Brian Chang

Brian Chang asked for additional information on the FDA Commissioner's National Priority Voucher, specifically its applicability to a particular line of setting in PDAC, and considerations for the Zoledronrasib combination Phase 3 trial in frontline PDAC, including doublet versus triplet approaches and active comparator selection.

Answer

Mark Goldsmith, Chairman and CEO, stated that no additional information on the voucher's specifics could be shared, noting ongoing dialogue with the FDA. Regarding Zoledronrasib, he indicated that more details on the trial design, including doublet/triplet strategies and active comparators, would be provided when the information is presented, emphasizing the company's multi-pronged approach to treating PDAC.

Brian Chang asked for additional information learned about the FDA voucher since mid-October, specifically which line of setting it applies to. He also asked about considerations for the Zoledronrasib combination Phase III in frontline PDAC, including doublet vs. triplet and the active comparator arm.

Answer

Mark Goldsmith, Chairman and CEO, stated no additional information on the voucher could be shared, as they are in ongoing dialogue with the FDA. Regarding Zoledronrasib, he noted the company is taking multiple approaches to treating pancreatic cancer and will provide more details when study information is explicitly laid out, emphasizing their commitment to significant investment.

Asked about the importance and timing of securing a partner for the CHS-114 (CCR8) program and about the company's confidence in achieving its revenue goals for Loktorzi.

Answer

The company is funded for CHS-114 through key data readouts in H1 2026 but expects partners to help offset future development costs. Partnering timing is influenced by competitor data expected in the next 6-12 months. They are confident in the Loktorzi revenue goal ($150M-$200M peak), citing strong uptake in academic centers following NCCN guideline updates, and are now focused on educating the community setting.