Release Date: March 27, 2025
For the complete transcript of the earnings call, please refer to the full earnings call transcript.
Q: Are the background doses for patients on GLP-1s low dose diabetic doses, or do they include high doses for weight loss? How many patients are enrolled on background SGLT2 inhibitors? A: The GLP-1 doses are mostly anti-diabetic, including semaglutide and other GLP-1 agonists. Approximately 6 to 8% of patients are on SGLT2 inhibitors at baseline. - Frederic Cren, CEO
Q: What is your confidence level in completing enrollment by April 30 to secure the EUR116 million capital increase? What are the plans for additional financing? A: Confidence is high as we have sufficient patients already randomized and in screening to meet our target. We are actively managing financial resources and evaluating options to secure funding for clinical trials and commercialization. - Frederic Cren, CEO
Q: Are there any specific rate-limiting steps in screening that could affect the last patient's enrollment? How do you see the market evolving with the introduction of lanifibranor? A: The screening process involves lab tests and biopsies, which take 8 to 12 weeks. We are confident in meeting our enrollment target. Lanifibranor is ideal for patients with advanced fibrosis and type 2 diabetes, a large and underserved population. - Frederic Cren, CEO
Q: What are the expected R&D expenses and potential milestone payments for this year? A: R&D expenses are expected to increase by 10% to 20% as we prepare for NDA filing and commercialization. We anticipate receiving the second $10 million milestone from our Chinese partner CTTQ after the last randomization disclosure. - Jean Volatier, CFO
Q: How soon after the last patient completes treatment will you share top-line data, and how does this align with your cash runway? A: We expect to publish top-line data a couple of months after the last patient's last visit. With the second tranche of financing, we will have the means to deliver on our clinical objectives. - Frederic Cren, CEO
For the complete transcript of the earnings call, please refer to the full earnings call transcript.
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