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Presentations underscore significant need for new PAD treatment approaches and the potential of cell therapy to improve patient outcomes while reducing healthcare costs

 

HAIFA, Israel, December 17, 2018 – 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 (KOL) breakfast meeting on peripheral artery disease (PAD) that the Company hosted on Friday, December 14 in New York. The meeting focused on the current treatment landscape, unmet medical need, economic impact and potential market opportunities for treating patients with PAD, a serious but common circulatory problem characterize by a blockage of the arteries and reduced blood flow to the limbs. Risk factors include smoking, diabetes, heavy weight, cardiovascular problems & hypertension.

 

In addition to a management update on the Company’s ongoing late-stage development of PLX- PAD, the meeting featured comprehensive presentations by John Lantis, MD, Vice Chairman of the Department of Surgery and Chief of Vascular and Endovascular Surgery at Mount Sinai West, and Mary L. Yost, MBA, Co-Founder of The Sage Group.

 

“The presentations offered by these Key Opinion Leaders underscore the significant unmet medical need in PAD, and particularly critical limb ischemia (CLI), and highlight the potential of cell therapies in improving patient outcomes while addressing the significant economic burden of treating this serious cardiovascular disease,” said Yaky Yanay, Co-CEO and President of Pluristem. “We believe PLX-PAD has the potential to become the standard of care in CLI treatment, and we look forward to data from our ongoing multinational pivotal Phase III CLI study.”

 

Among the highlights:

 

 

“Potentially, cellular therapies that can actually modify the diseased tissue into healthier more responsive tissue offer the possibility of cure and not just a treatment,” commented Dr. Lantis. Early studies have shown significant clinical benefit from this type of therapy and I am very pleased that significant further clinical research is well underway”.

 

 

“The global economic burden of CLI is staggering, and exceeds the burden of diabetes, cancer and carotid artery disease combined,” commented Ms. Yost. “Furthermore, with an aging global population and continued growth in the prevalence of diabetes, this burden is only projected to increase, which speaks to the urgent need for new innovative and cost-effective treatments for this serious disease.”

 

Pluristem’s pivotal Phase III study of PLX-PAD cells in the treatment of CLI, which has received an $8 million grant from the European Union’s Horizon 2020 program, has received the U.S. Food and Drug Administration’s (FDA) Fast Track designation for the treatment of CLI and has been included in the European Medicines Agency (EMA) Adaptive Pathways program, which may lead to early conditional marketing authorization based on an interim analysis following follow up on half of the total 246 patients to be enrolled in the study. The FDA recently cleared PLX-PAD for its Expanded Access Program (EAP), with cost recovery, for the treatment of patients with CLI who are not eligible for Pluristem’s Phase III study.

 

For PAD KOL day slides- link For PAD KOL day webcast- link

 

About Pluristem Therapeutics

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

 

Safe Harbor Statement

This press release contains express or implied forward-looking statements within the Private Securities Litigation Reform Act of 1995 and other U.S. Federal securities laws.
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; we may encounter delays or obstacles in launching and/or successfully completing our clinical trials; our products may not be approved by regulatory agencies, 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 process; our products may wind up being more expensive than we anticipate; 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; 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 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

Head of Investor and Public Relations 972-74-7108600

efratk@pluristem.com

Karine Kleinhaus, MD, MPH Divisional VP, North America

 

1-914-512-4109

karinek@pluristem.com

For those who are unable to attend in person, a live webcast and replay will be accessible here

 

HAIFA, Israel, December 13, 2018 – Pluristem Therapeutics Inc. (Nasdaq:PSTI) (TASE:PSTI), a leading regenerative medicine company developing novel placenta-based cell therapy products, will host a Key Opinion Leader (KOL) meeting on Peripheral Artery Disease (PAD) tomorrow, December 14, 2018 at 8am-9:30am EST, in New York City.

The meeting will feature presentations by KOLs John Lantis, MD, Vice Chairman of the Department of Surgery and Chief of Vascular and Endovascular Surgery at Mount Sinai West, and Mary L. Yost, MBA, Co-Founder of The Sage Group, who will discuss the current treatment landscape and unmet medical needs, the economic impact, and potential market opportunities for treating patients with PAD. Both KOLs will be available at the conclusion of the event to answer questions.

 

Pluristem’s management team will also provide a corporate overview of the company’s development strategy and recent achievements. Of note, the FDA recently approved an Expanded Access Program (EAP) for PLX-PAD in CLI patients. It is estimated that 5-6 million people in U.S. and Europe suffer from CLI, and this number is projected to grow, with an estimated cost of $25 billion per year in the U.S. alone.

This event is intended for institutional investors, sell-side analysts, investment bankers, and business development professionals only. Please RSVP in advance if you plan to attend, as space is limited. For those who are unable to attend in person, a live webcast and replay will be accessible here. If you would like to ask a question during the live Q&A, please submit your request via email.

