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

HAIFA, Israel, October 7, 2020 – Pluristem Therapeutics Inc. (Nasdaq:PSTI) (TASE:PSTI), a leading regenerative medicine company developing a platform of novel biological therapeutic products, announced today that it has received approval from the Israeli Ministry of Health to commence patient enrollment in Israel for the Company’s COVID-19 Phase II clinical trial, under the protocol that was approved by the Paul Ehrlich Institute (PEI), Germany’s regulatory agency.
A total of 40 patients hospitalized with severe COVID-19 complicated by Acute Respiratory Distress Syndrome (ARDS) will be enrolled at clinical sites in Israel and Germany.

The Phase II COVID-19 European clinical trial that is being expanded to Israel is in addition to Pluristem’s other COVID-19 clinical programs, including a Phase II study and an Expanded Access Program in the U.S., both under the U.S. Food and Drug Administration’s (FDA) approved protocol, and a per-patient compassionate use program in Israel.

The primary efficacy endpoint of the Phase II European study titled, “A Randomized, Controlled, Multicenter, Parallel-Group Phase II Study to Evaluate the Efficacy and Safety of Intramuscular Injections of PLX-PAD for the Treatment of severe COVID-19” is the number of ventilator free days during the 28 days from day 1 through to day 28 of the study. Safety and survival follow-up will be conducted up to week 52.

“We believe that the approval from the Israeli Ministry of Health will enable us to advance the treatment of severe COVID-19 patients. As the pandemic continues in Israel, we see it as our mission to treat those severe patients in need. With our broad COVID-19 clinical programs in Europe and the U.S., we are committed to advancing our research and developing a treatment that may help save lives,” stated Pluristem CEO and President Yaky Yanay.

PLX Cells for COVID-19

PLX cells are available off-the-shelf and once commercialized, can be manufactured in large scale quantities, which we believe offers a key advantage in addressing a global pandemic. PLX cells are allogeneic mesenchymal-like cells that have immunomodulatory properties that induce the immune system’s natural regulatory T cells and M2 macrophages, and thus may potentially reverse the dangerous overactivation of the immune system. Accordingly, PLX cells may potentially reduce the severity of COVID-19 pneumonia, leading hopefully to a better prognosis for the patients. Previous pre-clinical findings of PLX cells revealed therapeutic benefit in animal studies of pulmonary hypertension, lung fibrosis, acute kidney injury and gastrointestinal injury which are potential complications of the severe COVID-19 infection. Clinical data using PLX cells demonstrated the strong immunomodulatory potency of PLX cells in patients post major surgery.

 

Initial clinical data on COVID-19 ICU patients, treated under a Compassionate Use Program, at the conclusion of a 28 day follow up were previously published.
Taken together, PLX cells’ potential capabilities with the safety profile observed from clinical trials involving hundreds of patients worldwide potentially position them as a therapy for mitigating the tissue-damaging effects of COVID-19.

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 proposed study in Israel, its belief that the approval from the Israeli Ministry of Health will enable it to advance the treatment of severe COVID-19 patients, its belief that the ability to manufacture PLX cells in large scale quantities offers a key advantage in addressing a global pandemic, the potential of PLX cells in preventing or reversing the dangerous overactivation of the immune system, that PLX cells may potentially reduce the fatal symptoms of COVID-19 induced pneumonia, and PLX cells’ position as a therapy for mitigating the tissue-damaging effects of COVID-19.
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

The Malta Conferences address the shared desire to improve quality of life and political stability in the Middle East through scientific collaboration

HAIFA, Israel, October 1, 2020 – On Wednesday, September 30, 2020, Pluristem Therapeutics Inc. (Nasdaq:PSTI) (TASE:PSTI), a leading Israeli regenerative medicine company developing a platform of novel biological products, and the Abu Dhabi Stem Cells Center (ADSCC) unveiled their first joint projects in a presentation at the Malta Conferences Foundation, a global conference supported by the kENUP Foundation, a global promoter of research-based innovation with public and societal benefit.

Pluristem and ADSCC presented the new projects, part of the recently signed Memorandum of Understanding (MOU) aimed at harnessing the power of regenerative medicine.

