PSTI Pluristem Therapeutics Inc.

1.68
-0.02  -1%
Previous Close 1.7
Open 1.66
52 Week Low 1.36
52 Week High 8.6
Market Cap $53,927,353
Shares 32,099,615
Float 30,620,141
Enterprise Value $17,195,353
Volume 630,188
Av. Daily Volume 1,745,290
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Upcoming Catalysts

Drug Stage Catalyst Date
PLX-PAD
Muscle injury following hip fracture
Phase 3
Phase 3
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Drug Pipeline

Drug Stage Notes
PLX-R18
Incomplete hematopoietic recovery following hematopoietic cell transplantation (HCT)
Phase 1
Phase 1
Phase 1 data released April 29, 2021 - well-tolerated with a favorable safety profile.
PLX-PAD
COVID-19 / Acute Respiratory Distress Syndrome (ARDS)
Phase 2
Phase 2
Phase 2 data did not meet the primary efficacy endpoint of statistically significant improvement of ventilator free days (VFD) at 28 days. Taking into consideration the baseline risk factors of the ARDS patients, no differences in the safety profile were observed between PLX-PAD and placebo, noted December 27, 2021.
PLX-PAD (stem cells)
Critical limb ischemia (CLI)
Phase 3
Phase 3
Phase 3 trial to be terminated following interim analysis that trial is unlikely to meet primary endpoint.
PLX-PAD
Chronic Graft vs Host Disease
Phase 1/2
Phase 1/2
Phase 1/2 enrollment to move to cohort 2 phase - October 13, 2020.
PLX-PAD (stem cells)
Intermittent claudication, or IC
Phase 2
Phase 2
Phase 2 data released June 12, 2018 - primary endpoint met.

Latest News

  1. HAIFA, Israel, Dec. 27, 2021 (GLOBE NEWSWIRE) -- Pluristem Therapeutics Inc. (NASDAQ:PSTI) (TASE:PSTI) (the "Company"), a leading biotechnology company, today announced topline results from its Phase II dose escalation studies evaluating the safety and efficacy of intramuscular injections of PLX-PAD cells for the treatment of Acute Respiratory Distress Syndrome (ARDS) associated with COVID-19. The analysis is based on 89 patients enrolled in two Phase II studies in the U.S. (the "U.S. study") and in Europe and Israel (collectively, the "EU study" and together with the U.S. study, the "Studies").

    The primary efficacy endpoint was the number of ventilator free days (VFD) from day 1 through day 28 of the Studies. VFD at day 60 and all-cause…

    HAIFA, Israel, Dec. 27, 2021 (GLOBE NEWSWIRE) -- Pluristem Therapeutics Inc. (NASDAQ:PSTI) (TASE:PSTI) (the "Company"), a leading biotechnology company, today announced topline results from its Phase II dose escalation studies evaluating the safety and efficacy of intramuscular injections of PLX-PAD cells for the treatment of Acute Respiratory Distress Syndrome (ARDS) associated with COVID-19. The analysis is based on 89 patients enrolled in two Phase II studies in the U.S. (the "U.S. study") and in Europe and Israel (collectively, the "EU study" and together with the U.S. study, the "Studies").

    The primary efficacy endpoint was the number of ventilator free days (VFD) from day 1 through day 28 of the Studies. VFD at day 60 and all-cause mortality at days 28 and 60 were part of the secondary efficacy endpoints in the Studies. The Studies did not meet the primary efficacy endpoint of statistically significant improvement of VFD at 28 days. Taking into consideration the baseline risk factors of the ARDS patients, no differences in the safety profile were observed between PLX-PAD and placebo. 

    In July 2021, Pluristem announced its decision to bring the Studies to early clinical readout based on 89 patients enrolled, instead of the originally planned 180 patients (140 in the U.S. study and 40 in the EU study). The decision came in response to COVID-19's evolution as a disease, and the significant changes in the standard of care, leading to an increase in the severity of conditions of the intubated patients. These changes in the evolution of COVID-19 raised a major concern about the potential variability in the patient population in the Studies. The early termination of recruitment led to a significant reduction in the statistical power of the Studies.

