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Meeting included representatives from NIH and BARDA
HAIFA, Israel, January 3, 2019 – Pluristem Therapeutics Inc. (Nasdaq:PSTI) (TASE:PSTI), a leading regenerative medicine company developing novel placenta-based cell therapy products, today announced it has concluded a positive meeting with the U.S. Food and Drug Administration (FDA) regarding the ongoing development of PLX-R18 for the treatment of Acute Radiation Syndrome (ARS). The FDA provided Pluristem with feedback on the progress and data collected on PLX-R18 to date and gave guidance towards advancing the development of PLX-R18 with respect to the treatment of ARS. The meeting also included representatives from the U.S. National Institute of Allergy and Infectious Diseases (NIAID) and the U.S. Biomedical Advanced Research and Development Authority (BARDA).
“We are pleased to have completed a positive meeting with the FDA and U.S. government agencies representatives, which we believe has provided us with a clear and efficient path towards advancing the development of PLX-R18, targeting approval in the treatment of ARS,” said Mr. Yaky Yanay, Co-Chief Executive Officer and President of Pluristem. “For several years, we have successfully cooperated with the NIAID, which has supported and conducted studies of PLX-R18 in ARS. These studies demonstrated PLX- R18 potential to increase survival rates after radiation exposure, as well as protect and regenerate the bone marrow’s ability to produce blood cells, crucial for victims exposed to high levels of radiation. We are pleased to see interest from key governmental agencies such as NIAID, the U.S Department of Defense and BARDA in our novel regenerative medical countermeasure for radiation injuries and look forward to potentially supporting such medical needs of the U.S. government.”
PLX-R18 has been studied in Phase I and II-equivalent studies conducted and funded by NIAID via the FDA Animal Rule Pathway. Results from these studies showed that PLX-R18 supports the recovery of the bone marrow and increases survival rates. PLX-R18 has been granted an Investigational New Drug application (IND) and an orphan drug designation by the FDA for the treatment of ARS.
ARS involves severe, potentially lethal damage to the bone marrow’s ability to produce blood cells, as well as to other systems and organs. Severe damage to bone marrow renders victims vulnerable to life- threatening hemorrhage, infection and anemia.
Pluristem Therapeutics Inc. is a leading regenerative medicine company developing novel placenta-based cell therapy products.
The Company has reported robust clinical trial data in multiple indications for its patented PLX cells and is entering late stage trials in several indications.
PLX cell products release a range of therapeutic proteins in response to inflammation, ischemia, muscle trauma, hematological disorders, and radiation damage. The cells are grown using the Company’s proprietary three-dimensional expansion technology and can be administered to patients off-the-shelf, without tissue matching.
Pluristem has a strong intellectual property position; Company-owned and operated, GMP-certified manufacturing and research facilities; strategic relationships with major research institutions; and a seasoned management team.
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 states its belief that, as a result of its meeting with the FDA, it has a clear and efficient path towards advancing the development of PLX-R18 in the treatment of ARS and its potential support of the U.S. government with respect to its medical needs relating to radiation injuries.
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.
Efrat Kaduri
Head of Investor and Public Relations 972-74-7108600
Karine Kleinhaus, MD, MPH Divisional VP, North America
1-914-512-4109
Presentations underscore significant need for new PAD treatment approaches and the potential of cell therapy to improve patient outcomes while reducing healthcare costs
HAIFA, Israel, December 17, 2018 – Pluristem Therapeutics Inc. (Nasdaq:PSTI) (TASE:PSTI), a leading regenerative medicine company developing novel placenta-based cell therapy products, today provided a recap of the Key Opinion Leader (KOL) breakfast meeting on peripheral artery disease (PAD) that the Company hosted on Friday, December 14 in New York. The meeting focused on the current treatment landscape, unmet medical need, economic impact and potential market opportunities for treating patients with PAD, a serious but common circulatory problem characterize by a blockage of the arteries and reduced blood flow to the limbs. Risk factors include smoking, diabetes, heavy weight, cardiovascular problems & hypertension.
In addition to a management update on the Company’s ongoing late-stage development of PLX- PAD, the meeting featured comprehensive presentations by John Lantis, MD, Vice Chairman of the Department of Surgery and Chief of Vascular and Endovascular Surgery at Mount Sinai West, and Mary L. Yost, MBA, Co-Founder of The Sage Group.
“The presentations offered by these Key Opinion Leaders underscore the significant unmet medical need in PAD, and particularly critical limb ischemia (CLI), and highlight the potential of cell therapies in improving patient outcomes while addressing the significant economic burden of treating this serious cardiovascular disease,” said Yaky Yanay, Co-CEO and President of Pluristem. “We believe PLX-PAD has the potential to become the standard of care in CLI treatment, and we look forward to data from our ongoing multinational pivotal Phase III CLI study.”
Among the highlights:
“Potentially, cellular therapies that can actually modify the diseased tissue into healthier more responsive tissue offer the possibility of cure and not just a treatment,” commented Dr. Lantis. Early studies have shown significant clinical benefit from this type of therapy and I am very pleased that significant further clinical research is well underway”.
“The global economic burden of CLI is staggering, and exceeds the burden of diabetes, cancer and carotid artery disease combined,” commented Ms. Yost. “Furthermore, with an aging global population and continued growth in the prevalence of diabetes, this burden is only projected to increase, which speaks to the urgent need for new innovative and cost-effective treatments for this serious disease.”
Pluristem’s pivotal Phase III study of PLX-PAD cells in the treatment of CLI, which has received an $8 million grant from the European Union’s Horizon 2020 program, has received the U.S. Food and Drug Administration’s (FDA) Fast Track designation for the treatment of CLI and has been included in the European Medicines Agency (EMA) Adaptive Pathways program, which may lead to early conditional marketing authorization based on an interim analysis following follow up on half of the total 246 patients to be enrolled in the study. The FDA recently cleared PLX-PAD for its Expanded Access Program (EAP), with cost recovery, for the treatment of patients with CLI who are not eligible for Pluristem’s Phase III study.
