Seres Therapeutics Reports Fourth Quarter and Full Year 2016 Financial Results and Provides Operational Progress Update
- Positive SER-109 Type B FDA meeting -
- Company to initiate new Phase 2 SER-109 clinical trial that, as
agreed to by the
- Continued pipeline progress with both SER-287 and SER-262 Phase 1b studies; Both data read-outs expected in the second half of 2017 -
- Conference call at
“Seres has made important progress across all of our microbiome clinical
programs,” said
Dr. Pomerantz continued, “We also advanced our robust pipeline of microbiome clinical candidates and we anticipate the results of two Phase 1b clinical trials during the second half of this year, including our study of SER-287 in patients with ulcerative colitis and our study of SER-262, the first synthetically derived microbiome candidate to reach clinical development, in patients with primary C. difficile infection.”
Recent Highlights and Events
-
Positive SER-109 Type B meeting with
FDA and plan for new SER-109 clinical study: Seres plans to initiate a new SER-109 clinical study (ECOSPOR III) in approximately 320 patients with multiply recurrent Clostridium difficile (C. difficile) infection. Study participants will be randomized 1:1 between SER-109 and placebo. Diagnosis of C. difficile infection for both study entry and for endpoint analysis will be confirmed by C. difficile cytotoxin assay. Patients in the SER-109 arm will receive a total SER-109 dose, administered over three days, approximately 10-fold higher than the dose used in the prior 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. TheFDA has agreed that this new trial may qualify as a pivotal study with achievement of a persuasive clinical effect and addressingFDA requirements, including clinical and statistical factors, an adequately sized safety database, and certain CMC parameters. - Key findings from SER-109 Phase 2 study analyses: Seres announced the results of its in-depth analyses of the previously reported SER-109 Phase 2, eight-week clinical study data in patients with multiply recurrent C. difficile infection.
- Ongoing progress with SER-287 Phase 1b study: Seres continued to advance the SER-287 Phase 1b clinical study in subjects with mild-to-moderate ulcerative colitis who have failed first line therapy. SER-287 is a biologically sourced Ecobiotic® microbiome therapeutic candidate. Additional SER-287 Phase 1b study clinical sites were activated and increasing numbers of study subjects are being enrolled. Study results are expected in the second half of 2017.
- Ongoing progress with SER-262 Phase 1b study: Seres continued to advance the SER-262 Phase 1b clinical study in patients with primary C. difficile 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 are being enrolled. Study results are expected in the second half of 2017.
-
Preclinical microbiome program research: Seres continued to
advance its preclinical efforts, working in collaboration with
existing world-class academic researchers, 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) and rare genetic metabolic diseases, 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 continued to strengthen its intellectual property estate related to microbiome therapeutics. The United States Patent and Trademark Office issued a new patent (#9,585,921), assigned to Seres, covering compositions for treating multiple gastrointestinal diseases associated with dysbiosis of the microbiome.
- Manufacturing facility completed: Seres continued to broaden its differentiated microbiome therapeutic development capabilities. The construction of a new facility capable of the manufacture and formulation of microbiome therapeutic candidates was completed and is now fully operational.
Financial Results
The company reported a net loss of
Research and development expenses for the full year of 2016 were
General and administrative expenses for the full year of 2016 were
The decrease in cash balance during the quarter was
Financial Expectations
Based on the company’s current operating plan, Seres expects that its existing cash resources will enable it to fund operating expenses and capital expenditure requirements, excluding cash inflows or outflows from future business development activities, through 2018.
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 our SER-109 development plans, the timing, design, and potential results of the ECOSPOR III study for SER-109, the potential for the ECOSPOR III study to qualify as a pivotal study, the timing and results of our clinical trials, the potential benefits of our business collaborations, dysbiosis as an underlying cause of disease, the benefits of any of our issued patents, and our cash flow and business forecasts.
