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HAIFA, Israel, March 26, 2020 – Pluristem Therapeutics Inc. (Nasdaq:PSTI) (TASE:PSTI), a leading regenerative medicine company developing a platform of novel biological products, today issued an update to its shareholders from its Chief Executive Officer and President, Yaky Yanay.
Dear Fellow Shareholders,
In light of the novel coronavirus pandemic (COVID-19), today we wanted to provide an update on the impact of the coronavirus pandemic on our business and on our ongoing Phase III clinical studies of PLX-PAD in the treatment of Critical Limb Ischemia (CLI), and muscle regeneration following hip fracture, as well as update you on our actions to provide a PLX cell product as a potential treatment for the respiratory and inflammatory complications associated with COVID-19.
In managing our ongoing global clinical trials, as well as our daily operations at our headquarters in Israel, we are taking all necessary precautions for the safety and well-being of patients, healthcare providers involved in our trials, and our employees.
Pluristem continues its operational and manufacturing activities, subject to the directives of the Israeli Ministry of Health, with a dedicated team on site. In addition, Pluristem is using remote work technologies that enable other activities to be conducted without the need for a physical presence in our facilities. Today, and into the foreseeable future, we believe that we are well positioned to operate through the COVID-19 pandemic. Our allogenic, off-the-shelf approach and our advanced manufacturing capabilities enabled us to complete the manufacturing of the entire stock needed to complete all of our current clinical studies. We currently hold supplies of PLX cells in inventory in Israel, and in secure storage facilities in Europe and the U.S.
With regard to our operational business, while we are preparing for the potential ramp up in production to supply PLX-PAD cells for the potential treatment of COVID-19 complications, we have rapidly implemented a significant cost reduction plan. Our goal is to make sure that we will be able to operate through any unforeseen or foreseen scenario, and I am glad to say that the company’s stakeholders, including employees and suppliers, are fully cooperating with our request and have agreed to our significant cost reduction plan. Until we have better clarity on the global impact of COVID-19, we have applied a cost saving plan relating to employee compensation which includes a 50% reduction in compensation for C-level executives and our management team, and a gradual reduction of between 20% to 50% for all employees according to managerial level, with non-management employees having the lowest reduction. I would like to say that the past few days have shown me once again how committed the Pluristem team is to the success of our company. I feel proud and blessed to lead such a talented and committed team and I would like to thank each and every one of them for their loyalty and dedication.
While we continue to enroll and treat patients in our two ongoing pivotal Phase III studies of our PLX-PAD product candidate for the treatment of CLI and muscle regeneration following hip fracture, we do so within the new guidelines provided by the U.S. Food and Drug Administration’s (FDA), “FDA Guidance on Conduct of Clinical Trials of Medical Products during COVID-19 Pandemic”, issued on March 18, 2020, and the European Medicines Agency’s (EMA) “Guidance on the Management of Clinical Trials during the COVID-19 (Coronavirus) pandemic” issued on March 20, 2020. In Israel, our clinical studies are subject to the directives of the Israeli Ministry of Health.
As of today, we have enrolled over 80% of the patients in our pivotal Phase III CLI trial, and close to 60% in our Phase III study of muscle regeneration following hip fracture. While we continue enrollment in both studies, from what we have seen in the last few weeks, we believe it is reasonable to expect a certain slowdown in the enrollment rate, as it is our commitment and obligation to ensure the safety and health of our patients and medical team.
We are currently evaluating the impact of COVID-19 on the original timelines for our interim analysis and full study readouts and will continue to provide updates on our progress in our future quarterly reports.
In the last few months, we have been holding discussions with the FDA and EMA in order to confirm and agree on the changes in the parameters and final protocol design of the interim analysis of the CLI clinical data, which may lead to conditional marketing approval in Europe.
I expect to be able to update you on those understandings in the coming weeks.
For patients participating in our studies, patient safety remains our top priority. We are working closely with the clinical trial sites and evaluating options and adjustments.
In the next few days, we expect the clinical trial sites will publish guidelines for continuing to conduct these studies during this pandemic.
