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HAIFA, Israel, February 2, 2021, Pluristem Therapeutics Inc. (Nasdaq:PSTI) (TASE:PSTI), a leading regenerative medicine company developing a platform of novel biological therapeutic products (“Pluristem” or the “Company”), today announced it has entered into definitive agreements with institutional investors for the purchase and sale of 4,761,905 shares of its common stock at a purchase price of $6.30 per share in a registered direct offering, for gross proceeds of $30 million before deducting placement agent fees and expenses. The closing of the offering is expected to occur on or about February 4, 2021, subject to the satisfaction of customary closing conditions.
A.G.P./Alliance Global Partners is acting as sole placement agent for the offering.
This offering is being made pursuant to an effective shelf registration statement on Form S-3 (File No. 333-239890) previously filed with the U.S. Securities and Exchange Commission (the “SEC”), under the Securities Act of 1933, as amended.
A prospectus supplement describing the terms of the proposed offering will be filed with the SEC and will be available on the SEC’s website located at http://www.sec.gov. Electronic copies of the prospectus supplement may be obtained, when available, from A.G.P./Alliance Global Partners, 590 Madison Avenue, 28th Floor, New York, NY 10022, or by telephone at (212) 624-2060, or by email at prospectus@allianceg.com.
Before investing in this offering, interested parties should read in their entirety the prospectus supplement and the accompanying prospectus and the other documents that the Company has filed with the SEC that are incorporated by reference in such prospectus supplement and the accompanying prospectus, which provide more information about the Company and such offering.
This press release shall not constitute an offer to sell or the solicitation of an offer to buy nor shall there be any sale of these securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction.
Pluristem Therapeutics Inc. is a leading regenerative medicine company developing novel placenta-based cell therapy product candidates.
The Company has reported robust clinical trial data in multiple indications for its patented PLX cell product candidates and is currently conducting late-stage clinical trials in several indications.
PLX cell product candidates are believed to release a range of therapeutic proteins in response to inflammation, muscle trauma, hematological disorders and radiation damage.
The cells are grown using the Company’s proprietary three-dimensional expansion technology and can be administered to patients off- the-shelf, without tissue matching. Pluristem has a strong intellectual property position; a Company-owned and operated GMP-certified manufacturing and research facility; strategic relationships with major research institutions; and a seasoned management team.
This press release contains express or implied forward-looking statements within the Private Securities Litigation Reform Act of 1995 and other U.S. Federal securities laws.
For example, Pluristem is using forward-looking statements when it discusses the expected closing of the offering.
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, January 27, 2021 – Pluristem Therapeutics Inc. (Nasdaq:PSTI) (TASE:PSTI), a leading regenerative medicine company developing a platform of novel biological therapeutic products, announced that effective as of market open on January 29, 2021, its common shares have been approved for listing to the Nasdaq Global Market® and will continue trading under the company’s current ticker symbol – PSTI.
A listing on the Nasdaq Global Market® is considered an indicator of status and success for companies that qualify for listing.
Listed companies must satisfy stringent financial, liquidity and corporate governance requirements, both initially and on an ongoing basis.
“We believe that this move is important for the growth of our Company.
The listing of our common shares on the Nasdaq Global Market® may help increase our visibility within the institutional marketplace and enhance our ability to broaden our shareholder base with the goal of driving long-term shareholder value,” said Pluristem CEO and President, Yaky Yanay.
Pluristem Therapeutics Inc. is a leading regenerative medicine company developing novel placenta-based cell therapy product candidates.
The Company has reported robust clinical trial data in multiple indications for its patented PLX cell product candidates and is currently conducting late-stage clinical trials in several indications.
PLX cell product candidates are believed to release a range of therapeutic proteins in response to inflammation, muscle trauma, hematological disorders and radiation damage.
The cells are grown using the Company’s proprietary three-dimensional expansion technology and can be administered to patients off- the-shelf, without tissue matching. Pluristem has a strong intellectual property position; a Company-owned and operated GMP-certified manufacturing and research facility; strategic relationships with major research institutions; and a seasoned management team.
This press release contains express or implied forward-looking statements within the Private Securities Litigation Reform Act of 1995 and other U.S. Federal securities laws.
For example, Pluristem is using forward-looking statements when it discusses its belief that a listing on the Nasdaq Global Market® is important for its growth, that the listing may increase its visibility within the institutional marketplace and that such a listing may enhance its ability to broaden its shareholder base with the goal of driving long-term shareholder value. 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, January 6, 2021 – Pluristem Therapeutics Inc. (Nasdaq:PSTI) (TASE:PSTI), a leading regenerative medicine company developing a platform of novel biological therapeutic products, is pleased to announce the appointment of Ms. Maital Shemesh-Rasmussen, a global health-tech marketing strategist, and Mr. Rami Levi, a leader in global marketing and international governmental affairs, to its Board of Directors.
