Abony: “Pluri’s cell expansion technology has extraordinary potential across a range of industries.”
HAIFA, Israel, July 13, 2023– Pluri Inc. (Nasdaq: PLUR) (TASE: PLUR) (“Pluri” or the “Company”), a leading biotech company that transforms cells into solutions that promote wellbeing and sustainability, today announced the appointment of Lorne Abony to the Company’s Board of Directors, effective as of July 11, 2023.
Abony is a successful entrepreneur who has decades of experience building and scaling multi- billion-dollar global businesses – both public and private companies – across multiple industries.
He is a globally recognized leader who has invested, directly or indirectly, in more than 20 cellular agriculture and cultivated food companies. Bringing his expertise to Pluri’s board, he will contribute to the Company’s strategic growth plans by utilizing its cell-expansion technology platform across various sectors, such as cultivated food and cellular agriculture.
Mr. Lorne Abony “Lorne’s visionary leadership has made a profound impact across companies, industries, and continents. He understands how to develop and scale both public and private businesses – and how to inspire people along the way. Lorne has driven innovation and progress in cultivated food, as a well-respected leader in the space,” said Pluri CEO and President, Yaky Yanay.
“We are excited about the potential that Lorne brings to Pluri’s Board, and believe that he will make a tremendous contribution to our bold and ambitious growth strategy,” added Pluri Chairman of the Board, Zami Aberman.
“Cultivated foods and cellular agriculture are the future. These rapidly growing industries present a tremendous market opportunity for pioneering companies like Pluri,” Mr. Abony said.
“I’m thrilled to join Pluri’s Board. This proven pioneer in biotech has extraordinary potential to add tremendous value across a range of industries, and create a cleaner, healthier, and more sustainable planet, utilizing its cell expansion technology.”
As a founder and executive, Mr. Abony has scaled major ventures including FUN Technology Ltd, Emmac Life Sciences Limited and NuuVera Inc. He has raised over $1.7 billion through public and private debt and equity markets. In 2011, Mr. Abony received Canada’s Ernst & Young Entrepreneur of the Year Award for his founding and leadership of Mood Media Corporation (Mood). Mr. Abony scaled Mood from a pre-revenue startup to the world’s largest in-store media company with more than 3,300 employees, offices in 47 countries and over $750 million in annual revenue, before selling the company to a private equity firm. He was also featured on the hit network T.V. series, “Undercover Boss.” Mr. Abony is currently chair and board member of several companies in the field of cultivated food, AI, and technology such as VitroLabs Inc., AmyInsights, and Einride A.B.
Pluri is pushing the boundaries of science and engineering to create cell-based products for commercial use and is pioneering a biotech revolution that promotes global wellbeing and sustainability.
The Company’s technology platform, a patented and validated state-of-the-art 3D cell expansion system, advances novel cell-based solutions for a range of initiatives— from medicine and climate change to food scarcity, animal cruelty and beyond. Pluri’s method is uniquely accurate, scalable, cost-effective, and consistent from batch to batch.
Pluri currently operates in the field of regenerative medicine, food-tech and biologics and aims to establish partnerships that leverage the Company’s 3D cell-based technology to additional industries that require effective, mass cell production.
To learn more, visit us at www.pluri-biotech.com or follow us on LinkedIn and Twitter.
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, Pluri is using forward-looking statements when it discusses that its cell expansion technology has extraordinary potential across a range of industries.
These forward-looking statements and their implications are based on the current expectations of the management of Pluri 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 Pluri: changes in technology and market requirements; Pluri 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 it anticipates; 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 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 Pluri to differ materially from those contemplated in such forward-looking statements.
Except as otherwise required by law, Pluri 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 Pluri reference is made to Pluri’s reports filed from time to time with the Securities and Exchange Commission.