 

About Pluristem Therapeutics

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

 

Safe Harbor Statement

This press release contains express or implied forward-looking statements within the Private Securities Litigation Reform Act of 1995 and other U.S. Federal securities laws.
For example, we are using forward-looking statements when we discuss the estimated growth in the population in the U.S. and Europe suffering from CLI and projected cost of treatment of CLI in the U.S.
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; we may encounter delays or obstacles in launching and/or successfully completing our clinical trials; our products may not be approved by regulatory agencies, 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 process; our products may wind up being more expensive than we anticipate; 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; 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 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

Head of Investor and Public Relations 972-74-7108600

efratk@pluristem.com

Karine Kleinhaus, MD, MPH Divisional VP, North America

 

1-914-512-4109

karinek@pluristem.com

HAIFA, Israel, December 4, 2018 – Pluristem Therapeutics Inc. (Nasdaq:PSTI) (TASE:PSTI), a leading regenerative medicine company developing novel placenta-based cell therapy products, today announced that it has entered into a license agreement with a subsidiary of Chart Industries, Inc. regarding Pluristem’s thawing device for cell-based therapies. Per the terms of the agreement, Chart obtains the exclusive rights to manufacture and market the thawing device in all territories worldwide, excluding China, with Pluristem receiving royalties from sales of the product and supply of an agreed number of devices.

Pluristem’s point-of-care thawing device technology is designed to allow for the precise and automated thawing of cells in a controlled and monitored environment, and is expected to result in the highest levels of cell viability and quality.
The technology includes many advanced unique proprietary features which were designed to result in the leading thawing devices on the market.

“Regenerative medicine and cellular therapies products are making significant progress towards market, and we need to make sure the enabling tools are in place.
In order to get the best clinical efficacy outcome we need a full control of the cold chain, including, most importantly, the most effective method of thawing of cells before treatment of patients,” said Yaky Yanay, Co-Chief Executive Officer and President of Pluristem. “We are extremely pleased to have Chart Industries, Inc., a global leader in cryogenic equipment, as our marketing and manufacturing partner, and look forward to working with Chart to bring our thawing device technologies to clinical centers and labs across the globe.”

 

“For more than 50 years, Chart Industries, Inc. has been a leading innovator in the cryogenic freezing and storage of biological materials that are critical to the life sciences industry, including human tissue, cord blood, bone marrow and stem cells,” said Buzz Bies, Vice President and GM Chart Inc. – Cold Storage Sales. “I believe Pluristem’s best-in-class cellular thawing device is a perfect complement to Chart’s portfolio of solutions, and we look forward to offering this technology to our customer base worldwide.”

About Chart Industries, Inc.

Chart is a leading diversified global manufacturer of highly engineered equipment for the industrial gas, energy, and biomedical industries.
The majority of Chart’s products are used throughout the liquid gas supply chain for purification, liquefaction, distribution, storage and end-use applications, a large portion of which are energy-related. Chart has domestic operations located across the United States and an international presence in Asia, Australia, Europe and Latin America.
For more information, visit: http://www.chartindustries.com.

 

About Pluristem Therapeutics

 

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

 

Safe Harbor Statement

This press release contains express or implied forward-looking statements within the Private Securities Litigation Reform Act of 1995 and other U.S. Federal securities laws.
The 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

Head of Investor and Public Relations 972-74-7108600

efratk@pluristem.com

 

Karine Kleinhaus, MD, MPH Divisional VP, North America

 

1-914-512-4109

karinek@pluristem.com

 

HAIFA, Israel, December 3, 2018 – Pluristem Therapeutics Inc. (Nasdaq:PSTI) (TASE:PSTI), a leading regenerative medicine company developing novel placenta-based cell therapy products, today announced that the Company presented data from the first cohort of patients in its ongoing Phase I clinical trial of PLX-R18 for the treatment of incomplete hematopoietic recovery following hematopoietic cell transplantation (HCT) at the American Society of Hematology (ASH) 60th Annual Meeting and Exposition, which is being held December 1-4 in San Diego.

 

The poster, titled “Prospective, Multi-Center, Phase I Clinical Trial of PLX-R18 Placental Expanded Adherent Stromal Cells in Subjects with Incomplete Hematopoietic Recovery after Hematopoietic Cell Transplantation,” summarizes findings from the first cohort of three patients in the Company’s Phase I clinical study which is ongoing in the U.S. and Israel. Patients were administered two doses of PLX-R18 one week apart via intramuscular (IM) injections at the lowest of three doses to be evaluated (1 million PLX-R18 cells/kg). The treatment was found to be safe and well tolerated, with no unexpected toxicities. All safety data had been reviewed by an external safety committee and based on the safety presented to them study was approved to move forward. In addition, early signals of efficacy in improving blood counts were observed. As previously announced in September 2018, the PLX-R18 cell therapy for the treatment of incomplete hematopoietic recovery following HCT was granted Orphan Drug Designation by the

U.S. Food and Drug Administration.