The first joint project brings together the expertise and knowledge of Pluristem and ADSCC to advance a potential COVID-19 treatment. The project will involve the first-time administration of Pluristem’s PLX cells via a nebulizer, a drug delivery device that helps a patient inhale a medication through a mask or mouthpiece, to COVID-19 patients.
The collaboration will allow ADSCC to expand its stem cell therapy options using Pluristem’s novel PLX cells, while enabling Pluristem to leverage ADSCC’s nebulizer administration experience to develop a new treatment delivery model for PLX cells. ADSCC has reported effectively using nebulizers to treat patients suffering from COVID-19 infection with stem cells sourced from the patient’s own blood.

Further discussions for additional projects are underway, including for the potential collaboration in chronic Graft Versus Host Disease (cGvHD), a life-threatening immune response of the donor’s stem cells against the host (patient).

 

The parties presented the joint projects to a distinguished audience at the Malta Conferences Foundation, including Nobel Laureates, scientists, and diplomats.
The foundation’s mission is to address the shared desire to improve the quality of life and political stability in the Middle East by identifying unique opportunities for collaboration to meet the scientific and technological challenges of the region.

“I am delighted by the opportunity to convene this important meeting.
The Malta Conferences are the only platform in the world where scientists from 15 Middle East countries, Morocco and Pakistan can get together under the same roof with several Nobel Laureates. They develop collaborations and friendship which overcome the chasms of distrust and intolerance.” said Prof. Zafra Lerman, President of Malta Conferences Foundation.

“Embarking on this journey with Pluristem, to overcome one of this generation’s most complex medical challenges, marks an exciting new chapter full of possibilities when it comes to knowledge sharing and medical innovation. Our partnership speaks volumes about the power of collaboration between partners across previously divided borders.
While we simply do not yet know the long-term impact, the novel coronavirus will have on recovered patients, by working together we believe that we are able to leverage the best medical technologies and minds in the region to develop solutions to prevent and treat the lingering symptoms and long-term complications that are emerging,” said Dr. Yendry Ventura, General Manager of ADSCC.

“We were very honored to unveil our first joint projects with the ADSCC at the Malta Conferences Foundation. We see our partnership as a movement between Israel and the UAE, which we hope will lay the foundation for future collaborations that will help potentially bring change to our region and the entire world. As we work together to develop regenerative medicine for key unmet medical needs of benefit to patients around the world, we are excited for the future and its possibilities,” stated Pluristem CEO and President Yaky Yanay.

‘Two world-class players in the field of cell therapy join forces and cooperate on the fight of COVID-19. May this courageous cooperation serve as an example to the world,” says kENUP Foundation’s Executive Chairman, Holm Keller.

 

About Malta Conferences

The foundation’s mission is to address the shared desire to improve quality of life and political stability in the Middle East by identifying unique opportunities for collaboration to meet the scientific and technological challenges of the region.
The Malta Conferences deal with issues of science education, air and water quality, and alternative energy sources, among other topics of mutual interest.
Global leaders have recognized that science diplomacy is an extremely important mechanism for working toward stability in the Middle East, and this is what the Malta Conferences have done for the past 17 years.

 

About Abu Dhabi Stem Cells Center

Abu Dhabi Stem Cells Center (ADSCC) is an Abu Dhabi-based specialist healthcare center focused on cell therapy and regenerative medicine, as well as delivering cutting-edge research on stem cells in the region.
The Center was founded in March 2019 to meet growing domestic and regional demand for highly specialized medical services and treatments.
Equipped with the latest technologies, medical devices which are unique to the region, and a team of internationally recognized doctors working hand in hand with researchers, ADSCC is the first of its kind in the UAE. ADSCC specialties include immunology, hematology, clinical stem cell therapy, molecular biology, immunotherapy, orthopedics, and urology – amongst others.

 

About kENUP Foundation

kENUP is a global partnership in innovation, promoting research-based innovation for Europe with public and societal benefit.
It is a not-for-profit organization established as a foundation in the Republic of Malta by Public Deed on November 6, 2014. kENUP’s activities are published in the European Transparency Register.
The Foundation supports European corporations active in industries with substantive underlying market failures by preparing corporate innovation programs for an investment by the European Investment Bank (EIB), or by other public investment banks in the EU, often in close collaboration with private or venture investors.

