Piclidenoson is seeking to address $11 billion psoriasis market in need of treatments with minimal-to-no side effects

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 the last of approximately 400 psoriasis patients enrolled in its Phase III Comfort™ study is scheduled to complete a 16-week cycle of treatment with Piclidenoson, the Company’s lead drug candidate, at the beginning of January 2022. The 16-week treatment period is the primary endpoint of the study, and the Company expects to announce topline results during Q1 2022.

Piclidenoson is a novel, first-in-class, A3 adenosine receptor agonist (A3AR) small molecule, orally bioavailable drug with a favorable therapeutic index demonstrated in Phase II clinical studies.

The randomized, double blind, active and placebo controlled study is being conducted in Europe, Israel, and Canada. The study’s primary endpoint is the proportion of patients who achieve a PASI score response of ≥75% (PASI 75) vs. placebo at week 16. Secondary endpoints include non-inferiority to Otezla® in weeks 16 and 32. Patients enrolled in the study have been selected based on their over-expression of A3AR, Can-Fite’s therapeutic target.

“Completion of treatment in a Phase III study is a significant milestone for our lead drug candidate. We were encouraged by the positive interim data analysis provided by the Independent Data Monitoring Committee following treatment of the first 200 patients in this study. We are hopeful that Piclidenoson has helped the treated patients and that it may provide safe, long term relief from the symptoms of psoriasis,” stated Can-Fite CEO Dr. Pnina Fishman.

Otezla reported generating $2.2 billion in sales in 2020. According to iHealthcareAnalyst, the psoriasis therapeutic market is estimated to reach $11.3 billion by 2025. Piclidenoson has been out-licensed for the indication of psoriasis in major markets including Canada, Europe, and Asia with deal terms including potential upcoming milestone payments and double-digit royalties upon regulatory approval.

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, and inflammatory disease. The Company's lead drug candidate, Piclidenoson, is currently in a Phase III trial for psoriasis. 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.

Forward-Looking Statements

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