Investors: Director of Investor Relations, Aviva Banczewski, investor.relations@pluri-biotech.com
Israel Media: Shachar Yental at shacharye@gitam.co.il
U.S. Media: Nathan Miller at nathan@miller-ink.com / Meira Feinman at meira@miller-ink.com
HAIFA, Israel, July 11, 2023 – Pluri Inc. (Nasdaq: PLUR) (TASE: PLUR) (“Pluri” or the “Company”), a leading biotech company that transforms cells into solutions that promote wellbeing and sustainability, today announced that it has signed a three year $4.2M contract with the U.S. National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (NIH). Pluri will collaborate with the U.S. Department of Defense’s Armed Forces Radiobiology Research Institute (AFRRI)/Uniformed Services University of Health Sciences (USUHS) in Maryland, USA to further advance the development of its PLX-R18 cell therapy as a potential novel treatment for Hematopoietic Acute Radiation Syndrome (H-ARS). H-ARS is a deadly disease that can result from nuclear disasters and radiation exposure.
Recent geo-political events have reinforced the need for the global community to better prepare for nuclear disasters, such as seeking new medical treatments that are more cost-efficient and scalable than current options that can be proactively administered in advance of a potential nuclear event. H-ARS, also known as radiation poisoning, is caused by exposure to life- threatening amounts of ionizing radiation, such as what may occur during nuclear/radiological accidents, terrorist activities and warfare. H-ARS is characterized by dose dependent bone marrow depression, leading to life-threatening neutropenia, thrombocytopenia and anemia, and possible death.
This contract supports Pluri’s goal to achieve marketing approval for PLX-R18 with the U.S. Food and Drug Administration (FDA), which could qualify the product to be purchased for the U.S. Strategic National Stockpile as a medical countermeasure for exposure to radiation. The FDA previously cleared an Investigational New Drug (IND) application for PLX-R18 for the treatment of ARS in the case of nuclear events and granted it Orphan Drug Designation.
Pluri will collaborate with Prof. Vijay K. Singh of AFRRI, a world-renowned expert in radiation treatments.
His laboratory’s primary research interest is to develop radiation countermeasures for ARS.
“The current time calls for us to accelerate the development and accessibility of radiation treatments, especially as geopolitical instability rises, and nuclear power plants face the threat of warfare,” said Pluri CEO and President Yaky Yanay. “Through this strategic contract with NIAID, we believe that we can realize our mission of making PLX-R18 readily available for emergency preparedness. We look forward to collaborating with Prof. Singh and AFRRI to explore the potential of PLX-R18 as a uniquely, scalable treatment for H-ARS.”
Prof. Singh added, “PLX-R18’s potential as a medical countermeasure for H-ARS is supported by robust human and animal data, making it a unique asset for further investigation. I’m eager to commence our collaborative study with Pluri and have high expectations for results.”
Prior studies funded by the NIH/NIAID and conducted in accordance with the FDA’s Animal Rule pathway demonstrated that PLX-R18 administered to animals after radiation exposure for H-ARS significantly increased survival rates from 29% in the control group to 97% in the treated group (p<0.001). Studies conducted by the U.S. Department of Defense (DoD) have shown that PLX- R18, administered as a prophylactic measure 24 hours before radiation exposure, and again 72 hours after exposure, resulted in a significant increase in survival rates, from 4% survival rate in the placebo group to 74% in the treated group (log-rank test p< 0.0001). In addition, the data show a significant increase in recovery of white blood cells (p = 0.0047), platelets (p = 0.0070), neutrophils (p = 0.0003) and lymphocytes (p = 0.0025) counts compared to administration of vehicle, and a favorable safety profilei.
Additionally, PLX-R18 was tested in humans with incomplete hematopoietic recovery following Hematopoietic Cell Transplantation (HCT) and was well tolerated with a favorable safety profile. Patients treated with PLX-R18 showed an increase in all three blood cell types compared to the baseline with platelets (p<0.001), hemoglobin (p=0.02) and neutrophils (p=0.15) levels increasing, as early as 1 month following PLX-R18 administration and enduring up to 12 months following treatment, while experiencing a significant reduction in mean number of transfused units from a monthly 5.09 to 0.55 for platelets (p=0.045) and 2.91 to 0 for red blood cells (p=0.0005) over 12 months of follow-up.
