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
HAIFA, Israel, October 31, 2022 – Pluri Inc. (Nasdaq: PLUR) (TASE: PLUR) (“Pluri” or the “Company”) (formerly known as Pluristem Therapeutics, Inc.), a leading biotechnology company, today announced its participation in three upcoming conferences.
Conference: CPHI Frankfurt Date: November 1-3, 2022 Location: Frankfurt, Germany
Pluri’s Chief Commercial Officer, Nimrod Bar Zvi, and VP Business Development, Efrat Kaduri, will attend CPHI Frankfurt.
CPHI Frankfurt brings together pharma industry participants from across the full supply chain, to source, connect, and help their businesses grow.
Conference: Jefferies London Healthcare Conference 2022 Date: November 15-17, 2022
Location: London, England
Pluri’s Chief Financial Officer, Chen Franco-Yehuda will attend the conference.
The Jefferies London Healthcare Conference is the largest healthcare-dedicated conference in Europe. The conference will feature leading public and private companies from the pharmaceuticals, biotechnology, medical technology, and healthcare services sectors from the Americas, Europe, Middle East, Africa, Asia, and Australia.
Conference: Challenges and Opportunities for Mesenchymal Stem Cells Date: November 17-19, 2022
Location: Virtual
Pluri’s Chief Medical Officer, Nitsan Halevy, will be a Panelist on November 17th from 8:05 am – 8:50 am for the panel titled: What are the Current Barriers for Success?
Pluri’s Chief Technology Officer, Lior Raviv, will be giving a presentation titled: Scalability of MSC Production to aid Logistical Burdens, on November 18th from 9:20am – 9:50am.
The conference’s focus is—Bench to bedside: Address underserved disease areas with innovative approaches to improve regulatory outcomes, scale-up strategies, cryopreservation techniques & logistical planning.
Meetings with the Pluri team can be scheduled via the various conference partnering engines or via email at info@pluri-biotech.com
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.
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, September 29, 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 Chief Executive Officer and President Yaky Yanay announcing that it had signed its second technology collaboration agreement centered on Pluri’s 3D cell expansion platform and providing some financial status updates.
Dear fellow shareholders,
Today, I am proud to inform you that the strategy of using our robust 3D cell expansion assets to forge technology partnerships in a variety of industries continues to progress. It is becoming increasingly clear to us that our robust cell-based technology is ideally suited to meet the needs and drive innovation in a range of sectors. We believe that this will create long-term value for our shareholders.
Along with you, our shareholders, we are pioneering a biotech revolution to create a range of next- generation cell-based products that improve human wellbeing, increase sustainability, and advance solutions to humanity’s greatest challenges.
Earlier this year, Pluri signed a landmark collaboration agreement with Tnuva Group, Israel’s largest food producer to establish a cultivated food platform based on Pluri’s technology. Today, I am pleased to announce an additional technology collaboration, this time in the biologics industry. Due to a confidentiality agreement with our partner, I can only share limited details at this stage, and we will provide more information once we are able to do so.
We have entered a collaboration agreement with one of the world’s leading manufacturers of specialty biologic APIs for liver and gastroenterological diseases. We believe that proof of concept with this agreement and APIs will open opportunities for us to serve additional API manufacturers in the rapidly growing, multi-billion-dollar biologics market.
As part of our collaboration with this major European company, our platform is being utilized to develop and manufacture a unique biologic API used in drugs that treat liver and gastroenterological diseases. The current source of this API is derived from animals that are sacrificed during the extraction process. The joint goal of the collaboration is to grow the specific cells needed for this API in our 3D cell expansion bioreactor systems that are capable of secreting the biological molecule without harming animals. We expect to generate revenues from this collaboration during the coming months.
Our cell expansion platform could prove to be a game-changer in the production of biologics, enabling cost-effective, sustainable, and cruelty-free ingredients. Biologic medications, made from live organisms, comprise a rapidly growing industry valued at $366 billion in 2021 and projected to grow to $720 billion by 2030. The biologic drugs segment represents a tremendous opportunity for our Company, combining our pharma-grade, regulator-approved manufacturing infrastructure and our deep knowledge and expertise in the pharma industry.
We believe there is a significant market opportunity for Pluri to become a global leader in cell expansion technology for the food industry.
Cell expansion technology is the key to producing high-quality, mass- scale, cost-effective, cultivated food products in a more efficient and sustainable manner.
Pluri is uniquely positioned with established pharma-grade expertise and state-of-the-art manufacturing facilities to capitalize on this new opportunity in cultivated foods, which is projected to grow into a $140 billion market for cultivated meat by 20301; $8.7 billion for cultivated fish and seafood by 20312; and ~$7 billion for cultivated dairy by 20323.
Plurinuva Ltd., our joint venture with Tnuva, is currently developing its first cultivated meat product. Completion of proof of concept is expected this year, followed by first product launch in 2023. We look forward to sharing more about these developments in the coming months.
The growth projected in the cultivated foods market is driven by the need for more ecologically and economically sustainable food production systems to feed a growing global population; rising awareness around the use and treatment of animals; and technological advancements that could make cultivated foods more economical, healthier and tastier than traditional animal-based food.
This burgeoning area of biotechnology is increasingly gaining global support, with the aim to promote food security and economic advancement. For example, U.S. President Joe Biden recently issued an “Executive Order on Advancing Biotechnology and Biomanufacturing Innovation for a Sustainable, Safe, and Secure American Bioeconomy” in support of advancing cultivated cell-based foods. Again, we see this as another indication that Pluri’s business strategy and assets are ideally suited to this moment.
