UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

 

FORM 6-K

 

Report of Foreign Private Issuer Pursuant to Rule 13a-16 or 15d-16

Under the Securities Exchange Act of 1934

 

For the Month of August 2019

 

001-36203

(Commission File Number)

 

CAN-FITE BIOPHARMA LTD.

(Exact name of Registrant as specified in its charter)

 

10 Bareket Street

Kiryat Matalon, P.O. Box 7537

Petach-Tikva 4951778, Israel

(Address of principal executive offices)

 

Indicate by check mark whether the registrant files or will file annual reports under cover Form 20-F or Form 40-F.

 

Form 20-F þ       Form 40-F ☐

 

Indicate by check mark if the registrant is submitting the Form 6-K in paper as permitted by Regulation S-T Rule 101(b)(1): ____

 

Indicate by check mark if the registrant is submitting the Form 6-K in paper as permitted by Regulation S-T Rule 101(b)(7): ____

 

This Form 6-K (including Exhibits 99.1 and 99.2) are hereby incorporated by reference into the registrant’s Registration Statements on Form S-8 (File No. 333-227753) and Form F-3 (File Nos. 333-204795, 333-209037 and 333-220644), to be a part thereof from the date on which this report is submitted, to the extent not superseded by documents or reports subsequently filed or furnished.

 

 

 

 

 

 

On August 30, 2019, Can-Fite BioPharma Ltd. issued unaudited interim condensed consolidated financial statements as of June 30, 2019. Attached hereto and incorporated by reference herein are the following exhibits:

 

99.1 Operating and Financial Review and Prospects as of June 30, 2019
   
99.2 Unaudited Interim Condensed Consolidated Financial Statements as of June 30, 2019

 

 

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Exhibit Index

 

Exhibit No.   Description
     
99.1   Operating and Financial Review and Prospects as of June 30, 2019
     
99.2   Unaudited Interim Condensed Consolidated Financial Statements as of June 30, 2019

 

 

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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.

 

  Can-Fite BioPharma Ltd.
     
Date: August 30, 2019 By: /s/ Pnina Fishman
    Pnina Fishman
    Chief Executive Officer

 

 

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Exhibit 99.1

 

OPERATING AND FINANCIAL REVIEW AND PROSPECTS

 

You should read the following discussion of our operating and financial condition and prospects in conjunction with the financial statements and the notes thereto included elsewhere in this 6-K. Our financial statements are prepared in accordance with IFRS as issued by the International Accounting Standards Board, and reported in U.S. dollars. We maintain our accounting books and records in U.S. dollars and our functional currency is the U.S. dollar. Certain amounts presented herein may not sum due to rounding.

 

Unless the context requires otherwise, references in this report to “Can-fite,” the “Company,” “we,” “us” and “our” refer to Can-fite BioPharma Ltd, an Israeli company and our consolidated subsidiaries. “NIS” means New Israeli Shekel, and “$,” “US$,”“U.S. dollars” and “USD” mean United States dollars.

 

Forward Looking Statements

 

The following discussion contains “forward-looking statements,” including statements regarding expectations, beliefs, intentions or strategies for the future. These statements may identify important factors which could cause our actual results to differ materially from those indicated by the forward-looking statements. Given these uncertainties, readers are cautioned not to place undue reliance on such forward-looking statements. Factors that could cause our actual results to differ materially from those expressed or implied in such forward-looking statements include, but are not limited to:

 

  our history of losses and needs for additional capital to fund our operations and our inability to obtain additional capital on acceptable terms, or at all;
     
  uncertainties of cash flows and inability to meet working capital needs;
     
  uncertainties regarding the hostile takeover attempts of Capital Point and the related litigation;
     
  the initiation, timing, progress and results of our preclinical studies, clinical trials and other product candidate development efforts;

 

  our ability to advance our product candidates into clinical trials or to successfully complete our preclinical studies or clinical trials;

 

  our receipt of regulatory approvals for our product candidates, and the timing of other regulatory filings and approvals;

 

  the clinical development, commercialization and market acceptance of our product candidates;

 

  our ability to establish and maintain strategic partnerships and other corporate collaborations;

 

  the implementation of our business model and strategic plans for our business and product candidates;

 

  the scope of protection we are able to establish and maintain for intellectual property rights covering our product candidates and our ability to operate our business without infringing the intellectual property rights of others;

 

  competitive companies, technologies and our industry; and

 

  statements as to the impact of the political and security situation in Israel on our business.

 

All forward-looking statements attributable to us or persons acting on our behalf speak only as of the date of the 6-K to which this discussion is attached and are expressly qualified in their entirety by the cautionary statements included herein. 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.

 

 

 

 

Glossary of Certain Terms

 

As used herein, unless the context otherwise requires:

 

  references to “ADSs” refer to the Registrant’s American Depositary Shares;

 

  references to “A3AR” refer to the A3 adenosine receptor;

 

  references to “HCC” refer to hepatocellular carcinoma, also known as primary liver cancer;

 

  references to “NASH” refer to nonalcoholic steatohepatitis;
     
  references to “ordinary shares,” “our shares” and similar expressions refer to the Company’s Ordinary Shares, NIS 0.25 nominal (par) value per share;

 

  references to “RA” refer to rheumatoid arthritis; and

 

Overview

 

We are a clinical-stage biopharmaceutical company focused on developing orally bioavailable small molecule therapeutic products for the treatment of autoimmune inflammatory indications, oncology and liver diseases as well as sexual dysfunction. Our platform technology utilizes the Gi protein associated A3AR as a therapeutic target. A3AR is highly expressed in inflammatory and cancer cells, and not significantly expressed in normal cells, suggesting that the receptor could be a unique target for pharmacological intervention. Our pipeline of drug candidates are synthetic, highly specific agonists and allosteric modulators, or ligands or molecules that initiate molecular events when binding with target proteins, targeting the A3AR.

