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    Kaveri Pohlman • Clear Street

    Kaveri Pohlman's questions to Trevi Therapeutics Inc (TRVI) leadership

    Kaveri Pohlman's questions to Trevi Therapeutics Inc (TRVI) leadership • Q2 2025

    Question

    Kaveri Pohlman of Clear Street asked about plans to manage the placebo effect in longer Phase 3 trials, manufacturing readiness for commercialization, and the company's current perspective on commercial partnerships.

    Answer

    Chief Development Officer James Cassella expressed confidence in managing the placebo effect due to the drug's rapid onset and large effect size, and confirmed manufacturing is ready for Phase 3. CEO Jennifer Good stated that while partnerships for Europe or Japan are a consideration, the plan is for Trevy to commercialize in the U.S. itself, viewing a U.S. partnership as likely requiring a full company acquisition.

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    Kaveri Pohlman's questions to Trevi Therapeutics Inc (TRVI) leadership • Q1 2025

    Question

    Kaveri Pohlman inquired about the FDA's requirements for long-term patient safety data for a potential Phase III trial and asked about the company's current perspective on potential U.S. or ex-U.S. partnerships.

    Answer

    Chief Development Officer Dr. James Cassella clarified that the FDA requires 52 weeks of safety data for an NDA, which Trevi plans to collect via a long-term extension study in its Phase III program. Executive Jennifer Good added that while the company is prepared to commercialize in the U.S. itself, it remains in strategic discussions, particularly for potential commercial partners in Europe and Japan.

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    Kaveri Pohlman's questions to Trevi Therapeutics Inc (TRVI) leadership • Q4 2024

    Question

    Speaking on behalf of Kaveri Pohlman from Clear Street, an analyst asked which secondary endpoints across indications would be most crucial for driving prescriptions of Haduvio and minimizing resistance from payers.

    Answer

    Executive Jennifer Good explained that for regulatory purposes, key secondary endpoints will focus on measures like cough severity that are linked to the primary endpoint of objective cough frequency. For commercial success and payer acceptance, she highlighted that metrics related to patient quality of life will be important, and the commercial team is actively involved in selecting these endpoints for future studies.

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    Kaveri Pohlman's questions to Nuvation Bio Inc (NUVB) leadership

    Kaveri Pohlman's questions to Nuvation Bio Inc (NUVB) leadership • Q2 2025

    Question

    Kaveri Pohlman of Clear Street inquired about guidance for Iptrozy patient numbers, the expected rate of new patient starts, the breakdown between first- and second-line use, and details on upcoming data presentations at the World Lung Cancer Conference and ESMO.

    Answer

    CEO David Hung noted an early uptick in the daily patient start rate for Iptrozy, from approximately two to three per day, but stated it was too early to provide formal guidance. He explained that a detailed breakdown of patient lines of therapy is not yet available due to data visibility limitations. Hung confirmed data updates from the TRUST studies would be presented at World Lung and new data on post-entrectinib use would be shown at ESMO.

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    Kaveri Pohlman's questions to Madrigal Pharmaceuticals Inc (MDGL) leadership

    Kaveri Pohlman's questions to Madrigal Pharmaceuticals Inc (MDGL) leadership • Q2 2025

    Question

    Kaveri Pohlman of Clear Street inquired about the rationale for choosing a GLP-1 over dual/triple agonists, potential overlapping toxicities in a combination, and the clinical development plan for dosing and scheduling.

    Answer

    CEO Bill Sibold differentiated their strategy from the 'battle for greatest weight loss,' stating their goal is a well-tolerated oral GLP-1 that achieves the ~5% weight loss needed to enhance ResDiffera's effect. CMO David Soergel added that their due diligence on the molecule's preclinical profile was reassuring regarding its compatibility with resmetirom. They noted it was premature to discuss the full development plan.

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    Kaveri Pohlman's questions to Arcus Biosciences Inc (RCUS) leadership

    Kaveri Pohlman's questions to Arcus Biosciences Inc (RCUS) leadership • Q1 2024

    Question

    Kaveri Pohlman of Guggenheim Securities inquired about the HIF-2 alpha pathway's relationship with VEGF, asking about potential overlapping toxicities between casdatifan and cabozantinib. She also asked about the STAR-121 trial's dual primary endpoints (PFS/OS) and the acceptable variation for the zimberelimab monotherapy arm (Arm C).

    Answer

    CEO Terry Rosen stated that while HIF-2 alpha and VEGF are in the same pathway, overlapping toxicities are not expected, noting that casdatifan's AE profile is well-defined and manageable, primarily involving anemia. CMO Dimitry Nuyten clarified that for the STAR-121 trial, a statistically significant result in either PFS or OS would make the trial positive, but OS is the key registrational endpoint. He added that the contribution of components from Arm C is a review issue but expressed confidence in the study's design to meet regulatory expectations.

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