HAIFA, Israel, July 13, 2022 – Pluristem Therapeutics Inc. (Nasdaq:PSTI) (TASE:PSTI) (“Pluristem” or the “Company”), a leading biotechnology company, today announced topline results from its multinational double-blind, placebo-controlled phase III study. The Company designed the study to determine the efficacy, safety, and tolerability of intramuscular administration of allogeneic PLX-PAD cells for the treatment of muscle injury following arthroplasty for hip fracture. The study enrolled 240 patients in the United States, Europe, and Israel.
PLX-PAD was demonstrated to be an effective accelerator of muscle strength and regeneration. A significant increase in Hip Abduction Strength (HAS) was observed at week 26 and week 52 for patients treated with PLX-PAD (n=120), in the injured leg (p=0.047, p=0.0022) and uninjured leg (p=0.073, p=0.0046) compared to placebo (n=120).
This new data confirms the results demonstrated in Pluristem’s phase I/II study.
The study did not meet the primary endpoint, which was the Short Physical Performance Battery (SPPB) test at week 26. The SPPB is a series of physical performance tests used in older persons to assess lower extremity function and mobility.1
PLX-PAD was well tolerated and demonstrated a significant increase in HAS:
1 https://sppbguide.com/
The increase in HAS was further supported by a positive trend in a 6-minute walk test at week 52, showing an increase in walking distance:
Professor Tobias Winkler from the Center for Musculoskeletal Surgery, Charité Berlin, and the principal investigator of the study, stated: “I am very encouraged by these results. They confirm our phase I/II study results, now presented in an even older patient population with significantly more comorbidities, and I believe that this confirms that regenerative medicine is indeed effective in elderly people. We observed a significant increase in muscle strength, which we believe demonstrates PLX-PAD’s ability to trigger muscle regeneration and maintain it over time. As an orthopedic surgeon, I see this increase in muscle strength as meaningful clinical evidence that PLX-PAD can be potentially beneficial for sport-, surgery-, and traumatic muscle- related injuries.”
“We were pleased to learn that the data from this phase III study reinforced the data from the phase I/II study, with PLX-PAD demonstrating an increase in muscle strength,” said Pluristem Chief Executive Officer and President, Yaky Yanay.
“While we were disappointed that this significant benefit did not translate to an SPPB score improvement, Pluristem will seek further regulatory advice to find a way to bridge the gap between the clear impact on muscle strength and the functionality score. We believe that we have an important responsibility to make this treatment available for patients, and we will explore business opportunities and partnerships to advance the development of this product candidate.”
Pluristem is pushing the boundaries of science and engineering to produce cell-based products for various industries on a global scale.
Pluristem currently operates in the regenerative medicine and food tech sectors and aims to establish partnerships that leverage the company’s cell-based technology platform. Pluristem’s placental cell-based therapies show potentially groundbreaking applications for treating damaged muscle, hematology deficiencies, and inflammation.
The Company recently launched a landmark collaboration to produce cultured food products with sustainability as a guiding principle.
This Phase III study is a global, multicenter, randomized, double-blind, placebo-controlled study, designed to evaluate the efficacy, safety, and tolerability of intramuscular administration of allogeneic PLX-PAD cells in patients undergoing hip arthroplasty following fracture. 240 patients were enrolled in clinical study sites in the United States, Europe, and Israel.
The completed Phase I/II double-blind placebo controlled study demonstrated a statistically significant improvement in muscle strength and volume in patients treated with PLX-PAD who underwent total hip replacement surgery due to osteoarthritis.
PLX-PAD cells exhibit regenerative potential due to their capacity to release factors in response to distress signals from tissues that have been damaged by muscle trauma, ischemia, or inflammation. These factors harness the body’s repair mechanisms to support tissue regeneration and differentiation. PLX-PAD cells also exhibit immune-modulating capabilities, playing a central role in the body’s response to tissue injury.
In addition to muscle recovery following surgery for hip fracture, PLX-PAD is currently being studied in an investigator-initiated Phase I/II study conducted by Tel Aviv Sourasky Medical Center (Ichilov Hospital) for the treatment of steroid-refractory chronic graft versus host disease (cGvHD).
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 belief that the study results demonstrate PLX-PAD’s ability to trigger muscle regeneration and maintain it over time, that the increase in muscle strength demonstrated in the study is meaningful clinical evidence that PLX- PAD can be potentially beneficial for a variety of injuries, the belief that the study results confirm that regenerative medicine is indeed effective in elderly people, that Pluristem will seek further regulatory advice to find a way to bridge the gap between the study results showing a clear impact on muscle strength and the functionality score, its belief that it has an important responsibility to make PLX-PAD available for patients, and that it intends to explore business opportunities and partnerships to advance the development of its product candidate.
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.
Investors investor.relations@pluristem.com
U.S. Press
Meira Feinman at meira@miller-ink.com Tara DiMaio at tara.dimaio@miller-ink.com Israel Press
Shachar Yental at shacharye@gitam.co.il
Closing Bell Ringing Ceremony Will Take Place on Monday, March 28 at 3:45 pm ET at Nasdaq MarketSite in Times Square, New York
A live stream of the Nasdaq Closing Bell will be available at:
https://livestream.com/accounts/27896496/events/10177910
Haifa, Israel, March 28, 2022 —Pluristem Therapeutics Inc. (Nasdaq: PSTI) (TASE: PSTI) (“Pluristem”), a leading biotechnology company, and Tnuva Group (“Tnuva Group” or “Tnuva”), Israel’s largest food producer, today announced that Pluristem’s CEO and President Yaky Yanay and Tnuva Group’s Chairman, Haim Gavrieli, will ring the Closing Bell at Nasdaq MarketSite in Times Square, New York. The ceremony, in honor of the companies’ launch of an innovative collaboration to develop, manufacture and commercialize cultured cell-based products for the food industry, will take place on Monday, March 28, 2022 at 3:45 pm ET.
“We are honored to celebrate this important collaboration between Pluristem and Tnuva at Nasdaq,” said Yaky Yanay, CEO and President of Pluristem. “Over the years, Pluristem has developed one of the most advanced cell-based technology platforms, offering mass-scale, cost- effective, consistent cell production. During the last year, we made our strategy more precise, with the goal of leveraging our technology and expertise through partnerships to create cell- based products for a variety of industries. We are proud to join forces with a market leader, Tnuva Group, as they bring 96 years of experience in consumer food brands and innovation to the table.”
