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HAIFA, Israel, December 29, 2020 – Pluristem Therapeutics Inc. (Nasdaq:PSTI) (TASE:PSTI), a leading regenerative medicine company developing a platform of novel biological therapeutic products, announced today it has entered into a collaboration agreement with Mexican pharmaceutical company Innovare R&D to expand its ongoing clinical program of PLX cells in the treatment of Acute Respiratory Distress Syndrome (ARDS) associated with COVID-19 in Mexico.
The Phase II study in Mexico is subject to the approval of local authorities, with the goal of being conducted under the U.S. Food and Drug Administration (FDA) cleared protocol.

In accordance with the agreement, Innovare will open clinical sites and enroll patients for the proposed clinical study in Mexico.
Innovare will fund the study in Mexico and will purchase PLX cells for the study from Pluristem.
Subject to potential positive clinical study results and Mexican regulatory approval for commercialization, the agreement grants Innovare exclusive distribution rights in Mexico to supply PLX cells for treating severe COVID-19 cases complicated by ARDS. All intellectual property and manufacturing rights remain with Pluristem.

With 1,389,430 cases and 122,855 deaths as of December 29, 2020, Mexico’s COVID-19 infection and mortality rates have been increasing.
Mexico has the highest deaths proportionally to COVID- 19 cases or population in the world as of December 28, 2020, as reported by Johns Hopkins University of Medicine.

“We are pleased to join forces with Innovare, a leading innovative company aiming to be part of the solution for combating the COVID-19 pandemic in Mexico,” stated Pluristem CEO and President, Yaky Yanay. “Thanks to our key competitive advantage of having in-house manufacturing facility, advanced logistical capabilities, and a global reach, we are able to supply PLX cells to clinical centers around the world while extending our global support for COVID-19 into Latin America. By conducting the study in both the U.S. and Mexico, in parallel to the E.U. and Israel, we are continuing our focus on achieving clinical milestones and objectives, while bringing the potential treatment of PLX cells to those in need.”

Gerardo Cárdenas Vogel, CEO of Innovare R&D commented, “As a company that is seeking worldwide partners showing clinical promise for unmet medical needs, we are excited to collaborate with Pluristem.
We look forward to leveraging our clinical and commercial capabilities with Pluristem’s advanced cell therapy solution to help develop and potentially bring a much needed treatment for ARDS patients associated with COVID-19 to Mexico.”

Pluristem is currently conducting two Phase II studies in ARDS associated with COVID-19 in the U.S., Europe and Israel, an Expanded Access Program in the U.S. and a per patient compassionate use program in Israel.

About Innovare R&D

Innovare R&D comprises a group of pharmaceutical companies that develop and commercialize drugs in the areas of hematology, immunology, infectious disease, central nervous system, and urology.
They established a unique partnering model to collaborate with biopharmaceutical companies in a strategy to proof the applicability of their platform in improving patient´s outcomes. Innovare R&D has regional (Mexico) coverage for commercializing products that have already been approved by the FDA/ European Medicines Agency (EMA)/ Health Canada/ Swissmedic/ TGA, while Innovare R&D is leading their own product developments with partners in the U.S. and Europe.

 

About Pluristem Therapeutics

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

Safe Harbor Statement

This press release contains express or implied forward-looking statements within the Private Securities Litigation Reform Act of 1995 and other U.S. Federal securities laws.
For example, Pluristem is using forward-looking statements when it discusses the potential Phase II study in Mexico, subject to the approval of local authorities, that it continues to focus on achieving clinical milestones and objectives, while bringing the potential treatment of PLX cells to those in need and potentially bringing a much needed treatment for ARDS patients associated with COVID-19 to Mexico.
These forward-looking statements and their implications are based on the current expectations of the management of Pluristem only, and are subject to a number of factors and uncertainties that could cause actual results to differ materially from those described in the forward-looking statements. The following factors, among others, could cause actual results to differ materially from those described in the forward-looking statements: changes in technology and market requirements; Pluristem may encounter delays or obstacles in launching and/or successfully completing its clinical trials; Pluristem’s products may not be approved by regulatory agencies, Pluristem’s technology may not be validated as it progresses further and its methods may not be accepted by the scientific community; Pluristem may be unable to retain or attract key employees whose knowledge is essential to the development of its products; unforeseen scientific difficulties may develop with Pluristem’s process; Pluristem’s products may wind up being more expensive than it anticipates; results in the laboratory may not translate to equally good results in real clinical settings; results of preclinical studies may not correlate with the results of human clinical trials; Pluristem’s patents may not be sufficient; Pluristem’s products may harm recipients; changes in legislation may adversely impact Pluristem; inability to timely develop and introduce new technologies, products and applications; loss of market share and pressure on pricing resulting from competition, which could cause the actual results or performance of Pluristem to differ materially from those contemplated in such forward-looking statements. Except as otherwise required by law, Pluristem undertakes no obligation to publicly release any revisions to these forward-looking statements to reflect events or circumstances after the date hereof or to reflect the occurrence of unanticipated events. For a more detailed description of the risks and uncertainties affecting Pluristem, reference is made to Pluristem’s reports filed from time to time with the Securities and Exchange Commission.

