Second collaboration agreement for new PLX-RAD cell therapy product

HAIFA, ISRAEL, December 4, 2014 — Pluristem Therapeutics Inc. (NasdaqCM: PSTI; TASE: PLTR), a leading developer of placenta-based cell therapy products, announced today that it has entered into a long-term collaboration agreement with Hadassah Medical Center in Jerusalem. The medical center’s Department of Bone Marrow Transplantation and Cancer Immunotherapy, headed by Professor Reuven Or, will use preclinical models to assess the potential efficacy of PLX-RAD cells for treatment and prevention of hematological deficiencies and complications of bone marrow and umbilical cord blood transplantation. PLX-RAD cells are Pluristem’s second cell therapy product candidate.

“Hadassah is one of the leading medical centers in the world and we are honored to work with Dr. Or and his team. The preclinical studies to be conducted at Hadassah are expected to yield important data about the use of PLX-RAD cells in the treatment of hematological diseases. These data may help Pluristem to direct future clinical trials,” stated Pluristem CEO Zami Aberman. “This is our second collaboration with an academic institution to study PLX-RAD cells since announcing in October that we have the capability to manufacture this product candidate on a large scale.”

The Company’s development plan for PLX-RAD cells includes potential indications such as:

 

About Pluristem Therapeutics

Pluristem Therapeutics Inc. is a leading developer of placenta-based cell therapy products. The Company’s patented PLX (PLacental eXpanded) cells release a cocktail of therapeutic proteins in response to inflammation, hematological disorders, radiation damage, and ischemia. PLX cells are grown using the Company’s proprietary three- dimensional expansion technology and are an “off-the-shelf” product that requires no tissue matching prior to administration.

Pluristem has a strong intellectual property position, Company-owned, GMP-certified manufacturing and research facilities, strategic relationships with major research institutions and a seasoned management team. For more information visit www.pluristem.com, the content of which is not part of this press release.

Safe Harbor Statement

This press release contains forward-looking statements within the meaning of the “safe harbor” provisions of the Private Securities Litigation Reform Act of 1995 and federal securities laws. For example, forward-looking statements are used in this press release when we discuss the PLX- RAD preclinical studies to be conducted at Hadassah, the data they are expected to yield about PLX-RAD cells, that such data may help us to direct future clinical trials, or when we discuss the potential indications for PLX-RAD.
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 surgical 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:

Pluristem Therapeutics Inc.

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

karinek@pluristem.com

HAIFA, ISRAEL, December 1, 2014 — Pluristem Therapeutics Inc. (NasdaqCM: PSTI; TASE: PSTI), a leading developer of placenta-based cell therapy products, announced today it has been granted a patent in Singapore titled “Methods for Cell Expansion and Uses of Cells and Conditioned Media Produced Thereby for Therapy.”

Patent No. 170761 is Pluristem’s second granted patent in Singapore, and relates to methods of expanding adherent stromal cells from human placental or adipose tissue using Pluristem’s three-dimensional technology. Patents from the same family have previously been granted in Australia, India, Russia, and South Africa. Pluristem’s intellectual property portfolio now includes 33 patents issued and approximately 120 more pending worldwide.

“Singapore is a significant healthcare market and is a manufacturing center in the cell therapy space. We are happy to continue to build our relationship with its governmental agencies while strengthening our 3D technology-based competitive advantage in this important territory. We believe the regulatory environment for cell therapy to be advantageous and supportive of accelerated commercialization pathways in a number of Asian countries. For this reason we are actively seeking partners in Japan, and have already established a partnership with CHA Bio, a major biotechnology company in South Korea,” stated Pluristem CEO Zami Aberman.

 

About Pluristem Therapeutics

 Pluristem Therapeutics Inc. is a leading developer of placenta-based cell therapy products. The Company’s patented PLX (PLacental eXpanded) cells release a cocktail of therapeutic proteins in response to inflammation, hematological disorders, radiation damage, and ischemia. PLX cells are grown using the Company’s proprietary three- dimensional expansion technology and are an “off-the-shelf” product that requires no tissue matching prior to administration.

Pluristem has a strong intellectual property position, Company-owned, GMP-certified manufacturing and research facilities, strategic relationships with major research institutions and a seasoned management team. For more information visit www.pluristem.com, the content of which is not part of this press release.