Ms. Maital Shemesh-Rasmussen brings over 20 years of diverse commercialization experience across various industries. Driving growth in the health-tech sector, she has specifically focused on personalized care and patient-centric, data-driven products and value-based approaches. From 2018 to 2020, she served as Global Head of Solution Marketing at Roche Diagnostics Information Solutions, where she defined Roche’s new health-tech strategy, bringing to market advanced digital solutions and commercial models that positioned Roche as a world leader in health technology.
Key positions previously held by Ms. Shemesh-Rasmussen include: Director of Strategic and Product Marketing at Oracle Healthcare and Precision Medicine (2013-2016), where she drove penetration of the informatics, analytics and precision medicine market; Vice President of Global Marketing at JPMorgan Chase Bank (2002-2007), where she led global marketing and technology innovation to generate multimillion-dollar growth; Founder & CEO of Rasmussen Communications marketing agency, where she shaped marketing strategies and messaging for financial, health and technology firms; a consultant for startups; and a Board Member/Marketing Chair of Healthcare Information and Management Systems Society Northern California. Her education includes a BA in Behavioral Sciences, Magna Cum Laude, from Ben-Gurion University of the Negev, studies for an MA in Political Science and Communication at Bar-Ilan University, and the Executive Education Program in Strategy, Finance and Computer Science at Columbia University, New York.
Mr. Rami Levi, Founder and President of Catalyst Group International, brings over 30 years of experience in managing successful international projects on five continents, partnering with world leaders, and connecting nations and industry on a global scale. His career, spanning both the public and private sectors, has included five diplomatic missions on behalf of the State of Israel, as well as the founding of several successful companies. A leading expert in international affairs, global market development, crisis management, strategic planning and government regulatory management, Mr. Levi has generated and managed major cross countries agreements over the years.
As Senior Deputy General & Head of Marketing Administration at Israel’s Ministry of Tourism, Mr. Levi led numerous international initiatives and global partnerships involving 42 governments and world-leading conglomerates. In the private sector, he founded Catalyst Group, working as a consultant for governments, global law firms, banks, television networks and multinational NGOs. Mr. Levi’s holds an MA with Honors in Political Science from The Hebrew University of Jerusalem.
Pluristem Therapeutics Executive Chairman of the Board, Zami Aberman, said: “We are very happy to have Ms. Shemesh-Rasmussen and Mr. Levi on our Board of Directors. Maital is an innovation-driven global Health-Tech marketing strategist and an inspiring thinker, who is passionate about advancing healthcare through technology. Rami is a most impressive strategist and market developer, with proven business acumen and extensive global connections. Together they bring immense knowledge, experience and networking potential across industries in the global marketplace. We feel certain that their joint capabilities will boost our strategic resources, business development and market penetration, contributing significantly to the success of Pluristem’s endeavors.”
Pluristem Therapeutics Inc. is a leading regenerative medicine company developing novel placenta-based cell therapy product candidates.
The Company has reported robust clinical trial data in multiple indications for its patented PLX cell product candidates and is currently conducting late stage clinical trials in several indications.
PLX cell product candidates are believed to release a range of therapeutic proteins in response to inflammation, muscle trauma, hematological disorders and radiation damage.
The cells are grown using the Company’s proprietary three-dimensional expansion technology and can be administered to patients off-the-shelf, without tissue matching.
Pluristem has a strong intellectual property position; a Company-owned and operated GMP-certified manufacturing and research facility; strategic relationships with major research institutions; and a seasoned management team
This press release contains express or implied forward-looking statements within the Private Securities Litigation Reform Act of 1995 and other U.S. Federal securities laws.
For example, Pluristem is using forward-looking statements when it discusses that its new directors will enhance the Board’s strategic capabilities in preparation for future growth and commercialization endeavors.
These forward-looking statements and their implications are based on the current expectations of the management of Pluristem only, and are subject to a number of factors and uncertainties that could cause actual results to differ materially from those described in the forward-looking statements.
The following factors, among others, could cause actual results to differ materially from those described in the forward-looking statements: changes in technology and market requirements; Pluristem may encounter delays or obstacles in launching and/or successfully completing its clinical trials; Pluristem’s products may not be approved by regulatory agencies, Pluristem’s technology may not be validated as it progresses further and its methods may not be accepted by the scientific community; Pluristem may be unable to retain or attract key employees whose knowledge is essential to the development of its products; unforeseen scientific difficulties may develop with Pluristem’s process; Pluristem’s products may wind up being more expensive than it anticipates; results in the laboratory may not translate to equally good results in real clinical settings; results of preclinical studies may not correlate with the results of human clinical trials; Pluristem’s patents may not be sufficient; Pluristem’s products may harm recipients; changes in legislation may adversely impact Pluristem; inability to timely develop and introduce new technologies, products and applications; loss of market share and pressure on pricing resulting from competition, which could cause the actual results or performance of Pluristem to differ materially from those contemplated in such forward-looking statements.
