Pluristem’s ARS program is developed and funded by the U.S. National Institutes of Health and the U.S. Department of Defense, and is in preparation for a pivotal study
HAIFA, ISRAEL, October 19, 2017— Pluristem Therapeutics Inc. (NASDAQ: PSTI, TASE: PSTI), a leading developer of placenta-based cell therapy products, announced today that the U.S. Food and Drug Administration (FDA) has granted the company an orphan drug designation for its PLX-R18 cell therapy for the prevention and treatment of acute radiation syndrome (ARS).
ARS results from exposure to high levels of radiation, such as in the case of a nuclear accident or attack, and can lead to severe health consequences including death. The Orphan Drug Act provides for granting special status to a drug or biological product, to treat a rare disease or condition. The benefits of achieving Orphan Drug Designation include close guidance by the FDA, which may accelerate the path to potential marketing approval, orphan drug grants, tax credits, and 7-year market exclusivity upon marketing approval.
Pluristem recently reported positive data from non-human primates (NHPs) studies of PLX-R18 cells as a treatment for ARS conducted by the National Institute of Allergy and Infectious Diseases (NIAID) at the National Institutes of Health (NIH), U.S. Department of Health and Human Services (DHHS). The reported data demonstrated improvement in survival rates of such NHPs and the enhancement of recovery across all three major blood lineages—white blood cells, red blood cells, and platelets. In addition, PLX-R18 cells are also being studied by the U.S. Department of Defense’s (DOD) Armed Forces Radiobiology Research Institute (AFRRI) to examine the effectiveness of the cells as a treatment for ARS prior to, and within the first 24 hours of exposure to radiation. Pluristem PLX-R18 cells are also being studied by Fukushima Medical University in Japan for the treatment of ARS and as an adjunct to radiotherapy in cancer patients.
“Pluristem has a vast and dynamic program developing our PLX-R18 therapy as a treatment for ARS, which can potentially save many lives,” said Zami Aberman, Co-CEO and Chairman of Pluristem. “Receiving Orphan Drug Designation brings us one step closer to providing a next-generation medical countermeasure against ARS, which is especially important given today’s volatile political climate.”
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 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. 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, we are using forward- looking statements when we discuss developing our PLX-R18 therapy as a treatment for ARS, which can potentially save many lives, or when we discuss the benefits of receiving Orphan Drug Designation for our PLX-R18 therapy and that it brings us one step closer to providing a next-generation medical countermeasure against 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; 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
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 16, 2017 — Pluristem Therapeutics, Inc. (NASDAQ:PSTI; TASE: PSTI) today announced the publication of results from a preclinical study in the peer-reviewed journal STEM CELLS Translational Medicine. The article, titled “Placenta-derived adherent stromal cells improve diabetes mellitus-associated left ventricular diastolic performance”, highlights the ability of PLX cells to significantly improve cardiac function and describes the underlying mechanism of action. Results showed that treatment with PLX cells lead to improved diastolic function by significantly decreasing cardiomyocyte stiffness, endothelial inflammation, and improving vascularization.
The study was performed by investigators from the Berlin-Brandenburg Center for Regenerative Therapies, (BCRT) and the Charité-Universitätsmedizin Berlin, Germany, led by Professor Carsten Tschöpe. Dr. Tschöpe is also a member of the Translational Research Committee of the Heart Failure Association of the European Society of Cardiology.
In the study, diabetes mellitus was induced in immune competent mice by streptozotocin application during 5 subsequent days. Seven days after the first streptozotocin injection, animals were intravenously (IV) treated with either PLX cells or saline (placebo). Cardiac parameters were assessed two weeks later. The treatment using PLX cells led to improved diastolic function as indicated by the heart-rate independent 1.2-fold (p<0.005) lower time constant of LV relaxation parameter Tau and the 1.2-fold (p<0.05) increase of the relaxation parameter dP/dtmin.
