HAIFA, Israel – April 28, 2025 – Pluri Inc. (Nasdaq: PLUR) (TASE: PLUR) (“Pluri” or the “Company”), a leading biotechnology company leveraging its proprietary platform for cell-based solutions to create a collaborative network of ventures, today announced the completion of the acquisition of approximately 71% of the equity of Kokomodo Ltd. (“Kokomodo”), an innovative AgFoodTech company specializing in cultivated cacao production, for $4.5 million payable in 976,139 of the Company’s Common Shares (the “Common Shares” and the “Kokomodo Transaction”, respectively). Kokomodo will continue to operate as an independent company and a subsidiary of Pluri, maintaining its mission, team, and brand identity under the leadership of its Co-Founder and Chief Executive Officer Tal Govrin, while benefiting from being part of the Pluri group.
“We are incredibly excited to join forces with Pluri,” said Tal Govrin, Chief Executive Officer and Co-founder of Kokomodo. “Scaling breakthrough innovation in food requires both technological expertise and market reach. By teaming up with Pluri, we believe that we will gain the ability to accelerate our production capabilities, expand globally, and remain true to our founding mission. I am proud to continue leading Kokomodo and we look forward to demonstrating how cellular agriculture technology can revolutionize the cacao industry with more sustainable, consistent, and adaptable products.”
“At Pluri, we are committed to pioneering sustainable solutions that address critical challenges in the global food industry,” said Yaky Yanay, Chief Executive Officer and President of Pluri. “With the closing of this strategic acquisition, we believe that we are uniquely positioned to lead innovation in the cultivated cacao sector. This acquisition advances our mission of transforming global food systems through biotechnology while adding complementary technology to our portfolio. By combining Pluri’s proven expertise in scalable and cost-effective cell production with Kokomodo’s innovative approach to cultivated cacao, we believe that this acquisition can address growing concerns about climate change impacts on traditional cacao farming, while meeting increasing consumer demand for sustainable cacao-based products.”
According to Grand View Research, the global cacao market was valued at $13.5 billion in 2023 and expected to grow at a CAGR of 8.2% to $23.5 billion by 2030.
About Kokomodo
Kokomodo crafts real, controlled, climate-resilient cacao using cellular agriculture technology, making high-quality cacao accessible globally, all year round. By cultivating cacao directly from plant cells, Kokomodo preserves the rich flavor, functionality, and nutritional qualities of cacao while minimizing the environmental, ethical, and supply chain challenges of traditional production. With a diverse library of cacao cell lines, Kokomodo enables the development of tailored cacao ingredients that are essential for the chocolate industry, while also creating new opportunities for functional ingredients and wellness products. The company is led by Co-Founder and Chief Executive Officer, Tal Govrin, and Chief Technology Officer, Dario Breitel, PhD, and has been recognized by leading global accelerators for its innovation at the intersection of food, wellness, and sustainability. To learn more, visit www.thekokomodo.com or follow Kokomodo on Linkedin.
About Pluri Inc.
Pluri™ is pushing the boundaries of science and engineering to create cell-based products for commercial use and is pioneering a biotech revolution that promotes global well-being and sustainability. The Company’s technology platform, a patented and validated state-of-the-art 3D cell expansion system, enables the development of novel cell-based solutions to address some of the world’s most pressing challenges—from medicine and climate change to food scarcity and animal welfare. Pluri’s platform is uniquely accurate, scalable, cost-effective, and consistent from batch to batch. The Company operates in the regenerative medicine, foodtech, and agtech sectors and provides Contract Development and Manufacturing Organization services. Through strategic partnerships, Pluri aims to deploy its proprietary 3D cell-based technology across various industries that demand effective and scalable cell production. To learn more, visit www.pluri-biotech.com or follow Pluri on LinkedIn and X (formerly known as Twitter).
Safe Harbor Statement
This press release contains express or implied forward-looking statements within the meaning of 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 benefits from the completion of the Kokomodo Transaction; the belief that cellular agriculture technology can revolutionize the cacao industry; the expectation that the acquisition will accelerate its production capabilities and expansion into the cultivated cacao market, and support ongoing innovation and strategic growth across its cell-based technology platform; the belief that the acquisition of Kokomodo will enable Pluri to drive growth and expansion of Kokomodo’s operations by leveraging its cultivated cacao solutions to capitalize on growing demand for sustainable food technologies; and the belief that the synergy between Kokomodo’s advancements in cell line development and Pluri’s industrial-scale production will create a strong foundation for innovation and industry leadership in cultivated cacao.
These forward-looking statements and their implications are based on the current expectations of Pluri’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: the expected benefits from the completed transaction may not be realized as anticipated; Pluri may encounter delays or obstacles in integrating Kokomodo’s operations; changes in technology or market conditions; Pluri may face challenges in launching or scaling new products; regulatory developments could impact commercialization efforts; its technology may not be validated as it progresses further and its methods may not be accepted by the scientific community; unforeseen scientific or operational challenges; and intensified competition in the cultivated food space.
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 the Company’s reports filed from time to time with the Securities and Exchange Commission.
Contacts
Investors: investor.relations@pluri-biotech.com
Israel Media: Shachar Yental at shacharye@gitam.co.il
U.S. Media: Berry Brady at berry@quantum-corp.com
HAIFA, Israel – April 10, 2025 – Pluri Inc. (Nasdaq: PLUR) (TASE: PLUR) (“Pluri” or the “Company”), a biotechnology company leveraging its proprietary platform for cell-based solutions to create a collaborative network of ventures, today announced that the U.S. Patent and Trademark Office (“USPTO”) has issued a patent covering the Company’s immune cell expansion technologies. This patent specifically includes MAIT cells, a unique subset of T cells that are crucial in helping the body fight infection and repair tissue. Additionally, Pluri was issued a patent in Israel, which mirrors previously granted US patent. Pluri’s total intellectual property (“IP”) estate now includes over 250 patents pending, allowed, and granted.
Pluri’s placental MAIT cells are unique, unconventional immune T cells which are particularly suitable for the treatment of solid tumors, a significant unmet medical need. MAIT cells offer unique advantages compared to conventional T cells, holding immense potential for immunotherapy, but until now, their expansion has been a challenge, primarily due to the difficulty in expanding them outside of the human body. Leveraging two decades of cell expertise, Pluri believes that it has overcome the challenge to unlock the full potential of MAIT cells.
The granted patents titled “System and Methods For Immune Cells Expansion and Activation In Large Scale” focus on a system and method for culturing and/or activating immune cells in a large scale, within Pluri’s proprietary 3D cell expansion bioreactors.
“These latest granted patents, which further fortify our growing IP around MAIT cells, are very timely as the U.S. Food and Drug Administration has recently approved Tumor-infiltrating lymphocytes (TILs) and T Cell Receptor-engineered T cell (TCR-T) therapies for the treatment of solid cancers. We believe that MAIT cells represent an emerging field with significant potential in immunotherapy and we believe that our unmatched ability to scale production of MAIT cells, combined with our growing IP portfolio, position Pluri for collaborations that can potentially deliver immune therapies to people in need,” stated Yaky Yanay, Chief Executive Officer and President of Pluri. “We foresee the potential to further develop and bring to market our own proprietary placental-derived MAIT cell immunotherapy platform to revolutionize solid tumor treatment, as well as supporting others in commercializing their immunotherapy treatments.”
