4SC AG: 4SC announces Half-Year Report 2024 and provides update

Planegg-Martinsried (pta006/08.08.2024/07:30) -
* Marketing Authorization Application (MAA) for resminostat (Kinselby) submitted to the European Medicines Agency (EMA)
* Data from the pivotal RESMAIN study presented at the 5th World Congress of Cutaneous Lymphomas
* Pediatric Investigation Plan (PIP) product-specific waiver for resminostat (Kinselby) received from the UK Medicines & Healthcare Products Regulatory Agency (MHRA)

Planegg-Martinsried, Germany, 8 August 2024 – 4SC AG (4SC, FSE Prime Standard: VSC) today published its Half-Year Report 2024, presenting all material corporate developments up to 30 June 2024 and the Company's current outlook. The full communication is available for download on 4SC's website ( http://www.4sc.com/investors/investor-information/financial-reports/ ).

Jason Loveridge, Ph.D., CEO of 4SC, commented: "Given the positive topline data from the RESMAIN study, we filed our Marketing Authorization Application for Kinselby to the EMA in February 2024 and received questions at the beginning of July as part of the MAA evaluation. Our goal is to address these questions by end 2024 and hopefully receive authorization to market Kinselby in the EU by the middle of next year. We continue to believe that we are well placed for the next stage in the development of Kinselby as we look to license the drug for commercialization in the EU, UK and Switzerland. Kinselby remains uniquely positioned as a maintenance therapy in CTCL where it can offer significant benefits for patients by halting disease progression. For the remainder of 2024, we are focused on getting EMA approval so we can make Kinselby available to patients as quickly as possible."

Key highlights in H1 2024

* In February 2024, 4SC submitted its MAA to the EMA for resminostat (Kinselby) in advanced CTCL and this was accepted as sufficient for examination by the beginning of March 2024
* 4SC's partner for Japan, Yakult Honsha is responsible for the filing of a marketing application for Kinselby (resminostat) in Japan
* In the first quarter of 2024, 4SC entered into a second loan agreement with Santo Holding (Deutschland) GmbH giving the Company access to a further €3.5 million in available funding
* In April 2024, the company announced that the renowned dermato-oncology expert and principal investigator of the RESMAIN study, Professor Dr. Rudolf Stadler (University Hospital Johannes Wesling, Minden, Germany) presented landmark data from the pivotal RESMAN study of resminostat (Kinselby) at the 5th World Congress of Cutaneous Lymphomas (5WCCL), in Pasadena, California, USA
* Also, in April 2024 4SC received a Pediatric Investigation Plan (PIP) product-specific waiver for resminostat (Kinselby) from the UK Medicines & Healthcare Products Regulatory Agency (MHRA)
* 4SC entered into a partnership with Vuja De - a US based biotech company focused on evaluating domatinostat in combination with Rapamycin in cancers such as recurrent metastatic osteosarcoma and refractory sarcomas

Development of cash balance in H1 2024 and financial forecast

As of 30th June 2024, 4SC holds a cash balance/funds of €4.426 million, compared to €8.321 million as at 31th December 2023. The monthly use of cash from operations amounted to €0.649 million on average in the first half year of 2024 (H1 2023: €0.945 million) and was in the forecast range of €0.6 million and €0.9 million forecast for 2024.

The Management Board of 4SC estimates that current funds should be sufficient to finance 4SC into Q1 2025.

2024 business outlook

4SC is fully focused on the registration and commercialization of resminostat (Kinselby) in the European Union and evaluating the Company's options for the commercialization of resminostat (Kinselby).

- 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 30 June 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)