10-Q 1 f10q0915_ophthalixinc.htm QUARTERLY REPORT

 

 

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

 

FORM 10-Q

 

(Mark One)

☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934

 

For the quarterly period ended September 30, 2015

 

or

 

☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15 (d) OF THE SECURITIES EXCHANGE ACT OF 1934

 

For the transition period from __________to__________

 

Commission File Number: 000-52545

 

OPHTHALIX INC.

(Exact name of registrant as specified in its charter)

 

Delaware   88-0445167

(State or other jurisdiction of

incorporation or organization)

 

(I.R.S. Employer

Identification No.)

 

10 Bareket Street, Petach Tikva, Israel   4951778
(Address of principal executive offices)   (Zip Code)

 

+(972) 3-9241114

(Registrant’s telephone number, including area code)

 

Indicate by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days. Yes ☒   No ☐

 

Indicate by check mark whether the registrant has submitted electronically and posted on its corporate Web site, if any, every Interactive Data File required to be submitted and posted pursuant to Rule 405 of Regulation S-T (§232.405 of this chapter) during the preceding 12 months (or for such shorter period that the registrant was required to submit and post such files). Yes ☒   No ☐

 

Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, or a smaller reporting company. See the definitions of “large accelerated filer,” “accelerated filer” and “smaller reporting company” in Rule 12b-2 of the Exchange Act.

 

  Large accelerated filer Accelerated filer
  Non-accelerated filer Smaller reporting company

 

Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act). Yes ☐   No ☒

 

The number of shares outstanding of the registrant’s Common Stock on November 12, 2015 was 10,441,251.

 

 

 

 

 

 

TABLE OF CONTENTS

 

    Page
PART I - FINANCIAL INFORMATION  
   
Item 1. Financial Statements 3
     
Item 2. Management’s Discussion and Analysis of Financial Condition and Results of Operations 14
     
Item 3. Quantitative and Qualitative Disclosures About Market Risk 19
     
Item 4. Controls and Procedures 19
     
PART II - OTHER INFORMATION  
   
Item 1A. Risk Factors 19
     
Item 6. Exhibits 19
     
SIGNATURES 20

 

Throughout this report, unless otherwise designated, the terms “we,” “us,” “our,” “the Company” and “our company” refer to OphthaliX Inc., a Delaware corporation, and its Israeli subsidiary, Eyefite Ltd. (“Eyefite”). All amounts in this report are in U.S. Dollars, unless otherwise indicated.

 

  2  

 

 

PART I - FINANCIAL INFORMATION

 

Item 1. Financial Statements

 

OPHTHALIX INC. AND ITS SUBSIDIARY

 

CONDENSED CONSOLIDATED FINANCIAL STATEMENTS

 

AS OF SEPTEMBER 30, 2015

 

U.S. DOLLARS IN THOUSANDS

 

UNAUDITED

 

INDEX

 

  Page
   
Condensed Consolidated Balance Sheets 4
   
Condensed Consolidated Statements of Comprehensive Loss (Income) 5
   
Condensed Consolidated Statements of Changes in Stockholders' Deficiency 6
   
Condensed Consolidated Statements of Cash Flows 7
   
Notes to Condensed Consolidated Financial Statements 8 - 14

 

- - - - - - - - - - - - - - -

 

  3  

 

 

OPHTHALIX INC. AND ITS SUBSIDIARY

 

CONDENSED CONSOLIDATED BALANCE SHEETS

U.S. dollars in thousands, except share and per share data

 

   

September 30,

2015

   

December 31,

2014

 
    Unaudited        
ASSETS            
             
CURRENT ASSETS:            
Cash and cash equivalents   $ 14     $ 9  
Investment in Parent Company     962       794  
Other accounts receivable     150       209  
                 
Total current assets     1,126       1,012  
                 
PROPERTY AND EQUIPMENT, NET     3       1  
                 
Total assets   $ 1,129     $ 1,013  
                 
LIABILITIES AND STOCKHOLDERS' DEFICIENCY                
                 
CURRENT LIABILITIES:                
Related company   $ 3,304     $ 2,457  
Other accounts payable and accrued expenses     209       246  
                 
Total current liabilities     3,513       2,703  
                 
NON-CURRENT LIABILITIES:                
                 
Derivative related to Service Agreement     *) -     *) -
                 
STOCKHOLDERS' DEFICIENCY:                
Share capital                
Preferred Stock -                
Authorized : 1,000,000 shares at September 30, 2015 and December 31, 2014, respectively; Issued and Outstanding: 0 shares at September 30, 2015 and December 31, 2014     -       -  
Common Stock of $ 0.001 par value -                
Authorized: 100,000,000 shares at September 30, 2015 and December 31, 2014, respectively; Issued and Outstanding: 10,441,251 shares at September 30, 2015 and December 31, 2014, respectively     10       10  
Additional Paid-in capital     5,513       5,494  
Accumulated other comprehensive income     270       102  
Accumulated deficit     (8,177 )     (7,296 )
                 
Total stockholders' deficiency     (2,384 )     (1,690 )
                 
Total liabilities and stockholders' deficiency   $ 1,129     $ 1,013  

 

*) Represents an amount lower than $ 1

 

The accompanying notes are an integral part of the condensed consolidated financial statements.

