Pluri Inc. (PLUR)

Executive Summary / Key Takeaways

• Diversified Biotech Platform: Pluri Inc. is transforming from a pure-play cell therapy developer into a multi-vertical biotechnology company, leveraging its proprietary 3D cell expansion platform across regenerative medicine, immunotherapy, Contract Development and Manufacturing Organization (CDMO) services, food technology, and agriculture technology (AgTech). This diversification aims to de-risk its business model and tap into multiple high-growth markets.
• Technological Edge in Cell Expansion: The company's core competitive advantage lies in its patented 3D cell expansion platform, which offers high accuracy, scalability, cost-efficiency, and consistent batch-to-batch performance for both adherent and suspension cells. This technology is foundational to its product development and service offerings across all segments.
• Strategic Growth Initiatives: Recent strategic moves, including the launch of its MAIT cell immunotherapy platform, the establishment of PluriCDMO (already generating revenue), and significant investments in cultivated coffee (Coffeesai) and cacao (Kokomodo), underscore a clear strategy to commercialize its technology through various channels and partnerships.
• Financial Headwinds and Funding Needs: Despite a notable increase in revenues to $1.34 million in fiscal year 2025, Pluri continues to face substantial operating losses and negative cash flows, resulting in an accumulated deficit of $443.06 million. The company requires additional capital to sustain operations beyond the next twelve months and is actively discussing restructuring its $27.3 million EIB loan due in June 2026.
• High-Risk, High-Reward Investment: Pluri presents a high-risk, high-reward investment opportunity. Its success hinges on successful clinical development, regulatory approvals, effective commercialization of its diverse product pipeline, and securing adequate financing, all while navigating intense competition in each of its verticals.

A Biotech Evolution: Pluri's Multi-Front Approach to Cell-Based Solutions

Pluri Inc. (NASDAQ:PLUR), originally established as Pluristem Therapeutics Inc. in 2001, has evolved into a dynamic biotechnology firm, strategically pivoting its focus to harness its proprietary cell expansion platform across a broad spectrum of industries. Under the leadership of Chairman Zami Aberman and CEO Yaky Yanay, the company has transitioned from a primary focus on regenerative medicine to a diversified model encompassing immunotherapy, Contract Development and Manufacturing Organization (CDMO) services, food technology, and agriculture technology (AgTech). This strategic expansion is designed to capitalize on the versatility of its core technology and address critical global challenges, from healthcare to sustainable food production.

The global biotechnology market, valued at $1.37 trillion in 2022, is projected to grow at a Compound Annual Growth Rate (CAGR) of 13.96% from 2023 to 2030, highlighting a robust environment for innovation. Within this expanding landscape, Pluri's foundational strength lies in its patented 3D cell expansion platform. This state-of-the-art system is engineered to deliver high accuracy, scalability, cost-efficiency, and consistent batch-to-batch performance in cell production. Unlike traditional 2D cell culture methods, Pluri's 3D platform utilizes a synthetic scaffold to create a tissue-like environment, enabling the large-scale, monitored, and controlled production of reproducible, high-quality cell products in mass quantities. This technological differentiation is crucial for overcoming manufacturing challenges inherent in biological products, offering a significant advantage in both cost and consistency.

The "so what" for investors is clear: this core technology provides Pluri with a competitive moat, allowing it to pursue multiple high-growth verticals simultaneously. By enabling efficient, high-volume, and consistent cultivation of various cell types—from placenta-derived stromal and immune cells to plant cells—the platform underpins the company's ability to develop diverse solutions. This technological versatility is expected to contribute to improved financial performance through lower production costs, faster development cycles, and enhanced market positioning across its varied business lines.

Diversified Growth Engines: From Therapy to Table

Pluri's strategic diversification is evident in its four key business areas, each leveraging its core cell expansion technology.

Cell Therapy and Immunotherapy: Addressing Unmet Medical Needs

In regenerative medicine, Pluri continues to advance its placenta-based cell therapy product candidates, PLX-PAD and PLX-R18, for indications such as muscle recovery, hematologic conditions, and knee osteoarthritis. Management emphasizes that these indications represent "severe unmet medical need." The company's PLX cells are adherent stromal cells, expanded using its 3D platform, and can be administered off-the-shelf without matching.

A significant development in this segment is the launch of a novel allogeneic immunotherapy platform in May 2024, utilizing Mucosal Associated Invariant T (MAIT) cells. These placental MAIT cells are specifically designed to address solid tumors, a critical area with insufficient effective treatments. Pluri believes its MAIT cells offer "substantial potential benefits compared to conventional T cells," including potent effector capabilities, migration directly to tumor sites, and a minimized likelihood of inducing Graft versus Host Disease (GvHD). The Israel Innovation Authority (IIA) approved funding in October 2024 for a collaboration with Bar-Ilan University to integrate novel Chimeric Switch Receptors (CCR) into the CAR-MAIT cell therapy platform, aiming to enhance tumor specificity and therapeutic efficacy.