Haim Gavrieli, Chairman of Tnuva Group: “I am excited to note the groundbreaking collaboration between Pluristem and Tnuva Group. Through this joint venture, Tnuva is realizing its vision to become a leader in multiple fields, including food tech and protein substitutes. We believe this step will enable us to remain the leading food company in Israel and to expand globally. We are confident that together, the companies will revolutionize the cultured food industry.”
Zami Aberman, Chairman of Pluristem: “As Pluristem continues its cutting-edge work in the medical field, we also look to establish new partnerships that leverage our cell-based technology platform to advance other industries. Tnuva is an ideal collaborator in the food tech space and we believe that the two companies will lead the charge in creating high-quality, affordable, and accessible cultured meat for consumers with the new joint venture.”
Eyal Malis, CEO of Tnuva Group: “Tnuva Group has decades of experience developing and marketing innovative products for the Israeli market, leads the alternative protein market in Israel, and has recently taken its expertise globally. We chose to collaborate with Pluristem because we believe it owns one of the most advanced cell production technologies in the world. We expect the collaboration between the companies to revolutionize the cultured food industry and develop the next generation of alternative proteins.”
Pluristem (Nasdaq: PSTI) is pushing the boundaries of science and engineering to produce cell-based products for various industries on a global scale. Pluristem currently operates in the regenerative medicine and food tech sectors and aims to establish partnerships that leverage the company’s cell- based technology platform. Pluristem’s placental cell-based therapies show potentially groundbreaking applications for treating damaged muscle, hematology deficiencies, and inflammation. The Company recently launched a landmark collaboration to produce cultured food products with sustainability as a guiding principle. To learn more, visit us at www.pluristem.com or follow us on LinkedIn and Twitter @Pluristem.
Tnuva Group is the largest food producer in Israel, as well as the Israeli leader in the field of alternative dairy and protein products.
Tnuva was founded 96 years ago and currently employs 6,000 workers in 32 sites across Israel, with annual revenues of above 2 billion dollars. Tnuva’s investment fund, ‘Tnuva NEXT’, functions as a CVC fund.
Tnuva takes part in the establishment of advanced food tech platforms in Israel, including ‘Fresh Start,’ an innovative food tech incubator in Northern Israel with the goal of future development of the Israeli food industry.
The incubator, established in collaboration with the Israel Innovation Authority, Tempo, the investment platform Our Crowd, and the American investment fund Finistere, specializes in locating and accompanying groundbreaking Israeli food technologies.
Tnuva’s strategy is to invest in companies that are synergetic to Tnuva’s core fields that will produce value while acquiring production and marketing rights.
Tnuva brings beneficial expertise to collaborations with other start-ups, including its deep familiarity with the Israeli consumer, R&D capabilities, the largest distribution platform in Israel, as well as a direct sale platform for customers, access to the local and global markets and international partners, and a long list of well-known and loved brands.
Tnuva had recently signed a know-how licensing agreement with Swiss retail giant Migros, under which Tnuva will help the Swiss company to produce dairy alternatives.
This press release contains express or implied forward-looking statements within the Private Securities Litigation Reform Act of 1995 and other U.S. Federal securities laws.
For example, Pluristem is using forward-looking statements when it discusses the potential benefits to be realized by the collaboration, that it will revolutionize the cultured food industry with Tnuva Group.
These forward-looking statements and their implications are based on the current expectations of the management of Pluristem only and are subject to several 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 about Pluristem or the collaboration: changes in technology and market requirements; either may encounter delays or obstacles in launching and/or successfully completing its clinical trials, if necessary; their products may not be approved by regulatory agencies, their technology may not be validated as they progress further and their methods may not be accepted by the scientific community; they may be unable to retain or attract key employees whose knowledge is essential to the development of their products; unforeseen scientific difficulties may develop with their processes; their products may wind up being more expensive than they anticipate; results in the laboratory may not translate to equally good results in real clinical settings; their patents may not be sufficient; their products may harm recipients or consumers; changes in legislation with an adverse impact; 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 or the collaboration 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.
Investors investor.relations@pluristem.com
U.S. Press and Media Meira Feinman, Miller Ink Meira@miller-ink.com
Shachar Yental, Gitam Porter Novelli shacharye@gitam.co.il
Noy Kedem Madmon, Chief Communications Officer noyke@tnuva.co.il
HAIFA, Israel, March 23, 2022 – Pluristem Therapeutics Inc. (Nasdaq: PSTI) (TASE: PSTI), a leading biotechnology company developing novel cell therapies, today announced positive final results from its innovative hematology Phase I study to evaluate the safety and exploratory efficacy of intramuscular injections of PLX-R18 in subjects with incomplete hematopoietic recovery following HCT.
Incomplete hematopoietic recovery, or poor graft function (PGF), is a life-threatening complication for patients undergoing HCT. Current standard-of-care treatments do not result in 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 short-term benefits.
Data collated 12 months post-treatment with PLX-R18 demonstrate that:
1 When compared to data obtained from the CIBMTR registry during a 12-month interval from first observation. First observation was defined as the day of first PLX-R18 treatment for the Phase I patients and as day 100 post-HCT for the CIBMTR population. See About the CIBMTR for more details.
PLX-R18 cell therapy was previously granted an orphan drug designation by the FDA for the treatment of graft failure and incomplete hematopoietic recovery following HCT and for ARS. The final results of the Phase I study reinforce the preclinical results of studies conducted under the FDA’s Animal Rule, in collaboration with the U.S. National Institutes of Health (NIH) and the U.S. Department of Defense (DOD), in which PLX-R18 was found to be effective in supporting the recovery of bone marrow failure resulting from ARS. In addition, the FDA previously cleared Pluristem’s IND application for PLX-R18 in the treatment of ARS. The IND allows Pluristem to treat victims who may have been acutely exposed to high dose radiation due to a nuclear attack or accident.
