Seres Therapeutics Reports Second Quarter Financial Results and Provides Operational Updates
- Company preparing to initiate SER-287 Phase 2b study for ulcerative colitis -
- Initiation of SER-401 clinical study expected in patients with metastatic melanoma treated with checkpoint inhibitors by year end -
- Recent Seres R&D event highlighted microbiome scientific leadership across several clinical and preclinical programs -
- Conference call at
“Seres has made excellent progress across our deep pipeline of early and
late, clinical and preclinical stage microbiome programs, and we were
pleased to demonstrate the depth of our scientific leadership in this
new therapeutic modality at our recent investor R&D event highlighting
how we can change immunological tone using microbiome drugs.” said Roger
J. Pomerantz, M.D., President, CEO and Chairman of Seres. “We continue
to execute our SER-109 Phase 3 clinical study in patients with
multiply-recurrent C. difficile infection. Following constructive
meetings with the
Recent Highlights and Events
-
New analysis of clinical samples and preclinical data presented at
May 24 th R&D event: Seres provided an overview of its R&D approach to developing novel microbiome therapeutics and presented new scientific data regarding its scientific platform and its clinical and preclinical stage programs. Data were presented highlighting two bacterial pathways involving bile acid and tryptophan metabolism that modulate the immune system and were correlated with clinical outcome in the SER-287 Phase 1b study. Recent transcriptomic data from mucosal biopsies taken before and after SER-287 administration provides additional clinical evidence linking SER-287 administration to the modulation of host pathways, including innate immune signaling, epithelial barrier integrity, antibacterial defenses, and short chain fatty acid metabolism. Seres remains the only company with human clinical microbiome data sets, which are critical in determining mechanism of action, and the rational design of follow-on drugs. Seres also provided an overview of the published clinical data from its collaborators atMD Anderson Cancer Center and its own pre-clinical data supporting the potential for microbiome therapeutics to augment checkpoint inhibitor drugs in the PD-(L)1 pathway. The R&D day presentation is available on the Investor & Media section of Seres’ website and is expected to be archived for at least the next 21 days. -
SER-287 late stage development activity: The Company expects to
initiate the planned SER-287 Phase 2b clinical study in patients with
active mild-to-moderate ulcerative colitis (UC) in the coming months.
The SER-287 Phase 1b placebo-controlled induction study of 58 patients
with mild-to-moderate active UC who were failing current therapies
demonstrated that SER-287 administration resulted in a dose-dependent
improvement of both clinical remission rates and endoscopic scores.
The SER-287 safety and tolerability profile was favorable, with no
imbalance in adverse events in patients treated with SER-287, as
compared to placebo. Analyses of study microbiome data demonstrated
that SER-287 induced dose-dependent engraftment of SER-287-derived
bacterial species and identified specific bacterial signatures linked
to remission. SER-287 has been granted Orphan Drug Designation by the
Food & Drug Administration (FDA ) for the treatment of UC in pediatric patients. - Digestive Disease Week 2018 conference attendance: Seres presented various data sets and held a scientific symposium highlighting SER-287 clinical and microbiome results as well as the promise of microbiome therapeutics for UC, and other forms of inflammatory bowel disease.
- Continued execution of the SER-109 ECOSPOR III Phase 3 study: Seres continues to enroll its SER-109 Phase 3 clinical study in patients with multiply-recurrent C. difficile infection, at sites in both the U.S. and Canada. Several factors have impacted enrollment including primary use of C. difficile toxin testing to increase the accuracy of proper patient inclusion, the widespread availability of unapproved and unregulated fecal microbiota transplantation, and the fact that multiply recurrent C. difficile infection is an orphan disease. It remains premature to provide an estimate for the timing of study enrollment completion. The Company has made various operational changes to further expedite study execution. ECOSPOR III has been designated a Phase 3 trial and the Company expects that this single pivotal study could support SER-109 registration and approval. SER-109 has been designated by the FDA as a Breakthrough Therapy and has also been given Orphan Drug Designation.
-
Preparations for SER-401 immuno-oncology clinical study: In
collaboration with the
Parker Institute for Cancer Immunotherapy and MD Anderson Cancer Center, Seres is preparing to initiate a clinical study later this year to evaluate the potential for SER-401, a microbiome therapy, to augment checkpoint inhibitor response in patients with metastatic melanoma. We expect this to be the first microbiome drug study in the Immuno-oncology therapeutic area. - Completion of SER-262 clinical study: Seres obtained clinical data from the final patient cohort (cohort 8 of 8) of the SER-262 Phase 1b study in patients with primary C. difficile infection. SER-262 is the first rationally-designed, fermented microbiome therapeutic candidate to be evaluated in clinical development. The full study clinical data remains consistent with the top line results from the first 7 cohorts which have previously been reported. The observed recurrence rate of C. difficile was statistically significantly lower in patients treated with vancomycin and SER-262, as compared to those patients treated with metronidazole and SER-262. Phase 1b microbiome data suggest that treatment with vancomycin, followed by SER-262, results in more robust and kinetically more rapid engraftment, and thus may lead to corresponding clinical efficacy. Microbiome and metabolomic analyses from the study remain ongoing. Seres plans to present full study results at an upcoming medical conference.
