Positive Data from Phase IIa Can-Fite NASH Study Published in Leading Peer Reviewed Scientific Journal

Can-Fite BioPharma Ltd. (NYSE American: CANF) (TASE: CFBI), a biotechnology company advancing a pipeline of proprietary small molecule drugs that address inflammatory, cancer and liver diseases, today announced that Alimentary Pharmacology & Therapeutics, a peer reviewed scientific journal focused on gastroenterology and hepatology, published an article titled “Randomised clinical trial: A phase 2 double-blind study of namodenoson in non-alcoholic fatty liver disease and steatohepatitis" authored by Can-Fite’s CEO Dr. Pnina Fishman.

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Positive Data from Phase IIa Can-Fite NASH Study Published in Leading Peer Reviewed Scientific Journal (Photo: Business Wire)

The article includes highlights from Can-Fite’s Phase IIa NASH study of Namodenoson which achieved its study endpoints including significant anti-steatotic, anti-fibrotic, and anti-inflammatory effects.

Namodenoson is advancing into a Phase IIb NASH trial which is expected to commence patient enrollment in Q4 2021.

Principal Investigator of the Phase IIa study, Prof. Rifaat Safadi, commented, “The acceptance and publication of the article presenting our Phase IIa results in this prestigious journal demonstrates the high value of the data and the potential of Namodenoson as safe and effective treatment for NASH.”

NASH is a clear and urgent unmet medical need, as there currently is no U.S. approved drug to treat the disease. As of 2016, NASH was the leading cause for liver transplants among women and the second leading cause for liver transplants overall. NASH is expected to become the leading indication for liver transplants in males as well. The NIH estimates the incidence of NASH in the U.S. at 2-5% of the population. Incidence is increasing based on rising obesity rates. By 2025, the addressable pharmaceutical market for NASH is estimated to reach $35-40 billion.

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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