  

Our product candidates, CF101, CF102 and CF602, are being developed to treat autoimmune inflammatory indications, oncology and liver diseases as well as sexual dysfunction. CF101, also known as Piclidenoson, is in an advance stage of clinical development for the treatment of autoimmune-inflammatory diseases, including rheumatoid arthritis and psoriasis. CF102, also known as Namodenoson, is being developed for the treatment of HCC and has orphan drug designation for the treatment of HCC in the United States and Europe. Namodenoson was granted Fast Track designation by the FDA as a second line treatment to improve survival for patients with advanced HCC who have previously received Nexavar (sorafenib). Namodenoson is also being developed for the treatment of NASH, following our study which revealed compelling pre-clinical data on Namodenoson in the treatment of NASH, a disease for which no FDA approved therapies currently exist. CF602 is our second generation allosteric drug candidate for the treatment of sexual dysfunction, which has shown efficacy in the treatment of erectile dysfunction in preclinical studies and we are investigating additional compounds, targeting A3AR, for the treatment of sexual dysfunction. Preclinical studies revealed that our drug candidates have potential to treat additional inflammatory diseases, such as Crohn’s disease, oncological diseases, viral diseases, such as the JC virus, and obesity.

 

We believe our pipeline of drug candidates represent a significant market opportunity. For instance, according to Visiongain, the world rheumatoid arthritis market size is predicted to generate revenues of $34.6 billion in 2020 and the psoriasis drug market is forecasted to be worth $11.4 billion by 2020. According to DelveInsight, the HCC drug market in the G8 countries (U.S., Germany, France, Italy, Spain, UK, Japan and China) is expected to reach $3.8 billion by 2027.

 

We have in-licensed an allosteric modulator of the A3AR, CF602 from Leiden University. In addition, we have out-licensed the following:

 

  Piclidenoson for the treatment of (i) rheumatoid arthritis to Kwang Dong Pharmaceutical Co. Ltd., for South Korea, (ii) psoriasis and rheumatoid arthritis to Cipher Pharmaceuticals for Canada, (iii) rheumatoid arthritis and psoriasis to Gebro Holding, for Spain, Switzerland and Austria, (iv) rheumatoid arthritis and psoriasis to CMS Medical for China (including Hong Kong, Macao and Taiwan), and (v) for the treatment of psoriasis to Kyongbo Pharm Co., Ltd., or Kyongbo Pharm, for South Korea; and

 

  Namodenoson for the treatment of liver cancer in South Korea to Chong Kun Dang Pharmaceuticals, or CKD, and (ii) advanced liver cancer and NAFLD/NASH to CMS Medical for China (including Hong Kong, Macao and Taiwan).

 

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We are currently: (i) conducting a Phase III trial for Piclidenoson in the treatment of rheumatoid arthritis, (ii) conducting a Phase III trial for Piclidenoson in the treatment of psoriasis, (iii) preparing for an end-of-phase II study meeting with the FDA and preparing for a planned Phase III trial for Namodenoson in the treatment of liver cancer, (iv) conducting a Phase II trial of Namodenoson in the treatment of NASH with data release expected in the fourth quarter of 2019, and (v) investigating additional compounds, targeting the A3 adenosine receptor, for the treatment of sexual dysfunction and have therefore postponed a planned Investigational New Drug (IND) submission for this indication.

 

Since inception, we have incurred significant losses in connection with our research and development. At June 30, 2019, we had an accumulated deficit of approximately $105.5 million. Although we have recognized revenues in connection with our existing out-licensing agreements with KD, Cipher, CKD, Gebro and CMS and our historic out-licensing agreement with Seikagaku Corporation, or SKK, we expect to generate losses in connection with the research and development activities relating to our pipeline of drug candidates. Such research and development activities are budgeted to expand over time and will require further resources if we are to be successful. As a result, we expect to incur operating losses, which may be substantial over the next several years, and we will need to obtain additional funds to further develop or research and development programs.

 

We have funded our operations primarily through the sale of equity securities (both in private placements and in public offerings) and payments received under our existing out-licensing agreements with KD, Cipher, CKD Gebro, and CMS and our historic out-licensing agreement with SKK. We expect to continue to fund our operations over the next several years through our existing cash resources, potential future milestone payments that we expect to receive from our licensees, interest earned on our investments, if any, and additional capital to be raised through public or private equity offerings or debt financings. As of June 30, 2019, we had approximately $8.2 million of cash and cash equivalents and as of the date of issuance of this Report on Form 6-K, we estimate that we have approximately $6 million in cash and cash equivalents. A substantial part of this amount is designated for payments to be made in relation to the ongoing treatment of patients who are currently enrolled in the Company’s on-going trials.

