Seres Therapeutics Reports First Quarter 2017 Financial Results and Provides Update on Operational Progress
- Pre-enrollment activities underway for SER-109 ECOSPOR III clinical study initiation; Company expects study start in mid-year -
- Continued pipeline progress with both SER-287 and SER-262 Phase 1b studies; Data read-outs expected in the second half of 2017 -
- Conference call at
“Seres is making strong progress throughout our broad pipeline of
microbiome therapeutics.” said
Recent Highlights and Events
-
SER-109 ECOSPOR III clinical study planning following positive Type
B meeting with
FDA : Seres plans to initiate a new SER-109 clinical study (ECOSPOR III) in approximately 320 patients with multiply recurrent Clostridium difficile (C. difficile) infection. Study participants will be randomized 1:1 between SER-109 and placebo. Diagnosis of C. difficile infection for both study entry and for endpoint analysis will be confirmed by C. difficile cytotoxin assays. Patients in the SER-109 arm will receive a total SER-109 dose, administered over three days, approximately 10-fold higher than the dose used in the prior ECOSPOR study. ECOSPOR III will evaluate patients for 24 weeks and the primary endpoint will compare the C. difficile recurrence rate in subjects who receive SER-109 versus placebo at up to eight weeks after dosing. TheFDA has agreed that this new trial may qualify as a pivotal study with achievement of a persuasive clinical effect and addressingFDA requirements, including clinical and statistical factors, an adequately sized safety database, and certain CMC parameters.
The ECOSPOR III study protocol has been finalized, and the protocol has already been cleared by several institutional review boards. Seres has completed substantial clinical site feasibility work and has selected the large majority of ECOSPOR III investigator sites. ECOSPOR III subjects will include C. difficile patients being treated as outpatients, as well as those treated as inpatients located in hospitals, rehabilitation facilities and long term care facilities. Seres plans to utilize over 100 clinical sites in both the U.S. andCanada . The company expects to initiate ECOSPOR III in mid 2017.
-
Medical meeting oral presentation:
Michele Trucksis , M.D., Ph.D., Executive Vice President and Chief Medical Officer, delivered an oral presentation: SERES-004: First placebo-controlled trial of an investigational oral microbiome drug (SER-109) to reduce recurrence of Clostridium difficile infection at the 27thEuropean Congress of Clinical Microbiology and Infectious Diseases (ECCMID) meeting inVienna, Austria onApril 22, 2017 . - SER-287 Phase 1b study progress: Seres is advancing the SER-287 Phase 1b clinical study in subjects with mild-to-moderate ulcerative colitis, failing first line therapies. SER-287 is a biologically sourced Ecobiotic® microbiome therapeutic candidate. Seres activated additional SER-287 Phase 1b study clinical sites and the study enrolled an increasing number of subjects. Study results continue to be expected in the second half of 2017.
- SER-262 Phase 1b study progress: Seres is advancing the SER-262 Phase 1b clinical study in patients with primary C. difficile infection. SER-262, an Ecobiotic®, rationally-designed, fermented microbiome therapeutic candidate, is the first synthetically-derived and designed microbiome therapeutic candidate to reach clinical-stage development. Additional SER-262 Phase 1b study subjects were enrolled. Top-line data for SER-262 continues to be expected in the second half of 2017.
Financial Results
Seres reported a net loss of $25.5 million for the first quarter of 2017, as compared to a net loss of $19.7 million for the same period in 2016. The increase in first quarter net loss was driven primarily by continued growth in clinical and development expenses as well as increased headcount, and ongoing development of the Company’s microbiome therapeutics platform. The first quarter net loss figure was inclusive of $3.0 million in revenue recognized associated with the Company’s collaboration with Nestlé Health Science.
Research and development expenses for the first quarter were $20.1 million, as compared to $15.4 million for the same period in 2016. The increase in research and development expense was primarily due to expenses related to our microbiome therapeutics platform, the clinical development of SER-109, SER-262 and SER-287, as well as the Company’s preclinical programs.
General and administrative expenses for the first quarter were $8.8 million, as compared to $7.2 million for the same period in the prior year. The increase in general and administrative expense was primarily due to increased headcount, an increase in professional fees, and facility expansion to support overall growth.
The decrease in cash balance during the quarter was $27.8 million. Seres
ended the first quarter with approximately
Conference Call Information
Seres’ management will host a conference call today,
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 without limitation statements regarding the timing, design, and potential results of the ECOSPOR III study for SER-109, the potential for the ECOSPOR III study to qualify as a pivotal study, the timing and results of our clinical trials, and dysbiosis as an underlying cause of disease.
