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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 els

Key Takeaway: AND FINANCIAL REVIEW AND PROSPECTS 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, as well as in our Annual Report on Form 20-F filed o

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AND FINANCIAL REVIEW AND PROSPECTS
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, as well as in our Annual Report on Form 20-F filed on March 30,
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.
financial statements are prepared in accordance with IFRS as issued by the International Accounting Standards Board, and reported
in NIS. We maintain our accounting books and records in NIS and our functional currency is NIS. For the convenience of the reader,
the reported NIS amounts as of June 30, 2017 have been translated into U.S. dollars at the representative rate of exchange
on June 30, 2017 (U.S. $1 = NIS 3.496). The U.S. dollar amounts presented should not be construed as representing amounts
that are receivable or payable in dollars or convertible into U.S. dollars, unless otherwise indicated. Certain amounts presented
herein may not sum due to rounding.
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:
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
used herein, unless the context otherwise requires:
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;
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 RA 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 U.S. and Europe. Namodenoson was granted Fast Track designation by the FDA as
a second line treatment to improve survival for patients with advanced hepatocellular carcinoma 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 and viral diseases, such as the JC virus.
strategy is to build a fully integrated biotechnology company that discovers, in-licenses and develops an innovative and effective
small molecule drug portfolio of ligands that bind to a specific therapeutic target for the treatment of autoimmune-inflammatory,
oncological and ophthalmic diseases and more. We continue to develop and test our existing pipeline, while also testing other
indications for our existing drug candidates and examining, from time to time, the potential of other small molecules that may
fit our platform technology of utilizing small molecules to target the A3AR. We generally focus on drugs with global market potential
and we seek to create global partnerships to effectively assist us in developing our portfolio and to market our products.
have in-licensed an allosteric modulator of the A3AR, CF602 from Leiden University. In addition, we have out-licensed Piclidenoson
(i) for the treatment of RA to Kwang Dong Pharmaceutical Co. Ltd., a South Korean limited company, or KD for the Korean market,
and (ii) for the treatment of psoriasis and RA to Cipher Pharmaceuticals for the Canadian market.
respect to Namodenoson, in October 2016, we entered into an exclusive distribution agreement with Chong Kun Dang Pharmaceuticals,
or CKD for the exclusive right to distribute Namodenoson for the treatment of liver cancer in South Korea, upon receipt of regulatory
approvals. The distribution agreement provides for up to $3,000,000 in upfront and milestone payments, plus royalties on net sales
of 23%. The distribution agreement further provides that we will deliver finished product to CKD and grant CKD a right of first
refusal to distribute Namodenoson for other indications for which we develop Namodenoson.
July 2016, OphthaliX released top-line results from its Phase II clinical trial of Piclidenoson for the treatment of glaucoma.
In this trial, no statistically significant differences were found between the Piclidenoson treated group and the placebo group
in the primary endpoint of lowering intra ocular pressure, or IOP. High IOP is a characteristic of glaucoma. Piclidenoson was
found to have a favorable safety profile and was well tolerated. Based on these overall results, OphthaliX sees no immediate path
forward in glaucoma. As of the date hereof, OphthaliX has no active business operations. Subsequently, on May 21, 2017, OphthaliX,
Wize Pharma Ltd., a company formed under the laws of the State of Israel ("Wize"), and Bufiduck Ltd., a company formed
under the laws of the State of Israel and a wholly owned subsidiary of OphthaliX ("Merger Sub"), entered into an Agreement
and Plan of Merger (as may be amended from time to time, the "Merger Agreement") that provides for, among other things,
the merger of Merger Sub with and into Wize, with Wize continuing as the surviving entity and becoming a wholly owned subsidiary
of OphthaliX, on the terms and conditions set forth in the Merger Agreement (the "Merger"). The Merger is subject
to the satisfaction or waiver of the conditions set forth in the Merger Agreement and certain closing conditions.
June 2015, we received a lawsuit, filed with the District Court of Tel-Aviv, requesting recognition of this lawsuit as a class
action. The lawsuit named us, our Chief Executive Officer and directors as defendants. The lawsuit alleged, among other things,
that we misled the public with regard to disclosures concerning the efficacy of our drug candidate, Piclidenoson in relation to
the Psoriasis studies. The claimant alleged that he suffered personal damages of over NIS 73,000, while also claiming that our
shareholders suffered aggregate damages of approximately NIS 125 million. On March 31, 2016, we filed a response to the lawsuit.
On March 1, 2017, a hearing was held in the District Court on whether to certify the lawsuit as a class action. A final hearing
on the certification held on May 17, 2017. On July 18, 2017, the District Court of Tel-Aviv issued a ruling in which it denied
the request to recognize the lawsuit as a class action and awarded us an amount of NIS 50,000 to pay our expenses in relation
to such law suit. The time for filing an appeal has not expired.
are currently: (i) preparing to commence a Phase III trial for Piclidenoson in the treatment of RA, following agreement with
the EMA on our protocol design and expect to commence enrollment in the third quarter of 2017, (ii) conducting preparatory
work for a Phase III trial for Piclidenoson in the treatment of psoriasis following agreement with the EMA on our protocol
design and expect to commence Institutional Review Board, or IRB, submissions in the fourth quarter of 2017, (iii) conducting
a Phase II study with respect to the development of Namodenoson for the treatment of HCC and completed enrollment of 78
patients in the third quarter of 2017 with results expected in the second half of 2018, (iv) preparing to commence a Phase
II trial of Namodenoson in the treatment of NASH, a new indication identified by us for our liver cancer drug,
following approval of the study protocol by IRBs and anticipate commencing enrollment in the third quarter of 2017, 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.
inception, we have incurred significant losses in connection with our research and development. At June 30, 2017, we had an accumulated
deficit of approximately NIS 362 million ($103 million). Although we have recognized revenues in connection with our existing
out-licensing agreements with KD, Cipher and CKD and our historic out-licensing agreement with 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.
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 and CKD 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 payments under our out-licensing agreements, interest earned on our
investments, if any, payments from any future out-licensing of our product candidates, and additional capital to be raised
through public or private equity offerings or debt financings.
for the six months ended June 30, 2017 were NIS 0.53 million (U.S. $0.15 million) compared to NIS 0.43 million (U.S. $0.12 million)
in the first six months of 2016. The increase in revenue was mainly due to the recognition of a portion of the NIS 1.9 million
(U.S. $0.5 million) advance payment received in December 2016 under the distribution agreement with CKD.
Last updated: Sep 15, 2017