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The Company will host a Key Opinion Leader online event on muscle regeneration following hip fracture surgery on November 22 at 9:15am EST
HAIFA, Israel, November 15, 2021 – Pluristem Therapeutics Inc. (Nasdaq:PSTI) (TASE:PSTI) (the “Company”), a leading biotechnology company announced today that its multinational Phase III multicenter, randomized, double-blind, placebo-controlled study, designed to determine the efficacy, safety, and tolerability of intramuscular administration of allogeneic PLX-PAD cells for the treatment of muscle injury following arthroplasty for hip fracture, is fully enrolled with 240 patients.
The multinational clinical study includes patients from the U.S., Europe, and Israel, and topline results are expected in the third calendar quarter of 2022.
The Company will host a Key Opinion Leader online event on muscle regeneration following hip fracture surgery on November 22 at 9:15am EST, for registration: https://Veidan.activetrail.biz/pluristem
“Reaching our enrollment target for the Phase III PLX-PAD study is an important milestone,” said Pluristem CEO and President, Yaky Yanay. “Rising healthcare costs and aging demographic changes present an opportunity for allogenic, placenta-cell derived products to satisfy unmet clinical needs in the area of muscle regeneration following hip arthroplasty. The potential improvement of physical function following this common procedure could redefine the current standard of care and improve patients’ lives.”
Pluristem’s unique technology, based on a state-of-the-art cell expansion system designed to mimic conditions in the human body, provides a 3-D microenvironment where cells are multiplied and developed into therapeutic candidates. PLX-PAD cells secrete proteins to induce tissue healing in response to muscle trauma and inflammation and are applied via intramuscular administration.
During a completed Phase I/II double-blind placebo controlled trial, PLX-PAD cells demonstrated statistically significant superiority, in the ability to increase muscle strength and volume for patients who have undergone total hip replacement surgery due to osteoarthritis. If approved, PLX-PAD would be a first-of-its-kind innovative treatment for muscle regeneration.
Mr. Yanay concluded, “Hip fracture is a major cause of hospitalization for seniors and is associated with significant morbidity, mortality, loss of independence, and financial burden.
The annual number of hip fractures worldwide is expected to surpass 6 million in 2050 due to the increased prevalence of osteoporosis. As healthcare systems search for new opportunities to lower the cost of care and provide new treatments for aging populations, our PLX-PAD product candidate could potentially bring novel solutions for soft tissue regeneration.”
Estimated annual costs of care for patients suffering from hip fractures in the U.S. are between $10.3 billion and $15.2 billion. Approximately 20 percent of hip fracture patients die within one year from surgery due to immobility associated diseases, emphasizing the need for better and faster muscle rehabilitation for improved patient outcome.
Cell-based therapy for muscle regeneration could have potential for additional applications, including arthroplasty of the shoulders, knees, and other musculoskeletal indications.
Pluristem is pushing the boundaries of science and engineering to reimagine pharmacological treatments and improve the standard of care.
The Company’s cell therapies advance the field of regenerative medicine, with potentially groundbreaking applications for treating damaged muscle, hematology deficiencies, and inflammation.
Pluristem sources its therapeutic cells from the placenta, an ethically accepted and potent source.
Cells are easy to collect and do not require blood or tissue matching. Cells from one placenta can treat more than 20,000 patients.
The Company’s manufacturing platform is a patented and validated state-of-the-art 3D cell expansion system, designed to mimic the human body.
Pluristem’s method is uniquely accurate, cost-effective, and consistent batch-to-batch.
This press release contains express or implied forward-looking statements within the Private Securities Litigation Reform Act of 1995 and other U.S. Federal securities laws.
For example, Pluristem is using forward-looking statements when it discusses the expected timing of the Phase III topline results, that the potential use of PLX-PAD cells for patients recovering from hip fractures could redefine the current standard of care and improve patients’ lives, that if approved, PLX-PAD would be a first-of-its-kind innovative treatment for muscle regeneration, that the PLX-PAD product candidate could potentially bring novel solutions for soft tissue regeneration and that cell-based therapy for muscle regeneration could have potential for additional applications.
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
HAIFA, Israel, November 10, 2021 – Pluristem Therapeutics Inc. (Nasdaq:PSTI) (TASE:PSTI), a leading biotechnology company, today announced that it has received approval for an additional grant from the Israel Innovation Authority (IIA) to support research based on its cutting-edge PLX platform. The grant comes as part of the Company’s work as part of the CRISPR-IL consortium (“the Consortium”), which the IIA funds through its Bio-Convergence Program. The IIA approved a new budget for the Consortium to continue its work for an additional 18 months (“period B”) after evaluating its activity and results over the past 18 months (“period A”).
As part of the budget, Pluristem is expected to receive approximately 1,800,000 NIS (approximately $583,000) to continue its work in developing a new generation of PLX cells based on the use of CRISPR technology to genetically program desired cell functions in future allogenic products.
As the leader of the consortium’s Pharma Working Group, Pluristem is collaborating with other industry and academic leaders in the field of genome editing, bringing together leading experts in life science and computer science from academia, medicine, and industry, to develop artificial intelligence (AI) based, end-to-end, multi-species genome editing solutions.
These solutions are expected to maximize the efficiency and accuracy of CRISPR genome editing of human, plant and animal DNA, and have applications in the pharma, agriculture, and aquaculture industries.
Yaky Yanay, CEO and President said: “The evaluation of the CRISPR-IL Consortium’s work over the last 18 months was successfully completed.
The IIA’s continued investment in Pluristem’s participation in this work provides further opportunity to push forward the development of next generation allogeneic cell therapies. We continue to believe that the integration of CRISPR technology in our PLX platform holds great potential to develop the treatments of the future, and the IIA’s approval of additional funds is validation of that belief.”
