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    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 • Q4 2024

    Question

    Caroline Kimberly Pocher from JPMorgan Chase & Co., on behalf of Tessa Romero, asked how the recent FDA feedback on SER-155 aligned with the company's expectations, why the FDA recommended a Phase II study, and what the key differences would be between a standalone Phase II and a seamless Phase II/III trial design.

    Answer

    Eric Shaff, President and CEO, characterized the FDA feedback as constructive and robust, noting that the Breakthrough Therapy designation signals the agency's recognition of the high unmet need. Lisa von Moltke, CMO, elaborated that the primary difference with a seamless Phase II/III study is the requirement to prespecify and finalize more details upfront, which can take longer. She suggested the FDA's recommendation for more data is reasonable given the relatively small dataset from the initial Phase Ib study.

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    Caroline Kimberly Pocher's questions to Seres Therapeutics Inc (MCRB) leadership • Q3 2024

    Question

    Caroline Kimberly Pocher, on behalf of Tessa Romero, inquired about the profile of an ideal partner for SER-155, the targeted terms and timeline for a partnership, and the company's contingency plan if a deal does not materialize.

    Answer

    President and CEO Eric Shaff stated that an ideal partner would provide both capital and capabilities, such as global clinical trial expertise, to accelerate development. He emphasized the importance of aligned values and vision. While declining to provide a specific timeline, he confirmed Seres is proceeding with necessary study preparations. Shaff underscored that the company's primary focus is on securing a partnership and did not detail alternative steps.

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