For PAD KOL day slides- link For PAD KOL day webcast- link
Pluristem Therapeutics Inc. is a leading regenerative medicine company developing novel placenta-based cell therapy products.
The Company has reported robust clinical trial data in multiple indications for its patented PLX cells and is entering late stage trials in several indications.
PLX cell products release a range of therapeutic proteins in response to inflammation, ischemia, muscle trauma, hematological disorders, and radiation damage.
The cells are grown using the Company’s proprietary three-dimensional expansion technology and can be administered to patients off-the-shelf, without tissue matching.
Pluristem has a strong intellectual property position; Company-owned and operated, GMP-certified manufacturing and research facilities; strategic relationships with major research institutions; and a seasoned management team.
This press release contains express or implied forward-looking statements within the Private Securities Litigation Reform Act of 1995 and other U.S. Federal securities laws.
These forward-looking statements and their implications are based on the current expectations of the management of Pluristem only, and are subject to a number of factors and uncertainties that could cause actual results to differ materially from those described in the forward-looking statements.
The following factors, among others, could cause actual results to differ materially from those described in the forward-looking statements: changes in technology and market requirements; we may encounter delays or obstacles in launching and/or successfully completing our clinical trials; our products may not be approved by regulatory agencies, our technology may not be validated as we progress further and our methods may not be accepted by the scientific community; we may be unable to retain or attract key employees whose knowledge is essential to the development of our products; unforeseen scientific difficulties may develop with our process; our products may wind up being more expensive than we anticipate; results in the laboratory may not translate to equally good results in real clinical settings; results of preclinical studies may not correlate with the results of human clinical trials; our patents may not be sufficient; our products may harm recipients; changes in legislation; inability to timely develop and introduce new technologies, products and applications; loss of market share and pressure on pricing resulting from competition, which could cause the actual results or performance of Pluristem to differ materially from those contemplated in such forward-looking statements.
Except as otherwise required by law, Pluristem undertakes no obligation to publicly release any revisions to these forward-looking statements to reflect events or circumstances after the date hereof or to reflect the occurrence of unanticipated events.
For a more detailed description of the risks and uncertainties affecting Pluristem, reference is made to Pluristem’s reports filed from time to time with the Securities and Exchange Commission
Efrat Kaduri
Head of Investor and Public Relations 972-74-7108600
Karine Kleinhaus, MD, MPH Divisional VP, North America
1-914-512-4109
For those who are unable to attend in person, a live webcast and replay will be accessible here
HAIFA, Israel, December 13, 2018 – Pluristem Therapeutics Inc. (Nasdaq:PSTI) (TASE:PSTI), a leading regenerative medicine company developing novel placenta-based cell therapy products, will host a Key Opinion Leader (KOL) meeting on Peripheral Artery Disease (PAD) tomorrow, December 14, 2018 at 8am-9:30am EST, in New York City.
The meeting will feature presentations by KOLs John Lantis, MD, Vice Chairman of the Department of Surgery and Chief of Vascular and Endovascular Surgery at Mount Sinai West, and Mary L. Yost, MBA, Co-Founder of The Sage Group, who will discuss the current treatment landscape and unmet medical needs, the economic impact, and potential market opportunities for treating patients with PAD. Both KOLs will be available at the conclusion of the event to answer questions.
Pluristem’s management team will also provide a corporate overview of the company’s development strategy and recent achievements. Of note, the FDA recently approved an Expanded Access Program (EAP) for PLX-PAD in CLI patients. It is estimated that 5-6 million people in U.S. and Europe suffer from CLI, and this number is projected to grow, with an estimated cost of $25 billion per year in the U.S. alone.
This event is intended for institutional investors, sell-side analysts, investment bankers, and business development professionals only. Please RSVP in advance if you plan to attend, as space is limited. For those who are unable to attend in person, a live webcast and replay will be accessible here. If you would like to ask a question during the live Q&A, please submit your request via email.
Pluristem Therapeutics Inc. is a leading regenerative medicine company developing novel placenta-based cell therapy products.
The Company has reported robust clinical trial data in multiple indications for its patented PLX cells and is entering late stage trials in several indications.
PLX cell products release a range of therapeutic proteins in response to inflammation, ischemia, muscle trauma, hematological disorders, and radiation damage.
The cells are grown using the Company’s proprietary three-dimensional expansion technology and can be administered to patients off-the-shelf, without tissue matching.
Pluristem has a strong intellectual property position; Company-owned and operated, GMP-certified manufacturing and research facilities; strategic relationships with major research institutions; and a seasoned management team.
This press release contains express or implied forward-looking statements within the Private Securities Litigation Reform Act of 1995 and other U.S. Federal securities laws.
For example, we are using forward-looking statements when we discuss the estimated growth in the population in the U.S. and Europe suffering from CLI and projected cost of treatment of CLI in the U.S.
These forward-looking statements and their implications are based on the current expectations of the management of Pluristem only, and are subject to a number of factors and uncertainties that could cause actual results to differ materially from those described in the forward-looking statements.
The following factors, among others, could cause actual results to differ materially from those described in the forward-looking statements: changes in technology and market requirements; we may encounter delays or obstacles in launching and/or successfully completing our clinical trials; our products may not be approved by regulatory agencies, our technology may not be validated as we progress further and our methods may not be accepted by the scientific community; we may be unable to retain or attract key employees whose knowledge is essential to the development of our products; unforeseen scientific difficulties may develop with our process; our products may wind up being more expensive than we anticipate; results in the laboratory may not translate to equally good results in real clinical settings; results of preclinical studies may not correlate with the results of human clinical trials; our patents may not be sufficient; our products may harm recipients; changes in legislation; inability to timely develop and introduce new technologies, products and applications; loss of market share and pressure on pricing resulting from competition, which could cause the actual results or performance of Pluristem to differ materially from those contemplated in such forward-looking statements.