“PLX-R18 aims to improve the standard of care by stimulating the regenerative potential of the bone marrow, and we are gratified by results that I believe show we are on track to do so,” said Pluristem Chief Executive Officer and President Yaky Yanay. “A quick and effective way to improve the hematological profile of sick patients— resulting in faster recovery and decreased transfusions—would be a game-changer for the field, and we will continue to explore its clinical applications. The FDA’s recognition of PLX-R18’s potential to treat ARS is also significant. This treatment potentially carries great significance for current events in Ukraine and Europe, providing hope for treatment in the case of a nuclear event. We are proud of this product line, which might hold the key to promoting wellbeing, improving the standard of care, and possibly saving lives.”
Pluristem is pushing the boundaries of science and engineering to produce cell-based products for various industries on a global scale. The Company’s cell manufacturing platform is a patented and validated 3D cell expansion system, which is uniquely precise, cost-effective, and consistent from batch to batch. Pluristem currently operates
1 When compared to data generated from the CIBMTR registry during a 12-month interval from first observation. First observation was defined as the day of first PLX-R18 treatment for the Phase I patients and as day 100 post-HCT for the CIBMTR population. See About the CIBMTR for more details.
in the regenerative medicine and food tech sectors and aims to establish partnerships that leverage the Company’s cell-based technology platform for additional applications. Pluristem’s placental cell-based therapies advance the field of regenerative medicine, with potentially groundbreaking applications for treating damaged muscle, hematology deficiencies, and inflammation. The Company also recently launched a landmark collaboration with Israeli food giant Tnuva to produce cultured food products with sustainability as a guiding principle.
This Phase I study was designed as a multi-center, open-label, dose-escalating study to evaluate the safety of intramuscular (IM) injections of PLX-R18 cells in 21 patients with incomplete hematopoietic recovery/PGF persisting for at least three months after HCT. The follow-up period for safety was 12 months. Patients in the study were enrolled into one of three chronological treatment groups receiving two administrations, 1 week apart, of PLX-R18 at a dose of 1 million PLX-R18 cells/kg (n=3), 2 million PLX-R18 cells/kg (n=6), or 4 million PLX-R18 cells/kg (n=12). The primary endpoint was safety, and it was assessed throughout the study, and specifically at the end of each cohort, by an external DSMB. In addition, exploratory efficacy variables were collected, including changes in blood counts, transfusion frequency, and a shift from transfusion dependence to transfusion independence.
The PLX-R18 cell therapy product secretes a combination of cytokines, including IL-6, IL 8, SCF, G-CSF, MCP1, and Gro-β, and is designed to stimulate the regeneration of damaged bone marrow to produce blood cells lineages (white, red, and platelets). As efficacy studies are not permitted in humans for the ARS indication, pre-clinical studies were conducted via the FDA animal rule pathway to evaluate Pluristem’s PLX-R18 as a medical countermeasure for that indication. These studies were conducted and funded by the U.S. government (NIH, DOD).
The Center for International Blood and Marrow Transplant Research is a nonprofit research collaboration between the National Marrow Donor Program (NMDP)/Be The Match, in Minneapolis, and the Medical College of Wisconsin, in Milwaukee. The CIBMTR collaborates with the global scientific community to increase survival and enrich the quality of life for patients. The CIBMTR facilitates critical observational and interventional research through scientific and statistical expertise, a large network of centers, and a unique database of long-term clinical data for more than 600,000 people who have received HCT and other cellular therapies. Learn more at cibmtr.org or follow the CIBMTR on Facebook, LinkedIn, or on Twitter.
From the CIBMTR registry, Pluristem selected patients aged ≥18 years at time of first allogeneic HCT for a hematologic malignancy in the United States between January 2017 and June 2020 with characteristics as similar as possible to the patients treated with PLX R18 in the Phase I study. Such values include full donor chimerism at ≤30 days post-HCT, disease in remission at 100 days post-HCT, and no active Grade III/IV acute GVHD or severe chronic GVHD or CMV infection ≤30 days post-HCT. These patients were classified as PGF based on platelet count <50 × 109 cells/L by day 100 post-HCT. Mortality rates for this group were then compared to a comparable subset of the Phase I (n=17) study who had platelet count <50 × 109 cells/L at study baseline and were <300 days post-HCT.
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 safety, efficacy and benefits of PLX-R18 and that it aims to provide the standard of care and is on track to do so and the potential significance of PLX-R18 in case of a nuclear event.
These forward-looking statements and their implications are based on the current expectations of Pluristem’s management 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.
investor.relations@pluristem.com
Meira Feinman, Miller Ink meira@miller-ink.com
Tara DiMaio, Miller Ink tara.dimaio@miller-ink.com
Shachar Yental, Gitam Porter Novelli shacharye@gitam.co.il
HAIFA, Israel, Mar. 8, 2022 – Pluristem Therapeutics Inc. (Nasdaq: PSTI) (TASE: PSTI), a leading biotechnology company (“Pluristem”), and Tnuva Group (“Tnuva Group” or “Tnuva”), Israel’s largest food producer, today jointly announced the appointment of Eyal Rosenthal as Chief Executive Officer of their landmark joint venture to develop, manufacture and commercialize cultured meat.
Mr. Rosenthal is a seasoned entrepreneur and visionary leader in the agritech and food tech industries, serving until recently as venture partner and head of Israeli operations at Finistere Ventures, a pioneering global venture fund dedicated to identifying and nurturing promising agribusiness and food tech companies. He brings to his role over two decades of leadership within business, food tech, agriculture investment and sustainability, and will oversee the new venture’s growth into a scaled company.
Mr. Rosenthal also served as Executive Chairman of Fresh Start, a leading global food tech incubator backed by the Israel Innovation Authority, as well as top strategic and financial players. He was previously Managing Director at Infinity Group, a $600 million growth fund, and advised the International Finance Corporation, a World Bank Group member, on global food security issues.
The joint venture, which was incorporated through an agreement between Pluristem and Tnuva, has exclusive licensing rights to use Pluristem’s state-of-the-art proprietary technology and intellectual property to develop, manufacture and commercialize cultured meat.
It combines Pluristem’s technological advantage in mass-scale, cost-effective cell production with Tnuva’s expertise in food sector research and development (R&D), consumer marketing, and distribution.