 

On May 23, 2019, we received a letter on behalf of Capital Point Ltd. (“Capital Point”), stating that Capital Point acquired our shares of the Company representing more than 5% of our outstanding share capital and requesting that the Company convene a special shareholders’ meeting as requested by Capital Point. On June 11, 2019, we responded to the letter informing Capital Point that, among other things, under our articles of association and the Companies Law, 5759-1999 the appointment of members of the board of directors may only be made at the annual meeting of shareholders. Subsequently, on June 18, 2019, we filed a lawsuit against Capital Point, its co-CEOs, Shay Itzhak Lior and Yossi Tamar, its Chairman, Dr. Shuki Gleitman, and its major shareholders, Shir Roichman and Yehuda Kahane, in the District Court of Tel Aviv. The lawsuit alleges that Capital Point engaged in improper conduct in its attempt to exert control over the Company by, among things, unlawfully requesting that the Company convene a special shareholders’ meeting to replace its directors. We seek damages of NIS 40 million (approximately $11.1 million).

 

In a related lawsuit, on June 13, 2019, Capital Point initiated legal proceedings in the District Court of Tel Aviv to compel us to convene a special shareholders’ meeting no later than July 18, 2019 and to direct us to make no changes in our capital structure, including not issuing any securities, prior to the record date of such meeting. On June 30, 2019, the District Court issued a decision compelling us to convene a special shareholders’ meeting to replace our directors. The District Court temporarily stayed execution of the decision and on July 9, 2019, we filed an appeal to the Supreme Court together with a motion to stay execution of the District Court decision pending a decision on the appeal. The Supreme Court granted our motion to stay execution of a District Court decision. During the period of the stay, the Supreme Court requires that if there is an additional fundraising by us, then certain participation rights be granted. A hearing on the appeal has been scheduled for December 16, 2019.

 

Separately, on August 1, 2019, we received an additional letter from Capital Point requesting, among other things, that we convene a shareholders’ meeting in order to amend our articles of association, replace the members of the board of directors in accordance with the proposed amendment, dismiss our Chief Executive Officer and appoint a replacement Chief Executive Officer, and appoint an accounting firm to conduct an investigative audit. On August 21, 2019, we responded to Capital Point rejecting their requests. Subsequently, on August 28, 2019, Capital Point filed an emergency motion with the District Court of Tel Aviv to compel us to convene a special shareholders’ meeting and to schedule an emergency hearing. On August 30, 2019, the District Court rejected Capital Point’s motion for an emergency hearing, provided us until September 15, 2019 to respond, and gave Capital Point until September 8, 2019 to reconsider its motion to the court.

 

Results of Operations

 

Revenues 

 

Revenues for the six months ended June 30, 2019 were $0.7 million compared to revenues of $0.9 million during the first six months of 2018. The decrease in revenues was mainly due to recognition of a higher portion of the $2.2 million advance payment received in January 2018 under the distribution agreement with Gebro in the six month period ended June 30, 2018.

 

Research and development expenses

 

Research and development expenses for the six months ended June 30, 2019 were $3.9 million compared with $2.6 million for the same period of 2018. Research and development expenses for the first six months of 2019 comprised primarily of expenses associated with the Phase II studies for Namodenoson in the treatment of NASH and HCC, as well as expenses for ongoing Phase III studies of Piclidenoson in the treatment of rheumatoid arthritis and psoriasis. The increase is primarily due to increased costs associated with the initiation of the Phase III clinical trial of Piclidenoson for the treatment of rheumatoid arthritis.

 

General and administrative expenses

 

General and administrative expenses were $1.3 million for the six months ended June 30, 2019 compared to $1.8 million for the same period in 2018. The decrease is primarily due to a decrease in professional services and investor relations expenses.

 

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Financial expense, net

 

Financial expense, net for the six months ended June 30, 2019 was $0.3 million compared to financial income, net of $0.6 million for the same period in 2018. The increase in financial expense, net in the first six months of 2019 is mainly due to fair value revaluation of the investment in Wize Pharma Inc’s shares which is classified under short term investment.

 

Liquidity and Capital Resources

 

Since inception, we have funded our operations primarily through public (in Israel and US) and private offerings of our equity securities and payments received under our strategic licensing arrangements. At June 30, 2019, we had approximately $8.2 million in cash and cash equivalents, and have invested most of our available cash funds in ongoing cash accounts.  As of the date of issuance of this Report on Form 6-K, we estimate that we have approximately $6 million in cash and cash equivalents. A substantial part of this amount is designated for payments to be made in relation to the ongoing treatment of patients who are currently enrolled in the Company’s on-going trials. In January, April and May 2019, we raised $2.35 million, $3.2 million and $6 million, respectively, in registered direct offerings. Additionally, in April 2019 we received approximately $1 million from CKD as an upfront payment for entering into an amended distribution agreement with CKD and in August 2019, we received $0.75 million from Kyongbo Pharm as an upfront payment for entering into a distribution agreement with Kyongbo Pharm.

 

We may be able to use U.S. taxes withheld as credits against Israeli corporate income tax when we have income, if at all, but there can be no assurance that we will be able to realize the credits. In addition, we believe that we may be entitled to a refund of such withholding tax from the U.S. government but there can be no assurance that we will be entitled to such a refund.

