Cartesian Therapeutics(RNAC)

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Cartesian Therapeutics(RNAC) - 2025 Q2 - Quarterly Report
2025-08-07 11:08
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 June 30, 2025 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 registrant as specified in its charter) Delaware 26-1622110 (State or oth ...
Cartesian Therapeutics(RNAC) - 2025 Q2 - Quarterly Results
2025-08-07 11:05
Cartesian Therapeutics Reports Second Quarter 2025 Financial Results and Provides Business Update Initiated Phase 3 AURORA trial of Descartes-08 in myasthenia gravis Preliminary data from Phase 2 trial of Descartes-08 in systemic lupus erythematosus expected in 2H25 Exhibit 99.1 Initiation of Phase 2 pediatric basket trial of Descartes-08 in select autoimmune indications expected in 2H25 An encore presentation of the data, which were originally shared at the 2025 American Academy of Neurology Annual Meeting ...
Cartesian Therapeutics, Inc. (RNAC) Moves 9.9% Higher: Will This Strength Last?
ZACKS· 2025-07-24 12:40
Cartesian Therapeutics, Inc. (RNAC) shares soared 9.9% in the last trading session to close at $13.39. The move was backed by solid volume with far more shares changing hands than in a normal session. This compares to the stock's 17.6% gain over the past four weeks.The recent surge in the stock price is driven by positive investor expectations regarding the company's pipeline of novel mRNA cell therapy for autoimmune diseases. Cartesian is currently assessing its lead candidate, Descartes-08, in a phase III ...
Cartesian Therapeutics Announces First Participant Enrolled in the Phase 3 AURORA Trial of Descartes-08 in Patients with Myasthenia Gravis
GlobeNewswire News Room· 2025-05-30 11:00
Core Insights - Cartesian Therapeutics has enrolled the first participant in its Phase 3 AURORA trial for Descartes-08, a cell therapy for myasthenia gravis (MG) [1][3] - Descartes-08 is an autologous engineered CAR-T therapy targeting B-cell maturation antigen (BCMA), designed for outpatient administration without preconditioning chemotherapy [2][5] - The Phase 3 trial aims to compare Descartes-08 to a placebo in approximately 100 participants, focusing on improvements in MG Activities of Daily Living (MG-ADL) scores [3][4] Company Overview - Cartesian Therapeutics is a clinical-stage biotechnology company focused on cell therapy for autoimmune diseases, with Descartes-08 as its lead asset in Phase 3 development for generalized MG [5] - The company is also developing Descartes-15, a next-generation CAR-T therapy currently in Phase 1 trials for multiple myeloma [5] Clinical Trial Details - The Phase 3 AURORA trial will randomize participants 1:1 to receive either Descartes-08 or placebo, with the primary endpoint being a three-point improvement in MG-ADL scores at Month 4 [3][4] - Previous Phase 2b trial results showed a significant average reduction of 4.8 points in MG-ADL scores at Month 12, with even greater reductions in patients without prior biologic therapy [4]
Cartesian Therapeutics(RNAC) - 2025 Q1 - Quarterly Report
2025-05-08 11:05
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 March 31, 2025 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 registrant as specified in its charter) Delaware 26-1622110 (I.R.S. Empl ...
Cartesian Therapeutics(RNAC) - 2025 Q1 - Quarterly Results
2025-05-08 11:04
Exhibit 99.1 Cartesian Therapeutics Reports First Quarter 2025 Financial Results and Provides Business Update Initiation of Phase 3 AURORA trial of Descartes-08 in myasthenia gravis expected in 2Q25; deep and sustained benefits observed through Month 12 after a single course of therapy in Phase 2b trial Preliminary data from Phase 2 trial of Descartes-08 in systemic lupus erythematosus expected in 2H25 Initiation of Phase 2 pediatric basket trial of Descartes-08 in select autoimmune indications expected in ...
