Company: RNAC
Filing Date: 2025-04-08
Form Type: 8-K
Source: 0001453687-25-000064
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Company: Cartesian Therapeutics, Inc.
Filing Date: 2025-04-08
Form: 8-K
Item: Item 8.01
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Item 8.01 Other Information.

On April 8, 2025, the Company announced 12-month efficacy and safety data from the Phase 2b trial of Descartes-08 in participants with generalized MG. Participants dosed with a single six-week course of treatment of Descartes-08 were observed to continue to experience a sustained benefit in symptoms of MG at the 12-month assessment.

The primary efficacy dataset for the follow-up portion of the trial consisted of a modified intent-to-treat (“mITT”) population of all subjects enrolled at academic medical centers who received at least one dose of Descartes-08 and completed at least one post-Month 3 MG Activities of Daily Living (“ MG-ADL”) score follow-up assessment.

As of a March 31, 2025 cutoff date, 12 out of 15 participants who received Descartes-08 in the primary efficacy dataset completed their Month 12 follow-up assessments. Three participants, two of whom were MG Composite (“ MGC”) responders at Month 3, were lost to follow-up after their Month 3 assessments.

12-Month Efficacy Results

• Deep and sustained responses observed through Month 12 (n=12).

◦ Participants treated with Descartes-08 were observed to have deep responses following initial treatment and sustained symptom improvement, with an average MG-ADL reduction of 5.5 (±1.1) at Month 4 and 4.8 (±1.4) at Month 12.

◦ Participants treated with Descartes-08 were observed to have an average Quantitative Myasthenia Gravis Score (QMG) reduction of 4.8 (±1.7) points at Month 4, which deepened through Month 12 (6.0±2.1).

◦33% (4/12) of participants achieved minimum symptom expression (“ MSE”), defined as an MG-ADL score of 0 or 1, at Month 6, all of whom maintained MSE through Month 12.

◦83% (10/12) of evaluable participants maintained a clinically meaningful response through Month 12. Clinically meaningful response is defined as a reduction in MG-ADL score of at least 2 points.

• Deepest and most compelling sustained responses observed in participants without prior biologic therapies (n=7).

◦ The subset of participants who did not have exposure to prior biologic therapies, including complement or neonatal fragment