EXPECTED ONLINE SIGNING CEREMONY ON APRIL 30, 2020
HAIFA, Israel, April 24, 2020 – Pluristem Therapeutics Inc. (Nasdaq:PSTI) (TASE:PSTI), a leading regenerative medicine company developing a platform of novel biological therapeutic products, announced today that the European Investment Bank (“EIB”) has approved a €50 million non- dilutive financing for the Company (the “Approved Financing”). This Approved Financing, once received, will support Pluristem’s research and development in the EU to further advance its regenerative cell therapy platform, and to assist moving the products in its pipeline to market, with a special focus on clinical development of PLX cells as a treatment for complications associated with COVID-19. The Approved Financing will be deployed in three tranches, subject to the achievement of certain clinical, regulatory and scaling up milestones, with the first tranche consisting of €20 million. The expected signing date of the financing agreement relating to the Approved Financing is April 30, 2020.
Pluristem recently formed a wholly-owned subsidiary in Berlin, Germany, underscoring the Company’s commitment to having a physical presence in Europe to advance research and development, and to prepare for commercialization, for its product candidates.
The Approved Financing is backed by a guarantee from the European Fund for Strategic Investments (EFSI), the financial pillar of the Investment Plan for Europe, under which the EIB and the European Commission are working together as strategic partners to boost Europe’s economic competitiveness. The transaction has been initiated by kENUP Foundation, a global partnership in innovation, promoting research-based innovation for Europe with public and societal benefit.
The Approved Financing, once granted, will not be secured and will be payable to the EIB in a single payment following five years from the disbursement of the first and second tranches and in two annual payments starting on the fourth year from disbursement of the third tranche, with each tranche having an interest rate of between 3% to 4%. The Approved Financing will support up to 50% of Pluristem’s R&D project cost. In addition, the EIB would be entitled to receive royalties from future revenues for a period of seven years starting 2024, at a rate of 0.2% to 2.3%, pro-rated to the amounts that the Company received from the Approved Financing.
“We are extremely honored to have been selected by the EIB for this prestigious financing. We believe that this financing will allow us to significantly advance the clinical development of our lead product candidates, which if successful we expect will improve the quality of life for millions of patients around the world. Having established research partnerships with leading European institutions such as Charité University of Medicine Berlin, BIH Center for Regenerative Therapy (BCRT) and the Berlin Center for Advanced Therapies (BeCAT), as well as formed a subsidiary in Berlin, we understand the importance of having a physical presence in key markets,” stated Pluristem CEO and President, Yaky Yanay. “As we move forward into a multinational clinical trial for PLX cells to treat patients suffering from complications associated with COVID-19, we expect this EIB financing will accelerate our path to approval and to making a potentially effective COVID- 19 treatment available worldwide.”
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.
The Investment Plan for Europe (the Juncker Plan) is one of the EU’s key actions to boost investment in Europe, thereby creating jobs and fostering growth.
To this end, smarter use will be made of new and existing financial resources. The EIB Group, consisting of the European Investment Bank and the European Investment Fund, is playing a vital role in this investment plan.
With guarantees from the European Fund for Strategic Investments (EFSI), the EIB and EIF are able to take on a higher share of project risk, encouraging private investors to participate in the projects.
In addition to EFSI, the new European Investment Advisory Hub (EIAH) helps public and private sector project promoters to structure investment projects more professionally. The projects and agreements approved under EFSI (European Fund for Strategic Investments) so far are expected to mobilise almost €466 billion of investments and will benefit over 1 million start- ups and SMEs (Small Medium Enterprises) in the 27 Member States.
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 expectation that it will execute a definitive agreement for the Approved Financing and the proposed terms of such Approved Financing, the belief that the Approved Financing will support its research and development in the EU to further advance its regenerative cell therapy platform, to assist moving the products in its pipeline to market, with a special focus on clinical development of PLX cells as a treatment for complications associated with COVID-19, that such Approved Financing will allow it to significantly advance its clinical development of its lead product candidates which it expects will improve the quality of life for millions of patients around the world and the expectation that the Approved Financing will accelerate its path to approval of its COVID-19 multinational clinical trial and to making a potentially effective COVID-19 treatment available worldwide.
