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HAIFA, ISRAEL, December 12, 2017 — Pluristem Therapeutics Inc. (Nasdaq: PSTI, TASE: PSTI), a leading developer of placenta-based cell therapy products, announced today it received a GMP certification and manufacturer/importer authorization from Israel’s Ministry of Health (MOH). The GMP certificate was granted upon successful audit of Pluristem’s facilities.
The MOH approval is required for Pluristem to continue manufacturing its cell therapies for use in ongoing pivotal studies and will also facilitate readiness of manufacturing for marketing of Pluristem’s placental cell therapies worldwide.
This MOH authorization fulfills the requirements set by the World Health Organization (WHO) and also falls under the provision of the CAA agreement between Israel and the EU, which will also serve to qualify Pluristem’s facilities for marketing in the EU as well.
The approval supports the readiness of Pluristem’s manufacturing capabilities as the company advances in its pivotal-stage studies. Pluristem is currently enrolling patients in a global Phase III trial of PLX-PAD cells for the treatment of critical limb ischemia and expects to commence a phase III study of PLX-PAD for the treatment of hip fracture following surgery.
The company maintains close relationships with key regulators worldwide relating to the quality expectations for marketing and has already secured Chemistry, Manufacturing, and Controls (CMC) approval from key regulators including the U.S. Food and Drug Administration (FDA), Japan’s Pharmaceutical and Medical Devices Agency (PMDA,) and the European Medicines Agency (EMA).
“We are delighted to receive this GMP certification from the Israeli Ministry of Health,” said Zami Aberman, Chairman and Co-CEO of Pluristem. “We believe that this authorization affirms our ability to abide by the strict requirements demanded from advanced pharmaceutical companies while being the gold standard in cell therapy manufacturing and development.”
Pluristem Therapeutics is a leading developer of placenta-derived cell therapy products with patented PLX (PLacental eXpanded) cells entering late-stage trials in several indications. Our PLX cell products each release a different 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 3D expansion technology and can be administered to patients without tissue matching or immunosuppression.
Pluristem has company-owned and operated, GMP-certified manufacturing and research facilities, a strong intellectual property position, and strategic relationships with major research and U.S. government institutions.
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 its discusses that the GMP certification supports the manufacturing of Pluristem’s pivotal stage studies and readiness for future marketing as well as complying with future EU marketing purposes, Pluristem’s expectation to commence a phase III study in PLX-PAD for the treatment of hip fracture following surgery and its belief that the GMP certification affirms its ability to abide by the strict requirements demanded from advanced pharmaceutical companies while being the gold standard in cell therapy manufacturing and development. 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:
Karine Kleinhaus, MD, MPH Divisional VP, North America 1-914-512-4109
Efrat Kaduri
Investor and Public Relations Manager 972-74-7108600
HAIFA, ISRAEL, December 07, 2017 — Pluristem Therapeutics Inc. (NASDAQ: PSTI, TASE: PSTI), a leading developer of placenta-based cell therapy products, announced today the company will present data from its Phase II-equivalent study of PLX-R18 cells for the treatment of acute radiation syndrome (ARS) at the American Society of Hematology’s (ASH) 59th Annual Meeting to be held in Atlanta, Georgia, on December 9-12, 2017.
The results of the study will be presented during Program Session 506: Hematopoiesis and Stem Cells: Microenvironment, Cell Adhesion, and Stromal Stem Cells.
The poster, “Intramuscular Administration of Placenta-Derived Stromal Cells Enhances Survival of Rhesus Macaque Monkeys Exposed to Total Body Irradiation,” will describe data from a recently announced Phase II-equivalent study under the U.S. Food and Drug Administration (FDA) Animal Rule. The data demonstrate improved survival and hematological recovery of NHPs exposed to different levels of radiation. This study was conducted and funded by the
U.S. National Institute of Allergy and Infectious Diseases (NIAID), part of the NIH. The poster abstract will be published online in the supplemental volume of Blood, a peer-reviewed medical journal published by ASH.
“We are excited to present these promising data on our PLX-R18 cells in the treatment of ARS to the world’s thought leaders in hematology at this year’s ASH conference,” said Yaky Yanay, President and Co- CEO of Pluristem. “We believe that there is a crucial need for a therapy capable of effectively treating populations in case of nuclear or radioactive incidents.
These findings, which show recovery of the hematologic system, suggest that PLX-R18 has the potential to treat a large population exposed to different levels of radiation and might also be used for additional hematologic indications.”
