• FDA encouraged the Company to accelerate enrollment of adolescent patients due to Piclidenoson’s good safety profile
• There is an unmet need for safe, convenient, and effective drugs to treat chronic plaque psoriasis in children

PETACH TIKVA, Israel / Dec 18, 2023 / Business Wire / 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 it received a positive response from the U.S. Food and Drug Administration (FDA) on the Pediatric Study Plan for the treatment of children suffering from psoriasis with Piclidenoson.

The plan has been submitted to allow enrollment of children with psoriasis to Can-Fite’s upcoming Phase 3 pivotal clinical psoriasis studies, aiming at registration of Piclidenoson with both the FDA and the European Medicines Agency (EMA) for the treatment of plaque psoriasis.

There is a high market need for a safe and efficacious drug for the treatment of children who suffer from psoriasis. There are a couple of small molecule or biological drugs on the market, however all have safety issues and are not satisfactory regarding efficacy. Therefore, there is a high market need which will enable Can-Fite to position Piclidenoson with its favorable safety and good efficacy as a treatment for this chronic and devastating disease.

Can-Fite believes the inclusion of children in one or both of the Phase 3 studies significantly broadens any future market launch potential of the drug. Psoriasis affects millions of people worldwide, including a significant number of children who endure the physical and emotional burden of this challenging disease.

“We believe Piclidenoson’s oral formulation with its excellent safety profile, combined with its progressive effectiveness over time make it ideally suited for the chronic treatment of psoriasis in adults and children alike,” stated Can-Fite VP Drug Development, Dr. William Kerns.

About Can-Fite BioPharma Ltd.

Can-Fite BioPharma Ltd. (NYSE American: CANF) (TASE: CANF) 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 recently reported topline results in a Phase III trial for psoriasis and is expected to commence a pivotal Phase III. Can-Fite's cancer and liver drug, Namodenoson, is being evaluated in a Phase IIb trial for the treatment of steatotic liver disease (SLD), a Phase III pivotal trial for hepatocellular carcinoma (HCC), and the Company is planning a Phase IIa study in pancreatic 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 1,600 patients in clinical studies to date. For more information please visit: www.canfite.com.

Forward-Looking Statements

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