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number of required transfusions
R18 versus current standards of care, with the goal of executing a full contract once the study is completed”
HAIFA, Israel, September 16, 2019 – Pluristem Therapeutics Inc. (Nasdaq:PSTI) (TASE:PSTI), a leading regenerative medicine company developing novel placenta-based cell therapy products, today provided a recap of the Key Opinion Leader call hosted by the company this morning to review unmet medical needs in acute radiation syndrome (ARS) and hematological deficiencies, and to provide an update on the development of its novel cell therapy treatment, PLX-R18. PLX cell therapy was granted an Orphan Drug Designation by the U.S. Food and Drug Administration (FDA) for the treatment of ARS and incomplete hematopoietic recovery following hematopoietic cell transplantation (HCT).
An overview of HCT was provided by Dr. Jacob M. Rowe, MD, Chief of the Department of Hematology and The Ann and Pinky Sohn Chair in Hemato-Oncology at the Shaare Zedek Medical Center in Jerusalem and Emeritus Professor at the Technion, Israel Institute of Technology in Haifa, a member in the company’s ongoing hematology program steering committee. Dr. Rowe reviewed the medical condition of HCT and the unmet need for the significant proportion of patients that do not respond to current treatments. Dr. Rowe then discussed Pluristem’s ongoing Phase I study of PLX-R18 and data from the first two cohorts:
“Results from the first two cohorts in this study demonstrate that PLX-R18 is safe and well tolerated, with no unexpected toxicities,” said Dr. Rowe. “While the study’s primary endpoint was safety, we can’t disregard the potential benefits of this cell therapy drug, which even in the lower doses appears to regenerate damaged bone marrow, leading to increased production of platelets and red blood cells, ultimately reducing the number of required transfusions, although caution is appropriate in discussing early data with a small number of patients. Importantly, we see these positive benefits sustained at the nine months follow-up period, and we continue to monitor these patients. We look forward to results from Cohort 3, in which patients will be administered four million cells per kilogram, as we work to efficiently advance PLX-R18 as a candidate in additional bone marrow deficiency syndromes with similar unmet needs.”
The next presentation was delivered by Bert W. Maidment, Ph.D., who served as Assistant Director, Radiation Nuclear Countermeasures Program at the National Institutes of Health, National Institute of Allergy and Infectious Diseases, Division of Allergy, Immunology, and Transplantation (NIH/NIAID/DAIT) until retiring in 2016. Dr. Maidment discussed the health impact of radiation exposure and the need for more effective countermeasures. “There is a broad range of devastating health consequences resulting from radiation exposure, with hematopoietic, gastrointestinal, cardiovascular and central nervous systems all potentially impacted,” noted Dr. Maidment. “Notwithstanding several FDA-approved countermeasures, including Neupogen®, Neulasta® and Leukine®, significant treatment gaps remain, causing widespread manifestations across vital organ systems. I believe that a more efficacious countermeasure that can be administered pre- and post-exposure, particularly one that is easily stored and administered and potentially support multiple organ injuries, would have significant utility across a number of civilian and military applications where radiation exposure is a potential risk.”
Pluristem management provided an overview of the company’s acute radiation syndrome (ARS) projects that are running with several governments and agencies, including the U.S. National Institutes of Health (NIH), testing PLX-R18 as a potential treatment for ARS, the U.S. Department of Defense (DOD) testing the product as a potential prophylactic countermeasure against ARS and Fukushima University in Japan examining PLX-R18 cells for the treatment of hematological ARS and gastrointestinal (GI). Arik Eisenkraft, Director of Homeland Defense Projects at Pluristem and former Head of Chemical, Biological, Radiological and Nuclear Defense (CBRN) Protection Division in the Israeli Ministry of Defense, summarized PLX-R18’s potential to stimulate the regeneration of damaged bone marrow to produce blood cells while also increasing survival and benefiting additional body systems, suggesting that PLX-R18 has the ability to treat ARS as a multi-organ therapy.
Yaky Yanay, Chief Executive Officer of Pluristem, concluded the call with an update on the status of current projects and provided an overview of next steps. “I would like to thank Drs. Rowe and Maidment for offering their perspectives on these difficult-to-treat hematological conditions. We look forward to advancing our ARS program to complete the development and registration of PLX-R18 for ARS, targeting governmental purchase contracts.
We remain committed to completing our ongoing Phase I study of PLX-R18 in incomplete hematopoietic recovery following HCT as quickly as possible and will seek to expand PLX-R18 for use with respect to
additional medical conditions with the goal of bringing innovative, safe and effective treatments for patients with a variety of bone marrow deficiency indications.”
Pluristem Therapeutics Inc. is a leading regenerative medicine company developing novel placenta-based cell therapy product candidates.
The Company has reported robust clinical trial data in multiple indications for its patented PLX cell product candidates and is currently conducting late stage clinical trials in several indications.
PLX cell product candidates are believed to release a range of therapeutic proteins in response to inflammation, ischemia, muscle trauma, hematological disorders and radiation damage.
The cells are grown using the Company’s proprietary three-dimensional expansion technology and can be administered to patients off-the-shelf, without tissue matching. Pluristem has a strong intellectual property position; a Company-owned and operated GMP-certified manufacturing and research facility; strategic relationships with major research institutions; and a seasoned management team.
This press release contains express or implied forward-looking statements within the Private Securities Litigation Reform Act of 1995 and other U.S. Federal securities laws.
For example, Pluristem is using forward-looking statements when it discusses the potential benefits of PLX-R18 as identified in the study, the potential use of PLX-R18 in civilian and military applications where radiation exposure is a potential risk, that PLX-R18 has the ability to treat ARS as a multi-organ therapy, the advancement of its ARS program to ultimately target governmental purchase contracts, its progress with respect to small and large animal studies in relevant DoD models, as required by the FDA animal rule pathway, its aim to submit a proposal by the end of September with respect to BARDA, with the hopes of commencing a study designed to demonstrate the superiority of PLX-R18 in the treatment of ARS versus current standards of care and with the goal of executing a full contract once the study is completed and its aim to expand the focus of PLX-R18 to additional medical conditions with the goal of bringing innovative, safe and effective treatments for patients with a variety of bone marrow deficiency indications.