Over the past few months, we have made significant cost reductions to align our business with our new strategy. Our annual cash burn is expected to decrease by over 30% — from $36 million to approximately $24 million. With approximately $56 million in cash reported as of June 30, 2022, combined with our new
1 “The future of food”, 4 May 2021, Barclays news
2 https://www.factmr.com/report/fish-meal-market
3 https://www.futuremarketinsights.com/reports/cultured-dairy-blends-market
business strategy that potentially provides a shorter path to revenue generation, we believe Pluri is positioned to execute its growth strategy.
Our good manufacturing practice (GMP) 3D cell manufacturing facility and our portfolio of over 130 active patents granted globally were developed when we were primarily a healthcare biotech company focused on regenerative medicine. As we deploy our assets and know-how to industries such as food-tech and biologics, Pluri continues to innovate and utilize its technology to revolutionize additional industries.
To learn more:
We wish all our shareholders well and a Happy New Year. Best regards,
Yaky Yanay
Chief Executive Officer and President, Pluri
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 and food- tech 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 plans for future product development, its commercialization activities, its opportunities, the benefits that may be derived from its new strategy, including cost savings, potential creation of long-term value for shareholders, the benefits to be derived from its additional technology collaboration in the biologics industry, the expected timing and revenue generation from the second technology collaboration, the expected timing of the proof of concept and first product launch for its cultivated meat product, that its new business strategy potentially provides a shorter path to revenue generation, potential customers who are interested in cell development and manufacturing contracts and its belief that its new business strategy magnifies the value of its assets and that its unique cell manufacturing technology can revolutionize various 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: 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, September 6, 2022 – Pluri Inc. (Nasdaq: PLUR) (TASE: PLUR) (“Pluri” or the “Company”) (formerly known as Pluristem Therapeutics, Inc.), a leading biotechnology company, today announced that a €7.5 million non-dilutive grant from the European Union’s Horizon Europe program has been awarded to PROTO (Advanced PeRsOnalized Therapies for Osteoarthritis), an international collaboration led by Charité, Berlin Institute of Health Center for Regenerative Therapies. The goal of the PROTO project is to utilize Pluri’s PLX-PAD cells in a Phase I/IIa study for the treatment of mild to moderate knee osteoarthritis (OA). The project is currently under grant agreement preparation number 101095635.
Final approval of the grant is subject to completion of the consortium and Horizon Europe grant agreements. The funds from the grant are expected to be allocated between Pluri and other members of the consortium in accordance with budget and work packages which will be determined by the consortium.
The Phase I/IIa study will be carried out by Charité, Pluri and other members of the international consortium under the leadership of Professor Tobias Winkler, Principal Investigator (PI) at the Berlin Institute of Health Center for Regenerative Therapies, Julius Wolff Institute and Center for Musculoskeletal Surgery. Professor Winkler was also the lead PI in the Phase II and Phase III muscle regeneration studies using Pluri’s PLX-PAD cells.
“Having evaluated PLX-PAD in other advanced-stage clinical studies, we see clear potential for this cell- based product to treat OA,” Professor Winkler said. “The immunomodulatory properties of PLX-PAD appear well suited to address the significant chronic inflammatory components that underly OA pathophysiology, and we are eager to advance the product candidate into a clinical study for this indication. Financial support from Horizon Europe may accelerate this critical process.”
“This award underscores the vast potential of our PLX-PAD cells to treat chronic disease with regenerative medicine,” said Yaky Yanay, Pluri’s CEO and President. “We are proud to expand our collaboration with Professor Winkler and Charité and receive support from Horizon Europe for our platform technology and cell product candidates, as we advance Pluri’s clinical pipeline and seek new cell-based solutions to longstanding health challenges.”
OA is one of the most common chronic articular diseases, with a global prevalence of 16% in the adult population1. OA is the third most rapidly growing disease associated with disability2, showing an increase of 30% over the past decade, currently affecting more than 500 million people worldwide and about 50 million in Europe3. Globally, symptomatic OA affects ~10% of men and 18% of women over 60 years of age, with knee being the most commonly affected joint4. OA also represents a huge healthcare burden with U.S. indirect costs amounting to 1% of the gross national product5.
There is currently no effective disease-modifying treatment for OA, only symptomatic treatment at a late stage. OA increases the risks of joint inflammation, pain, stiffness, swelling, disability, morbidity and
1 Cui et al., 2020, PMID: 34505846
2 Hawker et al., 2019, PMID: 31621562
3 Hunter et al., 2020, PMID:33159851
4 A. Jaiswal et al., 2021
5 Kingsbury et al., 2014, PMID: 24489012
mortality, and it reduces quality of life and work performance. OA might lead to reduced mobility and chronic disability and is associated with cardiovascular and metabolic co-morbidities.
PLX-PAD is an innovative anti-inflammatory allogeneic placental cell therapy product candidate to treat patients with mild to moderate knee OA as a direct approach to reduce inflammation and cartilage degeneration.
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 and food-tech 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.
OA is the most common form of arthritis worldwide. Chronic low-grade inflammation in the articular environment causes cartilage degeneration at an early disease stage, resulting in chronic pain, disability and loss of independence due to progressive joint destruction. To date, no disease modifying treatment is available to sustainably combat low-grade inflammation in early-stage OA patients. Biomechanical causes for intra-articular inflammation and OA development have been detected in specific patient groups. The PROTO consortium strives to implement new evidence- and patient-centered treatment strategies for early- and pre-disease stages. For the first time, early-stage knee OA patients will be treated with local PLX-PAD injections, a novel allogeneic cell therapy product with distinct anti- inflammatory capacities that may halt or revert disease progression. Secondly, patients recovering from anterior cruciate ligament reconstructions with pathological gait patterns leading to knee OA, will be treated with a personalized sensor-based digital training intervention. We intend to prevent health to disease transition by restoring physiological movement and reducing joint inflammation. To assess treatment success in early- and pre-stage OA, PROTO gathers scientific and clinical specialists who have genuinely shaped clinical, radiological and biomarker outcome parameters for OA in recent years. This will be the first time that these renowned experts join forces to analyze, stratify and compare fundamentally novel disease modifying treatment strategies for OA in one consortium. PROTO was developed with the help of patient organizations, industry partners and research societies. Restoring physiological joint homeostasis at an early disease stage may be the key to understanding health to disease progression in OA. Targeting this ‘window of opportunity’ may fundamentally change the way OA is treated today and in the future.