I wish you all good health.
Pluristem is fully committed to the global drive towards developing and delivering healthcare products to potentially treat severe pneumonia resulting from COVID-19.
Towards this end, we are collaborating with the BIH Center for Regenerative Therapy (BCRT) and the Berlin Center for Advanced Therapies (BeCAT) at Charité University of Medicine to evaluate the therapeutic effects of our PLX cell product candidates for the treatment of the respiratory and inflammatory complications associated with COVID-19. We also received the Israeli Ministry of Health’s clearance to seek approvals to treat COVID-19 patients under a per-patient compassionate use framework in Israel.
Currently, our main effort is to initiate treatment of patients as soon as possible.
We are now holding discussions with regulators to define our clinical strategy for COVID-19, while we start with compassionate use programs in order to provide the product immediately to patients.
We are targeting a potential full development plan in the U.S., Europe and Israel with the goal of supporting global healthcare systems’ tremendous effort to fight off COVID-19 and bring life back to normal.
Pluristem is a strong company, and I believe we are well prepared for the challenges and opportunities we face with the COVID-19 situation.
Pluristem is committing and harnessing all of its knowledge, experience and dedication to be part of the global solution for this pandemic.
Our team is passionate about improving the wellbeing of patients and we believe that our regenerative medicine product candidate is ideally suited to today’s healthcare challenges. I thank you all for your support and loyalty to Pluristem and I wish you and your families good health.
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 belief that it is well positioned to operate through the COVID-19 pandemic, with ample supplies of PLX cells in inventory in Israel, and in secure storage facilities in Europe and the U.S., that it is preparing for the potential ramp up in production to supply PLX-PAD cells for the potential treatment of COVID-19 complications, its belief that it is reasonable to expect a slowdown in the enrollment rate of its clinical studies, its expectation to provide updates with respect to its original timelines for its interim analysis and full study readouts in its future quarterly reports as well as its discussions with the FDA and EMA regarding changes in the parameters and final protocol design of the interim analysis of the CLI clinical data which may lead to conditional marketing approval in Europe, that it is targeting a potential full development plan in the U.S. and Europe with the goal of supporting global healthcare systems’ tremendous effort to fight off COVID-19 and its belief that its regenerative medicine product candidate is ideally suited to today’s healthcare challenges.
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, March 17, 2020 – Pluristem Therapeutics Inc. (Nasdaq:PSTI) (TASE:PSTI), a leading regenerative medicine company developing a platform of novel biological products, today announced that the Israeli Ministry of Health has approved Pluristem’s request to seek approvals to treat COVID-19 coronavirus patients under the per-patient compassionate use framework in Israel. The Israeli Ministry of Health may approve proposed treatments on a per-patient basis for the use of PLX cell therapy including intra-muscular (IM) administration of PLX-PAD for the proposed treatment of severe pneumonia resulting from COVID-19 and preventing the deterioration of patients towards Acute Respiratory Distress Syndrome (ARDS) and sepsis. Pluristem has not yet submitted any such request for treatment of a specific COVID-19 patient, and there is no assurance that any such request will be approved by Israeli Ministry of Health.
Pluristem recently announced a collaborative agreement with the BIH Center for Regenerative Therapy (BCRT) and the Berlin Center for Advanced Therapies (BeCAT) at Charité University of Medicine Berlin to evaluate the therapeutic effects of PLX cell product candidates for the potential treatment of the respiratory and inflammatory complications associated with the COVID-19 coronavirus.
“Pluristem is highly committed to use its technology, knowledge and expertise in order to attempt to provide a better outcome to patients infected by complications associated with COVID-19. We hope and believe that the ease of use of our PLX cell product candidates, and their being readily available, may play an important role in case there is a need to treat large numbers of patients with respiratory complications.
Our collaborative research with Charité of Berlin on our PLX COVID-19 program enables us to accelerate the implementation of our cell therapies candidates towards this indication, as we continue our efforts to expand the program to additional countries,” stated Pluristem President and CEO Yaky Yanay.
