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HAIFA, Israel, December 17, 2019 – Pluristem Therapeutics Inc. (Nasdaq:PSTI) (TASE:PSTI), a leading regenerative medicine company developing novel placenta-based cell therapy products, today announced that it has enrolled 75% of the 246 patients planned for its Phase III clinical study of PLX-PAD in the treatment of Critical Limb Ischemia (CLI), the most severe form of peripheral artery disease, caused by fatty deposits in leg arteries obstructing blood flow.

 

While an estimated 5 to 6 million people in the U.S. and Europe suffer from CLI, up to 35% of patients are not eligible for the standard-of-care treatment of revascularization surgery. These patients are left with no treatment options and are at high risk of leg amputation and death. Incidence of CLI is increasing, driven by an aging population and a rise in risk factors, including diabetes and obesity.

PLX-PAD is among the most advanced drugs under development to treat CLI patients, with the goal to serve a large population for which there is a significant need for therapy. “We are pleased to be meeting our patient recruitment goals as we look forward to completing this pivotal study,” stated Pluristem President and CEO Yaky Yanay.
“We aim to bring hope to millions of CLI patients around the world by delivering a regenerative treatment that can save limbs and lives while also saving costs for the healthcare systems. We are pleased to receive significant regulatory and financial support while developing such a novel therapy for CLI, including fast track designation from the U.S. Food and Drug Administration (FDA) and Adaptive Pathway designation from the European Medicine Agency (EMA) that may enable faster regulatory approvals. We understand the importance of a successful outcome in this study for the benefit of this large population of patients and for the benefit of all of our stakeholders. We at Pluristem are fully committed to deliver the first and leading drug for CLI patients across the globe.”

PLX-PAD has been selected for the EMA’s Adaptive Pathways pilot project, allowing for potential accelerated approval in Europe based on an interim analysis of half of the patients in the study. In the U.S., PLX-PAD was granted a fast track designation and was accepted to an expanded access program by the FDA. €7.6 million has been granted to Pluristem’s Phase III CLI program – the PACE study, from the European Union’s Horizon 2020 program, the largest EU research and innovation program. The Phase III randomized, double blind, placebo-controlled study is enrolling 246 CLI patients who are unsuitable for revascularization in over 50 sites across Europe, the U.S., and Israel. Patients are treated with two intramuscular treatments of 300 million cells of PLX-PAD or placebo, at a randomized ratio of 2:1. The primary efficacy endpoint is time to occurrence of a major leg amputation or death.

 

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, 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; 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 potential of its PLX-PAD to become the first and leading drug approved to treat CLI patients across the globe, that its PLX-PAD drug is being targeted to serve a large population for which there is a significant need for therapy, the potential of Pluristem and its study to deliver a regenerative treatment that can save limbs and lives while also saving costs for the healthcare systems and the potential for accelerated regulatory approvals in the U.S. and Europe.
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:

Efrat Kaduri

Director of Business, Investor and Public Relations 972-74-7108600

efratk@pluristem.com

Multinational study in the U.S., Israel and Europe targeting to be the first product candidate supporting muscle regeneration after significant trauma such as hip fracture

HAIFA, Israel, December 3, 2019 – Pluristem Therapeutics Inc. (Nasdaq:PSTI) (TASE:PSTI), a leading regenerative medicine company developing novel placenta-based cell therapy products, today announced that it has completed enrollment of 50% of the 240 patients planned for its ongoing Phase III PLX-PAD study of muscle regeneration.

There are currently no approved treatments for the post-operative regeneration of injured or weak skeletal muscle, and up to 30% of hip fracture patients die within one year of surgery due to long-term complications resulting from immobility, with high financial costs of hospitalization and rehabilitation.

Pluristem’s ongoing Phase III multinational, randomized, double-blind and placebo-controlled study is assessing patients’ physical performance scores 26 weeks following surgery after administrating allogeneic PLX-PAD cells for the treatment of muscle injury following arthroplasty for hip fracture, as compared to placebo. Additional efficacy endpoints include muscle strength, muscle mass and volume, hospitalization time and lower extremity measure. Through clinical sites in the U.S., Europe and Israel, 240 patients are being randomized on a 1:1 allocation to be dosed with 150 million PLX-PAD cells or placebo on the day of surgery.

This Phase III study follows positive results from a Phase I/II study which demonstrated muscle regeneration when using PLX-PAD cells in total hip arthroplasty patients. The study demonstrated a significant change in muscle volume (p=0.004) and in muscle force (p=0.0067) at 6 months post-surgery, compared to the control group.

Pluristem CEO, Yaky Yanay, stated, “This study marks an important milestone for Pluristem, as we are moving forward with our main global studies and remain on track with recruitment. We believe that our advanced clinical pipeline is geared to bring regenerative medicine into standard-of-care use in hospitals and clinics while providing reduced costs for the healthcare systems. We are grateful to work with dedicated physicians around the world, and with the European Horizon 2020 Program which is funding this study with €7.4 million.”

The Principal Investigator of the study, Dr. Tobias Winkler of the Berlin Institute of Health for Regenerative Therapies, Julius Wolff Institute and Center for Musculoskeletal Surgery, commented, “We are eager to evaluate PLX-PAD’s ability to aid muscle regeneration in patients recovering from arthroplasty for hip fracture.
Many patients do not fully recover after surgery, suffering considerable morbidity due to poor muscle regeneration and impaired mobility.
PLX-PAD has the potential to improve and extend quality of life for patients with one simple injection of the cell therapy product.”

 

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, 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; 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 its PLX-PAD cells are being targeted to be the first product candidate supporting muscle regeneration after significant trauma such as hip fracture, the potential of its clinical pipeline to bring regenerative medicine into standard-of-care use in hospitals and clinics while providing reduced costs for the healthcare systems and the potential of PLX-PAD to improve and extend the quality of life for patients.
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:

Efrat Kaduri

Director of Business, Investor and Public Relations 972-74-7108600

efratk@pluristem.com

HAIFA, Israel, November 12, 2019 – Pluristem Therapeutics Inc. (Nasdaq:PSTI) (TASE:PSTI), a leading regenerative medicine company developing novel placenta-based cell therapy products, today issued an update to its shareholders from its Chief Executive Officer, Yaky Yanay.

Dear Fellow Shareholders,

 

Today we announce Pluristem’s update for the first fiscal quarter of 2020, as we are entering a very important period as we are in preparation towards the interim readout expected from our CLI phase III study.
We continued to develop our robust clinical pipeline, with significant advancements in our hematological programs for PLX-R18 and PLX-PAD in the treatment of critical limb ischemia (CLI) and muscle regeneration.

