4SC AG: AGM highlights - Positive progress in 2023/2024 leaves company well positioned for resminostat commercialisation

Planegg-Martinsried, Germany, 20 June 2024 – 4SC AG (4SC, FSE Prime Standard: VSC), a biotech company improving the lives of patients suffering with advanced-stage cutaneous T-cell lymphoma (CTCL), today publishes a summary of key highlights from its Annual General Meeting held earlier today in Martinsried, Germany. 

Jason Loveridge, Ph.D., CEO of 4SC, commented: “The last 18 months have been incredibly busy, but very successful for 4SC. The key highlights of the year were appropriately focused on resminostat (Kinselby), given this is the Company’s core value driver. I would like to thank all our shareholders, employees and partners for their contributions to a really successful period over the past 18 months. We remain optimistic that this success will continue as we respond to feedback from the EMA in the remainder of 2024 and review our commercialisation options for resminostat.”

Key highlights included:

• 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
• Excellent, well received presentation of the key outcomes of the RESMAIN study by the renowned dermato-oncology expert and principal investigator, Professor Dr. Rudolf Stadler, University Hospital Johannes Wesling, Minden, Germany, at:
• EORTC Cutaneous Lymphoma Tumour Group Annual Meeting 2023 at The Leiden University Medical Center in the Netherlands
• 5th World Congress of Cutaneous Lymphomas (5WCCL), at the City of Hope, Pasadena, California, USA
• On track submission of the company’s Marketing Authorisation Application (MAA) for resminostat (Kinselby) in February 2024
• Initial feedback from EMA received in late May 2024, currently awaiting associated questions
• Resminostat was awarded Orphan Drug Designation (ODD) for the treatment of patients with Cutaneous T Cell Lymphoma (CTCL) in the EU by EMA and in the US by the FDA
• 4SC received a Paediatric Investigation Plan (PIP) waiver for resminostat from the UK MHRA in April 2024
• 4SC received feedback from its pre-NDA interactions with the US FDA regarding resminostat (Kinselby) and, based on the agency’s response, has decided not to pursue further the registration of resminostat for CTCL in the US
• Yakult Honsha – our partner for resminostat in Japan - is preparing its filing with the Japanese PMDA and is currently waiting on data from the rollover arm of RESMAIN and longer-term overall survival outcomes, which will be available in Q4 2024
• We are waiting to file in other key geographies based on approval by the EMA
• We are currently in active discussions with potential partners regarding the market entry of resminostat (Kinselby) in the EU and longer-term commercialisation

Although reminostat (Kinselby) is the key value driver in 4SC, other items which should be mentioned include:

• Domatinostat was successfully partnered with Vuja De, a US biotech company focused on evaluating domatinostat plus Rapamycin, a low-dose FDA-approved oral mTOR inhibitor, in cancers, such as recurrent metastatic osteosarcoma and refractory sarcomas. Vuja De expects to begin the first clinical studies in late 2024
• Significant positive appreciation in the Company’s share price followed publication of the RESMAIN data for resminostat (Kinselby)
• Financial Resources were well managed with a closing cash balance ahead of budget for 2023
• 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 Q2 2025