These forward-looking statements and their implications are based on the current expectations of the management of Pluristem only, and are subject to a number of factors and uncertainties that could cause actual results to differ materially from those described in the forward-looking statements.
The following factors, among others, could cause actual results to differ materially from those described in the forward-looking statements: changes in technology and market requirements; Pluristem may encounter delays or obstacles in launching and/or successfully completing its clinical trials; Pluristem’s products may not be approved by regulatory agencies, Pluristem’s technology may not be validated as it progresses further and its methods may not be accepted by the scientific community; Pluristem may be unable to retain or attract key employees whose knowledge is essential to the development of its products; unforeseen scientific difficulties may develop with Pluristem’s process; Pluristem’s products may wind up being more expensive than it anticipates; results in the laboratory may not translate to equally good results in real clinical settings; results of preclinical studies may not correlate with the results of human clinical trials; Pluristem’s patents may not be sufficient; Pluristem’s products may harm recipients; changes in legislation may adversely impact Pluristem; inability to timely develop and introduce new technologies, products and applications; loss of market share and pressure on pricing resulting from competition, which could cause the actual results or performance of Pluristem to differ materially from those contemplated in such forward-looking statements.
Except as otherwise required by law, Pluristem undertakes no obligation to publicly release any revisions to these forward-looking statements to reflect events or circumstances after the date hereof or to reflect the occurrence of unanticipated events.
For a more detailed description of the risks and uncertainties affecting Pluristem, reference is made to Pluristem’s reports filed from time to time with the Securities and Exchange Commission.
Contact:
Efrat Kaduri
Director of Business, Investor and Public Relations 972-74-7108600
Data readout from second cohort of hematological study will be presented Call scheduled for Monday, September 16 at 10:00am ET
HAIFA, Israel, September 9, 2019 — Pluristem Therapeutics (PSTI), a leading regenerative medicine company developing novel placenta-based cell therapy products, today announced additional information relating to its live Key Opinion Leader (KOL) call regarding its hematological programs on September 16, 2019.
The call will feature presentations by Jacob M. Rowe, MD and Bert. W. Maidment, Ph.D, and will include discussions regarding the findings from Pluristem’s ongoing clinical study in hematological deficiencies, as well as opportunities and future product development. In addition, Pluristem’s management will review the status of the company’s radiation programs with the U.S government, including an overview of recent Department of Defense (DoD) data, potential markets and expected milestones.
Jacob M. Rowe, MD is chief of the Department of Hematology and The Ann and Pinky Sohn Chair in Hemato-Oncology at the Shaare Zedek Medical Center in Jerusalem, and Emeritus Professor at the Technion, Israel Institute of Technology in Haifa. Dr. Rowe has actively participated in a wide range of national and international research projects and initiatives. He is a former chairman of the Leukemia Committee of the Eastern Cooperative Oncology Group (ECOG) and has developed and chaired many Phase II and III studies on leukemia, lymphoma, and bone marrow transplantation. Dr. Rowe is also an Adjunct Professor at the Department of Medicine of Northwestern University, Chicago, IL. He has received many prestigious awards, including an honorary doctorate from the University of Gothenburg in Sweden, has published over 500 peer- reviewed articles, reviews and book chapters and is a frequent invited speaker or chairman at international meetings.
Bert. W. Maidment, Ph.D., is the Executive Consultant and former Associate Director for Radiation Countermeasures Research and Emergency Preparedness at the National Institutes of Health, NIAID/DAIT/Radiation Nuclear Countermeasures Program.
Monday, September 16th at 10am Eastern/7am Pacific
Domestic: 800-479-1004
International: 1-323-794-2597
Conference ID: 4428235
Webcast: http://bit.ly/2k7qkMQ
For those who are unable to listen at this time, a replay of the call will be available by clicking here.
Pluristem Therapeutics Inc. is a leading regenerative medicine company developing novel placenta-based cell therapy product candidates.
The Company has reported robust clinical trial data in multiple indications for its patented PLX cell product candidates and is currently conducting late stage clinical trials in several indications.
PLX cell product candidates are believed to release a range of therapeutic proteins in response to inflammation, ischemia, muscle trauma, hematological disorders and radiation damage.
The cells are grown using the Company’s proprietary three-dimensional expansion technology and can be administered to patients off- the-shelf, without tissue matching. Pluristem has a strong intellectual property position; a Company-owned and operated GMP-certified manufacturing and research facility; strategic relationships with major research institutions; and a seasoned management team.
This press release contains express or implied forward-looking statements within the Private Securities Litigation Reform Act of 1995 and other U.S. Federal securities laws.
For example, Pluristem is using forward-looking statements when it discusses the topics that will be discussed on the KOL call.
These forward-looking statements and their implications are based on the current expectations of the management of Pluristem only, and are subject to a number of factors and uncertainties that could cause actual results to differ materially from those described in the forward-looking statements.
The following factors, among others, could cause actual results to differ materially from those described in the forward-looking statements: changes in technology and market requirements; Pluristem may encounter delays or obstacles in launching and/or successfully completing its clinical trials; Pluristem’s products may not be approved by regulatory agencies, Pluristem’s technology may not be validated as it progresses further and its methods may not be accepted by the scientific community; Pluristem may be unable to retain or attract key employees whose knowledge is essential to the development of its products; unforeseen scientific difficulties may develop with Pluristem’s process; Pluristem’s products may wind up being more expensive than it anticipates; results in the laboratory may not translate to equally good results in real clinical settings; results of preclinical studies may not correlate with the results of human clinical trials; Pluristem’s patents may not be sufficient; Pluristem’s products may harm recipients; changes in legislation may adversely impact Pluristem; inability to timely develop and introduce new technologies, products and applications; loss of market share and pressure on pricing resulting from competition, which could cause the actual results or performance of Pluristem to differ materially from those contemplated in such forward-looking statements.
Except as otherwise required by law, Pluristem undertakes no obligation to publicly release any revisions to these forward-looking statements to reflect events or circumstances after the date hereof or to reflect the occurrence of unanticipated events.
For a more detailed description of the risks and uncertainties affecting Pluristem, reference is made to Pluristem’s reports filed from time to time with the Securities and Exchange Commission.
