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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 COVID-19 pandemic; | ||
| 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 and uncertainties.
used herein, unless the context otherwise requires:
| references to "NASH" refer to nonalcoholic steatohepatitis; and | ||
| 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 that develops orally bioavailable small molecule therapeutic products for the treatment
of cancer, liver and inflammatory diseases, COVID-19 and erectile dysfunction. We are also developing 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.
product candidates, CF101, CF102 and CF602, are being developed to treat cancer, liver and inflammatory 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 psoriasis. CF101 is also being developed for the treatment of COVID-19. During 2020, we decided to stop developing
Piclidenoson for the treatment of rheumatoid arthritis to focus on other indications, this following a detailed analysis of the interim
results of our Phase III ACROBAT study which showed that although Piclidenoson efficacy was significantly superior to placebo, the study
missed the primary endpoint which was non-inferiority vs. the comparator methotrexate. 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.
believe our pipeline of drug candidates represent a significant market opportunity. For instance, according to iHealthcareAnalyst, the
psoriasis drug market is forecasted to be worth $11.3 billion by 2025. 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 product
candidates for indications that we are currently pursuing:
are currently: (i) conducting a Phase III trial for Piclidenoson in the treatment of psoriasis, and expect to complete enrolment in
the second half of 2021, with topline results expected in the first quarter of 2022,
(ii) preparing to commence a Phase III trial for Namodenoson in the treatment of liver cancer and expect to initiate the study in
the fourth quarter of 2021, (iii) engaged in preparatory steps for the initiation of a clinical Phase IIb trial of Namodenoson in
the treatment of NASH and expect to initiate the study in the third quarter of 2021, (iv) conducting a Phase II trial for
Piclidenoson in the treatment of COVID-19 where patient enrolment is ongoing, (v) investigating additional compounds, targeting the
A3 adenosine receptor, for the treatment of erectile dysfunction, and (vi) developing 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, 2021, we had an accumulated
deficit of approximately $130.5 million. Although we have recognized revenues in connection with our existing out-licensing agreements
with KD, Cipher, CKD, Gebro, CMS, and Ewopharma 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, CMS, and Ewopharma 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, 2021, we had approximately $7.53 million in cash,
cash equivalents and short-term deposits.
of COVID-19 on our Operations
health epidemics or outbreaks could adversely impact our business. In late 2019, a novel strain of COVID-19 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 COVID-19 impacts our operations
will depend on future developments, which are highly uncertain and cannot be predicted with confidence, including the duration and severity
of the outbreak, and the actions that may be required to contain COVID-19 or treat its impact. In particular, the continued spread of
COVID-19 globally, could adversely impact our operations and workforce, including our research and clinical trials and our ability to
raise capital, could affect the operations of key governmental agencies, such as the FDA, which may delay the development of our product
candidates and could result in the inability of our suppliers to deliver components or raw materials on a timely basis or at all, each
of which in turn could have an adverse impact on our business, financial condition and results of operation.
for the six months ended June 30, 2021 were $0.39 million compared to revenues of $0.40 million during the six months ended June 30,
2020. The decrease is considered immaterial.
and development expenses
and development expenses for the six months ended June 30, 2021 were $3.81 million compared with $7.05 million for the same period in
2020. Research and development expenses for the first half of 2021 comprised primarily of expenses associated with two studies for Piclidenoson,
a Phase II study in COVID-19 and a Phase III study in the treatment of psoriasis. The decrease is primarily due to costs incurred in
the first six months of 2020 associated with Phase II studies for Namodenoson in the treatment of liver cancer and NASH, and a Phase
III study of Piclidenoson for the treatment of rheumatoid arthritis, partially offset by the two ongoing studies of Piclidenoson in the
first six months of 2021. We expect research and development expenses will increase through 2021 and beyond.
and administrative expenses