Seres Therapeutics (MCRB) investor relations material

Key technology and platform advancements

• Developed a novel drug technology using consortia of bacteria, leading to the first FDA-approved oral microbiome drug with an 88% sustained response for C. difficile recurrence.

• Integrated generative AI into the MbTx platform to optimize drug design and clinical trial planning, leveraging extensive clinical and preclinical datasets.

• AI tools are now improving target identification, patient stratification, and mechanistic understanding across the pipeline.

• The platform supports discovery through manufacturing, enabling rapid progression from concept to commercialization.

Pipeline progress and clinical milestones

• SER-155, a phase II-ready asset with breakthrough therapy designation, targets bloodstream infections in allo-HSCT patients and showed a 77% reduction in infection risk in phase Ib.

• An investigator-sponsored study in immune-related enterocolitis (irEC) is set to read out within weeks, aiming to address a major adverse event in ICI-treated cancer patients.

• Early-stage programs include IND-enabling studies for antimicrobial-resistant infections and inflammatory bowel disease (IBD).

• The IBD program has received support from the Crohn's & Colitis Foundation and recognition at a major GI conference.

Strategic priorities and commercial outlook

• Near-term focus is on partnering SER-155, achieving interim analysis, and securing expedited FDA development pathways.

• Positive irEC data could validate the platform and support further clinical development and partnerships.

• Commercialization of VOWST by Nestlé demonstrates viability of live biotherapeutics, though specific sales data are not disclosed.

• Ongoing efforts to aggregate capital and secure funding for clinical advancement and expansion.