4SC AG: AGM highlights - Positive progress in 2023/2024 leaves company well positioned for resminostat commercialisation

Planegg-Martinsried (pta033/20.06.2024/16:15) - Planegg-Martinsried, Germany, 20 June 2024 – 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 publishes a summary of key highlights from its Annual General Meeting held earlier today in Martinsried, Germany.

Jason Loveridge, Ph.D., CEO of 4SC, commented: "The last 18 months have been incredibly busy, but very successful for 4SC. The key highlights of the year were appropriately focused on resminostat (Kinselby), given this is the Company's core value driver. I would like to thank all our shareholders, employees and partners for their contributions to a really successful period over the past 18 months. We remain optimistic that this success will continue as we respond to feedback from the EMA in the remainder of 2024 and review our commercialisation options for resminostat."

Key highlights included:

* In May 2023, 4SC announced topline data from its pivotal RESMAIN study, confirming resminostat had successfully met the primary endpoint in the study, demonstrating a statistically significant improvement in progression free survival in CTCL patients of 97.6%, with a risk reduction of 38% compared to placebo. The study confirmed the already well-known safety profile of resminostat
* Excellent, well received presentation of the key outcomes of the RESMAIN study by the renowned dermato-oncology expert and principal investigator, Professor Dr. Rudolf Stadler, University Hospital Johannes Wesling, Minden, Germany, at:
* EORTC Cutaneous Lymphoma Tumour Group Annual Meeting 2023 at The Leiden University Medical Center in the Netherlands
* 5th World Congress of Cutaneous Lymphomas (5WCCL), at the City of Hope, Pasadena, California, USA

* On track submission of the company's Marketing Authorisation Application (MAA) for resminostat (Kinselby) in February 2024
* Initial feedback from EMA received in late May 2024, currently awaiting associated questions

* Resminostat was awarded Orphan Drug Designation (ODD) for the treatment of patients with Cutaneous T Cell Lymphoma (CTCL) in the EU by EMA and in the US by the FDA
* 4SC received a Paediatric Investigation Plan (PIP) waiver for resminostat from the UK MHRA in April 2024
* 4SC received feedback from its pre-NDA interactions with the US FDA regarding resminostat (Kinselby) and, based on the agency's response, has decided not to pursue further the registration of resminostat for CTCL in the US
* Yakult Honsha – our partner for resminostat in Japan - is preparing its filing with the Japanese PMDA and is currently waiting on data from the rollover arm of RESMAIN and longer-term overall survival outcomes, which will be available in Q4 2024
* We are waiting to file in other key geographies based on approval by the EMA
* We are currently in active discussions with potential partners regarding the market entry of resminostat (Kinselby) in the EU and longer-term commercialisation

Although reminostat (Kinselby) is the key value driver in 4SC, other items which should be mentioned include:

* Domatinostat was successfully partnered with Vuja De, a US biotech company focused on evaluating domatinostat plus Rapamycin, a low-dose FDA-approved oral mTOR inhibitor, in cancers, such as recurrent metastatic osteosarcoma and refractory sarcomas. Vuja De expects to begin the first clinical studies in late 2024
* Significant positive appreciation in the Company's share price followed publication of the RESMAIN data for resminostat (Kinselby)
* Financial Resources were well managed with a closing cash balance ahead of budget for 2023
* The Management Board estimates that the Company has sufficient cash to finance the Company's currently forecast expense and revenue planning projections until at least Q2 2025

- PRESS RELEASE ENDS -

For further information, please contact:

4SC AG

ir-pr@4sc.com

Optimum Strategic Communications

Nick Bastin, Eleanor Cooper, Vareen Outhonesack

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 ( http://www.4sc.com/product-pipeline/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 15 employees as of 31 March 2024 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)