HAIFA, Israel, February 10, 2020 – Pluristem Therapeutics Inc. (Nasdaq:PSTI) (TASE:PSTI), a leading regenerative medicine company developing a platform of novel cell therapy products, today issued an update to its shareholders from its Chief Executive Officer and President, Yaky Yanay.
Dear Fellow Shareholders,
Today we announce Pluristem’s update for the second quarter of fiscal 2020, including recent achievements and our next short-term milestones. Recently, Pluristem’s management attended the annual J.P. Morgan Healthcare Conference in San Francisco, and this year it was clear more than ever that the pharmaceutical industry is significantly increasing its interest in cell and gene therapy.
Many of the discussions and conversations about cell and gene therapy focus on the technological gaps and the lack of manufacturing platforms. As you know, Pluristem considers its manufacturing capabilities to be one of its key competitive advantages.
There is significant interest in our platform technology and in the fact that we have strong industrial manufacturing capabilities and high batch to batch consistency, while maintaining strong pipeline aimed for valuable markets with unmet medical needs.
The discussions during this week confirmed that we hold a leading position in the field of advanced therapies. My goal is to materialize this advantage to also benefit our shareholders.
During this past quarter, we were very focused on completing our pivotal Phase III clinical studies.
We made significant advancements in both of our Phase III studies for PLX-PAD, including achieving the 75% enrollment milestone in our multinational Phase III Critical Limb Ischemia (CLI) study and the 50% enrollment milestone in our multinational Phase III study in muscle regeneration following hip fracture.
I am very pleased with the fact that we have kept enrollment rates high.
We have strong cooperation from our clinical sites, and we are pushing forward to complete our mission to be the first company in U.S. and Europe with approved treatments for unmet medical needs such as CLI and muscle regeneration.
As recently announced, we have also concluded a thorough market analysis of the U.S. CLI market. This market access study, which included interviews with dozens of U.S. payers and key opinion leaders, demonstrated what we believe is a significant need with a potential addressable market estimated between $2 and $6 billion for PLX-PAD in the United States.
During this past quarter we also made important progress with our preparation for commercialization of CLI and advanced our relationships and discussions with potential collaborators and other stakeholders.
We have established a wholly owned subsidiary, based in Berlin, Germany, understanding the importance of a physical presence in our strategic markets, and advancing research and development activities with our long-term partner, the Charité and BCRT (BIH Center for Regenerative Therapies) of Berlin.
As we previously reported, Pluristem submitted a proposal to the U.S. Biomedical Advanced Research and Development Authority (BARDA) for a project designed to demonstrate the superiority of our PLX-R18 therapy versus current standards of care in the treatment of Acute Radiation Syndrome (ARS).
We were recently notified by BARDA that the proposal is still being evaluated and a final answer should be provided soon.
We recognize BARDA’s near-term focus may have shifted to the coronavirus threat over the past few weeks and believe that a decision made regarding PLX-R18 will be made within the context of the agency’s broader current and future needs.
Once we receive a response to our proposal from BARDA, we will announce it.
As of December 31, 2019, Pluristem had approximately $17.5 million in cash and cash equivalents, bank deposits and restricted deposits.
We strengthened our cash position in January by an additional approximately $4 million that was raised through our Open Market Sales Agreement with Jefferies LLC from several family offices and institutional investors that have shown long term interest in Pluristem.
The coming quarters are extremely important to us all, as Pluristem is well positioned to successfully meet milestones and become a global leading regenerative medicine company.
Sincerely, Yaky Yanay
Chief Executive Officer and President
Pluristem Therapeutics Inc. is a leading regenerative medicine company developing novel placenta-based cell therapy product candidates.
The Company has reported robust clinical trial data in multiple indications for its patented PLX cell product candidates and is currently conducting late stage clinical trials in several indications.
PLX cell product candidates are believed to release a range of therapeutic proteins in response to inflammation, ischemia, muscle trauma, hematological disorders and radiation damage.
The cells are grown using the Company’s proprietary three-dimensional expansion technology and can be administered to patients off- the-shelf, without tissue matching. Pluristem has a strong intellectual property position; a Company-owned and operated GMP-certified manufacturing and research facility; strategic relationships with major research institutions; and a seasoned management team.
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 next milestones, the pharmaceutical industry’s increasing interest in cell and gene therapy, materializing advantages for the benefit of shareholders, its belief regarding significant need and potential addressable market for PLX-PAD in the United States, preparation for commercialization of CLI, its proposal to BARDA, the timing of BARDA’s response and further shareholder communications.
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.
Dana Rubin
Director of Investor Relations 972-74-7107194
Ayala Michael
Marketing Communications Manager 972-74-7107135
HAIFA, Israel, February 3, 2020 – Pluristem Therapeutics Inc. (Nasdaq:PSTI) (TASE:PSTI), a leading regenerative medicine company developing a platform of novel biological products, today announced results from a market access comprehensive research study conducted by Marwood Group, a healthcare advisory firm, for the critical limb ischemia (CLI) market in the U.S.
The report included data from published literature as well as direct interviews regarding Pluristem’s PLX-PAD regenerative cell therapy with dozens of physicians, who are key opinion leaders (KOL) in CLI, and with payers covering millions of lives. Pluristem believes that the in- depth report reflects a favorable market for PLX-PAD, which is currently in a global Phase III study with clinical sites in the U.S., Europe, and Israel. According to the report, CLI is a significant unmet need indication, and constitutes a significant burden on the U.S. healthcare system.
