4SC Files Marketing Authorisation Application with EMA for Resminostat (Kinselby)

Planegg-Martinsried, Germany, 1 March 2024 – 4SC AG (4SC, FSE Prime Standard: VSC), a biotech company improving the lives of patients suffering with advanced-stage cutaneous T-cell lymphoma (CTCL), announced today that it has filed its Marketing Authorisation Application (MAA) for resminostat (Kinselby) with the European Medicines Agency (EMA) and that its MAA has been accepted by the EMA as sufficient for examination.

In September 2023, the Company announced data from its RESMAIN study on resminostat (Kinselby) that showed:

• A statistically significant improvement in progression free survival (median PFS: 8.3 vs. 4.2 months; p=0.015; HR: 0.623)
• A median time to next treatment versus placebo showed a significant improvement of 8.8 months compared to 4.2 months
• A clinically meaningful improvement in median “total” PFS of 24.3 months, compared to 14.9 months for those in the placebo group
• Side effects of resminostat were mainly mild to moderate, manageable and reversible.

Jason Loveridge, Ph.D., CEO of 4SC, commented: “The team has worked hard to successfully file the Marketing Authorisation Application for resminostat in CTCL ahead of schedule. This represents a significant step forward for 4SC and a great achievement for our team as it further de-risks our resminostat program and will assist our ongoing efforts to bring this important treatment to patients suffering with this disease, commercialise the asset and create value for shareholders.”