Except as otherwise required by law, Pluristem undertakes no obligation to publicly release any revisions to these forward-looking statements to reflect events or circumstances after the date hereof or to reflect the occurrence of unanticipated events.
For a more detailed description of the risks and uncertainties affecting Pluristem, reference is made to Pluristem’s reports filed from time to time with the Securities and Exchange Commission
Efrat Kaduri
Head of Investor and Public Relations 972-74-7108600
Karine Kleinhaus, MD, MPH Divisional VP, North America
1-914-512-4109
HAIFA, Israel, December 4, 2018 – Pluristem Therapeutics Inc. (Nasdaq:PSTI) (TASE:PSTI), a leading regenerative medicine company developing novel placenta-based cell therapy products, today announced that it has entered into a license agreement with a subsidiary of Chart Industries, Inc. regarding Pluristem’s thawing device for cell-based therapies. Per the terms of the agreement, Chart obtains the exclusive rights to manufacture and market the thawing device in all territories worldwide, excluding China, with Pluristem receiving royalties from sales of the product and supply of an agreed number of devices.
Pluristem’s point-of-care thawing device technology is designed to allow for the precise and automated thawing of cells in a controlled and monitored environment, and is expected to result in the highest levels of cell viability and quality.
The technology includes many advanced unique proprietary features which were designed to result in the leading thawing devices on the market.
“Regenerative medicine and cellular therapies products are making significant progress towards market, and we need to make sure the enabling tools are in place.
In order to get the best clinical efficacy outcome we need a full control of the cold chain, including, most importantly, the most effective method of thawing of cells before treatment of patients,” said Yaky Yanay, Co-Chief Executive Officer and President of Pluristem. “We are extremely pleased to have Chart Industries, Inc., a global leader in cryogenic equipment, as our marketing and manufacturing partner, and look forward to working with Chart to bring our thawing device technologies to clinical centers and labs across the globe.”
“For more than 50 years, Chart Industries, Inc. has been a leading innovator in the cryogenic freezing and storage of biological materials that are critical to the life sciences industry, including human tissue, cord blood, bone marrow and stem cells,” said Buzz Bies, Vice President and GM Chart Inc. – Cold Storage Sales. “I believe Pluristem’s best-in-class cellular thawing device is a perfect complement to Chart’s portfolio of solutions, and we look forward to offering this technology to our customer base worldwide.”
Chart is a leading diversified global manufacturer of highly engineered equipment for the industrial gas, energy, and biomedical industries.
The majority of Chart’s products are used throughout the liquid gas supply chain for purification, liquefaction, distribution, storage and end-use applications, a large portion of which are energy-related. Chart has domestic operations located across the United States and an international presence in Asia, Australia, Europe and Latin America.
For more information, visit: http://www.chartindustries.com.
Pluristem Therapeutics Inc. is a leading regenerative medicine company developing novel placenta-based cell therapy products.
The Company has reported robust clinical trial data in multiple indications for its patented PLX cells and is entering late stage trials in several indications. PLX cell products release a range of therapeutic proteins in response to inflammation, ischemia, muscle trauma, hematological disorders, and radiation damage. The cells are grown using the Company’s proprietary three-dimensional expansion technology and can be administered to patients off-the-shelf, without tissue matching. Pluristem has a strong intellectual property position; Company-owned and operated, GMP-certified manufacturing and research facilities; strategic relationships with major research institutions; and a seasoned management team.
This press release contains express or implied forward-looking statements within the Private Securities Litigation Reform Act of 1995 and other U.S. Federal securities laws.
The forward-looking statements and their implications are based on the current expectations of the management of Pluristem only, and are subject to a number of factors and uncertainties that could cause actual results to differ materially from those described in the forward-looking statements. The following factors, among others, could cause actual results to differ materially from those described in the forward-looking statements: changes in technology and market requirements; Pluristem may encounter delays or obstacles in launching and/or successfully completing its clinical trials; Pluristem’s products may not be approved by regulatory agencies, Pluristem’s technology may not be validated as it progresses further and its methods may not be accepted by the scientific community; Pluristem may be unable to retain or attract key employees whose knowledge is essential to the development of its products; unforeseen scientific difficulties may develop with Pluristem’s process; Pluristem’s products may wind up being more expensive than it anticipates; results in the laboratory may not translate to equally good results in real clinical settings; results of preclinical studies may not correlate with the results of human clinical trials; Pluristem’s patents may not be sufficient; Pluristem’s products may harm recipients; changes in legislation may adversely impact Pluristem; inability to timely develop and introduce new technologies, products and applications; loss of market share and pressure on pricing resulting from competition, which could cause the actual results or performance of Pluristem to differ materially from those contemplated in such forward-looking statements.
Except as otherwise required by law, Pluristem undertakes no obligation to publicly release any revisions to these forward-looking statements to reflect events or circumstances after the date hereof or to reflect the occurrence of unanticipated events.
For a more detailed description of the risks and uncertainties affecting Pluristem, reference is made to Pluristem’s reports filed from time to time with the Securities and Exchange Commission.
Efrat Kaduri
Head of Investor and Public Relations 972-74-7108600
Karine Kleinhaus, MD, MPH Divisional VP, North America
1-914-512-4109
HAIFA, Israel, December 3, 2018 – Pluristem Therapeutics Inc. (Nasdaq:PSTI) (TASE:PSTI), a leading regenerative medicine company developing novel placenta-based cell therapy products, today announced that the Company presented data from the first cohort of patients in its ongoing Phase I clinical trial of PLX-R18 for the treatment of incomplete hematopoietic recovery following hematopoietic cell transplantation (HCT) at the American Society of Hematology (ASH) 60th Annual Meeting and Exposition, which is being held December 1-4 in San Diego.
