Seres Therapeutics Inc Stock Price, News & Analysis

Seres Therapeutics (MCRB) has received FDA feedback on its SER-155 development strategy for allogeneic hematopoietic stem cell transplant (allo-HSCT) patients. The FDA supported using reduction in bloodstream infections at 30 days post-HSCT as the primary endpoint for the next study, recommending it be a Phase 2 trial.

The company is considering either a Phase 2 or a Phase 2/3 design for operational efficiency and plans to submit the protocol to FDA in Q2 2024. The upcoming study will build on the successful Phase 1b Cohort 2 trial, which demonstrated a 77% relative risk reduction in bloodstream infections, reduced systemic antibiotic exposure, and lower febrile neutropenia incidence.

Seres is actively seeking a development partner for SER-155 in allo-HSCT and awaits additional FDA feedback on submitted clarification questions.

Seres Therapeutics (MCRB) has received a $50 million installment payment from Nestlé Health Science, related to the previously announced sale of its VOWST business. This payment was received as planned, with Seres meeting its transition obligations. The company anticipates an additional $25 million installment payment (less approximately $1.5M in employment-related payments) from Nestlé Health Science in July 2025. Based on current cash position, including these payments and considering transaction-related obligations and operating plans, Seres expects to maintain operational funding into the first quarter of 2026.

Seres Therapeutics (MCRB) announced new biomarker results from its SER-155 Phase 1b study in allogenic stem cell transplantation patients. The data showed statistically significant improvements in epithelial barrier integrity and decreased systemic inflammatory biomarkers compared to placebo, supporting the previously reported 77% reduction in bloodstream infections.

The company received FDA Breakthrough Therapy designation for SER-155 in December 2024 and expects agency feedback on its next registrational study this quarter. Market research with healthcare professionals and payers confirmed high unmet need and strong value proposition for SER-155 in preventing bloodstream infections.

Financially, Seres had approximately $31 million in cash as of December 31, 2024, and expects to receive about $75 million in installment payments from Nestlé Health Science in 2025. The company projects its cash runway to extend into Q1 2026 and is actively seeking partnerships to advance SER-155 development.

Seres Therapeutics (MCRB) announced its participation in the 43rd Annual J.P. Morgan Healthcare Conference, where CEO Eric Shaff will present on January 16, 2025. The presentation will focus on the company's biotherapeutics pipeline, particularly SER-155, which recently received FDA Breakthrough Therapy designation for reducing bloodstream infections in adults undergoing allogeneic hematopoietic stem cell transplant.

The Phase 1b study results showed SER-155 achieved a 77% relative risk reduction in bloodstream infections, significant reduction in antibiotic exposure, and lower febrile neutropenia incidence. Seres is actively seeking partners to explore SER-155's development for additional vulnerable populations, including autologous-HSCT patients, cancer patients, CAR-T recipients, and others.

Seres Therapeutics (MCRB) announced FDA Breakthrough Therapy designation for SER-155, targeting bloodstream infections in adults undergoing allogeneic hematopoietic stem cell transplant. Phase 1b clinical data showed a 77% relative risk reduction in bacterial bloodstream infections versus placebo, with significantly reduced antibiotic exposure (9.2 vs 21.1 days).

The treatment demonstrated positive safety profile with no treatment-related serious adverse events. A Breakthrough Therapy meeting with FDA is expected in Q1 2025. The company is seeking strategic partnerships to accelerate development and expand to multiple target populations beyond the current ~40,000 worldwide allo-HSCT patients.

Seres Therapeutics (Nasdaq: MCRB) has announced its participation in the Piper Sandler 36th Annual Healthcare Conference. President and CEO Eric Shaff will engage in a fireside chat on December 3, 2024, at 4:30 p.m. ET. The event will be accessible via live webcast through the company's website under the 'Events and Presentations' tab in the 'Investors and News' section, with replay available after the event.

Seres Therapeutics (MCRB) reported Q3 2024 results highlighting positive clinical data for SER-155, showing a 77% reduction in bloodstream infections in patients undergoing allo-HSCT compared to placebo. The company completed the VOWST™ sale to Nestlé Health Science for approximately $175M upfront, with additional installment payments of $75M expected in 2025 and potential milestone payments up to $275M. Q3 saw a net loss from continuing operations of $51M, while reporting net income from discontinued operations of $139.8M. With current cash position and projected payments, Seres expects to fund operations into Q4 2025.

Seres Therapeutics (Nasdaq: MCRB) announced it will host a conference call and live audio webcast on November 13, 2024 at 8:30 a.m. ET to discuss third quarter 2024 financial results and provide business updates. Participants can access the call by dialing 800-715-9871 (domestic) or 646-307-1963 (international) with conference ID 5051385. A webcast replay will be available on the company's website for approximately 21 days after the event.

Seres Therapeutics (Nasdaq: MCRB) has completed the sale of its VOWST business to Nestlé Health Science, strengthening its financial position and focusing on developing novel live biotherapeutics for high-risk patient populations. The transaction provides $175M in gross proceeds, with additional future payments expected. This extends Seres' cash runway into Q4 2025.

The company plans to advance SER-155, which showed promising results in reducing bloodstream infections and antibiotic exposure in allogeneic HSCT patients. Seres will also evaluate SER-155 for other at-risk populations and develop SER-147 for chronic liver disease patients.

The deal results in a streamlined organization, reducing headcount from 200 to 100, and retiring all debt. Seres is considering both internal development and partnerships to maximize value creation in multiple target populations.