Seres Therapeutics Reports Fourth Quarter and Full Year Financial Results and Provides Operational Updates
- Initiated SER-287 Phase 2b study in mild-to-moderate ulcerative colitis -
- Initiated SER-401 Phase 1b study in metastatic melanoma -
- Conference call at
“This has been a highly eventful period where we advanced our microbiome
clinical programs and implemented a more focused R&D strategy. During
the last several months, we initiated two clinical studies and
implemented corporate changes to concentrate resources on the highest
priority programs,” said Eric Shaff, President and Chief Executive
Officer of
Seres also announced today the initiation of a SER-401 Phase 1b
study in patients with metastatic melanoma. SER-401 is an oral
microbiome therapeutic candidate sourced from healthy individuals
identified to have a microbiome bacterial signature similar to that
observed in immunotherapy responders. The Phase 1b study, conducted in
collaboration with
Recent Highlights and Events
- SER-109 Phase 3 study progress: Seres continues to recruit patients into the SER-109 Phase 3 study for recurrent C. difficile infection. The widespread use of fecal microbiota transplantation, an unapproved and uncontrolled practice, has impacted the enrollment rate of this placebo-controlled clinical trial. Seres is evaluating modification of the study design to expedite clinical results.
-
Corporate changes to focus on highest priority programs and
appointment of Chief Scientific Officer (
January 2019 ): The Company has concentrated resources on completing the SER-287 Phase 2b study in mild-to-moderate ulcerative colitis, the SER-109 Phase 3 study for recurrent C. difficile infection and the SER-401 Phase 1b study in metastatic melanoma. In addition, Seres will continue to advance its next generation, rationally-designed, fermented drug discovery capabilities, with a focus on SER-301 for ulcerative colitis. Seres made changes to its executive team and reduced its full-time workforce by approximately 30%.Matthew Henn , Ph.D., previously Executive Vice President and Head of Discovery and Microbiome R&D, was appointed Chief Scientific Officer. -
Chief Executive Officer appointed (
January 2019 ): Seres announced the appointment ofEric D. Shaff as President and Chief Executive Officer. Mr. Shaff, who was Chief Operating and Financial Officer, succeededRoger J. Pomerantz , M.D., who continues as Chair of Seres’ Board of Directors. -
SER-287 Phase 2b study initiated in ulcerative colitis (
January 2019 ): Seres announced the start of a Phase 2b trial, ECO-RESET, evaluating SER-287 in patients with active mild-to-moderate ulcerative colitis. Seres received$40 million in milestone payments associated with this study start from Nestlé Health Science. The Company obtained feedback from theFDA indicating that results from this study, in conjunction with data from a second pivotal study, could enable a Biologics License Application. The Company expects to complete trial enrollment by mid-2020. -
Chief Medical Officer appointed (
October 2018 ): Seres appointedKevin 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.
Financial Results
Seres reported a net loss of
Research and development expenses for the fourth quarter 2018 were
General and administrative expenses for the fourth quarter were
The increase in the Company’s 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. |
||||||||||
December 31, | ||||||||||
2018 | 2017 | |||||||||
Assets | ||||||||||
Current assets: | ||||||||||
Cash and cash equivalents | $ | 85,820 | $ | 36,088 | ||||||
Investments | — | 113,895 | ||||||||
Prepaid expenses and other current assets | 6,845 | 5,095 | ||||||||
Total current assets | 92,665 | 155,078 | ||||||||
Property and equipment, net | 26,294 | 32,931 | ||||||||
Restricted investments | 1,400 | 1,400 | ||||||||
Restricted cash | 113 | 113 | ||||||||
Total assets | $ | 120,472 | $ | 189,522 | ||||||
Liabilities and Stockholder's Equity (Deficit) | ||||||||||
Current liabilities: | ||||||||||
Accounts payable | $ | 6,415 | $ | 7,033 | ||||||
Accrued expenses and other current liabilities | 15,207 | 12,513 | ||||||||
Deferred revenue - related party | 20,419 | 12,079 | ||||||||
Total current liabilities | 42,041 | 31,625 | ||||||||
Lease incentive obligation, net of current portion | 7,250 | 8,989 | ||||||||
Deferred rent | 2,216 | 2,233 | ||||||||
Deferred revenue, net of current portion - related party | 116,840 | 84,847 | ||||||||
Other long-term liabilities | 170 | 1,129 | ||||||||
Total liabilities | 168,517 | 128,823 | ||||||||
Commitments and contingencies | ||||||||||
Stockholders’ equity (deficit): | ||||||||||
Preferred stock, $0.001 par value; 10,000,000 shares authorized at
December 31, 2018
and 2017; no shares issued and outstanding at December 31, 2018 and 2017 |
— | — | ||||||||
Common stock, $0.001 par value; 200,000,000 shares authorized at
December 31, 2018
and 2017; 40,936,735 and 40,571,015 shares issued and outstanding at December 31, 2018 and 2017 |
41 | 40 | ||||||||
Additional paid-in capital | 341,284 | 324,376 | ||||||||
Accumulated other comprehensive income (loss) | — | (146 | ) | |||||||
Accumulated deficit | (389,370 | ) | (263,571 | ) | ||||||
Total stockholders’ equity (deficit) | (48,045 | ) | 60,699 | |||||||
Total liabilities and stockholders’ equity (deficit) | $ | 120,472 | $ | 189,522 | ||||||
SERES THERAPEUTICS, INC. CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS (In thousands, except share and per share data) |
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Year Ended December 31, | |||||||||||||||
2018 | 2017 | 2016 | |||||||||||||
Revenue: | |||||||||||||||
Collaboration revenue - related party | $ | 26,917 | $ | 32,100 | $ | 21,766 | |||||||||
Grant revenue | 1,350 | — | — | ||||||||||||
Total revenue | 28,267 | 32,100 | 21,766 | ||||||||||||
Operating expenses: | |||||||||||||||
Research and development expenses | $ | 95,955 | 89,455 | 81,989 | |||||||||||
General and administrative expenses | 32,596 | 34,040 | 32,616 | ||||||||||||
Total operating expenses | 128,551 | 123,495 | 114,605 | ||||||||||||
Loss from operations | (100,284 | ) | (91,395 | ) | (92,839 | ) | |||||||||
Other income (expense): | |||||||||||||||
Interest income (expense), net | 1,172 | 1,590 | 1,260 | ||||||||||||
Other income | 170 | 425 | — | ||||||||||||
Total other income (expense), net | 1,342 | 2,015 | 1,260 | ||||||||||||
Net loss | $ | (98,942 | ) | (89,380 | ) | (91,579 | ) | ||||||||
Net loss per share attributable to common stockholders, basic and diluted | $ | (2.43 | ) | $ | (2.21 | ) | $ | (2.30 | ) | ||||||
Weighted average common shares outstanding, basic and diluted | 40,743,492 | 40,449,410 | 39,846,928 | ||||||||||||
Other comprehensive income (loss): | |||||||||||||||
Unrealized gain (loss) on investments, net of tax of $0 | 146 | 3 | (179 | ) | |||||||||||
Total other comprehensive income (loss) | 146 | 3 | (179 | ) | |||||||||||
Comprehensive loss | $ | (98,796 | ) | $ | (89,377 | ) | $ | (91,758 | ) |
View source version on businesswire.com: https://www.businesswire.com/news/home/20190306005199/en/
Source:
IR or PR Contact:
Carlo Tanzi, Ph.D., Seres Therapeutics,
617-203-3467
Vice President, Investor Relations and Corporate
Communications
ctanzi@serestherapeutics.com