4SC AG: 4SC provides Q2 2023 and H1 2023 update

• Positive topline data for resminostat in RESMAIN pivotal study demonstrating 97.6% improvement in progression free survival in CTCL patients and risk reduction of 38% compared to placebo
• Marketing Authorization Application for resminostat and nominated trade name of Kinselby accepted by EMA
• Kinselby uniquely positioned as maintenance treatment for CTCL
• Cash runway to Q3 2024

4SC AG (4SC, FSE Prime Standard: VSC) today published its Half-Year Report 2023, presenting all material developments up to 30 June 2023 and the Company’s current outlook. The full communication is available for download on 4SC’s website.

Jason Loveridge, Ph.D., CEO of 4SC, commented: "Given the positive topline data from the RESMAIN study, Kinselby is extremely well placed for the next stage of its development as we look to commercialize the drug through either a sale, licensing or partnership. Kinselby remains uniquely positioned as a maintenance therapy in CTCL, where there are no alternative comparable treatments and it offers significant benefits for patients by halting disease progression. We are focused on near term registrations of Kinselby to get this important drug to patients as quickly as possible."

Key highlights in Q2 2023

• Resminostat met the primary endpoint in the RESMAIN study, demonstrating a statistically significant improvement in progression free survival in CTCL patients by ninety seven point six percent (97.6%) with a risk reduction of thirty eight percent (38%) compared to placebo
• Further results from the RESMAIN study evaluating resminostat in maintenance treatment of patients with advanced cutaneous T-cell lymphoma (CTCL) will be presented by Professor Dr. Rudolf Stadler at the EORTC Cutaneous Lymphoma Tumour Group Annual Meeting 2023 on Saturday, 23rd September 2023 at 9:10h CEST at The Leiden University Medical Center in the Netherlands
• The European Medicines Agency (EMA) has notified 4SC that it has accepted its Letter of Intent to Submit a Marketing Authorization Application (MAA)
• EMA has notified 4SC that its nominated trade name for resminostat – Kinselby – has been accepted by its Name Review Group (NRG)
• 4SC is actively progressing the preparation of its Marketing Authorization Application in the European Union, Switzerland and UK, and intends to discuss with the US Food and Drug Administration regarding requirements for a resminostat marketing application for CTCL treatment in the US
• 4SC’s partner for Japan, Yakult Honsha is responsible for the filing of a marketing application for Kinselby (resminostat) in Japan

Development of cash balance in H1 2023 and financial forecast

As of 30 June 2023, 4SC holds cash balance/funds of €12.158 million, compared to €14.825 million as at 31 December 2022. The monthly use of cash from operations amounted to €0.945 million on average in the first half year of 2023 (H1 2022: €1.375 million) and was in the forecast range of €0.8 million and €1.1 million forecast for 2023.

The Management Board of 4SC estimates that current funds should be sufficient to finance 4SC into Q3 2024.

2023 business outlook

4SC is fully focused on the registration and commercialization of resminostat (Kinselby) in the European Union, Switzerland and the UK and defining the requirements for marketing resminostat for CTCL in the US through discussions with the United States (US) Food and Drug Administration. In July 2023, the Company engaged a global investment banking firm serving companies in the life sciences industry to assist 4SC in evaluating the Company’s options for the commercialization of resminostat (Kinselby).

Further information

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, primarily affects the skin, but may ultimately involve lymph nodes, blood and visceral organs.  

Currently, CTCL is not curable 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 is being 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 experience disease progression – while being on placebo – will be offered resminostat in an open label treatment arm.  

The primary goal of the study is to determine whether maintenance treatment with resminostat prolongs progression-free survival and other secondary objectives.

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.