 

  4  

 

 

OPHTHALIX INC. AND ITS SUBSIDIARY

 

CONDENSED CONSOLIDATED STATEMENTS OF COMPREHENSIVE LOSS (INCOME)

U.S. dollars in thousands, except share and per share data

 

   

Nine months ended

September 30,

   

Three months ended

September 30,

   

Year ended

December 31,

 
    2015     2014     2015     2014     2014  
    Unaudited        
                               
Operating expenses:                              
Research and development   $ 550     $ 509     $ 247     $ 169     $ 721  
General and administrative     270       292       85       109       425  
                                         
Total operating expenses     820       801       332       278       1,146  
                                         
Financial expenses, net     61       33       21       14       49  
                                         
Net loss   $ 881     $ 834     $ 353     $ 292     $ 1,195  
                                         
Net loss per share:                                        
Basic and diluted loss per share   $ 0.08     $ 0.08     $ 0.03     $ 0.03     $ 0.11  
Weighted average number of Common Stocks used in computing basic and diluted net loss per share     10,441,251       10,441,251       10,441,251       10,441,251       10,441,251  
                                         
Other comprehensive loss (income)                                        
 Available-for-sale investments:                                        
 Changes in net unrealized loss (income)   $ (168 )   $ 419     $ (462 )   $ 46     $ 381  
                                         
Comprehensive loss (income)   $ 713     $ 1,253     $ (109 )   $ 338     $ 1,576  

 

The accompanying notes are an integral part of the condensed consolidated financial statements.

 

  5  

 

 

OPHTHALIX INC. AND ITS SUBSIDIARY

 

CONDENSED STATEMENTS OF CHANGES IN STOCKHOLDERS' DEFICIENCY

U.S. dollars in thousands, except share and per share data

 

                            Accumulated        
    Shares of Common Stock     Additional paid-in     Accumulated     other comprehensive     Total stockholders'  
    Number     Amount     capital     deficit     income     deficiency  
    Unaudited  
                                     
Balance as of January 1, 2014     10,441,251     $ 10     $ 5,469     $ (6,101 )   $ 483     $ (139 )
                                                 
Stock based compensation     -       -       12       -       -       12  
Unrealized loss from investment in Parent Company     -       -       -       -       (419 )     (419 )
                                                 
Net loss     -       -       -       (834 )     -       (834 )
                                                 
Balance as of September 30, 2014     10,441,251       10       5,481       (6,935 )     64       (1,380 )
                                                 
Balance as of January 1, 2015     10,441,251       10       5,494       (7,296 )     102       (1,690 )
                                                 
Stock based compensation     -       -       19       -       -       19  
Unrealized gain from investment in Parent Company     -       -       -       -       168       168  
                                                 
Net loss     -       -       -       (881 )     -       (881 )
                                                 
Balance as of September 30, 2015     10,441,251     $ 10     $ 5,513     $ (8,177 )   $ 270     $ (2,384 )

 

The accompanying notes are an integral part of the condensed consolidated financial statements.

 

  6  

 

 

 OPHTHALIX INC. AND ITS SUBSIDIARY

 

CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS

U.S. dollars in thousands, except share and per share data

 

   

Nine months ended

September 30,

    Year ended December 31  
    2015     2014     2014  
    Unaudited        
                   
Cash flows from operating activities:                  
                   
Net loss   $ (881 )   $ (834 )   $ (1,195 )
Adjustments to reconcile net loss to net cash used in operating activities:                        
Decrease (increase) in other accounts receivable     59       -       (189 )
Decrease in other account payables and accrued expenses     (37 )     (62 )     (17 )
Increase in balance with Related company     847       524       970  
Depreciation     1       -       *)  -
Changes in fair value of the derivative related to service agreement     -       (6 )     (7 )
Stock based compensation     19       12       25  
                         
Net cash provided by (used in) operating activities     8       (366 )     (413 )
                         
Cash flows from investing activities:                        
Acquisition of fixed assets     (3 )     -       -  
                         
Net cash used in investing activities     (3 )     -       -  
                         
Change in cash and cash equivalents     5       (366 )     (413 )
Cash and cash equivalents at the beginning of the period     9       422       422  
                         
Cash and cash equivalents at the end of the period   $ 14     $ 56     $ 9  

 

*) Represents an amount lower than $1

 

The accompanying notes are an integral part of the condensed consolidated financial statements.

 

  7  

 

 

OPHTHALIX INC. AND ITS SUBSIDIARY

 

NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS

U.S. dollars in thousands, except share and per share data

 

NOTE 1:- GENERAL

 

a. OphthaliX Inc. (the "Company" or "OphthaliX"), originally incorporated in the State of Nevada on December 10, 1999 under the name Bridge Capital.com Inc., was a nominally capitalized corporation that did not commence its operations until it changed its name to Denali Concrete Management Inc. ("Denali"), in March 2001. Denali was a concrete placement company specializing in providing concrete improvements in the road construction industry. Denali operated primarily in Anchorage, Alaska, placing curb and gutter, sidewalks and retaining walls for state, municipal and military projects.

 

In December 2005, the Company ceased its principal business operations and focused its efforts on seeking a business opportunity, becoming a public shell company in the U.S.

 

Eye-Fite Ltd. ("Eye-Fite" or the "Subsidiary") was founded on June 27, 2011 in contemplation of the execution of a transaction between Can-Fite BioPharma Ltd. (the "Parent company" or "Can-Fite"), a public company in Israel and U.S, and the Company, as further detailed in Note 1b below.

 

The Company and its Subsidiary conduct research and development activities using an exclusive worldwide license for CF101, a synthetic A3 adenosine receptor, or A3AR, agonist (known generically as IB-MECA) solely for the field of ophthalmic diseases after the consummation of the transaction. See also Note 1b2.

 

Following the transaction, Denali changed its name to OphthaliX Inc. and also changed its corporate domicile from Nevada to Delaware.

 

b. Reverse Recapitalization and related arrangements:

 

1. Recapitalization:

 

On November 21, 2011 (the "Closing Date"), Can-Fite purchased 8,000,000 shares of the Company’s common stock, par value $0.001 per share in exchange for all of the issued and outstanding ordinary shares of Eyefite pursuant to the terms of a stock purchase agreement (the “Purchase Agreement”). As a result, Eyefite became a wholly-owned subsidiary of the Company and Can-Fite became its majority stockholder and a parent.

 

Also on November 21, 2011, the Company issued a warrant to Can-Fite by which Can-Fite has the right, until the earlier of (a) the November 21, 2016 and (b) the closing of the acquisition of the Company by another entity, resulting in the exchange of the Company’s outstanding common shares such that its stockholders prior to such transaction own, directly or indirectly, less than 50% of the voting power of the surviving entity, to convert its right to the Additional Payment (as defined below) into 480,022 shares of Common Stock (subject to adjustment in certain circumstances). The per share exercise price for the shares is $5.148.