The poster, titled “Prospective, Multi-Center, Phase I Clinical Trial of PLX-R18 Placental Expanded Adherent Stromal Cells in Subjects with Incomplete Hematopoietic Recovery after Hematopoietic Cell Transplantation,” summarizes findings from the first cohort of three patients in the Company’s Phase I clinical study which is ongoing in the U.S. and Israel. Patients were administered two doses of PLX-R18 one week apart via intramuscular (IM) injections at the lowest of three doses to be evaluated (1 million PLX-R18 cells/kg). The treatment was found to be safe and well tolerated, with no unexpected toxicities. All safety data had been reviewed by an external safety committee and based on the safety presented to them study was approved to move forward. In addition, early signals of efficacy in improving blood counts were observed. As previously announced in September 2018, the PLX-R18 cell therapy for the treatment of incomplete hematopoietic recovery following HCT was granted Orphan Drug Designation by the
U.S. Food and Drug Administration.
“We are pleased that the first cohort in this important study met its primary objective of safety, and are encouraged by the early signals of efficacy that we observed, even at the lowest dose in patients suffering from serious hematological condition failing to reach hematopoietic recovery,” commented Zami Aberman, Chairman and Co-Chief Executive Officer of Pluristem. “We are now enrolling the second cohort of patients to be evaluated at an intermediate dose of two million cells per kilogram, and we look forward to additional data as we continue to advance this promising regenerative cell therapy through clinical development.”
This Phase I study is designed as a multi-center, open-label, dose-escalating study to evaluate the safety of IM injections of PLX-R18 cells in 24 patients with incomplete hematopoietic recovery persisting for at least four months after HCT. The follow up period is 12 months. The patients in the study will be enrolled into three chronological treatment groups: two administrations of 1 million PLX-R18 cells/kg (n=3), two administrations of 2 million PLX-R18 cells/kg (n=6) and two administrations of 4 million PLX-R18 cells/kg (n=15). The primary endpoint is safety which is assessed, at the end of each cohort, by an external Data Safety Monitoring Board. In addition, exploratory evaluations are made, including changes in platelet and hemoglobin levels, changes in transfusion frequency, a shift from transfusion dependence to transfusion independence, changes in quality of life and changes in the serum immunological parameters.
About Pluristem Therapeutics
Pluristem Therapeutics Inc. is a leading regenerative medicine company developing novel placenta-based cell therapy products.
The Company has reported robust clinical trial data in multiple indications for its patented PLX cells and is entering late stage trials in several indications.
PLX cell products release a range of therapeutic proteins in response to inflammation, ischemia, muscle trauma, hematological disorders, and radiation damage.
The cells are grown using the Company’s proprietary three-dimensional expansion technology and can be administered to patients off-the-shelf, without tissue matching.
Pluristem has a strong intellectual property position; Company-owned and operated, GMP-certified manufacturing and research facilities; strategic relationships with major research institutions; and a seasoned management team.
Safe Harbor Statement
This press release contains express or implied forward-looking statements within the Private Securities Litigation Reform Act of 1995 and other U.S. Federal securities laws.
For example, Pluristem is using forward-looking statements when it discusses the timing and plans relating to its clinical trials, the safety of PLX-R18 in the clinical trial and the early signals of efficacy in improving blood counts observed in the clinical trial.
These forward-looking statements and their implications are based on the current expectations of the management of Pluristem only, and are subject to a number of factors and uncertainties that could cause actual results to differ materially from those described in the forward-looking statements.
The following factors, among others, could cause actual results to differ materially from those described in the forward-looking statements: changes in technology and market requirements; Pluristem may encounter delays or obstacles in launching and/or successfully completing its clinical trials; Pluristem’s products may not be approved by regulatory agencies, Pluristem’s technology may not be validated as it progresses further and its methods may not be accepted by the scientific community; Pluristem may be unable to retain or attract key employees whose knowledge is essential to the development of its products; unforeseen scientific difficulties may develop with Pluristem’s process; Pluristem’s products may wind up being more expensive than it anticipates; results in the laboratory may not translate to equally good results in real clinical settings; results of preclinical studies may not correlate with the results of human clinical trials; Pluristem’s patents may not be sufficient; Pluristem’s products may harm recipients; changes in legislation may adversely impact Pluristem; inability to timely develop and introduce new technologies, products and applications; loss of market share and pressure on pricing resulting from competition, which could cause the actual results or performance of Pluristem to differ materially from those contemplated in such forward-looking statements.
Except as otherwise required by law, Pluristem undertakes no obligation to publicly release any revisions to these forward-looking statements to reflect events or circumstances after the date hereof or to reflect the occurrence of unanticipated events.
For a more detailed description of the risks and uncertainties affecting Pluristem, reference is made to Pluristem’s reports filed from time to time with the Securities and Exchange Commission.
Contact:
Efrat Kaduri
Head of Investor and Public Relations 972-74-7108600
Karine Kleinhaus, MD, MPH Divisional VP, North America 1-914-512-4109
HAIFA, Israel, November 29, 2018 – Pluristem Therapeutics Inc. (Nasdaq:PSTI) (TASE:PSTI), a leading regenerative medicine company developing novel placenta-based cell therapy products, today announced that it will host a Key Opinion Leader (KOL) meeting on Peripheral Artery Disease (PAD) on December 14, 2018 in New York City.
The meeting will feature presentations by KOLs John Lantis, MD, Vice Chairman of the Department of Surgery and Chief of Vascular and Endovascular Surgery at Mount Sinai West, and Mary L. Yost, MBA, Co-Founder of The Sage Group, who will discuss the current treatment landscape and unmet medical needs, the economic impact, and potential market opportunities for treating patients with PAD. Both KOLs will be available at the conclusion of the event to answer questions.
