- Initiated SER-109 Phase 3 study in patients
with multiply recurrent C. difficile infection -
- SER-287 Phase 1b study in mild-to-moderate
ulcerative colitis patients, failing first line therapy, fully
enrolled; Top-line data read-out expected in the second half
of 2017 -
- Conference call at 8 a.m. ET today -
Seres Therapeutics, Inc. (NASDAQ:MCRB) today reported second
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 continues to make excellent progress advancing our
pipeline of clinical stage microbiome therapeutic candidates, and
we believe we are on track to develop SER-109 as the first
FDA-approved microbiome product,” said Roger J. Pomerantz, M.D.,
President, CEO and Chairman of Seres. “We recently initiated the
SER-109 Phase 3 study in patients with multiply recurrent C.
difficile infection and are working with alacrity to enroll the
study. This Phase 3 study is the first pivotal trial of a
microbiome drug candidate in this new field of medicine. We have
also now fully enrolled our Phase 1b study of SER-287, the first
microbiome therapeutic candidate for a chronic disease, in patients
with mild-to-moderate ulcerative colitis, who are failing first
line therapy, and are looking forward to obtaining microbiome and
clinical data from the SER-287 trial in the second half of
2017.”
Recent Highlights and Events
- SER-109 ECOSPOR III Phase 3 study
initiation: Seres has initiated a SER-109 Phase 3 clinical
study (ECOSPOR III), designed to enroll approximately 320 patients
with multiply recurrent Clostridium difficile (C. difficile)
infection, at sites in both the U.S. and Canada. Based on
interactions with the U.S. Food and Drug Administration (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, for this Breakthrough Therapy- and
Orphan Drug- designated drug candidate. Study participants are
randomized 1:1 between SER-109 and placebo. Diagnosis of C.
difficile infection for both study entry and for endpoint analysis
is being confirmed by C. difficile cytotoxin assay. Patients in the
SER-109 arm receive a total SER-109 dose, administered over three
days, approximately 10-fold higher than the dose used in the prior
Phase 2 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.
- SER-287 Phase 1b study fully
enrolled: Seres completed enrollment of its ongoing SER-287
Phase 1b clinical study of 58 patients suffering from
mild-to-moderate ulcerative colitis who are failing current first
line therapies. SER-287 is a biologically sourced Ecobiotic®
microbiome therapeutic candidate with the potential to offer
ulcerative colitis patients a novel, non-immunosuppressive
treatment option. Top line study results are expected in the second
half of 2017.
- 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. Top-line data from the study
are expected in early 2018.
- Appointment of Willard Dere, M.D.,
to the Seres Board of Directors: Dr. Dere brings more than two
decades of scientific, clinical and strategic biopharmaceutical
experience. He is currently Professor of Internal Medicine,
Executive Director of Personalized Health and Co-director of the
Center for Clinical and Translational Sciences at the University of
Utah Health Sciences Center. Previously, Dr. Dere served at Amgen,
where he held several positions including Head of Global
Development and for a decade, Chief Medical Officer. During his
career in the biopharmaceutical industry, Dr. Dere led the clinical
development of numerous approved products in diverse therapeutic
areas, including osteoporosis, inflammation, nephrology and
oncology.
Financial Results
Seres reported a net loss of $28.0 million for the
second quarter of 2017, as compared to a net loss of $27.9
million for the same period in 2016. The second quarter net
loss was driven primarily by clinical and development expenses,
personnel expenses, and ongoing development of the Company’s
microbiome therapeutics platform. The second quarter net loss
figure was inclusive of $3.0 million in recognized
revenue associated with the Company’s collaboration with Nestlé
Health Science.
Research and development expenses for the second quarter
were $23.1 million, as compared to $22.2 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 and SER-155 preclinical programs.
General and administrative expenses for the second quarter
were $8.4 million, as compared to $9.0 million for
the same period in the prior year. General and administrative
expenses were primarily due to headcount, professional fees, and
facility costs.
The Company expects to account for receipt of the previously
disclosed $20.0 milestone payment associated with the start of the
SER-109 Phase 3 study, under its collaboration agreement with
Nestlé, in the third quarter of 2017.