“Currently, there are limited treatment options for diastolic dysfunction and even fewer for diabetes- induced diastolic dysfunction,” said Dr. Tschöpe. “This study holds promise that PLX cells could potentially treat cardiac damage in diabetic patients, particularly in early-stage diabetic cardiomyopathy. PLX cells are particularly well suited for this indication because they can be used without the need for tissue matching or immunosuppression.”
“Diabetes-induced diastolic dysfunction is a chronic disease that represents a large unmet need. In this study, PLX cells were able to improve cardiac function when administered by simple IV injection.
This opens a potentially new method for an effective, low risk treatment for diastolic dysfunction,” said Zami Aberman, Chairman and Co-CEO of Pluristem. “These new data, combined with findings published in the Journal of Surgical Research, which showed that PLX cells were effective in treating cardiac ischemia, suggest that PLX cells have the potential to address a wide range of cardiac disorders.”
Diastolic heart failure or diastolic dysfunction refers to a decline in performance of one or both ventricles of the heart during diastole, when the heart is filling with blood. The National Heart, Lung, and Blood Institute reports that approximately 4.8 million Americans suffer from heart failure, with approximately 400,000 new cases appearing annually. Additionally, it has been reported that 50% of these heart failure patients are afflicted with diastolic heart failure (Curr Cardiol Rep, 2017). Heart Failure with Preserved Ejection Fraction and Future Pharmacological Strategies: a Glance in the Crystal Ball. Tschöpe C, Van Linthout S, Kherad B. Curr Cardiol Rep. 2017 Aug;19(8):70
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; and strategic relationships with major research 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 study holds promise that PLX cells may be able to treat cardiac damage in diabetic patients, particularly at the early stage of diabetic cardiomyopathy, that the study opens a potentially new method for an effective, low risk treatment for diastolic dysfunction and that the data derived from the study suggest that PLX cells have the potential to address the wide range of cardiac disorders.
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 2, 2017— Pluristem Therapeutics Inc. (NASDAQ: PSTI) (TASE: PSTI), a leading developer of placenta-based cell therapy products, today announced that a $7.9 million (€6.8 million) non-dilutive grant from the European Union’s Horizon 2020 program has been awarded to nTRACK, a collaborative project carried out by an international consortium led by LEITAT.
The goal of the nTRACK project, initiated and led scientifically by Prof. Rachela Popovtzer of Bar-Ilan University in Israel, is to develop a safe, scalable, and highly sensitive nanotechnology-based imaging approach to enable non-invasive, whole body monitoring of injected stem cells in humans, thereby providing early predictions of cellular therapy treatment outcomes. The nTRACK consortium will utilize Pluristem’s PLX-PAD cells to predict treatment success for muscle regeneration following a gastrocnemius muscle injury. Final approval of the grant is subject to the finalization of the consortium and Horizon 2020 grant agreements.
This marks Horizon 2020’s third grant to support development of Pluristem’s PLX-PAD cell therapy product, following an award of $8 million announced in August 2016 for Pluristem’s ongoing multinational Phase III trial in the treatment of critical climb ischemia (CLI) and an $8.7 million award announced in September 2017 for the company’s Phase III study in the treatment of muscle recovery following arthroplasty for hip fracture.
“We are honored to receive this additional grant from the European Union to further develop our PLX- PAD program,” said Zami Aberman, Chairman and Co-CEO of Pluristem. “We believe the continued support from international governments is a vote of confidence in our products, technology and methodology as our PLX cell therapies undergo advanced development and brings us closer to commercialization, offering new hope to patients and enabling them to lead healthier lives.”
