Namodenoson shows survival signal in Can-Fite (NYSE: CANF) Phase 2a

Rhea-AI Filing Summary

Can-Fite BioPharma reported Phase 2a results for its drug Namodenoson in advanced pancreatic ductal adenocarcinoma. The trial met its primary safety endpoint and showed durable overall survival in a subset of heavily pretreated patients.

The open-label study enrolled 20 patients who had progressed after standard therapies, including 14 on third-line treatment, five on second-line and one on fourth-line. One second-line patient remains alive more than 18 months after starting Namodenoson. Based on these outcomes and supporting preclinical data, Can-Fite plans a Phase 2b study combining Namodenoson with chemotherapy.

Key Figures

Phase 2a enrollment: 20 patients Third-line treatment group: 14 patients Second-line treatment group: 5 patients +3 more

6 metrics

Phase 2a enrollment 20 patients Advanced pancreatic ductal adenocarcinoma study population

Third-line treatment group 14 patients Received Namodenoson as third-line therapy

Second-line treatment group 5 patients Received Namodenoson as second-line therapy

Fourth-line treatment 1 patient Received Namodenoson as fourth-line therapy

Longest survivor duration more than 18 months Second-line Namodenoson-treated pancreatic cancer patient

Clinical safety exposure over 1,600 patients Patients treated with Can-Fite drugs in clinical studies

Key Terms

Phase 2a study, pancreatic ductal adenocarcinoma, Namodenoson, Orphan Drug Designation, +2 more

6 terms

Phase 2a study financial

"its Phase 2a study evaluating Namodenoson in patients with advanced pancreatic ductal adenocarcinoma"

pancreatic ductal adenocarcinoma medical

"Phase 2a study evaluating Namodenoson in patients with advanced pancreatic ductal adenocarcinoma"

A fast-growing cancer that starts in the cells lining the pancreas’ small ducts; it is the most common and aggressive form of pancreatic cancer. It matters to investors because its severity and limited treatment options drive high unmet medical need, large potential markets for effective drugs or diagnostics, and strong sensitivity of company valuations to clinical trial results, regulatory approvals, or changes in treatment guidelines—similar to how fixing a main leak can prevent major damage in a building.

Namodenoson medical

"Namodenoson was well tolerated, with a safety profile consistent with prior clinical trials"

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.

Metabolic Dysfunction-associated Steatohepatitis (MASH) medical

"a 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.

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

Available on EDGAR 07/01/2026 - 07:02 AM Accepted by SEC EDGAR 07/01/2026 - 07:02 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 July 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 six 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 July 1, 2026, Can-Fite BioPharma Ltd. issued a press release entitled “Can-Fite Phase 2a Pancreatic Cancer Study with Namodenoson Achieves Primary Safety Endpoint and Demonstrates Durable Survival Outcomes in Advanced Disease”. 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 July 1, 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: July 1, 2026	By:	/s/ Motti Farbstein
		Motti Farbstein
		Chief Executive Officer and Chief Financial Officer

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Exhibit 99.1

Can-Fite Phase 2a Pancreatic Cancer Study with Namodenoson
Achieves Primary Safety Endpoint and Demonstrates Durable
Survival Outcomes in Advanced Disease

Predominantly third-line pancreatic cancer patients demonstrated durable survival despite advanced disease; patient who received Namodenoson as second-line therapy remains alive more than 18 months

Ramat Gan, Israel, July 01, 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 its Phase 2a study evaluating Namodenoson in patients with advanced pancreatic ductal adenocarcinoma achieved its primary safety endpoint and demonstrated durable overall survival outcomes.

The open-label Phase IIa study enrolled 20 patients with advanced pancreatic ductal adenocarcinoma who had progressed following standard therapies. Fourteen patients received Namodenoson as third-line treatment, five as second-line treatment, and one as fourth-line treatment. Namodenoson was well tolerated, with a safety profile consistent with prior clinical trials.

Following extended follow-up, an updated survival analysis was performed in the third-line population, focusing on the eight patients who survived at least two months after treatment initiation, thereby excluding patients with rapidly progressive disease unlikely to derive benefit from systemic therapy.

