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 March 31, 2016

 

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 May 8, 2016 was 10,441,251.

 

 

 

TABLE OF CONTENTS

 

		Page
PART I-FINANCIAL INFORMATION
Item 1.	Financial Statements	1
Item 2.	Management’s Discussion and Analysis of Financial Condition and Results of Operations	12
Item 3.	Quantitative and Qualitative Disclosures About Market Risk	16
Item 4.	Controls and Procedures	16
PART II-OTHER INFORMATION
Item 1A.	Risk Factors	16
Item 6.	Exhibits	16
SIGNATURES		17

 

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.

 

 

PART I-FINANCIAL INFORMATION

 

Item 1. Financial Statements

  

OPHTHALIX INC. AND ITS SUBSIDIARY

 

CONDENSED CONSOLIDATED FINANCIAL STATEMENTS

 

AS OF MARCH 31, 2016

 

U.S. DOLLARS IN THOUSANDS

 

UNAUDITED

 

INDEX

 

	Page
Condensed Consolidated Balance Sheets	2
Condensed Consolidated Statements of Comprehensive Loss	3
Condensed Consolidated Statements of Changes in Stockholders' Deficiency	4
Condensed Consolidated Statements of Cash Flows	5
Notes to Condensed Consolidated Financial Statements	6 - 11

- - - - - - - - - - - - - - - 

 

 

OPHTHALIX INC. AND ITS SUBSIDIARY

 

CONDENSED CONSOLIDATED BALANCE SHEETS

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

 

		March 31, 2016				December 31, 2015
		Unaudited
ASSETS
CURRENT ASSETS:
Cash and cash equivalents		$	6			$	42
Investment in Parent Company			616				658
Other accounts receivable			34				-
Total current assets			656				700
PROPERTY AND EQUIPMENT, NET			-*	)			-*	)
Total assets		$	656			$	700
LIABILITIES AND STOCKHOLDERS' DEFICIENCY
CURRENT LIABILITIES:
Related company		$	3,907			$	3,690
Other accounts payable and accrued expenses			228				291
Total current liabilities			4,135				3,981
NON-CURRENT LIABILITIES:
Derivative related to Service Agreement			-*	)			-*	)
STOCKHOLDERS' DEFICIENCY:
Share capital
Preferred Stock - Authorized : 1,000,000 shares at March 31, 2016 and December 31, 2015, respectively; Issued and Outstanding: 0 shares at March 31, 2016 and December 31, 2015			-				-
Common Stock of  $ 0.001 par value - Authorized:  100,000,000 shares at March 31, 2016 and December 31, 2015, respectively; Issued and Outstanding: 10,441,251 shares at March 31, 2016 and December 31, 2015, respectively			10				10
Additional Paid-in capital			5,518				5,516
Accumulated other comprehensive income			(76	)			(34	)
Accumulated deficit			(8,931	)			(8,773	)
Total stockholders' deficiency			(3,479	)			(3,281	)
Total liabilities and stockholders' deficiency		$	656			$	700

 

*) Represents an amount lower than $1

 

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

 

 

OPHTHALIX INC. AND ITS SUBSIDIARY

 

CONDENSED CONSOLIDATED STATEMENTS OF COMPREHENSIVE LOSS

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

  

		Three months ended March 31,								Year ended December
		2016				2015				2015
		Unaudited
Operating expenses:
Research and development		$	85			$	106			$	812
General and administrative			44				82				573
Total operating expenses			129				188				1,385
Financial expenses, net			29				19				92
Net loss		$	158			$	207			$	1,477
Net loss per share:
Basic and diluted net loss per share		$	0.02			$	0.02			$	0.14
Weighted average number of shares of Common Stock used in computing  basic and diluted net loss per share			10,441,251				10,441,251				10,441,251
Other comprehensive loss:
Available-for-sale investments:
Changes in net unrealized loss			42				283				136
Total other comprehensive loss		$	42			$	283			$	136
Comprehensive loss		$	200			$	490			$	1,613

 

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

 

 

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 (loss)				deficiency
		Unaudited
Balance as of January 1, 2015			10,441,251			$	10			$	5,494			$	(7,296	)		$	102			$	(1,690	)
Stock based compensation			-				-				8				-				-				8
Unrealized loss from investment in Parent Company			-				-				-				-				(283	)			(283	)
Net loss			-				-				-				(207	)			-				(207	)
Balance as of March 31, 2015			10,441,251				10				5,502				(7,503	)			(181	)			(2,172	)
Balance as of January 1, 2016			10,441,251				10				5,516				(8,773	)			(34	)			(3,281	)
Stock based compensation			-				-				2				-				-				2
Unrealized loss from investment in Parent Company			-				-				-				-				(42	)			(42	)
Net loss			-				-				-				(158	)			-				(158	)
Balance as of March 31, 2016			10,441,251			$	10			$	5,518			$	(8,931	)		$	(76	)		$	(3,479	)

