Disclosure of inside information according to Article 17 MAR.
20 December 2023 | 10:30 CEST
4SC AG: Notice of loss pursuant to section 92 (1) German Stock Corporation Act (Aktiengesetz, AktG)
Planegg-Martinsried, Germany, 20. December 2023 – The Board of Management of 4SC AG (4SC, FSE Prime Standard: VSC) announced today that according to its best judgment, the Company has now incurred a cumulative loss amounting to more than half of its share capital based on the accounting principles of the German Commercial Code (Handelsgesetzbuch, HGB). This is due to planned operating losses that have accumulated from clinical drug development programs as a normal part of 4SC AG’s business and has been expected to occur in Q4 2023, as explained most recently in the Q3 Announcement of 19 October 2023.
A loss amounting to half of the share capital triggers a legal obligation under Section 92 (1) German Stock Corporation Act to convene a General Meeting of shareholders without undue delay. The Management Board of 4SC AG intends to inform shareholders at an Extraordinary Annual Meeting which is scheduled for 7th February 2024. The notice of the General Meeting including the agenda will be announced within the next few days.
The Management Board of 4SC AG makes clear that the Company’s current cash funds are sufficient to fund the Company’s operations into the fourth quarter of 2024.
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.
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 September 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.
For further information, please contact:
4SC AG
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Optimum Strategic Communications
Nick Bastin, Jonathan Edwards, Eleanor Cooper
Phone: +44 20 3922 0891
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