 

 

  8  

 

 

OPHTHALIX INC. AND ITS SUBSIDIARY

 

NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS

U.S. dollars in thousands, except share and per share data

 

NOTE 1:- GENERAL (Cont.)

 

The Company also received 714,922 ordinary shares in Can-Fite, representing approximately 7% of Can-Fite's issued and outstanding share capital as of the Closing Date. On June 17, 2013, the Company sold 268,095 Can-Fite ordinary shares for a total consideration of $511. As of September 30, 2015, the Company holds 446,827 Can-Fite ordinary shares, representing approximately 1.6% of Can-Fite's outstanding share capital.

 

In contemplation of the recapitalization transaction, it was agreed that for every four shares of Common Stock purchased by the New Investors and Can-Fite, they received nine warrants to acquire two shares of Common Stock of the Company. The exercise price of such warrants is $7.74 per share of Common Stock. The warrants are exercisable for a period of five years from the date of grant. The warrants do not contain nonstandard anti-dilution provisions (see also Note 6b to the consolidated financial statements as of December 31, 2014).

 

The transaction was accounted for as a reverse recapitalization which is outside the scope ASC 805, Business Combinations. Under reverse capitalization accounting, EyeFite is considered the acquirer for accounting and financial reporting purposes, and acquired the assets and assumed the liabilities of the Company. Assets acquired and liabilities assumed are reported at their historical amounts. Consequently, the condensed consolidated financial statements of the Company reflect the operations of the acquirer for accounting purposes together with a deemed issuance of shares, equivalent to the shares held by the former shareholders of the legal acquirer and a recapitalization of the equity of the accounting acquirer. These condensed consolidated financial statements include the accounts of the Company since the effective date of the reverse capitalization and the accounts of EyeFite since inception.

 

2. License and research and development services from Can-Fite:

 

In connection with the consummation of the recapitalization transaction, the Company and Can-Fite entered into a license agreement, pursuant to which Can-Fite granted EyeFite a sole and exclusive worldwide license for the use of CF101, solely in the field of ophthalmic diseases ("CF101"). EyeFite will be obligated to make to the U.S. National Institutes of Health ("NIH"), with regard to the patents of which are included in the license to EyeFite, for as long as the license agreement between the Company and NIH remains in effect, a nonrefundable minimum annual royalty fee and potential future royalties of 4.0% to 5.5% on net sales.

 

In addition, the Company will be obligated to make certain milestone payments ranging from $25 to $500 upon the achievement of various development milestones for each indication. EyeFite will also be required to make payments of 20% of sublicensing revenues, excluding royalties and net of the required milestone payments. During 2014 and 2015, the Company did not reach any milestone or generate revenue that would trigger additional payments to Can-Fite. As of September 30, 2015 the aggregate amount accrued for these milestones payment is $175.

 

  9  

 

 

OPHTHALIX INC. AND ITS SUBSIDIARY

 

NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS

U.S. dollars in thousands, except share and per share data

 

NOTE 1:- GENERAL (Cont.)

 

In addition, following the closing of the recapitalization transaction, Can-Fite, OphthaliX and EyeFite entered into a service agreement (the "Service Agreement"). Pursuant to the terms of the Service Agreement, Can-Fite will manage the research and development activities relating to pre-clinical and clinical studies for the development of the ophthalmic indications of CF101. In consideration for Can-Fite's services, EyeFite will pay to Can-Fite a service fee (consisting of all expenses and costs incurred by Can-Fite plus 15%). In addition, the Company is committed to future additional payments equal to 2.5% of any and all proceeds received by EyeFite relating to the activities regarding the drug (the "Additional Payment").

 

According to the Service Agreement, Can-Fite will have the right, at any time until November 21, 2016, to convert the Additional Payment into an additional 480,022 shares of Common Stock of the Company for total consideration of $2,471 (subject to adjustment in certain circumstances - See also Note 6 to the consolidated financial statements as of December 31, 2014).

 

c. Share Purchase Agreement:

 

On June 18, 2015, the Company entered into a Share Purchase Agreement with Improved Vision Systems (I.V.S) Ltd (“IVS”), an Israeli company and its shareholders (the “Sellers”). Subsequently, on August 25, 2015, the Share Purchase Agreement was amended (such Share Purchase Agreement, as amended, the “Agreement”). The agreement closing is pending the fulfillment of certain criteria, as further describe below.

 

Upon the terms and subject to the conditions further described in the Agreement, the Company will acquire IVS from the Sellers through the transfer to the Company of all issued and outstanding ordinary shares of IVS in exchange for (i) the issuance by the Company of an aggregate of 2,920,748 shares of common stock of the Company to the Sellers, (ii) the issuance by the Company of options to purchase an aggregate of 303,174 shares of Common stock of the Company to holders of commitments to be granted options to purchase ordinary shares of IVS (the “Option Holders”), and (iii) the issuance by the Company of an aggregate of 2,219,771 shares of common stock of the Company to the Sellers and options to purchase 230,411 shares of common stock of the Company to the Option Holders upon the fulfillment of certain milestones (collectively, the "Milestone Securities").

 

The Milestone Securities shall be issued as follows: (i) 1,289,569 Milestone Securities shall be issued upon successful completion of a human clinical study of the first application of the Company’s eye tracking product and (ii) 1,160,613 Milestone Securities shall be issued upon the first commercial sale of the Company’s eye tracking product.

 

The Company has agreed to file a registration statement registering the resale of the Company’s common stock issuable under the Agreement at such times and covering such amounts of shares as set forth in the Agreement.

