4SC AG: 4SC AG provides results for financial year 2023 and outlook for 2024

Planegg-Martinsried (pta006/22.03.2024/07:30) - Planegg-Martinsried, Germany, 22 March 2024 – 4SC AG (4SC, FSE Prime Standard: VSC) today published its financial results for the financial year ended 31 December 2023, presenting all material reporting period developments and providing an outlook for 2024. The full report is available at 4SC's website ( http://www.4sc.com/investors/investor-information/financial-reports/ ).

Jason Loveridge, Ph.D., CEO of 4SC, commented: "2023 was a real breakout year for 4SC, culminating with the filing of our MAA for resminostat (Kinselby) with the EMA in February 2024. This represents a very significant step forward for 4SC and was a great achievement for our team. It further de-risks our resminostat program and will assist our ongoing efforts to not only bring this important treatment to patients, but also commercialise the asset and create value for shareholders."

Key highlights of 2023

4SC had a very busy year in 2023, with key achievements summarized below, and further detail provided in respective press releases.

* In January 2023, the company's pre-authorisation eligibility request to the European Medicines Agency (EMA) for resminostat in cutaneous T-cell lymphoma was accepted. During its meeting in December 2022, the CHMP agreed, on the basis of the documentation provided, that resminostat was eligible to submit an application for European Union Marketing Authorisation according to the centralized procedure as detailed in Regulation (EC) No 726/2004.
* 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.
* Also in May 2023, the company submitted its letter of intent to file for Marketing Authorization for resminostat in CTCL and requested the appointment of a rapporteur with the EMA.
* In June 2023, the EMA notified 4SC that it had accepted its Letter of Intent to Submit a Marketing Authorization Application (MAA) and rapporteurs would be appointed. The EMA also notified 4SC that its nominated trade name for resminostat - Kinselby - had been accepted by its Name Review Group (NRG).
* In September 2023, RESMAIN study investigator, Professor Dr. Rudolf Stadler (University Hospital Johannes Wesling, Minden, Germany) presented positive new data from the pivotal RESMAN study at the EORTC Cutaneous Lymphoma Tumour Group Annual Meeting. The presented findings showed that maintenance therapy with resminostat is now clinically proven to postpone disease progression in advanced CTCL, which he expected, would lead to a significantly change in current clinical practice. Additional analyses established that patients receiving resminostat showed a clinically meaningful improvement in median "total" PFS (defined from the start of the last prior therapy to disease progression) of 24.3 months, compared to 14.9 months for those in the placebo group. Additionally, there was a significant delay in the development of new, or worsening of existing, skin tumours.
* Also in September 2023, the US Food and Drug Administration (FDA) granted 4SC's application for Orphan Drug Designation for resminostat for the treatment of CTCL.
* In October 2023, the EMA granted Orphan Drug Designation for resminostat for the treatment of CTCL.
* In December 2023, the Management Board of 4SC AG announced that the company had incurred a cumulative loss amounting to more than half of its share capital and pursuant to Section 92 (1) German Stock Corporation Act (AktG) would convene a general meeting. The meeting took place on 7 February 2024.

Business outlook for 2024

4SC's future success, or failure, as a company is closely linked to the outcome of the company's marketing authorization application for resminostat, an orally administered class I, IIb and IV histone deacetylase (HDAC) inhibitor that is in development as a maintenance therapy in CTCL.

Resminostat demonstrated significant benefit as maintenance therapy in the RESMAIN pivotal study – prolonging the period patients remain stable without progression and study results were published in May and September 2023. Given these data were positive, 4SC subsequently filed with the EMA for marketing approval for resminostat for the treatment of CTCL in Europe in February 2024. Filings for the UK and Switzerland are in preparation and, in addition, a pre-New Drug Application (NDA) meeting request was also submitted to the FDA in February 2024. In Japan, Yakult Honsha Co., Ltd. (Yakult Honsha) is responsible for filing the marketing authorization application for resminostat.

In 2024, 4SC expects to focus its resources on addressing questions from the EMA with respect to its MAA for resminostat as well as obtaining and assessing feedback from the USA FDA on 4SC's pre-NDA submission. In addition, 4SC continues to hold discussions with potential partners in the pharmaceutical industry regarding the commercialization of its resminostat program with the assistance of a global investment bank.

Cash balance development in full year 2023 and financial forecast

4SC's cash balance/funds were at €8,321 thousand on 31 December 2023. The average monthly operating cash burn in 2023 was €792 thousand, which was slightly lower than the forecast range of between €800 thousand and €1,100 thousand forecast for 2023. This is the result of later payments for agreed milestones in existing contracts for clinical trials. Taking into account the current financial planning and the intended operating activities, the Management Board estimates that current funds should be sufficient to finance 4SC for at least the next 12 months of operations.

Whilst 4SC's funds of €8,321 thousand at the end of 2023 represent a solid cash position entering 2024, it is also clear that the funding environment for biotech companies deteriorated significantly in 2023 and as such management remains cautious as to 4SC's ability to raise additional funds through further capital measures and to generate income with business partners. To address this risk, 4SC entered into a second loan agreement in the first quarter of 2024 with its largest shareholder giving the Company access to a further €3.5 million in available funding. For 2024, 4SC is expecting an average monthly use of cash from operations of between €600 thousand and €900 thousand.

- Press release ends -

For further information, please contact:

4SC AG

ir-pr@4sc.com

Optimum Strategic Communications

Nick Bastin, 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 15 employees as of 31 December 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) 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.

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)