Sean

Sean from Morgan Stanley inquired about the potential registrational pathway for REC-4881, including FDA alignment, regulatory updates, and patient population considerations.

Answer

Najat Khan, CEO and President, confirmed the company is on track for initial FDA engagement in H1 2026 to discuss registrational study design, patient population, and endpoints, leveraging compelling durability and polyp burden reduction data, along with natural history data. She also noted the 18-and-over cohort is recruiting, and dose optimization efforts are underway, with more data expected in H1 2027.

Sean from Morgan Stanley inquired about the potential registrational pathway for REC-4881 in FAP, seeking details on regulatory updates and the strategy for expanding the patient population.

Answer

CEO Najat Khan confirmed that Recursion Pharmaceuticals is on track for initial FDA engagement in the first half of 2026 to discuss registrational study design, patient population, and endpoints, leveraging compelling durability and polyp burden reduction data, along with natural history data. She also noted that the 18-and-over cohort is actively recruiting, and dose optimization efforts are underway, with more data expected in the first half of 2027.

Sean asked about the potential impact of several bispecific programs being developed in first-line colorectal cancer (CRC) on the later-line uptake of Atezolizumab plus Zanzalintinib, and sought clarification on why the Stellar-303 filing couldn't have been earlier.

Answer

Michael Morrissey, President and CEO, stated that it's difficult to comment on the impact of emerging bispecifics without pivotal trial data. He clarified that the Stellar-303 filing was delayed because no new NDAs or BLAs are being filed while the government is closed, and Exelixis hopes to file as soon as it reopens.

Sean asked about the potential impact of emerging bispecific programs in first-line colorectal cancer on the later-line uptake of Atezolizumab plus Zanzalintinib. He also sought clarification on why the STELLAR-303 trial could not be filed earlier, despite positive ITT population results.

Answer

Michael Morrissey, President and CEO, stated that the company is currently unable to file new NDAs due to the government shutdown, but intends to file as soon as it reopens. Regarding bispecifics, he noted that it's difficult to comment on their market impact without pivotal trial data, emphasizing that data drives the process and Exelixis will continue to advance its own data.