The report suggests that the addressable market for PLX-PAD for Rutherford 5 CLI patients that are unsuitable for revascularization is expected to reach $2 billion by 2023.
In addition, the physicians interviewed as part of the study suggest that they would use the PLX product in cases where multiple medical interventions are needed per year.
Based on the report, and assuming such an approach, this could support an annual addressable market in the U.S. of $6 billion.
The incidence of CLI in the U.S. is rising, driven by an aging population and the increase in the prevalence of diabetes, both underlying drivers for CLI.
Currently, there are between 2 and 3 million CLI patients in the U.S., with 500,000 to 600,000 new cases per year. Of these, 30% to 35% are classified as Rutherford 5, the target population in Pluristem’s ongoing Phase III study.
Approximately half of Rutherford 5 and Rutherford 6 CLI patients have diabetes, and this patient population has a 50% higher probability of amputation than patients without diabetes due to the rapid progression of the disease.
About 35% of CLI patients today are unsuitable for revascularization surgery, according to KOLs and market researches in this field, and face high rates of death and amputation, which carries high medical and personal costs.
The average cost for major amputation in the U.S. is estimated at $47,000, with ongoing annual costs for amputees estimated at $75,000 and estimated lifetime cost of $500,000-$800,000. The current cost of potential amputation, and of treating CLI, is well recognized by payers and many of them see amputation as a cost benchmark for a new treatment like PLX-PAD.
As disclosed in the report, vascular surgeons who typically treat CLI expressed interest in using PLX-PAD, which is provided as an outpatient setting, thus potentially reducing the need for hospitalization. Both KOLs and payers confirmed that amputation free survival (AFS), Pluristem’s primary efficacy endpoint for its Phase III study, is an endpoint that should drive adoption. Pluristem’s Phase III study population includes Rutherford 5 patients who are considered unsuitable for revascularization surgery.
In addition to treating these patients, more than three- quarters of vascular surgeons expressed an unmet need and willingness to use PLX-PAD for patients with non-healing wounds and who already receive two revascularizations, or more, annually.
“Based on this thorough market report, it is clear to us that CLI patients, and especially those unsuitable for revascularization that are suffering from a very poor quality of life and carry a heavy burden on the health care system, require better medical solutions.
We believe that this market report highlights payers’ and physicians’ interest in PLX-PAD as an alternative method of care for CLI patients,” said Yaky Yanay, Pluristem President and CEO. “We also believe that this market report validates our understandings regarding the potential substantial market for our PLX-PAD product in the U.S., and the importance of implementing novel regenerative medicine in CLI to control increased healthcare spending. Pluristem is committed to finding a solution for CLI and believes that our Phase III study will show promise in preventing amputation and help improve the lives of millions of CLI patients.”
Pluristem Therapeutics Inc. is a leading regenerative medicine company developing novel placenta-based cell therapy product candidates.
The Company has reported robust clinical trial data in multiple indications for its patented PLX cell product candidates and is currently conducting late stage clinical trials in several indications.
PLX cell product candidates are believed to release a range of therapeutic proteins in response to inflammation, ischemia, muscle trauma, hematological disorders and radiation damage.
The cells are grown using the Company’s proprietary three-dimensional expansion technology and can be administered to patients off- the-shelf, without tissue matching. Pluristem has a strong intellectual property position; a Company-owned and operated GMP-certified manufacturing and research facility; strategic relationships with major research institutions; and a seasoned management team.
Marwood Group is a healthcare focused strategic advisory and financial services firm headquartered in New York City with offices in Washington, D.C. and London. Marwood Group’s consulting practice, Marwood Group Advisory, is a leading healthcare-focused strategic advisory firm that provides due diligence, market access, and life cycle management consulting services for life sciences companies and investors.
Marwood operates at the intersection of healthcare policy analysis, market diligence and strategic consulting; Marwood’s senior team includes former healthcare and life sciences operators, investment bankers, and veterans of top-tier strategy consulting firms as well as former senior-level government officials and policy makers.
To inquire about Marwood’s work in the life sciences sector, please contact Nayan Ghosh at nghosh@marwoodgroup.com.
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 size of the U.S. market for patients suffering from CLI, the potential benefits and use of PLX-PAD in the treatment of CLI over the current standard of care in the context of preventing amputations and in place of revascularization, the belief that the market report highlights payers’ and doctors’ interest in PLX- PAD as an alternative method of care for CLI patients, the belief that the market report validates its understanding regarding the potential market for its PLX-PAD product in the U.S. and the importance of implementing novel regenerative medicine in CLI to control increased healthcare spending, and the belief that its Phase III study will show promise in preventing amputation and help improve the lives of millions of CLI patients.
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.
Reference herein to any specific commercial products, process, or service by trade name, trademark, manufacturer, or otherwise, does not necessarily constitute or imply its endorsement, recommendation, or favoring by Marwood Group Advisory, LLC (“Marwood”).
Marwood undertakes no obligation to provide the recipient of the information herein with any additional or supplemental information or any update to or correction of the information contained herein.
Neither Marwood nor its affiliates, nor their respective employees, officers, directors, managers or partners, shall be liable to any other entity or individual for any loss of profits, revenues, trades, data or for any direct, indirect, special, punitive, consequential or incidental loss or damage of any nature arising from any cause whatsoever, even if Marwood has been advised of the possibility of such damage. Marwood and its affiliates, and their respective employees, officers, directors, managers or partners, shall have no liability in tort, contract or otherwise to any third party. The information herein is proprietary to Marwood. Any duplication or use of such material is not permitted without Marwood’s written consent.
