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    Zaki Molvi • Jefferies

    Zaki Molvi's questions to Ionis Pharmaceuticals Inc (IONS) leadership

    Zaki Molvi's questions to Ionis Pharmaceuticals Inc (IONS) leadership • Q2 2025

    Question

    Zaki Molvi from Jefferies, on for Akash Tewari, asked about the potential for event variability to be a swing factor in the CORE studies' acute pancreatitis (AP) analysis, referencing a late-occurring AP event in the BALANCE study's treatment arm.

    Answer

    CEO Brett Monia and Chief Clinical Development Officer Eugene Schneider responded that they are taking steps to maximize statistical power for the AP analysis. This includes combining the CORE and CORE-2 studies and assessing the AP endpoint at the 12-month mark, which maximizes both patient numbers and observation time to account for such variability.

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    Zaki Molvi's questions to Cytokinetics Inc (CYTK) leadership

    Zaki Molvi's questions to Cytokinetics Inc (CYTK) leadership • Q4 2024

    Question

    Zaki Molvi, on for Akash Tewari at Jefferies, asked about dosing in the ACACIA trial for nonobstructive HCM, questioning the ability to maintain patients on the higher 20mg dose without ejection fraction issues and whether slower titration might be better.

    Answer

    EVP of R&D Fady Malik responded that the dosing strategy in ACACIA is based directly on the Phase 2 REDWOOD data, where 85% of patients reached 15mg within six weeks, with many eligible for 20mg. He noted that NT-proBNP decreased in a dose-dependent manner in REDWOOD and expects a similar or higher dose distribution in ACACIA. He expressed confidence in the current dosing and titration speed, seeing no fundamental difference in cardiac function between nHCM and oHCM patients.

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