Lab data show Can-Fite (NYSE: CANF) drug boosts pancreatic chemo

Rhea-AI Filing Summary

Can-Fite BioPharma Ltd. reported new preclinical findings showing that its drug namodenoson enhances the anti-cancer effect of gemcitabine chemotherapy in pancreatic cancer by increasing cleaved caspase-3–mediated apoptosis. These data provide mechanistic support for a planned randomized Phase IIb study in advanced pancreatic adenocarcinoma combining namodenoson with gemcitabine and nab-paclitaxel, following favorable safety and activity seen in a Phase 2a study. Clinical results from the Phase 2a trial have been accepted for presentation at the ESMO Congress 2026. Namodenoson is also in a pivotal Phase 3 trial for advanced liver cancer and a Phase 2b trial for MASH, while lead candidate piclidenoson is in Phase 3 for psoriasis and CF602 targets erectile dysfunction, with an overall clinical safety database of more than 1,600 patients.

Filing Explained

The August 17 Form 6-K incorporates the first three paragraphs of its press release by reference into specified Form S-8 and Form F-3 registration statements, making that content part of those filings from the submission date.

Key Figures

Patients in clinical studies: over 1,600 patients Namodenoson liver cancer trial phase: Phase 3 Namodenoson MASH trial phase: Phase 2b +4 more

7 metrics

Patients in clinical studies over 1,600 patients Total clinical experience across Can-Fite drug candidates to date

Namodenoson liver cancer trial phase Phase 3 Pivotal trial for advanced hepatocellular carcinoma (HCC)

Namodenoson MASH trial phase Phase 2b Ongoing trial for treatment of Metabolic Dysfunction-associated Steatohepatitis (MASH)

Namodenoson pancreatic cancer trial phases Phase 2a and planned Phase IIb Completed Phase 2a; randomized Phase IIb combination study planned in advanced pancreatic adenocarcinoma

Orphan Drug Designation regions U.S. and Europe Regulatory status for namodenoson in hepatocellular carcinoma

Fast Track Designation Second line HCC U.S. FDA Fast Track for namodenoson as a second line treatment for HCC

ESMO Congress year 2026 Year when Phase 2a pancreatic cancer results are to be presented

Key Terms

Phase IIb study, cleaved caspase-3, A3 adenosine receptor (A3AR), Metabolic Dysfunction-associated Steatohepatitis (MASH), +2 more

6 terms

Phase IIb study medical

"support the design of Can-Fite’s planned Phase IIb study evaluating namodenoson"

cleaved caspase-3 medical

"increased the level of a protein, cleaved caspase-3, a central mediator"

Cleaved caspase-3 is the activated form of caspase-3, an enzyme that carries out programmed cell death (apoptosis) by slicing key proteins inside a cell. Scientists measure cleaved caspase-3 as a biomarker to show that cells are being driven to die, much like checking a switched-on alarm to confirm a system is responding. For investors, its presence in studies signals whether a drug or treatment is producing intended cell-killing effects or causing unintended tissue damage, informing assessments of mechanism, efficacy, and safety.

A3 adenosine receptor (A3AR) medical

"drug that binds with high affinity and selectivity to the A3 adenosine receptor (A3AR)"

A3 adenosine receptor (A3AR) is a specific protein on the surface of cells that acts like a lock for the natural molecule adenosine, triggering signals that can reduce inflammation, control cell growth, or affect pain perception. It matters to investors because medicines that activate or block this receptor are drug development targets; success or failure in clinical trials, regulatory review, or partnerships around A3AR-targeting therapies can significantly change a biotech company’s value, much like a key unlocking commercial 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"

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.

FAQ

What did Can-Fite BioPharma (CANF) announce about namodenoson in pancreatic cancer?

Can-Fite reported preclinical findings showing namodenoson enhances the anti-cancer effect of gemcitabine in pancreatic cancer. The data increase cleaved caspase-3–mediated apoptosis and support the design of a planned randomized Phase IIb study in advanced pancreatic adenocarcinoma.

How will Can-Fite (CANF) test namodenoson in its planned Phase IIb pancreatic cancer trial?