 

“We are pleased that the first cohort in this important study met its primary objective of safety, and are encouraged by the early signals of efficacy that we observed, even at the lowest dose in patients suffering from serious hematological condition failing to reach hematopoietic recovery,” commented Zami Aberman, Chairman and Co-Chief Executive Officer of Pluristem. “We are now enrolling the second cohort of patients to be evaluated at an intermediate dose of two million cells per kilogram, and we look forward to additional data as we continue to advance this promising regenerative cell therapy through clinical development.”

 

This Phase I study is designed as a multi-center, open-label, dose-escalating study to evaluate the safety of IM injections of PLX-R18 cells in 24 patients with incomplete hematopoietic recovery persisting for at least four months after HCT. The follow up period is 12 months. The patients in the study will be enrolled into three chronological treatment groups: two administrations of 1 million PLX-R18 cells/kg (n=3), two administrations of 2 million PLX-R18 cells/kg (n=6) and two administrations of 4 million PLX-R18 cells/kg (n=15). The primary endpoint is safety which is assessed, at the end of each cohort, by an external Data Safety Monitoring Board. In addition, exploratory evaluations are made, including changes in platelet and hemoglobin levels, changes in transfusion frequency, a shift from transfusion dependence to transfusion independence, changes in quality of life and changes in the serum immunological parameters.

About Pluristem Therapeutics

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

 

Safe Harbor Statement

 

This press release contains express or implied forward-looking statements within the Private Securities Litigation Reform Act of 1995 and other U.S. Federal securities laws.
For example, Pluristem is using forward-looking statements when it discusses the timing and plans relating to its clinical trials, the safety of PLX-R18 in the clinical trial and the early signals of efficacy in improving blood counts observed in the clinical trial.
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

Head of Investor and Public Relations 972-74-7108600

efratk@pluristem.com

Karine Kleinhaus, MD, MPH Divisional VP, North America 1-914-512-4109

karinek@pluristem.com

HAIFA, Israel, November 29, 2018 – Pluristem Therapeutics Inc. (Nasdaq:PSTI) (TASE:PSTI), a leading regenerative medicine company developing novel placenta-based cell therapy products, today announced that it will host a Key Opinion Leader (KOL) meeting on Peripheral Artery Disease (PAD) on December 14, 2018 in New York City.

The meeting will feature presentations by KOLs John Lantis, MD, Vice Chairman of the Department of Surgery and Chief of Vascular and Endovascular Surgery at Mount Sinai West, and Mary L. Yost, MBA, Co-Founder of The Sage Group, who will discuss the current treatment landscape and unmet medical needs, the economic impact, and potential market opportunities for treating patients with PAD. Both KOLs will be available at the conclusion of the event to answer questions.

Pluristem’s management team will also provide a corporate overview of the company’s development strategy for PLX-PAD, which is currently in a multinational pivotal Phase III clinical study. Of note, the FDA recently approved an Expanded Access Program (EAP) for PLX-PAD in CLI patients. It is estimated that 5-6 million people in U.S. and Europe suffer from CLI, and this number is projected to grow, with an estimated cost of $25 billion per year in the U.S. alone.

This event is intended for institutional investors, sell-side analysts, investment bankers, and business development professionals only. Please RSVP in advance if you plan to attend, as space is limited. For those who are unable to attend in person, a live webcast and replay will be accessible here. If you would like to ask a question during the live Q&A, please submit your request via email.

 

About Pluristem Therapeutics

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

 

Safe Harbor Statement

This press release contains express or implied forward-looking statements within the Private Securities Litigation Reform Act of 1995 and other U.S. Federal securities laws.
For example, we are using forward-looking statements when we discuss the estimated growth in the population in the U.S. and Europe suffering from CLI and projected cost of treatment of CLI in the U.S.
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; we may encounter delays or obstacles in launching and/or successfully completing our clinical trials; our products may not be approved by regulatory agencies, 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 process; our products may wind up being more expensive than we anticipate; 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; 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 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

Head of Investor and Public Relations 972-74-7108600

efratk@pluristem.com

Karine Kleinhaus, MD, MPH Divisional VP, North America 1-914-512-4109

karinek@pluristem.com

HAIFA, ISRAEL, November 28, 2018 – Pluristem Therapeutics Inc. (NASDAQ: PSTI, TASE: PSTI), (Nasdaq:PSTI) (TASE:PSTI), a leading regenerative medicine company developing novel placenta-based cell therapy products, today announced that the company will present data from the first cohort of its Phase I study of PLX-R18 cells for the treatment of incomplete hematopoietic recovery following hematopoietic cell transplantation (HCT) at the American Society of Hematology’s (ASH) 60th Annual meeting to be held in San Diego, California, on December 1-4, 2018.