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 first project with ADSCC and that such collaboration will allow ADSCC to expand its stem cell therapy options using its novel PLX cells, while enabling it to leverage ADSCC’s nebulizer administration experience to develop a new treatment delivery model for PLX cells, potential future projects with ADSCC, including the potential collaboration in chronic GvHD, the belief that it and ADSCC are able to leverage the best medical technologies and minds in the region to develop solutions to prevent and treat the lingering symptoms and long-term complications that are emerging and that it sees its partnership with ADSCC as a movement between Israel and the UAE, which it hopes will lay the foundation for future collaborations that will help potentially bring change to its region and the entire world. 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, September 15, 2020 – Pluristem Therapeutics Inc. (Nasdaq:PSTI) (TASE:PSTI), a leading regenerative medicine company developing a platform of novel biological products, today issued an update to its shareholders from its Chief Executive Officer and President Yaky Yanay.

 

Dear Fellow Shareholders,

This year, we saw the unprecedented need for the collaboration between industry and government in order to meet the challenge of the COVID-19 pandemic.
Pluristem is fully engaged in this effort and is harnessing all of its knowledge, experience, and dedication to improve the wellbeing of patients.
We believe our regenerative medicine product candidates are ideally suited to today’s healthcare challenges.
Through our late stage pipeline of product candidates and indications, we are paving the way towards marketing and commercialization, and strengthening our global presence through strategic collaborations including our most recent one with the Abu Dhabi Stem Cells Center.

 

As reported on July 21, 2020, we are heading into a pivotal year with four clinical readouts expected including: interim analysis of the Phase III study in Critical Limb Ischemia (CLI), top line efficacy results of the Phase III study in muscle regeneration following hip fracture, top line efficacy results of the Phase II study in COVID-19 and data analysis of the Phase I study in incomplete hematopoietic recovery following hematopoietic cell transplantation (HCT).

 

Phase III CLI Study and Interim Data Analysis

In the fourth quarter of calendar 2020, we expect to announce the interim analysis results for our global pivotal Phase III study of PLX-PAD in CLI.
We continue to enroll patients in the full clinical study in the U.S., Europe, and Israel and we recently added clinical sites as part of our efforts to introduce our PLX cells at additional key medical centers. The interim and/or final data set results are expected to enable discussions with both the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) regarding the filing of a Biologics License Application (BLA).

Phase II COVID-19 Study

Over the past few weeks, we have shifted our clinical site openings from the New York area to other regions in the U.S., as we follow the spread of the COVID-19 pandemic, and we are also considering adding clinical partners to accelerate site openings. In line with these steps, we are updating our expectation of completing enrollment in the first quarter of calendar year 2021. In the U.S., under the Expanded Access Program, up to 100 patients suffering from severe COVID- 19 complicated by Acute Respiratory Distress Syndrome (ARDS), who are not eligible for inclusion to the Phase II study, may be treated with PLX-PAD and the gathered data will be evaluated alongside the Phase II study data. In Europe, we continue to advance the Phase II clinical study which has been cleared in Germany to commence patient enrollment, and in Israel we continue to treat patients under the per-patient Compassionate Use program.

Financial Update

Pluristem had $59 million in cash, cash equivalents and bank deposits as of June 30, 2020.

Moving forward into our 2021 fiscal year, which coincides with our Jewish New Year, we reiterate Pluristem’s commitment to all of our stakeholders including shareholders, patients, employees and our partners. While this year brought unprecedented challenges, we witnessed, more than ever, Pluristem’s resilience and ability to face those challenges. This is a credit to our dedicated and passionate employees who have a profound commitment to excellence.
We are proud of our tenured team of 160 employees, over 45% of which have been with the Company for 5-10 years. I truly believe that our very strong culture is the one reason that Pluristem has won recognition for being one of the best places to work in Israel, for four years in a row.
More importantly, we see the commitment of our employees as one of the main factors driving our success and we are all committed to continuing to drive for such success in the coming year.