 

Contact:

Dana Rubin

Director of Investor Relations 972-74-7107194

danar@pluristem.com

HAIFA, Israel, December 9, 2020 – Pluristem Therapeutics Inc. (Nasdaq:PSTI) (TASE:PSTI), a leading regenerative medicine company developing a platform of novel biological therapeutic products, today announced that the independent Data Monitoring Committee (DMC) of its global pivotal Phase III study for the treatment of critical limb ischemia (CLI) issued its recommendation letter following the interim analysis.
The clinical dataset was reviewed by the independent DMC for safety and analysis of the primary endpoint of amputation-free survival, defined as time to occurrence of major amputation of the index leg or death.

Based on the review, the DMC concluded that the CLI study is unlikely to meet the primary endpoint by the time of the final analysis.
The DMC advised the Company that the CLI study population has experienced a substantial low number of events (major amputation of the index leg or death), different from what is known in clinical medicine for the rate of these events in this patient population.
The lower than anticipated event rate in the placebo group reduced the statistical power of the study to meet its primary endpoint.

DMC noted that PLX-PAD was well tolerated, and no significant safety concerns were raised during the study.

Following the DMC’s recommendation, the Company decided to terminate the CLI study. Currently, the Company continues to be blinded to the CLI study clinical data.

“We are deeply disappointed by the outcome of the CLI interim analysis. In light of the DMC’s recommendation, we decided that it would be in the best interests of the Company and its shareholders to terminate the CLI study and focus our resources and efforts on our other lead indications,” stated Pluristem CEO and President, Yaky Yanay.

“We expect to present topline clinical results during calendar year 2021, including our Phase III study in muscle regeneration following hip fracture, Phase II studies in Acute Respiratory Distress Syndrome (ARDS) associated with COVID-19 and our Phase I study in incomplete hematopoietic recovery following hematopoietic cell transplantation (HCT). Pluristem is well positioned to advance and support future development of these indications.”

“Throughout the years, we have developed unique and propriety expertise, knowhow and intellectual property, alongside a diverse clinical pipeline and we possess a state-of-the-art cell manufacturing facility. We believe our platform and technology will be a meaningful force in regenerative medicine in a variety of therapeutic areas,” Mr. Yanay concluded.

The Company will host a conference call on December 9, 2020 at 8.30AM ET / 3.30PM Israel time. It can be accessed via:

https://webcasting.brrmedia.co.uk/broadcast/5fc769bd2ac82b2af52e277b

About Pluristem Therapeutics

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

Safe Harbor Statement

This press release contains express or implied forward-looking statements within the Private Securities Litigation Reform Act of 1995 and other U.S. Federal securities laws.
For example, Pluristem is using forward-looking statements when it discusses that it expects topline clinical results during the calendar year 2021 with respect to its Phase III study in muscle regeneration following hip fracture, its Phase II studies in ARDS associated with COVID-19 and its Phase I study in incomplete hematopoietic recovery following HCT, its belief that it is well positioned to support the future development of these indications and its belief that its platform and technology will be a meaningful force in regenerative medicine in a variety of therapeutic areas.
These forward- looking statements and their implications are based on the current expectations of the management of Pluristem only, and are subject to a number of factors and uncertainties that could cause actual results to differ materially from those described in the forward-looking statements. The following factors, among others, could cause actual results to differ materially from those described in the forward-looking statements: changes in technology and market requirements; Pluristem may encounter delays or obstacles in launching and/or successfully completing its clinical trials; Pluristem’s products may not be approved by regulatory agencies, Pluristem’s technology may not be validated as it progresses further and its methods may not be accepted by the scientific community; Pluristem may be unable to retain or attract key employees whose knowledge is essential to the development of its products; unforeseen scientific difficulties may develop with Pluristem’s process; Pluristem’s products may wind up being more expensive than it anticipates; results in the laboratory may not translate to equally good results in real clinical settings; results of preclinical studies may not correlate with the results of human clinical trials; Pluristem’s patents may not be sufficient; Pluristem’s products may harm recipients; changes in legislation may adversely impact Pluristem; inability to timely develop and introduce new technologies, products and applications; loss of market share and pressure on pricing resulting from competition, which could cause the actual results or performance of Pluristem to differ materially from those contemplated in such forward-looking statements. Except as otherwise required by law, Pluristem undertakes no obligation to publicly release any revisions to these forward-looking statements to reflect events or circumstances after the date hereof or to reflect the occurrence of unanticipated events.
For a more detailed description of the risks and uncertainties affecting Pluristem, reference is made to Pluristem’s reports filed from time to time with the Securities and Exchange Commission.