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 conducting late-stage trials in several indications. The PLX 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 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 format and use of PLX-PAD cells in the nTRACK project, that the final approval of the Horizon 2020 grant is subject to finalizing the consortium and Horizon 2020 grant agreements and that Pluristem believes the grant is a vote of confidence from international governments in its methodology, technology, and products as its cell therapies undergo advanced development and brings it closer to commercialization, offering new hope to patients and enabling them to lead healthier lives. 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, September 26, 2017— Pluristem Therapeutics Inc. (NASDAQ: PSTI, TASE: PSTI), a leading developer of placenta-based cell therapy products, has today reported the status of its planned Phase III hip fracture study. In previous discussions held with the U.S. Food and Drug Administration (FDA) and the European Medicine Agency (EMA), the company received positive feedback on the proposed study design and endpoints of its Phase III trial in PLX-PAD cells as a treatment for muscle recovery following arthroplasty for hip fracture. This trial was recently awarded an $8.7 million grant by the Horizon 2020 program, the European Union’s largest research and innovation program.
The proposed Phase III trial is intended to support marketing authorization and will be a double-blind, randomized, placebo-controlled trial with approximately 180 patients enrolled in clinical sites across the
U.S. and Europe. Patients will be injected intramuscularly with 150 million PLX-PAD cells during arthroplasty for hip fracture. The primary endpoint for the trial will be the change of Short Physical Performance Battery (SPPB) from baseline to six months after surgery. Additional endpoints may include objective measurements of muscle strength and muscle volume.
This Phase III trial follows positive results from a Phase I/II trial which demonstrated significant muscle regeneration when PLX-PAD cells were injected 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.
“Now that this Phase III trial has been awarded $8.7 million from the Horizon program, we are eager to move forward and are extremely pleased by the positive outlook of these key regulatory bodies regarding our proposed study design and endpoints, which we believe may allow for early recognition of performance improvement in patients,” noted Zami Aberman, Chairman and Co-CEO of Pluristem. “With this positive feedback from the FDA and EMA, we believe that this trial will again yield significant results, offering new hope for the thousands of patients around the world who have difficulty healing from hip surgeries due to poor muscle recovery.”
Pluristem plans to submit the Investigational New Drug (IND) and Clinical Trial Application (CTA) for the trial in the coming months. The company plans to use the results of this Phase III trial to achieve regulatory approval in both the U.S and Europe. Pluristem’s PLX-PAD program is one of only a handful to be accepted into Europe’s Adaptive Pathway program, which may also allow for early marketing approval in Europe.
Femoral neck fracture is the most common form of hip fracture, with mortality rates of up to 36%, and annual treatment costs estimated to be between $10-$15 billion in the U.S. alone. Following surgery, many patients do not fully recover due to poor muscle regeneration, leading to significant morbidity, loss of the ability to live independently, and an overall decline in quality of life.
The incidence of hip fracture is expected to increase as populations age.
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 timing and format of the proposed Phase III study, that the proposed Phase III trial is intended to support marketing authorization, that the proposed endpoints of the proposed Phase III trial may allow for early recognition of performance improvement in patients, that Pluristem believes that the proposed Phase III trial will yield significant results, that Pluristem plans to submit the IND and CTA for the proposed Phase III trial in the coming months and that Pluristem plans to use the results of the proposed Phase III trial to achieve regulatory approval in both the U.S. and Europe. 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, September 18, 2017 — Pluristem Therapeutics, Inc. (NASDAQ:PSTI; TASE: PSTI), a leading developer of placenta-based cell therapy products, today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track Designation to the company’s ongoing Phase III study of PLX-PAD cells for the treatment of Critical Limb Ischemia (CLI) in patients ineligible for revascularization. The FDA’s Fast Track Designation is a process designed to facilitate the development and expedite the review of drugs to treat serious conditions and unmet medical needs. With Fast Track Designation, there is an increased possibility for a priority review by the FDA of PLX-PAD cells for the treatment of CLI.
“We are extremely pleased with the FDA’s decision to grant Fast Track Designation to PLX-PAD in the treatment of CLI. Up to 40% of patients with CLI are ineligible for revascularization and are at high risk of amputation and death within the first year of diagnosis. This disease takes a heavy toll on patients and their families, while the cost of treating CLI in the U.S. alone is estimated at over $25 billion per year. We are working tirelessly to provide a cell therapy that will address this severe unmet medical need” said Zami Aberman, Chairman and Co-CEO of Pluristem.