The planned randomized Phase IIb study will evaluate namodenoson combined with gemcitabine and nab-paclitaxel in patients with advanced pancreatic adenocarcinoma. The design builds on favorable safety and encouraging clinical activity observed with namodenoson monotherapy in a prior Phase 2a study.

What other clinical programs does Can-Fite (CANF) have for namodenoson?

Namodenoson is in a pivotal Phase 3 trial for advanced hepatocellular carcinoma and a Phase 2b trial for MASH, and has completed a Phase 2a pancreatic cancer study. It has Orphan Drug Designation in the U.S. and Europe and Fast Track status for second-line HCC.

What is the mechanism of action of Can-Fite’s drug namodenoson (CANF)?

Namodenoson is an orally bioavailable small molecule that binds selectively and with high affinity to the A3 adenosine receptor (A3AR). A3AR is highly expressed in diseased cells but low in normal cells, which may help explain the drug’s excellent safety profile.

What other drug candidates are in Can-Fite’s (CANF) pipeline?

Can-Fite’s lead candidate piclidenoson is in Phase 3 trials for psoriasis, and CF602 has shown efficacy in erectile dysfunction. Together with namodenoson, these candidates target multi-billion dollar markets in cancer, liver, and inflammatory diseases with data from over 1,600 patients.

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

Available on EDGAR 08/17/2026 - 07:11 AM Accepted by SEC EDGAR 08/17/2026 - 07:10 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 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 17, 2026, Can-Fite BioPharma Ltd. issued a press release entitled “Can-Fite: Namodenoson Enhances the Anti-Cancer Effect of Chemotherapy in Pancreatic Cancer—New Mechanistic Findings Support Phase IIb Study Design”. 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 17, 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 17, 2026	By:	/s/ Motti Farbstein
		Motti Farbstein
		Chief Executive Officer and Chief Financial Officer

3

Exhibit 99.1

Can-Fite: Namodenoson Enhances the Anti-Cancer Effect of Chemotherapy in Pancreatic Cancer

The New Mechanistic Findings Support Can-Fite’s Ongoing Phase IIb Study Design Following Positive Phase IIa Results

Ramat Gan, Israel, Aug. 17, 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 new preclinical findings demonstrating that namodenoson enhances the anti-cancer effect of gemcitabine chemotherapy in pancreatic cancer. The findings provide mechanistic support for the design of Can-Fite’s planned Phase IIb study evaluating namodenoson in combination with gemcitabine and additional standard-of-care therapy in patients with advanced pancreatic adenocarcinoma.

In pre-clinical studies the combination of namodenoson and gemcitabine increased the level of a protein, cleaved caspase-3, a central mediator of cell death (apoptosis). These findings indicate that namodenoson weakens the survival mechanisms of pancreatic cancer cells, thereby increasing their susceptibility to chemotherapy and enabling a stronger tumor cell-death response.

The new findings directly support the scientific rationale underlying Can-Fite’s planned randomized Phase IIb study in advanced pancreatic adenocarcinoma. The proposed study will evaluate namodenoson in combination with gemcitabine and additional standard-of-care therapy, Nab-paclitaxel, building upon the favorable safety profile and encouraging clinical activity observed with namodenoson monotherapy in the Company’s Phase 2a pancreatic cancer study.

“These findings provide an important mechanistic explanation for the enhanced anti-cancer effect observed when namodenoson is combined with chemotherapy,” stated Pnina Fishman, Ph.D., Can-Fite’s Chief Scientific Officer and Chairperson. “Namodenoson suppressed key survival pathways in pancreatic cancer cells and increased caspase-3-mediated apoptosis, thereby enhancing the activity of gemcitabine. These results strongly support the combination approach incorporated into the design of our planned Phase IIb study.”

Clinical results from Can-Fite’s Phase 2a study of namodenoson in advanced pancreatic adenocarcinoma have been accepted for presentation at the European Society for Medical Oncology (ESMO) Congress 2026.

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 is enrolling patients in 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.

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 and plans to advance Namodenoson into a combination study. 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

1 document

Press Releases

• EX-99.1 PRESS RELEASE DATED AUGUST 17, 2026 12.2 KB