Pluri Inc.

Overview

We are a biotechnology company leveraging our proprietary 3D cell expansion platform, which is supported by an in-house, industrial-scale cell manufacturing facility and operates in accordance with Good Manufacturing Practice (“GMP”) standards on a self-declared basis. Our platform is designed to enable scalable, cost-efficient and reproducible expansion of human, plant and animal cells and supports cell-based products, services, therapeutics and related technologies across two primary application areas: (i) Human Health and Longevity and (ii) Foodtech and Bio-Farming.

We were incorporated in Nevada on May 11, 2001. Pluri Inc. has a wholly owned subsidiary, Pluri Biotech Ltd. (“Pluri Biotech”), which is incorporated under the laws of the State of Israel.

In January 2020, Pluri Biotech established a wholly owned subsidiary, Pluristem GmbH, which is incorporated under the laws of Germany.

In November 2021, Pluri Biotech established a new subsidiary, Ever After Foods, which is incorporated under the laws of the State of Israel. Pluri Biotech holds approximately 69% of Ever After Foods’ issued and outstanding shares.

In March 2024 Pluri Biotech established a wholly owned subsidiary, Coffeesai, which is incorporated under the laws of the State of Israel.

On April 28, 2025, the Company completed an acquisition of approximately 79% of the equity in Kokomodo, which is currently held as majority owned Israeli subsidiary of Pluri Biotech.

In November 2025, Pluri Biotech established a wholly owned subsidiary, Cellav™, which is incorporated under the laws of the State of Israel.

Our operations are dedicated to the research, development, manufacturing and commercialization of cell-based products, therapeutics and related technologies across two primary application areas: (i) Human Health and Longevity and (ii) Foodtech and Bio-Farming, as set forth below:

Our proprietary 3D cell expansion platform is the technological and manufacturing foundation for both business areas, designed to enable scalable, cost-efficient and reproducible production of cell-based products. It uses a synthetic scaffold to create a 3D environment in which adherent or non-adherent cells can grow in a tissue-like setting, and our automated manufacturing process is intended to support monitored, controlled and consistent production of high-quality cell products at scale. We also developed PluriMatrix, an industrial-scale cell manufacturing system built on this platform, to support commercially relevant cell production volumes.

HUMAN HEALTH AND LONGEVITY

This key business application includes our human-cell programs and services, comprised of cell therapy and immunotherapy product candidates, our PluriCDMO™ development and manufacturing services, and our regenerative aesthetics, wellness and longevity activities conducted through Cellav™.

CELL THERAPY

We use our proprietary 3D cell expansion platform in the field of regenerative medicine to develop placenta-based cell therapy product candidates and technologies. Cell therapy is an established field within regenerative medicine, and the characteristics and properties of cells vary depending on tissue source and growth conditions. The human placenta, the source of our PLX and MAIT cells, provides a reservoir of stromal and immune cells that supports our development of both regenerative medicine and immunotherapy product candidates. Our PLX cells are placenta-derived, mesenchymal-like adherent stromal cells expanded ex vivo using our 3D platform. They are designed to be administered off-the-shelf, without blood or tissue matching or additional manipulation prior to administration, and are believed to release therapeutic proteins in response to the patient’s condition. Our PLX product candidates include PLX-PAD, composed of maternal mesenchymal stromal cell, or MSC-like cells, originating from the placenta, and PLX-R18, composed of fetal MSC-like cells originating from the placenta.

Our clinical development activities currently include PLX-PAD and PLX-R18 product candidates, which have been tested in clinical studies in the United States, Europe and Israel. PLX-PAD was tested for acute muscle injuries following hip fracture, acute respiratory distress syndrome due to COVID-19, Graft versus Host Disease(“GvHD”), and peripheral artery disease, including intermittent claudication and critical limb ischemia. PLX-PAD is also being developed for mild to moderate knee osteoarthritis as part of the PROTO program, an international collaboration led by Charité Berlin Institute of Health Center for Regenerative Therapies (“Charité”), and the related clinical study was approved by the Paul-Ehrlich-Institut (“PEI”) in June 2025. PLX-R18 was tested in a Phase I trial for incomplete recovery following hematopoietic cell transplantation and was developed under the U.S. Food and Drug Administration’s (“FDA”) Animal Rule regulatory pathway for Acute Radiation Syndrome (“ARS”), including prior work with the National Institute of Allergy and Infectious Diseases (“NIAID”), the U.S. Department of Defense’s (“DoD”) Armed Forces Radiobiology Research Institute (“AFRRI”) and the Uniformed Services University of the Health Sciences (“USUHS”). In April 2025, NIAID terminated its contract for the Government’s convenience, which we believe reflected broader federal budgetary and administrative adjustments and was not related to performance issues on our part.

