Inotek Pharmaceuticals Corporation (NASDAQ: ITEK), a
clinical-stage biopharmaceutical company focused on the discovery,
development and commercialization of therapies for ocular diseases,
including glaucoma, today reported financial results and
operational highlights for the quarter ended June 30, 2017.
“Inotek recently announced top-line results from our Phase 2
fixed-dosed combination (FDC) trial of trabodenoson, which did not
show a clinically meaningful advantage of intraocular pressure
(IOP) reduction at two months for the FDC compared to latanoprost
alone. Based on the efficacy results shown to date for the FDC and
monotherapy programs, we have decided to discontinue all
preclinical and clinical development activities associated with
trabodenoson in order to preserve our cash for value-creating
opportunities,” said David P. Southwell, President and Chief
Executive Officer of Inotek. “We continue to actively evaluate
strategic alternatives to maximize shareholder value and are
well-funded with $108.8 million in cash and marketable securities
as of the end of the second quarter.”
Second Quarter 2017 and Recent Business Highlights:
- In July, Inotek announced top-line
results of the Phase 2 FDC trial of trabodenoson and latanoprost
for the treatment of glaucoma. The FDC did not meet the trial’s
primary endpoint of IOP reduction from diurnal baseline for a two
month treatment period when compared to latanoprost alone. Based on
the FDC top-line results and the results previously reported from
the Phase 3 MATrX-1 monotherapy trial, the Company will discontinue
further preclinical and clinical development of trabodenoson for
all indications.
- In conjunction with the FDC top-line
results, Inotek also announced that it has engaged Perella Weinberg
Partners as a financial advisor to assist the Company in exploring
strategic alternatives.
Second Quarter 2017 Financial Results:
- Cash and cash equivalents and
short-term investments as of June 30, 2017, were $108.8
million.
- At June 30, 2017, Inotek has
outstanding $52.0 million aggregate principal amount of 5.75%
Convertible Senior Notes due 2021.
- Research and development expenses
were $3.6 million for the quarter ended June 30,
2017, compared to $6.5 million for the quarter
ended June 30, 2016, and $10.7 million for the six months
ended June 30, 2017, compared to $14.1 million for
the six months ended June 30, 2016.
- General and administrative expenses
were $2.2 million for the quarter ended June 30,
2017, compared to $2.3 million for the quarter
ended June 30, 2016, and $5.1 million for the six months
ended June 30, 2017, compared to $4.8 million for
the six months ended June 30, 2016.
- Loss from operations was $5.9
million for the quarter ended June 30, 2017, compared to a
loss of $8.8 million for the quarter ended June 30,
2016, and $15.8 million for the six months ended June 30,
2017, compared to $18.9 million for the six months ended
June 30, 2016.
- Net loss was $6.6 million for
the quarter ended June 30, 2017, compared to a net loss
of $8.7 million for the quarter ended June 30, 2016,
and $17.2 million for the six months ended June 30, 2017,
compared to $18.8 million for the six months ended June
30, 2016.
- Approximately 27.0 million shares of
common stock were outstanding at June 30, 2017.
About Inotek Pharmaceuticals CorporationInotek
Pharmaceuticals is a clinical-stage biopharmaceutical company
focused on the discovery, development and commercialization of
therapies for ocular diseases, including glaucoma. In July 2017,
the Company announced top-line results of its Phase 2 fixed-dose
combination trial of trabodenoson and latanoprost for the treatment
of glaucoma. The trial did not meet its primary efficacy endpoint
and the Company has since discontinued development of trabodenoson
in order to focus on evaluating strategic alternatives. 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 its ability to identify or consummate a strategic
alternative; Inotek’s expectations regarding reporting top-line
data of its Phase 2 trial for its FDC or other trials; Inotek’s
expectations with respect to the timing and success of its clinical
studies and pre-clinical studies for trabodenoson, its FDC program,
and orphan diseases; and Inotek’s expectations regarding its
successful potential future development of trabodenoson for any
indications; 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
identify and execute on its strategic alternatives, Inotek’s
ability to successfully demonstrate the efficacy and safety of
trabodenoson, its FDC program, its pre-clinical studies for orphan
diseases, 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 June 30, 2017 December 31, 2016
Cash and cash equivalents and short-term investments $
108,754 $ 126,473 Other assets 2,311 3,174 Total
assets $ 111,065 $ 129,647 Accounts payable, accrued
expenses and other liabilities $ 4,293 $ 7,519 2021 Convertible
Notes, net of issuance costs 49,242 48,960 Stockholders’ equity
57,530 73,168 Total liabilities and stockholders’
equity $ 111,065 $ 129,647
Consolidated Statements of Operations Three Months Ended
June 30, Six Months Ended June 30, 2017
2016 2017 2016 Operating
expenses: Research and development $ (3,624 ) $ (6,465 ) $ (10,721
) $ (14,080 ) General and administrative (2,232 )
(2,315 ) (5,101 ) (4,837 ) Loss from operations
(5,856 ) (8,780 ) (15,822 ) (18,917 ) Interest expense (889
) - (1,765 ) - Interest income 183 96
355 165 Net loss $ (6,562 ) $ (8,684 )
$ (17,232 ) $ (18,752 ) Net loss per share attributable to
common stockholders—basic and diluted $ (0.24 ) $ (0.33 ) $ (0.64 )
$ (0.71 ) Weighted-average number of shares
outstanding—basic and diluted 26,994,454
26,623,280 26,990,409 26,523,337
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version on businesswire.com: http://www.businesswire.com/news/home/20170803006269/en/
Inotek Contact:Claudine Prowse, Ph.D., 781-552-4305Vice
President, Corporate Development and IROIR@inotekpharma.com
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