Cartesian Therapeutics, Inc. (RNAC) FY2025 10-K Annual Report

Filed: Mar 9, 2026
Health Care
Pharmaceutical PreparationsSEC EDGAR

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 Metrics
XBRL

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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