Full Press Release Details
Seres Therapeutics Reports Third Quarter 2017 Financial Results and Provides Update on
Operational Progress
Positive results from SER-287 Phase 1b study in mild-to-moderate Ulcerative Colitis;
Company to move program into further development
Company awarded CARB-X grant to advance SER-155 for allogeneic stem cell and solid
organ transplantation
Conference call at 8:00 a.m. ET today
CAMBRIDGE, Mass., Nov. 8, 2017 Seres Therapeutics, Inc. (NASDAQ:MCRB) today reported third quarter 2017 financial results and provided a
progress update on multiple microbiome clinical programs, including three clinical-stage therapeutic candidates seeking to address serious human diseases and the SER-155 preclinical program for patients receiving solid organ and stem cell
Seres continues to make excellent progress advancing both our clinical stage and preclinical stage microbiome pipeline assets. We
obtained encouraging clinical results with SER-287 demonstrating proof of concept in Ulcerative Colitis, and we continued to enroll our SER-109 Phase 3 and SER-262 Phase 1b programs for C. difficile infection. In addition, we were awarded a
grant to advance our preclinical program SER-155, for allogeneic stem cell and solid organ transplant patients, said Roger J. Pomerantz, M.D., President, CEO and Chairman of Seres. In the coming months, we look forward to obtaining
microbiome data from the SER-287 Phase 1b study and we plan to move SER-287 forward in Ulcerative Colitis. In early 2018, we anticipate results from the SER-262 Phase 1b study in primary C. difficile infection.
Recent Highlights and Events
The highest efficacy was observed in the vancomycin pre-treatment, daily SER-287 arm of the
study. Based on an intent-to-treat observed data analysis, 40% (6 of 15 subjects) reached clinical remission; in the placebo group 10% (1 of 10) achieved this endpoint. Based on an intent-to-treat missing data counted as
failure, where the use of prohibited additional UC therapies was also counted as failure in the analysis, 40% (6 of 15 subjects) reached clinical remission; in the placebo group 0% (0 of 11) achieved this endpoint. This result was
statistically significant (p-value = 0.0237). In addition to the clinical remission endpoint, compelling treatment effects of a similar magnitude were also observed on direct endoscopic measures in both statistical analyses.
The SER-287 Phase 1b results were also analyzed under the new U.S. Food and Drug Administration (FDA) definition for clinical remission and
endoscopy, and the efficacy results for the SER-287 daily arm compared to the placebo arm were found to be highly compelling. Even in this modestly sized initial trial of SER-287, the results were statistically significant when analyzed by the
missing data counted as failure approach. Per the new FDA definition, clinical response is not defined, nor recommended as a primary endpoint.
High clinical response placebo rates that were not differentiated from the SER-287 treatment arms were observed. Clinical response is a
subjective endpoint that is prone to high variability and high placebo rates, as previously observed in several other UC trials. As a result, response rates are difficult to interpret in UC clinical studies, particularly those from modestly-sized
trials. In the most recently available FDA regulatory guidance, the agency now recommends the use of clinical remission, and not clinical response, as the primary endpoint in UC registrational studies.
The SER-287 safety and tolerability profile was favorable, and study results demonstrated no imbalance in adverse events in patients treated
with SER-287 as compared to patients treated with placebo. There were no drug-related serious adverse events associated with SER-287.
Microbiome data, a co-primary endpoint of the study, are expected in the coming months. Seres intends to work to rapidly advance SER-287 into
further development for UC. The Company also continues to assess development in Crohn s disease and pediatric forms of inflammatory bowel disease.
