PLX cells are allogeneic mesenchymal-like cells that have immunomodulatory properties that induce the immune system’s natural regulatory T cells and M2 macrophages, and thus may prevent or reverse the dangerous overactivation of the immune system. 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. 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. Safety and survival follow-up will be conducted at day 60, week 26 and week 52. The Company has reported robust clinical trial data in multiple indications for its patented PLX cell product candidates and is currently conducting late stage clinical trials in several indications. HAIFA, Israel, Aug. 10, 2020 (GLOBE NEWSWIRE) -- 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. Pluristem is committed to utilizing what we believe is the major competitive advantages of our technological platform and to bringing regenerative medicine to patients in Europe and around the world,” stated Pluristem CEO and President Yaky Yanay.In addition to this study in Germany, Pluristem is currently conducting a Phase II COVID-19 trial in the U.S. which will enroll 140 patients.PLX cells are available off-the-shelf and once commercialized, can be manufactured in large scale quantities. Pluristem believes its PLX cells will offer a key advantage in addressing the COVID-19 global pandemic. Initial clinical data at the conclusion of a 28 day follow up from COVID-19 ICU patients that were treated under a Compassionate Use Program, were previously published. PLX cell product candidates are believed to 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. “We are pleased to expand our COVID-19 program to an additional territory and look forward to commencing a clinical trial of our PLX cells for the treatment of severe COVID-19 cases complicated by ARDS in Europe. Pluristem … Initial clinical data at the conclusion of a 28 day follow up from COVID-19 ICU patients that were treated under a Compassionate Use Program, were previously published. Previous pre-clinical findings of PLX cells revealed therapeutic benefit in animal studies of pulmonary hypertension, lung fibrosis, acute kidney injury and gastrointestinal injury which are potential complications of the severe COVID-19 infection. Safety and survival follow-up will be conducted at day 60, week 26 and week 52. PLX Cells for COVID-19 For example, Pluristem is using forward-looking statements when it discusses its proposed study in Europe, its belief that its study will be a standalone study, with the active arm compared to the current standard of care, the potential receipt of funds from the EIB, that it is committed to utilizing what it believes is the major competitive advantages of its technological platform and to bringing regenerative medicine to patients in Europe and around the world, when it discusses the potential of PLX cells in preventing or reversing the dangerous overactivation of the immune system, that PLX cells may potentially reduce the fatal symptoms of COVID-19 induced pneumonia, and PLX cells’ position as a therapy for mitigating the tissue-damaging effects of COVID-19.

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