Key highlights:
- Positive top-line 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 Authorisation 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 have 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 top-line data from the RESMAIN study, Kinselby is extremely well placed for the next stage of its development as we look to commercialise 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.”
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 Authorisation 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 Authorisation 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 commercialisation 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 commercialisation of resminostat (Kinselby).