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 February 2026
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 ☐
The first six paragraphs of the press release
attached hereto as Exhibit 99.1, other than the fifth paragraph, are hereby incorporated by reference into the registrant’s Registration
Statements on Form S-8 (File Nos. 333-227753,
333-271384 and 333-278525)
and Form F-3 (File Nos. 333-236064,
333-274316, 333-262055,
333-276000 and 333-281872),
to be a part thereof from the date on which this report is submitted, to the extent not superseded by documents or reports subsequently
filed or furnished.
On February 9, 2026, Can-Fite BioPharma Ltd. issued
a press release entitled “Can-Fite: Receives Canadian Patent Allowance for Namodenoson as an Anti-Obesity Therapy”. A copy
of this press release is furnished herewith as Exhibit 99.1.
Exhibit
Index
| Exhibit No. |
|
Description |
| 99.1 |
|
Press Release dated February 9, 2026 |
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: February 9, 2026 |
By: |
/s/ Motti Farbstein |
| |
|
Motti Farbstein |
| |
|
Chief Executive Officer and
Chief Financial Officer |
3
Exhibit 99.1
Can-Fite: Receives Canadian Patent
Allowance for Namodenoson as an Anti-Obesity Therapy
Namodenoson’s oral safety profile
and metabolic activity, position it as a promising candidate in the rapidly growing obesity treatment market
Ramat Gan, Israel, Feb. 09, 2026 (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 that the Canadian Patent Office has issued a notice of allowance for
Canadian Patent Application No. 3,126,002, titled “An A3 adenosine receptor ligand for use for achieving a fat loss effect.
The patent covers the use of Namodenoson, Can-Fite’s
orally bioavailable A3 adenosine receptor (A3AR) agonist, for reducing fat mass and body weight, providing intellectual property protection
in Canada for its development as an anti-obesity therapy.
Can-Fite already holds corresponding patents in the United States and
Australia for the use of Namodenoson in obesity and metabolic disorders. Namodenoson is currently in clinical development for Metabolic
Dysfunction-Associated Steatohepatitis (MASH), advanced liver cancer, and pancreatic cancer, and has demonstrated an excellent safety
profile across multiple clinical studies following oral administration.
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 high fat diet. In a MASH Phase
IIa study, in patients treated with Namodenoson, a 2.3% weight loss has been observed after 3 months with a significant increase in serum
adiponectin levels.
“Expanding our intellectual property estate
into metabolic indications such as fat loss creates new development and partnering opportunities and reinforces the long-term value of
our A3 adenosine receptor platform,” said Pnina Fishman, Ph.D., Can-Fite CSO and Chairperson.
The global obesity treatment market is projected
to reach $60.5 billion by 2030, growing at a compound annual growth rate (CAGR) of approximately 22%, driven by increasing disease prevalence
and demand for safe, effective oral therapies.
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 Metabolic Dysfunction-associated Steatohepatitis (MASH),
and in 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 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 and is expected to commence a pivotal Phase III. Can-Fite's liver drug, Namodenoson,
is being evaluated in a Phase III trial for hepatocellular carcinoma (HCC), a Phase IIb trial for the treatment of MASH, and in 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: https://www.canfite.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 April 14, 2025 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
