PSTI Pluristem Therapeutics Inc.

3
+0.04  (+1%)
Previous Close 2.96
Open 2.93
52 Week Low 2.81
52 Week High 11.85
Market Cap $96,014,355
Shares 32,004,785
Float 30,525,311
Enterprise Value $54,368,163
Volume 141,172
Av. Daily Volume 226,991
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Upcoming Catalysts

Drug Stage Catalyst Date
PLX-PAD
COVID-19 / Acute Respiratory Distress Syndrome (ARDS)
Phase 2
Phase 2
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Drug Pipeline

Drug Stage Notes
PLX-PAD
Muscle injury following hip fracture
Phase 3
Phase 3
Phase 3 trial ongoing.
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 (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, 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

    danar@pluristem.com

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



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    • The company will analyze data based on patients enrolled to date in COVID-19 Phase II studies in U.S., Europe and Israel

    • Topline results are expected during the fourth quarter of 2021

    HAIFA, Israel, July 08, 2021 (GLOBE NEWSWIRE) -- Pluristem Therapeutics Inc. (NASDAQ:PSTI) (TASE:PSTI) (the "Company"), a leading biotechnology company announced today that it is bringing its Acute Respiratory Distress Syndrome (ARDS) associated with COVID-19 Phase II studies to clinical readout. The Company's COVID-19 program included over 100 patients across two Phase II studies in the U.S., Europe and Israel, and in compassionate use and expanded access programs in the U.S. and Israel. The analysis will be based on 89 patients enrolled in the previously announced…

    • The company will analyze data based on patients enrolled to date in COVID-19 Phase II studies in U.S., Europe and Israel



    • Topline results are expected during the fourth quarter of 2021

    HAIFA, Israel, July 08, 2021 (GLOBE NEWSWIRE) -- Pluristem Therapeutics Inc. (NASDAQ:PSTI) (TASE:PSTI) (the "Company"), a leading biotechnology company announced today that it is bringing its Acute Respiratory Distress Syndrome (ARDS) associated with COVID-19 Phase II studies to clinical readout. The Company's COVID-19 program included over 100 patients across two Phase II studies in the U.S., Europe and Israel, and in compassionate use and expanded access programs in the U.S. and Israel. The analysis will be based on 89 patients enrolled in the previously announced two Phase II studies, which investigated the safety and efficacy of Pluristem's PLX cells as a treatment for severe COVID-19 cases complicated by ARDS.

    This decision comes in response to COVID-19's evolution as a disease, as well as changes in the standard of care and a decline in the most severe cases. For the same reason, the Company will not pursue plans announced in December 2020 to expand Pluristem's COVID-19 program to Mexico in collaboration with Innovare R&D. Pluristem expects to announce the topline results of the readout during the fourth quarter of 2021.

    As part of the clinical readout, Pluristem will examine the safety and efficacy of PLX cells for treating ARDS, a condition associated with a number of illnesses in addition to COVID-19 including sepsis, smoke and toxic chemical inhalation, head and chest injuries, and pancreatitis. ARDS continues to pose a significant clinical challenge that affects over 200,000 Americans annually, roughly 10 percent of Intensive Care Unit patients and 23 percent of ventilated patients worldwide.

    Pluristem continues to advance its product candidate pipeline – PLX-PAD and PLX-R18 – on a number of fronts. Pluristem's PLX-PAD treatment exhibits the potential to stimulate tissue regeneration in response to muscle trauma and inflammation. PLX-PAD is currently in a Phase III multinational clinical trial testing the safety and efficacy of accelerating muscle regeneration following HIP fracture surgery. Additionally, Pluristem recently reported positive Phase I topline results from its evaluation of PLX-R18 cells to address incomplete hematopoietic recovery following Hematopoietic Cell Transplantation (HCT). The Company's unique proprietary process and advanced development and manufacturing capabilities enable it to produce PLX cells at significant scale.                                 

    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 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 Phase II study clinical readout, the expected examination of the clinical readout in relating to treating ARDS for illnesses and causes in addition to COVID-19, the potential of its product candidates and its pipeline. 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

    danar@pluristem.com



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  2. HAIFA, Israel, May 25, 2021 (GLOBE NEWSWIRE) -- Pluristem Therapeutics Inc. (NASDAQ:PSTI) (TASE:PSTI) (the "Company"), a leading biotechnology company, today announced the receipt of a "Disbursement Offer" in the amount of €20 million (approximately $24 million) from the European Investment Bank (EIB). This disbursement – the first of three tranches of funding – reflects that Pluristem has achieved a key milestone in a previously announced 50 million non-dilutive financing agreement. Pursuant to the EIB agreement, Pluristem expects to receive the first tranche of funds during June 2021.

    The proceeds of the first tranche will support research and development (R&D) in the European Union to advance Pluristem's proprietary regenerative cell…

    HAIFA, Israel, May 25, 2021 (GLOBE NEWSWIRE) -- Pluristem Therapeutics Inc. (NASDAQ:PSTI) (TASE:PSTI) (the "Company"), a leading biotechnology company, today announced the receipt of a "Disbursement Offer" in the amount of €20 million (approximately $24 million) from the European Investment Bank (EIB). This disbursement – the first of three tranches of funding – reflects that Pluristem has achieved a key milestone in a previously announced 50 million non-dilutive financing agreement. Pursuant to the EIB agreement, Pluristem expects to receive the first tranche of funds during June 2021.