Pluri’s Placental Allogeneic MAIT Platform
Offering substantial potential benefits compared to conventional T cells, Pluri’s MAIT cells are isolated from the human placenta, a source rich in highly potent allogeneic immune cells. These cells are potent effector cells, potentially targeting tumors through multiple mechanisms while expressing high levels of various chemokine receptors, which facilitate their migration directly to tumor sites. Furthermore, unlike conventional T cells typically collected from peripheral blood, Pluri’s MAIT cells demonstrate a lower alloreactivity profile. This characteristic not only minimizes their likelihood of inducing Graft versus Host Disease, a significant advantage over other potential allogeneic products, but also suggests that they may persist in the body for a longer duration, enhancing their therapeutic efficacy.
When combined with Pluri’s 3D cell expansion technology, we believe that the MAIT platform will enable commercial scale production of powerful immune cells as a potential first-in-class, ready to use, “off-the-shelf” therapy for cancer patients.
About Pluri’s 3D Immune Cell Expansion Technology
Pluri’s novel technology represents a paradigm shift in immune cell expansion methodologies because, unlike traditional approaches, its method employs a fundamentally different concept. Pluri’s proprietary 3D cell expansion technology mimics the natural lymph node like environment that immune cells have within the human body. The tightly controlled and fully automated bioreactor system provides cells with the conditions they need in order to expand, enabling efficient expansion of immune cells at scale and quality. We believe that this innovative approach ensures that the produced immune cells retain their integrity, functionality, and therapeutic efficacy, thus offering a potentially promising solution to meet the escalating demand for advanced cell-based therapies for immune disorders and neurodegenerative diseases.
About Pluri Inc.
Pluri™ is pushing the boundaries of science and engineering to create cell-based products for commercial use and is pioneering a biotech revolution that promotes global well-being and sustainability. The Company’s technology platform, a patented and validated state-of-the-art 3D cell expansion system, advances novel cell-based solutions for a range of challenges— from medicine and climate change to food scarcity, animal cruelty and beyond. Pluri’s method is uniquely accurate, scalable, cost-effective and consistent from batch to batch. Pluri currently operates in the field of regenerative medicine, foodtech and agtech. The Company also offers Contract Development and Manufacturing Organization services. Pluri establishes partnerships that leverage the Company’s proprietary 3D cell-based technology across various industries that require effective, mass cell production. To learn more, visit us at www.pluri-biotech.com or follow Pluri on LinkedIn and X (formerly known as Twitter).
Safe Harbor Statement
This press release contains express or implied forward-looking statements within the Private Securities Litigation Reform Act of 1995 and other U.S. Federal securities laws. For example, Pluri is using forward-looking statements when it discusses the potential of its MAIT platform and its ability to enable commercial scale production of powerful immune cells as a potential first-in-class, ready to use, “off-the-shelf” therapy for cancer patients; the potential size of the global immune cell engineering market and the global cancer immunotherapy market; the belief that it unlocked the full potential of MAIT cells; the belief that the immunotherapy field will emerge; the belief that its IP portfolio will grow; the expectation that its own proprietary placental-derived MAIT cell immunotherapy platform will continue to develop, revolutionize solid tumor treatment and support others in commercializing their immunotherapy treatments; and the potential of Pluri’s 3D immune expansion technology as a solution to meet the escalating demand for advanced cell-based therapies for immune disorders and neurodegenerative diseases. These forward-looking statements and their implications are based on the current expectations of the management of Pluri only and are subject to a number of factors and uncertainties that could cause actual results to differ materially from those described in the forward-looking statements. The following factors, among others, could cause actual results to differ materially from those described in the forward-looking statements about Pluri: changes in technology and market requirements; Pluri may encounter delays or obstacles in launching and/or successfully completing its clinical trials, if necessary; its products may not be approved by regulatory agencies, its technology may not be validated as it progresses further and its methods may not be accepted by the scientific community; it may be unable to retain or attract key employees whose knowledge is essential to the development of its products; unforeseen scientific difficulties may develop with its processes; its products may wind up being more expensive than it anticipates; results in the laboratory may not translate to equally good results in real clinical settings; its patents may not be sufficient; its products may harm recipients or consumers; changes in legislation with an adverse impact; inability to timely develop and introduce new technologies, products and applications; loss of market share and pressure on pricing resulting from competition, which could cause the actual results or performance of Pluri to differ materially from those contemplated in such forward-looking statements. Except as otherwise required by law, Pluri undertakes no obligation to publicly release any revisions to these forward-looking statements to reflect events or circumstances after the date hereof or to reflect the occurrence of unanticipated events. For a more detailed description of the risks and uncertainties affecting Pluri reference is made to Pluri’s reports filed from time to time with the Securities and Exchange Commission.
Contacts
Investors: investor.relations@pluri-biotech.com
Israel Media: Shachar Yental at shacharye@gitam.co.il
U.S. Media: Berry Brady at berry@quantum-corp.com
Haifa, Israel – March 5, 2025 – Pluri Inc. (Nasdaq: PLUR) (TASE: PLUR) (“Pluri” or the “Company”), a leading biotechnology company leveraging its proprietary platform for cell-based solutions to create a collaborative network of ventures, today announced that it has signed an exclusive collaboration agreement with Hemafund Ltd. (“Hemafund”), a Ukrainian umbilical cord blood bank with clinical and research laboratories and facilities specializing in cell preservation and cryostorage (the “Collaboration” or the “Collaboration Agreement”). This Collaboration aims to establish a strategic initiative for stockpiling, distribution, and potential clinical advancement of Pluri’s innovative PLX-R18 cell therapy (“PLX-R18”) as a countermeasure against Hematopoietic Acute Radiation Syndrome (“H-ARS”) in Ukraine. Subject to certain conditions, the Collaboration Agreement will be effective for an initial period of three years and can be extended by the parties for an additional period of three years.
Pursuant to the Collaboration Agreement, Pluri will produce and supply PLX-R18 as a potential treatment for H-ARS following nuclear radiation exposure. Hemafund will leverage its infrastructure and expertise in biostorage, logistics, and regulatory processes to support local distribution and ensure compliance with Ukrainian and European biobank standards. The parties will seek funding to build the necessary capacity of PLX-R18 and expect to enter into a specific separate definitive agreement once such funding becomes available.
This Collaboration comes in response to recent escalations, including a recent Russian drone strike on the Chernobyl nuclear power plant, which caused a fire in the containment shell. Although the blaze was extinguished without an increase in radiation levels, the incident underscores the critical need for effective and readily available radiation countermeasures in the region.
As part of this Collaboration, Pluri and Hemafund will work toward securing external funding to build an initial capacity of 12,000 doses of PLX-R18, ensuring preparedness for radiation-related emergencies. The PLX-R18 doses will be stored and managed by Hemafund, leveraging its state-of-the-art biobank infrastructure and logistics network to enable rapid deployment in case of need.
The Collaboration, if successful, could potentially generate over $100 million in value for both parties, based on the estimated cost per dose and the projected stockpile of 12,000 doses, which is expected to be sufficient to treat 6,000 individuals (as each patient is expected to require two doses). The calculation of 12,000 doses is based on the actual availability of countermeasures in the U.S. Strategic National Stockpile for the U.S. population. This approach aligns with established preparedness measures designed to ensure the availability of countermeasures against H-ARS in response to public health emergencies[1].