 

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

 

 

OPHTHALIX INC. AND ITS SUBSIDIARY

 

CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS

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

 

		Three months ended March 31,								Year ended December 31,
		2016				2015				2015
		Unaudited
Cash flows from operating activities:
Net loss		$	(158	)		$	(207	)		$	(1,477	)
Adjustments to reconcile net loss to net cash used in operating activities:
Decrease (increase) in other accounts receivable			(34	)			(34	)			209
Increase (decrease) in other account payables and accrued expenses			(63	)			(11	)			45
Increase in balance with Related company			217				240				1,233
Depreciation			-*	)			-*	)			1
Stock based compensation			2				8				22
Net cash used in operating activities			(36	)			(4	)			33
Cash flows from investing activities:
Acquisition of fixed assets			-				-				(3	)
Proceeds from sale of property and equipment			-				-				3
Net cash provided by investing activities			-				-				-
Change in cash and cash equivalents			(36	)			(4	)			33
Cash and cash equivalents at the beginning of the period			42				9				9
Cash and cash equivalents at the end of the period		$	6			$	5			$	42

 

*) Represents an amount lower than $1

 

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

 

 

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) 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.

 

On November 21, 2011, the Company completed a private placement of shares of its common stock for gross proceeds of $3,330 through the sale of 646,776 shares of Common Stock to third party investors and sold 466,139 shares of Common Stock to Can-Fite in exchange for 714,922 ordinary shares of Can-Fite, valued at $2,400 and 97,112 shares to Can-Fite for gross proceeds of $500. In addition, the Company issued to Can-Fite and each of the other investors, for each four shares of the Company’s Common Stock purchased in the financing, nine warrants valid for a period of five years from the closing of the financing to acquire two shares of the Company for an exercise price of $7.74.

 

 

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.)

 

On June 17, 2013, the Company sold 268,095 Can-Fite ordinary shares for a total consideration of $511. As of March 31, 2016, the Company holds 446,827 Can-Fite ordinary shares, representing approximately 1.6% of Can-Fite's outstanding share capital.

 

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 Reverse Recapitalization, the Company through EyeFite and Can-Fite entered into a license agreement, pursuant to which Can-Fite granted to EyeFite a sole and exclusive worldwide license for the use of CF101, solely in the field of ophthalmic diseases ("CF101").

 

In connection with the license agreement, referred to above, Eye-Fite was 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 Eye-Fite, for as long as the license agreement between Can-Fite 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 was obligated to make certain milestone payments to NIH ranging from $25 to $500 upon the achievement of various development milestones for each indication.

 

In June 2015, the license agreement between Can-Fite and NIH terminated due to patent expiration. As of March 31, 2016, the Company accrued an amount of $100 related to its DES Phase III clinical trial and $75 related to its Phase II glaucoma Phase II clinical trial. Eye-Fite will also be required to make payments of 20% of sublicensing revenues, excluding royalties and net of the required milestone payments. During 2015, the Company did not reach any milestone or generate revenue that would trigger additional payments to Can-Fite.

 

 

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 Reverse Recapitalization, an agreement was signed between Can-Fite, OphthaliX and Eye-Fite (the "Service Agreement"). According to 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.

 

According to the Service Agreement, in consideration for Can-Fite's services, Eye-Fite will pay to Can-Fite a service fee (consisting of all expenses and costs incurred by Can-Fite plus 15%).

 

As part of the Service Agreement, the Company is required to pay Can-Fite additional payments from future proceeds (due to commercialization or sublicense agreement) in relation to CF101 (the “Additional Payment”). Can-Fite has the right to exchange such future payments for additional shares of OphthaliX upon payment of an exercise price.

 

c.

Liquidity and Capital Resources:

 

During the three months ended March 31, 2016 and the year ended December 31, 2015, the Company incurred operating losses amounting to $129 and $1,385, respectively. The Company will be required to obtain additional liquidity resources in the near term in order to support the commercialization of its products and maintain its research and development activities.

 

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. Also, 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 will expire in October 2016 and any related balance shall bear an interest at a rate of 3% per annum. As of March 31, 2016, the deferred payments to Can-Fite totaled $3,907.

 

There are no assurances, however, that the Company will be able to obtain an adequate level of financial resources that are required for the short and long-term development and commercialization of its product candidates. According to management estimates, liquidity resources as of March 31, 2016, together with the support letters from the Parent Company described above, will be sufficient to maintain the Company's operations at least through October 2016. 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.

