Seres Therapeutics Reports Third Quarter Financial Results and Provides Operational Updates
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- Planning for two new microbiome clinical studies in ulcerative
colitis and metastatic melanoma; Company expects to receive
- Conference call at
“Based on a growing body of promising clinical data and preclinical data
from our laboratories and others, Seres has increased its strategic
focus toward immunology and immuno-oncology, and we are very pleased to
have hired
Recent Highlights and Events
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SER-109 ECOSPOR III Phase 3 Study: Enrollment for ECOSPOR III
remains ongoing with approximately 100 clinical sites open across the
U.S. and
Canada . Study enrollment has been impacted by the widespread availability of unapproved fecal microbiota transplantation. The Company is considering alternatives, including study design modification, to expedite the availability of clinical results. Based on ECOSPOR III screening to date, 38% of subjects screened have had a negative C. difficile toxin test, despite having a positive C. difficile PCR test. In agreement with recent clinical guidelines, these subjects were deemed to not have an active C. difficile infection and were not eligible for study inclusion. These data provide additional support for our important requirement of a positive toxin test implemented in ECOSPOR III, and suggest that C. difficile clinical studies relying on PCR-based testing alone may include a significant proportion of subjects without active disease. - New data supporting SER-109 activity presented at ID Week 2018 conference: SER-109 data from the completed Phase 2 study provided insights into the potential mechanism of action of microbiome therapeutics for C. difficile infection. Presented results showed that SER-109 administration led to changes in the metabolic products created by the microbiome, including higher concentrations of secondary bile acids thought to be inhibitory to C. difficile growth.
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SER-287 development activity: The Company has made operational
progress towards initiating a SER-287 Phase 2b clinical study in
patients with active mild-to-moderate ulcerative colitis (UC). To
expedite the time and resources required to obtain top-line results
from this study, the Company has modified the previously planned
four-arm placebo-controlled study design into a smaller, three-arm
study in approximately 200 patients that will include two different
doses of SER-287, both following pretreatment with oral vancomycin,
and a placebo arm. Seres has designed this study as a potentially
pivotal trial, and the Company is awaiting feedback from the
FDA on this final study design.
Based on modification to the Nestlé Health Science collaboration agreement, Seres now expects to receive$40 million in milestone payments from Nestlé Health Science following initiation of the SER-287 Phase 2b study. Because the SER-287 Phase 2b study could serve as a pivotal trial, the parties agreed that at initiation of the SER-287 Phase 2b study Seres would receive$40 million in contractual payments corresponding to both the Phase 2 milestone and a payment of the Phase 3 milestone.
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SER-401 immuno-oncology development activity: In collaboration
with the
Parker Institute for Cancer Immunotherapy andMD Anderson Cancer Center , Seres is continuing activities to prepare the evaluation of the potential for SER-401 to augment checkpoint inhibitor response in patients with metastatic melanoma. -
New Chief Medical Officer: Seres appointed
Kevin Horgan , M.D., as Executive Vice President and Chief Medical Officer. Dr. Horgan will lead Seres’ clinical development, clinical operations, regulatory affairs, and medical affairs functions, and report directly to Dr. Pomerantz. He succeeds Seres’ outgoing Chief Medical Officer,Michele Trucksis , Ph.D., M.D., who will continue to provide clinical consulting services to the Company. Over a three-decade academic and industry career, Dr. Horgan has contributed to the development and approval of multiple therapeutics across immunology and oncology indications. Most recently, Dr. Horgan was Vice President of Clinical Development atAstraZeneca where he led the development of combination immuno-oncology programs. Dr. Horgan earned his medical degree from University College Cork inIreland and did his medical residency atThe Johns Hopkins Hospital inBaltimore, Maryland .
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, cash equivalents and investments balance during
the quarter was
Conference Call Information
Seres’ management will host a conference call today,
A webcast replay will be available on the Seres website beginning approximately two hours after the event and will be archived for at least 21 days.
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 our development plans, the ability of ECOSPOR III to support SER-109 approval, the promise and potential impact of any of our microbiome therapeutics or clinical trial data, timing of and plans to initiate clinical studies of SER-287 and SER-401, the timing and results of any clinical studies, and the sufficiency of cash to fund operations.