 

Contact:

Dana Rubin

Director of Investor Relations 972-74-7107194

danar@pluristem.com

 

 

HAIFA, Israel, November 18, 2020 – Pluristem Therapeutics Inc. (Nasdaq:PSTI) (TASE:PSTI), a leading regenerative medicine company developing a platform of novel biological therapeutic products, today reported the first clinical results for PLX-R18 in humans from its Phase I study evaluating PLX-R18 as a treatment for incomplete hematopoietic recovery following hematopoietic cell transplantation (HCT). The initial results consisted of the analysis of the first 19 patients enrolled, and not all patients completed a one year follow up.

The initial data from the Phase I trial demonstrated:

 

Incomplete hematopoietic recovery poses a significant life-threatening condition to HCT recipients who fail to respond to standard of care treatments, making them vulnerable to infections and bleeding. PLX-R18 may address the unmet need in this patient population by stimulating the regenerative potential of bone marrow where other treatments have proven ineffective. The U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation to PLX-R18 in this indication.

 

A presentation titled “Safety and Demonstrated Efficacy of Placenta-Derived Cell Therapy PLX- R18 in Subjects with Incomplete Hematopoietic Recovery Following Hematopoietic Cell Transplantation: A Phase I International Multi-Center Study” will be held by Mr. Hillard M. Lazarus, MD, FACP, Professor of Medicine, Case Western Reserve University, and Member of the study’s Steering Committee at the virtual 62nd ASH Annual Meeting and Exposition on December 5, 2020.

Prof Hillard M. Lazarus commented on the results, “The use of Pluristem’s PLX-R18 product candidate in a group of patients who had extremely low blood counts resulted in actual clinical improvement with a significant rise in critical blood counts.”

Pluristem CEO and President Yaky Yanay stated, “These first PLX-R18 data in humans support our expectations that our PLX platform can yield multiple regenerative therapeutics. This significant milestone adds to a pivotal year ahead with four readouts in Critical Limb Ischemia (CLI), muscle regeneration following hip fracture, COVID-19 complicated by Acute Respiratory Distress Syndrome (ARDS), and HCT evaluating both our PLX-PAD and PLX-R18 product candidates. We are committed to developing solutions for unmet medical needs based on our expertise attained over a decade and supported by our advanced platform technology and in-house manufacturing capabilities.”

The ASH Annual Meeting is the world’s most comprehensive hematology event of the year featuring scientific abstracts highlighting updates on the most critical topics in hematology. With more than 18,000 members from nearly 100 countries, ASH is the world’s largest professional society serving both clinicians and scientists around the world who are working to conquer blood diseases.

