HAIFA, Israel, January 8 2024 – Pluri Inc. (Nasdaq: PLUR) (TASE: PLUR) (“Pluri” or the “Company”), a leading biotech company that transforms cells into solutions that promote global wellbeing and sustainability, today announced it has launched a new business division offering cell therapy manufacturing services as a Contract Development and Manufacturing Organization (CDMO): PluriCDMO™.
PluriCDMO™ will offer its unique knowledge and technology and over 20 years of development and manufacturing experience. Its state-of-the-art 47 thousand square foot Good Manufacturing Practice (GMP) cell therapy production facility is expected to help customers and partners address key challenges in the development and manufacturing of cell-based therapies.
Clean Room, Pluri’s Manufacturing Facility PluriCDMO™ will offer services relating to early preclinical development, through late-stage clinical trials and commercialization, with a mission to deliver high-quality, essential therapies to patients. Over the past two decades, Pluri has cultivated a wealth of experience in process and analytical development, process scale-up, validation, logistics, automation, and regulatory approved comparability studies.
The Company’s proprietary, patented bioreactor system enables 3D cell expansion, producing high-quality cells in mass quantities through an automated, fully controlled and validated process. Pluri’s unique technology supports the large-scale growth of cells, with unique batch-to-batch consistency in a scalable, cost-effective manner, under GMP conditions, and has been used to support late-stage clinical trials in key jurisdictions, including the United States Food and Drug Administration (FDA); the European Medicines Agency; Israeli’s Ministry of Health; Japan’s Pharmaceuticals and Medical Devices Agency; and the Ministry of Food and Drug Safety of the Republic of Korea. Furthermore, the Company’s PluriMatrix™ technology enables unprecedented industrial scale production of cell-based products.
Pluri has appointed industry expert, Andy Lewin, to lead the business of its CDMO division. Mr. Lewin brings 25 years of commercial leadership experience within the CDMO sector in global companies including Ascend Gene and Cell Therapies Ltd., Oxford Biomedica, and AGC Biologics Inc.
“Pluri has an established track record of development and manufacturing in this arena and has solved many of the challenges that confront innovative companies in the cell therapy market,” said Andy Lewin. “The Company has developed innovative production technologies, which allow it to offer large scale (and further scalable) production of cell- based products in GMP grade. Pluri’s technology, long-standing collaborations and extensive experience enable the manufacturing of a wide range of products, including Mesenchymal Stem Cells (MSCs), Induced Pluripotent Stem Cells (iPSCs), Extracellular Vesicles (EVs) and gene modified cells, including CAR-T cells. Pluri offers a level of support to its partners that is second to none. I am excited to lead this new division, addressing the prevalent challenges and need in this sector, helping to accelerate the development and commercialization of high-quality cell and gene therapy products.”
Pluri’s CEO and President Yaky Yanay said, “Opening the CDMO division is a strategic move that we expect will boost revenues and cash flow utilizing our well-established technology and manufacturing facility. PluriCDMO™’s vision is to provide our clients with the best-in- class facility, but more importantly, the access to valuable knowledge in cell therapy development that has been generated over the last two decades. PluriCDMO™, as a high- end boutique CDMO, can accelerate the development efforts of our partners and provide better control of the risks. We believe that our proposition is strong and unique, working with PluriCDMO™ can be the launching pad that so many companies can benefit from. Our new CDMO division is another reflection of Pluri’s strategy to use our robust 3D cell expansion assets and in-house production facilities to create long-term value for our shareholders.”
For further information on PluriCDMO™ please visit http://www.pluri-biotech.com/cdmo/
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 challenges— 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 offers CDMO services. The company establishes partnerships that leverage its 3D cell-based technology for various industries that require effective, mass cell production.
To learn more, visit us at www.pluri-biotech.com or follow us on LinkedIn and X (formerly known as 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 benefits and services that may be provided by PluriCDMO™, that it expects that PluriCDMO™ will provide it with revenues and cash flow, and that PluriCDMO™ is another reflection of its strategy to use its robust 3D cell expansion assets and in-house production facilities to create long-term value for its shareholders.
