Form 8-K

 

 

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): August 6, 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.)

 

131 Hartwell Avenue, Suite 105

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 August 6, 2015, Inotek Pharmaceuticals Corporation announced its financial results for the quarter ended June 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 August 6, 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: August 6, 2015   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 August 6, 2015, furnished herewith.
EX-99.1

Exhibit 99.1

 

LOGO

 

Inotek Pharmaceuticals Corporation Reports Second Quarter 2015 Financial Results and Operational Highlights

– End-of-Phase 2 Meeting with FDA Informs Phase 3 Development Plan for Trabodenoson –

– Key Hires Strengthen Senior Management Team –

– 1st Phase 3 Study to Commence in 4Q15 with Top-line Data In 2016 –

 

Lexington, MA – August 6, 2015 – Inotek Pharmaceuticals Corporation (NASDAQ: ITEK) (the “Company”), 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 June 30, 2015.

“The second quarter marked a critical inflection point for the Company as we made significant progress in the preparation for a comprehensive Phase 3 program for trabodenoson, our lead drug candidate for glaucoma,” commented David P. Southwell, President and Chief Executive Officer of Inotek. “Importantly, our End-of-Phase 2 meeting with the FDA was a critical milestone for advancing the development of trabodenoson. Based on this meeting with the FDA, we reported the design for our first Phase 3 clinical trial of trabodenoson that provides a more efficient path to define the drug’s clinical and safety profile through a superiority trial statistically compared to placebo. We are excited to begin recruiting patients for this trial in the fourth quarter of this year.”

“Additionally, to support the development of the emerging trabodenoson franchise, we have bolstered the Inotek team with several new senior management hires that bring relevant domain expertise, including the appointments of Dr. Claudine Prowse as Vice President, Strategy and Investor Relations Officer and Dr. Cadmus Rich as Vice President, Medical Affairs and Clinical Development. We were also pleased to add Dr. Richard Spivey, former SVP of Global Regulatory Affairs at Allergan, to our board of directors.”

“Finally, we are excited to report that we have strengthened our balance sheet as a result of the conversion of the 5.0% Convertible Senior Notes issued in conjunction with our initial public offering in February 2015.”


Trabodenoson Development Program Highlights:

 

    In July, Inotek announced the Phase 3 development plan for trabodenoson based on a positive End-of-Phase 2 meeting with the Food and Drug Administration (FDA). The trial design for the first Phase 3 study is a five-arm superiority trial that will include three doses of trabodenoson: 1000 mcg QD, 1500 mcg BID, and 2000 mcg QD. These doses were selected to optimize lowering of intraocular pressure while maintaining the good tolerability observed in Phase 2 trials. The primary efficacy endpoint of the study is the reduction of intraocular pressure (IOP), statistically superior as compared to placebo. A comparator arm of timolol will also be included for study validation, but not for statistical comparison.

Second Quarter 2015 and Recent Business Highlights:

 

    In July, Inotek 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
    In July, Inotek appointed Richard N. Spivey, PharmD, Ph.D., to its Board of Directors

Upcoming Milestones:

 

    Inotek expects to initiate the first Phase 3 study of trabodenoson in 4Q15.

Second Quarter and Recent 2015 Financial Results:

 

    Cash and cash equivalents as of June 30, 2015 were $49.0 million
    Research and development expenses were $2.0 million for the quarter ended June 30, 2015, compared to $1.9 million for the quarter ended June 30, 2014 and $3.0 million for the six months ended June 30, 2015, compared to $3.4 million for the six months ended June 30, 2014
    General and administrative expenses were $1.7 million for the quarter ended June 30, 2015, compared to $0.3 million for the quarter ended June 30, 2014 and $3.7 million for the six months ended June 30, 2015, compared to $0.5 million for the six months ended June 30, 2014
    Loss from operations was $3.7 million for the quarter ended June 30, 2015, compared to a loss of $2.2 million for the quarter ended June 30, 2014 and $6.7 million for the six months ended June 30, 2015, compared to $3.9 million for the six months ended June 30, 2014
    Net loss was $2.4 million for the quarter ended June 30, 2015, compared to a net loss of $2.8 million for the quarter ended June 30, 2014 and $3.8 million for the six months ended June 30, 2015, compared to $5.0 million for the six months ended June 30, 2014
   

Inotek Pharmaceuticals announces conversion of $20,985,000 principal amount of its 5.0% Convertible Senior Notes (the “Notes”) maturing


 

February 15, 2020 into approximately 3.86 million shares of the Company’s common stock, par value $0.01 per share. $15,000 of these Notes remain outstanding.

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 developed in Inotek’s laboratories 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.

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 Contact:

Claudine Prowse, Ph.D.

Vice President, Strategy and Investor Relations Officer

cprowse@inotekpharma.com

781.552.4305

Media Contact:

Karen Sharma

ksharma@macbiocom.com

781.235.3060


Consolidated Financial Tables

Inotek Pharmaceuticals Corporation

(Unaudited)

(in thousands, except share and per share amounts)

Balance Sheets

 

     June 30,
2015
     December 31,
2014
 

Cash and cash equivalents

   $ 49,012       $ 3,618   

Other assets

     2,676         1,902   
  

 

 

    

 

 

 

Total assets

   $ 51,688       $ 5,520   
  

 

 

    

 

 

 
     

Accounts payable, accrued expenses and other liabilities

   $ 2,476       $ 2,162   

2020 Convertible Notes, net

     8,926         —     

2020 Convertible Notes derivative liability

     8,567         —     

Notes payable

     —           5,613   

Convertible Bridge Notes

     —           1,541   

Warrant and Convertible Bridge Notes redemption rights derivative liabilities

     —           962   
  

 

 

    

 

 

 

Total liabilities

     19,969         10,278   

Series AA redeemable convertible preferred stock

     —           46,253   

Series X redeemable convertible preferred stock

     —           548   

Stockholders’ equity (deficit)

     31,719         (51,559
  

 

 

    

 

 

 

Total Liabilities, Redeemable Convertible Preferred Stock and Stockholders’ Equity (Deficit)

   $ 51,688       $ 5,520   
  

 

 

    

 

 

 

Statements of Operations

 

     Three Months ended June 30,     Six Months ended June 30,  
     2015     2014     2015     2014  

Operating expenses:

        

Research and development

   $ (1,954   $ (1,862   $ (3,023   $ (3,412

General and administrative

     (1,728     (332     (3,708     (494
  

 

 

   

 

 

   

 

 

   

 

 

 

Loss from operations

     (3,682     (2,194     (6,731     (3,906

Interest expense

     (564     (248     (1,038     (491

Loss on extinguishment of debt

     —          —          (683     —     

Change in fair value of warrant liabilities

     —          (405     267        (598

Change in fair value of Convertible Bridge Notes redemption rights derivative

     —          —          480        —     

Change in fair value of 2020 Convertible Notes derivative liability

     1,859        —          3,856        —     
  

 

 

   

 

 

   

 

 

   

 

 

 

Net loss

   $ (2,387   $ (2,847   $ (3,849   $ (4,995
  

 

 

   

 

 

   

 

 

   

 

 

 

Net loss per share attributable to common stockholders—basic and diluted

   $ (0.15   $ (3.81   $ (0.33   $ (6.89

Weighted-average number of shares outstanding—basic and diluted

     16,327,003        1,020,088        12,026,183        1,020,088