Can-Fite Reports Ten-Year Survival Milestone for Advanced Liver Cancer Patient from Phase II Namodenoson Study

The Phase III survival observation includes both Namodenoson and placebo patients; treatment-specific efficacy awaits analysis.

Rhea-AI Summary

Can-Fite BioPharma (CANF) reported ten-year overall survival for a patient with advanced liver cancer from its completed Phase II Namodenoson study. The patient, whose complete response was previously reported, remains cancer-free and in good health.

Namodenoson is being evaluated in an ongoing randomized, double-blind, placebo-controlled pivotal Phase III study in advanced hepatocellular carcinoma and underlying Child-Pugh B7 cirrhosis. Can-Fite said longer-than-anticipated survival across the pooled, blinded population prompted evaluation of earlier timing for the planned interim analysis. That observation includes both treatment and placebo patients; treatment-specific efficacy awaits the planned analysis.

Positive

• Minor pointA Phase II patient reached ten years of overall survival and remains cancer-free and in good health.
• Minor pointPooled, blinded Phase III survival appeared longer than anticipated against study design assumptions.
• Minor pointCan-Fite is evaluating earlier timing for the planned Phase III interim analysis.

Negative

• Minor point. Forward-looking: it has not happened yet and may not happen.Phase III survival includes both Namodenoson and placebo patients; treatment-specific efficacy awaits the planned analysis.

Key Figures

Overall survival milestone: 10 years

Overall survival milestone

10 years

Individual patient from completed Phase II Namodenoson study

Previous Clinical trial Reports

1 past event · Latest: Sep 02

Same Type 1 event

1. Sep 02

   Phase III survival update

   24h Move

   -28.3%

   Blinded pooled Phase III survival appeared longer than design assumptions; treatment-specific efficacy remained unassessed.

24h Move is the share-price change in the day after each event; other market factors may also have contributed.

Key Terms

hepatocellular carcinoma, overall survival, child-pugh b7, double-blind, +2 more

6 terms

hepatocellular carcinoma medical

"exceptional individual outcome in advanced hepatocellular carcinoma (HCC)"

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.

overall survival medical

"has reached ten years of overall survival"

Overall survival is the average or median length of time patients remain alive after starting a treatment or entering a clinical study, measured regardless of cause of death. Investors care because it is a clear, hard measure of a therapy’s real-world benefit — like timing how long a new battery actually runs — and strong improvements in overall survival can drive regulatory approval, market adoption and revenue potential.

child-pugh b7 medical

"underlying Child-Pugh B7 cirrhosis"

A Child‑Pugh B7 designation is a clinical score indicating moderate chronic liver dysfunction, based on a short set of lab results and physical signs that together produce a numeric rating of 7. For investors, this matters because patients with B7 often face higher risks, different drug tolerances and narrower treatment options, so trial results, approval pathways and market size can differ compared with patients who have milder or more severe liver disease.

double-blind medical

"ongoing randomized, double-blind, placebo-controlled pivotal Phase III study"

A double-blind process means that neither the people conducting an activity nor the people involved know certain key details, such as who is receiving a treatment or a placebo. This approach helps prevent bias from influencing the results, making the outcome more trustworthy. For investors, it ensures that decisions or judgments are based on unbiased information rather than preconceived opinions or expectations.

placebo-controlled medical

"randomized, double-blind, placebo-controlled pivotal Phase III study"

"Placebo-controlled" describes a testing method where one group receives the actual treatment or intervention, while another group receives a harmless, inactive version called a placebo. This approach helps determine whether the real treatment has genuine effects beyond psychological expectations. For investors, understanding this ensures confidence that reported benefits are real and not influenced by bias or false perceptions.

interim analysis technical

"evaluate earlier timing for the planned interim analysis"

An interim analysis is an early review of a project or process before it is fully completed. For investors, it provides a snapshot of progress or performance, helping to identify whether things are on track, need adjustment, or should be stopped early. Think of it as a progress report that can influence decisions before the final outcome is known.

AI-generated analysis. How Rhea-AI works. Not financial advice.

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Patient from the Company’s completed Phase II study remains cancer-free and in good health at the ten-year survival milestone

Ramat Gan, Israel, Nov. 09, 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 a patient with advanced liver cancer who participated in its completed Phase II study of Namodenoson has reached ten years of overall survival. The patient, whose complete response was previously reported by the Company, remains cancer-free and in good health.

This decade-long survival marks an exceptional individual outcome in advanced hepatocellular carcinoma (HCC), the most common form of liver cancer. Following the Company’s announcement of nine-year survival in November 2025, the patient’s continued well-being adds another year to this remarkable clinical story.

“Behind this ten-year milestone is a woman who continues to live well a decade after participating in our study with advanced liver cancer. For patients, families, and those of us working to develop new treatments, this is a deeply meaningful achievement,” said Prof. Pnina Fishman, Chairperson and Chief Scientific Officer of Can-Fite. “Her exceptional outcome strengthens our commitment to advancing Namodenoson and evaluating its potential to provide durable clinical benefit for patients with liver cancer.”

Namodenoson is currently being evaluated in Can-Fite’s ongoing randomized, double-blind, placebo-controlled pivotal Phase III study in patients with advanced HCC and underlying Child-Pugh B7 cirrhosis. As announced on September 2, 2026, overall survival across the pooled, blinded study population appeared longer than anticipated based on the study’s design assumptions, prompting the Company to evaluate earlier timing for the planned interim analysis. The study remains blinded, and the survival observation includes both Namodenoson- and placebo-treated patients; treatment-specific efficacy will be assessed through the planned analysis.

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, is being evaluated in a pivotal Phase III study for the treatment of moderate-to-severe plaque psoriasis, which has completed enrollment of the first 247 patients for a pre-specified interim analysis, with interim efficacy and safety data expected in the first quarter of 2027. 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 1,700 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, Namodenoson’s potential therapeutic benefits, the conduct, timing, progress and results of the Company’s ongoing Phase III study in HCC, the potential timing and results of the planned interim analysis, and the Company’s product-development and regulatory plans.. 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

FAQ

AI-generated questions and answers. How Rhea-AI works. Not financial advice.

What survival milestone did Can-Fite report for the Phase II Namodenoson patient?

A patient with advanced liver cancer reached ten years of overall survival after participating in the completed Phase II Namodenoson study. The patient remains cancer-free and in good health, with a complete response previously reported.

Does Can-Fite's Phase III survival observation establish Namodenoson's efficacy?

The observation does not establish treatment-specific efficacy: the study remains blinded, and pooled survival includes both Namodenoson- and placebo-treated patients. Treatment-specific efficacy will be assessed through the planned analysis.