On December 20, 2023, we entered into an agreement assigning the joint patent rights to develop Pluri’s PLX cells in the treatment of cocaine addiction to Bar-Ilan University Research and Development Company Ltd. (“BIRAD”), the commercial arm of Bar-Ilan University. Under the agreement, Bar-Ilan University, through BIRAD, received the right to further develop and commercialize PLX cells as a cocaine anti-addiction product, and we are entitled to 20% revenue sharing from future sales of the product for anti-addiction.

In March 2025, we entered into an exclusive collaboration agreement with Hemafund, a Ukrainian umbilical cord blood bank with clinical and research laboratories and facilities specializing in cell preservation and cryostorage. The collaboration aims to establish a strategic initiative for stockpiling, local distribution and potential clinical advancement of our PLX-R18 cell therapy as a countermeasure for Hematopoietic ARS, (“H-ARS”), in Ukraine. Such collaboration is currently not active.

Immunotherapy

In May 2024, we launched a novel allogeneic immunotherapy platform utilizing placental MAIT cells designed to address solid tumors, an area where effective treatments remain insufficient. MAIT cells are a distinct type of unconventional immune T cells with characteristics that include cytotoxic activity and a low alloreactivity profile. We believe placental MAIT cells, together with our research, development and manufacturing capabilities, may support the development of cell therapy products and applications, with potential advantages over conventional T cells. In October 2024, we announced IIA funding for our collaboration with BIRAD to support the continued development of MAIT cells for the treatment of solid tumors, and in March 2026, the IIA approved a second year of funding for such collaboration.

Cell Therapy Regulatory and Clinical Affairs Strategy

Our cell therapy development strategy is to maintain open and frequent discussions with regulators, as appropriate, from preclinical development through more advanced regulatory stages. We have applied this strategy in interactions with regulatory authorities, including the FDA, the European Medicines Agency (“EMA”), Germany’s PEI and other European national competent authorities, the Israeli Ministry of Health (“MOH”), Japan’s Pharmaceuticals and Medical Devices Agency (“PMDA”) and the Ministry of Food and Drug Safety (“MFDS”) of South Korea. Our current active cell therapy regulatory engagement is primarily focused on the PROTO program for PLX-PAD in mild to moderate knee osteoarthritis, including the clinical study approved by Germany’s PEI in June 2025.

Cell Therapy Collaborations

U.S. Department of Defense

In August 2017, we announced that a pilot study of our PLX-R18 cell therapy was initiated by the DoD. The study examined the effectiveness of PLX-R18 as a treatment for ARS prior to, and within the first 24 hours of exposure to radiation. In July 2019, we presented positive results from a series of studies of our PLX-R18 cell therapy product conducted by the DoD.

Charité / Horizon Europe PROTO Program

In September 2022, we announced that a €7.5 million non-dilutive grant from the European Union’s Horizon Europe program was awarded to PROTO, an international collaboration led by Charité. The PROTO project is intended to support the development of novel interventional strategies for knee osteoarthritis, including a Phase I clinical study of our PLX-PAD cells for the treatment of mild to moderate knee osteoarthritis. Approximately €500,000 (approximately $540,000) of the grant was allocated to us, and through June 30, 2026, we received approximately $449,000 in cash under the PROTO program.

In June 2025, the clinical study was approved by Germany’s PEI, and the study was initiated in January 2026. The study is being conducted at Charité as part of the PROTO consortium, under the leadership of Professor Tobias Winkler, Principal Investigator, at the Berlin Institute of Health Center of Regenerative Therapies, the Julius Wolff Institute and Center for Musculoskeletal Surgery.

In November 2025, we entered into an agreement with Charité governing the execution of the Phase I study of PLX-PAD for the treatment of mild to moderate knee osteoarthritis, and the allocation of rights in potential joint inventions arising from the study. Under the agreement, each party retains ownership of its pre-existing intellectual property, while certain project results arising from the use of PLX-PAD in knee osteoarthritis may be jointly owned by the parties. Subject to the terms of the agreement, Charité assigns or licenses to us certain rights in joint results, joint inventions and related pseudonymized data necessary for the further development and commercialization of PLX-PAD for osteoarthritis. If a regulatory-approved PLX-PAD-containing product for the treatment of osteoarthritis is commercialized, Charité is entitled to receive a 2% royalty on net sales for a period of eight years from first commercial sale and may also be entitled to receive 4% of certain license income received by us, excluding royalties on net sales.

Government Regulation - Pharma

The development, manufacturing, and future commercialization of our cell therapy product candidates are subject to the laws and regulations of governmental authorities in the United States, the European Union, Israel, and other potential markets, including Japan and South Korea.

In the United States and the European Union, the FDA and the EMA, respectively, must approve products prior to marketing. Furthermore, various governmental statutes and regulations also govern or influence testing, manufacturing, safety, labeling, storage and record keeping related to such products and their marketing. Governments in other countries may have similar requirements for testing and marketing.