Except as otherwise required by law, Pluristem undertakes no obligation to publicly release any revisions to these forward-looking statements to reflect events or circumstances after the date hereof or to reflect the occurrence of unanticipated events.
For a more detailed description of the risks and uncertainties affecting Pluristem, reference is made to Pluristem’s reports filed from time to time with the Securities and Exchange Commission.
Dana Rubin
Director of Investor Relations 972-74-7107194
HAIFA, Israel, December 29, 2020 – Pluristem Therapeutics Inc. (Nasdaq:PSTI) (TASE:PSTI), a leading regenerative medicine company developing a platform of novel biological therapeutic products, announced today it has entered into a collaboration agreement with Mexican pharmaceutical company Innovare R&D to expand its ongoing clinical program of PLX cells in the treatment of Acute Respiratory Distress Syndrome (ARDS) associated with COVID-19 in Mexico.
The Phase II study in Mexico is subject to the approval of local authorities, with the goal of being conducted under the U.S. Food and Drug Administration (FDA) cleared protocol.
In accordance with the agreement, Innovare will open clinical sites and enroll patients for the proposed clinical study in Mexico.
Innovare will fund the study in Mexico and will purchase PLX cells for the study from Pluristem.
Subject to potential positive clinical study results and Mexican regulatory approval for commercialization, the agreement grants Innovare exclusive distribution rights in Mexico to supply PLX cells for treating severe COVID-19 cases complicated by ARDS. All intellectual property and manufacturing rights remain with Pluristem.
With 1,389,430 cases and 122,855 deaths as of December 29, 2020, Mexico’s COVID-19 infection and mortality rates have been increasing.
Mexico has the highest deaths proportionally to COVID- 19 cases or population in the world as of December 28, 2020, as reported by Johns Hopkins University of Medicine.
“We are pleased to join forces with Innovare, a leading innovative company aiming to be part of the solution for combating the COVID-19 pandemic in Mexico,” stated Pluristem CEO and President, Yaky Yanay. “Thanks to our key competitive advantage of having in-house manufacturing facility, advanced logistical capabilities, and a global reach, we are able to supply PLX cells to clinical centers around the world while extending our global support for COVID-19 into Latin America. By conducting the study in both the U.S. and Mexico, in parallel to the E.U. and Israel, we are continuing our focus on achieving clinical milestones and objectives, while bringing the potential treatment of PLX cells to those in need.”
Gerardo Cárdenas Vogel, CEO of Innovare R&D commented, “As a company that is seeking worldwide partners showing clinical promise for unmet medical needs, we are excited to collaborate with Pluristem.
We look forward to leveraging our clinical and commercial capabilities with Pluristem’s advanced cell therapy solution to help develop and potentially bring a much needed treatment for ARDS patients associated with COVID-19 to Mexico.”
Pluristem is currently conducting two Phase II studies in ARDS associated with COVID-19 in the U.S., Europe and Israel, an Expanded Access Program in the U.S. and a per patient compassionate use program in Israel.
Innovare R&D comprises a group of pharmaceutical companies that develop and commercialize drugs in the areas of hematology, immunology, infectious disease, central nervous system, and urology.
They established a unique partnering model to collaborate with biopharmaceutical companies in a strategy to proof the applicability of their platform in improving patient´s outcomes. Innovare R&D has regional (Mexico) coverage for commercializing products that have already been approved by the FDA/ European Medicines Agency (EMA)/ Health Canada/ Swissmedic/ TGA, while Innovare R&D is leading their own product developments with partners in the U.S. and Europe.
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 Phase II study in Mexico, subject to the approval of local authorities, that it continues to focus on achieving clinical milestones and objectives, while bringing the potential treatment of PLX cells to those in need and potentially bringing a much needed treatment for ARDS patients associated with COVID-19 to Mexico.
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, December 9, 2020 – Pluristem Therapeutics Inc. (Nasdaq:PSTI) (TASE:PSTI), a leading regenerative medicine company developing a platform of novel biological therapeutic products, today announced that the independent Data Monitoring Committee (DMC) of its global pivotal Phase III study for the treatment of critical limb ischemia (CLI) issued its recommendation letter following the interim analysis.
The clinical dataset was reviewed by the independent DMC for safety and analysis of the primary endpoint of amputation-free survival, defined as time to occurrence of major amputation of the index leg or death.
Based on the review, the DMC concluded that the CLI study is unlikely to meet the primary endpoint by the time of the final analysis.
