Company Overview - Cartesian Therapeutics is a clinical-stage biotechnology company focused on pioneering mRNA cell therapies for autoimmune diseases [2] - The lead asset, Descartes-08, is in Phase 2b clinical development for generalized myasthenia gravis and Phase 2 development for systemic lupus erythematosus, with plans for a Phase 2 basket trial in additional autoimmune indications [2] - The clinical-stage pipeline also includes Descartes-15, a next-generation, autologous anti-BCMA mRNA CAR-T [2] Upcoming Events - The company management is scheduled to participate in several investor conferences in February and March 2025, including: - A fireside chat at the H.C. Wainright & Co. 3rd Annual Cell Therapy Virtual Conference on February 25, 2025 [3] - A presentation at the TD Cowen 45th Annual Health Care Conference on March 3, 2025, in Boston, MA [3] - A fireside chat at the Leerink Global Healthcare Conference on March 10, 2025, in Miami, FL [3] - Live webcasts of these presentations will be accessible on the company's website, with archived replays available for a limited time [1]

Core Viewpoint - Cartesian Therapeutics has received FDA agreement on the Phase 3 AURORA trial design for its mRNA cell therapy candidate Descartes-08, aimed at treating myasthenia gravis (MG), indicating a clear path toward potential approval [1][2] Company Overview - Cartesian Therapeutics is a clinical-stage biotechnology company focused on mRNA cell therapy for autoimmune diseases, with its lead asset Descartes-08 in development for generalized myasthenia gravis and systemic lupus erythematosus [6] Trial Details - The Phase 3 AURORA trial will be a randomized, double-blind, placebo-controlled study involving approximately 100 participants with acetylcholine receptor autoantibody positive MG, assessing the efficacy of Descartes-08 compared to placebo [2][3] - The primary endpoint of the trial is to evaluate the proportion of participants showing a three-point or greater improvement in the MG Activities of Daily Living (MG-ADL) score at Month 4 [2] Previous Results - Positive results from the Phase 2b trial indicated that participants treated with Descartes-08 experienced an average MG-ADL reduction of 5.5 (±1.1) at Month 4, demonstrating deep and durable improvements [3] Treatment Characteristics - Descartes-08 is an autologous mRNA-engineered chimeric antigen receptor T-cell therapy that does not require preconditioning chemotherapy and can be administered in an outpatient setting, reducing risks associated with conventional therapies [5] - The therapy has received Orphan Drug Designation and Regenerative Medicine Advanced Therapy Designation from the FDA for treating MG [5] Disease Context - Myasthenia gravis is a chronic autoimmune disorder characterized by muscle weakness and fatigue, with no current cure available, necessitating chronic immunosuppressive treatments that carry risks and side effects [4]

Core Viewpoint - Cartesian Therapeutics has received FDA agreement on the Phase 3 AURORA trial design for its mRNA cell therapy candidate Descartes-08, aimed at treating myasthenia gravis (MG), indicating a clear path toward potential approval [1][2] Company Overview - Cartesian Therapeutics is a clinical-stage biotechnology company focused on mRNA cell therapy for autoimmune diseases, with its lead asset being Descartes-08 [6] - The company is also developing Descartes-15, a next-generation mRNA CAR-T therapy [6] Product Details - Descartes-08 is an autologous mRNA-engineered chimeric antigen receptor T-cell therapy targeting B-cell maturation antigen (BCMA) for generalized myasthenia gravis and systemic lupus erythematosus [5] - The therapy does not require preconditioning chemotherapy and can be administered in an outpatient setting, reducing risks associated with conventional therapies [5] Clinical Trial Information - The Phase 3 AURORA trial will involve approximately 100 participants with acetylcholine receptor autoantibody positive MG, comparing Descartes-08 to a placebo with a primary endpoint focused on improvement in MG-ADL scores [2][3] - The trial is set to commence in the first half of 2025 [1][2] Previous Trial Results - Positive results from the Phase 2b trial showed an average MG-ADL reduction of 5.5 points at Month 4 for participants treated with Descartes-08, indicating deep and durable improvements [3]