PLX-R18, for the treatment of acute radiation syndrome (ARS), is advancing towards an important study with the potential for demonstrating the superiority of our cell therapy product versus the current standard of treatment, as we target governmental purchase contracts.
We are preparing PLX-PAD, for the treatment of CLI, for potential conditional marketing approval in Europe, based on interim data we expect to receive in the second calendar quarter of 2020.
We strongly believe, based on clinical data combined with our ability to manufacture large and consistent quantities of cell therapies, that Pluristem can heal and improve the lives of millions of patients while creating a new regenerative medicine model for healthcare.

 

I believe we have a significant upcoming value creating milestone in our ongoing Phase III CLI study.
Interim data from this 246-patient study, which is being conducted in the U.S., Europe and Israel, is expected as mentioned in the calendric Q2 of 2020. Assuming the data from the study show good efficacy, we intend to submit an application to the European Medical Agency (EMA) for conditional marketing approval.
We anticipate meeting with the EMA in order to confirm understanding towards the readout, as well as to set agreed process with our application for conditional marketing approval once positive data is reported.
We are putting our resources and focus towards a commercialization event through discussions with payers regarding reimbursement, and with doctors and Key Opinion Leaders (KOLs) regarding integrating PLX-PAD as a standard of care treatment for CLI patients.

PLX-R18 has obtained Orphan Drug Designation in the U.S. for the treatment of ARS and for incomplete hematopoietic recovery following hematopoietic cell transplantation (HCT). We have been working in close partnership with various U.S. government agencies to develop PLX-R18 as a lifesaving treatment for victims exposed to high levels of radiation.
During the last quarter, we reported positive data from the most recent studies conducted by the U.S. Department of Defense (DoD), which evaluated PLX-R18 as a prophylactic countermeasure against ARS, administered prior to radiation exposure.
These animal studies, administering PLX-R18 24 hours before radiation exposure, and again 72 hours after exposure, resulted in a significant increase in survival rates, from a 4% survival rate in the placebo group to 74% in the treated group.

We have submitted a proposal to the Biomedical Advanced Research and Development Authority (BARDA) that is strategically designed to demonstrate the superiority of PLX-R18 versus current standards of care. KOLs in the ARS space have affirmed that despite the availability of several FDA approved countermeasures for ARS, there still remain significant treatment gaps. We believe that PLX-R18 is the best candidate to meet this need and that Pluristem can provide the U.S. government with effective countermeasures that can be easily stored, transported and deployed both pre-and post-exposure to military or civilian populations.

While the ARS studies are conducted under the FDA’s animal rule pathway, PLX-R18 is also showing favorable results in clinical study for the treatment of HCT, a medical condition in which patients do not respond to current treatments.
Pluristem’s Phase I study of PLX-R18, conducted in the U.S. and Israel, has reported data from its first two cohorts, with the third and final cohort now in the process of enrolling and dosing. PLX-R18 appeared to regenerate damaged bone marrow, leading to increased production of platelets and red blood cells, ultimately reducing the number of required transfusions.
While enrollment and treatment of the third cohort is ongoing, we seek to evaluate PLX-R18 as a candidate in additional bone marrow deficiency syndromes with similar unmet needs.

Pluristem is making significant momentum towards transitioning to the commercial, revenue generating stage of the Company. We appreciate and thank all of our shareholders for your support of Pluristem in its mission to improve healthcare through regenerative medicine.

 

Sincerely, Yaky Yanay

Chief Executive Officer

 

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, 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; 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 its preparation for PLX-PAD for the treatment of CLI for potential conditional marketing approval in Europe, the belief that it can heal and improve the lives of millions of patients while creating a new regenerative medicine model for healthcare, the belief that it has a significant upcoming value creating milestone in its ongoing Phase III CLI study, its intent to submit an application to the EMA for conditional marketing approval with respect to its ongoing Phase III CLI study, its anticipated meeting with the EMA in order to confirm understanding towards the readout, as well as to set agreed process with its application for conditional marketing approval with respect to its Phase III CLI study, its belief that PLX-R18 is the best candidate to fill the gap in treatment for ARS, its seeking to evaluate PLX-R18 as a candidate in additional bone marrow deficiency syndromes with similar unmet needs and that it is making significant momentum towards transitioning to the commercial, revenue generating stage of the Company.
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:

Efrat Kaduri

Director of Business, Investor and Public Relations 972-74-7108600, efratk@pluristem.com

HAIFA, Israel, November 4, 2019 – Pluristem Therapeutics Inc. (Nasdaq:PSTI) (TASE:PSTI), a leading regenerative medicine company developing novel placenta-based cell therapy products, today announced that the RESTORE Consortium is hosting its 1st Advanced Therapies Science Meeting (ATSM), which is being held November 25-26, 2019 in Berlin. As a leading member of the large-scale research initiative, Pluristem, along with additional respected members, is committed to accelerating the availability of advanced therapies to all those in need, a main motivation standing behind RESTORE.

Led by Charité-Universitätsmedizin Berlin, and coordinated by Professor Hans-Dieter Volk from the BIH- Center for Regenerative Therapies in Berlin, RESTORE aims to promote groundbreaking research, drive Europe to the forefront in advanced therapies and deliver a pipeline of potentially transformative cures to patients in need. “Advanced Therapies are a potential game changer in health care, aiming to shift our focus from chronic treatment of disease to regeneration of health,” said Prof. Volk. “We are determined to translate promising research findings into safe therapies, and we are working across disciplines and national borders in order to achieve this goal. The 1st Advanced Therapies Science Meeting provides the opportunity to discuss the still numerous obstacles in the way of implementing these promising therapies in routine clinical care.”

“This initiative may hold the key for changing the approach towards medicine in Europe, and advancing solutions for patients in need,” said Zami Aberman, Executive Chairman of Pluristem. “The European Commission is poised to make a significant investment of up to €1 billion in a consortium of companies that can drive forward the development of novel regenerative therapies, and we are pleased to be a leading part in this effort. Given our proprietary cell manufacturing technology and broad, late-stage pipeline, we believe we can play a key role toward making the transforming promise of advanced therapies into a reality.”

The 1st ATSM will bring together experts from industry, patient organizations and academia to discuss the challenges within the field of advanced therapies, which include gene and cell therapies and tissue- engineering approaches. The ATSM is focused on trying to drive forward a concerted interdisciplinary effort, making use of science, infrastructure and funding within Europe to make regenerative therapies available to the broadest possible patient population.

 

The two-day program will include talks from Nobel Prize winner Ada Yonath (Director of Weizmann Institute of Science, Israel), Michele De Luca (University of Modena, Italy), Timothy O’Brien (National University of Ireland, Galway, Ireland), Maksim Mamonkin (Baylor College of Medicine, USA), Manuela Gomes (University of Minho, Portugal) and others.

