Can-Fite BioPharma Ltd. announced that it received feedback and advice from the U.S. Food and Drug Administration with respect to non-clinical and clinical development and registration plans for Piclidenoson for the treatment of patients with moderate to severe plaque psoriasis. The FDA had a positive view of the non-clinical studies conducted by the Company and the accumulated safety data that the Company submitted to the agency as part of the registration plan. The FDA provided advice on the randomized, double-blind, placebo-controlled Phase 3 clinical trial protocol with Piclidenoson that is aimed at demonstrating clinical safety and efficacy for the treatment of patients withmoderate to severe plaque psoriasis".

The FDA requested two Phase 3 safety and efficacy studies and also encouraged the Company to enroll adolescent patients due to the strong safety profile of the drug demonstrated over the development history and prior clinical studies. To harmonize the requests of the European Medicines Agency and the FDA, Can-Fite plans to conduct two Phase 3 studies in parallel, including adolescent patients. Can-Fite believes the inclusion of adolescent patients in one or both of the Phase 3 studies significantly broadens the market launch potential of the drug.

The Company believes that Piclidenoson represents a promising oral option for this underserved population. Upon positive conclusion of the Phase 3 program, the Company plans to submit a New Drug Application to the U.S. FDA and Marketing Authorization Plan to the EMA.