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Seres Therapeutics (MCRB) Reports Second Quarter 2017 Financial Results And Provides Update On Operational Progress



8/3/2017 7:12:00 AM

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CAMBRIDGE, Mass.--(BUSINESS WIRE)--Seres Therapeutics, Inc. (NASDAQ:MCRB) today reported second quarter 2017 financial results and provided a progress update on multiple microbiome clinical programs, including three clinical-stage therapeutic candidates seeking to address serious human diseases.

Seres continues to make excellent progress advancing our pipeline of clinical stage microbiome therapeutic candidates, and we believe we are on track to develop SER-109 as the first FDA-approved microbiome product,” said Roger J. Pomerantz, M.D., President, CEO and Chairman of Seres. “We recently initiated the SER-109 Phase 3 study in patients with multiply recurrent C. difficile infection and are working with alacrity to enroll the study. This Phase 3 study is the first pivotal trial of a microbiome drug candidate in this new field of medicine. We have also now fully enrolled our Phase 1b study of SER-287, the first microbiome therapeutic candidate for a chronic disease, in patients with mild-to-moderate ulcerative colitis, who are failing first line therapy, and are looking forward to obtaining microbiome and clinical data from the SER-287 trial in the second half of 2017.”

Recent Highlights and Events

  • SER-109 ECOSPOR III Phase 3 study initiation: Seres has initiated a SER-109 Phase 3 clinical study (ECOSPOR III), designed to enroll approximately 320 patients with multiply recurrent Clostridium difficile (C. difficile) infection, at sites in both the U.S. and Canada. Based on interactions with the U.S. Food and Drug Administration (FDA), ECOSPOR III has been designated a Phase 3 trial and the Company expects that this single pivotal study may support SER-109 registration and approval, for this Breakthrough Therapy- and Orphan Drug- designated drug candidate. Study participants are randomized 1:1 between SER-109 and placebo. Diagnosis of C. difficile infection for both study entry and for endpoint analysis is being confirmed by C. difficile cytotoxin assay. Patients in the SER-109 arm receive a total SER-109 dose, administered over three days, approximately 10-fold higher than the dose used in the prior Phase 2 ECOSPOR study. ECOSPOR III will evaluate patients for 24 weeks, and the primary endpoint will compare the C. difficile recurrence rate in subjects who receive SER-109 versus placebo at up to eight weeks after dosing.
  • SER-287 Phase 1b study fully enrolled: Seres completed enrollment of its ongoing SER-287 Phase 1b clinical study of 58 patients suffering from mild-to-moderate ulcerative colitis who are failing current first line therapies. SER-287 is a biologically sourced Ecobiotic® microbiome therapeutic candidate with the potential to offer ulcerative colitis patients a novel, non-immunosuppressive treatment option. Top line study results are expected in the second half of 2017.
  • SER-262 Phase 1b study progress: Seres is advancing the SER-262 Phase 1b, dose-escalating, first-in-human, clinical study in patients with primary C. difficile infection. SER-262, a rationally-designed, fermented, Ecobiotic® microbiome therapeutic candidate, is the first synthetically-derived and designed microbiome therapeutic candidate to reach clinical-stage development. Top-line data from the study are expected in early 2018.
  • Appointment of Willard Dere, M.D., to the Seres Board of Directors: Dr. Dere brings more than two decades of scientific, clinical and strategic biopharmaceutical experience. He is currently Professor of Internal Medicine, Executive Director of Personalized Health and Co-director of the Center for Clinical and Translational Sciences at the University of Utah Health Sciences Center. Previously, Dr. Dere served at Amgen, where he held several positions including Head of Global Development and for a decade, Chief Medical Officer. During his career in the biopharmaceutical industry, Dr. Dere led the clinical development of numerous approved products in diverse therapeutic areas, including osteoporosis, inflammation, nephrology and oncology.

Financial Results

Seres reported a net loss of $28.0 million for the second quarter of 2017, as compared to a net loss of $27.9 million for the same period in 2016. The second quarter net loss was driven primarily by clinical and development expenses, personnel expenses, and ongoing development of the Company’s microbiome therapeutics platform. The second quarter net loss figure was inclusive of $3.0 million in recognized revenue associated with the Company’s collaboration with Nestlé Health Science.

Research and development expenses for the second quarter were $23.1 million, as compared to $22.2 million for the same period in 2016. The research and development expense was primarily related to Seres’ microbiome therapeutics platform, the clinical development of SER-109, SER-262 and SER-287, as well as the Company’s SER-301 and SER-155 preclinical programs.

General and administrative expenses for the second quarter were $8.4 million, as compared to $9.0 million for the same period in the prior year. General and administrative expenses were primarily due to headcount, professional fees, and facility costs.

The Company expects to account for receipt of the previously disclosed $20.0 milestone payment associated with the start of the SER-109 Phase 3 study, under its collaboration agreement with Nestlé, in the third quarter of 2017.

The decrease in cash balance during the quarter was $27.0 million. Seres ended the second quarter with approximately $175.2 million in cash, cash equivalents and investments.

Conference Call Information

Seres’ management will host a conference call today, August 3, 2017, at 8:00 a.m. ET. To access the conference call, please dial 844-277-9450 (domestic) or 336-525-7139 (international) and reference the conference ID number 62118608. To join the live webcast, please visit the “Investors and Media” section of the Seres website at www.serestherapeutics.com.

About Seres Therapeutics

Seres Therapeutics, Inc., is a leading microbiome therapeutics platform Company developing a novel class of biological drugs that are designed to treat disease by restoring the function of a dysbiotic microbiome, where the natural state of bacterial diversity and function is imbalanced. Seres’ lead program, SER-109, has obtained Breakthrough Therapy and Orphan Drug designations from the U.S. Food and Drug Administration and is in Phase 3 development for multiply recurrent C. difficile infection. Seres’ clinical candidate SER-287 is being evaluated in a Phase 1b study in patients with mild-to-moderate ulcerative colitis. Seres is also developing SER-262, the first ever synthetic microbiome therapeutic candidate, in a Phase 1b study in patients with primary C. difficile infection. For more information, please visitwww.serestherapeutics.com. Follow us on Twitter @SeresTx.


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