PLX-R18 is Pluristem’s second cell therapy product in development. It is designed to treat bone marrow that is unable to produce enough blood cells due to a variety of causes including ARS, certain cancers or cancer treatments, or immune-mediated bone marrow failure. Pluristem is currently enrolling patients in a U.S. Phase I trial of PLX-R18 in incomplete bone marrow recovery following hematopoietic cell transplantation. PLX-R18’s first animal studies in ARS were performed in collaboration with Prof. Gorodetsky at Hadassah Medical Center. Further preclinical data from trials conducted by the U.S. National Institutes of Health, Hadassah, the Charite in Berlin and other prominent research institutions, have shown that PLX-R18 cells secrete a range of specific proteins that trigger the regeneration of bone marrow hematopoietic cells, thereby supporting the recovery of blood cell production. With its capabilities, PLX-R18 could potentially treat a broad range of hematologic indications, which together constitute a substantial global market.
Pluristem Therapeutics Inc. is a leading developer of placenta-based cell therapy products.
The Company has reported robust clinical trial data in multiple indications for its patented PLX (PLacental eXpanded) cells, and is entering late-stage trials in several indications. Our PLX cell products release a range of therapeutic proteins in response to inflammation, ischemia, muscle trauma, hematological disorders, and radiation damage.
The cells are grown using the Company’s proprietary three-dimensional expansion technology and can be administered to patients off-the-shelf, without tissue matching.
Pluristem has a strong intellectual property position; Company-owned and operated, GMP-certified manufacturing and research facilities; strategic relationships with major research institutions; and a seasoned management team.
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 its discusses that PLX-R18 has the potential to treat a large population exposed to different levels of radiation and might also be used for additional hematologic indications, and the potential market for such indications. These forward-looking statements and their implications are based on the current expectations of the management of Pluristem only, and are subject to a number of factors and uncertainties that could cause actual results to differ materially from those described in the forward-looking statements. The following factors, among others, could cause actual results to differ materially from those described in the forward-looking statements: changes in technology and market requirements; Pluristem may encounter delays or obstacles in launching and/or successfully completing its clinical trials; Pluristem’s products may not be approved by regulatory agencies, Pluristem’s technology may not be validated as it progresses further and its methods may not be accepted by the scientific community; Pluristem may be unable to retain or attract key employees whose knowledge is essential to the development of its products; unforeseen scientific difficulties may develop with Pluristem’s process; Pluristem’s products may wind up being more expensive than it anticipates; results in the laboratory may not translate to equally good results in real clinical settings; results of preclinical studies may not correlate with the results of human clinical trials; Pluristem’s patents may not be sufficient; Pluristem’s products may harm recipients; changes in legislation may adversely impact Pluristem; inability to timely develop and introduce new technologies, products and applications; loss of market share and pressure on pricing resulting from competition, which could cause the actual results or performance of Pluristem to differ materially from those contemplated in such forward-looking statements.
Except as otherwise required by law, Pluristem undertakes no obligation to publicly release any revisions to these forward-looking statements to reflect events or circumstances after the date hereof or to reflect the occurrence of unanticipated events.
For a more detailed description of the risks and uncertainties affecting Pluristem, reference is made to Pluristem’s reports filed from time to time with the Securities and Exchange Commission.
Karine Kleinhaus, MD, MPH Divisional VP, North America
1-914-512-4109
Efrat Kaduri
Head of Investor and Public Relations 972-74-7108600
Data supports advanced PLX-PAD clinical studies including dosing regimen, systemic therapeutic effects and superiority of the cells over cytokines
HAIFA, ISRAEL, November 29, 2017 — Pluristem Therapeutics Inc. (NASDAQ: PSTI, TASE: PSTI), a leading developer of placenta-based cell therapy products, announced the publication of a peer-reviewed article in Cytotherapy, the official journal of the International Society for Cellular Therapy, titled, “Placenta- Derived PLX-PAD Mesenchymal-Like Stromal Cells are Efficacious in Rescuing Blood Flow in Hind Limb Ischemia Mouse Model by a Dose- and Site-Dependent Mechanism of Action (MOA).” The article is based on the Company’s preclinical findings and will be published in the December 2017 issue of Cytotherapy.
The study utilized a mouse model of hind limb ischemia (HLI) to study the efficacy and MOA of PLX-PAD cells in the treatment of peripheral artery disease (PAD). Pluristem is currently conducting a global, pivotal Phase III study in critical limb ischemia (CLI), and is expecting clinical data from its Phase II study in intermittent claudication (IC). Both are forms of peripheral artery disease. In both conditions, blood supply to the legs is obstructed, leading to impaired blood flow and tissue ischemia.
Data from this study showed that intramuscularly (IM) administered PLX-PAD cells restored blood flow to the lower limbs of mice with HLI, in a dose- and site-dependent manner. IM administration of PLX-PAD cells had a systemic effect, thereby restoring blood flow to parts of the limb in need even when injected to the contralateral leg. Administration of a second dose was found to boost the effect of a single administration and lead to greater improvement in blood flow. The study demonstrated the cells’ MOA: secreting therapeutic proteins systemically that promote the creation of new blood vessels.