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 / Brianna Ziegler at brianna@miller- ink.com
Ï Agreement signed following positive pre-clinical data demonstrating a one-time treatment with PLX-PAD significantly increased neurogenesis, offering immediate, long- term therapeutic effect in treating cocaine addiction
Ï There are no FDA-approved medications to treat cocaine addiction, a severely unmet need as demand for treatment increases in the U.S. and Europe
Ï Bar-Ilan University through its tech transfer arm BIRAD Research & Development Company Ltd. receives the right to develop and commercialize the product, Pluri entitled to 20% revenue sharing from future sales of PLX cells as anti-addiction product
HAIFA, Israel, December 21, 2023 – Pluri Inc. (Nasdaq: PLUR) (TASE: PLUR) (“Pluri” or the “Company”), a leading biotech company that transforms cells into solutions that promote well-being and sustainability, announced it has signed an agreement assigning the joint patent rights to develop Pluri’s PLX cells in the treatment of cocaine addiction, to BIRAD–Research & Development Company Ltd., the commercial arm of Bar-Ilan University. Under the agreement, Bar-Ilan University via BIRAD will receive the right to further develop and commercialize PLX cells as a cocaine anti-addiction product, and Pluri is entitled to 20% revenue sharing from future sales of the product for anti- addiction.
The agreement stems from a collaboration between Pluri and Bar-Ilan University researchers that presented compelling findings. Data from the studies were published in the peer-reviewed journal Pharmaceutics.
PLX-PAD Cells (PAD) attenuate cocaine craving in animal model for drug addiction (level presses indicate the compulsive demand of a rat to inject cocaine intravenous)
**The control group indicates rats that were trained to inject (lever pressing) cocaine; the sham group was trained to consume a non-addictive substance (saline) instead of cocaine; the PAD group indicates rats trained to inject cocaine that were treated with PAD.
The studies evaluated PLX-PAD cells’ efficacy in treating cocaine addiction in animal models. Findings demonstrate that PLX-PAD cells:
Prof. Gal Yadid of The Leslie and Susan Gonda Multidisciplinary Brain Research Center of Bar-Ilan University, a leading neuropsychopharmacologist focused on developing novel neuropsychiatric therapeutics for various indications such as addictions, depression, PTSD and more, including peptide drugs, microbiotics and others commented, “Based on several models, PLX offers great hope as a healing modality for the treatment of cocaine addiction as compared to traditional pharmacological methods that only address symptoms such as depression and anxiety, resulting in high relapse rate to drug usage even after long time of detoxification. The data suggest PLX offers a noninvasive one-time treatment that produces an immediate, long-term effect. We look forward to further exploring PLX’s mechanism of action, which we believe is likely through the cells’ migration to specific mesolimbic regions of the brain, thereby improving the regions’ plasticity by restoring neurons in the hippocampus.”
“PLX cells showed great data to act as a potential treatment for the millions of people around the world who suffer from cocaine addiction,” said Pluri Chief Executive Officer and President Yaky Yanay. “Pluri’s collaboration with BIRAD and Bar-Ilan is a great example of our co-development strategy, utilizing our advanced technology together with partners to develop life-changing products.”
In the U.S. alone, 1.2 million people suffered from cocaine use disorder in 2021, and approximately 24,500 people died from an overdose involving cocaine. Across North America and Europe, demand for treatment has steadily increased over the last decade, according to the U.N. Office on Drugs and Crime.
BIRAD – Research & Development Company Ltd. was established in order to translate new inventions made at Bar-Ilan University into useful products that can be effectively commercialized, thus strengthening the economy, promoting innovation and improving lives.
BIRAD’s innovative approach, combined with Bar-Ilan University’s rapid growth leading Israel’s growth in students’ number, including the largest Nanotechnology center in Israel and new Medical School in Safed, provides BIRAD with a wide range of opportunities. Thus, BIRAD offer corporate partnerships and alliances, intellectual property management, and technology commercialization through venture creation and licensing.
PLX-PAD cells have a “nose” that can recognize pathological tissue and navigate directly to this target, home in and release their cargo.
Hence, they exhibit regenerative potential due to their capacity to release specific loaded 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.
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 well-being 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 in additional industries that require effective, mass cell production. To learn more, visit us at pluri-biotech.com or follow us on LinkedIn and X(formerly known as 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 uses forward-looking statements when it discusses the potential of PLX-PAD cells to treat people with cocaine addictions.