The decrease in cash balance during the quarter was $27.0
million. Seres ended the second quarter with approximately $175.2
million in cash, cash equivalents and investments.
Conference Call Information
Seres’ management will host a conference call today, August 3,
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 62118608. 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. 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 is being evaluated in a Phase 1b study in
patients with mild-to-moderate ulcerative colitis. Seres is also
developing SER-262, the first ever synthetic microbiome therapeutic
candidate, in a Phase 1b study in patients with primary C.
difficile infection. For more information, please
visitwww.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 of data for our clinical studies, the design
of our clinical studies, whether we are on track in our clinical
development plans, any potential approval or registration of our
various therapeutic candidates, the objective for SER-109 to
meaningfully reduce the risk of recurrence of C. diff. infection,
the potential for SER-287 to offer a novel, non-immunosuppressive
treatment option for ulcerative colitis patients, and the timing of
accounting for the Nestlé SER-109 Phase 3 milestone payment.
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 Quarterly Report on Form 10-Q filed with the Securities and
Exchange Commission, or SEC, on May 4, 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)
June 30, December 31,
2017 2016 Assets Current assets: Cash and cash
equivalents $ 33,642 $ 54,539 Investments 137,570 138,704 Prepaid
expenses and other current assets 4,839 5,126 Total
current assets 176,051 198,369 Property and equipment, net 34,813
36,125 Long-term investments 3,962 36,752 Restricted cash
1,513 1,400 Total assets $ 216,339 $ 272,646
Liabilities
and Stockholders’ Equity Current liabilities: Accounts payable
$ 3,889 $ 7,587 Accrued expenses and other current liabilities
9,718 10,812 Deferred revenue - related party 12,058
12,058 Total current liabilities 25,665 30,457 Lease incentive
obligation, net of current portion 9,859 10,730 Deferred rent 2,159
2,072 Deferred revenue, net of current portion - related party
90,727 96,756 Total liabilities 128,410
140,015 Commitments and contingencies Stockholders’ equity:
Preferred stock, $0.001 par value; 10,000,000 shares authorized at
June 30, 2017 and December 31, 2016; no shares issued and
outstanding at June 30, 2017 and December 31, 2016 — — Common
stock, $0.001 par value; 200,000,000 shares authorized at June 30,
2017 and December 31, 2016; 40,412,035 and 40,355,753 shares issued
and outstanding at June 30, 2017 and December 31, 2016,
respectively 40 40 Additional paid-in capital 315,748 306,931
Accumulated other comprehensive loss (176 ) (149 ) Accumulated
deficit (227,683 ) (174,191 ) Total stockholders’
equity 87,929 132,631 Total liabilities and
stockholders’ equity $ 216,339 $ 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 June 30,
Six Months Ended June 30, 2017
2016 2017 2016 Revenue:
Collaboration revenue - related party $ 3,014 $ 3,004 $ 6,029 $
5,714 Total revenue 3,014 3,004 6,029 5,714 Operating expenses:
Research and development expenses 23,060 22,174 43,203 37,590
General and administrative expenses 8,370 8,970
17,132 16,180 Total operating expenses 31,430
31,144 60,335 53,770 Loss from operations
(28,416 ) (28,140 ) (54,306 ) (48,056 )
Other income (expense): Interest income 615 495 1,390 763 Other
income (expense) (217 ) (268 ) (576 )
(324 ) Total other income, net 398 227 814
439 Net loss $ (28,018 ) $ (27,913 ) $ (53,492 ) $ (47,617 )
Net loss per share attributable to common stockholders, basic and
diluted $ (0.69 ) $ (0.70 ) $ (1.32 ) $ (1.21 ) Weighted average
common shares outstanding, basic and diluted 40,394,605
39,600,344 40,381,643 39,393,238 Other
comprehensive (loss) income: Unrealized (loss) gain on investments,
net of tax of $0 $ (25 ) $ (25 ) $ (27 ) $ 53 Total other
comprehensive (loss) income (25 ) (25 ) (27 )
53 Comprehensive loss $ (28,043 ) $ (27,938 ) $ (53,519 ) $
(47,564 )
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version on businesswire.com: http://www.businesswire.com/news/home/20170803005227/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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