Cartesian Therapeutics, Inc. (RNAC) FY2025 10-K Annual Report
Cartesian Therapeutics, Inc. (RNAC) 10-K annual report for fiscal year 2025, filed with SEC EDGAR on Mar 9, 2026. This page provides AI-powered analysis including business overview, management discussion & analysis (MD&A), risk factors, and key financial data such as revenue, net income, gross margin, operating margin, and return on equity (ROE) extracted from XBRL.
Cartesian Therapeutics, Inc. FY2025 10-K Analysis
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
Cartesian Therapeutics, Inc. FY2025 Key Financial MetricsXBRL
Revenue
$400,000
▼ -99.0% YoY
Net Income
-$130M
▼ -68.3% YoY
Operating Margin
-35851.3%
▼ -3573656bp YoY
Net Margin
-32575.5%
▼ -3237322bp YoY
ROE
103.2%
▼ -103504bp YoY
Total Assets
$296M
▼ -31.9% YoY
EPS (Diluted)
$-5.02
▼ -11.8% YoY
Operating Cash Flow
-$74M
▼ -212.3% YoY
Source: XBRL data from Cartesian Therapeutics, Inc. FY2025 10-K filing on SEC EDGAR. All figures in USD.
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