“We are pleased to share these findings, which suggest the potential of our cells to secrete an adaptive, slow-release cocktail of therapeutic proteins via their interaction with tissue surrounding the area in need of healing and repair,” stated Zami Aberman, Chairman and Co-CEO of Pluristem. “We believe this data supports our current pivotal trial in CLI by affirming our dosing methods and quantities. The data is also valuable in understanding the therapeutic role of PLX products in additional medical indications. We believe these important findings also provide additional support for the scientific rationale behind our unique mechanism of action, and for the systemic effect and therapeutic benefits of injecting the cells intramuscularly.”
Pluristem Therapeutics Inc. is a leading developer of placenta-based cell therapy products.
The Company has reported robust clinical trial data in multiple indications for its patented PLX (PLacental eXpanded) cells, and is entering late-stage trials in several indications. Our PLX cell products release a range of therapeutic proteins in response to inflammation, ischemia, muscle trauma, hematological disorders, and radiation damage.
The cells are grown using the Company’s proprietary three-dimensional expansion technology and can be administered to patients off-the-shelf, without tissue matching.
Pluristem has a strong intellectual property position; Company-owned and operated, GMP-certified manufacturing and research facilities; strategic relationships with major research institutions; and a seasoned management team.
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 its discusses the various studies relating to its cell therapy products, Pluristem’s belief that the findings of the preclinical HLI study support its dosing methods and quantities, the scientific rationale of its unique MOA and the positive influence of IM Injections on the systemic therapeutic effect of the cells as well as its understanding of the therapeutic role of PLX products in additional medical indications. These forward-looking statements and their implications are based on the current expectations of the management of Pluristem only, and are subject to a number of factors and uncertainties that could cause actual results to differ materially from those described in the forward- looking statements. The following factors, among others, could cause actual results to differ materially from those described in the forward-looking statements: changes in technology and market requirements; Pluristem may encounter delays or obstacles in launching and/or successfully completing its clinical trials; Pluristem’s products may not be approved by regulatory agencies, Pluristem’s technology may not be validated as it progresses further and its methods may not be accepted by the scientific community; Pluristem may be unable to retain or attract key employees whose knowledge is essential to the development of its products; unforeseen scientific difficulties may develop with Pluristem’s process; Pluristem’s products may wind up being more expensive than it anticipates; results in the laboratory may not translate to equally good results in real clinical settings; results of preclinical studies may not correlate with the results of human clinical trials; Pluristem’s patents may not be sufficient; Pluristem’s products may harm recipients; changes in legislation may adversely impact Pluristem; inability to timely develop and introduce new technologies, products and applications; loss of market share and pressure on pricing resulting from competition, which could cause the actual results or performance of Pluristem to differ materially from those contemplated in such forward-looking statements. Except as otherwise required by law, Pluristem undertakes no obligation to publicly release any revisions to these forward-looking statements to reflect events or circumstances after the date hereof or to reflect the occurrence of unanticipated events.
For a more detailed description of the risks and uncertainties affecting Pluristem, reference is made to Pluristem’s reports filed from time to time with the Securities and Exchange Commission.
Karine Kleinhaus, MD, MPH Divisional VP, North America 1-914-512-4109
Efrat Kaduri
Head of Investor and Public Relations 972-74-7108600
HAIFA, ISRAEL, November 22, 2017— Pluristem Therapeutics Inc. (NASDAQ: PSTI, TASE: PSTI), a leading developer of placenta-based cell therapy products, announced today that the U.S. Patent and Trademark Office (USPTO) has issued a patent titled, “Skeletal muscle regeneration using mesenchymal system cells.” This key patent, which has already been granted in Europe, Hong Kong and Israel, addresses the use of MSCs for skeletal muscle regeneration used either directly after, or shortly after, post-surgical muscle injury.
The Company received positive feedback from the U.S. Food and Drug Administration (FDA) and the European Medicine Agency (EMA) for the proposed study design and endpoints of its Phase III trial for the treatment of muscle recovery following arthroplasty for hip fracture. This planned study was recently awarded an $8.7 million grant by the Horizon 2020 program, the European Union’s largest research and innovation program. If successful, Pluristem plans to use the study results to achieve marketing approval in both the U.S. and Europe.
Previous clinical studies using PLX-PAD cells demonstrated significant muscle regeneration following arthroplasty, including a 300% improvement in muscle volume (p=0.004) and a 500% (p=0.0067) boost in muscle force when observed six months after surgery compared to the control group.
“This very important patent comes at the right time, just ahead of our planned Phase III study in muscle regeneration following hip fracture,” stated Zami Aberman, Chairman and Co-CEO of Pluristem. “The patent substantially strengthens our intellectual property around muscle regeneration, particularly as it pertains to repair and regeneration following surgery. In an industry that demands constant technological and scientific advances, a robust patent portfolio covering our core innovations strengthens Pluristem’s competitive edge.”
