Pluri Inc.

Pluri Inc. operates as a biotechnology company leveraging a proprietary three-dimensional (3D) cell expansion platform supported by an in-house, industrial-scale cell manufacturing facility that operates in accordance with Good Manufacturing Practice (GMP) standards on a self-declared basis. The 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: Human Health and Longevity and Foodtech and Bio-Farming. The regenerative medicine field is characterized by intense competition, with global and local pharma players becoming more engaged in the cell therapy field. 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, with 1,712 ongoing clinical trials in Phases I–III registered globally, of which 355 trials were in solid tumors. The company also participates in the competitive and rapidly evolving markets for aesthetics, wellness and longevity products, and its 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.

The company faces competition from both allogeneic and autologous cell therapy companies, academic, commercial and research institutions, pharmaceutical companies, biopharmaceutical companies, and governmental agencies. 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, with notable examples including 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. The company expects to compete based upon its IP portfolio, its in-house manufacturing efficiencies and capabilities, and the potential efficacy of its products. In the CDMO services market, the company competes with several companies like Lonza Group AG, AGC Biologics A/S and Charles River Laboratories International, Inc. In the cell-cultured coffee market, competitors include California Cultured, Inc., Food Brewer AG, Another Food Pte. Ltd., and Atomo Foods, Inc., among others. In the cell-cultured cacao market, participants include Celleste Bio Ltd., California Cultured, Inc., and Food Brewer AG, among others. The company believes its integration of scale-up technology, proprietary bioprocessing capabilities, and scientific expertise may support an efficient, cost-effective, and sustainable production model.

The company generates revenue primarily through its PluriCDMO™ business division, which offers cell therapy development and manufacturing services to pharmaceutical and biotechnology companies, and through proof-of-concept (POC) collaborations in the FoodTech field. Revenues for the year ended June 30, 2026 were primarily generated from services provided to CDMO clients for process and product development as well as additional revenues from POC collaborations in the FoodTech field. The company’s business model also includes developing and commercializing cell-based products and therapeutics across two primary application areas, with a strategy to collaborate with partners and license its technology to other companies, including establishing joint ventures and partnerships that leverage its cell expansion technology and cell-based product portfolio.

In the Human Health and Longevity application area, the company develops placenta-based cell therapy product candidates, including PLX-PAD, composed of maternal mesenchymal stromal cell (MSC)-like cells originating from the placenta, and PLX-R18, composed of fetal MSC-like cells originating from the placenta. PLX-PAD has been tested for acute muscle injuries following hip fracture, acute respiratory distress syndrome due to COVID-19, Graft versus Host Disease, and peripheral artery disease, and is being developed for mild to moderate knee osteoarthritis as part of the PROTO program. PLX-R18 was tested in a Phase I trial for incomplete recovery following hematopoietic cell transplantation and was developed under the FDA’s Animal Rule regulatory pathway for Acute Radiation Syndrome. The company also launched a novel allogeneic immunotherapy platform utilizing placental MAIT cells designed to address solid tumors. Through Cellav™, a wholly owned subsidiary established in November 2025, the company develops, manufactures and markets skin care and cosmetic products and cell-derived ingredients, including exosomes and cell ingredients, conditioned media for integration into third-party formulations and for use in professional and consumer skincare and haircare products. During calendar year 2026, Cellav completed the development and U.S. cosmetic product listings of two professional regenerative aesthetic products, Regenativo+ and Placento+, and completed the cosmetic regulatory registration and notification process for Regenativo+ in the United Kingdom.

In the Foodtech and Bio-Farming application area, the company is involved in several initiatives applying its 3D cell expansion technology, 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. Coffeesai, a wholly owned Israeli subsidiary established in March 2024, focuses on developing cultivated, cell-cultured coffee. Kokomodo, an Israeli agfood startup of which the company completed the acquisition of approximately 79% of the equity on April 28, 2025, develops cellular agriculture technology for the sustainable production of cacao. Ever After Foods, a joint venture with Tnuva, develops and commercializes scalable production technologies for cultivated meat, and has advanced a business-to-business platform intended to enable food producers to manufacture cultivated protein products efficiently and at commercially relevant scale. In June 2024, Ever After Foods entered into a share purchase agreement with Tnuva and certain other international strategic investors, issuing and selling ordinary shares in a private placement offering for aggregate gross proceeds of $10 million, with the company investing $1.25 million. In February 2025, Ever After Foods announced a strategic collaboration with Bühler Group to jointly advance scalable cultivated meat production systems.