“Regulators in some of the largest healthcare markets in the world are now in alignment regarding the need for accelerated approval pathways for our cell therapy product in the treatment of CLI. Programs like the Fast Track Designation offer real hope for patients battling this disease and we look forward to accelerating the path to market for PLX-PAD,” stated Pluristem President and Co-CEO, Yaky Yanay.
Pluristem’s Phase III CLI study is ongoing and actively enrolling patients in the U.S. and Europe.
The European Medicines Agency (EMA) has included PLX-PAD in its Adaptive Pathways program. Positive results from an interim analysis following treatment of half (125) of the study’s population may lead to early conditional marketing authorization.
In Japan, the Pharmaceuticals and Medical Devices Agency (PDMA) has accepted PLX-PAD for the treatment of CLI into its accelerated regulatory pathway for regenerative therapies and has agreed on the design of a single study (N=75) that may lead to early conditional marketing approval and reimbursement.
In Critical Limb Ischemia (CLI), fatty deposits block arteries in the leg, leading to greatly reduced blood flow. This causes leg pain at rest, non-healing ulcers and gangrene.
Patients with CLI are at immediate risk for limb amputation and death. It is estimated that 5-6 million people in the U.S. and Europe suffer from CLI, and this number is projected to grow with the increasing rate of diabetes. While some non- surgical treatments exist to relieve pain and provide local ulcer care, most patients will ultimately need revascularization with vascular bypass surgery or an endovascular procedure to try to prevent major limb amputation and prolong survival.
However, up to 40% of patients are unsuitable for revascularization and experience up to a 40% amputation rate at 1 year.
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 the Fast Track Designation of its Phase III study of PLX-PAD cells for the treatment of CLI may increase the possibility of a priority review by the FDA, its belief that regulators in some of the largest healthcare markets in the world are now in alignment on the need for accelerated approval pathways for its cell therapy product in the treatment of CLI, that positive results from an interim analysis of its Phase III CLI study in Europe may lead to early conditional marketing authorization and that its single study in Japan, which has been approved by the PDMA, may lead to early conditional marketing approval and reimbursement in Japan. 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 goodresults 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, September 13, 2017— Pluristem Therapeutics Inc. (NASDAQ: PSTI, TASE: PSTI), a leading developer of placenta-based cell therapy products, announced today that the company has been issued two new patents by Hong Kong Patents Registry for its cell therapy products relating to two of the company’s leading indications, Critical Limb Ischemia (CLI) and muscle regeneration.
The first patent addresses the use of mesenchymal stem cells for the treatment of skeletal muscle damage or injury. The second is for the use of adherent cells to treat ischemia and for connective tissue regeneration and repair.
Pluristem holds over 100 patents globally, including 19 approved patents in China and Hong Kong, that cover various innovations, including the application of Pluristem’s proprietary PLacental eXpanded (PLX) cells, to a wide variety of medical indications like Intermittent Claudication (IC), CLI, hematological disorders such as Acute Radiation Syndrome (ARS), and recovery and repair of injured skeletal muscle.
The approval for the patents follows a recent “Smart Money” grant from Israel’s Ministry of Economy and Industry to support marketing activities in Hong Kong and China. Pluristem’s progress in these markets reflects the company’s goal of offering accessible cell therapy treatments to Asia’s growing healthcare market.
“Receiving approval for these patents strengthens our position in Asia, where we believe our PLX cells can have a lasting and beneficial impact on the way millions of patients are treated for prevalent medical conditions,” noted Yaky Yanay, President and Co-CEO of Pluristem. “We view these patent approvals as a vote of confidence in our innovative treatments and intellectual property, as our cell therapies move closer to commercialization.”