RESTORE partners include the Charité Universitätsmedizin Berlin and Berlin Institute of Health (Germany), the University of Zurich (Switzerland), Cell and Gene Therapy Catapult (United Kingdom), TissUse GmbH (Germany), Pluristem (Israel), Miltenyi Biotec GmbH (Germany), INSERM – Institut National de la Santé et de la Recherche (France), Innovation Acta S.r.l. (Italy), Fondazione Telethon Milan (Italy), and the University of Minho (Portugal).

 

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, 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; 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 potential for the RESTORE Consortium to receive up to a €1 billion award by the European Commission and the timing of the potential award, that RESTORE’s aim is to promote groundbreaking research, drive Europe to the forefront in advanced therapies and deliver a pipeline of potentially transformative cures to patients in need, that RESTORE and the 1st ATSM may hold the key for changing the approach towards medicine in Europe, and advancing solutions for patients in need, and its belief that given its proprietary cell manufacturing technology and broad, late- stage pipeline, it believes it can play a key role toward making the transforming promise of advanced therapies into a reality.
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:           Efrat Kaduri

Director of Business, Investor and Public Relations 972-74-7108600, efratk@pluristem.com

number of required transfusions

R18 versus current standards of care, with the goal of executing a full contract once the study is completed”

 

HAIFA, Israel, September 16, 2019 – Pluristem Therapeutics Inc. (Nasdaq:PSTI) (TASE:PSTI), a leading regenerative medicine company developing novel placenta-based cell therapy products, today provided a recap of the Key Opinion Leader call hosted by the company this morning to review unmet medical needs in acute radiation syndrome (ARS) and hematological deficiencies, and to provide an update on the development of its novel cell therapy treatment, PLX-R18. PLX cell therapy was granted an Orphan Drug Designation by the U.S. Food and Drug Administration (FDA) for the treatment of ARS and incomplete hematopoietic recovery following hematopoietic cell transplantation (HCT).

An overview of HCT was provided by Dr. Jacob M. Rowe, MD, Chief of the Department of Hematology and The Ann and Pinky Sohn Chair in Hemato-Oncology at the Shaare Zedek Medical Center in Jerusalem and Emeritus Professor at the Technion, Israel Institute of Technology in Haifa, a member in the company’s ongoing hematology program steering committee. Dr. Rowe reviewed the medical condition of HCT and the unmet need for the significant proportion of patients that do not respond to current treatments. Dr. Rowe then discussed Pluristem’s ongoing Phase I study of PLX-R18 and data from the first two cohorts:

“Results from the first two cohorts in this study demonstrate that PLX-R18 is safe and well tolerated, with no unexpected toxicities,” said Dr. Rowe. “While the study’s primary endpoint was safety, we can’t disregard the potential benefits of this cell therapy drug, which even in the lower doses appears to regenerate damaged bone marrow, leading to increased production of platelets and red blood cells, ultimately reducing the number of required transfusions, although caution is appropriate in discussing early data with a small number of patients. Importantly, we see these positive benefits sustained at the nine months follow-up period, and we continue to monitor these patients. We look forward to results from Cohort 3, in which patients will be administered four million cells per kilogram, as we work to efficiently advance PLX-R18 as a candidate in additional bone marrow deficiency syndromes with similar unmet needs.”

The next presentation was delivered by Bert W. Maidment, Ph.D., who served as Assistant Director, Radiation Nuclear Countermeasures Program at the National Institutes of Health, National Institute of Allergy and Infectious Diseases, Division of Allergy, Immunology, and Transplantation (NIH/NIAID/DAIT) until retiring in 2016. Dr. Maidment discussed the health impact of radiation exposure and the need for more effective countermeasures. “There is a broad range of devastating health consequences resulting from radiation exposure, with hematopoietic, gastrointestinal, cardiovascular and central nervous systems all potentially impacted,” noted Dr. Maidment. “Notwithstanding several FDA-approved countermeasures, including Neupogen®, Neulasta® and Leukine®, significant treatment gaps remain, causing widespread manifestations across vital organ systems. I believe that a more efficacious countermeasure that can be administered pre- and post-exposure, particularly one that is easily stored and administered and potentially support multiple organ injuries, would have significant utility across a number of civilian and military applications where radiation exposure is a potential risk.”

 

Pluristem management provided an overview of the company’s acute radiation syndrome (ARS) projects that are running with several governments and agencies, including the U.S. National Institutes of Health (NIH), testing PLX-R18 as a potential treatment for ARS, the U.S. Department of Defense (DOD) testing the product as a potential prophylactic countermeasure against ARS and Fukushima University in Japan examining PLX-R18 cells for the treatment of hematological ARS and gastrointestinal (GI). Arik Eisenkraft, Director of Homeland Defense Projects at Pluristem and former Head of Chemical, Biological, Radiological and Nuclear Defense (CBRN) Protection Division in the Israeli Ministry of Defense, summarized PLX-R18’s potential to stimulate the regeneration of damaged bone marrow to produce blood cells while also increasing survival and benefiting additional body systems, suggesting that PLX-R18 has the ability to treat ARS as a multi-organ therapy.

 

Yaky Yanay, Chief Executive Officer of Pluristem, concluded the call with an update on the status of current projects and provided an overview of next steps. “I would like to thank Drs. Rowe and Maidment for offering their perspectives on these difficult-to-treat hematological conditions. We look forward to advancing our ARS program to complete the development and registration of PLX-R18 for ARS, targeting governmental purchase contracts.

  1. After reaching an understanding with the FDA on the regulatory pathway needed and conducting additional mechanism studies with the support of the NIH, we have progressed our discussions with the Biomedical Advanced Research and Development Authority (BARDA) to submit a proposal by the end of September, aiming for a study, strategically designed to demonstrate the superiority of PLX-R18 versus current standards of care, with the goal of executing a full contract once the study is completed.
  2. Following the studies conducted by the U.S. Department of Defense, we are now progressing to further small and large animal studies in relevant DoD models, as required by the FDA animal rule

We remain committed to completing our ongoing Phase I study of PLX-R18 in incomplete hematopoietic recovery following HCT as quickly as possible and will seek to expand PLX-R18 for use with respect to

 

additional medical conditions with the goal of bringing innovative, safe and effective treatments for patients with a variety of bone marrow deficiency indications.”

