Company: RNAC
Filing Date: 2025-04-08
Form Type: 8-K
Source: 0001453687-25-000064
Chunk: 1

Company: Cartesian Therapeutics, Inc.
Filing Date: 2025-04-08
Form: 8-K
Item: Item 8.01
Chunk 1
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 crystallizable receptor (FcRn) inhibitors, were observed to exhibit a deepening of responses throughout the year, with an average MG-ADL reduction of 6.6 (±1.5) at Month 4 and 7.1 (±1.9) at Month 12.

◦ The participants treated with Descartes-08 without exposure to prior biologic therapies were observed to have an average QMG reduction of 5.9 (±2.4) points at Month 4, which deepened through Month 12 (9.4±2.6).

◦57% (4/7) of these participants were observed to achieve MSE at Month 6 which was maintained through Month 12.

◦100% (7/7) of these participants were observed to maintain at least a clinically meaningful response through Month 12.

Safety

• Well-tolerated safety profile supports outpatient administration without the need for lymphodepleting chemotherapy.

◦ Consistent with previously reported data, Descartes-08 was observed to be well-tolerated across the safety dataset through Month 12 (n=12), and adverse events were transient and mostly mild, with no new adverse events reported in the 12-month follow-up data. Notably, there were no cases of cytokine release syndrome (“ CRS”), and no cases of immune effector cell-associated neurotoxicity syndrome (“ ICANS”). In addition, treatment with Descartes-08 was not observed to lead to a decrease in vaccine titers for common viruses and was not associated with increased rates of infection or hypogammaglobulinemia.

◦ There were no Descartes-08-related adverse events reported in Month 4 through Month 12 follow-up. As previously reported, common side effects through the Month 3 primary endpoint observed in participants who received any does of Descartes-08 were infusion-related reactions manifesting as fever (60% of participants receiving Descartes-08), chills (60% of participants receiving Descartes-08), headache (55% of participants receiving Descartes-08) and nausea (45% of participants receiving Descartes-08), all of which typically resolved within 24 hours of infusion.

Forward Looking Statements

Any statements in this Current Report on Form 8-K about the future expectations, plans and prospects of the Company, including without limitation, statements regarding observations and data from the Company’s clinical trials of Descartes-08 in MG, the