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, 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. |
|||||||||||
June 30, 2018 |
December 31, 2017 |
||||||||||
Assets | |||||||||||
Current assets: | |||||||||||
Cash and cash equivalents | $ | 57,960 | $ | 36,088 | |||||||
Investments | 38,106 | 113,895 | |||||||||
Prepaid expenses and other current assets | 5,471 | 5,095 | |||||||||
Total current assets | 101,537 | 155,078 | |||||||||
Property and equipment, net | 29,904 | 32,931 | |||||||||
Restricted cash | 1,513 | 1,513 | |||||||||
Total assets | $ | 132,954 | $ | 189,522 | |||||||
Liabilities and Stockholders’ Equity/(Deficit) | |||||||||||
Current liabilities: | |||||||||||
Accounts payable | $ | 5,158 | $ | 7,033 | |||||||
Accrued expenses and other current liabilities | 13,651 | 12,513 | |||||||||
Deferred revenue - related party | 17,962 | 12,079 | |||||||||
Total current liabilities | 36,771 | 31,625 | |||||||||
Lease incentive obligation, net of current portion | 8,119 | 8,989 | |||||||||
Deferred Rent | 2,231 | 2,233 | |||||||||
Deferred revenue, net of current portion - related party | 97,959 | 84,847 | |||||||||
Other long-term liabilities | 1,129 | 1,129 | |||||||||
Total liabilities | 146,209 | 128,823 | |||||||||
Commitments and contingencies | |||||||||||
Stockholders’ equity: | |||||||||||
Preferred stock, $0.001 par value; 10,000,000 shares authorized at June 30, 2018 and December 31, 2017; no shares issued and outstanding at June 30, 2018 and December 31, 2017 | — | — | |||||||||
Common stock, $0.001 par value; 200,000,000 shares authorized at June 30, 2018 and December 31, 2017; 40,754,681 and 40,571,015 shares issued and outstanding at June 30, 2018 and December 31, 2017, respectively | 40 | 40 | |||||||||
Additional paid-in capital | 332,870 | 324,376 | |||||||||
Accumulated other comprehensive loss | (29 | ) | (146 | ) | |||||||
Accumulated deficit | (346,136 | ) | (263,571 | ) | |||||||
Total stockholders’ equity/(deficit) | (13,255 | ) | 60,699 | ||||||||
Total liabilities and stockholders’ equity | $ | 132,954 | $ | 189,522 | |||||||
SERES THERAPEUTICS, INC. |
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Three Months Ended June 30, | Six Months Ended June 30, | ||||||||||||||||||
2018 | 2017 | 2018 | 2017 | ||||||||||||||||
Revenue: | |||||||||||||||||||
Collaboration revenue - related party | $ | 4,271 | $ | 3,014 | $ | 8,037 | $ | 6,029 | |||||||||||
Grant revenue | 341 | — | 546 | — | |||||||||||||||
Total revenue | 4,612 | 3,014 | 8,583 | 6,029 | |||||||||||||||
Operating expenses: | |||||||||||||||||||
Research and development expenses | 24,053 | 23,060 | 47,513 | 43,203 | |||||||||||||||
General and administrative expenses | 8,695 | 8,370 | 17,472 | 17,132 | |||||||||||||||
Total operating expenses | 32,748 | 31,430 | 64,985 | 60,335 | |||||||||||||||
Loss from operations | (28,136 | ) | (28,416 | ) | (56,402 | ) | (54,306 | ) | |||||||||||
Other income (expense): | |||||||||||||||||||
Interest income | 349 | 615 | 696 | 1,390 | |||||||||||||||
Other income (expense) | — | (217 | ) | — | (576 | ) | |||||||||||||
Total other income, net | 349 | 398 | 696 | 814 | |||||||||||||||
Net loss | $ | (27,787 | ) | $ | (28,018 | ) | $ | (55,706 | ) | $ | (53,492 | ) | |||||||
Net loss per share attributable to common stockholders, basic and diluted | $ | (0.68 | ) | $ | (0.69 | ) | $ | (1.37 | ) | $ | (1.32 | ) | |||||||
Weighted average common shares outstanding, basic and diluted | 40,661,464 | 40,394,605 | 40,645,040 | 40,381,643 | |||||||||||||||
Other comprehensive (loss) income: | |||||||||||||||||||
Unrealized (loss) gain on investments, net of tax of $0 | 77 | $ | (25 | ) | $ | 117 | $ | (27 | ) | ||||||||||
Total other comprehensive (loss) income | 77 | (25 | ) | 117 | (27 | ) | |||||||||||||
Comprehensive loss | $ | (27,710 | ) | $ | (28,043 | ) | $ | (55,589 | ) | $ | (53,519 | ) |
View source version on businesswire.com: https://www.businesswire.com/news/home/20180802005177/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