The process of obtaining these approvals and the subsequent compliance with appropriate statutes and regulations require the expenditure of substantial time, resources and money. There can be no assurance that our product candidates will ultimately receive marketing approval, or, if approved, will be reimbursed by public and private health insurance.

There are several stages every drug undergoes during its development process. Among these are:

Approval of a drug for clinical studies in humans and approval of marketing are sovereign decisions of states, made by national, or, in case of the European Union, international regulatory competent authorities.

The Regulatory Process in the United States:

In the United States, our product candidates are subject to regulation as a biological product under the Public Health Service Act and the Federal Food, Drug and Cosmetic Act. The FDA, regulating the approval of clinical studies and marketing applications in the United States, generally requires the following steps prior to approving a new biological product for use either for clinical studies or for commercial sale:

Certain states, including Florida and Utah, have enacted laws that authorize the administration or use of certain stem cell therapies that have not been approved by the FDA, subject to specified eligibility, informed-consent, physician oversight, manufacturing, and other requirements. These laws may provide a state-law pathway for the therapeutic use of qualifying stem cell products within those states; however, they do not constitute FDA approval, nor do they authorize interstate commercial distribution, or establish a federal marketing authorization for any such product.

The Regulatory Process in Europe:

In the European Union, our investigational cellular products are regulated under the Advanced Therapy Medicinal Products regulation, a regulation specific to cell and tissue products. Additionally, as of January 31, 2022, the Clinical Trials Regulation harmonizes the submission, assessment and supervision processes of clinical trials in the European Union. This European Union regulation requires:

Clinical Studies

Typically, in the United States, as well as in the European Union, clinical development involves a series of clinical studies from early, small scale, Phase I studies to late-stage large, Phase III studies, although the phases may overlap. Phase I, clinical studies are conducted in a small number of healthy volunteers, or patients with the disease or condition. These studies are designed to provide information about product safety and dosage by gathering information on the interaction of the drug with the human body, its side effects as well as early preliminary information on effectiveness.

Phase II clinical studies are conducted in a homogenous group of patients afflicted with the specific target disease, to explore preliminary efficacy, optimal dosages and confirm the safety profile. In some cases, an initial study is conducted in patients to assess both preliminary efficacy and preliminary safety and patterns of drug metabolism and distribution, in which case it is referred to as a Phase I/II study. Phase III clinical studies, sometimes known as pivotal studies, are generally large-scale, multi-center, controlled studies conducted with a heterogeneous group of patients afflicted with the target disease, aiming to provide statistically significant support for efficacy, as well as safety and potency. The Phase III studies are considered confirmatory for establishing the efficacy and safety of the drug and are critical for approval. In some circumstances, a regulatory agency may require Phase IV, or post-marketing studies in case additional information needs to be collected after the drug is on the market.

During all phases of clinical development, regulatory agencies require extensive monitoring and auditing of all clinical activities, clinical data and clinical study sites investigators to minimize risks and ensure high quality and integrity of the collected data. The sponsor of a clinical study is required to submit an annual safety report to the relevant regulatory agencies, in which serious adverse events are reported, and to submit in an expedited manner any individual serious adverse events that are suspected of being related to the tested drug and are unexpected with its use. An agency may, at its discretion, re-evaluate, alter, suspend, or terminate the clinical study based upon the data that have been accumulated to that point and its assessment of the risk/benefit ratio to the patient.

Competition - Regenerative medicine

The regenerative medicine field is characterized by intense competition, as global and local pharma players are becoming more engaged in the cell therapy field based on the advancements made in clinical studies and due to the favorable regenerative medicine legislation in certain regions. We face competition from both allogeneic and autologous cell therapy companies, academic, commercial and research institutions, pharmaceutical companies, biopharmaceutical companies, and governmental agencies. Some of the clinical indications we currently have under development are also being investigated in preclinical and clinical programs by others.

According to the Alliance for Regenerative Medicine’s July 2026 Report, there were 1,806 active cell and gene therapy developers worldwide, including 1,031 developing cell therapies and 729 developing gene-modified cell therapies and cell-based immuno-oncology (GMCT and CBIO), with 1,712 ongoing clinical trials in Phases I–III registered globally, of which 355 trials were in solid tumors (Source: ARM Q2 2026 Sector Snapshot and Sector Data, July 2026 Report).

In the global market (excluding China), while most allogeneic cell therapies remain in the preclinical stage, approximately 20 allogeneic Chimeric Antigen Receptor (“CAR”)-T therapy products being studied for solid tumors have advanced into clinical stages. Notable examples include Adicet Bio’s allogeneic CD70-CAR gamma-delta T cells, Poseida’s Allogenic MUC1-CAR Tscm cells, Fate’s allogeneic MICA/B-CAR T cells, and MD Anderson’s TROP2-CAR NK cells (Source: GlobalData; Clinicaltrial.gov).

