Seres Therapeutics

This morning we reported Q4 and full year 2024 earnings and provided business updates. Key highlights include: ??Regulatory Discussions and Study Planning: Seres received FDA feedback supporting a Phase 2 study with a primary endpoint of BSI reduction at 30 days post-HSCT. The company plans to submit the protocol in Q2 2025, potentially as a Phase 2/3 seamless design with interim analyses. ??FDA Breakthrough Therapy Designation: In December 2024, the FDA granted Breakthrough Therapy status to SER-155 for preventing BSIs in allo-HSCT patients, expediting its development. ??Strong Phase 1b Results: In September 2024, SER-155 data showed a 77% reduction in bloodstream infections, lower systemic antibiotic use, and reduced febrile neutropenia in allo-HSCT patients. The therapy was well tolerated with no serious adverse events. ??Biomarker Data Reinforces MOA: Exploratory biomarker results further supported SER-155’s mechanism, showing improved gut barrier integrity and reduced systemic inflammation. Findings support potential expansion into inflammatory diseases like ulcerative colitis and Crohn’s disease. ??Advancing Strategic Partnership Discussions: Seres is actively seeking an external partner to help accelerate the next SER-155 study in allo-HSCT and maximize its clinical and commercial potential. We’re excited by the progress made in 2024 and are looking forward to the months ahead as we continue to progress preparation for the SER-155 study and other corporate priorities. Read more in the full release: https://lnkd.in/gDUJqYHb Check out the webcast replay: https://lnkd.in/gfEp2QVY

Tomorrow morning our team will host a conference call and live video webcast to review our Q4 and full-year 2024 financial results, along with key business updates. A webcast replay will also be available on the Seres website following the call. Check out our press release for dial-in info: https://lnkd.in/eDz_VJ38

“We’ve got the right technology, the right team, the right science to change lives, and we're in the process of doing so.” Check out this recent #JPM2025 Flagship Pioneering CEO Chat with Eric Shaff as he explains how Seres is building on its experience developing VOWST, the first-ever FDA-approved oral life biotherapeutic, as it pioneers new therapies like SER-155 to address unmet need in in?allo-HSCT. The full interview can be found here: https://lnkd.in/ej_xSteM

We’re excited to be back in San Francisco for #JPM2025! If you’re attending, don’t miss the chance to connect with the Seres Therapeutics leadership team: Eric Shaff, Marella Thorell, Terri Young, and Matthew Henn. Make sure to also mark your calendar for Thursday, January 16th, at 7:30 AM PST, when Eric will present a company overview. He’ll spotlight our plans to advance our innovative pipeline, including our lead program, SER-155. https://lnkd.in/eFRsd2_T

Today we're thrilled to announce that our lead live biotherapeutic, SER-155, has received Breakthrough Therapy Designation from the FDA for the reduction of blood stream infections in adults undergoing an allogeneic stem cell transplant. This designation ensures communication and guidance from FDA to expedite the development of medicines which are intended to treat serious or life-threatening diseases, and in which preliminary clinical evidence indicates that the drug may demonstrate substantial improvement on a clinically significant endpoint over available therapies. We look forward to working closely with the FDA in the?new year to discuss the next SER-155 clinical study, which we believe could be a single registrational study for efficacy. Read more in our latest release: https://lnkd.in/ecZMqrVS

Our CEO Eric Shaff will be participating in a fireside chat at the upcoming Piper Sandler Annual Healthcare Conference on December 3rd. Can't make it to the event? We'll also be streamlining?a live webcast through our website and will post the recording afterwards. Read the release: https://lnkd.in/gb7wJ_-q

Today we reported our Q3 financial results and provided business updates, including planned next steps for SER-155 following encouraging Phase 1b data in allo-HSCT patients. Read more in the full release: https://lnkd.in/eMfU2T7e

Today we’re pleased to share Cohort 2 data from our Phase 1b study evaluating SER-155 in patients undergoing allo-HSCT. Read the full release here: https://lnkd.in/ekKD-Tqf --- Summary of Cohort 2 Results (through day 100 post HSCT) - SER-155 was associated with a significant reduction in both bacterial bloodstream infections (BSIs) and systemic antibiotic exposure, as well as lower incidence of febrile neutropenia - SER-155 demonstrated a generally well tolerated safety profile and had confirmed drug bacteria strain engraftment; no treatment-related serious adverse events were observed - Seres will seek Breakthrough Therapy designation from the FDA and discuss plans to advance development of SER-155 in allo-HSCT.

Today we're excited to announce that we've signed the VOWST asset purchase agreement with Nestlé. The completion of the transaction, which is subject to Seres’ shareholder approval and other customary conditions, is expected to occur in the next 90 days.? ? Read the full release: https://lnkd.in/eZmJuF7y

Our team had a great time at Friday’s #BioBall event, sponsored by Special Olympics Massachusetts. Not only was it fun to get together for the afternoon, but we helped raise money to support our local #SpecialOlympics athletes! Check out the Special Olympics Massachusetts website to learn about the organization’s mission to support over 14,000 athletes with intellectual disabilities:?https://lnkd.in/e48swYSF