Disclosure of inside information according to Article 17 MAR

3 March 2025 | 11:55 CET

4SC Announces EMA’s Feedback relating to Resminostat’s (Kinselby) Marketing Authorisation Application

Planegg-Martinsried, Germany, 3 March 2025 – The management board of 4SC AG (“4SC”) (Frankfurt Stock Exchange, Prime Standard: VSC; ISIN: DE000A3E5C40) was informed by the European Medicines Agency (EMA) today that based on its review of the final data and the Company’s responses to questions, the application for resminostat (Kinselby) an orphan medicinal product for the treatment of patients with CTCL is currently not approvable since “major objections” preclude a recommendation for marketing authorisation at this stage (Day-180 Assessment Report).

4SC will now evaluate the feedback and decide how best to respond to EMA’s objections and list of outstanding issues in line with the given response deadline of one month.

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

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Optimum Strategic Communications

Nick Bastin, Vareen Outhonesack

Phone: +44 20 3922 0891

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