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 receipt of the grant from the Israel Innovation Authority, the potential for PLX-PAD to be used to treat OA, that the receipt of the grant may accelerate the clinical study of PLX-PAD, that the grant underscores the potential for PLX-PAD cells to treat chronic disease and that it is advancing its clinical pipeline and seeking new cell-based solutions to longstanding health challenges, that targeting the current ‘window of opportunity’ may fundamentally change the way OA is treated today and in the future and the potential of the Company’s products and solutions to promote global wellbeing and sustainability.
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, July 25, 2022 – Pluri Inc. (Nasdaq: PLUR) (TASE: PLUR) (“Pluri” or the “Company”), a leading biotechnology company, today announced its name change (from Pluristem Therapeutics Inc. Nasdaq: PSTI), reflecting a broader strategy of leveraging its 3D cell expansion technology to develop innovative cell-based products that can be harnessed for a range of fields beyond medicine, providing solutions for various areas of the life sciences. As of July 26, 2022, Pluri will begin trading on Nasdaq under the new ticker symbol “PLUR,” CUSIP number 72942G 104.
Pluri’s technology will continue to fuel medical research and develop pharmaceuticals, while also being used to potentially create novel cell-based solutions for other innovative initiatives—such as food-tech, agri-tech, and biologics—either independently or through partnerships, to drive global wellbeing and sustainability.
“We believe that there is tremendous need in many industries for a cell-based development platform that provides quality and precision yet is also efficient, scalable, cost effective, and consistent batch to batch. Pluri’s technology offers all these capabilities and more,” said Pluri’s CEO and President Yaky Yanay. “After nearly two decades as Pluristem, we are proud to expand as Pluri, leveraging our revolutionary technology to increase our market share across multiple verticals. Like our new logo’s dot-connecting arch suggests, it is time for Pluri to move from this single point to next generation products across a range of fields.”
Pluri’s first collaboration, based on its innovative 3D cell-based technology platform, was formed in January 2022 to produce sustainable cultured food with Israeli food giant Tnuva Group.
The Company intends to continue bringing technology to life, creating next-generation cell-based products that improve human wellbeing, increase environmental sustainability, and advance solutions to the challenges of the future.
“Our goal is to transform cells into solutions that make the world a better place,” said Yanay. “Increasing our activity across multiple verticals means we can do even more to improve human life and contribute to a more sustainable planet. We look to solve our globe’s largest and most pressing issues starting with the smallest unit of any organism: a single cell.”
For more information, visit our new website at: www.pluri-biotech.com
# # #
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 and food-tech 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 plans for future product development, its commercialization activities, the market opportunity for the Company’s products and the potential of the Company’s products and solutions to improve human wellbeing, increase environmental sustainability, and advance solutions to future challenges.
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; its 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 / Tara DiMaio at tara.dimaio@miller-ink.com
HAIFA, Israel, July 25, 2022 – Pluri Inc. (Nasdaq: PLUR) (TASE: PLUR) (“Pluri” or the “Company”) (formerly known as Pluristem Therapeutics, Inc.), a leading biotechnology company, today issued an update to its shareholders from its Chief Executive Officer and President Yaky Yanay.
Pluri: One simple, short word of Greek origin that encapsulates the strategic evolution for our Company. This is our new name.
Today, I am proud to share the vision of Pluri: to help pioneer a biotech revolution to create a range of next-generation cell-based products that improve human wellbeing, increase sustainability, and advance solutions to humanity’s greatest challenges.
In early 2021, we launched the Phoenix Project at Pluristem to lay the foundation for the rebirth of a stronger Company that built on the expertise we developed over the course of nearly two decades. This legacy includes a deep understanding of cells, a state-of-the-art cell expansion technology—and the combination of the two: a novel cell-based platform.
Pluri will seek collaborations and strategic alliances with industries that require cells and cell-extract development and manufacturing. We will develop strategic partners who understand market demands and have access to a strong customer base. Our commercialization strategy will consist of licensing and joint ventures that we like to call “Pluri focus units”. We expect that these will have separate funding and seasoned management but will benefit from full access to our platform.
Pluri will continue to drive forward medical research and develop life-changing treatments for patients, but will also offer and develop novel cell-based solutions in other areas—such as food-tech (as in our recent partnership with Tnuva), agri-tech, and biologics—using our innovative 3D cell expansion technology platforms.
Coming full circle to our roots in regenerative medicine, we are also targeting early development collaborations with pharmaceutical partners, to create the next generation of cell-based product candidates, which are targeted and tailored, differentiated by gene editing. We intend to develop our cell therapies in several therapeutic areas to focus our attention, understanding and expertise on specific medical indications.
So, who are we? We are Pluri.
We push the boundaries of science with our cell-based technology platform to offer more solutions for more industries, in vertices where we can offer a major advantage—and lead the world towards a brighter tomorrow.
To learn more:
Best regards, Yaky Yanay
Chief Executive Officer and President, Pluri
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 and food-tech 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 plans for future product development, its commercialization activities, that it designed a strategy that should serve it effectively for the coming decades, its ability to seek and collaborate with strategic partners, the market opportunity for the Company’s products and the potential of the Company’s products and solutions to improve human wellbeing, increase environmental sustainability, and advance solutions to future challenges.