 

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, 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; 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 potential benefits of PLX-R18 as identified in the study, the potential use of PLX-R18 in civilian and military applications where radiation exposure is a potential risk, that PLX-R18 has the ability to treat ARS as a multi-organ therapy, the advancement of its ARS program to ultimately target governmental purchase contracts, its progress with respect to small and large animal studies in relevant DoD models, as required by the FDA animal rule pathway, its aim to submit a proposal by the end of September with respect to BARDA, with the hopes of commencing a study designed to demonstrate the superiority of PLX-R18 in the treatment of ARS versus current standards of care and with the goal of executing a full contract once the study is completed and its aim to expand the focus of PLX-R18 to additional medical conditions with the goal of bringing innovative, safe and effective treatments for patients with a variety of bone marrow deficiency indications.
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:

Efrat Kaduri

Director of Business, Investor and Public Relations 972-74-7108600

efratk@pluristem.com

CONTACT US

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Terms of Use

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privacy policy

©2025 pluri™ inc

Terms of use

Use of the Pluri Web Site

General

Pluri Biotech Ltd., on its behalf and on behalf of its related companies, including without limitations, its parent company, Pluri Inc. (collectively: “Pluri”) maintains [https://www.pluri-biotech.com/] (this “Website”) for informational purposes in favor of the Internet community. Access to and use of information presented on this Website is subject to the following terms and conditions which may be revised at any time by Pluri and to the Privacy Notice located on this Website and incorporated hereto by reference.

The information contained in these pages is not intended to provide medical advice, recommendation or instruction on the appropriate use of Pluri’s technology, nor that Pluri technology is marketable nor fit for a particular purpose.  In addition, nothing herein shall be deemed as solicitation for purchasing any of Pluri’s securities.

Please read carefully the following terms and conditions. The use of this Website is governed by these terms and conditions and our Privacy Policy, By using and accessing this Website, you agree to be bound by these terms of use including any amendments that may be made by Pluri from time to time at its sole discretion. Pluri encourages the users of this Website to periodically review these terms of use for any changes or amendments.

Forward-Looking Statements; SEC / TASE Filings

Pluri Inc., is a public company, which securities are traded on the Tel Aviv Stock Exchange (TASE) and Nasdaq.  Statements on this Website regarding Pluri’s business which are not historical facts are “forward-looking statements” within the meaning of the “safe harbor” provisions of the Private Securities Litigation Reform Act of 1995 and federal securities laws, that involve risks and uncertainties. Forward-looking statements can be identified by, among other things, the use of forward-looking language, such as “anticipate”, “believe”, “could”, “estimate”, “expect”, “future”, “intend”, “plan”, “potential”, and may describe opinions about future events. These forward-looking statements are based on the current expectations of the management of Pluri 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; we may encounter delays or obstacles in launching our clinical trials; our technology may not be validated as we progress further and our methods may not be accepted by the scientific community; we may be unable to retain or attract key employees whose knowledge is essential to the development of our products; unforeseen scientific difficulties may develop with our progress; our products may wind up being more expensive than we anticipate; results in the laboratory may not translate to equally good results in real surgical settings; our patents may not be sufficient; our products may harm recipients; changes in legislation; 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 Pluri to differ materially from those contemplated in such forward-looking statements. For a more detailed description of the risks and uncertainties affecting Pluri, reference is made to Pluri’s reports filed from time to time with the Securities and Exchange Commission (“SEC”). Pluri disclaims any intention or obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise. No information or statement in this website is intended to solicit in any manner whatsoever any person to purchase or deal in any securities of Pluri. Pluri may provide links to its filings with the SEC for informational purposes only, and not for trading or investment purposes. Pluri does not guarantee the sequence, accuracy or completeness of any information or data displayed through these links. Pluri does not assume any duty of disclosure and expressly disclaims any duty to update information set forth in its filings with the SEC.  The stock price performance shown on stock quotes may be available on or through this Website is not necessarily indicative of future price performance. All content is for informational purposes only and no content is intended to be relied upon for trading or investment purposes. Nothing on this website constitutes an invitation or offer to invest or deal in the securities of Pluri. In particular, actual results and developments may be substantially and materially different from any opinion or forecast expressed on this website.

Links to Third Party Websites

The Website may provide links to World Wide Web sites or resources. Because Pluri has no control over such sites and resources, you acknowledge and agree that Pluri is not responsible for the availability of such external sites or resources, and does not endorse and is not responsible or liable for any information, advertising, products, or other materials on or available from such sites or resources. You further acknowledge and agree that Pluri shall not be responsible or liable, directly or indirectly, for any damage or loss caused or alleged to be caused by or in connection with use of or reliance on any such information, goods or services available on or through any such site or resource.

Conduct

Within the course of your use of the Website you will strictly adhere with the following policies, such that, you must not:

·         Scan or use this Website via operation of a computer program designed to gather information or perform operations imitating a human user (including, without limitation, Bots or Crawlers);

·         Manipulate the architecture of this Website, or otherwise gain access to any of its engines and/or databases to which we did not provide you with an expressly permitted access (including, without limitation, URL Hacking);

·         Carry out any action which may infringe the copyrights and/or any other proprietary information of ours or any other copyright holder;

·         Copy, transmit, decompile, modify, create derivative works, reproduce, disassemble, republish, scrape, and/or reverse engineer (including any extraction of the work process) any algorithm, code, syntax and/or any other content associated with this Website and/or any components thereof and/or act to collect, harvest and/or data mine any data associated with the Website and/or any of its users (whether by computer programs, identity theft, impersonation, or otherwise) and/or take any action which may be deemed as impersonating another person or entity, identity theft, etc.;

·         Carry out any action which may infringe any laws, regulations, orders or any guidelines of any governmental authority, is likely to offend or harm any other users of this Website and/or the general public;

·         Steal or attempt to steal private information from other users of this Website;

·         Email us content which is or could be considered libelous, defamatory, indecent, vulgar, obscene, pornographic, sexually explicit or suggestive, racially or ethically offensive, harmful, harassing, intimidating, threatening, discriminatory, or abusive;

·         Carry out any action that violates these Terms, Privacy Notice and/or any other guidelines or policies as prescribed herein and/or as otherwise published by us from time to time.

·         Assist, encourage or enable others to do any of the preceding prohibited activities.

Intellectual Property Rights

You acknowledge that Pluri owns all copyrights in the information, selection, coordination, arrangement and enhancement of this Website, which may contain information, software, photos, video, text, graphics, or other material posted or uploaded by Pluri (collectively, the “Pluri Content”), and that these rights are valid and protected in all forms, media and technologies existing now or here after developed. Pluri has the full rights and authorization to use this Website’s name and logo. You may not modify, publish, transmit, participate in the transfer or sell, create derivative works, or in any way exploit, any of the Pluri Content, in whole or in part. Modification of the Pluri Content or use of any Pluri Content on any other website, networked computer environment or elsewhere is strictly prohibited. The Pluri Content is subject to copyright protection. You may not copy the contents of this Website other than for non-commercial individual reference with all copyright or other proprietary notices retained, and thereafter the contents may not be recopied, reproduced or otherwise redistributed. You may not distribute, modify, repost, copy, publish license or use the contents of this website, including information, photos, video, text, graphics or other material posted or upload by Pluri for public or commercial purposes. Some of the tradenames or trademarks used in this Website are registered trademarks of Pluri and/or its affiliates. The use or misuse of any of these trademarks or unregistered trademarks or any other materials, except as permitted herein, is expressly prohibited and may result, inter alia, in violation of copyright laws and trademark laws.

