HAIFA, Israel, December 22, 2022 – Pluri Inc. (Nasdaq: PLUR) (TASE: PLUR) (“Pluri” or the “Company”) (formerly known as Pluristem Therapeutics, Inc.), a leading biotechnology Company, today issued the following update to shareholders from CEO and President Yaky Yanay and announced that as planned the Company’s joint venture with Tnuva Group has successfully achieved proof of concept in its development of cultivated meat based on Pluri’s proprietary 3D cell-based technology platform.
Dear fellow shareholders,
As we look toward a promising year ahead, I am proud to reflect on all that Pluri has achieved throughout 2022. This year, we launched a new Company strategy leveraging on our 3D cell-based technology platform to improve human wellbeing, increase sustainability, and advance solutions to humanity’s greatest challenges. We are working to deploy Pluri’s assets across the field of life sciences, from health to biologics to food tech, as we aim to capitalize on our substantial technological advantage in new and innovative ways.
We marked this evolution of our Company by adopting a new name, Pluri, representative of the many ways that our cell-based solutions can tackle some of our planet’s greatest challenges. One of the corner stones of our strategy is building long term strategic alliances and partnerships with companies that have market access, a similar innovation approach and are committed to pioneering a biotech revolution together with us; in 2022 we have already forged two collaborations to that end. At the same time, we have strengthened our financial position by creating an efficiency plan, cost cutting and ramping toward revenue generation based on our cell-based technology platform. We believe that the combination of these actions will shorten Pluri’s path to commercialization while driving long-term value for shareholders in the coming months.
Earlier this year, we formed a joint venture with Tnuva Group, Israel’s largest food producer, to develop cultivated meat products. We heralded this major collaboration in March by ringing the closing bell at the Nasdaq MarketSite in Times Square alongside our Tnuva partners.
Today, I am proud to report that our joint venture has successfully completed proof of concept in its development of cultivated meat based on our cell-based technology platform. While we were setting an aggressive development plan for the R&D teams it was important for me to see that we were able to meet each and every milestone we set, which indeed happened – and most of the time ahead of schedule.
We look forward to sharing additional details in the months ahead as we provide more details about our amazing activity in the cultivated meat industry.
I must say this process gave me a lot of confidence in our ability to expand to more industries that could benefit from our cell-based technology platform.
We believe Pluri’s patented and validated cell expansion technology and state-of-the-art manufacturing facilities are the keys to unlocking cost- effective production of cell-based food products at mass scale. With these proven assets, we believe Pluri is strategically positioned to become a global leader in this growing market, which is projected to reach $140 billion by 20301 for cultivated meat alone. Along with rapid market growth, cultivated food products have the potential to deliver significant benefits for people, animals and the environment.
Pluri launched a second technology collaboration in September, this time with one of the leading European manufacturers of active pharmaceutical ingredients (APIs). The market for biologic medications (made from live organisms) is expected to nearly double by 2030 to an estimated $720 billion, and Pluri anticipates to continue to generate revenues from this collaboration in the coming months.
This partnership can leverage our platform to create unique biologic APIs used in the treatment of liver and gastroenterological diseases.
These APIs are currently derived from animals that are sacrificed during the extraction process. We aim to replace that model with a more cost-effective and cruelty-free process that involves growing these specialty cells in our 3D cell expansion system.
Even as we broaden our horizons across the life sciences landscape, Pluri remains committed to advancing cell-based solutions for our most pressing health care needs.
We are constantly innovating, expanding our patent portfolio and actively working on new potential collaborations within the world of medicine.
Earlier this year, we announced positive final results from a Phase I hematology study of the safety and potential efficacy of injecting Pluri’s PLX-R18 cells in patients recovering from hematopoietic cell transplantation (HCT). This study found lower mortality rates, an increase in all three blood cell types and a decrease in blood transfusion units for patients with incomplete hematopoietic recovery following HCT who were treated with PLX-R18.
In addition, Pluri and our partners in PROTO, an international collaboration led by Charité, Berlin Institute of Health Center for Regenerative Therapies, studying the treatment of mild-to-moderate knee osteoarthritis (OA) using Pluri’s PLX-PAD cells, were awarded a €7.5 million non-dilutive grant from the European Union’s Horizon Europe program.