H-ARS is caused by exposure to life-threatening amounts of ionizing radiation, such as those which may occur during a radiological or nuclear accident, terrorist activities, and/or warfare. The condition is characterized by a dose-dependent bone marrow suppression, leading to severe neutropenia, thrombocytopenia, anemia, and a heightened risk of mortality.
Strategic Goals of the Collaboration:
“As a company committed to leveraging cell-based technology for humanity’s greatest challenges, we see this Collaboration as a proactive measure to ensure our PLX-R18 therapy is readily available where it is needed,” said Yaky Yanay, Chief Executive Officer and President of Pluri. “We believe that Hemafund’s deep-rooted expertise in Ukraine’s biotech landscape makes them an ideal partner to facilitate local accessibility, storage, and regulatory integration of our solution.”
Yaroslav Issakov, Founder of Hemafund Ltd., added, “We are excited to combine our efforts with Pluri to address this urgent medical need together. We believe that our state-of-the-art cryostorage facilities and logistics network position us well to support the introduction of PLX-R18 as a potential vital tool for radiation emergency preparedness in Ukraine. While we hope such treatments remain precautionary, our goal is to stand ready to distribute this potential therapy in the event of an emergency.”
About Hemafund
Hemafund is a family cord blood bank, located in a biotechnological complex in Ukraine, and specializing in the preservation of umbilical cord blood, placenta, and umbilical cord tissues. The company also provides long-term cryostorage services for human cells and tissues, with a focus on stem cell preservation. Hemafund operates a comprehensive facility that includes facilities such as clinical diagnostic laboratories, processing laboratories, and cryostorage facilities, and is a member of the international Cord Blood Association, coordinating a nationwide program for the application of cord blood in Ukraine. Learn more at https://international.hemafund.com/
About 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 well-being and sustainability. The Company’s technology platform, a patented and validated state-of-the-art 3D cell expansion system, advances novel cell-based solutions for a range of challenges— from medicine and climate change to food scarcity, animal cruelty and beyond. Pluri’s method is uniquely accurate, scalable, cost-effective and consistent from batch to batch. Pluri currently operates in the regenerative medicine, foodtech and agtech fields. The Company also offers Contract Development and Manufacturing Organization services. Pluri establishes partnerships that are aimed to leverage the Company’s proprietary 3D cell-based technology across various industries that require effective, mass cell production. To learn more, visit us at www.pluri-biotech.com or follow Pluri on LinkedIn and X (formerly known as Twitter).
Safe Harbor Statement
This press release contains express or implied forward-looking statements within the Private Securities Litigation Reform Act of 1995 and other U.S. Federal securities laws. For example, Pluri is using forward-looking statements when it discusses the potential benefits of the Collaboration and each party’s obligation pursuant to the Collaboration Agreement, the potential for PLX-R18 to be used for the potential treatment of H-ARS, the potential doses required and potential revenue to be derived from the Collaboration, the potential for both parties to secure necessary funds to build the necessary capacity of PLX-R18 and the expectation of the parties to enter into a separate definitive agreement when such funds become available. 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.
Media Contacts
Investors: investor.relations@pluri-biotech.com
Israel Media: Or Erez at Or.Erez@gitam.co.il
U.S. Media: Jennifer Ringler at jringler@quantum-corp.com
1 HHS boosts stockpile of products to treat acute radiation syndrome | HHS.govBARDA Awards $37.6 million Contract to Sanofi to Supply Leukine® (sargramostim) for Potential Public Health Emergency | Business WireGoLocalProv | U.S. Shells Out $290M to Stockpile Radiation Sickness Pills — Made by Amgen
HAIFA, Israel – February 4, 2025 –Pluri Inc. (Nasdaq: PLUR) (TASE:PLUR) (“Pluri” or the “Company”), a leading biotechnology company leveraging its proprietary platform for cell-based solutions to create a collaborative network of ventures, today announced the pricing of a private placement of $3.5 million by long-term shareholder Merchant Adventure Fund, L.P., a major existing shareholder of Pluri, under the same terms as the previously announced investment by Alejandro Weinstein.
Pursuant to a securities purchase agreement between the Company and Merchant Adventure Fund, L.P., the Company has agreed to issue and sell 759,219 shares of the Company’s common shares, at a purchase price of $4.61 per Common Share and warrants to purchase up to 45,553 common shares at an exercise price of $5.568 per share, for aggregate gross proceeds of $3.5 million to Pluri. The closing of the offering is expected to occur on or about February 20, 2025, subject to the satisfaction of certain customary closing conditions.
With this latest commitment, Pluri has successfully secured a total of $10 million in strategic investments over the past two weeks. This includes current $3.5 million investment from Merchant Adventure Fund and the $6.5 million investment from Alejandro Weinstein, which also involves Pluri entering into an agreement to acquire Kokomodo Ltd., subject to shareholder approval, and potentially enter the cacao market.
The Company believes that the continued investment from a major, long-term shareholder is a strong vote of confidence in Pluri’s vision, technology, and execution strategy. These funds are expected to support the Company’s growth as a global leader in cell-based technology, reinforcing its ability to expand across multiple industries, including pharma, foodtech, and agtech.
“I believe that the additional investment from one of our largest shareholders reaffirms the strength of Pluri’s strategy and the trust of our long-term investors in our ability to execute,” said Yaky Yanay, Chief Executive Officer and President of Pluri. “We believe that we are well-positioned to advance our mission of leveraging our cell-based technology platform to revolutionize multiple industries.”
The Company believes that this investment further strengthens Pluri’s financial position as it continues to drive innovation, scale its platform, and unlock new market opportunities.
The securities described above were offered pursuant to an exemption from the registration requirements under Section 4(a)(2) of the Securities Act of 1933, as amended (the “Securities Act”), and Rule 506(b) of Regulation D promulgated thereunder. The securities have not been registered under the Securities Act or applicable state securities laws. Accordingly, the securities may not be offered or sold in the United States except pursuant to an effective registration statement or an applicable exemption from the registration requirements of the Securities Act and such applicable state securities laws.
This press release shall not constitute an offer to sell or the solicitation of an offer to buy any of the securities described herein, 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.
About Pluri Inc.
Pluri™ is pushing the boundaries of science and engineering to create cell-based products for commercial use and is pioneering a biotech revolution that promotes global well-being and sustainability. The Company’s technology platform, a patented and validated state-of-the-art 3D cell expansion system, advances novel cell-based solutions for a range of challenges— from medicine and climate change to food scarcity, animal cruelty and beyond. Pluri’s method is uniquely accurate, scalable, cost-effective and consistent from batch to batch. Pluri currently operates in the regenerative medicine, foodtech and agtech fields. The Company also offers Contract Development and Manufacturing Organization services. Pluri establishes partnerships that are aimed to leverage the Company’s proprietary 3D cell-based technology across various industries that require effective, mass cell production. To learn more, visit us at www.pluri-biotech.com or follow Pluri on LinkedIn and X (formerly known as Twitter).