Dana Rubin
Director of Investor Relations 972-74-7107194
Ayala Michael
Marketing Communications Manager 972-74-7107135
HAIFA, Israel, December 17, 2019 – Pluristem Therapeutics Inc. (Nasdaq:PSTI) (TASE:PSTI), a leading regenerative medicine company developing novel placenta-based cell therapy products, today announced that it has enrolled 75% of the 246 patients planned for its Phase III clinical study of PLX-PAD in the treatment of Critical Limb Ischemia (CLI), the most severe form of peripheral artery disease, caused by fatty deposits in leg arteries obstructing blood flow.
While an estimated 5 to 6 million people in the U.S. and Europe suffer from CLI, up to 35% of patients are not eligible for the standard-of-care treatment of revascularization surgery. These patients are left with no treatment options and are at high risk of leg amputation and death. Incidence of CLI is increasing, driven by an aging population and a rise in risk factors, including diabetes and obesity.
PLX-PAD is among the most advanced drugs under development to treat CLI patients, with the goal to serve a large population for which there is a significant need for therapy. “We are pleased to be meeting our patient recruitment goals as we look forward to completing this pivotal study,” stated Pluristem President and CEO Yaky Yanay.
“We aim to bring hope to millions of CLI patients around the world by delivering a regenerative treatment that can save limbs and lives while also saving costs for the healthcare systems. We are pleased to receive significant regulatory and financial support while developing such a novel therapy for CLI, including fast track designation from the U.S. Food and Drug Administration (FDA) and Adaptive Pathway designation from the European Medicine Agency (EMA) that may enable faster regulatory approvals. We understand the importance of a successful outcome in this study for the benefit of this large population of patients and for the benefit of all of our stakeholders. We at Pluristem are fully committed to deliver the first and leading drug for CLI patients across the globe.”
PLX-PAD has been selected for the EMA’s Adaptive Pathways pilot project, allowing for potential accelerated approval in Europe based on an interim analysis of half of the patients in the study. In the U.S., PLX-PAD was granted a fast track designation and was accepted to an expanded access program by the FDA. €7.6 million has been granted to Pluristem’s Phase III CLI program – the PACE study, from the European Union’s Horizon 2020 program, the largest EU research and innovation program. The Phase III randomized, double blind, placebo-controlled study is enrolling 246 CLI patients who are unsuitable for revascularization in over 50 sites across Europe, the U.S., and Israel. Patients are treated with two intramuscular treatments of 300 million cells of PLX-PAD or placebo, at a randomized ratio of 2:1. The primary efficacy endpoint is time to occurrence of a major leg amputation or death.
Pluristem Therapeutics Inc. is a leading regenerative medicine company developing novel placenta-based cell therapy product candidates.
The Company has reported robust clinical trial data in multiple indications for its patented PLX cell product candidates and is currently conducting late stage clinical trials in several indications.
PLX cell product candidates are believed to release a range of therapeutic proteins in response to inflammation, ischemia, muscle trauma, hematological disorders and radiation damage.
The cells are grown using the Company’s proprietary three-dimensional expansion technology and can be administered to patients off-the-shelf, without tissue matching. Pluristem has a strong intellectual property position; a Company-owned and operated GMP-certified manufacturing and research facility; strategic relationships with major research institutions; and a seasoned management team.
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 its PLX-PAD to become the first and leading drug approved to treat CLI patients across the globe, that its PLX-PAD drug is being targeted to serve a large population for which there is a significant need for therapy, the potential of Pluristem and its study to deliver a regenerative treatment that can save limbs and lives while also saving costs for the healthcare systems and the potential for accelerated regulatory approvals in 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.
Contact:
Efrat Kaduri
Director of Business, Investor and Public Relations 972-74-7108600
Multinational study in the U.S., Israel and Europe targeting to be the first product candidate supporting muscle regeneration after significant trauma such as hip fracture
HAIFA, Israel, December 3, 2019 – Pluristem Therapeutics Inc. (Nasdaq:PSTI) (TASE:PSTI), a leading regenerative medicine company developing novel placenta-based cell therapy products, today announced that it has completed enrollment of 50% of the 240 patients planned for its ongoing Phase III PLX-PAD study of muscle regeneration.
There are currently no approved treatments for the post-operative regeneration of injured or weak skeletal muscle, and up to 30% of hip fracture patients die within one year of surgery due to long-term complications resulting from immobility, with high financial costs of hospitalization and rehabilitation.
Pluristem’s ongoing Phase III multinational, randomized, double-blind and placebo-controlled study is assessing patients’ physical performance scores 26 weeks following surgery after administrating allogeneic PLX-PAD cells for the treatment of muscle injury following arthroplasty for hip fracture, as compared to placebo. Additional efficacy endpoints include muscle strength, muscle mass and volume, hospitalization time and lower extremity measure. Through clinical sites in the U.S., Europe and Israel, 240 patients are being randomized on a 1:1 allocation to be dosed with 150 million PLX-PAD cells or placebo on the day of surgery.
This Phase III study follows positive results from a Phase I/II study which demonstrated muscle regeneration when using PLX-PAD cells in total hip arthroplasty patients. The study demonstrated a significant change in muscle volume (p=0.004) and in muscle force (p=0.0067) at 6 months post-surgery, compared to the control group.