“Food tech is on the rise and I am excited to be joining this new venture as we aim to transform the food system, especially the way we produce meat,” said Mr. Rosenthal. “Cultured meat can potentially address consumer concerns about our food system —from health to sustainability to animal welfare—and we are uniquely positioned to deliver. Pluristem’s unique proprietary technology, combined with Tnuva’s market leadership in alternative protein, manufacturing expertise and robust logistics, brands and infrastructure, can potentially enable us to overcome some of the biggest market challenges such as producing cost-effective products and mass-scale production,” concluded Mr. Rosenthal.
“We believe that Eyal will position us as a leader in the global food tech industry,” said Yaky Yanay, Chief Executive Officer and President of Pluristem. “His business and technology background combined with his expertise in the food sector will make him a powerful force for ingenuity. We are excited to bring Eyal on board to a talented team of innovators that will propel us into the future of food.”
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“Eyal is a food tech veteran and has an impressive track record as a trailblazer in the industry,” said Eyal Malis, Chief Executive Officer of Tnuva Group. “Making cultured meat accessible to every household is our vision and we believe Eyal’s experience can turn it into a reality. Eyal reached extraordinary achievements following the foundation of the “Fresh Start” incubator, which currently operates a number of unique start-ups that will put Israel on the global food innovation map. Alternative meat is estimated to be a $140 billion market by 20301 and we are happy to be part of this growing industry.”
Tnuva Group is the largest food producer in Israel, as well as the Israeli leader in the field of alternative dairy and protein products.
Tnuva was founded 96 years ago and currently employs 6,000 workers in 32 sites across Israel, with annual revenues of above 2 billion dollars.
Tnuva’s investment fund, ‘Tnuva NEXT’, functions as a CVC fund. Tnuva takes part in the establishment of advanced food tech platforms in Israel, including ‘Fresh Start,’ an innovative food tech incubator in Northern Israel with the goal of future development of the Israeli food industry. The incubator, established in collaboration with the Israel Innovation Authority, Tempo, the investment platform Our Crowd, and the American investment fund Finistere, specializes in locating and accompanying groundbreaking Israeli food technologies.
Tnuva’s strategy is to invest in companies that are synergetic to Tnuva’s core fields, that will produce value while acquiring production and marketing rights.
Tnuva brings beneficial expertise to collaborations with other start-ups, including its deep familiarity with the Israeli consumer, R&D capabilities, the largest distribution platform in Israel and also a direct sale platform for customers, access to the local and global markets and international partners, and a long list of well-known and loved brands.
Tnuva had recently signed a know-how licensing agreement with Swiss retail giant Migros, under which Tnuva will help the Swiss company to produce dairy alternatives.
Pluristem is pushing the boundaries of science and engineering to create cell-based products for commercial use. The Company’s cell therapies advance the field of regenerative medicine, with potentially groundbreaking applications for treating damaged muscle, hematology deficiencies, and inflammation. Pluristem sources its therapeutic cells from the placenta, an ethically accepted and potent source. The Company’s manufacturing platform, the bioreactor, is a patented and validated state-of-the-art 3D cell expansion system. Pluristem’s method is uniquely accurate, cost-effective, and consistent from batch to batch. The collaboration with Tnuva supports Pluristem’s continued strategy to establish partnerships leveraging Pluristem’s cell-based technology platform.
1 “The future of food”, 4 May 2021, Barclays news
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 growth of the alternative cultured meat industry, the potential benefits that may be derived from cultured meat products and the belief that Pluristem’s unique proprietary technology, and Tnuva’s market leadership, potentially allows the joint venture to overcome market challenges.
These forward-looking statements and their implications are based on the current expectations of the management of Pluristem only and are subject to a number of factors and uncertainties that could cause actual results to differ materially from those described in the forward-looking statements.
The following factors, among others, could cause actual results to differ materially from those described in the forward-looking statements: changes in technology and market requirements; Pluristem may encounter delays or obstacles in launching and/or successfully completing its clinical trials; Pluristem’s products may not be approved by regulatory agencies; Pluristem’s technology may not be validated as it progresses further and its methods may not be accepted by the scientific community; Pluristem may be unable to retain or attract key employees whose knowledge is essential to the development of its products; unforeseen scientific difficulties may develop with Pluristem’s process; Pluristem’s products may wind up being more expensive than it anticipates; results in the laboratory may not translate to equally good results in real clinical settings; results of preclinical studies may not correlate with the results of human clinical trials; Pluristem’s patents may not be sufficient; Pluristem’s products may harm recipients; changes in legislation may adversely impact Pluristem; inability to timely develop and introduce new technologies, products and applications; loss of market share and pressure on pricing resulting from competition, which could cause the actual results or performance of Pluristem to differ materially from those contemplated in such forward-looking statements.
Except as otherwise required by law, Pluristem undertakes no obligation to publicly release any revisions to these forward-looking statements to reflect events or circumstances after the date hereof or to reflect the occurrence of unanticipated events.
For a more detailed description of the risks and uncertainties affecting Pluristem, reference is made to Pluristem’s reports filed from time to time with the Securities and Exchange Commission.
Contacts:
Investors
investor.relations@pluristem.com
U.S. Press and Media Meira Feinman, Miller Ink Meira@miller-ink.com
Shachar Yental, Gitam Porter Novelli shacharye@gitam.co.il
Noy Kedem Madmon, Chief Communications Officer noyke@tnuva.co.il
HAIFA, Israel, March 2, 2022 – Pluristem Therapeutics Inc. (Nasdaq: PSTI) (TASE: PSTI), a leading biotechnology company, today issued an update to its shareholders from its Chief Executive Officer and President, Yaky Yanay.
Dear Shareholders,
As I look ahead, I am more confident about the direction of Pluristem than ever before. We believe that our state-of-the-art cell expansion platform has the potential for high demand in the medical field and beyond. Our proven technology is well-positioned to develop high quality cell-based products for a range of emerging industries. This strategy is already bearing fruit – or should I say, meat.
We recently closed a partnership with Israel’s largest food producer, Tnuva, to develop cultured food.1 This is yet another example of Pluristem using cell technology to solve a global challenge: feeding the planet. The goal is to produce food that will be of the highest quality and nutritional value. Cultured meat offers a sustainable option in light of growing environmental concerns with livestock farming. If produced at mass scale with cost-effective methods, it can pave the way to a healthier food supply.2 Pluristem’s unique technology and expertise could make us a leader in this field, as the partnership plans to present proof of concept in 2022 with the goal of launching its first raw cultured meat product in 2023.