 

In addition to customary closing conditions, the initial closing is subject to, among other things, the following: (i) the Sellers shall have obtained a ruling from the Israeli Tax Authority, and (ii) completion of a fundraising by the Company in an amount no less than $3,000. If the initial closing does not take place prior to October 30, 2015, then the Agreement shall automatically terminate, unless otherwise agreed to in writing between the Company, IVS and its shareholder. As of the date hereof, an initial closing has not occurred and the Company is presently evaluating its alternatives.

 

  10  

 

 

OPHTHALIX INC. AND ITS SUBSIDIARY

 

NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS

U.S. dollars in thousands, except share and per share data

 

NOTE 1:- GENERAL (Cont.)

 

d. The Company devotes most of its efforts toward research and development activities. As of September 30, 2015, the Company does not have sufficient capital resources to conduct its research and development activities until commercialization of the underlying products.

 

The Company's inability to raise funds to conduct its research and development activities will have a severe negative impact on its ability to remain a viable company.

 

The Company is addressing its liquidity issues by implementing initiatives to raise additional funds as well as other measures that will allow it to cover its anticipated budget deficit. Such initiatives include a plan to monetize part or all of the Company's investment in Can-Fite's ordinary shares. In addition, in February 2013 Can-Fite issued to the Company a formal letter, which has been updated periodically (most recently in August 2015), stating that Can-Fite agrees to defer payments owing to it under the Services Agreement from January 31, 2013 for the performance of the clinical trials of CF101 in ophthalmic indications until the completion of fundraising by the Company sufficient to cover such deferred payments.

 

In addition, in August 2015, Can-Fite issued a financial support letter pursuant to which it committed to cover any shortfall in the costs and expenses of operations of the Company which are in excess of the Company's available cash to finance its operations, including cash generated from any future sale of Can-Fite shares held by the Company. Both letters remain in effect for a period of at least 14 months from August 2015 and any related balance bears interest at a rate of 3% per annum.

 

As of September 30, 2015, the deferred payments to Can-Fite totaled $3,304. There are no assurances that the Company will be successful in obtaining an adequate level of financing needed for its long-term research and development activities. If the Company will not have sufficient liquidity resources, the Company may not be able to continue the development of all of its products or may be required to delay part of the development programs.

 

The Company's inability to raise funds to conduct its research and development activities will have a severe negative impact on its ability to remain a viable company. Liquidity resources, as of September 30, 2015, together with the Parent company support letters described above, will be sufficient to maintain the Company's operations for at least 12 months.

 

NOTE 2:- UNAUDITED CONDENSED FINANCIAL STATEMENTS

 

The unaudited Condensed Consolidated Financial Statements of OphthaliX Inc. have been prepared in accordance with U.S. generally accepted accounting principles ("U.S. GAAP") for interim financial information and the rules and regulations of the U.S. Securities and Exchange Commission ("SEC"). Accordingly, they do not include all of the information and footnotes required by U.S. GAAP for complete financial statements. The condensed consolidated balance sheets as of September 30, 2015, included herein were derived from the audited consolidated financial statements for the year ended December 31, 2014. In the opinion of management, all adjustments, including normal recurring accruals, considered necessary for a fair presentation have been included. The results of operations for the three months ended September 30, 2015, are not necessarily indicative of the results that may be expected for the year ending December 31, 2015, or any future period.

 

  11  

 

 

OPHTHALIX INC. AND ITS SUBSIDIARY

 

NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS

U.S. dollars in thousands, except share and per share data

 

NOTE 2:- UNAUDITED CONDENSED FINANCIAL STATEMENTS (Cont.)

 

The information included in this interim report should be read in conjunction with "Management's Discussion and Analysis of Financial Condition and Results of Operations," "Risk Factors," "Quantitative and Qualitative Disclosures About Market Risk," and the consolidated financial statements and footnotes thereto included in the Company's Annual Report on Form 10-K for the year ended December 31, 2014.

 

The preparation of financial statements in accordance with U.S. GAAP requires management to make estimates and assumptions that affect the amounts reported in the condensed consolidated financial statements and accompanying notes. Actual results could differ materially from those estimates under different assumptions or conditions.

 

NOTE 3:- FAIR VALUE MEASUREMENTS

 

The significant accounting policies applied in the annual financial statements of the Company as of December 31, 2014 are applied consistently in these condensed financial statements. For further information, refer to the consolidated financial statements as of December 31, 2014.

 

The Company considers an active market to be one in which transactions for the asset or liability occur with sufficient frequency and volume to provide pricing information on an ongoing basis, and views an inactive market as one in which there are few transactions for the asset or liability, the prices are not current, or price quotations vary substantially either over time or among market makers.

 

Since the quoted market value of the Company’s Common Stock was based on a sporadically traded stock with little volume, the Company's management determined the Company's stock price fair value based on ASC 820 Fair Value Measurement using the income approach assisted by a third party specialist. Consequently, the derivatives are classified within Level 3 because they are valued using valuation techniques.

 

The fair value of the Derivative was determined using the binomial option-pricing model. This model requires a number of assumptions, of which most significant are the expected stock price volatility and the expected term.

 

The fair value of the Derivative as of September 30, 2015 and December 31, 2014 was immaterial.

 

The Company's investment in Parent Company ordinary shares is measured in accordance with ASC 820, based on the Parent Company's ordinary shares fair value as quoted in the Tel Aviv Stock Exchange.

 

These securities are classified as available-for-sale securities carried at fair value, with unrealized gains and losses reported as a separate component of shareholders' equity under accumulated other comprehensive loss (income) in the condensed consolidated balance sheets. The assets are classified within Level 1 on the fair value hierarchy.

  

  12  

 

  

OPHTHALIX INC. AND ITS SUBSIDIARY

 

NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS

U.S. dollars in thousands, except share and per share data

 

NOTE 3:- FAIR VALUE MEASUREMENTS (Cont.)

 

The following table provides information by value level for financial assets and liabilities that are measured at fair value, as defined by ASC 820, on a recurring basis as of September 30, 2015 and December 31, 2014.