     Efficacy trends from the Studies included:

    • A single administration of 300 million PLX-PAD cells demonstrated overall better results, compared to other treatment groups
    • Patients in the U.S. study treated with a single dose of 300 million PLX-PAD cells (n=14) showed an increased survival rate by 40% at day 60 compared to placebo group (n=14) (50% vs. 35%)
    • Patients in the EU Study treated with a single dose of 300 million PLX-PAD cells (n=11) showed an increased survival rate by 27% at day 60 compared to control group (n=12) (64% vs. 50%)
    • In the EU Study, patients treated with a single dose of 300 million PLX-PAD cells showed increased VFD at day 28 by 3.6 days, from 0.2 days in the control group (n=12) to 3.8 days in the treated group (n=11)
    • In the EU Study, patients treated with a single dose of 300 million PLX-PAD cells showed increased VFD at day 60 by 112% or 6.6 days, from 5.9 days in the control group (n=12) to 12.5 days in the treated group (n=11)

    Pluristem's CEO and President, Yaky Yanay said: "Pluristem joined the global effort to fight the evolving and unexpected COVID-19 pandemic.  We chose to focus on the most severe intubated patients suffering from ARDS associated with COVID-19, that have no viable treatment to date and are challenging healthcare systems worldwide. With the new coming wave of the Omicron variant, we intend to explore the opportunities based on the efficacy trends obtained from the Studies. I would like to thank everyone who has been involved in the Studies including the patients and their families, our investigators and study personnel, and the team at Pluristem for making extraordinary efforts to conduct these important studies during very challenging times."

    About the Studies:

    The U.S. Study included 66 patients enrolled to a randomized, double-blind, placebo-controlled, multicenter, parallel-group study, with three treatment groups of PLX-PAD cells - single administration of 300 million cells, single administration of 600 million cells, or 300 million cells administered twice in a one-week interval; and two placebo control groups single administration, and two administrations in a one-week interval. All groups received a study treatment in addition to the best standard medical care according to local practices.

    The EU Study enrolled 23 patients in Germany, Bulgaria, and Israel to a randomized, controlled, multicenter, parallel-group study with a single treatment group (single dose of 300 million PLX-PAD cells) in addition to best standard medical care according to local practices, and a control group received the best standard medical care according to local practices.

    About Pluristem

    Pluristem is pushing the boundaries of science and engineering to reimagine pharmacological treatments and improve the standard of care. The Company's cell therapies advance the field of regenerative medicine, with potentially groundbreaking applications for treating damaged muscle, hematology deficiencies, and inflammation. Pluristem sources its therapeutic cells from the placenta, an ethically accepted and potent source. Cells are easy to collect and do not require blood or tissue matching. Cells from one placenta can potentially treat more than 20,000 patients. The Company's manufacturing platform is a patented and validated state-of-the-art 3D cell expansion system, designed to mimic the human body. Pluristem's method is uniquely accurate, cost-effective, and consistent batch-to-batch.

    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 it discusses the intention to explore opportunities based on the data obtained from the Studies. 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:

    Dana Rubin,

    Director of Investor Relations

    +972-74-7107194



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  2. Having recruited patients in the U.S., Europe and Israel, the Company anticipates topline results in the third calendar quarter of 2022

    The Company will host a Key Opinion Leader online event on muscle regeneration following hip fracture surgery on November 22 at 9:15am EST

    HAIFA, Israel, Nov. 15, 2021 (GLOBE NEWSWIRE) -- Pluristem Therapeutics Inc. (NASDAQ:PSTI) (TASE:PSTI) (the "Company"), a leading biotechnologycompany announced today that its multinational Phase IIImulticenter, randomized, double-blind, placebo-controlled study, designed to determine the efficacy, safety, and tolerability of intramuscular administration of allogeneic PLX-PAD cells for the treatment of muscle injury following arthroplasty for hip fracture,is…

