Seres Therapeutics Reports Fourth Quarter and Full Year 2015 Financial Results and Provides Business Update
Company highlights progress in commercial preparedness, pipeline expansion
Strong financial position; existing cash expected to support operations well into 2018
The company highlighted the progress it made in advancing its commercial strategy and expanding its pipeline into new indications.
“The fourth quarter 2015 and early 2016 has been a period of
unprecedented growth for Seres in which we made tremendous progress in
preparing for the expected commercialization of our therapies for
Clostridium difficile (CDI) infection, while also expanding into new
therapeutic areas with our Ecobiotic® microbiome therapeutics
platform,” said
Fourth Quarter and Recent Business Highlights:
-
Initiation of SER-287 Phase 1b study in ulcerative colitis
(
December 2015 ): SER-287 is an oral capsule developed using Seres’ proprietary microbiome therapeutics platform. The randomized, placebo-controlled multiple dose study will be conducted in 20 centers around the U.S. and is expected to enroll up to 55 subjects with active mild-to-moderate UC. The Phase 1b study will evaluate the change in the microbiome resulting from SER-287 treatment as well as clinical response, mucosal healing, and metabolomic, immunological and safety findings. UC is a prevalent and serious chronic condition affecting approximately 700,000 people inthe United States alone. Growing evidence indicates that UC is marked by an imbalance of bacteria, or dysbiosis, in the gut. Published clinical reports suggest that modulation of the microbiome through repetitive fecal microbiota transplants may lead to meaningful clinical response in certain UC patients. -
Strategic collaboration with Nestlé Health Science (
January 2016 ): Seres granted Nestlé Health Science development and commercialization rights in global markets outside ofthe United States andCanada to SER-109 and SER-262 for CDI, and SER-287 and SER-301 for IBD. Seres has received an upfront payment of$120 million and expects to receive an additional$30 million in milestone payments in 2016. The full potential value of the up-front payment and milestone payments is over$1.9 billion , assuming all products receive regulatory approval and are successfully commercialized. Seres is eligible to receive tiered royalties on sales ranging from the high single digit percentages up to the high teens for all products. Nestlé Health Science has also agreed to contribute to certain development efforts, including 33 percent of expenses for potential global Phase 3 studies for SER-287, SER-301 and SER-262. Seres intends to use capital obtained in the deal to drive continued pipeline growth and development. Seres continues to retain US and Canadian rights for all products, and global rights for all product candidates outside of CDI and IBD. -
Commercial team leadership expansion (
January 2016 ):Wael Hashad has joined Seres as Chief Commercial Officer and Executive Vice President. Hashad is responsible for all activities related to the anticipated commercialization of the company’s products in development. Hashad has 25 years of commercial leadership experience launching first- and best-in-class therapies atAmgen , Boehringer Ingelheim and Lilly. -
Publication of SER-109 Phase 1b/2 clinical results (
February 2016 ): Positive results from the Phase 1b/2 study of SER-109 in recurrent CDI were published inThe Journal of Infectious Diseases . In the study 87 percent of patients (26 of 30) met the predefined endpoint of preventing recurrent CDI within eight weeks following administration of SER-109, and 97 percent (29 of 30) achieved a clinical cure during the eight-week period after SER-109 dosing. TheFDA has granted SER-109 Orphan Drug, as well as Breakthrough Therapy, designations.
Financial Results and Guidance:
The company reported a net loss of
Research and development expenses for the full year of 2015 were
General and administrative expenses for the full year were
Seres ended the third quarter of 2015 with
During the fourth quarter of 2015, Seres signed an agreement to lease a
facility that will house its corporate headquarters, including
laboratories, office space, and a pilot manufacturing facility. The
pilot facility will broaden capabilities in bioprocess development and
synthetic microbiome candidate manufacturing. The company expects that
build-out and equipment investment related to the facility will require
approximately
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 business development activities, well into 2018.
About
Ecobiotic is a registered trademark of Seres. All other brand names, product names, trademarks or service marks belong to their respective holders.
