Core Insights - Seres Therapeutics is preparing to submit a Phase 2 study protocol for SER-155 to the FDA, targeting bloodstream infections in adults undergoing allogeneic hematopoietic stem cell transplantation (allo-HSCT) [1][4][10] - The Phase 1b study of SER-155 demonstrated a significant 77% relative risk reduction in bloodstream infections, reinforcing its potential in treating inflammatory and immune diseases [1][15] - The company is actively seeking strategic partnerships to support the development of SER-155 and expand its application to other vulnerable patient populations [3][4] Financial Performance - For Q1 2025, Seres reported a net income of $32.7 million, a significant improvement from a net loss of $32.9 million in Q1 2024, primarily due to a $50 million installment payment from Nestlé [16][25] - Research and development expenses decreased to $11.8 million in Q1 2025 from $19.5 million in Q1 2024, reflecting cost management efforts [16][25] - General and administrative expenses also declined to $11.9 million in Q1 2025 from $14.9 million in Q1 2024 [16][25] Development Updates - The upcoming Phase 2 study is expected to enroll 248 participants and will include an adaptive design with an interim analysis planned after half of the participants reach the primary endpoint [4][5] - SER-155 has received Breakthrough Therapy and Fast Track designations from the FDA, highlighting its potential to address significant unmet medical needs in the allo-HSCT patient population [15][17] - The company is exploring the use of SER-155 in additional patient populations, including those undergoing autologous-HSCT, cancer patients with neutropenia, and solid organ transplant recipients [3][17] Recent Corporate Actions - On April 21, 2025, Seres executed a 1-for-20 reverse stock split, which commenced trading on a split-adjusted basis on April 22, 2025 [7][16] - As of March 31, 2025, Seres had $58.8 million in cash and cash equivalents, which is expected to fund operations into Q1 2026 [12][16] Upcoming Milestones - The company plans to present additional SER-155 clinical results at the American Society of Clinical Oncology (ASCO) 2025 conference from May 30 to June 3, 2025 [10] - Seres anticipates receiving a $25 million installment payment from Nestlé in July 2025 [10]
Seres Therapeutics Reports First Quarter 2025 Financial Results and Provides Business Updates