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OPERATING AND FINANCIAL REVIEW AND PROSPECTS
You 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.
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; | ||
| 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 unfavorable economic and market conditions and adverse developments with respect to financial institutions and associated liquidity risk; | ||
| risks related to not satisfying the continued listing requirements of NYSE American; and |
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 "ordinary shares," "our shares" and similar expressions refer to the Company's ordinary shares, no nominal (par) value per share; and | ||
| references to the "SLD" are to the steatotic liver disease |
are a clinical-stage biopharmaceutical company that develops orally bioavailable small molecule therapeutic products for the treatment
of cancer, liver and inflammatory diseases 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
A3 adenosine receptor, or A3AR, as a therapeutic target. A3AR is highly expressed in pathological body cells such as inflammatory and
cancer cells, and has a low expression in normal cells, suggesting that the receptor could be a specific target for pharmacological intervention.
Our pipeline of drug candidates are synthetic, highly specific agonists and allosteric modulators 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, 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. During 2021, we decided to stop developing Piclidenoson for the treatment of COVID-19 to focus on other
indications. 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 U.S. Food and Drug Administration, or 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 SLD, 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:
(i) we are doing the preparatory work for pivotal Phase III studies for Piclidenoson in the treatment of psoriasis following meetings
with the FDA & EMA, (ii) we are conducting a pivotal Phase III trial for Namodenoson in the treatment of advanced liver cancer which
is open for enrollment, (iii) we are conducting a Phase IIb study of Namodenoson in the treatment of SLD which is open for enrollment,
(iv) we are doing the preparatory work for Phase IIb study of Namodenoson in the treatment of pancreatic cancer, (v) we are investigating
additional compounds, targeting the A3 adenosine receptor, for the treatment of erectile dysfunction, and (vi) we are conducting pre-clinical
studies with formulations of cannabis components for the treatment of diseases in which there is an overexpression of A3AR. Since inception,
we have incurred significant losses in connection with our research and development.
we believe characteristics of Piclidenoson, as exhibited in our clinical studies to date, including its good safety profile, clinical
activity, simple and less frequent delivery through oral administration and its low cost of production, position it well against the competition
in psoriasis markets, where treatments, when available, often include injectable drugs, many of which can be highly toxic, expensive and
not always effective.
Piclidenoson, Namodenoson has a good safety profile, is orally administered and has a low cost of goods, which we believe may position
it well in the HCC market, where no drug has yet been approved by the FDA for patients with advanced liver cancer disease defined as Child
Pugh B7. In addition, pre-clinical studies show Namodenoson's novel mechanism of action which entails de-regulation of three key
signaling pathways which mediate the etiology and pathology of SLD and are responsible for the anti-inflammatory and anti-fibrogenic
effect in the liver. Most recently, pre-clinical data support Namodenoson's potential utilization as an anti-obesity drug.
other drugs on the market, new drugs under development (including drugs that are in more advanced stages of development in comparison
to our drug candidates) and additional drugs that were originally intended for other purposes, but were found effective for purposes targeted
by us, may all be competitive to the current drugs in our pipeline. In fact, some of these drugs are well established and accepted among
patients and physicians in their respective markets, are orally bioavailable, can be efficiently produced and marketed, and are relatively
safe. None of our product candidates have been approved for sale or marketing and, to date, there have been no commercial sales of any
of our product candidates.
Results of Operations
Revenues for the six months
ended June 30, 2023 were $0.39 million compared to revenues of $0.41 million during the six months ended June 30, 2022. Revenues for the
six months ended June 30, 2023 and June 30, 2022 comprised of recognition of a portion of advance payments received under distribution
agreements with Gebro, CKD, Cipher and Ewopharma.
Research and development expenses
Research and development expenses
for the six months ended June 30, 2023 were $3.41 million compared with $3.27 million for the same period in 2022. Research and development
expenses for the first half of 2023 comprised primarily of expenses associated with the completion of the Phase 3 study of Piclidenoson
for the treatment of psoriasis and two ongoing studies for Namodenoson, a Phase 3 study in the treatment of advanced liver cancer and
a Phase 2b study for SLD. The increase is primarily due to an increase in expenses associated with Namodenoson.
General and administrative expenses
General and administrative
expenses were $1.47 million for the six months ended June 30, 2023 compared to $1.57 million for the same period in 2022. The decrease
is primarily due to the decrease in public and investor relations expenses and in directors and officer's insurance policy premium.
We expect that general and administrative expenses will remain at the same level through 2023.
Financial income, net
Financial income, net for
the six months ended June 30, 2023 was $0.27 million compared to financial expense, net of $0.18 million for the same period in 2022.