Can-Fite (CANF) highlights $325M Vetbiolix deal and new canine OA data

Rhea-AI Filing Summary

Can-Fite BioPharma Ltd. furnished a report highlighting a new peer-reviewed publication on its lead drug candidate Piclidenoson in canine osteoarthritis. The article in Frontiers in Veterinary Science describes a study where oral Piclidenoson produced statistically significant improvements in mobility and pain in dogs, with a favorable safety profile.

Piclidenoson is being developed for veterinary use by Vetbiolix under a licensing agreement potentially valued at up to $325 million in upfront, milestone and royalty payments, and is currently in an advanced Phase 2 clinical study in dogs. Can-Fite also reiterates its broader clinical pipeline, including Piclidenoson in psoriasis Phase 3 trials and Namodenoson in multiple Phase II/III studies in liver and oncology indications, all supported by safety experience in over 1,600 patients.

Key Figures

Vetbiolix licensing deal value: up to $325 million Patients in clinical studies: over 1,600 patients Piclidenoson psoriasis stage: Phase 3 +3 more

6 metrics

Vetbiolix licensing deal value up to $325 million Potential upfront, milestone and royalty payments for Piclidenoson veterinary rights

Patients in clinical studies over 1,600 patients Combined safety experience across Can-Fite’s drug candidates

Piclidenoson psoriasis stage Phase 3 Topline results reported and pivotal trial commenced in psoriasis

Namodenoson HCC stage Phase III Trial for hepatocellular carcinoma

Namodenoson MASH stage Phase 2b Trial for treatment of MASH

Namodenoson pancreatic cancer stage Phase 2a Study in pancreatic cancer

Key Terms

peer-reviewed, A3 adenosine receptor agonist, Orphan Drug Designation, Fast Track Designation, +2 more

6 terms

peer-reviewed technical

"announced publication of a peer-reviewed scientific article regarding previously reported positive findings"

Peer-reviewed means a study, report or paper has been examined and approved by independent experts in the same field before publication, like having multiple qualified inspectors check a building plan. For investors, peer review signals that methods and conclusions have passed scrutiny beyond the author’s claims, making scientific, clinical or technical findings more reliable and reducing the chance that decisions or valuation are based on unchecked or flawed evidence.

A3 adenosine receptor agonist medical

"“Piclidenoson, an A3 Adenosine Receptor Agonist, Improves Clinical Signs in Dogs"

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.

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 financial

"The Company’s lead drug candidate, Piclidenoson recently reported topline results in a Phase 3 trial for psoriasis"

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, and in a Phase 2a study in pancreatic cancer"

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

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 May 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 May 18, 2026, Can-Fite BioPharma Ltd. issued a press release entitled “Scientific Publication of Can-Fite and Vetbiolix Validates Piclidenoson’s Potential in the Multi-Billion Dollar Canine Osteoarthritis Market”. 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 May 18, 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: May 18, 2026	By:	/s/ Motti Farbstein
		Motti Farbstein
		Chief Executive Officer and Chief Financial Officer

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Exhibit 99.1

Scientific Publication of Can-Fite and Vetbiolix Validates Piclidenoson’s Potential in the Multi-Billion Dollar Canine Osteoarthritis Market

Ramat Gan, Israel, May 18, 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 publication of a peer-reviewed scientific article regarding previously reported positive findings from a study evaluating Piclidenoson for the treatment of canine osteoarthritis. The article abstract, titled “Piclidenoson, an A3 Adenosine Receptor Agonist, Improves Clinical Signs in Dogs with Osteoarthritis” was published in the peer-reviewed journal Frontiers in Veterinary Science and is available online.

The study described in the publication demonstrated that oral treatment with Piclidenoson resulted in statistically significant improvement in mobility and pain assessments in dogs suffering from osteoarthritis, while maintaining a favorable safety profile. The study supports the continued development of Piclidenoson as a potential oral disease-modifying therapy for canine osteoarthritis.

Key findings reported in the publication include:

● Significant improvement in Liverpool Osteoarthritis in Dogs (LOAD) scores in dogs treated with Piclidenoson at 500 µg/kg BID

● Significant reduction in pain scores measured by the Visual Analog Scale (VAS)

● Significant reduction in veterinarian-assessed lameness and pain

● Favorable safety profile with no serious treatment-related adverse events reported

● Data supporting Piclidenoson’s potential as a novel oral therapy for canine osteoarthritis

Piclidenoson is being developed for veterinary indications by Vetbiolix under a licensing agreement with Can-Fite potentially valued at up to $325 million in upfront, milestone, and royalty payments. Vetbiolix is currently conducting an advanced Phase 2 clinical study evaluating Piclidenoson in dogs with osteoarthritis.

