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CAN-FITE BIOPHARMA ANNOUNCES ADVANCEMENT OF CLINICAL STUDIES AND NEW EUROPEAN LICENSING AGREEMENTS

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by Mark Gilman

Can-Fite BioPharma Ltd. (NYSE: CANF) (TASE: CFBI), an Israeli-based biotechnology company advancing a pipeline of proprietary small-molecule drugs that address inflammatory, cancer and liver diseases, continues to expand its reach in the treatment of cancer, liver and inflammatory disease.

"Our robust advanced-stage clinical pipeline, including a pivotal trial in liver cancer expected to commence in the fourth quarter of 2021, is supported by our growing number of global distribution agreements and accompanying non dilutive funding," Can-Fite CEO Dr. Pnina Fishman said. "Recent efficacy findings in cannabis and ED [erectile dysfunction] create additional co-development and funding opportunities for Can-Fite with pharma partners."

Can-Fite's clinical trial updates include:

Phase II Comfort™ study was designed to establish Piclidenoson's superiority comparing a placebo to apremilast (Otezla®) in patients with moderate to severe plaque psoriasis. The stated goal of the company is a complete enrollment, which is now at 75%, by Q3 2021, with results expected in Q4.

Phase IIb NASH study, based on a successfully concluded Phase IIa NASH/NAFLD study with Namodenoson, met its primary endpoint. Can-Fite is preparing to commence its pivotal Phase III trial for the treatment of hepatocellular carcinoma (HCC) based on a protocol agreed upon with the U.S. Food and Drug Association (FDA) and the European Medicines Agency. If the study meets its efficacy endpoint and wins approval, Namodenoson would become one of only a few drugs available to treat advanced liver cancer patients.

A new preclinical study of Can-Fite's drug candidate CF602 in the treatment of erectile dysfunction in a diabetes experimental model showed that topically applied CF602 resulted in a statistically significant improvement in ED compared to controls. It's estimated that 35% to 75% of men with diabetes will experience at least some degree of ED during their lifetime and 10 to 15 years earlier than men without diabetes. Can-Fite believes that CF602 may be an ideal candidate for development because of its topical efficacy, as ED is difficult to treat with systemic drugs because of a high-risk patient profile.

Preclinical studies of cannabis compounds found that CBD-rich T3/C15 induced inhibition of liver cancer cell growth also had an inhibitory effect on liver fibrosis. Liver fibrosis is associated with increased liver disease, including NAFLD/NASH, cirrhosis and liver cancer. Can-Fite has reported filing patent applications to protect its discovery of cannabinoid-based therapies where the A3AR target is overexpressed.

Can-Fite also is making continued inroads in its European licensing. The company has signed an out-licensing deal for the distribution of its drug candidates in Central Eastern Europe and Switzerland worth $42.7 million. Can-Fite's partnership with Switzerland-based Ewopharma has resulted in out-licensing deals worth a potential $130 million in future milestone payments.

The company reported first-quarter revenue of $150,000, a decrease of 25.2%, compared to 2020 results. Can-Fite attributed the decrease in revenue to smaller levels of advance payments received under distribution agreements from Gebro, Chong Kun Dung Pharmaceuticals and Cipher Pharmaceuticals. Those losses were offset in part by an advance payment received under the distribution agreement with Ewopharma.

More information on Can-Fite can be found at www.canfite.com.

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