Seres reported a net loss of $6.9 million for the third quarter of 2017, as compared to a net loss of $18.7 million for the same period in
2016. The third quarter net loss was driven primarily by clinical and development expenses, personnel expenses, and ongoing development of the Company s microbiome therapeutics platform. The third quarter net loss figure was inclusive
of $23.0 million in recognized revenue associated with the Company s collaboration with Nestl Health Science.
development expenses for the third quarter were $22.2 million, as compared to $24.1 million for the same period in 2016. The research and development expense was primarily related to Seres microbiome therapeutics platform, the
clinical development of SER-109, SER-262 and SER-287, as well as the Company s SER-301, SER-155 and immuno-oncology preclinical programs.
and administrative expenses for the third quarter were $8.1 million, as compared to $8.0 million for the same period in the prior year. General and administrative expenses were primarily due to headcount, professional fees, and
During the third quarter, the Company received a $20.0 million milestone payment associated with the start of the SER-109 Phase 3 study,
under its collaboration agreement with Nestl .
The decrease in our cash, cash equivalents and investments balance during the quarter was $3.9
million. Seres ended the third quarter with approximately $171.3 million in cash, cash equivalents and investments.
Conference Call Information
Seres management will host a conference call today, November 8, 2017, at 8:00 a.m. ET. To access the conference call, please dial
844-277-9450 (domestic) or (336) 525-7139 (international) and reference the conference ID number 1184039. Accompanying slides will be made available on the Seres website prior to the call. To join the live webcast, please visit the
Investors and Media section of the Seres website at www.serestherapeutics.com.
A webcast replay will be available on the Seres website beginning approximately two hours after the event and
will be archived for approximately 21 days.
About Seres Therapeutics
Seres Therapeutics, Inc., is a leading microbiome therapeutics platform company developing a novel class of biological drugs that are designed to treat disease
by restoring the function of a dysbiotic microbiome, where the natural state of bacterial diversity and function is imbalanced. Seres lead program, SER-109, has obtained Breakthrough Therapy and Orphan Drug designations from the U.S. Food and
Drug Administration and is in Phase 3 development for multiply recurrent C. difficile infection. Seres clinical candidate SER-287 has successfully completed a Phase 1b study in patients with mild-to-moderate Ulcerative Colitis. Seres is
Forward-looking Statements
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 potential advancement of our preclinical program SER-155 and the benefits of any collaboration therein, the timing and results of additional data from the SER-287
Phase 1b study, the timing and potential advancement of SER-287, the potential development of programs in Crohn s disease or pediatric forms of inflammatory bowel disease, the enrollment of patients in ECOSPOR III, the potential for ECOSPOR III
to support SER-109 registration and approval, the timing and results of the SER-262 Phase 1b study, the potential to receive future milestone payments under the CARB-X grant, and any benefits resulting from the CARB-X grant.
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, including potential delays in regulatory approval; 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;
patents being found invalid or unenforceable; risks associated with international operations; our ability to retain key personnel and to manage our growth; the potential volatility of our common
stock; our management and principal stockholders have the ability to control or significantly influence our business; and we are currently subject to securities class action litigation. These and other important factors discussed under the caption
Risk Factors in our Quarterly Report on Form 10-Q filed with the Securities and Exchange Commission, or SEC, on August 3, 2017 and our other reports filed with the SEC, including the Quarterly Report we intend to file later today,
could cause actual results to differ materially from those indicated by the forward-looking statements made in this press release. Any such forward-looking statements represent management s estimates as of the date of this press release. While
we may elect to update such forward-looking statements at some point in the future, we disclaim any obligation to do so, even if subsequent events cause our views to change. These forward-looking statements should not be relied upon as representing
our views as of any date subsequent to the date of this press release.
SERES THERAPEUTICS, INC.
