• Topical psoriasis treatments account for 42% of the $11.37 billion psoriasis drug market
• Topline results from Phase III oral Piclidenoson study expected Q2 2022
• Piclidenoson has been out-licensed for the systemic indication of psoriasis in certain major markets

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 it is developing a topical psoriasis treatment with Piclidenoson, its Phase III psoriasis oral drug candidate. The Company’s scientists reported that in a preclinical model, imiquimod-induced skin psoriasis, daily treatment with topical Piclidenoson significantly inhibited the disease as measured by the psoriasis area severity index (PASI) calculated based on observation of erythema, thickness, scaling, and a score of skin lesions.

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

The Company expects to announce topline results during Q2 2022 from its Phase III randomized, double blind, active and placebo-controlled study 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 and secondary endpoints include non-inferiority vs. Otezla®.

"The current preclinical data are important and serve as a basis for further development of a topical Piclidenoson treatment for psoriasis skin lesions, as it may serve as a good complementary product to our oral Piclidenoson drug. We are encouraged by the positive interim analysis reported last year from our Phase III oral Piclidenoson study based on data from 200 patients, and we hope that the data will be reproducible, offering patients safe and long term relief from the symptoms of psoriasis,” stated Can-Fite CEO Dr. Pnina Fishman.

According to Persistence Market Research, topical psoriasis treatments account for 41.7% of the psoriasis drug market which was valued at $11.37 billion in 2021 and is projected to grow at a CAGR of 6.5% to $21.48 billion by 2031.

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 has completed enrollment in a Phase III trial for psoriasis. Can-Fite's liver drug, Namodenoson, is being evaluated in a Phase IIb trial for the treatment of non-alcoholic steatohepatitis (NASH), and enrollment is expected to commence in a Phase III trial for hepatocellular carcinoma (HCC), the most common form of liver 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 1,500 patients in clinical studies to date. For more information please visit: www.can-fite.com.

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