Pluristem’s management team will also provide a corporate overview of the company’s development strategy for PLX-PAD, which is currently in a multinational pivotal Phase III clinical study. Of note, the FDA recently approved an Expanded Access Program (EAP) for PLX-PAD in CLI patients. It is estimated that 5-6 million people in U.S. and Europe suffer from CLI, and this number is projected to grow, with an estimated cost of $25 billion per year in the U.S. alone.
This event is intended for institutional investors, sell-side analysts, investment bankers, and business development professionals only. Please RSVP in advance if you plan to attend, as space is limited. For those who are unable to attend in person, a live webcast and replay will be accessible here. If you would like to ask a question during the live Q&A, please submit your request via email.
Pluristem Therapeutics Inc. is a leading regenerative medicine company developing novel placenta-based cell therapy products.
The Company has reported robust clinical trial data in multiple indications for its patented PLX cells and is entering late stage trials in several indications.
PLX cell products release a range of therapeutic proteins in response to inflammation, ischemia, muscle trauma, hematological disorders, and radiation damage.
The cells are grown using the Company’s proprietary three-dimensional expansion technology and can be administered to patients off-the-shelf, without tissue matching.
Pluristem has a strong intellectual property position; Company-owned and operated, GMP-certified manufacturing and research facilities; strategic relationships with major research institutions; and a seasoned management team.
This press release contains express or implied forward-looking statements within the Private Securities Litigation Reform Act of 1995 and other U.S. Federal securities laws.
For example, we are using forward-looking statements when we discuss the estimated growth in the population in the U.S. and Europe suffering from CLI and projected cost of treatment of CLI in the U.S.
These forward-looking statements and their implications are based on the current expectations of the management of Pluristem only, and are subject to a number of factors and uncertainties that could cause actual results to differ materially from those described in the forward-looking statements.
The following factors, among others, could cause actual results to differ materially from those described in the forward-looking statements: changes in technology and market requirements; we may encounter delays or obstacles in launching and/or successfully completing our clinical trials; our products may not be approved by regulatory agencies, our technology may not be validated as we progress further and our methods may not be accepted by the scientific community; we may be unable to retain or attract key employees whose knowledge is essential to the development of our products; unforeseen scientific difficulties may develop with our process; our products may wind up being more expensive than we anticipate; results in the laboratory may not translate to equally good results in real clinical settings; results of preclinical studies may not correlate with the results of human clinical trials; our patents may not be sufficient; our products may harm recipients; changes in legislation; inability to timely develop and introduce new technologies, products and applications; loss of market share and pressure on pricing resulting from competition, which could cause the actual results or performance of Pluristem to differ materially from those contemplated in such forward-looking statements.
Except as otherwise required by law, Pluristem undertakes no obligation to publicly release any revisions to these forward-looking statements to reflect events or circumstances after the date hereof or to reflect the occurrence of unanticipated events.
For a more detailed description of the risks and uncertainties affecting Pluristem, reference is made to Pluristem’s reports filed from time to time with the Securities and Exchange Commission
Efrat Kaduri
Head of Investor and Public Relations 972-74-7108600
Karine Kleinhaus, MD, MPH Divisional VP, North America 1-914-512-4109
HAIFA, ISRAEL, November 28, 2018 – Pluristem Therapeutics Inc. (NASDAQ: PSTI, TASE: PSTI), (Nasdaq:PSTI) (TASE:PSTI), a leading regenerative medicine company developing novel placenta-based cell therapy products, today announced that the company will present data from the first cohort of its Phase I study of PLX-R18 cells for the treatment of incomplete hematopoietic recovery following hematopoietic cell transplantation (HCT) at the American Society of Hematology’s (ASH) 60th Annual meeting to be held in San Diego, California, on December 1-4, 2018.
A Phase I study of PLX-R18 cells to treat incomplete hematopoietic recovery following HCT is ongoing in U.S. and Israel.
The trial is designed as a multi-center, open-label, dose-escalating study to evaluate the safety of intramuscular injections (IM) of PLX-R18 cells in 24 subjects with incomplete hematopoietic recovery persisting for at least 4 months after HCT.
The 24 patients in the study will be enrolled into three treatment groups: two administrations of 1 million PLX-R18 cells (n=3), two administrations of 2 million PLX-R18 cells (n=6), two administrations of 4 million PLX-R18 cells (n=15).
The primary endpoint will be safety which will be assessed at the end of each cohort by an external safety committee. There will also be exploratory endpoints, including changes in platelet and hemoglobin levels, changes in transfusion frequency, a shift from transfusion dependence to transfusion independence, changes in quality of life, and changes in the serum immunological parameters.
Pluristem Therapeutics Inc. is a leading regenerative medicine company developing novel placenta-based cell therapy products.
The Company has reported robust clinical trial data in multiple indications for its patented PLX cells and is entering late stage trials in several indications.
PLX cell products release a range of therapeutic proteins in response to inflammation, ischemia, muscle trauma, hematological disorders, and radiation damage.
The cells are grown using the Company’s proprietary three-dimensional expansion technology and can be administered to patients off-the-shelf, without tissue matching.
Pluristem has a strong intellectual property position; Company-owned and operated, GMP-certified manufacturing and research facilities; strategic relationships with major research institutions; and a seasoned management team.
This press release contains express or implied forward-looking statements within the Private Securities Litigation Reform Act of 1995 and other U.S. Federal securities laws.
The forward-looking statements and their implications are based on the current expectations of the management of Pluristem only, and are subject to a number of factors and uncertainties that could cause actual results to differ materially from those described in the forward-looking statements.
