4SC (VSC) Corporate Presentation summary

Company overview

• 4SC focuses on developing Resminostat (Kinselby) as a maintenance therapy for advanced cutaneous T-cell lymphoma (CTCL), addressing a high unmet medical need.

• Led by an experienced management team with expertise in life sciences, clinical development, and capital markets.

• Discontinued the Domatinostat program, now partnered with VujaDe Sciences for further development and potential milestone payments.

Product and clinical highlights

• Kinselby is a selective HDAC inhibitor, formulated as an oral tablet, and would be the first of its class approved for CTCL maintenance in the EU.

• The pivotal RESMAIN trial met its primary endpoint, showing significant improvement in progression-free survival (PFS) and time to next treatment (TTNT) versus placebo.

• Median PFS was 8.3 months for Kinselby vs 4.2 months for placebo; median TTNT was 8.8 vs 4.2 months.

• Safety profile confirmed as manageable, with most side effects mild to moderate and reversible.

Regulatory and market strategy

• Marketing Authorization Application (MAA) for Kinselby filed with EMA in February 2024; initial feedback received, awaiting further questions.

• Orphan Drug Designation granted in the EU, US, and Switzerland, with 10 years of data exclusivity in the EU if approved.

• Plans to file in the UK and Switzerland post-EMA approval; Japan filing expected in 2025 via partner Yakult Honsha.

• US registration not pursued after pre-NDA discussions with FDA.

• Estimated 7,500 addressable patients in Europe and potential sales of €500 million over 10 years.