4SC (VSC) Q2 2024 earnings summary

Executive summary

• Filed marketing authorization application (MAA) for resminostat (Kinselby) in advanced CTCL with the EMA in early 2024, supported by positive pivotal RESMAIN study results.

• Orphan drug designation granted for resminostat in Switzerland, EU, and US, enhancing commercial protection.

• US registration for resminostat in CTCL will not be pursued after FDA feedback; focus is on EU and Switzerland post-EMA approval.

• Domatinostat program discontinued internally but partnered with Vuja De Sciences for further development, with first clinical studies expected in late 2024.

• Net loss for H1 2024 was €3.96 million, improved from €4.66 million in H1 2023.

Financial highlights

• Revenue for H1 2024 was €182,000, up from €127,000 in H1 2023, mainly from domatinostat sales and service reimbursements.

• Operating costs reduced by 18% year-over-year due to fewer active clinical trials; personnel expenses decreased by 15% following headcount reduction to 15.

• Cash position at end of H1 2024 was €4.43 million, with an additional €3.5 million loan facility available, supporting operations into Q1 2025.

• Equity ratio declined to 20.7% as of 30 June 2024; total assets at €5.29 million.

• Average monthly cash use from operations was €649,000, down from €945,000 in H1 2023.

Outlook and guidance

• Primary focus for H2 2024 is addressing EMA questions and refiling the MAA in Q4 2024; EMA approval decision pending.

• Yakult Honsha to file for Japanese approval after receiving final RESMAIN rollover data in Q4 2024.

• Market entry and reimbursement work in the EU ongoing, with estimated 7,500 addressable patients and potential sales of €500 million over 10 years.

• Current funds, including the new loan, expected to finance operations into Q1 2025; further equity or debt may be needed for longer-term viability.

• Management expects continued focus on resminostat commercialization and value from partnerships.