- Positive SER-109 Type B FDA meeting -
- Company to initiate new Phase 2 SER-109
clinical trial that, as agreed to by the FDA, may qualify as a
Pivotal Study with achievement of a persuasive clinical effect and
addressing FDA requirements -
- Continued pipeline progress with both SER-287
and SER-262 Phase 1b studies; Both data read-outs expected in the
second half of 2017 -
- Conference call at 8 a.m. ET today -
Seres Therapeutics Inc., (NASDAQ:MCRB), a leading microbiome
therapeutics platform company, today reported fourth quarter and
full year 2016 financial results and provided an update on multiple
clinical programs, including three clinical-stage candidates
seeking to address multiple serious medical indications. In a
separate announcement today, Seres provided an update on plans to
initiate a new SER-109 clinical study following its positive FDA
Type B meeting.
“Seres has made important progress across all of our microbiome
clinical programs,” said Roger J. Pomerantz, M.D., President, CEO
and Chairman of Seres. “Following the completion of our
comprehensive analyses of the SER-109 study results, we had very
productive discussions with the FDA, in which we gained highly
positive and constructive guidance on further SER-109 clinical
development. If the new ECOSPOR III study achieves a persuasive
clinical effect and addresses FDA requirements, we would expect to
be able to file for SER-109 product registration.”
Dr. Pomerantz continued, “We also advanced our robust pipeline
of microbiome clinical candidates and we anticipate the results of
two Phase 1b clinical trials during the second half of this year,
including our study of SER-287 in patients with ulcerative colitis
and our study of SER-262, the first synthetically derived
microbiome candidate to reach clinical development, in patients
with primary C. difficile infection.”
Recent Highlights and Events
- Positive SER-109 Type B meeting with
FDA and plan for new SER-109 clinical study: 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 assay. 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.
- Key findings from SER-109 Phase 2
study analyses: Seres announced the results of its in-depth
analyses of the previously reported SER-109 Phase 2, eight-week
clinical study data in patients with multiply recurrent C.
difficile infection.
- Ongoing progress with SER-287 Phase
1b study: Seres continued to advance the SER-287 Phase 1b
clinical study in subjects with mild-to-moderate ulcerative colitis
who have failed first line therapy. SER-287 is a biologically
sourced Ecobiotic® microbiome therapeutic candidate. Additional
SER-287 Phase 1b study clinical sites were activated and increasing
numbers of study subjects are being enrolled. Study results are
expected in the second half of 2017.
- Ongoing progress with SER-262 Phase
1b study: Seres continued to advance 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 clinical sites were
activated and increasing numbers of study subjects are being
enrolled. Study results are expected in the second half of
2017.
- Preclinical microbiome program
research: Seres continued to advance its preclinical efforts,
working in collaboration with existing world-class academic
researchers, including projects targeting hematopoietic stem cell
transplantation and immuno-oncology treatment, with Memorial Sloan
Kettering Cancer Center; liver diseases including primary
sclerosing cholangitis and Non-Alcoholic Steatohepatitis (NASH),
with Mayo Clinic; inflammatory bowel disease (IBD) and rare genetic
metabolic diseases, with the University of Pennsylvania, Medical
University of Graz, Austria and the Research Institute of St.
Joseph’s Hamilton; and obesity and metabolic syndrome, with the
Massachusetts General Hospital of the Harvard Medical School.
- Additional microbiome patent
issued: Seres continued to strengthen its intellectual property
estate related to microbiome therapeutics. The United States Patent
and Trademark Office issued a new patent (#9,585,921), assigned to
Seres, covering compositions for treating multiple gastrointestinal
diseases associated with dysbiosis of the microbiome.
- Manufacturing facility
completed: Seres continued to broaden its differentiated
microbiome therapeutic development capabilities. The construction
of a new facility capable of the manufacture and formulation of
microbiome therapeutic candidates was completed and is now fully
operational.
Financial Results
The company reported a net loss of $91.6 million for the full
year, as compared to a net loss of $54.8 million for the prior
year. Seres reported a net loss of $25.3 million for the fourth
quarter of 2016, as compared to a net loss of $19.6 million for the
same period in 2015. The increase in fourth 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 fourth 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 full year of 2016 were
$82 million, as compared to $38.1 million for the prior year.