Efrat Kaduri
Director of Business, Investor and Public Relations 972-74-7108600
HAIFA, Israel, August 21, 2019 – Pluristem Therapeutics Inc. (Nasdaq:PSTI) (TASE:PSTI), a leading regenerative medicine company developing novel placenta-based cell therapy products, today announced that the company will host a live Key Opinion Leader (KOL) call on its hematological programs on September 16, 2019.
The call will feature presentations by KOLs and Pluristem’s management who will explain and discuss the status of the company’s radiation programs with the U.S government, including an overview of recent Department of Defense (DoD) radiation data, potential markets and expected milestones. In addition, KOLs will discuss findings from Pluristem’s ongoing clinical study in hematological deficiencies, as well as opportunities and future product development. A detailed list of participating KOLs will be provided closer to the date of the event.
This event is intended for institutional investors, sell-side analysts, investment bankers, and business development professionals. Pluristem will release a summary following the call.
Pluristem Therapeutics Inc. is a leading regenerative medicine company developing novel placenta-based cell therapy product candidates.
The Company has reported robust clinical trial data in multiple indications for its patented PLX cell product candidates and is currently conducting late stage clinical trials in several indications.
PLX cell product candidates are believed to release a range of therapeutic proteins in response to inflammation, ischemia, muscle trauma, hematological disorders and radiation damage.
The cells are grown using the Company’s proprietary three-dimensional expansion technology and can be administered to patients off- the-shelf, without tissue matching. Pluristem has a strong intellectual property position; a Company-owned and operated GMP-certified manufacturing and research facility; strategic relationships with major research institutions; and a seasoned management team.
This press release contains express or implied forward-looking statements within the Private Securities Litigation Reform Act of 1995 and other U.S. Federal securities laws.
For example, Pluristem is using forward-looking statements when it discusses the topics that will be discussed on the KOL call.
These forward-looking statements and their implications are based on the current expectations of the management of Pluristem only, and are subject to a number of factors and uncertainties that could cause actual results to differ materially from those described in the forward-looking statements.
The following factors, among others, could cause actual results to differ materially from those described in the forward-looking statements: changes in technology and market requirements; Pluristem may encounter delays or obstacles in launching and/or successfully completing its clinical trials; Pluristem’s products may not be approved by regulatory agencies, Pluristem’s technology may not be validated as it progresses further and its methods may not be accepted by the scientific community; Pluristem may be unable to retain or attract key employees whose knowledge is essential to the development of its products; unforeseen scientific difficulties may develop with Pluristem’s process; Pluristem’s products may wind up being more expensive than it anticipates; results in the laboratory may not translate to equally good results in real clinical settings; results of preclinical studies may not correlate with the results of human clinical trials; Pluristem’s patents may not be sufficient; Pluristem’s products may harm recipients; changes in legislation may adversely impact Pluristem; inability to timely develop and introduce new technologies, products and applications; loss of market share and pressure on pricing resulting from competition, which could cause the actual results or performance of Pluristem to differ materially from those contemplated in such forward-looking statements.
Except as otherwise required by law, Pluristem undertakes no obligation to publicly release any revisions to these forward-looking statements to reflect events or circumstances after the date hereof or to reflect the occurrence of unanticipated events.
For a more detailed description of the risks and uncertainties affecting Pluristem, reference is made to Pluristem’s reports filed from time to time with the Securities and Exchange Commission.
Efrat Kaduri
Director of Business, Investor and Public Relations 972-74-7108600
HAIFA, Israel, July 31, 2019 – Pluristem Therapeutics Inc. (Nasdaq:PSTI) (TASE:PSTI), a leading regenerative medicine company developing novel placenta-based cell therapy products, is presenting positive results from a series of studies of the company’s PLX-R18 cell therapy product conducted by the U.S. Department of Defense’s (DoD) Armed Forces Radiobiology Research Institute at the Uniformed Services University of the Health Sciences. The studies were designed to evaluate PLX-R18 as a potential prophylactic countermeasure against acute radiation syndrome (ARS) administered prior to radiation exposure.
These animal studies demonstrate that PLX-R18, administered 24 hours before radiation exposure, and again 72 hours after exposure, resulted in a significant increase in survival rates, from 4% survival rate in the placebo group to 74% in the treated group. In addition, the data show an increase in recovery of blood lineages (platelets, neutrophils, white blood cells, and lymphocytes) and a favorable safety profile. Furthermore, histopathological analysis and hematopoietic progenitor clonogenic assay of tissues collected show a significant increase in bone marrow cell numbers and improved regenerative capability into all blood lineages.
“We are very pleased with the positive results from the studies showing that PLX-R18 can potentially be used prophylactically, before exposure to radiation.
We believe that this outcome is an important contribution to protect the armed and medical forces which may need to enter contaminated areas,” said Yaky Yanay, President and Chief Executive Officer of Pluristem. “It is Pluristem’s goal to provide the different federal agencies access to PLX-R18 that it may be used as a countermeasure both before and after radiation exposure in order to minimize hematological and other organ damage. We look forward to the continued development of this unique agent as an off the shelf product.”
In addition to the DoD study, PLX-R18 is also being evaluated by the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (NIH), as a treatment following radiation exposure (ARS). Data from these studies demonstrated a significant increase in survival rates and enhanced neutrophil and lymphocyte recovery in radiation subjects. PLX-
R18 cell therapy product candidate was granted an FDA orphan drug designation and an IND for the treatment of ARS.
The animal studies were conducted following guidance from the U.S. Food and Drug Administration (FDA) relating to its animal rule pathway.
ARS results from exposure to high levels of radiation, as in the case of a nuclear accident or attack, and it may cause severe or fatal systemic effects such as injuries that hinder the bone marrow’s ability to produce blood cells and platelets, as well as other organs and systems within the body, increasing patients’ susceptibility to life-threatening hemorrhage, infection, and anemia.
Pluristem Therapeutics Inc. is a leading regenerative medicine company developing novel placenta-based cell therapy products.
The Company has reported robust clinical trial data in multiple indications for its patented PLX cell product and is currently conducting late stage clinical trials in several indications.
PLX cell products release a range of therapeutic proteins in response to inflammation, ischemia, muscle trauma, hematological disorders and radiation damage.
The cells are grown using the Company’s proprietary three-dimensional expansion technology and can be administered to patients off-the-shelf, without tissue matching.
Pluristem has a strong intellectual property position; a Company-owned and operated GMP-certified manufacturing and research facility; strategic relationships with major research institutions; and a seasoned management team.