The purpose of the contract is to support the development of PLX-R18 as a novel cellular medical countermeasure for the prevention, mitigation and treatment of all aspects of H-ARS. Through in vitro, ex vivo and animal studies, the aim is to demonstrate the efficacy of PLX-R18, manufactured according to cGMP standards, as a treatment even when administered 48 hours or later following radiation exposure.
Following in vitro and ex vivo studies, mice that have been exposed to total body irradiation will be dosed with clinical grade PLX-R18 as well as CRISPR/Cas9-edited PLX-R18 cells. Dose regimen, radiation levels, and corresponding increasing survival will be assessed, as well as analysis into the mechanisms of action.
PLX-R18 is a novel cell-based medicinal product, comprised of human placenta derived stromal cells delivered through intramuscular (im) injection. The living cells adaptively secrete a cocktail of active hematopoietic factors. These factors act together to produce optimal therapeutic efficacy by facilitating the recovery of hematopoietic progenitor cells in the bone marrow and the regeneration of multiple blood lineage cell counts in the peripheral blood. Preclinical studies have shown that PLX-R18 cells ameliorate or prevent the toxicity of H-ARS. Further preclinical data from trials conducted by the NIH, the Charité in Berlin, Indiana University (Prof. Christie M Orschell) AFRRI (Dr. Sanchita Ghosh) and other prominent research institutions, have shown that PLX-R18 cells secrete a range of specific factors that salvage and trigger the regeneration of bone marrow hematopoietic cells, thereby supporting the recovery of blood cell production. With its capabilities, PLX-R18 could potentially be used in several indications to treat a broad range of hematologic disorders, which together constitute a substantial global market.
Pluri is pushing the boundaries of science and engineering to create cell-based products for commercial use and is pioneering a biotech revolution that promotes global wellbeing and sustainability.
The Company’s cGMP-grade technology platform, a patented and validated state- of-the-art 3D cell expansion system, advances novel cell-based solutions for a range of initiatives — from medicine and climate change to food scarcity, animal cruelty and beyond. Pluri’s method is uniquely accurate, scalable, cost-effective, and consistent from batch to batch. Pluri currently operates in the field of regenerative medicine, food-tech and biologics and aims to establish partnerships that leverage the Company’s 3D cell-based technology to additional industries that require effective mass cell production.
To learn more, visit us at www.pluri-biotech.com or follow us on LinkedIn and Twitter.
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, Pluri is using forward-looking statements when it discusses the potential value of the contract and program, that the contract supports its goal to achieve marketing approval for PLX-R18 with the FDA, the belief that the strategic contract with NIAID can help it realize its mission of making PLX-R18 readily available for emergency preparedness and the potential benefits to be derived from the use of PLX-R18.
These forward-looking statements and their implications are based on the current expectations of the management of Pluri 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 Pluri: changes in technology and market requirements; Pluri 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 it anticipates; 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 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 Pluri to differ materially from those contemplated in such forward-looking statements.
Except as otherwise required by law, Pluri 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 Pluri, reference is made to Pluri’s reports filed from time to time with the Securities and Exchange Commission.
Investors: Director of Investor Relations, Aviva Banczewski, investor.relations@pluri- biotech.com
Israel Media: Shachar Yental at shacharye@gitam.co.il
U.S. Media: Nathan Miller at nathan@miller-ink.com / Meira Feinman at meira@miller-ink.com
i https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9601513/
HAIFA, Israel, April 27, 2023– Pluri Inc. (Nasdaq: PLUR) (TASE: PLUR) (“Pluri” or the “Company”), a leading biotech company that transforms cells into solutions that promote wellbeing and sustainability, today unveiled a breakthrough in cell manufacturing that potentially solves one of the biggest hurdles facing cell-based industries: cost-effective, industrial scale cell manufacturing. PluriMatrix, built upon Pluri’s platform 3D cell expansion technology, significantly scales high-quality cell production, potentially having a catalytic impact across numerous industries that require mass-scale cell production including pharma, biologics, foodtech, agri-tech, and beyond. The patented technology offers Pluri and its subsidiaries unparalleled advantages in developing and producing cell-based products.
