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 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 two 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 No. 333-227753,
333-271384 and 333-278525)
and Form F-3 (File Nos. 333-236064,
333-276000, 333-281872,
333-262055, 333-294760,
333-298625 and 333-299160), to be a part thereof from the date on which this report is submitted, to the extent not superseded by documents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
November 9, 2026, Can-Fite BioPharma Ltd. issued a press release entitled “Can-Fite Reports Ten-Year Survival Milestone for Advanced
Liver Cancer Patient from Phase II Namodenoson Study”. A copy of this press release is furnished herewith as Exhibit 99.1.
Exhibit
Index
| Exhibit
No. |
|
Description |
| 99.1 |
|
Press Release dated November 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: November 9, 2026 |
By: |
/s/ Motti
Farbstein |
| |
|
Motti Farbstein |
| |
|
Chief Executive Officer
and Chief Financial Officer |
Exhibit 99.1
Can-Fite
Reports Ten-Year Survival Milestone for Advanced Liver Cancer Patient from Phase II Namodenoson Study
Patient
from the Company’s completed Phase II study remains cancer-free and in good health at the ten-year survival milestone
Ramat
Gan, Israel, November 9, 2026 -- Can-Fite BioPharma Ltd. (NYSE American: CANF) (TASE: CANF), a clinical-stage biotechnology company developing
a pipeline of proprietary small molecule drugs targeting oncological and inflammatory diseases, today announced that a patient with advanced
liver cancer who participated in its completed Phase II study of Namodenoson has reached ten years of overall survival. The patient,
whose complete response was previously reported by the Company, remains cancer-free and in good health.
This
decade-long survival marks an exceptional individual outcome in advanced hepatocellular carcinoma (HCC), the most common form of liver
cancer. Following the Company’s announcement of nine-year survival in November 2025, the patient’s continued well-being adds
another year to this remarkable clinical story.
“Behind
this ten-year milestone is a woman who continues to live well a decade after participating in our study with advanced liver cancer. For
patients, families, and those of us working to develop new treatments, this is a deeply meaningful achievement,” said Prof. Pnina
Fishman, Chairperson and Chief Scientific Officer of Can-Fite. “Her exceptional outcome strengthens our commitment to advancing
Namodenoson and evaluating its potential to provide durable clinical benefit for patients with liver cancer.”
Namodenoson
is currently being evaluated in Can-Fite’s ongoing randomized, double-blind, placebo-controlled pivotal Phase III study in patients
with advanced HCC and underlying Child-Pugh B7 cirrhosis. As announced on September 2, 2026, overall survival across the pooled, blinded
study population appeared longer than anticipated based on the study’s design assumptions, prompting the Company to evaluate earlier
timing for the planned interim analysis. The study remains blinded, and the survival observation includes both Namodenoson- and placebo-treated
patients; treatment-specific efficacy will be assessed through the planned analysis.
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 3 trial for advanced liver cancer, concluded successfully a Phase 2a study in pancreatic
cancer and is enrolling patients in a Phase 2b trial for the treatment of Metabolic Dysfunction-associated Steatohepatitis (MASH). 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, is being evaluated in a pivotal Phase III study for the treatment of moderate-to-severe plaque psoriasis,
which has completed enrollment of the first 247 patients for a pre-specified interim analysis, with interim efficacy and safety data
expected in the first quarter of 2027. Can-Fite’s liver drug, Namodenoson, is being evaluated in a Phase III trial for hepatocellular
carcinoma (HCC), a Phase 2b trial for the treatment of MASH, and in a Phase 2a 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 1,700 patients in clinical studies to date. For more information please visit: 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, Namodenoson’s potential therapeutic benefits, the conduct, timing, progress and results of the Company’s ongoing
Phase III study in HCC, the potential timing and results of the planned interim analysis, and the Company’s product-development
and regulatory plans.. 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 market and other conditions, 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 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 26, 2026 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