Pluristem Therapeutics Inc. is a leading developer of placenta-based cell therapy products.
The Company has reported robust clinical trial data in multiple indications for its patented PLX (PLacental eXpanded) cells, and is entering late-stage trials in several indications. PLX cell products release a range of therapeutic proteins in response to inflammation, ischemia, muscle trauma, hematological disorders, and radiation damage.
The cells are grown using the Company’s proprietary three-dimensional expansion technology and can be administered to patients off-the-shelf, without tissue matching.
Pluristem has a strong intellectual property position; Company-owned and operated, GMP-certified manufacturing and research facilities; strategic relationships with major research institutions; and a seasoned management team.
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 its discusses the positive feedback it received from regulatory authorities and the potential that such feedback will result in approval to conduct clinical trials, the actual receipt of grants, the initiation and successful completion of planned clinical trials, the potential to receive marketing approval for Pluristem’s products and the potential of the patent reported above to and other intellectual property rights Pluristem owns to support Pluristem’s competitive edge. . 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.
Karine Kleinhaus, MD, MPH Divisional VP, North America 1-914-512-4109
Efrat Kaduri
Head of Investor and Public Relations 972-74-7108600
HAIFA, Israel, November 14, 2017– Pluristem Therapeutics Inc. (Nasdaq:PSTI) (TASE:PSTI), a leading developer of placenta-based cell therapy products, today reported financial results and corporate developments for its first quarter of fiscal 2018 ended September 30, 2017.
“Our activities in this quarter demonstrate our continued drive to develop and commercialize cell therapy products that have the potential to help millions of patients facing unmet medical needs, while also generating value for our shareholders,” stated Pluristem Chairman and Co-CEO, Zami Aberman. “We have seen a burgeoning interest in our cell therapy products from external parties including key regulatory agencies, government bodies, business partners, physicians and patients around the world. We believe this interest shows broad confidence that Pluristem can fill a significant gap in the current global healthcare system. As we come closer to marketing approval and commercialization, we believe Pluristem maintains a significant advantage in the industry with our proprietary 3D manufacturing technology, strong intellectual property and business partnerships, and positive data from our completed studies.”
Clinical and Corporate Highlights:
Pluristem’s multinational Phase III study of PLX-PAD cells in the treatment of Critical Limb Ischemia (CLI) was granted Fast Track Designation from the U.S. Food and Drug Administration (FDA) and is currently enrolling patients in the U.S. and Europe. Fast Track Designation increases the chance of a priority review by the FDA. This trial was recently awarded an $8 million grant from the European Horizon 2020 program.
The Company reported that in previous discussions with the FDA and the European Medicines Agency (EMA), it received positive feedback on the proposed study design and endpoints for its Phase III trial in the treatment of muscle recovery following arthroplasty for hip fracture. Pluristem plans to submit the Investigational New Drug (IND) and Clinical Trial Application (CTA) for the trial in the coming months. This trial was recently awarded an $8.7 million grant from the European Horizon 2020 program.
Pluristem’s PLX-R18 was granted Orphan Drug Designation by the FDA as a treatment for Acute Radiation Syndrome (ARS), which may accelerate the path to potential marketing approval and includes a seven year grant market exclusivity upon marketing approval. Pluristem’s ARS trial is supported and conducted by the National Institutes of Health (NIH), the U.S. Department of Defense and Fukushima Medical University.
Pluristem reported that, following approval from Israel’s Ministry of Health, it will open clinical centers in Israel for its Phase I trial of PLX-R18 cell therapy as a treatment for insufficient hematopoietic recovery following hematopoietic cell transplantation (HCT). The trial is already recruiting patients in the United States. Up to 30 patients will be recruited in total from the United States and Israel.
Pluristem signed an agreement with Tel Aviv Sourasky Medical Center (Ichilov Hospital) to conduct a Phase I/II trial in PLX-PAD cell therapy for the treatment of Steroid-Refractory Chronic Graft-versus-Host- Disease (GvHD).
Pluristem was granted three significant patents.
Two of the patents were issued by the Hong Kong Patents Registry for cell therapy products related to CLI and muscle regeneration.
The third patent was granted to Pluristem by the European Patent Office for PLX-R18 to be used to treat a host of new indications, including ARS, genetic disorders, and autoimmune diseases, while also supporting chemotherapy treatments.
Financial Update:
As of September 30, 2017, Pluristem had $21.3 million in cash and cash equivalents, bank deposits, restricted deposits and marketable securities. The Company’s net cash used for operating activities for the quarter ended September 30, 2017 was $5.2 million. In addition, during October, the company conducted a public offering in Israel for aggregate gross proceeds of $15.1million.
Pluristem also announced that a $7.9 million non-dilutive grant from the European Horizon 2020 program has been awarded to nTRACK, a collaborative project designed to study nanoparticle effects on PLX-PAD cell viability and functionality.
