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 April 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 four 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, 333-274316, 333-281872, 333-262055,
and 333-294760), 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a part thereof from the date on which this report is submitted, to the extent not superseded by documents or reports subsequently filed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 April 30, 2026, Can-Fite BioPharma Ltd. issued
a press release entitled “Can-Fite Reports Positive Phase 2a Data with Namodenoson in Pancreatic Cancer; 35% of Patients Remain
on Therapy, Including One Beyond 16 Months”. A copy of this press release is furnished herewith as Exhibit 99.1.
Exhibit
Index
| Exhibit No. |
|
Description |
| 99.1 |
|
Press Release dated April 30, 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: April 30, 2026 |
By: |
/s/ Motti Farbstein |
| |
|
Motti Farbstein |
| |
|
Chief Executive Officer and
Chief Financial Officer |
Exhibit
99.1
Can-Fite
Reports Positive Phase 2a Data with Namodenoson in Pancreatic Cancer; 35% of Patients Remain on Therapy, Including One Beyond 16 Months
Ramat
Gan, Israel, April 30, 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
positive clinical data from its Phase 2a study of namodenoson in patients with advanced pancreatic cancer.
The
data from the fully enrolled study demonstrate preliminary evidence of clinical activity, including durable disease stabilization in
a heavily pretreated patient population, in addition to the previously reported favorable safety profile.
Key
findings include:
| ● | Stable
disease observed in >30% of evaluable patients |
| ● | Prolonged
treatment duration includes one patient extending beyond 16 months. |
| ● | 35%
of patients remain on therapy and follow up |
| ● | Favorable
safety and tolerability profile consistent with prior reports |
The
prolonged treatment duration observed in several patients suggests a potential for durable clinical benefit in this difficult-to-treat
population.
“As
we continue to analyse the data, we are encouraged by the emerging signal of durable disease stabilization observed in this study,”
said Pnina Fishman, Chairperson and Chief Scientific Officer of Can-Fite. “Importantly, a meaningful proportion of patients remain
on therapy for extended periods, supporting the continued clinical development of namodenoson in pancreatic cancer.”
As
a substantial proportion of patients remain on treatment, full efficacy analyses, including progression-free survival and overall survival,
top-line results are expected in the coming months and will be presented in a forthcoming clinical conference.
About
Namodenoson
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
Pancreatic Cancer Phase 2a Study
The
Phase 2a study of namodenoson is an open-label trial in patients with advanced pancreatic adenocarcinoma whose disease has progressed
on at least first line therapy or who refuse standard treatment. The trial is evaluating the safety, clinical activity, and pharmacokinetics
(PK) of namodenoson in this population. All patients receive oral namodenoson 25 mg administered twice daily for consecutive 28-day cycles.
Patients are being evaluated regularly for safety. 20 evaluable patients were enrolled to the study. The primary objective of this trial
is to characterize the safety profile of namodenoson and the secondary objective is to evaluate the clinical activity as determined by
the Objective Response Rate (ORR) using Response Evaluation Criteria in Solid Tumors (RECIST 1.1), Progression-Free Survival (PFS), Disease
Control Rate (DCR), Duration of Response (DoR), and Overall Survival (OS). The study met its primary endpoint, which was safety, demonstrating
that namodenoson was very well tolerated in this heavily pretreated patient population. No new safety signals were identified, and the
safety profile was consistent with the known clinical experience of namodenoson in other oncological diseases.
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: 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 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 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