During fiscal year 2026, the company completed the acquisition of approximately 79% of the equity in Kokomodo on April 28, 2025, and established Cellav™, a wholly owned subsidiary, in November 2025. The company also entered into an exclusive collaboration agreement with Hemafund in March 2025 to establish a strategic initiative for stockpiling, local distribution and potential clinical advancement of PLX-R18 cell therapy as a countermeasure for Hematopoietic ARS in Ukraine. In November 2025, the company 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. In April 2025, NIAID terminated its contract for the Government’s convenience. On August 12, 2026, Ever After Foods entered into a share purchase agreement to acquire Fishway BV, a Belgium-based biotechnology company, which closed on August 18, 2026, reducing the company’s indirect ownership interest in Ever After Foods to approximately 58%. In August 2026, Pluri Biotech received ISO 13485:2016 certification for contract manufacturing services. On August 17, 2026, the company was 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.

For the fiscal year ended June 30, 2026, revenues were $1,016,000, compared to $1,336,000 for the year ended June 30, 2025. Cost of revenues were $563,000, compared to $682,000 in the prior year. Research and development expenses, net, increased by 17% from $12,851,000 to $15,092,000. General and administrative expenses increased by 3% from $9,979,000 to $10,299,000. Other financial income (expenses), net, changed from $206,000 in financial expenses to $476,000 in financial income. Interest expenses increased from $873,000 to $932,000. Net loss increased from $23,250,000 to $25,369,000.

A key growth vector is the PROTO program for PLX-PAD in mild to moderate knee osteoarthritis, an international collaboration led by Charité Berlin Institute of Health Center for Regenerative Therapies. The related clinical study was approved by Germany’s Paul-Ehrlich-Institut in June 2025, and the study was initiated in January 2026. A €7.5 million non-dilutive grant from the European Union’s Horizon Europe program was awarded to PROTO, with approximately €500,000 (approximately $540,000) allocated to the company, and through June 30, 2026, the company received approximately $449,000 in cash under the PROTO program. 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 the company, excluding royalties on net sales.

Another growth vector is the company’s CDMO business, PluriCDMO™, which offers cell therapy development and manufacturing expertise to companies from early preclinical development, through late-stage clinical trials and commercialization. PluriCDMO™ leverages more than 15 years of experience in GMP manufacturing, proprietary 3D cell expansion technologies, and a flexible 4400 square meter purpose-built facility. In August 2026, Pluri Biotech received ISO 13485:2016 certification for contract manufacturing services, further supporting PluriCDMO™’s quality infrastructure and enhancing the ability to support customers operating in regulated life sciences environments. The company has entered into several commercial agreements with clients for development and manufacturing services since 2024.

The company’s FoodTech operations represent a significant growth vector, with Ever After Foods advancing a B2B platform for cultivated protein production. In February 2025, Ever After Foods announced a strategic collaboration with Bühler Group to jointly advance scalable cultivated meat production systems, intending 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, to expand complementary research capabilities and establish a corporate presence in Europe. The Fishway Acquisition closed on August 18, 2026, and following its completion, the company’s indirect ownership interest in Ever After Foods was reduced to approximately 58%. Kokomodo continued the development of its cell-cultured cacao platform through research and industry collaborations, including with Cargill under a POC Co-Financing Instrument of the EIT, participation in the COCO-AI project, and collaboration with CSM Ingredients S.r.l through the Generate Program 2025.

The company’s regenerative aesthetics, wellness and longevity activities through Cellav™ represent a growth vector, with the completion of U.S. cosmetic product listings for Regenativo+ and Placento+ and the UK cosmetic product notification for Regenativo+ during calendar year 2026. 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.