We have a robust pipeline of cell therapy candidates that have the potential to revolutionize the standard of medical care. In the next month, we expect to report final results of our Phase I study to support recovery following hematopoietic cell transplantation. We also plan to release topline results from our multinational Phase III study for muscle regeneration following hip fracture surgery during the third calendar quarter of 2022. An additional clinical hematological study is anticipated later this year and we plan to advance the development of next generation products using cutting edge technologies such as CRISPR and induction.
Understanding that our technology may be suitable to a variety of cells, we began evaluating new applications where our platform can make a dramatic impact. We will identify verticals where we believe that we can offer a major advantage to industries that require cells and cell extract manufacturing. We are targeting collaborations with strategic partners who understand market demands and have access to a strong customer base. To help lead execution of this strategy, we recently brought on Chief Commercial Officer Nimrod Bar Zvi to strengthen our commercial activities.
I believe Pluristem’s future is bright. Our team has the talent, breadth, vision, and courage to create a transformative global impact. The world is just starting to see that there are major opportunities in cell technology. We believe this is Pluristem’s moment to seize, and I know we will rise to the occasion. Thank you for your commitment to our mission.
Best regards,
Yaky Yanay
Chief Executive Officer and President Pluristem Therapeutics Inc.
Pluristem is pushing the boundaries of science and engineering to create cell-based products for commercial use.
The Company’s cell therapies advance the field of regenerative medicine, with potentially groundbreaking applications for treating damaged muscle, hematology deficiencies, and inflammation.
Pluristem sources its therapeutic cells from the placenta, an ethically accepted and potent source.
The Company’s manufacturing platform is a patented and validated state-of- the-art 3D cell expansion system.
Pluristem’s method is uniquely accurate, cost-effective, and consistent from batch to batch.
The collaboration with Tnuva supports Pluristem’s strategy to establish partnerships leveraging Pluristem’s cell-based technology platform.
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 states that it believes that its state-of-the- art cell expansion platform has the potential for high demand in the medical field and beyond and that it can develop cell-based products for a range of emerging industries, the potential for it to be a leader in the cultured meat field, the expected timing of the proof of concept and launch of its first raw cultured meat product, the expected timing for the release of the results of its various studies and its intent to evaluate additional industries that may utilize its cell expansion platform.
These forward-looking statements and their implications are based on the current expectations of Pluristem’s management only and are subject to several 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, if necessary; its products may not be approved by regulatory agencies, its technology may not be validated as it progresses further and its methods may not be accepted by the scientific community; it 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 its processes; its products may wind up being more expensive than they anticipate; results in the laboratory may not translate to equally good results in real clinical settings; its patents may not be sufficient; its products may harm recipients or consumers; changes in legislation may have an adverse impact; its 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 its actual results or performance 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.
investor.relations@pluristem.com
Meira Feinman, Miller Ink Meira@miller-ink.com
Dan Chaison, Miller Ink dan.chaison@miller-ink.com
Shachar Yental, Gitam Porter Novelli shacharye@gitam.co.il
HAIFA, Israel, Feb. 24, 2022 – Leading biotechnology company Pluristem Therapeutics Inc. (Nasdaq: PSTI) (TASE: PSTI) (“Pluristem”) and Israel’s largest food producer Tnuva Group (“Tnuva”) announced today the closing of its landmark collaboration to develop, manufacture and commercialize cell-based products for the food industry. The collaboration is a major step forward to bringing sustainable cultured food to everyday consumers globally.
The closing of the deal marks the incorporation of a new company (“NewCo”) that will receive exclusive, global, royalty bearing licensing rights to use Pluristem’s proprietary technology, intellectual property, and knowhow, to be used in the field of cultured meat products of all kinds.
Tnuva invested $7.5 million in NewCo, according to a pre-money valuation of $40 million, and currently owns approximately 16% of NewCo, while Pluristem owns approximately 84% of NewCo’s outstanding shares. Tnuva has an option to invest up to an additional $7.5 million over the next 12 months.
The announcement of NewCo’s CEO is planned for March 2022.
# # #
Tnuva Group is the largest food producer in Israel, as well as the Israeli leader in the field of alternative dairy and protein products.
Tnuva Group has annual revenues of over $2 billion, 6,000 employees in 32 sites country wide.
The Tnuva brand can be found in almost every home and every meal in Israel, with the country’s largest distribution network for chilled and frozen products, including a wide range of dairy products, meat, eggs, fish, frozen vegetables, pastries, and frozen and chilled food. Tnuva holds Israel’s leading and most loved food brands in Israel, with approximately 4 million of Tnuva Group’s products sold daily.
Tnuva takes part in the establishment of advanced food tech platforms in Israel, including ‘FRESH START,’ an innovative food tech incubator in Northern Israel with the goal of future development of the Israeli food industry.
The incubator, established in collaboration with the Israel Innovation Authority, Tempo Beverages Ltd, the investment platform Our Crowd, and the American investment fund Finistere, specializes in locating and accompanying groundbreaking Israeli food technologies. Tnuva also supports innovative startups food companies, and academic researchers in Israel.
Tnuva has recently signed a know-how licensing agreement with Swiss retail giant “Migros”, under which Tnuva will help the Swiss company produce dairy alternatives.
Pluristem is pushing the boundaries of science and engineering to create cell-based products for commercial use.
The Company’s cell therapies advance the field of regenerative medicine, with potentially groundbreaking applications for treating damaged muscle, hematology deficiencies, and inflammation. Pluristem sources its therapeutic cells from the placenta, an ethically accepted and potent source.
The Company’s manufacturing platform is a patented and validated state-of- the-art 3D cell expansion system.
Pluristem’s method is uniquely accurate, cost-effective, and consistent from batch to batch.
The collaboration with Tnuva supports Pluristem’s strategy to establish partnerships leveraging Pluristem’s cell-based technology platform.