 

 

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.)

 

These conditions raise substantial doubt about the Company's ability to continue as a going concern. The accompanying financial statements do not include any adjustments to reflect the possible future effects on recoverability and classification of assets or the amounts and classification of liabilities that may result from the outcome of this uncertainty.

 

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 March 31, 2016, included herein was derived from the audited consolidated financial statements for the year ended December 31, 2015. 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 March 31, 2016, are not necessarily indicative of the results that may be expected for the year ending December 31, 2016, or any future period. 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, 2015.

 

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.

 

The significant accounting policies applied in the annual financial statements of the Company as of December 31, 2015 are applied consistently in these condensed financial statements For further information, refer to the consolidated financial statements as of December 31, 2015.

 

 

 

OPHTHALIX INC. AND ITS SUBSIDIARY

 

NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS

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

 

NOTE 3:-

IMPACT OF RECENTLY ACCOUNTING STANDARDS

 

a.

In August 2014, the Financial Accounting Standards Board (“FASB”) issued Accounting Standards Update (“ASU”) 2014-15, Presentation of Financial Statements-Going Concern (Subtopic 205-40): Disclosure of Uncertainties about an Entity’s Ability to Continue as a Going Concern, which defines management’s responsibility to assess an entity’s ability to continue as a going concern, and to provide related footnote disclosures if there is substantial doubt about its ability to continue as a going concern. The pronouncement is effective for annual reporting periods ending after December 15, 2016 with early adoption permitted. The Company is evaluating the effect, if any, that the adoption of this guidance will have on its consolidated financial statements.

 

b.

In November 2015, the FASB issued ASU No. 2015-17, "Income Taxes – Balance Sheet Classification of Deferred Taxes” ("ASU 2015-17"). The purpose of the standard is to simplify the presentation of deferred taxes on a classified balance sheet. Under current GAAP, deferred income tax assets and liabilities are separated into current and noncurrent amounts in the balance sheet. The amendments in ASU 2015-17 require that all deferred tax assets and liabilities be classified as noncurrent in the balance sheet. ASU 2015-17 is effective for interim and annual periods beginning after December 15, 2017, and interim periods within annual periods beginning after December 15, 2018. Companies can adopt the guidance either prospectively or retrospectively. The Company does not expect the adoption of ASU 2015-17 to have a material impact on its consolidated financial statements or presentation.

 

NOTE 4:-

FAIR VALUE MEASUREMENTS

 

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 as of March 31, 2016 and December 31, 2015 amounted to $0, was determined using the binomial option-pricing model. The aforementioned option-pricing model requires a number of assumptions, of which most significant are the expected stock price volatility and the expected term.

 

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.

 

 

OPHTHALIX INC. AND ITS SUBSIDIARY

 

NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS

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

 

NOTE 4:-

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 March 31, 2016 and December 31, 2015.

 

			March 31, 2016
			Fair value measurements
	Description		Fair Value				Level 1				Level 2				Level 3(1)
	Investment in Parent Company		$	616			$	616			$	-			$	-
	Derivative related to Service Agreement			-*	)			-				-				-*	)
	Total Financial Assets, net		$	616			$	616			$	-			$	-

 

*) Represents an amount lower than $1

 

			December 31, 2015
			Fair value measurements
	Description		Fair Value				Level 1				Level 2				Level 3(1)
	Investment in Parent company		$	658			$	658			$	-			$	-
	Derivative related to Service Agreement			-*	)			-				-				-*	)
	Total Financial Assets, net		$	658			$	658			$	-			$	-

 

*) Represents an amount lower than $1

 

(1)

Fair value measurements using significant unobservable inputs

 

NOTE 5:-

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, 2016 and March 31, 2016			117,500				7.96				6.61			$	-
	Exercisable as of March 31, 2016			112,604				8.0				6.59				-
	Vested and expected to be vested			117,500				7.96				6.61			$	-

 

(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 March 31, 2016.

 

As of March 31, 2016, there was $1 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 0.25 years.

 

 

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, 2015 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 2, 2016.

 

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-α, 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. This study is a randomized, double-masked, placebo-controlled, parallel-group study of the safety and efficacy of daily CF101 administered orally in subjects with elevated IOP. The objective of this study is to determine the safety and efficacy of oral CF101 in lowering IOP when administered BID for 16 weeks in subjects with elevated IOP. We have enrolled 44 subjects in the first segment of the study, randomized in a 3:1 ratio of CF101 1.0 mg treatment to the placebo. In 2015, we amended the ongoing Phase II study protocol and enrolled a further 44 subjects for the second segment, which was randomized in a 3:1 ratio of CF101 2.0 mg treatment to the placebo. This decision was based on certain positive data from the psoriasis Phase II/III study of CF101 by our majority stockholder and parent, Can-Fite BioPharma Ltd, or Can-Fite. As a result, there will not be an interim analysis and the full study data is expected to be announced in the second 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 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 Market Scope, the global glaucoma pharmaceutical market is expected to be nearly $6.1 billion in 2020 and according to GlobalData 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.