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, which may not be available;
our limited operating history; the unpredictable nature of our early
stage development efforts for marketable drugs; the unproven approach to
therapeutic intervention of our microbiome therapeutics; the lengthy and
expensive process of clinical drug development, which has an uncertain
outcome; potential delays in enrollment of patients which could affect
the receipt of necessary regulatory approvals; potential delays in
regulatory approval, which would impact the ability to commercialize our
product candidates and affect our ability to generate revenue; any fast
track or Breakthrough Therapy designation may not lead to faster
development, regulatory approval or marketing approval; our possible
inability to receive orphan drug designation should we choose to seek
it; our reliance on third parties to conduct our clinical trials and the
potential for those third parties to not perform satisfactorily; our
reliance on third parties to manufacture our product candidates, which
may delay, prevent or impair our development and commercialization
efforts; our lack of experience in manufacturing our product candidates;
the potential failure of our product candidates to be accepted on the
market by the medical community; our lack of experience selling,
marketing and distributing products and our lack of internal capability
to do so; failure to compete successfully against other drug companies;
potential competition from biosimilars; failure to obtain marketing
approval internationally; post-marketing restrictions or withdrawal from
the market; anti-kickback, fraud, abuse, and other healthcare laws and
regulations exposing us to potential criminal sanctions; recently
enacted or future legislation; compliance with environmental, health,
and safety laws and regulations; protection of our proprietary
technology; protection of the confidentiality of our trade secrets;
changes in
SERES THERAPEUTICS, INC. CONDENSED CONSOLIDATED BALANCE SHEETS (unaudited, in thousands, except share and per share data) |
||||||||||
March 31, | December 31, | |||||||||
2017 | 2016 | |||||||||
Assets | ||||||||||
Current assets: | ||||||||||
Cash and cash equivalents | $ | 41,899 | $ | 54,539 | ||||||
Investments | 145,174 | 138,704 | ||||||||
Prepaid expenses and other current assets | 5,188 | 5,126 | ||||||||
Total current assets | 192,261 | 198,369 | ||||||||
Property and equipment, net | 36,089 | 36,125 | ||||||||
Long-term investments | 15,099 | 36,752 | ||||||||
Restricted cash | 1,401 | 1,400 | ||||||||
Total assets | $ | 244,850 | $ | 272,646 | ||||||
Liabilities and Stockholders’ Equity | ||||||||||
Current liabilities: | ||||||||||
Accounts payable | 5,636 | 7,587 | ||||||||
Accrued expenses and other current liabilities | 9,550 | 10,812 | ||||||||
Deferred revenue - related party | 12,058 | 12,058 | ||||||||
Total current liabilities | 27,244 | 30,457 | ||||||||
Lease incentive obligation, net of current portion | 10,295 | 10,730 | ||||||||
Deferred rent | 2,117 | 2,072 | ||||||||
Deferred revenue, net of current portion - related party | 93,741 | 96,756 | ||||||||
Total liabilities | 133,397 | 140,015 | ||||||||
Commitments and contingencies | ||||||||||
Stockholders’ equity: | ||||||||||
Preferred stock, $0.001 par value; 10,000,000 shares authorized at March 31, 2017 and December 31, 2016; no shares issued and outstanding at March 31, 2017 and December 31, 2016 | — | — | ||||||||
Common stock, $0.001 par value; 200,000,000 shares authorized at March 31, 2017 and December 31, 2016; 40,386,878 and 40,355,753 shares issued and outstanding at March 31, 2017 and December 31, 2016, respectively | 40 | 40 | ||||||||
Additional paid-in capital | 311,229 | 306,931 | ||||||||
Accumulated other comprehensive income | (151 | ) | (149 | ) | ||||||
Accumulated deficit | (199,665 | ) | (174,191 | ) | ||||||
Total stockholders’ equity | 111,453 | 132,631 | ||||||||
Total liabilities and stockholders’ equity | $ | 244,850 | $ | 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 March 31, | |||||||||||
2017 | 2016 | ||||||||||
Revenue: | |||||||||||
Collaboration revenue - related party | $ | 3,015 | $ | 2,710 | |||||||
Total revenue | 3,015 | 2,710 | |||||||||
Operating expenses: | |||||||||||
Research and development expenses | $ | 20,143 | 15,416 | ||||||||
General and administrative expenses | 8,762 | 7,210 | |||||||||
Total operating expenses | 28,905 | 22,626 | |||||||||
Loss from operations | (25,890 | ) | (19,916 | ) | |||||||
Other income (expense): | |||||||||||
Interest income | 775 | 268 | |||||||||
Other income (expense): | (359 | ) | (56 | ) | |||||||
Total other income, net | 416 | 212 | |||||||||
Net loss | $ | (25,474 | ) | $ | (19,704 | ) | |||||
Net loss per share attributable to common stockholders, basic
and diluted |
$ | (0.63 | ) | $ | (0.50 | ) | |||||
Weighted average common shares outstanding, basic and diluted | 40,368,536 | 39,186,130 | |||||||||
Other comprehensive (loss) income: | |||||||||||
Unrealized (loss) gain on investments, net of tax of $0 | (2 | ) | 78 | ||||||||
Total other comprehensive (loss) income | (2 | ) | 78 | ||||||||
Comprehensive loss | $ | (25,476 | ) | $ | (19,626 | ) |
View source version on businesswire.com: http://www.businesswire.com/news/home/20170504005254/en/
Source:
IR or PR Contact:
Seres
Therapeutics
Carlo Tanzi, Ph.D., 617-203-3467
Head of Investor
Relations and Corporate Communications
ctanzi@serestherapeutics.com