The company’s margin and cost outlook is influenced by its cost-reduction plan, which included a reduction in headcount, and the CEO’s waiver of 25% of his salary from July through December 2025, and 30% of his salary between January and February 2026. Research and development expenses, net, increased by 17% from $12,851,000 for the year ended June 30, 2025, to $15,092,000 for the year ended June 30, 2026, partly due to the addition of new employees following the acquisition of Kokomodo, partially offset by headcount reductions as part of the cost-reduction plan. General and administrative expenses increased by 3% from $9,979,000 to $10,299,000, partly due to an increase in share-based compensation expenses, partially offset by a reduction in the CEO’s salary and a decrease in expenses related to corporate activities.

The company’s operational outlook includes its in-house capability for clinical cell manufacturing at its GMP-grade facility in Haifa, Israel, which 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. As of June 30, 2026, the company 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.

The company’s capital allocation priorities include research and development spending, which increased to $15,092,000 for the year ended June 30, 2026, and investments in its subsidiaries, including the $1.25 million investment in Ever After Foods as part of its private placement offering in June 2024. The company does not have a dividend policy, and the EIB Finance Agreement contains limitations on distributions of future potential dividends. The company’s cash balances (cash and cash equivalents, short-term bank deposits, restricted cash and restricted bank deposits) totaled $8,851,000 as of June 30, 2026, and according to management estimates, the company only has sufficient resources to meet its operating obligations for a period of less than three months from the issuance date of the consolidated financial statements.

The company faces significant headwinds and constraints, including the need to raise additional capital to sustain operations beyond a period of less than three months from the issuance date of the consolidated financial statements. The company’s independent registered public accounting firm has included an explanatory paragraph relating to its ability to continue as a going concern. The company is also at risk of delisting from Nasdaq, having received a deficiency letter on July 7, 2026, notifying it that it is not in compliance with the MVLS Requirement under Nasdaq Listing Rule 5550(b)(2), and has been provided with an initial period of 180 calendar days, until January 4, 2027, to regain compliance. The company’s operations are subject to risks related to the political, economic and military conditions in Israel, including the armed conflict between Israel and terrorist organizations, and the company’s principal R&D and manufacturing facilities are located in Haifa, Israel.

The company faces a high degree of risk, with its independent registered public accounting firm including an explanatory paragraph relating to its ability to continue as a going concern, as recurring operating losses and negative cash flow raise substantial doubt about the company’s ability to continue as a going concern ¹. As of June 30, 2026, cash balances totaled $8,851,000 ², and management estimates the company only has sufficient resources to meet its operating obligations for a period of less than three months from the issuance date of the consolidated financial statements ³. The company is at risk of delisting from Nasdaq, having received a deficiency letter on July 7, 2026, for non-compliance with the MVLS Requirement, and must regain compliance by January 4, 2027 ⁴. The company’s failure to reach an agreement with the EIB about the repayment of the EIB Loan, which had an outstanding principal of €20 million ⁵ and accrued interest of approximately €4.1 million ⁶ as of June 30, 2026, could materially affect its financial condition and liquidity. The company’s operations are subject to risks related to the political, economic and military conditions in Israel, with its principal R&D and manufacturing facilities located in Haifa, Israel ⁷, and any escalation of hostilities could disrupt its business operations.

Management’s message emphasizes the company’s position as a biotechnology company leveraging its proprietary 3D cell expansion platform across two primary application areas: Human Health and Longevity and Foodtech and Bio-Farming. The forward-looking statements highlight expectations regarding the development, time-to-market, scalability, cost-efficiency, reproducibility and potential benefits of cell-products services, therapeutics and related technologies, including those supported by the proprietary 3D cell expansion platform and industrial-scale manufacturing capabilities. Management also emphasizes the expectation to solve medicine’s unmet needs and demonstrate a real-world impact and value from the pipeline, technology platform and commercial-scale manufacturing capacity. Key strategic priorities include advancing the PROTO program for PLX-PAD in mild to moderate knee osteoarthritis, expanding the PluriCDMO™ business, and progressing the FoodTech initiatives through Ever After Foods, Coffeesai and Kokomodo. Management also highlights the ongoing discussions with the EIB regarding the EIB Loan, with the objective of reaching a mutually agreed resolution, and the intention to take appropriate actions to regain compliance with Nasdaq’s MVLS Requirement.