PLX cells are available off-the-shelf and once commercialized, can be manufactured in large scale quantities, offering a key advantage in addressing a global pandemic.
PLX cells are allogeneic mesenchymal-like cells that have immunomodulatory properties that induce the immune system’s natural regulatory T cells and M2 macrophages, and thus may prevent or reverse the dangerous overactivation of the immune system.
Accordingly, PLX cells may potentially reduce the incidence and\or severity of COVID-19 pneumonia and pneumonitis leading hopefully to a better prognosis for the patients.
Previous pre-clinical findings of PLX cells revealed therapeutic benefit in animal studies of pulmonary hypertension, lung fibrosis, acute kidney injury and gastrointestinal injury which are potential complications of the severe COVID-19 infection.
Clinical data using PLX cells demonstrated the strong immunomodulatory potency of PLX cells in patients post major surgery.
Taken together, PLX cells’ potential capabilities with the safety profile observed from clinical trials involving hundreds of patients worldwide potentially position them as a therapy for mitigating the tissue-damaging effects of COVID-19.
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 use of its PLX cell product candidates for the proposed treatment of severe pneumonia resulting from COVID-19 and preventing the deterioration of patients towards ARDS, sepsis and death, its commitment to use its technology, knowledge and expertise in order to attempt to provide a better outcome to patients afflicted by complications associated with COVID-19, its hope and belief that the ease of use of its PLX cell product candidates and their being readily available, may play an important role in case there is a need to treat large numbers of patients with respiratory complications, that its collaborative research with Charité of Berlin on the PLX COVID-19 program enables Pluristem to accelerate the implementation of its cell therapies candidates towards this indication, its intention to continue efforts to expand its PLX COVID-19 program to additional countries, the belief that PLX cells being available off-the-shelf and can be manufactured in large scale quantities, may offer a potential key advantage in addressing a global pandemic and the belief that PLX cells may potentially reduce the incidence and\or severity of COVID-19 induced pneumonia and pneumonitis.
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, March 12, 2020 – Pluristem Therapeutics Inc. (Nasdaq:PSTI) (TASE:PSTI), a leading regenerative medicine company developing a platform of novel biological products, today announced it has signed a collaborative agreement with the BIH Center for Regenerative Therapy (BCRT) and the Berlin Center for Advanced Therapies (BeCAT) at Charite’ University of Medicine Berlin to expand its existing framework and research agreement and conduct a joint project evaluating the therapeutic effects of Pluristem’s patented PLX cell product candidates for potential treatment of the respiratory and inflammatory complications associated with the COVID-19 coronavirus.
PLX cells are allogeneic mesenchymal-like cells that have immunomodulatory properties that induce the immune system’s natural regulatory T cells and M2 macrophages, and thus may prevent or reverse the dangerous overactivation of the immune system.
Accordingly, PLX cells may potentially reduce the fatal symptoms of COVID-19 induced pneumonia and pneumonitis. Previous pre-clinical findings of PLX cells revealed significant therapeutic effects in animal studies of pulmonary hypertension, lung fibrosis, acute kidney injury and gastrointestinal injury which are potential complications of the severe COVID-19 infection.
Clinical data using PLX cells demonstrated the strong immunomodulatory potency of PLX cells in patients post major surgery.
Taken together, PLX cells’ potential capabilities with the safety profile observed from clinical trials involving hundreds of patients worldwide potentially position them as a therapy for mitigating the tissue-damaging effects of COVID-19.
“The collaboration with Charité researchers will allow us to expedite our program to potentially enable the use of PLX cells to treat patients infected with COVID-19 that have respiratory and immunological complications.
The fact that PLX is available off-the-shelf, combined with our ability to manufacture large scale quantities, is a key advantage in case a large number of patients may need respiratory support. The primary target is to prevent the deterioration of patients towards Acute Respiratory Distress Syndrome (ARDS) and sepsis.
We intend to start the joint collaboration immediately, with an aim to bringing much needed treatment to a rapidly expanding global health threat,” stated Yaky Yanay, Pluristem President and CEO.