 

Safe Harbor Statement

This press release contains forward-looking statements within the meaning of the “safe harbor” provisions of the Private Securities Litigation Reform Act of 1995 and federal securities laws. For example, forward-looking statements are used in this press release when we discuss our belief that regulatory environment for cell therapy is advantageous and supportive of accelerated commercialization pathways in a number of Asian countries.
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 surgical 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:

Pluristem Therapeutics Inc.:

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

karinek@pluristem.com

Presentations to focus on Pluristem’s industry-leading expertise in 3D cell culturing and cell expansion technologies

HAIFA, ISRAEL, November 25th, 2014 — Pluristem Therapeutics Inc. (NasdaqCM: PSTI; TASE: PSTI), a leading developer of placenta-based cell therapy products, announced today that Dr. Ohad Karnieli, the Company’s vice president of development and manufacturing, will present at two scientific conferences on the latest advancements in large-scale cell therapy manufacturing.

On November 25, 2014 at the 11th Annual bioProcessUK Conference Dr. Karnieli will give a presentation titled, “The Road Not Taken-Challenges and Possible Solutions in Moving Cell Therapy from Bench Top to Industry.” The bioProcessUK conference will take place in Liverpool, England on November 25-26, 2014 and is organized by the UK BioIndustry Association.

At the Cell Therapy Manufacturing conference on December 4, 2014 Dr. Karnieli will give a presentation titled, “Challenges and Possible Solutions for Optimizing Cell Therapy Manufacturing and its Influence on Quality and Cost of the Product.” He will also be a presenter and panelist for the panel titled, “Top Tips When Moving a Process from Phase I to Phase II to Phase III.” The conference will take place from December 3- 4, 2014 in Brussels, Belgium, in association with the International Society for Cellular Therapy.

 

About Pluristem Therapeutics

Pluristem Therapeutics Inc. is a leading developer of placenta-based cell therapy products.
The Company’s patented PLX (PLacental eXpanded) cells release a cocktail of therapeutic proteins in response to inflammation, hematological disorders, radiation damage, and ischemia. PLX cells are grown using the Company’s proprietary three- dimensional expansion technology and are an “off-the-shelf” product that requires no tissue matching prior to administration.

Pluristem has a strong intellectual property position, Company-owned, GMP-certified manufacturing  and  research  facilities,  strategic  relationships  with  major  research institutions and a seasoned management team. For more information visit www.pluristem.com, the content of which is not part of this press release.

 

Safe Harbor Statement

This press release contains forward-looking statements within the meaning of the “safe harbor” provisions of the Private Securities Litigation Reform Act of 1995 and 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 surgical 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:

Pluristem Therapeutics Inc.:

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

karinek@pluristem.com

Indications include orthopedic, nerve injury and neurodegenerative diseases

HAIFA, ISRAEL, November 12, 2014 — Pluristem Therapeutics Inc. (Nasdaq: PSTI; TASE: PSTI), a leading developer of placenta-based cell therapy products, announced today that it has been granted a patent in both Australia and New Zealand for the use of a specified population of placental cells for treating several medical indications. The patent, titled “Adherent cells from placenta and use of same in disease treatment” has been issued in Australia, Patent No. 2010322808, and in New Zealand, Patent No. 600651.

The patents’ claims include the use of the population of placental cells in the treatment of muscle trauma, muscle defect, neuropathic pain, peripheral nerve injury, and neurodegenerative diseases.

“These patents, which cover multiple indications and bring the Company’s total to 32 granted patents, are timely, as we’ve demonstrated Pluristem’s ability to use its technology platform to develop distinct cell therapy product lines for the potential treatment of different conditions. We continue to evaluate additional indications for PLX- PAD and PLX-RAD, our first two cell therapy products,” stated Pluristem CEO Zami Aberman.

 

About Pluristem Therapeutics

Pluristem Therapeutics Inc. is a leading developer of placenta-based cell therapy products. The Company’s patented PLX (PLacental eXpanded) cells release a cocktail of therapeutic proteins in response to inflammation, hematological disorders, radiation damage, and ischemia. PLX cells are grown using the Company’s proprietary three- dimensional expansion technology and are an “off-the-shelf” product that requires no tissue matching prior to administration.

