Business and Pipeline Update Cartesian Therapeutics updated its clinical pipeline, detailing progress for Descartes-08 in autoimmune diseases and Descartes-15 for multiple myeloma Overview and Key Milestones Cartesian Therapeutics reported a strong start to 2025, highlighting positive long-term data for Descartes-08 in MG and outlining key upcoming clinical milestones - Initiation of the Phase 3 AURORA trial for Descartes-08 in myasthenia gravis (MG) is expected in Q2 202513 - Preliminary data from the Phase 2 trial of Descartes-08 in systemic lupus erythematosus (SLE) are anticipated in the second half of 2025129 - A Phase 2 pediatric basket trial for Descartes-08 in select autoimmune diseases is planned to start in the second half of 2025129 - CEO Carsten Brunn highlighted that a single course of Descartes-08 therapy resulted in deep and sustained benefits at Month 12 for MG patients, particularly those without prior exposure to biologic therapies2 Descartes-08 Program Descartes-08 demonstrated sustained efficacy in MG Phase 2b, with a Phase 3 trial planned and expansion into other autoimmune indications - In the Phase 2b trial for MG, Descartes-08 treatment led to an average 4.8-point reduction in the MG-ADL score at Month 12. Patients without prior biologic therapy exposure experienced a more significant 7.1-point reduction3 - The Phase 3 AURORA trial for MG is a randomized, placebo-controlled study set to begin in Q2 2025, enrolling about 100 patients. The primary endpoint is a ≥3-point improvement in MG-ADL score at Month 434 - A Phase 2 pediatric basket trial is expected to initiate in 2H 2025, targeting juvenile SLE, juvenile MG, juvenile dermatomyositis (JDM), and other vasculitis9 - Descartes-08 is an autologous anti-BCMA CAR-T therapy that does not require preconditioning chemotherapy and avoids the risk of genomic integration. It has received Orphan Drug and Regenerative Medicine Advanced Therapy (RMAT) designations from the FDA for MG treatment6 Descartes-15 Program Descartes-15, a next-gen anti-BCMA CAR-T, is in Phase 1 for multiple myeloma, showing tenfold increased CAR expression, with future autoimmune plans - Dosing is ongoing in the first-in-human Phase 1 trial for multiple myeloma to assess safety and tolerability9 - Descartes-15 is a next-generation therapy observed in preclinical studies to have an approximately ten-fold increase in CAR expression and selective killing compared to Descartes-087 - Similar to Descartes-08, it is designed for outpatient administration without preconditioning chemotherapy7 - The company plans to assess Descartes-15 in autoimmune indications after the completion of the Phase 1 trial9 Financial Performance Cartesian Therapeutics reported Q1 2025 financial results, showing a reduced net loss, strong cash, and shifts in operating expenses Financial Highlights (Q1 2025) Cartesian Therapeutics reported a Q1 2025 net loss of $17.7 million, a significant improvement, with $182.1 million cash expected to fund operations into mid-2027 - The company held $182.1 million in cash, cash equivalents, and restricted cash as of March 31, 2025, which is expected to support planned operations into mid-202719 Q1 2025 Financial Summary | Metric | Q1 2025 | Q1 2024 | Change | | :--- | :--- | :--- | :--- | | Total Revenue | $1.1M | $5.8M | -81.2% | | R&D Expenses | $14.7M | $9.7M | +51.5% | | G&A Expenses | $8.3M | $9.5M | -12.6% | | Net Loss | $(17.7)M | $(56.8)M | Improved | | Net Loss Per Share | $(0.68) | $(10.50) | Improved | Consolidated Balance Sheet As of March 31, 2025, total assets decreased to $409.1 million, primarily due to lower cash, with an increased stockholders' deficit Consolidated Balance Sheet Summary | Category | March 31, 2025 ($ thousands) | December 31, 2024 ($ thousands) | | :--- | :--- | :--- | | Assets | | | | Cash and cash equivalents | 180,434 | 212,610 | | Total Current Assets | 185,120 | 216,626 | | Total Assets | 409,130 | 435,023 | | Liabilities & Stockholders' Deficit | | | | Total Current Liabilities | 14,998 | 22,976 | | Total Liabilities | 430,919 | 441,825 | | Total Stockholders' Deficit | (21,789) | (6,802) | | Total Liabilities & Stockholders' Deficit | 409,130 | 435,023 | Consolidated Statement of Operations Q1 2025 revenue decreased to $1.1 million, operating loss widened, but net loss significantly narrowed to $17.7 million due to fair value adjustments Consolidated Statement of Operations Summary | Metric ($ thousands) | Q1 2025 | Q1 2024 | | :--- | :--- | :--- | | Total Revenue | 1,100 | 5,840 | | Research and development | 14,674 | 9,738 | | General and administrative | 8,315 | 9,450 | | Operating loss | (21,889) | (13,348) | | Change in fair value of contingent value right liability | 346 | (39,300) | | Net loss | (17,710) | (56,824) | | Net loss per share (basic and diluted) | $(0.68) | $(10.50) |
SELECTA BIOSCI(SELB) - 2025 Q1 - Quarterly Results