    The proceeds of the first tranche will support research and development (R&D) in the European Union to advance Pluristem's proprietary regenerative cell therapy platform.

    The first tranche of €20 million will not be secured and will be payable to the EIB in a single payment five years after the disbursement, with an interest rate of 4%. Following the receipt of the €20 million tranche, Pluristem will have a cash balance of more than $90 million.

    Pluristem's CEO and President, Yaky Yanay, said: "The EIB funding allows Pluristem to execute our operational, clinical and R&D activities to advance our regenerative medicine platform. Europe's aging population is growing rapidly, and we believe has a clear need for novel treatments for a range of diseases and conditions to improve quality of life. We are committed to leveraging this funding mechanism to strengthen the development of our product candidates to maturation. We are grateful to the EIB for their ongoing support and confidence in our technology.

    Pluristem's key competitive advantages include a state-of-the-art, automated cell expansion technology that draws on 17 years of cell therapy research. Additionally, our in-house manufacturing capabilities enable the production of allogeneic cell product candidates on a mass-scale with batch-to-batch consistency."

    Chen Franco-Yehuda, Pluristem's CFO, added, "Pluristem has a strong cash balance to accelerate our R&D efforts to bring new regenerative medicines to those in need. We believe that the EIB financing agreement reflects a creative, non-dilutive form of financing and believe it positions us strongly for the future."

    About the European Investment Bank

    The European Investment Bank (EIB) is the long-term lending institution of the European Union, owned by its Member States. It makes long-term finance available for sound investment in order to contribute towards EU policy goals.

    About Pluristem Therapeutics

    Pluristem Therapeutics Inc. is a leading regenerative medicine company developing novel placenta-based cell therapy product candidates. 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. PLX cell product candidates are believed to release a range of therapeutic proteins in response to inflammation, 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; a Company-owned and operated GMP-certified manufacturing and research facility; 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 it discusses the expected timing and use of proceeds of the first tranche of funds from the EIB, the belief that the funding will allow it to execute it operational, clinical and R&D activities to advance its regenerative medicine platform and that the funds position it strongly for the future. 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

    danar@pluristem.com 



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    • New therapy has potential to generate improved blood counts in all three blood cell lineages, a meaningful advantage over existing treatments
    • The company will conduct an analyst and investor call on May 3, 2021, at 10am EDT

    HAIFA, Israel, April 29, 2021 (GLOBE NEWSWIRE) -- Pluristem Therapeutics Inc. (NASDAQ:PSTI) (TASE: PSTI), a leading regenerative medicine company, today reported positive topline results in its first study to evaluate the safety and exploratory efficacy of PLX-R18 in humans. The company's Phase I, open-label, dose-escalation study is evaluating the safety and exploratory efficacy of intramuscular injections of PLX-R18 in subjects with incomplete hematopoietic recovery following Hematopoietic Cell Transplantation (HCT).

    • New therapy has potential to generate improved blood counts in all three blood cell lineages, a meaningful advantage over existing treatments
    • The company will conduct an analyst and investor call on May 3, 2021, at 10am EDT

    HAIFA, Israel, April 29, 2021 (GLOBE NEWSWIRE) -- Pluristem Therapeutics Inc. (NASDAQ:PSTI) (TASE: PSTI), a leading regenerative medicine company, today reported positive topline results in its first study to evaluate the safety and exploratory efficacy of PLX-R18 in humans. The company's Phase I, open-label, dose-escalation study is evaluating the safety and exploratory efficacy of intramuscular injections of PLX-R18 in subjects with incomplete hematopoietic recovery following Hematopoietic Cell Transplantation (HCT).

    Pluristem CEO and President, Yaky Yanay, said, "The promising topline results demonstrate insight into how PLX cells may provide a more effective therapeutic benefit than current technologies. We believe that PLX-R18 affects the regeneration activity of the hematopoietic cells. By supporting blood cell lineage's recovery, this approach could be used to address a variety of hematological deficiencies. We intend to push forward the clinical development of PLX-R18 with the goal of establishing it as the new standard of care in the field."

    Poor graft function is a life-threatening complication for patients undergoing HCT. Current standard-of-care treatments do not develop satisfactory blood counts in some or all blood cell lineages. Consequently, patients are vulnerable to bleeding and recurrent infections, and require repeated costly transfusions of blood products, which only provide a short-term effect. Pluristem's PLX-R18 aims to improve the standard of care by stimulating the regenerative potential of the bone marrow. This potentially enhances the production of all three blood cell lineages, differentiating it from other products which target only one of the three blood cell lineages.

    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 two treatments of the assigned dose.

    The results demonstrate that PLX-R18 has the potential to stimulate the implanted hematopoietic cells to realize their therapeutic potential and generate improved blood counts over the long term in all three blood cell lineages at once – a meaningful advantage over other existing and proposed treatments.