 

      September 30, 2015  
      Fair value measurements  
  Description   Fair Value     Level 1     Level 2     Level 3(1)  
                           
  Investment in Parent Company   $ 962     $ 962     $ -     $ -  
  Derivative related to Service Agreement     *) -     -       -       *) -
                                   
  Total Financial Assets, net   $ 962     $ 962     $ -     $ *) -  

 

*) Represents an amount lower than $1

 

   

December 31, 2014

 
      Fair value measurements  
  Description   Fair Value     Level 1     Level 2     Level 3(1)  
                           
  Investment in Parent company   $ 794     $ 794     $ -     $ -  
  Derivative related to Service Agreement     *) -     -       -       *) -
                                   
  Total Financial Assets, net   $ 794     $ 794     $ -     $ *) -  

 

*)     Represents an amount lower than $1

 

(1)    Fair value measurements using significant unobservable inputs

 

During the nine months ended September 30, 2015 the changes in Level 3 instruments measured on a recurring basis was immaterial.

 

NOTE 4:- EQUITY

 

The following table summarizes the activity of stock options:

 

      Shares Subject to Options Outstanding  
  Description  

Number of

Shares

   

Weighted

Average

Exercise

Price

   

Weighted-

Average

Remaining

Contractual

Term
(in years)

   

Aggregate

Intrinsic

Value(1)

 
  Outstanding as of January 1, 2015     117,500       7.96       7.8     $ -  
  Granted     -       -       -       -  
  Expired     -       -       -       -  
  Forfeited/cancelled     -       -       -       -  
                                   
  Outstanding as of September 30, 2015     117,500       7.96       7.15     $ -  
                                   
  Exercisable as of September 30, 2015     102,812       8.10       7.06       -  
                                   
  Vested and expected to be vested     117,500       7.96       7.15     $ -  

 

(1) The aggregate intrinsic value is calculated as the difference between the exercise price of the stock options and the closing price of the shares of the Company’s Common Stock of $ 0.99 as of September 30, 2015.

 

As of September 30, 2015, there was $7 of unrecognized stock-based compensation expense all of which is related to stock options. This unrecognized compensation expense, expected to be recognized over a weighted-average period of approximately 0.5 years.

 

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Item 2. Management’s Discussion and Analysis of Financial Condition and Results of Operations

 

Management’s Discussion and Analysis of Financial Condition and Results of Operations analyzes the major elements of our balance sheets, statements of income and cash flows. This section should be read in conjunction with our Annual Report on Form 10-K for the Year Ended December 31, 2014 and our interim financial statements and accompanying notes to these financial statements. All amounts are in U.S. dollars and rounded.

 

Forward-Looking Statement Notice

 

This quarterly report on Form 10-Q contains forward-looking statements about our expectations, beliefs or intentions regarding, among other things, our product development efforts, business, financial condition, results of operations, strategies or prospects. In addition, from time to time, we or our representatives have made or may make forward-looking statements, orally or in writing. Forward-looking statements can be identified by the use of forward-looking words such as “believe,” “expect,” “intend,” “plan,” “may,” “should” or “anticipate” or their negatives or other variations of these words or other comparable words or by the fact that these statements do not relate strictly to historical or current matters. These forward-looking statements may be included in, but are not limited to, various filings made by us with the United States Securities and Exchange Commission, or the SEC, press releases or oral statements made by or with the approval of one of our authorized executive officers. Forward-looking statements relate to anticipated or expected events, activities, trends or results as of the date they are made. Because forward-looking statements relate to matters that have not yet occurred, these statements are inherently subject to risks and uncertainties that could cause our actual results to differ materially from any future results expressed or implied by the forward-looking statements. Many factors could cause our actual activities or results to differ materially from the activities and results anticipated in forward-looking statements, including, but not limited to, those set forth in our most recent annual reports referenced below.

 

This report identifies important factors which could cause our actual results to differ materially from those indicated by the forward-looking statements, particularly those set forth under Item 1A. “Risk Factors” as disclosed in our Annual Report on Form 10-K, as filed with the SEC on March 25, 2015.

 

Such risk factors are not necessarily all of the important factors that could cause actual results to differ materially from those expressed in any of our forward-looking statements. Given these uncertainties, readers are cautioned not to place undue reliance on such forward-looking statements.

 

All forward-looking statements attributable to us or persons acting on our behalf speak only as of the date of this report and are expressly qualified in their entirety by the cautionary statements included in this report. We undertake no obligations to update or revise forward-looking statements to reflect events or circumstances that arise after the date made or to reflect the occurrence of unanticipated events. In evaluating forward-looking statements, you should consider these risks and uncertainties.

 

Description of Business

 

We are a clinical-stage biopharmaceutical company focused on developing therapeutic products for the treatment of ophthalmic disorders. We have in-licensed certain patents and patent applications protecting the use in the ophthalmic field of our current pipeline drug under development, a synthetic A3 adenosine receptor, or A3AR, agonist, CF101 (known generically as IB-MECA). CF101 is currently being developed by us to treat two ophthalmic indications: glaucoma and uveitis. We are currently conducting a Phase II trial with respect to the development of CF101 for the treatment of glaucoma or related syndromes of ocular hypertension.

 

CF101 is a highly-selective, orally bioavailable small molecule synthetic drug, which targets the A3AR. We believe that CF101 has a favorable safety profile and a potent anti-inflammatory activity, mediated via its capability to inhibit the production of inflammatory cytokines, such as TNF-, MMPs, IL-1, and IL-6. This is mediated by activation of the A3AR, which is highly expressed in inflammatory tissues in contrast to normal tissues where expression levels of the receptor are very low. We believe that the anti-inflammatory and neuro-protective effects of CF101 make it a candidate for use in the treatment of ophthalmic indications.

