Descartes-08 / Cartesian Therap - LARVOL DELTA

First Quarter 2025 Financial Results (GlobeNewswire) - "Cash, cash equivalents and restricted cash as of March 31, 2025 was $182.1 million and is expected to support planned operations, including completion of planned Phase 3 AURORA trial for Descartes-08 in MG, into mid-2027; Research and development expenses were $14.7 million for the three months ended March 31, 2025, compared to $9.7 million for the three months ended March 31, 2024. The increase in expenses was primarily a result of increased expenses for the Phase 2b trial and the activities associated with the Phase 3 AURORA trial for Descartes-08 for MG."

Commercial • Myasthenia Gravis

Cartesian Therapeutics Reports First Quarter 2025 Financial Results and Provides Business Update (GlobeNewswire) - "Initiation of Phase 3 AURORA Trial of Descartes-08 in MG on Track for 2Q25. The randomized, double-blind, placebo-controlled Phase 3 AURORA 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 participants with acetylcholine receptor autoantibody positive (AChR Ab+) MG...Preliminary Data from Ongoing Phase 2 Open-Label Trial of Descartes-08 in Patients with SLE Expected in the Second Half of 2025....Phase 2 Pediatric Basket Trial of Descartes-08 in Select Autoimmune Diseases Expected to Initiate in the Second Half of 2025."

New P2 trial • P2 data • Trial status • Immunology • Myasthenia Gravis • Systemic Lupus Erythematosus

Investigating an mRNA CAR T-cell Therapy, Known as Descartes-08, as a Potential Approach to Treat Myasthenia Gravis (clinicaltrials.gov) - P3 | N=100 | Recruiting | Sponsor: Cartesian Therapeutics | Not yet recruiting ➔ Recruiting

Enrollment open • CNS Disorders • Myasthenia Gravis

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) - P2 | N=30 | NCT04146051 | Sponsor: Cartesian Therapeutics | "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; Deepest and most compelling sustained responses 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; Safety profile consistent with previously reported data and continues to support outpatient administration; Phase 3 AURORA trial on track to dose first patient in 2Q25."

P2b data • Trial status • Myasthenia Gravis

Cartesian Therapeutics Reports Full Year 2024 Financial Results and Provides Business Update (GlobeNewswire) - "Preliminary Data from Ongoing Phase 2 Open-Label Trial of Descartes-08 in Patients with SLE Expected in the Second Half of 2025. This pediatric basket trial will target juvenile SLE, juvenile MG, juvenile dermatomyositis (JDM) and anti-neutrophil cytoplasmic antibody (ANCA) associated vasculitis....Phase 2 Pediatric Basket Trial of Descartes-08 in Select Autoimmune Diseases Expected to Initiate in the Second Half of 2025....Cash, cash equivalents and restricted cash as of December 31, 2024 was $214.3 million and is expected to support planned operations...Research and development expenses were $45.1 million for the year ended December 31, 2024, compared to $71.3 million for the year ended December 31, 2023."

Commercial • New P2 trial • P2 data • Dermatomyositis • Immunology • Myasthenia Gravis • Systemic Lupus Erythematosus

Efficacy and Safety of Autologous BCMA-directed mRNA CAR T-Cell Therapy in Generalized Myasthenia Gravis: Results from a Phase 2b Randomized Placebo-controlled Trial (AAN 2025) - P2 | "Outpatient Descartes-08 administration was associated with significant reduction in disease activity scores compared to placebo with no concerning safety signals. Efficacy of Descartes-08 will be tested in a Phase 3 trial."

