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Japan backs Can-Fite (NYSE: CANF) Namodenoson obesity patent expansion

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Form Type
6-K

Rhea-AI Filing Summary

Can-Fite BioPharma Ltd. reports that the Japan Patent Office has allowed a patent covering the use of A3 adenosine receptor agonists, including its lead drug Namodenoson, for fat loss, obesity and related metabolic disorders. This strengthens protection for Namodenoson’s anti-obesity technology in a major pharmaceutical market and adds to existing patents in the United States, Canada, Australia and Israel.

The company highlights preclinical and clinical findings suggesting Namodenoson’s potential to reduce fat accumulation and improve metabolic parameters as an oral, highly selective A3 adenosine receptor agonist with an established safety profile. Management views the growing patent estate, alongside a pivotal Phase 3 liver cancer trial and other oncology and liver indications, as enhancing Namodenoson’s value and future partnering opportunities in an obesity therapeutics market forecast to exceed $60 billion by 2030.

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Insights

Japanese patent allowance expands Namodenoson’s IP footprint in obesity but clinical and regulatory risks remain.

Can-Fite has secured a Japanese patent allowance for Namodenoson’s anti-obesity use, adding to coverage in the United States, Canada, Australia and Israel. This broadens intellectual property protection for an oral A3 adenosine receptor agonist positioned for obesity and metabolic disorders.

The filing notes supportive preclinical and clinical data and publication in the International Journal of Obesity, plus an established safety profile from clinical studies. However, Namodenoson is still in clinical development for other indications, and any obesity program would face standard efficacy, safety and regulatory hurdles.

The company cites forecasts that the global obesity therapeutics market may exceed $60 billion by 2030, underscoring commercial potential. It also reminds readers of risks including funding needs, regulatory approvals, competitive therapies such as GLP-1 receptor agonists, and listing requirements, suggesting overall risk remains typical for a clinical-stage biotech.

Japanese patent application Japanese Patent Application No. 2025-049941 Divisional application of JP 2023-078136 allowed by Japan Patent Office
Global obesity therapeutics market forecast Exceed $60 billion Expected by 2030 according to industry forecasts
Namodenoson liver cancer trial stage Pivotal Phase 3 trial For advanced hepatocellular carcinoma (HCC)
Namodenoson pancreatic cancer study Phase 2a concluded Pancreatic cancer clinical study completed
Namodenoson MASH trial stage Phase 2b trial enrolling For Metabolic Dysfunction-associated Steatohepatitis (MASH)
Patients in clinical studies Over 1,600 patients Cumulative exposure across Can-Fite drug candidates
A3 adenosine receptor agonist medical
"Namodenoson, an orally administered, highly selective A3 adenosine receptor agonist"
An a3 adenosine receptor agonist is a drug that binds to and activates a specific protein on cell surfaces called the a3 adenosine receptor, which helps regulate inflammation, pain signals and tissue protection. Think of it as flipping a targeted biological switch to calm harmful processes. Investors watch these drugs because their clinical trial results, safety profile and regulatory approval determine whether they can become new treatments with significant market value and revenue potential.
Metabolic Dysfunction-associated Steatohepatitis (MASH) medical
"Phase 2b trial for the treatment of Metabolic Dysfunction-associated Steatohepatitis (MASH)"
Metabolic dysfunction-associated steatohepatitis (MASH) is a liver condition characterized by inflammation and fat buildup caused by metabolic issues like obesity and insulin resistance. It can lead to liver damage over time, similar to rust gradually weakening metal. Because it is linked to widespread health problems such as diabetes and heart disease, MASH is becoming an important factor in overall health risks and healthcare costs, which can impact economic and investment considerations.
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.
pivotal Phase 3 trial medical
"Namodenoson is currently being evaluated in a pivotal Phase 3 trial for advanced liver cancer"
A pivotal phase 3 trial is the late-stage clinical study designed to provide the decisive evidence regulators need to approve a new drug or medical treatment. Think of it as the final exam where the treatment must prove it works and is safe in a large group of people; investors watch the results closely because a positive outcome can unlock regulatory approval, sales, milestone payments and big changes in a company’s valuation.
GLP-1 receptor agonists medical
"driven by increasing disease prevalence and the commercial success of GLP-1 receptor agonists"
GLP-1 receptor agonists are medicines that mimic a natural gut hormone to lower blood sugar and reduce appetite, often used to treat diabetes and obesity. Investors care because these drugs can drive large prescription sales, face strict regulatory approval and patent timelines, and their safety, pricing, or label changes can meaningfully affect a drug maker’s revenue much like a bestselling product or a recalled item would impact any company’s financial outlook.
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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. 333-227753333-271384 and 333-278525) and Form F-3 (File Nos. 333-236064333-276000333-274316333-281872333-262055, 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 26, 2026, Can-Fite BioPharma Ltd. issued a press release entitled “Can-Fite Secures Japanese Patent Allowance for Namodenoson’s Anti-Obesity Technology”. A copy of this press release is furnished herewith as Exhibit 99.1.