In addition to its strong intellectual property position, Pluristem has Company-owned, GMP-certified manufacturing and research facilities, strategic relationships with major research institutions and a seasoned management team. For more information visit www.pluristem.com, the content of which is not part of this press release.

Safe Harbor Statement

This press release contains forward-looking statements within the meaning of the “safe harbor” provisions of the Private Securities Litigation Reform Act of 1995 and federal securities laws.
For example, we are using forward-looking statements in this press release when we discuss the potential of our product candidates to treat different conditions or that we continue to evaluate additional indications for PLX-PAD and PLX-RAD. 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 surgical 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:

Pluristem Therapeutics Inc.:

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

karinek@pluristem.com

London Regenerative Medicine Network Meeting

Alliance for Regenerative Medicine’s 2nd Annual European Advanced Therapies Investor Day

HAIFA, ISRAEL, November 10th, 2014 — Pluristem Therapeutics Inc. (NasdaqCM: PSTI; TASE: PLTR), a leading developer of placenta-based cell therapy products, announced today that the Company’s CEO, Zami Aberman, has been invited to present at two regenerative medicine conferences in London regarding Pluristem’s cell therapy platform, large-scale manufacturing methods, and intellectual property strategy.

At the London Regenerative Medicine Network’s (LRMN) November 12 meeting, Mr. Aberman will deliver a presentation titled, “Maturing adherent-cell therapies for commercialization: strategies, technology barriers and possible solutions.” Mr. Aberman is one of three international speakers invited to present on the topic of scalable manufacturing therapies, which will be the focus of LRMN’s November 2014 meeting sponsored by Thermo Fisher Scientific.

Mr. Aberman will also present at the Alliance for Regenerative Medicine’s (ARM) 2nd Annual European Advanced Therapies Investor Day on November 13. His presentation, entitled “The Placenta as a superior source for cell therapy products – strategy and implementation”, will focus on Pluristem’s proprietary three-dimensional cell expansion technology platform, and the Company’s unique methods for developing and manufacturing distinct cell therapy products to treat specific diseases. Mr. Aberman will also discuss Pluristem’s successful intellectual property strategy, which serves as a model for IP protection in the regenerative medicine industry.

 

About Pluristem Therapeutics

Pluristem Therapeutics Inc. is a leading developer of placenta-based cell therapy products. The Company’s patented PLX (PLacental eXpanded) cells release a cocktail of therapeutic proteins in response to inflammation, hematological disorders, radiation damage, and ischemia. PLX cells are grown using the Company’s proprietary three- dimensional expansion technology and are an “off-the-shelf” product that requires no tissue matching prior to administration.

Pluristem has a strong intellectual property position, Company-owned GMP certified manufacturing and research facilities, strategic relationships with major research institutions and a seasoned management team. For more information visit www.pluristem.com, the content of which is not part of this press release.

Safe Harbor Statement

This press release contains forward-looking statements within the meaning of the “safe harbor” provisions of the Private Securities Litigation Reform Act of 1995 and federal securities laws.
For example, forward-looking statements are used in this press release when we discuss our potential to develop cell therapy products to treat specific diseases, and that Pluristem’s IP assets will in fact protect its position in the regenerative medicine industry.
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 surgical 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:

Pluristem Therapeutics Inc.:

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

karinek@pluristem.com

The study will determine whether Pluristem’s second major product line may help cord blood cells to successfully replace damaged bone marrow

HAIFA, ISRAEL, October 27, 2014 — Pluristem Therapeutics Inc. (NasdaqCM: PSTI) TASE: PLTR), a leading developer of placenta-derived cell therapy products, announced today that researchers at Case Western Reserve University will conduct a preclinical study of the Company’s PLacental eXpanded (PLX)-RAD cells. The study will evaluate whether PLX-RAD cells increase the success rate of human umbilical cord blood transplantation.

Umbilical cord blood cells are transplanted to replace a patient’s unhealthy bone marrow cells. When successful, a transplant can treat bone marrow failure, which can result from immune system disorders, genetic diseases, and leukemia treatment. When cord blood cells are administered to a patient, they travel to the bone marrow and produce healthy white and red blood cells and platelets after the patient’s own abnormal cells have been eliminated. Sometimes, however, the cord blood cells fail to take hold and the transplant fails. The study at Case Western Reserve will research the feasibility of using PLX-RAD cells to help the cord blood to engraft more effectively, resulting in higher rates of successful transplantation and treatment.