Pluristem Therapeutics is a leading developer of placenta-derived cell therapy products with patented PLX (PLacental eXpanded) cells entering late-stage trials in several indications.
Our PLX cell products each release a different 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 3D expansion technology and can be administered to patients without tissue matching or immunosuppression. Pluristem has Company-owned and operated, GMP-certified manufacturing and research facilities, a strong intellectual property position, and strategic relationships with major research and U.S. government institutions.
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 broad interest in its products by key regulatory agencies, government bodies, business partners, physicians and patients around the world reflects confidence that it can fill a significant gap in the current global healthcare system, its belief that it holds a significant advantage in the industry, that the fast track designation of its multinational Phase III study of PLX-PAD cells in the treatment of CLI increases the chance of a priority review by the FDA, its plans to submit an IND and CTA for the Phase III trial in the treatment of muscle recovery following arthroplasty for hip fracture, the potential accelerated path to potential marketing approval of its PLX- R18 due to its being granted Orphan Drug Designation by the FDA, its plan to open clinical trial centers in Israel and the recruitment of patients for its Phase I trial of PLX-R18 cell therapy as a treatment for insufficient hematopoietic recovery following HCT and the timing of its various planned trials and studies. 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.
Karine Kleinhaus, MD, MPH Divisional VP, North America 1-914-512-4109
Efrat Kaduri
Head of Investor and Public Relations 972-74-7108600
HAIFA, ISRAEL, November 7, 2016 — Pluristem Therapeutics Inc. (NasdaqCM: PSTI, TASE: PSTI), a leading developer of placenta-based cell therapy products, today announced that the State Intellectual Property Office of the People’s Republic of China has issued an allowance to Pluristem for its patent application titled, “Adherent Cells From Adipose or Placenta Tissues and Use Thereof In Therapy”. The patent addresses methods of treating ischemic conditions such as CLI using placental cells. Additional patents of Pluristem in China cover methods of expending placental cells in 3D apparatus, various therapeutic uses of placental cells and devices for 3D culturing of placental cells
“This most recent patent strengthens our intellectual property position globally, and specifically in the Chinese market. With our recent announcement of potential strategic partnership with Innovative Medical, we believe that PLX cell therapy products may have an important role in addressing the needs of China’s rapidly growing healthcare market and aging population,” stated Pluristem Chairman and CEO, Zami Aberman.
Pluristem Therapeutics Inc. is a leading developer of placenta-based cell therapy products. The Company has reported robust clinical trial data in multiple indications for its patented PLX (PLacental eXpanded) cells. The cell products release a range of therapeutic proteins in response to inflammation, ischemia, hematological disorders, and radiation damage. PLX cell products are grown using the Company’s proprietary three-dimensional expansion technology. They are off- the-shelf, requiring no tissue matching prior to administration.
Pluristem has a strong intellectual property position; Company-owned and operated, GMP- certified manufacturing and research facilities; strategic relationships with major research institutions; and a seasoned management team.
This press release contains forward-looking statements within the meaning of the “safe harbor” provisions of the Private Securities Litigation Reform Act of 1995 and federal securities laws.
For example, we are using forward-looking statements when we discuss that our products may have an important role in addressing the needs of China’s rapidly growing healthcare market and aging population.
These forward-looking statements and their implications are based on the current expectations of the management of Pluristem only, and are subject to a number of factors and uncertainties that could cause actual results to differ materially from those described in the forward-looking statements.
The following factors, among others, could cause actual results to differ materially from those described in the forward-looking statements: changes in technology and market requirements; we may encounter delays or obstacles in launching and/or successfully completing our clinical trials; our products may not be approved by regulatory agencies, our technology may not be validated as we progress further and our methods may not be accepted by the scientific community; we may be unable to retain or attract key employees whose knowledge is essential to the development of our products; unforeseen scientific difficulties may develop with our process; our products may wind up being more expensive than we anticipate; results in the laboratory may not translate to equally good results in real clinical settings; results of preclinical studies may not correlate with the results of human clinical trials; our patents may not be sufficient; our products may harm recipients; changes in legislation; inability to timely develop and introduce new technologies, products and applications; loss of market share and pressure on pricing resulting from competition, which could cause the actual results or performance of Pluristem to differ materially from those contemplated in such forward-looking statements. Except as otherwise required by law, Pluristem undertakes no obligation to publicly release any revisions to these forward-looking statements to reflect events or circumstances after the date hereof or to reflect the occurrence of unanticipated events.
For a more detailed description of the risks and uncertainties affecting Pluristem, reference is made to Pluristem’s reports filed from time to time with the Securities and Exchange Commission.
