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 July 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a part thereof from the date on which this report is submitted, to the extent not superseded by documents or reports subsequently filed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 July 6, 2026, Can-Fite BioPharma Ltd.
issued a press release entitled “Can-Fite Achieves Key Pivotal Phase 3 Psoriasis Milestone with Completion of Patient
Enrolment for the Interim Analysis: Data Expected Q4 2026/Q1 2027”. A copy of this press release is furnished herewith as
Exhibit 99.1.
Exhibit
Index
| Exhibit No. |
|
Description |
| 99.1 |
|
Press Release dated July 6, 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: July 6, 2026 |
By: |
/s/ Motti Farbstein |
| |
|
Motti Farbstein |
| |
|
Chief Executive Officer and Chief Financial Officer |
Exhibit 99.1
Can-Fite Achieves Key Pivotal Phase 3 Psoriasis
Milestone with Completion
of Patient Enrolment for the Interim Analysis: Data Expected Q4 2026/Q1 2027
Interim analysis to be conducted under an FDA- and EMA-agreed protocol
Ramat Gan, Israel, July 06, 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 targeting oncological and inflammatory diseases, today announced completion of enrolment of the first 247 patients in its
pivotal Phase 3 study evaluating Piclidenoson for the treatment of moderate-to-severe plaque psoriasis.
The study has now reached the pre-specified interim analysis stage
under a protocol agreed with both the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA). The interim analysis
will evaluate efficacy and safety data from the enrolled patients. Results are expected during Q4
2026/Q1 2027.
The study is a randomized, double-blind, placebo-controlled Phase 3
trial aimed at demonstrating clinical safety and efficacy for the treatment of patients with moderate to severe plaque psoriasis. Patients
are treated with 3 mg Piclidenoson tablets or placebo administered orally twice daily. The co-primary efficacy objectives of this study
are the proportion of subjects who achieve a Psoriasis Area and Severity Index (PASI) score response of ≥75% (PASI 75) and the proportion
of subjects who achieve a Static Physician’s Global Assessment (sPGA) at of 0 or 1 at Week 16.
Piclidenoson is a first-in-class oral A3 adenosine receptor (A3AR)
agonist with a differentiated mechanism of action targeting key inflammatory pathways implicated in psoriasis. Unlike injectable biologic
therapies, Piclidenoson is administered orally as a tablet and has demonstrated a favourable safety profile in more than 1,500 subjects
treated across clinical studies, supporting its potential use as a chronic long-term treatment.
“We are pleased to achieve this important enrolment milestone
in our pivotal Phase 3 psoriasis study,” said Motti Farbstein, Chief Executive Officer of Can-Fite. “This study is being conducted
under a protocol agreed with both the FDA and EMA, providing a clear regulatory pathway for Piclidenoson. We believe Piclidenoson’s unique
combination of oral administration, favourable safety profile, and potential suitability for chronic treatment differentiates it from
existing therapies and may offer a valuable new option for patients living with psoriasis.”
The global psoriasis therapeutics market continues to expand, driven
by increasing disease prevalence and demand for safe, effective, and convenient long-term treatment options. Can-Fite believes Piclidenoson’s
differentiated profile as an oral small-molecule therapy positions it to address important unmet needs within this large and growing market.
About Piclidenoson
Piclidenoson is an orally bioavailable, highly selective A3 adenosine
receptor agonist with anti-inflammatory activity demonstrated in both preclinical and clinical studies. The drug has accumulated an extensive
clinical safety database involving more than 1,500 subjects and is being developed as a potential chronic therapy for psoriasis and other
inflammatory diseases. The drug’s mechanism of action entails inhibition of the inflammatory cytokines interleukin 17 and 23 (IL-17
and IL-23) and the induction of apoptosis of patients’ skin cell keratinocytes involved with the disease pathogenicity.
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 previously
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,
the potential of Piclidenoson and the potential timing of interim analysis 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. 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:
Motti Farbstein
info@canfite.com
+972-3-9241114