Subject to any applicable terms and conditions set forth in our Privacy Notice, any communication or other material that you send to us through the Internet or post on the Website by electronic mail or otherwise, such as any questions, comments, suggestions or the like, is and will be deemed to be non-confidential and we shall have no obligation of any kind with respect to such information. Pluri shall be free to use any ideas, concepts, know-how or techniques contained in such communication for any purpose whatsoever, including but not limited to, developing, manufacturing and marketing products.

Disclaimers

THE INFORMATION AND/OR STATEMENTS PROVIDED ON THIS WEBSITE ARE PROVIDED ‘AS IS’ AND FOR NO COST AND YOU MAY USE IT AT YOUR SOLE RISK. PLURI EXPRESSLY DISCLAIMS ALL WARRANTIES OF ANY KIND, WHETHER EXPRESS OR IMPLIED, INCLUDING, BUT NOT LIMITED TO THE IMPLIED WARRANTIES OF MERCHANTABILITY, FITNESS FOR A PARTICULAR PURPOSE AND NON-INFRINGEMENT. WITHOUT LIMITATION, PLURI MAKES NO WARRANTY THAT THIS WEBSITE AND/OR THE INFORMATION PROVIDED THEREIN WILL MEET YOUR REQUIREMENTS, THAT IT WILL BE UNINTERRUPTED, TIMELY, SECURE, OR ERROR-FREE, THAT THE RESULTS OBTAINED FROM THE USE OF THIS WEBSITE WILL BE ACCURATE OR RELIABLE, OR THAT THE QUALITY OF ANY INFORMATION OR OTHER MATERIAL OBTAINED THROUGH THIS WEBSITE WILL MEET YOUR EXPECTATIONS. ANY MATERIAL DOWNLOADED OR OTHERWISE OBTAINED THROUGH THE USE OF THIS WEBSITE IS DONE AT YOUR SOLE RISK AND YOU WILL BE SOLELY RESPONSIBLE FOR ANY DAMAGE TO YOUR COMPUTER SYSTEM OR LOSS OF DATA THAT RESULTS FROM THE DOWNLOAD OF ANY SUCH MATERIAL.

Limitation of Liability

YOU EXPRESSLY UNDERSTAND AND AGREE THAT PLURI INCLUDING ITS OFFICERS, DIRECTORS, SHAREHOLDERS, EMPLOYEES, SUB-CONTRACTORS AND AGENTS SHALL NOT BE LIABLE FOR ANY DIRECT, INDIRECT, INCIDENTAL, SPECIAL, CONSEQUENTIAL OR EXEMPLARY DAMAGES, INCLUDING BUT NOT LIMITED TO, DAMAGES FOR LOSS OF PROFITS, GOODWILL, USE, DATA OR OTHER INTANGIBLE LOSSES (EVEN IF PLURI HAS BEEN ADVISED OF THE POSSIBILITY OF SUCH DAMAGES), RESULTING FROM THE USE OF OR THE INABILITY TO USE THIS WEBSITE AND/OR INFORMATION PROVIDED THEREIN. SOME JURISDICTIONS DO NOT ALLOW THE EXCLUSION OF CERTAIN WARRANTIES OR THE LIMITATION OR EXCLUSION OF LIABILITY FOR INCIDENTAL OR CONSEQUENTIAL DAMAGES. ACCORDINGLY, SOME OF THE ABOVE LIMITATIONS MAY NOT APPLY TO YOU.

WITHOUT DEROGATING FROM THE GENERAL NATURE OF THE FOREGOING, WE ASSUME NO LIABILITY FOR ANY DAMAGES CAUSED BY VIRUSES, WORMS AND/OR OTHER MALICIOUS SOFTWARE WHICH MAY INFECT THE USER’S MACHINE(S).

Indemnification

You agree to indemnify, defend and hold harmless Pluri, its officers, directors, shareholders, employees, sub-contractors, affiliates, agents and anyone acting on their behalf, at your own expense and immediately after receiving a written notice from Pluri, from and against any damages, loss, costs, expenses and payments, including reasonable attorney’s fees and legal expenses, resulting from any complaint, claim, or demand, arising from or related to your breach of these terms of use, or any other terms, rules or regulations applicable to this website, or your violation, or infringement of other persons rights.

Miscellaneous

Governing Law. These terms of use shall be governed in accordance with the laws of the State of Israel without giving effect to any conflicts of law principles. Any dispute in connection with these terms of use shall be submitted to the exclusive jurisdiction of the competent courts situated in Tel Aviv, Israel.

Entire Agreement. These terms and conditions contain the entire agreement between the parties with respect to the subject matter hereof, and supersede all prior and contemporaneous representations, promises, agreements and understandings, whether oral or written, between the parties concerning the subject matter hereof.

Severability. If any provision of these terms of use shall be deemed to be invalid, void, illegal or for any reason unenforceable, that term or condition shall be deemed severable and shall not affect the validity and enforceability of the remaining terms set forth herein. Subject to any applicable law, all disputes between you and us shall only be resolved on an individual basis and you shall not have the right to bring any claim against us as a plaintiff or a member of a class, consolidated or representative actions (or any other legal proceedings conducted by a group or by representatives on behalf of others).

Assignment. You may not assign any rights and/or obligations you may have under these terms and conditions and/or Privacy Notice without our prior written consent. We may freely assign any of its rights and/or obligations herein, without limitations; provided that, your rights herein shall not be adversely affected.

Change of Control. It is clarified that in the event of a merger, change of control and/or any similar transaction involving Pluri, Pluri may transfer and export all information it may have gained through the course of the use of the Website, and your use of this Website constitutes as consent for the foregoing; provided however, that any such transfer shall be subject to applicable data privacy requirements and standards.

Amendment. Pluri reserves the right to amend or revise any of these terms of use. Any such change or amendment shall be updated on this Website.

The content, text, graphics, data, and services offered herein are provided solely to educate users of this Website on Pluri and the goods and/or services it may provide.  Nothing in said content should be considered, or used as a substitute for, medical advice, diagnosis or treatment.  Always seek the advice of your physician or other qualified health provider with any questions you may have regarding a medical condition.  Reliance on said content or any portion thereof, or other visitors to the web site, is solely at your own risk.

