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 2025

 

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 registrantfiles or will file annual reports under cover Form 20-F or Form 40-F.

 

Form 20-F ☒           Form 40-F ☐

 

 

 

 

On July 28, 2025, Can-Fite BioPharma Ltd. issueda press release entitled “Breakthrough Study from UCLA Demonstrate Can-Fite’s Piclidenoson as a Treatment for Vascular Dementia”.A copy of this press release is furnished herewith as Exhibit 99.1.

 

1

 

ExhibitIndex

 

Exhibit No.   Description
99.1   Press Release dated July 28, 2025

 

2

 

SIGNATURES

 

Pursuant to the requirementsof the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned, thereuntoduly authorized.

 

  Can-Fite BioPharma Ltd.
     
Date: July 28, 2025 By: /s/ Motti Farbstein
    Motti Farbstein
    Chief Executive Officer and
Chief Financial Officer

 

 

3

 

Exhibit 99.1

 

Breakthrough Study from UCLA Demonstrate Can-Fite’sPiclidenoson as a Treatment for Vascular Dementia

 

Ramat Gan, Israel, July 28, 2025 (GLOBENEWSWIRE) -- Can-Fite BioPharma Ltd. (NYSE American: CANF) (TASE: CANF), a clinical-stage biotechnology company developing apipeline of proprietary small molecule drugs for the treatment of cancer and inflammatory diseases, today announced that a leadinggroup from University of Los Angeles (UCLA), demonstrate that Piclidenoson showed efficacy in an experimental model of vasculardementia.

 

The study headed by Dr. S. Thomas Carmichael, M.D., Ph.D., Professorand Chair Frances Stark Chair, Department of Neurology, Geffen School of Medicine at UCLA, utilized a vascular dementia mouse model withfocal ischemia replicating many elements of the complex pathophysiology of human vascular dementia. Piclidenoson was found to restoretissue integrity and behavioral function in this vascular dementia model.

 

Vascular dementia is the second most common causeof dementia after Alzheimer’s disease, and caused by impaired blood flow to the brain, often due to stroke or chronic small vessel disease.There are no U.S. FDA approved therapies for this condition. Drugs that are used off-label, including donepezil or memantine, are usedsymptomatically or to address co-morbidities. Additionally, antihypertensives, antiplatelets, and statins are used to prevent furthervascular damage, but none of these medications are disease-modifying. Nevertheless, due to an aging population and increasing diagnosis,the global market for Vascular Dementia is estimated at $6 billion as of 2025, with an expected CAGR of 5% through 2035.

 

“A first-in-class agent such as Piclidenosonthat could provide neuroprotection and improve vascular health would fill a significant unmet need and likely capture a large share ofthe growing Vascular Dementia market.,” stated Pnina Fishman, Ph.D., Chief Scientific Officer of Can-Fite BioPharma.

 

Piclidenoson is a highly selective A3 adenosine receptor (A3AR) agonist,which has shown a compelling safety profile in hundreds of patients with Psoriasis and demonstrated anti-inflammatory activity in Phase2 and Phase 3 clinical studies.

 

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-billiondollar markets in the treatment of cancer, liver, and inflammatory disease. The Company’s lead drug candidate, Piclidenoson recentlyreported 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 Phase2a study in pancreatic cancer. Namodenoson has been granted Orphan Drug Designation in the U.S. and Europe and Fast Track Designationas a second line treatment for HCC by the U.S. Food and Drug Administration. Namodenoson has also shown proof of concept to potentiallytreat other cancers including colon, prostate, and melanoma. CF602, the Company’s third drug candidate, has shown efficacy in thetreatment of erectile dysfunction. These drugs have an excellent safety profile with experience in over 1,600 patients in clinical studiesto date. For more information please visit: www.can-fite.com.

 

 

Forward-Looking Statements

 

This press release may contain forward-lookingstatements, about Can-Fite’s expectations, beliefs or intentions regarding, among other things, its product development efforts,business, financial condition, results of operations, strategies or prospects. All statements in this communication, other than thoserelating to historical facts, are “forward looking statements”. Forward-looking statements can be identified by the use offorward-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 bythe fact that these statements do not relate strictly to historical or current matters. For example, the Company is using forward-lookingstatements when it discusses the completion of the offerings, the satisfaction of customary closing conditions related to the offeringsand the intended use of proceeds therefrom. Forward-looking statements relate to anticipated or expected events, activities, trends orresults as of the date they are made. Because forward-looking statements relate to matters that have not yet occurred, these statementsare inherently subject to known and unknown risks, uncertainties and other factors that may cause Can-Fite’s actual results, performanceor achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-lookingstatements. Important factors that could cause actual results, performance or achievements to differ materially from those anticipatedin these forward-looking statements include, among other things, our market and other conditions, history of losses and needs for additionalcapital to fund our operations and our inability to obtain additional capital on acceptable terms, or at all; uncertainties of cash flowsand inability to meet working capital needs; the initiation, timing, progress and results of our preclinical studies, clinical trialsand other product candidate development efforts; our ability to advance our product candidates into clinical trials or to successfullycomplete our preclinical studies or clinical trials; our receipt of regulatory approvals for our product candidates, and the timing ofother regulatory filings and approvals; the clinical development, commercialization and market acceptance of our product candidates; ourability to establish and maintain strategic partnerships and other corporate collaborations; the implementation of our business modeland strategic plans for our business and product candidates; the scope of protection we are able to establish and maintain for intellectualproperty rights covering our product candidates and our ability to operate our business without infringing the intellectual property rightsof others; competitive companies, technologies and our industry; risks related to not satisfying the continued listing requirements ofNYSE American; and statements as to the impact of the political and security situation in Israel on our business. More information onthese risks, uncertainties and other factors is included from time to time in the “Risk Factors” section of Can-Fite’sAnnual Report on Form 20-F filed with the SEC on April 14, 2025 and other public reports filed with the SEC and in its periodic filingswith the TASE. Existing and prospective investors are cautioned not to place undue reliance on these forward-looking statements, whichspeak only as of the date hereof. Can-Fite undertakes no obligation to publicly update or review any forward-looking statement, whetheras 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