Can-Fite BioPharma (CANF) outlines FDA and EMA paths for Phase III cancer and psoriasis drugs

Rhea-AI Filing Summary

Can-Fite BioPharma Ltd. reports that its two lead oral A3 adenosine receptor agonists, Namodenoson and Piclidenoson, are both in Phase III development under regulatory frameworks agreed with the FDA and EMA, providing defined pathways toward potential marketing applications.

Namodenoson is in a pivotal Phase III trial for hepatocellular carcinoma (HCC) in patients with Child-Pugh B7 cirrhosis and holds FDA Fast Track status plus Orphan Drug Designation in both the U.S. and Europe as a second-line HCC treatment. Piclidenoson is in a Phase III program for moderate-to-severe plaque psoriasis. The company also advances Namodenoson in Phase 2b for MASH and Phase 2a in pancreatic cancer, and has a third candidate, CF602, for erectile dysfunction. Across its programs, Can-Fite reports clinical experience in over 1,600 patients, supporting an established safety profile.

Key Figures

Namodenoson development stage in HCC: Phase III Piclidenoson development stage in psoriasis: Phase III Namodenoson MASH trial stage: Phase 2b +2 more

5 metrics

Namodenoson development stage in HCC Phase III Pivotal trial for hepatocellular carcinoma with Child-Pugh B7 cirrhosis

Piclidenoson development stage in psoriasis Phase III Clinical program for moderate-to-severe plaque psoriasis

Namodenoson MASH trial stage Phase 2b Trial for treatment of MASH

Namodenoson pancreatic cancer trial stage Phase 2a Study in pancreatic cancer

Clinical patients exposed over 1,600 patients Total clinical experience across Can-Fite drug candidates

Key Terms

Fast Track Designation, Orphan Drug Designation, hepatocellular carcinoma, MASH, +1 more

5 terms

Fast Track Designation regulatory

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

Fast track designation is a status the U.S. Food and Drug Administration grants to drugs intended to treat serious conditions and address an unmet medical need. It gives the developer more frequent communication with the FDA and can allow parts of the application to be reviewed on a rolling basis, and it may pave the way to priority review or accelerated approval. It can shorten development timelines, though it does not guarantee approval.

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.

hepatocellular carcinoma medical

"Phase III trial for hepatocellular carcinoma (HCC), a Phase 2b trial for the treatment of MASH"

Hepatocellular carcinoma is the most common form of primary liver cancer, arising from the main functional cells of the liver. For investors it matters because its serious health impact drives demand for diagnostic tests, treatments and long-term care; progress in trials or approvals can change a drugmaker’s revenue outlook much like a successful product launch can reshape a company’s future.

MASH medical

"a Phase 2b trial for the treatment of MASH, and in a Phase 2a study in pancreatic cancer"

A3 adenosine receptor technical

"Namodenoson, Can-Fite’s orally administered A3 adenosine receptor (A3AR) agonist, is currently being evaluated"

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.

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FAQ

What did Can-Fite BioPharma (CANF) disclose about its lead drug Namodenoson?

Can-Fite reported that Namodenoson is in a pivotal Phase III trial for hepatocellular carcinoma (HCC) in Child-Pugh B7 patients and holds FDA Fast Track and Orphan Drug Designations in both the U.S. and Europe as a second-line HCC treatment.

What is the development status of Piclidenoson at Can-Fite BioPharma (CANF)?

Piclidenoson is described as Can-Fite’s lead oral A3AR agonist for inflammatory diseases and is in a Phase III clinical program for moderate-to-severe plaque psoriasis. The company notes that topline Phase 3 psoriasis results were reported and a pivotal Phase 3 trial has commenced.

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

Namodenoson has been granted Orphan Drug Designation in the U.S. and Europe and Fast Track Designation by the FDA as a second-line treatment for HCC. Can-Fite states these designations provide additional regulatory advantages as its pivotal HCC program advances.

What other indications is Namodenoson being studied for at Can-Fite (CANF)?