CRISPR is a genome-editing technology intended to modify specific DNA sequences, which enables the development of unique bio-based products and novel therapeutics while reducing the time and cost of development.
Pluristem is pushing the boundaries of science and engineering to reimagine pharmacological treatments and improve the standard of care.
The Company’s cell therapies advance the field of regenerative medicine, with potentially groundbreaking applications for treating damaged muscle, hematology deficiencies, and inflammation.
Pluristem sources its therapeutic cells from the placenta, an ethically accepted and potent source. Cells are easy to collect and do not require blood or tissue matching.
Cells from one placenta can treat more than 20,000 patients.
The Company’s manufacturing platform is a patented and validated state-of-the-art 3D cell expansion system, designed to mimic the human body. Pluristem’s method is uniquely accurate, cost- effective, and consistent batch-to-batch.
This press release contains express or implied forward-looking statements within the Private Securities Litigation Reform Act of 1995 and other U.S. Federal securities laws.
For example, Pluristem is using forward-looking statements when it discusses the expected receipt of the grant from the Israel Innovation Authority, that it intends to push forward the development of next generation allogeneic cell therapies and that the integration of CRISPR technology and its PLX platform holds great potential to develop the treatments of the future and the IIA’s approval of additional funds is validation of that belief.
These forward-looking statements and their implications are based on the current expectations of the management of Pluristem only, and are subject to a number of factors and uncertainties that could cause actual results to differ materially from those described in the forward-looking statements.
The following factors, among others, could cause actual results to differ materially from those described in the forward-looking statements: changes in technology and market requirements; Pluristem may encounter delays or obstacles in launching and/or successfully completing its clinical trials; Pluristem’s products may not be approved by regulatory agencies, Pluristem’s technology may not be validated as it progresses further and its methods may not be accepted by the scientific community; Pluristem may be unable to retain or attract key employees whose knowledge is essential to the development of its products; unforeseen scientific difficulties may develop with Pluristem’s process; Pluristem’s products may wind up being more expensive than it anticipates; results in the laboratory may not translate to equally good results in real clinical settings; results of preclinical studies may not correlate with the results of human clinical trials; Pluristem’s patents may not be sufficient; Pluristem’s products may harm recipients; changes in legislation may adversely impact Pluristem; inability to timely develop and introduce new technologies, products and applications; loss of market share and pressure on pricing resulting from competition, which could cause the actual results or performance of Pluristem to differ materially from those contemplated in such forward-looking statements.
Except as otherwise required by law, Pluristem undertakes no obligation to publicly release any revisions to these forward-looking statements to reflect events or circumstances after the date hereof or to reflect the occurrence of unanticipated events.
For a more detailed description of the risks and uncertainties affecting Pluristem, reference is made to Pluristem’s reports filed from time to time with the Securities and Exchange Commission.
Contact:
Dana Rubin
Director of Investor Relations 972-74-7107194
HAIFA, Israel, September 22, 2021 – Pluristem Therapeutics Inc. (Nasdaq: PSTI) (TASE: PSTI), a leading biotechnology company, today issued an update to its shareholders from its Chief Executive Officer and President Yaky Yanay.
Dear Shareholders,
Less than three months into a new fiscal year, there are several important developments on the horizon for Pluristem, including four studies heading to clinical readout in the coming quarters. These studies align with our mission to develop novel cell therapy product candidates, built using Pluristem’s advanced technology.
During the coming year, we expect to meet multiple clinical milestones, which represent significant potential for our cellular platform.
First, our Phase I study evaluating PLX-R18 cells in subjects with incomplete hematopoietic recovery following Hematopoietic Cell Transplantation (HCT) demonstrated positive topline results as reported in April 2021, and we expect to present full data readout in the fourth quarter of this calendar year.
We also expect to continue the development of the program and to initiate a Phase II study in hematological indication.
Second, we expect topline results in the fourth quarter of this calendar year for both of our Phase II studies of PLX-PAD cells to treat acute respiratory distress syndrome (ARDS) associated with COVID-19 in the U.S., Europe, and Israel.
Third, our Phase III study evaluating PLX-PAD cells to support muscle regeneration after hip fracture surgery has enrolled more than 95 percent of its patients and is expected to complete enrollment in October 2021.
Figure 1 – Clinical Pipeline: Milestones
In the last decade, we have developed an automated and robust current Good Manufacturing Practice (cGMP) manufacturing platform for allogeneic cells originating from the fetal and maternal cells from the placenta.
Using this platform, we can produce large quantities of high- quality cells suitable for a variety of applications and uses.
The manufacturing platform enables us to develop targeted pipelines of cellular product candidates including induced or modified PLX cells:
Induced PLX cells: These cells from the placenta are induced with different cytokines to transiently alter their secretion profile.
Our first product candidate under this technology is PLX-R18. The positive data presented in the hematology study in April 2021 supports our approach of targeting cells with superior activity per indication.
We expect to continue developing this platform for inducing cells and are in advanced development to complete additional targeted product candidates of this nature.
Modified PLX cells using CRISPR technology: We are also working on integrating CRISPR’s revolutionary genetic engineering technology to potentially engineer PLX cells with novel and targeted functionality.
Combined with our placenta-derived cell manufacturing platform, Pluristem would use CRISPR technology to potentially develop a new class of ex vivo modified allogenic PLX cell therapy product candidates to address new indications.
In short, we have developed a reliable, stable, and cost-effective cell expansion platform.