Pluri remains well positioned to capitalize on these achievements and expand on our progress in 2023, following actions earlier this year to reduce the Company’s cash burn by an estimated 30%. I am also 1 “The future of food”, May 4, 2021, Barclays news pleased to highlight a new combined $8.4 million investment in Pluri, after a series of securities purchase agreements were executed last week.
I deeply believe in the promise of Pluri and the new path forward that we began forging this year.
We believe our new strategy has yielded significant achievements in recent months that set us up for further success in 2023.
With that in mind, I decided to forego $375,000 of my cash salary over the next 12 months and instead receive equity grants.
This decision reflects my firm commitment, along with that of Pluri’s entire management team, to creating significant value for our shareholders in the year ahead.
We are doubling down on our core strength ― our game-changing cell technology ― and I am more confident than ever in our ability to establish Pluri as a global leader in this field.
I wish you all happy and healthy holidays, and I look forward to continuing the execution of our new strategy together in 2023.
Best regards,
Yaky Yanay
Chief Executive Officer and President, Pluri Inc.
Pluri is pushing the boundaries of science and engineering to create cell-based products for commercial use and is pioneering a biotech revolution that promotes global wellbeing and sustainability.
The Company’s technology platform, a patented and validated state-of-the-art 3D cell expansion system, advances novel cell-based solutions for a range of initiatives— from medicine and climate change to food scarcity, animal cruelty and beyond. Pluri’s method is uniquely accurate, scalable, cost-effective, and consistent from batch to batch.
Pluri currently operates in the field of regenerative medicine, food- tech and biologics and aims to establish partnerships that leverage the Company’s 3D cell-based technology to additional industries that require effective, mass cell production.
To learn more, visit us at www.pluri-biotech.com or follow us on LinkedIn and Twitter.
This press release contains express or implied forward-looking statements within the Private Securities Litigation Reform Act of 1995 and other U.S. Federal securities laws.
For example, Pluri is using forward- looking statements when it discusses Its expected product launch with Tnuva in 2023 and its expected timeline for providing an update on future progress, that it is actively seeking partnerships, its belief that it has shortened its path to commercialization while driving long-term value for shareholders, its belief that it is well position to become a global leader in the cultivated food product field, the benefits to be derived from its various products and technologies and its expectation to generate revenue from its collaborations.
These forward-looking statements and their implications are based on the current expectations of the management of Pluri only and are subject to a number of factors and uncertainties that could cause actual results to differ materially from those described in the forward-looking statements.
The following factors, among others, could cause actual results to differ materially from those described in the forward-looking statements about Pluri: changes in technology and market requirements; Pluri may encounter delays or obstacles in launching and/or successfully completing its clinical trials, if necessary; its products may not be approved by regulatory agencies, its technology may not be validated as it progresses further and its methods may not be accepted by the scientific community; it may be unable to retain or attract key employees whose knowledge is essential to the development of its products; unforeseen scientific difficulties may develop with its processes; its products may wind up being more expensive than it anticipates; results in the laboratory may not translate to equally good results in real clinical settings; its patents may not be sufficient; its products may harm recipients or consumers; changes in legislation with an adverse impact; inability to timely develop and introduce new technologies, products and applications; loss of market share and pressure on pricing resulting from competition, which could cause the actual results or performance of Pluri to differ materially from those contemplated in such forward-looking statements.
Except as otherwise required by law, Pluri undertakes no obligation to publicly release any revisions to these forward-looking statements to reflect events or circumstances after the date hereof or to reflect the occurrence of unanticipated events.
For a more detailed description of the risks and uncertainties affecting Pluri reference is made to Pluri’s reports filed from time to time with the Securities and Exchange Commission.
Investors: investor.relations@pluri-biotech.com
Israel Media: Shachar Yental at shacharye@gitam.co.il
U.S. Media: Nathan Miller at nathan@miller-ink.com / Meira Feinman at meira@miller-ink.com
HAIFA, Israel, December 15, 2022 – Pluri Inc. (Nasdaq: PLUR) (TASE: PLUR) (“Pluri” or the “Company”), a leading biotechnology company, announced today that it has signed securities purchase agreements with domestic and non-U.S. investors for the sale of an aggregate of 7,885,900 of the Company’s common shares and warrants to purchase up to an aggregate of 7,885,900 of the Company’s common shares. On December 13, 2022, the Company executed securities purchase agreements to sell, at a purchase price of $1.03 per share, up to 5,579,883 of the Company’s common shares and warrants to purchase up to 5,579,883 of the Company’s common shares, with an exercise price of $1.03 per share and a term of three years. On December 14, 2022, the Company executed securities purchase agreements to sell, at a purchase price of $1.05 per share, up to 2,068,517 of the Company’s common shares and warrants to purchase up to 2,068,517 of the Company’s common shares, with an exercise price of $1.05 per share and a term of three years.