Among the eight evaluable third-line patients:

● Median overall survival exceeded 5 months

● 62.5% of patients survived five months or longer

● 37.5% survived seven months or longer

● Two patients remain alive at the data cutoff, including one patient continuing treatment and another followed for almost nine months

● Durable disease control was observed, including progression-free survival extending beyond seven months.

The findings identify a subset of heavily pretreated pancreatic cancer patients achieving prolonged survival despite receiving Namodenoson as third-line therapy, supporting further clinical development of Namodenoson.

Notably, among the five patients treated in the second-line setting, one patient remains alive more than 18 months after initiation of Namodenoson therapy, representing the longest survivor in the study.

Prof. Salomon Stemmer, who is leading the Phase 2a study and is an oncology key opinion leader and Professor at the Davidoff Institute of Oncology, Rabin Medical Center, Israel, commented: “Pancreatic cancer remains one of the most difficult malignancies to treat, particularly after failure of standard therapies. The results of Namodenoson monotherapy are impressive and the favorable safety profile together with the prolonged survival observed in a subgroup of patients, suggest biological activity worthy of further investigation. Based on these findings and the growing preclinical evidence demonstrating enhancement of chemotherapy activity, I believe the next logical step is evaluation of Namodenoson in combination with chemotherapy.”

Based on these findings and discussions with the study’s principal investigator, Can-Fite plans to advance Namodenoson into a Phase 2b combination study with chemotherapy. The decision follows recently published peer-reviewed preclinical data demonstrating that Namodenoson (2-Cl-IB-MECA) enhances the anti-tumor activity of chemotherapeutic agents in pancreatic cancer models by simultaneously inhibiting multiple tumor proliferation and drug-resistance pathways, including Wnt/β-catenin and Hedgehog signalling, while reducing expression of multidrug-resistance proteins. The publication further demonstrated that Namodenoson increased chemosensitivity in pancreatic cancer cells, providing a strong mechanistic rationale for combination therapy

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.

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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 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

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FAQ

What did Can-Fite (CANF) report in its July 2026 6-K filing?

Can-Fite reported Phase 2a results for Namodenoson in advanced pancreatic ductal adenocarcinoma. The trial met its primary safety endpoint and showed durable overall survival in a subset of heavily pretreated patients, prompting plans for a Phase 2b combination study with chemotherapy.

How many patients were included in Can-Fite’s Namodenoson Phase 2a pancreatic cancer trial?

The Phase 2a pancreatic ductal adenocarcinoma study enrolled 20 patients with advanced disease. Fourteen received Namodenoson as third-line therapy, five as second-line therapy, and one as fourth-line therapy after progressing following standard treatments, reflecting a heavily pretreated population.

What survival outcomes were highlighted for Namodenoson in pancreatic cancer?

The company highlighted durable overall survival in a subset of heavily pretreated patients. Notably, among five patients treated in the second-line setting, one patient remains alive more than 18 months after initiation of Namodenoson therapy, representing the longest survivor reported in the study.

What are Can-Fite’s next clinical plans for Namodenoson after this Phase 2a study?

Can-Fite plans to advance Namodenoson into a Phase 2b combination study with chemotherapy. This decision follows the Phase 2a safety and survival findings and preclinical data indicating Namodenoson can enhance chemotherapeutic activity in pancreatic cancer models by affecting multiple tumor proliferation and drug-resistance pathways.

In which other indications is Namodenoson currently being developed by Can-Fite (CANF)?

Namodenoson is being evaluated in a pivotal Phase 3 trial for advanced hepatocellular carcinoma and a Phase 2b trial for Metabolic Dysfunction-associated Steatohepatitis (MASH). It has Orphan Drug Designation in the U.S. and Europe and Fast Track Designation as a second-line treatment for hepatocellular carcinoma.

What broader drug pipeline does Can-Fite BioPharma maintain besides Namodenoson?

Can-Fite’s pipeline includes Piclidenoson, which recently reported topline Phase 3 psoriasis results and commenced another pivotal Phase 3 trial, and CF602, which has shown efficacy in erectile dysfunction. Across programs, the company reports an excellent safety profile in over 1,600 patients to date.

Filing Exhibits & Attachments

1 document

Press Releases

• EX-99.1 PRESS RELEASE DATED JULY 1, 2026 21.3 KB