We believe that using the placenta as a unique cell source combined with our innovative research, development, and high-quality manufacturing capabilities will be the engine that drives this platform technology towards the successful development of additional PLX cell therapy product candidates and indications.
We are excited to continue developing the powerful therapeutic capabilities of placental cells while using our advanced technology to push boundaries.
What is Pluristem’s biggest advantage? Our talented management team and I asked this question in recent months as part of our five-year strategic discussions.
The outcome is clear: Develop effective and innovative cellular product candidates while assuring manufacturing capacity on the back end when the product candidate is ready for market.
We believe that this is our defining competitive advantage. Over the years, we have received interest from potential partners to use our platform for pharmaceuticals and other industries.
Pluristem intends to use its unmatched technological advantage to establish mutually advantageous partnerships towards the best utilization and optimization of our assets for the benefit of our shareholders.
Sincerely, Yaky Yanay
CEO & President
Pluristem is pushing the boundaries of science and engineering to reimagine pharmacological treatments and improve the standard of care.
The Company’s cell therapies advance the field of regenerative medicine, with potentially groundbreaking applications for treating damaged muscle, hematology deficiencies, and inflammation.
Pluristem sources its therapeutic cells from the placenta, an ethically accepted and potent source.
Cells are easy to collect and do not require blood or tissue matching. Cells from one placenta can treat 20,000 patients.
The Company’s manufacturing platform, the bioreactor, is a patented and validated state-of-the-art 3D cell expansion system, designed to mimic the human body.
Pluristem’s method is uniquely accurate, cost-effective, and consistent batch-to-batch.
This press release contains express or implied forward-looking statements within the Private Securities Litigation Reform Act of 1995 and other U.S. Federal securities laws.
For example, Pluristem is using forward-looking statements when it discusses the expected timing of the topline results from its Phase II studies of PLX-PAD cells to ARDS associated with COVID-19 and the presentation of the full data readout of the HCT Phase I study evaluating PLX-R18 cells, the expected completed enrollments in its Phase III study evaluating PLX-PAD cells to support muscle regeneration after hip fracture surgery, its expectation that it will continue the development of its platform for inducing cells and is in advanced development to complete additional targeted product candidates of this nature, its intention to use CRISPR technology to potentially develop a new class of ex vivo modified allogenic PLX cell therapy product candidates to address new indications and that it intends to use its technological advantage to establish mutually advantageous partnerships towards the best utilization and optimization of its assets.
These forward-looking statements and their implications are based on the current expectations of the management of Pluristem only and are subject to several 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
HAIFA, Israel, July 19, 2021 – Pluristem Therapeutics Inc. (Nasdaq: PSTI) (TASE: PSTI), a leading biotechnology company, today announced the Board of Director appointments of Prof. Varda Shalev, a physician, medical researcher, and Professor of Medicine at the Tel Aviv University’s School of Public Health, and Mr. Doron Birger, a high-tech industry executive with a background in bringing groundbreaking products to market.
Prof. Shalev has more than 30 years of experience working in clinical environments and research settings at the intersection of health and technology. She was the founder and Chief Executive Officer of the KSM Institute of Research and Innovation and Maccabitech, the epidemiological and clinical research arm of Israel’s Maccabi Healthcare Services, where she established the largest biobank in Israel and developed a computerized system for predicting the risk of colon cancer in patients using a database of two million people. This work led Maccabi Healthcare Services to win the Director General of the Ministry of Health’s Excellence in Logistics in Health Systems award. Prof. Shalev founded the Department of Medical Informatics at Maccabi Healthcare Services and was the head of Primary Care division of Maccabi Healthcare Services.
Prof. Shalev is Chief Medical Officer and co-founder of the digital health startup, Alike, which is developing an artificial intelligence-based platform to empower patients to track their own health conditions. In addition to informatics and predictive analytics, Prof. Shalev’s research expertise includes epidemiology. She has authored more than 250 publications in peer-reviewed journals and was included in the Marker newspaper’s list of “100 Most Influential People.” Prof. Shalev earned her medical degree from Ben-Gurion University of the Negev, School of Medicine, her Master of Public Health Administration from Clark University in the United States and completed her post-doctoral fellowship in Medical Informatics at Johns Hopkins.
Mr. Birger is a prominent business leader with more than 30 years of experience in the Israeli high-tech sector as a chief executive officer, board chairman, director, and advisor to several private and publicly traded firms, with an emphasis in the life science industry.
Mr. Birger served as the president and Chief Executive Officer of Elron (Nasdaq, TASE: ELRNF) from 2002 to 2009. At Elron, he successfully led the development and acceleration of numerous cutting-edge technology firms, including multiple mergers and public offerings. He currently chairs several technology companies, including Sight Diagnostic, Ultrasight, Nurami, Matricelf (TASE: MTLF), and Intelicanna (TASE: INTL).
Mr. Birger was also the Chairman of the Board at Given Imaging from 2002 to 2007, and a director until it was sold to Covidien in 2014. From 1978 to 2001, Mr. Birger was Chief Financial Officer at several companies from various sectors, including the Chief Financial Officer of Elron from 1994- 2001. He is currently a director in a variety of medical device and advanced technology companies, including IceCure (TASE: ICCM), Citrine Global (OTCQB: CTGL), Kadimastem (TASE: KDST), HeraMED (ASX: HMD) Vibrant, and Netive Haor. Mr. Birger earned his bachelor’s degree and Master of Economics from the Hebrew University, Jerusalem.