 

Net cash used in operating activities was $5.6 million for the six months ended June 30, 2019, compared with net cash used in operating activities of $2.1 million for the same period in 2018. The $3.4 million increase in the net cash used in operating activities during the six months ended June 30, 2019 compared to the same period in 2018, was mainly due to increase in net loss of $1.9 million, increase in accounts receivable, prepaid expenses and lease deposit of $1.1 million and increase in deferral revenues of $1 million which was offset by changes in fair value of investment in Wize Pharma Inc’s shares which is classified under short-term investment of $1 million.

 

Net cash used in investing activities for the six months ended June 30, 2019 and for the same period in 2018 was immaterial.

 

Net cash provided by financing activities for the six months ended June 30, 2019 was $10.1 million compared to net cash provided by financing activities of $4.4 million for the same period in 2018. Net cash provided by financing activities for the six months ended June 30, 2019 was due to our registered direct offerings in January, April and May 2019 while the net cash provided by financing activities for the same period in 2018 was due to our registered direct offering in March 2018.

 

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 financial resources as of the date of issuance of this Form 6-K, will be sufficient to fund our projected cash requirements at least through the next twelve months, we will require significant additional financing to fund our operations. Additional financing may not be available on acceptable terms, if at all. Our future capital requirements will depend on many factors, including:

 

  the level of research and development investment required to develop our product candidates;
     
  the failure to obtain regulatory approval or achieve commercial success of our product candidates, including Piclidenoson, Namodenoson and CF602;

 

  the results of our preclinical studies and clinical trials for our earlier stage product candidates, and any decisions to initiate clinical trials if supported by the preclinical results;

 

  the costs, timing and outcome of regulatory review of our product candidates that progress to clinical trials;

 

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  the costs of preparing, filing and prosecuting patent applications, maintaining and enforcing our issued patents and defending intellectual property-related claims;

 

  the cost of commercialization activities if any of our product candidates are approved for sale, including marketing, sales and distribution costs;

 

  the cost of manufacturing our product candidates and any products we successfully commercialize;

 

  the timing, receipt and amount of sales of, or royalties on, our future products, if any;

 

  the expenses needed to attract and retain skilled personnel;

 

  any product liability or other lawsuits related to our products;

 

  the extent to which we acquire or invest in businesses, products or technologies and other strategic relationships;

 

  the costs of financing unanticipated working capital requirements and responding to competitive pressures;
     
  maintaining minimum shareholders’ equity requirements under the NYSE American Company Guide; and
     
 

the outcome of the hostile takeover attempts of Capital Point and the related litigation.

 

Until we can generate significant continuing revenues, we expect to satisfy our future cash needs through payments received under our license agreements, debt or equity financings, or by out-licensing other product candidates. 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. 

 

Research and Development, Patents and Licenses, Etc.

 

Our research and development expenses consist primarily of salaries and related personnel expenses, fees paid to external service providers, up-front and milestone payments under our license agreements, patent-related legal fees, costs of preclinical studies and clinical trials, drug and laboratory supplies and costs for facilities and equipment. We charge all research and development expenses to operations as they are incurred. We expect our research and development expense to remain our primary expense in the near future as we continue to develop our products. Increases or decreases in research and development expenditures are attributable to the number and/or duration of the pre-clinical and clinical studies that we conduct.

 

The following table identifies our current major research and development projects:

 

Project   Status   Expected or Recent Near Term Milestone
Piclidenoson   ACRobat Phase III study in rheumatoid arthritis   Enrolling patients to the study
    COMFORT Phase III study in psoriasis   Enrolling patients to the study
         
Namodenoson   Phase II in HCC   Preparing for end-of-phase II study meeting with the FDA and preparing for planned Phase III trial
    Phase II study in NASH   Top-line results expected in fourth quarter of 2019

 

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We record certain costs for each development project on a “direct cost” basis, as they are recorded to the project for which such costs are incurred. Such costs include, but are not limited to, CRO expenses, drug production for pre-clinical and clinical studies and other pre-clinical and clinical expenses. However, certain other costs, including but not limited to, salary expenses (including salaries for research and development personnel), facilities, depreciation, share-based compensation and other overhead costs are recorded on an “indirect cost” basis, i.e., they are shared among all of our projects and are not recorded to the project for which such costs are incurred. We do not allocate direct salaries to projects due to the fact that our project managers are generally involved in several projects at different stages of development, and the related salary expense is not significant to the overall cost of the applicable projects. In addition, indirect labor costs relating to our support of the research and development process, such as manufacturing, controls, pre-clinical analysis, laboratory testing and initial drug sample production, as well as rent and other administrative overhead costs, are shared by many different projects and have never been considered by management to be of significance in its decision-making process with respect to any specific project. Accordingly, such costs have not been specifically allocated to individual projects.