Safe Harbor Statement
This press release contains express or implied forward-looking statements within the Private Securities Litigation Reform Act of 1995 and other U.S. Federal securities laws. For example, Pluri is using forward-looking statements when it discusses the expected closing of the offering, the receipt of the proceeds and the intended use of the proceeds from the offering, the belief that the investment is a strong vote of confidence in Pluri’s vision, technology, and execution strategy and its ability to execute. 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: the conditions to the closing of the Transactions, including shareholder approval, may not be met; the parties may not successfully negotiate final documentation with respect to the Kokomodo Transaction; the expected benefits from the Transactions may not be realized; changes in technology and market requirements; Pluri may encounter delays or obstacles in launching and/or successfully completing its clinical trials, if necessary; its products may not be approved by regulatory agencies, its technology may not be validated as it progresses further and its methods may not be accepted by the scientific community; it may be unable to retain or attract key employees whose knowledge is essential to the development of its products; unforeseen scientific difficulties may develop with its processes; its products may wind up being more expensive than it anticipates; results in the laboratory may not translate to equally good results in real clinical settings; its patents may not be sufficient; its products may harm recipients or consumers; changes in legislation with an adverse impact; inability to timely develop and introduce new technologies, products and applications; loss of market share and pressure on pricing resulting from competition, which could cause the actual results or performance of Pluri to differ materially from those contemplated in such forward-looking statements. Except as otherwise required by law, Pluri undertakes no obligation to publicly release any revisions to these forward-looking statements to reflect events or circumstances after the date hereof or to reflect the occurrence of unanticipated events. For a more detailed description of the risks and uncertainties affecting Pluri reference is made to Pluri’s reports filed from time to time with the Securities and Exchange Commission.
Contacts
Investors: investor.relations@pluri-biotech.com
Israel Media: Shachar Yental at shacharye@gitam.co.il
U.S. Media: Jessica Daitch at Jessica@quantum-corp.com
HAIFA, Israel – January 23, 2025 –Pluri Inc. (Nasdaq: PLUR) (TASE:PLUR) (“Pluri” or the “Company”), a leading biotechnology company leveraging its proprietary platform for cell-based solutions to create a collaborative network of ventures, today announced a $6.5 million strategic private investment (“the Investment”) led by global investor Alejandro Weinstein (the “Investor”), who will join Pluri’s Board of Directors. Concurrently, Pluri is acquiring a 71% stake in Kokomodo Ltd. (“Kokomodo”), an AgTech company specializing in cultivated cacao production, for $4.5 million payable in the Company’s Common Shares (the “Common Shares” and the “Kokomodo Transaction”, respectively). The Investment and the Kokomodo Transaction position Pluri to expand its leadership in sustainable food technologies and strengthen its strategic growth and operational capabilities.
Pursuant to a securities purchase agreement (the “Purchase Agreement”) between the Company and a company wholly-owned by the Investor, the Investment consists of the issuance and sale of (i) 1,383,948 shares of the Company’s Common Shares , at a purchase price of $4.61 per Common Share; (ii) warrants to purchase up to 84,599 Common Shares at an exercise price of $5.568 per share (the “Common Warrants”); and (iii) pre-funded warrants to purchase up to 26,030 Common Shares with an exercise price equal to $0.0001 per share (the “Pre-Funded Warrants”), for aggregate gross proceeds of $6.5 million to Pluri. The Company intends to use the net proceeds from the Investment for working capital and general corporate purposes. The exercise of the Common Warrants and Pre-Funded Warrants sold in the Investment are subject to Pluri shareholder approval. The closing of the Investment is expected to occur on or about January 31, 2025 (the “Closing Date”), subject to the satisfaction of certain customary closing conditions.
Concurrently with the Investment, the Company and the Investor entered into a binding term sheet (the “Term Sheet”) for the purchase by Pluri of shares representing approximately 71% of Kokomodo for an aggregate purchase price of $4.5 million, payable by the Company in 976,139 newly issued Common Shares. The transactions contemplated by the Term Sheet, including the issuance of the Common Shares to the Investor, will be subject to, among other conditions, the successful completion of due diligence by both parties, the execution of a binding definitive agreement, which shall include customary closing conditions, and compliance with any regulatory and corporate approvals, including approval by Pluri’s shareholders.
The Investment and the Kokomodo Transaction (together, the “Transactions”) are aimed at strengthening Pluri’s financial position and accelerating its expansion into the cultivated cacao market through the acquisition of a majority stake in Kokomodo, an Israeli company focused on crafting climate-resilient cacao using cellular agriculture technology. According to Grand View Research, the global cacao market was valued at $13.5 billion in 2023 and expected to grow at a CAGR of 8.2% to $23.5 billion by 2030.
Key Highlights of the Transactions:
“At Pluri, we are committed to pioneering sustainable and impactful solutions for the food industry, as demonstrated by our launch of both Ever After Foods for cultivated meat and Coffeesai for cell-based coffee,” said Yaky Yanay, Chief Executive Officer and President of Pluri. “We are pleased that Mr. Weinstein understands our mission and will take part in shaping our strategy as we progress. We believe that Mr. Weinstein’s equity investment will strengthen our financial foundation and allow us to advance our entry into the cultivated cacao market, with the goal of positioning Pluri as a leader in this sector, where demand is growing and alternative agricultural solutions are needed to feed our global population. We believe that the synergy between Kokomodo’s advancements in cell line development and Pluri’s industrial-scale production creates a strong foundation for innovation, positioning the company to lead the field of cultivated cacao and set new benchmarks in cultivated cacao technologies.”
Mr. Weinstein added that, “Pluri has already demonstrated the great potential of cell-based technologies to drive innovation forward in both the regenerative medicine and AgTech space. I welcome the opportunity to contribute to Pluri’s growth as I believe that sustainable and scalable food production is a global priority. I believe that these Transactions mark the beginning of a powerful partnership.”
Mr. Weinstein is a seasoned global investor and entrepreneur with over 20 years of leadership experience in the pharmaceutical, biotechnology, and sustainable technology sectors. As the former Chief Executive Officer of CFR Pharmaceuticals S.A., he successfully spearheaded the company’s growth and its eventual acquisition by Abbott Laboratories in 2014, achieving an enterprise value of $3.2 billion. Throughout his career, Mr. Weinstein has played a pivotal role in mergers and acquisitions exceeding $5 billion, while also making strategic investments in healthcare and healthtech. His collaboration with Pluri underscores his commitment to advancing innovative technologies that address critical global challenges, including sustainable food production.
The securities described above were offered pursuant to an exemption from the registration requirements under Section 4(a)(2) of the Securities Act of 1933, as amended (the “Securities Act”), and Rule 506(b) of Regulation D promulgated thereunder. The securities have not been registered under the Securities Act or applicable state securities laws. Accordingly, the securities may not be offered or sold in the United States except pursuant to an effective registration statement or an applicable exemption from the registration requirements of the Securities Act and such applicable state securities laws.
The Kokomodo Transaction is expected to close during the second quarter of 2025. There is no guarantee when or if the Kokomodo Transaction will be completed. However, in the event that the Kokomodo Transaction does not close for any reason other than due to Investor’s failure to meet its covenants and/or undertakings, or due to major diligence findings, then Investor agreed to sell to the Company, and the Company agreed to purchase from Investor, a certain portion of his shares in Kokomodo for an aggregate amount of $1 million at the same pre-money valuation as the original transaction, and for the Company to invest an additional $0.5 million in Kokomodo pursuant to a Simple Agreement for Future Equity (“SAFE”) instrument.