 

Sincerely, Yaky Yanay

Chief Executive Officer

 

About Pluristem Therapeutics

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

 

Safe Harbor Statement

This press release contains express or implied forward-looking statements within the Private Securities Litigation Reform Act of 1995 and other U.S. Federal securities laws.
For example, Pluristem is using forward-looking statements when it discusses its belief that its regenerative medicine product candidates are ideally suited to today’s healthcare challenges, its belief that it is heading into a pivotal year with four clinical readouts expected including interim analysis of the Phase III study in CLI, top line efficacy results of the Phase III study in muscle regeneration following hip fracture, top line efficacy results of the Phase II study in COVID-19 and data analysis of the Phase I study in incomplete hematopoietic recovery following HCT, that it expects the interim and/or final data set results from the Phase III CLI study to enable discussions with both the FDA and the EMA regarding the filing of a BLA, that it expects to complete enrollment of its Phase II COVID-19 study in the first quarter of calendar year 2021 and its belief that its strong culture is the one reason that it has won recognition for being one of the best places to work in Israel, for four years in a row.
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

Top line efficacy results expected Q1 2021

 

HAIFA, Israel, August 19, 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 completed patient enrollment in its Phase I study evaluating PLX-R18 as a treatment for incomplete hematopoietic recovery following hematopoietic cell transplantation (HCT), in the U.S. and in Israel.

Incomplete hematopoietic recovery poses a significant risk 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.

The Phase I multi-center, open-label, 3 cohort dose-escalating study is evaluating the safety of intramuscular (IM) injections of PLX-R18 cells in 20 subjects, with incomplete hematopoietic recovery persisting for at least 3 months after HCT. The follow up period is 12 months. Safety is the primary endpoint, with efficacy endpoints including changes in white blood cells, platelets counts, hemoglobin levels, changes in blood products requirements, and changes in quality of life. As previously reported, Pluristem expects to announce top line efficacy results during the first quarter of calendar year 2021.

“We are glad to meet an additional important clinical milestone that keeps us on track for our expected time to readout, and is one of four data readouts we expect to announce in the coming twelve months. We look forward to seeing data that may position PLX-R18 as an important drug candidate for hematological disorders. We would like to thank the medical teams across the clinical sites supporting our program in the most professional and caring way,” 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 expected timing of the top line results for its Phase I study and other readouts and the ability of PLX-R18 to address unmet needs in patients by stimulating the regenerative potential of the bone marrow.
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

Agreement comes as United Arab Emirates (UAE) and Israel Reach Historic Agreement to Fully Normalize Diplomatic Relations

HAIFA, Israel, August 17, 2020 – Pluristem Therapeutics Inc. (Nasdaq:PSTI) (TASE:PSTI), a leading regenerative medicine company developing a platform of novel biological therapeutic products, announced today its subsidiary, Pluristem Ltd., has signed a non-binding Memorandum of Understanding (MOU) with the United Arab Emirates-based Abu Dhabi Stem Cells Center (ADSCC), a specialist healthcare center focused on cell therapy and regenerative medicine. Executives from both companies took part in a signing ceremony held via video conference between Israel and the UAE. The aim of the collaboration is to capitalize on each company’s respective areas of expertise in cell therapies to deliver regenerative medicine for the benefit not only of the citizens of the UAE and Israel, but for humanity as a whole. The collaboration between the parties was initiated by the Better Alternatives advisory firm.

The parties have agreed to exchange research results, share samples, join usage of equipment and testing, and other essential activities related to advancing the treatment and research of cell therapies for a broad range of medical conditions, including COVID-19.

ADSCC has been treating COVID-19 patients with stem cells sourced from the patient’s blood, by returning the cells back into the patient’s lungs as a fine mist through a nebulizer, a machine that helps a patient breathe in medicine through a mask or mouthpiece. Pluristem has treated patients with its placental PLX-PAD allogenic product via compassionate use programs in Israel and the U.S. and is currently conducting phase II studies in the U.S. and EU.

“We are extremely proud to partner with our colleagues at the ADSCC by sharing knowledge and expertise that we believe will advance healthcare within and across our borders. We see l ife science and regenerative medicine as a bridge for building peace, prosperity, and well-being in our region and for the entire world. I believe it is our obligation and privilege as business and scientific leaders to lead the way forward to strengthen collaborations, and promote innovation and education. We are honored to be on the front line of this historical moment,” stated Pluristem CEO and President Yaky Yanay.

 

Dr Yendry Ventura, General Manager of the ADSCC commented, “Pluristem is a major player in the cell therapy field with years of experience, a unique platform and a robust clinical pipeline. We are excited to join forces and to promote the research and development of cell therapies for the best of the patients and the human society as a whole.”