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 states that the collaboration is a major step forward to bringing affordable, sustainable cultured food to everyday consumers globally as well as the expected timing of the announcement of the CEO of NewCo. These forward-looking statements and their implications are based on the current expectations of the management of Pluristem only and are subject to several 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 about Pluristem or NewCo or the collaboration: changes in technology and market requirements; either may encounter delays or obstacles in launching and/or successfully completing its clinical trials, if necessary; their products may not be approved by regulatory agencies, their technology may not be validated as they progress further and their methods may not be accepted by the scientific community; they may be unable to retain or attract key employees whose knowledge is essential to the development of their products; unforeseen scientific difficulties may develop with their processes; their products may wind up being more expensive than they anticipate; results in the laboratory may not translate to equally good results in real clinical settings; their patents may not be sufficient; their products may harm recipients or consumers; changes in legislation with an adverse impact; 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, NewCo or the collaboration 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.
investor.relations@pluristem.com
Meira Feinman, Miller Ink Meira@miller-ink.com
Dan Chaison, Miller Ink dan.chaison@miller-ink.com
Shachar Yental, Gitam Porter Novelli shacharye@gitam.co.il
HAIFA, Israel, Jan. 10, 2022 – Pluristem Therapeutics Inc. (Nasdaq: PSTI) (TASE: PSTI) (“Pluristem” or “the Company”), a leading biotechnology company, and Tnuva Group (“Tnuva Group” or “Tnuva”), Israel’s largest food producer, (together, “Parties”) today announced the launch of an innovative collaboration to develop, manufacture and commercialize cultured cell-based products for the food industry. The collaboration started with the incorporation of a new company (“NewCo”), that will receive exclusive, global, royalty bearing licensing rights to use Pluristem’s proprietary technology, intellectual property and knowhow, to be used in the field of cultured meat.
Tnuva Group will invest $7.5 million in NewCo, according to a pre-money valuation of $40 million, with the option to invest up to an additional $7.5 million over a period of 12 months following the closing. NewCo will use its own funding and resources to promote its mission with a dedicated management team and staff, and Pluristem will support the establishment, research and development activities of NewCo pursuant to a services agreement.
Tnuva will provide the R&D platform to develop consumer products and will receive preferred marketing rights of any developed NewCo’s products in Israel.
Pluristem has the industry-leading capacity to design, develop, and manufacture cells for commercial use.
Over the last two decades, the Company developed a proprietary three- dimensional (3D) expansion platform that can produce high-quality cells in a cost-effective manner with batch-to-batch consistency.
According to both Parties’ estimates and plans, NewCo intends to present its technology Proof of Concept in 2022, with the goal of launching its first raw cultured meat product in 2023.
As part of the collaboration, the Parties may expand the collaboration to include cultured dairy and cultured fish products by establishing separate, new ventures.
Haim Gavrieli, Chairman of Tnuva Group: “Our collaboration with Pluristem is part of the execution of Tnuva Group’s strategy and vision.
Tnuva strives to lead the alternative protein industry in Israel and to continue to expand in the industry on a global scale.
We chose to collaborate with Pluristem because we believe it owns one of the most advanced cell production technologies in the world.
We expect the collaboration between the companies to revolutionize the cultured food industry and develop the next generation of alternative proteins.”
Zami Aberman, Chairman of Pluristem: “Both Parties are leading companies in their fields, each with proven experience and tremendous capabilities, and the collaboration between us holds vast potential to lead towards a better future for the food industry.
The collaboration with Tnuva supports Pluristem’s strategy to establish partnerships that leverage its cell-based technology platform. As we embark on this collaboration with Tnuva, Pluristem is still dedicated to its core business of developing cell therapy products.”
Yaky Yanay, CEO & President of Pluristem: “Over the years, Pluristem has developed one of the most advanced cell manufacturing platforms.
During the last year, we made our strategy more precise, with the goal of leveraging our technology and expertise through partnerships and collaborations.
Today, we are proud to join forces with a market leader, Tnuva Group, as they bring 96 years of experience in consumer food brands and innovation to the table.
We believe that Tnuva’s and Pluristem’s vast experience will support fast and effective development of large- scale cultured meat products, relying on our existing infrastructures and talented teams.
This collaboration is the first showcase of Pluristem’s intention to expand its business to verticals that need superior cell expansion proprietary technologies.”
Eyal Malis, CEO of the Tnuva Group: “Tnuva Group has decades of experience developing and marketing innovative products for the Israeli market.
Tnuva leads the alternative protein market in Israel and has recently taken its expertise globally.
Just as Tnuva made the field of alternative proteins accessible to every Israeli home, we intend to make cultured food products available to all.
The collaboration between two proven pioneers in their fields, each of which with proven experience and tremendous abilities, can create a better future for the food industry.”
Alternative meat is one of the fastest growing industries in the world and is estimated to be a $140 billion market by 20301. Affordable cultured food will require mass-produced, high-quality cells at competitive costs.
Pluristem to host online investor and analyst call on January 11, 2022 at 9:00 am EST (4:00 pm IST). Click here to register: https://veidan.activetrail.biz/pluristem
# # #
1 “The future of food”, 4 May 2021, Barclays news
About Tnuva Group
Tnuva Group is the largest food producer in Israel, as well as the Israeli leader in the field of alternative dairy and protein products.
Tnuva Group has annual revenues of over $2 billion, 6,000 employees in 32 sites country wide.
The Tnuva brand can be found in almost every home and every meal in Israel, with the country’s largest distribution network for chilled and frozen products, including a wide range of dairy products, meat, eggs, fish, frozen vegetables, pastries and frozen and chilled food.
Tnuva holds Israel’s leading and most loved food brands in Israel, with approximately 4 million of Tnuva Group’s products sold daily.
Tnuva takes part in the establishment of advanced food tech platforms in Israel, including ‘FRESH START,’ an innovative food tech incubator in Northern Israel with the goal of future development of the Israeli food industry.
The incubator, established in collaboration with the Israel Innovation Authority, Tempo Beverages Ltd, the investment platform Our Crowd, and the American investment fund Finistere, specializes in locating and accompanying groundbreaking Israeli food technologies.
Tnuva also supports innovative startups food companies, and academic researchers in Israel.
Tnuva has recently signed a know-how licensing agreement with Swiss retail giant “Migros”, under which Tnuva will help the Swiss company produce dairy alternatives.