This press release shall not constitute an offer to sell or the solicitation of an offer to buy any of the securities described herein, 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.
About Pluri Inc.
Pluri™ is pushing the boundaries of science and engineering to create cell-based products for commercial use and is pioneering a biotech revolution that promotes global well-being and sustainability. The Company’s technology platform, a patented and validated state-of-the-art 3D cell expansion system, advances novel cell-based solutions for a range of challenges— from medicine and climate change to food scarcity, animal cruelty and beyond. Pluri’s method is uniquely accurate, scalable, cost-effective and consistent from batch to batch. Pluri currently operates in the regenerative medicine, foodtech and agtech fields. The Company also offers Contract Development and Manufacturing Organization services. Pluri establishes partnerships that are aimed to leverage the Company’s proprietary 3D cell-based technology across various industries that require effective, mass cell production. To learn more, visit us at www.pluri-biotech.com or follow Pluri on LinkedIn and X (formerly known as Twitter).
Safe Harbor Statement
This press release contains express or implied forward-looking statements within the Private Securities Litigation Reform Act of 1995 and other U.S. Federal securities laws. For example, Pluri is using forward-looking statements when it discusses the expected closing of the Investment, the receipt of the proceeds and the intended use of the proceeds from the Investment, the expected purchase of Kokomodo’s shares by the Company for an aggregate purchase price of $4.5 million, the expectation that due diligence will be successfully completed by both parties, that a definitive agreement will be executed, that it will be compliant with any regulatory and corporate approvals, including shareholder approval, that the Kokomodo Transaction will close during the second quarter of 2025, and the potential transactions that may occur if the Kokomodo Transaction does not close, the expectation that the Investment will strengthen Pluri’s financial position, balance sheet, accelerate its expansion into the cultivated cacao market, support ongoing innovation and strategic growth across its cell-based technology platform, the expectation that the Company’s purchase of Kokomodo shares will enable Pluri to drive growth and expansion of Kokomodo’s operations by leveraging its innovative cultivated cacao solutions to capitalize on the growing demand for sustainable food technologies, the expectation that the Company will appoint Mr. Weinstein to its Board of Directors pursuant to the terms of the Purchase Agreement, the expectation that the Transactions will receive regulatory and corporate approvals, the expectation that Mr. Weinstein will provide the Company with strategic counseling, the belief that Pluri will be positioned as a leader in the cacao sector and the belief that the synergy between Kokomodo’s advancements in cell line development and Pluri’s industrial-scale production creates a strong foundation for innovation, positioning the company to lead the field of cultivated cacao and set new benchmarks in cultivated cacao technologies. 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: the conditions to the closing of the Transactions, including shareholder approval, may not be met; the parties may not successfully negotiate final documentation with respect to the Kokomodo Transaction; the expected benefits from the Transactions may not be realized; changes in technology and market requirements; Pluri may encounter delays or obstacles in launching and/or successfully completing its clinical trials, if necessary; its products may not be approved by regulatory agencies, its technology may not be validated as it progresses further and its methods may not be accepted by the scientific community; it may be unable to retain or attract key employees whose knowledge is essential to the development of its products; unforeseen scientific difficulties may develop with its processes; its products may wind up being more expensive than it anticipates; results in the laboratory may not translate to equally good results in real clinical settings; its patents may not be sufficient; its products may harm recipients or consumers; changes in legislation with an adverse impact; inability to timely develop and introduce new technologies, products and applications; loss of market share and pressure on pricing resulting from competition, which could cause the actual results or performance of Pluri to differ materially from those contemplated in such forward-looking statements. Except as otherwise required by law, Pluri undertakes no obligation to publicly release any revisions to these forward-looking statements to reflect events or circumstances after the date hereof or to reflect the occurrence of unanticipated events. For a more detailed description of the risks and uncertainties affecting Pluri reference is made to Pluri’s reports filed from time to time with the Securities and Exchange Commission.
Contacts
Investors: investor.relations@pluri-biotech.com
Israel Media: Shachar Yental at shacharye@gitam.co.il
U.S. Media: Jessica Daitch at Jessica@quantum-corp.com
HAIFA, Israel – December 19, 2024 –Pluri Inc. (Nasdaq: PLUR) (TASE:PLUR) (“Pluri” or the “Company”), an innovator in the development of leading cell-based technologies for various indications, congratulates Mesoblast Ltd. (“Mesoblast”) and its Chief Executive Officer, Silviu Itescu, on the U.S. Food and Drug Administration (the “FDA”) approval of the first MSC-based therapy for steroid-refractory acute graft-versus-host disease (“SR-aGVHD”). This landmark achievement marks a pivotal moment in the advancement of regenerative medicine and highlights the growing clinical and regulatory recognition of MSC therapies’ transformative potential.
“This milestone is not just a triumph for Mesoblast, but for the entire field of cellular medicine,” said Yaky Yanay, Chief Executive Officer and President of Pluri. “Silviu and the team at Mesoblast have opened a new chapter in harnessing MSC therapies to treat devastating conditions like SR-aGVHD. This approval validates the immense therapeutic promise of MSCs and inspires all of us working in this space to redouble our efforts to bring innovative solutions to patients in need.”
The FDA approval also underscores the critical role of regenerative medicine in transforming healthcare systems globally. “Regenerative medicine has the potential to shift the paradigm from managing chronic conditions to enabling true healing and regeneration,” Mr. Yanay added. “By addressing the root causes of diseases rather than just their symptoms, regenerative therapies can potentially improve patient outcomes while creating more sustainable and efficient healthcare systems.”
Pluri has long championed the potential of MSCs through its proprietary platform, harnessing its unique 3D cell-expansion technology to develop robust and scalable cell-based therapies. The Company’s innovative approach positions it at the forefront of cell therapy development, enabling the creation of next-generation solutions that address critical unmet medical needs.
“At Pluri, we share a vision of a future where cell-based technologies transform lives across a spectrum of diseases,” Mr. Yanay said. “We believe that the FDA’s decision underscores the importance and opportunity to accelerate the development of MSC-based therapies globally.”
Pluri remains steadfast in its mission to expand the therapeutic boundaries of cell-based solutions , leveraging its expertise to pioneer new treatments that meet the highest standards of efficacy, safety, and accessibility. Pluri’s PLacental eXpanded cells are placenta-derived, mesenchymal-like adherent stromal cells which are being studied for the treatment of hematopoietic indications such as Acute Radiation Syndrome as well as orthopedic indications such as Knee Osteoarthritis. For more information about Pluri and its advanced cell therapy product candidates, visit https://pluri-biotech.com/solutions-pluri-health/.
About Pluri Inc.
Pluri™ is pushing the boundaries of science and engineering to create cell-based products for commercial use and is pioneering a biotech revolution that promotes global well-being and sustainability. The Company’s technology platform, a patented and validated state-of-the-art 3D cell expansion system, advances novel cell-based solutions for a range of challenges— from medicine and climate change to food scarcity, animal cruelty and beyond. Pluri’s method is uniquely accurate, scalable, cost-effective and consistent from batch to batch. Pluri currently operates in the regenerative medicine, foodtech and agtech fields. The Company also offers contract development and manufacturing organization services. Pluri establishes partnerships that are aimed to leverage the Company’s proprietary 3D cell-based technology across various industries that require effective, mass cell production. To learn more, visit us at www.pluri-biotech.com or follow Pluri on LinkedIn and X (formerly known as Twitter).
