Poorna Kannan

Poorna Kannan asked how soon Revolution Medicines could achieve commercialization if the first interim analysis for daraxonrasib in pancreatic cancer is positive, and what aspects of commercialization preparations still need to be completed.

Answer

Chairman and CEO Mark A. Goldsmith and Chief Global Commercialization Officer Anthony Mancini expressed satisfaction with the launch readiness plan, noting the addition of experienced team members and broad organizational readiness across the U.S., Europe, and Japan. Anthony Mancini highlighted that U.S. launch preparations are well underway, with leadership teams in place across commercialization functions and recruitment initiated for field sales teams. He committed to providing more details closer to filing and launch.

Poorna Kannan asked how soon Revolution Medicines could commercialize if the first interim data is positive and what aspects of commercialization preparations still need to be addressed.

Answer

Anthony Mancini, Chief Global Commercialization Officer, expressed satisfaction with the launch readiness plan, noting the addition of experienced team members and broad organizational readiness across the U.S., Europe, and Japan. He highlighted that U.S. launch preparations are progressing well, with leadership teams and field-based leaders in place, and recruitment for sales teams underway. He committed to providing more details closer to filing and launch.

Poorna Kannan from Needham & Company, on for Ami Fadia, asked if there was a scenario for seeking accelerated approval for RESOLUTE-302 following the 2026 data update. She also requested an explanation for how combining a RasOn inhibitor with a PD-1/VEGF inhibitor could improve efficacy in RAS-driven tumors.

Answer

CEO Mark Goldsmith clarified that the trial is designed to generate a complete data package for a standard review, not an accelerated approval pathway, but noted the Breakthrough Therapy Designation could speed up the review process. Chief Medical Officer Wei Lin and CEO Mark Goldsmith explained the biological rationale, citing historical precedent with EGFR/VEGF combinations and preclinical data showing RAS inhibitors can reverse local immunosuppression, making tumors more sensitive to PD-1 blockade.

Poorna Kannan, on behalf of Ami Fadia at Needham & Company, asked what additional data is needed for zoldonrasib to support initiating pivotal combination trials and if updates would include other indications like CRC.

Answer

CEO Dr. Mark Goldsmith explained that the company is currently evaluating zoldonrasib in combination with daraxonrasib and other standard-of-care agents. He stated that generating this data is a high priority for the year, with additional clinical data on zoldonrasib expected mid-year. The goal is to use this information to define at least one pivotal trial for a mutant-selective inhibitor to start in 2026.

Poorna Kannan asked about the expected DAY301 initial data update in H2 2026, specifically inquiring about the number of dose cohorts, any observed DLTs or MTDs, and the number of doses planned for Phase 2 expansion.

Answer

CEO Jeremy Bender stated that specific parameters for the DAY301 data update have not yet been defined, as the program is in dose escalation with backfilling at certain doses. He noted that the company is observing an efficacy and safety profile consistent with continued development but would not provide further details until a more comprehensive dataset is available.

Poorna Kannan asked about the expected DAY301 initial data update in H2 2026, specifically regarding the number of dose cohorts, if DLTs or MTDs have been reached, and how many doses are planned for Phase 2 expansion.

Answer

CEO Jeremy Bender stated that specific parameters for the data update have not been defined, but the program is in dose escalation, backfilling at certain doses, and enriching for specific patient populations. He noted that an efficacy and safety profile consistent with continued development is being observed, but further details will be provided once a more comprehensive dataset is available.

Poorna Kannan requested recent updates on enrollment for the ARGUS and LIGHTHOUSE studies. She also asked about the targets for the recent sales force expansion and when the impact from this expansion is expected to be seen.

Answer

Kumar Budur, Chief Medical and Scientific Officer, confirmed that the ARGUS and LIGHTHOUSE studies continue to enroll and are on track for top-line data in the first half of 2027 and PDUFA in 2028. Adam Zaeske, EVP and Chief Commercial Officer, clarified that approximately 5% more targets were added with the sales force expansion, which primarily aims to improve share of voice and rebalance territories. He expects the impact to be seen from the end of the current quarter, as new personnel are anticipated to be in place by then.

Poorna Kannan inquired about any recent enrollment updates for the ARGUS and LIGHTHOUSE studies and the targets for the recent sales force expansion, including when its impact is expected to be seen.

Answer

Dr. Kumar Budur, Chief Medical and Scientific Officer, confirmed that the ARGUS and LIGHTHOUSE studies continue to enroll and make progress, remaining on track for top-line data in H1 2027 and PDUFA in 2028. Adam Zaeske, EVP and Chief Commercial Officer, stated that the sales force expansion involved adding about 5% to targets, primarily aimed at improving share of voice and rebalancing territories within the existing target base. He expects the impact to be seen from the end of Q1 2026, as new hires are anticipated to be in place by then.

Poorna Kannan, on for Ami Fadia, asked for details on Cimbravo's sampling program, including utilization, conversion rates to prescriptions, and any initial barriers to the launch.

Answer

Chief Commercial Officer Ari Maizel confirmed the existence of a sampling program and a patient savings program, noting encouraging early signs of samples being accompanied by prescriptions. He added that they are already seeing covered claims, which helps mitigate access barriers.

Poorna Kannan from Needham & Company asked how baseline MADRS scores in KOASTAL-1 compared to the severity in the successful Phase II study and inquired about the gender mix being observed in the ongoing KOASTAL-2 and -3 trials.

Answer

Daljit Aurora, Chief Operating and Development Officer, stated that while different scales were used (MADRS vs. HAMD-17), both the Phase II and KOASTAL-1 studies targeted a similar moderate-to-severe MDD population. He also confirmed that the gender mix in KOASTAL-2 and -3 is now more representative of historical norms (approx. 2/3 female) compared to the anomalous male-heavy mix in KOASTAL-1.