Can-Fite: Complete Response and 6.9 Years Overall Survival in a Patient with Advanced Liver Cancer Treated with Namodenoson

Can-Fite: Complete Response and 6.9

Years Overall Survival in a Patient with Advanced Liver Cancer Treated with Namodenoson

PETACH TIKVA, Israel, November 22, 2023 - Can-Fite

BioPharma Ltd. (NYSE American: CANF) (TASE: CANF), a biotechnology company advancing a pipeline of proprietary small molecule drugs that

address oncological and inflammatory diseases, today announced that a patient who participated in the Phase II Liver Cancer Study and

was treated with namodenoson has a complete response and overall survival of 6.9 years (82.8 months).

Liver Cancer designated as hepatocellular carcinoma

(HCC), is a major global health problem due to its incidence, associated mortality, and lack of effective treatment modalities, particularly

for patients with advanced hepatic dysfunction known as disease stage Child Pugh B.

A patient with advanced HCC that was enrolled

in the former Can-Fite Phase II study continues to receive treatment with namodenoson and has now an overall survival of 6.9 years with

the disappearance of ascites, normal liver function, and good quality of life and defined as a complete response.

Can-Fite has received agreement from both the

U.S. Food and Drug Administration (FDA) and European Medicines Agency (EMA) on a pivotal Phase III clinical study which is now enrolling

patients in Israel, Europe and the US. Namodenoson has Orphan Drug status with both the FDA and EMA, as well as Fast Track Status with

the FDA for the treatment of HCC. A compassionate use program has been ongoing in Israel and Romania.

The double blind, placebo-controlled trial will

enroll 450 patients diagnosed with HCC and underlying Child Pugh B7 (CPB7) through clinical sites worldwide. Patients will be randomized

to oral treatment with either 25 mg Namodenoson or matching placebo given twice daily. The primary efficacy endpoint of the trial is overall

survival. Other oncology trial efficacy outcomes, such as tumor radiographic response rates and median progression-free survival, as well

as standard safety parameters, will be assessed.

An interim analysis will be conducted by an Independent

Data Monitoring Committee (IDMC) after 50% of enrolled patients are treated. Namodenoson will be evaluated as a 2nd or 3rd line treatment

for CPB7 patients in whom other approved therapies have not been or are no longer effective.

"We are currently enrolling patients for

the pivotal Phase III clinical study and hope that if the interim analysis data will be positive, we will be able to get a conditional

approval, and that patients who suffer from this devastating disease will enjoy our drug" stated Can-Fite CEO Motti Farbstein.

According to the American Cancer Society, liver

cancer accounts for more than 700,000 deaths globally each year. HCC is commonly aggressive with poor survival rates. As new drugs that

effectively and safely treat HCC are developed and approved, the market for HCC treatments is estimated by Delveinsight to reach $3.8

billion by 2027 for the G8 countries.

Namodenoson is a small orally bioavailable drug

that binds with high affinity and selectivity to the A3 adenosine receptor (A3AR). Namodenoson was evaluated in Phase II trials for two

indications, as a second line treatment for hepatocellular carcinoma, and as a treatment for non-alcoholic fatty liver disease (NAFLD)

and non-alcoholic steatohepatitis (NASH). A3AR is highly expressed in diseased cells whereas low expression is found in normal cells.

This differential effect accounts for the excellent safety profile of the drug.

About Can-Fite BioPharma Ltd.

Can-Fite BioPharma Ltd. (NYSE American: CANF)

(TASE: CFBI) 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, inflammatory disease and COVID-19. The Company's lead drug candidate, Piclidenoson,

is currently in a Phase III trial for psoriasis and a Phase II study in the treatment of moderate COVID-19. Can-Fite's liver drug, Namodenoson,

is headed into a Phase III trial for hepatocellular carcinoma (HCC), the most common form of liver cancer, and a Phase IIb trial for the

treatment of non-alcoholic steatohepatitis (NASH). 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 1,500 patients in clinical

studies to date. For more information please visit: www.can-fite.com.

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