HAIFA, Israel, March 6, 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 the appointment of attorney James Roosevelt, Jr. to the Company’s Advisory Board.
Having served in public-service positions in Washington, D.C., followed by a successful decade in the private sector as CEO of Tufts Health Plan, Mr. Roosevelt is a trusted and sought-after advisor on business matters, legislative and regulatory issues, governance, and personnel matters. The intersection of public policy and health is a passion for him. As CEO of Tufts Health Plan, his leadership achieved consistent profitability while attaining the #1 ranking from the National Committee for Quality Assurance.
“My career advocating for equitable access to quality healthcare is informed by my belief that we can never stop innovating as we search for new approaches and therapeutics for patients. I am excited to join Pluri’s Advisory Board to provide advice and inspiration that will advance their mission of developing new cell-based, sustainable treatments targeting populations with unmet medical needs, using their remarkable 3D cell expansion platform,” said Mr. Roosevelt.
Bringing his expertise to Pluri’s Advisory Board, Mr. Roosevelt will contribute to the Company’s strategic growth plans, particularly in the area of regenerative medicine, by advising on longevity opportunities, best practices for securing and maintaining ongoing grants and contracts with U.S. government agencies, and facilitating relationships with investors and partners.
“An inspiring leader, Jim has devoted his career to protecting peoples’ health in both the public and private sector, always advocating for improved access to health care,” said Pluri CEO and President Yaky Yanay. “Given his knowledge and excitement about the potential of regenerative medicine and our proprietary technology, he will surely contribute to our future growth.”
“We welcome Jim to our Advisory Board and look forward to incorporating his insights and strategies. Together, we will advance our understanding of how our groundbreaking cell therapies targeting a variety of medical indications will lead to more personalized and well-tolerated treatments,” added Zami Aberman, chairman of the board at Pluri.
Before joining Tufts Health Plan, Mr. Roosevelt served as associate commissioner of the U.S. Social Security Administration and is a national speaker and published author writing about the Affordable Care Act, Medicare and Medicaid policy, and Social Security. He has also been a visiting fellow at the Institute of Politics of the Harvard Kennedy School of Government and continues as a clinical instructor in the Public Health and Community Medicine Department of Tufts University School of Medicine.
In the tradition of his grandfather and other members of the Roosevelt family, Mr. Roosevelt co-chairs the Rules and Bylaws Committee of the Democratic National Committee and serves as volunteer legal counsel for the Massachusetts Democratic Party. Mr. Roosevelt is also a trustee of the Cambridge Public Library, the Cambridge Community Foundation, and the Atrius Health Equity Foundation. In the past, he has co-chaired Rhode Island Governor Gina Raimondo’s Health-Care Leaders Task Force on Health-Care Cost Growth and the Massachusetts Hospital Association’s work group on access to behavioral health care.
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 agtech and aims to establish partnerships that leverage the Company’s 3D cell-based technology to additional industries that require effective, mass cell production.
Pluri also offers CDMO services.
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 mission of developing new cell-based, sustainable treatments targeting populations with unmet medical needs, using its 3D cell expansion platform; its growth plans and Mr. Roosevelt’s contribution to its future growth; the advancement of its understanding of how cell therapies targeting a variety of medical indications will lead to more personalized and well-tolerated treatments.
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 / Jennifer Zimmons at Jen@quantum-corp.com
Israel Media: Shachar Yental at Shacharye@gitam.co.il
U.S. Media: Madeline Weirman at Maddie@quantum-corp.com / Jessica Daitch at Jessica@quantum- corp.com
HAIFA, Israel – February 28, 2024 – Leading biotechnology company Pluri Inc. (NASDAQ:PLUR) (TASE:PLUR) (“Pluri” or the “Company”) today issued the following update from CEO and President, Yaky Yanay:
Dear Fellow Shareholders,
As we move into 2024, I’m proud to share my thoughts about all the exciting things happening at Pluri right now.
As a purpose-driven company with goal-oriented leadership and a deep commitment to our shareholders, we enter 2024 with significant momentum in every area of our business, validating our approach and demonstrating strong execution.
Over the past several months, we’ve launched PluriAgtech, a new business vertical focused on applying our cell- based technologies to improve agriculture; and PluriCDMO, a contract development and manufacturing organization (CDMO) division, with the goal to drive revenues and cash flow while continuing to advance healthcare therapeutics.
We are building long-term strategic alliances and partnerships with companies that are leaders in their respective fields, have market access, employ a similar approach to innovation, and are committed to pioneering a biotech revolution with us, with the goal to accelerate time to market.
