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HAIFA, Israel, April 29, 2021 – Pluristem Therapeutics Inc. (Nasdaq:PSTI) (TASE: PSTI), a leading regenerative medicine company, today reported positive topline results in its first study to evaluate the safety and exploratory efficacy of PLX-R18 in humans.
The company’s Phase I, open-label, dose-escalation study is evaluating the safety and exploratory efficacy of intramuscular injections of PLX-R18 in subjects with incomplete hematopoietic recovery following Hematopoietic Cell Transplantation (HCT).
Pluristem CEO and President, Yaky Yanay, said, “The promising topline results demonstrate insight into how PLX cells may provide a more effective therapeutic benefit than current technologies.
We believe that PLX-R18 affects the regeneration activity of the hematopoietic cells. By supporting blood cell lineage’s recovery, this approach could be used to address a variety of hematological deficiencies.
We intend to push forward the clinical development of PLX-R18 with the goal of establishing it as the new standard of care in the field.”
Poor graft function is a life-threatening complication for patients undergoing HCT.
Current standard-of-care treatments do not develop satisfactory blood counts in some or all blood cell lineages.
Consequently, patients are vulnerable to bleeding and recurrent infections, and require repeated costly transfusions of blood products, which only provide a short-term effect.
Pluristem’s PLX-R18 aims to improve the standard of care by stimulating the regenerative potential of the bone marrow.
This potentially enhances the production of all three blood cell lineages, differentiating it from other products which target only one of the three blood cell lineages.
The study enrolled 21 patients in the U.S. and Israel, who were at least three months after the HCT procedure (median: 236 days), and had low blood counts in at least one blood cell lineage. They were assigned to one of three treatment arms: 1 million cells/kg, 2 million cells/kg or 4 million cells/kg. Each patient received two treatments of the assigned dose.
The results demonstrate that PLX-R18 has the potential to stimulate the implanted hematopoietic cells to realize their therapeutic potential and generate improved blood counts over the long term in all three blood cell lineages at once – a meaningful advantage over other existing and proposed treatments.
Available data1 at six-month follow-up demonstrates:
The study supports previous preclinical results, conducted via the U.S. Food and Drug Administration’s (FDA) Animal Rule in collaboration with the U.S. National Institutes of Health (NIH), in which PLX-R18 was found effective in treating bone marrow failure from Acute Radiation Syndrome (ARS).
PLX-R18 is the first product candidate manufactured using Pluristem’s proprietary serum-free media on its 3D bioreactor system.
The company will conduct an analyst and investor call on May 3, 2021, at 10am EDT, for registration: https://Veidan.activetrail.biz/pluristem
1 Data from the six-month follow-up is available for 14 of the 21 treated patients: one patient was terminated early, three patients missed the 6-month visit and three died prior to the 6-month visit (two fatal events in the 2 million cell dose, and one fatal event in the 4 million cell dose).
All fatal events in the study were considered unrelated to the study treatment.
Mortality rates were in line with publicly available information (references: Gao et al 2020, , Halahleh et al 2021, Tang et al 2018, Sun et al. 2015, Zhao et al 2019)
Pluristem Therapeutics Inc. is a leading regenerative medicine company developing novel placenta-based cell therapy product candidates.
The Company has reported robust clinical trial data in multiple indications for its patented PLX cell product candidates and is currently conducting late-stage clinical trials in several indications.
PLX cell product candidates are believed to release a range of therapeutic proteins in response to inflammation, muscle trauma, hematological disorders and radiation damage.
The cells are grown using the Company’s proprietary three-dimensional expansion technology and can be administered to patients off-the-shelf, without tissue matching.
Pluristem has a strong intellectual property position; a Company- owned and operated GMP-certified manufacturing and research facility; strategic relationships with major research institutions; and a seasoned management team.
This press release contains express or implied forward-looking statements within the Private Securities Litigation Reform Act of 1995 and other U.S. Federal securities laws.
For example, Pluristem is using forward-looking statements when it discusses that PLX cells may provide a more effective therapeutic benefit than current technologies, that PLX-R18 may potentially enhance the production of three blood cell lineages, the belief that PLX-R18 affects the regeneration activity of the hematopoietic cells and its intention to push forward with the clinical development of PLX-R18 with the goal of establishing it as the new standard of care in the field.
These forward-looking statements and their implications are based on the current expectations of the management of Pluristem only, and are subject to a number of factors and uncertainties that could cause actual results to differ materially from those described in the forward-looking statements.
The following factors, among others, could cause actual results to differ materially from those described in the forward-looking statements: changes in technology and market requirements; Pluristem may encounter delays or obstacles in launching and/or successfully completing its clinical trials; Pluristem’s products may not be approved by regulatory agencies, Pluristem’s technology may not be validated as it progresses further and its methods may not be accepted by the scientific community; Pluristem may be unable to retain or attract key employees whose knowledge is essential to the development of its products; unforeseen scientific difficulties may develop with Pluristem’s process; Pluristem’s products may wind up being more expensive than it anticipates; results in the laboratory may not translate to equally good results in real clinical settings; results of preclinical studies may not correlate with the results of human clinical trials; Pluristem’s patents may not be sufficient; Pluristem’s products may harm recipients; changes in legislation may adversely impact Pluristem; inability to timely develop and introduce new technologies, products and applications; loss of market share and pressure on pricing resulting from competition, which could cause the actual results or performance of Pluristem to differ materially from those contemplated in such forward-looking statements.
Except as otherwise required by law, Pluristem undertakes no obligation to publicly release any revisions to these forward-looking statements to reflect events or circumstances after the date hereof or to reflect the occurrence of unanticipated events.
For a more detailed description of the risks and uncertainties affecting Pluristem, reference is made to Pluristem’s reports filed from time to time with the Securities and Exchange Commission.
Dana Rubin
Director of Investor Relations 972-74-7107194
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
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