If you have cause to believe any content found on the Platform to be in violation of these terms and conditions and/or infringe any third party proprietary rights and/or applicable law, kindly notify us of such content via email to info@pluri-biotech.com,  stating the violating content and the nature of violation.

Physical address:  Matam Park, Building 05, Haifa, 3508409, Israel

Accessibility

Accessibility Statement

Pluri Biotech Ltd. is committed to making its electronic and information technologies accessible to individuals with disabilities by meeting or exceeding the requirements of the Web Content Accessibility Guidelines and we make every effort to ensure our communications – including this website – are accessible to people with special needs.

We have striven to make this website adhere to priority 1 and 2 guidelines of the W3 Web Content Accessibility Guidelines.

 

Navigation and navigation aids

  • The full site navigation is located on every page.
  • A link to the home page is available on each page.
  • Navigation menus are marked up as HTML lists and styled with CSS.
  • Some links have title attributes, which describe the link in greater detail. Most links are self-explanatory.
  • Links are written so as to make sense out of context.
  • Some links, mostly to downloadable files such as PDFs, open a new browser tab.

Help with finding content

Although we do our best to meet the requirements and guidelines, it is possible that some of the content is not yet fully accessible and compatible to people with special needs.

We continue to develop and improve our website as part of our general commitment to make every effort to ensure our communications are accessible to all.
If you require assistance or wish to report an issue related to the accessibility of any content on this website, please contact info@pluri-biotech.com. If applicable, please include the web address or URL and the specific problems you have encountered.

Privacy and Data Protection Policy and Notice

Last updated on 13 January 2025

Pluri Biotech Ltd. and its affiliates and related companies (“Pluri”, “we”, “our” or the “Company”, and their cognates) respects the privacy of its research partners, academic affiliate representatives, investors, clinical studies participants, employees, vendors and sites and website visitors, and others of whom we collect information, and is committed to protecting the personal information you may share with us (these and any others with respect to whom we collect personal data, shall collectively be referred to as “you”, “user”, or “data subject”).

Pluri develops platforms to manufacture cell-based products aimed at improving human well-being, increasing sustainability, and addressing significant global challenges (the “Services”). This policy and notice (the “Privacy Policy”) explains the types of information we may collect from you, that we may receive about you or that you may provide in the course of your interest or in our Services, transactions, conferences or when you use our platforms or services or visit our website. We are transparent about our practices regarding the information we collect, use, maintain and process and describe our practices in this policy and notice. Please read the following carefully to understand our practices regarding your personal data and how we will treat it.

For the purposes of EU General Data Protection Regulation ( “GDPR”), the California Consumer Privacy Act of 2018, as amended by the California Privacy Rights Act of 2020 (“CCPA”) other US State privacy laws, and any other applicable data protection and privacy laws, Pluri is usually a data controller (or ‘owner’) in relation to the personal data collected and processed through our Services or provided to us by our research partners.

 

  1. WHICH INFORMATION MAY WE COLLECT?

Summary: we collect various categories of personal data in order to meet our contractual obligations, and also to meet various legitimate interests, such as service improvement, fraud prevention and marketing.

We collect data about you in connection with your transactions with us, or in processing data for our research partners. We also collect data about our visitors and website visitors. One type of data collected is non-identifiable and anonymous information (“non-personal data”). We also collect several categories of personal data (“Personal Data”), as described below.

Personal Data which is being gathered consists of any details which are personally identifiable and which are provided consciously and voluntarily by you, or by an organization you represent or are associated with or through your use of our website and registration to and use of our Services (as described below), by email, or other ways in which you communicate and interact with us. This generally includes your name (first and last), email address, phone number, postal address, position and organization name and other information you may choose to provide to Pluri directly and willingly through your use of our Services. Additionally, we may obtain data related to the geographic location of your laptop, mobile device or other digital device on which the Pluri website or platform are used.

You do not have any legal obligation to provide any information to Pluri, however, we require certain information in order to perform contracts, or to provide any services. If you choose not to provide us with certain information, then we may not be able to provide you or your organization with some or all of the services.

By contacting us or submitting requests for information or support via the website, email etc., Pluri will collect details, including also your name, phone number and personal or company email you provided, country, professional details and other information provided by you. Pluri may use this information to offer Pluri’s services and support.

When participating in clinical research conducted by us or in collaboration with our research partners, we collect the necessary information, including health-related data.

 

  1. HOW DO WE COLLECT PERSONAL DATA OF YOURS ON PLURI FACILITIES AND SERVICES?

Summary: we collect Personal Data when you or your organization send it to us, or when a vendor, distributor or other research partner sends it to us so; we collect Personal Data through our website and Services, and through our interactions with you.

We collect Personal Data required to provide Services when you register interest, or when you provide us such information by entering it manually or automatically, or through your use of our facilities, website and Services, in the course of preparing a contract, or otherwise in engaging with us. We also may collect Personal Data when you call us for support, in which case we collect the information you provide us.

On our website, we collect technical and behavioral information such as the user’s Internet protocol (IP) address used to connect your device to the Internet, your uniform resource locators (URL), operating system, type of browser, browser plug-in types and versions, screen resolution, time zone setting, the user’s ‘clickstream’ on our website, the period of time the user visited the platform etc. We also We likewise may place cookies on your browsing devices (see ‘Cookies’ section below).

 

  1. WHAT ARE THE PURPOSES OF PERSONAL DATA WE COLLECT?

Summary: we process Personal Data to meet our obligations, protect our rights, and manage our activities.

We will use Personal Data to provide and improve our services to you or to our research partners and others and meet our contractual, ethical and legal obligations. All Personal Data will remain accurate complete and relevant for the stated purposes for which it was processed, including for example:

Processing which is necessary for the performance of a contract to which you are a party or in order to take steps at your request prior to entering into a contract:

  • Carrying out our obligations arising from any contracts entered into between you or your employer or organization and Pluri or Pluri’s research partners and/or any contracts entered into with Pluri and to provide you with the information, products, support and services that you request from Pluri and its research partners;
  • Verifying and carrying out financial transactions in relation to payments you make in connection with the Services.

Processing which is necessary for the purposes of the legitimate interests pursued by Pluri or by a third party of providing an efficient and wide-ranging service to research partners:

  • Notifying you about changes to our service;
  • Collecting data from various publicly available sources, including commercially licensed databases to develop and improve our Services;
  • Contacting you to give you commercial and marketing information about events or promotions or additional services offered by Pluri which may be of interest to you, including in other locations;
  • Soliciting feedback in connection with the services;
  • Tracking use of Pluri services to enable us to optimize them.
  • For security purposes and to identify and authenticate your access to the Services.