    Having recruited patients in the U.S., Europe and Israel, the Company anticipates topline results in the third calendar quarter of 2022

    The Company will host a Key Opinion Leader online event on muscle regeneration following hip fracture surgery on November 22 at 9:15am EST

    HAIFA, Israel, Nov. 15, 2021 (GLOBE NEWSWIRE) -- Pluristem Therapeutics Inc. (NASDAQ:PSTI) (TASE:PSTI) (the "Company"), a leading biotechnologycompany announced today that its multinational Phase IIImulticenter, randomized, double-blind, placebo-controlled study, designed to determine the efficacy, safety, and tolerability of intramuscular administration of allogeneic PLX-PAD cells for the treatment of muscle injury following arthroplasty for hip fracture,is fully enrolled with 240 patients.The multinational clinical study includes patients from the U.S., Europe, and Israel, and topline results are expected in the third calendar quarter of 2022.

    The Company will host a Key Opinion Leader online event on muscle regeneration following hip fracture surgery on November 22 at 9:15am EST, for registration: https://Veidan.activetrail.biz/pluristem

    "Reaching our enrollment target for the Phase III PLX-PAD study is an important milestone," said Pluristem CEO and President, Yaky Yanay. "Rising healthcare costs and aging demographic changes present an opportunity for allogenic, placenta-cell derived products to satisfy unmet clinical needs in the area of muscle regeneration following hip arthroplasty. The potential improvement of physical function following this common procedure could redefine the current standard of care and improve patients' lives."

    Pluristem's unique technology, based on a state-of-the-art cell expansion system designed to mimic conditions in the human body, provides a 3-D microenvironment where cells are multiplied and developed into therapeutic candidates. PLX-PAD cells secrete proteins to induce tissue healing in response to muscle trauma and inflammation and are applied via intramuscular administration.

    During a completed Phase I/II double-blind placebo controlled trial, PLX-PAD cells demonstrated statistically significant superiority, in the ability to increase muscle strength and volume for patients who have undergone total hip replacement surgery due to osteoarthritis. If approved, PLX-PAD would be a first-of-its-kind innovative treatment for muscle regeneration.  

    Mr. Yanay concluded, "Hip fracture is a major cause of hospitalization for seniors and is associated with significant morbidity, mortality, loss of independence, and financial burden. The annual number of hip fractures worldwide is expected to surpass 6 million in 2050 due to the increased prevalence of osteoporosis. As healthcare systems search for new opportunities to lower the cost of care and provide new treatments for aging populations, our PLX-PAD product candidate could potentially bring novel solutions for soft tissue regeneration."

    Estimated annual costs of care for patients suffering from hip fractures in the U.S. are between $10.3 billion and $15.2 billion. Approximately 20 percent of hip fracture patients die within one year from surgery due to immobility associated diseases, emphasizing the need for better and faster muscle rehabilitation for improved patient outcome. Cell-based therapy for muscle regeneration could have potential for additional applications, including arthroplasty of the shoulders, knees, and other musculoskeletal indications.

                                            

    About Pluristem

    Pluristem is pushing the boundaries of science and engineering to reimagine pharmacological treatments and improve the standard of care. The Company's cell therapies advance the field of regenerative medicine, with potentially groundbreaking applications for treating damaged muscle, hematology deficiencies, and inflammation. Pluristem sources its therapeutic cells from the placenta, an ethically accepted and potent source. Cells are easy to collect and do not require blood or tissue matching. Cells from one placenta can treat more than 20,000 patients. The Company's manufacturing platform is a patented and validated state-of-the-art 3D cell expansion system, designed to mimic the human body. Pluristem's method is uniquely accurate, cost-effective, and consistent batch-to-batch.