 

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Exhibit Index

 

Exhibit No.   Description
99.1   Press Release dated June 26, 2026

 

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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 26, 2026 By: /s/ Motti Farbstein
    Motti Farbstein
    Chief Executive Officer and
Chief Financial Officer

 

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Exhibit 99.1

 

Can-Fite Secures Japanese Patent Allowance for Namodenoson’s Anti-Obesity Technology

 

The allowed Patent strengthens protection in one of the world’s largest pharmaceutical markets and further supports
Namodenoson’s positioning in obesity and metabolic diseases

 

Ramat Gan, Israel, June 26, 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 that the Japan Patent Office has allowed Japanese Patent Application No. 2025-049941, a divisional application of JP 2023-078136, titled “An A3 Adenosine Receptor Ligand for Use for Achieving a Fat Loss Effect.”

 

The allowed patent covers the use of A3 adenosine receptor (A3AR) agonists, including the Company’s lead drug candidate Namodenoson, for inducing fat loss and treating obesity and related metabolic disorders.

 

The Japanese patent allowance represents another significant milestone in Can-Fite’s expanding global intellectual property portfolio covering Namodenoson’s anti-obesity activity. The Company has already secured patent protection for this technology in major jurisdictions including the United States, Canada, Australia and Israel, further strengthening its worldwide exclusivity strategy for this promising therapeutic indication.

 

The growing patent estate is supported by scientific evidence recently published in the peer-reviewed International Journal of Obesity (https://rdcu.be/e37sf ), demonstrating Namodenoson’s anti-obesity activity and providing independent scientific validation for its novel mechanism of action.

 

The global obesity therapeutics market continues to experience rapid expansion, driven by increasing disease prevalence and the commercial success of GLP-1 receptor agonists. Despite this growth, currently available therapies are frequently associated with gastrointestinal side effects, injectable administration, treatment discontinuation, and high cost. Namodenoson, an orally administered, highly selective A3 adenosine receptor agonist with an established safety profile from clinical studies, offers a differentiated mechanism of action by targeting key pathways involved in adipogenesis, inflammation, and metabolic regulation. Preclinical and clinical findings suggest its potential to reduce fat accumulation while improving metabolic parameters, positioning it as a promising candidate for future obesity therapy.

 

 

 

“The allowance of this patent in Japan significantly strengthens our global intellectual property portfolio in one of the world’s most important pharmaceutical markets,” said Dr. Pnina Fishman, Chairperson and Chief Scientific Officer of Can-Fite. “Together with our growing body of scientific evidence and established clinical safety database, this expanding patent estate enhances the value of Namodenoson as a differentiated oral therapeutic candidate for obesity and metabolic diseases and further supports future partnering opportunities.”

 

According to industry forecasts, the global obesity therapeutics market is expected to exceed $60 billion by 2030, driven by increasing obesity prevalence and demand for safe, effective, and convenient oral therapies.

 

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 enrol patients for 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 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.

 

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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

 

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FAQ

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

Can-Fite BioPharma announced that the Japan Patent Office allowed a patent covering Namodenoson’s use for fat loss, obesity, and related metabolic disorders. This expands the drug’s intellectual property protection into Japan, one of the world’s largest pharmaceutical markets, supporting its global anti-obesity strategy.

How does the Japanese patent affect Namodenoson’s obesity and metabolic disease program?

The Japanese patent allowance strengthens protection for Namodenoson’s anti-obesity technology by covering A3 adenosine receptor agonists for inducing fat loss and treating obesity. Together with patents in the United States, Canada, Australia and Israel, it supports a worldwide exclusivity strategy for this therapeutic indication.

What differentiates Namodenoson from current obesity drugs, according to Can-Fite?

Namodenoson is described as an orally administered, highly selective A3 adenosine receptor agonist with an established clinical safety profile. Can-Fite notes it targets pathways in adipogenesis, inflammation and metabolic regulation, offering a different mechanism from injectable GLP-1 therapies often associated with gastrointestinal side effects and high costs.

How large is the obesity therapeutics market Can-Fite is targeting with Namodenoson?

According to the company, industry forecasts suggest the global obesity therapeutics market could exceed $60 billion by 2030. This reflects rising obesity prevalence and demand for safe, effective, convenient oral therapies, which Can-Fite believes aligns with Namodenoson’s profile and positioning.

In which other indications is Namodenoson currently being clinically evaluated?

Namodenoson is being evaluated in a pivotal Phase 3 trial for hepatocellular carcinoma, has concluded a Phase 2a study in pancreatic cancer, and is enrolling a Phase 2b trial for Metabolic Dysfunction-associated Steatohepatitis (MASH). These programs contribute to its clinical safety and efficacy database.

What broader drug pipeline does Can-Fite BioPharma (CANF) report alongside Namodenoson?

Can-Fite reports an advanced clinical-stage pipeline including Piclidenoson, which recently reported topline Phase 3 psoriasis results and started a pivotal Phase 3 trial, and CF602, which has shown efficacy in erectile dysfunction. Across its drugs, the company cites experience in over 1,600 patients.

Filing Exhibits & Attachments

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