The DMC advised the Company that the CLI study population has experienced a substantial low number of events (major amputation of the index leg or death), different from what is known in clinical medicine for the rate of these events in this patient population.
The lower than anticipated event rate in the placebo group reduced the statistical power of the study to meet its primary endpoint.
DMC noted that PLX-PAD was well tolerated, and no significant safety concerns were raised during the study.
Following the DMC’s recommendation, the Company decided to terminate the CLI study. Currently, the Company continues to be blinded to the CLI study clinical data.
“We are deeply disappointed by the outcome of the CLI interim analysis. In light of the DMC’s recommendation, we decided that it would be in the best interests of the Company and its shareholders to terminate the CLI study and focus our resources and efforts on our other lead indications,” stated Pluristem CEO and President, Yaky Yanay.
“We expect to present topline clinical results during calendar year 2021, including our Phase III study in muscle regeneration following hip fracture, Phase II studies in Acute Respiratory Distress Syndrome (ARDS) associated with COVID-19 and our Phase I study in incomplete hematopoietic recovery following hematopoietic cell transplantation (HCT). Pluristem is well positioned to advance and support future development of these indications.”
“Throughout the years, we have developed unique and propriety expertise, knowhow and intellectual property, alongside a diverse clinical pipeline and we possess a state-of-the-art cell manufacturing facility. We believe our platform and technology will be a meaningful force in regenerative medicine in a variety of therapeutic areas,” Mr. Yanay concluded.
The Company will host a conference call on December 9, 2020 at 8.30AM ET / 3.30PM Israel time. It can be accessed via:
https://webcasting.brrmedia.co.uk/broadcast/5fc769bd2ac82b2af52e277b
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 that it expects topline clinical results during the calendar year 2021 with respect to its Phase III study in muscle regeneration following hip fracture, its Phase II studies in ARDS associated with COVID-19 and its Phase I study in incomplete hematopoietic recovery following HCT, its belief that it is well positioned to support the future development of these indications and its belief that its platform and technology will be a meaningful force in regenerative medicine in a variety of therapeutic areas.
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, November 18, 2020 – Pluristem Therapeutics Inc. (Nasdaq:PSTI) (TASE:PSTI), a leading regenerative medicine company developing a platform of novel biological therapeutic products, today reported the first clinical results for PLX-R18 in humans from its Phase I study evaluating PLX-R18 as a treatment for incomplete hematopoietic recovery following hematopoietic cell transplantation (HCT). The initial results consisted of the analysis of the first 19 patients enrolled, and not all patients completed a one year follow up.
The initial data from the Phase I trial demonstrated:
Incomplete hematopoietic recovery poses a significant life-threatening condition to HCT recipients who fail to respond to standard of care treatments, making them vulnerable to infections and bleeding. PLX-R18 may address the unmet need in this patient population by stimulating the regenerative potential of bone marrow where other treatments have proven ineffective. The U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation to PLX-R18 in this indication.
A presentation titled “Safety and Demonstrated Efficacy of Placenta-Derived Cell Therapy PLX- R18 in Subjects with Incomplete Hematopoietic Recovery Following Hematopoietic Cell Transplantation: A Phase I International Multi-Center Study” will be held by Mr. Hillard M. Lazarus, MD, FACP, Professor of Medicine, Case Western Reserve University, and Member of the study’s Steering Committee at the virtual 62nd ASH Annual Meeting and Exposition on December 5, 2020.
Prof Hillard M. Lazarus commented on the results, “The use of Pluristem’s PLX-R18 product candidate in a group of patients who had extremely low blood counts resulted in actual clinical improvement with a significant rise in critical blood counts.”
Pluristem CEO and President Yaky Yanay stated, “These first PLX-R18 data in humans support our expectations that our PLX platform can yield multiple regenerative therapeutics.
This significant milestone adds to a pivotal year ahead with four readouts in Critical Limb Ischemia (CLI), muscle regeneration following hip fracture, COVID-19 complicated by Acute Respiratory Distress Syndrome (ARDS), and HCT evaluating both our PLX-PAD and PLX-R18 product candidates.
We are committed to developing solutions for unmet medical needs based on our expertise attained over a decade and supported by our advanced platform technology and in-house manufacturing capabilities.”
The ASH Annual Meeting is the world’s most comprehensive hematology event of the year featuring scientific abstracts highlighting updates on the most critical topics in hematology.
With more than 18,000 members from nearly 100 countries, ASH is the world’s largest professional society serving both clinicians and scientists around the world who are working to conquer blood diseases.
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 its Phase I HCT study, expected timing for reporting top line results from the full clinical study, its anticipation for a significant year with four readouts in CLI, muscle regeneration following hip fracture, COVID-19 complicated by ARDS, and HCT evaluating both our PLX-PAD and PLX-R18 product candidates, that these first PLX-R18 data in humans support its expectations that its PLX platform can yield multiple regenerative therapeutics or when it discusses developing solutions for unmet medical needs.