Contact:
Pluristem Therapeutics Inc. Karine Kleinhaus, MD, MPH Divisional VP, North America 1-914-512-4109
HAIFA, ISRAEL, November 6, 2017— Pluristem Therapeutics Inc. (NASDAQ: PSTI) (TASE: PSTI), a leading developer of placenta-based cell therapy products, today announced that it has signed an agreement with Tel Aviv Sourasky Medical Center (Ichilov Hospital) to conduct a Phase I/II trial in PLX-PAD cell therapy for the treatment of Steroid-Refractory Chronic Graft-versus-Host-Disease (GvHD).
The trial will be an investigator initiated study. As such, Tel Aviv Sourasky Medical Center will support the study and will be responsible for its design and implementation. Dr. Ron Ram, Director of the Hematology Blood and Marrow Stem Cell Transplantation Unit for the Tel Aviv Sourasky Medical Center will act as principal investigator.
GvHD is a potentially lethal complication of hematopoietic cell transplantation (HCT) from a donor. When a patient receives a donor’s stem cells, the transplanted cells identify the patient’s body as foreign and attack it. The chronic form of GvHD occurs at least 100 days following the transplantation. The GvHD market is predicted to exceed $500 million by 2023.
Preclinical studies showed that Pluristem’s PLX-PAD cell product potentially mitigates symptoms of GvHD, and in addition the secretion profile and mechanism of action properties suggest that it may be a novel and effective treatment for the condition. Pluristem hopes to address this severe unmet medical need and help patients lead full lives after undergoing a transplant.
“We’re excited to work with Pluristem towards developing an effective treatment for chronic GvHD,” noted Dr. Ron Ram at the Tel Aviv Sourasky Center. “Our Clinical Research Center is a hub for groundbreaking treatments and is the perfect testing ground for Pluristem’s cell therapy.”
“Studies have shown that our PLX cells have beneficial effects in a number of hematologic indications. We are very pleased to enter into this collaboration with Tel Aviv Sourasky Medical Center while continuing to focus on advancing our lead indications into pivotal and Phase III studies,” said Zami Aberman, Chairman and Co-CEO of Pluristem. “Our unique, proprietary technology platform and the versatility of our cells allow us to develop our cell products to treat a number of conditions with inadequate treatment options. We look forward to offering new hope to patients worldwide”
Chronic GvHD occurs in approximately 40% of patients who have received a transplant of hematopoietic stem cells sourced from the bone marrow or peripheral blood of a donor. These hematopoietic stem cell transplants are used to treat some blood or bone marrow cancers as well as other hematologic conditions, 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 chronic GvHD. 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.
Pluristem Therapeutics is a leading developer of placenta-derived cell therapy products with patented PLX (PLacental eXpanded) cells entering late-stage trials in several indications. Our PLX cell products each release a different 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 3D expansion technology and can be administered to patients without tissue matching or immunosuppression. Pluristem has Company-owned and operated, GMP-certified manufacturing and research facilities, a strong intellectual property position, and strategic relationships with major research and U.S. government institutions.
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 its discusses its proposed Phase I/II trial studying Pluristem’s PLX-PAD cell therapy, the potential for PLX-PAD and Pluristem’s hopes to address GvHD to help patients lead full lives after undergoing a transplant.
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.
Karine Kleinhaus, MD, MPH Divisional VP, North America 1-914-512-4109
Efrat Kaduri
Head of Investor and Public Relations 972-74-7108600
Haifa, Israel – October 29, 2017 – Pluristem Therapeutics Inc. (NASDAQCM: PSTI, TASE: PLTR) announced today that in connection with its proposed public offering of its shares of Common Stock on the Tel Aviv Stock Exchange (TASE) it has concluded an Israeli institutional investors tender. In the tender the Company has received overall commitments from Israeli institutional investors and accredited investors for the purchase of 8,873,700 shares in different prices for a total amount of approximately $15 million and chose to accept commitments of 7,123,700 shares at a purchase price of $1.61 (or NIS 5.70 per share) for a total amount of approximately $11.5 million. Upon the approval of the TASE, the Company intends to conduct a public offering of its shares on the TASE on Monday, October 30, 2017 at a minimum purchase price of $1.61, for up to 9,000,000 shares in the aggregate (including those shares underlying the institutional investors’ commitments specified above).
The Company has engaged Leader Underwriters (1993) Ltd. (“Leader”) as its advisor for the offering. Leader is not purchasing or selling any of the shares offered in the offering in its capacity as an advisor nor is Leader required to arrange for the sale of any specific number or dollar amount of securities, but has agreed to use its best efforts to arrange for the sale of the securities offered.
The closing of the offering is expected to occur on or about October 31, 2017, subject to customary closing conditions. The Company intends to use the net proceeds of the offering for research and product development activities, clinical trial activities, investment in capital equipment and for working capital and other general corporate purposes. In order to participate in the public offering, prospective investors should place orders through their brokers.
