UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 6-K
Report of Foreign Private Issuer
Pursuant to Rule 13a-16 or 15d-16
Under the Securities Exchange Act of 1934
For the Month of November 2024
001-36203
(Commission File Number)
CAN-FITE BIOPHARMA LTD.
(Exact name of Registrant as specified in its charter)
26 Ben Gurion Street
Ramat Gan 5257346 Israel
(Address of principal executive offices)
Indicate by check mark whether the registrant
files or will file annual reports under cover Form 20-F or Form 40-F.
Form 20-F ☒ Form 40-F ☐
On November 4, 2024, Can-Fite BioPharma Ltd. issued
a press release entitled “Can-Fite anti-Obesity Drug Namodenoson Received Patent Allowance in Australia.” A copy of this
press release is furnished herewith as Exhibit 99.1.
Exhibit Index
SIGNATURES
Pursuant to the requirements
of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned, thereunto
duly authorized.
| Date: November 4, 2024 |
By: |
/s/ Motti Farbstein |
| |
|
Motti Farbstein |
| |
|
Chief Executive Officer and
Chief Financial Officer |
Exhibit 99.1
Can-Fite
anti-Obesity Drug Namodenoson Received Patent Allowance in Australia
Namodenoson is an oral drug with a proven favorable safety
profile
RAMAT GAN, Israel, Nov. 04, 2024 (GLOBE NEWSWIRE) -- Can-Fite
BioPharma Ltd. (NYSE American: CANF) (TASE:CANF), a biotechnology company advancing a pipeline of proprietary small molecule drugs that
address oncological and inflammatory diseases, today announced an update related to the intellectual property (IP) status of its lead
drug candidate Namodenoson, currently being developed for the treatment of Metabolic Dysfunction-associated Steatohepatitis (MASH), advanced
liver cancer and pancreatic cancer. In all clinical studies that have been conducted, Namodenoson had a very favorable safety profile
when administered orally.
The patent application
No.2020205042, entitled “An A3 adenosine receptor ligand for use for achieving a fat loss effect”,
has been accepted by the Australian Patent Office and expires in 2040.
The patent application covers methods of treating
obese patients by administering Namodenoson in an oral formulation. Can-Fite has already multiple approved patents and corresponding applications
in a variety of territories around the world, including Europe and the US for the different clinical applications of the drug.
The anti-obesity patent application is based on data demonstrating
that treatment of fat cells with Namodenoson, reduced fat levels via the increase of the hormone adiponectin, a regulator of fat production
in the body. Namodenoson also reduced body weight in an experimental animal model of obesity, induced by a high fat diet. In a Phase IIa
study in MASH patients treated with Namodenoson, a 2.3 % weight loss has been observed after 3 months with a significant increase in serum
adiponectin levels.
”We are delighted that the product protection
of Namodenoson in the area of obesity has been accepted in Australia and will be valid till 2040. Namodenoson is currently being developed
for the treatment of MASH in a Phase IIb study, where most patients are obese. We look forward to see the anti-obesity effect in this
clinical study”, said Pnina Fishman, Ph.D., Can-Fite CSO and Chairperson.
The global obesity treatment market is lucrative due to the awareness
of a link between chronic diseases and obesity and according to Market Research Future was valued at USD 12 billion in 2023. In Australia
only, there are expected to be approximately 1.85 Million MASH patients https://pmc.ncbi.nlm.nih.gov/articles/PMC7540570/pdf/JGH-35-1628.pdf
About Namodenoson
Namodenoson is a small orally bioavailable drug
that binds with high affinity and selectivity to the A3 adenosine receptor (A3AR). Namodenoson is currently being evaluated in a pivotal
Phase III trial for advanced liver cancer, a Phase IIb trial for the treatment of steatotic liver disease (SLD), and the Company is planning
a Phase IIa study in pancreatic cancer. A3AR is highly expressed in diseased cells whereas low expression is found in normal cells. This
differential expression may be one of the important factors that accounts for the excellent safety profile of the drug.