“By harnessing the regenerative power of placenta cells using our unique bioreactor for cell expansion, Pluristem believes that it is poised to unlock a new generation of medical treatments,” said Pluristem Executive Chairman of the Board, Zami Aberman. “Prof. Shalev and Mr. Birger both bring unique expertise and experience that we believe will provide invaluable insight as we move our product candidate pipelines forward. Their combined 60 years of life science experience, both clinical and commercial, are perfectly aligned for Pluristem’s mission to potentially bring its PLX cells to market and reach patients around the world. Pluristem’s strategic goals will be served well by their skillsets and counsel.”
Pluristem is pushing the boundaries of science and engineering to reimagine pharmacological treatments and improve the standard of care.
The Company’s cell therapies advance the field of regenerative medicine, with potentially groundbreaking applications for treating damaged muscle, hematology deficiencies, and inflammation. Pluristem sources its therapeutic cells from the placenta, an ethically accepted and potent source.
Cells are easy to collect and do not require blood or tissue matching. Cells from one placenta can treat 20,000 patients. The Company’s manufacturing platform, the bioreactor, is a patented and validated state-of-the-art 3D cell expansion system, designed to mimic the human body. Pluristem’s method is uniquely accurate, cost-effective, and consistent batch-to-batch.
This press release contains express or implied forward-looking statements within the Private Securities Litigation Reform Act of 1995 and other U.S. Federal securities laws.
For example, Pluristem is using forward-looking statements when it discusses its belief that it is poised to unlock a new generation of medical treatments and that its new directors will enhance the Board’s strategic goals in preparation for future growth and commercialization endeavors.
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
HAIFA, Israel, July 8, 2021 – Pluristem Therapeutics Inc. (Nasdaq:PSTI) (TASE:PSTI) (the “Company”), a leading biotechnology company announced today that it is bringing its Acute Respiratory Distress Syndrome (ARDS) associated with COVID-19 Phase II studies to clinical readout. The Company’s COVID-19 program included over 100 patients across two Phase II studies in the U.S., Europe and Israel, and in compassionate use and expanded access programs in the U.S. and Israel. The analysis will be based on 89 patients enrolled in the previously announced two Phase II studies, which investigated the safety and efficacy of Pluristem’s PLX cells as a treatment for severe COVID-19 cases complicated by ARDS.
This decision comes in response to COVID-19’s evolution as a disease, as well as changes in the standard of care and a decline in the most severe cases. For the same reason, the Company will not pursue plans announced in December 2020 to expand Pluristem’s COVID-19 program to Mexico in collaboration with Innovare R&D. Pluristem expects to announce the topline results of the readout during the fourth quarter of 2021.
As part of the clinical readout, Pluristem will examine the safety and efficacy of PLX cells for treating ARDS, a condition associated with a number of illnesses in addition to COVID-19 including sepsis, smoke and toxic chemical inhalation, head and chest injuries, and pancreatitis. ARDS continues to pose a significant clinical challenge that affects over 200,000 Americans annually, roughly 10 percent of Intensive Care Unit patients and 23 percent of ventilated patients worldwide.
Pluristem continues to advance its product candidate pipeline – PLX-PAD and PLX-R18 – on a number of fronts. Pluristem’s PLX-PAD treatment exhibits the potential to stimulate tissue regeneration in response to muscle trauma and inflammation. PLX-PAD is currently in a Phase III multinational clinical trial testing the safety and efficacy of accelerating muscle regeneration following HIP fracture surgery.
Additionally, Pluristem recently reported positive Phase I topline results from its evaluation of PLX-R18 cells to address incomplete hematopoietic recovery following Hematopoietic Cell Transplantation (HCT).
The Company’s unique proprietary process and advanced development and manufacturing capabilities enable it to produce PLX cells at significant scale.
Pluristem is pushing the boundaries of science and engineering to reimagine pharmacological treatments and improve the standard of care.
The Company’s cell therapies advance the field of regenerative medicine, with potentially groundbreaking applications for treating damaged muscle, hematology deficiencies, and inflammation.
Pluristem sources its therapeutic cells from the placenta, an ethically accepted and potent source. Cells are easy to collect and do not require blood or tissue matching.
Cells from one placenta can treat 20,000 patients.
The Company’s manufacturing platform, the bioreactor, is a patented and validated state-of-the-art 3D cell expansion system, designed to mimic the human body.
Pluristem’s method is uniquely accurate, cost-effective, and consistent batch-to-batch.
This press release contains express or implied forward-looking statements within the Private Securities Litigation Reform Act of 1995 and other U.S. Federal securities laws.
For example, Pluristem is using forward-looking statements when it discusses the expected timing of the Phase II study clinical readout, the expected examination of the clinical readout in relating to treating ARDS for illnesses and causes in addition to COVID-19, the potential of its product candidates and its pipeline.
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
Die erste Tranche der Finanzierung wird ausgeschüttet, da der Biotech- Innovator einen wichtigen Zwischenschritt in der zuvor angekündigten 50-Millionen-Euro-Vereinbarung erreicht
HAIFA, Israel, 26. Mai 2021 /PRNewswire/ — Pluristem Therapeutics Inc. (Nasdaq: PSTI) (TASE: PSTI) (das „Unternehmen”), ein führendes Biotechnologie- Unternehmen, gab heute den Erhalt eines „Auszahlungsangebots” in Höhe von 20 Millionen Euro (ca. 24 Millionen US-Dollar) von der Europäischen Investitionsbank (EIB) bekannt.
Mit dieser Auszahlung – der ersten von drei Finanzierungstranchen – hat Pluristem einen wichtigen Zwischenschritt in einer zuvor angekündigten, nicht verwässernden Finanzierungsvereinbarung über 50 Millionen Euro erreicht. Gemäß der EIB-Vereinbarung erwartet Pluristem, diese erste Tranche der Mittel im Juni 2021 zu erhalten.