    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 it discusses the expected timing of the Phase III topline results, that the potential use of PLX-PAD cells for patients recovering from hip fractures could redefine the current standard of care and improve patients' lives, that if approved, PLX-PAD would be a first-of-its-kind innovative treatment for muscle regeneration, that the PLX-PAD product candidate could potentially bring novel solutions for soft tissue regeneration and that cell-based therapy for muscle regeneration could have potential for additional applications. 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:

    Dana Rubin

    Director of Investor Relations

    +972-74-7107194



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  3. HAIFA, Israel, Nov. 10, 2021 (GLOBE NEWSWIRE) -- Pluristem Therapeutics Inc. (NASDAQ:PSTI) (TASE:PSTI), a leading biotechnology company, today announced that it has received approval for an additional grant from the Israel Innovation Authority (IIA) to support research based on its cutting-edge PLX platform. The grant comes as part of the Company's work as part of the CRISPR-IL consortium ("the Consortium"), which the IIA funds through its Bio-Convergence Program. The IIA approved a new budget for the Consortium to continue its work for an additional 18 months ("period B") after evaluating its activity and results over the past 18 months ("period A").

    As part of the budget, Pluristem is expected to receive approximately 1,800,000 NIS (approximately…

    HAIFA, Israel, Nov. 10, 2021 (GLOBE NEWSWIRE) -- Pluristem Therapeutics Inc. (NASDAQ:PSTI) (TASE:PSTI), a leading biotechnology company, today announced that it has received approval for an additional grant from the Israel Innovation Authority (IIA) to support research based on its cutting-edge PLX platform. The grant comes as part of the Company's work as part of the CRISPR-IL consortium ("the Consortium"), which the IIA funds through its Bio-Convergence Program. The IIA approved a new budget for the Consortium to continue its work for an additional 18 months ("period B") after evaluating its activity and results over the past 18 months ("period A").

    As part of the budget, Pluristem is expected to receive approximately 1,800,000 NIS (approximately $583,000) to continue its work in developing a new generation of PLX cells based on the use of CRISPR technology to genetically program desired cell functions in future allogenic products.

    As the leader of the consortium's Pharma Working Group, Pluristem is collaborating with other industry and academic leaders in the field of genome editing, bringing together leading experts in life science and computer science from academia, medicine, and industry, to develop artificial intelligence (AI) based, end-to-end, multi-species genome editing solutions. These solutions are expected to maximize the efficiency and accuracy of CRISPR genome editing of human, plant and animal DNA, and have applications in the pharma, agriculture, and aquaculture industries.

    Yaky Yanay, CEO and President said: "The evaluation of the CRISPR-IL Consortium's work over the last 18 months was successfully completed. The IIA's continued investment in Pluristem's participation in this work provides further opportunity to push forward the development of next generation allogeneic cell therapies. We continue to believe that the integration of CRISPR technology in our PLX platform holds great potential to develop the treatments of the future, and the IIA's approval of additional funds is validation of that belief."

    CRISPR is a genome-editing technology intended to modify specific DNA sequences, which enables the development of unique bio-based products and novel therapeutics while reducing the time and cost of development.

    About Pluristem Therapeutics

    Pluristem is pushing the boundaries of science and engineering to reimagine pharmacological treatments and improve the standard of care. The Company's cell therapies advance the field of regenerative medicine, with potentially groundbreaking applications for treating damaged muscle, hematology deficiencies, and inflammation. Pluristem sources its therapeutic cells from the placenta, an ethically accepted and potent source. Cells are easy to collect and do not require blood or tissue matching. Cells from one placenta can treat more than 20,000 patients. The Company's manufacturing platform is a patented and validated state-of-the-art 3D cell expansion system, designed to mimic the human body. Pluristem's method is uniquely accurate, cost-effective, and consistent batch-to-batch.