While there are hundreds of companies in the regenerative medicine space globally, there are multiple participants in the cell therapy field based in the United States, Europe, Japan, Korea, and Australia. Among other things, we expect to compete based upon our IP portfolio, our in-house manufacturing efficiencies and capabilities, and the potential efficacy of our products. Our ability to compete successfully will depend on our continued ability to attract and retain experienced and skilled executives, scientific and clinical development personnel, to identify and develop viable cellular therapeutic candidates and exploit these products commercially and keep expanding and improving our unique technological capabilities.

REGENERATIVE AESTHETICS, WELLNESS AND LONGEVITY

In November 2025, we established Cellav™, a wholly owned subsidiary focused on developing regenerative skin and hair solutions using our proprietary 3D cell expansion technology. Cellav develops, manufactures and markets skin care and cosmetic products and cell-derived ingredients, including exosomes and cell ingredients (human or plant-derived), conditioned media for integration into third-party formulations and for use in professional and consumer skincare and haircare products. These products and ingredients are also offered as finished, ready-to-sell products, professional kits or consumable products.

During calendar year 2026, Cellav completed the development and U.S. cosmetic product listings of two professional regenerative aesthetic products, Regenativo+ and Placento+, supporting a planned commercial launch in the United States. Cellav also completed the cosmetic regulatory registration and notification process for Regenativo+ in the United Kingdom through the UK Cosmetic Product Notification portal, enabling commercial marketing of the product in the UK. These regulatory and product-listing milestones support Cellav’s transition from product development toward commercialization and its ongoing commercial discussions with distributors, clinic networks and strategic partners in the United States, the United Kingdom and additional international markets. Collectively, these collaborations and regulatory milestones reflect continued progress in applying our proprietary technology platform across multiple industries and in advancing selected subsidiaries toward potential development, commercialization and distribution opportunities.

Government Regulations - Aesthetic Products

Through Cellav, we develop cosmetic and professional aesthetic products and ingredients that may be subject to applicable cosmetic product regulatory requirements in the jurisdictions in which they are marketed or intended to be marketed. These requirements may include, as applicable, product safety assessments, ingredient restrictions, labeling requirements, claims substantiation, product notification or registration, responsible-person obligations, manufacturing practices, adverse-event reporting and post-market surveillance.

During calendar year 2026, Cellav completed U.S. cosmetic product listings for its Regenativo+ and Placento+ products and completed the applicable cosmetic product notification process for Regenativo+ in the United Kingdom through the UK Cosmetic Product Notification portal. Regenativo+ is a plant-derived product, and Placento+ is a placenta-derived formulation; both products are intended for topical professional aesthetic use. Cellav is pursuing commercialization opportunities for these products through discussions with distributors, aesthetic clinics and other potential commercial partners in the United States, the United Kingdom and other international markets.

Competition - Aesthetics, Wellness and Longevity

Through Cellav, we participate in the competitive and rapidly evolving markets for aesthetics, wellness and longevity products, including skincare, aesthetics, consumer health, biotechnology and regenerative products. We compete with established companies and emerging participants, including companies developing or commercializing products based on exosomes, cell-derived ingredients, plant-derived ingredients, conditioned media, bioactive formulations and other technologies. Competition in these markets is based on a range of factors, including product performance, scientific support, product quality and safety, regulatory compliance, manufacturing capabilities and scale, distribution relationships, brand recognition, customer experience and pricing. Our competitors include companies with greater financial, commercial, manufacturing, research and development, regulatory and marketing resources, as well as direct-to-consumer brands and providers of aesthetic, wellness and longevity products and services. The markets for aesthetics, wellness and longevity products are global and include significant activity in North America, Europe and Asia. Participants in these markets include multinational consumer-products, pharmaceutical, biotechnology and medical-aesthetics companies, as well as specialized skincare, wellness and direct-to-consumer brands, many of which are headquartered in the United States, Europe and Asia. Competitive dynamics may vary by product category, applicable regulatory requirements, distribution channels and local consumer preferences.

PLURICDMO™

In-House Clinical Manufacturing

We maintain an in-house capability for clinical cell manufacturing at our GMP-grade facility in Haifa, Israel, operational since February 2013 and previously approved for the production of PLX-PAD and PLX-R18 for clinical use by multiple regulatory authorities, including the FDA, EMA, MFDS, PMDA, and the MOH. The facility was approved by the MOH for a Phase III PLX-PAD trial and received GMP certification and manufacturer-importer authorization, which remained valid through March 2023. In addition, the facility was inspected by a European Union Qualified Person in December 2024, confirming compliance with current GMP requirements for the purposes of the PROTO clinical trial.