This press release contains express or implied forward-looking statements within the Private Securities Litigation Reform Act of 1995 and other U.S. Federal securities laws.
For example, Pluristem is using forward-looking statements when it discusses the potential benefits of PLX- R18 and when it states that it believes the outcome of the studies is an important contribution to protect the armed and medical forces, that its goal is to provide the different federal agencies access to PLX-R18 so that it may be used as a countermeasure both before and after radiation exposure and that it looks forward to the development of PLX-R18 as an off the shelf product.
These forward-looking statements and their implications are based on the current expectations of the management of Pluristem only, and are subject to a number of factors and uncertainties that could cause actual results to differ materially from those described in the forward-looking statements.
The following factors, among others, could cause actual results to differ materially from those described in the forward-looking statements: changes in technology and market requirements; Pluristem may encounter delays or obstacles in launching and/or successfully completing its clinical trials; Pluristem’s products may not be approved by regulatory agencies, Pluristem’s technology may not be validated as it progresses further and its methods may not be accepted by the scientific community; Pluristem may be unable to retain or attract key employees whose knowledge is essential to the development of its products; unforeseen scientific difficulties may develop with Pluristem’s process; Pluristem’s products may wind up being more expensive than it anticipates; results in the laboratory may not translate to equally good results in real clinical settings; results of preclinical studies may not correlate with the results of human clinical trials; Pluristem’s patents may not be sufficient; Pluristem’s products may harm recipients; changes in legislation may adversely impact Pluristem; inability to timely develop and introduce new technologies, products and applications; loss of market share and pressure on pricing resulting from competition, which could cause the actual results or performance of Pluristem to differ materially from those contemplated in such forward-looking statements.
Except as otherwise required by law, Pluristem undertakes no obligation to publicly release any revisions to these forward-looking statements to reflect events or circumstances after the date hereof or to reflect the occurrence of unanticipated events.
For a more detailed description of the risks and uncertainties affecting Pluristem, reference is made to Pluristem’s reports filed from time to time with the Securities and Exchange Commission.
Efrat Kaduri
Director of Business, Investor and Public Relations 972-74-7108600
HAIFA, Israel, July 24, 2019 – Pluristem Therapeutics Inc. (Nasdaq:PSTI) (TASE:PSTI), a leading regenerative medicine company developing novel placenta-based cell therapy products, today announced that, its Board of Directors has approved a 1-for-10 reverse split of the Company’s (a) authorized shares of common stock; and (b) issued and outstanding shares of common stock. The reverse split will be effective as of market open on July 25, 2019 on Nasdaq. Pursuant to Part 3 of the Tel-Aviv Stock Exchange Regulations (Chapter A, Section B(1)), the Company’s common stock will not trade on the Tel-Aviv Stock Exchange on July 25, 2019.
The reverse split will result in each outstanding ten pre-split shares of common stock automatically combining into one new share of common stock without any action on the part of the shareholders.
The total number of outstanding shares of common stock will be reduced from approximately 153 million to approximately 15.3 million shares. The Company’s authorized number of shares of common stock will also be proportionately decreased from 300,000,000 to 30,000,000 shares, and its authorized number of preferred stock will also be proportionally decreased from 10,000,000 to 1,000,000 shares, each as a result of the reverse split and pursuant to Nevada Revised Statutes (NRS) Section 78.207. No fractional shares will be issued as a result of the reverse split as any fractional shares resulting from the reverse split will be rounded up to the nearest whole share on a per shareholder basis.
The Board of Directors of the Company approved the action in accordance with Nevada law (NRS Section 78.207). No additional Company or shareholder approval is required because both the number of authorized shares of common stock and the number of outstanding shares of common stock will be proportionally reduced as a result of the reverse split, and the reverse split will not adversely affect any other class of stock of the Company and the Company will not pay money or issue scrip to shareholders who would otherwise be entitled to receive a fractional share as a result of the reverse split.
All options, unvested shares of restricted stock, restricted stock units and warrants of the Company outstanding immediately prior to the reverse split, including, but not limited to, those warrants issued by the Company in its securities offerings which closed on April 8, 2019, January 25, 2017 and June 30, 2015, respectively, will be appropriately adjusted by dividing the number of shares of common stock into which the options and warrants are exercisable or convertible by 10 and multiplying the exercise or conversion price thereof by 10, as a result of the reverse split.
The reverse split will not impact any shareholder’s percentage ownership of Pluristem or voting power, except for minimal effects resulting from the treatment of fractional shares.
Pluristem’s shares of common stock will continue to trade on the Nasdaq Capital Market (Nasdaq) under the symbol ”PSTI” but will trade under a new CUSIP Number 72940R300.
American Stock Transfer and Trust Company, LLC, Pluristem’s transfer agent, will act as the exchange agent for the reverse split. Please contact American Stock Transfer and Trust Company, LLC for further information at (877) 248-6417 or (718) 921-8317.
Pluristem Therapeutics Inc. is a leading regenerative medicine company developing novel placenta-based cell therapy products.
The Company has reported robust clinical trial data in multiple indications for its patented PLX cell product and is currently conducting late stage clinical trials in several indications.
PLX cell products release a range of therapeutic proteins in response to inflammation, ischemia, muscle trauma, hematological disorders and radiation damage.
The cells are grown using the Company’s proprietary three-dimensional expansion technology and can be administered to patients off-the-shelf, without tissue matching.
Pluristem has a strong intellectual property position; a Company-owned and operated GMP-certified manufacturing and research facility; strategic relationships with major research institutions; and a seasoned management team.
This press release contains express or implied forward-looking statements within the Private Securities Litigation Reform Act of 1995 and other U.S. Federal securities laws.
For example, Pluristem is using forward-looking statements when it discusses the timing of its reverse split.
These forward-looking statements and their implications are based on the current expectations of the management of Pluristem only, and are subject to a number of factors and uncertainties that could cause actual results to differ materially from those described in the forward-looking statements.