Safe Harbor Statement
This press release contains express or implied forward-looking statements within the Private Securities Litigation Reform Act of 1995 and other U.S. Federal securities laws. For example, Pluri is using forward-looking statements when it discusses that Mesoblast’s landmark achievement marks a pivotal moment in the advancement of regenerative medicine and highlights the growing clinical and regulatory recognition of MSC therapies’ transformative potential, that regenerative medicine has the potential to shift the paradigm from managing chronic conditions to enabling true healing and regeneration and potentially improve patient outcomes while creating more sustainable and efficient healthcare systems, that the Company’s innovative approach positions it at the forefront of cell therapy development, enabling the creation of next-generation solutions that address critical unmet medical needs, Company’s vision and mission and its belief that the FDA’s decision underscores the urgency and opportunity to accelerate the development of MSC-based therapies globally. These forward-looking statements and their implications are based on the current expectations of the management of Pluri only and are subject to a number of factors and uncertainties that could cause actual results to differ materially from those described in the forward-looking statements. The following factors, among others, could cause actual results to differ materially from those described in the forward-looking statements about Pluri: changes in technology and market requirements; Pluri may encounter delays or obstacles in launching and/or successfully completing its clinical trials, if necessary; its products may not be approved by regulatory agencies, its technology may not be validated as it progresses further and its methods may not be accepted by the scientific community; it may be unable to retain or attract key employees whose knowledge is essential to the development of its products; unforeseen scientific difficulties may develop with its processes; its products may wind up being more expensive than it anticipates; results in the laboratory may not translate to equally good results in real clinical settings; its patents may not be sufficient; its products may harm recipients or consumers; changes in legislation with an adverse impact; inability to timely develop and introduce new technologies, products and applications; loss of market share and pressure on pricing resulting from competition, which could cause the actual results or performance of Pluri to differ materially from those contemplated in such forward-looking statements. Except as otherwise required by law, Pluri undertakes no obligation to publicly release any revisions to these forward-looking statements to reflect events or circumstances after the date hereof or to reflect the occurrence of unanticipated events. For a more detailed description of the risks and uncertainties affecting Pluri reference is made to Pluri’s reports filed from time to time with the Securities and Exchange Commission.
Contacts
Investors: investor.relations@pluri-biotech.com
Israel Media: Shachar Yental at shacharye@gitam.co.il
U.S. Media: Jessica Daitch at Jessica@quantum-corp.com
PluriCDMO™, the Company’s contract development and manufacturing organization, recognized as a leading manufacturing collaborator offering scalability and mass scale production to a growing number of innovative life science companies
HAIFA, Israel – December 9, 2024 –Pluri Inc. (Nasdaq: PLUR) (TASE:PLUR) (“Pluri” or the “Company”), a leading biotechnology company leveraging its proprietary platform for cell-based solutions to create a collaborative network of ventures, today announced that its PluriCDMO™ business, launched earlier this year, has been shortlisted for the CDMO of the Year Award by the prestigious Advanced Therapies Awards 2025.
“This recognition is particularly meaningful as it comes less than a year after we launched our CDMO division,” stated Yaky Yanay, Chief Executive Officer and President of Pluri. “I couldn’t be prouder of what we’ve accomplished together at Pluri including signing agreements with valued clients and making strides towards our vision of supporting transformative therapies for patients worldwide. We’re excited to continue expanding our CDMO work and contributing to this dynamic and impactful industry. A heartfelt thank you to the Advanced Therapies Awards team for this recognition and congratulations to all the outstanding finalists.”
Pluri launched its CDMO division in January 2024, leveraging its proprietary knowledge, cutting-edge technology and cell therapy production facility on behalf of clients. PluriCDMO™ clients gain access to Pluri’s 47,000 square foot state-of-the-art GMP facilities, and to Pluri’s patented bioreactor system, which enables 3D cell expansion at mass scale via a fully controlled, automated and validated process. For more information visit https://pluri-biotech.com/transforming-cell-therapy/ or contact CDMO@Pluri-biotech.com.
About Pluri Inc.
Pluri™ is pushing the boundaries of science and engineering to create cell-based products for commercial use and is pioneering a biotech revolution that promotes global well-being and sustainability. The Company’s technology platform, a patented and validated state-of-the-art 3D cell expansion system, advances novel cell-based solutions for a range of challenges— from medicine and climate change to food scarcity, animal cruelty and beyond. Pluri’s method is uniquely accurate, scalable, cost-effective and consistent from batch to batch. Pluri currently operates in the regenerative medicine, foodtech and agtech fields. The Company also offers Contract Development and Manufacturing Organization services. Pluri establishes partnerships that are aimed to leverage the Company’s proprietary 3D cell-based technology across various industries that require effective, mass cell production. To learn more, visit us at www.pluri-biotech.com or follow Pluri on LinkedIn and X (formerly known as Twitter).
Safe Harbor Statement
This press release contains express or implied forward-looking statements within the Private Securities Litigation Reform Act of 1995 and other U.S. Federal securities laws. For example, Pluri is using forward-looking statements when it discusses its vision, continued expansion of its CDMO work and its contribution to the industry. These forward-looking statements and their implications are based on the current expectations of the management of Pluri only and are subject to a number of factors and uncertainties that could cause actual results to differ materially from those described in the forward-looking statements. The following factors, among others, could cause actual results to differ materially from those described in the forward-looking statements about Pluri: changes in technology and market requirements; Pluri may encounter delays or obstacles in launching and/or successfully completing its clinical trials, if necessary; its products may not be approved by regulatory agencies, its technology may not be validated as it progresses further and its methods may not be accepted by the scientific community; it may be unable to retain or attract key employees whose knowledge is essential to the development of its products; unforeseen scientific difficulties may develop with its processes; its products may wind up being more expensive than it anticipates; results in the laboratory may not translate to equally good results in real clinical settings; its patents may not be sufficient; its products may harm recipients or consumers; changes in legislation with an adverse impact; inability to timely develop and introduce new technologies, products and applications; loss of market share and pressure on pricing resulting from competition, which could cause the actual results or performance of Pluri to differ materially from those contemplated in such forward-looking statements. Except as otherwise required by law, Pluri undertakes no obligation to publicly release any revisions to these forward-looking statements to reflect events or circumstances after the date hereof or to reflect the occurrence of unanticipated events. For a more detailed description of the risks and uncertainties affecting Pluri reference is made to Pluri’s reports filed from time to time with the Securities and Exchange Commission.
Contacts
Investors: investor.relations@pluri-biotech.com
Israel Media: Shachar Yental at shacharye@gitam.co.il
U.S. Media: Jessica Daitch at Jessica@quantum-corp.com
Haifa, Israel – November 25, 2024 – PLURI Inc. (Nasdaq: PLUR) (TASE: PLUR) (“Pluri” or the “Company”), a biotechnology company leveraging its proprietary platform for cell-based solutions to create a collaborative network of ventures, today announced that it is assessing its readiness to initiate mass production of PLX-R18, a novel potential treatment for hematopoietic complications of the acute radiation syndrome (H-ARS) following exposure to nuclear radiation, in response to heightened global tensions and escalating nuclear threats, particularly in Ukraine.