 

About the study

A Phase I study of PLX-R18 cells to treat incomplete hematopoietic recovery following HCT is ongoing in U.S. and Israel.
The trial is designed as a multi-center, open-label, dose-escalating study to evaluate the safety of intramuscular injections (IM) of PLX-R18 cells in 24 subjects with incomplete hematopoietic recovery persisting for at least 4 months after HCT.
The 24 patients in the study will be enrolled into three treatment groups: two administrations of 1 million PLX-R18 cells (n=3), two administrations of 2 million PLX-R18 cells (n=6), two administrations of 4 million PLX-R18 cells (n=15).
The primary endpoint will be safety which will be assessed at the end of each cohort by an external safety committee. There will also be exploratory endpoints, including changes in platelet and hemoglobin levels, changes in transfusion frequency, a shift from transfusion dependence to transfusion independence, changes in quality of life, and changes in the serum immunological parameters.

 

About Pluristem Therapeutics

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

 

Safe Harbor Statement

 

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

Contact:

 

Karine Kleinhaus, MD, MPH Divisional VP, North America 1-914-512-4109

karinek@pluristem.com

 

Efrat Kaduri

Head of Investor and Public Relations 972-74-7108600

efratk@pluristem.com

Additional data from Pluristem’s Phase II IC study were presented at the 2018 American Heart Association Scientific Sessions

 

HAIFA, Israel, November 12, 2018 – Pluristem Therapeutics Inc. (Nasdaq:PSTI) (TASE:PSTI), a leading regenerative medicine company developing novel placenta-based cell therapy products, today announced that the Company presented additional data from its Phase II clinical study evaluating PLX-PAD for the treatment of Intermittent Claudication (IC) at the 2018 American Heart Association Scientific Sessions in Chicago. The data were presented by Prof. Norbert Weiss, MD, Director of the Vascular Center at the Technical University of Dresden, Germany, and the lead European Principal Investigator for the Phase II IC study.

 

Among the study findings:

 

 

indicates better glucose control in patients and is the most commonly used measurement to evaluate treatment efficacy in diabetics.

 

“We are very encouraged with the results and additional findings seen in this study. PAD patients, especially those suffering from CLI, often display high level of inflammation and, as seen within our IC study, most are diabetic,” commented Prof. Weiss. “The data we presented at the AHA suggest that PLX- PAD may play a meaningful role in lowering inflammation and maintain better glycemic control reflecting the potential of this non-surgical cell-based therapeutic to address key unmet needs of PAD and the associated co-morbidities.”

“This study was important in confirming the design of our ongoing Phase III trial evaluating PLX-PAD for the treatment of CLI, and we are optimistic that these promising results will be reproducible in larger patient populations,” said Zami Aberman, Chairman and Co-Chief Executive Officer of Pluristem. “The recent findings provide comprehensive understanding of PLX-PAD cells mechanism of action in PAD patients by supporting angiogenesis, reducing inflammation and lowering the average glucose levels of this patients. The recent FDA approval of the expanded access program in CLI, together with the multiple special regulatory pathways that we have been granted in the U.S. and Europe, and the significant funding that we have received for this project to date, justify our growing enthusiasm for PLX-PAD as a potential new and groundbreaking treatment for PAD. We look forward to Phase III data as we work to introduce this treatment as an innovative solution for PAD patients.”

Initial topline results from this Phase II IC study were previously announced by the Company in June 2018.

 

About Pluristem’s Phase II IC Study

Pluristem’s Phase II IC study was designed to evaluate the safety, efficacy and optimal dosing regimen for PLX-PAD cells in patients with IC Rutherford categories 2-3. Enrollment took place at 28 clinical sites in the U.S., Germany, South Korea and Israel. The 172 patients in the study were randomized into four treatment groups: two administrations of 300 million PLX-PAD cells (“main efficacy group”); two administrations of 150 million PLX-PAD cells; two administrations of placebo; or one administration of 300 million PLX-PAD cells followed by placebo. In each of these study arms, the two administrations were given intramuscularly (IM), 3 months apart. The primary efficacy endpoint was the change from baseline in maximal walking distance (MWD) at 52 weeks compared to placebo. The key secondary endpoint was the change from baseline in MWD at 52 weeks compared to placebo, in patients treated with 2 doses of PLX-PAD originating from different donors (Pluristem’s proprietary Bio-Therapeutic approach). Other endpoints included risk of revascularization and other hemodynamic and clinical outcome measures.