 

Set forth below is a summary of the gross direct costs allocated to our main projects on an individual basis, as well as the gross direct costs allocated to our less significant projects on an aggregate basis, for the years ended December 31, 2016, 2017 and 2018 and for the six months ended June 30, 2019 and on an aggregate basis since project inception:

 

    ($ in thousands)     Six Months Ended     Costs
Since
 
    Year Ended December 31,     June 30,     Project  
    2016     2017     2018     2019     Inception  
                               
Piclidenoson     1,946       1,894       2,987       2,433       28,795  
Namodenoson     1,907       1,827       1,103       1,148       9,706  
CF602     1,126       15       276       20       1,703  
                                         
Other projects     -       -       -       -       1,729  
Total gross direct project costs (1)     4,979       3,736       4,366       3,601       41,933  

 

(1) Does not include indirect project costs and overhead, such as payroll and related expenses (including stock-based compensation), facilities, depreciation and impairment of intellectual property, which are included in total research and development expenses in our financial statements.

 

From our inception through June 30, 2019, we have incurred research and development expenses of approximately $103.8 million. We expect that a large percentage of our research and development expense in the future will be incurred in support of our current and future preclinical and clinical development projects. Due to the inherently unpredictable nature of preclinical and clinical development processes and given the early stage of our preclinical product development projects, we are unable to estimate with any certainty the costs we will incur in the continued development of the product candidates in our pipeline for potential commercialization. Clinical development timelines, the probability of success and development costs can differ materially from expectations. We expect to continue to test our product candidates in preclinical studies for toxicology, safety and efficacy, and to conduct additional clinical trials for each product candidate. If we are not able to enter into an out-licensing arrangement with respect to any product candidate prior to the commencement of later stage clinical trials, we may fund the trials for the product candidates ourselves.

 

While we are currently focused on advancing each of our product development projects, our future research and development expenses will depend on the clinical success of each product candidate, as well as ongoing assessments of each product candidate’s commercial potential. In addition, we cannot forecast with any degree of certainty which product candidates may be subject to future out-licensing arrangements, when such out-licensing arrangements will be secured, if at all, and to what degree such arrangements would affect our development plans and capital requirements.

 

As we obtain results from clinical trials, we may elect to discontinue or delay clinical trials for certain product candidates or projects in order to focus our resources on more promising product candidates or projects. Completion of clinical trials by us or our licensees may take several years or more, but the length of time generally varies according to the type, complexity, novelty and intended use of a product candidate.

 

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The cost of clinical trials may vary significantly over the life of a project as a result of differences arising during clinical development, including, among others:

 

  the number of sites included in the clinical trials;

 

  the length of time required to enroll suitable patients;

 

  the number of patients that participate in the clinical trials;

 

  the duration of patient follow-up;

 

  the development stage of the product candidate; and

 

  the efficacy and safety profile of the product candidate.

 

We expect our research and development expenses to increase in the future from current levels as we continue the advancement of our clinical trials and preclinical product development and to the extent we in-license new product candidates. The lengthy process of completing clinical trials and seeking regulatory approval for our product candidates requires expenditure of substantial resources. Any failure or delay in completing clinical trials, or in obtaining regulatory approvals, could cause a delay in generating product revenue and cause our research and development expenses to increase and, in turn, have a material adverse effect on our operations. Because of the factors set forth above, we are not able to estimate with any certainty when we would recognize any net cash inflows from our projects.

 

Trend Information.

 

We are a development stage company and it is not possible for us to predict with any degree of accuracy the outcome of our research, development or commercialization efforts. As such, it is not possible for us to predict with any degree of accuracy any significant trends, uncertainties, demands, commitments or events that are reasonably likely to have a material effect on our net sales or revenues, income from continuing operations, profitability, liquidity or capital resources, or that would cause financial information to not necessarily be indicative of future operating results or financial condition. However, to the extent possible, certain trends, uncertainties, demands, commitments and events are identified in the preceding subsections.

 

Off-Balance Sheet Arrangements.

 

We have no off-balance sheet arrangements that have had or are reasonably likely to have a current or future effect on our financial condition, changes in financial condition, revenues or expenses, results of operations, liquidity, capital expenditures or capital resources that are material to investors.

 

 

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Exhibit 99.2

  

 

CAN-FITE BIOPHARMA LTD.

 

 

INTERIM CONDENSED CONSOLIDATED FINANCIAL STATEMENTS

 

 

AS OF JUNE 30, 2019

 

 

UNAUDITED

 

IN U.S. DOLLARS

  

INDEX

 

    Page
     
Interim Condensed Consolidated Statements of Financial Position   2 - 3
     
Interim Condensed Consolidated Statements of Comprehensive Loss   4
     
Interim Condensed Consolidated Statements of Changes in Equity   5
     
Interim Condensed Consolidated Statements of Cash Flows   6 - 7
     
Notes to Interim Condensed Consolidated Financial Statements   8 - 11

  

- - - - - - - - - - -

  

 

 

 

CAN-FITE BIOPHARMA LTD.

 

INTERIM CONDENSED CONSOLIDATED STATEMENTS OF FINANCIAL POSITION

U.S dollars in thousands (except for share and per share data)

 

    June 30,     December 31,  
    2019     2018  
    Unaudited     Audited  
             
ASSETS            
             
CURRENT ASSETS:            
             
Cash and cash equivalents   $ 8,202     $ 3,615  
Other receivable and prepaid expenses     5,239       4,015  
Short-term investment     178       273  
                 
Total current assets     13,619       7,903  
                 
NON-CURRENT ASSETS:                
                 
Lease deposits     8       2  
Property, plant and equipment, net     40       47  
                 
Total long-term assets     48       49  
                 
Total assets   $ 13,667     $ 7,952  

 

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

 

-2-

 

 

CAN-FITE BIOPHARMA LTD.