“Case Western Reserve is one of the top research institutes in the U.S. and we are delighted to work with them. Pluristem will provide the PLX-RAD cells and the university’s researchers will conduct the study,” stated Pluristem’s Chairman and CEO Zami Aberman.

“If animal data show that PLX-RAD cells increase the success rate of umbilical cord blood transplants, this would motivate us to apply to conduct human clinical trials for bone marrow reconstitution following radiation in a number of life-threatening diseases including leukemia, where development of new, healthy bone marrow is the only available cure,” Aberman concluded.

PLX-RAD cells are also being studied by the U.S. National Institutes of Health (NIH) for the treatment of acute radiation syndrome (ARS), which involves bone marrow failure after exposure to high levels of radiation, as can happen after a nuclear catastrophe.

 

About the Study 

The primary objective of the study at Case Western Reserve is to determine the benefits of administering PLX-RAD cells at the time of transplantation of human hematopoietic CD34+ cells collected from umbilical cord blood. Scientists will compare the success rates of transplant engraftment in the control arm versus those treated with PLX-RAD cells. The secondary objective is to determine if there are any histologic changes in the liver, lung, spleen and intestine in the control versus treated groups. The preclinical study will be conducted in an immunodeficient mouse model that has undergone non-lethal radiation to destroy its own bone marrow cells. There will be three arms in the study: 1) IV (intravenous) injection of human Hematopoietic Cells (hHC) alone for the control; 2) IV injection of hHC plus IV injection of 1 million PLX-RAD cells; 3) IV injection of hHC plus intramuscular (IM) injection of 1 million PLX RAD cells. At 8 weeks bone marrow of the mice will be analyzed.

 

About Pluristem Therapeutics 

Pluristem Therapeutics Inc. is a leading developer of placenta-based cell therapy products. The Company’s patented PLX (PLacental eXpanded) cells release a cocktail of therapeutic proteins in response to inflammation or ischemia. PLX cells are grown using the Company’s proprietary 3D micro-environmental technology and are an “off-the-shelf” product that requires no tissue matching prior to administration.

Pluristem has a strong intellectual property position, Company-owned GMP certified manufacturing and research facilities, strategic relationships with major research institutions and a seasoned management team. For more information visit www.pluristem.com, the content of which is not part of this press release.

 

 

Safe Harbor Statement

This press release contains forward-looking statements within the meaning of the “safe harbor” provisions of the Private Securities Litigation Reform Act of 1995 and federal securities laws. For example, forward looking statements are used in this press release when we discuss the feasibility of PLX-RAD cells to help cord blood cells to successfully replace damaged bone marrow, or when we discuss the PLX-RAD study we are going to conduct at Case Western Reserve University, or when we discuss the possibility of applying to conduct human clinical trials in a number of life-threatening diseases. 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 be more expensive than we anticipate; results in the laboratory may not translate to equally good results in real surgical 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:

Pluristem Therapeutics Inc.:

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

karinek@pluristem.com

Marks second major cell therapy product line developed on Company’s PLX platform; PLX-RAD cells address multiple indications associated with bone marrow deficiency

HAIFA, ISRAEL, October 21, 2014– Pluristem Therapeutics Inc. (NasdaqCM: PSTI; TASE: PLTR), a leading developer of placenta-based cell therapy products, announced today that it has completed development of its second major product line, and can now begin manufacturing the cells on a large-scale at its state-of-the art facility in order to meet demand for anticipated studies in a range of hematologic conditions. This second cell product candidate, called PLX-RAD, was created using Pluristem’s proprietary three dimensional cell expansion technology platform. The Company’s first product, PLX- PAD, is already in clinical trials for the treatment of peripheral artery disease, muscle injury and pulmonary arterial hypertension.

Pluristem’s development plan for the PLX-RAD cells considers numerous potential clinical indications such as: 1) enhancement of engraftment of transplanted hematopoietic stem cells for the treatment of bone marrow deficiency, which can result from immune system disorders, genetic diseases, and treatment of leukemia and other blood cancers; 2) treatment of bone marrow deficiency in patients who have undergone chemotherapy; 3) treatment of acute radiation syndrome (ARS) in conjunction with the U.S. National Institutes of Health’s National Institute of Allergy and Infectious Diseases.