 

About Pluristem Therapeutics

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

 

Safe Harbor Statement

This press release contains express or implied forward-looking statements within the Private Securities Litigation Reform Act of 1995 and other U.S. Federal securities laws.
For example, Pluristem is using forward-looking statements when it discusses the potential of PLX-PAD to play a meaningful role in lowering levels of CRP and HbA1c and to address key unmet needs of PAD, the ability to reproduce the results of clinical trials in larger patient populations and the potential for PLX-PAD to be a new and groundbreaking treatment for PAD.
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

 

Contact:

Efrat Kaduri

Head of Investor and Public Relations 972-74-7108600

efratk@pluristem.com

Karine Kleinhaus, MD, MPH Divisional VP, North America 1-914-512-4109

karinek@pluristem.com

HAIFA, Israel, November 8, 2018 – Pluristem Therapeutics Inc. (Nasdaq:PSTI) (TASE:PSTI), a leading regenerative medicine company developing novel placenta-based cell therapy products, today reported financial results for its fiscal first quarter 2019 ended September 30, 2018 and provided a corporate update.

“We were very pleased to announce this quarter on FDA approval of an expanded access program that will provide critical limb ischemia patients who are not suitable for enrollment in our Phase III trial with access to PLX-PAD while the trial is ongoing,” said Yaky Yanay, Co-Chief Executive Officer and President of Pluristem. “Importantly, the FDA approved reimbursement for the procedure with a cost recovery that may provide a key reference point for eventual commercial pricing, assuming product approval.”

“During the fiscal first quarter and subsequent period, we continued to make progress advancing our pipeline of novel placenta-based cell therapy products in multiple indications,” Mr. Yanay continued “, we are making good progress in enrolling patients in both ongoing Phase III clinical trials of PLX-PAD in critical limb ischemia (CLI) and the treatment of muscle injury following hip fracture. We were pleased to expand the studies to Israel, following the Israel’s Ministry of Health approvals, in addition to existing sites in the U.S. and Europe, which we expect should allow us to reach our enrollment goals faster. We look forward to data from these advanced trials, which are being funded by more than $16 million in grants from the European Union’s Horizon 2020 program, as we continue on the path toward becoming a commercial- stage regenerative medicine company.”

“Regarding our second cell therapy product, PLX-R18, which we are developing for several hematopoietic indications, during the quarter we received Orphan Drug Designation for the treatment of graft failure and incomplete recovery following hematopoietic cell transplantation. We are currently evaluating this novel therapeutic cell therapy product in an open-label Phase I clinical trial being conducted in the U.S. and Israel, and we look forward to data that will help guide our next steps in the development of this promising therapeutic,” Mr. Yanay concluded.

 

Financial Update:

As of September 30, 2018, Pluristem had approximately $30 million in resources, out of which $22.5 million in cash and cash equivalents, bank deposits and restricted deposits, and remaining are derived from approved grants to be payable over time.
The Company’s net cash used for operating activities was $8.5 million for this quarter.

 

About Pluristem Therapeutics

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

 

Safe Harbor Statement

 

This press release contains express or implied forward-looking statements within the Private Securities Litigation Reform Act of 1995 and other U.S. Federal securities laws.
For example, Pluristem is using forward-looking statements when it discusses its belief that, with respect to its two Phase III clinical trials of PLX-PAD in CLI, the opening of trial sites in Israel, in addition to existing sites in the U.S. and Europe, should allow it to reach it enrollment goals faster, and also opens the door to potential commercial approval in Israel, its belief that it may be reimbursed for the procedure relating to its expanded access program for CLI with a cost recovery that may provide a key reference point for eventual commercial pricing, assuming product approval, and its belief that the data derived from its open-label Phase I clinical trial being conducted in the U.S. and Israel relating to PLX-R18 will help guide its next steps in the development of the promising therapeutic cell therapy product.
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

Head of Investor and Public Relations 972-74-7108600

efratk@pluristem.com

 

 

Karine Kleinhaus, MD, MPH Divisional VP, North America 1-914-512-4109

karinek@pluristem.com

The Company will also present at the BioEurope, Annual Vascular Interventional Advances and Cell and Gene Therapy Manufacturing conferences, all held in November

 

HAIFA, Israel, October 18, 2018 – Pluristem Therapeutics Inc. (Nasdaq:PSTI) (TASE:PSTI), a leading regenerative medicine company developing novel placenta-based cell therapy products, today announced that the Company will be presenting at four conferences during November: at the BioEurope conference, which is being held November 5–7, 2018 in Copenhagen, at the 15th Annual Vascular Interventional Advances (VIVA) Conference, which is being held November 5-8 in Las Vegas, at the 2018 American Heart Association (AHA) Scientific Sessions, which are being held November 10-12 in Chicago and the Cell and Gene Therapy Manufacturing conference, which is being held November 14-15 in London.

