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– 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
“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,”
Recent Highlights and Events
Positive clinical results from SER-287 Phase 1b study: Seres
reported positive topline results from a SER-287 Phase 1b
placebo-controlled induction study in patients with mild-to-moderate
Ulcerative Colitis (UC) who were failing current first line therapies.
SER-287 is a biologically sourced Ecobiotic® microbiome therapeutic
candidate with the potential to offer UC patients a novel,
non-immunosuppressive treatment option. SER-287 administration
resulted in a dose-dependent improvement of both clinical remission
rates and endoscopic scores.
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 FDAdefinition, 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
FDAregulatory 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.
Ongoing progress with SER-109 ECOSPOR III Phase 3 study: Seres
is advancing its SER-109 Phase 3 clinical study, which plans to enroll
approximately 320 patients with multiply recurrent C. difficile
infection, at sites in both the U.S. and
Canada. The SER-109 Phase 3 study obtained clinical trial application clearance from Health Canada, and Canadian clinical sites are expected to be opened in the coming weeks. Based on interactions with the FDA, ECOSPOR III has been designated a Phase 3 trial and the Company expects that this single pivotal study may support SER-109 registration and approval. SER-109 has been designated by the FDAas a Breakthrough Therapy and also has obtained Orphan Drug designation.
- SER-262 Phase 1b study progress: Seres is advancing the SER-262 Phase 1b, dose-escalating, first-in-human, clinical study in patients with primary C. difficile infection. SER-262, a rationally-designed, fermented, Ecobiotic® microbiome therapeutic candidate, is the first synthetically-derived and designed microbiome therapeutic candidate to reach clinical-stage development. Topline data from the study are expected in early 2018.
CARB-X grant award: Seres was awarded a CARB-X
(Combating Antibiotic Resistant Bacteria Biopharmaceutical
Accelerator) grant to support early development efforts for
preclinical-stage program SER-155, to prevent antibiotic-resistant
bacterial infections and graft versus host disease in patients who
have received either allogeneic stem cell or solid organ
transplantation. The CARB-X grant provides Seres with up to
$2.5 millionof research funding with potential for an additional $3.1 millionupon completion of milestones.
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 Nestlé Health Science.
Research and 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.
General 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 facility costs.
During the third quarter, the Company received a
The decrease in our cash, cash equivalents and investments balance
during the quarter was $3.9 million. Seres ended the third quarter with
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 approximately 21 days.
About Seres Therapeutics
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 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; our 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
SERES THERAPEUTICS, INC.
CONDENSED CONSOLIDATED BALANCE SHEETS
(unaudited, in thousands, except share and per share data)
|September 30,||December 31,|
|Cash and cash equivalents||$||46,025||$||54,539|
|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|
|Liabilities and Stockholders’ Equity|
|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 revenue, net of current portion - related party||87,712||96,756|
|Commitments and contingencies|
|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, $0.001 par value; 200,000,000 shares authorized at September 30, 2017 and December 31, 2016; 40,512,639 and 40,355,753 shares issued and outstanding at September 30, 2017 and December 31, 2016, respectively||40||40|
|Additional paid-in capital||320,189||306,931|
|Accumulated other comprehensive loss||(99||)||(149||)|
|Total stockholders’ equity||85,512||132,631|
|Total liabilities and stockholders’ equity||$||211,882||$||272,646|
SERES THERAPEUTICS, INC.
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS
(unaudited, in thousands, except share and per share data)
|Three Months Ended September 30,||Nine Months Ended September 30,|
|Collaboration revenue - related party||$||23,015||$||13,015||$||29,044||$||18,730|
|Research and development expenses||22,210||24,143||65,413||61,733|
|General and administrative expenses||8,119||7,967||25,251||24,163|
|Total operating expenses||30,329||32,110||90,664||85,896|
|Loss from operations||(7,314||)||(19,095||)||(61,620||)||(67,166||)|
|Other income (expense):|
|Other income (expense)||(123||)||(312||)||(699||)||(620||)|
|Total other income, net||379||407||1,193||863|
|Net loss per share attributable to common stockholders, basic and diluted||$||(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||)|
IR or PR Contact:
Carlo Tanzi, Ph.D., 617-203-3467
Head of Investor Relations and Corporate Communications