While the EIB has announced the approval of the Approved Financing, there is no guarantee that the Company and the EIB will execute the definitive agreement on April 30, 2020, if at all, or that it will achieve the milestones necessary to receive any or all of the three tranches.
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, April 13, 2020 – Pluristem Therapeutics Inc. (Nasdaq:PSTI) (TASE:PSTI), a leading regenerative medicine company developing a platform of novel biological therapeutic products, announced today that it has treated its first patient suffering from COVID-19 complications in the United States under the U.S. Food and Drug Administration’s (FDA) Single Patient Expanded Access Program, also called a compassionate use program, which is part of the U.S. Coronavirus Treatment Acceleration Program (CTAP), an emergency program for possible therapies that uses every available method to move new treatments to patients as quickly as possible.
The patient was treated with PLX cell therapy at Holy Name Medical Center in New Jersey, an acute care facility that is currently an active site for Pluristem’s Phase III critical limb ischemia (CLI) study. Prior to treatment with PLX, the patient was critically ill with respiratory failure due to acute respiratory distress syndrome (ARDS) and was under mechanical ventilation in an intensive care unit (ICU) for three weeks.
“We are receiving many inquiries and requests for treatment from healthcare providers and families worldwide. In parallel with our planned clinical trial, we expect to continue treating patients under compassionate use through the appropriate regulatory clearances in the United States and Israel, as well as expanding treatment under compassionate use in other countries. Our main focus remains however, the initiation of a multinational clinical study,” stated Pluristem CEO and President Yaky Yanay.
Pluristem’s main target is to initiate a multinational clinical trial as soon as possible for PLX cells in the treatment of patients suffering from complications associated with COVID-19. As the Company focus is the initiation of such clinical trial, it does not intend to provide further updates on the status of patients treated under compassionate use. Pluristem will update on the status and progress of its planned COVID-19 clinical trial program.
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 its expectation that it will continue treating patients under compassionate use through the appropriate regulatory clearances in the United States and Israel, that it expects to expand treatment under compassionate use in other countries, that Pluristem’s main target is to initiate a multinational clinical trial as soon as possible for PLX cells in the treatment of patients suffering from complications associated with COVID-19, its intention not to provide further updates on the status of COVID-19 patients treated under compassionate use, when it discusses updating on the status and progress of its contemplated clinical trial program, when it discusses 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, April 7, 2020 – Pluristem Therapeutics Inc. (Nasdaq:PSTI) (TASE:PSTI), a leading regenerative medicine company developing a platform of novel biological therapeutic products, announced today preliminary data from its compassionate use program, treating seven patients suffering from acute respiratory failure and inflammatory complications associated with COVID-19 with Pluristem’s PLX cells, in three medical centers in Israel.
All seven patients approved for treatment under compassionate use program with PLX cells exhibited, prior to treatment, respiratory failure due to ARDS, which is a major cause of mortality and required mechanical ventilation in an ICU. Four of the patients also demonstrated failure of other organ systems, including cardiovascular and kidney failure, indicating critical disease and poor prognosis.
Six of the seven patients have completed the seven day follow up period (“Group A”). The seventh patient has not yet completed seven day follow up.
As a next step, the Company plans to apply for initiation of a multinational regulated clinical trial program for the potential use of PLX cells in the treatment of patients suffering from complications associated with COVID-19. In this regard, while Pluristem expects to continue treating patients for complications associated with COVID-19 under the compassionate use program in Israel, Pluristem does not intend to provide further updates on the status of this program and rather update on the status and progress of its contemplated clinical trial program.
“We are pleased with this initial outcome of the compassionate use program, and committed to harnessing PLX cells for the benefit of patients and healthcare systems. In order to maximize PLX cells’ impact on patient recovery and to work towards making our treatment widely available, we plan to quickly move forward into a clinical development program. Pluristem is dedicated to using its competitive advantages in large-scale manufacturing to potentially deliver PLX cells to a large number of patients in significant need. We believe that research and governmental funding may be available to Pluristem to support the use of PLX cells for patients suffering from COVID- 19 and are targeting such funding,” stated Pluristem CEO and President, Yaky Yanay.