 

INTERIM CONDENSED CONSOLIDATED STATEMENTS OF FINANCIAL POSITION

U.S dollars in thousands (except for share and per share data)

 

    June 30,     December 31,  
    2019     2018  
    Unaudited     Audited  
             
             
LIABILITIES AND SHAREHOLDERS’ EQUITY            
             
CURRENT LIABILITIES:            
             
Trade payables   $ 1,510     $ 1,071  
Deferred revenues     1,963       926  
Other accounts payable     445       1,122  
                 
Total current liabilities     3,918       3,119  
                 
NON-CURRENT LIABILITIES:                
                 
Deferred revenues     1,308       1,818  
                 
Total long-term liabilities     1,308       1,818  
                 
CONTINGENT LIABILITIES AND COMMITMENTS                
                 
EQUITY ATTRIBUTABLE TO EQUITY HOLDERS OF THE COMPANY:                
                 
Share capital     6,747       2,635  
Share premium     100,132       * 94,076  
Capital reserve from share-based payment transactions     5,951       5,800  
Accumulated other comprehensive income     1,127       1,127  
Accumulated deficit     (105,516 )     (100,623 )
                 
Total equity     8,441       3,015  
                 
Total liabilities and equity   $ 13,667     $ 7,952  

 

(*) Warrants exercisable into shares as of December 31, 2018 were reclassified into Share premium.

 

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

 

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CAN-FITE BIOPHARMA LTD.

 

INTERIM CONDENSED CONSOLIDATED STATEMENTS OF COMPREHENSIVE LOSS

U.S dollars in thousands (except for share and per share data)

 

   

Six months ended

June 30,

 
    2019     2018  
    Unaudited  
             
Revenues   $ 688     $ 902  
                 
Research and development expenses     (3,960 )     (2,638 )
General and administrative expenses     (1,333 )     (1,819 )
                 
Operating loss     (4,605 )     (3,555 )
                 
Finance expenses     (324 )     (346 )
Finance income     36       936  
                 
Total financial income (expense), net     (288 )     590  
                 
Net loss     (4,893 )     (2,965 )
                 
Net loss per share attributable to equity holders of the Company:                
Basic and diluted net loss per share     (0.08 )     (0.08 )

 

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

 

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CAN-FITE BIOPHARMA LTD.

 

INTERIM CONDENSED CONSOLIDATED STATEMENTS OF CHANGES IN EQUITY (UNAUDITED)

U.S dollars in thousands (except for share and per share data)

 

   

Share

capital

   

Share premium

(*)

   

Capital

reserve from share-based payment transactions

    Accumulated other comprehensive income     Accumulated deficit     Total equity  
                                     
Balance as of January 1, 2019   $ 2,635     $ 94,076     $ 5,800     $ 1,127     $ (100,623 )   $ 3,015  
                                                 
Net loss     -       -       -       -       (4,893 )     (4,893 )
                                                 
Issuance of share capital and warrants, net of issuance expenses of USD 1,382     4,112       6,056       -       -       -       10,168  
                                                 
Share-based payment     -       -       151       -       -       151  
                                                 
Balance as of June 30, 2019   $ 6,747     $ 100,132     $ 5,951     $ 1,127     $ (105,516 )   $ 8,441  
                                                 
Balance as of January 1, 2018   $ 2,123     $ 89,919     $ 5,547     $ -     $ (92,575 )   $ 5,014  
                                                 
Net loss     -       -       -       -       (2,965 )     (2,965 )
                                                 
IAS 18 to IFRS 15 implementation     -       -       -       -       (350 )     (350 )
                                                 
Issuance of share capital and warrants, net of issuance expenses of USD 613     482       3,905       -       -       -       4,387  
                                                 
Issuance of share capital     28       230       -       -       -       258  
                                                 
Share-based payment     -       -       166       -       -       166  
                                                 
Balance as of June 30, 2018   $ 2,633     $ 94,054     $ 5,713     $ -     $ (95,890 )   $ 6,510  

 

* Warrants exercisable into shares as of December 31, 2018 were reclassified into Share premium.

 

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

  

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CAN-FITE BIOPHARMA LTD.

 

INTERIM CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS

U.S dollars in thousands (except for share and per share data)

 

    Six months ended
June 30,
 
    2019     2018  
    Unaudited  
             
Cash flows from operating activities:            
             
Net loss   $ (4,893 )   $ (2,965 )
                 
Adjustments to reconcile net loss to net cash used:                
                 
Depreciation of property, plant and equipment     8       7  
Share-based payment     151       424  
Changes in fair value of short-term investment     95       (912 )
Exchange differences on balances of cash and cash equivalents     (2 )     (78 )
                 
      252       (559 )
Working capital adjustments:                
Increase in accounts receivable, prepaid expenses and lease deposit     (1,230 )     (127 )
Increase in trade payables     439       242  
Increase in deferred revenues     527       1,583  
Decrease in other accounts payable     (677 )     (300 )
                 
      (941 )     1,398  
                 
Net cash used in operating activities   $ (5,582 )   $ (2,126 )
                 

  

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

 

-6-

 

 

CAN-FITE BIOPHARMA LTD.