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 its strategy is to penetrate Asian markets and offer accessible cell therapy treatments to patients, its belief that the Asian continent’s aging populations and growing healthcare market make it ripe for cell therapy treatments and its belief that PLX cells can have a lasting and beneficial impact on the way millions of patients are treated for prevalent medical conditions. 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, September 11, 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 fourth quarter and fiscal year ended June 30, 2017.
“Fiscal 2017 has marked a significant advancement in our clinical development pipeline,” stated Pluristem Chairman and Co-CEO Zami Aberman. “We have completed patient enrollment in our Phase II Trial of PLX-PAD in Intermittent Claudication (IC) and expect clinical data from this study in the first half of 2018. We are currently in Phase III trials, with an ongoing pivotal Phase III study in Critical Limb Ischemia (CLI), and another Phase III planned for hip fracture. Our pipeline has been awarded non-dilutive funding of over
$19 million, which we believe will cover significant portion of the costs of these studies. Our PLX-R18 development has had significant progress and is heading towards a pivotal trial as a countermeasure for Acute Radiation Syndrome (ARS) as the U.S. National Institutes of Health (NIH) concludes a successful Phase II equivalent animal dosing study, enabling the selection of optimal dosage for the Pivotal study. The NIH’s promising results have led to an additional agreement with the U.S. Department of Defense (DOD) to evaluate PLX-R18 based on the scope needed for the U.S. armed forces, thereby broadening PLX-R18’s potential to protect troops and civilians before and after a nuclear incident.”
Pluristem Co-CEO and President Yaky Yanay commented, “Looking ahead to fiscal 2018, we look forward to meeting our enrollment target for our Phase III CLI trial, which may put us in a position to apply for conditional marketing approval of PLX-PAD for the treatment of CLI in Europe through the Adaptive Pathways project. We intend to continue our work with U.S. agencies on PLX-R18, including the NIH and DOD, towards approval that would qualify PLX-R18 for stockpiling. Pluristem has worked diligently throughout the fiscal year to bring the benefits of cell therapies closer to the patients and healthcare systems that need them.”
PLX-R18 Advances Towards Pivotal Trial in Treatment of ARS; Investigated by the NIH and DOD as ARS Antidote Both Before and After Radiation Exposure- During fiscal 2017, the U.S. NIH released data from a successful large animal study that evaluated PLX-R18 as an antidote for ARS when administered 24 hours after exposure to radiation. Study results showed that all three doses of PLX-R18 demonstrated improved survival rates compared to placebo. The PLX-R18-treated groups also showed better and faster recovery of blood lineages, a major component of recovery after radiation-induced damage to bone marrow. Safety data showed that PLX-R18 cells can be safely administered without determining an individual’s level of exposure to radiation and without any matching or blood tests, offering a significant and time-critical advantage when treating a mass casualty disaster.
In August 2017, we announced that the U.S. DOD will examine whether PLX-R18 administered prior to, or within the first 24 hours of, exposure to radiation will mitigate ARS. The DOD studies will be conducted in parallel with the NIH studies, allowing for a broader understanding of the potential therapeutic effects of PLX-R18 as a novel medical countermeasure for ARS. This announcement enjoyed broad media coverage, including features in media outlets such as CNN, I24 News and more.
Additional Regulatory Approvals for Pivotal Phase III CLI Trial; Actively Enrolling Patients with Goal of 40 Active Sites Worldwide by the End of 2017– Pluristem’s multinational Phase III study of PLX-PAD cells in the treatment of CLI is currently enrolling in the U.S., U.K., Germany and Austria. An interim efficacy analysis is planned based on data from the first 125 patients. Positive results are expected to lead to early conditional marketing approval in Europe via the Adaptive Pathways project. Following completion of the study, data from all 250 patients will be submitted to the U.S. Food and Drug Administration (FDA) and the European Medicine Agency (EMA) for full marketing approval.
