PSTI Pluristem Therapeutics Inc

Pluristem Therapeutics Inc. (Nasdaq:PSTI) (TASE:PSTI), a leading developer of placenta-based cell therapy products, today announced that the top-line results of the company’s multinational Phase II clinical trial of PLX-PAD cells in the treatment of Intermittent Claudication (IC) will be released on June 12, 2018.

Pluristem's Phase II IC trial is evaluating the safety and efficacy of PLX-PAD cells as compared to placebo in 172 patients with IC, Rutherford category 2-3. Enrollment took place at 30 clinical sites in the U.S., Germany, South Korea and Israel. Patients received either two courses of 150 ×106 PLX-PAD cells, two courses of 300 ×106 cells, two courses of placebo, or one course of 300 ×106 cells followed by placebo. In each of these study arms, the two courses were given intramuscularly, 3 months apart. The primary efficacy endpoint is the change in maximal walking distance one year after the first administration. Other endpoints include rate of revascularization and other hemodynamic and clinical parameters.

IC is a subset of peripheral artery disease (PAD). It is caused by obstruction to arterial flow in the legs and is characterized by muscle pain, cramping, numbness or a sense of fatigue, classically in the calf muscle, which occurs during walking or similar exercise and is relieved by a period of rest. Almost fifth of the population over the age of 65 has IC and as a result of demographic changes in many developed countries, its prevalence in the general population is likely to rise dramatically over the next 20 years. PLX-PAD cells may offer a non-surgical procedure that may contributed significantly to the quality of life of PAD patients as well as provide additional treatment possibilities to the angioplasty and vascular medical communities.

About Pluristem Therapeutics

Pluristem Therapeutics Inc. is a leading developer of placenta-based cell therapy products. The Company has reported robust clinical trial data in multiple indications for its patented PLX cells and is entering late-stage trials in several indications. PLX cell products release a range of therapeutic proteins in response to inflammation, ischemia, muscle trauma, hematological disorders, and radiation damage. The cells are grown using the Company's proprietary three-dimensional expansion technology and can be administered to patients off-the-shelf, without tissue matching. Pluristem has a strong intellectual property position; Company-owned and operated, GMP-certified manufacturing and research facilities; strategic relationships with major research institutions; and a seasoned management team.

Safe Harbor Statement

This press release contains express or implied forward-looking statements within the Private Securities Litigation Reform Act of 1995 and other U.S. Federal securities laws. For example, Pluristem is using forward-looking statements when its discusses the expected date for the release of the results of its Phase II clinical trial of PLX-PAD cells in the treatment of IC and that PLX-PAD cells may offer a non-surgical procedure that may contributed significantly to the quality of life of PAD patients as well as provide additional treatment possibilities to the angioplasty and vascular medical communities. These forward-looking statements and their implications are based on the current expectations of the management of Pluristem only, and are subject to a number of factors and uncertainties that could cause actual results to differ materially from those described in the forward-looking statements. The following factors, among others, could cause actual results to differ materially from those described in the forward-looking statements: changes in technology and market requirements; Pluristem may encounter delays or obstacles in launching and/or successfully completing its clinical trials; Pluristem’s products may not be approved by regulatory agencies, Pluristem’s technology may not be validated as it progresses further and its methods may not be accepted by the scientific community; Pluristem may be unable to retain or attract key employees whose knowledge is essential to the development of its products; unforeseen scientific difficulties may develop with Pluristem’s process; Pluristem’s products may wind up being more expensive than it anticipates; results in the laboratory may not translate to equally good results in real clinical settings; results of preclinical studies may not correlate with the results of human clinical trials; Pluristem’s patents may not be sufficient; Pluristem’s products may harm recipients; changes in legislation may adversely impact Pluristem; inability to timely develop and introduce new technologies, products and applications; loss of market share and pressure on pricing resulting from competition, which could cause the actual results or performance of Pluristem to differ materially from those contemplated in such forward-looking statements. Except as otherwise required by law, Pluristem undertakes no obligation to publicly release any revisions to these forward-looking statements to reflect events or circumstances after the date hereof or to reflect the occurrence of unanticipated events. For a more detailed description of the risks and uncertainties affecting Pluristem, reference is made to Pluristem's reports filed from time to time with the Securities and Exchange Commission.

Contact:

Karine Kleinhaus, MD, MPH

Divisional VP, North America

1-914-512-4109

karinek@pluristem.com

                                   

Efrat Kaduri

Head of Investor and Public Relations

972-74-7108600

efratk@pluristem.com