About Pluristem Therapeutics

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

Safe Harbor Statement

This press release contains express or implied forward-looking statements within the Private Securities Litigation Reform Act of 1995 and other U.S. Federal securities laws.
For example, Pluristem is using forward-looking statements when it discusses its Phase I HCT study, expected timing for reporting top line results from the full clinical study, its anticipation for a significant year with four readouts in CLI, muscle regeneration following hip fracture, COVID-19 complicated by ARDS, and HCT evaluating both our PLX-PAD and PLX-R18 product candidates, that these first PLX-R18 data in humans support its expectations that its PLX platform can yield multiple regenerative therapeutics or when it discusses developing solutions for unmet medical needs.
These forward-looking statements and their implications are based on the current expectations of the management of Pluristem only, and are subject to a number of factors and uncertainties that could cause actual results to differ materially from those described in the forward-looking statements.
The following factors, among others, could cause actual results to differ materially from those described in the forward-looking statements: changes in technology and market requirements; Pluristem may encounter delays or obstacles in launching and/or successfully completing its clinical trials; Pluristem’s products may not be approved by regulatory agencies, Pluristem’s technology may not be validated as it progresses further and its methods may not be accepted by the scientific community; Pluristem may be unable to retain or attract key employees whose knowledge is essential to the development of its products; unforeseen scientific difficulties may develop with Pluristem’s process; Pluristem’s products may wind up being more expensive than it anticipates; results in the laboratory may not translate to equally good results in real clinical settings; results of preclinical studies may not correlate with the results of human clinical trials; Pluristem’s patents may not be sufficient; Pluristem’s products may harm recipients; changes in legislation may adversely impact Pluristem; inability to timely develop and introduce new technologies, products and applications; loss of market share and pressure on pricing resulting from competition, which could cause the actual results or performance of Pluristem to differ materially from those contemplated in such forward-looking statements.
Except as otherwise required by law, Pluristem undertakes no obligation to publicly release any revisions to these forward-looking statements to reflect events or circumstances after the date hereof or to reflect the occurrence of unanticipated events.
For a more detailed description of the risks and uncertainties affecting Pluristem, reference is made to Pluristem’s reports filed from time to time with the Securities and Exchange Commission.

Contact:

Dana Rubin

Director of Investor Relations 972-74-7107194

danar@pluristem.com

HAIFA, Israel, October 20, 2020 – Pluristem Therapeutics Inc. (Nasdaq:PSTI) (TASE:PSTI), a leading regenerative medicine company developing a platform of novel biological products, today named medical experts to form the Steering Committee for its clinical program relating to Acute Respiratory Distress Syndrome (ARDS) associated with COVID-19. Pluristem is currently conducting Phase II studies of its PLX-PAD cells to treat hospitalized patients suffering from severe COVID-19 complicated by ARDS in the U.S., Europe and Israel. The Company is also conducting an Expanded Access Program in the U.S. and a per-patient Compassionate Use Program in Israel.

 

The Steering Committee announcement follows Pluristem’s recent expansion of its Phase II COVID-19 trial to Israel earlier this month. Comprised of five prominent professors and medical doctors in the fields of infectious diseases, critical care, pulmonology and internal medicine, Pluristem’s COVID-19 Steering Committee is chaired by Professor Dellinger, MD and includes:

R. Phillip Dellinger, MD, MSc, MCCM, Cooper University Health Care, U.S.

Professor Dellinger is a Professor of Medicine and Distinguished Scholar at Cooper Medical School of Rowan University (CMSRU) and Senior Critical Care Attending at Cooper University Hospital. Professor Dellinger is a past-President of the Society of Critical Care Medicine (SCCM) and was the 15th recipient of the SCCM Lifetime Achievement Award in 2015. He was the lead author of the 2004, 2008, and 2012 Surviving Sepsis Campaign International Guidelines on the Management of Severe Sepsis and Septic Shock and senior author on the 2016 guidelines.

 

Galia Rahav, MD, PhD Sheba Medical Center, Israel

Professor Rahav is the Head of the Infectious Diseases Unit and Laboratories at the Sheba Medical Center, and a full academic Professor of Internal Medicine and Infectious Diseases at the Sackler Faculty of Medicine, Tel Aviv University. Professor Rahav earned her MD from the Hebrew University Hadassah Medical School, Jerusalem and has specialization certificates in internal medicine, infectious diseases, and clinical microbiology.

Mitchell Levy, MD, MCCM, FCCP, Brown University, U.S.

Professor Levy is the Chief of the Division of Critical Care, Pulmonary, and Sleep Medicine, Department of Medicine, at The Warren Alpert Medical School of Brown University, where he also serves as a Professor of Medicine. He is also the Medical Director of the Medical Intensive Care Unit at Rhode Island Hospital, Providence, Rhode Island. Dr. Levy is a founding member and Executive Committee member of the Surviving Sepsis Campaign, a global initiative to improve the care of patients with severe sepsis. Professor Levy earned his MD from State University of New York at Buffalo. He is a past-President of the Society of Critical Care Medicine.