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 / Tara DiMaio at tara.dimaio@miller-ink.com
HAIFA, Israel, July 13, 2022 – Pluristem Therapeutics Inc. (Nasdaq:PSTI) (TASE:PSTI) (“Pluristem” or the “Company”), a leading biotechnology company, today announced topline results from its multinational double-blind, placebo-controlled phase III study. The Company designed the study to determine the efficacy, safety, and tolerability of intramuscular administration of allogeneic PLX-PAD cells for the treatment of muscle injury following arthroplasty for hip fracture. The study enrolled 240 patients in the United States, Europe, and Israel.
PLX-PAD was demonstrated to be an effective accelerator of muscle strength and regeneration. A significant increase in Hip Abduction Strength (HAS) was observed at week 26 and week 52 for patients treated with PLX-PAD (n=120), in the injured leg (p=0.047, p=0.0022) and uninjured leg (p=0.073, p=0.0046) compared to placebo (n=120).
This new data confirms the results demonstrated in Pluristem’s phase I/II study.
The study did not meet the primary endpoint, which was the Short Physical Performance Battery (SPPB) test at week 26. The SPPB is a series of physical performance tests used in older persons to assess lower extremity function and mobility.1
PLX-PAD was well tolerated and demonstrated a significant increase in HAS:
1 https://sppbguide.com/
The increase in HAS was further supported by a positive trend in a 6-minute walk test at week 52, showing an increase in walking distance:
Professor Tobias Winkler from the Center for Musculoskeletal Surgery, Charité Berlin, and the principal investigator of the study, stated: “I am very encouraged by these results. They confirm our phase I/II study results, now presented in an even older patient population with significantly more comorbidities, and I believe that this confirms that regenerative medicine is indeed effective in elderly people. We observed a significant increase in muscle strength, which we believe demonstrates PLX-PAD’s ability to trigger muscle regeneration and maintain it over time. As an orthopedic surgeon, I see this increase in muscle strength as meaningful clinical evidence that PLX-PAD can be potentially beneficial for sport-, surgery-, and traumatic muscle- related injuries.”
“We were pleased to learn that the data from this phase III study reinforced the data from the phase I/II study, with PLX-PAD demonstrating an increase in muscle strength,” said Pluristem Chief Executive Officer and President, Yaky Yanay.
“While we were disappointed that this significant benefit did not translate to an SPPB score improvement, Pluristem will seek further regulatory advice to find a way to bridge the gap between the clear impact on muscle strength and the functionality score. We believe that we have an important responsibility to make this treatment available for patients, and we will explore business opportunities and partnerships to advance the development of this product candidate.”
Pluristem is pushing the boundaries of science and engineering to produce cell-based products for various industries on a global scale.
Pluristem currently operates in the regenerative medicine and food tech sectors and aims to establish partnerships that leverage the company’s cell-based technology platform. Pluristem’s placental cell-based therapies show potentially groundbreaking applications for treating damaged muscle, hematology deficiencies, and inflammation.
The Company recently launched a landmark collaboration to produce cultured food products with sustainability as a guiding principle.
This Phase III study is a global, multicenter, randomized, double-blind, placebo-controlled study, designed to evaluate the efficacy, safety, and tolerability of intramuscular administration of allogeneic PLX-PAD cells in patients undergoing hip arthroplasty following fracture. 240 patients were enrolled in clinical study sites in the United States, Europe, and Israel.
The completed Phase I/II double-blind placebo controlled study demonstrated a statistically significant improvement in muscle strength and volume in patients treated with PLX-PAD who underwent total hip replacement surgery due to osteoarthritis.
PLX-PAD cells exhibit regenerative potential due to their capacity to release factors in response to distress signals from tissues that have been damaged by muscle trauma, ischemia, or inflammation. These factors harness the body’s repair mechanisms to support tissue regeneration and differentiation. PLX-PAD cells also exhibit immune-modulating capabilities, playing a central role in the body’s response to tissue injury.
In addition to muscle recovery following surgery for hip fracture, PLX-PAD is currently being studied in an investigator-initiated Phase I/II study conducted by Tel Aviv Sourasky Medical Center (Ichilov Hospital) for the treatment of steroid-refractory chronic graft versus host disease (cGvHD).
This press release contains express or implied forward-looking statements within the Private Securities Litigation Reform Act of 1995 and other U.S. Federal securities laws.
For example, Pluristem is using forward-looking statements when it discusses the belief that the study results demonstrate PLX-PAD’s ability to trigger muscle regeneration and maintain it over time, that the increase in muscle strength demonstrated in the study is meaningful clinical evidence that PLX- PAD can be potentially beneficial for a variety of injuries, the belief that the study results confirm that regenerative medicine is indeed effective in elderly people, that Pluristem will seek further regulatory advice to find a way to bridge the gap between the study results showing a clear impact on muscle strength and the functionality score, its belief that it has an important responsibility to make PLX-PAD available for patients, and that it intends to explore business opportunities and partnerships to advance the development of its product candidate.
These forward-looking statements and their implications are based on the current expectations of the management of Pluristem only, and are subject to a number of factors and uncertainties that could cause actual results to differ materially from those described in the forward-looking statements.