Beyond HCC, Can-Fite reports Namodenoson is in a Phase 2b trial for MASH and a Phase 2a study in pancreatic cancer. The company also notes proof-of-concept data suggesting potential in other cancers such as colon, prostate, and melanoma.

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

Can-Fite states that its drug candidates, including Piclidenoson, Namodenoson, and CF602, have shown an excellent safety profile with experience in over 1,600 patients across clinical studies to date, supporting its advanced clinical-stage positioning.

What is CF602 and how does it fit into Can-Fite BioPharma’s (CANF) pipeline?

CF602 is described as Can-Fite’s third drug candidate and has shown efficacy in the treatment of erectile dysfunction. Alongside Namodenoson and Piclidenoson, it broadens the company’s clinical-stage pipeline across oncology, liver, inflammatory, and sexual health indications.

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 August 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 No. 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 August 12, 2026, Can-Fite BioPharma Ltd. issued a press release entitled “Can-Fite Highlights Advanced FDA and EMA Regulatory Status of its Phase III Drug Candidates”. A copy of this press release is furnished herewith as Exhibit 99.1.

1

Exhibit Index

Exhibit No.		Description
99.1		Press Release dated August 12, 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: August 12, 2026	By:	/s/ Motti Farbstein
		Motti Farbstein
		Chief Executive Officer and Chief Financial Officer

3

Exhibit 99.1

Can-Fite Highlights Advanced FDA and EMA Regulatory Status of its Phase III Drug Candidates

Namodenoson Holds FDA Fast Track and U.S. and European Orphan Drug Designations; Piclidenoson and Namodenoson Are Advancing in Phase III Programs

Ramat Gan, Israel, August 12, 2026 -- 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 provided an update on the regulatory status of its two lead drug candidates, Piclidenoson and Namodenoson. Both drug candidates are being advanced in Phase III clinical development programs under regulatory frameworks established with the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA), providing defined regulatory pathways toward potential marketing approval.

Namodenoson, Can-Fite’s orally administered A3 adenosine receptor (A3AR) agonist, is currently being evaluated in a pivotal Phase III study for the treatment of patients with advanced liver cancer, hepatocellular carcinoma (HCC) and underlying Child-Pugh B7 liver cirrhosis. The Phase III study is being conducted under regulatory guidance from both the FDA and EMA and is designed to support potential marketing authorization applications in the United States and Europe, if the study meets its predefined efficacy and safety endpoints.

Piclidenoson, Can-Fite’s oral A3AR agonist for inflammatory diseases, is currently being evaluated in a Phase III clinical program for the treatment of moderate-to-severe plaque psoriasis.

Can-Fite’s clinical development strategy is focused on advancing its lead drug candidates through late-stage clinical development under regulatory pathways established with leading regulatory authorities.

Namodenoson’s FDA Fast Track and FDA and EMA Orphan Drug designations provide additional regulatory advantages as the Company advances its pivotal HCC program, while Piclidenoson is progressing through Phase III development in psoriasis.

Can-Fite believes that the advanced regulatory status of both programs significantly strengthens the Company’s late-stage clinical pipeline and provides a clear framework for advancing Piclidenoson and Namodenoson toward potential regulatory submissions and commercialization.

“Can-Fite has reached an important stage in its development, with both of our lead drug candidates in Phase III programs and with established regulatory pathways in the United States and Europe,” stated Dr. Pnina Fishman, Can-Fite’s Chief Scientific Officer and Executive Chairperson. “Namodenoson’s Fast Track and Orphan Drug designations, together with our ongoing pivotal Phase III HCC study, and the Phase III development of Piclidenoson in psoriasis, demonstrate the maturity of our clinical pipeline. We believe these regulatory achievements provide greater clarity regarding the development and potential approval pathways for our drug candidates and bring us closer to our goal of delivering new oral therapies to patients with significant unmet medical needs.”

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, the Company’s development programs, regulatory status, and potential approval pathways.. 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

Filing Exhibits & Attachments

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Press Releases

• EX-99.1 PRESS RELEASE DATED AUGUST 12, 2026 12.3 KB