Core Insights - Seres Therapeutics is finalizing the Phase 2 study protocol for SER-155 aimed at preventing bloodstream infections in adults undergoing allogeneic hematopoietic stem cell transplant, following positive feedback from the FDA [1][2][3] - The company is actively seeking funding to support the Phase 2 study, with interim clinical results expected within 12 months of study initiation [1][2][3] - Cost-reduction measures have been implemented, and the company anticipates funding operations through Q2 2026 based on current plans [2][3][9] SER-155 Development - SER-155 has received Breakthrough Therapy designation and is expected to enroll approximately 248 participants in the Phase 2 study, which will include an adaptive design and interim data analysis [3][12] - Positive results from the Phase 2 study could lead to a significant value-creating event for the company and its shareholders, potentially advancing to a Phase 3 trial [2][3] - An ongoing investigator-sponsored study at Memorial Sloan Kettering Cancer Center is expected to provide insights into SER-155's broader therapeutic potential, with initial results anticipated in early 2026 [2][7] Financial Performance - For Q3 2025, Seres reported a net income of $8.2 million, a significant improvement from a net loss of $51.0 million in Q3 2024, primarily due to a gain on the sale of VOWST [8][20] - Research and development expenses decreased to $12.6 million in Q3 2025 from $16.5 million in Q3 2024, reflecting cost-reduction efforts [8][20] - As of September 30, 2025, the company had $47.6 million in cash and cash equivalents, expecting to fund operations through Q2 2026 [9][20] Strategic Initiatives - The company is exploring various deal structures to leverage its expertise in live biotherapeutics, as demonstrated by the successful development of VOWST [3] - Seres is also investigating potential partnerships to advance the development of its biotherapeutics targeting inflammatory and immune diseases, including ulcerative colitis and Crohn's disease [7]

Core Insights - Seres Therapeutics, Inc. will host a conference call on November 5, 2025, at 8:30 a.m. ET to discuss Q3 2025 financial results and business updates [1][2] Company Overview - Seres Therapeutics is a clinical-stage company focused on improving patient outcomes in medically vulnerable populations through novel live biotherapeutics [3] - The company developed VOWST™, the first FDA-approved orally administered microbiome therapeutic, which was sold to Nestlé Health Science in September 2024 [3] - Seres is developing SER-155, which has received Breakthrough Therapy designation for reducing bloodstream infections in adults undergoing allo-HSCT and Fast Track designation for reducing infection risk and graft-versus-host disease in the same patient group [3] - SER-155 demonstrated a significant reduction in bloodstream infections and related complications compared to placebo in a Phase 1b clinical study [3] - The company plans to evaluate SER-155 and other cultivated live biotherapeutic candidates in various medically vulnerable populations, including autologous-HSCT patients, cancer patients with neutropenia, CAR-T recipients, and solid organ transplant recipients [3]

Core Insights - Seres Therapeutics has received up to $3.6 million in non-dilutive funding from CARB-X to support the development of an oral liquid formulation of SER-155, aimed at improving access for medically vulnerable patients, particularly those in intensive care who cannot take oral capsules [1][3][5] - SER-155 is being developed for patients undergoing allogeneic hematopoietic stem cell transplants (allo-HSCT) and has shown a 77% reduction in bacterial bloodstream infections (BSIs) compared to placebo in a Phase 1b study [2][5] - The development of a liquid formulation is expected to broaden the impact of SER-155 in additional high-risk patient populations susceptible to BSIs and antimicrobial resistant infections [3][5] Funding and Support - CARB-X, a global non-profit partnership, is providing funding to accelerate the development of antibacterial products, specifically targeting drug-resistant bacteria [1][4] - The funding is supported by various federal and international health organizations, including the U.S. Department of Health and Human Services and the UK Department of Health and Social Care [3][4] Clinical Development - SER-155 has received Breakthrough Therapy designation and Fast Track designation from the FDA, indicating its potential to significantly reduce the risk of infections in allo-HSCT patients [5][6] - The company is finalizing the clinical protocol for a well-powered, placebo-controlled Phase 2 study following positive feedback from the FDA [2][5] Company Background - Seres Therapeutics is focused on improving outcomes for medically vulnerable populations through live biotherapeutics and has previously developed VOWST™, the first FDA-approved orally administered microbiome therapeutic [5][6] - The company aims to evaluate SER-155 in various patient populations, including those undergoing autologous-HSCT, cancer patients with neutropenia, and patients in intensive care [6]

