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]