Die Vereinbarung wurde von der kENUP Foundation initiiert, einer globalen Partnerschaft zur Förderung von Innovationen mit hohem öffentlichen und gesellschaftlichen Nutzen.
Der Erlös der ersten Tranche wird für Forschung und Entwicklung (F&E) in der Europäischen Union genutzt, um die proprietäre regenerative Zelltherapie-Plattform von Pluristem zum Erfolg führen soll.
Die erste Tranche in Höhe von 20 Millionen Euro ist nicht besichert und wird fünf Jahre nach der Auszahlung in einer einzigen Zahlung an die EIB fällig. Der Zinssatz beträgt 4 %. Nach Erhalt der Tranche von 20 Millionen Euro wird Pluristem über einen Kassenbestand von mehr als 90 Millionen US-Dollar verfügen.
Der CEO und Präsident von Pluristem, Yaky Yanay, sagte: „Die Finanzierung durch die EIB ermöglicht es Pluristem, unsere operativen, klinischen und F&E-Aktivitäten durchzuführen, um unsere Plattform für regenerative Medizin weiterzuentwickeln. Die europäische Bevölkerung altert schnell und es besteht unserer Meinung nach ein klarer Bedarf an neuartigen Behandlungen für eine Reihe von Krankheiten und Leiden, um ihre Lebensqualität zu verbessern. Wir wollen diesen Finanzierungsmechanismus nutzen, um unsere Produktkandidaten bis zur Reife zu entwickeln. Wir danken der EIB für ihre andauernde Unterstützung und ihr Vertrauen in unsere Technologie.”
„Zu den wichtigsten Stärken von Pluristem gehört eine hochmoderne, automatisierte Zellexpansionstechnologie, die auf 17 Jahren Zelltherapieforschung basiert. Darüber hinaus ermöglichen unsere hauseigenen Produktionskapazitäten die Herstellung von allogenen Zellproduktkandidaten in großen Mengen mit einer Konsistenz von Charge zu Charge.”
Chen Franco-Yehuda, der CFO von Pluristem, fügte hinzu: „Pluristem verfügt über einen starken Barmittelbestand, mit denen wir unsere F&E-Bemühungen beschleunigen können, so dass wir neue regenerative Medikamente für Bedürftige bereitstellen können. Die Finanzierungsvereinbarung mit der EIB stellt für uns eine kreative, nicht verwässernde Form der Finanzierung dar und wir glauben, dass sie uns für die Zukunft gut positioniert.”
Die Europäische Investitionsbank (EIB) ist die Institution der Europäischen Union für langfristige Finanzierungen.
Ihre Anteilseigner sind die Mitgliedstaaten.
Sie stellt langfristige Finanzierungen für solide Investitionen zur Verfügung und trägt damit zur Erreichung der politischen Ziele der EU bei.
Pluristem Therapeutics Inc. ist ein führender Hersteller im Bereich der regenerativen Medizin, der neuartige plazentabasierte Produktkandiaten für Zelltherapien entwickelt.
Das Unternehmen konnte robuste klinische Studiendaten mit mehreren Indikationen für seine patentierten PLX-Zell-Produktkandidaten zeigen und führt zurzeit klinische Studien mit mehreren Indikationen im Spätstadium durch.
Es wird angenommen, dass PLX-Zellproduktkandidaten eine Reihe therapeutischer Proteine als Reaktion auf Entzündungen, Ischämie, Muskeltrauma, hämatologische Störungen und Strahlenschäden freisetzen.
Die Zellen werden mit der firmeneigenen dreidimensionalen Expansionstechnologie gezüchtet und können Patienten „von der Stange” verabreicht werden, ohne dass ein Abgleich der Gewebemerkmale notwendig ist.
Pluristem verfügt über eine starke IP-Position, eine unternehmenseigene und vom Unternehmen selbst betriebene GMP-zertifizierte Produktions- und Forschungseinrichtung, strategische Beziehungen zu großen Forschungsinstituten und ein erfahrenes Managementteam.
Diese Mitteilung enthält zukunftsgerichtete Informationen im Sinne des U.S. Securities Act und der Safe Harbor-Bestimmungen des U.S. Private Securities Litigation Reform Act von 1995 und anderer US-amerikanischer Wertpapiergesetze.
Pluristem verwendet beispielsweise zukunftsgerichtete Aussagen, wenn es den erwarteten Zeitpunkt und die Verwendung der Erlöse aus der ersten Tranche der EIB-Mittel erörtert und davon ausgeht, dass die Finanzierung es dem Unternehmen ermöglichen wird, seine operativen, klinischen und F&E-Aktivitäten durchzuführen, um seine Plattform für regenerative Medizin weiterzuentwickeln, und dass die Mittel das Unternehmen gut für die Zukunft positionieren. Diese zukunftsgerichteten Aussagen basieren ausschließlich auf den aktuellen Erwartungen des Managements von Pluristem und unterliegen einer Reihe von Faktoren und Ungewissheiten, die dazu führen könnten, dass sich die tatsächlichen Ergebnisse erheblich von jenen unterscheiden, die in vorausblickenden Aussagen zum Ausdruck gebracht wurden.