Total of $19 million in Non-Dilutive Funding Awarded to PLX Programs- Pluristem’s planned Phase III study to support recovery following surgery for hip fracture was awarded an $8.7 million non-dilutive grant from the European Union’s Horizon 2020 program. Previously, Horizon 2020 awarded $8 million for Pluristem’s Phase III study in the treatment of CLI. The two grants are expected to cover a significant portion of the costs of these Phase III studies.
Pluristem also received approval for a $1.5 million grant from the Israel Innovation Authority within the Israeli Ministry of Economy to support its PLX-PAD program and was also awarded a “Smart Money” grant from Israel’s Ministry of Economy and Industry to advance its product candidates towards marketing in China-Hong Kong markets.
The PLX-R18 Program also received $900,000 in funding from the Israel-U.S. Binational Industrial Research and Development Foundation (BIRD) for a collaborative study with the New York Blood Center on umbilical cord blood transplantation.
As of June 30, 2017, Pluristem had $26.7 million in cash and cash equivalents, bank deposits, restricted deposits and marketable securities. During the fiscal year, Pluristem conducted a public offering for aggregate net proceeds of $15.7 million. The Company’s net cash used for operating activities for the quarter ended June 30, 2017 was $6.4 million and $21.6 million during the fiscal year.
“Throughout our history, Company management has evaluated financing opportunities and market conditions in the best interest of our shareholders to ensure that we are able to execute on our business strategy. This year, we enjoyed major successes as our PLX programs were awarded $19 million through non-dilutive grants, most recently in the amount of $8.7 million by the E.U. to support our Phase III hip fracture trial. We continue to evaluate additional financing options available also through strategic and licensing opportunities,” stated Yaky Yanay, Pluristem President and Co-CEO.
“We expect to meet significant milestones in the coming 12 months that will position Pluristem as a global leading cell therapy company,” stated Zami Aberman and Yaky Yanay. “These milestones include completion of a partnership deal in Asia, continued development of our ARS project including 3rd party funding of pivotal studies from the
U.S. government, expected data readouts from several clinical trials, launch of our phase III study for hip fracture, preparations for Biological License Application (BLA) submission in ARS and meeting enrollment goals for our CLI study.
We look forward to leveraging our PLX platform technology for new and exciting business partnerships and opportunities, strengthening our balance sheet and bringing significant value to our shareholders.
Over the past 12 months, we’ve made significant progress building our pipeline and technology platform. This year’s upcoming milestones will enable us to monetize our capabilities for the benefit of the company and its shareholders.”
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 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 expects clinical data from its Phase II trial of PLX-PAD in IC during the first half of 2018, when it discusses its planned Phase III trial in hip fractures, when it discusses its goal of having 40 active sites worldwide by the end of 2017 for its Phase III CLI trial, the expected recruitment plan in its Phase III CLI trial and possibly being in a position to apply for conditional marketing approval of PLX-PAD for the treatment of CLI in Europe through the Adaptive Pathways project, that the DOD studies relating to PLX-R18 as a treatment for ARS will be conducted in parallel with the NIH studies and that data from all 250 participants planned for the study will be submitted to the FDA and the EMA for full marketing approval and that the two grants provided by the Horizon 2020 program are expected to cover significant portion of the costs of these Phase III 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
karinek@pluristem.com 1-914-512-4109
Efrat Kaduri
Head of Investor and Public Relations efratk@pluristem.com 972-74-7108600
Lorem ipsum dolor sit amet, consectetur adipiscing elit. Ut elit tellus, luctus nec ullamcorper mattis, pulvinar dapibus leo.
Lorem ipsum dolor sit amet, consectetur adipiscing elit. Ut elit tellus, luctus nec ullamcorper mattis, pulvinar dapibus leo.
Lorem ipsum dolor sit amet, consectetur adipiscing elit. Ut elit tellus, luctus nec ullamcorper mattis, pulvinar dapibus leo.