Release Date: August 08, 2024
For the complete transcript of the earnings call, please refer to the full earnings call transcript.
Positive Points
- 4SC AG (FRA:VSC, Financial) filed a marketing authorization application for Resminostat with the European Medicines Agency, marking significant progress in drug development.
- The company received orphan drug designation for Resminostat in Switzerland, adding to its existing designations in the European Union and the United States.
- Positive data from the RESMAIN study showed Resminostat significantly improved progression-free survival in advanced stage cutaneous T-cell lymphoma.
- Operating costs were reduced by 18%, and personnel expenses decreased by 15%, reflecting effective cost management.
- 4SC AG has engaged a global investment bank and third-party contractor to assist with market entry and pricing strategies in the EU, indicating proactive commercialization efforts.
Negative Points
- The company decided not to pursue further registration of Resminostat in the United States based on the FDA's response, limiting its market potential.
- Resminostat's side effects, such as nausea, diarrhea, and vomiting, were noted, which could impact patient experience and drug adoption.
- Financially, 4SC AG reported a loss of just below EUR4 million in the first half of 2024, highlighting ongoing financial challenges.
- Monthly cash usage remains high at EUR649,000, which could strain resources if revenue generation does not improve.
- The company's future value creation is heavily dependent on the EMA's assessment of the marketing authorization application, posing a significant risk if approval is delayed or denied.
Q & A Highlights
Q: Can you provide an update on the progress of Resminostat's marketing authorization application with the European Medicines Agency (EMA)?
A: Jason Loveridge, CEO, stated that 4SC AG filed the marketing authorization application for Resminostat in advanced stage cutaneous T-cell lymphoma with the EMA in February 2024. They received questions from the EMA in the second quarter and plan to address these issues with the intention of refiling the submission in the last quarter of 2024.
Q: What are the key findings from the RESMAIN study for Resminostat?
A: The RESMAIN study demonstrated that Resminostat significantly improved progression-free survival in advanced stage CTCL, with a median PFS of 8.3 months compared to 4.2 months for placebo. The study also showed a clinically meaningful improvement in total progression-free survival and time to next treatment.
Q: What is the status of Resminostat's registration in other regions like the US and Japan?
A: In the US, 4SC AG filed a pre-NDA with the FDA but decided not to pursue further registration based on the RESMAIN data. In Japan, their partner Yakult Honsha is preparing its filing with the PMDA, awaiting final data from the RESMAIN study's longer-term survival data, expected in the fourth quarter of 2024.
Q: How is 4SC AG planning to commercialize Resminostat in the EU?
A: The company has appointed a global investment bank to evaluate commercial options and is in discussions with potential partners with a strong EU presence. They are also assessing market entry and pricing strategies, engaging with third-party contractors and reimbursement agencies to validate pricing assumptions.
Q: Can you summarize the financial performance of 4SC AG for the first half of 2024?
A: Revenues were EUR182,000, with a loss of just below EUR4 million. Operating costs were reduced by 18%, and personnel expenses decreased due to a 15% reduction in staff. The company had EUR4.4 million to EUR5 million in the bank, with an expected run rate into the first quarter of 2025.
For the complete transcript of the earnings call, please refer to the full earnings call transcript.