 

INTERIM CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS

U.S dollars in thousands (except for share and per share data)

 

    Six months ended
June 30,
 
    2019     2018  
    Unaudited  
             
Cash flows from investing activities:            
             
Purchase of property, plant and equipment     (1 )     (4 )
                 
Net cash used in investing activities   $ (1 )   $ (4 )
                 
Cash flows from financing activities:                
                 
Issuance of share capital and warrants, net of issuance expenses     10,168       4,387  
                 
Net cash provided by financing activities   $ 10,168     $ 4,387  
                 
Exchange differences on balances of cash and cash equivalents     2       78  
                 
Increase in cash and cash equivalents     4,587       2,335  
Cash and cash equivalents at the beginning of the period     3,615       3,505  
                 
Cash and cash equivalents at the end of the period   $ 8,202     $ 5,840  
                 
Supplemental disclosure of cash flow information:                
                 
Cash received during the year for interest     36       15  

 

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

 

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CAN-FITE BIOPHARMA LTD.

 

NOTES TO INTERIM CONDENSED CONSOLIDATED FINANCIAL STATEMENTS (UNAUDITED)

U.S dollars in thousands (except for share and per share data)

 

NOTE 1:- GENERAL

 

a. These financial statements have been prepared in a condensed format as of June 30, 2019 and for the six months then ended. These financial statements should be read in conjunction with the Company’s annual consolidated financial statements as of December 31, 2018 and for the year then ended and accompanying.

 

b. Definitions:

 

In these consolidated financial statements:

 

  The Company - Can-Fite Biopharma Ltd.
       
  USD - U.S. dollar
       
  - European Union Euro
       
  CAD - Canadian dollar
       
  ADS - American Depositary Share (“ADS”). Each ADS represents  30 ordinary shares of the Company

 

c. In the six months ended June 30, 2019, the Company incurred net losses of USD 4,893 and it had accumulated losses at the amount of USD 105,516.

 

The Company has not yet generated any material revenues from sales of its own developed products and has financed its activities by raising capital and by collaborating with multinational companies in the industry.

 

The Company has other alternative plans for financing its ongoing activities. 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 its development programs. The Company’s management and board of directors are of the opinion that these financial resources will be sufficient to continue the development of the Company’s products at least for twelve months from the balance sheet date.

 

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CAN-FITE BIOPHARMA LTD.

 

NOTES TO INTERIM CONDENSED CONSOLIDATED FINANCIAL STATEMENTS (UNAUDITED)

U.S dollars in thousands (except for share and per share data)

 

NOTE 1:- GENERAL (CONT.)

 

d.

In January 2019, the Company’s board of directors approved a grant of unlisted options exercisable into 340,000 of the Company’s ordinary shares to two of its employees and one senior officer for an exercise price of NIS 2.344 per shares. The options vest on a quarterly basis for a period of 4 years from the grant date.

 

The fair value of the Company’s share options granted was estimated using the binomial option pricing model using the following assumptions:

 

Description   January 2019  
       
Risk-free interest rate     2.40 %
Expected volatility     75.86 %
Dividend yield     0  
Contractual life     10  
Early Exercise Multiple (Suboptimal Factor)     2.5  
Exercise price (NIS)     2.344  

 

e.

On January 18, 2019, the Company completed a registered direct offering with an institutional investor, pursuant to which it sold an aggregate 149,206 ADSs representing 4,476,192 ordinary shares. In addition, in a concurrent private placement, the Company issued to the investor unregistered warrants to purchase 149,206 ADSs representing 4,476,192 ordinary shares for an aggregate purchase price of USD 2,350 (excluding issuance cost of USD 428). The warrants have an exercise price of USD 19.50 per ADS, are immediately exercisable and expire five and one-half years from the issuance date. The Company also issued unregistered placement agent warrants to purchase an aggregate of 7,460 ADSs representing 223,810 ordinary shares on the same terms as the warrants except they have a term of five years. 

 

f. On February 25, 2019, the Company’s Distribution Agreement with CKD was amended to expand the exclusive right to distribute Namodenoson for the treatment of NASH in addition to liver cancer in South Korea. CKD has agreed to pay the Company up to an additional USD 6,000 in upfront and milestone payments payable with respect to the NASH indication. The Company will also be entitled to a transfer price for delivering finished product to CKD following commercial launch. In April 2019, the Company received an upfront payment of USD 1,000.

 

g.

On March 11, 2019, a Special General Meeting of shareholders of the Company approved a grant of unlisted options exercisable into 400,000 of the Company’s ordinary shares to the Company’s chief executive officer for an exercise price of NIS 2.344 per share. The options vest on a quarterly basis for a period of 48 months from the date of approval by the Company’s Board of Directors on January 7, 2019.

 

The fair value of the Company’s share options granted was estimated using the binomial option pricing model using the following assumptions:

 

Description   March 2019  
       
Risk-free interest rate     2.17 %
Expected volatility     65.63 %
Dividend yield     0  
Contractual life     9.83  
Early Exercise Multiple (Suboptimal Factor)     2.5  
Exercise price (NIS)     2.344  

 

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CAN-FITE BIOPHARMA LTD.