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; our limited operating
history; our unproven approach to therapeutic intervention; the lengthy,
expensive, and uncertain process of clinical drug development; our
reliance on third parties and collaborators to conduct our clinical
trials, manufacture our product candidates, and develop and
commercialize our product candidates, if approved; our lack of
experience in manufacturing, selling, marketing, and distributing our
product candidates; failure to compete successfully against other drug
companies; protection of our proprietary technology and the
confidentiality of our trade secrets; potential lawsuits for, or claims
of, infringement of third-party intellectual property or challenges to
the ownership of our intellectual property; our patents being found
invalid or unenforceable; our ability to retain key personnel and to
manage our growth; the potential volatility of our common stock; and our
management and principal stockholders have the ability to control or
significantly influence our business. These and other important factors
discussed under the caption “Risk Factors” in our Quarterly Report on
Form 10-Q filed with the
SERES THERAPEUTICS, INC. |
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CONDENSED CONSOLIDATED BALANCE SHEETS |
||||||||||
(unaudited, in thousands, except share and per share data) |
||||||||||
September 30, |
December 31, | |||||||||
2018 | 2017 | |||||||||
Assets | ||||||||||
Current assets: | ||||||||||
Cash and cash equivalents | $ | 55,713 | $ | 36,088 | ||||||
Investments | 17,177 | 113,895 | ||||||||
Prepaid expenses and other current assets | 6,556 | 5,095 | ||||||||
Total current assets | 79,446 | 155,078 | ||||||||
Property and equipment, net | 28,083 | 32,931 | ||||||||
Restricted cash | 1,513 | 1,513 | ||||||||
Total assets | $ | 109,042 | $ | 189,522 | ||||||
Liabilities and Stockholders’ Equity/(Deficit) | ||||||||||
Current liabilities: | ||||||||||
Accounts payable | $ | 6,475 | $ | 7,033 | ||||||
Accrued expenses and other current liabilities | 14,634 | 12,513 | ||||||||
Deferred revenue - related party | 17,901 | 12,079 | ||||||||
Total current liabilities | 39,010 | 31,625 | ||||||||
Lease incentive obligation, net of current portion | 7,685 | 8,989 | ||||||||
Deferred rent | 2,229 | 2,233 | ||||||||
Deferred revenue, net of current portion - related party | 89,554 | 84,847 | ||||||||
Other long-term liabilities | 1,129 | 1,129 | ||||||||
Total liabilities | 139,607 | 128,823 | ||||||||
Commitments and contingencies | ||||||||||
Stockholders’ equity/(deficit): | ||||||||||
Preferred stock, $0.001 par value; 10,000,000 shares authorized at September 30, 2018 and December 31, 2017; no shares issued and outstanding at September 30, 2018 and December 31, 2017 |
— | — | ||||||||
Common stock, $0.001 par value; 200,000,000 shares authorized at September 30, 2018 and December 31, 2017; 40,844,455 and 40,571,015 shares issued and outstanding at September 30, 2018 and December 31, 2017, respectively |
41 | 40 | ||||||||
Additional paid-in capital | 337,486 | 324,376 | ||||||||
Accumulated other comprehensive loss | (9 | ) | (146 | ) | ||||||
Accumulated deficit | (368,083 |
) |
(263,571 | ) | ||||||
Total stockholders’ equity/(deficit) |
(30,565 |
) |
60,699 | |||||||
Total liabilities and stockholders’ equity | $ | 109,042 | $ | 189,522 | ||||||
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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2018 | 2017 | 2018 | 2017 | ||||||||||||||
Revenue: | |||||||||||||||||
Collaboration revenue - related party | $ | 8,684 | $ | 23,015 | $ | 16,721 | $ | 29,044 | |||||||||
Grant revenue | 371 | — | 917 | — | |||||||||||||
Total revenue | 9,055 | 23,015 | 17,638 | 29,044 | |||||||||||||
Operating expenses: | |||||||||||||||||
Research and development expenses | 23,675 | 22,210 | 71,188 | 65,413 | |||||||||||||
General and administrative expenses | 7,591 | 8,119 | 25,063 | 25,251 | |||||||||||||
Total operating expenses | 31,266 | 30,329 | 96,251 | 90,664 | |||||||||||||
Loss from operations | (22,211 | ) | (7,314 |
) |
(78,613 | ) | (61,620 | ) | |||||||||
Other income (expense): | |||||||||||||||||
Interest income (expense), net | 262 | 379 | 958 | 1,193 | |||||||||||||
Total other income (expense), net | 262 | 379 | 958 | 1,193 | |||||||||||||
Net loss | $ | (21,949 | ) | $ | (6,935 | ) | $ | (77,655 | ) | $ | (60,427 | ) | |||||
Net loss per share attributable to common stockholders, basic
and diluted |
$ | (0.54 | ) | $ | (0.17 | ) | $ | (1.91 | ) | $ | (1.49 | ) | |||||
Weighted average common shares outstanding, basic and diluted | 40,806,413 | 40,494,049 | 40,699,422 | 40,419,522 | |||||||||||||
Other comprehensive income: | |||||||||||||||||
Unrealized gain on investments, net of tax of $0 | $ | 20 | $ | 77 | $ | 137 | $ | 50 | |||||||||
Total other comprehensive income | 20 | 77 | 137 | 50 | |||||||||||||
Comprehensive loss | $ | (21,929 | ) | $ | (6,858 | ) | $ | (77,518 | ) | $ | (60,377 | ) | |||||
View source version on businesswire.com: https://www.businesswire.com/news/home/20181108005072/en/
Source:
IR or PR Contact:
Seres Therapeutics
Carlo Tanzi,
Ph.D., 617-203-3467
Vice President, Investor Relations and
Corporate Communications
ctanzi@serestherapeutics.com