CONDENSED CONSOLIDATED BALANCE SHEETS
(unaudited, in thousands, except share and per share data)
| September 30, | December 31, | |||||||
| 2017 | 2016 | |||||||
| Assets | ||||||||
| Current assets: | ||||||||
| Cash and cash equivalents | $ | 46,025 | $ | 54,539 | ||||
| Investments | 125,274 | 138,704 | ||||||
| Prepaid expenses and other current assets | 5,346 | 5,126 | ||||||
| Total current assets | 176,645 | 198,369 | ||||||
| Property and equipment, net | 33,724 | 36,125 | ||||||
| Long-term investments | 36,752 | |||||||
| Restricted cash | 1,513 | 1,400 | ||||||
| Total assets | $ | 211,882 | $ | 272,646 | ||||
| Liabilities and Stockholders Equity | ||||||||
| Current liabilities: | ||||||||
| Accounts payable | $ | 5,380 | $ | 7,587 | ||||
| Accrued expenses and other current liabilities | 9,594 | 10,812 | ||||||
| Deferred revenue related party | 12,058 | 12,058 | ||||||
| Total current liabilities | 27,032 | 30,457 | ||||||
| Lease incentive obligation, net of current portion | 9,424 | 10,730 | ||||||
| Deferred rent | 2,202 | 2,072 | ||||||
| Deferred revenue, net of current portion related party | 87,712 | 96,756 | ||||||
| Total liabilities | 126,370 | 140,015 | ||||||
| Commitments and contingencies | ||||||||
| Stockholders equity: | ||||||||
| Preferred stock, $0.001 par value; 10,000,000 shares authorized at September 30, 2017 and December 31, 2016; no shares issued and outstanding at September 30, 2017 and December 31, 2016 | ||||||||
| Common stock, $0.001 par value; 200,000,000 shares authorized at September 30, 2017 and December 31, 2016; 40,512,639 and 40,355,753 shares issued and outstanding at September 30, 2017 and December 31, 2016, respectively | 40 | 40 | ||||||
| Additional paid-in capital | 320,189 | 306,931 | ||||||
| Accumulated other comprehensive loss | (99 | ) | (149 | ) | ||||
| Accumulated deficit | (234,618 | ) | (174,191 | ) | ||||
| Total stockholders equity | 85,512 | 132,631 | ||||||
| Total liabilities and stockholders equity | $ | 211,882 | $ | 272,646 |
SERES THERAPEUTICS, INC.
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS
(unaudited, in thousands, except share and per share data)
| Three Months Ended September 30, | Nine Months Ended September 30, | |||||||||||||||
| 2017 | 2016 | 2017 | 2016 | |||||||||||||
| Revenue: | ||||||||||||||||
| Collaboration revenue related party | $ | 23,015 | $ | 13,015 | $ | 29,044 | $ | 18,730 | ||||||||
| Total revenue | 23,015 | 13,015 | 29,044 | 18,730 | ||||||||||||
| Operating expenses: | ||||||||||||||||
| Research and development expenses | 22,210 | 24,143 | 65,413 | 61,733 | ||||||||||||
| General and administrative expenses | 8,119 | 7,967 | 25,251 | 24,163 | ||||||||||||
| Total operating expenses | 30,329 | 32,110 | 90,664 | 85,896 | ||||||||||||
| Loss from operations | (7,314 | ) | (19,095 | ) | (61,620 | ) | (67,166 | ) | ||||||||
| Other income (expense): | ||||||||||||||||
| Interest income | 502 | 719 | 1,892 | 1,483 | ||||||||||||
| Other income (expense) | (123 | ) | (312 | ) | (699 | ) | (620 | ) | ||||||||
| Total other income, net | 379 | 407 | 1,193 | 863 | ||||||||||||
| Net loss | $ | (6,935 | ) | $ | (18,688 | ) | $ | (60,427 | ) | $ | (66,303 | ) | ||||
| Net loss per share attributable to common stockholders, basic and diluted | $ | (0.17 | ) | $ | (0.46 | ) | $ | (1.49 | ) | $ | (1.67 | ) | ||||
| Weighted average common shares outstanding, basic and diluted | 40,494,049 | 40,235,623 | 40,419,522 | 39,676,085 | ||||||||||||
| Other comprehensive (loss) income: | ||||||||||||||||
| Unrealized (loss) gain on investments, net of tax of $0 | $ | 77 | $ | (150 | ) | $ | 50 | $ | (97 | ) | ||||||
| Total other comprehensive (loss) income | 77 | (150 | ) | 50 | (97 | ) | ||||||||||
| Comprehensive loss | $ | (6,858 | ) | $ | (18,838 | ) | $ | (60,377 | ) | $ | (66,400 | ) |
Carlo Tanzi, Ph.D., Seres Therapeutics, 617-203-3467
Head of Investor Relations and Corporate Communications