The following factors, among others, could cause actual results to differ materially from those described in the forward-looking statements: changes in technology and market requirements; Pluristem may encounter delays or obstacles in launching and/or successfully completing its clinical trials; Pluristem’s products may not be approved by regulatory agencies, Pluristem’s technology may not be validated as it progresses further and its methods may not be accepted by the scientific community; Pluristem may be unable to retain or attract key employees whose knowledge is essential to the development of its products; unforeseen scientific difficulties may develop with Pluristem’s process; Pluristem’s products may wind up being more expensive than it anticipates; results in the laboratory may not translate to equally good results in real clinical settings; results of preclinical studies may not correlate with the results of human clinical trials; Pluristem’s patents may not be sufficient; Pluristem’s products may harm recipients; changes in legislation may adversely impact Pluristem; inability to timely develop and introduce new technologies, products and applications; loss of market share and pressure on pricing resulting from competition, which could cause the actual results or performance of Pluristem to differ materially from those contemplated in such forward-looking statements.
Except as otherwise required by law, Pluristem undertakes no obligation to publicly release any revisions to these forward-looking statements to reflect events or circumstances after the date hereof or to reflect the occurrence of unanticipated events.
For a more detailed description of the risks and uncertainties affecting Pluristem, reference is made to Pluristem’s reports filed from time to time with the Securities and Exchange Commission.
Investors investor.relations@pluristem.com
U.S. Press
Meira Feinman at meira@miller-ink.com Tara DiMaio at tara.dimaio@miller-ink.com Israel Press
Shachar Yental at shacharye@gitam.co.il
Closing Bell Ringing Ceremony Will Take Place on Monday, March 28 at 3:45 pm ET at Nasdaq MarketSite in Times Square, New York
A live stream of the Nasdaq Closing Bell will be available at:
https://livestream.com/accounts/27896496/events/10177910
Haifa, Israel, March 28, 2022 —Pluristem Therapeutics Inc. (Nasdaq: PSTI) (TASE: PSTI) (“Pluristem”), a leading biotechnology company, and Tnuva Group (“Tnuva Group” or “Tnuva”), Israel’s largest food producer, today announced that Pluristem’s CEO and President Yaky Yanay and Tnuva Group’s Chairman, Haim Gavrieli, will ring the Closing Bell at Nasdaq MarketSite in Times Square, New York. The ceremony, in honor of the companies’ launch of an innovative collaboration to develop, manufacture and commercialize cultured cell-based products for the food industry, will take place on Monday, March 28, 2022 at 3:45 pm ET.
“We are honored to celebrate this important collaboration between Pluristem and Tnuva at Nasdaq,” said Yaky Yanay, CEO and President of Pluristem. “Over the years, Pluristem has developed one of the most advanced cell-based technology platforms, offering mass-scale, cost- effective, consistent cell production. During the last year, we made our strategy more precise, with the goal of leveraging our technology and expertise through partnerships to create cell- based products for a variety of industries. We are proud to join forces with a market leader, Tnuva Group, as they bring 96 years of experience in consumer food brands and innovation to the table.”
Haim Gavrieli, Chairman of Tnuva Group: “I am excited to note the groundbreaking collaboration between Pluristem and Tnuva Group. Through this joint venture, Tnuva is realizing its vision to become a leader in multiple fields, including food tech and protein substitutes. We believe this step will enable us to remain the leading food company in Israel and to expand globally. We are confident that together, the companies will revolutionize the cultured food industry.”
Zami Aberman, Chairman of Pluristem: “As Pluristem continues its cutting-edge work in the medical field, we also look to establish new partnerships that leverage our cell-based technology platform to advance other industries. Tnuva is an ideal collaborator in the food tech space and we believe that the two companies will lead the charge in creating high-quality, affordable, and accessible cultured meat for consumers with the new joint venture.”
Eyal Malis, CEO of Tnuva Group: “Tnuva Group has decades of experience developing and marketing innovative products for the Israeli market, leads the alternative protein market in Israel, and has recently taken its expertise globally. We chose to collaborate with Pluristem because we believe it owns one of the most advanced cell production technologies in the world. We expect the collaboration between the companies to revolutionize the cultured food industry and develop the next generation of alternative proteins.”
Pluristem (Nasdaq: PSTI) is pushing the boundaries of science and engineering to produce cell-based products for various industries on a global scale. Pluristem currently operates in the regenerative medicine and food tech sectors and aims to establish partnerships that leverage the company’s cell- based technology platform. Pluristem’s placental cell-based therapies show potentially groundbreaking applications for treating damaged muscle, hematology deficiencies, and inflammation. The Company recently launched a landmark collaboration to produce cultured food products with sustainability as a guiding principle. To learn more, visit us at www.pluristem.com or follow us on LinkedIn and Twitter @Pluristem.
Tnuva Group is the largest food producer in Israel, as well as the Israeli leader in the field of alternative dairy and protein products.
Tnuva was founded 96 years ago and currently employs 6,000 workers in 32 sites across Israel, with annual revenues of above 2 billion dollars. Tnuva’s investment fund, ‘Tnuva NEXT’, functions as a CVC fund.
Tnuva takes part in the establishment of advanced food tech platforms in Israel, including ‘Fresh Start,’ an innovative food tech incubator in Northern Israel with the goal of future development of the Israeli food industry.
The incubator, established in collaboration with the Israel Innovation Authority, Tempo, the investment platform Our Crowd, and the American investment fund Finistere, specializes in locating and accompanying groundbreaking Israeli food technologies.
Tnuva’s strategy is to invest in companies that are synergetic to Tnuva’s core fields that will produce value while acquiring production and marketing rights.
Tnuva brings beneficial expertise to collaborations with other start-ups, including its deep familiarity with the Israeli consumer, R&D capabilities, the largest distribution platform in Israel, as well as a direct sale platform for customers, access to the local and global markets and international partners, and a long list of well-known and loved brands.
Tnuva had recently signed a know-how licensing agreement with Swiss retail giant Migros, under which Tnuva will help the Swiss company to produce dairy alternatives.
This press release contains express or implied forward-looking statements within the Private Securities Litigation Reform Act of 1995 and other U.S. Federal securities laws.
