Release Date: August 22, 2024
For the complete transcript of the earnings call, please refer to the full earnings call transcript.
Positive Points
- Medivir AB (FRA:MVR0, Financial) presented strong data for the Fostrox Lenvima combination at the ESMO GI Congress, showing superior efficacy in second-line liver cancer.
- The liver-targeted approach of Fostrox demonstrated the ability to kill cancer cells without negatively impacting normal liver function.
- The median time to progression for the Fostrox Lenvima combination was 10.8 months, which is significantly longer than other second-line treatments.
- The company is accelerating the Fostrox development program according to plan, with preparations for a Phase 2b study underway.
- Financial performance for Q2 was in line with expectations, with a cash position of around $127 million, providing a runway into Q1 2025.
Negative Points
- The company faces a challenging funding situation, with cash expected to last only until the end of Q1 2025.
- Costs are expected to increase in the next three quarters due to ongoing clinical and CMC investments.
- There is still no confirmed partner for the Fostrox development program, which is critical for future progress.
- The initiation of the Phase 2b study has been delayed and is now expected to start in the first half of 2025.
- The patient population in the Fostrox Lenvima study includes third-line patients, which may complicate the interpretation of results.
Q & A Highlights
Q: What are the cost activities planned for the next three quarters, given the cash position and guidance?
A: (Magnus Christensen, CFO) The costs are not evenly distributed throughout the months and quarters. We have some CMC investments for the next phase, Phase 2b. We follow this closely and will update as needed. The current assumption is a positive cash flow into Q1 2025.
Q: Can you provide more details on the partner search process and what data potential partners are looking for?
A: (Jens Lindberg, CEO) Partner discussions are fluid, and data maturity is key. The data has strengthened over time, and we are looking forward to presenting more mature data at ESMO in Barcelona. This will likely be close to a final readout, making it a good time to close out partnering discussions.
Q: When do you expect to submit the IND and start the Phase 2 study?
A: (Jens Lindberg, CEO) We aim to file for the IND in the second half of the year, with the study initiation planned for the first half of 2025. Preparatory activities are progressing well.
Q: Are the patient characteristics in the Fostrox plus Lenvima study typical of liver cancer patients?
A: (Pia Baumann, CMO) The study includes an all-comer population, including second-line and some third-line patients, making it representative of typical liver cancer patients in a clinical setting.
Q: What is the significance of the 10.8 months median time to progression in the Phase 1b/2a study?
A: (Pia Baumann, CMO) The 10.8 months median time to progression is significantly longer than the 2-6 months seen with other second-line treatments, highlighting the efficacy of the Fostrox and Lenvima combination.
Q: How does the Fostrox mechanism ensure selectivity in killing tumor cells without affecting normal liver cells?
A: (Fredrik Oberg, CSO) Fostrox is designed for liver-directed activity, stable in the GI tract and blood but rapidly metabolized in the liver. This ensures high liver exposure and low systemic exposure, sparing normal hepatocytes.
Q: What are the next steps for the Fostrox development program?
A: (Pia Baumann, CMO) We are planning a randomized Phase 2b study with Fostrox in combination with Lenvima versus Lenvima alone in second-line advanced HCC. Recruitment will take place in Europe, Asia, and the US.
Q: What is the market potential for Fostrox in the second-line liver cancer space?
A: (Jens Lindberg, CEO) The second-line liver cancer market is valued at over $2.5 billion by 2030 and continues to grow. There are currently no approved treatment options in the second-line setting after IO combinations, making this a significant commercial opportunity.
Q: How does the combination of Fostrox and Lenvima address the unmet medical need in liver cancer treatment?
A: (Jens Lindberg, CEO) The combination shows a unique and targeted mechanism that selectively kills cancer cells in the liver, with a median time to progression of 10.8 months, offering a potential first-to-market treatment in a high-value, high-need patient population.
Q: What are the financial highlights for Q2 2024?
A: (Magnus Christensen, CFO) Q2 was in line with our plan, with turnover around $1 million from royalty income. Operating loss was higher due to clinical and CMC costs. The cash position at the end of Q2 is around $127 million, with a cash run rate into the end of Q1 2025.
For the complete transcript of the earnings call, please refer to the full earnings call transcript.