The following factors, among others, could cause actual results to differ materially from those described in the forward-looking statements: changes in technology and market requirements; Pluristem may encounter delays or obstacles in launching and/or successfully completing its clinical trials; Pluristem’s products may not be approved by regulatory agencies, Pluristem’s technology may not be validated as it progresses further and its methods may not be accepted by the scientific community; Pluristem may be unable to retain or attract key employees whose knowledge is essential to the development of its products; unforeseen scientific difficulties may develop with Pluristem’s process; Pluristem’s products may wind up being more expensive than it anticipates; results in the laboratory may not translate to equally good results in real clinical settings; results of preclinical studies may not correlate with the results of human clinical trials; Pluristem’s patents may not be sufficient; Pluristem’s products may harm recipients; changes in legislation may adversely impact Pluristem; inability to timely develop and introduce new technologies, products and applications; loss of market share and pressure on pricing resulting from competition, which could cause the actual results or performance of Pluristem to differ materially from those contemplated in such forward-looking statements.
Except as otherwise required by law, Pluristem undertakes no obligation to publicly release any revisions to these forward-looking statements to reflect events or circumstances after the date hereof or to reflect the occurrence of unanticipated events.
For a more detailed description of the risks and uncertainties affecting Pluristem, reference is made to Pluristem’s reports filed from time to time with the Securities and Exchange Commission.
Karine Kleinhaus, MD, MPH Divisional VP, North America 1-914-512-4109
Efrat Kaduri
Head of Investor and Public Relations 972-74-7108600
Additional data from Pluristem’s Phase II IC study were presented at the 2018 American Heart Association Scientific Sessions
HAIFA, Israel, November 12, 2018 – Pluristem Therapeutics Inc. (Nasdaq:PSTI) (TASE:PSTI), a leading regenerative medicine company developing novel placenta-based cell therapy products, today announced that the Company presented additional data from its Phase II clinical study evaluating PLX-PAD for the treatment of Intermittent Claudication (IC) at the 2018 American Heart Association Scientific Sessions in Chicago. The data were presented by Prof. Norbert Weiss, MD, Director of the Vascular Center at the Technical University of Dresden, Germany, and the lead European Principal Investigator for the Phase II IC study.
Among the study findings:
indicates better glucose control in patients and is the most commonly used measurement to evaluate treatment efficacy in diabetics.
“We are very encouraged with the results and additional findings seen in this study. PAD patients, especially those suffering from CLI, often display high level of inflammation and, as seen within our IC study, most are diabetic,” commented Prof. Weiss. “The data we presented at the AHA suggest that PLX- PAD may play a meaningful role in lowering inflammation and maintain better glycemic control reflecting the potential of this non-surgical cell-based therapeutic to address key unmet needs of PAD and the associated co-morbidities.”
“This study was important in confirming the design of our ongoing Phase III trial evaluating PLX-PAD for the treatment of CLI, and we are optimistic that these promising results will be reproducible in larger patient populations,” said Zami Aberman, Chairman and Co-Chief Executive Officer of Pluristem. “The recent findings provide comprehensive understanding of PLX-PAD cells mechanism of action in PAD patients by supporting angiogenesis, reducing inflammation and lowering the average glucose levels of this patients. The recent FDA approval of the expanded access program in CLI, together with the multiple special regulatory pathways that we have been granted in the U.S. and Europe, and the significant funding that we have received for this project to date, justify our growing enthusiasm for PLX-PAD as a potential new and groundbreaking treatment for PAD. We look forward to Phase III data as we work to introduce this treatment as an innovative solution for PAD patients.”
Initial topline results from this Phase II IC study were previously announced by the Company in June 2018.
Pluristem’s Phase II IC study was designed to evaluate the safety, efficacy and optimal dosing regimen for PLX-PAD cells in patients with IC Rutherford categories 2-3. Enrollment took place at 28 clinical sites in the U.S., Germany, South Korea and Israel. The 172 patients in the study were randomized into four treatment groups: two administrations of 300 million PLX-PAD cells (“main efficacy group”); two administrations of 150 million PLX-PAD cells; two administrations of placebo; or one administration of 300 million PLX-PAD cells followed by placebo. In each of these study arms, the two administrations were given intramuscularly (IM), 3 months apart. The primary efficacy endpoint was the change from baseline in maximal walking distance (MWD) at 52 weeks compared to placebo. The key secondary endpoint was the change from baseline in MWD at 52 weeks compared to placebo, in patients treated with 2 doses of PLX-PAD originating from different donors (Pluristem’s proprietary Bio-Therapeutic approach). Other endpoints included risk of revascularization and other hemodynamic and clinical outcome measures.
Pluristem Therapeutics Inc. is a leading regenerative medicine company developing novel placenta-based cell therapy products.
The Company has reported robust clinical trial data in multiple indications for its patented PLX cells and is entering late stage trials in several indications. PLX cell products release a range of therapeutic proteins in response to inflammation, ischemia, muscle trauma, hematological disorders, and radiation damage.
The cells are grown using the Company’s proprietary three-dimensional expansion technology and can be administered to patients off-the-shelf, without tissue matching.
Pluristem has a strong intellectual property position; Company-owned and operated, GMP-certified manufacturing and research facilities; strategic relationships with major research institutions; and a seasoned management team.
This press release contains express or implied forward-looking statements within the Private Securities Litigation Reform Act of 1995 and other U.S. Federal securities laws.
For example, Pluristem is using forward-looking statements when it discusses the potential of PLX-PAD to play a meaningful role in lowering levels of CRP and HbA1c and to address key unmet needs of PAD, the ability to reproduce the results of clinical trials in larger patient populations and the potential for PLX-PAD to be a new and groundbreaking treatment for PAD.
These forward-looking statements and their implications are based on the current expectations of the management of Pluristem only, and are subject to a number of factors and uncertainties that could cause actual results to differ materially from those described in the forward- looking statements.