This press release does not constitute an offer to sell, or a solicitation of an offer to buy, nor shall there be any sale of these securities in any state or jurisdiction in which such an offer, solicitation, or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction. The securities described above are being offered by the Company pursuant to an Israeli “shelf” registration statement previously filed with the Israel Securities Authority and the Tel Aviv Stock Exchange, an Israeli “prospectus supplement” filed with the Israel Securities Authority and the Tel Aviv Stock Exchange on October 30, 2017 as well as pursuant to a “shelf” registration statement previously filed with and declared effective by the Securities and Exchange Commission (the “SEC”) on June 30, 2017. The U.S. prospectus supplement related to the offering and the related prospectus are expected to be filed with the SEC and copies can be obtained by contacting the Company at MATAM Advanced Technology Park, Building No. 5, Haifa, Israel 31905 or at 011-972-74-710-8600.
About Pluristem Therapeutics
Pluristem Therapeutics is a leading developer of placenta-derived cell therapy products with patented PLX (PLacental eXpanded) cells entering late-stage trials in several indications. Our PLX cell products each release a different 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 3D expansion technology and can be administered to patients without tissue matching or immunosuppression.
Pluristem has Company-owned and operated, GMP-certified manufacturing and research facilities, a strong intellectual property position, and strategic relationships with major research and U.S. government institutions.
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 launch of its public offering in Israel, the closing of its public offering and its intended use of proceeds. 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: market risks and uncertainties and risks and uncertainties relating to the satisfaction of customary closing conditions for the offering of Pluristem’s securities; 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 SEC.
Contact:
Pluristem Therapeutics Inc. Karine Kleinhaus, MD, MPH Divisional VP, North America 1-914-512-4109
Efrat Kaduri
Investor and Public Relations Manager 972-74-7108600
HAIFA, ISRAEL, October 26, 2017 — Pluristem Therapeutics Inc. (Nasdaq: PSTI , TASE: PSTI), a leading developer of placenta-based cell therapy products, announced today that it received approval from Israel’s Ministry of Health to initiate a Phase I trial studying the company’s PLX-R18 cell therapy as a treatment for insufficient hematopoietic recovery following hematopoietic cell transplantation (HCT). As previously announced, the trial was also approved by the U.S. Food and Drug Administration (FDA) and recruitment is ongoing in the United States. Up to 30 patients will be recruited in total from the United States and Israeli trial sites. Ethics committees at both Hadassah Medical Center and Rambam Hospital in Israel have cleared the trial and recruitment can begin in both hospitals.
“We’re very pleased with the Israeli Ministry of Health’s vote of confidence in our innovative therapies and efforts to provide treatments for a range of hematopoietic conditions, including insufficient recovery from hematopoietic stem cell transplants,” stated Zami Aberman, Pluristem’s Co-CEO and Chairman. “Hadassah Medical Center and Rambam Hospital are well known for their groundbreaking treatments and we are happy for this collaboration. Previous studies with PLX-R18 cells have yielded promising results, which we believe suggest that our cells can improve patient outcomes.”
Pluristem’s PLX-R18 cells are in late-stage development as a treatment for acute radiation syndrome (ARS) and the program is supported by the U.S. National Institutes of Health (NIH), which is conducting the trials. The cells are also being studied by the U.S. Department of Defense and the Fukushima Medical University in Japan. Pluristem recently reported a new granted patent to cover PLX-R18 cells in additional indications related to the bone marrow’s inability to produce blood cells, including autoimmune diseases, genetic disorders, chemotherapy, and radiation therapy.
Bone marrow failure is the inability of bone marrow to produce sufficient numbers of platelets, white or red blood cells.
This inability may result in serious illness or death, because these cells are necessary to prevent hemorrhage, infection or severe anemia.
Bone marrow failure can be caused either by medical conditions such as aplastic anemia, myelodysplastic syndrome, hematologic malignancies, or as a side effect of radiation or chemotherapy cancer treatment. The incidence of bone marrow failure resulting from these conditions varies widely, but is increasing.
The only known cure for bone marrow failure is HCT, although supportive therapies and treatments can reduce symptoms and prolong life for some patients.
The hematopoietic cells for HCT can come from a donor or from the patient, and can be harvested from peripheral blood, bone marrow or umbilical cord blood.
Transplant patients require extensive care and monitoring, and sometimes need intensive treatment for complications.
In cases of incomplete engraftment, blood cell counts are insufficient, causing the patient to be at high risk of severe or lethal complications. In severe cases, the patient may need to undergo the arduous and dangerous process of a second transplant.
