Seres Therapeutics Reports Third Quarter 2016 Financial Results and Provides Operational Progress Update
- Analyses of SER-109 Phase 2 results on track for completion by year
end;
Company intends to discuss proposed future SER-109
clinical development plans with the
- Pipeline progress with SER-287 and SER-262 Phase 1b study execution;
data
read-outs continue to be expected in 2017 -
- New microbiome patent strengthens the Company’s intellectual property estate -
- Conference call at
“Our focus has been on completing data analyses related to the
previously reported SER-109 Phase 2 study results in patients with
multiply recurrent C. difficile infection,” said
Dr. Pomerantz continued: “Seres also continues to advance our broad pipeline of microbiome therapeutic candidates, including a SER-287 Phase 1b study in patients with ulcerative colitis, and a Phase 1b study of SER-262, the first synthetically derived microbiome therapeutic candidate, in patients with primary C. difficile infection. We look forward to obtaining SER-287 and SER-262 study results in 2017.”
Recent Highlights and Events
-
SER-109 Phase 2 study execution and analyses: Seres continues
to conduct analyses to better understand the previously reported
SER-109 Phase 2 interim study data. The Phase 2 study enrolled 89
subjects in a randomized, double-blind, placebo-controlled 24-week
study conducted to evaluate the safety and efficacy of SER-109 in
patients with multiply recurrent Clostridium difficile (CDI)
infection. Interim, eight-week, primary endpoint results demonstrated
that the relative risk of CDI recurrence for the placebo population,
compared to the SER-109 population, was not statistically significant.
All patients from the SER-109 Phase 2 have now completed their 24-week
end of study visit, and full study clinical results are expected in
early 2017. The Company also continues to obtain results from the
SER-109 Phase 2 open label extension study. Seres intends to complete
its full SER-109 study analyses and then discuss plans for further
SER-109 clinical development with the
U.S. Food and Drug Administration (FDA ). The Company expects to provide an update on the SER-109 program in early 2017. - Ongoing progress with SER-287 Phase 1b study execution: Seres continues to advance the SER-287 Phase 1b study in subjects with mild-to-moderate ulcerative colitis. SER-287 is a biologically sourced Ecobiotic® microbiome therapeutic candidate that has been formulated for chronic administration. Additional SER-287 Phase 1b study clinical sites were activated and increasing numbers of study subjects were enrolled. Study results are expected in 2017.
- Ongoing progress with SER-262 Phase 1b study execution: Seres continues to advance the SER-262 Phase 1b clinical study in patients with primary CDI infection. SER-262, an Ecobiotic®, rationally-designed, fermented microbiome therapeutic candidate, is the first synthetically-derived and designed microbiome therapeutic candidate to reach clinical-stage development. Additional SER-262 Phase 1b study clinical sites were activated and increasing numbers of study subjects were enrolled. Study results are expected in 2017.
-
Preclinical microbiome program research: Seres continues to
advance its preclinical efforts, working in collaboration with
existing academic collaborators, including projects targeting:
hematopoietic stem cell transplantation and immuno-oncology treatment,
with
Memorial Sloan Kettering Cancer Center ; liver diseases including primary sclerosing cholangitis and Non-Alcoholic Steatohepatitis (NASH), withMayo Clinic ; inflammatory bowel disease (IBD), with theUniversity of Pennsylvania ,Medical University ofGraz, Austria and theResearch Institute of St. Joseph’sHamilton ; and obesity and metabolic syndrome, with theMassachusetts General Hospital of theHarvard Medical School . - Additional microbiome patent issued: Seres continues to strengthen its intellectual property estate related to microbiome therapeutics. The United States Patent and Trademark Office issued a new patent (#9,446,080), assigned to Seres, covering the use of a composition of bacterial spores to treat gastrointestinal diseases associated with dysbiosis of the microbiome. The patent provides coverage through at least 2034.