Die folgenden Faktoren könnten unter anderem dazu führen, dass die tatsächlichen Ergebnisse wesentlich von denen abweichen, die in den zukunftsgerichteten Aussagen beschrieben sind: Änderungen der Technologie und der Marktanforderungen; Pluristem könnte auf Verzögerungen oder Hindernisse bei der Einleitung und/oder dem erfolgreichen Abschluss seiner klinischen Studien stoßen; die Produkte von Pluristem könnten von den Aufsichtsbehörden nicht genehmigt werden, die Technologie von Pluristem könnte im weiteren Verlauf nicht validiert werden und die Methoden von Pluristem könnten von der wissenschaftlichen Gemeinschaft nicht akzeptiert werden; Pluristem könnte nicht in der Lage sein, wichtige Mitarbeiter, deren Wissen für die Entwicklung seiner Produkte wesentlich ist, in Schlüsselpositionen zu halten oder zu gewinnen; es könnten unvorhergesehene wissenschaftliche Schwierigkeiten mit dem Verfahren von Pluristem auftreten; die Produkte von Pluristem könnten sich als teurer erweisen als erwartet; die Ergebnisse im Labor könnten nicht zu gleich guten Ergebnissen in realen klinischen Umgebungen führen; die Ergebnisse präklinischer Studien könnten nicht mit den Ergebnissen klinischer Studien am Menschen korrelieren; Pluristems Patente könnten nicht ausreichend sein; Pluristems Produkte könnten den Empfängern schaden; Änderungen in der Gesetzgebung könnten sich negativ auf Pluristem auswirken; die Unfähigkeit, rechtzeitig neue Technologien, Produkte und Anwendungen zu entwickeln und einzuführen; der Verlust von Marktanteilen und der Preisdruck, der sich aus dem Wettbewerb ergibt, könnten dazu führen, dass die tatsächlichen Ergebnisse oder Leistungen von Pluristem wesentlich von jenen abweichen, die in solchen zukunftsgerichteten Aussagen zum Ausdruck gebracht wurden. Sofern nicht anderweitig gesetzlich vorgeschrieben, ist Pluristem nicht verpflichtet, Revisionen dieser zukunftsgerichteten Aussagen zu veröffentlichen, um Ereignisse oder Umstände nach dem Datum dieses Dokuments oder das Eintreten unvorhergesehener Ereignisse zu berücksichtigen. Für eine detailliertere Beschreibung der Risiken und Ungewissheiten bezüglich Pluristem wird auf die Berichte von Pluristem verwiesen, die regelmäßig bei der Securities and Exchange Commission eingereicht werden.
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Dana Rubin
Director of Investor Relations
+972-74-7107194
SOURCE Pluristem Therapeutics Inc.
La première tranche de financement doit être distribuée puisque l’innovateur en biotechnologie a franchi une étape clé dans l’accord de €50 millions d’euros annoncé précédemment
HAIFA, Israël, 27 mai 2021 /PRNewswire/ — Pluristem Therapeutics Inc. (Nasdaq : PSTI) (TASE : PSTI) (la « Société »), une société importante de biotechnologie, a annoncé aujourd’hui la réception d’une « offre de décaissement » d’un montant de €20 millions d’euros (environ $24 millions de dollars) de la Banque européenne d’investissement (BEI). Ce décaissement – le premier de trois tranches de financement – montre que Pluristem a franchi une étape clé dans l’accord de financement non dilutif de €50 millions d’euros annoncé précédemment. Conformément à l’accord de la BEI, Pluristem prévoit de recevoir la première tranche de fonds en juin 2021.
Le produit de la première tranche servira à financer la recherche et le développement (R&D) dans l’Union européenne afin de faire progresser la plateforme de thérapie cellulaire régénérative exclusive de Pluristem.
La première tranche de €20 millions d’euros ne sera pas sécurisée et sera payable à la BEI en un seul versement cinq ans après le décaissement, avec un taux d’intérêt de 4 %. Après avoir reçu la tranche de €20 millions d’euros, Pluristem disposera d’un solde de trésorerie de plus de $90 millions de dollars.
Le PDG et président de Pluristem, Yaky Yanay, a déclaré : « Le financement de la BEI permet à Pluristem de mener à bien ses activités opérationnelles, cliniques et de R&D pour faire progresser sa plateforme de médecine régénérative.
La population vieillissante de l’Europe connaît une croissance rapide et nous pensons qu’elle a un besoin évident de nouveaux traitements pour un certain nombre de maladies et d’affections afin d’améliorer la qualité de vie.
Nous sommes déterminés à tirer parti de ce mécanisme de financement pour renforcer le développement de nos produits candidats jusqu’à leur maturation. Nous sommes reconnaissants à la BEI pour son soutien continu et sa confiance en notre technologie.
« Les principaux avantages concurrentiels de Pluristem comprennent une technologie d’expansion cellulaire automatisée de pointe qui s’appuie sur 17 années de recherche en thérapie cellulaire. En outre, nos capacités de fabrication en interne permettent de fabriquer des produits candidats à base de cellules allogéniques à grande échelle e d’assurer la conformité des lots. »
Chen Franco-Yehuda, directeur financier de Pluristem, a ajouté : « Pluristem dispose d’un important solde de trésorerie pour accélérer nos actions en matières de R&D afin d’apporter de nouveaux médicaments régénérateurs à ceux qui en ont besoin.
Nous pensons que le contrat de financement de la BEI représente une forme de financement créative et non dilutive, et nous sommes convaincus qu’il nous place en bonne position pour l’avenir. »
La Banque européenne d’investissement (BEI) est l’institution de financement à long terme de l’Union européenne, détenue par ses États membres. Elle met à disposition des financements à long terme pour des investissements viables afin de contribuer à la réalisation des objectifs politiques de l’UE.
Pluristem Therapeutics Inc. est une des principales sociétés de médecine régénérative qui développe de nouveaux produits candidats de thérapie cellulaire à base de placenta.
La société a rapporté des données d’essais cliniques fiables dans différentes indications pour ses produits candidats brevetés à base de cellules PLX et mène actuellement des essais cliniques de stade avancé dans plusieurs indications.