On December 15, 2022, the Company executed securities purchase agreements to sell, at a purchase price of $1.06 per share, up to 237,500 of the Company’s common shares and warrants to purchase up to 237,500 of the Company’s common shares, with an exercise price of $1.06 per share and a term of three years. The warrants sold in the offerings will be exercisable upon the later of six months from their issuance date, or until the Company increases its authorized shares. In addition, Yaky Yanay, the Company’s Chief Executive Officer, has committed to forgo $375,000 of his annual cash salary for the next twelve months in return for equity grants issuable under the Company’s existing equity compensation plans. The offerings are expected to close by January 31, 2023.
The offerings are being made in the United States pursuant to the exemption from securities registration afforded by Section 4(a)(2) of the Securities Act of 1933, as amended, and Rule 506 of Regulation D as promulgated by the Securities and Exchange Commission (the “SEC”). The securities have not been registered under the Securities Act of 1933, as amended, or applicable state securities laws, and accordingly may not be offered or sold in the United States absent registration with the SEC or an applicable exemption from such registration requirements.
This press release shall not constitute an offer to sell or the solicitation of an offer to buy nor shall there be any sale of these securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction.
Pluri is pushing the boundaries of science and engineering to create cell-based products for commercial use and is pioneering a biotech revolution that promotes global wellbeing and sustainability.
The Company’s technology platform, a patented and validated state-of-the-art 3D cell expansion system, advances novel cell-based solutions for a range of initiatives— from medicine and climate change to food scarcity, animal cruelty and beyond. Pluri’s method is uniquely accurate, scalable, cost-effective, and consistent from batch to batch.
Pluri currently operates in the field of regenerative medicine, food-tech and biologics and aims to establish partnerships that leverage the Company’s 3D cell-based technology to additional industries that require effective, mass cell production.
To learn more, visit us at www.pluri- biotech.com or follow us on LinkedIn and Twitter.
This press release contains express or implied forward-looking statements within the Private Securities Litigation Reform Act of 1995 and other U.S. Federal securities laws.
For example, Pluri is using forward- looking statements when it discusses the expected closing date.
These forward-looking statements and their implications are based on the current expectations of the management of Pluri only and are subject to a number of factors and uncertainties that could cause actual results to differ materially from those described in the forward-looking statements.
The following factors, among others, could cause actual results to differ materially from those described in the forward-looking statements about Pluri: changes in technology and market requirements; Pluri may encounter delays or obstacles in launching and/or successfully completing its clinical trials, if necessary; its products may not be approved by regulatory agencies, its technology may not be validated as it progresses further and its methods may not be accepted by the scientific community; it may be unable to retain or attract key employees whose knowledge is essential to the development of its products; unforeseen scientific difficulties may develop with its processes; its products may wind up being more expensive than it anticipates; results in the laboratory may not translate to equally good results in real clinical settings; its patents may not be sufficient; its products may harm recipients or consumers; changes in legislation with an adverse impact; inability to timely develop and introduce new technologies, products and applications; loss of market share and pressure on pricing resulting from competition, which could cause the actual results or performance of Pluri to differ materially from those contemplated in such forward-looking statements.
Except as otherwise required by law, Pluri undertakes no obligation to publicly release any revisions to these forward-looking statements to reflect events or circumstances after the date hereof or to reflect the occurrence of unanticipated events.
For a more detailed description of the risks and uncertainties affecting Pluri reference is made to Pluri’s reports filed from time to time with the Securities and Exchange Commission.
Investors: investor.relations@pluri-biotech.com
HAIFA, Israel, November 10, 2022 –Pluri Inc. (Nasdaq: PLUR) (TASE: PLUR) (“Pluri” or the “Company” (formerly known as Pluristem Therapeutics, Inc.), a leading biotechnology company, won Cell Innovation award in the Cell Biology category of the second annual BioTech Breakthrough Awards. Pluri received the award for its patented and validated technology platform, a state-of-the-art 3D cell expansion system that advances novel cell-based solutions to longstanding challenges in health, food, biologics and beyond, promoting global wellbeing and sustainability.