 

We are focused on the development of CF101 for the treatment of glaucoma, with a Phase II study ongoing in Israel and Europe. We amended the ongoing Phase II study protocol and continue to the second cohort, where patients are treated with 2 mg CF101 or placebo. This decision is based on positive data from the psoriasis Phase II/III study currently conducted with CF101 by our majority stockholder and parent, Can-Fite. As a result, there will not be an interim analysis and the full study data is expected to be announced during the first half of 2016. If successful, the treatment of glaucoma with an oral drug has the potential to be a breakthrough treatment in resolving patient compliance issues with current topical treatments. A third-party validation for the utilization of A3 adenosine receptor agonists for lowering intraocular pressure and treating glaucoma has been recently published by Professor M. Francesca Cordeiro, a Professor of Glaucoma & Retinal Neuro-degeneration at the University College of London and Imperial College in London.

 

According to GlobalData, the global market for glaucoma drugs is estimated to exceed $3 billion by 2018 and the global uveitis therapeutics market is expected to grow from $0.3 billion in 2010 to $1.6 billion by 2017. None of our product candidates have been approved for sale or marketing and, to date, there have been no commercial sales of any of our product candidates.

 

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Our corporate strategy is to build a specialized ophthalmic company that develops and in-licenses drugs for the treatment of ophthalmic diseases. We intend to seek to obtain technologies that complement and expand our existing pipeline by entering into in-license or co-development agreements with academic institutions and biotechnology or pharmaceutical companies. We intend to commercialize our products through out-licensing arrangements with third parties who may perform any or all of the following tasks: completing development, securing regulatory approvals, manufacturing, marketing and sales. We do not intend to develop our own manufacturing facilities or sales forces.

 

Recent Developments

 

On June 18, 2015, we entered into a Share Purchase Agreement with Improved Vision Systems (I.V.S) Ltd (“IVS”), an Israeli company, Dan Oz, founder and shareholder of IVS and all other shareholders of IVS (Mr. Oz, together with all other shareholders, the “Sellers”). Subsequently, on August 25, 2015, the Share Purchase Agreement was amended (such Share Purchase Agreement, as amended, the “Share Purchase Agreement”). The agreement closing is pending the fulfillment of certain criteria, as further describe below.

 

Upon the terms and subject to the conditions set forth in the Share Purchase Agreement, we will acquire IVS from the Sellers through the transfer to us of all issued and outstanding ordinary shares of IVS in exchange for (i) the issuance by us of an aggregate of 2,920,748 shares of our common stock to the Sellers, (ii) the issuance by us of options to purchase an aggregate of 303,174 shares of our common stock to holders of commitments to be granted options to purchase ordinary shares of IVS (the “Option Holders”), and (iii) the issuance by us of an aggregate of 2,219,771 shares of our common stock to the Sellers and options to purchase 230,411 shares of our common stock to the Option Holders upon the fulfillment of certain milestones (collectively, the "Milestone Securities").

 

The Milestone Securities shall be issued as follows: (i) 1,289,569 Milestone Securities shall be issued upon successful completion of a human clinical study of the first application of our eye tracking product as shall be approved by an independent expert, mutually agreed upon by Mr. Oz and us, and acceptance for publication of the study in a reputable peer reviewed journal, and (ii) 1,160,613 Milestone Securities shall be issued upon the first commercial sale of our eye tracking product.

 

We have agreed to file a registration statement registering the resale of our common stock issuable under the Share Purchase Agreement at such times and covering such amounts of shares as set forth in the Share Purchase Agreement.

 

The Share Purchase Agreement further provides that concurrently with the initial closing, Ran Yam shall be appointed as our Chief Executive Officer replacing Pnina Fishman who is currently serving as our interim Chief Executive Officer and Mr. Oz shall be appointed as our Chief Technology Officer and that both Mr. Yam and Mr. Oz shall be appointed to our board of directors.

 

In addition to customary closing conditions, the initial closing is subject to, among other things, the following: (i) the Sellers shall have obtained a ruling from the Israeli Tax Authority, and (ii) completion of a fundraising by us in an amount no less than $3 million. If the initial closing does not take place prior to October 30, 2015, then the Share Purchase Agreement shall automatically terminate, unless otherwise agreed to in writing between us, IVS and Mr. Oz. As of the date hereof, an initial closing has not occurred and we are presently evaluating our alternatives.

 

Each of us, IVS and Sellers have made customary representations and warranties in the Share Purchase Agreement and the Share Purchase Agreement contains customary indemnification provisions subject to certain limitations of liability contained in the Share Purchase Agreement.

 

The foregoing description of the Share Purchase Agreement does not purport to be complete and is qualified in its entirety by reference to the full text of the Share Purchase Agreement and Amendment to Share Purchase Agreement, which are attached as Exhibit 2.1 to our Current Report on Form 8-K filed with the SEC on June 19, 2015 and August 27, 2015 and are incorporated herein by reference. The Share Purchase Agreement has been included to provide investors and stockholders with information regarding its terms. It is not intended to provide any other factual information about us. The Share Purchase Agreement contains representations and warranties that the parties to the Agreement made to and solely for the benefit of each other, and the assertions embodied in such representations and warranties are qualified by information contained in confidential disclosure schedules that the parties exchanged in connection with signing the Share Purchase Agreement. Accordingly, investors and stockholders should not rely on such representations and warranties as characterizations of the actual state of facts or circumstances, since they were only made as of the date of the Share Purchase Agreement (or such other date as specified therein) and are modified in important part by the underlying disclosure schedules.

 

Since the Share Purchase Agreement is subject to approvals and other conditions, there can be no assurance that the transactions contemplated by the Share Purchase Agreement will be consummated in a timely basis or at all.

 

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Results of Operations - Nine Months Ended September 30, 2015 Compared to the Nine Months Ended September 30, 2014

 

    Nine Months ended
September 30,
 
    2015     2014  
    (in thousands)  
Operating expenses:            
Research and development   $ 550     $ 509  
General and administrative     270       292  
Total operating costs     820       801  
Financial expenses, net     61       33  
Net loss   $ 881     $ 834  

 

Revenues 

 

We did not generate any revenues from operations. We had no revenues because we do not have any commercial products and we do not expect to have such products for several years, if at all.