The following factors, among others, could cause actual results to differ materially from those described in the forward-looking statements: changes in technology and market requirements; Pluristem may encounter delays or obstacles in launching and/or successfully completing its clinical trials; Pluristem’s products may not be approved by regulatory agencies, Pluristem’s technology may not be validated as it progresses further and its methods may not be accepted by the scientific community; Pluristem may be unable to retain or attract key employees whose knowledge is essential to the development of its products; unforeseen scientific difficulties may develop with Pluristem’s process; Pluristem’s products may wind up being more expensive than it anticipates; results in the laboratory may not translate to equally good results in real clinical settings; results of preclinical studies may not correlate with the results of human clinical trials; Pluristem’s patents may not be sufficient; Pluristem’s products may harm recipients; changes in legislation may adversely impact Pluristem; inability to timely develop and introduce new technologies, products and applications; loss of market share and pressure on pricing resulting from competition, which could cause the actual results or performance of Pluristem to differ materially from those contemplated in such forward-looking statements.
Except as otherwise required by law, Pluristem undertakes no obligation to publicly release any revisions to these forward-looking statements to reflect events or circumstances after the date hereof or to reflect the occurrence of unanticipated events.
For a more detailed description of the risks and uncertainties affecting Pluristem, reference is made to Pluristem’s reports filed from time to time with the Securities and Exchange Commission.
Efrat Kaduri
Director of Business, Investor and Public Relations 972-74-7108600
HAIFA, Israel, July 24, 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, commenting on the Company’s proposed reverse stock split.
Today we announced a 1-for-10 reverse split of the company’s authorized, as well as issued and outstanding shares of common stock and authorized preferred stock.
We elected to execute the reverse split at this time, as we believe that it is an important step to improve our capital structure and market positioning while also maintaining compliance with the Nasdaq minimum bid price requirement.
We plan to continue adopting a proactive financial approach that will enable us to better control our capital structure, which we believe is essential to achieve our goals and long term growth plan.
By executing this reverse stock split, I see a potential opportunity to attract high-quality healthcare investors who have shown interest in our technology and pipeline but are sometimes technically unable to invest in Pluristem’s shares due to low market price. Strengthening our capital structure also places us in what I believe is a good position to advance business collaborations that can support the growth of our company as we move towards important milestones.
I would like to thank you for your long-standing support in Pluristem.
Today we believe that we are starting to pave a new path of growth, pro-activeness and success.
I am excited and committed to execute on the opportunities in front of us and look forward to keeping you updated on our progress.
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 belief that the implementation of the reverse stock split is an important step to improve its capital structure and market positioning while also maintaining compliance with the Nasdaq minimum bid price requirement, its plan to continue adopting a proactive financial approach to enable it to better control its capital structure and its belief that its capital structure will place it in a position to attract high-quality healthcare investors and advance business collaborations that can support the growth of the company as it moves towards important milestones.
These forward-looking statements and their implications are based on the current expectations of the management of Pluristem only, and are subject to a number of factors and uncertainties that could cause actual results to differ materially from those described in the forward-looking statements.
The following factors, among others, could cause actual results to differ materially from those described in the forward-looking statements: changes in technology and market requirements; Pluristem may encounter delays or obstacles in launching and/or successfully completing its clinical trials; Pluristem’s products may not be approved by regulatory agencies, Pluristem’s technology may not be validated as it progresses further and its methods may not be accepted by the scientific community; Pluristem may be unable to retain or attract key employees whose knowledge is essential to the development of its products; unforeseen scientific difficulties may develop with Pluristem’s process; Pluristem’s products may wind up being more expensive than it anticipates; results in the laboratory may not translate to equally good results in real clinical settings; results of preclinical studies may not correlate with the results of human clinical trials; Pluristem’s patents may not be sufficient; Pluristem’s products may harm recipients; changes in legislation may adversely impact Pluristem; inability to timely develop and introduce new technologies, products and applications; loss of market share and pressure on pricing resulting from competition, which could cause the actual results or performance of Pluristem to differ materially from those contemplated in such forward-looking statements.
Except as otherwise required by law, Pluristem undertakes no obligation to publicly release any revisions to these forward-looking statements to reflect events or circumstances after the date hereof or to reflect the occurrence of unanticipated events.
For a more detailed description of the risks and uncertainties affecting Pluristem, reference is made to Pluristem’s reports filed from time to time with the Securities and Exchange Commission.
Efrat Kaduri
Director of Business, Investor and Public Relations 972-74-7108600
HAIFA, Israel, July 17, 2019 – Pluristem Therapeutics Inc. (Nasdaq:PSTI) (TASE:PSTI), a leading regenerative medicine company developing novel placenta-based cell therapy products, announced that results from a series of studies of the company’s PLX-R18 cell therapy product conducted by the U.S. Department of Defense’s Armed Forces Radiobiology Research Institute at the Uniformed Services University of the Health Sciences, will be jointly presented at the upcoming 2019 Radiation Injury Treatment Network (RITN) Workshop on July 31st.
The animal studies, conducted following guidance from the U.S. Food and Drug Administration (FDA) relating to its animal rule pathway, are designed to evaluate PLX-R18 as a potential prophylactic countermeasure against acute radiation syndrome (ARS) administered prior to radiation exposure.
In addition to the DoD study, PLX-R18 is also being evaluated by the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (NIH), as a treatment following radiation exposure. Data from these studies demonstrated a significant increase in survival rates and enhanced neutrophil and lymphocyte recovery in radiation subjects. The company’s PLX-R18 cell therapy product was granted an FDA orphan drug designation and an IND for the treatment of ARS.
ARS results from exposure to high levels of radiation, as in the case of a nuclear accident or attack, and it may cause severe or fatal systemic effects such as injuries that hinder the bone marrow’s ability to produce blood cells and platelets, as well as other organs and systems within the body, increasing patients’ susceptibility to life-threatening hemorrhage, infection, and anemia.
Pluristem Therapeutics Inc. is a leading regenerative medicine company developing novel placenta-based cell therapy products.
The Company has reported robust clinical trial data in multiple indications for its patented PLX cell product and is currently conducting late stage clinical trials in several indications.
PLX cell products release a range of therapeutic proteins in response to inflammation, ischemia, muscle trauma, hematological disorders and radiation damage.
The cells are grown using the Company’s proprietary three-dimensional expansion technology and can be administered to patients off-the-shelf, without tissue matching.
Pluristem has a strong intellectual property position; a Company-owned and operated GMP-certified manufacturing and research facility; strategic relationships with major research institutions; and a seasoned management team.