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, October 20, 2020 – Pluristem Therapeutics Inc. (Nasdaq:PSTI) (TASE:PSTI), a leading regenerative medicine company developing a platform of novel biological products, today named medical experts to form the Steering Committee for its clinical program relating to Acute Respiratory Distress Syndrome (ARDS) associated with COVID-19. Pluristem is currently conducting Phase II studies of its PLX-PAD cells to treat hospitalized patients suffering from severe COVID-19 complicated by ARDS in the U.S., Europe and Israel. The Company is also conducting an Expanded Access Program in the U.S. and a per-patient Compassionate Use Program in Israel.
The Steering Committee announcement follows Pluristem’s recent expansion of its Phase II COVID-19 trial to Israel earlier this month. Comprised of five prominent professors and medical doctors in the fields of infectious diseases, critical care, pulmonology and internal medicine, Pluristem’s COVID-19 Steering Committee is chaired by Professor Dellinger, MD and includes:
Professor Dellinger is a Professor of Medicine and Distinguished Scholar at Cooper Medical School of Rowan University (CMSRU) and Senior Critical Care Attending at Cooper University Hospital. Professor Dellinger is a past-President of the Society of Critical Care Medicine (SCCM) and was the 15th recipient of the SCCM Lifetime Achievement Award in 2015. He was the lead author of the 2004, 2008, and 2012 Surviving Sepsis Campaign International Guidelines on the Management of Severe Sepsis and Septic Shock and senior author on the 2016 guidelines.
Professor Rahav is the Head of the Infectious Diseases Unit and Laboratories at the Sheba Medical Center, and a full academic Professor of Internal Medicine and Infectious Diseases at the Sackler Faculty of Medicine, Tel Aviv University. Professor Rahav earned her MD from the Hebrew University Hadassah Medical School, Jerusalem and has specialization certificates in internal medicine, infectious diseases, and clinical microbiology.
Professor Levy is the Chief of the Division of Critical Care, Pulmonary, and Sleep Medicine, Department of Medicine, at The Warren Alpert Medical School of Brown University, where he also serves as a Professor of Medicine. He is also the Medical Director of the Medical Intensive Care Unit at Rhode Island Hospital, Providence, Rhode Island. Dr. Levy is a founding member and Executive Committee member of the Surviving Sepsis Campaign, a global initiative to improve the care of patients with severe sepsis.
Professor Levy earned his MD from State University of New York at Buffalo. He is a past-President of the Society of Critical Care Medicine.
Professor Putensen is a Professor of Intensive Care Medicine and Head of the Division of Intensive Care Medicine, Department of Anaesthesiology and Intensive Care Medicine, at the University Hospital Bonn.
Professor Putensen is the past Executive Committee member and past chair of the Respiratory Section of the European Society of Intensive Care Medicine.
Currently, he serves as Chairperson of the Intensive Care Medicine Scientific Subcommittee of the European Society of Anaesthesiology and Intensive Care Medicine. Professor Putensen’s research focus is pathophysiology and treatment of acute respiratory distress syndrome and sepsis.
Professor van der Poll is the Professor of Medicine and Chair of the Department of Medicine at the Amsterdam University Medical Centers (Academic Medical Center – University of Amsterdam – and Free University Medical Center) in the Netherlands. He is board certified in internal medicine and infectious diseases.
Professor van der Poll has made fundamental contributions to the understanding of the pathophysiology of sepsis.
Professor Dellinger, Chair of Pluristem’s COVID-19 Steering Committee, commented, “With no approved treatments for ARDS due to COVID-19 available today, I am honored to chair Pluristem’s Steering Committee.
I look forward to working with my esteemed colleagues to advise on the development of Pluristem’s COVID-19 treatment, which has the potential to help severe patients in need throughout the world.”
“We’ve assembled this Steering Committee, comprised of prestigious leaders in their fields from around the world, to guide and help accelerate PLX-PAD’s clinical development path at this critical time.
We highly value the knowledge, talent, and experience shared by each of these key opinion leaders as we join forces to deliver an effective cell therapy for the most severe cases of COVID-19,” stated Pluristem CEO and President, Yaky Yanay.
Pluristem Therapeutics Inc. is a leading regenerative medicine company developing novel placenta-based cell therapy product candidates.
The Company has reported robust clinical trial data in multiple indications for its patented PLX cell product candidates and is currently conducting late stage clinical trials in several indications.
PLX cell product candidates are believed to release a range of therapeutic proteins in response to inflammation, ischemia, muscle trauma, hematological disorders and radiation damage.