Pluristem CEO, Yaky Yanay, stated, “This study marks an important milestone for Pluristem, as we are moving forward with our main global studies and remain on track with recruitment. We believe that our advanced clinical pipeline is geared to bring regenerative medicine into standard-of-care use in hospitals and clinics while providing reduced costs for the healthcare systems. We are grateful to work with dedicated physicians around the world, and with the European Horizon 2020 Program which is funding this study with €7.4 million.”
The Principal Investigator of the study, Dr. Tobias Winkler of the Berlin Institute of Health for Regenerative Therapies, Julius Wolff Institute and Center for Musculoskeletal Surgery, commented, “We are eager to evaluate PLX-PAD’s ability to aid muscle regeneration in patients recovering from arthroplasty for hip fracture.
Many patients do not fully recover after surgery, suffering considerable morbidity due to poor muscle regeneration and impaired mobility.
PLX-PAD has the potential to improve and extend quality of life for patients with one simple injection of the cell therapy product.”
Pluristem Therapeutics Inc. is a leading regenerative medicine company developing novel placenta-based cell therapy product candidates.
The Company has reported robust clinical trial data in multiple indications for its patented PLX cell product candidates and is currently conducting late stage clinical trials in several indications.
PLX cell product candidates are believed to release a range of therapeutic proteins in response to inflammation, ischemia, muscle trauma, hematological disorders and radiation damage.
The cells are grown using the Company’s proprietary three-dimensional expansion technology and can be administered to patients off-the-shelf, without tissue matching. Pluristem has a strong intellectual property position; a Company-owned and operated GMP-certified manufacturing and research facility; strategic relationships with major research institutions; and a seasoned management team.
This press release contains express or implied forward-looking statements within the Private Securities Litigation Reform Act of 1995 and other U.S. Federal securities laws.
For example, Pluristem is using forward-looking statements when it discusses that its PLX-PAD cells are being targeted to be the first product candidate supporting muscle regeneration after significant trauma such as hip fracture, the potential of its clinical pipeline to bring regenerative medicine into standard-of-care use in hospitals and clinics while providing reduced costs for the healthcare systems and the potential of PLX-PAD to improve and extend the quality of life for patients.
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
Director of Business, Investor and Public Relations 972-74-7108600
HAIFA, Israel, November 12, 2019 – Pluristem Therapeutics Inc. (Nasdaq:PSTI) (TASE:PSTI), a leading regenerative medicine company developing novel placenta-based cell therapy products, today issued an update to its shareholders from its Chief Executive Officer, Yaky Yanay.
Today we announce Pluristem’s update for the first fiscal quarter of 2020, as we are entering a very important period as we are in preparation towards the interim readout expected from our CLI phase III study.
We continued to develop our robust clinical pipeline, with significant advancements in our hematological programs for PLX-R18 and PLX-PAD in the treatment of critical limb ischemia (CLI) and muscle regeneration.
PLX-R18, for the treatment of acute radiation syndrome (ARS), is advancing towards an important study with the potential for demonstrating the superiority of our cell therapy product versus the current standard of treatment, as we target governmental purchase contracts.
We are preparing PLX-PAD, for the treatment of CLI, for potential conditional marketing approval in Europe, based on interim data we expect to receive in the second calendar quarter of 2020.
We strongly believe, based on clinical data combined with our ability to manufacture large and consistent quantities of cell therapies, that Pluristem can heal and improve the lives of millions of patients while creating a new regenerative medicine model for healthcare.
I believe we have a significant upcoming value creating milestone in our ongoing Phase III CLI study.
Interim data from this 246-patient study, which is being conducted in the U.S., Europe and Israel, is expected as mentioned in the calendric Q2 of 2020. Assuming the data from the study show good efficacy, we intend to submit an application to the European Medical Agency (EMA) for conditional marketing approval.
We anticipate meeting with the EMA in order to confirm understanding towards the readout, as well as to set agreed process with our application for conditional marketing approval once positive data is reported.
We are putting our resources and focus towards a commercialization event through discussions with payers regarding reimbursement, and with doctors and Key Opinion Leaders (KOLs) regarding integrating PLX-PAD as a standard of care treatment for CLI patients.
PLX-R18 has obtained Orphan Drug Designation in the U.S. for the treatment of ARS and for incomplete hematopoietic recovery following hematopoietic cell transplantation (HCT). We have been working in close partnership with various U.S. government agencies to develop PLX-R18 as a lifesaving treatment for victims exposed to high levels of radiation.
During the last quarter, we reported positive data from the most recent studies conducted by the U.S. Department of Defense (DoD), which evaluated PLX-R18 as a prophylactic countermeasure against ARS, administered prior to radiation exposure.
These animal studies, administering PLX-R18 24 hours before radiation exposure, and again 72 hours after exposure, resulted in a significant increase in survival rates, from a 4% survival rate in the placebo group to 74% in the treated group.
We have submitted a proposal to the Biomedical Advanced Research and Development Authority (BARDA) that is strategically designed to demonstrate the superiority of PLX-R18 versus current standards of care. KOLs in the ARS space have affirmed that despite the availability of several FDA approved countermeasures for ARS, there still remain significant treatment gaps. We believe that PLX-R18 is the best candidate to meet this need and that Pluristem can provide the U.S. government with effective countermeasures that can be easily stored, transported and deployed both pre-and post-exposure to military or civilian populations.