PLX-R18 is Pluristem’s second cell therapy product in development. It is designed to treat bone marrow that is unable to produce enough blood cells due to a variety of causes including ARS, certain cancers or cancer treatments, or immune-mediated bone marrow failure. PLX-R18’s first animal studies in ARS were performed in collaboration with Prof. Gorodetsky at Hadassah Medical Center. Further preclinical data from trials conducted by the NIH, Hadassah, the Charite in Berlin and other prominent research institutions have shown that PLX-R18 cells secrete a range of specific proteins that trigger the regeneration of bone marrow hematopoietic cells, thereby supporting the recovery of blood cell production. Pluristem is currently enrolling patients in a U.S. Phase I trial of PLX-R18 in incomplete bone marrow recovery following HCT and is preparing for a pivotal trial in ARS.
Pluristem Therapeutics is a leading developer of placenta-derived cell therapy products with patented PLX (PLacental eXpanded) cells entering late-stage trials in several indications. Our PLX cell products each release a different 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 3D expansion technology and can be administered to patients without tissue matching or immunosuppression. Pluristem has Company-owned and operated, GMP-certified manufacturing and research facilities, a strong intellectual property position, and strategic relationships with major research and U.S. government institutions.
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 its discusses the timing and patient recruitment of its proposed Phase I trial studying the company’s PLX-R18 cell therapy and its belief that its cells can improve patient outcomes. 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:
Karine Kleinhaus, MD, MPH Divisional VP, North America 1-914-512-4109
Efrat Kaduri
Investor and Public Relations Manager 972-74-7108600
Patent significantly expands potential indications for PLX-R18 and grants Pluristem broad coverage in the treatment of damaged hematopoietic systems
HAIFA, ISRAEL, October 23, 2017— Pluristem Therapeutics Inc. (NASDAQ: PSTI, TASE: PSTI), a leading developer of placenta-based cell therapy products, announced today that the European Patent Office has issued the company a patent titled, “Methods for Treating Radiation or Chemical Injury” for its PLX-R18 cell therapy.
Pluristem currently holds several patents worldwide to cover placental 3D-expanded cells in the treatment of impaired hematopoietic systems when a bone marrow, cord blood, or peripheral blood transplant takes place. This important patent expands Pluristem’s IP assets to include a new set of indications related to the bone marrow’s inability to produce blood cells, such as acute radiation syndrome (ARS), autoimmune diseases such as aplastic anemia, genetic disorders, chemotherapy, radiation therapy, and side effects from other treatments. Pluristem currently holds over 115 issued patents and 100 pending patent applications worldwide.
“PLX-R18 is covered by several patents in key markets for the treatment of bone marrow failure following a transplant of hematopoietic stem cells, or for the support of such a transplant. What makes this a key patent for our IP assets is that it addresses the treatment of a much broader range of medical conditions in which bone marrow is damaged and the patient has not received a transplant,” stated Yaky Yanay, Co- CEO and President of Pluristem. “PLX-R18 cells have shown the ability to trigger regeneration of the hematopoietic system, thereby supporting the recovery and production of white blood cells, red blood cells and platelets. With its capabilities, we believe that PLX-R18 has the potential to treat a broad range of hematologic indications, which together constitute a substantial global market.”
PLX-R18 is Pluristem’s second cell therapy product in development. It is designed to treat bone marrow that is unable to produce enough blood cells due to a variety of causes, including acute radiation syndrome (ARS), certain cancers or cancer treatments, or immune-mediated bone marrow failure. . PLX-R18’s first animal studies to prove their activity in ARS, as reflected in the new patent, were performed in collaboration with Prof. Gorodetsky at Hadassah Medical Center. Further preclinical data from trials conducted by the U.S. National Institutes of Health, Hadassah, the Charite in Berlin and other prominent research institutions have shown that PLX-R18 cells secrete a range of specific proteins that trigger the regeneration of bone marrow hematopoietic cells, thereby supporting the recovery of blood cell production. Pluristem is currently enrolling patients in a U.S. Phase I trial of PLX-R18 in incomplete bone marrow recovery following hematopoietic cell transplantation (HCT) and is preparing for a pivotal trial in ARS.
Pluristem Therapeutics Inc. is a leading developer of placenta-based cell therapy products.
The Company has reported robust clinical trial data in multiple indications for its patented PLX (PLacental eXpanded) cells, and is entering late-stage trials in several indications. PLX cell products release a range of therapeutic proteins in response to inflammation, ischemia, muscle trauma, hematological disorders, and radiation damage.
The cells are grown using the Company’s proprietary three-dimensional expansion technology and can be administered to patients off-the-shelf, without tissue matching.
Pluristem has a strong intellectual property position; Company-owned and operated, GMP-certified manufacturing and research facilities; strategic relationships with major research institutions; and a seasoned management team.
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 its discusses that it believes that PLX-R18 has the potential to treat a broad range of hematologic indications and when it discusses the progress of its Phase I trial of PLX-R18 in the U.S. as well as its pivotal trial in ARS. 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.
Karine Kleinhaus, MD, MPH Divisional VP, North America 1-914-512-4109
Efrat Kaduri
Head of Investor and Public Relations 972-74-7108600
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