|SERES THERAPEUTICS, INC. filed this Form 8-K on 03/06/2019|
Corporate changes to focus on highest priority programs and appointment of chief scientific officer (January
2019): The Company has concentrated resources on completing the SER-287 Phase 2b study in mild-to-moderate ulcerative
colitis, the SER-109 Phase 3 study for recurrent C. difficile infection and the SER-401 Phase 1b study in metastatic melanoma. In addition, Seres will
continue to advance its next generation, rationally-designed, fermented drug discovery capabilities, with a focus on SER-301 for ulcerative colitis. Seres made changes to its executive team and reduced its
full-time workforce by approximately 30%. Matthew Henn, Ph.D., previously Executive Vice President and Head of Discovery and Microbiome R&D, was appointed Chief Scientific Officer.
Chief executive officer appointed (January 2019): Seres announced the appointment of Eric D. Shaff as
President and Chief Executive Officer. Mr. Shaff, who was Chief Operating and Financial Officer, succeeded Roger J. Pomerantz, M.D., who continues as Chair of Seres Board of Directors.
SER-287 Phase 2b study initiated in ulcerative colitis (January 2019):
Seres announced the start of a Phase 2b trial, ECO-RESET, evaluating SER-287 in patients with active mild-to-moderate ulcerative colitis. Seres received $40 million in milestone payments associated with this study start from Nestlé Health Science. The Company obtained feedback from the FDA
indicating that results from this study, in conjunction with data from a second pivotal study, could enable a Biologics License Application. The Company expects to complete trial enrollment by mid-2020.
Chief medical officer appointed (October 2018): Seres appointed Kevin Horgan, M.D., as Executive Vice
President and Chief Medical Officer. Dr. Horgan will lead Seres clinical development, clinical operations, regulatory affairs and medical affairs functions.
a net loss of $98.9 million for the full year 2018, as compared to a net loss of $89.4 million for the prior year. Seres reported a net loss of $21.3 million for the fourth quarter of 2018, as compared to a net loss of
$29.0 million for the same period in 2017. The fourth quarter net loss was driven primarily by clinical and development expenses, personnel expenses and ongoing development of the Companys microbiome therapeutics platform. The fourth
quarter net loss figure was inclusive of $10.6 million in recognized revenue associated primarily with the Companys collaboration with Nestlé Health Science.
Research and development expenses for the fourth quarter 2018 were $24.8 million, as compared to $24.0 million for the same period
in 2017. The research and development expense was primarily related to Seres microbiome therapeutics platform, the clinical development of SER-109 and SER-287, as
well as the Companys immuno-oncology efforts.
General and administrative expenses for the fourth quarter were $7.5 million, as
compared to $8.8 million for the same period in the prior year. General and administrative expenses were primarily due to headcount, professional fees and facility costs.
The increase in the Companys cash, cash equivalents and investments balance during the quarter was $12.9 million. Seres ended
the fourth quarter with approximately $85.8 million in cash, cash equivalents and investments. The increase in cash in Q4 was inclusive of $40.0 million in milestones received under the Companys collaboration with Nestlé
Health Science. Based on the Companys current operating plan, cash resources are expected to fund operating expenses and capital expenditure requirements, excluding net cash flows from future business development activities or potential
incoming milestone payments, into the fourth quarter of this year.
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