4SC AG: 4SC: RESMAIN study data to be presented at the EORTC Cutaneous Lymphoma Tumour Group Annual Meeting

Planegg-Martinsried (pta007/15.09.2023/07:30 UTC+2)

Planegg-Martinsried, Germany, 15 September 2023 – 4SC AG (4SC, FSE Prime Standard: VSC), a biotech company improving the lives of patients suffering with advanced-stage cutaneous T-cell lymphoma (CTCL), today announced that renowned dermato-oncology key opinion leader and study investigator, Professor Rudolf Stadler, University Hospital Johannes Wesling, Minden, Germany, will give an oral presentation on the findings from its RESMAIN study investigating the efficacy of resminostat as a maintenance treatment for cutaneous T-cell lymphoma, at the EORTC Cutaneous Lymphoma Tumour Group Annual Meeting at the Leiden University Medical Center, the Netherlands, September 21-23.

Title: RESMAIN: Results of a multicenter, randomized, double blind, placebo controlled trial to evaluate resminostat for maintenance treatment in advanced stage Mycosis fungoides or Sézary syndrome

Presenting Author: Professor Rudolf Stadler, University Hospital Johannes Wesling, Ruhr University Bochum, Minden, Germany

Date and Time: Saturday 23rd September, 9:10am CET

Location: Leiden University Medical Center, the Netherlands, Room: O-143

4SC will host a webinar to present an analysis of the findings showcased at the EORTC CLTG Annual Meeting on Wednesday 4th October. Clinical experts, Professor Rudolf Stadler and Professor Julia Scarisbrick, will discuss the results and there will be the opportunity to ask questions during a Q&A session moderated by 4SC's Chief Executive Officer, Jason Loveridge.

Title: Presentation by Professor Rudolf Stadler and Professor Julia Scarisbrick on recent new positive data from the RESMAIN study

Date and Time: Wednesday 4th October, 3.00pm CET

Register and submit questions: https://stream.brrmedia.co.uk/broadcast/64f5f2dac6e9d7476c27f154

Jason Loveridge, Ph.D., Chief Executive Officer of 4SC, commented: "Our pivotal RESMAIN study was conducted at more than 50 clinical centers across Europe and by Yakult Honsha in Japan, investigating the efficacy of resminostat as a maintenance treatment for cutaneous T-cell lymphoma. Resminostat is an orally administered class I, IIb and IV histone deacetylase (HDAC) inhibitor which is well tolerated and can inhibit tumor growth and proliferation, cause tumor regression, and strengthen the body's immune response to cancer. We look forward to presenting the results of the trial for the first time during this prestigious conference and our live webinar in October."

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For further information, please contact:

4SC AG

ir-pr@4sc.com

Optimum Strategic Communications

Mary Clark, Jonathan Edwards, Eleanor Cooper

Phone: +44 20 3922 0891

4SC@optimumcomms.com

Speaker biography

Prof. Rudolf Stadler started his medical career at the free university of Berlin under the chairmanship of Prof. C. E. Orfanos. From the beginning, he was involved in the transition of dermatology from morphology and local therapies towards functional understanding of skin physiology and introduction of systemic compounds into dermatology, like retinoids and interferons. For these accomplishments, he received the Oscar-Gans-Price of the German Society of Dermatology. He was involved as deputy secretary in the organization of the 17th World Congress of Dermatology in Berlin. In 1988, he was appointed deputy chairman of the Department of Dermatology, Klinikum Steglitz at the Free University of Berlin and thereafter moved as chairman to the University Clinic of Dermatology Minden, Ruhr University Bochum. In 2016, he received the German skin cancer prize. His main scientific interest is focussed on the development and advancement of dermato-oncology, especially in cutaneous T-cell lymphoma and cutaneous B-cell Lymphoma. He conducted one of the first randomized trials of interferons in cutaneous T-cell lymphoma and accompanied the development of new therapies in cutaneous lymphoma. He was chairman of the EORTC/CLTF group and meanwhile board member of the ISCL. In April 2023, for outstanding accomplishments in Dermatology, he received the Karl Herxheimer medal, the highest award of the German Dermatological Society.

About 4SC

4SC AG is a clinical-stage biopharmaceutical company developing small-molecule drugs that target key indications in cancer with high unmet medical needs. 4SC's pipeline is protected by a comprehensive portfolio of patents and currently comprises one drug candidate in clinical development: Kinselby - resminostat.

4SC aims to generate future growth and enhance its enterprise value by entering into partnerships with pharmaceutical and biotech companies and/or the eventual marketing and sales of approved drugs in select territories by 4SC itself.

4SC is headquartered in Planegg-Martinsried near Munich, Germany. The Company had 16 employees as of 30 June 2023 and is listed on the Prime Standard of the Frankfurt Stock Exchange (FSE Prime Standard: VSC; ISIN: DE000A3E5C40).

About Kinselby (resminostat)  

Resminostat is an orally administered class I, IIb and IV histone deacetylase (HDAC) inhibitor that potentially offers an approach to treating different kinds of cancer. Resminostat demonstrated that it is well tolerated and can inhibit tumor growth and proliferation, cause tumor regression, and strengthen the body's immune response to cancer. Resminostat is currently being investigated in a pivotal study in cutaneous T-cell lymphoma (CTCL) as maintenance treatment by 4SC in Europe and by Yakult Honsha in Japan.  

About cutaneous T-cell lymphoma (CTCL)  

CTCL is a rare disease with approximately 5,000 patients being newly diagnosed in Europe each year. The disease arises from malignant transformation of T-cells, a specialized subgroup of immune cells, and primarily affects the skin, but may ultimately involve lymph nodes, blood and visceral organs.  

Currently, CTCL is incurable and treatment options for advanced-stage CTCL are limited. Although patients respond to the available treatment options, the duration of response is often short-lived and declines as the severity of the disease increases. The key therapeutic challenge in advanced-stage CTCL is therefore to make remissions more durable by halting disease progression and improving patient's quality of life.  

About the RESMAIN study – resminostat for maintenance treatment of CTCL  

The pivotal RESMAIN study was conducted at more than 50 clinical centers in 11 European countries and Japan. It included 201 patients who suffer from advanced-stage cutaneous T-cell lymphoma (CTCL) that have achieved disease control with systemic therapy. The patients were randomized 1:1 to receive either resminostat or placebo. Patients who experienced disease progression – while being on placebo – were offered resminostat in an open label treatment arm.  

The primary goal of the study was to determine whether maintenance treatment with resminostat prolongs progression-free survival and other secondary objectives. Data demonstrating that resminostat met the primary endpoint of the RESMAIN study was published in May 2023.

About the concept of maintenance therapy  

The pivotal RESMAIN study is focused on patients with advanced-stage, incurable, cutaneous T-cell lymphoma (CTCL). Such patients suffer from painful and itchy skin lesions resulting in disfigurement and a severely impaired quality of life. Furthermore, lymph nodes, blood or visceral organs can be involved. The current therapeutic options rarely provide long-lasting responses or stabilization of disease for meaningful periods, with most patients progressing within a few months.  

Resminostat is being evaluated as maintenance treatment - a unique innovative treatment approach in CTCL (Stadler et al., 2021) - intended to prolong the period patients are stable and not progressing.

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