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    Etzer Darout • BMO Capital Markets

    Etzer Darout's questions to Novartis AG (NVS) leadership

    Etzer Darout's questions to Novartis AG (NVS) leadership • Q4 2024

    Question

    Etzer Darout asked for additional commentary on the delay of the HORIZON Phase III trial readout for pelacarsen, inquiring about the potential drivers of the event rate dynamics.

    Answer

    CEO Vasant Narasimhan clarified that the delay is due to event rate modeling on the blinded data, not an interim analysis. He explained that cardiovascular outcome studies have been trending toward lower event rates over time, and it's preferable to ensure the study is adequately powered by waiting for the target number of events, which is now expected in early 2026. He remains confident in the drug's mechanism.

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    Etzer Darout's questions to Scholar Rock Holding Corp (SRRK) leadership

    Etzer Darout's questions to Scholar Rock Holding Corp (SRRK) leadership • Q3 2024

    Question

    Etzer Darout inquired about the planned dosing strategy for the OPAL study in SMA patients under two years old, considering the learnings from the SAPPHIRE trial. He also asked for Scholar Rock's perspective on the differences between various muscle preservation approaches in obesity, such as myostatin inhibition versus amylins.

    Answer

    Executive Jay Backstrom stated that for the OPAL study, the company will leverage all PK/PD data from both the TOPAZ and SAPPHIRE studies to model and confirm the dose, which is expected to be based on the effective 10 mg/kg dose. Regarding obesity therapies, he emphasized that lean muscle loss is a common issue across different weight loss methods. He positioned Scholar Rock's SRK-439 as being agnostic to the primary weight loss drug, suggesting its favorable safety profile makes it suitable for broad combination strategies.

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    Etzer Darout's questions to Y-mAbs Therapeutics Inc (YMAB) leadership

    Etzer Darout's questions to Y-mAbs Therapeutics Inc (YMAB) leadership • Q3 2024

    Question

    Etzer Darout inquired about the price-to-mix dynamics for DANYELZA sales in the third quarter and the key criteria for selecting the optimal antibody dose for Part B of the GD2-SADA study.

    Answer

    Chief Commercial Officer Sue Smith explained that a $1.5 million charge for Medicaid claims impacted the price mix, causing a 5% revenue decline despite a 5% increase in vial volume. President and CEO Michael Rossi and Chief Medical Officer Dr. Vignesh Rajah stated that the GD2-SADA protein dose of 1 mg/kg was chosen for Part B because it aligns with preclinical PK data, allowing for dosing near the nadir. They added that dosimetry in the tumor and normal tissues, along with safety, are key factors for determining the optimal dose and interval.

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    Etzer Darout's questions to Y-mAbs Therapeutics Inc (YMAB) leadership • Q2 2024

    Question

    Etzer Darout inquired about the anticipated number of patients for the randomized portion of the frontline BCC study and whether the SADA Part A study could yield enough data on GD2 expression to inform expansions into specific tumor types.

    Answer

    Chief Medical Officer Dr. Vignesh Rajah stated that the design for the randomized BCC study is still under evaluation, so patient numbers cannot be confirmed yet. President and CEO Michael Rossi added that while the SADA study collects data on various tumor expressions, Part A likely won't provide enough information to focus on or eliminate a specific tumor type for Part B.

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    Etzer Darout's questions to Arvinas Inc (ARVN) leadership

    Etzer Darout's questions to Arvinas Inc (ARVN) leadership • Q3 2024

    Question

    Etzer Darout from BMO Capital Markets inquired about expectations for the fulvestrant control arm in the VERITAC-2 trial and whether there are any potential read-throughs from upcoming data from Eli Lilly's EMBER-3 trial.

    Answer

    CEO John Houston stated the trial is designed to show superiority over fulvestrant. CMO Noah Berkowitz elaborated, expecting the fulvestrant arm's PFS to be in the 3-4 month range. He noted that for Lilly's data, they will need to analyze the prior CDK4/6 exposure of the patient population to make a valid comparison.

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    Etzer Darout's questions to Exelixis Inc (EXEL) leadership

    Etzer Darout's questions to Exelixis Inc (EXEL) leadership • Q3 2024

    Question

    Lukas Shumway, on behalf of Etzer Darout, asked about the zanzalintinib colorectal cancer trial, specifically how patients without liver metastases are identified and if a companion diagnostic would be required.

    Answer

    Chief Medical Officer Amy Peterson explained that identifying liver metastases is a standard part of care for advanced colorectal cancer patients, done via routine imaging scans. She clarified that it is a straightforward clinical assessment and does not require a companion diagnostic.

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    Etzer Darout's questions to Genmab A/S (GMAB) leadership

    Etzer Darout's questions to Genmab A/S (GMAB) leadership • Q1 2024

    Question

    Etzer Darout of BMO Capital Markets requested details on planned Phase III trial designs. He asked about the target patient population and control arm for Tivdak in head and neck cancer, and the expected initial indication and line of therapy for ProfoundBio's Rina-S, which has a potential 2027 launch.

    Answer

    Chief Development Officer Judith Klimovsky explained that for Tivdak, Genmab is finalizing the Phase III design with health authorities, based on data in second and third-line head and neck cancer patients who have progressed after standard therapies. Chief Medical Officer Tahamtan Ahmadi, citing the pending acquisition, carefully noted that ProfoundBio has publicly stated plans for a Phase III trial for Rina-S and a study to evaluate folate receptor expression.

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