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): November 12, 2015
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 November 12, 2015, Inotek Pharmaceuticals Corporation announced its financial results for the quarter ended September 30, 2015. 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 November 12, 2015, 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: November 12, 2015 | INOTEK PHARMACEUTICALS CORPORATION | |||||
| By: | /s/ Dale Ritter | |||||
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| Dale Ritter | ||||||
| Vice President —Finance | ||||||
EXHIBIT INDEX
| Exhibit No. |
Description | |
| 99.1 | Press release issued by Inotek Pharmaceuticals Corporation on November 12, 2015, furnished herewith. | |
Exhibit 99.1
Inotek Pharmaceuticals Corporation Reports Third Quarter 2015
Financial Results and Operational Highlights
-Initiated MATrX-1, the First Pivotal Phase 3 Clinical Trial of Trabodenoson, a
Novel Treatment for Glaucoma-
-Completed $79.2 Million Public Offering -
-Expanded Management and Board of Directors with Proven Business Leaders-
-First R&D Day to be held on December 17th, 2015-
Lexington, MA — November 12, 2015 — Inotek Pharmaceuticals Corporation (NASDAQ: ITEK) (the “Company” or “Inotek”), 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 September 30, 2015.
“The third quarter was marked by meaningful regulatory, clinical and financial accomplishments,” commented David P. Southwell, President and Chief Executive Officer of Inotek. “The U.S. Food and Drug Administration’s (the “FDA”) acceptance of our trabodenoson Phase 3 development program in July marked a critical milestone for the company. We are excited to have initiated patient dosing for MATrX-1, the first pivotal Phase 3 trial of trabodenoson in patients with glaucoma.”
“During the quarter, we substantially strengthened our financial position by completing an oversubscribed public equity offering that raised $79.2 million in gross proceeds, including full exercise of underwriters’ overallotment,” added Mr. Southwell. “In addition, we strengthened our leadership team with senior management hires that bring relevant domain expertise, including Dr. Claudine Prowse, Vice President, Strategy, and Dr. Cadmus Rich, Vice President, Medical Affairs and Clinical Development. We also welcomed two recognized industry leaders to our Board of Directors, Dr. Richard Spivey, former SVP of Global Regulatory Affairs at Allergan, and Dr. Gary Phillips, SVP and Chief Strategy Officer of Mallinckrodt joined in October. Finally, we look forward to hosting our first R&D Day on December 17, 2015 in New York City.”
Third Quarter 2015 and Recent Trabodenoson Development Program Highlights:
| • | Commenced dosing of patients in MATrX-1, a Phase 3 randomized, double-masked, placebo-controlled trial of trabodenoson in approximately 335 patients diagnosed with primary open-angle glaucoma (“POAG”) or ocular hypertension (“OHT”) in October; and |
| • | Announced Phase 3 development strategy for trabodenoson, following positive end-of-phase 2 meeting with the FDA. |
Third Quarter 2015 and Recent Business Highlights:
| • | Raised $79.2 million in gross proceeds from secondary offering of 6.2 million shares of common stock; |
| • | Reported conversion of $21.0 million of 5.0% convertible senior notes due 2020 into 3.9 million shares of common stock of the Company; |
| • | Appointed Gary M. Phillips, MD, MBA in October and Dr. Richard Spivey, PharmD, PhD to Inotek’s Board of Directors; and |
| • | Appointed Claudine Prowse, Ph.D., as Vice President, Strategy and Investor Relations Officer, and Cadmus Collins Rich, M.D., as Vice President, Medical Affairs and Clinical Development. |
Upcoming Highlights:
| • | Inotek will present at the Ophthalmology Innovations Summit on November 12, 2015, in conjunction with the American Association of Ophthalmology Annual Meeting; |
| • | Inotek will present at the Piper Jaffray Annual Healthcare Conference on December 2, 2015; and |
| • | Inotek will host its first annual R&D Day, featuring distinguished guests from the scientific and medical community on December 17, 2015, in New York City. |
Third Quarter 2015 Financial Results:
| • | Cash and cash equivalents and short-term investments as of September 30, 2015, were $118.4 million; |
| • | Research and development expenses were $3.6 million for the quarter ended September 30, 2015, compared to $1.2 million for the quarter ended September 30, 2014, and $6.6 million for the nine months ended September 30, 2015, compared to $4.7 million for the nine months ended September 30, 2014; |
| • | General and administrative expenses were $1.8 million for the quarter ended September 30, 2015, compared to $0.8 million for the quarter ended September 30, 2014, and $5.5 million for the nine months ended September 30, 2015, compared to $1.3 million for the nine months ended September 30, 2014; |