The following factors, among others, could cause actual results to differ materially from those described in the forward-looking statements: changes in technology and market requirements; Pluristem may encounter delays or obstacles in launching and/or successfully completing its clinical trials; Pluristem’s products may not be approved by regulatory agencies, Pluristem’s technology may not be validated as it progresses further and its methods may not be accepted by the scientific community; Pluristem may be unable to retain or attract key employees whose knowledge is essential to the development of its products; unforeseen scientific difficulties may develop with Pluristem’s process; Pluristem’s products may wind up being more expensive than it anticipates; results in the laboratory may not translate to equally good results in real clinical settings; results of preclinical studies may not correlate with the results of human clinical trials; Pluristem’s patents may not be sufficient; Pluristem’s products may harm recipients; changes in legislation may adversely impact Pluristem; inability to timely develop and introduce new technologies, products and applications; loss of market share and pressure on pricing resulting from competition, which could cause the actual results or performance of Pluristem to differ materially from those contemplated in such forward-looking statements.
Except as otherwise required by law, Pluristem undertakes no obligation to publicly release any revisions to these forward-looking statements to reflect events or circumstances after the date hereof or to reflect the occurrence of unanticipated events.
For a more detailed description of the risks and uncertainties affecting Pluristem, reference is made to Pluristem’s reports filed from time to time with the Securities and Exchange
Efrat Kaduri
Head of Investor and Public Relations 972-74-7108600
Karine Kleinhaus, MD, MPH Divisional VP, North America 1-914-512-4109
HAIFA, Israel, November 8, 2018 – Pluristem Therapeutics Inc. (Nasdaq:PSTI) (TASE:PSTI), a leading regenerative medicine company developing novel placenta-based cell therapy products, today reported financial results for its fiscal first quarter 2019 ended September 30, 2018 and provided a corporate update.
“We were very pleased to announce this quarter on FDA approval of an expanded access program that will provide critical limb ischemia patients who are not suitable for enrollment in our Phase III trial with access to PLX-PAD while the trial is ongoing,” said Yaky Yanay, Co-Chief Executive Officer and President of Pluristem. “Importantly, the FDA approved reimbursement for the procedure with a cost recovery that may provide a key reference point for eventual commercial pricing, assuming product approval.”
“During the fiscal first quarter and subsequent period, we continued to make progress advancing our pipeline of novel placenta-based cell therapy products in multiple indications,” Mr. Yanay continued “, we are making good progress in enrolling patients in both ongoing Phase III clinical trials of PLX-PAD in critical limb ischemia (CLI) and the treatment of muscle injury following hip fracture. We were pleased to expand the studies to Israel, following the Israel’s Ministry of Health approvals, in addition to existing sites in the U.S. and Europe, which we expect should allow us to reach our enrollment goals faster. We look forward to data from these advanced trials, which are being funded by more than $16 million in grants from the European Union’s Horizon 2020 program, as we continue on the path toward becoming a commercial- stage regenerative medicine company.”
“Regarding our second cell therapy product, PLX-R18, which we are developing for several hematopoietic indications, during the quarter we received Orphan Drug Designation for the treatment of graft failure and incomplete recovery following hematopoietic cell transplantation. We are currently evaluating this novel therapeutic cell therapy product in an open-label Phase I clinical trial being conducted in the U.S. and Israel, and we look forward to data that will help guide our next steps in the development of this promising therapeutic,” Mr. Yanay concluded.
As of September 30, 2018, Pluristem had approximately $30 million in resources, out of which $22.5 million in cash and cash equivalents, bank deposits and restricted deposits, and remaining are derived from approved grants to be payable over time.
The Company’s net cash used for operating activities was $8.5 million for this quarter.
Pluristem Therapeutics Inc. is a leading regenerative medicine company developing novel placenta-based cell therapy products.
The Company has reported robust clinical trial data in multiple indications for its patented PLX cells and is entering late stage trials in several indications.
PLX cell products release a range of therapeutic proteins in response to inflammation, ischemia, muscle trauma, hematological disorders, and radiation damage.
The cells are grown using the Company’s proprietary three-dimensional expansion technology and can be administered to patients off-the-shelf, without tissue matching.
Pluristem has a strong intellectual property position; Company-owned and operated, GMP-certified manufacturing and research facilities; strategic relationships with major research institutions; and a seasoned management team.
This press release contains express or implied forward-looking statements within the Private Securities Litigation Reform Act of 1995 and other U.S. Federal securities laws.
For example, Pluristem is using forward-looking statements when it discusses its belief that, with respect to its two Phase III clinical trials of PLX-PAD in CLI, the opening of trial sites in Israel, in addition to existing sites in the U.S. and Europe, should allow it to reach it enrollment goals faster, and also opens the door to potential commercial approval in Israel, its belief that it may be reimbursed for the procedure relating to its expanded access program for CLI with a cost recovery that may provide a key reference point for eventual commercial pricing, assuming product approval, and its belief that the data derived from its open-label Phase I clinical trial being conducted in the U.S. and Israel relating to PLX-R18 will help guide its next steps in the development of the promising therapeutic cell therapy product.
These forward-looking statements and their implications are based on the current expectations of the management of Pluristem only, and are subject to a number of factors and uncertainties that could cause actual results to differ materially from those described in the forward-looking statements.