Core Insights - Cartesian Therapeutics is advancing its mRNA cell therapy pipeline, particularly focusing on Descartes-08 for myasthenia gravis and systemic lupus erythematosus [1][2][3] Descartes-08 Updates - The Phase 3 AURORA trial for Descartes-08 in myasthenia gravis is set to begin in the first half of 2025, following positive Phase 2b results showing an average MG Activities of Daily Living (MG-ADL) reduction of 5.5 at Month 4 [1][3] - Descartes-08 has demonstrated a favorable safety profile, allowing for outpatient administration without preconditioning chemotherapy [2][3] - The ongoing Phase 2 trial for systemic lupus erythematosus is expected to provide data readout in the second half of 2025, with the disease affecting approximately 1.5 million people in the U.S. [3] Future Trials and Designations - A Phase 2 basket trial for Descartes-08 in pediatric patients with select autoimmune diseases is anticipated to start later in 2025, with Rare Pediatric Disease Designation already granted for juvenile dermatomyositis [3][5] - Descartes-08 has received Orphan Drug Designation and Regenerative Medicine Advanced Therapy Designation from the FDA for treating myasthenia gravis [5] Descartes-15 Development - The first-in-human Phase 1 clinical trial for Descartes-15, an autologous anti-BCMA mRNA CAR-T cell therapy, is currently underway, focusing on safety and tolerability in multiple myeloma patients [4][6] - Descartes-15 has shown a ten-fold increase in CAR expression in preclinical studies compared to Descartes-08, maintaining the outpatient administration advantage [6] Company Overview - Cartesian Therapeutics is a clinical-stage biotechnology company specializing in mRNA cell therapy for autoimmune diseases, with a pipeline that includes both Descartes-08 and Descartes-15 [7]

Phase 3 AURORA trial on track to commence in 1H2025; Primary endpoint to assess proportion of Descartes-08-treated participants with myasthenia gravis demonstrating an MG-ADL improvement of ≥3 points at Month 4 relative to placebo Deepening responses observed over time in Phase 2b trial, with Descartes-08-treated participants observed to have a 5.5-point reduction in MG-ADL at Month 4 Durable responses observed through Month 12 in Phase 2b trial Safety profile consistent with previously reported data and co ...

FREDERICK, Md., Nov. 21, 2024 (GLOBE NEWSWIRE) -- Cartesian Therapeutics, Inc. (NASDAQ: RNAC) (the “Company”), a clinical-stage biotechnology company pioneering mRNA cell therapy for autoimmune diseases, today announced that updated efficacy and safety data from the Phase 2b trial of Descartes-08 in patients with generalized myasthenia gravis will be presented at the 2nd Annual Cell Therapy for Autoimmune Disease Summit, being held December 2-4, 2024 in Philadelphia. Details of the presentation are as follo ...

Live Chat on The Biotech Forum has been dominated by discussion of lucrative buy-write or covered call opportunities on selected biotech stocks over the past several months. To see what I and the other season biotech investors are targeting as trading ideas real-time, just join our community at The Biotech Forum by clicking HERE . Thinly traded shares of mRNA cell therapy concern Cartesian Therapeutics, Inc. (NASDAQ: RNAC ) have had a huge rebound off their August 2024 low, with seemingly little to no news ...

Cartesian Therapeutics, Inc. (RNAC) came out with a quarterly loss of $0.69 per share versus the Zacks Consensus Estimate of a loss of $0.78. This compares to loss of $2.40 per share a year ago. These figures are adjusted for non-recurring items.This quarterly report represents an earnings surprise of 11.54%. A quarter ago, it was expected that this company would post a loss of $0.81 per share when it actually produced earnings of $0.54, delivering a surprise of 166.67%.Over the last four quarters, the comp ...

Securities registered pursuant to Section 12(b) of the Act: UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 10-Q þ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended September 30, 2024 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from _______ to _______ Commission File Number: 001-37798 Cartesian Therapeutics, Inc. (Exact name of registra ...

Exhibit 99.1 Cartesian Therapeutics Reports Third Quarter 2024 Financial Results and Provides Business Update Company expects to commence Phase 3 trial of Descartes-08 in patients with myasthenia gravis in 1H2025 following recent meeting with U.S. Food and Drug Administration Presentation of updated efficacy and safety data from Phase 2b trial and Phase 3 trial design of Descartes-08 in patients with myasthenia gravis expected by year-end Dosing underway in Phase 2 trial of Descartes-08 in patients with sys ...