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4SC AG: 4SC publishes Q1 2025 report
Planegg-Martinsried (pta006/17.04.2025/07:30 UTC+2)
Planegg-Martinsried, Germany, 17 April 2025 – 4SC AG (4SC, FSE Prime Standard: VSC) today published its Q1 2025 report, presenting all material developments up to 31 March 2025, as well as the Company's current outlook. The full report is available for download on 4SC's website.
Jason Loveridge, Ph.D., CEO of 4SC, commented: "What is most critical for the company in 2025 is the progress, and ultimately the outcome, of our marketing authorization application with the European Medicines Agency. Having filed our MAA in Q1 2024 and received feedback in May we subsequently filed our response as required before the end of 2024. In Q1 this year we received the EMA's 180 Day Assessment Report and have again responded to the EMA's major objections in the required timeframe. We are currently awaiting further EMA feedback, which we expect to be end of April 2025, and will continue to keep stakeholders informed of any outcome."
Development of cash balance in Q1 2025 and financial forecast
As of 31 March 2025, 4SC holds cash balance/funds of €6.8 million, as compared to €8.3 million at 31 December 2024. The monthly cash burn from operations amounted to €490 thousand on average during the first quarter of 2025 (Q1 2024: €740 thousand), within the range of €400 thousand and €700 thousand million forecast for 2025.
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 into Q2 2026.
- PRESS RELEASE ENDS -
For further information, please contact:
4SC AG
ir-pr@4sc.com
Optimum Strategic Communications
Nick Bastin, Vareen Outhonesack
Phone: +44 20 3922 0891
4SC@optimumcomms.com
About 4SC
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 March 2025 and is listed on the Prime Standard of the Frankfurt Stock Exchange (FSE Prime Standard: VSC; ISIN: DE000A3E5C40).
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 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.
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.
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.
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| Emitter: |
4SC AG Fraunhoferstr. 22 82152 Planegg-Martinsried Germany |
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|---|---|---|
| Contact Person: | Jason Loveridge | |
| Phone: | +49 89 700763-0 | |
| E-Mail: | ir-pr@4sc.com | |
| Website: | www.4sc.de | |
| ISIN(s): | DE000A3E5C40 (Share) | |
| Stock Exchange(s): | Regulated Market in Frankfurt; Free Market in Berlin, Dusseldorf, Hamburg, Munich, Stuttgart, Tradegate |