The facility continues to operate in alignment with current GMP standards and principles under a self-declared compliance framework. We remain committed to maintaining rigorous quality and regulatory practices consistent with applicable GMP principles.

In January 2024, we launched a business division offering cell therapy manufacturing services as a CDMO: PluriCDMO™. PluriCDMO™ offers cell therapy development and manufacturing expertise to companies from early preclinical development, through late-stage clinical trials and commercialization, with a mission to deliver high-quality, essential therapies to patients, as well as other services. Through PluriCDMO™, we have entered into several commercial agreements with clients for development and manufacturing services.

Since 2024, our CDMO business has offered manufacturing, process development and related services to pharmaceutical and biotechnology companies. PluriCDMO™ leverages more than 15 years of our experience in GMP manufacturing, proprietary 3D cell expansion technologies, highly skilled team and flexible 4400 square meter purpose-built facilities to support cell therapy development and manufacturing from preclinical stages through clinical trials and potential commercial supply, including on-site analytical testing, method development, gap assessment, method transfer and validation, and support through audited third-party vendors.

In August 2026, Pluri Biotech received ISO 13485:2016 certification for contract manufacturing services as a contract manufacturing organization for companies engaged in the manufacturing and development of medical devices, further supporting PluriCDMO™’s quality infrastructure and enhancing our ability to support customers operating in regulated life sciences environments. Our CDMO business may be subject to additional regulations, depending on the services we provide to companies under such business division.

Competition - CDMO

We compete in the cell therapy CDMO services with several companies like Lonza Group AG, AGC Biologics A/S and Charles River Laboratories International, Inc. for outsourced services from development to manufacturing in biotechnology and pharmaceutical cell-based products. The majority of our competitors are large service providers with multiple offerings for different technologies, range of dosage form capabilities and medicine products. The competition is driven by geographic location, technological capabilities, operational capacity, manufacturing expertise, and price.

While there are multiple competitors that compete in the CDMO services arena, we have a few competitors that compete in advanced stages of cell therapy clinical trials and can provide access to state-of-the-art manufacturing efficiency and capabilities. Our ability to compete successfully will depend on our continued ability to attract and retain customers, support clinical development, identify new opportunities and keep expanding our unique know-how, technology and manufacturing capabilities.

FOODTECH AND BIOFARMING

We are involved in several initiatives that apply our 3D cell expansion technology in the FoodTech and Biofarming market, including collaborations focused on bioactive carrier and biostimulant delivery, sustainable vegetable production, and plant-cell activities in coffee and cacao through Coffeesai and Kokomodo, respectively.

In October 2023, we entered into a proof-of-concept (“POC”) collaboration with ICL Group Ltd. (“ICL”), a global specialty minerals company, through its Open Innovation program, to evaluate the potential of our technology to enhance the delivery of biostimulants in agriculture. The initial phase of the collaboration was focused on exploring the use of plant-derived bioactive compounds in combination with our proprietary platform to improve crop resilience and yield under abiotic stress conditions. In December 2024 and March 2026, we signed amendments extending the POC collaboration with ICL, reflecting continued mutual interest in further developing and validating the underlying technology for agricultural applications.

In March 2024, we announced an expansion of our intellectual property portfolio with a patent approval from the Israel Patent Office relating to our proprietary 3D bioreactor technology for plant-cell cultivation. The patent has also been granted in the United States, and related patent applications are pending in several additional jurisdictions.

In July 2024, we announced the signing of a €1 million POC agreement with a leading international agriculture corporation (the “POC Party”) with a goal to enhance the global sustainable vegetable supply. This strategic POC agreement is intended to boost the global vegetable product supply, streamline supply chains, and combat global climate change while ensuring a natural and more sustainable future for agriculture. The result of the planned collaboration has the potential to minimize environmental impact and foster greater food security, as well as to build a better agronomic and environmentally friendly infrastructure, bringing sustainable, high-quality solutions to the market. Pursuant to this POC agreement, the POC Party will provide its know-how and other IP rights related to vegetable products while the Company will provide its know-how and other IP rights related to its proprietary 3D cell expansion technology to develop a solution aimed at increasing the global vegetable products supply. Currently, we are in discussions with the POC Party to evaluate potential opportunities for further collaboration following the completion of Phase II.

Coffeesai - In March 2024, we established Coffeesai Ltd., a wholly owned Israeli subsidiary focused on developing cultivated, cell-cultured coffee. Coffeesai leverages our 3D cell expansion technology and controlled, scalable bioprocesses to develop cultivated coffee products intended to address demand for sustainable, high-quality coffee production at scale, including challenges facing the traditional coffee industry such as climate-related crop instability, supply chain disruptions and environmental impact. Coffeesai has been engaged in a POC project relating to the development of a coffee beverage using its technology platform. Following the successful demonstration of the potential application of Coffeesai’s technology to coffee production, current efforts are focused on optimizing the bioprocess and downstream processing to further enhance the flavor and aroma characteristics of the resulting beverage.