    Available data1 at six-month follow-up demonstrates:

    • PLX-R18 was well-tolerated with a favorable safety profile.
    • Statistically significant improvement from baseline counts was observed in all cohorts for hemoglobin and platelet counts (p<0.05). The patients in the high dose arm (4 million cells/kg) exhibited statistically significant improvements in all three blood cells lineages (p<0.01).
    • 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.
    • 13 patients were transfusion dependent at baseline. Six of those became transfusion independent at six-month follow up. No patients who were transfusion independent at baseline became transfusion dependent.

    The study supports previous preclinical results, conducted via the U.S. Food and Drug Administration's (FDA) Animal Rule in collaboration with the U.S. National Institutes of Health (NIH), in which PLX-R18 was found effective in treating bone marrow failure from Acute Radiation Syndrome (ARS).

    PLX-R18 is the first product candidate manufactured using Pluristem's proprietary serum-free media on its 3D bioreactor system.

    The company will conduct an analyst and investor call on May 3, 2021, at 10am EDT, for registration: https://Veidan.activetrail.biz/pluristem

    ___________________

    1 Data from the six-month follow-up is available for 14 of the 21 treated patients: 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. Mortality rates were in line with publicly available information (references: Gao et al 2020Halahleh et al 2021, Tang et al 2018, Sun et al. 2015, Zhao et al 2019)  

    About Pluristem Therapeutics

    Pluristem Therapeutics Inc. is a leading regenerative medicine company developing novel placenta-based cell therapy product candidates. 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. PLX cell product candidates are believed to release a range of therapeutic proteins in response to inflammation, 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; a Company-owned and operated GMP-certified manufacturing and research facility; 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 it discusses that PLX cells may provide a more effective therapeutic benefit than current technologies, that PLX-R18 may potentially enhance the production of three blood cell lineages, the belief that PLX-R18 affects the regeneration activity of the hematopoietic cells and its intention to push forward with the clinical development of PLX-R18 with the goal of establishing it as the new standard of care in the field. 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

    danar@pluristem.com



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  3. HAIFA, Israel, Feb. 02, 2021 (GLOBE NEWSWIRE) -- Pluristem Therapeutics Inc. (NASDAQ:PSTI) (TASE:PSTI), a leading regenerative medicine company developing a platform of novel biological therapeutic products ("Pluristem" or the "Company"), today announced it has entered into definitive agreements with institutional investors for the purchase and sale of 4,761,905 shares of its common stock at a purchase price of $6.30 per share in a registered direct offering, for gross proceeds of $30 million before deducting placement agent fees and expenses. The closing of the offering is expected to occur on or about February 4, 2021, subject to the satisfaction of customary closing conditions.

    A.G.P./Alliance Global Partners is acting as sole placement…

    HAIFA, Israel, Feb. 02, 2021 (GLOBE NEWSWIRE) -- Pluristem Therapeutics Inc. (NASDAQ:PSTI) (TASE:PSTI), a leading regenerative medicine company developing a platform of novel biological therapeutic products ("Pluristem" or the "Company"), today announced it has entered into definitive agreements with institutional investors for the purchase and sale of 4,761,905 shares of its common stock at a purchase price of $6.30 per share in a registered direct offering, for gross proceeds of $30 million before deducting placement agent fees and expenses. The closing of the offering is expected to occur on or about February 4, 2021, subject to the satisfaction of customary closing conditions.

    A.G.P./Alliance Global Partners is acting as sole placement agent for the offering.

      

    This offering is being made pursuant to an effective shelf registration statement on Form S-3 (File No. 333-239890) previously filed with the U.S. Securities and Exchange Commission (the "SEC"), under the Securities Act of 1933, as amended. A prospectus supplement describing the terms of the proposed offering will be filed with the SEC and will be available on the SEC's website located at http://www.sec.gov. Electronic copies of the prospectus supplement may be obtained, when available, from A.G.P./Alliance Global Partners, 590 Madison Avenue, 28th Floor, New York, NY 10022, or by telephone at (212) 624-2060, or by email at prospectus@allianceg.com. Before investing in this offering, interested parties should read in their entirety the prospectus supplement and the accompanying prospectus and the other documents that the Company has filed with the SEC that are incorporated by reference in such prospectus supplement and the accompanying prospectus, which provide more information about the Company and such offering.

    This press release shall not constitute an offer to sell or the solicitation of an offer to buy nor shall there be any sale of these securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction.

    About Pluristem

    Pluristem Therapeutics Inc. is a leading regenerative medicine company developing novel placenta-based cell therapy product candidates. 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. PLX cell product candidates are believed to release a range of therapeutic proteins in response to inflammation, 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; a Company-owned and operated GMP-certified manufacturing and research facility; strategic relationships with major research institutions; and a seasoned management team.

    Forward-Looking Statements

    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 closing of the offering. 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.

    Pluristem Investor Contact

    Dana Rubin

    Director of Investor Relations

    972-74-7107194

    danar@pluristem.com



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