- 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 8 a.m. ET today -
Seres Therapeutics Inc. (NASDAQ:MCRB) today reported first
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.
“Seres is making strong progress throughout our broad pipeline
of microbiome therapeutics.” said Roger J. Pomerantz, M.D.,
President, CEO and Chairman of Seres. “Following positive feedback
from the FDA, we are working to rapidly initiate the SER-109
ECOSPOR III clinical study, and we expect study start in mid-year.
This trial could potentially serve as the basis for the approval of
SER-109, which may represent the first approved microbiome
therapeutic. In addition, we have advanced our Phase 1b study of
SER-287 in patients with ulcerative colitis, as well as our Phase
1b study of SER-262 in patients with primary C.
difficile infection. We look forward to a highly data rich
period ahead, with readouts from both the SER-287 and SER-262
studies expected in the second half of 2017.”
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. The FDA has agreed that this new
trial may qualify as a pivotal study with achievement of a
persuasive clinical effect and addressing FDA 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. and
Canada. 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 27th European Congress of
Clinical Microbiology and Infectious Diseases (ECCMID) meeting in
Vienna, Austria on April 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 $202.2
million in cash, cash equivalents and investments.
Conference Call Information
Seres’ management will host a conference call today, May 4,
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 11167224. To join the live
webcast please visit the “Investors and Media” section of the Seres
website at www.serestherapeutics.com.
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. The Phase 2 study of Seres’
program SER-109 has been completed in multiply recurrent
Clostridium difficile infection. Seres’ second clinical candidate,
SER-287, is being evaluated in a Phase 1b study in patients with
mild-to-moderate ulcerative colitis (UC). Seres is also developing
SER-262, the first ever synthetic microbiome therapeutic candidate,
in a Phase 1b study in patients with primary CDI. For more
information, please visit www.serestherapeutics.com. Follow us on
Twitter @SeresTx.
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
United States patent law; potential lawsuits for infringement of
third-party intellectual property; our patents being found invalid
or unenforceable; compliance with patent regulations; claims
challenging the inventorship or ownership of our patents and other
intellectual property; claims asserting that we or our employees
misappropriated a third-party’s intellectual property or otherwise
claiming ownership of what we regard as our intellectual property;
adequate protection of our trademarks; ability to attract and
retain key executives; managing our growth could result in
difficulties; risks associated with international operations;
potential system failures; the price of our common stock may
fluctuate substantially; our executive officers, directors, and
principal stockholders have the ability to control all matters
submitted to the stockholders; a significant portion of our total
outstanding shares are eligible to be sold into the market;
unfavorable or lacking analyst research or reports; and we are
currently subject to securities class action litigation. These and
other important factors discussed under the caption “Risk Factors”
in our Annual Report on Form 10-K filed with the Securities and
Exchange Commission, or SEC, on March 16, 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)
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 )
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version on businesswire.com: http://www.businesswire.com/news/home/20170504005254/en/
IR or PR Contact:Seres
TherapeuticsCarlo Tanzi, Ph.D., 617-203-3467Head of Investor
Relations and Corporate
Communicationsctanzi@serestherapeutics.com
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