While the NIAID terminated a $4.20 million contract for PLX-R18 development for H-ARS in April 2025, Pluri views this as a result of "broader federal budgetary and administrative adjustments" rather than performance issues. The company remains committed to H-ARS, entering an exclusive collaboration with Hemafund in Ukraine in March 2025 to stockpile up to 12,000 doses of PLX-R18, a collaboration with a potential value exceeding $100 million. The PROTO project, utilizing PLX-PAD for knee osteoarthritis, also secured a €7.50 million non-dilutive grant from the European Union’s Horizon program.

PluriCDMO: Capitalizing on Manufacturing Expertise

Launched in January 2024, PluriCDMO offers cell therapy manufacturing services from preclinical development through commercialization. This division leverages Pluri's "over 15 years of experience in GMP manufacturing, our highly skilled team and utilizing our proprietary technologies and flexible 4400 square meter purpose-built facilities." The company has already "signed several agreements with clients and are currently generating revenues from PluriCDMO." This business line provides a more immediate revenue stream and a pathway to commercialization for other biotech companies, diversifying Pluri's revenue base beyond its own product pipeline.

AgTech: Cultivating a Sustainable Future

Pluri is actively applying its 3D cell expansion technology to agriculture, addressing global challenges like climate change and food security. This includes a collaboration with ICL Group Ltd. (ICL) to enhance biostimulant delivery and a $1 million proof-of-concept (POC) agreement with a leading international agriculture corporation to boost sustainable vegetable production.

The company's plant-based vertical includes two key subsidiaries:

• Coffeesai: Established in 2024, Coffeesai focuses on developing cell-cultured coffee to mitigate climate-related crop instability, supply chain disruptions, and environmental impact. Coffeesai has successfully demonstrated a POC coffee beverage, and a "third-party techno-economic assessment has confirmed the cost-competitiveness of the platform at scale."
• Kokomodo: Acquired in April 2025 (Pluri Biotech holds approximately 79% equity), Kokomodo pioneers sustainable cacao production from plant cells. Pluri's CEO, Yaky Yanay, stated that this acquisition positions the company "uniquely... to lead innovation in the cultivated cacao sector," combining Pluri's expertise with Kokomodo's approach to address "growing concerns about climate change impacts on traditional cacao farming." Kokomodo's CEO, Tal Govrin, believes teaming with Pluri will "accelerate our production capabilities, expand globally." The global cacao market, valued at $13.5 billion in 2023, is projected to grow to $23.5 billion by 2030, representing an 8.2% CAGR.

Food Tech: Redefining Meat Production

Ever After Foods, a joint venture with Tnuva established in 2022, is dedicated to developing scalable production technologies for cultivated meat. Pluri invested $1.25 million in a $10 million private placement for Ever After Foods in June 2024, maintaining approximately 69% ownership. The technology license was expanded to include fish and seafood. Management believes Ever After Foods is "poised to revolutionize the food industry" with its "unique proprietary technology that is optimized for natural cell growth," enabling production at a "significantly lower cost and on a larger scale." A strategic collaboration with Bühler Group in February 2025 aims to advance commercial-scale cultivated meat production systems.

Financial Performance and Liquidity: A Path to Sustainability

Pluri's financial performance for the fiscal year ended June 30, 2025, reflects its transitional phase and significant investments in R&D and new ventures. Revenues saw a substantial increase to $1.34 million, up from $326,000 in the prior year, primarily driven by higher services provided to CDMO clients and AgTech collaborations. Cost of revenues also increased to $682,000, reflecting manufacturing costs in these growing segments.

Despite revenue growth, the company reported an increased net loss of $23.25 million for fiscal year 2025, compared to $21.34 million in the previous year. This was mainly attributed to exchange rate differences expenses related to the EIB loan and decreased interest income. Research and development, net costs, rose by 3% to $12.85 million, driven by immunotherapy and AgTech projects, while general and administrative expenses slightly decreased by 0.50% to $9.98 million due to reduced share-based compensation, partially offset by salary reinstatements and bonus expenses.