 

Operating Expenses

 

Research and development expenses. Research and development expenses were $550,000 for the nine months ended September 30, 2015, compared to $509,000 for the nine months ended September 30, 2014, an increase of $41,000 or 8%. The increase in research and development expenses is primarily related to the increase in expenses related to our Phase II CF101 study for glaucoma in 2015 offset by completion of our Phase III study in DES during 2014 and a reduction in patent and licensing maintenance fees.

 

General and administrative expenses. General and administrative expenses were $270,000 for the nine months ended September 30, 2015, compared to $292,000 for the nine months ended September 30, 2014, a decrease of $22,000 or 8%. The decrease in general and administrative expenses was primarily related to a reduction in compensation related to the termination of a CEO during 2014 offset by an increase in legal and professional expenses, share based payment and general expenses.

 

Financial Expenses, Net

 

Financial expenses, net were $61,000 for the nine months ended September 30, 2015 compared to financial expenses, net of $33,000 for the nine months ended September 30, 2014, an increase of $28,000 or 46%. Financial expenses, net consisted primarily of interest expenses due to deferred payments to our parent company, Can-Fite. The increase of financial expenses, net was mainly attributable to interest expenses due to deferred payments to our parent company. 

 

Net Loss

 

As a result of the foregoing, we incurred a net loss of $881,000 for the nine months ended September 30, 2015 compared to $834,000 for the nine months ended September 30, 2014, an increase of $47,000 or 6%.

 

Results of Operations - Three Months Ended September 30, 2015 Compared to the Three Months Ended September 30, 2014 

 

    Three Months ended
September 30,
 
    2015     2014  
    (in thousands)  
Operating expenses:            
Research and development   $ 247     $ 169  
General and administrative     85       109  
Total operating costs     332       278  
Financial expenses, net     21       14  
Net loss   $ 353     $ 292  

 

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Revenues

 

We did not generate any revenues from operations. We had no revenues because we do not have any commercial products and we do not expect to have such products for several years, if at all.

 

Operating Expenses

 

Research and development expenses. Research and development expenses were $247,000 for the three months ended September 30, 2015, compared to $169,000 for the three months ended September 30, 2014, an increase of $78,000 or 46%. The increase in research and development expenses is primarily related to an increase in expenses related to our Phase II CF101 study for glaucoma in 2015 offset by a reduction in patent and licensing maintenance fees.

 

General and administrative expenses. General and administrative expenses were $85,000 for the three months ended September 30, 2015, compared to $109,000 for the three months ended September 30, 2014, a decrease of $24,000 or 22%. The decrease in the general and administrative expenses was primarily related to reduction in compensation related to the termination of a CEO during 2014 offset by an increase in legal and professional expenses, share based payment and general expenses.

 

Financial Expenses, Net

 

Financial expenses, net was $21,000 for the three months ended September 30, 2015 compared to $14,000 for the three months ended September 30, 2014, an increase of $7,000 or 33%. The increase of financial expenses, net was mainly attributable to the interest expenses due to deferred payments to our parent company.

 

Net Loss

 

As a result of the foregoing, we incurred a net loss of $353,000 for the three months ended September 30, 2015 compared $292,000 for the three months ended September 30, 2014, an increase of $61,000 or 17%.

 

Liquidity and Capital Resources

 

Liquidity is the ability of a company to generate funds to support its current and future operations, satisfy its obligations, and otherwise operate on an ongoing basis. Significant factors in the management of liquidity are funds generated by operations, levels of accounts receivable and accounts payable and capital expenditures.

 

As of September 30, 2015 and December 31, 2014, we had $14,000 and $9,000 in cash and cash equivalents, a working capital deficit of $2,387,000 and $1,691,000 and an accumulated deficit of $8,177,000 and $7,296,000. The increase in working capital deficit was primarily due to an increase in deferred payments to Can-Fite offset by the increase in the fair value of our investment in Can-Fite’s securities.

 

Net cash provided by operating activities was $8,000 for the nine months ended September 30, 2015, compared with net cash used in operating activities of $366,000 for the nine months ended September 30, 2014. The decrease in net cash used in operating activities was primarily related to the increase in debt to our parent company.

 

Net cash used in investing activities was $3,000 and $0 for the nine months ended September 30, 2015 and September 30, 2014, respectively. The increase of $3,000 was related to fixed assets purchase.

 

There was no net cash from financing activities for the nine months ended September 30, 2015 and 2014.

 

In February 2013, Can-Fite issued us a formal letter, which has been updated periodically (most recently in August 2015), stating that Can-Fite agrees to defer payments owed to it under the Services Agreement (under which Can-Fite manages, as an independent contractor, all activities relating to pre-clinical and clinical studies performed for the development of the ophthalmic indications of CF101) beginning on January 31, 2013 until the completion of fundraising by us sufficient to cover such deferred payments. As of September 30, 2015, the deferred payments to Can-Fite totaled approximately $3,304. In addition, in August 2015, Can-Fite issued a financial support letter pursuant to which it committed to cover any shortfall in our costs and expenses of the operations which are in excess of our available cash to finance our operations, including cash generated from any future sale of Can-Fite shares held by us. Both letters remain in effect for a period of at least 14 months from August 2015 and any related balance bears interest at a rate of 3% per annum.

 

  17  

 

 

Liquidity resources, as of September 30, 2015, together with the Can-Fite support letters as discussed above, will be sufficient to maintain the Company's operations for at least twelve months. For a long term solution, we will need to seek additional capital for the purpose of further testing our products, managing our business and obtaining certifications necessary in order to market them.