- Manufacturing facility construction progress: Seres continues to broaden its differentiated microbiome drug development capabilities. The construction of a new manufacturing facility capable of the manufacture and formulation of microbiome therapeutic candidates is near completion. The Company continues to perform activities to support full validation of the new facility.
Financial Results
Seres reported a net loss of
Research and development expenses for the third quarter were
General and administrative expenses for the third quarter were
The decrease in cash balance during the quarter was
Conference Call Information
Seres’ management will host a conference call today,
About Seres Therapeutics
Forward-looking Statements
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. All statements contained in this press release that do not relate to matters of historical fact should be considered forward-looking statements, including without limitation statements regarding the timing and results of our clinical trials, the timing of the analyses of the SER-109 Phase 2 study data, our SER-109 development plans, identification, development and potential success of our microbiome therapeutic candidates, the completion and success of our manufacturing facility, the potential success of our microbiome therapeutic approach, and dysbiosis of the microbiome as an underlying cause of disease.
These forward-looking statements are based on management’s current
expectations. These statements are neither promises nor guarantees, but
involve known and unknown risks, uncertainties and other important
factors that may cause our actual results, performance or achievements
to be materially different from any future results, performance or
achievements expressed or implied by the forward-looking statements,
including, but not limited to, the following: we have incurred
significant losses, are not currently profitable and may never become
profitable; our need for additional funding, which may not be available;
our limited operating history; the unpredictable nature of our early
stage development efforts for marketable drugs; the unproven approach to
therapeutic intervention of our microbiome therapeutics; the lengthy and
expensive process of clinical drug development, which has an uncertain
outcome; potential delays in enrollment of patients which could affect
the receipt of necessary regulatory approvals; potential delays in
regulatory approval, which would impact the ability to commercialize our
product candidates and affect our ability to generate revenue; any fast
track or Breakthrough Therapy designation may not lead to faster
development, regulatory approval or marketing approval; our possible
inability to receive orphan drug designation should we choose to seek
it; our reliance on third parties to conduct our clinical trials and the
potential for those third parties to not perform satisfactorily; our
reliance on third parties to manufacture our product candidates, which
may delay, prevent or impair our development and commercialization
efforts; our lack of experience in manufacturing our product candidates;
the potential failure of our product candidates to be accepted on the
market by the medical community; our lack of experience selling,
marketing and distributing products and our lack of internal capability
to do so; failure to compete successfully against other drug companies;
potential competition from biosimilars; failure to obtain marketing
approval internationally; post-marketing restrictions or withdrawal from
the market; anti-kickback, fraud, abuse, and other healthcare laws and
regulations exposing us to potential criminal sanctions; recently
enacted or future legislation; compliance with environmental, health,
and safety laws and regulations; protection of our proprietary
technology; protection of the confidentiality of our trade secrets;
changes in
SERES THERAPEUTICS, INC. |
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CONDENSED CONSOLIDATED BALANCE SHEETS |
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(unaudited, in thousands, except share and per share data) |
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September 30, | December 31, | |||||||||
2016 | 2015 | |||||||||