While the ARS studies are conducted under the FDA’s animal rule pathway, PLX-R18 is also showing favorable results in clinical study for the treatment of HCT, a medical condition in which patients do not respond to current treatments.
Pluristem’s Phase I study of PLX-R18, conducted in the U.S. and Israel, has reported data from its first two cohorts, with the third and final cohort now in the process of enrolling and dosing. PLX-R18 appeared to regenerate damaged bone marrow, leading to increased production of platelets and red blood cells, ultimately reducing the number of required transfusions.
While enrollment and treatment of the third cohort is ongoing, we seek to evaluate PLX-R18 as a candidate in additional bone marrow deficiency syndromes with similar unmet needs.
Pluristem is making significant momentum towards transitioning to the commercial, revenue generating stage of the Company. We appreciate and thank all of our shareholders for your support of Pluristem in its mission to improve healthcare through regenerative medicine.
Sincerely, Yaky Yanay
Chief Executive Officer
Pluristem Therapeutics Inc. is a leading regenerative medicine company developing novel placenta-based cell therapy product candidates.
The Company has reported robust clinical trial data in multiple indications for its patented PLX cell product candidates and is currently conducting late stage clinical trials in several indications.
PLX cell product candidates are believed to release a range of therapeutic proteins in response to inflammation, ischemia, muscle trauma, hematological disorders and radiation damage.
The cells are grown using the Company’s proprietary three-dimensional expansion technology and can be administered to patients off-the-shelf, without tissue matching. Pluristem has a strong intellectual property position; a Company-owned and operated GMP-certified manufacturing and research facility; strategic relationships with major research institutions; and a seasoned management team.
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 preparation for PLX-PAD for the treatment of CLI for potential conditional marketing approval in Europe, the belief that it can heal and improve the lives of millions of patients while creating a new regenerative medicine model for healthcare, the belief that it has a significant upcoming value creating milestone in its ongoing Phase III CLI study, its intent to submit an application to the EMA for conditional marketing approval with respect to its ongoing Phase III CLI study, its anticipated meeting with the EMA in order to confirm understanding towards the readout, as well as to set agreed process with its application for conditional marketing approval with respect to its Phase III CLI study, its belief that PLX-R18 is the best candidate to fill the gap in treatment for ARS, its seeking to evaluate PLX-R18 as a candidate in additional bone marrow deficiency syndromes with similar unmet needs and that it is making significant momentum towards transitioning to the commercial, revenue generating stage of the Company.
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
Director of Business, Investor and Public Relations 972-74-7108600, efratk@pluristem.com
HAIFA, Israel, November 4, 2019 – Pluristem Therapeutics Inc. (Nasdaq:PSTI) (TASE:PSTI), a leading regenerative medicine company developing novel placenta-based cell therapy products, today announced that the RESTORE Consortium is hosting its 1st Advanced Therapies Science Meeting (ATSM), which is being held November 25-26, 2019 in Berlin. As a leading member of the large-scale research initiative, Pluristem, along with additional respected members, is committed to accelerating the availability of advanced therapies to all those in need, a main motivation standing behind RESTORE.
Led by Charité-Universitätsmedizin Berlin, and coordinated by Professor Hans-Dieter Volk from the BIH- Center for Regenerative Therapies in Berlin, RESTORE aims to promote groundbreaking research, drive Europe to the forefront in advanced therapies and deliver a pipeline of potentially transformative cures to patients in need. “Advanced Therapies are a potential game changer in health care, aiming to shift our focus from chronic treatment of disease to regeneration of health,” said Prof. Volk. “We are determined to translate promising research findings into safe therapies, and we are working across disciplines and national borders in order to achieve this goal. The 1st Advanced Therapies Science Meeting provides the opportunity to discuss the still numerous obstacles in the way of implementing these promising therapies in routine clinical care.”
“This initiative may hold the key for changing the approach towards medicine in Europe, and advancing solutions for patients in need,” said Zami Aberman, Executive Chairman of Pluristem. “The European Commission is poised to make a significant investment of up to €1 billion in a consortium of companies that can drive forward the development of novel regenerative therapies, and we are pleased to be a leading part in this effort. Given our proprietary cell manufacturing technology and broad, late-stage pipeline, we believe we can play a key role toward making the transforming promise of advanced therapies into a reality.”
The 1st ATSM will bring together experts from industry, patient organizations and academia to discuss the challenges within the field of advanced therapies, which include gene and cell therapies and tissue- engineering approaches. The ATSM is focused on trying to drive forward a concerted interdisciplinary effort, making use of science, infrastructure and funding within Europe to make regenerative therapies available to the broadest possible patient population.
The two-day program will include talks from Nobel Prize winner Ada Yonath (Director of Weizmann Institute of Science, Israel), Michele De Luca (University of Modena, Italy), Timothy O’Brien (National University of Ireland, Galway, Ireland), Maksim Mamonkin (Baylor College of Medicine, USA), Manuela Gomes (University of Minho, Portugal) and others.
RESTORE partners include the Charité Universitätsmedizin Berlin and Berlin Institute of Health (Germany), the University of Zurich (Switzerland), Cell and Gene Therapy Catapult (United Kingdom), TissUse GmbH (Germany), Pluristem (Israel), Miltenyi Biotec GmbH (Germany), INSERM – Institut National de la Santé et de la Recherche (France), Innovation Acta S.r.l. (Italy), Fondazione Telethon Milan (Italy), and the University of Minho (Portugal).
