• FDA encouraged the Company to enroll 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 the adolescents

PETACH TIKVA, Israel / Aug 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 oncology, inflammatory, and liver diseases, today announced that it submitted a pediatric study plan to the U.S. Food and Drug Administration (FDA) for the treatment of adolescents suffering from psoriasis with Piclidenoson.

The plan has been submitted to allow enrollment of adolescents with psoriasis to Can-Fite’s upcoming two 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 adolescents who suffer from psoriasis. There are a couple of small molecule or biological drugs on the market in use for adolescents with psoriasis, all have safety issues and are not satisfactory regarding the 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 adolescent patients 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 adolescents who endure the physical and emotional burden of this challenging disease.

“Based on the FDA’s recommendation to enroll adolescents into the upcoming Phase 3 psoriasis trials, we believe Piclidenoson’s oral formulation with an excellent safety record, combined with its progressive effectiveness over time, make it ideally suited for the chronic treatment of psoriasis in adults and adolescents alike,” stated Can-Fite CEO & CFO Motti Farbstein.

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 anti-inflammatory drug Piclidenoson reported topline results in a Phase 3 trial for psoriasis and is expected to commence a pivotal Phase 3 program. Can-Fite's cancer and liver drug, Namodenoson, is being evaluated in a Phase 2b trial for the treatment of non-alcoholic steatohepatitis (NASH), enrollment is expected to commence in a Phase 3 trial for hepatocellular carcinoma (HCC), and the Company is planning a Phase 2a 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 1,500 patients in clinical studies to date. For more information please visit: www.can-fite.com.

Forward-Looking Statements

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