About Abu Dhabi Stem Cells Center

Abu Dhabi Stem Cells Center (ADSCC) is an Abu Dhabi-based specialist healthcare center focused on cell therapy and regenerative medicine, as well as delivering cutting-edge research on stem cells in the region.
The Center was founded in March 2019 to meet growing domestic and regional demand for highly specialized medical services and treatments. Equipped with the latest technologies, medical devices which are unique to the region, and a team of internationally recognized doctors working hand in hand with researchers, ADSCC is the first of its kind in the UAE. ADSCC specialties include immunology, hematology, clinical stem cell therapy, molecular biology, immunotherapy, orthopedics, and urology – amongst others.

 

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 aim of the collaboration with the ADSCC is to capitalize on each company’s respective areas of expertise in cell therapies to deliver regenerative medicine for the benefit not only of the citizens of the UAE and Israel , but for humanity as a whole and the belief that it is its obligation and privilege as business and scientific leaders to lead the way forward to strengthen collaborations, and promote innovation and education.
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

Pluristem étend la portée de son programme sur la COVID-19 à l’Europe et reçoit une autorisation du PEI pour commencer une étude de phase II en Allemagne

HAÏFA, Israël, 12 août 2020 /PRNewswire/ — Pluristem Therapeutics Inc. (Nasdaq: PSTI) (TASE: PSTI), une société de premier plan dans le domaine de la médecine régénérative développant une plateforme de produits thérapeutiques biologiques novateurs, a annoncé aujourd’hui que l’agence allemande de réglementation de la santé, le Paul Ehrlich Institute (PEI), a approuvé le protocole clinique de phase II de la société pour son étude intitulée « A Randomized, Controlled, Multicenter, Parallel-Group Phase II Study to Evaluate the Efficacy and Safety of Intramuscular Injections of PLX PAD for the Treatment of severe COVID-19 » (Une étude de phase II randomisée, contrôlée, multicentrique, en groupes parallèles pour évaluer l’efficacité et l’innocuité d’injections intramusculaires de PLX PAD pour le traitement des cas graves de COVID-19). Quarante

(40) patients hospitalisés présentant une forme grave de la COVID-19 accompagné de complications du syndrome de détresse respiratoire aiguë (SDRA) seront recrutés dans l’étude.

Le critère principal qui permettra de mesurer l’efficacité de l’étude est le nombre de jours passés sans respirateur pendant la totalité des 28 jours de l’étude. Le suivi du taux de survie et du niveau d’innocuité sera effectué au 60 ème jour , ainsi qu’aux semaines 26 et 52.

« Nous sommes ravis d’étendre notre programme sur la COVID-19 à un territoire supplémentaire et nous sommes impatients de commencer l’essai clinique de nos cellules PLX pour le traitement des cas graves de COVID-19 et ayant développé des complications du SDRA en Europe. Sur la base de nos discussions avec le PEI, il s’agira d’une étude indépendante, où le groupe expérimental sera comparé au groupe dit de contrôle suivant les recommandations thérapeutiques standards. Pluristem mène plusieurs programmes de développement clinique avancé en Europe qui sont soutenus par Horizon 2020 et, dès réception des fonds, par la Banque européenne d’investissement (BEI). Nous sommes reconnaissants de leur soutien important à notre plateforme thérapeutique. Pluristem est déterminée à utiliser ce qui, selon nous, constitue les principaux avantages concurrentiels de notre plateforme technologique et à apporter des médicaments régénératifs aux patients en Europe et dans le monde entier », a déclaré Yaky Yanay, CEO et President de Pluristem.

Outre cette étude en Allemagne, Pluristem mène actuellement un essai de phase II sur la COVID-19 aux États-Unis, qui recrutera 140 patients.