R&D expenses for the fourth quarter of 2016 were $20.3 million,
as compared to $13.9 million for the same period in 2015. The
increase in R&D expense was primarily due to expenses related
to the company’s 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 full year of 2016
were $32.6 million, as compared to $16.8 million for the prior
year. G&A expenses for the fourth quarter of 2016 were $8.5
million, as compared to $5.9 million for the same period in 2015.
The increase in G&A 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 $26.5
million. Seres ended the fourth quarter with approximately $230.0
million in cash, cash equivalents and investments.
Financial Expectations
Based on the company’s current operating plan, Seres expects
that its existing cash resources will enable it to fund operating
expenses and capital expenditure requirements, excluding cash
inflows or outflows from future business development activities,
through 2018.
Conference Call Information
Seres’ management will host a conference call today, March 16,
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 84302413. To join the live
webcast and access slides to accompany the conference call, 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 our SER-109 development plans, 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, the potential
benefits of our business collaborations, dysbiosis as an underlying
cause of disease, the benefits of any of our issued patents, and
our cash flow and business forecasts.
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 November 10, 2016 and our other
reports filed with the SEC, 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.
CONSOLIDATED BALANCE SHEETS
(In thousands, except share and per
share data)
December 31, 2016 2015
Assets Current assets: Cash and cash equivalents $ 54,539 $
73,933 Investments 138,704 131,149 Prepaid expenses and other
current assets 5,126 2,528 Total current assets
198,369 207,610 Property and equipment, net 36,125 7,751 Long-term
investments 36,752 — Restricted cash 1,400 1,539
Total assets $ 272,646 $ 216,900
Liabilities and Stockholder's
Equity Current liabilities: Accounts payable $ 7,587 $ 5,397
Accrued expenses and other current liabilities 10,812 5,523
Deferred revenue - related party 12,058 — Total
current liabilities 30,457 10,920 Lease incentive obligation, net
of current portion 10,730 586 Deferred rent 2,072 — Deferred
revenue, net of current portion - related party 96,756
— Total liabilities 140,015 11,506 Commitments
and contingencies Stockholders’ equity: Preferred stock, $0.001 par
value; 10,000,000 shares authorized at December 31, 2016 and 2015;
no shares issued and outstanding at December 31, 2016 and 2015 — —
Common stock, $0.001 par value; 200,000,000 shares authorized at
December 31, 2016 and 2015; 40,355,753 and 39,082,017 shares issued
and outstanding at December 31, 2016 and 2015 40 39 Additional
paid-in capital 306,931 287,937 Accumulated other comprehensive
income (loss) (149 ) 30 Accumulated deficit (174,191 )
(82,612 ) Total stockholders’ equity 132,631
205,394 Total liabilities, convertible preferred stock and
stockholders’ equity $ 272,646 $ 216,900
SERES THERAPEUTICS, INC.
CONSOLIDATED STATEMENTS OF OPERATIONS
AND COMPREHENSIVE LOSS
(In thousands, except share and per
share data)
Year Ended December 31, 2016
2015 2014 Revenue: Collaboration
revenue - related party $ 21,766 $ — $ — Total revenue 21,766 — —
Operating expenses: Research and development expenses $ 81,989
38,095 10,718 General and administrative expenses 32,616
16,761 4,364 Total operating expenses 114,605
54,856 15,082 Loss from operations (92,839 )
(54,856 ) (15,082 ) Other income (expense): Interest
income 2,229 638 — Interest expense (969 ) (555 ) (209 )
Revaluation of preferred stock warrant liability — (7
) (1,418 ) Total other income (expense), net 1,260
76 (1,627 ) Net loss $ (91,579 ) (54,780 ) (16,709 )
Accretion of convertible preferred stock to redemption value
— — (1,291 ) Net loss attributable to common
stockholders $ (91,579 ) $ (54,780 ) $ (18,000 ) Net loss per share
attributable to common stockholders, basic and diluted $ (2.30 ) $
(2.33 ) $ (2.67 ) Weighted average common shares outstanding, basic
and diluted 39,846,928 23,532,400 6,748,037
Other comprehensive income (loss): Unrealized gain (loss) on
investments, net of tax of $0 (179 ) 30 —
Total other comprehensive income (loss) (179 ) 30
— Comprehensive loss $ (91,758 ) $ (54,750 ) $ (18,000 )
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version on businesswire.com: http://www.businesswire.com/news/home/20170316005281/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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