    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 it discusses the expected receipt of the grant from the Israel Innovation Authority, that it intends to push forward the development of next generation allogeneic cell therapies and that the integration of CRISPR technology and its PLX platform holds great potential to develop the treatments of the future and the IIA's approval of additional funds is validation of that belief. 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:

    Dana Rubin

    Director of Investor Relations

    972-74-7107194



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  4. HAIFA, Israel, Sept. 22, 2021 (GLOBE NEWSWIRE) -- Pluristem Therapeutics Inc. (NASDAQ:PSTI) (TASE: PSTI), a leading biotechnology company, today issued an update to its shareholders from its Chief Executive Officer and President Yaky Yanay.

    Dear Shareholders,

    Less than three months into a new fiscal year, there are several important developments on the horizon for Pluristem, including four studies heading to clinical readout in the coming quarters. These studies align with our mission to develop novel cell therapy product candidates, built using Pluristem's advanced technology.

    Clinical Pipeline: Milestones

    During the coming year, we expect to meet multiple clinical milestones, which represent significant potential for our cellular platform…

    HAIFA, Israel, Sept. 22, 2021 (GLOBE NEWSWIRE) -- Pluristem Therapeutics Inc. (NASDAQ:PSTI) (TASE: PSTI), a leading biotechnology company, today issued an update to its shareholders from its Chief Executive Officer and President Yaky Yanay.

    Dear Shareholders,

    Less than three months into a new fiscal year, there are several important developments on the horizon for Pluristem, including four studies heading to clinical readout in the coming quarters. These studies align with our mission to develop novel cell therapy product candidates, built using Pluristem's advanced technology.

    Clinical Pipeline: Milestones

    During the coming year, we expect to meet multiple clinical milestones, which represent significant potential for our cellular platform.

    First, our Phase I study evaluating PLX-R18 cells in subjects with incomplete hematopoietic recovery following Hematopoietic Cell Transplantation (HCT) demonstrated positive topline results as reported in April 2021, and we expect to present full data readout in the fourth quarter of this calendar year. We also expect to continue the development of the program and to initiate a Phase II study in hematological indication. Second, we expect topline results in the fourth quarter of this calendar year for both of our Phase II studies of PLX-PAD cells to treat acute respiratory distress syndrome (ARDS) associated with COVID-19 in the U.S., Europe, and Israel. Third, our Phase III study evaluating PLX-PAD cells to support muscle regeneration after hip fracture surgery has enrolled more than 95 percent of its patients and is expected to complete enrollment in October 2021.

    A photo accompanying this announcement is available at https://www.globenewswire.com/NewsRoom/AttachmentNg/d88b55bc-a12f-4421-ad52-adca69bf0b5d

    Strategic Plan: Platform Expansion

    In the last decade, we have developed an automated and robust current Good Manufacturing Practice (cGMP) manufacturing platform for allogeneic cells originating from the fetal and maternal cells from the placenta. Using this platform, we can produce large quantities of high-quality cells suitable for a variety of applications and uses. The manufacturing platform enables us to develop targeted pipelines of cellular product candidates including induced or modified PLX cells:

    Induced PLX cells: These cells from the placenta are induced with different cytokines to transiently alter their secretion profile. Our first product candidate under this technology is PLX-R18. The positive data presented in the hematology study in April 2021 supports our approach of targeting cells with superior activity per indication. We expect to continue developing this platform for inducing cells and are in advanced development to complete additional targeted product candidates of this nature.

    Modified PLX cells using CRISPR technology: We are also working on integrating CRISPR's revolutionary genetic engineering technology to potentially engineer PLX cells with novel and targeted functionality. Combined with our placenta-derived cell manufacturing platform, Pluristem would use CRISPR technology to potentially develop a new class of ex vivo modified allogenic PLX cell therapy product candidates to address new indications.

    In short, we have developed a reliable, stable, and cost-effective cell expansion platform. We believe that using the placenta as a unique cell source combined with our innovative research, development, and high-quality manufacturing capabilities will be the engine that drives this platform technology towards the successful development of additional PLX cell therapy product candidates and indications.

