Completion of SER-262 clinical study: Seres obtained clinical data from the final patient cohort (cohort 8
of 8) of the SER-262 Phase 1b study in patients with primary C. difficile infection. SER-262 is the first rationally-designed, fermented microbiome therapeutic
candidate to be evaluated in clinical development. The full study clinical data remains consistent with the top line results from the first 7 cohorts which have previously been reported. The observed recurrence rate of C. difficile was
statistically significantly lower in patients treated with vancomycin and SER-262, as compared to those patients treated with metronidazole and SER-262. Phase 1b
microbiome data suggest that treatment with vancomycin, followed by SER-262, results in more robust and kinetically more rapid engraftment, and thus may lead to corresponding clinical efficacy. Microbiome and
metabolomic analyses from the study remain ongoing. Seres plans to present full study results at an upcoming medical conference.
Seres reported a net loss of
$27.8 million for the second quarter of 2018, as compared to a net loss of $28.0 million for the same period in 2017. The second quarter net loss was driven primarily by clinical and development expenses, personnel expenses, and
ongoing development of the Companys microbiome therapeutics platform. The second quarter net loss figure was inclusive of $4.6 million in recognized revenue primarily associated with the Companys collaboration with
Nestlé Health Science.
Research and development expenses for the second quarter were $24.1 million, as compared to $23.1 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,
SER-262 and SER-287, as well as the Companys SER-301, SER-155 and immuno-oncology
General and administrative expenses for the second quarter were $8.7 million, as compared to $8.4 million for the
same period in the prior year. General and administrative expenses were primarily due to headcount, professional fees, and facility costs.
in cash, cash equivalents and investments balance during the quarter was $26.1 million. Seres ended the second quarter with approximately $96.1 million in cash, cash equivalents and investments. Current resources are expected to fund the
Company into the second quarter of 2019. This estimate does not include a $20.0 million milestone payment that the Company expects to receive with the start of the SER-287 Phase 2b study.