Kokomodo- On April 28, 2025, we completed the acquisition of approximately 79% of the equity in Kokomodo (held as a majority owned subsidiary of our wholly owned subsidiary, Pluri Biotech). Kokomodo, an Israeli company, is an innovative agfood startup developing cellular agriculture technology for the sustainable production of cacao. Instead of relying on traditional tropical farming, Kokomodo cultivates real cacao directly from plant cells in controlled environments, such as bioreactors, making climate-resilient cacao accessible year-round on a global scale. Founded in 2024, Kokomodo aims to transform the cacao industry, reducing environmental impact while ensuring a steady, high-quality supply for chocolate and related products.

During fiscal year 2026, Kokomodo continued the development of its cell-cultured cacao platform through research and industry collaborations. During that period, Kokomodo collaborated with Cargill under a POC Co-Financing Instrument of the food innovation community of the European Institute of Innovation and Technology (“EIT”), an EU body, to evaluate the functionality, sensory performance and scalability of its cell-cultured cacao ingredients for potential food applications; participated as a consortium member in the COCO-AI project, a Horizon Europe-funded initiative focused on advancing AI-enabled plant cell culture technologies for sustainable cocoa production; and collaborated with CSM Ingredients S.r.l, a global ingredients research and production company focused on food and bakery ingredient solutions, through the Generate Program 2025 in connection with the development of sustainable cacao ingredients for commercial applications.

Ever After Foods - In 2022, we announced the establishment of a joint venture with Tnuva Food Industries - Agricultural Cooperative in Israel Ltd. (“Tnuva”), Ever After Foods, incorporated under the laws of the State of Israel. The purpose of the joint venture is to develop and commercialize scalable production technologies for cultivated meat, supporting the development of a wide range of cultivated meat products by industry partners.

Leveraging Pluri’s technology, Ever After Foods has advanced a business-to-business (“B2B”) platform intended to enable food producers to manufacture cultivated protein products efficiently and at commercially relevant scale. Ever After Foods has demonstrated the production of muscle and fat tissues from various animal cells and seeks to support cultivated meat and seafood production through its proprietary technology platform and strategic collaborations.

In June 2024, Ever After Foods entered into a share purchase agreement with Tnuva and certain other international strategic investors, pursuant to which Ever After Foods issued and sold ordinary shares in a private placement offering for aggregate gross proceeds of $10 million. As part of the offering, we invested $1.25 million. In addition, Pluri Biotech and Ever After Foods executed an Amended and Restated Technology License Agreement, dated June 12, 2024, which amended the parties’ existing license agreement dated February 23, 2022, to expand the scope of the license to include fish and seafood. Following the closing of that offering, Pluri Biotech held approximately 69% of Ever After Foods. This private placement offering was intended to support Ever After Foods’ B2B technology platform and its development as a technology enabler for cultivated protein production.

In February 2025, Ever After Foods announced a strategic collaboration with Bühler Group (“Bühler”), a global provider of food processing technologies, to jointly advance scalable cultivated meat production systems for the food industry. The collaboration is intended to combine Bühler’s engineering and market access capabilities with Ever After Foods’ proprietary edible packed-bed (EPB™) bioreactor platform to support commercial-scale cultivated meat production systems. The parties intend to develop and deploy manufacturing equipment that enables food producers to produce cultivated meat at reduced cost and at volumes suitable for market entry.

On August 12, 2026, Ever After Foods entered into a share purchase agreement to acquire Fishway BV, a Belgium-based biotechnology company engaged in development-stage research relating to aquatic cell biology, cell lines and animal-component-free media for potential use in the cultivated protein industry (the “Fishway Acquisition”). The Fishway Acquisition is intended to support Ever After Foods’ strategy by expanding complementary research capabilities and establishing a corporate presence in Europe. The Fishway Acquisition closed on August 18, 2026, and following its completion, our indirect ownership interest in Ever After Foods, held through Pluri Biotech, was reduced to approximately 58%, reflecting dilution to all Ever After Foods’ shareholders as a result of the Fishway Acquisition.

Government Regulations - FoodTech

Regulators around the world are in the process of developing or implementing a regulatory approval process for cultivated meat. Although some companies have recently received regulatory approval for their cultivated meat products in the United States, Israel and Singapore cultivated meat is not yet generally commercially available. However, technologies like the one being developed by Ever After Foods are anticipated to facilitate the scaling up of cultivated meat production. In general, cultivated meat production is subject to extensive regulatory laws and regulations. In the United States, the FDA and the U.S. Department of Agriculture (“USDA”), are in the process of developing guidance and regulations applicable to cultivated meat.