Les produits candidats de la cellule PLX sont censés libérer de nombreuses protéines thérapeutiques en réponse à l’inflammation, aux traumatismes musculaires, aux troubles hématologiques et aux radiolésions.
Les cellules sont cultivées à l’aide de la technologie brevetée d’expansion tridimensionnelle de la société et peuvent être administrées aux patients sans qu’il n’y ait nécessairement de compatibilité tissulaire.
Pluristem est bien placée en matière de propriété intellectuelle, dispose d’une usine de fabrication et de recherche certifiée BPF détenue et exploitée par la société, de relations stratégiques avec d’importantes institutions de recherche et d’une équipe de direction chevronnée.
Déclaration d’exonération de responsabilité
Le présent communiqué de presse contient des déclarations prospectives, explicites ou implicites, au sens de la loi Private Securities Litigation Reform Act de 1995 et d’autres lois fédérales américaines sur les valeurs mobilières. Par exemple, Pluristem utilise des déclarations prospectives lorsqu’elle parle du calendrier et de l’utilisation prévus du produit de la première tranche de fonds versés par la BEI, de sa conviction que le financement lui permettra d’exécuter ses activités opérationnelles, cliniques et de R&D pour faire progresser sa plateforme de médecine régénérative et que les fonds la placent en bonne position pour l’avenir.
Ces déclarations prospectives et leurs implications sont fondées uniquement sur les attentes actuelles de la direction de Pluristem et sont soumises à un certain nombre de facteurs et d’incertitudes qui pourraient faire en sorte que les résultats réels diffèrent sensiblement de ceux décrits dans les déclarations prospectives.
Les facteurs suivants, entre autres, pourraient faire en sorte que les résultats réels diffèrent sensiblement de ceux décrits dans les déclarations prospectives : des changements dans la technologie et les exigences du marché ; Pluristem pourrait rencontrer des retards ou des obstacles dans le lancement et/ou la réussite de ses essais cliniques ; les produits de Pluristem pourraient ne pas être approuvés par les organismes de réglementation, la technologie de Pluristem pourrait ne pas être validée au fur et à mesure de ses progrès et ses méthodes pourraient ne pas être acceptées par la communauté scientifique ; Pluristem pourrait ne pas être en mesure de retenir ou d’attirer des employés clés dont les connaissances sont essentielles au développement de ses produits ; des difficultés scientifiques imprévues pourraient se développer avec le processus de Pluristem ; les produits de Pluristem pourraient s’avérer plus coûteux que prévu ; les résultats obtenus en laboratoire peuvent ne pas se traduire par des résultats aussi bons dans des environnements cliniques réels ; les résultats des études précliniques peuvent ne pas être en corrélation avec les résultats des essais cliniques chez l’homme ; les brevets de Pluristem peuvent ne pas être suffisants ; les produits de Pluristem peuvent nuire aux receveurs ; des changements dans la législation peuvent avoir un impact négatif sur Pluristem ; l’incapacité de développer et d’introduire en temps opportun de nouvelles technologies, de nouveaux produits et de nouvelles applications ; la perte de parts de marché et la pression sur les prix résultant de la concurrence, ce qui pourrait faire en sorte que les résultats ou les performances réels de Pluristem diffèrent sensiblement de ceux envisagés dans ces déclarations prospectives.
Sauf si la loi l’exige, Pluristem ne s’engage pas à publier une révision de ces déclarations prospectives pour tenir compte d’événements ou de circonstances postérieurs à la date des présentes ou pour refléter la survenance d’événements imprévus. Pour une description plus détaillée des risques et incertitudes affectant Pluristem, il est fait référence aux rapports de Pluristem déposés ponctuellement auprès de la Securities and Exchange Commission.
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Contact :
Dana Rubin
Directrice des relations avec les investisseurs
+972-74-7107194
First tranche of funding is to be distributed as biotech innovator meets a key milestone in previously announced €50 million agreement
HAIFA, Israel, May 25, 2021 – Pluristem Therapeutics Inc. (Nasdaq:PSTI) (TASE:PSTI) (the “Company”), a leading biotechnology company, today announced the receipt of a “Disbursement Offer” in the amount of €20 million (approximately $24 million) from the European Investment Bank (EIB). This disbursement – the first of three tranches of funding – reflects that Pluristem has achieved a key milestone in a previously announced €50 million non-dilutive financing agreement. Pursuant to the EIB agreement, Pluristem expects to receive the first tranche of funds during June 2021.
The proceeds of the first tranche will support research and development (R&D) in the European Union to advance Pluristem’s proprietary regenerative cell therapy platform.
The first tranche of €20 million will not be secured and will be payable to the EIB in a single payment five years after the disbursement, with an interest rate of 4%. Following the receipt of the €20 million tranche, Pluristem will have a cash balance of more than $90 million.
Pluristem’s CEO and President, Yaky Yanay, said: “The EIB funding allows Pluristem to execute our operational, clinical and R&D activities to advance our regenerative medicine platform. Europe’s aging population is growing rapidly, and we believe has a clear need for novel treatments for a range of diseases and conditions to improve quality of life. We are committed to leveraging this funding mechanism to strengthen the development of our product candidates to maturation. We are grateful to the EIB for their ongoing support and confidence in our technology.
Pluristem’s key competitive advantages include a state-of-the-art, automated cell expansion technology that draws on 17 years of cell therapy research. Additionally, our in-house manufacturing capabilities enable the production of allogeneic cell product candidates on a mass-scale with batch-to-batch consistency.”
Chen Franco-Yehuda, Pluristem’s CFO, added, “Pluristem has a strong cash balance to accelerate our R&D efforts to bring new regenerative medicines to those in need.
