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OPERATING AND FINANCIAL REVIEW AND PROSPECTS
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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 and our Annual Report on Form 20-F for the year ended December 31, 2023 (the "Annual
Report"). 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 the resurgence of the COVID-19 pandemic and the Russian invasion of Ukraine; | ||
| risks related to not satisfying the continued listing requirements of NYSE American; |
| statements as to the impact of the political, economic and security situation in Israel on our business, including due to the current war between Israel and Hamas; and | ||
| those factors referred to under the headings "Risk Factors" and "Operating and Financial Review and Prospects" in our Annual Report, as well as in our Annual Report generally. |
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:
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. In addition, our product candidateds also induce the production of positive cytokines such as granulocyte
colony stimulating factor (G-CSF) and adiponectin which are responsible for the chemo-protective and liver-protective effects of the drugs
product candidates, CF101, CF102 and CF602, are being developed to treat oncological and inflammatory diseases, as well as erectile
dysfunction. CF101, also known as Piclidenoson, is in an advanced stage of clinical development for the treatment of psoriasis.
CF102, also known as Namodenoson, is being developed for the treatment of HCC and has orphan drug designation for this indication in
the United States and Europe. Namodenoson was granted Fast Track designation by the FDA for patients with advanced HCC. who failed
first line treatment. Namodenoson is also being developed for the treatment of pancreatic cancer based on pre-clinical findings
showing robust anti-pancreatic tumor growth and we have submitted an application to the FDA for orphan drug designation. Due to the liver protective effect of Namidenoson, it is also being developed for the
treatment of NASH (also known as MASH). 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 such as
prostate cancer, viral diseases, such as the JC virus, obesity and Lowe Syndrome.
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 undertaking preparatory work for pivotal Phase III studies for Piclidenoson in the treatment of psoriasis following
meetings with the FDA & EMA, which we expect to commence in the fourth quarter of 2024 (ii) we are conducting a pivotal Phase
III trial for Namodenoson in the treatment of advanced liver cancer which is enrolling patients, (iii) we are conducting a Phase IIb
study of Namodenoson in the treatment of MASH which is enrolling patients, (iv) we are undertaking preparatory work for a Phase IIa
study with Namodenoson for the treatment of pancreatic cancer which we expect to commence in the third quarter of 2024, (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 NAFLD/MASH and are responsible for the anti-inflammatory, anti-steatotic
and anti-fibrotic effect in the liver. Most recently, pre-clinical data support Piclidenoson's potential utilization for the treatment
of Lowe Syndrome and 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.
inception, we have incurred significant losses in connection with our research and development. As of June 30, 2024, we had an accumulated
deficit of approximately $162.44 million. Although we have recognized revenues in connection with our existing out-licensing agreements
with, Cipher, CKD, Gebro and Ewopharma, and our historic out-licensing agreement with KD, CMS, Kyongbo and 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 Kyongbo 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, 2024, we had approximately $4.72 million of cash,
cash equivalents and short-term deposits, which does not include the approximately $5.0 million in gross proceeds (approximately $4.47
million net of issuance costs) from a warrant repricing transaction in August 2024. A substantial part of this amount is designated for
payments to be made in relation to support the Company's clinical trials.
Results of Operations