PLURISTEM THERAPEUTICS INC. (NASDAQ:PSTI) Files An 8-K Regulation FD Disclosure
Item 7.01
On December 9, 2020, Pluristem Therapeutics Inc., or the registrant, held an investor and analyst call to which it shared a presentation. The presentation is furnished as Exhibit 99.1 to this Current Report on Form 8-K.
On December 9, 2020, the registrant announced that the independent Data Monitoring Committee, or DMC, of its global pivotal Phase III study of the registrant’s PLX-PLD product for the treatment of critical limb ischemia, or CLI, issued its recommendation letter following an interim analysis. The clinical dataset was reviewed by the independent DMC for safety and analysis of the primary endpoint of amputation-free survival, defined as time to occurrence of major amputation of the index leg or death. Based on the review, the DMC advised that the CLI study is unlikely to meet the primary endpoint by the time of the final analysis. The DMC advised the registrant that the CLI study population has experienced a substantial low number of events (major amputation of the index leg or death), different from what is known in clinical medicine for the rate of these events in this patient population. The lower than anticipated event rate in the placebo group reduced the statistical power of the study to meet its primary endpoint. The DMC noted that PLX-PAD was well tolerated, and no significant safety concerns were raised during the study. Following the DMC’s recommendation, the registrant decided to terminate the CLI study. Currently, the registrant continues to be blinded to the CLI study clinical data.
(d) Exhibits.
| 99.1 | Investor and analyst call presentation, dated December 9, 2020 (furnished herewith) |
PLURISTEM THERAPEUTICS INC Exhibit
EX-99.1 2 ea131312ex99-1_pluristem.htm INVESTOR AND ANALYST CALL PRESENTATION,…
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About PLURISTEM THERAPEUTICS INC. (NASDAQ:PSTI)
Pluristem Therapeutics Inc. is a developer of placenta-based cell therapy product candidates for the treatment of multiple ischemic, inflammatory and hematologic conditions. The Company’s lead indications are critical limb ischemia (CLI), recovery after surgery for femoral neck fracture and acute radiation syndrome. Its operations are focused on the research, development, clinical trials and manufacturing of cell therapeutics and related technologies. The Company’s products include PLX-PAD and PLX R18. The Company’s PLX cells are adherent stromal cells (ASCs) that are expanded using a three dimensional (3D) process. The system utilizes a synthetic scaffold to create an artificial 3D environment where placental-derived stromal cells can grow. The Company’s PLX products are administered using a standard needle and syringe. The Company’s PLX products are in clinical-stage development for multiple indications, such as cardiovascular, orthopedic, pulmonary and women’s health diseases.
