Release Date: November 12, 2024
For the complete transcript of the earnings call, please refer to the full earnings call transcript.
Q: In the Phase 2 portion of the investigator-sponsored study, will the top-line results expected in the first half of next year include both the escalation and expansion cohorts? A: Yes, the top-line results will include data from both the escalation cohorts and the expansion cohort, which is dosed at 2.1 mg per kg along with 160 mg per day of Enzalutamide. The results will mature over time as more patients reach the six-month RPFS data point. (Thane Wettig, CEO)
Q: Regarding the PET imaging agent, how long do patients typically have to wait to get a PET image after administration? A: The expectation is that it will be days post-exposure to the PET imaging agent, not minutes. The exact number of days will be determined in the ongoing work at UCSF, but it is likely to be around six days. (Thane Wettig, CEO)
Q: For the Phase 2 trial planned for Q1 2025, will all 75 patients be imaged with FG-3180? A: The majority of the 75 patients will be treated with the imaging agent at the outset of therapy, followed by treatment with the ADC. The PET imaging agent will be ready shortly after the first patient is dosed in the monotherapy trial. (Thane Wettig, CEO)
Q: Can you explain the sequential decrease in guidance for Roxadustat net sales in the fourth quarter? A: The guidance considers a potential approval of the CIA indication, which would require accruing further into deferred revenue due to future expected performance. If the CIA approval flows into 2025, we may be on the higher end of the guidance spectrum. (Juan Graham, CFO)
Q: Was there a $12.5 million change in deferred revenue this quarter? A: Yes, there was a $12.5 million release from deferred revenue this quarter, which increased the revenue. However, if future expected revenue increases, we would need to defer more revenue, reducing the revenue for that specific quarter. (Juan Graham, CFO)
For the complete transcript of the earnings call, please refer to the full earnings call transcript.
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