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SEC Filings

8-K
SERES THERAPEUTICS, INC. filed this Form 8-K on 11/08/2018
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EX-99.1

Exhibit 99.1

 

LOGO

Seres Therapeutics Reports Third Quarter Financial Results and Provides Operational Updates

-        Kevin Horgan, M.D. an accomplished drug developer and immunology expert, hired as Chief Medical Officer        -

-        Planning for two new microbiome clinical studies in ulcerative colitis and metastatic melanoma; Company expects to receive $40M in payments from Nestlé Health Science with SER-287 Phase 2b study start        -

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

CAMBRIDGE, Mass., November 8, 2018 Seres Therapeutics, Inc. (NASDAQ:MCRB) today reported third quarter 2018 financial results and provided an operational update.

“Based on a growing body of promising clinical data and preclinical data from our laboratories and others, Seres has increased its strategic focus toward immunology and immuno-oncology, and we are very pleased to have hired Kevin Horgan, M.D., an expert in these key areas, as our new Chief Medical Officer. Kevin has led the development and approval of numerous important drugs, and he has an ideal background to drive the Company’s clinical programs forward,” said Roger J. Pomerantz, M.D., President, CEO and Chairman of Seres. “Seres has also been working to expedite data read outs from the ongoing SER-109 clinical study for recurrent C. difficile infection, and the soon-to-be initiated SER-287 Phase 2b study for ulcerative colitis. In addition, Seres and our collaborators at MD Anderson Cancer Center and the Parker Institute for Cancer Immunotherapy have taken significant steps to advance our SER-401 immuno-oncology program toward the clinic.”

Recent Highlights and Events

 

   

SER-109 ECOSPOR III Phase 3 Study: Enrollment for ECOSPOR III remains ongoing with approximately 100 clinical sites open across the U.S. and Canada. Study enrollment has been impacted by the widespread availability of unapproved fecal microbiota transplantation. The Company is considering alternatives, including study design modification, to expedite the availability of clinical results. Based on ECOSPOR III screening to date, 38% of subjects screened have had a negative C. difficile toxin test, despite having a positive C. difficile PCR test. In agreement with recent clinical guidelines, these subjects were deemed to not have an active C. difficile infection and were not eligible for study inclusion. These data provide additional support for our important requirement of a positive toxin test implemented in ECOSPOR III, and suggest that C. difficile clinical studies relying on PCR-based testing alone may include a significant proportion of subjects without active disease.


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