| • | Loss from operations was $5.4 million for the quarter ended September 30, 2015, compared to a loss of $2.1 million for the quarter ended September 30, 2014, and $12.2 million for the nine months ended September 30, 2015, compared to $6.0 million for the nine months ended September 30, 2014; |
| • | Net loss was $56.0 million for the quarter ended September 30, 2015, compared to a net loss of $2.4 million for the quarter ended September 30, 2014, and $59.8 million for the nine months ended September 30, 2015, compared to $7.4 million for the nine months ended September 30, 2014; |
| • | In connection with the full conversion of the 2020 Convertible Notes into common stock in the three months ended September 30, 2015, the Company incurred a noncash charge of $46.6 million and $42.8 million in the three and nine months ended September 30, 2015, respectively, related to marking the 2020 Convertible Notes derivative liability to market value at the time of the conversions; these noncash charges are included in net loss for the three and nine months ended September 30, 2015; and |
| • | 26.4 million shares of common stock were outstanding at September 30, 2015. |
About 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 designed to restore the eye’s natural pressure control mechanism. The development of trabodenoson monotherapy delivered in a once-daily eye drop formulation will be followed by a fixed-dose combination of trabodenoson with latanoprost. 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
Forward-Looking Statements
This press release contains forward-looking statements, which are subject to substantial risks, uncertainties and assumptions. You should not place reliance on these statements often include words such as “believe,” “expect,” “anticipate,” “intend,” “plan,” “estimate,” “seek,” “will,” “may” or similar expressions. Although the Company believes that the expectations reflected in the forward-looking statements are reasonable, the Company cannot guarantee such outcomes. 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
| September 30, 2015 | December 31, 2014 | |||||||
| Cash and cash equivalents and short-term investments |
$ | 118,365 | $ | 3,618 | ||||
| Other assets |
1,759 | 1,902 | ||||||
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| Total Assets |
$ | 120,124 | $ | 5,520 | ||||
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| Accounts payable, accrued expenses and other liabilities |
$ | 3,649 | $ | 2,162 | ||||
| Notes payable |
— | 5,613 | ||||||
| Convertible Bridge Notes |
— | 1,541 | ||||||
| Warrant and Convertible Bridge Notes redemption rights derivative liabilities |
— | 962 | ||||||
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| Total liabilities |
3,649 | 10,278 | ||||||
| Series AA redeemable convertible preferred stock |
— | 46,253 | ||||||
| Series X redeemable convertible preferred stock |
— | 548 | ||||||
| Stockholders’ equity (deficit) |
116,475 | (51,559 | ) | |||||
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| Total Liabilities, Redeemable Convertible Preferred |
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| Stock and Stockholders’ Equity (Deficit) |
$ | 120,124 | $ | 5,520 | ||||
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Statements of Operations
| Three Months ended September 30, | Nine Months ended September 30, | |||||||||||||||
| 2015 | 2014 | 2015 | 2014 | |||||||||||||
| Operating expenses: |
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| Research and development |
$ | (3,612 | ) | $ | (1,243 | ) | $ | (6,635 | ) | $ | (4,655 | ) | ||||
| General and administrative |
(1,825 | ) | (843 | ) | (5,533 | ) | (1,337 | ) | ||||||||
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| Loss from operations |
(5,437 | ) | (2,086 | ) | (12,168 | ) | (5,992 | ) | ||||||||
| Interest, net |
(159 | ) | (244 | ) | (1,197 | ) | (735 | ) | ||||||||
| Loss on extinguishment of debt |
(3,716 | ) | — | (4,399 | ) | — | ||||||||||
| Change in fair value of warrant liabilities |
— | (58 | ) | 267 | (656 | ) | ||||||||||
| Change in fair value of Convertible Bridge Notes redemption rights derivative |
— | — | 480 | — | ||||||||||||
| Change in fair value of 2020 Convertible Notes derivative liability |
(46,649 | ) | — | (42,793 | ) | — | ||||||||||
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| Net loss |
$ | (55,961 | ) | $ | (2,388 | ) | $ | (59,810 | ) | $ | (7,383 | ) | ||||
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| Net loss per share attributable to common stockholders—basic and diluted |
$ | (2.48 | ) | $ | (3.42 | ) | $ | (3.85 | ) | $ | (10.30 | ) | ||||
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| Weighted-average number of shares outstanding—basic and diluted |
22,573,195 | 1,020,088 | 15,580,487 | 1,020,088 | ||||||||||||
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Inotek Contact:
Claudine Prowse, PhD
Vice President, Strategy and Investor Relations Officer
cprowse@inotekpharma.com
781.552.4305
Media Contact:
Karen Sharma
MacDougall Biomedical Communications
781.235.3060