Can-Fite (NYSE: CANF) touts peer-reviewed A3AR data and late-stage pipeline

Rhea-AI Filing Summary

Can-Fite BioPharma Ltd. filed a Form 6-K highlighting a new peer-reviewed article that reviews the broad therapeutic potential of its lead A3 adenosine receptor (A3AR) agonists, Piclidenoson and Namodenoson, across multiple major diseases. The article, published in the Biomolecules journal, compiles data from the company and independent research groups worldwide, which the company views as important scientific validation of its A3AR platform.

The filing reiterates that Namodenoson is in Phase 3 development for hepatocellular carcinoma, Phase 2 for pancreatic cancer, and Phase 2b for MASH, while Piclidenoson is in a pivotal Phase 3 study for psoriasis. It also notes Orphan Drug and Fast Track designations for Namodenoson, and states that Can-Fite’s drug candidates have shown an excellent safety profile in more than 1,600 patients to date.

Key Figures

Clinical patients: over 1,600 patients Namodenoson HCC trial phase: Phase 3 Namodenoson MASH trial phase: Phase 2b +2 more

5 metrics

Clinical patients over 1,600 patients Patients treated with Can-Fite drug candidates in clinical studies to date

Namodenoson HCC trial phase Phase 3 Namodenoson clinical development stage for hepatocellular carcinoma

Namodenoson MASH trial phase Phase 2b Namodenoson development stage for treatment of MASH

Piclidenoson psoriasis trial phase Phase 3 Pivotal Phase 3 study in psoriasis

Target markets size multi-billion dollar markets Cancer, liver and inflammatory disease markets targeted by platform

Key Terms

A3 adenosine receptor, Adenosine A3 Receptor Agonists, Orphan Drug Designation, Fast Track Designation, +2 more

6 terms

A3 adenosine receptor medical

"activation of the A3 adenosine receptor (A3AR) modulates key pathological pathways"

A3 adenosine receptor is a specific protein on the surface of certain cells that acts like a lock responding to the natural molecule adenosine; when activated it influences inflammation, blood flow, and cell survival. For investors, it matters because drugs that selectively target this receptor can change disease outcomes or side-effect profiles, so clinical trial results or regulatory decisions about such drugs can materially affect biotech valuations and the potential market for new therapies.

Adenosine A3 Receptor Agonists medical

"“Adenosine A3 Receptor Agonists as Multisystemic Disease Modifiers"

Orphan Drug Designation regulatory

"Namodenoson has been granted Orphan Drug Designation in the U.S. and Europe"

Orphan drug designation is a special status given to medicines developed to treat rare diseases affecting only a small number of people. This status often provides benefits like faster approval processes and financial incentives, making it more attractive for companies to develop these drugs. For investors, it signals potential for exclusive market rights and reduced competition, which can impact the drug’s profitability.

Fast Track Designation regulatory

"Fast Track Designation as a second line treatment for HCC by the U.S. Food and Drug Administration"

A "fast track designation" is a process that speeds up the review and approval of a product or project, allowing it to reach the market or be completed more quickly than usual. For investors, it can signal that a product may become available sooner, potentially leading to earlier revenue or benefits, and indicating a priority status that might influence company performance and market opportunities.

Phase 3 trial medical

"Namodenoson is being evaluated in a Phase III trial for hepatocellular carcinoma"

A Phase 3 trial is a large, late-stage test of a new drug or medical treatment done on many people to make sure it really works and is safe. For investors, it matters because a successful Phase 3 usually means the company can ask regulators to sell the product and could earn lots of money, while failure can sharply reduce the company’s value.

MASH medical

"a Phase 2b trial for the treatment of MASH"

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Form 6-K: How Foreign Companies Report to the SEC →

Available on EDGAR 06/22/2026 - 07:04 AM Accepted by SEC EDGAR 06/22/2026 - 07:03 AM Learn about SEC filing dates

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 June 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 three 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 June 22, 2026, Can-Fite BioPharma Ltd. issued a press release entitled “Can-Fite Publishes Peer-Reviewed Scientific Article Demonstrating the Broad Therapeutic Potential of Piclidenoson and Namodenoson”. A copy of this press release is furnished herewith as Exhibit 99.1.

