Core Insights - Seres Therapeutics is advancing its SER-155 Phase 2 study protocol for preventing bloodstream infections in adults undergoing allogeneic hematopoietic stem cell transplant, following positive feedback from the FDA [1][2][4] - The company is actively seeking capital to support the Phase 2 study and has implemented cost-reduction measures, including a 25% workforce reduction, to extend its cash runway into Q2 2026 [2][3][5] Company Developments - The SER-155 Phase 2 study is designed to be a placebo-controlled trial with approximately 248 participants, focusing on the prevention of bloodstream infections through 30 days post-transplant as the primary endpoint [4][7] - Interim clinical results are expected within 12 months of study initiation, which will facilitate timely engagement with the FDA regarding a potential Phase 3 study [4][7] - The company has received Breakthrough Therapy designation for SER-155, which has shown a 77% relative risk reduction in bloodstream infections in a prior Phase 1b study [7][8] Financial and Operational Strategy - The workforce reduction is expected to incur cash payments of approximately $1.0 to $1.4 million, primarily for severance costs, to be paid in Q4 2025 [5] - Cost-saving initiatives are anticipated to provide the company with additional opportunities to advance its strategic priorities and support its broader portfolio of product candidates [3][4]
Seres Therapeutics Announces Further Constructive Feedback from FDA on SER-155 Phase 2 Study Protocol and Implements Cost Reduction Actions to Extend Cash Runway