Seres Therapeutics Reports Second Quarter Financial Results and Provides Operational Progress Update
- Comprehensive review of initial SER-109 Phase 2 study data underway -
- Strong cash position to support operations well into 2018, and through the anticipated Phase 1b study read-outs for SER-287 and SER-262 –
- Conference call at
“Following our announcement of initial eight-week data from our SER-109
Phase 2 study, we continue to gather further data and have begun an
intense review of all available information so that we can fully
understand the results, and apply our learnings to SER-109, as well as
our other R&D efforts,” said
Recent Highlights and Events:
-
Interim results of SER-109 Phase 2 clinical study announced (
July 2016 ): Seres announced 8 week results from the ongoing SER-109 Phase 2 ECOSPORTM clinical study for the prevention of multiply recurrent Clostridium difficile infection (CDI). The study did not achieve its primary endpoint of reducing the relative risk of CDI recurrence at 8 weeks. Multiple sub-group analyses are being deeply analyzed to further help clarify the initial findings in this trial. The company expects to continue to gather and analyze study data throughout the coming months, and will consult with theFDA to make appropriate adjustments to its SER-109 development plans. -
Initiation of a Phase 1b clinical trial of SER-262 (
July 2016 ): Seres initiated a Phase 1b clinical trial evaluating SER-262 in patients with primary CDI. SER-262, an Ecobiotic®, rationally-designed, fermented microbiome therapeutic is the first synthetically-derived and designed microbiome therapeutic to reach clinical-stage development. The 24-week, randomized, placebo-controlled dose escalation study is expected to enroll approximately 60 patients who have experienced a first episode of CDI. The primary endpoint will compare the CDI recurrence rate between the SER-262 and placebo groups at up to 8 weeks after dosing. Study results are expected in 2017. - Ongoing progress with SER-287 Phase 1b study execution: Seres continued to advance the SER-287 Phase 1b study in subjects with mild-to-moderate ulcerative colitis. Additional study clinical sites continued to be activated and increasing numbers of study subjects were enrolled. Study results are expected in 2017.
-
Research collaboration with
Mayo Clinic to identify new microbiome therapeutics for liver diseases (June 2016 ): The company initiated a sponsored research agreement with Mayo Clinic’sCenter for Individualized Medicine focused on identifying new microbiome therapeutic candidates for liver diseases, including primary sclerosing cholangitis and non-alcoholic steatohepatitis (NASH). -
Collaboration agreement with
Massachusetts General Hospital to identify microbiome therapeutics for obesity and metabolic syndrome (June 2016 ): Seres will help fund a placebo-controlled, proof-of concept clinical study to evaluate the impact of fecal microbiota transplantation derived from lean individuals, on the body weight and glycemic control of adults suffering from clinically significant obesity and metabolic disorders. The company will analyze patient samples to determine metagenomics signatures, metabolic markers and other key clinical biomarkers that may inform the design of microbiome therapeutics for obesity and associated metabolic disease. -
Collaboration with Emulate (
July 2016 ): Seres initiated a collaboration withEmulate, Inc. , a private company commercializing Organs-on-Chips technology, to further advance Emulate’s Intestine-Chip platform, a micro-engineered, living-tissue-based system that models the human intestine. Seres intends to use the technology to identify novel bacteria compositions with therapeutic potential for inflammatory bowel disease and other serious conditions
Financial Results:
Seres reported a net loss of
Research and development expenses for the second quarter were
General and administrative expenses for the second 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 analysis and potential application of SER-109’s Phase 2 clinical study and related data, adjustments to our SER-109 development plans, the timing and results of our clinical trials including the SER-262 and SER-287 clinical trials, identification and development of microbiome therapeutic candidates, including those for inflammatory bowel disease, liver diseases, obesity, metabolic syndrome or other indications, available cash to fund operations in the future, the potential of SER-109 to treat CDI and fundamentally change the management of CDI, and dysbiosis of the microbiome as an underlying cause of CDI.
