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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. 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.
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.
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; |
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 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.
have in-licensed an allosteric modulator of the A3AR, CF602 from Leiden University. In addition, we have out-licensed the following:
(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.
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.
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.
and development expenses