Yuxi Dong

Yuxi Dong, on behalf of Kelly Shi at Jefferies, inquired about the key criteria for resource allocation across the company's broad pipeline, including NSCLC, pancreatic cancer, and early-stage programs, and asked about the expected cadence for initiating pivotal combination trials in lung cancer.

Answer

Dr. Mark Goldsmith, CEO, stated that first-line combination trials are expected to begin rolling out in 2026. Regarding resource allocation, he described it as a complex decision driven by clinical data, biological rationale, the competitive landscape, and the potential to deliver durable clinical benefit. He emphasized that the company's strong financial position allows it to advance all high-priority programs to establish a leading RAS franchise.

Yuxi Dong, on behalf of Kelly Shi at Jefferies, asked if the company plans to provide an update on the median overall survival (OS) data for the daraxonrasib Phase I study in PDAC, which was previously immature.

Answer

CEO Dr. Mark Goldsmith clarified that a median OS estimate of 14.5 months was previously reported for an aggregate of dose cohorts. The specific 300mg cohort was less mature. He confirmed the data continues to mature and an update will likely be provided at some point, but there is no specific timeline for the disclosure.

Yuxi Dong, on for Kelly Shi, asked for clarification on the registrational endpoints for the Phase II trials of sonrotoclax in refractory mantle cell lymphoma and the BTK CDAC. She also inquired about the typical regulatory review timeline in China for the sonrotoclax filing.

Answer

Lai Wang, Global Head of R&D, explained that both are single-arm Phase II studies where the primary endpoints, Overall Response Rate (ORR) and Duration of Response (DOR), could support accelerated approval. For the China filing, he noted that sonrotoclax has received priority review and anticipates potential approval in the first half of the following year.

Yuxi Dong inquired about the qualitative impact of the CINVANTI litigation settlement on near-term financials and the expected sales momentum for ZYNRELEF in the latter half of the year, given recent catalysts.

Answer

Craig Collard, Chief Executive Officer, explained that while he couldn't share quantitative details, the settlement with Mylan secures the future of CINVANTI and APONVIE. Regarding ZYNRELEF, he noted that Q1 unit demand outpaced the market and highlighted that several new accounts are currently onboarding. Collard expressed strong confidence in a sales inflection point mid-year and beyond, driven by the Crosslink partnership and other initiatives, and stated the company is comfortable with consensus estimates.

Yuxi Dong, on for Kelly Shi, asked if the long-term redosing durability data from SOL-1 would be available by the time of the NDA submission, which is planned after the SOL-R primary endpoint is reached. She also sought to clarify if the FDA requires this specific data to support redosing flexibility on the product label.

Answer

President and CEO Dr. Pravin Dugel clarified that the NDA submission requires positive primary endpoints from SOL-1 (at 9 months) and SOL-R (at 56 weeks). While the longer-term redosing data is not required for the initial submission, it will fulfill FDA safety requirements and generate a wealth of data, including a numeric comparison to high-dose Eylea, which the company can leverage for a stronger commercial label.