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. |
|||||||||
June 30, | December 31, | ||||||||
2016 | 2015 | ||||||||
Assets | |||||||||
Current assets: | |||||||||
Cash and cash equivalents | $ | 59,824 | $ | 73,933 | |||||
Investments | 152,032 | 131,149 | |||||||
Prepaid expenses and other current assets | 5,247 | 2,528 | |||||||
Total current assets | 217,103 | 207,610 | |||||||
Property and equipment, net | 26,985 | 7,751 | |||||||
Long-term investments | 60,589 | - | |||||||
Restricted cash | 1,540 | 1,539 | |||||||
Total assets | $ | 306,217 | $ | 216,900 | |||||
Liabilities and Stockholders’ Equity | |||||||||
Current liabilities: | |||||||||
Accounts payable | $ | 4,454 | $ | 5,397 | |||||
Accrued expenses and other current liabilities | 10,865 | 5,523 | |||||||
Deferred revenue - related party | 12,012 | — | |||||||
Total current liabilities | 27,331 | 10,920 | |||||||
Lease incentive obligation | 9,119 | 586 | |||||||
Deferred revenue, net of current portion - related party | 102,371 | — | |||||||
Total liabilities | 138,821 | 11,506 | |||||||
Commitments and contingencies | |||||||||
Stockholders’ equity: | |||||||||
Preferred stock, $0.001 par value; 10,000,000 shares authorized at June 30, 2016 and December 31, 2015; no shares issued and outstanding at June 30, 2016 and December 31, 2015 | — | — | |||||||
Common stock, $0.001 par value; 200,000,000 shares authorized at June 30, 2016 and December 31, 2015; 39,859,155 and 39,082,017 shares issued and outstanding at June 30, 2016 and December 31, 2015, respectively | 40 | 39 | |||||||
Additional paid-in capital | 297,502 | 287,937 | |||||||
Accumulated other comprehensive income | 83 | 30 | |||||||
Accumulated deficit | (130,229 | ) | (82,612 | ) | |||||
Total stockholders’ equity | 167,396 | 205,394 | |||||||
Total liabilities and stockholders’ equity | $ | 306,217 | $ | 216,900 |
SERES THERAPEUTICS, INC. |
||||||||||||||||||||
Three Months Ended June 30, | Six Months Ended June 30, | |||||||||||||||||||
2016 | 2015 | 2016 | 2015 | |||||||||||||||||
Revenue: | ||||||||||||||||||||
Collaboration revenue - related party | $ | 3,004 | $ | — | $ | 5,714 | $ | — | ||||||||||||
Total revenue | 3,004 | — | 5,714 | — | ||||||||||||||||
Operating expenses: | ||||||||||||||||||||
Research and development expenses | 22,174 | 8,784 | 37,590 | 14,345 | ||||||||||||||||
General and administrative expenses | 8,970 | 3,556 | 16,180 | 6,162 | ||||||||||||||||
Total operating expenses | 31,144 | 12,340 | 53,770 | 20,507 | ||||||||||||||||
Loss from operations | (28,140 | ) | (12,340 | ) | (48,056 | ) | (20,507 | ) | ||||||||||||
Other income (expense): | ||||||||||||||||||||
Interest income | 495 | 151 | 763 | 199 | ||||||||||||||||
Interest expense | (268 | ) | (146 | ) | (324 | ) | (211 | ) | ||||||||||||
Revaluation of preferred stock warrant liability | — | (220 | ) | — | (7 | ) | ||||||||||||||
Total other income (expense), net | 227 | (215 | ) | 439 | (19 | ) | ||||||||||||||
Net loss | $ | (27,913 | ) | $ | (12,555 | ) | $ | (47,617 | ) | $ | (20,526 | ) | ||||||||
Net loss per share attributable to common stockholders, basic and diluted | $ | (0.70 | ) | $ | (1.45 | ) | $ | (1.21 | ) | $ | (2.64 | ) | ||||||||
Weighted average common shares outstanding, basic and diluted | 39,600,344 | 8,640,218 | 39,393,238 | 7,777,679 | ||||||||||||||||
Other comprehensive income: | ||||||||||||||||||||
Unrealized gain/(loss) on investments, net of tax of $0 | $ | (25 | ) | $ | (8 | ) | $ | 53 | $ | 23 | ||||||||||
Total other comprehensive income | (25 | ) | (8 | ) | 53 | 23 | ||||||||||||||
Comprehensive loss | $ | (27,938 | ) | $ | (12,563 | ) | $ | (47,564 | ) | $ | (20,503 | ) |
View source version on businesswire.com: http://www.businesswire.com/news/home/20160811005189/en/
Source:
Seres Therapeutics
Carlo Tanzi, Ph.D., 617-203-3467
Head of
Investor Relations and Corporate Communications
Ctanzi@serestherapeutics.com