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Can-Fite BioPharma (NYSE: CANF) to present Phase 2a pancreatic cancer data

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Rhea-AI Filing Summary

Can-Fite BioPharma Ltd. reported that positive data from its Phase 2a study of oral Namodenoson in advanced pancreatic ductal adenocarcinoma have been accepted for poster presentation at the ESMO Congress 2026, a leading global oncology meeting. The study in heavily pretreated, predominantly third-line patients achieved its primary safety endpoint and showed encouraging survival with durable disease stabilization, including a patient treated in second line who remains alive for more than 18 months.

Namodenoson, a highly selective A3 adenosine receptor agonist, is also in a pivotal Phase 3 trial for hepatocellular carcinoma and a Phase 2b trial in MASH, while a Phase 2b pancreatic cancer study combining Namodenoson with chemotherapy is being planned.

Positive

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Negative

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Patient survival duration more than 18 months One patient receiving Namodenoson as second-line therapy remains alive more than 18 months
Pancreatic cancer study phase Phase 2a Namodenoson was evaluated in a Phase 2a study in advanced pancreatic ductal adenocarcinoma
Planned pancreatic cancer trial phase Phase 2b Next clinical development step is a planned Phase 2b study combining Namodenoson with chemotherapy
Liver cancer trial phase Phase 3 Namodenoson is being evaluated in a pivotal Phase 3 trial for hepatocellular carcinoma
MASH trial phase Phase 2b Namodenoson is enrolling patients in a Phase 2b trial for the treatment of MASH
Clinical study exposure over 1,600 patients Company drugs have an excellent safety profile with experience in over 1,600 patients in clinical studies
pancreatic ductal adenocarcinoma (PDAC) medical
"advanced pancreatic ductal adenocarcinoma (PDAC), has been accepted for poster presentation"
Pancreatic ductal adenocarcinoma (PDAC) is the most common form of pancreatic cancer, arising in the cells that line the small ducts which carry digestive juices. It behaves aggressively and is often diagnosed late, like a clogged pipe that causes widespread damage before it’s noticed. For investors, PDAC matters because its poor prognosis and limited approved treatments create a large unmet medical need—meaning successful new therapies can bring significant returns but carry high clinical and regulatory risk.
A3 adenosine receptor agonist medical
"Namodenoson is a highly selective A3 adenosine receptor agonist with a unique mechanism of action"
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.
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.
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"
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.

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FAQ

What did Can-Fite BioPharma (CANF) announce regarding its pancreatic cancer program?

Can-Fite BioPharma (CANF) announced that positive data from its Namodenoson Phase 2a study in advanced pancreatic cancer were accepted for poster presentation at ESMO Congress 2026, highlighting safety, durable disease stabilization, and encouraging survival in a heavily pretreated patient population.

What are the key findings from CANF's Namodenoson Phase 2a pancreatic cancer study?

The Namodenoson Phase 2a study in advanced pancreatic ductal adenocarcinoma met its primary safety endpoint and showed durable disease stabilization with encouraging survival, including predominantly third-line patients and one second-line patient who remains alive for more than 18 months after starting therapy.

How is Can-Fite BioPharma (CANF) planning to advance Namodenoson after the Phase 2a PDAC study?

Following the Phase 2a pancreatic cancer results, Can-Fite BioPharma (CANF) is planning a Phase 2b study of Namodenoson in combination with chemotherapy, based on encouraging clinical findings and preclinical evidence of synergistic anti-tumor activity supporting further development in this difficult-to-treat setting.

What other clinical trials is Namodenoson involved in for Can-Fite BioPharma (CANF)?

Namodenoson for Can-Fite BioPharma (CANF) is being evaluated in a pivotal Phase 3 trial for advanced hepatocellular carcinoma and a Phase 2b trial for MASH, in addition to the completed Phase 2a pancreatic cancer study and its planned Phase 2b combination trial.