 

Christian Putensen, MD, PhD, University Hospital Bonn, Germany

Professor Putensen is a Professor of Intensive Care Medicine and Head of the Division of Intensive Care Medicine, Department of Anaesthesiology and Intensive Care Medicine, at the University Hospital Bonn.
Professor Putensen is the past Executive Committee member and past chair of the Respiratory Section of the European Society of Intensive Care Medicine.
Currently, he serves as Chairperson of the Intensive Care Medicine Scientific Subcommittee of the European Society of Anaesthesiology and Intensive Care Medicine. Professor Putensen’s research focus is pathophysiology and treatment of acute respiratory distress syndrome and sepsis.

 

Tom van der Poll, MD, PhD, Amsterdam University Medical Centers, Netherlands

Professor van der Poll is the Professor of Medicine and Chair of the Department of Medicine at the Amsterdam University Medical Centers (Academic Medical Center – University of Amsterdam – and Free University Medical Center) in the Netherlands. He is board certified in internal medicine and infectious diseases.
Professor van der Poll has made fundamental contributions to the understanding of the pathophysiology of sepsis.

Professor Dellinger, Chair of Pluristem’s COVID-19 Steering Committee, commented, “With no approved treatments for ARDS due to COVID-19 available today, I am honored to chair Pluristem’s Steering Committee.
I look forward to working with my esteemed colleagues to advise on the development of Pluristem’s COVID-19 treatment, which has the potential to help severe patients in need throughout the world.”

“We’ve assembled this Steering Committee, comprised of prestigious leaders in their fields from around the world, to guide and help accelerate PLX-PAD’s clinical development path at this critical time. We highly value the knowledge, talent, and experience shared by each of these key opinion leaders as we join forces to deliver an effective cell therapy for the most severe cases of COVID-19,” stated Pluristem CEO and President, Yaky Yanay.

 

About Pluristem Therapeutics

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

 

Safe Harbor Statement

This press release contains express or implied forward-looking statements within the Private Securities Litigation Reform Act of 1995 and other U.S. Federal securities laws.
For example, Pluristem is using forward-looking statements when it discusses the potential for Pluristem’s COVID-19 treatment to help severe patients in need throughout the world and that Pluristem and its COVID-19 steering committee will guide and help accelerate PLX-PAD’s clinical development and path. These forward-looking statements and their implications are based on the current expectations of the management of Pluristem only, and are subject to a number of factors and uncertainties that could cause actual results to differ materially from those described in the forward-looking statements.
The following factors, among others, could cause actual results to differ materially from those described in the forward-looking statements: changes in technology and market requirements; Pluristem may encounter delays or obstacles in launching and/or successfully completing its clinical trials; Pluristem’s products may not be approved by regulatory agencies, Pluristem’s technology may not be validated as it progresses further and its methods may not be accepted by the scientific community; Pluristem may be unable to retain or attract key employees whose knowledge is essential to the development of its products; unforeseen scientific difficulties may develop with Pluristem’s process; Pluristem’s products may wind up being more expensive than it anticipates; results in the laboratory may not translate to equally good results in real clinical settings; results of preclinical studies may not correlate with the results of human clinical trials; Pluristem’s patents may not be sufficient; Pluristem’s products may harm recipients; changes in legislation may adversely impact Pluristem; inability to timely develop and introduce new technologies, products and applications; loss of market share and pressure on pricing resulting from competition, which could cause the actual results or performance of Pluristem to differ materially from those contemplated in such forward-looking statements.
Except as otherwise required by law, Pluristem undertakes no obligation to publicly release any revisions to these forward-looking statements to reflect events or circumstances after the date hereof or to reflect the occurrence of unanticipated events.
For a more detailed description of the risks and uncertainties affecting Pluristem, reference is made to Pluristem’s reports filed from time to time with the Securities and Exchange Commission.

Contact:

Dana Rubin

Director of Investor Relations 972-74-7107194

danar@pluristem.com

Reports internal efficacy and safety data from first cohort

 

HAIFA, Israel, October 13, 2020 – Pluristem Therapeutics Inc. (Nasdaq:PSTI) (TASE:PSTI), a leading regenerative medicine company developing a platform of novel biological products, today announced that it has received clearance from the safety committee of an investigator initiated Phase I/II study to move forward with patient enrollment for cohort II. The study will evaluate PLX-PAD cells in the treatment of steroid-refractory chronic graft vs. host disease (GvHD) and is led by Principal Investigator Prof. Ron Ram, Director of the Hematology Blood and Marrow Stem Cell Transplantation Unit at Tel Aviv Sourasky Medical Center, Ichilov Hospital, Israel. Prof. Ram and his research staff are responsible for the design and implementation of the study at Sourasky Medical Center.