Despite the myriad of challenges associated with scaling a business during these difficult times, the last few months have been especially exciting for Pluri, bringing significant progress in multiple areas.
Just as Israel has demonstrated resilience, Pluri has also demonstrated immense strength over the last few months, showing our partners and customers that we deliver innovation no matter what the current circumstances are. In fact, we’re coming off a year of successes that offer a glimpse of the bright future ahead for Pluri:
In January 2024, we launched our cell-based coffee business, pioneering a new and game- changing way to address the rapidly growing $130 billion coffee industry in a more sustainable, eco-friendly way. The coffee industry is currently at risk as global warming is expected to slash the amount of land available for coffee production by up to 50% by 2050.
Leveraging our proprietary 3D technology platform, our new vertical PluriAgtech can create high-quality cell-based coffee with 98% less water than traditional coffee production. We also estimate that our innovative new production process will reduce the amount of growing area by 95%, potentially preventing deforestation.
We are receiving a lot of interest from partners and strategics around this unique project, that can potentially transform and solve some main challenges of the industry.
Our goal is to build our cell- based coffee business as a new subsidiary focused on the coffee industry and we are working to secure sufficient funding to support the development process, scaleup and regulatory phase.
In January 2024, we launched our CDMO division, to provide services to innovative biotech companies in the rapidly growing $5.2 billion cell and gene therapy sector.
PluriCDMO includes not only our experienced clinical and bio-manufacturing team but also our robust Good Manufacturing Practice (GMP) facility and our proprietary 3D cell-expansion technology. We believe PluriCDMO can be the launchpad so many companies need to take their cell and gene therapies to the next level.
While we already started generating revenues from this division, we are receiving a lot of additional interest and are currently negotiating several CDMO agreements. PluriCDMO provides substantial value to our clients by offering; access to extensive knowledge, mass scale production opportunities and expedited time to market. We expect this division to boost Pluri’s revenues and cash flow through the utilization of our well-established technology and GMP- certified facility.
Russia’s invasion of Ukraine and Vladmir Putin’s dangerous rhetoric have raised the specter of nuclear war, and the global medical community must prepare for the worst-case scenario.
Unfortunately, the world remains unprepared for a nuclear attack or a major accident. Medical responses to nuclear radiation poisoning have failed to keep pace, while nuclear weaponry has grown exponentially more powerful since World War II.
In July 2023, we signed a 3-year, $4.2 million contract with the U.S. National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (NIH), to advance the development of our PLX-R18 cell therapy as a potential novel treatment for Hematopoietic Acute Radiation Syndrome (H-ARS). We are collaborating with the U.S. Department of
Defense’s (DoD) Armed Forces Radiobiology Research Institute (AFRRI)/Uniformed Services University of Health Sciences (USUHS) in Maryland.
PLX-R18 is being developed with the intention of being eligible for purchase by the U.S. Strategic National Stockpile as a medical countermeasure for exposure to nuclear radiation, following U.S. Food and Drug Administration (FDA) approval.
Another example of executing our partnered-based strategy is the agreement we signed with BIRAD, the commercial division of Bar-Ilan University. BIRAD – Research & Development Company has the right to further develop and commercialize PLX cells as a product to treat cocaine addiction and Pluri is entitled to a 20% revenue share from future sales of the product.
The lack of any FDA-approved medications to treat cocaine addiction presents a significant opportunity in a critical health area with significant unmet need.
We expect that additional partnership agreements will continue to drive our current PluriHealth pipeline to commercialization.
Within one year of its establishment, Ever After Foods announced a 700% increase in productivity compared to other cultivated meat companies, showing the great promise of our technology when it comes to scale and cost parity. Ever After Foods’ long-term goal is to serve as a technology enabler for the broader industry.
Ever After Foods is led by a stellar management and operational team and we expect to share some exciting developments over the coming months.
We believe our technology is pivotal for solving some of the most important trials facing humanity today. As a global leader in cell-based technology, Pluri is setting the stage for a future full of hope in the areas of food security, climate change, sustainability, health and aging.
Today I am proud to say that we are building the strongest pipeline of collaborations and negotiations that we’ve ever had. By creating novel cell-based products both independently and through partnerships, Pluri is showing what’s possible when we all work together. As such, our transformative technology is not only creating long-term value for our shareholders; it’s also making the world a better place. Thank you for your support.
