UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 8-K
CURRENT REPORT
Pursuant to Section 13 or 15(d)
of The Securities Exchange Act of 1934
Date of Report (Date of Earliest Event Reported): May 11, 2016
Inotek Pharmaceuticals Corporation
(Exact name of registrant as specified in its charter)
| DELAWARE | 001-36829 | 04-3475813 | ||
| (State or other jurisdiction of incorporation) |
(Commission File Number) |
(I.R.S. Employer Identification No.) |
| 91 Hartwell Avenue Lexington, MA |
02421 | |
| (Address of principal executive offices) | (Zip Code) |
Registrant’s telephone number, including area code (781) 676-2100
Not Applicable
(Former name or former address, if changed since last report)
Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:
| ¨ | Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425) |
| ¨ | Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12) |
| ¨ | Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b)) |
| ¨ | Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c)) |
| Item 2.02 | Results of Operations and Financial Condition |
On May 11, 2016, Inotek Pharmaceuticals Corporation announced its financial results for the quarter ended March 31, 2016. A copy of the press release is being furnished as Exhibit 99.1 to this Report on Form 8-K.
The information in this Report on Form 8-K and Exhibit 99.1 attached hereto is intended to be furnished and shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934 (the “Exchange Act”) or otherwise subject to the liabilities of that section, nor shall it be deemed incorporated by reference in any filing under the Securities Act of 1933 or the Exchange Act, except as expressly set forth by specific reference in such filing.
| Item 9.01 | Financial Statements and Exhibits. |
(d) Exhibits
| Exhibit No. |
Description | |
| 99.1 | Press release issued by Inotek Pharmaceuticals Corporation on May 11, 2016, furnished herewith. | |
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
| Date: May 11, 2016 | INOTEK PHARMACEUTICALS CORPORATION | |||||
| By: | /s/ Dale Ritter | |||||
| Dale Ritter | ||||||
| Vice President —Finance | ||||||
EXHIBIT INDEX
| Exhibit No. |
Description | |
| 99.1 | Press release issued by Inotek Pharmaceuticals Corporation on May 11, 2016, furnished herewith. | |
Exhibit 99.1
Inotek Pharmaceuticals Corporation Reports First Quarter 2016 Financial Results and Operational Highlights
LEXINGTON, Mass – May 11, 2016 – 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, 2016.
“The Phase 3 MATrX-1 study of trabodenoson continues to enroll well, and we continue to expect top-line data from this study in the fourth quarter of 2016,” commented David P. Southwell, President and Chief Executive Officer. “Additionally, we have recently added to the body of literature supporting the profile of trabodenoson as a potential novel treatment for glaucoma with two new peer-reviewed publications, one describing our Phase 1 clinical safety trial and one reporting our Phase 2 monotherapy trial showing the activity of trabodenoson in patients with glaucoma or ocular hypertension. Additionally, we plan to extend the scope of the trabodenoson development program in 2016 by initiating a Phase 2 combination study of trabodenoson and latanoprost, as a fixed-dose combination, in a single eye drop.”
First Quarter 2016 and Recent Trabodenoson Development Program Highlights:
| • | Inotek announced the issuance of a U.S. composition of matter patent covering crystalline forms of trabodenoson which facilitate its formulation as an eye drop in March 2016. |
| • | Peer-reviewed articles describing trabodenoson’s Phase 1 and Phase 2 clinical data were published online in the Journal of Ocular Pharmacology and Therapeutics. |
| • | Inotek presented three research posters at the annual meeting of the Association for Research in Vision and Ophthalmology in May 2016. |
First Quarter 2016 and Recent Business Highlights:
| • | Inotek announced J. Martin Carroll’s election to the Board of Directors and, as of the 2016 Annual Meeting of Stockholders in June, election as Chairperson. |
Upcoming Highlights:
| • | Initiate a Phase 2 dose-ranging trial of a fixed-dose combination of trabodenoson and latanoprost in 2H 2016. |
| • | Report top-line Phase 3 MATrX-1 results in 4Q 2016. |
First Quarter 2016 Financial Results:
| • | Cash and cash equivalents and short-term investments as of March 31, 2016, were $102.3 million. |
| • | Research and development expenses were $7.6 million for the quarter ended March 31, 2016, compared to $1.1 million for the quarter ended March 31, 2015. |
| • | General and administrative expenses were $2.5 million for the quarter ended March 31, 2016, compared to $2.0 million for the quarter ended March 31, 2015. |
| • | Loss from operations was $10.1 million for the quarter ended March 31, 2016, compared to a loss of $3.0 million for the quarter ended March 31, 2015. |
| • | Net loss was $10.1 million for the quarter ended March 31, 2016, compared to a net loss of $1.5 million for the quarter ended March 31, 2015. |
| • | 26.4 million shares of common stock were outstanding at March 31, 2016. |
About Inotek Pharmaceuticals Corporation
Inotek 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. 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
This press release contains forward-looking statements, which are subject to substantial risks, uncertainties and assumptions. These forward-looking statements often include words such as “believe,” “expect,” “anticipate,” “intend,” “plan,” “estimate,” “seek,” “will,” “may” or similar expressions. 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)
Balance Sheets
| March 31, 2016 | December 31, 2015 | |||||||
| Cash and cash equivalents and short-term investments |
$ | 102,265 | $ | 111,280 | ||||
| Other assets |
1,942 | 2,041 | ||||||
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| Total assets |
$ | 104,207 | $ | 113,321 | ||||
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| Accounts payable, accrued expenses and other liabilities |
$ | 4,965 | $ | 4,508 | ||||
| Stockholders’ equity |
99,242 | 108,813 | ||||||
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| Total liabilities and stockholders’ equity |
$ | 104,207 | $ | 113,321 | ||||
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Statements of Operations
| Three Months Ended March 31, | ||||||||
| 2016 | 2015 | |||||||
| Operating expenses: |
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| Research and development |
$ | (7,615 | ) | $ | (1,069 | ) | ||
| General and administrative |
(2,522 | ) | (1,980 | ) | ||||
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| Loss from operations |
(10,137 | ) | (3,049 | ) | ||||
| Interest expense |
— | (474 | ) | |||||
| Interest income |
69 | — | ||||||
| Loss on extinguishment of debt |
— | (683 | ) | |||||
| Change in fair value of warrant liabilities |
— | 267 | ||||||
| Change in fair value of Convertible Bridge Notes redemption rights derivative |
— | 480 | ||||||
| Change in fair value of 2020 Convertible Notes derivative liability |
— | 1,997 | ||||||
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| Net loss |
$ | (10,068 | ) | $ | (1,462 | ) | ||
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| Net loss per share attributable to common stockholders—basic and diluted |
$ | (0.38 | ) | $ | (0.21 | ) | ||
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| Weighted-average number of shares outstanding—basic and diluted |
26,423,394 | 7,677,575 | ||||||
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Source: Inotek Pharmaceuticals
Inotek Contact:
Claudine Prowse, Ph.D., 781-552-4305
Vice President, Strategy and Investor Relations Officer
cprowse@inotekpharma.com