In the cultivated plant-based initiatives (e.g., coffee, cacao), we are working with an external regulatory consultant to evaluate the technical and scientific requirements for determining whether our cultured coffee product is Generally Recognized as Safe (“GRAS”), under section 201(s) of the Federal Food, Drug, and Cosmetic Act (“FDCA”), and FDA’s implementing regulations (21 C.F.R. § 170.30). If the plant-based cultivated products (including all components) are determined to be GRAS in accordance with U.S. FDA requirements, it will be exempt from the definition of “food additive” in section 201(s) of the FDCA and can therefore be lawfully marketed as a food in the United States without the need to obtain a premarket authorization from the FDA.

Competition - FoodTech

Our FoodTech operations operate in a competitive and evolving industry that includes cultivated meat and cultivated protein companies, plant cell culture companies, bioprocess equipment suppliers, bioreactor developers, scaffold technology providers, and established producers of plant-derived ingredients, flavors, and other food products. Industry development is being driven by advances in biotechnology, increased focus on sustainability, and efforts to develop more efficient and environmentally responsible alternatives to traditional agricultural and food-production methods.

Ever After Foods is developing a proprietary technology platform designed to support natural cell growth for cultivated protein applications, including cultivated meat. Unlike certain conventional approaches that adapt cells for growth in stirred-tank bioreactors, Ever After Foods’ technology is designed to enable production at lower cost and greater scale. We believe that this technology, together with our capabilities in aquatic cell biology and animal-component-free media development, experienced personnel, and strategic relationships with industry participants, may provide us with a competitive advantage in the cultivated food market.

Our plant-based FoodTech operations are advancing two principal product streams: cell-cultured coffee through Coffeesai and cell-cultured cacao and cocoa-derived ingredients through Kokomodo. These businesses operate in distinct but related markets characterized by evolving technology, early-stage commercialization, and growing demand for sustainable and resilient ingredient supply chains.

Coffeesai operates in the emerging cell-cultured coffee market, which includes participants such as California Cultured, Inc., Food Brewer AG, Another Food Pte. Ltd., and Atomo Foods, Inc., among others. We believe that Coffeesai’s integration of scale-up technology, proprietary bioprocessing capabilities, and scientific expertise may support an efficient, cost-effective, and sustainable production model. We also believe that potential partnerships across the coffee value chain may enhance Coffeesai’s ability to develop and commercialize its products.

Kokomodo operates in the developing market for cell-cultured cacao and cocoa-derived ingredients. Participants in this market include Celleste Bio Ltd., California Cultured, Inc., and Food Brewer AG, among others. These companies are seeking to develop alternatives or supplements to conventional cacao cultivation in response to concerns relating to climate impact, supply volatility, and ethical sourcing. More broadly, competitors in our plant-based Foodtech markets include companies focused on plant cell culture for specialty ingredients, as well as established producers of plant-derived compounds and flavors, including DSM-Firmenich AG and Givaudan International SA.

We believe that our ability to compete successfully across our Foodtech operations will depend on continued innovation, the performance and scalability of our production systems, our ability to protect and improve our proprietary technologies, the availability of sufficient capital and strategic partnerships, regulatory developments, and our ability to develop products that meet customer, consumer, and commercial requirements. We may face competition from companies with greater financial resources, broader product portfolios, more established customer relationships, and greater manufacturing, regulatory, and commercialization capabilities than we have.

Intellectual Property

We recognize that our success depends, in part, on securing our intellectual property, and therefore we are committed to protecting our technology and product candidates through patents and other means, as outlined below.

We are the sole owner of 149 issued patents, and approximately 57 pending patent applications, including 5 applications that have been allowed but not yet granted, in the United States, Europe, China, Japan and Israel, as well as in additional countries worldwide, including countries in the Far East and South America (in calculating the number of issued patents, each European patent validated in multiple jurisdictions was counted as a single patent).

Based on the well-established understanding that the characteristics and therapeutic potential of a cell product are largely determined by their source, the methods, and conditions used during their culture, our patent portfolio includes various types of claims that protect the unique aspects of our technology.

Our multi-national patent portfolio and pending applications include claims directed at:

Through our development of adherent stromal cell-based products, we have built expertise and proprietary know-how, establishing robust procedures for the manufacturing of clinical-grade PLX cells in our facilities. Leveraging this foundation, we have expanded our capabilities to include the handling and expansion of suspension cells including immune cells, thereby broadening our platform in cellular therapies. Certain elements of our manufacturing process are protected by issued patents and pending applications. In parallel, we safeguard proprietary aspects of our technology, trade secrets and know-how, maintained through confidentiality agreements with our employees, consultants, contractors, manufacturers and advisors. These agreements typically include provisions to protect confidential information, restrict material use and require the assignment of inventions developed in the course of such engagement.