 

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.

 

Results of Operations -Three Months Ended March 31, 2016 Compared to the Three Months Ended March 31, 2015

 

		Three Months Ended March 31,
		2016				2015
Operating expenses:
Research and development		$	85,000			$	106,000
General and administrative			44,000				82,000
Total operating costs			129,000				188,000
Financial expenses, net			29,000				19,000
Net loss		$	158,000			$	207,000

 

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 $85,000 for the three months ended March 31, 2016, compared to $106,000 for the three months ended March 31, 2015, a decrease of $21,000 or 20%. The decrease in research and development expenses is primarily related to the fact that the Phase II CF101 study for glaucoma is in its final stages. Assuming we will have sufficient funding, we anticipate incurring significantly higher costs in the future if our Phase II CF101 study for glaucoma is successful.

 

General and administrative expenses. General and administrative expenses were $44,000 for the three months ended March 31, 2016, compared to $82,000 for the three months ended March 31, 2015, a decrease of $38,000 or 46%. The decrease in general and administrative expenses was primarily due to a decrease in legal and professional expenses related to a proposed acquisition of Improved Vision Systems (I.V.S.) Ltd that was not completed

 

 

Financial Expenses

 

Financial expenses, net were $29,000 for the three months ended March 31, 2016 compared to financial expenses of $19,000 for the three months ended March 31, 2015, a change of $10,000 or 53%. Financial expenses, net consisted primarily of interest expenses due to deferred payments to our majority shareholder and parent company, Can-Fite. The increase of financial expenses, net was mainly attributable to interest expenses due to deferred payments to Can-Fite.

 

Net Loss

 

As a result of the foregoing, we incurred a net loss of $158,000 for the three months ended March 31, 2016 compared $207,000 for the three months ended March 31, 2015, a decrease of $49,000 or 24%.

 

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 March 31, 2016 and December 31, 2015, we had $6,000 and $42,000 in cash and cash equivalents, a working capital deficit of $3,479,000 and $3,281,000 and an accumulated deficit of $8,931,000 and $8,773,000, respectively. The increase in working capital deficit was primarily due to our expenses financed by our parent company.

 

Net cash used in operating activities was approximately $36,000 for the three months ended March 31, 2016, compared with net cash used in operating activities of approximately $4,000 for the three months ended March 31, 2015. The increase in net cash used in operating activities was primarily related to changes in account payables.

 

There was no net cash used in investing activities and no net cash provided by financing activities for the three months ended March 31, 2016 and 2015.

 

We have no current source of revenue to sustain our research and development activities, and we do not expect to generate revenue until, and unless, we commercialize any product candidate, which we do not expect to occur for several years. 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 the Company sufficient to cover such deferred payments. As of March 31, 2016, the deferred payments to Can-Fite totaled approximately $3,907,000. 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 expire in October 2016 and any related balance bears interest at a rate of 3% per annum.

 

According to management estimates, liquidity resources as of March 31, 2016, together with the support letters from Can-Fite described above, will be sufficient to maintain our operations at least through October 2016. Our inability to raise funds to conduct our research and development activities will have a severe negative impact on our ability to remain a viable company. These conditions raise substantial doubt about our ability to continue as a going concern. As such, the opinion of our independent registered public accounting firm on our audited financial statements as of and for the year ended December 31, 2015 contains an explanatory paragraph regarding substantial doubt about our ability to continue as a going concern. This going concern opinion could materially limit our ability to raise additional funds through the issuance of new debt or equity securities or otherwise. Future reports on our financial statements may include an explanatory paragraph with respect to our ability to continue as a going concern.

 

 

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. 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.

 

 

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 three months ended March 31, 2016 included in this Quarterly Report on Form 10-Q for the three months ended March 31, 2016.

 

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 March 31, 2016, 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 2, 2016.

 

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 March 31, 2016 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.

 

 

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: May 9, 2016	By	/s/ Pnina Fishman,
		Pnina Fishman, Chief Executive Officer
		(Principal Executive Officer)
Date: May 9, 2016	By	/s/ Itay Weinstein
		Itay Weinstein, Chief Financial Officer
		(Principal Financial Officer)

 

 

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