This press release contains express or implied forward-looking statements within the Private Securities Litigation Reform Act of 1995 and other U.S. Federal securities laws.
For example, Pluristem is using forward-looking statements when it discusses the potential benefits of PLX- R18 and when it states that its PLX-R18 studies via the FDA’s animal rule pathway are designed to evaluate PLX-R18 as a potential prophylactic countermeasure against ARS administered prior to radiation exposure.
These forward-looking statements and their implications are based on the current expectations of the management of Pluristem only, and are subject to a number of factors and uncertainties that could cause actual results to differ materially from those described in the forward-looking statements.
The following factors, among others, could cause actual results to differ materially from those described in the forward-looking statements: changes in technology and market requirements; Pluristem may encounter delays or obstacles in launching and/or successfully completing its clinical trials; Pluristem’s products may not be approved by regulatory agencies, Pluristem’s technology may not be validated as it progresses further and its methods may not be accepted by the scientific community; Pluristem may be unable to retain or attract key employees whose knowledge is essential to the development of its products; unforeseen scientific difficulties may develop with Pluristem’s process; Pluristem’s products may wind up being more expensive than it anticipates; results in the laboratory may not translate to equally good results in real clinical settings; results of preclinical studies may not correlate with the results of human clinical trials; Pluristem’s patents may not be sufficient; Pluristem’s products may harm recipients; changes in legislation may adversely impact Pluristem; inability to timely develop and introduce new technologies, products and applications; loss of market share and pressure on pricing resulting from competition, which could cause the actual results or performance of Pluristem to differ materially from those contemplated in such forward-looking statements. Except as otherwise required by law, Pluristem undertakes no obligation to publicly release any revisions to these forward-looking statements to reflect events or circumstances after the date hereof or to reflect the occurrence of unanticipated events.
For a more detailed description of the risks and uncertainties affecting Pluristem, reference is made to Pluristem’s reports filed from time to time with the Securities and Exchange Commission.
Efrat Kaduri
Director of Business, Investor and Public Relations 972-74-7108600
HAIFA, Israel, July 2, 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.
Following our recently announced CEO transition, I want to take this opportunity to share with you my point of view and short term goals and objectives for Pluristem. Most importantly, I wanted to share why I believe Pluristem is such a great company, and why I have strong faith in what we do and in the bright vision I see for our company.
This might not be a straight-forward CEO letter, but in this letter, I would like to speak to you, our loyal shareholder base, who have stayed with us for years and want to see us succeed.
I would also like to address our new shareholders who we believe see the potential of this company and seek to fully realize Pluristem’s potential.
Pluristem is much more than an investment, however.
Pluristem is a company with innovative technology, a medical and social vision and a unique approach to the way we take care of patients, our families and our parents. P
luristem is comprised of the most talented and committed people I have ever met, who are working hard every day to achieve excellence in everything they do.
They share a common goal and vision to develop a truly novel drug that can communicate with the patients’ own bodies and provide them with the regenerative biologic factors they need to heal.
I joined Pluristem thirteen years ago with the understanding that I have to be part of what I believe to be the coming healthcare revolution.
I am sure most of you have known sick family members who are not happy with the current standard of care they receive.
I am sure you all believe that you are paying too much for your healthcare services, and are worried about our aging societies. Today I believe, more than ever, in the need for regenerative medicine to meet these challenges, and Pluristem is a leader in this emerging field of medicine.
I believe that our bioreactors not only expand cells, they expand the future of medicine.
I was blessed to work with Zami Aberman for many years, and I would like to take this opportunity to thank him for being such a visionary leader, a mentor, partner and friend. Pluristem is a company that builds on common values, trust and respect. I look forward to continuing to work with Zami as our Executive Chairman as we lead Pluristem to great success.
The policy I intend to lead is: “Focus on the fundamentals and taking advantage of opportunities.” As we approach significant milestones, my main focus will be on transitioning to a commercial stage, revenue generating company. During the last few months, we believe that our valuation was affected by our recent financing, as we took the opportunity to secure financial resources that should assist us in achieving our key near-term milestones.
I would like to assure you that I will be very focused on creating value for you, our shareholders, and I believe we have many opportunities to do so.
Therefore, and as a vote of confidence in our future success, our board of directors approved, at my suggestion, a reduction in my own compensation and all other directors’ compensation for the 2020 financial year, until the earlier of one year or when our market capitalization doubles.
In addition, I have implemented a broad cost reduction plan to increase efficiency and allow us to reach important milestones with our current resources.
Now, I would like to provide a brief update on the status of our development programs.
These programs are the key elements in transforming Pluristem into a mature, profitable company that we believe will generate significant long-term value.
PLX-R18 for acute radiation syndrome (ARS): Among our near-term priorities is to secure an agreement with the U.S. government this year.
We developed this unique, lifesaving product candidate with the support of the U.S. National Institute of Allergy and Infectious Diseases (NIAID). During the past year, we have completed a series of required studies and I intend to closely work with the agencies to satisfy the remaining development steps in order to bring to market this important product that can improve civilian and armed forces safety and preparedness.
In parallel, we continue to work with the U.S. Department of Defense (DoD) on the development of this novel compound as a countermeasure for ARS, prior to exposure to radiation. A series of studies conducted by the DoD was recently completed and I expect to be able to share the data with you in the coming weeks.
PLX-PAD for critical limb ischemia – (as amputation is not a reasonable standard of care): We are working hard to prepare the company for the interim data readout, which we expect in the first half of 2020 that, if positive, could support an application for conditional marketing approval in Europe under the European Union’s Adaptive Pathways Program.
This program could allow us to enter the market and begin generating revenue sooner than anticipated, which would be a true inflection point for our company.
We also seek to advance our U.S. Food and Drug Administration’s (FDA) expanded access program, which could provide us with meaningful real- world data and potential cost recovery.
PLX-PAD for muscle regeneration following hip fracture: We are advancing a multinational Phase III study and expect data in the second half of 2020. Today, there is no suitable medical treatment for the regeneration of damaged muscle and we see many reports that suggest up to 30% of hip
fracture patients die within one year following the fracture due to immobility associated with the disease.
This makes PLX-PAD a much-needed treatment which could potentially improve patients’ lives while also saving hospitalization and rehabilitation costs.
