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David Chang, CEO, explained the choice was based on the benefit-risk profile for autoimmune disease, as removing fludarabine improves safety and cyclophosphamide is familiar to rheumatologists. For proof-of-concept, he said they will look for deep B-cell depletion, the phenotype of returning B-cells, disappearance of autoantibodies, and ultimately, positive clinical responses.

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Dr. Zachary Roberts, EVP of R&D and CMO, stated the target is around 50 sites in North America, with global expansion details to follow. He noted their model assumes a 1-in-5 MRD positivity rate. He also explained that investigators now introduce the trial early, which has improved consent rates by educating patients about MRD before they assume a clean PET scan means they are cured.

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COO Igor Bilinsky confirmed that manufacturing success rates rebounded in Q2, with lower drop-offs and out-of-spec rates, reflected by a decrease in scrap costs noted in the quarterly filing. CCO Dan Kirby added that the specialty pharmacy channel could have a significant long-term impact by providing access to healthier patients earlier and opening up hospital networks that were previously constrained by direct purchasing costs.

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EVP of Medical Affairs Dr. Brian Gastman described a 'white glove service' where field teams work directly with new surgeons to accelerate the learning curve. Interim CEO Frederick Vogt explained the initial guidance was based on a maximum manufacturing ramp-up, but has now been revised to more accurately reflect the observed ATC adoption timelines and referral patterns, which also aligns cash spend.

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Chief Medical Officer Dr. Friedrich Graf Finckenstein stated that for NSCLC (IOV-LUN-202), the company will provide an update on the registrational cohorts, with a regulatory decision anticipated by the end of 2027. For endometrial cancer (IOV-END-201), an initial, meaningful data set will be shared in the second half of the year to show early signals, without committing to specific patient numbers for either trial at this time.

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Executive Dave Gancarz clarified that the HARMONi trial uses dual primary endpoints, tested hierarchically with PFS first, then OS. COO and CFO Manmeet Soni addressed geopolitical concerns, stating that the company is mitigating manufacturing risk by transferring know-how to third-party contract manufacturers in the U.S. and Europe, in addition to its supply from Akeso. He also affirmed that the company's intellectual property for ivonescimab is secure into the late 2030s.

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Executive Dave Gancarz clarified they are dual primary endpoints with hierarchical testing. COO & CFO Manmeet Soni addressed geopolitical concerns, stating that Summit is mitigating risk by transferring know-how to third-party contract manufacturers in their licensed territories, in addition to their supply from Akeso. He also confirmed their IP is secure into the late 2030s and that adding new CMOs would follow standard regulatory filing processes.

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An executive explained their strategy is multifaceted, leveraging Akeso's Phase II data, branching out via their MD Anderson collaboration and IST program, and running their own studies. Manmeet Soni, COO & CFO, highlighted a new Phase II colorectal cancer study with Akeso that Summit is now activating. Regarding HARMONi-7, Mr. Soni stated that while specific numbers are not provided, they expect most sites to be activated by the end of 2025.

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Lai Wang, Global Head of R&D, expressed excitement for all upcoming readouts, noting that most molecules that entered the clinic last year should yield data this year. Regarding the MANGROVE trial, he stated it is an event-driven study and that the company hopes the interim analysis will occur in the second half of 2025.

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Wang Lai, Global Head of R&D, expressed excitement for all upcoming readouts, declining to name a favorite, and noted that data is expected this year for most molecules that entered the clinic last year. Regarding the MANGROVE study, he stated it is an event-driven trial and the company hopes the required events for the interim analysis will occur in the second half of 2025.

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CEO John Oyler celebrated the rapid 14-month enrollment as proof of strong execution. He clarified that the study is event-driven with a PFS endpoint and did not provide a specific timeline, noting that the active control arm (venetoclax + obinutuzumab) means it will take time for sufficient events to accrue.

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Steven Stein, an executive, confirmed that as a first filing, it will require a comprehensive safety database and reiterated the guidance for a potential 2026 approval. He stated that market positioning against other orals or biologics will depend on the final Phase III efficacy profile. He noted the addressable moderate-to-severe patient population seeking therapy is between 150,000 and 300,000.

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