Processing which is necessary for compliance with a legal obligation to which Pluri is subject:

  • Compliance and audit purposes, such as meeting our reporting obligations in our various jurisdictions, anti-money laundering, and for crime prevention and prosecution in so far as it relates to our staff, research partners, facilities etc;
  • If necessary, we will use Personal Data to enforce our terms, policies and legal agreements, to comply with court orders and warrants and assist law enforcement agencies as required by law, to collect debts, to prevent fraud, infringements, identity thefts and any other service misuse, and to take any action in any legal dispute and proceeding;

We aggregate and de-identify Personal Data (i.e., use your data in a way which no longer allows to identify you) to analyze and improve our Services, and to conduct research, and for other similar purposes. We may share non-personal aggregated information with third parties, as described below.

 

  1. SHARING DATA WITH THIRD PARTIES

Summary: we share Personal Data with our service providers, research partners and academic institutions, group companies, and authorities where required.

We transfer Personal Data to:

 

Research partners, Academic institutions and Collaborators. We transfer or receive Personal Data from our various partners in order to facilitate joint research projects, enhance the quality and scope of our studies, and ensure the accuracy and reliability of our findings. This data exchange enables us to conduct collaborative research and development activities, fulfill contractual obligations with research partners and collaborators, comply with regulatory requirements applicable to clinical studies and research and advance scientific discoveries and innovations in line with our mission.  

Third Parties. We transfer Personal Data to third parties in a variety of circumstances. We endeavor to ensure that these third parties use your information only to the extent necessary to perform their functions, and to have a contract in place with them to govern their processing on our behalf. These third parties include business partners, suppliers, affiliates, agents and/or sub- contractors for the performance of any contract we enter into with you. They assist us in providing the services we offer, processing transactions, fulfilling requests for information, receiving and sending communications, analyzing data, providing IT and other support services or in other tasks, from time to time. These third parties also include analytics and search engine providers that assist us in the improvement and optimization of our platform, website, and our marketing.

We periodically add and remove third party providers. At present services provided by third-party providers to whom we may transfer Personal Data include also the following:

– Website and platform analytics, including Google Analytics;

– Expression and language measurement services;

– Document management and sharing services;

– Ticketing and support;

– On-site and cloud-based database services;

– CRM software;

– Data security, data backup, and data access control systems;

– Project management systems;

– Our lawyers, accountants, and other standard business software and partners.

In addition, we will disclose your Personal Data to third parties if some or all of our companies or assets are acquired by a third party including by way of a merger, share acquisition, asset purchase or any similar transaction, in which case Personal Data will be one of the transferred assets. Likewise, we transfer Personal Data to third parties if we are under a duty to disclose or share your Personal Data in order to comply with any legal or audit or compliance obligation, in the course of any legal or regulatory proceeding or investigation, or in order to enforce or apply our terms and other agreements with you or with a third party; or to assert or protect the rights, property, or safety of Pluri, our research partners, or others. This includes exchanging information with other companies and organizations for the purposes of fraud protection and credit risk reduction and to prevent cybercrime.

For purposes of the California Consumer Privacy Act as amended (“CCPA”) or other US privacy state laws, Pluri does not “sell” or “share” personal information, nor do we allow any personal information to be used by third parties for their own marketing. However, we use analytics tools and other technologies (as described above), which may be construed as a “sale” under privacy laws to which you may opt- out of. For avoidance of doubt, Pluri may transfer and disclose non-Personal Data to third parties at its own discretion.

 

  1. WHERE DO WE STORE YOUR DATA?

Summary: we store your Personal Data across multiple locations globally

We store your Personal Data in databases owned or controlled by us, or processed by third parties on our behalf, by reputable cloud-service providers (see the following section regarding international transfers).

 

  1. INTERNATIONAL DATA TRANSFERS

Summary: we transfer Personal Data within and to the EEA, USA, Israel and elsewhere, with appropriate safeguards in place.

Personal Data may be transferred to, and stored and processed at, a destination outside its origin. EU data may be transferred outside the European Economic Area (EEA). This includes transfer to Israel, a jurisdiction deemed adequate by the EU Commission, and to the USA, which may be deemed adequate under certain circumstances but not always. Where your Data is transferred outside of the EEA, we will take all steps reasonably necessary to ensure that your Data is subject to appropriate safeguards, including entering into contracts that require the recipients to adhere to data protection standards that are considered satisfactory under EU law and other applicable, and that it is treated securely and in accordance with this Privacy Policy. Transfers to Israel are made based on an adequacy ruling by the EU Commission. Transfers to the USA are made based either on an adequacy ruling to members of the data privacy framework, or based on the Standard Contractual Clauses published by the EU Commission. For more information about these safeguards, please contact us as set forth below.

We may transfer your Personal Data outside of the EEA, in order to:

– Store or backup the information;

– Enable us to provide you with the services and products and fulfill our contract with you;

– Fulfill any legal, audit, ethical or compliance obligations which require us to make that transfer;

– Facilitate the operation of our group businesses, where it is in our legitimate interests and we have concluded these are not overridden by your rights;

– Collaborate with our research partners across multiple jurisdictions.

 

  1. DATA RETENTION

Summary: we retain Personal Data according to our data retention policy, as required to meet our obligations, protect our rights, and manage our business and activities.

Pluri will retain Personal Data it processes only for as long as required in our view, to provide the Services and as necessary to comply with our legal and other obligations, to resolve disputes and to enforce agreements. We will also retain Personal Data to meet any audit, compliance and industry practices.

Data that is no longer retained may be anonymized or deleted. Likewise, some metadata and statistical information concerning the use of our services are not subject to the deletion procedures in this policy and will be retained by Pluri. We will not be able to identify you from this data. Some data may also be retained on our third-party service providers’ servers until deleted in accordance with their privacy policy and their retention policy, and in our backups until overwritten.

 

  1. SERVICES AND WEBSITE DATA COLLECTION AND COOKIES

Summary: we retain Personal Data according to our data retention policy, as required to meet our obligations, protect our rights, and manage our business.

Summary: with your consent, we place cookies on your device. You control our use of cookies through a cookie management tool on our website, or through your device and browser.

Pluri uses cookies, pixel tags and other forms of identification and local storage (together referred to as “tags/files” hereunder) to distinguish you from other users of the website and of websites of our network. This helps us to provide you with a good user-experience when you browse the website and websites of our network and also allows us to improve our website and our services.

In many cases, these tags/files lead to the use of your device’s processing or storage capabilities. Some of these tags/files are set by Pluri itself, others by third parties; some only last as long as your browser session, while others can stay active on your device for a longer period of time.

These tags/files can fall into several categories: (i) those that are necessary for functionality or services that you request or for the transmission of communications (functionality tags/files); (ii) those that we use to carry out website performance and audience metrics (analytics tags/files) and (iii) the rest (tracking across a network of other websites, advertising, etc.) (other tags/files).