This important program also provided us with the opportunity to collaborate with NASA and examine our cells’ ability to support muscle regeneration in the challenging microgravity environment which causes muscle and bone loss.
Both critical limb ischemia (CLI) and hip fracture represent large patient populations, and, based upon the positive outcomes that we observed in earlier trials, we believe PLX-PAD may be able to capture a significant share of these markets.
Pluristem’s cell therapy products, PLX-PAD and PLX-R18, are both promising candidates that emerged from our proprietary cell processing and 3-D manufacturing capabilities. We are currently in discussions and negotiations with potential partners as we consider which products and territories we will open to potential licensing agreements. Our existing collaborations, which include the NIH, DoD, NASA, Fukushima University and Hospital, Chart Industries, Thermo Fisher Scientific and CHA Biotech reflect what we believe to be the broad and growing interest in our cell therapy capabilities. I am pleased with these partnerships and we intend to work hand in hand to create more business opportunities for the benefit of all of us. Collaborations such as these provide multiple opportunities for value creation using our current technology platform, allowing us to remain focused on advancing and expanding our lead programs.
We will also continue to seek short-term opportunities to leverage our technology to potentially generate cash and profits, and we are exploring collaborations in additional industries and in new areas of interest. One example is our recent announcement that we secured initial intellectual property surrounding the potential use of our cell culturing technology in the manufacture of cannabinoid producing cells. We believe this is an exciting opportunity to create additional value for our company and reflects the potential broad applicability of our technology.
In closing, I believe that the future is very promising, and I am excited about the opportunities we have to create a positive impact for our company and long-term shareholder value. We have assembled a world class leadership team that is key to achieving value creating milestones. I look forward to providing you with positive future corporate updates, and in the meantime, I would like to thank you for your continued support of Pluristem.
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.
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 its goal and vision to develop a drug that can communicate with the patients’ bodies and provide them the regenerative biologic factors they need to heal; the belief for the need for regenerative medicine and that Pluristem’s bioreactors expand the future of medicine; that Mr. Yanay and Mr. Aberman will work to lead Pluristem to great success; that the broad cost reduction plan will allow it to reach important milestones with its current resources; its policy and focus on transitioning Pluristem to a commercial stage, revenue generating company; its goal of ensuring shareholders fully realize Pluristem’s potential; the expected data read out of its CLI study and the potential for conditional marketing approval in Europe which could lead it to generating revenue sooner than anticipated, while also seeking to advance the FDA’s expanded access program, which could provide it with meaningful real-world data and potential cost recovery; the expected timing of the study and data from its Phase III study in PLX-PAD for recovery from hip fracture, and the potential for PLX- PAD treatment to potentially improve patients’ lives while also saving hospitalization and rehabilitation costs; that it could gain significant market share with respect to its PLX-PAD treatment of CLI and hip fracture; the potential future data read out from the studies conducted by the DoD relating to the treatment of ARS with PLX-R18; that it seeks to seek opportunities to leverage its technology to potentially produce cash injections and profits, while also seeking collaborations in additional industries and areas of interest; the potential broad applicability of its technology; and that its partnerships and collaborations provide potential business opportunities.
These forward-looking statements and their implications are based on the current expectations of the management of Pluristem only, and are subject to a number of factors and uncertainties that could cause actual results to differ materially from those described in the forward-looking statements. The following factors, among others, could cause actual results to differ materially from those described in the forward-looking statements: changes in technology and market requirements; Pluristem may encounter delays or obstacles in launching and/or successfully completing its clinical trials; Pluristem’s products may not be approved by regulatory agencies, Pluristem’s technology may not be validated as it progresses further and its methods may not be accepted by the scientific community; Pluristem may be unable to retain or attract key employees whose knowledge is essential to the development of its products; unforeseen scientific difficulties may develop with Pluristem’s process; Pluristem’s products may wind up being more expensive than it anticipates; results in the laboratory may not translate to equally good results in real clinical settings; results of preclinical studies may not correlate with the results of human clinical trials; Pluristem’s patents may not be sufficient; Pluristem’s products may harm recipients; changes in legislation may adversely impact Pluristem; inability to timely develop and introduce new technologies, products and applications; loss of market share and pressure on pricing resulting from competition, which could cause the actual results or performance of Pluristem to differ materially from those contemplated in such forward-looking statements.
Except as otherwise required by law, Pluristem undertakes no obligation to publicly release any revisions to these forward-looking statements to reflect events or circumstances after the date hereof or to reflect the occurrence of unanticipated events.
For a more detailed description of the risks and uncertainties affecting Pluristem, reference is made to Pluristem’s reports filed from time to time with the Securities and Exchange Commission.
Efrat Kaduri
Director of Business, Investor and Public Relations 972-74-7108600
HAIFA, Israel, June 24, 2019 – Pluristem Therapeutics Inc. (Nasdaq:PSTI) (TASE:PSTI), a leading regenerative medicine company developing novel placenta-based cell therapy products, today announced the completion of the transition period of its Co-CEO structure and the appointment of Yaky Yanay as sole Chief Executive Officer and President of Pluristem and the appointment of Zami Aberman as Executive Chairman of the Board.
“I am proud and pleased in successfully completing the transition period and the appointment of Yaky as Pluristem’s sole CEO,” said Zami Aberman. “As Executive Chairman I will continue to take an active role in shaping Pluristem’s corporate development and business strategy as we are advancing towards completion of our phase III studies and targeting our marketing phase. For the past two years, the Co-CEO structure has served us well, and now allows us to implement this transition as seamlessly as possible. Pluristem today holds major assets and I look forward to continuing to serve Pluristem as Executive Chairman and to work with Yaky and the team to generate value for these assets. I am delighted with this appointment and I am confident in Yaky’s capabilities to lead the company to become a global leader in the development, manufacture and marketing of Pluristem’s novel cell-based therapeutics.”
“In the last thirteen years, I proudly served Pluristem in different roles under Zami’s leadership,” said Yaky Yanay. “During these years, we were able to grow Pluristem from an early stage R&D company to a multi-phase III studies company targeting major markets. Our PLX technology is a powerful technology that is aimed to save lives, increase quality of life and could have a major economic positive impact on the global healthcare system. I am honored with this appointment and I would like to thank Zami and the Board of Directors for their trust. My mission now is to lead Pluristem to become a large, successful, profitable company that will impact the medical world for the benefit of our patients, shareholders, employees and partners.”
