Full Press Release Details
Inotek Pharmaceuticals Corporation Reports First Quarter 2017 Financial Results and
Operational Highlights
Mass May 10, 2017 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:
First Quarter 2017 Financial Results:
Inotek Pharmaceuticals Corporation
Inotek 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 Statements
Various 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.
Claudine Prowse, PhD, 781-552-4305
Vice President, Corporate Development and IRO
Inotek Pharmaceuticals Corporation
(in thousands, except share and per share
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 | ||||||
| Stockholder s equity | 63,264 | 73,168 | ||||||
| Total liabilities and stockholder s 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 |