Cartesian Therapeutics, Inc.

Overview

Cartesian Therapeutics is a late-stage biotechnology company developing autologous, mRNA-modified CAR-T cell therapies for autoimmune diseases. The company uses a proprietary platform to introduce messenger RNA (mRNA) into a patient’s cells to produce therapeutic effects. Its approach is designed for outpatient administration, without preconditioning chemotherapy and without integration of genetic material into the genome.

Lead program and clinical status

• Descartes-08 (lead candidate)

  • Primary target: myasthenia gravis (MG). Development is also underway for myositis (dermatomyositis and antisynthetase syndrome) and was previously explored in systemic lupus erythematosus (SLE; program paused).
  • Regulatory designations: FDA Orphan Drug Designation for MG; RMAT Designation; Rare Pediatric Disease Designation for juvenile dermatomyositis (JDM).
  • Planned Phase 3 AURORA trial for MG: randomized, double-blind, placebo-controlled, roughly 100 patients; six outpatient infusions without preconditioning chemotherapy.
  • Clinical experience: Descartes-08 has been administered to over 100 patients across MG, myositis, and other indications in open-label and randomized trials. Reported product-related safety profile includes no cases of cytokine release syndrome (CRS), neurotoxicity, or infections attributed to the product; the most common adverse events were headache, nausea, and fever, typically self-limiting within 24 hours.
  • Phase 2 MG data: durable improvements observed through Month 9–12 follow-up after six weekly infusions; some patients showed deepening responses and rapid, durable responses on retreatment.

• Other programs

  • Descartes-15: an anti-BCMA mRNA CAR-T for multiple myeloma. Phase 1 dose-escalation showed no significant adverse events; further development is paused to prioritize Descartes-08.
  • In‑vivo delivery: exploratory programs to deliver cell therapies directly in the body rather than via autologous manufacturing.

Pipeline overview

• Descartes-08: lead program in MG with expansion into myositis and other autoimmune indications.
• Myositis program: IND filed December 2025 with a planned Phase 2 randomized trial.
• Descartes-15: development paused to focus resources on MG and myositis.
• In‑vivo delivery platform under exploration.
• Manufacturing: wholly owned, internal cGMP manufacturing; Descartes-08 is manufactured in-house.

Intellectual property

As of December 31, 2025:

• Legacy Selecta assets: 294 issued patents worldwide (14 US; 280 non-US); 75 patent applications pending worldwide (13 US; 62 non-US); 2 registered marks.
• US patents with expiration ranges of 2032–2040 and foreign patent families expiring 2040–2044, subject to potential extensions and adjustments.
• Licenses and collaborations provide access to additional IP and rights.

Partnerships and licenses

• Biogen License Agreement (Sept 8, 2023)

  • Non-exclusive, worldwide, perpetual license to certain engineered T-cell technologies using licensed mRNA sequences. Term runs to the expiration of the last licensed patent unless earlier terminated for breach.

• NCI License Agreement (Sept 16, 2019)

  • Non-exclusive license to certain NCI patents for anti-BCMA CAR-T products (including indications such as MG, pemphigus vulgaris, and immune thrombocytopenic purpura).
  • Financial terms include a one-time $100,000 license royalty, low five-digit annual royalties, low single-digit net sales royalties, and up to $0.8 million in milestone royalties.
  • Development and commercialization obligations include milestones tied to clinical progress and regulatory filings.

• Sobi License Agreement (June 11, 2020; amended Oct 31, 2023)

  • Exclusive worldwide license to NASP (Nanoencapsulated Sirolimus + Pegadricase) for chronic refractory gout (global rights except Greater China).
  • Potential milestones up to $630 million and tiered royalties in the low double digits to high teens; contingent value rights (CVRs) apply.
  • Sobi retains termination rights with defined notice; Cartesian retains certain licensing options if termination occurs.

Manufacturing and facilities

• In-house cGMP manufacturing and development capabilities.
• Main facility: Frederick, Maryland — over 35,000 sq. ft. of integrated manufacturing and office space; lease through June 2031.
• Additional facilities:
  • Gaithersburg, Maryland — approximately 7,909 sq. ft.; lease through January 2027.
  • Watertown, Massachusetts — approximately 32,294 sq. ft.; lease through May 2028.
• Manufacturing details:
  • Descartes-08 is produced in-house with typical lot release time of about three weeks.
  • Product candidates are autologous and manufactured on a patient-by-patient basis.
  • More than 200 cGMP runs across programs to date.

People and corporate resources

• Employees: 75 full-time as of December 31, 2025.
  • 62 in research and development; 13 in corporate functions.
  • 60% hold at least a Master’s, PhD, or MD degree.
  • All employees are based in the United States; no union representation.
• Company culture emphasizes patient focus, talent development, and maintaining in-house manufacturing capability.

Financials

• Net loss for the year ended December 31, 2025: $130.3 million.
• Net loss for the year ended December 31, 2024: $77.4 million.
• Accumulated deficit as of December 31, 2025: $822.4 million.
• Cash and runway: existing cash, cash equivalents, and restricted cash as of December 31, 2025 are expected to fund operating expenses and capital expenditures for at least the next 12 months.
• Funding plans: the company intends to pursue additional public or private financing, collaboration arrangements, or monetization of potential royalty/milestone payments from existing agreements.
• Ongoing investments include manufacturing scale-up, clinical development, regulatory activities, and potential commercialization preparation.

Business model and strategy

• Focused on autoimmune diseases using an mRNA CAR-T approach intended to reset immune responses with outpatient administration and no preconditioning chemotherapy.
• Strategy priorities include advancing Descartes-08 through clinical development, expanding indications (including myositis), optimizing manufacturing, and pursuing regulatory designations to support development timelines.
• Revenue to date has been driven by collaborations, licensing, and potential milestone/royalty arrangements rather than product sales.

Summary

Cartesian Therapeutics develops autologous, mRNA-based CAR-T cell therapies for autoimmune diseases, with Descartes-08 as the lead program in MG and planned expansion into myositis. The company operates internal cGMP manufacturing facilities, holds an extensive patent portfolio (including legacy Selecta assets), and maintains licensing relationships with Biogen, NCI, and Sobi. As of year-end 2025, the company employed 75 people and continues to fund clinical development and manufacturing scale-up through a combination of cash resources and planned financing activities.