The following table outlines our key patents and patent applications. It is not intended to represent a legal assessment of claims, scope, enforceability or limitations. In certain instances, a jurisdiction may appear under both “pending” and “granted” status within a single patent family, reflecting the existence of continuation or divisional applications filed in parallel with a granted patent.

The expiration dates of these patents, based on filing dates, range from 2027 to 2046. Actual expiration dates will be determined according to extensions received based on the Drug Price Competition and Patent Term Restoration Act of 1984 (P.L. 98-417), commonly known as the “Hatch-Waxman” Act, which permits extensions of pharmaceutical patents to reflect regulatory delays encountered in obtaining FDA market approval. The Hatch-Waxman Act is based on a U.S. federal law and therefore only relevant to U.S. patents.

There is a risk that our patents will be invalidated, and that our pending patent applications will not result in issued patents. We also cannot be certain that we will not infringe on any patents that may be issued to others. See “Risk Factors – The patent approval process is complex, and we cannot be sure that our pending patent applications or future patent applications will be approved.”

Our Patent Portfolio

Employees

As of June 30, 2026, we employed a total of 92 full-time employees and 21 part-time employees, of whom 73 full-time employees and 14 part-time employees are engaged in cell research, development, and manufacturing including clinical and regulation affairs.

EIB Financing Agreement

In April 2020, we and our subsidiaries, Pluri Biotech and Pluristem GmbH, entered into a finance agreement with EIB, providing for non-dilutive funding of up to €50 million, payable in three tranches (the “EIB Loan”). In June 2021, we received the first tranche in the amount of €20 million, which represents the only amount disbursed under the EIB finance agreement, as the initial funding period expired on December 31, 2022, and no additional funds were made available thereunder.

The €20 million loan bears annual interest at a rate of 4% and was repayable on June 1, 2026, with interest payable together with the principal. As of June 30, 2026, accrued interest amounted to approximately €4.1 million. In addition to the interest, the EIB is entitled to royalty payments, pro-rated to the amount disbursed from the EIB Loan, on our consolidated revenues from fiscal year 2024 through fiscal year 2030, at rates of up to 2.3% on consolidated revenues below $350 million, 1.2% on consolidated revenues between $350 million and $500 million, and 0.2% on consolidated revenues exceeding $500 million. As of June 30, 2026, accrued royalties amounted to $9 thousand. On April 21, 2026, we received a notice from the EIB that the EIB is reserving its rights under the finance agreement while discussions with the EIB regarding potential resolution of the EIB Loan remain ongoing. On May 28, 2026, the EIB confirmed to us that while the parties remain engaged in constructive discussions, and without prejudice to any of the EIB’s rights and remedies, no enforcement action was contemplated by the EIB.

On August 17, 2026, we were notified by the EIB that its relevant committee had approved, subject to certain conditions, a proposed sale of the EIB Loan not involving the Company as purchaser, on terms agreed with a third-party purchaser who may be a related party. The completion of such sale remains subject to, among other things, execution of definitive legal documentation and completion of the EIB’s review process and other conditions. If the proposed sale is completed, the Company intends to seek to reach an arrangement with the purchaser regarding the settlement of the purchased loan, which may include the conversion of all or a portion of the outstanding loan amount into equity of the Company. Any such arrangement would be subject to negotiation with the purchaser and the receipt of all required corporate and other approvals. Until the proposed sale is finalized and any subsequent arrangement with the purchaser is agreed and approved, there can be no assurance as to the outcome of these discussions or the timing or terms of any resolution, or that the EIB will continue to refrain from exercising remedies available to it under the finance agreement, that any sale of the EIB Loan will be completed, that any settlement or conversion arrangement will be entered into or consummated, or as to the timing, structure, accounting treatment or financial statement impact of any such transaction.

Available Information

Additional information about us is available on our website at www.pluri-biotech.com. Information contained on, or accessible through, our website is not incorporated by reference into, and should not be considered part of this Annual Report. Under the “Financial Reports” and “SEC Filings” subsections of the “Investors” section on our website, our Annual Reports on Form 10-K, Quarterly Reports on Form 10-Q, Current Reports on Form 8-K, and amendments to those reports filed or furnished pursuant to Section 13(a) of the Securities Exchange Act of 1934, as amended (“the Exchange Act”), are available as soon as reasonably practicable after we electronically file such material with, or furnish it to, the SEC. Our reports filed with the SEC are also made available on the SEC’s website at www.sec.gov. The following Corporate Governance documents are also posted on our website under the “Governance” subsection of the “Investors” section: Trading Policy, Code of Business Conduct and Ethics, Anti Bribery and Corruption and Anti Money Laundering and Terrorist Financing Compliance Policy, Clawback Policy and the Charters for each of the Committees of our Board of Directors (the “Board”).