Release Date: August 06, 2024
For the complete transcript of the earnings call, please refer to the full earnings call transcript.
Q: Given the singular focus on FG-3246 now, do you have any plans on accelerating its development to maximize the asset's value for shareholders? Also, how do you as a US entity access the cash derived from roxadustat revenue in China? A: Thane Wettig, CEO: FG-3246 has always been a priority asset, and we are prosecuting it with speed. We have an important interaction with the FDA this quarter to inform the Phase 2 trial design. Juan Graham, CFO: We have been repatriating cash from China through a registered debt facility and are exploring other avenues to continue this process.
Q: How soon could you look to partner your two preclinical candidates, and would you wait for Phase 1 data or proceed with preclinical data? A: Thane Wettig, CEO: We plan to showcase a preclinical data set to potential partners. Our anti-galectin-9 antibody has an extensive data set, and we feel confident about the optimization work on our CCR8 antibody. We will start partnership activities immediately.
Q: What's the nature of the update we can expect from the top-line data of FG-3246's combo trial with enzalutamide? What would be considered a clinically meaningful PFS benefit? A: Deyaa Adib, CMO: The combination study has shown encouraging results with a 10.2-month radiographic PFS in heavily pretreated patients. The current bar for this setting is around six months. We expect to publish top-line results from the combination study in the first half of 2025, with a total of 36 patients.
Q: Can you comment on how much of the updated guidance is driven by potential approval of a CIA indication versus continued volume growth from the CKD indication? Also, what are your thoughts on the pricing impact from the generic launch of roxadustat? A: Thane Wettig, CEO: The guidance raise is due to strong performance in the CKD indication alone. Christine Chung, SVP China Operations: We have not seen the launch of generics in the market yet, and there are no plans to change pricing until we are subject to volume-based purchasing.
Q: Regarding FG-3246, beyond PET positive patients, is there any other population that might benefit from the combination? A: Thane Wettig, CEO: The Phase 2 trial will explore the correlation between CD46 expression and response to the drug. Deyaa Adib, CMO: While PET46 pre-selection is the primary focus, there could be opportunities in all-comers if data continues to show strong signals.
For the complete transcript of the earnings call, please refer to the full earnings call transcript.
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