Prof. Pnina Fishman, Chairperson and Chief Scientific Officer of Can-Fite, stated,“Publication of these findings in a peer-reviewed scientific journal represents important external validation of Piclidenoson’s therapeutic potential in canine osteoarthritis. We believe the data demonstrate the potential of Piclidenoson to provide a safe and effective oral treatment option for dogs suffering from this highly prevalent disease while further supporting the commercial opportunity of our collaboration with Vetbiolix.”

Canine osteoarthritis is one of the most common chronic diseases affecting dogs worldwide and represents a significant and growing veterinary market. Current treatment options are limited and are often associated with safety and tolerability concerns during long-term use.

About Piclidenoson

Piclidenoson is a novel, first-in-class, A3 adenosine receptor agonist (A3AR) small molecule, orally bioavailable drug with an excellent safety and efficacy profile demonstrated in a Phase III clinical study in psoriasis. 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 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/.

About VETBIOLIX SAS

VETBIOLIX develops innovative products for the treatment of diseases affecting pets. VETBIOLIX has built a unique pipeline of First-in-class oral small molecules in-licensed (exclusive and worldwide license) from Human Biotech worldwide which are intended to answer veterinary unmet medical needs in periodontitis (VBX-1000; Cathepsin-K inhibitor), osteoarthritis (VBX-2000; A3 Adenosine receptor agonist) and gut motility disorders (VBX-3000; 5-HT4 agonist). VETBIOLIX focuses exclusively on clinical developments of its drug candidates: the company invests in (i) clinical proof of concept studies, (ii) CMC-Pharmaceutical developments, (iii) regulatory Pilot clinical studies and (iv) regulatory Pivotal clinical studies. Revenue generation of the company will be based on out-licensing and/or co-developments deals with the Veterinary Pharmaceutical Industry.

For more information please visit: https://www.vetbiolix.com

Contact: matthieu.dubruque@vetbiolix.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, product development efforts and prospects of its licensing agreement with Vetbiolix. 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 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 the security situation in Israel; 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 about Piclidenoson in dogs?

Can-Fite reported a peer-reviewed publication showing Piclidenoson improved mobility and pain in dogs with osteoarthritis. The study found statistically significant benefits from oral treatment and maintained a favorable safety profile, supporting further development as an oral disease-modifying therapy for canine osteoarthritis.

How large is Can-Fite’s licensing deal with Vetbiolix for Piclidenoson?

Piclidenoson is licensed to Vetbiolix under an agreement potentially valued at up to $325 million. The value reflects possible upfront, milestone and royalty payments tied to development and commercialization milestones in veterinary indications, including canine osteoarthritis, rather than guaranteed revenue today.

What clinical stage is Piclidenoson in for human indications at Can-Fite (CANF)?

Piclidenoson has completed a Phase 3 trial in psoriasis with reported topline results and has commenced a pivotal Phase 3 trial. It is described as a first-in-class A3 adenosine receptor agonist with an excellent safety and efficacy profile demonstrated in prior clinical studies for psoriasis patients.

What are the main drug candidates in Can-Fite BioPharma’s pipeline?

Can-Fite highlights three main candidates: Piclidenoson for psoriasis and veterinary osteoarthritis, Namodenoson for hepatocellular carcinoma, MASH and pancreatic cancer, and CF602 for erectile dysfunction. These programs target multi-billion dollar markets in cancer, liver disease and inflammatory conditions using orally available small molecules.

What regulatory designations has Namodenoson received according to Can-Fite?

Namodenoson has been granted Orphan Drug Designation in the U.S. and Europe and Fast Track Designation as a second line treatment for hepatocellular carcinoma by the U.S. Food and Drug Administration. These designations can provide development incentives and expedited regulatory interactions for the program.

How extensive is Can-Fite’s clinical safety experience across its drug candidates?

Can-Fite states that Piclidenoson, Namodenoson and CF602 have shown an excellent safety profile. The company notes clinical experience in over 1,600 patients across studies to date, supporting ongoing late-stage development in oncology, liver and inflammatory diseases, as well as emerging veterinary applications.

Filing Exhibits & Attachments

1 document

Press Releases

• EX-99.1 PRESS RELEASE DATED MAY 18, 2026 17.3 KB