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 agtech 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 its various products, its goals relating to its coffee business, the belief that PluriCDMOTM can be a launchpad for companies needing assistance with their cell and gene therapies, that it aims to build its cell-based coffee business as a new subsidiary and is working to secure sufficient funding to support the development process, scaleup and regulatory phase, that it is negotiating several CDMO agreements, that it expects its CDMO business to boost its revenues and cash flow, that it expects that additional partnership agreements will continue to drive its current PluriHealth pipeline to commercialization and that it expects Ever After Foods to share exciting developments over the coming months.
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 / Jennifer Zimmons at Jen@quantum-corp.com Israel Media: Shachar Yental at Shacharye@gitam.co.il
U.S. Media: Madeline Weirman at Maddie@quantum-corp.com / Jessica Daitch at Jessica@quantum-corp.com
HAIFA, Israel, January 23, 2024 – Pluri Inc. (Nasdaq: PLUR) (TASE: PLUR) (“Pluri” or the “Company”), a leading biotech company that transforms cells into solutions that promote global well-being and sustainability, announced today that it has launched its cell-based coffee business activity, an innovative product that will potentially revolutionize the traditional coffee industry.
Pluri’s cell-based coffee product is designed to address the growing global demand for sustainable, high-quality coffee at mass scale production.
Pluri is pioneering plant cell-based, industrial scale manufacturing solutions for the coffee industry, leveraging its 3D cell expansion technology to create high quality coffee under the Company’s new business vertical, PluriAgtech. PluriAgtech aims to forge a brighter, greener future for agriculture by using breakthrough cell technology to create more eco-friendly alternatives to traditional farming methods.
PluriAgtech’s cell-based coffee has been developed to deliver authentic coffee while solving key challenges faced by the industry.
Compared to traditional methods of coffee production, Pluri’s cell-based coffee is estimated to slash water usage by 98%.
This innovation promises to confront the reduction of suitable growing areas that are expected to decline by up to 50% by 2050; reduce price instability in a traditional commodity market; and minimize the environmental impact of coffee production, as current production methods have a high carbon footprint and upcoming regulations are expected to further strain producers. While coffee production challenges persist, world demand for coffee is expected to triple by 2050.
Pluri’s goal is to spin out its cell-based coffee as a new subsidiary focused on developing innovative products, technologies and intellectual property for the coffee industry. This new planned subsidiary will be led by Michal Ogolnik, a dynamic, results-driven business leader. She has over 20 years of executive management experience in the pharma and energy sectors.
“We are uniquely positioned to transform the coffee industry with our sustainable cell-based coffee,” said Michal Ogolnik.
“By harnessing the power of Pluri’s cutting-edge technology, we could create a brighter, more sustainable future for our planet. By bringing innovation to the forefront, we can tackle some of the coffee industry’s most pressing challenges.”
“We believe deeply in the power of cell technology to make farming and food cultivation more productive and sustainable. Pluri’s advanced agtech solutions potentially reduce the environmental footprint of traditional agricultural production. PluriAgtech can deliver numerous solutions ranging from products like cell-based coffee to bioactive in order to address the biggest challenges in agriculture,” said Pluri CEO and President Yaky Yanay. “We see great interest in the development of additional cell-based products under the PluriAgtech vertical from potential partners. We are excited about the opportunities presented by cell- based coffee.”
To learn more about Pluri’s cell-based coffee visit our website.
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 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, agtech and biologics and offers CDMO services. Pluri establishes partnerships that leverage the Company’s proprietary 3D cell-based technology across various industries that require effective, mass cell production.
To learn more, visit us at www.pluri-biotech.com or follow Pluri 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 intended use of its proprietary 3D technology platform to develop cell-based products for the coffee industry under its new business vertical PluriAgtech; the growth of the coffee industry; the potential benefits of PluriAgtech and its potential to address issues in the coffee market, as well as the environment; its belief that its cell-based coffee product will revolutionize the traditional coffee industry and address the growing global demand for sustainable, high-quality coffee at mass scale production; the aim of PluriAgtech to forge a brighter, greener future for agriculture by using breakthrough cell technology to create more eco-friendly alternatives to traditional farming methods; Pluri’s goal to spin out its cell-based coffee as a new subsidiary focused on developing innovative products, technologies and IP for the coffee industry; that its technology could create a brighter, more sustainable future for the planet; its collaborations with current and potential strategic partners; its aim to develop cutting- edge products and technology; and its ability to address the biggest challenges in agriculture. 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 proposed plans, including research and developmentry; 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; 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 world 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: Brianna Ziegler at brianna@miller-ink.com
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
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