Inotek Pharmaceuticals Corporation (NASDAQ: ITEK), a
clinical-stage biopharmaceutical company focused on the discovery,
development and commercialization of therapies for ocular diseases,
today reported financial results and operational highlights for the
quarter ended March 31, 2017.
“Our Phase 2 fixed-dose combination (FDC) trial of trabodenoson
and latanoprost is ongoing, and we recently completed the active
recruitment phase,” said David P. Southwell, President and Chief
Executive Officer. “We look forward to top-line results from this
trial in July, and providing an update on our strategy for the
development path for trabodenoson in glaucoma. We have communicated
with the US Food and Drug Administration (FDA) regarding the
MATrX-1 results. The FDA is in agreement with our conclusions that
the trial did not meet its primary efficacy endpoint, however the
safety profile of trabodenoson was comparable to placebo and there
was minimal drug-related hyperemia.”
Mr. Southwell continued, “We are also looking into
trabodenoson’s utility beyond the lowering of eye pressure. As an
example, preclinical data supporting trabodenoson’s neuroprotective
and neuro-enhancement activity in the back of the eye is being
presented this week at the Association for Research in Vision and
Ophthalmology (ARVO) 2017 Annual Meeting. Additionally, Inotek is
evaluating the potential for selective adenosine mimetics to
address optic neuropathies and other degenerative retinal diseases
and to improve the patho-physiology associated with dry eye
disease. We are encouraged by these early results and will provide
additional information on our preclinical program in mid-2017.”
First Quarter 2017 and Recent Business Highlights:
- Inotek completed the active recruitment
phase of its Phase 2 dose-ranging FDC trial of trabodenoson and
latanoprost for the treatment of glaucoma. Top-line results are
expected in July.
- Several research posters on
trabodenoson as a monotherapy and combination were presented at the
annual meetings of the American Glaucoma Society and the
Association for Research in Vision and Ophthalmology.
Upcoming Events:
- Present additional data from
trabodenoson preclinical program in mid-2017.
- Report top-line results of the Phase 2
FDC trial in July.
First Quarter 2017 Financial Results:
- Cash and cash equivalents and
short-term investments as of March 31, 2017, were $114.7
million.
- Research and development expenses
were $7.1 million for the quarter ended March 31,
2017, compared to $7.6 million for the quarter
ended March 31, 2016.
- General and administrative expenses
were $2.9 million for the quarter ended March 31,
2017, compared to $2.5 million for the quarter
ended March 31, 2016.
- Loss from operations was $10.0
million for the quarter ended March 31, 2017, compared to a
loss of $10.1 million for the quarter ended March
31, 2016.
- Net loss was $10.7
million for the quarter ended March 31, 2017, compared to
a net loss of $10.1 million for the quarter
ended March 31, 2016.
- Approximately 27.0 million shares of
common stock were outstanding at March 31, 2017.
About Inotek Pharmaceuticals CorporationInotek
Pharmaceuticals is a clinical-stage biopharmaceutical company
focused on the discovery, development and commercialization of
therapies for glaucoma and other eye diseases. The Company’s lead
product candidate, trabodenoson, is a first-in-class selective
adenosine mimetic currently in Phase 3 development. Trabodenoson
was developed in Inotek’s laboratories and is designed to restore
the eye’s natural pressure control mechanism. Additionally, the
Company is evaluating the potential for selective adenosine
mimetics to address optic neuropathies and other degenerative
retinal diseases, including NAION, and to improve the
patho-physiology associated with dry eye disease. For more
information, please visit www.inotekpharma.com. The inclusion of
our website address here and elsewhere in this press release does
not include or incorporate by reference the information on our
website into this press release.
