Descartes-08 / Cartesian Therapeutics - LARVOL DELTA

Topline Data from Phase 2 Trial of Descartes-08 in SLE (GlobeNewswire) - "Initial data reported significant reduction in disease activity following initial Descartes-08 treatment with 100% of participants who reached Month 3 follow-up (n=3) achieving Lupus Low Disease Activity State (LLDAS) response, defined by specific criteria that indicate low disease activity, improved patient outcomes, and sustained symptom improvement....The Company will continue to analyze the data from SLE to determine the next steps for the program. Disease remission reported as DORIS response was seen in 2 out of 3 participants at Month 3....At this time, Cartesian plans to pause further development of Descartes-08 in SLE, including enrollment in the Phase 2 trial, to prioritize the opportunities in MG, currently in Phase 3, and myositis."

Enrollment status • P2 data • Systemic Lupus Erythematosus

Recent Pipeline Progress and Anticipated Milestones (GlobeNewswire) - "Preliminary Data from Ongoing Phase 2 Open-Label Trial of Descartes-08 in Patients with SLE Expected by End of Year...Phase 2 Pediatric Basket Trial of Descartes-08 in Select Autoimmune Diseases Expected to Initiate by End of Year."

New P2 trial • P2 data • Immunology • Systemic Lupus Erythematosus

SLE-001: Descartes-08 for Patients With Systemic Lupus Erythematosus (clinicaltrials.gov) - P2 | N=6 | Active, not recruiting | Sponsor: Cartesian Therapeutics | Recruiting ➔ Active, not recruiting | N=30 ➔ 6

Enrollment change • Enrollment closed • Immunology • Inflammatory Arthritis • Lupus • Systemic Lupus Erythematosus

Myositis Expansion (GlobeNewswire) - "...Cartesian today announced the planned expansion of Descartes-08 into myositis, a significantly underserved market with high unmet need. The Company plans to initiate a seamless adaptive clinical trial design which provides a potential opportunity for a single pivotal trial planned to commence in the first half of 2026. The randomized, double-blind, placebo-controlled Phase 2 trial in myositis is designed to assess Descartes-08 versus placebo (1:1 randomization) administered as six weekly outpatient infusions without preconditioning chemotherapy in up to 50 patients with moderate to severe multi-refractory dermatomyositis and antisynthetase syndrome....The Company plans to file an investigational new drug application (IND) for this trial by the end of 2025."

IND • New P2 trial • Dermatomyositis

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

Third Quarter 2025 Financial Results (GlobeNewswire) - "Cash, cash equivalents and restricted cash as of September 30, 2025 was $145.1 million and is expected to support planned operations, including completion of the ongoing Phase 3 AURORA trial for Descartes-08 in MG, into mid-2027; Research and development expenses were $13.8 million for the three months ended September 30, 2025, compared to $11.4 million for the three months ended September 30, 2024. The increase in expenses was primarily a result of increased expenses associated with the ongoing Phase 3 AURORA trial for Descartes-08 for MG coupled with an increase in employee expenses as the result of headcount growth."

Commercial • Myasthenia Gravis

Descartes-08 for Children, Adolescents and Young Adults With Childhood-onset Systemic Lupus Erythematosus, ANCA-associated Vasculitis, Juvenile Myasthenia Gravis, and Juvenile Dermatomyositis (clinicaltrials.gov) - P1/2 | N=50 | Not yet recruiting | Sponsor: Cartesian Therapeutics

New P1/2 trial • ANCA Vasculitis • CNS Disorders • Dermatomyositis • Immunology • Inflammatory Arthritis • Lupus • Myasthenia Gravis • Myositis • Systemic Lupus Erythematosus • Vasculitis

Durability of Response to B-Cell Maturation Antigen-Directed mRNA Cell Therapy in Myasthenia Gravis. (PubMed, Ann Clin Transl Neurol) - P2 | "These data support continued development of Descartes-08 in myasthenia gravis and other autoantibody-associated autoimmune disorders."

IO biomarker • Journal • CNS Disorders • Immunology • Myasthenia Gravis

Descartes-08 CAR-T Cells in Generalized Myasthenia Gravis (MG) (clinicaltrials.gov) - P2 | N=30 | Active, not recruiting | Sponsor: Cartesian Therapeutics | Recruiting ➔ Active, not recruiting | Trial primary completion date: Mar 2025 ➔ Jul 2025

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

Cartesian Therapeutics Announces First Participant Enrolled in the Phase 3 AURORA Trial of Descartes-08 in Patients with Myasthenia Gravis (GlobeNewswire) - "Cartesian Therapeutics, Inc...today announced that the first participant has been enrolled in its Phase 3 AURORA trial of Descartes-08 in patients with myasthenia gravis (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."

Trial status • Myasthenia Gravis

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

…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