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 develop and introduce new technologies in a timely fashion, 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 / Brianna Ziegler at brianna@miller- ink.com
Anat Lev – Confortes: anat.lev1@biu.ac.il
HAIFA, Israel, August 16th, 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 publication of an article titled “Placental expanded mesenchymal-like cells (PLX-R18) for poor graft function after hematopoietic cell transplantation: A phase I study” in the peer reviewed journal Nature Bone Marrow Transplantation.
As described in the article, in a successful Phase I first-in-human study which achieved its primary endpoint, patients with incomplete hematopoietic recovery post- hematopoietic cell transplantation (HCT) were treated with escalating doses of Pluri’s cell therapy, PLX-R18. While patients received only two administrations of PLX-R18 during the first week, as compared to the standard of care which requires frequent and ongoing dosing, treated patients showed increased blood cell counts for as long as 12 months from administration, and a reduction in the need for blood transfusions. PLX-R18 was well tolerated with a favorable safety profile.
PLX-R18, a placental-derived cell therapy, has been granted Orphan Drug Designation by the U.S. Food and Drug Administration (FDA) for the treatment of graft failure, incomplete hematopoietic recovery following HCT, and the treatment of ARS.
Low levels of blood cells (cytopenia) post-HCT can persist despite adequate engraftment of donor cells. Pluri’s PLX-R18 cells secrete a large array of hematopoietic factors which promote regeneration, maturation, and differentiation of hematopoietic cells and stimulate their migration to peripheral blood.
Dr. Joseph P. McGuirk, lead author of the published study and Schutte-Speas Professor, Hematologic Malignancies and Cellular Therapeutics at the University of Kansas Medical Center, commented, “This study suggested that PLX-R18 was able to increase blood cell counts and reduce the need for transfusions regardless of whether or not patients received hematopoietic growth factors, strengthening our conclusion that it was indeed PLX-R18, and not the other medications given to the patients, which contributed to the demonstrated efficacy. PLX-R18 shows promise in improving incomplete hematopoietic recovery post-HCT and has potential in other condition where cytopenia is a problem, for example after CAR-T therapy.”
Pluri’s Chief Medical Officer Nitsan Halevy added, “These results reinforce PLX-R18’s role as a potent potential therapy for hematological disorders, encompassing its proposed application in treating acute radiation syndrome. The publication of these findings in the esteemed Nature BMT journal, along with the backing of NIAID, significantly bolsters our H-ARS program and advances us toward the goal of marketing authorization. As a groundbreaking, first-in-class solution, PLX- R18’s capacity to augment hematopoietic system recovery and effectively manage diverse cytopenia holds immense promise.”
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 benefits of PLX-R18, that PLX- R18 shows promise in improving incomplete hematopoietic recovery post-HCT and has potential in other condition where cytopenia is a problem, that the study results reinforce PLX-R18’s role as a potent potential therapy for hematological disorders and advances it toward the goal of marketing authorization.
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
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
HAIFA, Israel, December 22, 2022 – Pluri Inc. (Nasdaq: PLUR) (TASE: PLUR) (“Pluri” or the “Company”) (formerly known as Pluristem Therapeutics, Inc.), a leading biotechnology Company, today issued the following update to shareholders from CEO and President Yaky Yanay and announced that as planned the Company’s joint venture with Tnuva Group has successfully achieved proof of concept in its development of cultivated meat based on Pluri’s proprietary 3D cell-based technology platform.
Dear fellow shareholders,
As we look toward a promising year ahead, I am proud to reflect on all that Pluri has achieved throughout 2022. This year, we launched a new Company strategy leveraging on our 3D cell-based technology platform to improve human wellbeing, increase sustainability, and advance solutions to humanity’s greatest challenges. We are working to deploy Pluri’s assets across the field of life sciences, from health to biologics to food tech, as we aim to capitalize on our substantial technological advantage in new and innovative ways.
We marked this evolution of our Company by adopting a new name, Pluri, representative of the many ways that our cell-based solutions can tackle some of our planet’s greatest challenges. One of the corner stones of our strategy is building long term strategic alliances and partnerships with companies that have market access, a similar innovation approach and are committed to pioneering a biotech revolution together with us; in 2022 we have already forged two collaborations to that end. At the same time, we have strengthened our financial position by creating an efficiency plan, cost cutting and ramping toward revenue generation based on our cell-based technology platform. We believe that the combination of these actions will shorten Pluri’s path to commercialization while driving long-term value for shareholders in the coming months.