“We’ve just completed a two-year development cycle for our PLX-RAD cells, and have also developed new manufacturing equipment, methods and know-how. We believe that our state-of-the-art technology platform can be used to create additional cell products from the placenta, tailored to potentially deliver targeted treatments for a variety of new indications,” stated Zami Aberman, Chairman and CEO of Pluristem.

“Our technology platform, robust manufacturing capabilities and broad IP portfolio open the door for potential institutional and commercial partners, and we’re pleased with the level of interest we have received in our technology platform. Pluristem is in a unique position to be a leader in the cell therapy industry,” Aberman concluded.

Data from a study of PLX-RAD cells conducted at Hadassah Medical Center were published in the peer-reviewed journal, PLOS ONE.

 

About Pluristem Therapeutics

Pluristem Therapeutics Inc. is a leading developer of placenta-based cell therapy products. The Company’s patented PLX (PLacental eXpanded) cells release a cocktail of therapeutic proteins in response to inflammation or ischemia. PLX cells are grown using the Company’s proprietary three dimensional expansion technology and are an “off-the- shelf” product that requires no tissue matching prior to administration.

Pluristem has a strong intellectual property position, Company-owned GMP certified manufacturing and research facilities, strategic relationships with major research institutions and a seasoned management team. For more information visit www.pluristem.com, the content of which is not part of this press release.

Safe Harbor Statement

This press release contains forward-looking statements within the meaning of the “safe harbor” provisions of the Private Securities Litigation Reform Act of 1995 and federal securities laws. For example, forward-looking statements are used in this press release when we discuss our development plan for the PLX-RAD and anticipated studies in a range of hematologic conditions; when we discuss our belief that our technology platform can be used to create additional cell products from the placenta, tailored to potentially deliver targeted treatments for a variety of new indications; when we discuss the feasibility of potential institutional and commercial new partnerships, or that we are in a unique position to lead the cell therapy industry. 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 surgical 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:

Pluristem Therapeutics Inc.: Karine Kleinhaus, MD, MPH

 

Divisional VP, North America 1-914-512-4109

karinek@pluristem.com

HAIFA, ISRAEL, September 08, 2014 — Pluristem Therapeutics Inc. (NasdaqCM: PSTI; TASE: PLTR), a leading developer of placenta-based cell therapy products, announced today that its licensee, United Therapeutics Corporation, has completed the dosing of the first cohort of patients in its Phase I study using Pluristem’s PLacental eXpanded (PLX-PAD) cells in patients diagnosed with pulmonary arterial hypertension (PAH). PAH, with a global market estimated at approximately $3 billion, is characterized by abnormally high blood pressure in the arteries of the lungs; it can disrupt lung and heart function, leading to debilitating conditions such as heart failure.

The Phase I study, being conducted in Australia, is an open-label, dose-escalation study designed to enroll 9 patients diagnosed with PAH. The first cohort of 3 patients has received 0.5 million PLX cells per kilogram body weight. An independent Data Safety Monitoring Board recommended advancement to the second cohort. The second cohort will receive 1 million cells per kilogram, while the third cohort is planned to be administered 2 million cells per kilogram. The primary endpoint of the study is the safety of PLX-PAD cells, which will be evaluated at 12 weeks and one year after dosing. Secondary efficacy endpoints are to be measured at six weeks post-treatment in order to assess changes in the ability to exercise, disease severity and cardio-respiratory function; measures include six-minute walk distance and cardio-pulmonary hemodynamic parameters evaluated via right heart catheterization and echocardiogram.

“We look forward to preliminary results for this trial in 2015, after completion of dosing in all three cohorts,” stated Pluristem Chairman and CEO Zami Aberman. “This Phase I study is important to the development of our PAH program in conjunction with United Therapeutics, and we are delighted to work with United Therapeutics in advancing the promise of cell therapy to treat pulmonary diseases.”

The Phase I study is being conducted as part of a 2011 licensing agreement between United Therapeutics and Pluristem. Pursuant to the agreement, United Therapeutics will develop, market and sell Pluristem’s PLX-PAD cells for PAH. Pluristem is eligible to receive up to $55 million based on successful achievement of clinical milestones and commercialization,  and  reimbursement  of  certain  R&D  costs.  Following

commercialization, United Therapeutics will purchase commercial supplies of PLX-PAD cells from Pluristem at a specified margin over Pluristem’s cost, and will pay royalties at a percentage of its gross profits.