1

Exhibit Index

Exhibit No.		Description
99.1		Press Release dated June 22, 2026

2

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: June 22, 2026	By:	/s/ Motti Farbstein
		Motti Farbstein
		Chief Executive Officer and Chief Financial Officer

3

Exhibit 99.1

Can-Fite Publishes Peer-Reviewed Scientific Article Demonstrating the Broad Therapeutic Potential of Piclidenoson and Namodenoson

Ramat-Gan, Israel, June 22, 2026 (GLOBE NEWSWIRE) -- Can-Fite BioPharma Ltd. (NYSE American: CANF) (TASE: CANF), a biotechnology company advancing a pipeline of proprietary small molecule drugs that address oncological and inflammatory diseases, today announced the publication of a peer-reviewed scientific article demonstrating the broad therapeutic potential of its lead drug candidates, Piclidenoson and Namodenoson, across multiple major diseases.

“The article, entitled “Adenosine A3 Receptor Agonists as Multisystemic Disease Modifiers: From Molecular Signaling to Clinical Translation” was published in the peer-reviewed Biomolecules Journal (link). The publication reviews findings from Can-Fite work and numerous independent academic and clinical research groups worldwide demonstrating that activation of the A3 adenosine receptor (A3AR) modulates key pathological pathways involved in:

The review details evidence supporting A3AR agonist activity in:

● Solid tumors, including hepatocellular carcinoma and pancreatic cancer

● Metabolic dysfunction-associated steatohepatitis (MASH) and liver fibrosis

● Autoimmune and inflammatory diseases

● Osteoarthritis and musculoskeletal disorders

● Neurodegenerative diseases, including Alzheimer’s disease and vascular dementia

● Obesity and metabolic disorders

● Rare genetic diseases, including Lowe syndrome

“This publication represents an important scientific validation of Piclidenoson and Namodenoson and the broader A3AR platform technology,” stated Pnina Fishman, CSO and Chairperson of Can-Fite. “Particularly compelling is the fact that many of the findings summarized in this review originate from independent research institutions worldwide and extend well beyond our current clinical development programs. Collectively, we believe these data reinforce the potential of A3AR agonists to address multiple diseases with significant unmet medical needs.”

Can-Fite’s clinical pipeline currently includes Namodenoson in Phase 3 development for hepatocellular carcinoma, Phase 2 development for pancreatic cancer, and Phase 2b development for MASH. Piclidenoson is currently being evaluated in a pivotal Phase 3 study in psoriasis. The publication further supports the Company’s strategy of leveraging A3AR agonists as a platform technology applicable to multiple therapeutic indications.

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. 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

FAQ

What did Can-Fite BioPharma (CANF) announce in this Form 6-K?

Can-Fite reported publication of a peer-reviewed article reviewing its A3 adenosine receptor agonists Piclidenoson and Namodenoson. The paper summarizes company and independent data supporting their therapeutic potential across multiple major diseases.

Which drug candidates from Can-Fite (CANF) are highlighted in the article?

The article focuses on Piclidenoson and Namodenoson, Can-Fite’s lead small molecule A3AR agonists. It reviews how activating the A3 adenosine receptor may modulate key pathological pathways in various oncological and inflammatory conditions.

What is the clinical development status of Namodenoson at Can-Fite (CANF)?

Namodenoson is in a Phase 3 trial for hepatocellular carcinoma, a Phase 2b trial for MASH, and a Phase 2a study for pancreatic cancer. It has also shown proof of concept in other cancers including colon, prostate, and melanoma.

What is the clinical status of Piclidenoson in Can-Fite’s (CANF) pipeline?

Piclidenoson recently reported topline results in a Phase 3 trial for psoriasis and has commenced a pivotal Phase 3 study. The company positions Piclidenoson as a key part of its A3AR-based platform for inflammatory diseases.

Which regulatory designations has Namodenoson received according to Can-Fite (CANF)?

Namodenoson has Orphan Drug Designation in the U.S. and Europe and Fast Track Designation as a second-line treatment for hepatocellular carcinoma from the U.S. Food and Drug Administration, supporting its development in serious liver cancers.

How extensive is clinical experience with Can-Fite’s (CANF) drug candidates?

Can-Fite states its drug candidates, including Piclidenoson, Namodenoson and CF602, have demonstrated an excellent safety profile. They have been administered to more than 1,600 patients in clinical studies across various indications.

Filing Exhibits & Attachments

1 document

Press Releases

• EX-99.1 PRESS RELEASE DATED JUNE 22, 2026 14.2 KB