Earlier this year, we formed a joint venture with Tnuva Group, Israel’s largest food producer, to develop cultivated meat products. We heralded this major collaboration in March by ringing the closing bell at the Nasdaq MarketSite in Times Square alongside our Tnuva partners.
Today, I am proud to report that our joint venture has successfully completed proof of concept in its development of cultivated meat based on our cell-based technology platform. While we were setting an aggressive development plan for the R&D teams it was important for me to see that we were able to meet each and every milestone we set, which indeed happened – and most of the time ahead of schedule.
We look forward to sharing additional details in the months ahead as we provide more details about our amazing activity in the cultivated meat industry.
I must say this process gave me a lot of confidence in our ability to expand to more industries that could benefit from our cell-based technology platform.
We believe Pluri’s patented and validated cell expansion technology and state-of-the-art manufacturing facilities are the keys to unlocking cost- effective production of cell-based food products at mass scale. With these proven assets, we believe Pluri is strategically positioned to become a global leader in this growing market, which is projected to reach $140 billion by 20301 for cultivated meat alone. Along with rapid market growth, cultivated food products have the potential to deliver significant benefits for people, animals and the environment.
Pluri launched a second technology collaboration in September, this time with one of the leading European manufacturers of active pharmaceutical ingredients (APIs). The market for biologic medications (made from live organisms) is expected to nearly double by 2030 to an estimated $720 billion, and Pluri anticipates to continue to generate revenues from this collaboration in the coming months.
This partnership can leverage our platform to create unique biologic APIs used in the treatment of liver and gastroenterological diseases.
These APIs are currently derived from animals that are sacrificed during the extraction process. We aim to replace that model with a more cost-effective and cruelty-free process that involves growing these specialty cells in our 3D cell expansion system.
Even as we broaden our horizons across the life sciences landscape, Pluri remains committed to advancing cell-based solutions for our most pressing health care needs.
We are constantly innovating, expanding our patent portfolio and actively working on new potential collaborations within the world of medicine.
Earlier this year, we announced positive final results from a Phase I hematology study of the safety and potential efficacy of injecting Pluri’s PLX-R18 cells in patients recovering from hematopoietic cell transplantation (HCT). This study found lower mortality rates, an increase in all three blood cell types and a decrease in blood transfusion units for patients with incomplete hematopoietic recovery following HCT who were treated with PLX-R18.
In addition, Pluri and our partners in PROTO, an international collaboration led by Charité, Berlin Institute of Health Center for Regenerative Therapies, studying the treatment of mild-to-moderate knee osteoarthritis (OA) using Pluri’s PLX-PAD cells, were awarded a €7.5 million non-dilutive grant from the European Union’s Horizon Europe program.
Pluri remains well positioned to capitalize on these achievements and expand on our progress in 2023, following actions earlier this year to reduce the Company’s cash burn by an estimated 30%. I am also 1 “The future of food”, May 4, 2021, Barclays news pleased to highlight a new combined $8.4 million investment in Pluri, after a series of securities purchase agreements were executed last week.
I deeply believe in the promise of Pluri and the new path forward that we began forging this year.
We believe our new strategy has yielded significant achievements in recent months that set us up for further success in 2023.
With that in mind, I decided to forego $375,000 of my cash salary over the next 12 months and instead receive equity grants.
This decision reflects my firm commitment, along with that of Pluri’s entire management team, to creating significant value for our shareholders in the year ahead.
We are doubling down on our core strength ― our game-changing cell technology ― and I am more confident than ever in our ability to establish Pluri as a global leader in this field.
I wish you all happy and healthy holidays, and I look forward to continuing the execution of our new strategy together in 2023.
Best regards,
Yaky Yanay
Chief Executive Officer and President, 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.
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 expected product launch with Tnuva in 2023 and its expected timeline for providing an update on future progress, that it is actively seeking partnerships, its belief that it has shortened its path to commercialization while driving long-term value for shareholders, its belief that it is well position to become a global leader in the cultivated food product field, the benefits to be derived from its various products and technologies and its expectation to generate revenue from its collaborations.