 

At the AHA Scientific Sessions, Prof. Norbert Wiess, the Principal Investigator of the Company’s Phase II intermittent claudication (IC) study, will present detailed results from the study. The presentation will be held on Saturday, November 10, 2018 from 9:00-10:15am. In June 2018, the Company announced positive top-line results from its multinational Phase II clinical study of PLX-PAD cells in the treatment of IC. Data demonstrated PLX-PAD’s ability to reduce the incidence of revascularization and improved patients’ mobility. Study results also validate the design of Pluristem’s ongoing pivotal Phase III study in critical limb ischemia (CLI), a more severe stage of PAD.

At the VIVA Conference, during the Disruptive Technology session, Pluristem will present an overview of its off-the-shelf, placenta-derived cell therapy technology and development plans for its lead cell therapy candidate, PLX-PAD, for the treatment of peripheral artery disease (PAD). The presentation will be held on Wednesday, November 7, 2018 from 8:15-9:15am.

At the BioEurope conference, during the cell and gene track, Pluristem will present an overview of its cell therapy products and clinical development. The presentation will be held on Tuesday, November 6, 2018, from 10:00-11:00am.

At the Cell and Gene Therapy Manufacturing conference, Pluristem will present an overview of its in- house manufacturing process. The presentation will be held on Thursday, November 15, 2018 from 9:10- 9:50am.

About Pluristem Therapeutics

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

 

Safe Harbor Statement

 

This press release contains express or implied forward-looking statements within the Private Securities Litigation Reform Act of 1995 and other U.S. Federal securities laws.
For example, Pluristem is using forward-looking statements when it discusses the timing, description and results of its clinical studies and its belief that the PLX-PAD study results validate the design of its ongoing Phase III study in CLI.
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

Head of Investor and Public Relations 972-74-7108600

efratk@pluristem.com

 

 

Karine Kleinhaus, MD, MPH Divisional VP, North America 1-914-512-4109

karinek@pluristem.com

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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.

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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.

 

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Pluri – Privacy Policy

Last updated on 26 December 2022

  1. Introduction

Pluri Biotech Ltd., on its behalf and on behalf of its related companies (“Pluri” “we” or “us”) respects the privacy of its participants, employees, sites visitors and website visitors (these and any others with respect to whom we collect personal data, shall collectively be referred to as “you” or “Data Subjects”) and is committed to protecting the personal information you may share with us.

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 during your participation in our services, business transactions, conferences or when you visit our sites or website. We are transparent about our practices regarding the information we may collect, use, maintain and process and describe our practices in this Privacy Policy. Please read the following carefully to understand our practices regarding your personal data and how we will treat it.

What is Personal Data?

Regarding our relations with you in connection with your use of our services, “Personal Data” means any data, which may enable the identification of a specific person, or is otherwise linked to such potentially identifying data.

  1. For What Purposes Do We Collect Your Personal Data?

We will use your Personal Data to provide and improve our services to our participants 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 and Pluri and to provide you with the information, and services that you request from Pluri.

Processing which is necessary for the purposes of the legitimate interests pursued by Pluri:

  • Notifying you about changes to our terms;
  • Contacting you for the purpose of providing you with technical assistance and other related information about the services;
  • Replying to your queries, troubleshooting problems, detecting and protecting against error, fraud or other criminal activity;
  • Contacting you to give you commercial and marketing information about events or promotions or additional services and products offered by Pluri, including in other locations;
  • Soliciting feedback in connection with your use of the services;
  • Tracking use of Pluri facilities and services to enable us to optimize them;
  • Contacting you to inform you of additional services which may be of interest to you;

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, and for crime prevention and prosecution in so far as it relates to our staff, participants, 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;
  • For security purposes and to identify and authenticate your access to the parts of the facilities;

Non-Personal Data. We may share or otherwise use non-Personal Data in our sole discretion and without the need for further approval.

 

  1. How Do We Collect Your Data?

We collect two main categories of Personal Data:

  1. Data Received From 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 through your use of our website, facilities and services, or in connection with site visits, 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. We also collect Personal Data through our CCTV recordings which automatically collect information about your presence in the Pluri facilities. You may provide us Personal Data voluntarily, such as your name, e-mail address, phone number, and location when you contact us. We urge you not to share any medical or other related sensitive information with us when communicating with us unless specifically requested by us for the services. Regardless of our data retention policies, we may remove from our records, at any time, any such sensitive information.
  2. Data Automatically Collected or Generated Through Your Use of Our website. When you visit, interact with or use our website, including any e-mail sent to you by us, we may collect or generate technical data about you. We collect or generate such data either independently or with the help of third-party services, including through the use of cookies and other tracking technologies (as further detailed in our ‘cookies’ section below). Such data consists of connectivity, technical or aggregated usage data, such as IP address, non-identifying data regarding the device, operating system, browser version locale and language settings used, the cookies and pixels installed on such device, and the activity (clicks and other interactions) of users of our website.