About Namodenoson
Namodenoson is a small orally bioavailable drug that binds with high
affinity and selectivity to the A3 adenosine receptor (A3AR). Namodenoson was evaluated in Phase II trials for two indications, as a second
line treatment for hepatocellular carcinoma, and as a treatment for non-alcoholic fatty liver disease (NAFLD) and non-alcoholic steatohepatitis
(NASH). A3AR is highly expressed in diseased cells whereas low expression is found in normal cells. This differential effect accounts
for the excellent safety profile of the drug.
About Can-Fite BioPharma Ltd.
Can-Fite BioPharma Ltd. (NYSE American: CANF) (TASE: CANF) is an advanced
clinical stage drug development Company with a platform technology that is designed to address multi-billion dollar markets in the treatment
of cancer, liver, and inflammatory disease. The Company's lead drug candidate, Piclidenoson recently reported topline results in a Phase
III trial for psoriasis. Can-Fite's liver drug, Namodenoson, is being evaluated in a Phase IIb trial for the treatment of MASH a Phase
III trial for hepatocellular carcinoma (HCC), and the Company is planning a Phase IIa study in pancreatic cancer. Namodenoson has been
granted Orphan Drug Designation in the U.S. and Europe and Fast Track Designation as a second line treatment for HCC by the U.S. Food
and Drug Administration. Namodenoson has also shown proof of concept to potentially treat other cancers including colon, prostate, and
melanoma. CF602, the Company's third drug candidate, has shown efficacy in the treatment of erectile dysfunction. These drugs have an
excellent safety profile with experience in over 1,600 patients in clinical studies to date. For more information please visit: www.can-fite.com.
Forward-Looking Statements
This press release may contain forward-looking statements, about Can-Fite’s
expectations, beliefs or intentions regarding, among other things, its product development efforts, business, financial condition, results
of operations, strategies or prospects. All statements in this communication, other than those relating to historical facts, are “forward
looking statements”. Forward-looking statements can be identified by the use of forward-looking words such as “believe,”
“expect,” “intend,” “plan,” “may,” “should” or “anticipate” or
their negatives or other variations of these words or other comparable words or by the fact that these statements do not relate strictly
to historical or current matters. Forward-looking statements relate to anticipated or expected events, activities, trends or results as
of the date they are made. Because forward-looking statements relate to matters that have not yet occurred, these statements are inherently
subject to known and unknown risks, uncertainties and other factors that may cause Can-Fite’s actual results, performance or achievements
to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements.
Important factors that could cause actual results, performance or achievements to differ materially from those anticipated in these forward-looking
statements include, among other things, 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;
our ability to advance our product candidates into clinical trials or to successfully complete our preclinical studies or clinical trials;
our receipt of regulatory approvals for our product candidates, and the timing of other regulatory filings and approvals; the clinical
development, commercialization and market acceptance of our product candidates; our ability to establish and maintain strategic partnerships
and other corporate collaborations; the implementation of our business model and strategic plans for our business and product candidates;
the scope of protection we are able to establish and maintain for intellectual property rights covering our product candidates and our
ability to operate our business without infringing the intellectual property rights of others; competitive companies, technologies and
our industry; risks related to any resurgence of the COVID-19 pandemic and the war between Israel and Hamas; risks related to not satisfying
the continued listing requirements of NYSE American; and statements as to the impact of the political and security situation in Israel
on our business. More information on these risks, uncertainties and other factors is included from time to time in the “Risk Factors”
section of Can-Fite’s Annual Report on Form 20-F filed with the SEC on March 28, 2024 and other public reports filed with the SEC
and in its periodic filings with the TASE. Existing and prospective investors are cautioned not to place undue reliance on these forward-looking
statements, which speak only as of the date hereof. Can-Fite undertakes no obligation to publicly update or review any forward-looking
statement, whether as a result of new information, future developments or otherwise, except as may be required by any applicable securities
laws.
Contact
Can-Fite BioPharma
Motti Farbstein
info@canfite.com
+972-3-9241114
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