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Cartesian Therapeutics — Third Quarter 2026 Earnings Summary

  • Financial Performance:

    • Reported net loss of $11.5 million ($0.38 per share) for the three months ended September 30, 2026, compared to a net loss of $35.9 million ($1.38 per share) for the same period in 2025.
    • Research and development expenses were $15.6 million for the quarter, an increase from $13.8 million in the prior year period, driven by the Phase 3 AURORA trial and Phase 2 TRITON trial costs.
    • General and administrative expenses were $9.4 million for the quarter, up from $7.7 million in the prior year period, due to higher professional fees and employee-related expenses.
    • Total revenues were $0 for the quarter, compared to $452,000 in the prior year period (derived entirely from grants).
    • Cash, cash equivalents, and restricted cash totaled $124.7 million as of September 30, 2026, expected to support operations into 2028.
    • Long-term debt of $50.2 million was recorded as of September 30, 2026, compared to zero in the prior year.
    • Contingent value rights liability decreased to $346.0 million as of September 30, 2026, from $392.1 million at December 31, 2025.
    • Total assets were $294.3 million as of September 30, 2026, compared to $296.4 million at December 31, 2025.
    • Stockholders' deficit was $130.5 million as of September 30, 2026, compared to $126.2 million at December 31, 2025.
  • Guidance and Future Outlook:

    • Phase 3 AURORA trial data readout is expected in the first quarter of 2027, with a Biologics License Application (BLA) filing planned for mid-2027.
    • Data from the Phase 2 TRITON trial in myositis and the Phase 1/2 HELIOS pediatric trial in juvenile dermatomyositis (JDM) are expected in the first half of 2027.
    • The company is expanding medical affairs and commercial teams to prepare for a potential commercial launch.
    • The in vivo CAR-T program in partnership with WestGene BioPharma is advancing through preclinical development with plans to move into clinical development upon completion.
  • Business Segments and Product Lines:

    • Descartes-08 (autologous anti-BCMA CAR-T therapy) is the lead asset in development for myasthenia gravis (MG), myositis, and pediatric autoimmune diseases.
    • Retreatment data for Descartes-08 in MG showed a mean 6.6-point reduction in MG-ADL scores from baseline at Month 12 with no new safety signals.
    • The Phase 3 AURORA trial is a randomized, double-blind, placebo-controlled study in approximately 100 patients with AChR Ab+ MG, assessing improvement in MG-ADL scores of three points or more at Month 4.
    • The Phase 2 TRITON trial assesses Descartes-08 in patients with moderate to severe multi-refractory dermatomyositis and antisynthetase syndrome.
    • The Phase 1/2 HELIOS trial is ongoing in children and young adults with autoimmune diseases, including JDM, for which the FDA has granted Rare Pediatric Disease Designation.
    • Descartes-08 holds Orphan Drug Designation and Regenerative Medicine Advanced Therapy Designation for MG, and Rare Pediatric Disease Designation for JDM.
  • Market and Competitive Landscape:

    • Descartes-08 is differentiated by its ability to be administered in an outpatient setting without preconditioning chemotherapy and its lack of genomic integration risk associated with conventional DNA-based CAR-T therapies.
    • The company positions Descartes-08 as a potential treatment paradigm changer for MG due to its safety profile and durable responses.
  • Risks and Challenges:

    • Risks include uncertainties in clinical trial initiation, completion, costs, and outcomes, as well as the potential for preliminary results to be non-predictive of final results.
    • Challenges include potential delays in patient enrollment, regulatory approvals, and the unproven nature of the technology.
    • The company faces risks related to reliance on third parties for clinical trials, maintaining collaborations, and protecting intellectual property.
    • Financial risks include recurring losses, negative cash flows, and the need for sufficient funding for operating expenses.
  • Management Commentary and Tone:

    • CEO Carsten Brunn, Ph.D., emphasized a focus on execution in the clinic and commercial launch preparation ahead of the anticipated BLA submission.
    • Management expressed excitement about the opportunity to expand awareness of Descartes-08's differentiation, citing deep and durable responses from retreatment data.
    • The tone reflects confidence in the product's potential to meaningfully change MG treatment and expand to other autoimmune diseases.
  • Other Key Points:

    • Received an initial $50 million tranche of non-dilutive financing from K2 HealthVentures (K2HV).
    • Raised $22.8 million year-to-date through the Company's at-the-market offering program.
    • Issued 30,487,384 shares of common stock as of September 30, 2026, compared to 26,011,106 shares at December 31, 2025.
    • The company is a late clinical-stage biotechnology company pioneering cell therapy for autoimmune diseases.
Company
CARTESIAN THERAPEUTICS INC
Sector
Healthcare
Industry
Biotechnology