PLX Cells for COVID-19
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.
About Pluristem Therapeutics
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.
Safe Harbor Statement
This press release contains express or implied forward-looking statements within the Private Securities Litigation Reform Act of 1995 and other U.S. Federal securities laws.
For example, Pluristem is using forward-looking statements when it discusses the interim results from the use of PLX cells on certain patients suffering from COVID-19, its expectation to continue treating patients for complications associated with for COVID-19 under the compassionate use program in Israel and its intention not to provide further updates on the status of this program and rather update on the status and progress of its contemplated clinical trial program, its plans to apply for initiation of a multinational clinical trial in order to maximize PLX cells’ impact on patient recovery and to work towards making its treatment widely available, its dedication to using its competitive advantages in large-scale manufacturing to potentially deliver PLX cells to a large number of patients in significant need, its belief that research and governmental funding may be available to it to support its PLX cells for COVID-19 patients and its intent to target such funding, 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.
Contact:
Dana Rubin
Director of Investor Relations 972-74-7107194
HAIFA, Israel, March 30, 2020 – Pluristem Therapeutics Inc. (Nasdaq:PSTI) (TASE:PSTI), a leading regenerative medicine company developing a platform of novel biological therapeutic products, announced today that since its last update on COVID-19, it has dosed three patients in two different hospitals in Israel under a compassionate use program for the treatment of COVID-19, as approved by the Israeli Ministry of Health. Pluristem expects to enroll additional patients in Israel in the coming days and anticipates providing updates on clinical outcomes once significant data has been gathered.
All three treated patients are in a high-risk group based on age and preexisting conditions, have been experiencing severe respiratory failure, and intubation with a ventilator. Pluristem is closely following the medical condition of these patients in conjunction with the hospitals’ medical professionals delivering the care.
Pluristem is prepared for immediate ramp-up of PLX cell production with consistent batch-to- batch cell production quality through its GMP certified manufacturing facilities in order to meet potential demand.
“In this time of emergency, we are honored to be taking part in the global effort to support patients and healthcare systems.
We watch with great admiration the endless efforts of the outstanding medical teams at the hospitals, and we would like to thank them for their collaboration and support.
It is our hope that our mutual desire to help patients will result in improved outcomes for those hard hit by the life threating complications of COVID-19,” stated Pluristem CEO and President, Yaky Yanay. “In addition to our current activity in Israel, we are in discussions with regulators in the U.S and Europe to define our clinical strategy for COVID-19. Pluristems’ advanced manufacturing capabilities enable us to serve potential need of treating large numbers of patients under compassionate use and clinical studies across numerous countries and hospitals in accordance with our expansion program and regulatory approvals.
We are facing a very different global condition right now, and the entire Pluristem team is committed to being an important part of the solution.”
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.
The potential therapeutic effects of PLX cells for the treatment of respiratory and inflammatory complications associated with the COVID-19 are currently being studied through a collaborative agreement between Pluristem and the BIH Center for Regenerative Therapy (BCRT) and the Berlin Center for Advanced Therapies (BeCAT) at Charite’ University of Medicine Berlin.
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 expectation to enroll additional patients in Israel in the coming days and anticipation of providing updates on clinical outcomes once significant data has been gathered, or when it discusses preparation for immediate ramp-up of PLX cell production with consistent batch-to-batch cell production quality through its manufacturing facilities in order to meet potential demand, or when it discusses that its advanced manufacturing capabilities enable it to serve potential need of treating large numbers of patients under compassionate use and clinical studies across numerous countries and hospitals in accordance with its expansion program and regulatory approvals, when it discusses the benefits and potential therapeutic effects of PLX cells that they may prevent or reverse the dangerous overactivation of the immune system, that they may potentially reduce the incidence and\or severity of COVID-19 pneumonia and pneumonitis leading hopefully to a better prognosis for the patients or that PLX cells’ potential capabilities with the safety profile observed from clinical trials potentially position them 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 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
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