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Seres Therapeutics Reports Second Quarter Financial Results and Provides Operational Progress Update

CAMBRIDGE, Mass., Aug 11, 2016 (BUSINESS WIRE) -- Seres Therapeutics Inc., MCRB, -3.36% a leading microbiome therapeutics platform company, today reported second quarter financial results and provided an update on multiple clinical programs, including three clinical-stage candidates addressing multiple medical indications.

“Following our announcement of initial eight-week data from our SER-109 Phase 2 study, we continue to gather further data and have begun an intense review of all available information so that we can fully understand the results, and apply our learnings to SER-109, as well as our other R&D efforts,” said Roger Pomerantz, M.D., President, CEO and Chairman of Seres. “We made important progress in advancing our multiple clinical stage programs, including our Phase 1b study of SER-287 in patients with mild-to-moderate ulcerative colitis, and our recently initiated Phase 1b study of SER-262 for primary C. difficile infection, the first synthetic microbiome therapeutic candidate to reach clinical development. We remain confident in our microbiome therapeutics approach, and we are committed to achieving our goal of developing meaningful new microbiome treatments for patients suffering from serious diseases.”

Recent Highlights and Events:

  • Interim results of SER-109 Phase 2 clinical study announced (July 2016): Seres announced 8 week results from the ongoing SER-109 Phase 2 ECOSPOR [TM] clinical study for the prevention of multiply recurrent Clostridium difficile infection (CDI). The study did not achieve its primary endpoint of reducing the relative risk of CDI recurrence at 8 weeks. Multiple sub-group analyses are being deeply analyzed to further help clarify the initial findings in this trial. The company expects to continue to gather and analyze study data throughout the coming months, and will consult with the FDA to make appropriate adjustments to its SER-109 development plans.
  • Initiation of a Phase 1b clinical trial of SER-262 (July 2016): Seres initiated a Phase 1b clinical trial evaluating SER-262 in patients with primary CDI. SER-262, an Ecobiotic®, rationally-designed, fermented microbiome therapeutic is the first synthetically-derived and designed microbiome therapeutic to reach clinical-stage development. The 24-week, randomized, placebo-controlled dose escalation study is expected to enroll approximately 60 patients who have experienced a first episode of CDI. The primary endpoint will compare the CDI recurrence rate between the SER-262 and placebo groups at up to 8 weeks after dosing. Study results are expected in 2017.
  • Ongoing progress with SER-287 Phase 1b study execution: Seres continued to advance the SER-287 Phase 1b study in subjects with mild-to-moderate ulcerative colitis. Additional study clinical sites continued to be activated and increasing numbers of study subjects were enrolled. Study results are expected in 2017.
  • Research collaboration with Mayo Clinic to identify new microbiome therapeutics for liver diseases (June 2016): The company initiated a sponsored research agreement with Mayo Clinic’s Center for Individualized Medicine focused on identifying new microbiome therapeutic candidates for liver diseases, including primary sclerosing cholangitis and non-alcoholic steatohepatitis (NASH).
  • Collaboration agreement with Massachusetts General Hospital to identify microbiome therapeutics for obesity and metabolic syndrome (June 2016): Seres will help fund a placebo-controlled, proof-of concept clinical study to evaluate the impact of fecal microbiota transplantation derived from lean individuals, on the body weight and glycemic control of adults suffering from clinically significant obesity and metabolic disorders. The company will analyze patient samples to determine metagenomics signatures, metabolic markers and other key clinical biomarkers that may inform the design of microbiome therapeutics for obesity and associated metabolic disease.
  • Collaboration with Emulate (July 2016): Seres initiated a collaboration withEmulate, Inc., a private company commercializing Organs-on-Chips technology, to further advance Emulate’s Intestine-Chip platform, a micro-engineered, living-tissue-based system that models the human intestine. Seres intends to use the technology to identify novel bacteria compositions with therapeutic potential for inflammatory bowel disease and other serious conditions

Financial Results:

Seres reported a net loss of $27.9 million for the second quarter of 2016, as compared to a net loss of $12.6 million for the same period in 2015. The increase in net loss was driven primarily by continued growth in clinical and development expenses as well as increased headcount, and ongoing development of our microbiome therapeutics platform.

Research and development expenses for the second quarter were $22.2 million, as compared to...