“It’s an exciting time in the industry and we are thrilled to highlight the ‘breakthrough’ biotechnology solutions, services and companies around the world for our 2022 program. We extend our sincerest congratulations to our 2022 BioTech Breakthrough Award winners,” said Bryan Vaughn, Managing Director of BioTech Breakthrough Awards.
This year’s program attracted more than 1,350 nominations from over 12 different countries throughout the world. Other winners in various categories include Abbott, Brightseed, Honeywell, Pfizer, Promontory Therapeutics, Quanterix, Vizgen, and Waters.
Pluri’s proprietary 3D technology platform can expand a single cell into billions of cells by mimicking the cell’s natural environment. This proprietary technology delivers cost effective high-quality cells in mass quantities and with proven batch-to-batch consistency across human, animal and plant cell sources.
Pluri operates a state-of-the-art good manufacturing practice (GMP) manufacturing facility; maintains an IP portfolio of over 130 active, granted patents; and is cultivating a fast-growing network of global partnerships that expand the impact of its technology to industries that require efficient mass cell production, such as pharma, food-tech and biologics.
“We are proud to be recognized for our industry-leading technology, which can leverage the basic building blocks of life—cells—to produce medicine, food, and other products for a better tomorrow,” said Pluri’s CEO and President Yaky Yanay.
Pluri is pushing the boundaries of science and engineering to create cell-based products for commercial use and is pioneering a biotech revolution that promotes global wellbeing and sustainability. The Company’s technology platform, a patented and validated state-of-the-art 3D cell expansion system, advances novel cell-based solutions for a range of initiatives— from medicine and climate change to food scarcity, animal cruelty and beyond.
Pluri’s method is uniquely accurate, scalable, cost-effective, and consistent from batch to batch. Pluri currently operates in the field of regenerative medicine, food- tech and biologics and aims to establish partnerships that leverage the Company’s 3D cell-based technology to additional industries that require effective, mass cell production.
To learn more, visit us at www.pluri-biotech.com or follow us on LinkedIn and Twitter.
This press release contains express or implied forward-looking statements within the Private Securities Litigation Reform Act of 1995 and other U.S. Federal securities laws.
For example, Pluri is using forward – looking statements when it discusses , its ability to seek and collaborate with strategic partners, and the ability of its network of global partnerships to expand the impact of its technologies into various industries, and the potential of the Company’s products and solutions to produce medicine, food, and other products.
These forward-looking statements and their implications are based on the current expectations of the management of Pluri only and are subject to a number of factors and uncertainties that could cause actual results to differ materially from those described in the forward-looking statements.
The following factors, among others, could cause actual results to differ materially from those described in the forward-looking statements about Pluri: changes in technology and market requirements; Pluri may encounter delays or obstacles in launching and/or successfully completing its clinical trials, if necessary; its products may not be approved by regulatory agencies, its technology may not be validated as it progresses further and its methods may not be accepted by the scientific community; it may be unable to retain or attract key employees whose knowledge is essential to the development of its products; unforeseen scientific difficulties may develop with its processes; its products may wind up being more expensive than it anticipates; results in the laboratory may not translate to equally good results in real clinical settings; its patents may not be sufficient; its products may harm recipients or consumers; changes in legislation with an adverse impact; inability to timely develop and introduce new technologies, products and applications; loss of market share and pressure on pricing resulting from competition, which could cause the actual results or performance of Pluri to differ materially from those contemplated in such forward-looking statements.
Except as otherwise required by law, Pluri undertakes no obligation to publicly release any revisions to these forward-looking statements to reflect events or circumstances after the date hereof or to reflect the occurrence of unanticipated events.
For a more detailed description of the risks and uncertainties affecting Pluri reference is made to Pluri’s reports filed from time to time with the Securities and Exchange Commission.
Investors: investor.relations@pluri-biotech.com
Israel Media: Shachar Yental at shacharye@gitam.co.il
U.S. Media: Meira Feinman at meira@miller-ink.com / Ryan McCrimmon at ryan.mccrimmon@miller- ink.com
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
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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
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