Core Insights - Seres Therapeutics, Inc. announced new post hoc data from its SER-155 Phase 1b trial, which will be presented at IDWeek 2025 [1] - SER-155 demonstrated a 77% reduction in bloodstream infections (BSIs) in patients undergoing allogeneic hematopoietic stem cell transplant (allo-HSCT) [3] - The company received positive FDA feedback for a Phase 2 study design of SER-155 and is finalizing the clinical protocol [4] Presentation Details - The presentation will cover clinical and microbiology outcomes of BSIs in adults undergoing allo-HCT, including differences in bacterial and fungal organisms between SER-155 and placebo groups [2] - The session is scheduled for October 20, 2025, at 10:30-10:42 am EDT [2] Company Background - Seres Therapeutics focuses on live biotherapeutics to improve outcomes in medically vulnerable populations [6] - The company developed VOWST™, the first FDA-approved orally administered microbiome therapeutic, sold to Nestlé Health Science in September 2024 [6] - SER-155 has received Breakthrough Therapy and Fast Track designations for its potential in reducing infections and complications in allo-HSCT patients [6]

Core Insights - Seres Therapeutics, Inc. is a clinical-stage company focused on live biotherapeutics aimed at improving patient outcomes in medically vulnerable populations [2] - The company will present an overview at the H.C. Wainwright Global Investment Conference on September 8, 2025 [1] Company Overview - Seres Therapeutics is known for developing VOWST™, the first FDA-approved orally administered microbiome therapeutic, which was sold to Nestlé Health Science in September 2024 [2] - The company is currently developing SER-155, which has received Breakthrough Therapy designation for reducing bloodstream infections in adults undergoing allo-HSCT and Fast Track designation for reducing infection risk and graft-versus-host disease in the same patient group [2] - SER-155 has shown a significant reduction in bloodstream infections and related complications compared to placebo in a Phase 1b clinical study [2] Pipeline and Future Plans - The company’s pipeline includes SER-155 and other cultivated live biotherapeutic candidates targeting various disease-relevant pathways [2] - In addition to allo-HSCT, SER-155 and other candidates will be evaluated in other medically vulnerable populations, including autologous-HSCT patients, cancer patients with neutropenia, CAR-T recipients, individuals with chronic liver disease, solid organ transplant recipients, and patients in intensive care and long-term acute care facilities [2]

Core Insights - Seres Therapeutics, Inc. will host a conference call on August 6, 2025, at 8:30 a.m. ET to discuss its second quarter 2025 financial results and provide business updates [1][2] Company Overview - Seres Therapeutics is a clinical-stage company focused on improving patient outcomes in medically vulnerable populations through novel live biotherapeutics [3] - The company successfully developed and approved VOWST™, the first FDA-approved orally administered microbiome therapeutic, which was sold to Nestlé Health Science in September 2024 [3] - Seres is developing SER-155, which has received Breakthrough Therapy designation for reducing bloodstream infections in adults undergoing allo-HSCT and Fast Track designation for reducing the risk of infection and graft-versus-host disease in the same patient population [3] - SER-155 demonstrated a significant reduction in bloodstream infections and related complications compared to placebo in a Phase 1b clinical study [3] - The company plans to evaluate SER-155 and other cultivated live biotherapeutic candidates in various medically vulnerable patient populations, including autologous-HSCT patients, cancer patients with neutropenia, CAR-T recipients, individuals with chronic liver disease, solid organ transplant recipients, and patients in intensive care units and long-term acute care facilities [3]