The following factors, among others, could cause actual results to differ materially from those described in the forward-looking statements: changes in technology and market requirements; Pluristem may encounter delays or obstacles in launching and/or successfully completing its clinical trials; Pluristem’s products may not be approved by regulatory agencies, Pluristem’s technology may not be validated as it progresses further and its methods may not be accepted by the scientific community; Pluristem may be unable to retain or attract key employees whose knowledge is essential to the development of its products; unforeseen scientific difficulties may develop with Pluristem’s process; Pluristem’s products may wind up being more expensive than it anticipates; results in the laboratory may not translate to equally good results in real clinical settings; results of preclinical studies may not correlate with the results of human clinical trials; Pluristem’s patents may not be sufficient; Pluristem’s products may harm recipients; changes in legislation may adversely impact Pluristem; inability to timely develop and introduce new technologies, products and applications; loss of market share and pressure on pricing resulting from competition, which could cause the actual results or performance of Pluristem to differ materially from those contemplated in such forward-looking statements.
Except as otherwise required by law, Pluristem undertakes no obligation to publicly release any revisions to these forward-looking statements to reflect events or circumstances after the date hereof or to reflect the occurrence of unanticipated events.
For a more detailed description of the risks and uncertainties affecting Pluristem, reference is made to Pluristem’s reports filed from time to time with the Securities and Exchange Commission.
Efrat Kaduri
Head of Investor and Public Relations 972-74-7108600
Karine Kleinhaus, MD, MPH Divisional VP, North America 1-914-512-4109
The Company will also present at the BioEurope, Annual Vascular Interventional Advances and Cell and Gene Therapy Manufacturing conferences, all held in November
HAIFA, Israel, October 18, 2018 – Pluristem Therapeutics Inc. (Nasdaq:PSTI) (TASE:PSTI), a leading regenerative medicine company developing novel placenta-based cell therapy products, today announced that the Company will be presenting at four conferences during November: at the BioEurope conference, which is being held November 5–7, 2018 in Copenhagen, at the 15th Annual Vascular Interventional Advances (VIVA) Conference, which is being held November 5-8 in Las Vegas, at the 2018 American Heart Association (AHA) Scientific Sessions, which are being held November 10-12 in Chicago and the Cell and Gene Therapy Manufacturing conference, which is being held November 14-15 in London.
At the AHA Scientific Sessions, Prof. Norbert Wiess, the Principal Investigator of the Company’s Phase II intermittent claudication (IC) study, will present detailed results from the study. The presentation will be held on Saturday, November 10, 2018 from 9:00-10:15am. In June 2018, the Company announced positive top-line results from its multinational Phase II clinical study of PLX-PAD cells in the treatment of IC. Data demonstrated PLX-PAD’s ability to reduce the incidence of revascularization and improved patients’ mobility. Study results also validate the design of Pluristem’s ongoing pivotal Phase III study in critical limb ischemia (CLI), a more severe stage of PAD.
At the VIVA Conference, during the Disruptive Technology session, Pluristem will present an overview of its off-the-shelf, placenta-derived cell therapy technology and development plans for its lead cell therapy candidate, PLX-PAD, for the treatment of peripheral artery disease (PAD). The presentation will be held on Wednesday, November 7, 2018 from 8:15-9:15am.
At the BioEurope conference, during the cell and gene track, Pluristem will present an overview of its cell therapy products and clinical development. The presentation will be held on Tuesday, November 6, 2018, from 10:00-11:00am.
At the Cell and Gene Therapy Manufacturing conference, Pluristem will present an overview of its in- house manufacturing process. The presentation will be held on Thursday, November 15, 2018 from 9:10- 9:50am.
Pluristem Therapeutics Inc. is a leading regenerative medicine company developing novel placenta-based cell therapy products.
The Company has reported robust clinical trial data in multiple indications for its patented PLX cells and is entering late stage trials in several indications.
PLX cell products release a range of therapeutic proteins in response to inflammation, ischemia, muscle trauma, hematological disorders, and radiation damage.
The cells are grown using the Company’s proprietary three-dimensional expansion technology and can be administered to patients off-the-shelf, without tissue matching.
Pluristem has a strong intellectual property position; Company-owned and operated, GMP-certified manufacturing and research facilities; strategic relationships with major research institutions; and a seasoned management team.
This press release contains express or implied forward-looking statements within the Private Securities Litigation Reform Act of 1995 and other U.S. Federal securities laws.
For example, Pluristem is using forward-looking statements when it discusses the timing, description and results of its clinical studies and its belief that the PLX-PAD study results validate the design of its ongoing Phase III study in CLI.
These forward-looking statements and their implications are based on the current expectations of the management of Pluristem only, and are subject to a number of factors and uncertainties that could cause actual results to differ materially from those described in the forward-looking statements.
The following factors, among others, could cause actual results to differ materially from those described in the forward- looking statements: changes in technology and market requirements; Pluristem may encounter delays or obstacles in launching and/or successfully completing its clinical trials; Pluristem’s products may not be approved by regulatory agencies, Pluristem’s technology may not be validated as it progresses further and its methods may not be accepted by the scientific community; Pluristem may be unable to retain or attract key employees whose knowledge is essential to the development of its products; unforeseen scientific difficulties may develop with Pluristem’s process; Pluristem’s products may wind up being more expensive than it anticipates; results in the laboratory may not translate to equally good results in real clinical settings; results of preclinical studies may not correlate with the results of human clinical trials; Pluristem’s patents may not be sufficient; Pluristem’s products may harm recipients; changes in legislation may adversely impact Pluristem; inability to timely develop and introduce new technologies, products and applications; loss of market share and pressure on pricing resulting from competition, which could cause the actual results or performance of Pluristem to differ materially from those contemplated in such forward-looking statements.
Except as otherwise required by law, Pluristem undertakes no obligation to publicly release any revisions to these forward-looking statements to reflect events or circumstances after the date hereof or to reflect the occurrence of unanticipated events.
For a more detailed description of the risks and uncertainties affecting Pluristem, reference is made to Pluristem’s reports filed from time to time with the Securities and Exchange Commission.
Efrat Kaduri
Head of Investor and Public Relations 972-74-7108600
Karine Kleinhaus, MD, MPH Divisional VP, North America 1-914-512-4109
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