Prof. Hans-Dieter Volk, Director of the BCRT at Charite’ University Medicine Berlin, commented, “Through our long-term collaboration with Pluristem, we have a thorough understanding of PLX cells and their mechanism of action. Charite’s’ unique knowledge, which includes research and
clinical expertise in the immunopathogenesis of viral infections and critically ill patients, provides us an accelerated framework in which we believe PLX cells can be explored as a potential therapy for patients infected with COVID-19.”
The BIH Center for Regenerative Therapies (BCRT) is a cooperative translational research institution of the Charité University Hospital in Berlin and the Berlin Institute of Health (BIH). The mission of the BCRT is to develop a translational platform for Regenerative Therapies from bench- to-bedside.
The clinical platforms — Immune, muskuloskleletal, and cardiovascular system — are cross-linked by cross-field clinical fields (cachexia/sarcopenia, genetic diseases) and technology and translation support platforms.
There are extended experiences in clinical trials with cell therapy, including phase 1-3 trials with PLX cells.
The Berlin Center for Advanced Therapies is a spin-off of the BCRT focusing on translation of cell and gene therapies in the major research fields of regenerative medicine and cancer.
It consists of four research fields (endogenous regeneration, tissue engineering, anti-cancer immunotherapy, and rare diseases) and three technology platforms (manufacturing, product characteristics and biomarker, and clinical development and regulatory affairs.
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 expanding its collaborative agreement with the BCRT to conduct a joint project evaluating the therapeutic effects of Pluristem’s patented PLX cells product candidates for potential treatment of the respiratory and inflammatory complications associated with COVID-19, and the timing thereof, the potential of PLX cells in preventing or reversing the dangerous overactivation of the immune system, that PLX cells may potentially reduce the fatal symptoms of COVID-19 induced pneumonia and pneumonitis, and PLX cells’ position as a therapy for mitigating the tissue-damaging effects of COVID-19.
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, March 3, 2020 – Pluristem Therapeutics Inc. (Nasdaq:PSTI) (TASE:PSTI), a leading regenerative medicine company developing a platform of novel biological products, today announced it received a response to the proposal it submitted to the U.S. Biomedical Advanced Research and Development Authority (BARDA) for funding a study designed to demonstrate the superiority of PLX-R18 therapy versus current standard of care in the treatment of Acute Radiation Syndrome (ARS). At this time, BARDA has chosen not to move forward with the funding of the current proposal. The decision is based on BARDA’s technical considerations as determined by a Technical Evaluation Panel.
Other factors considered by BARDA included BARDA’s current strategic needs, availability of funds and resources, and an aim to balance BARDA’s current portfolio. In its response, BARDA encouraged and invited Pluristem to participate in future relevant BARDA opportunities.
“While we had hoped to receive the funding of the proposal, we understand that at this time there are a set of parameters that led BARDA to this decision.
We will continue to advance our current ARS projects with the U.S. National Institute of Allergy and Infectious Diseases (NIAID), U.S. Department of Defense (DOD), Fukushima Hospital and the University in Japan and pursue additional opportunities and collaborations in this area.
We believe that Pluristem’s extensive platform technology can address a broad range of medical conditions and we plan to continue the future development of PLX-R18’s pipeline in hematological indications, including our ongoing clinical development in incomplete hematopoietic recovery following hematopoietic cell transplants, for which PLX-R18 received the U.S. Food and Drug Administration’s (FDA) Orphan Drug Designation.
Pluristem has several significant milestones coming ahead and we intend to present these developments in the next few months,” said Yaky Yanay, Pluristem President and CEO.
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 belief that its extensive platform technology can address a broad range of medical conditions and that it plans to continue the future development of PLX-R18’s pipeline in hematological indications, its intent to continue to advance its current ARS projects with the U.S. NIAID, DOD Fukushima Hospital and the University of Japan, and pursue additional opportunities and collaborations in this area, and its intention to present updates to several significant milestones in the next few months.
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, 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
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