The cells are grown using the Company’s proprietary three-dimensional expansion technology and can be administered to patients off- the-shelf, without tissue matching. Pluristem has a strong intellectual property position; a Company-owned and operated GMP-certified manufacturing and research facility; strategic relationships with major research institutions; and a seasoned management team.
This press release contains express or implied forward-looking statements within the Private Securities Litigation Reform Act of 1995 and other U.S. Federal securities laws.
For example, Pluristem is using forward-looking statements when it discusses the potential for Pluristem’s COVID-19 treatment to help severe patients in need throughout the world and that Pluristem and its COVID-19 steering committee will guide and help accelerate PLX-PAD’s clinical development and path.
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, October 13, 2020 – Pluristem Therapeutics Inc. (Nasdaq:PSTI) (TASE:PSTI), a leading regenerative medicine company developing a platform of novel biological products, today announced that it has received clearance from the safety committee of an investigator initiated Phase I/II study to move forward with patient enrollment for cohort II. The study will evaluate PLX-PAD cells in the treatment of steroid-refractory chronic graft vs. host disease (GvHD) and is led by Principal Investigator Prof. Ron Ram, Director of the Hematology Blood and Marrow Stem Cell Transplantation Unit at Tel Aviv Sourasky Medical Center, Ichilov Hospital, Israel. Prof. Ram and his research staff are responsible for the design and implementation of the study at Sourasky Medical Center.
GvHD is a severe complication in patients who have undergone an allogeneic hematopoietic cell transplantation (HCT) and is a major cause of morbidity and mortality in these patients in which the donated stem cells identify the recipient’s body as foreign and attack it.
The chronic form of GvHD (cGvHD) usually appears later than 100 days post-transplant.
Cohort I included 6 patients treated with 2 injections of 150 million cells, a week apart. At the 3- month follow up, interim safety results concluded that PLX-PAD cells were safe and that no treatment related side effects were reported.
Efficacy results demonstrated that 4 out of the 6 patients reported improvement in symptoms that translated into a reduction in the severity of cGvHD with notable reduction in the required steroid doses for part of the patients. Based on these results, the study was approved to commence enrollment of 14 patients in cohort II to be treated with 4 injections of 150 million cells.
Prof. Ram of Ichilov Hospital commented, “From our experience in having treated 6 patients in the study to date, we have so far found no negative side effects from the use of the PLX-PAD cells in the treatment of steroid-refractory cGvHD. Patients with significant GvHD skin disorders previously unresponsive to multiple types of therapy showed remarkable response. Responses were also observed for severe mouth ulcers which prevented patients from eating solid foods.
This resulted in a major improvement of quality of life and tapering of steroid doses.”
“Pluristem is committed to contributing to the wellbeing and quality of life of our patients. cGvHD is an indication where we see a significant need to enhance the current course of treatment for this life-threatening condition among patients undergoing bone marrow transplants.
The preliminary results from cohort I of this Phase I/II study, and prior preclinical data, both indicate that PLX-PAD cells may potentially treat cGvHD patients and mitigate symptoms.
We are very pleased to cooperate with Prof. Ram and Sourasky Medical Center, and we place a high importance in examining PLX-PAD for this indication,” stated Pluristem CEO and President, Yaky Yanay.
Chronic graft-versus-host disease (cGvHD) remains a common and potentially life-threatening complication of allogeneic hematopoietic stem cell transplantation (HCT).
The 2-year cumulative incidence of chronic GvHD requiring systemic treatment is ∼30% to 40% by National Institutes of Health criteria1.
The hematopoietic stem cell transplants are used to treat bone marrow failure resulting from treatment of some blood or bone marrow cancers as well as other hematologic failures, such as aplastic anemia, which are not related to cancer.
The donated cells identify the recipient’s body as foreign and attack it as a result. While acute GvHD usually appears in the first 100 days after a transplant, and in specific body systems, chronic GvHD can occur at any time (even several years) after a transplant, and may manifest in many parts of the body such as: skin, mouth, eyes, liver, intestines, lungs and joints.
Long term immunosuppression is given to try to prevent or treat cGvHD.
Since this treatment suppresses the immune system for a very long time, patients are at high risk of infections, and are prescribed multiple medications to try to address this major risk.
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.
1 Flowers ME, Martin PJ. How we treat chronic graft-versus-host disease. Blood. 2015 Jan 22;125(4):606-15. doi: 10.1182/blood-2014-08-551994. Epub 2014 Nov 14. PMID: 25398933; PMCID: PMC4304105.,
https://pubmed.ncbi.nlm.nih.gov/25398933/
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 patient enrollment for cohort II for its Phase I/II study of its PLX-PAD cells, the implication from the results of the first patient cohort in the study, the belief that GvHD is an indication that has a significant need for enhanced treatments among patients undergoing bone marrow transplants and that the preliminary results from cohort I of the study, and the prior preclinical data, indicate that PLX- PAD cells may potentially treat chronic GvHD patients and mitigate symptoms.