About Pluristem
Pluristem is pushing the boundaries of science and engineering to create cell-based products for commercial use.
The Company’s cell therapies advance the field of regenerative medicine, with potentially groundbreaking applications for treating ischemia, damaged muscle, hematology deficiencies, and inflammation. Pluristem sources its therapeutic cells from the placenta, an ethically accepted and potent source.
The Company’s manufacturing platform is a patented and validated state-of-the-art 3D cell expansion system. Pluristem’s method is uniquely accurate, cost-effective, and consistent from batch to batch.
The collaboration with Tnuva supports Pluristem’s strategy to establish partnerships leveraging Pluristem’s cell-based technology platform.
Safe Harbor Statement
This press release contains express or implied forward-looking statements within the Private Securities Litigation Reform Act of 1995 and other U.S. Federal securities laws.
For example, Pluristem is using forward-looking statements when it discusses the expected contributions of each of the Parties with respect to the collaboration and NewCo, the expected timing of the presentation of the proof of concept and the goal for the timing of the launch of the first cultured meat product, the potential benefits to be realized by the collaboration and the potential for expanded collaboration with respect to cultured dairy and cultured fish products.
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 about Pluristem or NewCo or the collaboration: changes in technology and market requirements; either may encounter delays or obstacles in launching and/or successfully completing its clinical trials, if necessary; their products may not be approved by regulatory agencies, their technology may not be validated as they progress further and their methods may not be accepted by the scientific community; they may be unable to retain or attract key employees whose knowledge is essential to the development of their products; unforeseen scientific difficulties may develop with their processes; their products may wind up being more expensive than they anticipate; results in the laboratory may not translate to equally good results in real clinical settings; their patents may not be sufficient; their products may harm recipients or consumers; changes in legislation with an adverse impact; 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, NewCo or the collaboration 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, Pluristem
+972-74-7107194
Noy Kedem Madmon,
Chief Communications Officer, Tnuva Group
+972-50-5200509
HAIFA, Israel, Dec 27, 2021 – Pluristem Therapeutics Inc. (Nasdaq:PSTI) (TASE:PSTI) (the “Company”), a leading biotechnology company, today announced topline results from its Phase II dose escalation studies evaluating the safety and efficacy of intramuscular injections of PLX- PAD cells for the treatment of Acute Respiratory Distress Syndrome (ARDS) associated with COVID-19. The analysis is based on 89 patients enrolled in two Phase II studies in the U.S. (the “U.S. study”) and in Europe and Israel (collectively, the “EU study” and together with the U.S. study, the “Studies”).
The primary efficacy endpoint was the number of ventilator free days (VFD) from day 1 through day 28 of the Studies. VFD at day 60 and all-cause mortality at days 28 and 60 were part of the secondary efficacy endpoints in the Studies. The Studies did not meet the primary efficacy endpoint of statistically significant improvement of VFD at 28 days. Taking into consideration the baseline risk factors of the ARDS patients, no differences in the safety profile were observed between PLX-PAD and placebo.
In July 2021, Pluristem announced its decision to bring the Studies to early clinical readout based on 89 patients enrolled, instead of the originally planned 180 patients (140 in the U.S. study and 40 in the EU study).
The decision came in response to COVID-19’s evolution as a disease, and the significant changes in the standard of care, leading to an increase in the severity of conditions of the intubated patients.
These changes in the evolution of COVID-19 raised a major concern about the potential variability in the patient population in the Studies.
The early termination of recruitment led to a significant reduction in the statistical power of the Studies.
Efficacy trends from the Studies included:
Pluristem’s CEO and President, Yaky Yanay said: “Pluristem joined the global effort to fight the evolving and unexpected COVID-19 pandemic. We chose to focus on the most severe intubated patients suffering from ARDS associated with COVID-19, that have no viable treatment to date and are challenging healthcare systems worldwide.
With the new coming wave of the Omicron variant, we intend to explore the opportunities based on the efficacy trends obtained from the Studies.
I would like to thank everyone who has been involved in the Studies including the patients and their families, our investigators and study personnel, and the team at Pluristem for making extraordinary efforts to conduct these important studies during very challenging times.”
About the Studies:
The U.S. Study included 66 patients enrolled to a randomized, double-blind, placebo-controlled, multicenter, parallel-group study, with three treatment groups of PLX-PAD cells – single administration of 300 million cells, single administration of 600 million cells, or 300 million cells administered twice in a one-week interval; and two placebo control groups single administration, and two administrations in a one-week interval. All groups received a study treatment in addition to the best standard medical care according to local practices.
The EU Study enrolled 23 patients in Germany, Bulgaria, and Israel to a randomized, controlled, multicenter, parallel-group study with a single treatment group (single dose of 300 million PLX- PAD cells) in addition to best standard medical care according to local practices, and a control group received the best standard medical care according to local practices.
Pluristem is pushing the boundaries of science and engineering to reimagine pharmacological treatments and improve the standard of care.
The Company’s cell therapies advance the field of regenerative medicine, with potentially groundbreaking applications for treating damaged muscle, hematology deficiencies, and inflammation.
Pluristem sources its therapeutic cells from the placenta, an ethically accepted and potent source.
Cells are easy to collect and do not require blood or tissue matching.
Cells from one placenta can potentially treat more than 20,000 patients.
The Company’s manufacturing platform is a patented and validated state-of-the-art 3D cell expansion system, designed to mimic the human body.
Pluristem’s method is uniquely accurate, cost-effective, and consistent batch-to-batch.
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 intention to explore opportunities based on the data obtained from the Studies.
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 Company will host a Key Opinion Leader online event on muscle regeneration following hip fracture surgery on November 22 at 9:15am EST
HAIFA, Israel, November 15, 2021 – Pluristem Therapeutics Inc. (Nasdaq:PSTI) (TASE:PSTI) (the “Company”), a leading biotechnology company announced today that its multinational Phase III multicenter, randomized, double-blind, placebo-controlled study, designed to determine the efficacy, safety, and tolerability of intramuscular administration of allogeneic PLX-PAD cells for the treatment of muscle injury following arthroplasty for hip fracture, is fully enrolled with 240 patients.
The multinational clinical study includes patients from the U.S., Europe, and Israel, and topline results are expected in the third calendar quarter of 2022.