PLX-R18 has shown potential promise in significantly improving survival and accelerating recovery from H-ARS in preclinical animal and human studies, conducted with support from leading global health and U.S. defense agencies. PLX-R18 demonstrated the ability to stimulate blood cell regeneration and potentially mitigate the effects of radiation exposure.
H-ARS is caused by exposure to life-threatening amounts of ionizing radiation, such as those which may occur during a radiological or nuclear accident, terrorist activities, and/or warfare. The condition is characterized by a dose-dependent bone marrow depression, leading to neutropenia, thrombocytopenia, anemia, and possibly death. The U.S. Food and Drug Administration (“FDA”) previously approved an Investigational New Drug application for PLX-R18 for the treatment of H-ARS in the case of nuclear or radiological or incidents and granted it Orphan Drug Designation.
Beyond what is required for ongoing clinical studies, the Company is actively examining the steps required to ramp up production in the event of increased and urgent global demand. PLURI’s state-of-the-art manufacturing facility is designed to handle large-scale production of cellular therapies and could be mobilized to scale up to mass production, if necessary.
“At Pluri, we stand ready to support communities in need by leveraging our expertise to respond to global emergencies,” said Yaky Yanay, Chief Executive Officer and President of Pluri. “That is why we are evaluating our readiness to scale production if global circumstances escalate and demand arises. We believe that our proactive approach will ensure global preparedness.”
Pluri™ is pushing the boundaries of science and engineering to create cell-based products for commercial use and is pioneering a biotech revolution that promotes global well-being and sustainability. The Company’s technology platform, a patented and validated state-of-the-art 3D cell expansion system, advances novel cell-based solutions for a range of challenges— from medicine and climate change to food scarcity, animal cruelty and beyond. Pluri’s method is uniquely accurate, scalable, cost-effective and consistent from batch to batch.
Pluri currently operates in the regenerative medicine, foodtech and agtech fields. The Company also offers Contract Development and Manufacturing Organization services. Pluri establishes partnerships that are aimed to leverage the Company’s proprietary 3D cell-based
technology across various industries that require effective, mass cell production. To learn more, visit us at www.pluri-biotech.com or follow Pluri on LinkedIn and X (formerly known as Twitter).
This press release contains express or implied forward-looking statements within the Private Securities Litigation Reform Act of 1995 and other U.S. Federal securities laws. For example, Pluri is using forward-looking statements when it discusses the use of PLX-R18 as a potential treatment for hematopoietic complications of H-ARS, that its manufacturing facility’s ability to handle large-scale production of cell therapies could be mobilized to scale up to mass production and its belief that its proactive approach will ensure global preparedness. 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: Jessica Daitch at Jessica@quantum-corp.com
HAIFA, Israel – October 28, 2024 – Pluri Inc. (Nasdaq:PLUR) (TASE:PLUR) (“Pluri” or the “Company”), a leading biotechnology company that transforms cells into solutions, today announced that the Israel Innovation Authority (“IIA”) will fund Pluri’s collaboration with the Bar-Ilan University Research and Development Company Ltd., (“BIRAD”), the commercial arm of Bar-Ilan University, to support the continued development of Placental Mucosal Associated Invariant T (“MAIT”) cells for solid tumors. MAIT cells are known to have unique advantages compared to conventional T-cells but have previously been difficult to expand and scale for clinical investigation and potential commercialization. MAIT cells are believed to be particularly suitable for the treatment of solid tumors, a significant unmet medical need.
Under this collaboration, Prof. Cohen’s novel Siglec-based Chimeric Switch Receptors (“CCR”) will be integrated into Pluri’s CAR-MAIT cell therapy platform to significantly enhance CAR-MAIT’s efficacy and tumor specificity. By leveraging the complementary strengths of both parties, Pluri’s expertise in the MAIT cell platform and the experience of Prof. Cohen’s group in developing clinically relevant and optimized T-cell genetic modification vectors, this collaboration is poised to advance innovative allogeneic cell therapies targeting solid tumors. The IIA will fund Pluri and BIRAD’s collaboration over the next year, with an option of funding an additional year. The goal of this collaboration is to effectively integrate both innovative technologies and advance to preclinical studies.
As announced in May 2024, Pluri leveraged two decades of cell expansion expertise and its proprietary technology to create a novel, patented method for expansion of immune cells. Pluri’s MAIT cells are isolated from healthy human placentas, a source rich in highly potent immune cells. Notable characteristics of Pluri’s placental MAIT cells include their potency as effector cells, their potential ability to target tumors through multiple mechanisms, and their expression of high levels of various chemokine receptors, which facilitate their migration to tumor sites. MAIT cells hold unique properties that minimize their likelihood of inducing Graft versus Host Disease (GvHD), a serious complication associated with other potential allogeneic products.
“I’m thrilled to collaborate with Pluri on this innovative project to be supported by the Israel Innovation Authority,” said Prof. Cyrille Cohen. “By combining our patent pending Siglec-based receptor technology and our expertise in designing potent CAR vectors for clinical applications, together with Pluri’s advanced capabilities in cultivating MAIT cells, we aim to harness the unique biological properties of these cells. While immunotherapy has shown great success in treating blood cancers, an equivalent success has yet to be duplicated in solid tumor malignancies. This collaboration offers the potential to overcome that challenge by creating powerful, off-the-shelf CAR T-cell therapies that specifically target solid tumors.”
“For over two decades, our team has been at the forefront of cell therapy research. We are excited to partner with BIRAD to combine our MAIT platform with Prof. Cohen’s innovative CCR technology,” said Yaky Yanay, Chief Executive Officer and President of Pluri. “This promising collaboration, recognized by the Israel Innovation Authority for its innovative potential, will help us create more effective immunotherapies for patients with solid cancer. We appreciate the IIA’s support in making this possible”.
Total Addressable Market
The global cancer immunotherapy market was valued at $111 billion in 2023 and is expected to surpass $312 billion by 2033, poised to grow at a compound annual growth rate of 10.9%.
About Pluri Inc.
Pluri™ is pushing the boundaries of science and engineering to create cell-based products for commercial use and is pioneering a biotech revolution that promotes global well-being and sustainability. The Company’s technology platform, a patented and validated state-of-the-art 3D cell expansion system, advances novel cell-based solutions for a range of challenges— from medicine and climate change to food scarcity, animal cruelty and beyond. Pluri’s method is uniquely accurate, scalable, cost-effective and consistent from batch to batch. Pluri currently operates in the regenerative medicine, foodtech and agtech fields. The Company also offers CDMO services. Pluri establishes partnerships that leverage the Company’s proprietary 3D cell-based technology across various industries that require effective, mass cell production. To learn more, visit us at www.pluri-biotech.com or follow Pluri on LinkedIn and X (formerly known as Twitter).
About BIRAD
BIRAD – Research & Development Company Ltd. was established in order to translate new inventions made at Bar-Ilan University into useful products that can be effectively commercialized, thus strengthening the economy, promoting innovation and improving lives.