Liquidity remains a critical focus. As of June 30, 2025, Pluri had a working capital deficit of $10.23 million and an accumulated deficit of $443.06 million. Cash balances totaled $21.91 million. Management estimates that current resources are insufficient to meet operating obligations for at least twelve months from the September 17, 2025, issuance date of its financial statements, raising "substantial doubt about its ability to continue as a going concern." The company is actively pursuing additional capital and is in "advanced discussions with the EIB regarding a potential restructuring of the EIB Loan terms," including an extension of the June 1, 2026, maturity date.

Cash used in operating activities increased to $18.21 million in fiscal year 2025, while financing activities provided $9.53 million, primarily from recent private placements totaling $10 million.

Competitive Landscape: Differentiating Through Technology

Pluri operates in highly competitive sectors. In regenerative medicine, it faces established players like Mesoblast , Vericel (VCEL), and Organogenesis (ORGO), as well as numerous academic institutions and pharmaceutical companies. Pluri aims to compete based on its intellectual property portfolio, in-house manufacturing efficiencies, and the potential efficacy of its products. While competitors like Mesoblast (MESO) may have more mature pipelines and established partnerships, Pluri's placenta-derived cell technology offers a unique differentiator, particularly in immunomodulation, potentially leading to faster innovation cycles and superior margins in niche applications. However, Pluri's earlier stage of development means it generally lags in profitability and cash flow generation compared to these more established rivals.

In the cultivated food sector, Ever After Foods competes with consumer-facing companies such as Upside Foods and Believer Meats, and B2B players like Gelatex and Ark Biotech. Ever After Foods distinguishes itself with a "unique proprietary technology that is optimized for natural cell growth," enabling production at a "significantly lower cost and on a larger scale" compared to traditional bioreactor approaches. Similarly, in AgTech, Coffeesai and Kokomodo compete with companies focused on plant cell culture for specialty ingredients. Pluri believes its "competitive positioning is derived from our technology platform capabilities and our innovative developments," with its 3D cell expansion platform offering "meaningful advantages in scalability, cost-efficiency and product quality."

The CDMO space is also competitive, with large service providers like Lonza Group AG (LZAGY) and Charles River Laboratories International, Inc. (CRL). PluriCDMO differentiates itself through its specialized cell therapy manufacturing expertise and state-of-the-art facilities.

Risks and Outlook: A High-Stakes Growth Trajectory

Pluri's investment profile carries significant risks. The "substantial doubt about its ability to continue as a going concern" due to recurring losses and negative cash flow is paramount, underscoring the urgency of securing additional financing and restructuring the EIB loan. The termination of the NIAID contract highlights the inherent uncertainties in government funding and clinical development.

The cultivated food and plant-based ventures, while promising, face their own set of challenges, including limited operating history, the need for industrial-scale technology development, and regulatory uncertainties. For cell-based cacao, specifically, the "regulatory landscape... remains uncertain," and scaling "technology beyond the POC stage to reach industrial-scale production" involves substantial operational, financial, and technical risks. Geopolitical risks, given its R&D and manufacturing facilities in Haifa, Israel, also present a potential threat to operations. Cybersecurity and the nascent integration of AI tools introduce additional operational and compliance risks.

Despite these challenges, Pluri's outlook is anchored in its diversified strategy and technological innovation. Management "do not anticipate generating significant revenues from sales of products in the next twelve months," and it is "unlikely that near-term revenues will exceed our operating costs." However, the company's ability to execute its business plan hinges on "obtain sufficient additional capital, enter licensing or other commercial, partnerships and collaboration agreements, provid CDMO services to clients, finaliz discussions with the EIB regarding loan restructuring and receiv other sources of funding, including non-diluting sources such as grants." The recent capital raises and ongoing discussions with the EIB are critical steps in addressing its liquidity needs and fueling its growth initiatives.

Conclusion

Pluri Inc. stands at a pivotal juncture, transforming its scientific prowess into a multi-faceted commercial enterprise. The core investment thesis revolves around the company's proprietary 3D cell expansion platform, a technological cornerstone enabling its ambitious diversification into regenerative medicine, immunotherapy, CDMO services, cultivated coffee, cacao, and meat. This innovative technology provides a distinct competitive advantage, promising scalability, cost-efficiency, and consistent product quality across its varied applications.

While the company's financial health presents immediate challenges, marked by recurring losses and a need for further capital, its strategic initiatives and partnerships are designed to unlock long-term value. The successful advancement of its MAIT cell immunotherapy, the revenue-generating PluriCDMO, and the high-growth potential of its AgTech and Food Tech ventures, particularly in the burgeoning cultivated food market, are critical catalysts. For discerning investors, Pluri represents a high-conviction play on the future of cell-based technologies, where technological leadership and strategic diversification are paramount to overcoming current financial headwinds and realizing its significant, albeit risky, growth potential.