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SERES THERAPEUTICS, INC. filed this Form 8-K on 03/06/2019
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Seres Therapeutics Reports Fourth Quarter and Full Year Financial Results and

Provides Operational Updates

- Initiated SER-287 Phase 2b study in mild-to-moderate ulcerative colitis -

- Initiated SER-401 Phase 1b study in metastatic melanoma -

- Conference call at 8:30 a.m. ET today -

CAMBRIDGE, Mass., March 6, 2019Seres Therapeutics, Inc. (Nasdaq: MCRB) today reported fourth quarter and full year 2018 financial results and provided an operational update.

“This has been a highly eventful period where we advanced our microbiome clinical programs and implemented a more focused R&D strategy. During the last several months, we initiated two clinical studies and implemented corporate changes to concentrate resources on the highest priority programs,” said Eric Shaff, President and Chief Executive Officer of Seres Therapeutics. “Seres is working to expeditiously progress our ongoing clinical studies to data read outs while also advancing our next generation, rationally-designed, fermented microbiome drug discovery capabilities centered on SER-301 for ulcerative colitis. We expect to complete SER-287 Phase 2b study enrollment by mid-2020 and obtain SER-401 Phase 1b study results in 2020. We continue to evaluate design options around our SER-109 Phase 3 study in order to expedite trial results.”

Seres also announced today the initiation of a SER-401 Phase 1b study in patients with metastatic melanoma. SER-401 is an oral microbiome therapeutic candidate sourced from healthy individuals identified to have a microbiome bacterial signature similar to that observed in immunotherapy responders. The Phase 1b study, conducted in collaboration with The University of Texas MD Anderson Cancer Center and the Parker Institute for Cancer Immunotherapy, will evaluate the potential for SER-401 to augment response to anti-PD-1 checkpoint inhibitor therapy. The study is designed to enroll 30 patients, who will receive the FDA-approved anti-PD-1 inhibitor nivolumab and will be randomized 2:1 to receive either SER-401 or placebo. The study will evaluate safety, impact on the gastrointestinal microbiome and various clinical and immunological outcome measures.

Recent Highlights and Events



SER-109 Phase 3 study progress: Seres continues to recruit patients into the SER-109 Phase 3 study for recurrent C. difficile infection. The widespread use of fecal microbiota transplantation, an unapproved and uncontrolled practice, has impacted the enrollment rate of this placebo-controlled clinical trial. Seres is evaluating modification of the study design to expedite clinical results.

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