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 January 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, fourth 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to be a part thereof from the date on which this report is submitted, to the extent not superseded by documents or reports subsequently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 January 20, 2026, Can-Fite BioPharma Ltd. issued
a press release entitled “Can-Fite Completes Patient Enrollment in Phase 2a Pancreatic Cancer Study of Namodenoson”. A copy
of this press release is furnished herewith as Exhibit 99.1.
Exhibit
Index
| Exhibit No. |
|
Description |
| 99.1 |
|
Press Release dated January 20, 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: January 20, 2026 |
By: |
/s/ Motti Farbstein |
| |
|
Motti Farbstein |
| |
|
Chief Executive Officer and
Chief Financial Officer |
3
Exhibit 99.1
Can-Fite Completes Patient Enrollment in Phase
2a Pancreatic Cancer Study of Namodenoson
Primary Safety Endpoint Demonstrated to Date;
Top-Line Efficacy Data Expected in Q3 2026
Ramat Gan, Israel, Jan. 20, 2026 (GLOBE NEWSWIRE) – Can-Fite
BioPharma Ltd. (NYSE American: CANF) (TASE: CANF), a clinical-stage biotechnology company developing a pipeline of proprietary small
molecule drugs for the treatment of cancer and inflammatory diseases, today announced that patient enrollment has been completed in its
Phase 2a pancreatic cancer clinical trial of Namodenoson.
The Phase 2a study is a multicenter, open-label trial enrolling patients
with advanced pancreatic adenocarcinoma whose disease has progressed following at least one line of prior therapy. The study is evaluating
the safety (primary endpoint), clinical activity, and pharmacokinetics (PK) of Namodenoson in this patient population. Participants receive
oral Namodenoson at a dose of 25 mg, administered twice daily in continuous 28-day cycles. Patients are regularly monitored for safety,
and to date, Namodenoson has demonstrated a favorable safety profile. The study is led by Prof. Salomon Stemmer, a renowned oncologist
and key opinion leader at the Davidoff Center, Rabin Medical Center, Israel.
“This achievement marks a significant step forward in the clinical
development of Namodenoson in pancreatic cancer,” said Pnina Fishman, Ph.D., Chief Scientific Officer of Can-Fite BioPharma. “With
enrollment now complete and safety continuing to be favorable, we believe we are well positioned to generate meaningful efficacy top-line
data in Q3 2026.”
Namodenoson is a highly selective A3 adenosine receptor (A3AR) agonist,
which has shown a compelling safety profile and demonstrated anti-tumor activity in preclinical pancreatic cancer models. The drug is
also being evaluated in clinical trials for advanced liver cancer.
Namodenoson has received Orphan Drug Designation
from the U.S. Food and Drug Administration (FDA) for the treatment of pancreatic cancer.
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 3 trial for psoriasis and commenced a pivotal Phase 3 trial. 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 1,600 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, its product development efforts,
timing of efficacy data and prospects for generating meaningful efficacy data. 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. For example, the Company is using forward-looking
statements when it discusses the completion of the offerings, the satisfaction of customary closing conditions related to the offerings
and the intended use of proceeds therefrom. 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 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
