Sign in

    Caroline Kimberly Pocher • JPMorgan Chase & Co.

    Caroline Kimberly Pocher's questions to Seres Therapeutics Inc (MCRB) leadership

    Caroline Kimberly Pocher's questions to Seres Therapeutics Inc (MCRB) leadership • Q1 2025

    Question

    Caroline Kimberly Pocher, on behalf of Tessa Romero, inquired if partnership discussions for SER-155 are dependent on developmental milestones like protocol submission, and asked for details on the powering assumptions and adaptive design of the upcoming Phase 2 study.

    Answer

    President and CEO Eric Shaff clarified that securing a partnership is the primary gating item for initiating the SER-155 study, although progress is being made in parallel on operational readiness and FDA interactions. Regarding the study design, Eric Shaff and SVP of Clinical Development Dr. Dennis Walling explained that while specific powering statistics are not being shared, the Phase 2 study will be well-powered and its data could be part of a future submission. The adaptive design includes an interim analysis after about 12 months, intended to provide an early look at efficacy and facilitate earlier discussions with the FDA about a potential Phase 3 trial.

    Ask Fintool Equity Research AI

    Caroline Kimberly Pocher's questions to Xenon Pharmaceuticals Inc (XENE) leadership

    Caroline Kimberly Pocher's questions to Xenon Pharmaceuticals Inc (XENE) leadership • Q4 2024

    Question

    Caroline Pocher of JPMorgan, on behalf of Tessa Romero, requested confirmation that enrollment in the X-TOLE2 study is not yet complete and asked for details on the Phase III trial design for bipolar depression, including patient population and endpoints.

    Answer

    President and CEO Ian Mortimer confirmed that the company has not yet commented on the completion of enrollment, reiterating the H2 2025 guidance for top-line data. He stated that specific details on the bipolar depression trial design will be disclosed closer to its initiation around mid-year. Chief Medical Officer Dr. Chris Kenney clarified that both planned bipolar studies will enroll a combination of patients with bipolar I and bipolar II disorders.

    Ask Fintool Equity Research AI