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, October 7, 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 received approval from the Israeli Ministry of Health to commence patient enrollment in Israel for the Company’s COVID-19 Phase II clinical trial, under the protocol that was approved by the Paul Ehrlich Institute (PEI), Germany’s regulatory agency.
A total of 40 patients hospitalized with severe COVID-19 complicated by Acute Respiratory Distress Syndrome (ARDS) will be enrolled at clinical sites in Israel and Germany.
The Phase II COVID-19 European clinical trial that is being expanded to Israel is in addition to Pluristem’s other COVID-19 clinical programs, including a Phase II study and an Expanded Access Program in the U.S., both under the U.S. Food and Drug Administration’s (FDA) approved protocol, and a per-patient compassionate use program in Israel.
The primary efficacy endpoint of the Phase II European study titled, “A Randomized, Controlled, Multicenter, Parallel-Group Phase II Study to Evaluate the Efficacy and Safety of Intramuscular Injections of PLX-PAD for the Treatment of severe COVID-19” is the number of ventilator free days during the 28 days from day 1 through to day 28 of the study. Safety and survival follow-up will be conducted up to week 52.
“We believe that the approval from the Israeli Ministry of Health will enable us to advance the treatment of severe COVID-19 patients. As the pandemic continues in Israel, we see it as our mission to treat those severe patients in need. With our broad COVID-19 clinical programs in Europe and the U.S., we are committed to advancing our research and developing a treatment that may help save lives,” stated Pluristem CEO and President Yaky Yanay.
PLX cells are available off-the-shelf and once commercialized, can be manufactured in large scale quantities, which we believe offers 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 potentially reverse the dangerous overactivation of the immune system. Accordingly, PLX cells may potentially reduce the severity of COVID-19 pneumonia, 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.
Initial clinical data on COVID-19 ICU patients, treated under a Compassionate Use Program, at the conclusion of a 28 day follow up were previously published.
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 proposed study in Israel, its belief that the approval from the Israeli Ministry of Health will enable it to advance the treatment of severe COVID-19 patients, its belief that the ability to manufacture PLX cells in large scale quantities offers a key advantage in addressing a global pandemic, 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 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
The Malta Conferences address the shared desire to improve quality of life and political stability in the Middle East through scientific collaboration
HAIFA, Israel, October 1, 2020 – On Wednesday, September 30, 2020, Pluristem Therapeutics Inc. (Nasdaq:PSTI) (TASE:PSTI), a leading Israeli regenerative medicine company developing a platform of novel biological products, and the Abu Dhabi Stem Cells Center (ADSCC) unveiled their first joint projects in a presentation at the Malta Conferences Foundation, a global conference supported by the kENUP Foundation, a global promoter of research-based innovation with public and societal benefit.
Pluristem and ADSCC presented the new projects, part of the recently signed Memorandum of Understanding (MOU) aimed at harnessing the power of regenerative medicine.
The first joint project brings together the expertise and knowledge of Pluristem and ADSCC to advance a potential COVID-19 treatment. The project will involve the first-time administration of Pluristem’s PLX cells via a nebulizer, a drug delivery device that helps a patient inhale a medication through a mask or mouthpiece, to COVID-19 patients.
The collaboration will allow ADSCC to expand its stem cell therapy options using Pluristem’s novel PLX cells, while enabling Pluristem to leverage ADSCC’s nebulizer administration experience to develop a new treatment delivery model for PLX cells. ADSCC has reported effectively using nebulizers to treat patients suffering from COVID-19 infection with stem cells sourced from the patient’s own blood.
Further discussions for additional projects are underway, including for the potential collaboration in chronic Graft Versus Host Disease (cGvHD), a life-threatening immune response of the donor’s stem cells against the host (patient).
The parties presented the joint projects to a distinguished audience at the Malta Conferences Foundation, including Nobel Laureates, scientists, and diplomats.
The foundation’s mission is to address the shared desire to improve the quality of life and political stability in the Middle East by identifying unique opportunities for collaboration to meet the scientific and technological challenges of the region.
“I am delighted by the opportunity to convene this important meeting.
The Malta Conferences are the only platform in the world where scientists from 15 Middle East countries, Morocco and Pakistan can get together under the same roof with several Nobel Laureates. They develop collaborations and friendship which overcome the chasms of distrust and intolerance.” said Prof. Zafra Lerman, President of Malta Conferences Foundation.
“Embarking on this journey with Pluristem, to overcome one of this generation’s most complex medical challenges, marks an exciting new chapter full of possibilities when it comes to knowledge sharing and medical innovation. Our partnership speaks volumes about the power of collaboration between partners across previously divided borders.
