The Tip Desk

Earnings

Cartesian Narrows Loss as AURORA Readout Holds 2027 Date

Net loss was $11.5 million, or $0.38 a share, in the three months ended September 30, 2026, as cash of $124.7 million is still expected to fund operations into 2028.

Cartesian Therapeutics, Inc. (RNAC), a late clinical-stage biotechnology company developing cell therapy for autoimmune diseases, reported a narrower net loss for the third quarter as it kept its Phase 3 myasthenia gravis timeline intact and presented retreatment data for Descartes-08.

Net loss was $11.5 million, or $0.38 a share, for the three months ended September 30, 2026, compared with $35.9 million, or $1.38 a share, a year earlier. The quarter included a $10.7 million gain on the change in fair value of the contingent value rights liability and a $3.3 million gain on the change in fair value of a derivative liability, plus $2.0 million of interest expense.

The randomized, double-blind, placebo-controlled Phase 3 AURORA trial of Descartes-08 in acetylcholine receptor autoantibody-positive myasthenia gravis remains on a path toward a data readout expected in the first quarter of 2027, with a biologics license application planned for mid-2027. The trial is designed to enroll approximately 100 patients and compare six once-weekly outpatient infusions of the autologous anti-BCMA CAR-T against placebo, without preconditioning chemotherapy. The primary endpoint is the proportion of Descartes-08 participants with an improvement in MG Activities of Daily Living score of three points or more at Month 4.

President and Chief Executive Officer Carsten Brunn said the company’s focus remained on execution in the clinic and on preparing the organization for a commercial launch. Cartesian said it had expanded medical affairs and commercial teams ahead of the anticipated BLA submission.

In September 2026, Cartesian presented additional retreatment data at a neuromuscular meeting. Five patients who completed a full course of Descartes-08 in the Phase 2 portion of the trial and whose symptoms returned after 12 months of follow-up were retreated a median 16.6 months after the initial course. At Month 12 following retreatment, the group achieved a mean MG-ADL reduction of 6.6 points from baseline. All five experienced a clinically meaningful reduction in MG Composite and MG-ADL scores, and four of five maintained a clinically meaningful MG-ADL reduction through Month 12. The company said consistent safety data to date supported potential retreatment after recurrence, with no new safety signals.

The Phase 2 TRITON trial of Descartes-08 in myositis remains on track, with data from a subset of patients expected in the first half of 2027 to inform the path to a pivotal trial. Enrollment continues in the Phase 1/2 HELIOS pediatric trial of Descartes-08 in autoimmune diseases, including juvenile dermatomyositis, with data also expected in the first half of 2027. Descartes-08 holds Rare Pediatric Disease Designation for JDM.

The in vivo CAR-T partnership with WestGene BioPharma shifted from a planned Phase 1 in MG patients, expected to initiate in the second half of 2026 with clinical data in the first half of 2027, to a preclinical-stage program. Cartesian said in vitro testing showed WestGene’s targeted lipid nanoparticles generated CAR-T cells in a dose-dependent manner, supporting the delivery approach, and that the company plans to move the program into clinical development after preclinical testing.

Cash, cash equivalents and restricted cash was $124.7 million as of September 30, 2026, down from $149.3 million as of June 30, 2026. The September 30 balance included the initial $50 million tranche of non-dilutive financing from K2 HealthVentures and $22.8 million raised year to date after commissions and expenses through the at-the-market offering program. Long-term debt, net, was $50.2 million at September 30, 2026, versus none at December 31, 2025. The company said current cash resources are expected to support planned operations, including completion of AURORA, into 2028.

Research and development expenses were $15.6 million for the three months ended September 30, 2026, compared with $13.8 million a year earlier. Cartesian attributed the increase primarily to the ongoing Phase 3 AURORA trial and Descartes-08 work in dermatomyositis, including the Phase 2 TRITON trial, partially offset by lower early-stage program costs. General and administrative expenses were $9.4 million, compared with $7.7 million a year earlier, which the company attributed primarily to higher professional and consulting fees and employee-related expenses. Collaboration and license revenue and grant revenue were both zero in the quarter.

More on RNAC

RNAC — all coverage and financials