Item 8.01. Other Events.

On April 29, 2021, Pluristem Therapeutics Inc., or the registrant, announced topline results in its first study evaluating PLX-R18 as a treatment for incomplete hematopoietic recovery following hematopoietic cell transplantation, or HCT. The study enrolled 21 patients in the U.S. and Israel who were at least three months after the HCT procedure (median: 236 days) and had low blood counts in at least one blood cell lineage. They were assigned to one of three treatment arms: 1 million cells/kg, 2 million cells/kg or 4 million cells/kg. Each patient received 2 treatments of the assigned dose.

Data from the six-month follow-up were available (for 14 of the 21 treated patients) and demonstrated that (i) PLX-R18 was well-tolerated with a favorable safety profile; (ii) statistically significant improvement from baseline counts was observed in all cohorts for hemoglobin and platelet counts (p<0.05) and the patients in the high dose arm (4 million cells/kg) exhibited statistically significant improvements in all three blood cell lineages (p<0.01); (iii) approximately 60% of patients exhibited improvements in all three blood cell lineages: hemoglobin, neutrophil and platelet counts that are above the initial criteria for inclusion in the study and (iv) 13 patients were transfusion dependent at baseline; 6 of those became transfusion independent at 6 month follow-up and no patients who were transfusion independent at baseline became transfusion dependent. Data from the six-month follow-up were available for 14 of the 21 treated patients due to the following reasons: one patient was terminated early, three patients missed the 6-month visit and three died prior to the 6-month visit (two fatal events in the 2 million cell dose, and one fatal event in the 4 million cell dose). All fatal events in the study were considered unrelated to the study treatment.


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