    We are excited to continue developing the powerful therapeutic capabilities of placental cells while using our advanced technology to push boundaries.

    Summary: Key Competitive Advantage

    What is Pluristem's biggest advantage? Our talented management team and I asked this question in recent months as part of our five-year strategic discussions. The outcome is clear: Develop effective and innovative cellular product candidates while assuring manufacturing capacity on the back end when the product candidate is ready for market. We believe that this is our defining competitive advantage. Over the years, we have received interest from potential partners to use our platform for pharmaceuticals and other industries. Pluristem intends to use its unmatched technological advantage to establish mutually advantageous partnerships towards the best utilization and optimization of our assets for the benefit of our shareholders.

    Sincerely,

    Yaky Yanay

    CEO & President

    About Pluristem Therapeutics

    Pluristem is pushing the boundaries of science and engineering to reimagine pharmacological treatments and improve the standard of care. The Company's cell therapies advance the field of regenerative medicine, with potentially groundbreaking applications for treating damaged muscle, hematology deficiencies, and inflammation. Pluristem sources its therapeutic cells from the placenta, an ethically accepted and potent source. Cells are easy to collect and do not require blood or tissue matching. Cells from one placenta can treat 20,000 patients. The Company's manufacturing platform, the bioreactor, is a patented and validated state-of-the-art 3D cell expansion system, designed to mimic the human body. Pluristem's method is uniquely accurate, cost-effective, and consistent batch-to-batch.

    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 it discusses the expected timing of the topline results from its Phase II studies of PLX-PAD cells to ARDS associated with COVID-19 and the presentation of the full data readout of the HCT Phase I study evaluating PLX-R18 cells, the expected completed enrollments in its Phase III study evaluating PLX-PAD cells to support muscle regeneration after hip fracture surgery, its expectation that it will continue the development of its platform for inducing cells and is in advanced development to complete additional targeted product candidates of this nature, its intention to use CRISPR technology to potentially develop a new class of ex vivo modified allogenic PLX cell therapy product candidates to address new indications and that it intends to use its technological advantage to establish mutually advantageous partnerships towards the best utilization and optimization of its assets. These forward-looking statements and their implications are based on the current expectations of the management of Pluristem only and are subject to several 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:

    Dana Rubin

    Director of Investor Relations

    +972-74-7107194



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  5. HAIFA, Israel, July 19, 2021 (GLOBE NEWSWIRE) -- Pluristem Therapeutics Inc. (NASDAQ:PSTI) (TASE: PSTI), a leading biotechnology company, today announced the Board of Director appointments of Prof. Varda Shalev, a physician, medical researcher, and Professor of Medicine at the Tel Aviv University's School of Public Health, and Mr. Doron Birger, a high-tech industry executive with a background in bringing groundbreaking products to market.

    Prof. Shalev has more than 30 years of experience working in clinical environments and research settings at the intersection of health and technology. She was the founder and Chief Executive Officer of the KSM Institute of Research and Innovation and Maccabitech, the epidemiological and clinical research…

    HAIFA, Israel, July 19, 2021 (GLOBE NEWSWIRE) -- Pluristem Therapeutics Inc. (NASDAQ:PSTI) (TASE: PSTI), a leading biotechnology company, today announced the Board of Director appointments of Prof. Varda Shalev, a physician, medical researcher, and Professor of Medicine at the Tel Aviv University's School of Public Health, and Mr. Doron Birger, a high-tech industry executive with a background in bringing groundbreaking products to market.