For example, Pluristem is using forward-looking statements when it discusses the potential benefits to be realized by the collaboration, that it will revolutionize the cultured food industry with Tnuva Group.
These forward-looking statements and their implications are based on the current expectations of the management of Pluristem only and are subject to several factors and uncertainties that could cause actual results to differ materially from those described in the forward-looking statements.
The following factors, among others, could cause actual results to differ materially from those described in the forward-looking statements about Pluristem or the collaboration: changes in technology and market requirements; either may encounter delays or obstacles in launching and/or successfully completing its clinical trials, if necessary; their products may not be approved by regulatory agencies, their technology may not be validated as they progress further and their methods may not be accepted by the scientific community; they may be unable to retain or attract key employees whose knowledge is essential to the development of their products; unforeseen scientific difficulties may develop with their processes; their products may wind up being more expensive than they anticipate; results in the laboratory may not translate to equally good results in real clinical settings; their patents may not be sufficient; their products may harm recipients or consumers; changes in legislation with an adverse impact; inability to timely develop and introduce new technologies, products and applications; loss of market share and pressure on pricing resulting from competition, which could cause the actual results or performance of Pluristem or the collaboration to differ materially from those contemplated in such forward-looking statements.
Except as otherwise required by law, Pluristem undertakes no obligation to publicly release any revisions to these forward-looking statements to reflect events or circumstances after the date hereof or to reflect the occurrence of unanticipated events.
For a more detailed description of the risks and uncertainties affecting Pluristem, reference is made to Pluristem’s reports filed from time to time with the Securities and Exchange Commission.
Investors investor.relations@pluristem.com
U.S. Press and Media Meira Feinman, Miller Ink Meira@miller-ink.com
Shachar Yental, Gitam Porter Novelli shacharye@gitam.co.il
Noy Kedem Madmon, Chief Communications Officer noyke@tnuva.co.il
HAIFA, Israel, March 23, 2022 – Pluristem Therapeutics Inc. (Nasdaq: PSTI) (TASE: PSTI), a leading biotechnology company developing novel cell therapies, today announced positive final results from its innovative hematology Phase I study to evaluate the safety and exploratory efficacy of intramuscular injections of PLX-R18 in subjects with incomplete hematopoietic recovery following HCT.
Incomplete hematopoietic recovery, or poor graft function (PGF), is a life-threatening complication for patients undergoing HCT. Current standard-of-care treatments do not result in satisfactory blood counts in some or all blood cell lineages. Consequently, patients are vulnerable to bleeding and recurrent infections, and require repeated costly transfusions of blood products, which only provide short-term benefits.
Data collated 12 months post-treatment with PLX-R18 demonstrate that:
1 When compared to data obtained from the CIBMTR registry during a 12-month interval from first observation. First observation was defined as the day of first PLX-R18 treatment for the Phase I patients and as day 100 post-HCT for the CIBMTR population. See About the CIBMTR for more details.
PLX-R18 cell therapy was previously granted an orphan drug designation by the FDA for the treatment of graft failure and incomplete hematopoietic recovery following HCT and for ARS. The final results of the Phase I study reinforce the preclinical results of studies conducted under the FDA’s Animal Rule, in collaboration with the U.S. National Institutes of Health (NIH) and the U.S. Department of Defense (DOD), in which PLX-R18 was found to be effective in supporting the recovery of bone marrow failure resulting from ARS. In addition, the FDA previously cleared Pluristem’s IND application for PLX-R18 in the treatment of ARS. The IND allows Pluristem to treat victims who may have been acutely exposed to high dose radiation due to a nuclear attack or accident.
“PLX-R18 aims to improve the standard of care by stimulating the regenerative potential of the bone marrow, and we are gratified by results that I believe show we are on track to do so,” said Pluristem Chief Executive Officer and President Yaky Yanay. “A quick and effective way to improve the hematological profile of sick patients— resulting in faster recovery and decreased transfusions—would be a game-changer for the field, and we will continue to explore its clinical applications. The FDA’s recognition of PLX-R18’s potential to treat ARS is also significant. This treatment potentially carries great significance for current events in Ukraine and Europe, providing hope for treatment in the case of a nuclear event. We are proud of this product line, which might hold the key to promoting wellbeing, improving the standard of care, and possibly saving lives.”
Pluristem is pushing the boundaries of science and engineering to produce cell-based products for various industries on a global scale. The Company’s cell manufacturing platform is a patented and validated 3D cell expansion system, which is uniquely precise, cost-effective, and consistent from batch to batch. Pluristem currently operates
1 When compared to data generated from the CIBMTR registry during a 12-month interval from first observation. First observation was defined as the day of first PLX-R18 treatment for the Phase I patients and as day 100 post-HCT for the CIBMTR population. See About the CIBMTR for more details.
in the regenerative medicine and food tech sectors and aims to establish partnerships that leverage the Company’s cell-based technology platform for additional applications. Pluristem’s placental cell-based therapies advance the field of regenerative medicine, with potentially groundbreaking applications for treating damaged muscle, hematology deficiencies, and inflammation. The Company also recently launched a landmark collaboration with Israeli food giant Tnuva to produce cultured food products with sustainability as a guiding principle.
This Phase I study was designed as a multi-center, open-label, dose-escalating study to evaluate the safety of intramuscular (IM) injections of PLX-R18 cells in 21 patients with incomplete hematopoietic recovery/PGF persisting for at least three months after HCT. The follow-up period for safety was 12 months. Patients in the study were enrolled into one of three chronological treatment groups receiving two administrations, 1 week apart, of PLX-R18 at a dose of 1 million PLX-R18 cells/kg (n=3), 2 million PLX-R18 cells/kg (n=6), or 4 million PLX-R18 cells/kg (n=12). The primary endpoint was safety, and it was assessed throughout the study, and specifically at the end of each cohort, by an external DSMB. In addition, exploratory efficacy variables were collected, including changes in blood counts, transfusion frequency, and a shift from transfusion dependence to transfusion independence.
