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Seres Therapeutics (MCRB) guidance and outlook

Seres Therapeutics' 10-Q filed Nov 4, 2026 makes 36 forward-looking statements.

Guidance and outlook

Forward-looking statements, 10-Q filed Nov 4, 2026

• We have established field-leading capabilities and platforms that are powered by best-in-field human data sets to advance a portfolio of products that can uniquely address diseases by targeting host pathways that are modulated by microbes in the human body, and, in particular, diseases associated with mucosal epithelial barrier-immune interface targets.
• We believe clinical and nonclinical data across our programs support the development of LBPs to address unmet medical needs in oncology that can lead to interruption to patients' cancer treatment and/or mortality (by targeting the prevention and treatment of a broad swath of infection risks faced by cancer patients and by treating irEC), and to treat I&I diseases.
• We plan to advance SER-155 into a next study in irEC evaluating prophylactic oral administration and dose optimization in patients initiating ICI cancer therapy.
• As part of the development program, we intend to engage with FDA to discuss study design and potential endpoints including incidence of irEC (all grades), ICI administration and safety.
• In addition, we intend to seek feedback from FDA on our plans to optimize dosing for prophylaxis, which could include a healthy volunteer study component or a dosing lead-in element, the results of which are expected to inform the prophylactic dosing course before initiating dosing in the broader ICI population.
• We expect to submit the study design to the FDA in the first quarter of 2027.
• The clinical data from our SER-155 Phase 1b study in allo-HCT and the IST in irEC, in particular the drug pharmacology translational biomarker data, along with our extensive preclinical and translational clinical data compiled over the past decade support and inform the advancement of our earlier stage programs targeting I&I diseases and our current strategy continues to prioritize these indications.
• We continue to leverage microbiome pharmacokinetic and pharmacodynamic data from across our clinical and preclinical portfolios, using our reverse translational development platform to prioritize future drug targets and to identify opportunities for monotherapy treatment and in combination with existing therapies across various indications, including inflammatory and immune diseases, cancer, and metabolic diseases.
• We plan to focus our investment in the near-term on advancing our early-stage live biotherapeutic candidates, including advancing IND-enabling studies for SER-603, evaluating the next stage of development for SER-155 in irEC, and, subject to receiving additional funding, progressing the development of SER-155 into a Phase 2 study in allo-HCT.
• We expect to incur losses for the foreseeable future and may never achieve or maintain profitability. ”
• In addition, if we obtain marketing approval for any of our product candidates, we expect to incur costs related to product manufacturing and commercialization, including marketing, sales and distribution.
• Furthermore, we expect to continue to incur additional costs associated with operating as a public company.

Seres Therapeutics' latest quarter

Questions

What does Seres Therapeutics expect?

We have established field-leading capabilities and platforms that are powered by best-in-field human data sets to advance a portfolio of products that can uniquely address diseases by targeting host pathways that are modulated by microbes in the human body, and, in particular, diseases associated with mucosal epithelial barrier-immune interface targets. We believe clinical and nonclinical data across our programs support the development of LBPs to address unmet medical needs in oncology that can lead to interruption to patients' cancer treatment and/or mortality (by targeting the prevention an

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Updated Nov 8, 2026. Read automatically from SEC filings and public data; errors are possible. Not investment advice.