Li Wang Watsek • Cantor Fitzgerald & Co.

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CEO Michael Rossi stated that a comprehensive update will be provided at the R&D event on May 28. He noted that the trial is a platform safety study in a challenging relapsed/refractory non-Hodgkin's lymphoma population and is planned to enroll a smaller cohort of approximately 12 to 15 patients.

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CEO Michael Rossi confirmed that all nine patients who showed significant uptake on the diagnostic scan received a follow-up therapeutic dose as per the protocol. Regarding business development, Rossi explained that the company has identified three core franchise areas for internal commercialization. Targets falling outside these areas would be ideal candidates for partnerships or out-licensing to maximize efficiency. He also mentioned openness to in-licensing targets from external partners.

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Chief Financial Officer Pete Pfreundschuh expressed confidence in achieving the lower half of the $87-$95 million revenue guidance, noting that Q3 results were impacted by the timing of a SciClone sale and a Medicaid adjustment, which will positively affect Q4. Chief Medical Officer Dr. Vignesh Rajah commented that it is too early to determine radiation sensitivity across the different tumor types in the GD2-SADA trial, which include osteosarcoma, melanoma, and small cell lung cancer, but the company will provide updates as more data becomes available.

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Richard Miller, an executive, explained that the placebo response was typical, noting the wide standard error bars indicated variability. He pointed out that unlike longer studies for DUPIXENT or JAK inhibitors, no placebo patients in this 28-day trial reached the key EASI 75 or IGA 0/1 endpoints. Regarding prior treatments, Miller stated it was too early for a definitive conclusion but highlighted two DUPIXENT-refractory patients in Cohort 3 who responded significantly to soquelitinib, suggesting a non-overlapping mechanism of action.

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Richard Miller, an executive at Corvus, explained that clinical improvement is rapid, seen within the first week. He noted expectations for a durable effect based on the drug's mechanism and stated that the company will compare its 28-day data against approved agents like Dupixent to define success.

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Joshua Smiley, President and COO, expressed confidence in VYVGART's position due to its strong data, safety, and NRDL status, suggesting new entrants will help grow the overall market. Jonathan Wang, CBO, reported that licensing is 'business as usual' with continued high interest from multinational companies in the China market.

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President Juan Jaen explained that while full details are not yet disclosed for competitive reasons, a key goal is to lower the high rate of primary progressive disease seen with current IO/IO therapies like ipi/nivo. The initial focus will be on safety and early efficacy signals, particularly the rate of progressive disease. He noted significant investigator interest in a TKI-free frontline option.

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CEO Terry Rosen deferred comment on the AstraZeneca collaboration's timeline until the trial is public and clarified that while statistical plans are always under review, no changes are currently being made for domvanalimab. CMO Dimitry Nuyten emphasized that stable disease is highly relevant for patients and equally important as a response for the registrational endpoint of progression-free survival (PFS).

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CFO Scott Smith stated that the largest gross-to-net driver will be mandatory government rebates in the low 20% range. EVP Jay Wu added that commercial contracting is expected to be minimal and not materially impact the overall figure. Regarding the COACH trial, Chief Medical Officer Aimee Shu explained there is a safe, universal starting dose for TransCon Growth Hormone, with physicians having the flexibility to titrate based on clinical response and IGF-1 levels.

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Jan Mikkelsen, President and CEO, described the adult growth hormone deficiency market as a highly underpenetrated segment that could rival the pediatric market in size. He explained the basket trial (including ISS, SGA, and SHOX/Turner) is a key part of the strategy to cover the entire growth hormone market and build SKYTROFA into a blockbuster.

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President and CEO Jan Mikkelsen and CFO Scott Smith explained the guidance was based on a conservative projection of Q1-to-Q2 volume growth, without assuming a seasonal second-half uplift. On breakeven, Mikkelsen pointed to strong expense control and potential revenue upside from YORVIPATH. Smith added that the new $150M financing provides a buffer while they maintain cost scrutiny, with the company still guiding to quarterly operating cash flow breakeven in 2024 or 2025.

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Chief Medical Officer Noah Berkowitz explained that any read-through from VERITAC-2 would primarily impact the second-line trial design rather than the first-line. CEO John Houston stated that Arvinas is well-capitalized to advance the LRRK2 program to a significant milestone internally, though a future strategic partnership remains a possibility.

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CMO Noah Berkowitz explained that following the VERITAC-2 results, Arvinas will engage in discussions with health authorities. Key topics will include the choice of comparator arm, the specific patient population, and, particularly for a first-line trial with two novel agents like atirmociclib and vepdegestrant, the regulatory requirement to demonstrate contribution of components.

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CEO Troy Wilson explained that the 2028 timeline is a conservative estimate based on alignment with the FDA and EMA on accelerated approval pathways, with more trial details to be shared later. He confirmed that Kura has received constructive feedback and has alignment with the FDA for the NDA submission, with the Q2 timeline being driven by the final clinical data package.

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CEO Dr. Troy Wilson explained that while survival is the base case endpoint, they intend to discuss using MRD negativity as a surrogate with health authorities. EVP of Clinical Development, Dr. Mollie Leoni, added that they plan a central analysis of MRD samples for uniform reporting. Dr. Wilson confirmed the ASH update will include data from over 100 patients and is expected to show consistent activity and improved safety at higher doses.

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