    Prof. Shalev has more than 30 years of experience working in clinical environments and research settings at the intersection of health and technology. She was the founder and Chief Executive Officer of the KSM Institute of Research and Innovation and Maccabitech, the epidemiological and clinical research arm of Israel's Maccabi Healthcare Services, where she established the largest biobank in Israel and developed a computerized system for predicting the risk of colon cancer in patients using a database of two million people. This work led Maccabi Healthcare Services to win the Director General of the Ministry of Health's Excellence in Logistics in Health Systems award. Prof. Shalev founded the Department of Medical Informatics at Maccabi Healthcare Services and was the head of Primary Care division of Maccabi Healthcare Services.

    Prof.Shalev is Chief Medical Officer and co-founder of the digital health startup, Alike, which is developing an artificial intelligence-based platform to empower patients to track their own health conditions. In addition to informatics and predictive analytics, Prof. Shalev's research expertise includes epidemiology. She has authored more than 250 publications in peer-reviewed journals and was included in the Marker newspaper's list of "100 Most Influential People." Prof. Shalev earned her medical degree from Ben-Gurion University of the Negev, School of Medicine, her Master of Public Health Administration from Clark University in the United States and completed her post-doctoral fellowship in Medical Informatics at Johns Hopkins.

    Mr. Birger is a prominent business leader with more than 30 years of experience in the Israeli high-tech sector as a chief executive officer, board chairman, director, and advisor to several private and publicly traded firms, with an emphasis in the life science industry.

    Mr. Birger served as the president and Chief Executive Officer of Elron from 2002 to 2009. At Elron, he successfully led the development and acceleration of numerous cutting-edge technology firms, including multiple mergers and public offerings. He currently chairs several technology companies, including Sight Diagnostic, Ultrasight, Nurami, Matricelf (TASE: MTLF), and Intelicanna (TASE: INTL).

    Mr. Birger was also the Chairman of the Board at Given Imaging from 2002 to 2007, and a director until it was sold to Covidien in 2014. From 1978 to 2001, Mr. Birger was Chief Financial Officer at several companies from various sectors, including the Chief Financial Officer of Elron from 1994-2001. He is currently a director in a variety of medical device and advanced technology companies, including IceCure (TASE: ICCM), Citrine Global (OTCQB:CTGL), Kadimastem (TASE: KDST), HeraMED (ASX: HMD) Vibrant, and Netive Haor. Mr. Birger earned his bachelor's degree and Master of Economics from the Hebrew University, Jerusalem.

    "By harnessing the regenerative power of placenta cells using our unique bioreactor for cell expansion, Pluristem believes that it is poised to unlock a new generation of medical treatments," said Pluristem Executive Chairman of the Board, Zami Aberman. "Prof. Shalev and Mr. Birger both bring unique expertise and experience that we believe will provide invaluable insight as we move our product candidate pipelines forward. Their combined 60 years of life science experience, both clinical and commercial, are perfectly aligned for Pluristem's mission to potentially bring its PLX cells to market and reach patients around the world. Pluristem's strategic goals will be served well by their skillsets and counsel."

    About Pluristem Therapeutics

    Pluristem is pushing the boundaries of science and engineering to reimagine pharmacological treatments and improve the standard of care. The Company's cell therapies advance the field of regenerative medicine, with potentially groundbreaking applications for treating damaged muscle, hematology deficiencies, and inflammation. Pluristem sources its therapeutic cells from the placenta, an ethically accepted and potent source. Cells are easy to collect and do not require blood or tissue matching. Cells from one placenta can treat 20,000 patients. The Company's manufacturing platform, the bioreactor, is a patented and validated state-of-the-art 3D cell expansion system, designed to mimic the human body. Pluristem's method is uniquely accurate, cost-effective, and consistent batch-to-batch.

    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 it discusses its belief that it is poised to unlock a new generation of medical treatments and that its new directors will enhance the Board's strategic goals in preparation for future growth and commercialization endeavors. 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:

    Dana Rubin

    Director of Investor Relations

    +972-74-7107194

    A photo accompanying this announcement is available at https://www.globenewswire.com/NewsRoom/AttachmentNg/35e041c8-fdc0-4ae8-8ad8-666d2908b199



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