If you choose to give us your e-mail address, we will communicate with you via e-mail. We do not share your e-mail address with other individuals, entities and/or parties outside of Pluri. Depending on how your email application is set up, information about your actions, use of the email sent by us, may be transmitted automatically when you receive, open and/ or click on an e-mail from Pluri. In any event, you may opt out from receipt of any additional e-mails from Pluri, at any time.

 

  1. Website Data Collection and Cookies

When you access or use our services or website, Pluri may use industry standard technologies such as cookies, pixels and similar technologies, which store certain information on your computer or browsing device and which will allow us to identify the computer or device and, in some cases, to identify them with the user, and to enable automatic activation of certain features, and make your user experience more convenient and effortless. We use different types of cookies: some cookies are strictly necessary, they are required for the operation of our website and services under our terms with you; We also use analytical and performance monitoring cookies, which allow us to recognize and count the number of visitors and to see how visitors move around our website and services when they are using it. Finally, we use functionality cookies which are used to recognize you when you return to our website. This enables us to personalize content to your preferences, including for example, your choice of language or region.

Different cookies are kept for different periods. Session cookies are used to keep track of your activities online in a given browsing session; these cookies generally expire when the browser is closed but may be retained for a period on your device. Permanent cookies remain in operation even when you have closed the browser; they are used to remember your login details and password. Third-party cookies are installed by third parties with the aim of collecting certain information to research behavior, demographics. Third party cookies on our site include, for example, Google Analytics. Likewise, pixels from Youtube and others enable integration of third-party service providers may be embedded on our site. Third party cookies will be retained according to the terms of those third parties, and you can control those cookies in your browser settings.

We use cookies and other technologies on the basis that they are necessary for the performance of a contract with you, or because using them is in our legitimate interests of improving, optimizing and personalizing our services, and these are not overridden by your rights.

Most browsers will allow you to erase cookies from your computer’s hard drive, block acceptance of cookies, or receive a warning before a cookie is stored. However, if you block or erase cookies your online experience on our websites and services will be limited.

How to disable cookies: the effect of disabling cookies depends on which cookies you disable but, in general, the websites and some services delivered through them may not operate properly, may not recognize your device, may not remember your preferences and so on, if cookies are disabled or removed. However, allowing or disabling cookies is your choice and in your control. If you want to disable cookies on our site, you need to change your browser settings to reject cookies. How you can do this will depend on the browser you use. Further details on how to disable cookies can be found here: Microsoft Edge, Google Chrome, Firefox, Safari.

  1. How Do We Retain and Store Your Data?

Pluri Biotech Ltd. is located and operates under the jurisdiction of the State of Israel, which has been declared by the European Commission, on the basis of Article 45 of Regulation (EU) 2016/679 as a country outside the European Union (the “EU”) which offers an adequate level of data protection.

Company’s parent, Pluri Therapeutics Inc. is a Nevada-based corporation, and thus abides by the applicable U.S. privacy law; however, it has also taken upon itself, to adopt additional security measures regarding the storage of your Personal Data, and only to use it in accordance with this Privacy Policy.

While privacy laws may vary between jurisdictions, Pluri has taken reasonable steps to ensure that your Personal Data is treated by its affiliates and Service Providers in a secure and lawful manner, and in accordance with common industry practices, regardless of any lesser legal requirements that may apply in their jurisdiction.

Pluri retains 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 business best-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 may 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.

Please note that except as required by applicable law, we will not be obligated to retain your data for any particular period, and are free to securely delete it for any reason and at any time, with or without notice to you.

  1. With Whom Do We Share Data?

We may share your data (including Personal Data) with certain third parties, including law enforcement agencies, our service providers, and our affiliates – but only in accordance with this Privacy Policy:

  1. Compliance with Laws, Legal Orders and Authorities.We may disclose or allow government and law enforcement officials access to certain Personal Data, in response to a subpoena, search warrant or court order (or similar requirement), or in compliance with applicable laws and regulations, including for national security purposes. Such disclosure or access may occur with or without notice to you, if we have a good faith belief that we are legally compelled to do so, or that disclosure is appropriate in connection with efforts to investigate, prevent, or take action regarding actual or suspected illegal activity, fraud, or other wrongdoing.
  2. Service Providers and Business Partners.We may engage selected third-party companies and individuals to perform services complementary to our own (hosting services, data analytics services, media sources, e-mail distribution and monitoring services, and our business, legal, financial and compliance advisors) (collectively: “Service Providers”). These Service Providers may have access to your Personal Data, depending on each of their specific roles and purposes in facilitating the goals of our website, and may only use it for such purposes. A list of the Service Providers we currently engage that have access to your Personal Data can be viewed
  3. Protecting Rights and Safety. We may share your Personal Data with others, if we believe in good faith that this will help protect the rights, property or personal safety of Pluri, any of our users or any members of the general public.
  4. Security Measures

Pluri maintains physical, electronic and procedural safeguards to help guard your Personal Data. We restrict access to personally identifiable information to those persons who need to know that information to provide products or services to you and any persons you have authorized to have access to such information. While we strive to protect your Personal Data, we cannot guaranty the security of any information you transmit to us.