 

 

About Pulmonary Arterial Hypertension

PAH is characterized by abnormally high blood pressure in the arteries of the lungs which leads to an increased workload on the right side of the heart; this can lead to heart failure and other negative health outcomes. It is a serious illness that becomes progressively worse and is sometimes fatal. PAH isn’t curable, although treatments are available that can help lessen symptoms and improve quality of life.

About Pluristem Therapeutics

Pluristem Therapeutics Inc. is a leading developer of placenta-based cell therapy products. The Company’s patented PLX (PLacental eXpanded) cells are a protein delivery platform that releases a cocktail of therapeutic proteins in response to inflammation or ischemia. PLX cells are grown using the Company’s proprietary 3D micro-environmental technology and are an “off-the-shelf” product that requires no tissue matching prior to administration.

Pluristem has a strong intellectual property position, Company-owned GMP certified manufacturing and research facilities, strategic relationships with major research institutions and a seasoned management team. For more information visit www.pluristem.com, the content of which is not part of this press release.

Safe Harbor Statement

This press release contains forward-looking statements within the meaning of the “safe harbor” provisions of the Private Securities Litigation Reform Act of 1995 and federal securities laws. Forward-looking statements include statements about future progress and completion of the Phase 1 study of PLX-PAD in PAH patients, milestone payments based on further clinical development, the possible commercialization of PLX-PAD by United Therapeutics and royalty payments and supply arrangements upon commercialization. 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 surgical 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:

Pluristem Therapeutics Inc.:

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

karinek@pluristem.com

HAIFA, ISRAEL, October 7th, 2014 – Pluristem Therapeutics Inc. (NasdaqCM: PSTI, TASE: PLTR), a leading developer of placenta-based cell therapy products, announced today that its European Patent No. EP2200622, titled, “ADHERENT CELLS FROM ADIPOSE OR PLACENTA TISSUES AND USE THEREOF IN THERAPY”, was upheld by the European Patent Office in amended form, affirming its validity

Pluristem’s patent went through Opposition Proceedings before the Opposition Division of the European Patent Office, as a result of a challenge from a cell therapy company. The European Patent Office concluded that Pluristem’s patent, whose claims cover treatment of ischemia with adherent placental cells which are propagated using a 3D culture, is valid.

“With a portfolio of 30 issued patents and another 120 pending, intellectual property is a core asset for Pluristem. We will continue to invest in and defend our patents,” stated Zami Aberman, Chairman and CEO of Pluristem.

“We believe this case, which was brought to the Opposition Division of the European Patent Office from a cell therapy company, afforded Pluristem a clear opportunity. We have proven that we are determined to protect our IP assets that cover our unique, proprietary inventions, and that we are committed to protect our patents from any challenge,” Aberman concluded.

 

About Opposition Proceedings before the European Patent Office (EPO)

EPO Opposition Proceedings are post-grant adversarial proceedings in which interested third parties can challenge the validity of all the national parts of a European patent via a single centralized procedure. The decision of the Opposition Division to uphold Pluristem’s EP2200622 in amended form is open to an appeal to one of the EPO’s Technical Boards of Appeal for all parties involved.

 

About Pluristem Therapeutics

Pluristem Therapeutics Inc. is a leading developer of placenta-based cell therapy products. The Company’s patented PLX (PLacental eXpanded) cells release a cocktail of therapeutic proteins in response to inflammation or ischemia. PLX cells are grown using the Company’s proprietary three dimensional expansion technology and are an “off-the- shelf” product that requires no tissue matching prior to administration.

Pluristem has a strong intellectual property position, Company-owned GMP certified manufacturing and research facilities, strategic relationships with major research institutions and a seasoned management team. For more information visit www.pluristem.com, the content of which is not part of this press release.