Pluri’s majority-owned subsidiary Ever After Foods, a joint venture with Tnuva Group, Israel’s largest food producer, is using PluriMatrix to produce cultivated meat and expects a 700% increase in productivity over other cultivated meat technology platforms.
PluriMatrix draws on the unique expertise in cell-based manufacturing that Pluri has developed over the last two decades. It enables industrial scale production of cell-based products by using a packed-bed system design in which cells expand as tissue on scaffolds, increasing surface area and providing a uniquely effective growth environment. Cells can either be harvested as single cells or used along with the scaffolds as completed tissue. The system also enables the simultaneous expansion of various cell types within the same platform, giving each cell type its own growth space. PluriMatrix’ state-of-the-art mass scale, highly scalable, modular cell production system enables a smaller infrastructure by reducing the size of the manufacturing facility compared to other existing methods, significantly reducing cost and ecological footprint.
“PluriMatrix is an important breakthrough in cell technology by our assessment, and we believe it has the potential to solve some of humanity’s greatest needs by improving health, increasing access to food and food safety, and creating a wide range of cell-based products, while taking better care of our earth,” stated Pluri CEO and President, Yaky Yanay. “We’ve evolved our original healthcare-focused technology to potentially serve a multitude of other industries where efficient, cost-effective, industrial-scale cell production will be a core competitive advantage. We are very pleased about the potential benefits for humanity as we can transform cells into solutions that promote global wellbeing and sustainability. Moreover, PluriMatrix is transformative for our platform technology and business, as it vastly extends Pluri’s target markets. We believe we have unlocked tremendous value and expect to capitalize on it in conjunction with industry-specific subsidiaries and strategic partners.”
Pluri is pushing the boundaries of science and engineering to create cell-based products for commercial use and is pioneering a biotech revolution that promotes global wellbeing and sustainability.
The Company’s technology platform, a patented and validated state-of-the-art 3D cell expansion system, advances novel cell-based solutions for a range of initiatives— from medicine and climate change to food scarcity, animal cruelty and beyond. Pluri’s method is uniquely accurate, scalable, cost-effective, and consistent from batch to batch.
Pluri currently operates in the field of regenerative medicine, food-tech and biologics and aims to establish partnerships that leverage the Company’s 3D cell-based technology to additional industries that require effective, mass cell production.
To learn more, visit us at www.pluri-biotech.com or follow us on LinkedIn and Twitter.
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, Pluri is using forward-looking statements when it discusses the potential improvements that may be realized through the PluriMatrix technology, the potential sectors that may benefit from this technological improvement and that the technology vastly extends its target markets, that the PluriMatrix technology potentially unlocks tremendous value and has the potential to solve some of humanity’s greatest needs by improving health, increasing access to food and food safety, and creating a wide range of cell-based products, while taking better care of our earth.
These forward-looking statements and their implications are based on the current expectations of the management of Pluri 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 Pluri: changes in technology and market requirements; Pluri 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 it anticipates; 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 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 Pluri to differ materially from those contemplated in such forward-looking statements.
Except as otherwise required by law, Pluri 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 Pluri reference is made to Pluri’s reports filed from time to time with the Securities and Exchange Commission.
Investors: investor.relations@pluri-biotech.com
Israel Media: Shachar Yental at shacharye@gitam.co.il
U.S. Media: Nathan Miller at nathan@miller-ink.com / Meira Feinman at meira@miller-ink.com
HAIFA, Israel, March. 13, 2023 – Pluri Inc. (Nasdaq: PLUR) (TASE: PLUR) (“Pluri” or the “Company” (formerly known as Pluristem Therapeutics, Inc.), a leading biotechnology company, announced today that Israel’s Ministry of Labor, Social Affairs and Social Services has selected Pluri as the winner of the 2022 Egalitarian Employment Award in the Large Company category. Pluri was selected for this highly prestigious honor for the second time in a row in recognition of its achievements in diversity, pay equity, and the promotion of women in its workforce. Pluri’s Chief Executive Officer and President, Yaky Yanay, will accept the award from Nir Barkat, Israel’s Minister of Economy and Industry, at a ceremony today in Jerusalem.
