4SC AG: 4SC AG – Company Update

Planegg-Martinsried (pta014/20.12.2023/10:40) - Planegg-Martinsried, Germany, 20 December 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), announced today that, having incurred a loss amounting to half of its issued share capital, it will convene an Extraordinary General Meeting of shareholders for the 7th February 2024, as provided for by the provisions of the German Stock Corporation Act.

In calling such a meeting, the Management Board of 4SC AG wishes to stress several key points:

* Such losses are common to companies in the biotech industry and was fully anticipated by the Management Board.
* The Company's operations remain on track; including its forecast cash expenditure, which is significantly below the forecast for 2023, and in particular the filing of the Company's Marketing Authorisation Application (MAA) with the European Medicines Agency in Q1 2024, and discussions with potential partners for commercialisation of Kinselby (resminostat).
* That the operating expenses that underlie these losses have been largely invested in the development of the Company's key asset Kinselby (resminostat), which demonstrated significant positive data in the pivotal RESMAIN study and is the subject of an ongoing Marketing Authorisation Application.
* The Company's current cash funds are sufficient to finance the business into the fourth quarter of 2024.
* The Management Board remains confident with the respect to commercialisation of Kinselby (resminostat) in the EU.

Jason Loveridge, Ph.D., CEO of 4SC, commented: "Under the German Stock Corporation Act we are obliged to convene a General Meeting without undue delay to inform shareholders of this news. However, I want to assure investors that this was a fully anticipated development and we continue our work as before with a cash runway into the fourth quarter of next year. The Management Board is confident regarding the commercialization of Kinselby (resminostat) in the EU.

The RESMAIN data we recently announced demonstrates the significant benefit that Kinselby (resminostat) delivers as a maintenance treatment for patients suffering from CTCL, a debilitating and incurable condition. Securing orphan drug designation in both the US and Europe reinforces the commercial benefit and opportunity. All the monies invested in the Kinselby (resminostat) program, and which are recognized in this loss, have the potential to create significant value for our shareholders. Finally, we are well advanced in our efforts to secure marketing authorization for Kinselby (resminostat) in the EU, UK and Switzerland."

- Press release ends -

For further information, please contact:

4SC AG

ir-pr@4sc.com

Optimum Strategic Communications

Nick Bastin, Jonathan Edwards, Eleanor Cooper

Phone: +44 20 3922 0891

4SC@optimumcomms.com

About 4SC

4SC AG ( http://www.4SC.com ) 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 ( http://www.4sc.com/product-pipeline/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 ( https://clinicaltrials.gov/ct2/show/NCT02953301 ) 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 ( https://clinicaltrials.gov/ct2/show/NCT02953301 ) 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.

(Ende)