Short answer
Cartesian Therapeutics, Inc. (RNAC) filed its fiscal 2025 10-K annual report with the SEC on Mar 9, 2026. It reported revenue of $400,000 (−99.0% year over year) and net income of −$130M.
- Top risk flagged: FDA investigation of T-cell malignancy risk for CAR-T therapies including Descartes-08, with potential for boxed warnings or REMS requirements in 2024-2025
FY2025 key financial metrics · XBRL
- Revenue
- $400,000
- −99.0% YoY
- Net income
- −$130M
- −68.3% YoY
- Operating margin
- -35851.3%
- −35736.6 pp YoY
- EPS (diluted)
- −$5.02
- −11.8% YoY
- ROE
- 103.2%
- −1035.0 pp YoY
- Operating cash flow
- −$74M
- −212.3% YoY
Source: XBRL data from the Cartesian Therapeutics, Inc. (RNAC) FY2025 10-K on SEC EDGAR. USD.
Cartesian Therapeutics, Inc. FY2025 10-K analysis
AI summary of each section, grounded in the filing text
Business Overview
- Core business: Late clinical-stage biopharma pioneering outpatient mRNA-engineered autologous cell therapies for autoimmune diseases targeting B-cell maturation antigen (BCMA)
- New emphasis: Expansion of Descartes-08 into myositis (dermatomyositis, antisynthetase syndrome) with FDA IND accepted December 2025, Phase 2 trial to start H1 2026
- Strategic shift: Prioritization of Descartes-08 development after pausing Descartes-08 in SLE and halting Descartes-15 for multiple myeloma to focus on MG and myositis
- Quantitative highlight: Over 100 patients treated with Descartes-08 outpatient through Phase 1/2 trials; Phase 3 AURORA trial launched May 2025 targeting 100 MG patients
- Noteworthy: FDA granted Orphan Drug, RMAT, and Rare Pediatric Disease Designations for Descartes-08; first mRNA CAR-T with no CRS, neurotoxicity, or genomic integration risks reported
Management Discussion & Analysis
- Revenue $2.8M in 2025 vs $38.9M in 2024, collaboration and license revenue down $37.9M primarily from Sobi License milestone
- Operating expenses $146.2M in 2025 vs $82.8M in 2024, R&D up 29% to $58.0M, G&A slightly up 4% to $31.5M
- Operating loss $(143.4)M in 2025 vs $(43.9)M in 2024; net loss $(130.3)M vs $(77.4)M, loss increased 68%
- Best segment: Grant revenue $2.4M in 2025, up $1.8M; worst segment: collaboration/license revenue down 99% to $0.4M
- Cash $126.9M at year-end; $60.25M raised via Series A Preferred in 2023 Private Placement; no product sales yet
- Management expects continued significant R&D, operating losses, and reliance on equity/debt financings; revenue from product sales not expected for several years
Risk Factors
- FDA investigation of T-cell malignancy risk for CAR-T therapies including Descartes-08, with potential for boxed warnings or REMS requirements in 2024-2025
- Geopolitical conflict risks delaying patient enrollment in clinical trials, impacting multinational trial sites and timelines
- Supply chain vulnerability due to reliance on third-party manufacturers for patient-specific mRNA CAR-T product candidates
- Competition from DNA-based CAR-T therapies with established FDA approvals and safety track records
- Cash burn risks from clinical trial delays and increased development costs, with potential premature trial termination impacting financial condition
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