4SC AG: Resminostat (Kinselby) received a Negative CHMP Opinion in the EU

Planegg-Martinsried (pta025/23.05.2025/17:00 UTC+2)

Planegg-Martinsried, Germany, 23 May 2025 – As already expected and announced on Tuesday, 20 May 2025, 4SC AG ("4SC") (Frankfurt Stock Exchange, Prime Standard: VSC; ISIN: DE000A3E5C40) received a Negative Opinion on the Company's Market Authorization Application for Resminostat (Kinselby) for the treatment of patients with advanced stage cutaneous T-cell lymphoma (CTCL) from the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA)

Following an Oral Explanation on 20 May 2025, and the CHMP's review of the data on quality, safety and efficacy for Resminostat (Kinselby) in the treatment of patients with advanced stage mycosis fungoides (MF) and Sézary syndrome (SS) that have achieved at least stable disease with at least one prior systemic therapy or Total Skin Electron Beam therapy (TSEB) - the CHMP considers by consensus that the efficacy of the above-mentioned medicinal product is not sufficiently demonstrated, and therefore, recommends the refusal of the granting of the marketing authorisation for Resminostat (Kinselby).

As already communicated on 20 May 2025, 4SC will thus cease all efforts to develop and commercialize Resminostat (Kinselby). Currently, 4SC has at least a 12-month cash runway to finance the Company's projected expenses as the Management and Supervisory Boards consider all options for the Company, including liquidation.

Jason Loveridge, Ph.D., CEO of 4SC, commented: "We had hoped that the long wait for a maintenance treatment to help manage CTCL would soon be over. We are therefore deeply disappointed with this outcome as it is a further setback for people living with this rare and incurable disease."

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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

About 4SC

4SC is a biotech company focused on trying to improve the lives of patients suffering with advanced-stage cutaneous T-cell lymphoma (CTCL), a high unmet medical need.

4SC's goal is to increase the value of the Company by advancing its own drug development programs through to market and entering into partnerships with pharmaceutical and biotech companies for the further development or commercialization of its drug candidates.

4SC is headquartered in Planegg-Martinsried near Munich, Germany. The Company had 15 employees as of 31 March 2025 and is listed on the Prime Standard of the Frankfurt Stock Exchange (FSE Prime Standard: VSC; ISIN: DE000A3E5C40).

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.

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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