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, second, third and fifth paragraphs of the press release attached hereto as Exhibit 99.1 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to the extent not superseded by documents or reports subsequently filed or furnished.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 5, 2026, Can-Fite BioPharma Ltd. issued a press release entitled “Can-Fite: Patient with Decompensated Liver Cirrhosis
Successfully Undergoes Liver Transplantation Following Treatment with Namodenoson”. A copy of this press release is furnished herewith
as Exhibit 99.1.
Exhibit
Index
| Exhibit
No. |
|
Description |
| 99.1 |
|
Press Release dated February 5, 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 5, 2026 |
By: |
/s/
Motti Farbstein |
| |
|
Motti
Farbstein |
| |
|
Chief
Executive Officer and
Chief Financial Officer |
3
Exhibit 99.1
Can-Fite: Patient with Decompensated
Liver Cirrhosis Successfully
Undergoes Liver Transplantation Following Treatment with Namodenoson
Namodenoson Provided Clinical Stabilization
as a Potential Bridge to Transplant in Advanced Liver Failure
Ramat Gan, Israel, Feb. 05, 2026 (GLOBE NEWSWIRE) –
Can-Fite BioPharma Ltd. (NYSE American: CANF) (TASE: CANF), a biotechnology company developing a pipeline of proprietary small molecule
drugs targeting oncological and inflammatory diseases, today announced that a patient with advanced decompensated liver cirrhosis who
was treated with Namodenoson subsequently underwent a successful liver transplantation.
The patient received Namodenoson treatment under
a compassionate use framework while suffering from liver disease and complications consistent with decompensated cirrhosis. Throughout
the treatment period, Namodenoson contributed to clinical stabilization, allowing the patient to remain a suitable candidate for liver
transplantation until a compatible donor organ became available, ultimately resulting in a successful, life-saving liver transplantation.
While this is a single case, the outcome suggests a potential supportive role for Namodenoson in patients with severe liver dysfunction
awaiting transplantation. Due to the ongoing shortage of donor organs, many patients with decompensated cirrhosis deteriorate rapidly
and, tragically, do not survive long enough to receive a suitable transplant, highlighting the importance of therapies that may help maintain
stability during this critical period.
Namodenoson is an orally bioavailable A3 adenosine
receptor (A3AR) agonist with anti-inflammatory and anti-fibrotic properties, which has demonstrated a favourable safety profile in previous
clinical studies. The drug is currently being evaluated in advanced liver diseases, including MASH and hepatocellular carcinoma.
“This case represents an encouraging clinical
observation in a patient with advanced liver disease,” stated Prof. Ohad Etzion, Chief of Gastroenterology and Liver Diseases at
Soroka Medical Center in Israel. “Although individual cases must be interpreted with caution, the ability to maintain clinical stability
in such a fragile patient population is highly meaningful. We believe these findings support the continued clinical development of Namodenoson
in liver disorders where treatment options remain extremely limited.”
In 2017, an estimated 10.6 million people
globally were affected by decompensated cirrhosis, and the available treatment options remain scarce, especially for patients who
have reached the advanced stages of the disease. Highlighting the urgent need for new therapies, the American Liver Foundation has
stated that there are more patients in need of a liver transplant than available organs, with some patients waiting over five years
for a transplant. The global liver cirrhosis treatment market is projected to grow from approximately $7.6 billion in 2024 to more
than $15 billion by 2031.
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 reported topline
results in a Phase III trial for psoriasis and commenced a pivotal Phase III trial. 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
