4SC AG: EMA signals a Negative CHMP Opinion on the Marketing Authorization Application for Resminostat (Kinselby)

Planegg-Martinsried (pta029/20.05.2025/17:50 UTC+2)

Planegg-Martinsried, Germany, 20 May 2025 – Today, the Management Board of 4SC AG ("4SC") (Frankfurt Stock Exchange, Prime Standard: VSC; ISIN: DE000A3E5C40) has been informed by representatives of the European Medicines Agency (EMA) that a Negative Opinion from the Committee for Medicinal Products for Human Use (CHMP) with respect to the Market Authorization Application (MAA) for Resminostat (Kinselby) for the treatment of patients with advanced stage cutaneous T-cell lymphoma (CTCL) is to be expected on May 22, 2025

The information that a Negative Opinion is to be expected comes despite the extensive efforts made by 4SC to resolve the EMA's last remaining Major Objection regarding the demonstration of a positive benefit-risk ratio for patients with advanced stage CTCL in an Oral Explanation earlier today.

As a result, 4SC is now discontinuing the further development and commercialization of Resminostat (Kinselby). In the immediate future the Management and Supervisory Boards of 4SC will now debate the future direction of the Company and will inform shareholders as soon as practically possible. 4SC has at least 12 months of funds available to finance the Company's currently projected expenses.

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Information and Explanation of the Issuer to this News:

Forward-looking information

Information set forth in this press release contains forward-looking statements, which involve risks and uncertainties. The forward-looking statements contained herein represent the judgement of 4SC as of the date of this press release. Such forward-looking statements are neither promises nor guarantees, but are subject to a variety of risks and uncertainties, many of which are beyond 4SC's control, and which could cause actual results to differ materially from those contemplated in these forward-looking statements. 4SC expressly disclaims any obligation or undertaking to release any updates or revisions to any such statements to reflect any change in its expectations or any change in events, conditions or circumstances on which any such statement is based.

For further information, please contact:

4SC AG

ir-pr@4sc.com

Optimum Strategic Communications

Nick Bastin, Vareen Outhonesack

Phone: +44 20 3922 0891

4SC@optimumcomms.com

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Emitter:	4SC AG Fraunhoferstr. 22 82152 Planegg-Martinsried Germany
Contact Person:	Jason Loveridge
Phone:	+49 89 700763-0
E-Mail:	ir-pr@4sc.com
Website:	www.4sc.de
ISIN(s):	DE000A3E5C40 (Share)
Stock Exchange(s):	Regulated Market in Frankfurt; Free Market in Berlin, Dusseldorf, Hamburg, Munich, Stuttgart, Tradegate