Seres Therapeutics, Inc. announced receipt of additional constructive feedback from the U.S. Food and Drug Administration (FDA) on the Phase 2 study protocol for its lead program, SER-155. This feedback is expected to support the finalization of the protocol for the prevention of bloodstream infections (BSIs) in adults undergoing allogeneic hematopoietic stem cell transplant (allo-HSCT).
The planned SER-155 Phase 2 study is designed as a well-powered, placebo-controlled trial, evaluating BSI prevention through 30 days post allo-HSCT as its primary endpoint. It includes a planned interim analysis when approximately half of the 248 enrolled participants reach the primary endpoint, with interim clinical results anticipated within 12 months of study initiation.
In conjunction with streamlining operations, Seres is reducing its workforce by approximately 25%, including reductions effective in August 2025. These cost reduction actions, combined with current operating plans, are expected to extend the company's cash runway well into the second quarter of 2026. The workforce reduction is projected to result in cash payments of approximately $1.0 million to $1.4 million, primarily for severance costs, to be paid in the fourth quarter of 2025. The company continues to engage in active discussions to secure capital and other resources to advance the SER-155 Phase 2 study and its broader portfolio.
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