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 sufficiency of the
company’s existing cash resources, the commercialization of its CDI
therapies, the timing of clinical trials and results from clinical
trials, the value and impact of the agreement with Nestle Health Science
and the Phase 1b/2 clinical study of SER-287, the sites, enrolled
patients and evaluation criteria in the Phase 1b/2 clinical study of
SER-287, dysbiosis of the microbiome as an underlying cause of UC,
expected milestone payments under the agreement with
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, | |||||||||
2015 | 2014 | ||||||||
Assets | |||||||||
Current assets: | |||||||||
Cash and cash equivalents | $ | 73,933 | $ | 114,185 | |||||
Investments | 131,149 | — | |||||||
Prepaid expenses and other current assets | 2,528 | 58 | |||||||
Total current assets | 207,610 | 114,243 | |||||||
Property and equipment, net | 7,751 | 1,264 | |||||||
Restricted cash | 1,539 | 139 | |||||||
Deferred offering costs | — | 1,684 | |||||||
Deferred financing costs | — | 15 | |||||||
Total assets | $ | 216,900 | $ | 117,345 | |||||
Liabilities, Convertible Preferred Stock and Stockholders’
Equity |
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Current liabilities: | |||||||||
Accounts payable | $ | 5,397 | $ | 2,166 | |||||
Accrued expenses and other current liabilities | 5,523 | 1,737 | |||||||
Notes payable; current portion | — | 1,200 | |||||||
Total current liabilities | 10,920 | 5,103 | |||||||
Lease incentive obligation | 586 | — | |||||||
Notes payable, net of discount | — | 1,304 | |||||||
Preferred stock warrant liability | — | 1,582 | |||||||
Total liabilities | 11,506 | 7,989 | |||||||
Commitments and contingencies | |||||||||
Convertible preferred stock (Series A, A-2, B, C, D and D-1),
$0.001 |
— | 136,077 | |||||||
Stockholders’ equity (deficit): | |||||||||
Common stock, $0.001 par value; 200,000,000 and 38,000,000 |
39 | 7 | |||||||
Additional paid-in capital | 287,937 | 1,104 | |||||||
Accumulated other comprehensive income | 30 | — | |||||||
Accumulated deficit | (82,612 | ) | (27,832 | ) | |||||
Total stockholders’ equity (deficit) | 205,394 | (26,721 | ) | ||||||
Total liabilities, convertible preferred stock and stockholders’ |
$ | 216,900 | $ | 117,345 | |||||
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, | ||||||||||||||
2015 | 2014 | 2013 | ||||||||||||
Revenue | $ | — | $ | — | $ | — | ||||||||
Operating expenses: | ||||||||||||||
Research and development expenses | $ | 38,095 | $ | 10,718 | $ | 4,805 | ||||||||
General and administrative expenses | 16,761 | 4,364 | 1,247 | |||||||||||
Total operating expenses | 54,856 | 15,082 | 6,052 | |||||||||||
Loss from operations | (54,856 | ) | (15,082 | ) | (6,052 | ) | ||||||||
Other income (expense): | ||||||||||||||
Interest income (expense), net | 83 | (209 | ) | (42 | ) | |||||||||
Revaluation of preferred stock warrant liability | (7 | ) | (1,418 | ) | (8 | ) | ||||||||
Total other income (expense), net | 76 | (1,627 | ) | (50 | ) | |||||||||
Net loss | $ | (54,780 | ) | (16,709 | ) | (6,102 | ) | |||||||
Accretion of convertible preferred stock to redemption value | — | (1,291 | ) | (875 | ) | |||||||||
Net loss attributable to common stockholders | $ | (54,780 | ) | $ | (18,000 | ) | $ | (6,977 | ) | |||||
Net loss per share attributable to common stockholders, basic and diluted | $ | (2.33 | ) | $ | (2.67 | ) | $ | (1.09 | ) | |||||
Weighted average common shares outstanding, basic and diluted | 23,532,400 | 6,748,037 | 6,394,916 | |||||||||||
Other comprehensive income (loss): | ||||||||||||||
Unrealized gain on investments, net of tax of $0 | 30 | — | — | |||||||||||
Total other comprehensive income | 30 | — | — | |||||||||||
Comprehensive loss | $ | (54,750 | ) | $ | (18,000 | ) | $ | (6,977 | ) | |||||
View source version on businesswire.com: http://www.businesswire.com/news/home/20160225005395/en/
Source:
Seres Therapeutics
IR Contact:
Carlo Tanzi, Ph.D., 617-203-3467
Head
of Investor Relations and Corporate Communications
Ctanzi@serestherapeutics.com
or
PR
Contact:
Ten Bridge Communications
Dan Quinn, 781-475-7974
Dan@tenbridgecommunications.com