Internet browsers allow you to change your cookie settings, for example to block certain kinds of cookies or files. You can therefore block cookies by activating the setting on your browser that allows you to refuse the setting of all or some cookies. However, if you use your browser settings to block all cookies, you may not be able to access all or parts of the website, due to the fact that some may be functionality cookies. For further information about deleting or blocking cookies, please visit: https://www.aboutcookies.org/how-to-delete-cookies/

Functionality and analytical tags/files do not require your consent. For other tags/files, however, we request your consent before placing them on your device. You can allow cookies in your browser settings and using our website cookie management too.

To consult the list of cookies which we use on our website, please check your browser’s settings. Instructions: https://www.wikihow.com/View-Cookies

 

  1. SECURITY AND STORAGE OF INFORMATION

Summary: we retain Personal Data according to our data retention policy, as required to meet our obligations, protect our rights, and manage our business.

We take great care in implementing, enforcing and maintaining the security of the Personal Data we process. Pluri implements, enforces and maintains security measures, technologies and policies to prevent the unauthorized or accidental access to or destruction, loss, modification, use or disclosure of Personal Data. We likewise take steps to monitor compliance of such policies on an ongoing basis. Where we deem it necessary in light of the nature of the data in question and the risks to data subjects, we may encrypt data. Likewise, we take industry standard steps to ensure our website and services are safe.

Note however, that no data security measures are perfect or impenetrable, and we cannot guarantee that unauthorized access, leaks, viruses and other data security breaches will never occur.

Within Pluri, we endeavor to limit access to Personal Data to those of our personnel who: (i) require access in order for Pluri to fulfill its obligations, including also under its agreements, and as described in this Privacy Policy, and (ii) have been appropriately and periodically trained with respect to the requirements applicable to the processing, care and handling of the Personal Data, and (iii) are under confidentiality obligations as may be required under applicable law.

Pluri shall act in accordance with its policies and with applicable law to promptly notify the relevant authorities and data subjects in the event that any Personal Data processed by Pluri is lost, stolen, or where there has been any unauthorized access to it, all in accordance with applicable law and on the instructions of qualified authority. Pluri shall promptly take reasonable remedial measures.

 

  1. DATA SUBJECT RIGHTS

Summary: depending on the law that applies to your Personal Data, you may have various data subject rights, such as rights to access, erase, and correct Personal Data, and information rights. We will respect any lawful request to exercise those rights.

Data subjects with respect to whose data GDPR, CCPA or other data protection or privacy laws apply, have rights under GDPR and local laws, including, in different circumstances, rights to data portability, rights to access data, rectify data, object to processing, and erase data. It is clarified for the removal of doubt, that where Personal Data is provided by a research partner or academic institution being the data subject’s employer or data controller, such data subject rights will have to be effected through that research partner, the data subject’s employer or supplier. In addition, data subject rights cannot be exercised in a manner inconsistent with the rights of Pluri employees and staff, with Pluri proprietary rights, and third-party rights. As such, job references, reviews, internal notes and assessments, documents and notes including proprietary information or forms of intellectual property, cannot be accessed or erased or rectified by data subjects. In addition, these rights may not be exercisable where they relate to data that is not in a structured form, for example emails, or where other exemptions apply. If processing occurs based on consent, data subjects have a right to withdraw their consent.

A data subject who wishes to modify, delete or retrieve their Personal Data, including from our database, or to opt-out from using data to train our models, may do so by contacting Pluri (dataprotection@pluri-biotech.com). Note that Pluri may have to undertake a process to identify a data subject exercising their rights. Pluri may keep details of such rights exercised for its own compliance and audit requirements. Please note that Personal Data may be either deleted or retained in an aggregated manner without being linked to any identifiers or Personal Data, depending on technical commercial capability. Such information may continue to be used by Pluri.

Data subjects in the EU, and in other locations have the right to lodge a complaint, with a data protection supervisory authority in the place of their habitual residence. If the supervisory authority fails to deal with a complaint, you may have the right to an effective judicial remedy.

 

  1. GENERAL

Summary: depending on the law that applies to your Personal Data, you may have various data subject rights, such as rights to access, erase, and correct Personal Data, and information rights. We will respect any lawful request to exercise those rights.

Minors. We do not knowingly collect or solicit information or data from or about children under the age of 16 or knowingly allow children under the age of 16 to register for Pluri services. If you are under 16, do not register or attempt to register for any of the Pluri service or send any information about yourself to us. If we learn that we have collected or have been sent Personal Data from a child under the age of 16 unlawfully, we will delete that Personal Data as soon as reasonably practicable without any liability to Pluri. If you believe that we might have collected or been sent information from a minor under the age of 16, please contact us at: dataprotection@pluri-biotech.com, as soon as possible.

Changes to this Privacy Policy. The terms of this Privacy Policy will govern the use of the Services, website, and any information collected in connection with them. Pluri may amend or update this Privacy Policy from time to time. The most current version of this Privacy Policy will be available at: www. pluri-biotech.com/privacy-policy. Changes to this Privacy Policy are effective as of the stated “Last Revised” date and your continued use of our services will constitute your active acceptance of the changes to and terms of the Privacy Policy.

Pluri aims to process only adequate, accurate and relevant data limited to the needs and purposes for which it is gathered. Note that due to the nature of the Services we cannot guarantee the accuracy of the output of the Services. You may request correction or removal of your data by reaching out to us at: dataprotection@pluri-biotech.com.

Pluri aims to store data for the time period necessary to fulfill the purpose for which the data is gathered. we only collect data in connection with a specific lawful purpose and only processes data in accordance with this Privacy Policy. Our policies and practices are constantly evolving and improving, and we invite any suggestions for improvements, questions, complaints or comments concerning this Privacy Policy, you are welcome to contact us (details below) and we will make an effort to reply within a reasonable time frame.

Pluri’s data protection officer (DPO) may be contacted at: info@pluristem.com; dataprotection@pluristem.com

Physical address: Pluristem Ltd. Attention: Legal Counsel and DPO

Matam Park, Building 05 Haifa, 3508409, Israel

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©2023 Pluri™ Inc.

©2023 Pluri™ Inc., its logo, brand, product, and process names appearing in this issue are the trademarks of Pluri™ Inc. or its affiliated companies. All other brand, product, and process names appearing are the trademarks of their respective holders. Reference to or use of a product, or process other than those of Pluri™ Inc. does not imply recommendation, approval, affiliation, or sponsorship of that product, or process by Pluri™ Inc. Nothing contained herein shall be construed as conferring by implication, estoppel, or otherwise any license or right under any patent, copyright, trademark, or other intellectual property right of Pluri™ Inc. or any third party, except as expressly granted herein.  All information herein is for general information only and is subject for change without notice.

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