Item 8.01. Other Events.

On August 10, 2020, Pluristem Therapeutics Inc., or the registrant, announced that Germany's health regulatory agency, the Paul Ehrlich Institute, has cleared the registrant's Phase II clinical protocol for its study titled, "A Randomized, Controlled, Multicenter, Parallel-Group Phase II Study to Evaluate the Efficacy and Safety of Intramuscular Injections of PLX PAD for the Treatment of severe COVID-19." Forty patients hospitalized with severe cases of COVID-19 complicated by Acute Respiratory Distress Syndrome will be enrolled in the study. The primary efficacy endpoint of the study is the number of ventilator free days during the 28 days from day 1 through day 28 of the study. Safety and survival follow-up will be conducted at day 60, week 26 and week 52.


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