Core Insights - Seres Therapeutics has appointed Thomas DesRosier and Marella Thorell as co-CEOs, succeeding Eric Shaff who will remain a Director on the Board [1][3] - The company is actively engaging with multiple parties for potential business development and partnerships to secure additional capital for the advancement of SER-155 and other live biotherapeutic candidates [1][2] Leadership Transition - Eric Shaff is stepping down after a decade, during which he led significant advancements including the first FDA-approved oral microbiome therapy [3] - Thomas DesRosier and Marella Thorell bring extensive experience in biopharma, with DesRosier previously serving as Chief Legal Officer and Thorell as Chief Financial Officer [4][6] Product Development - SER-155 has received Breakthrough Therapy designation for reducing bloodstream infections in adults undergoing allo-HSCT, showing a 77% relative risk reduction in a Phase 1b study [2][7] - The company aims to leverage its live biotherapeutics platform to address various inflammatory and immune diseases, including ulcerative colitis and Crohn's disease [2][7] Strategic Focus - Seres is focused on advancing its pipeline, particularly SER-155, and is exploring various deal structures to enhance its capital resources [2][7] - The company intends to evaluate SER-155 in other medically vulnerable populations, including cancer patients and organ transplant recipients [7]

Core Insights - Seres Therapeutics is presenting new exploratory biomarker data from its SER-155 Phase 1b study at the 2025 ASCO Annual Meeting, highlighting its potential role in promoting peripheral T-cell recovery and immune reconstitution post allo-HSCT [1][2] Group 1: SER-155 Study Findings - The SER-155 Phase 1b study showed improved intestinal epithelial barrier integrity and modulation of systemic inflammatory responses, with a 77% relative risk reduction in bloodstream infections (BSIs) [2][5] - New biomarker data indicates significantly higher levels of the homeostatic cytokine IL-7 and increased frequency of CD4+ T cells in the SER-155 treatment group compared to placebo, suggesting enhanced immune recovery [2][3] Group 2: Clinical Development Plans - The company plans to submit a Phase 2 trial protocol for SER-155 to the FDA soon and is seeking partners for continued clinical development [3] - SER-155 has received Breakthrough Therapy designation for reducing bloodstream infections and Fast Track designation for reducing infection risk and graft-versus-host disease in allo-HSCT patients [5][6] Group 3: About SER-155 - SER-155 is an investigational oral live biotherapeutic designed to decolonize gastrointestinal pathogens, improve epithelial barrier integrity, and induce immune homeostasis to prevent bacterial bloodstream infections in allo-HSCT patients [4][6] - The product has demonstrated a significant reduction in bloodstream infections and related complications in a Phase 1b clinical study [6]

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]

Company Overview - Seres Therapeutics, Inc. (Nasdaq: MCRB) is a clinical-stage company focused on improving patient outcomes in medically vulnerable populations through novel live biotherapeutics [4] - The company successfully developed and approved VOWST™, the first FDA-approved orally administered microbiome therapeutic, which was sold to Nestlé Health Science in September 2024 [4] - Seres is developing SER-155, which has received Breakthrough Therapy designation for reducing bloodstream infections in adults undergoing allo-HSCT and Fast Track designation for reducing the risk of infection and graft-versus-host disease in the same patient population [4] Clinical Developments - SER-155 has demonstrated a significant reduction in bloodstream infections and related complications compared to placebo in a Phase 1b clinical study involving patients undergoing allo-HSCT [4] - The company plans to evaluate SER-155 and other cultivated live biotherapeutic candidates in various medically vulnerable patient populations, including autologous-HSCT patients, cancer patients with neutropenia, CAR-T recipients, individuals with chronic liver disease, solid organ transplant recipients, and patients in intensive care units and long-term acute care facilities [4] Upcoming Events - Management will host a conference call and live audio webcast on May 7, 2025, at 8:30 a.m. ET to discuss first quarter 2025 financial results and provide business updates [1] - Access to the conference call can be made by dialing 800-715-9871 (domestic) or 646-307-1963 (international) with conference ID number 4618787 [2] - A webcast replay will be available on the Seres website approximately two hours after the event and will be archived for about 21 days [3]