Cartesian Therapeutics Reports First Quarter 2025 Financial Results and Provides Business Update
Globenewswire· 2025-05-08 11:00
Core Insights - Cartesian Therapeutics is advancing its lead product candidate, Descartes-08, with significant milestones expected in 2025, including the initiation of a Phase 3 trial for myasthenia gravis (MG) and preliminary data from a Phase 2 trial for systemic lupus erythematosus (SLE) [1][2][3] Pipeline Progress - The Phase 2b trial of Descartes-08 in MG showed deep and sustained benefits, with a 4.8-point reduction in the MG Activities of Daily Living Scale (MG-ADL) at Month 12 after a single therapy course [3] - In participants without prior exposure to biologic therapies, there was a 7.1-point reduction in MG-ADL, with 57% maintaining minimal symptoms at Month 12 [3] - The Phase 3 AURORA trial is set to begin in Q2 2025, involving approximately 100 participants and assessing the efficacy of Descartes-08 compared to placebo [3] Financial Overview - As of March 31, 2025, the company reported approximately $182.1 million in cash and equivalents, expected to fund operations through mid-2027 [1][8] - Research and development expenses for Q1 2025 were $14.7 million, up from $9.7 million in Q1 2024, primarily due to increased trial activities [8] - The net loss for Q1 2025 was $(17.7) million, a significant reduction from $(56.8) million in the same period of 2024, with a net loss per share of $(0.68) compared to $(10.50) [8][14] Future Trials - Preliminary data from the ongoing Phase 2 trial of Descartes-08 in SLE is anticipated in the second half of 2025 [1][8] - A Phase 2 pediatric basket trial targeting juvenile autoimmune diseases is also expected to initiate in the second half of 2025 [1][8]
Cartesian Therapeutics’ Descartes-08 Observed to Provide Deep and Sustained Benefits Through Month 12 After a Single Course of Therapy in Phase 2b Myasthenia Gravis Trial
Globenewswire· 2025-04-08 11:00
Core Insights - Cartesian Therapeutics announced positive 12-month efficacy and safety data from the Phase 2b trial of Descartes-08 for generalized myasthenia gravis (MG), showing sustained symptom improvement in participants [2][4][9] - Descartes-08 demonstrated a significant average reduction in MG-ADL scores, particularly in patients without prior biologic therapy, indicating its potential as a transformative treatment option [9][11] Efficacy Results - Participants treated with Descartes-08 experienced an average MG-ADL reduction of 4.8 points at Month 12, with deeper responses observed over time [7][11] - In the subgroup of participants without prior biologic therapy, the average MG-ADL reduction was 7.1 points at Month 12, with 57% maintaining minimum symptom expression [11] - 83% of evaluable participants maintained a clinically meaningful response through Month 12, defined as a reduction of at least 2 points in MG-ADL [7] Safety Profile - The safety profile of Descartes-08 was consistent with previously reported data, supporting its outpatient administration without the need for preconditioning chemotherapy [4][10] - Adverse events were mostly mild and transient, with no new adverse events reported during the 12-month follow-up [10][11] Future Development - The Phase 3 AURORA trial is on track to dose the first patient in the second quarter of 2025, with the trial design accepted by the FDA under the Special Protocol Assessment process [9][14] - Descartes-08 has received Regenerative Medicine Advanced Therapy and Orphan Drug Designations from the FDA, highlighting its potential in treating MG [9][13]
Cartesian Therapeutics' Descartes-08 Observed to Provide Deep and Sustained Benefits Through Month 12 After a Single Course of Therapy in Phase 2b Myasthenia Gravis Trial
Newsfilter· 2025-04-08 11:00
Core Insights - Cartesian Therapeutics announced positive 12-month efficacy and safety data from the Phase 2b trial of Descartes-08 for generalized myasthenia gravis (MG) [2][4] - Descartes-08 demonstrated sustained symptom improvement with an average reduction of 4.8 points in MG Activities of Daily Living (MG-ADL) at Month 12 [6][8] - The therapy showed particularly strong results in participants without prior exposure to biologic therapies, achieving an average 7.1-point reduction in MG-ADL [10] Efficacy Results - In the Phase 2b trial, participants receiving Descartes-08 experienced deep responses, with an average MG-ADL reduction of 5.5 at Month 4 and 4.8 at Month 12 [6][4] - 83% of evaluable participants maintained a clinically meaningful response through Month 12, defined as a reduction of at least 2 points in MG-ADL [6] - Among participants without prior biologic therapy, 100% maintained a clinically meaningful response through Month 12 [10] Safety Profile - Descartes-08 was well-tolerated, with no new adverse events reported during the 12-month follow-up [10] - Common side effects included transient infusion-related reactions such as fever (60%), chills (60%), headache (55%), and nausea (45%), all resolving within 24 hours [10] - No cases of cytokine release syndrome (CRS) or immune effector cell-associated neurotoxicity syndrome (ICANS) were reported [10] Future Developments - The Phase 3 AURORA trial is set to dose the first patient in the second quarter of 2025, following FDA agreement on the trial design [8][10] - Descartes-08 has received Regenerative Medicine Advanced Therapy (RMAT) and Orphan Drug Designations from the FDA for the treatment of MG [12][8] - The company aims to transform the treatment landscape for MG with Descartes-08, offering a safe and durable outpatient therapy option [8][10]
Cartesian Therapeutics to Participate in the 24th Annual Needham Virtual Healthcare Conference
Globenewswire· 2025-04-01 11:00
Core Insights - Cartesian Therapeutics, Inc. is a clinical-stage biotechnology company focused on mRNA cell therapies for autoimmune diseases [3] - The company will participate in the 24th Annual Needham Virtual Healthcare Conference on April 8, 2025 [1] Company Overview - Cartesian Therapeutics is pioneering mRNA CAR-T therapies, with its lead asset Descartes-08 entering Phase 3 clinical development for generalized myasthenia gravis and Phase 2 for systemic lupus erythematosus [3] - Descartes-08 has received FDA agreement under the Special Protocol Assessment for its Phase 3 trial [3] - The company also has Descartes-15, an autologous anti-BCMA mRNA CAR-T in Phase 1 trial for multiple myeloma [3] Event Information - A live webcast of the conference presentation will be available on the company's website, along with an archived replay for a limited time [2]