Phase 2 study design and adaptive design, partnership discussions and timeline, primary endpoint and study objectives, partnership discussions and gating items, phase 2 study design and focus are the key contradictions discussed in
Therapeutics' latest 2025Q1 earnings call.
SER-155 Development and Partnership:
-
is advancing SER-155 into the next stage of development in allo-HSCT, with the aim to initiate the next clinical study.
- The Phase 1b study showed a 77% relative risk reduction in bloodstream infections compared to placebo, with a favorable safety profile. The company is seeking a partnership that can provide financial support to move SER-155 forward and achieve the next clinical data milestone.
Clinical Progress and Regulatory Engagement:
- Seres reported encouraging clinical and mechanistic data, including improved biomarker results, supporting SER-155's potential in addressing inflammatory and immune diseases.
- The company has had constructive interactions with the FDA, and has received feedback for a standalone Phase 2 study, with a well-powered, placebo-controlled design.
Financial Overview and Cash Runway:
- Seres reported
net income from continuing operations of
$32.7 million in Q1 2025, driven primarily by a
$50 million installment payment from Nestle.
- The company has a cash balance of
$58.8 million and expects to fund operations into the first quarter of 2026, pending receipt of an anticipated
$23.5 million installment payment from Nestle in July.
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