We believe that the EIB financing agreement reflects a creative, non-dilutive form of financing and believe it positions us strongly for the future.”
About the European Investment Bank
The European Investment Bank (EIB) is the long-term lending institution of the European Union, owned by its Member States. It makes long-term finance available for sound investment in order to contribute towards EU policy goals.
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, 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 expected timing and use of proceeds of the first tranche of funds from the EIB, the belief that the funding will allow it to execute it operational, clinical and R&D activities to advance its regenerative medicine platform and that the funds position it strongly for the future.
These forward-looking statements and their implications are based on the current expectations of the management of Pluristem only, and are subject to a number of factors and uncertainties that could cause actual results to differ materially from those described in the forward-looking statements.
The following factors, among others, could cause actual results to differ materially from those described in the forward-looking statements: changes in technology and market requirements; Pluristem may encounter delays or obstacles in launching and/or successfully completing its clinical trials; Pluristem’s products may not be approved by regulatory agencies, Pluristem’s technology may not be validated as it progresses further and its methods may not be accepted by the scientific community; Pluristem may be unable to retain or attract key employees whose knowledge is essential to the development of its products; unforeseen scientific difficulties may develop with Pluristem’s process; Pluristem’s products may wind up being more expensive than it anticipates; results in the laboratory may not translate to equally good results in real clinical settings; results of preclinical studies may not correlate with the results of human clinical trials; Pluristem’s patents may not be sufficient; Pluristem’s products may harm recipients; changes in legislation may adversely impact Pluristem; inability to timely develop and introduce new technologies, products and applications; loss of market share and pressure on pricing resulting from competition, which could cause the actual results or performance of Pluristem to differ materially from those contemplated in such forward-looking statements. Except as otherwise required by law, Pluristem undertakes no obligation to publicly release any revisions to these forward-looking statements to reflect events or circumstances after the date hereof or to reflect the occurrence of unanticipated events.
For a more detailed description of the risks and uncertainties affecting Pluristem, reference is made to Pluristem’s reports filed from time to time with the Securities and Exchange Commission.
Contact:
Dana Rubin
Director of Investor Relations 972-74-7107194
For a full recording of the webcast click here
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HAIFA, Israel, April 29, 2021 – Pluristem Therapeutics Inc. (Nasdaq:PSTI) (TASE: PSTI), a leading regenerative medicine company, today reported positive topline results in its first study to evaluate the safety and exploratory efficacy of PLX-R18 in humans.
The company’s Phase I, open-label, dose-escalation study is evaluating the safety and exploratory efficacy of intramuscular injections of PLX-R18 in subjects with incomplete hematopoietic recovery following Hematopoietic Cell Transplantation (HCT).
Pluristem CEO and President, Yaky Yanay, said, “The promising topline results demonstrate insight into how PLX cells may provide a more effective therapeutic benefit than current technologies.
We believe that PLX-R18 affects the regeneration activity of the hematopoietic cells. By supporting blood cell lineage’s recovery, this approach could be used to address a variety of hematological deficiencies.
We intend to push forward the clinical development of PLX-R18 with the goal of establishing it as the new standard of care in the field.”
Poor graft function is a life-threatening complication for patients undergoing HCT.
Current standard-of-care treatments do not develop satisfactory blood counts in some or all blood cell lineages.
Consequently, patients are vulnerable to bleeding and recurrent infections, and require repeated costly transfusions of blood products, which only provide a short-term effect.
Pluristem’s PLX-R18 aims to improve the standard of care by stimulating the regenerative potential of the bone marrow.
This potentially enhances the production of all three blood cell lineages, differentiating it from other products which target only one of the three blood cell lineages.
The study enrolled 21 patients in the U.S. and Israel, who were at least three months after the HCT procedure (median: 236 days), and had low blood counts in at least one blood cell lineage. They were assigned to one of three treatment arms: 1 million cells/kg, 2 million cells/kg or 4 million cells/kg. Each patient received two treatments of the assigned dose.
The results demonstrate that PLX-R18 has the potential to stimulate the implanted hematopoietic cells to realize their therapeutic potential and generate improved blood counts over the long term in all three blood cell lineages at once – a meaningful advantage over other existing and proposed treatments.
Available data1 at six-month follow-up demonstrates:
The study supports previous preclinical results, conducted via the U.S. Food and Drug Administration’s (FDA) Animal Rule in collaboration with the U.S. National Institutes of Health (NIH), in which PLX-R18 was found effective in treating bone marrow failure from Acute Radiation Syndrome (ARS).
PLX-R18 is the first product candidate manufactured using Pluristem’s proprietary serum-free media on its 3D bioreactor system.
The company will conduct an analyst and investor call on May 3, 2021, at 10am EDT, for registration: https://Veidan.activetrail.biz/pluristem
1 Data from the six-month follow-up is available for 14 of the 21 treated patients: one patient was terminated early, three patients missed the 6-month visit and three died prior to the 6-month visit (two fatal events in the 2 million cell dose, and one fatal event in the 4 million cell dose).
All fatal events in the study were considered unrelated to the study treatment.
Mortality rates were in line with publicly available information (references: Gao et al 2020, , Halahleh et al 2021, Tang et al 2018, Sun et al. 2015, Zhao et al 2019)
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, 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 PLX cells may provide a more effective therapeutic benefit than current technologies, that PLX-R18 may potentially enhance the production of three blood cell lineages, the belief that PLX-R18 affects the regeneration activity of the hematopoietic cells and its intention to push forward with the clinical development of PLX-R18 with the goal of establishing it as the new standard of care in the field.
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
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