Pluristem Therapeutics Inc. is a leading regenerative medicine company developing novel placenta-based cell therapy product candidates.
The Company has reported robust clinical trial data in multiple indications for its patented PLX cell product candidates and is currently conducting late stage clinical trials in several indications.
PLX cell product candidates are believed to release a range of therapeutic proteins in response to inflammation, ischemia, muscle trauma, hematological disorders and radiation damage.
The cells are grown using the Company’s proprietary three-dimensional expansion technology and can be administered to patients off-the-shelf, without tissue matching. Pluristem has a strong intellectual property position; a Company-owned and operated GMP-certified manufacturing and research facility; strategic relationships with major research institutions; and a seasoned management team.
This press release contains express or implied forward-looking statements within the Private Securities Litigation Reform Act of 1995 and other U.S. Federal securities laws.
For example, Pluristem is using forward-looking statements when it discusses the potential for the RESTORE Consortium to receive up to a €1 billion award by the European Commission and the timing of the potential award, that RESTORE’s aim is to promote groundbreaking research, drive Europe to the forefront in advanced therapies and deliver a pipeline of potentially transformative cures to patients in need, that RESTORE and the 1st ATSM may hold the key for changing the approach towards medicine in Europe, and advancing solutions for patients in need, and its belief that given its proprietary cell manufacturing technology and broad, late- stage pipeline, it believes it can play a key role toward making the transforming promise of advanced therapies into a reality.
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
Director of Business, Investor and Public Relations 972-74-7108600, efratk@pluristem.com
number of required transfusions
R18 versus current standards of care, with the goal of executing a full contract once the study is completed”
HAIFA, Israel, September 16, 2019 – 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 call hosted by the company this morning to review unmet medical needs in acute radiation syndrome (ARS) and hematological deficiencies, and to provide an update on the development of its novel cell therapy treatment, PLX-R18. PLX cell therapy was granted an Orphan Drug Designation by the U.S. Food and Drug Administration (FDA) for the treatment of ARS and incomplete hematopoietic recovery following hematopoietic cell transplantation (HCT).
An overview of HCT was provided by Dr. Jacob M. Rowe, MD, Chief of the Department of Hematology and The Ann and Pinky Sohn Chair in Hemato-Oncology at the Shaare Zedek Medical Center in Jerusalem and Emeritus Professor at the Technion, Israel Institute of Technology in Haifa, a member in the company’s ongoing hematology program steering committee. Dr. Rowe reviewed the medical condition of HCT and the unmet need for the significant proportion of patients that do not respond to current treatments. Dr. Rowe then discussed Pluristem’s ongoing Phase I study of PLX-R18 and data from the first two cohorts:
“Results from the first two cohorts in this study demonstrate that PLX-R18 is safe and well tolerated, with no unexpected toxicities,” said Dr. Rowe. “While the study’s primary endpoint was safety, we can’t disregard the potential benefits of this cell therapy drug, which even in the lower doses appears to regenerate damaged bone marrow, leading to increased production of platelets and red blood cells, ultimately reducing the number of required transfusions, although caution is appropriate in discussing early data with a small number of patients. Importantly, we see these positive benefits sustained at the nine months follow-up period, and we continue to monitor these patients. We look forward to results from Cohort 3, in which patients will be administered four million cells per kilogram, as we work to efficiently advance PLX-R18 as a candidate in additional bone marrow deficiency syndromes with similar unmet needs.”
The next presentation was delivered by Bert W. Maidment, Ph.D., who served as Assistant Director, Radiation Nuclear Countermeasures Program at the National Institutes of Health, National Institute of Allergy and Infectious Diseases, Division of Allergy, Immunology, and Transplantation (NIH/NIAID/DAIT) until retiring in 2016. Dr. Maidment discussed the health impact of radiation exposure and the need for more effective countermeasures. “There is a broad range of devastating health consequences resulting from radiation exposure, with hematopoietic, gastrointestinal, cardiovascular and central nervous systems all potentially impacted,” noted Dr. Maidment. “Notwithstanding several FDA-approved countermeasures, including Neupogen®, Neulasta® and Leukine®, significant treatment gaps remain, causing widespread manifestations across vital organ systems. I believe that a more efficacious countermeasure that can be administered pre- and post-exposure, particularly one that is easily stored and administered and potentially support multiple organ injuries, would have significant utility across a number of civilian and military applications where radiation exposure is a potential risk.”
Pluristem management provided an overview of the company’s acute radiation syndrome (ARS) projects that are running with several governments and agencies, including the U.S. National Institutes of Health (NIH), testing PLX-R18 as a potential treatment for ARS, the U.S. Department of Defense (DOD) testing the product as a potential prophylactic countermeasure against ARS and Fukushima University in Japan examining PLX-R18 cells for the treatment of hematological ARS and gastrointestinal (GI). Arik Eisenkraft, Director of Homeland Defense Projects at Pluristem and former Head of Chemical, Biological, Radiological and Nuclear Defense (CBRN) Protection Division in the Israeli Ministry of Defense, summarized PLX-R18’s potential to stimulate the regeneration of damaged bone marrow to produce blood cells while also increasing survival and benefiting additional body systems, suggesting that PLX-R18 has the ability to treat ARS as a multi-organ therapy.