 

NOTES TO INTERIM CONDENSED CONSOLIDATED FINANCIAL STATEMENTS (UNAUDITED)

U.S dollars in thousands (except for share and per share data)

 

NOTE 1:- GENERAL (CONT.)

 

h.

On April 4, 2019, the Company completed a registered direct offering with certain institutional investors, pursuant to which it sold an aggregate 328,205 ADSs representing 9,846,156 ordinary shares. In addition, in a concurrent private placement, the Company issued to the investor unregistered warrants to purchase 328,205 ADSs representing 9,846,156 ordinary shares for an aggregate purchase price of USD 3,200 (excluding issuance cost of USD 414). The warrants have an exercise price of USD 12.90 per ADS, are immediately exercisable and expire five and one-half years from the issuance date. The Company also issued unregistered placement agent warrants to purchase an aggregate of 16,410 ADSs representing 492,308 ordinary shares on the same terms as the warrants except they have a term of five years. 

 

i.

On May 10, 2019, the Company effected a change in the ratio of our ADS to ordinary shares from one (1) ADS representing two (2) ordinary shares to a new ratio of one (1) ADS representing thirty (30) ordinary shares. For ADS holders, the ratio change had the same effect as a one-for-fifteen reverse ADS split. All ADS and per ADS data in the financial statements and their related notes have been retroactively adjusted for all periods presented to reflect the ratio change.

 

j.

On May 22, 2019, the Company completed a registered direct offering with certain institutional investors, pursuant to which it sold an aggregate 1,500,000 ADSs representing 45,000,000 ordinary shares. In addition, in a concurrent private placement, the Company issued to the investor unregistered warrants to purchase 1,500,000 ADSs representing 45,000,000 ordinary shares for an aggregate purchase price of USD 6,000 (excluding issuance cost of USD 540). The warrants have an exercise price of USD 4.00 per ADS, are immediately exercisable and expire five and one-half years from the issuance date. The Company also issued unregistered placement agent warrants to purchase an aggregate of 75,000 ADSs representing 2,250,000 ordinary shares on the same terms as the warrants except they have a term of five years. 

 

NOTE 2:- SIGNIFICANT ACCOUNTING POLICIES

 

Basis of presentation of the financial statements

 

The interim condensed consolidated financial statements for the six months period ended June 30, 2019 have been prepared in accordance with IAS 34, “Interim Financial Reporting”.

 

The accounting policies adopted in the preparation of the interim condensed consolidated financial statements are consistent with those followed in the preparation of the Company’s annual financial statements for the year ended December 31, 2018 except as described below

 

NOTE 3:- DISCLOSURE OF NEW STANDARDS IN THE PERIOD

 

IFRS 16, “Leases”:

 

In January 2016, the IASB issued IFRS 16, “Leases” (“new Standard”), which supersedes IAS 17, “Leases”, IFRIC 4, “Determining Whether an Arrangement Contains a Lease”, and SIC-15, “Operating Leases - Incentives”. According to the Standard, a lease is a contract, or part of a contract, that conveys the right to use an asset for a period of time in exchange for consideration.

 

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CAN-FITE BIOPHARMA LTD.

 

NOTES TO INTERIM CONDENSED CONSOLIDATED FINANCIAL STATEMENTS (UNAUDITED)

U.S dollars in thousands (except for share and per share data)

 

NOTE 3:- DISCLOSURE OF NEW STANDARDS IN THE PERIOD (CONT.)

 

The effects of the adoption of the new standard are as follows:

 

  According to the new standard, lessees are required to recognize all leases in the statement of financial position (excluding certain exceptions, see below). Lessees will recognize a liability for lease payments with a corresponding right-of-use asset, similar to the accounting treatment for finance leases under the existing standard, IAS 17, “Leases”. Lessees will also recognize interest expense and depreciation expense separately.

 

  Variable lease payments that are not dependent on changes in the Consumer Price Index (“CPI”) or interest rates, but are based on performance or use are recognized as an expense by the lessees as incurred and recognized as income by the lessors as earned.

 

  In the event of change in variable lease payments that are CPI-linked, lessees are required to remeasure the lease liability and record the effect of the remeasurement as an adjustment to the carrying amount of the right-of-use asset.

 

  The accounting treatment by lessors remains substantially unchanged from the existing standard, namely classification of a lease as a finance lease or an operating lease.

 

The new standard is effective for annual periods beginning on or after January 1, 2019.

 

The impact of the adoption of the new standard, does not have a material effect on the financial statements.

 

NOTE 4:- SUBSEQUENT EVENTS

 

On July 31, 2019, the Company signed a distribution agreement with Kyongbo Pharm Co., Ltd. (“Kyongbo Pharm”), to distribute the Company’s lead drug candidate, Piclidenoson, for the treatment of psoriasis in South Korea, upon receipt of regulatory approvals. Under the terms of the distribution agreement, Kyongbo Pharm, in exchange for exclusive distribution rights to sell Piclidenoson in the treatment of psoriasis in South Korea, is required to make a total upfront payment of USD 750 to the Company, with additional payments of up to USD 3,250 upon achievement of certain milestones. The Company will also be entitled to a transfer price for delivering finished product to Kyongbo Pharm upon commercial launch. In August 2019, the Company received the upfront payment of USD 750 from Kyongbo Pharm.

 

 

-11-