The Company will also receive a government grant of 40,000 NIS along with the prize.
Chief Financial Officer Chen Franco-Yehuda and Vice President of Human Resources Efrat Livne-Hadass issued the following letter to employees and stakeholders following the announcement:
“Dear stakeholders,
Israel’s first female Prime Minister, Golda Meir, said, “To be successful, a woman has to be much better at her job than a man.” Sadly, this is still the case in our world today. For far too long, far too few women have occupied senior roles.
The gender gap creates enormous costs. Women’s dreams and professional aspirations have been deferred and denied. Half of the available talent pool has been overlooked by our most dynamic companies, which leads to fewer scientific advancements, less medical breakthroughs, and lower profits. The biotechnology industry, like many others, has not yet done its part to push forward a more equal society.
We are proud that Pluri has been an exception to the rule when it comes to this gender gap. Female employees represent an equal part of our company’s total workforce, including senior management and executive level positions.
Pluri focuses on various aspects of female employment and empowerment; promotion, flexibility, a healthy work-family balance and the encouragement of inclusion and self-appreciation. We also have a robust compensation policy in place to ensure gender pay equity.
In recognition of our work, Israel’s Ministry of Labor, Social Affairs and Social Services has selected Pluri as the winner of the 2022 Egalitarian Employment Award in the Large Company category.
We are honored and proud to be part of a company and management team where employees are chosen and promoted based on their qualifications, not their gender. As senior executives at Pluri, every day we see the tremendous business benefit of being part of a C-Suite where more than half of our fellow leaders are also women. We hope that Pluri’s example can inspire others to recognize the business and societal benefits to advancing gender equality in their companies – and show women interested in this field that there is a path for them, as shared with the hundreds of high schoolers and students with an interest in biotechnology who come to tour our offices every year.
This month, we celebrate International Women’s Day with the understanding that every day can – and should – be rooted in the values of a more equal workplace. We believe this award will bring hope to future generations all around the world, setting an example for young women and showing them that they have the power to make their dreams come true. All of us – men and women – have a responsibility to ensure that women recognize that the sky is the limit of their potential.
Sincerely,
Chief Financial Officer Chen Franco-Yehuda
Vice President of Human Resources Efrat Livne-Hadass
About Pluri Inc.
Pluri is pushing the boundaries of science and engineering to create cell-based products for commercial use and is pioneering a biotech revolution that promotes global wellbeing and sustainability. The Company’s technology platform, a patented and validated state-of-the-art 3D cell expansion system, advances novel cell-based solutions for a range of initiatives— from medicine and climate change to food scarcity, animal cruelty and beyond. Pluri’s method is uniquely accurate, scalable, cost-effective, and consistent from batch to batch. Pluri currently operates in the field of regenerative medicine, food- tech and biologics and aims to establish partnerships that leverage the Company’s 3D cell-based technology to additional industries that require effective, mass cell production.
To learn more, visit us at www.pluri-biotech.com or follow us on LinkedIn and Twitter.
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, Pluri is using forward- looking statements when it discusses its belief that it has been an exception to the rule when it comes to this gender gap.
These forward-looking statements and their implications are based on the current expectations of the management of Pluri 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 Pluri: changes in technology and market requirements; Pluri 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 it anticipates; 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 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 Pluri to differ materially from those contemplated in such forward-looking statements.
Except as otherwise required by law, Pluri 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 Pluri reference is made to Pluri’s reports filed from time to time with the Securities and Exchange Commission.
Contacts
Investors: investor.relations@pluri-biotech.com
U.S. Media: Meira Feinman at meira@miller-ink.com / Ryan McCrimmon at ryan.mccrimmon@miller- ink.com
Israel Media: Shachar Yental at shacharye@gitam.co.il