Yaky Yanay, Chief Executive Officer of Pluristem, concluded the call with an update on the status of current projects and provided an overview of next steps. “I would like to thank Drs. Rowe and Maidment for offering their perspectives on these difficult-to-treat hematological conditions. We look forward to advancing our ARS program to complete the development and registration of PLX-R18 for ARS, targeting governmental purchase contracts.
We remain committed to completing our ongoing Phase I study of PLX-R18 in incomplete hematopoietic recovery following HCT as quickly as possible and will seek to expand PLX-R18 for use with respect to
additional medical conditions with the goal of bringing innovative, safe and effective treatments for patients with a variety of bone marrow deficiency indications.”
Pluristem Therapeutics Inc. is a leading regenerative medicine company developing novel placenta-based cell therapy product candidates.
The Company has reported robust clinical trial data in multiple indications for its patented PLX cell product candidates and is currently conducting late stage clinical trials in several indications.
PLX cell product candidates are believed to release a range of therapeutic proteins in response to inflammation, ischemia, muscle trauma, hematological disorders and radiation damage.
The cells are grown using the Company’s proprietary three-dimensional expansion technology and can be administered to patients off-the-shelf, without tissue matching. Pluristem has a strong intellectual property position; a Company-owned and operated GMP-certified manufacturing and research facility; strategic relationships with major research institutions; and a seasoned management team.
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 benefits of PLX-R18 as identified in the study, the potential use of PLX-R18 in civilian and military applications where radiation exposure is a potential risk, that PLX-R18 has the ability to treat ARS as a multi-organ therapy, the advancement of its ARS program to ultimately target governmental purchase contracts, its progress with respect to small and large animal studies in relevant DoD models, as required by the FDA animal rule pathway, its aim to submit a proposal by the end of September with respect to BARDA, with the hopes of commencing a study designed to demonstrate the superiority of PLX-R18 in the treatment of ARS versus current standards of care and with the goal of executing a full contract once the study is completed and its aim to expand the focus of PLX-R18 to additional medical conditions with the goal of bringing innovative, safe and effective treatments for patients with a variety of bone marrow deficiency indications.
These forward-looking statements and their implications are based on the current expectations of the management of Pluristem only, and are subject to a number of factors and uncertainties that could cause actual results to differ materially from those described in the forward-looking statements.
The following factors, among others, could cause actual results to differ materially from those described in the forward-looking statements: changes in technology and market requirements; Pluristem may encounter delays or obstacles in launching and/or successfully completing its clinical trials; Pluristem’s products may not be approved by regulatory agencies, Pluristem’s technology may not be validated as it progresses further and its methods may not be accepted by the scientific community; Pluristem may be unable to retain or attract key employees whose knowledge is essential to the development of its products; unforeseen scientific difficulties may develop with Pluristem’s process; Pluristem’s products may wind up being more expensive than it anticipates; results in the laboratory may not translate to equally good results in real clinical settings; results of preclinical studies may not correlate with the results of human clinical trials; Pluristem’s patents may not be sufficient; Pluristem’s products may harm recipients; changes in legislation may adversely impact Pluristem; inability to timely develop and introduce new technologies, products and applications; loss of market share and pressure on pricing resulting from competition, which could cause the actual results or performance of Pluristem to differ materially from those contemplated in such forward-looking statements.
Except as otherwise required by law, Pluristem undertakes no obligation to publicly release any revisions to these forward-looking statements to reflect events or circumstances after the date hereof or to reflect the occurrence of unanticipated events.
For a more detailed description of the risks and uncertainties affecting Pluristem, reference is made to Pluristem’s reports filed from time to time with the Securities and Exchange Commission.
Contact:
Efrat Kaduri
Director of Business, Investor and Public Relations 972-74-7108600
Data readout from second cohort of hematological study will be presented Call scheduled for Monday, September 16 at 10:00am ET
HAIFA, Israel, September 9, 2019 — Pluristem Therapeutics (PSTI), a leading regenerative medicine company developing novel placenta-based cell therapy products, today announced additional information relating to its live Key Opinion Leader (KOL) call regarding its hematological programs on September 16, 2019.
The call will feature presentations by Jacob M. Rowe, MD and Bert. W. Maidment, Ph.D, and will include discussions regarding the findings from Pluristem’s ongoing clinical study in hematological deficiencies, as well as opportunities and future product development. In addition, Pluristem’s management will review the status of the company’s radiation programs with the U.S government, including an overview of recent Department of Defense (DoD) data, potential markets and expected milestones.
Jacob M. Rowe, MD is chief of the Department of Hematology and The Ann and Pinky Sohn Chair in Hemato-Oncology at the Shaare Zedek Medical Center in Jerusalem, and Emeritus Professor at the Technion, Israel Institute of Technology in Haifa. Dr. Rowe has actively participated in a wide range of national and international research projects and initiatives. He is a former chairman of the Leukemia Committee of the Eastern Cooperative Oncology Group (ECOG) and has developed and chaired many Phase II and III studies on leukemia, lymphoma, and bone marrow transplantation. Dr. Rowe is also an Adjunct Professor at the Department of Medicine of Northwestern University, Chicago, IL. He has received many prestigious awards, including an honorary doctorate from the University of Gothenburg in Sweden, has published over 500 peer- reviewed articles, reviews and book chapters and is a frequent invited speaker or chairman at international meetings.
Bert. W. Maidment, Ph.D., is the Executive Consultant and former Associate Director for Radiation Countermeasures Research and Emergency Preparedness at the National Institutes of Health, NIAID/DAIT/Radiation Nuclear Countermeasures Program.