Forward-Looking StatementsVarious statements in this
release concerning Inotek’s future expectations, plans and
prospects, including without limitation, Inotek’s expectations
regarding the use of trabodenoson and its fixed-dose combination
(FDC) program with latanoprost as treatments for primary open-angle
glaucoma or ocular hypertension; Inotek’s expectations regarding
reporting top-line data of its Phase 2 trial for its FDC; Inotek’s
expectations with respect to the timing and success of its clinical
studies and pre-clinical studies for trabodenoson its FDC, orphan
diseases, and the possibility of selective adenosine mimetics to
address optic neuropathies and other degenerative retinal diseases,
including NAION, and to improve the patho-physiology associated
with dry eye disease; may constitute forward-looking statements for
the purposes of the safe harbor provisions under The Private
Securities Litigation Reform Act of 1995 and other federal
securities laws and are subject to substantial risks, uncertainties
and assumptions. You should not place reliance on these forward
looking statements, which often include words such as "believe,"
"expect," "anticipate," "intend," "plan," "will give," "estimate,"
"seek," "will," "may," "suggest" or similar terms, variations of
such terms or the negative of those terms. Although the Company
believes that the expectations reflected in the forward-looking
statements are reasonable, the Company cannot guarantee such
outcomes. Actual results may differ materially from those indicated
by these forward-looking statements as a result of various
important factors, including, without limitation, Inotek’s ability
to successfully demonstrate the efficacy and safety of
trabodenoson, its FDC program, its pre-clinical studies for orphan
diseases, or selective adenosine mimetics to address optic
neuropathies and other degenerative retinal diseases, including
NAION, and to improve the patho-physiology associated with dry eye
disease, the pre-clinical and clinical results for its product
candidates, which may not support further development and marketing
approval, the potential advantages of Inotek’s product candidates,
actions of regulatory agencies, which may affect the initiation,
timing and progress of pre-clinical studies and clinical trials of
its product candidates, Inotek’s ability to obtain, maintain and
protect its intellectual property, Inotek’s ability to enforce its
patents against infringers and defend its patent portfolio against
challenges from third parties, the timing, cost or other aspects of
a potential commercial launch of Inotek’s product candidates and
potential future sales of our current product candidates or any
other potential products if any are approved for marketing,
competition from others developing products for similar uses,
Inotek’s ability to manage operating expenses, Inotek’s ability to
obtain additional funding to support its business activities and
establish and maintain strategic business alliances and new
business initiatives, Inotek’s dependence on third parties for
development, manufacture, marketing, sales and distribution of
product candidates, the outcome of litigation, and unexpected
expenditures, as well as those risks more fully discussed in the
section entitled “Risk Factors” in Inotek’s most recent Quarterly
Report on Form 10-Q filed with the Securities and Exchange
Commission as well as discussions of potential risks,
uncertainties, and other important factors in Inotek’s subsequent
filings with the Securities and Exchange Commission. Accordingly,
you should not place undue reliance on these forward-looking
statements. All such statements speak only as of the date made, and
the Company undertakes no obligation to update or revise publicly
any forward-looking statements, whether as a result of new
information, future events or otherwise.
Inotek
Pharmaceuticals Corporation (Unaudited) (in
thousands, except share and per share amounts)
Consolidated Balance Sheets March 31, 2017
December 31, 2016 Cash and cash equivalents and
short-term investments $ 114,705 $ 126,473 Other assets
3,218 3,174 Total assets $ 117,923 $ 129,647 Accounts
payable, accrued expenses and other liabilities $ 5,560 $ 7,519
2021 Convertible Notes, net of issuance costs 49,099 48,960
Stockholders’ equity 63,264 73,168 Total liabilities
and stockholders’ equity $ 117,923 $ 129,647
Consolidated Statements of
Operations Three Months Ended March 31, 2017
2016 Operating expenses: Research and development $ (7,097 )
$ (7,615 ) General and administrative (2,869 ) (2,522
) Loss from operations (9,966 ) (10,137 ) Interest expense
(876 ) - Interest income 172 69 Net
loss $ (10,670 ) $ (10,068 ) Net loss per share attributable
to common stockholders—basic and diluted $ (0.40 ) $ (0.38 )
Weighted-average number of shares outstanding—basic and diluted
26,986,318 26,423,394
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version on businesswire.com: http://www.businesswire.com/news/home/20170510005198/en/
Inotek Contact:Claudine Prowse, PhD, 781-552-4305Vice
President, Corporate Development and IROIR@inotekpharma.com
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