The Company will host a Key Opinion Leader online event on muscle regeneration following hip fracture surgery on November 22 at 9:15am EST, for registration: https://Veidan.activetrail.biz/pluristem
“Reaching our enrollment target for the Phase III PLX-PAD study is an important milestone,” said Pluristem CEO and President, Yaky Yanay. “Rising healthcare costs and aging demographic changes present an opportunity for allogenic, placenta-cell derived products to satisfy unmet clinical needs in the area of muscle regeneration following hip arthroplasty. The potential improvement of physical function following this common procedure could redefine the current standard of care and improve patients’ lives.”
Pluristem’s unique technology, based on a state-of-the-art cell expansion system designed to mimic conditions in the human body, provides a 3-D microenvironment where cells are multiplied and developed into therapeutic candidates. PLX-PAD cells secrete proteins to induce tissue healing in response to muscle trauma and inflammation and are applied via intramuscular administration.
During a completed Phase I/II double-blind placebo controlled trial, PLX-PAD cells demonstrated statistically significant superiority, in the ability to increase muscle strength and volume for patients who have undergone total hip replacement surgery due to osteoarthritis. If approved, PLX-PAD would be a first-of-its-kind innovative treatment for muscle regeneration.
Mr. Yanay concluded, “Hip fracture is a major cause of hospitalization for seniors and is associated with significant morbidity, mortality, loss of independence, and financial burden.
The annual number of hip fractures worldwide is expected to surpass 6 million in 2050 due to the increased prevalence of osteoporosis. As healthcare systems search for new opportunities to lower the cost of care and provide new treatments for aging populations, our PLX-PAD product candidate could potentially bring novel solutions for soft tissue regeneration.”
Estimated annual costs of care for patients suffering from hip fractures in the U.S. are between $10.3 billion and $15.2 billion. Approximately 20 percent of hip fracture patients die within one year from surgery due to immobility associated diseases, emphasizing the need for better and faster muscle rehabilitation for improved patient outcome.
Cell-based therapy for muscle regeneration could have potential for additional applications, including arthroplasty of the shoulders, knees, and other musculoskeletal indications.
Pluristem is pushing the boundaries of science and engineering to reimagine pharmacological treatments and improve the standard of care.
The Company’s cell therapies advance the field of regenerative medicine, with potentially groundbreaking applications for treating damaged muscle, hematology deficiencies, and inflammation.
Pluristem sources its therapeutic cells from the placenta, an ethically accepted and potent source.
Cells are easy to collect and do not require blood or tissue matching. Cells from one placenta can treat more than 20,000 patients.
The Company’s manufacturing platform is a patented and validated state-of-the-art 3D cell expansion system, designed to mimic the human body.
Pluristem’s method is uniquely accurate, cost-effective, and consistent batch-to-batch.
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 timing of the Phase III topline results, that the potential use of PLX-PAD cells for patients recovering from hip fractures could redefine the current standard of care and improve patients’ lives, that if approved, PLX-PAD would be a first-of-its-kind innovative treatment for muscle regeneration, that the PLX-PAD product candidate could potentially bring novel solutions for soft tissue regeneration and that cell-based therapy for muscle regeneration could have potential for additional applications.
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, November 10, 2021 – Pluristem Therapeutics Inc. (Nasdaq:PSTI) (TASE:PSTI), a leading biotechnology company, today announced that it has received approval for an additional grant from the Israel Innovation Authority (IIA) to support research based on its cutting-edge PLX platform. The grant comes as part of the Company’s work as part of the CRISPR-IL consortium (“the Consortium”), which the IIA funds through its Bio-Convergence Program. The IIA approved a new budget for the Consortium to continue its work for an additional 18 months (“period B”) after evaluating its activity and results over the past 18 months (“period A”).
As part of the budget, Pluristem is expected to receive approximately 1,800,000 NIS (approximately $583,000) to continue its work in developing a new generation of PLX cells based on the use of CRISPR technology to genetically program desired cell functions in future allogenic products.
As the leader of the consortium’s Pharma Working Group, Pluristem is collaborating with other industry and academic leaders in the field of genome editing, bringing together leading experts in life science and computer science from academia, medicine, and industry, to develop artificial intelligence (AI) based, end-to-end, multi-species genome editing solutions.
These solutions are expected to maximize the efficiency and accuracy of CRISPR genome editing of human, plant and animal DNA, and have applications in the pharma, agriculture, and aquaculture industries.
Yaky Yanay, CEO and President said: “The evaluation of the CRISPR-IL Consortium’s work over the last 18 months was successfully completed.
The IIA’s continued investment in Pluristem’s participation in this work provides further opportunity to push forward the development of next generation allogeneic cell therapies. We continue to believe that the integration of CRISPR technology in our PLX platform holds great potential to develop the treatments of the future, and the IIA’s approval of additional funds is validation of that belief.”
CRISPR is a genome-editing technology intended to modify specific DNA sequences, which enables the development of unique bio-based products and novel therapeutics while reducing the time and cost of development.
Pluristem is pushing the boundaries of science and engineering to reimagine pharmacological treatments and improve the standard of care.
The Company’s cell therapies advance the field of regenerative medicine, with potentially groundbreaking applications for treating damaged muscle, hematology deficiencies, and inflammation.
Pluristem sources its therapeutic cells from the placenta, an ethically accepted and potent source. Cells are easy to collect and do not require blood or tissue matching.
Cells from one placenta can treat more than 20,000 patients.
The Company’s manufacturing platform is a patented and validated state-of-the-art 3D cell expansion system, designed to mimic the human body. Pluristem’s method is uniquely accurate, cost- effective, and consistent batch-to-batch.
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 receipt of the grant from the Israel Innovation Authority, that it intends to push forward the development of next generation allogeneic cell therapies and that the integration of CRISPR technology and its PLX platform holds great potential to develop the treatments of the future and the IIA’s approval of additional funds is validation of that belief.
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
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Lorem ipsum dolor sit amet, consectetur adipiscing elit. Ut elit tellus, luctus nec ullamcorper mattis, pulvinar dapibus leo.
Lorem ipsum dolor sit amet, consectetur adipiscing elit. Ut elit tellus, luctus nec ullamcorper mattis, pulvinar dapibus leo.