CAR T-Cell Therapy • Clinical • P2b data • CNS Disorders • Inflammation • Myasthenia Gravis

Investigating an mRNA CAR T-cell Therapy, Known as Descartes-08, as a Potential Approach to Treat Myasthenia Gravis (clinicaltrials.gov) - P3 | N=100 | Not yet recruiting | Sponsor: Cartesian Therapeutics | Trial completion date: Apr 2026 ➔ Sep 2027 | Trial primary completion date: Apr 2026 ➔ Nov 2026

Trial completion date • Trial primary completion date • CNS Disorders • Myasthenia Gravis

Investigating an mRNA CAR T-cell Therapy, Known as Descartes-08, as a Potential Approach to Treat Myasthenia Gravis (clinicaltrials.gov) - P3 | N=100 | Recruiting | Sponsor: Cartesian Therapeutics

New P3 trial • CNS Disorders • Myasthenia Gravis

Cartesian Therapeutics Announces FDA Special Protocol Assessment Agreement for Phase 3 AURORA Trial of Descartes-08 in Myasthenia Gravis (GlobeNewswire) - "Cartesian Therapeutics, Inc...today announced that it has received written agreement from the U.S. Food and Drug Administration (FDA) under the Special Protocol Assessment (SPA) process on the overall design of the Company’s planned Phase 3 AURORA trial for Descartes-08, its lead mRNA cell therapy candidate, in myasthenia gravis (MG). The SPA agreement indicates that the FDA has determined that the proposed trial design is acceptable to support a future Biologics License Application for Descartes-08 in MG, subject to the ultimate outcome of the trial...'We look forward to commencing the Phase 3 AURORA trial in the first half of this year.'"

New P3 trial • Special protocol assessment • Immunology • Myasthenia Gravis

Cartesian Therapeutics Highlights Progress and 2025 Strategic Priorities Across Pipeline of mRNA Cell Therapies for Autoimmune Diseases (GlobeNewswire) - "Phase 2 systemic lupus erythematosus (SLE) trial of Descartes-08 ongoing with expected data readout in 2H25; Cash resources expected to support planned operations, including completion of planned Phase 3 trial for Descartes-08 for myasthenia gravis, into mid-2027...The Company expects to commence a Phase 2 basket trial of Descartes-08 in pediatric patients with select autoimmune diseases, including juvenile dermatomyositis (JDM), in 2025."

New P2 trial • New P3 trial • P2 data • Trial completion • Dermatomyositis • Immunology • Myasthenia Gravis • Systemic Lupus Erythematosus

Cartesian Therapeutics Reports Third Quarter 2024 Financial Results and Provides Business Update (GlobeNewswire) - "Descartes-08 in Generalized Myasthenia Gravis (MG): The Company announced today that it plans to present updated efficacy and safety data from the Phase 2b trial by year-end....Following a recent meeting with the FDA, the Company expects to commence its planned Phase 3 study of Descartes-08 in patients with MG in the first half of 2025. The Company plans to announce details regarding the trial design by year-end....By year-end 2024, the Company plans to file an investigational new drug (IND) application for a pediatric basket trial of Descartes-08 in certain autoimmune diseases, including JDM."

Clinical protocol • IND • New P3 trial • P2b data • Dermatomyositis • Immunology • Myasthenia Gravis

Safety and Tolerability of BCMA-Directed mRNA CAR T-Cell Therapy in Multiple Myeloma and Autoimmune Disease (ASH 2024) - P1, P2 | "Clinical experience to date supports administration of mRNA CAR-T therapy in an outpatient setting and without lymphodepletion chemotherapy. Further clinical development of Descartes-08 is focused on adult and pediatric autoimmune disease, including MG (NCT04146051) and SLE (NCT06038474)."

CAR T-Cell Therapy • Clinical • CNS Disorders • Fatigue • Hematological Disorders • Hematological Malignancies • Immunology • Inflammatory Arthritis • Lupus • Multiple Myeloma • Musculoskeletal Pain • Myasthenia Gravis • Oncology • Pain • Pediatrics • Systemic Lupus Erythematosus • Thrombocytopenia

Safety and Tolerability of BCMA-Directed mRNA CAR T-Cell Therapy in Multiple Myeloma and Autoimmune Disease (ASH 2024) - P1, P2 | "Clinical experience to date supports administration of mRNA CAR-T therapy in an outpatient setting and without lymphodepletion chemotherapy. Further clinical development of Descartes-08 is focused on adult and pediatric autoimmune disease, including MG (NCT04146051) and SLE (NCT06038474)."

