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    Karina Rabayeva • Truist Securities

    Karina Rabayeva's questions to Summit Therapeutics Inc (SMMT) leadership

    Karina Rabayeva's questions to Summit Therapeutics Inc (SMMT) leadership • Q1 2025

    Question

    Karina Rabayeva, on behalf of Asthika Goonewardene, asked when the Chinese NMPA label for HARMONi-2 would be publicly available, whether the company has seen the OS curves, and if there have been discussions with the FDA about leveraging Project Front-Runner for an accelerated approval for HARMONi-3.

    Answer

    Executive Dave Gancarz explained that the Chinese label release process differs from the U.S. and that the company would defer to its partner Akeso for the release of detailed OS curve data. Regarding regulatory discussions, he declined to comment on the specifics of conversations with the FDA, such as Project Front-Runner, but affirmed that the company's trial designs are aligned with agency feedback.

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    Karina Rabayeva's questions to Summit Therapeutics Inc (SMMT) leadership • Q1 2025

    Question

    Karina Rabayeva, on for Asthika Goonewardene, asked when the Chinese NMPA label for HARMONi-2 would be public, whether Summit has seen the OS curves, and if there have been discussions with the FDA about using Project Front-Runner for HARMONi-3.

    Answer

    Executive Dave Gancarz explained the Chinese label is not published online like in the U.S. but is included with the physical product. He deferred questions on the OS curves to their partner Akeso. Regarding Project Front-Runner, he stated that while Summit has regular FDA discussions, they do not disclose the specific details of those conversations.

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    Karina Rabayeva's questions to Arcus Biosciences Inc (RCUS) leadership

    Karina Rabayeva's questions to Arcus Biosciences Inc (RCUS) leadership • Q1 2025

    Question

    Karina Rabayeva, on behalf of Asthika Goonewardene, asked if Arcus has plans for additional registrational studies for casdatifan in combination with PD-1s in the frontline setting, beyond the current collaboration with AstraZeneca.

    Answer

    President Juan Jaen stated that no new registrational studies have been disclosed, but highlighted an ongoing cohort in the ARC-20 study combining casdatifan with their own anti-PD-1 antibody, which could inform a future registrational trial. CEO Terry Rosen emphasized their strategy is to conduct early-stage work to validate combinations before committing to large Phase III studies.

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