 

 

Safe Harbor Statement

This press release contains forward-looking statements within the meaning of the “safe harbor” provisions of the Private Securities Litigation Reform Act of 1995 and federal securities laws. For example, we are using forward-looking statements when we discuss investing in and defending our patents. 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 end up being more expensive than we anticipate; results in the laboratory may not translate to equally good results in real surgical 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:

Pluristem Therapeutics Inc.:

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

karinek@pluristem.com

HAIFA, ISRAEL, September 16, 2014 — Pluristem Therapeutics Inc. (NasdaqCM: PSTI) TASE: PLTR), a leading developer of placenta-based cell therapy products, announced today it is evaluating strategic opportunities to co-develop and commercialize its PLacental eXpanded (PLX) cell therapies in Japan.

Recent changes in Japan’s laws governing regenerative medicine and the approval of stem cell therapies indicate the country may now offer the fastest track to commercialization in the world for regenerative medicine treatments. As part of Pluristem’s strategy in Japan, on September 16, 2014, Company executives presented to a group of Japanese pharmaceutical executives in Tokyo, and conducted a series of one-on- one meetings with Japanese companies exploring a potential partnership with Pluristem.

To support its strategy in Japan, Pluristem is working with The Sage Group, a consulting firm specializing in healthcare industry transactions and business strategy, and Sage’s partner Waterfield HealthCom, a Japan-based firm managed by Yoshi Mizuta. Mr. Mizuta is a highly experienced pharmaceutical industry executive with more than 40 years in the business of financial healthcare transactions in the Japanese arena.

Japan’s government passed a bill in 2013, which goes into effect in November of this year, effectively fast-tracking the approval of stem cell therapies for marketing. According to the law, stem cell regenerative medicine therapies can receive conditional, time-limited approval for marketing, and be eligible for reimbursement, upon proof of safety but prior to verification of efficacy; safety and effectiveness need to be confirmed after the conditional approval.

Waterfield HealthCom’s Mr. Mizuta commented, “With its broad portfolio of indications and its commercial scale 3D cell manufacturing capabilities, Pluristem is a very desirable partner for Japanese pharmaceutical companies looking to bring cell therapies to the market in the near term.”

“As a result of Japan’s favorable new law, cell therapies like Pluristem’s PLX cells can receive market approval in Japan upon completion of Phase II trials when good safety and efficacy data is available. This could potentially reduce approval time down to two or three years,” Mr. Mizuta concluded.

Pluristem CEO Zami Aberman added, “The opportunity in Japan opens an accelerated path for the global regenerative medicine industry to prove the efficacy of cell therapies in a broad patient population in Japan. Japan has one of the most advanced healthcare systems, and the second largest healthcare market in the world.”

Pluristem currently has co-development and out-licensing partnership agreements with United Therapeutics (NASDAQ: UTHR) and South-Korea-based CHA Bio&Diostech (KOSDAQ: CHA).

 

About Pluristem Therapeutics 

Pluristem Therapeutics Inc. is a leading developer of placenta-based cell therapy products. The Company’s patented PLX (PLacental eXpanded) cells are a protein delivery platform that releases a cocktail of therapeutic proteins in response to inflammation or ischemia. PLX cells are grown using the Company’s proprietary 3D micro-environmental technology and are an “off-the-shelf” product that requires no tissue matching prior to administration.

Pluristem has a strong intellectual property position, Company-owned GMP certified manufacturing and research facilities, strategic relationships with major research institutions and a seasoned management team. For more information visit www.pluristem.com, the content of which is not part of this press release.

 

 

Safe Harbor Statement

This press release contains forward-looking statements within the meaning of the “safe harbor” provisions of the Private Securities Litigation Reform Act of 1995 and federal securities laws. For example, forward-looking statements are used in this press release when we discuss the opportunity in Japan including receiving market approval in Japan for our products upon completion of phase II which could potentially reduce approval time. 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 surgical 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:

Pluristem Therapeutics Inc.:

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

karinek@pluristem.com

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.

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 EdgeGoogle ChromeFirefoxSafari.

  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.comdataprotection@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.

NAME

Title

Lorem ipsum dolor sit amet, consectetur adipiscing elit. Ut elit tellus, luctus nec ullamcorper mattis, pulvinar dapibus leo.

Lorem ipsum dolor sit amet, consectetur adipiscing elit. Ut elit tellus, luctus nec ullamcorper mattis, pulvinar dapibus leo.

Lorem ipsum dolor sit amet, consectetur adipiscing elit. Ut elit tellus, luctus nec ullamcorper mattis, pulvinar dapibus leo.