The PLX-R18 cell therapy product secretes a combination of cytokines, including IL-6, IL 8, SCF, G-CSF, MCP1, and Gro-β, and is designed to stimulate the regeneration of damaged bone marrow to produce blood cells lineages (white, red, and platelets). As efficacy studies are not permitted in humans for the ARS indication, pre-clinical studies were conducted via the FDA animal rule pathway to evaluate Pluristem’s PLX-R18 as a medical countermeasure for that indication. These studies were conducted and funded by the U.S. government (NIH, DOD).
The Center for International Blood and Marrow Transplant Research is a nonprofit research collaboration between the National Marrow Donor Program (NMDP)/Be The Match, in Minneapolis, and the Medical College of Wisconsin, in Milwaukee. The CIBMTR collaborates with the global scientific community to increase survival and enrich the quality of life for patients. The CIBMTR facilitates critical observational and interventional research through scientific and statistical expertise, a large network of centers, and a unique database of long-term clinical data for more than 600,000 people who have received HCT and other cellular therapies. Learn more at cibmtr.org or follow the CIBMTR on Facebook, LinkedIn, or on Twitter.
From the CIBMTR registry, Pluristem selected patients aged ≥18 years at time of first allogeneic HCT for a hematologic malignancy in the United States between January 2017 and June 2020 with characteristics as similar as possible to the patients treated with PLX R18 in the Phase I study. Such values include full donor chimerism at ≤30 days post-HCT, disease in remission at 100 days post-HCT, and no active Grade III/IV acute GVHD or severe chronic GVHD or CMV infection ≤30 days post-HCT. These patients were classified as PGF based on platelet count <50 × 109 cells/L by day 100 post-HCT. Mortality rates for this group were then compared to a comparable subset of the Phase I (n=17) study who had platelet count <50 × 109 cells/L at study baseline and were <300 days post-HCT.
This press release contains express or implied forward-looking statements within the Private Securities Litigation Reform Act of 1995 and other U.S. Federal securities laws.
For example, Pluristem is using forward-looking statements when it discusses the potential safety, efficacy and benefits of PLX-R18 and that it aims to provide the standard of care and is on track to do so and the potential significance of PLX-R18 in case of a nuclear event.
These forward-looking statements and their implications are based on the current expectations of Pluristem’s management only and are subject to a number of factors and uncertainties that could cause actual results to differ materially from those described in the forward-looking statements.
The following factors, among others, could cause actual results to differ materially from those described in the forward-looking statements: changes in technology and market requirements; Pluristem may encounter delays or obstacles in launching and/or successfully completing its clinical trials; Pluristem’s products may not be approved by regulatory agencies, Pluristem’s technology may not be validated as it progresses further and its methods may not be accepted by the scientific community; Pluristem may be unable to retain or attract key employees whose knowledge is essential to the development of its products; unforeseen scientific difficulties may develop with Pluristem’s process; Pluristem’s products may wind up being more expensive than it anticipates; results in the laboratory may not translate to equally good results in real clinical settings; results of preclinical studies may not correlate with the results of human clinical trials; Pluristem’s patents may not be sufficient; Pluristem’s products may harm recipients; changes in legislation may adversely impact Pluristem; inability to timely develop and introduce new technologies, products and applications; loss of market share and pressure on pricing resulting from competition, which could cause the actual results or performance of Pluristem to differ materially from those contemplated in such forward-looking statements.
Except as otherwise required by law, Pluristem undertakes no obligation to publicly release any revisions to these forward- looking statements to reflect events or circumstances after the date hereof or to reflect the occurrence of unanticipated events.
For a more detailed description of the risks and uncertainties affecting Pluristem, reference is made to Pluristem’s reports filed from time to time with the Securities and Exchange Commission.
investor.relations@pluristem.com
Meira Feinman, Miller Ink meira@miller-ink.com
Tara DiMaio, Miller Ink tara.dimaio@miller-ink.com
Shachar Yental, Gitam Porter Novelli shacharye@gitam.co.il
HAIFA, Israel, Mar. 8, 2022 – Pluristem Therapeutics Inc. (Nasdaq: PSTI) (TASE: PSTI), a leading biotechnology company (“Pluristem”), and Tnuva Group (“Tnuva Group” or “Tnuva”), Israel’s largest food producer, today jointly announced the appointment of Eyal Rosenthal as Chief Executive Officer of their landmark joint venture to develop, manufacture and commercialize cultured meat.
Mr. Rosenthal is a seasoned entrepreneur and visionary leader in the agritech and food tech industries, serving until recently as venture partner and head of Israeli operations at Finistere Ventures, a pioneering global venture fund dedicated to identifying and nurturing promising agribusiness and food tech companies. He brings to his role over two decades of leadership within business, food tech, agriculture investment and sustainability, and will oversee the new venture’s growth into a scaled company.
Mr. Rosenthal also served as Executive Chairman of Fresh Start, a leading global food tech incubator backed by the Israel Innovation Authority, as well as top strategic and financial players. He was previously Managing Director at Infinity Group, a $600 million growth fund, and advised the International Finance Corporation, a World Bank Group member, on global food security issues.
The joint venture, which was incorporated through an agreement between Pluristem and Tnuva, has exclusive licensing rights to use Pluristem’s state-of-the-art proprietary technology and intellectual property to develop, manufacture and commercialize cultured meat.