While we simply do not yet know the long-term impact, the novel coronavirus will have on recovered patients, by working together we believe that we are able to leverage the best medical technologies and minds in the region to develop solutions to prevent and treat the lingering symptoms and long-term complications that are emerging,” said Dr. Yendry Ventura, General Manager of ADSCC.
“We were very honored to unveil our first joint projects with the ADSCC at the Malta Conferences Foundation. We see our partnership as a movement between Israel and the UAE, which we hope will lay the foundation for future collaborations that will help potentially bring change to our region and the entire world. As we work together to develop regenerative medicine for key unmet medical needs of benefit to patients around the world, we are excited for the future and its possibilities,” stated Pluristem CEO and President Yaky Yanay.
‘Two world-class players in the field of cell therapy join forces and cooperate on the fight of COVID-19. May this courageous cooperation serve as an example to the world,” says kENUP Foundation’s Executive Chairman, Holm Keller.
The foundation’s mission is to address the shared desire to improve quality of life and political stability in the Middle East by identifying unique opportunities for collaboration to meet the scientific and technological challenges of the region.
The Malta Conferences deal with issues of science education, air and water quality, and alternative energy sources, among other topics of mutual interest.
Global leaders have recognized that science diplomacy is an extremely important mechanism for working toward stability in the Middle East, and this is what the Malta Conferences have done for the past 17 years.
Abu Dhabi Stem Cells Center (ADSCC) is an Abu Dhabi-based specialist healthcare center focused on cell therapy and regenerative medicine, as well as delivering cutting-edge research on stem cells in the region.
The Center was founded in March 2019 to meet growing domestic and regional demand for highly specialized medical services and treatments.
Equipped with the latest technologies, medical devices which are unique to the region, and a team of internationally recognized doctors working hand in hand with researchers, ADSCC is the first of its kind in the UAE. ADSCC specialties include immunology, hematology, clinical stem cell therapy, molecular biology, immunotherapy, orthopedics, and urology – amongst others.
kENUP is a global partnership in innovation, promoting research-based innovation for Europe with public and societal benefit.
It is a not-for-profit organization established as a foundation in the Republic of Malta by Public Deed on November 6, 2014. kENUP’s activities are published in the European Transparency Register.
The Foundation supports European corporations active in industries with substantive underlying market failures by preparing corporate innovation programs for an investment by the European Investment Bank (EIB), or by other public investment banks in the EU, often in close collaboration with private or venture investors.
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 first project with ADSCC and that such collaboration will allow ADSCC to expand its stem cell therapy options using its novel PLX cells, while enabling it to leverage ADSCC’s nebulizer administration experience to develop a new treatment delivery model for PLX cells, potential future projects with ADSCC, including the potential collaboration in chronic GvHD, the belief that it and ADSCC are able to leverage the best medical technologies and minds in the region to develop solutions to prevent and treat the lingering symptoms and long-term complications that are emerging and that it sees its partnership with ADSCC as a movement between Israel and the UAE, which it hopes will lay the foundation for future collaborations that will help potentially bring change to its region and the entire world. These forward-looking statements and their implications are based on the current expectations of the management of Pluristem only, and are subject to a number of factors and uncertainties that could cause actual results to differ materially from those described in the forward-looking statements.
The following factors, among others, could cause actual results to differ materially from those described in the forward-looking statements: changes in technology and market requirements; Pluristem may encounter delays or obstacles in launching and/or successfully completing its clinical trials; Pluristem’s products may not be approved by regulatory agencies, Pluristem’s technology may not be validated as it progresses further and its methods may not be accepted by the scientific community; Pluristem may be unable to retain or attract key employees whose knowledge is essential to the development of its products; unforeseen scientific difficulties may develop with Pluristem’s process; Pluristem’s products may wind up being more expensive than it anticipates; results in the laboratory may not translate to equally good results in real clinical settings; results of preclinical studies may not correlate with the results of human clinical trials; Pluristem’s patents may not be sufficient; Pluristem’s products may harm recipients; changes in legislation may adversely impact Pluristem; inability to timely develop and introduce new technologies, products and applications; loss of market share and pressure on pricing resulting from competition, which could cause the actual results or performance of Pluristem to differ materially from those contemplated in such forward-looking statements.
Except as otherwise required by law, Pluristem undertakes no obligation to publicly release any revisions to these forward-looking statements to reflect events or circumstances after the date hereof or to reflect the occurrence of unanticipated events.
For a more detailed description of the risks and uncertainties affecting Pluristem, reference is made to Pluristem’s reports filed from time to time with the Securities and Exchange Commission.
Dana Rubin
Director of Investor Relations 972-74-7107194
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