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]

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]

Core Insights - Seres Therapeutics, Inc. will present three related posters at the 2025 Digestive Disease Week (DDW) Conference, highlighting advancements in live biotherapeutics for inflammatory and immune diseases [1][2] Company Developments - The company previously reported exploratory translational biomarker data from its SER-155 Phase 1b study, indicating its potential to enhance intestinal epithelial barrier integrity and modulate systemic inflammatory responses [2] - Seres is actively seeking partnership opportunities to further develop its biotherapeutics targeting inflammatory and immune diseases [3] Presentation Details - The first presentation will focus on the characterization of IBD microbiomes to evaluate candidate biomarkers for patient selection, scheduled for May 3, 2025 [4] - The second presentation will discuss candidate biomarkers of microbiome disruption for patient selection in clinical trials of microbiome therapeutics in ulcerative colitis, also on May 3, 2025 [4] - An encore presentation will cover pharmacokinetic and pharmacodynamic results from a Phase 1b study of SER-155 in adults undergoing allo-HCT, set for May 4, 2025 [5] Industry Context - The Digestive Disease Week (DDW) is a significant international event in gastroenterology, showcasing nearly 6,000 abstracts and over 1,000 invited talks on the latest advances in GI research, medicine, and technology [5]

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]

Core Insights - Seres Therapeutics is advancing SER-155, a live biotherapeutic candidate aimed at preventing bloodstream infections in patients undergoing allogeneic hematopoietic stem cell transplantation (allo-HSCT), with a significant 77% relative risk reduction in bloodstream infections reported in Phase 1b studies [3][4][14] - The FDA has granted SER-155 Breakthrough Therapy designation, facilitating expedited development and communication with the agency [4][14] - The company plans to submit a draft study protocol for the next phase of SER-155 to the FDA in Q2 2025, with potential study designs being either a standalone Phase 2 or a Phase 2/3 seamless design [3][6] Financial Performance - For the full year 2024, Seres reported a net loss from continuing operations of $125.8 million, an improvement from a net loss of $190.1 million in 2023 [10][24] - Research and development expenses decreased to $64.6 million in 2024 from $117.6 million in 2023, reflecting a strategic focus on SER-155 [10][24] - The company had $30.8 million in cash and cash equivalents as of December 31, 2024, and expects to fund operations into Q1 2026 based on current cash and anticipated payments from Nestlé [11][10] Strategic Developments - Seres is in discussions for strategic partnerships to accelerate the development of SER-155 and explore its application in other high-risk patient populations [3][6] - The company has identified significant market opportunities for SER-155, with an estimated 9,300 allo-HSCT procedures conducted annually in the US and approximately 20,000 in Europe [6][10] - The recent exploratory biomarker data from the Phase 1b study supports the therapeutic mechanisms of SER-155 and its potential to address inflammatory and immune diseases [6][10] Corporate Updates - In September 2024, Seres sold its VOWST business to Nestlé for approximately $175 million, which included an upfront payment and future milestone payments based on sales [5][7] - The company appointed Dr. Hans-Juergen Woerle as a director, fulfilling rights granted to Nestlé as part of their investment in Seres [7] - Seres plans to present SER-155 data at upcoming medical meetings to engage with potential European investigators [10]

Core Insights - The FDA has provided constructive feedback on Seres Therapeutics' SER-155 development plans, supporting a Phase 2 study with a primary efficacy endpoint focused on reducing bloodstream infections (BSIs) post-allo-HSCT [1][2][4] - Seres Therapeutics plans to submit a proposed protocol for the next SER-155 study to the FDA in Q2 2025, incorporating the agency's feedback [1][2] - SER-155 has shown a 77% relative risk reduction in BSIs in a Phase 1b study, along with reduced systemic antibiotic exposure and lower incidence of febrile neutropenia [2][4] Company Overview - Seres Therapeutics, Inc. is a clinical-stage company focused on live biotherapeutics aimed at improving outcomes for medically vulnerable populations [5] - The company has received Breakthrough Therapy designation for SER-155, targeting the reduction of BSIs in allo-HSCT patients, and Fast Track designation for reducing infection risk and graft-versus-host disease [5][4] - SER-155 is designed to decolonize gastrointestinal pathogens and improve immune tolerance in patients undergoing allo-HSCT for hematological malignancies [3][5] Future Development Plans - The next study design for SER-155 may retain elements from the previous Phase 1b trial, which demonstrated significant clinical benefits [2][4] - The company is actively seeking partnerships to support the further development of SER-155 in allo-HSCT [2]