Domatinostat tosylate

Planegg-Martinsried, Germany, 28 March 2025 – 4SC AG (4SC, FSE Prime Standard: VSC) today published its financial results for the financial year ended 31 December 2024, presenting all material reporting period developments and providing an outlook for 2025. The full report is available at 4SC’s website. Jason Loveridge, Ph.D., CEO of 4SC, commented: “4SC continues to be one hundred percent focused on the development of resminostat and as such has now responded to the EMA’s180 Day Assessment Report within the required deadline. 4SC is now awaiting further feedback from the Committee for Medicinal Products for Human Use, which is still expected around the end of April 2025. Depending on the decision of the CHMP we will then consider what could be the future direction of the Company.” 4SC had a very busy year in 2024, with key achievements summarized below, and further detail provided in respective press releases. In February 2024, at an Extraordinary General Meeting the Management and Supervisory Boards fulfilled their duty to inform the shareholders of a loss amounting to half of the share capital in accordance with the rules pursuant to Section 92 (1) German Stock Corporation Act (AktG). Also in February 2024, 4SC AG submitted its Marketing Authorisation Application (MAA) for resminostat in advanced CTCL to the European Medicines Agency (EMA) and this was accepted – by the EMA – as sufficient for examination by the beginning of March 2024. In March 2024, 4SC entered into a second loan agreement with Santo Holding (Deutschland) GmbH (Santo Holding) 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 from the UK Medicines & Healthcare Products Regulatory Agency (MHRA) for resminostat (Kinselby). In May 2024, 4SC entered into a partnership with Vuja De Sciences, Inc., New Jersey, USA (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. In July 2024, 4SC announced that it had been granted Orphan Drug Status for resminostat (Kinselby) in CTCL in Switzerland. In September 2024, 4SC completed a capital increase from authorized capital by issuing a total of 792,080 of new no-par value bearer shares, each with a notional par value of €1.00. At a subscription price of €5.05 per offered share, 4SC secured gross proceeds of circa €4.0 As a result of the transaction, 4SC’s share capital increased from €10,114,009 to €10,906,089. The new shares were subscribed for by the Company’s main shareholder, Santo Holding. Statu­tory subscription rights were excluded pursuant to Section 186 Para. 3 sentence 4 of the German Stock Corporation Act (Aktiengesetz). 4SC is fully focused on the registration of resminostat (Kinselby) in the key geographies of the European Union, UK and Switzerland. Subject to a final decision from the EMA, the opportunity for value creation through the commercialization of resminostat (Kinselby) in the EU remains possible, but subject to very significant risk given EMA’s 180 Day Assessment Report issued in March 2025. 4SC AG has recently responded to the EMA’s Day-180 Assessment Report within the required deadline and expects to receive feedback from the Committee for Medicinal Products for Human Use (CHMP) around the end of April 2025. Depending on the decision of the CHMP the Management Board will then consider all options for the future direction of the Company. In the meantime, it is likely that the Company will continue to report annual net losses in the short to medium term future. 4SC continued to hold discussions with potential partners in the pharmaceutical industry regarding resminostat (Kinselby) in 2024 and early 2025, but these are currently on hold until it is clear the MAA is approvable. For Japan, 4SC has an ongoing Collaboration Agreement with Yakult Honsha for the commercialization of resminostat (Kinselby). 4SC’s cash balance/funds were at €8,311 thousand on 31 December 2024. The average monthly operating cash burn in 2024 was €626 thousand, which was between the forecast range of €600 thousand and €900 thousand for 2024. Taking into account the current financial planning and the intended operating activities, the Management Board estimates that currently available funds should be sufficient to finance 4SC for at least the next 12 months of operations and in particular, to receive a final decision from the EMA with respect to the company’s MAA for resminostat (Kinselby). Whilst 4SC’s funds of €8,311 thousand (at the end of 2024) represent a solid cash position, management remains cautious as to 4SC’s ability to raise additional funds through further capital measurements and or to generate income from business partners. For 2025, 4SC is expecting an average monthly use of cash from operations of between €400 thousand and €700 thousand. 4SC estimates that the net loss will decrease significantly in 2025 as compared to 2024, due mainly to the completion of the open label component of the RESMAIN study and the filling of responses to the EMA in relation to 4SC’s MAA in late 2024. 4SC AG ir-pr@4sc.com Optimum Strategic Communications Nick Bastin, Vareen Outhonesack Phone: +44 20 3922 0891 4SC@optimumcomms.com 4SC is a biotech company focused on trying to improve the lives of patients suffering with advanced-stage cutaneous T-cell lymphoma (CTCL), a high unmet medical need. 4SC’s goal is to increase the value of the Company by advancing its own drug development programs through to market and entering into partnerships with pharma­ceutical and biotech companies for the further develop­ment or commerciali­zation of its drug candi­dates. 4SC is headquartered in Planegg-Martinsried near Munich, Germany. The Company had 15 employees as of 31 December 2024 and is listed on the Prime Standard of the Frankfurt Stock Exchange (FSE Prime Standard: VSC; ISIN: DE000A3E5C40). 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 was investigated in a pivotal study in cutaneous T-cell lymphoma (CTCL) as maintenance treatment by 4SC in Europe and by Yakult Honsha in Japan. In 2023, the Company announced positive topline data from its RESMAIN study on resminostat (Kinselby), one of the largest clinical trials in cutaneous T-cell lymphoma (CTCL) to-date, which showed A statistically significant improvement of 97.6% in progression free survival (PFS) compared to placebo (median PFS: 8.3 months versus 4.2 months) A median time to next treatment (median TTNT) versus placebo showed a significant improvement, more than doubling (8.8 months compared to 4.2 months) A clinically meaningful improvement in median “total” PFS of 24.3 months, compared to 14.9 months for those in the placebo group The side effects of resminostat were mainly mild to moderate, manageable, and reversible. 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 options; 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. 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) and 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. 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. 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.