 

Developing drugs, conducting clinical trials and commercializing products is expensive and we will need to raise substantial additional funds to achieve our strategic objectives. Although we believe our existing cash and other financial assets resources will be sufficient to fund our current projected cash requirements, factoring in the deferment letter from Can-Fite, to operate our business as currently conducted at least for twelve months from the balance sheet date, we will require significant additional financing in the future. Additional financing may not be available on acceptable terms, if at all. Our future capital requirements will depend on many factors, including:

 

the failure to obtain regulatory approval or achieve commercial success of our product candidates, which currently includes only CF101;
   
the level of research and development investment required to develop our product candidates, and maintain and improve our patented or licensed technology position;
   
the costs of obtaining or manufacturing product candidates for research and development and testing;
   
the results of preclinical and clinical testing, which can be unpredictable in product candidate development and any decision to initiate additional preclinical or clinical studies;
   
changes in product candidate development plans needed to address any difficulties that may arise in manufacturing, preclinical activities or clinical studies;

 

our success in establishing and effecting out-licensing agreements with strategic partners, the terms of these agreements and the success of these potential future licensees and partners in selling our products;
   
our success rate in preclinical and clinical efforts associated with milestones and royalties, if applicable;
   
the costs of investigating patents that might block us from developing potential product candidates;
   
the costs of recruiting and retaining qualified personnel;
   
the costs, timing and outcomes involved in obtaining regulatory approvals;
   
the number of product candidates we pursue in the future;
   
our revenues, if any;
   
the costs of filing, prosecuting, defending and enforcing patent claims and other intellectual property rights;
   
our need or decision to acquire or license complementary technologies or new platform or product candidate targets; and
   
the costs of financing unanticipated working capital requirements and responding to competitive pressures.

 

We currently have no agreements, arrangements, or understandings with any person to obtain funds through bank loans, lines of credit, or any other sources, other than the formal letter from Can-Fite agreeing to defer payments owed to it under the services agreement. Until we can generate significant continuing revenues, we expect to satisfy our future cash needs through debt or equity financings, or by out-licensing our product candidate. We cannot be certain that additional funding will be available to us on acceptable terms, or at all. If funds are not available, we may be required to delay, reduce the scope of, or eliminate one or more of our research or development programs or our commercialization efforts.

 

We are addressing our liquidity issues by implementing initiatives to raise additional funds as well as other measures that we believe will allow the coverage of our anticipated budget deficit. Such initiatives may include monetizing of our assets, by intention to realize our remaining investment in Can-Fite’s shares.

 

As of the date of this report, we have no material capital commitments.

 

  18  

 

 

Off-Balance Sheet Arrangements

 

We do not have any off-balance sheet arrangements that have or are reasonably likely to have a current or future material effect on our consolidated financial condition, changes in financial condition, revenues or expenses, results of operations, liquidity capital expenditures or capital resources.

 

Critical Accounting Policies

 

Our significant accounting policies, which include management’s best estimates and judgments, are included in Note 2 to the financial statements for the nine months ended September 30, 2015 included in this Quarterly Report on Form 10-Q for the nine months ended September 30, 2015.

 

Item 3. Quantitative and Qualitative Disclosures About Market Risk

 

As a smaller reporting company, we have elected not to provide the disclosure required by this item.

 

Item 4. Controls and Procedures

 

Evaluation of disclosure controls and procedures

 

Our management, with the participation of our Chief Executive Officer and Chief Financial Officer, evaluated the effectiveness of our disclosure controls and procedures (as defined in Rule 13a-15(e) of the Securities Exchange Act of 1934, as amended (the “Exchange Act”)) as of the end of the period covered by this report. Based on that evaluation, our Chief Executive Officer and Chief Financial Officer concluded that our disclosure controls and procedures as of the end of the period covered by this report were effective in ensuring that information required to be disclosed by us in reports that we file or submit under the Exchange Act (i) is recorded, processed, summarized and reported within the time periods specified in the Securities and Exchange Commission’s rules and forms, and (ii) is accumulated and communicated to the Company’s management, including its principal executive and principal financial officers, or persons performing similar functions, as appropriate to allow timely decisions regarding required disclosure.

 

Changes in internal control over financial reporting

 

There has been no change in our internal control over financial reporting, as defined in Rule 13a-15(f) of the Exchange Act, during our most recent fiscal quarter ended September 30, 2015, that has materially affected, or is reasonably likely to materially affect, our internal control over financial reporting.

 

PART II-OTHER INFORMATION

 

Item 1A. Risk Factors

 

See Item 1A. “Risk Factors” as disclosed in our Annual Report on Form 10-K, as filed with the SEC on March 25, 2015.

 

Item 6. Exhibits

 

SEC Ref. No.   Title of Document
31.1   Rule 13a-14(a) Certification by Principal Executive Officer
31.2   Rule 13a-14(a) Certification by Principal Financial Officer
32.1   Section 1350 Certification of Principal Executive Officer
32.2   Section 1350 Certification of Principal Financial Officer
101.INS   XBRL Instance Document *
101.SCH   XBRL Taxonomy Extension Schema Document *
101.CAL   XBRL Taxonomy Extension Calculation Linkbase Document *
101.DEF   XBRL Taxonomy Extension Definition Linkbase Document *
101.LAB   XBRL Taxonomy Extension Label Linkbase Document *
101.PRE   XBRL Taxonomy Extension Presentation Linkbase Document *

 

* Attached as Exhibit 101 to this report are the following financial statements from the Company’s Quarterly Report on Form 10-Q for the quarter ended September 30, 2015 formatted in XBRL (eXtensible Business Reporting Language): (i) the Condensed Consolidated Balance Sheets, (ii) the Condensed Consolidated Statements of Comprehensive Loss, (iii) the Condensed Statements of Changes in Stockholders’ Deficiency, (iv) the Condensed Consolidated Statements of Cash Flows, and (v) Notes to Financial Statements.

 

  19  

 

 

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 thereunto duly authorized. 

 

  OphthaliX Inc.
     
Date: November 13, 2015 By  /s/ Pnina Fishman
    Pnina Fishman, Chief Executive Officer
    (Principal Executive Officer)
     
Date: November 13, 2015 By  /s/ Itay Weinstein 
    Itay Weinstein, Chief Financial Officer
    (Principal Financial Officer)

 

 

20