It combines Pluristem’s technological advantage in mass-scale, cost-effective cell production with Tnuva’s expertise in food sector research and development (R&D), consumer marketing, and distribution.
“Food tech is on the rise and I am excited to be joining this new venture as we aim to transform the food system, especially the way we produce meat,” said Mr. Rosenthal. “Cultured meat can potentially address consumer concerns about our food system —from health to sustainability to animal welfare—and we are uniquely positioned to deliver. Pluristem’s unique proprietary technology, combined with Tnuva’s market leadership in alternative protein, manufacturing expertise and robust logistics, brands and infrastructure, can potentially enable us to overcome some of the biggest market challenges such as producing cost-effective products and mass-scale production,” concluded Mr. Rosenthal.
“We believe that Eyal will position us as a leader in the global food tech industry,” said Yaky Yanay, Chief Executive Officer and President of Pluristem. “His business and technology background combined with his expertise in the food sector will make him a powerful force for ingenuity. We are excited to bring Eyal on board to a talented team of innovators that will propel us into the future of food.”
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“Eyal is a food tech veteran and has an impressive track record as a trailblazer in the industry,” said Eyal Malis, Chief Executive Officer of Tnuva Group. “Making cultured meat accessible to every household is our vision and we believe Eyal’s experience can turn it into a reality. Eyal reached extraordinary achievements following the foundation of the “Fresh Start” incubator, which currently operates a number of unique start-ups that will put Israel on the global food innovation map. Alternative meat is estimated to be a $140 billion market by 20301 and we are happy to be part of this growing industry.”
Tnuva Group is the largest food producer in Israel, as well as the Israeli leader in the field of alternative dairy and protein products.
Tnuva was founded 96 years ago and currently employs 6,000 workers in 32 sites across Israel, with annual revenues of above 2 billion dollars.
Tnuva’s investment fund, ‘Tnuva NEXT’, functions as a CVC fund. Tnuva takes part in the establishment of advanced food tech platforms in Israel, including ‘Fresh Start,’ an innovative food tech incubator in Northern Israel with the goal of future development of the Israeli food industry. The incubator, established in collaboration with the Israel Innovation Authority, Tempo, the investment platform Our Crowd, and the American investment fund Finistere, specializes in locating and accompanying groundbreaking Israeli food technologies.
Tnuva’s strategy is to invest in companies that are synergetic to Tnuva’s core fields, that will produce value while acquiring production and marketing rights.
Tnuva brings beneficial expertise to collaborations with other start-ups, including its deep familiarity with the Israeli consumer, R&D capabilities, the largest distribution platform in Israel and also a direct sale platform for customers, access to the local and global markets and international partners, and a long list of well-known and loved brands.
Tnuva had recently signed a know-how licensing agreement with Swiss retail giant Migros, under which Tnuva will help the Swiss company to produce dairy alternatives.
Pluristem is pushing the boundaries of science and engineering to create cell-based products for commercial use. The Company’s cell therapies advance the field of regenerative medicine, with potentially groundbreaking applications for treating damaged muscle, hematology deficiencies, and inflammation. Pluristem sources its therapeutic cells from the placenta, an ethically accepted and potent source. The Company’s manufacturing platform, the bioreactor, is a patented and validated state-of-the-art 3D cell expansion system. Pluristem’s method is uniquely accurate, cost-effective, and consistent from batch to batch. The collaboration with Tnuva supports Pluristem’s continued strategy to establish partnerships leveraging Pluristem’s cell-based technology platform.
1 “The future of food”, 4 May 2021, Barclays news
This press release contains express or implied forward-looking statements within the Private Securities Litigation Reform Act of 1995 and other U.S. Federal securities laws.
For example, Pluristem is using forward-looking statements when it discusses the growth of the alternative cultured meat industry, the potential benefits that may be derived from cultured meat products and the belief that Pluristem’s unique proprietary technology, and Tnuva’s market leadership, potentially allows the joint venture to overcome market challenges.
These forward-looking statements and their implications are based on the current expectations of the management of Pluristem only and are subject to a number of factors and uncertainties that could cause actual results to differ materially from those described in the forward-looking statements.
The following factors, among others, could cause actual results to differ materially from those described in the forward-looking statements: changes in technology and market requirements; Pluristem may encounter delays or obstacles in launching and/or successfully completing its clinical trials; Pluristem’s products may not be approved by regulatory agencies; Pluristem’s technology may not be validated as it progresses further and its methods may not be accepted by the scientific community; Pluristem may be unable to retain or attract key employees whose knowledge is essential to the development of its products; unforeseen scientific difficulties may develop with Pluristem’s process; Pluristem’s products may wind up being more expensive than it anticipates; results in the laboratory may not translate to equally good results in real clinical settings; results of preclinical studies may not correlate with the results of human clinical trials; Pluristem’s patents may not be sufficient; Pluristem’s products may harm recipients; changes in legislation may adversely impact Pluristem; inability to timely develop and introduce new technologies, products and applications; loss of market share and pressure on pricing resulting from competition, which could cause the actual results or performance of Pluristem to differ materially from those contemplated in such forward-looking statements.
Except as otherwise required by law, Pluristem undertakes no obligation to publicly release any revisions to these forward-looking statements to reflect events or circumstances after the date hereof or to reflect the occurrence of unanticipated events.
For a more detailed description of the risks and uncertainties affecting Pluristem, reference is made to Pluristem’s reports filed from time to time with the Securities and Exchange Commission.
Contacts:
Investors
investor.relations@pluristem.com
U.S. Press and Media Meira Feinman, Miller Ink Meira@miller-ink.com
Shachar Yental, Gitam Porter Novelli shacharye@gitam.co.il
Noy Kedem Madmon, Chief Communications Officer noyke@tnuva.co.il
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