CAR T-Cell Therapy • Clinical • CNS Disorders • Fatigue • Hematological Disorders • Hematological Malignancies • Immunology • Inflammatory Arthritis • Lupus • Multiple Myeloma • Musculoskeletal Pain • Myasthenia Gravis • Oncology • Pain • Pediatrics • Systemic Lupus Erythematosus • Thrombocytopenia

…Outlines Design of Planned Phase 3 Trial (GlobeNewswire) - "Cartesian Therapeutics...Overview of Planned Phase 3 AURORA Trial: The Company today provided details on the design of its planned Phase 3 trial of Descartes-08 in patients with 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....Cartesian expects to commence the trial in the first half of 2025."

Clinical protocol • New P3 trial • Immunology • Myasthenia Gravis

Cartesian Therapeutics Announces Positive Updated Results from Phase 2b Trial of Descartes-08 in Participants with Myasthenia Gravis… (GlobeNewswire) - P2b | N=30 | NCT04146051 | Sponsor: Cartesian Therapeutics | "Updated Phase 2b Trial Results: The primary efficacy dataset for the follow-up portion of the trial consisted of a modified intent-to-treat (mITT) population of all subjects enrolled at academic medical centers who received at least one dose of Descartes-08 and completed at least one post-Month 3 MG-ADL score follow-up assessment....Updated Efficacy Results: Deepening responses were observed over time, with participants included in the primary efficacy dataset (n=12) experiencing an average MG-ADL reduction of 5.5 (±1.1) at Month 4....Safety: Descartes-08 continues to be observed as well-tolerated, supporting outpatient administration without the need for lymphodepleting chemotherapy. Consistent with previously reported data, Descartes-08 was observed to be well-tolerated across the safety dataset (n=36), and adverse events were transient and mostly mild."

P2b data • Immunology • Myasthenia Gravis

Cartesian Therapeutics to Present Updated Data from Phase 2b Trial of Descartes-08 in Patients with Myasthenia Gravis at the 2nd Annual Cell Therapy for Autoimmune Disease Summit (GlobeNewswire) - "Cartesian Therapeutics...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."

P2b data • Myasthenia Gravis

Cartesian Therapeutics Announces Presentation at the Upcoming 66th ASH Annual Meeting (GlobeNewswire) - "Cartesian Therapeutics, Inc...today announced that safety and tolerability data from patients treated with Descartes-08 will be featured during a poster presentation at the upcoming 66th American Society of Hematology (ASH) Annual Meeting and Exposition, being held December 7-10, 2024 in San Diego."

Clinical data • Immunology • Multiple Myeloma

Cartesian Therapeutics Receives FDA Regenerative Medicine Advanced Therapy (RMAT) Designation for Descartes-08 for the Treatment of Myasthenia Gravis (GlobeNewswire) - "Cartesian Therapeutics...today announced that the U.S. Food and Drug Administration ('FDA') has granted Regenerative Medicine Advanced Therapy ('RMAT') designation for Descartes-08 for the treatment of myasthenia gravis ('MG').....The Company remains on track to report topline data from its Phase 2b randomized, double-blind, placebo-controlled trial of Descartes-08 in patients with MG (NCT04146051) in mid-2024."

FDA event • P2b data • Myasthenia Gravis

Cartesian Therapeutics Announces Presentation of Results from Phase 2b Trial of Descartes-08 in Patients with Myasthenia Gravis at the 2024 MGFA Scientific Session of the AANEM Annual Meeting (GlobeNewswire) - P2b | N=30 | NCT04146051 | Sponsor: Cartesian Therapeutics | "Cartesian Therapeutics...today announced the presentation of data from its Phase 2b trial of Descartes-08 in patients with generalized myasthenia gravis (MG)...The trial achieved its primary endpoint with statistical significance in the pre-specified modified intent-to-treat efficacy population, with 71% (10/14) of patients treated with Descartes-08 observed to have 5-point or greater improvements in MG Composite (MGC) score at Month 3 compared to 25% (3/12) of patients treated with placebo (p=0.018)...'The Company expects to hold an End-of-Phase 2 meeting with the FDA by year-end 2024 to review data from the Phase 2b trial and discuss plans for initiating a Phase 3 clinical trial of Descartes-08 in MG.'"