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 advance towards completion of its phase III studies and targeting its marketing phase; generation of value for its assets; becoming a global leader in the development, manufacture and marketing of Pluristem’s novel cell-based therapeutics; its ability to save lives, increase quality of life and have a major economic positive impact on the global healthcare system; and its ability to become a large, successful, profitable company that will impact the medical world for the benefit of its patients, shareholders, employees and partners.
These forward-looking statements and their implications are based on the current expectations of the management of Pluristem only, and are subject to a number of factors and uncertainties that could cause actual results to differ materially from those described in the forward-looking statements.
The following factors, among others, could cause actual results to differ materially from those described in the forward-looking statements: changes in technology and market requirements; Pluristem may encounter delays or obstacles in launching and/or successfully completing its clinical trials; Pluristem’s products may not be approved by regulatory agencies, Pluristem’s technology may not be validated as it progresses further and its methods may not be accepted by the scientific community; Pluristem may be unable to retain or attract key employees whose knowledge is essential to the development of its products; unforeseen scientific difficulties may develop with Pluristem’s process; Pluristem’s products may wind up being more expensive than it anticipates; results in the laboratory may not translate to equally good results in real clinical settings; results of preclinical studies may not correlate with the results of human clinical trials; Pluristem’s patents may not be sufficient; Pluristem’s products may harm recipients; changes in legislation may adversely impact Pluristem; inability to timely develop and introduce new technologies, products and applications; loss of market share and pressure on pricing resulting from competition, which could cause the actual results or performance of Pluristem to differ materially from those contemplated in such forward-looking statements.
Except as otherwise required by law, Pluristem undertakes no obligation to publicly release any revisions to these forward-looking statements to reflect events or circumstances after the date hereof or to reflect the occurrence of unanticipated events.
For a more detailed description of the risks and uncertainties affecting Pluristem, reference is made to Pluristem’s reports filed from time to time with the Securities and Exchange Commission.
Efrat Kaduri
Director of Business, Investor and Public Relations 972-74-7108600
This marketing grade serum-free media enables Pluristem large-scale, highly consistent production with operational independency from third party suppliers
HAIFA, Israel, June 17, 2019 – Pluristem Therapeutics Inc. (Nasdaq:PSTI) (TASE:PSTI), a leading regenerative medicine company developing novel placenta-based cell therapy products, today announced the Company has developed a serum-free formulation to support the manufacturing of cell therapy products.
This serum-free media formulation was developed using Pluristem’s deep understanding in cell therapy industrial scale production standards, and the quality methods designed to support implementation in Phase III development and marketing. Achieving this significant technological challenge enables Pluristem large-scale, highly consistent production with operational independency from third- party suppliers for standard serum, an expensive and quantity limited product. PLX-R18 is the first product that Pluristem intends to manufacture using the serum-free media.
Cell therapy products, like Pluristem’s PLX cells, are grown in cell culture media, whose particular composition and quality are essential to manufacture a desired cell product. Products manufactured using Pluristem’s serum-free media demonstrated comparable potency, quality and cellular composition compared to production that relies on serum-containing media.
Pluristem’s serum free media formulation supports cell therapy production in both standard two-dimensional cell culture and the proprietary three- dimensional bioreactor-based cell culture platform that is unique to Pluristem.
In addition, unlike standard cell culture media, which often contain undefined blood derived materials, Pluristem believes that its serum-free media formulation will result in a reduced risk of contaminates.
“Pluristem is in the midst of its final pivotal studies, which we are targeting for marketing approval, and believes that quantity and quality are both vital in manufacturing cell therapies products, so that such products will be accessible to any patient who needs them,” said Pluristem chairman and co-CEO Zami Aberman. “We are pleased that in adopting serum-free formulation to grow our cells, Pluristem will elevate the standard of cell therapy production and we believe we will be able to increase our supply volume while, in parallel, shift away from third-party serum manufacturers with limited supply. The evolving industry is attempting to move toward serum-free cell therapy production, and this achievement speaks to the strength of our proprietary R&D and manufacturing capabilities.”
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.
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 ability to manufacture cell therapy products using a serum-free formulation enables it to produce large-scale, highly consistent production with operational independency from third-party suppliers for standard serum and that in adopting a serum-free formulation to grow its cells, that PLX-R18 is the first product candidate that Pluristem intends to manufacture using the serum-free media, the belief that Pluristem’s serum-free media formulation will result in a reduced risk of contaminates, that Pluristem is targeting marketing approval for its final pivotal studies and that Pluristem will elevate the standard of cell therapy production and believes it will be able to increase its supply volume while, in parallel, shift away from third-party serum manufacturers with limited supply.
These forward-looking statements and their implications are based on the current expectations of the management of Pluristem only, and are subject to a number of factors and uncertainties that could cause actual results to differ materially from those described in the forward- looking statements.
The following factors, among others, could cause actual results to differ materially from those described in the forward-looking statements: changes in technology and market requirements; Pluristem may encounter delays or obstacles in launching and/or successfully completing its clinical trials; Pluristem’s products may not be approved by regulatory agencies, Pluristem’s technology may not be validated as it progresses further and its methods may not be accepted by the scientific community; Pluristem may be unable to retain or attract key employees whose knowledge is essential to the development of its products; unforeseen scientific difficulties may develop with Pluristem’s process; Pluristem’s products may wind up being more expensive than it anticipates; results in the laboratory may not translate to equally good results in real clinical settings; results of preclinical studies may not correlate with the results of human clinical trials; Pluristem’s patents may not be sufficient; Pluristem’s products may harm recipients; changes in legislation may adversely impact Pluristem; inability to timely develop and introduce new technologies, products and applications; loss of market share and pressure on pricing resulting from competition, which could cause the actual results or performance of Pluristem to differ materially from those contemplated in such forward-looking statements.
Except as otherwise required by law, Pluristem undertakes no obligation to publicly release any revisions to these forward-looking statements to reflect events or circumstances after the date hereof or to reflect the occurrence of unanticipated events.
For a more detailed description of the risks and uncertainties affecting Pluristem, reference is made to Pluristem’s reports filed from time to time with the Securities and Exchange Commission.
Efrat Kaduri
Director of Business, Investor and Public Relations 972-74-7108600
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