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. Transfer of Personal Data Between the Pluri Group Entities / Service Providers

We may allow access to your Personal Data for the uses prescribed in this Privacy Policy, internally, between our group entities. In instances where Personal Data is collected from individuals within the EU, we will make sure that for the transfer outside EU borders (a) an EU Commission Adequacy Decision is in place, or (b) we have a legitimate interest of such transfer, and the recipient entity is bound by similar security measures that we apply, and further subject to the provisions of Section 5.

  1. EU Data Subject Rights Regarding Personal Data under GDPR

Please note that you may have certain rights regarding the manner of collection, processing and usage of your Personal Data pursuant to applicable privacy laws such as the EU General Data Protection Regulations (“GDPR”). Under the GDPR (to the extent it applies to you) you may be eligible for the following rights:

  • Right to Access. You have a right to access your personal data that we process and receive a copy of it.
  • Right to Rectification. You have the right to ask us to rectify inaccurate personal data concerning you and to have incomplete personal data completed.
  • Right to Data Portability. You have a right to receive the personal data that you provided to us, in a structured, commonly used and machine-readable format. You have the right to transmit this data to a third party. Where technically feasible, you have the right that your personal data be transmitted directly from us to a third party that you designated.
  • Right to Withdraw Consent. You have the right to withdraw your consent for processing your personal data at any time. If you do that, we will not collect any further personal data, but we will further process the data we already collected for reasons described in this Policy. Withdrawing your consent will not affect the lawfulness of data processing we carried out based on your consent before such withdrawal.
  • Right to Object. If you previously agreed that your personal data may be used for other purposes other than registering and/or placing an order, you may have a right to object to the use of your personal data for such additional purposes.
  • Right to Restrict. You have the right to restrict processing of your Personal Data (except for storing it) if you contest the accuracy of your Personal Data, for a period enabling us to verify its accuracy; if you believe that the processing is unlawful and you oppose the erasure of the Personal Data and request instead to restrict its use; if we no longer need the Personal Data for the purposes outlined in this Policy, but they are required by you to establish, exercise or defense relating to legal claims, or if you object to processing, pending the verification whether our legitimate grounds for processing override yours.
  • Right to be Forgotten. Under certain circumstances, such as when you withdraw your consent, you have the right to ask us to erase your Personal Data. However, we may still process your Personal Data if it is necessary to comply with a legal obligation we are subject to under the laws in EU Member States.

Please note that the above list contains a summary of the main rights you may have under the GDPR. Under no circumstances shall the above be deemed as an exhaustive list, nor should you rely on it in terms of fully understanding all of your rights under the GDPR.

Additional Information for users entitled to rights under GDPR:

EU Representative. Our European representative, for the purposes of this Privacy Policy, is Pluri GmbH. If you are within the European Economic Area, you may contact our European representative at the following address: Brentanoweg 9, 14469 Potsdam, Germany, or by email address: dataprotection@Pluri.com

If you believe your right have been infringed, you can lodge a complaint with a supervisory authority operating under the GDPR. For a list of supervisory authorities in the EU, click here.

  1. Children

This website is directed towards and designed for use by persons aged 18 and older. We do not solicit or knowingly collect Personal Data from children under the age of 18. If we nevertheless receive Personal Data from an individual who indicates that he or she is, or whom we otherwise have reason to believe is, under the age of 18, we will delete such information from our systems.

  1. Links to Third Party Websites

The website may contain links to other websites. While we try to link only to websites that share our respect for privacy, please be aware that Pluri is not responsible for the privacy practices or the content of other websites. Websites that are accessible by hyperlinks from our website may use cookies. We encourage you to read the privacy statements provided by other websites before you provide personally identifiable information to them.

  1. Changes to this Privacy Policy

This Privacy Policy may change over time as we modify or expand our service. If we decide to change our Privacy Policy, we will prominently post those changes on this page. Your continued use of this website after we post such notice constitutes your agreement to any such changes.

  1. Contacting Us

If you have any questions about this Privacy Policy, or in the event that you wish to exercise certain rights you are eligible for with respect to your Personal Data, please contact us via the below online contact form. We welcome your questions and suggestions about our Privacy Policy.

Contact Information:

By mail: info@pluri-biotech.com; dataprotection@pluri-biotech.com

(Kindly state the nature of your inquiry at the subject line of the email)

Physical address:

Pluri Biotech Ltd.

Attention: General Counsel and DPO

Matam Park, Building 05

Haifa, 3508409, Israel

©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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