in children, adolescents and young adults with childhood-onset autoimmune diseases, including JDM. The U.S. Food and Drug Administration (FDA) previously granted Rare Pediatric Disease Designation to Descartes-08 for the treatment of JDM.

Corporate Updates

Chief Medical Officer (CMO), Miloš Miljković, has informed the Company that he intends to step down from his role for personal reasons to return to practicing medicine. Dr. Miljković has helped support the development of both Descartes-08 and Cartesian through the Company's transition from an early-stage research and development company to a late-stage clinical company.

Peter Traber, MD, Cartesian's Head of R&D, who assisted in directing the Company's clinical trials over the past year, is expected to continue supporting Cartesian through the full completion of the Company's ongoing clinical trials and the preparation for BLA filing of Descartes-08 in MG in mid-2027. Dr. Traber brings more than three decades of leadership spanning academic medicine and biotechnology. He previously served as CMO of Selecta Biosciences, CEO of Galectin Therapeutics and CMO at GlaxoSmithKline. In previous academic roles, he served as the President of the Baylor College of Medicine and Chairman of Medicine and CEO of the University of Pennsylvania Health System.