Monday, September 16th at 10am Eastern/7am Pacific
Domestic: 800-479-1004
International: 1-323-794-2597
Conference ID: 4428235
Webcast: http://bit.ly/2k7qkMQ
For those who are unable to listen at this time, a replay of the call will be available by clicking here.
Pluristem Therapeutics Inc. is a leading regenerative medicine company developing novel placenta-based cell therapy product candidates.
The Company has reported robust clinical trial data in multiple indications for its patented PLX cell product candidates and is currently conducting late stage clinical trials in several indications.
PLX cell product candidates are believed to release a range of therapeutic proteins in response to inflammation, ischemia, muscle trauma, hematological disorders and radiation damage.
The cells are grown using the Company’s proprietary three-dimensional expansion technology and can be administered to patients off- the-shelf, without tissue matching. Pluristem has a strong intellectual property position; a Company-owned and operated GMP-certified manufacturing and research facility; strategic relationships with major research institutions; and a seasoned management team.
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 topics that will be discussed on the KOL call.
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
Director of Business, Investor and Public Relations 972-74-7108600
HAIFA, Israel, August 21, 2019 – 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 host a live Key Opinion Leader (KOL) call on its hematological programs on September 16, 2019.
The call will feature presentations by KOLs and Pluristem’s management who will explain and discuss the status of the company’s radiation programs with the U.S government, including an overview of recent Department of Defense (DoD) radiation data, potential markets and expected milestones. In addition, KOLs will discuss findings from Pluristem’s ongoing clinical study in hematological deficiencies, as well as opportunities and future product development. A detailed list of participating KOLs will be provided closer to the date of the event.
This event is intended for institutional investors, sell-side analysts, investment bankers, and business development professionals. Pluristem will release a summary following the call.
Pluristem Therapeutics Inc. is a leading regenerative medicine company developing novel placenta-based cell therapy product candidates.
The Company has reported robust clinical trial data in multiple indications for its patented PLX cell product candidates and is currently conducting late stage clinical trials in several indications.
PLX cell product candidates are believed to release a range of therapeutic proteins in response to inflammation, ischemia, muscle trauma, hematological disorders and radiation damage.
The cells are grown using the Company’s proprietary three-dimensional expansion technology and can be administered to patients off- the-shelf, without tissue matching. Pluristem has a strong intellectual property position; a Company-owned and operated GMP-certified manufacturing and research facility; strategic relationships with major research institutions; and a seasoned management team.
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 topics that will be discussed on the KOL call.
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
Director of Business, Investor and Public Relations 972-74-7108600
HAIFA, Israel, July 31, 2019 – Pluristem Therapeutics Inc. (Nasdaq:PSTI) (TASE:PSTI), a leading regenerative medicine company developing novel placenta-based cell therapy products, is presenting positive results from a series of studies of the company’s PLX-R18 cell therapy product conducted by the U.S. Department of Defense’s (DoD) Armed Forces Radiobiology Research Institute at the Uniformed Services University of the Health Sciences. The studies were designed to evaluate PLX-R18 as a potential prophylactic countermeasure against acute radiation syndrome (ARS) administered prior to radiation exposure.
These animal studies demonstrate that PLX-R18, administered 24 hours before radiation exposure, and again 72 hours after exposure, resulted in a significant increase in survival rates, from 4% survival rate in the placebo group to 74% in the treated group. In addition, the data show an increase in recovery of blood lineages (platelets, neutrophils, white blood cells, and lymphocytes) and a favorable safety profile. Furthermore, histopathological analysis and hematopoietic progenitor clonogenic assay of tissues collected show a significant increase in bone marrow cell numbers and improved regenerative capability into all blood lineages.
“We are very pleased with the positive results from the studies showing that PLX-R18 can potentially be used prophylactically, before exposure to radiation.
We believe that this outcome is an important contribution to protect the armed and medical forces which may need to enter contaminated areas,” said Yaky Yanay, President and Chief Executive Officer of Pluristem. “It is Pluristem’s goal to provide the different federal agencies access to PLX-R18 that it may be used as a countermeasure both before and after radiation exposure in order to minimize hematological and other organ damage. We look forward to the continued development of this unique agent as an off the shelf product.”
In addition to the DoD study, PLX-R18 is also being evaluated by the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (NIH), as a treatment following radiation exposure (ARS). Data from these studies demonstrated a significant increase in survival rates and enhanced neutrophil and lymphocyte recovery in radiation subjects. PLX-
R18 cell therapy product candidate was granted an FDA orphan drug designation and an IND for the treatment of ARS.
The animal studies were conducted following guidance from the U.S. Food and Drug Administration (FDA) relating to its animal rule pathway.
ARS results from exposure to high levels of radiation, as in the case of a nuclear accident or attack, and it may cause severe or fatal systemic effects such as injuries that hinder the bone marrow’s ability to produce blood cells and platelets, as well as other organs and systems within the body, increasing patients’ susceptibility 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 cell product and is currently conducting late stage clinical 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; a Company-owned and operated GMP-certified manufacturing and research facility; 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 benefits of PLX- R18 and when it states that it believes the outcome of the studies is an important contribution to protect the armed and medical forces, that its goal is to provide the different federal agencies access to PLX-R18 so that it may be used as a countermeasure both before and after radiation exposure and that it looks forward to the development of PLX-R18 as an off the shelf 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
Director of Business, Investor and Public Relations 972-74-7108600
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