FDA event • P2b data • Myasthenia Gravis

Cartesian Therapeutics Receives FDA Rare Pediatric Disease Designation for Descartes-08 for the Treatment of Juvenile Dermatomyositis (GlobeNewswire) - "Cartesian Therapeutics...announced that the U.S. Food and Drug Administration (FDA) has granted Rare Pediatric Disease Designation to Descartes-08 for the treatment of juvenile dermatomyositis (JDM)."

FDA event • Dermatomyositis

Cartesian Therapeutics Announces $130 Million Private Placement Equity Financing (GlobeNewswire) - "Descartes-08 for Pediatric Autoimmune Diseases: Cartesian plans to file an Investigational New Drug (IND) application for Descartes-08 in pediatric autoimmune disease indications by year-end 2024....Descartes-15 for Autoimmune Diseases: The Company expects to dose the first patient in its planned Phase 1 trial of Descartes-15 in the second half of 2024.....Completed $130 Million Private Placement Equity Financing...Cartesian announced a private investment in public equity (PIPE) financing, which included participation from both new and existing investors, resulting in gross proceeds of approximately $130.0 million....Cartesian expects to use the net proceeds to advance and expand its autoimmune pipeline through continued development of Descartes-08 for SLE, Descartes-15 for autoimmune diseases."

Financing • IND • New P1 trial • Immunology

Cartesian Therapeutics Announces Positive Topline Results from Phase 2b Trial of Descartes-08 in Patients with Myasthenia Gravis (GlobeNewswire) - P2 | N=30 | NCT04146051 | Sponsor: Cartesian Therapeutics | "Cartesian Therapeutics...today announced positive topline results from its Phase 2b trial of Descartes-08 in patients with generalized myasthenia gravis (MG)....'Our recently granted RMAT designation supports the continued development of Descartes-08 in collaboration with the FDA, with plans to hold an End-of-Phase 2 meeting by the end of the year. The results also exemplify what we hope to obtain with other assets in our existing and future pipeline.'...The trial achieved its primary endpoint with statistical significance in the pre-specified mITT efficacy population, with 71% (10/14) of patients treated with Descartes-08 observed to have 5-point or greater improvements in MGC score at Month 3 compared to 25% (3/12) of patients treated with placebo (p=0.018)....Today, Cartesian also announced that the first patient has been dosed in a clinical trial evaluating Descartes-08 in patients with SLE."

FDA event • P2b data • Trial status • Myasthenia Gravis • Systemic Lupus Erythematosus

Cartesian Therapeutics Announces First Patient Dosed in Phase 2 Trial of Descartes-08 in Systematic Lupus Erythematosus (GlobeNewswire) - "Cartesian Therapeutics...announced that the first patient has been dosed in its Phase 2 open-label clinical trial evaluating Descartes-08 in patients with systematic lupus erythematosus (SLE)....The Phase 2 open-label trial (NCT06038474), which is expected to enroll up to 30 adult patients, is designed to evaluate the safety and tolerability of outpatient administration of Descartes-08 without preconditioning chemotherapy for the treatment of patients with moderate or severe SLE refractory to immunosuppressant therapy."

Trial status • Systemic Lupus Erythematosus

Autologous CD8+ T-cells Expressing an Anti-BCMA CAR in Patients With Myeloma (clinicaltrials.gov) - P1 | N=32 | Terminated | Sponsor: Cartesian Therapeutics | Phase classification: P2 ➔ P1 | Completed ➔ Terminated; Phase 1 enrollment completed. Further clinical development terminated

Phase classification • Trial termination • Hematological Malignancies • Multiple Myeloma • Oncology

Descartes-08 Consolidation Treatment in Patients With High-Risk Multiple Myeloma High-Risk Multiple Myeloma Who Have Residual Disease After Induction Therapy (clinicaltrials.gov) - P2 | N=13 | Terminated | Sponsor: Cartesian Therapeutics | N=30 ➔ 13 | Recruiting ➔ Terminated; Sponsor decision

Enrollment change • Trial termination • Hematological Malignancies • Multiple Myeloma • Oncology