Seres Therapeutics(US:MCRB)2025-06-25 11:20SER-155 Clinical Data and Development - SER-155 Phase 1b study showed a 77% relative risk reduction in bacterial bloodstream infections (BSIs) compared to placebo[6,44,83] - SER-155 treatment was associated with significantly lower mean cumulative exposure to systemic antibacterials/antimycotics compared to placebo[44,49] - The company plans to submit a Phase 2 protocol to the FDA in Q2 2025, incorporating FDA feedback[6,31,73,83] - The FDA granted SER-155 Breakthrough Therapy designation in December 2024[6,73,82] Financial Position and Strategy - The VOWST asset sale to Nestlé closed in September 2024, providing capital to support SER-155 advancement[6,9,10,12,83] - The VOWST asset sale included a $100 million upfront payment, less ~$20 million in net obligations, a $15 million equity investment, and a $60 million prepaid sales-based milestone at closing[10] - As of March 31, 2025, the company had approximately $588 million in cash/cash equivalents, projecting a cash runway into Q1 2026[83] - The company is pursuing a strategic partnership for SER-155 to accelerate the next study in allo-HSCT and expand to multiple target populations[6,73,83] Pipeline and Platform - VOWST was FDA approved in April 2023 to prevent the recurrence of C difficile infection in adults, demonstrating an approximately 88% sustained clinical response rate[6,9] - SER-155 is being developed initially in allo-HSCT, with potential to expand to autologous-HSCT, blood cancers, and CAR-T recipients[6,30] - SER-147 is designed to prevent infections in chronic liver disease, with IND-enabling activities underway[6,30,74,82]