Les cellules PLX contre la COVID-19

Les cellules PLX peuvent être administrées sans ordonnance et, une fois commercialisées, elles peuvent être fabriquées en grandes quantités. Pluristem estime que ses cellules PLX offriront un avantage clé dans la lutte contre la pandémie mondiale

 

de COVID-19. Les cellules PLX sont semblables aux cellules allogéniques mésenchymateuses; les propriétés immunomodulatrices de ces cellules provoquent les régulateurs naturels du système immunitaire – les macrophages M2 et les lymphocytes T, et peuvent ainsi prévenir ou inverser la suractivation dangereuse du système immunitaire.
Par conséquent, les cellules PLX peuvent potentiellement réduire l’incidence et/ou la gravité de la pneumonie provoquée par la COVID-19, menant, nous l’espérons, à un meilleur pronostic pour les patients. Les résultats de précédent es études précliniques sur les cellules PLX ont révélé des bienfaits thérapeutiques dans des études sur les animaux concernant l’hypertension pulmonaire, la fibrose pulmonaire, les lésions rénales aiguës et les lésions gastro-intestinales, qui sont des complications potentielles des graves infections à la COVID-19. Les données cliniques sur l’utilisation de cellules PLX ont démontré la grande puissance immunomodulatrice de celles -ci chez des patients ayant subi une intervention chirurgicale majeure. Les données cliniques préliminaires, obtenues au terme d’un suivi de 28 jours chez les patients atteints de la COVID-19 en unité de soins intensifs et traités dans le cadre d’un programme d’usage compassionnel, ont été précédemment publiées.
Les capacités potentielles des cellules PLX, combinées avec le profil d’innocuité observé lors d’essais cliniques impliquant des centaines de patients dans le monde entier, placent les cellules PLX comme traitement potentiel pour atténuer les effets néfastes de la COVID-19 sur les tissus.

À propos de Pluristem Therapeutics

Pluristem Therapeutics Inc. est une société de premier plan dans le domaine de la médecine régénérative qui développe des produits candidats novateurs de thérapie cellulaire à base de placenta. La société a rendu compte de solides données d’essais cliniques dans plusieurs indications pour ses produits candidats brevetés à cellules PLX et mène actuellement des essais cliniques en phase avancée dans plusieurs indications. On estime que les produits candidats à cellules PLX libèrent une variété de protéines thérapeutiques en réponse à l’inflammation, à l’ischémie, aux traumatismes musculaires, aux troubles hématologiques et aux dommages par radiations. Les cellules sont développées à l’aide de la technologie d’expansion tridimensionnelle exclusive de la société et peuvent être administrées aux patients sans requérir une compatibilité tissulaire. Pluristem possède une solide position en matière de propriété intellectuelle : une usine de fabrication et de recherche certifiée GMP détenue et exploitée par la société, des relations stratégiques avec de grandes institutions de recherche et une équipe de direction chevronnée.

Le présent avis contient des informations prospectives au sens de l’U.S. Securities Act et des Safe Harbor provisions de l’U.S. Private Securities Litigation Reform Act of 1995. Pour plus de détails sur les mots et expressions régissant les informations prospectives, veuillez consulter l’annonce officielle en anglais publiée par la société et apparaissant sur le site web de la Bourse de Tel Aviv (TASE).

Contact :

Dana Rubin

Director of Investor Relations

+972-74-7107194

danar@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.

Privacy and Data Protection Policy and Notice

Last updated on 13 January 2025

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

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

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

 

  1. WHICH INFORMATION MAY WE COLLECT?

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

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

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

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

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

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

 

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

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

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

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

 

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

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

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

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

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

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

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

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

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

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

 

  1. SHARING DATA WITH THIRD PARTIES

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

We transfer Personal Data to:

 

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

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

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

– Website and platform analytics, including Google Analytics;

– Expression and language measurement services;

– Document management and sharing services;

– Ticketing and support;

– On-site and cloud-based database services;

– CRM software;

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

– Project management systems;

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

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

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

 

  1. WHERE DO WE STORE YOUR DATA?

Summary: we store your Personal Data across multiple locations globally

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

 

  1. INTERNATIONAL DATA TRANSFERS

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

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

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

– Store or backup the information;

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

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

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

– Collaborate with our research partners across multiple jurisdictions.

 

  1. DATA RETENTION

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

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

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

 

  1. SERVICES AND WEBSITE DATA COLLECTION AND COOKIES

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

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

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

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

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

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

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

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

 

  1. SECURITY AND STORAGE OF INFORMATION

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

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

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

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

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

 

  1. DATA SUBJECT RIGHTS

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

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

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

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

 

  1. GENERAL

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

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

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

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

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

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

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

Matam Park, Building 05 Haifa, 3508409, Israel

*           *           *           *           *

 

©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.