GvHD is a severe complication in patients who have undergone an allogeneic hematopoietic cell transplantation (HCT) and is a major cause of morbidity and mortality in these patients in which the donated stem cells identify the recipient’s body as foreign and attack it. The chronic form of GvHD (cGvHD) usually appears later than 100 days post-transplant.

Cohort I included 6 patients treated with 2 injections of 150 million cells, a week apart. At the 3- month follow up, interim safety results concluded that PLX-PAD cells were safe and that no treatment related side effects were reported. Efficacy results demonstrated that 4 out of the 6 patients reported improvement in symptoms that translated into a reduction in the severity of cGvHD with notable reduction in the required steroid doses for part of the patients. Based on these results, the study was approved to commence enrollment of 14 patients in cohort II to be treated with 4 injections of 150 million cells.

Prof. Ram of Ichilov Hospital commented, “From our experience in having treated 6 patients in the study to date, we have so far found no negative side effects from the use of the PLX-PAD cells in the treatment of steroid-refractory cGvHD. Patients with significant GvHD skin disorders previously unresponsive to multiple types of therapy showed remarkable response. Responses were also observed for severe mouth ulcers which prevented patients from eating solid foods. This resulted in a major improvement of quality of life and tapering of steroid doses.”

“Pluristem is committed to contributing to the wellbeing and quality of life of our patients. cGvHD is an indication where we see a significant need to enhance the current course of treatment for this life-threatening condition among patients undergoing bone marrow transplants. The preliminary results from cohort I of this Phase I/II study, and prior preclinical data, both indicate that PLX-PAD cells may potentially treat cGvHD patients and mitigate symptoms. We are very pleased to cooperate with Prof. Ram and Sourasky Medical Center, and we place a high importance in examining PLX-PAD for this indication,” stated Pluristem CEO and President, Yaky Yanay.

 

About cGvHD

Chronic graft-versus-host disease (cGvHD) remains a common and potentially life-threatening complication of allogeneic hematopoietic stem cell transplantation (HCT).
The 2-year cumulative incidence of chronic GvHD requiring systemic treatment is ∼30% to 40% by National Institutes of Health criteria1.
The hematopoietic stem cell transplants are used to treat bone marrow failure resulting from treatment of some blood or bone marrow cancers as well as other hematologic failures, such as aplastic anemia, which are not related to cancer.
The donated cells identify the recipient’s body as foreign and attack it as a result. While acute GvHD usually appears in the first 100 days after a transplant, and in specific body systems, chronic GvHD can occur at any time (even several years) after a transplant, and may manifest in many parts of the body such as: skin, mouth, eyes, liver, intestines, lungs and joints.
Long term immunosuppression is given to try to prevent or treat cGvHD.
Since this treatment suppresses the immune system for a very long time, patients are at high risk of infections, and are prescribed multiple medications to try to address this major risk.

 

About Pluristem Therapeutics

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

 

1 Flowers ME, Martin PJ. How we treat chronic graft-versus-host disease. Blood. 2015 Jan 22;125(4):606-15. doi: 10.1182/blood-2014-08-551994. Epub 2014 Nov 14. PMID: 25398933; PMCID: PMC4304105.,

https://pubmed.ncbi.nlm.nih.gov/25398933/

 

Safe Harbor Statement

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

 

Contact:

Dana Rubin

Director of Investor Relations 972-74-7107194

danar@pluristem.com

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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 Edge, Google Chrome, Firefox, Safari.

  1. How Do We Retain and Store Your Data?

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

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

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

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

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

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

  1. With Whom Do We Share Data?

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

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

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

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

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

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

  1. EU Data Subject Rights Regarding Personal Data under GDPR

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

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

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

Additional Information for users entitled to rights under GDPR:

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

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

  1. Children

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

  1. Links to Third Party Websites

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

  1. Changes to this Privacy Policy

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

  1. Contacting Us

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

Contact Information:

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

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

Physical address:

Pluri Biotech Ltd.

Attention: General Counsel and DPO

Matam Park, Building 05

Haifa, 3508409, Israel

©2023 Pluri™ Inc.

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

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