What broader pipeline does Can-Fite BioPharma (CANF) report beyond Namodenoson?

Can-Fite BioPharma (CANF) highlights Piclidenoson, which reported topline results and entered a pivotal Phase 3 psoriasis trial, Namodenoson across liver, MASH and pancreatic cancer, and CF602 for erectile dysfunction, with its drugs collectively studied in over 1,600 patients to date.

What regulatory designations has Namodenoson received, according to CANF?

Can-Fite BioPharma (CANF) states that Namodenoson has Orphan Drug Designation in the U.S. and Europe and Fast Track Designation from the U.S. FDA as a second-line treatment for hepatocellular carcinoma, supporting its development in serious liver cancer 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 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

 

 

 

 

 

 

On July 20, 2026, Can-Fite BioPharma Ltd. issued a press release entitled “Can-Fite Positive Phase 2a Pancreatic Cancer Study Data Accepted for Presentation at ESMO Congress 2026, One of the World’s Premier Scientific Meetings in Oncology”. A copy of this press release is furnished herewith as Exhibit 99.1.

 

1

 

 

Exhibit Index

 

Exhibit No.   Description
99.1   Press Release dated July 20, 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: July 20, 2026 By: /s/ Motti Farbstein
    Motti Farbstein
    Chief Executive Officer and
Chief Financial Officer

 

3

 

Exhibit 99.1

 

Can-Fite Positive Phase 2a Pancreatic Cancer Study Data Accepted for Presentation at ESMO Congress 2026, One of the World’s Premier Scientific Meetings in Oncology

 

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 20, 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 an abstract highlighting positive results from its Phase 2a study of Namodenoson in patients with advanced pancreatic ductal adenocarcinoma (PDAC), has been accepted for poster presentation at the European Society for Medical Oncology (ESMO) Congress 2026.

 

The accepted abstract, entitled “Durable Disease Stabilization with Namodenoson in Advanced Pancreatic Adenocarcinoma: Results from a Phase 2a Study,” will be presented as a poster during the ESMO Congress, one of the world’s premier scientific meetings in oncology.

 

The Phase 2a study evaluated oral Namodenoson in patients with advanced pancreatic cancer who had progressed following prior standard therapies. As previously announced, the study successfully achieved its primary safety endpoint and demonstrated encouraging survival outcomes together with durable disease stabilization in this difficult-to-treat patient population.

 

“We are pleased that our abstract has been selected for presentation at ESMO, one of the most prestigious international oncology conferences,” said Pnina Fishman, Ph.D., Chairperson and Chief Scientific Officer of Can-Fite BioPharma. “Acceptance by ESMO provides important scientific recognition of our pancreatic cancer program and offers an opportunity to present our clinical findings to the global oncology community. We believe these data further support the continued development of Namodenoson for patients with advanced pancreatic cancer.”

 

Namodenoson is a highly selective A3 adenosine receptor agonist with a unique mechanism of action that induces apoptosis of cancer cells while exhibiting an excellent safety profile. The drug has demonstrated anti-tumor activity across multiple preclinical models, including pancreatic cancer, and is also being developed for hepatocellular carcinoma and MASH.

 

Can-Fite is currently planning the next stage of clinical development for Namodenoson in pancreatic cancer, with a Phase 2b study designed to evaluate Namodenoson in combination with chemotherapy based on encouraging clinical findings and supportive preclinical evidence demonstrating synergistic anti-tumor activity.

 

Additional details regarding the poster presentation, including presentation date, session information, and poster number, will be announced when they become available.

 

About Pancreatic Ductal Adenocarcinoma (PDAC)

 

Pancreatic ductal adenocarcinoma is among the most aggressive malignancies and remains a leading cause of cancer-related mortality worldwide. Patients with advanced disease who progress following standard therapies have limited treatment options and continue to face poor clinical outcomes, underscoring the need for novel therapeutic approaches.

 

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