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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CONSOLIDATED BALANCE SHEETS |
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(In thousands, except share and per share data) |
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December 31, | |||||||||||
2016 | 2015 | ||||||||||
Assets | |||||||||||
Current assets: | |||||||||||
Cash and cash equivalents | $ | 54,539 | $ | 73,933 | |||||||
Investments | 138,704 | 131,149 | |||||||||
Prepaid expenses and other current assets | 5,126 | 2,528 | |||||||||
Total current assets | 198,369 | 207,610 | |||||||||
Property and equipment, net | 36,125 | 7,751 | |||||||||
Long-term investments | 36,752 | — | |||||||||
Restricted cash | 1,400 | 1,539 | |||||||||
Total assets | $ | 272,646 | $ | 216,900 | |||||||
Liabilities and Stockholder's Equity | |||||||||||
Current liabilities: | |||||||||||
Accounts payable | $ | 7,587 | $ | 5,397 | |||||||
Accrued expenses and other current liabilities | 10,812 | 5,523 | |||||||||
Deferred revenue - related party | 12,058 | — | |||||||||
Total current liabilities | 30,457 | 10,920 | |||||||||
Lease incentive obligation, net of current portion | 10,730 | 586 | |||||||||
Deferred rent | 2,072 | — | |||||||||
Deferred revenue, net of current portion - related party | 96,756 | — | |||||||||
Total liabilities | 140,015 | 11,506 | |||||||||
Commitments and contingencies | |||||||||||
Stockholders’ equity: | |||||||||||
Preferred stock, $0.001 par value; 10,000,000 shares authorized at December 31, 2016 and 2015; no shares issued and outstanding at December 31, 2016 and 2015 | — | — | |||||||||
Common stock, $0.001 par value; 200,000,000 shares authorized at December 31, 2016 and 2015; 40,355,753 and 39,082,017 shares issued and outstanding at December 31, 2016 and 2015 | 40 | 39 | |||||||||
Additional paid-in capital | 306,931 | 287,937 | |||||||||
Accumulated other comprehensive income (loss) | (149 | ) | 30 | ||||||||
Accumulated deficit | (174,191 | ) | (82,612 | ) | |||||||
Total stockholders’ equity | 132,631 | 205,394 | |||||||||
Total liabilities, convertible preferred stock and stockholders’ equity | $ | 272,646 | $ | 216,900 | |||||||
SERES THERAPEUTICS, INC. |
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CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS |
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(In thousands, except share and per share data) |
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Year Ended December 31, | ||||||||||||||||
2016 | 2015 | 2014 | ||||||||||||||
Revenue: | ||||||||||||||||
Collaboration revenue - related party | $ | 21,766 | $ | — | $ | — | ||||||||||
Total revenue | 21,766 | — | — | |||||||||||||
Operating expenses: | ||||||||||||||||
Research and development expenses | $ | 81,989 | 38,095 | 10,718 | ||||||||||||
General and administrative expenses | 32,616 | 16,761 | 4,364 | |||||||||||||
Total operating expenses | 114,605 | 54,856 | 15,082 | |||||||||||||
Loss from operations | (92,839 | ) | (54,856 | ) | (15,082 | ) | ||||||||||
Other income (expense): | ||||||||||||||||
Interest income | 2,229 | 638 | — | |||||||||||||
Interest expense | (969 | ) | (555 | ) | (209 | ) | ||||||||||
Revaluation of preferred stock warrant liability | — | (7 | ) | (1,418 | ) | |||||||||||
Total other income (expense), net | 1,260 | 76 | (1,627 | ) | ||||||||||||
Net loss | $ | (91,579 | ) | (54,780 | ) | (16,709 | ) | |||||||||
Accretion of convertible preferred stock to redemption value | — | — | (1,291 | ) | ||||||||||||
Net loss attributable to common stockholders | $ | (91,579 | ) | $ | (54,780 | ) | $ | (18,000 | ) | |||||||
Net loss per share attributable to common stockholders, basic and diluted | $ | (2.30 | ) | $ | (2.33 | ) | $ | (2.67 | ) | |||||||
Weighted average common shares outstanding, basic and diluted | 39,846,928 | 23,532,400 | 6,748,037 | |||||||||||||
Other comprehensive income (loss): | ||||||||||||||||
Unrealized gain (loss) on investments, net of tax of $0 | (179 | ) | 30 | — | ||||||||||||
Total other comprehensive income (loss) | (179 | ) | 30 | — | ||||||||||||
Comprehensive loss | $ | (91,758 | ) | $ | (54,750 | ) | $ | (18,000 | ) | |||||||
View source version on businesswire.com: http://www.businesswire.com/news/home/20170316005281/en/
Source:
IR or PR Contact:
Seres
Therapeutics
Carlo Tanzi, Ph.D., 617-203-3467
Head of Investor
Relations and Corporate Communications
ctanzi@serestherapeutics.com