Assets | ||||||||||
Current assets: | ||||||||||
Cash and cash equivalents | $ | 55,611 | $ | 73,933 | ||||||
Investments | 147,768 | 131,149 | ||||||||
Prepaid expenses and other current assets | 5,055 | 2,528 | ||||||||
Total current assets | 208,434 | 207,610 | ||||||||
Property and equipment, net | 34,560 | 7,751 | ||||||||
Long-term investments | 53,098 | — | ||||||||
Restricted cash | 1,422 | 1,539 | ||||||||
Total assets | $ | 297,514 | $ | 216,900 | ||||||
Liabilities and Stockholders’ Equity | ||||||||||
Current liabilities: | ||||||||||
Accounts payable | $ | 4,228 | $ | 5,397 | ||||||
Accrued expenses and other current liabilities | 15,623 | 5,523 | ||||||||
Deferred revenue - related party | 12,027 | — | ||||||||
Total current liabilities |
31,878 | 10,920 | ||||||||
Lease incentive obligation, net of current portion | 10,740 | 586 | ||||||||
Deferred rent | 1,381 | — | ||||||||
Deferred revenue, net of current portion - related party | 99,518 | — | ||||||||
Total liabilities | 143,517 | 11,506 | ||||||||
Commitments and contingencies | ||||||||||
Stockholders’ equity: | ||||||||||
Preferred stock, $0.001 par value; 10,000,000 shares authorized at September 30, 2016 and December 31, 2015; no shares issued and outstanding at September 30, 2016 and December 31, 2015 | — | — | ||||||||
Common stock, $0.001 par value; 200,000,000 shares authorized at September 30, 2016 and December 31, 2015; 40,355,753 and 39,082,017 shares issued and outstanding at September 30, 2016 and December 31, 2015, respectively | 40 | 39 | ||||||||
Additional paid-in capital | 302,939 | 287,937 | ||||||||
Accumulated other comprehensive income | (67 | ) | 30 | |||||||
Accumulated deficit | (148,915 | ) | (82,612 | ) | ||||||
Total stockholders’ equity | 153,997 | 205,394 | ||||||||
Total liabilities and stockholders’ equity | $ | 297,514 | $ | 216,900 | ||||||
SERES THERAPEUTICS, INC. |
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CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS |
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(unaudited, in thousands, except share and per share data) |
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Three Months Ended |
Nine Months Ended |
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September 30, |
September 30, |
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2016 | 2015 | 2016 | 2015 | |||||||||||||||
Revenue: | ||||||||||||||||||
Collaboration revenue - related party | $ | 13,015 | $ | — | $ | 18,730 | $ | — | ||||||||||
Total revenue | 13,015 | — | 18,730 | — | ||||||||||||||
Operating expenses: | ||||||||||||||||||
Research and development expenses | 24,143 | 9,850 | 61,733 | 24,195 | ||||||||||||||
General and administrative expenses | 7,967 | 4,711 | 24,163 | 10,873 | ||||||||||||||
Total operating expenses |
32,110 | 14,561 | 85,896 | 35,068 | ||||||||||||||
Loss from operations | (19,095 | ) | (14,561 | ) | (67,166 | ) | (35,068 | ) | ||||||||||
Other income (expense): | ||||||||||||||||||
Interest income | 719 | 172 | 1,483 | 372 | ||||||||||||||
Interest expense | (312 | ) | (231 | ) | (620 | ) | (443 | ) | ||||||||||
Revaluation of preferred stock warrant liability | — | $ | — | — | (7 | ) | ||||||||||||
Total other income (expense), net | 407 | (59 | ) | 863 | (78 | ) | ||||||||||||
Net loss | $ | (18,688 | ) | $ | (14,620 | ) | $ | (66,303 | ) | $ | (35,146 | ) | ||||||
Net loss per share attributable to common stockholders, basic and diluted | $ | (0.46 | ) | $ | (0.38 | ) | $ | (1.67 | ) | $ | (1.92 | ) | ||||||
Weighted average common shares outstanding, basic and diluted | 40,235,623 | 38,980,839 | 39,676,085 | 18,292,002 | ||||||||||||||
Other comprehensive income: | ||||||||||||||||||
Unrealized gain/(loss) on investments, net of tax of $0 | $ | (150 | ) | $ | (33 | ) | $ | (97 | ) | $ | (10 | ) | ||||||
Total other comprehensive income |
(150 | ) | (33 | ) | (97 | ) | (10 | ) | ||||||||||
Comprehensive loss | $ | (18,838 | ) | $ | (14,653 | ) | $ | (66,400 | ) | $ | (35,156 | ) |
View source version on businesswire.com: http://www.businesswire.com/news/home/20161110005455/en/
Source:
Seres Therapeutics
Carlo Tanzi, Ph.D., 617-203-3467
Head of
Investor Relations and Corporate Communications
Ctanzi@serestherapeutics.com