On May 8, 2024 Cartesian Therapeutics, Inc. (NASDAQ: RNAC) (the "Company"), a clinical-stage biotechnology company pioneering mRNA cell therapy for autoimmune diseases, reported financial results for the first quarter ended March 31, 2024, and recent corporate updates (Press release, Selecta Biosciences, MAY 8, 2024, View Source [SID1234642892]).

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"We continue to make meaningful progress advancing our innovative pipeline of product candidates and remain on track to report topline results from the Phase 2b trial of our lead product candidate, Descartes-08 for MG, in mid-2024," said Carsten Brunn, Ph.D., President and Chief Executive Officer of Cartesian. "Looking ahead, we also expect to commence dosing in our Phase 2 trial of Descartes-08 in patients with SLE by the end of the second quarter. Descartes-08 is designed with our novel mRNA-engineered CAR-T technology, is not expected to require preconditioning chemotherapy, and is intended to be administered in an outpatient setting. We remain confident Descartes-08 has the potential to expand the reach of cell therapy to patients with autoimmune diseases and serve as the first CAR-T cell therapy for the treatment of autoimmunity."

Dr. Brunn continued, "Additionally, we were excited to announce plans to transition to new corporate headquarters in Frederick, Maryland, that will provide us with the infrastructure to support our next phase of growth. We expect this new facility will allow us to scale our wholly owned, in-house cGMP manufacturing capabilities for late-stage clinical and commercial supply of our mRNA cell therapy product candidates, while continuing to maintain control over product quality and production."

Recent Pipeline Progress and Anticipated Milestones

Descartes-08 for Myasthenia Gravis (MG)

Topline data from randomized Phase 2b trial in patients with MG on track for mid-2024.
Recently granted Orphan Drug Designation by the U.S. Food and Drug Administration (FDA) for the treatment of MG.
Previously disclosed positive, long-term follow-up results from Phase 2a trial. In April 2024, the Company announced that these data will be featured in an oral presentation at the American Society of Gene and Cell Therapy (ASGCT) (Free ASGCT Whitepaper) 27th Annual Meeting on May 10, 2024 in Baltimore, Maryland.
Descartes-08, the Company’s lead product candidate, is an autologous anti-B cell maturation antigen (BCMA) mRNA-engineered chimeric antigen receptor T-cell therapy (mRNA CAR-T).
Descartes-08 for Systemic Lupus Erythematosus (SLE)

Dosing of first patient in Phase 2 trial of Descartes-08 in patients with SLE expected in second quarter of 2024.
The Phase 2 trial is designed to assess the safety and tolerability of outpatient Descartes-08 administration without preconditioning chemotherapy.
SLE is an incurable autoimmune disease marked by systemic inflammation that affects multiple organ systems and impacts approximately 1.5 million people in the United States.
Descartes-15 for Multiple Myeloma

Planning for the first-in-human Phase 1 dose escalation trial is underway to assess the safety and tolerability of outpatient Descartes-15 administration in patients with multiple myeloma.
Descartes-15 is a next-generation autologous anti-BCMA mRNA CAR-T product candidate designed to have predictable and controllable pharmacokinetics, potentially circumventing preconditioning chemotherapy, and avoiding the risk of genomic integration.
The Company expects to subsequently assess Descartes-15 in autoimmune indications.
Corporate Updates

Preferred Stock Conversion and Reverse Stock Split Approved at Special Meeting of Stockholders

In March 2024, Cartesian announced the approval for the conversion of the Company’s Series A Non-Voting Convertible Preferred Stock into the Company’s common stock and a 1-for-30 reverse stock split of the Company’s common stock.
Following the reverse stock split and the automatic conversion of the Company’s Series A Non-Voting Convertible Preferred Stock into common stock, the number of issued and outstanding shares of the Company’s common stock is approximately 17.8 million shares.
Transitioning Corporate Headquarters to Frederick, Maryland

In March 2024, the Company announced plans to transition its corporate headquarters to Frederick, Maryland. Following this announcement, Cartesian further expanded the footprint of this facility by approximately 30% through an amended agreement.
The Company now has approximately 27,000 square feet of state-of-the-art current good manufacturing practice (cGMP) compliant manufacturing and laboratory space, as well as general and administrative office space to support the Company’s continued growth. This facility reinforces the development of Cartesian’s clinical and preclinical programs through clinical and commercial manufacturing scale capabilities and advanced research and development laboratory space.
By conducting all manufacturing in-house, Cartesian expects to optimize processes more rapidly and iteratively while directly working to ensure adherence to strict quality standards. The Company believes this facility will facilitate production of potent yet safer, cost-effective mRNA cell therapy product candidates for late-stage clinical and commercial supply.
First Quarter 2024 Financial Results

Cash, cash equivalents, and restricted cash of approximately $104.8 million as of March 31, 2024. The Company’s cash, cash equivalents and restricted cash as of March 31, 2024 is expected to support planned operations and the development of Cartesian’s pipeline into the second half of 2026, including the planned Phase 3 trial of Descartes-08 in MG.
Research and development expenses were $9.7 million for the quarter ended March 31, 2024, compared to $18.6 million for the quarter ended March 31, 2023. The decrease in research and development expenses of $8.9 million for the quarter ended March 31, 2024 was primarily the result of reductions in expenses incurred for preclinical and clinical programs due to the strategic reprioritization in the Company’s clinical pipeline.
General and administrative expenses were $9.5 million for the quarter ended March 31, 2024, compared to $5.7 million for the quarter ended March 31, 2023. The increase in expense of $3.8 million for the quarter ended March 31, 2024 was primarily due to an increase in professional fees incurred in connection with the Company’s merger in November 2023.
Net loss was $(56.8) million, or $(10.50) per share (basic/diluted), for the quarter ended March 31, 2024, compared to net loss of $(21.7) million, or $(4.24) per share (basic/diluted), for the quarter ended March 31, 2023.