BIRAD’s innovative approach, combined with Bar-Ilan University’s rapid growth leading Israel’s growth in students’ number, including the largest Nanotechnology center in Israel and new Medical School in Safed, provides BIRAD with a wide range of opportunities. Thus, BIRAD (https://birad.biz/) offers corporate partnerships and alliances, intellectual property management, and technology commercialization through venture creation and licensing.
Safe Harbor Statement
This press release contains express or implied forward-looking statements within the Private Securities Litigation Reform Act of 1995 and other U.S. Federal securities laws. For example, Pluri is using forward-looking statements when it discusses the development of MAIT cells and their potential advantages, the potential size of the global cancer immunotherapy market, the integration of CCRs into Pluri’s CAR-MAIT cell therapy platform and the potential benefits resulting from the collaboration between Pluri and BIRAD. 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.
Media Contacts
Investors: investor.relations@pluri-biotech.com
Israel Media: Shachar Yental at shacharye@gitam.co.il
U.S. Media: Jessica Daitch at Jessica@quantum-corp.com
PluriCDMO™, the Company’s contract development and manufacturing organization, recognized as a leading manufacturing partner offering scalability and mass scale production to a growing number of innovative life science companies
HAIFA, Israel – July 18, 2024 – Leading biotechnology company Pluri Inc. (Nasdaq:PLUR) (TASE:PLUR) (“Pluri” or the “Company”), which transforms cells into solutions that promote global wellbeing and sustainability, today announced it has signed a tech transfer and manufacturing agreement with Kadimastem Ltd. (TASE: KDST), a clinical stage biotechnology company developing therapeutic cells for ALS and diabetes treatments. PluriCDMO™, launched earlier this year, leverages Pluri’s 47,000 square foot good manufacturing practice (GMP) cell production facility to manufacture cell-based products for life science companies.
PluriCDMO™ will manufacture two cell therapy product candidates for Kadimastem: AstroRx®, clinical grade human astrocytes (nervous system supporting cells) for the treatment of ALS for an upcoming U.S. Food and Drug Administration (FDA) Phase 2a study; and IsletRx, clinical grade pancreatic islet cells which produce and secrete insulin and glucagon in response to blood glucose levels, for the treatment of diabetes.
Key to Kadimastem’s selection of PluriCDMO™ is Pluri’s unparalleled expertise and experience in developing and manufacturing cell-based products in GMP grade for clinical use. From initial clinical trial batches to mass scale commercial production, PluriCDMO™ is a long-term partner and service provider for the cell therapy production needs of the most innovative companies.
“Working with Pluri marks a pivotal milestone, enhancing Kadimastem’s capacity to manufacture our products under GMP conditions,” stated Ronen Twito, Executive Chairman & President of Kadimastem. “This collaboration is integral to our strategy as we prepare for clinical trials and expand into the U.S. market with our AstroRx® product candidate.”
“We are excited to work with Kadimastem and support their development of cell therapies, potentially improving the lives of patients with ALS and diabetes,” stated Yaky Yanay, Chief Executive Officer and President of Pluri. “This collaboration underscores the versatility of our PluriCDMO™ platform and our commitment to aiding innovative companies in advancing their life-saving therapies. We look forward to a successful collaboration with Kadimastem as they make progress with their clinical development programs.”
About Pluri Inc.
Pluri™ is pushing the boundaries of science and engineering to create cell-based products for
commercial use and is pioneering a biotech revolution that promotes global well-being and
sustainability. The Company’s technology platform, a patented and validated state-of-the-art 3D cell expansion system, advances novel cell-based solutions for a range of challenges— from medicine and climate change to food scarcity, animal cruelty and beyond. Pluri’s method is uniquely accurate, scalable, cost-effective and consistent from batch to batch. Pluri currently operates in the field of regenerative medicine, foodtech and agtech. The Company also offers CDMO services. Pluri establishes partnerships that leverage the Company’s proprietary 3D cell-based technology across various industries that require effective, mass cell production. To learn more, visit us at www.pluri-biotech.com or follow Pluri on LinkedIn and X (formerly known as Twitter).
About PluriCDMO™
Pluri launched its CDMO division in January 2024, leveraging its proprietary knowledge, cutting-edge technology and cell therapy production facility on behalf of clients. PluriCDMO™ clients gain access to Pluri’s state-of-the-art GMP facilities, and to Pluri’s patented bioreactor system, which enables 3D cell expansion at mass scale via a fully controlled, automated and validated process. For more information visit https://pluri-biotech.com/transforming-cell-therapy/ or contact CDMO@Pluri-biotech.com
About Kadimastem Ltd.
Kadimastem is a clinical stage cell therapy company, developing “off-the-shelf”, allogeneic, proprietary cell products based on its technology platform for the expansion and differentiation of Human Embryonic Stem Cells (hESCs) into functional cells. AstroRx®, healthy and functional human astrocytes, is the company’s lead product in clinical development for the treatment for ALS and in pre-clinical development stage for other neurodegenerative indications. IsletRx is the company’s treatment for diabetes. IsletRx is comprised of functional pancreatic islet cells producing and releasing insulin and glucagon, intended to treat and potentially cure patients with insulin-dependent diabetes. Kadimastem was founded by Professor Michel Revel, CSO of the company and Professor Emeritus of Molecular Genetics at the Weizmann Institute of Science. Professor Revel received the Israel Prize for the invention and development of Rebif®, a multiple sclerosis blockbuster drug sold worldwide. Kadimastem is traded on the Tel Aviv Stock Exchange (TASE: KDST).
Safe Harbor Statement
This press release contains express or implied forward-looking statements within the Private Securities Litigation Reform Act of 1995 and other U.S. Federal securities laws. For example, Pluri is using forward-looking statements when it discusses the expected manufacturing of cell therapy product candidates for Kadimastem and that the collaboration underscores the versatility of its platform. These forward-looking statements and their implications are based on the current expectations of the management of Pluri only and are subject to a number of factors and uncertainties that could cause actual results to differ materially from those described in the forward-looking statements. The following factors, among others, could cause actual results to differ materially from those described in the forward-looking statements about Pluri: changes in technology and market requirements; Pluri may encounter delays or obstacles in launching and/or successfully completing its clinical trials, if necessary; its products may not be approved by regulatory agencies, its technology may not be validated as it progresses further and its methods may not be accepted by the scientific community; it may be unable to retain or attract key employees whose knowledge is essential to the development of its products; unforeseen scientific difficulties may develop with its processes; its products may wind up being more expensive than it anticipates; results in the laboratory may not translate to equally good results in real clinical settings; its patents may not be sufficient; its products may harm recipients or consumers; changes in legislation with an adverse impact; inability to timely develop and introduce new technologies, products and applications; loss of market share and pressure on pricing resulting from competition, which could cause the actual results or performance of Pluri to differ materially from those contemplated in such forward-looking statements. Except as otherwise required by law, Pluri undertakes no obligation to publicly release any revisions to these forward-looking statements to reflect events or circumstances after the date hereof or to reflect the occurrence of unanticipated events. For a more detailed description of the risks and uncertainties affecting Pluri reference is made to Pluri’s reports filed from time to time with the Securities and Exchange Commission.
Contacts
Investors: investor.relations@pluri-biotech.com
Israel Media: Shachar Yental at shacharye@gitam.co.il
U.S. Media: Jessica Daitch at Jessica@quantum-corp.com