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, December 15, 2022 – Pluri Inc. (Nasdaq: PLUR) (TASE: PLUR) (“Pluri” or the “Company”), a leading biotechnology company, announced today that it has signed securities purchase agreements with domestic and non-U.S. investors for the sale of an aggregate of 7,885,900 of the Company’s common shares and warrants to purchase up to an aggregate of 7,885,900 of the Company’s common shares. On December 13, 2022, the Company executed securities purchase agreements to sell, at a purchase price of $1.03 per share, up to 5,579,883 of the Company’s common shares and warrants to purchase up to 5,579,883 of the Company’s common shares, with an exercise price of $1.03 per share and a term of three years. On December 14, 2022, the Company executed securities purchase agreements to sell, at a purchase price of $1.05 per share, up to 2,068,517 of the Company’s common shares and warrants to purchase up to 2,068,517 of the Company’s common shares, with an exercise price of $1.05 per share and a term of three years.
On December 15, 2022, the Company executed securities purchase agreements to sell, at a purchase price of $1.06 per share, up to 237,500 of the Company’s common shares and warrants to purchase up to 237,500 of the Company’s common shares, with an exercise price of $1.06 per share and a term of three years. The warrants sold in the offerings will be exercisable upon the later of six months from their issuance date, or until the Company increases its authorized shares. In addition, Yaky Yanay, the Company’s Chief Executive Officer, has committed to forgo $375,000 of his annual cash salary for the next twelve months in return for equity grants issuable under the Company’s existing equity compensation plans. The offerings are expected to close by January 31, 2023.
The offerings are being made in the United States pursuant to the exemption from securities registration afforded by Section 4(a)(2) of the Securities Act of 1933, as amended, and Rule 506 of Regulation D as promulgated by the Securities and Exchange Commission (the “SEC”). The securities have not been registered under the Securities Act of 1933, as amended, or applicable state securities laws, and accordingly may not be offered or sold in the United States absent registration with the SEC or an applicable exemption from such registration requirements.
This press release shall not constitute an offer to sell or the solicitation of an offer to buy nor shall there be any sale of these securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction.
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 expected closing date.
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
HAIFA, Israel, November 10, 2022 –Pluri Inc. (Nasdaq: PLUR) (TASE: PLUR) (“Pluri” or the “Company” (formerly known as Pluristem Therapeutics, Inc.), a leading biotechnology company, won Cell Innovation award in the Cell Biology category of the second annual BioTech Breakthrough Awards. Pluri received the award for its patented and validated technology platform, a state-of-the-art 3D cell expansion system that advances novel cell-based solutions to longstanding challenges in health, food, biologics and beyond, promoting global wellbeing and sustainability.
“It’s an exciting time in the industry and we are thrilled to highlight the ‘breakthrough’ biotechnology solutions, services and companies around the world for our 2022 program. We extend our sincerest congratulations to our 2022 BioTech Breakthrough Award winners,” said Bryan Vaughn, Managing Director of BioTech Breakthrough Awards.
This year’s program attracted more than 1,350 nominations from over 12 different countries throughout the world. Other winners in various categories include Abbott, Brightseed, Honeywell, Pfizer, Promontory Therapeutics, Quanterix, Vizgen, and Waters.
Pluri’s proprietary 3D technology platform can expand a single cell into billions of cells by mimicking the cell’s natural environment. This proprietary technology delivers cost effective high-quality cells in mass quantities and with proven batch-to-batch consistency across human, animal and plant cell sources.
Pluri operates a state-of-the-art good manufacturing practice (GMP) manufacturing facility; maintains an IP portfolio of over 130 active, granted patents; and is cultivating a fast-growing network of global partnerships that expand the impact of its technology to industries that require efficient mass cell production, such as pharma, food-tech and biologics.
“We are proud to be recognized for our industry-leading technology, which can leverage the basic building blocks of life—cells—to produce medicine, food, and other products for a better tomorrow,” said Pluri’s CEO and President Yaky Yanay.
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 , its ability to seek and collaborate with strategic partners, and the ability of its network of global partnerships to expand the impact of its technologies into various industries, and the potential of the Company’s products and solutions to produce medicine, food, and other products.
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: Meira Feinman at meira@miller-ink.com / Ryan McCrimmon at ryan.mccrimmon@miller- ink.com
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.
Lorem ipsum dolor sit amet, consectetur adipiscing elit. Ut elit tellus, luctus nec ullamcorper mattis, pulvinar dapibus leo.