Full Press Release Details
AND FINANCIAL REVIEW AND PROSPECTS
should read the following selected financial data and 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 U.S. GAAP, 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.
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; | ||
| risks related to the coronavirus outbreak; | ||
| the initiation, timing, progress and results of our preclinical studies, clinical trials and other product candidate development efforts; |
| competitive companies, technologies and our industry; | ||
| risks related to not satisfying the continued listing requirements of NYSE American; and |
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; |
stage biopharmaceutical company focused on developing orally bioavailable small molecule therapeutic products for the treatment
of cancer, liver, inflammatory diseases and COVID-19. We also co-develop specific formulations of cannabis components for the
treatment of cancer, inflammatory, autoimmune, and metabolic diseases. 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.
product pipeline is based on the research of Dr. Pnina Fishman, who investigated a clinical observation that tumor metastasis
can be found in most body tissues, but are rarely found in muscle tissue, which constitutes approximately 60% of human body weight.
Dr. Fishman's research revealed that one reason that striated muscle tissue is resistant to tumor metastasis is that muscle
cells release small molecules which bind with high selectivity to the A3AR. As part of her research, Dr. Fishman also discovered
that A3ARs have significant expression in tumor and inflammatory cells, whereas normal cells have low or no expression of this
receptor. The A3AR agonists and allosteric modulators, currently our pipeline of drug candidates, bind with high selectivity and
affinity to the A3ARs and upon binding to the receptor initiate down-stream signal transduction pathways resulting in apoptosis,
or programmed cell death, of tumors and inflammatory cells and to the inhibition of inflammatory cytokines. Cytokines are proteins
produced by cells that interact with cells of the immune system in order to regulate the body's response to disease and
infection. Overproduction or inappropriate production of certain cytokines by the body can result in disease.
Our product candidates,
CF101, CF102 and CF602, are being developed to treat autoimmune inflammatory indications, oncology and liver diseases, COVID-19
as well as erectile 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. CF101 is also being developed for the treatment
of coronavirus. 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, a disease for which no FDA approved therapies currently exist. CF602 is our
second generation allosteric drug candidate for the treatment of erectile 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 erectile 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 iHealthcareAnalyst, the world rheumatoid
arthritis market size is predicted to generate revenues of $50.5 billion by 2025 and according to SNS Research, the psoriasis
drug market is forecasted to be worth $11.5 billion by the end of 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:
September 10, 2019, we entered into a collaboration agreement with Univo Pharmaceuticals, or Univo, a medical cannabis company,
to identify and co-develop specific formulations of cannabis components for the treatment of cancer, inflammatory, autoimmune,
and metabolic diseases. Under the collaboration agreement, Univo will provide us with cannabis and cannabis components, as well
as full access to its laboratories for both research and manufacturing. We agreed to pay Univo a total of $500,000 in two installments
and issued to Univo 19,934,355 ordinary shares through a private placement, representing approximately 16.6% of Can-Fite's
ordinary shares outstanding after giving effect to the issuance. In addition, in connection therewith, we issued 996,690 ordinary
shares to a consultant. The companies will initially share ownership of intellectual property developed in this collaboration.
Revenues derived from the collaboration will generally be shared between us and Univo on the basis of each party's contribution.
Golan Bitton, Univo's CEO was appointed to our board of directors in December 2019. On February 17, 2020, we entered into
an amendment to the collaboration agreement pursuant to which the parties expanded the collaboration to allow the testing of minute
cannabidiol (CBD) concentrations/dosages in combination with Namodenoson on liver cancer and additional oncological indications.
As part of the expansion, we agreed to fund the research and development activities for the two new indications, to be jointly
performed, for an amount of $200,000 per indication. On February 27, 2020, Golan Bitton resigned from our board of directors,
effective immediately.
(i) conducting a Phase III trial for Piclidenoson in the treatment of rheumatoid arthritis with an interim analysis expected to
be released in the fourth quarter of 2020, (ii) conducting a Phase III trial for Piclidenoson in the treatment of psoriasis with
an interim analysis expected to be released in the fourth quarter of 2020, (iii) preparing to commence a Phase III trial for Namodenoson
in the treatment of liver cancer, (iv) engaged in preparatory steps for the initiation of a clinical trial of Namodenoson in the
treatment of NASH, (v) investigating Piclidenoson for the treatment of coronavirus which includes a planned Phase II clinical
trial in the U.S., (vi) investigating additional compounds, targeting the A3 adenosine receptor, for the treatment of erectile
dysfunction, and (vii) co-developing with Univo formulations of cannabis components for the treatment of diseases in which there
is an overexpression of A3AR.
inception, we have incurred significant losses in connection with our research and development. At June 30, 2020, we had an accumulated
deficit of approximately $119.3 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.
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, 2020, we had
approximately $9.05 million of cash and cash equivalents.
Impact of COVID-19 on our Operations
Public health epidemics
or outbreaks could adversely impact our business. In late 2019, a novel strain of COVID-19, also known as coronavirus, was reported
in Wuhan, China. Initially the outbreak was largely concentrated in China, but it rapidly spread to countries across the globe,
including in Israel and the United States. Many countries around the world, including in Israel and the United States, implemented
significant governmental measures to control the spread of the virus, including temporary closure of businesses, severe restrictions
on travel and the movement of people, and other material limitations on the conduct of business. In response, we implemented remote
working and workplace protocols for our employees in accordance Israeli Ministry of Health requirements to ensure employee safety.
The extent to which the coronavirus impacts our operations will depend on future developments, which are highly uncertain and cannot