Company Overview

Pluri Inc. (NASDAQ:PLUR) is a leading biotechnology company that has developed a unique three-dimensional (3D) technology platform for industrial-scale cell expansion. Leveraging this innovative platform, Pluri is driving advancements across diverse verticals, including regenerative medicine, immunotherapy, food technology, agricultural technology, and contract development and manufacturing services.

Founded on May 11, 2001, and headquartered in Haifa, Israel, Pluri has established itself as a pioneer in the field of cell-based solutions. The company, formerly known as Pluristem Therapeutics Inc., has developed its proprietary 3D cell expansion technology with an industrial-scale in-house Good Manufacturing Practice cell manufacturing facility. In 2020, Pluri expanded its operations by establishing a wholly owned German subsidiary, Pluristem GmbH. Further diversifying its portfolio, the company created two new subsidiaries: Ever After Foods Ltd. in Israel in 2022, following a collaboration agreement with Tnuva Food Industries Agricultural Cooperative in Israel Ltd., and Coffeesai Ltd. in Israel in 2024 to develop cultivated coffee.

Historical Challenges and Achievements

Throughout its history, Pluri has faced and overcome various challenges. In 2020, the company secured a finance contract with the European Investment Bank for non-dilutive funding of up to 50 million euros to support its research and development in the European Union and advance its regenerative cell therapy platform. However, the project term ended in 2022, and the company does not expect to receive additional funds from this agreement. Despite these obstacles, Pluri has achieved significant milestones, including signing an agreement with the Tel-Aviv Sourasky Medical Center in 2017 to conduct a Phase III trial of its PLX-PAD cell therapy for the treatment of Steroid-Refractory Chronic Graft-Versus-Host-Disease. In 2022, the company established a joint venture with Tnuva Food Industries Agricultural Cooperative in Israel Ltd. to develop cultivated meat products. Pluri has also been awarded various grants from the Israel Innovation Authority, the European Union's Horizon programs, and the U.S. National Institutes of Health to support its research and development activities.

Financials

Pluri's financial performance in recent years has been marked by consistent revenue growth and an unwavering commitment to R&D. In the fiscal year ended June 30, 2024, the company reported total revenue of $326,000, a significant increase from $287,000 in the prior year. While Pluri continues to invest heavily in research and development, with net R&D expenses of $12.45 million in fiscal 2024, the company has also made strides in diversifying its revenue streams through its contract development and manufacturing organization (CDMO) business.

For the most recent fiscal year (2024), Pluri reported a net income of -$20,888,000, operating cash flow (OCF) of -$18,021,000, and free cash flow (FCF) of -$18,344,000. In the most recent quarter (Q1 2025), the company reported revenue of $326,000, net income of -$5,882,000, OCF of -$4,064,000, and FCF of -$4,272,000. The increase in revenue compared to the prior year quarter is mainly attributed to the launch of new business verticals, specifically in the CDMO and agtech fields. The increase in net loss is primarily due to higher financial expenses and continued investment in R&D.

Liquidity

The company's balance sheet reflects a strong financial position, with $26.68 million in total cash, cash equivalents, short-term bank deposits, restricted cash, and restricted bank deposits as of September 30, 2024. However, Pluri has accumulated a sizable deficit of $426.35 million since its inception, highlighting the capital-intensive nature of its research and development efforts.

As of September 30, 2024, Pluri's debt-to-equity ratio stood at -4.91, indicating a negative shareholders' equity position. The company's current ratio and quick ratio both stood at 5.90, suggesting a strong ability to meet short-term obligations. No available credit line has been disclosed by the company.

Strategic Partnerships and Collaborations

One of Pluri's key strategic priorities has been to establish partnerships and collaborations to advance its technology and product pipeline. In July 2023, the company signed a three-year, $4.2 million contract with the U.S. National Institute of Allergy and Infectious Diseases (NIAID) to further develop its PLX-R18 cell therapy as a potential treatment for hematopoietic acute radiation syndrome (H-ARS). Additionally, in September 2022, Pluri announced a $7.5 million non-dilutive grant from the European Union's Horizon program for a Phase III study of its PLX-PAD cells in the treatment of mild to moderate knee osteoarthritis.

Business Model and Market Conditions

Pluri's diversified business model and strategic partnerships have enabled it to navigate challenging market conditions, including the COVID-19 pandemic and ongoing geopolitical tensions in the Middle East. The company's Haifa-based operations, however, remain vulnerable to potential disruptions from the escalating military conflict between Israel and surrounding terrorist groups, which could impact its manufacturing and research capabilities.

Pluri operates in one primary segment - cell-based technology. The company utilizes its technology in the fields of regenerative medicine, food technology, agricultural technology, and has also launched a Contract Development and Manufacturing Organization (CDMO) business.

In the cell therapy segment, Pluri's core focus is on the research, development, and manufacturing of cell-based products for regenerative medicine. The company's PLX cells are the primary product in this segment, which are adherent stromal cells expanded using the company's 3D platform. These PLX cells can be administered to patients off-the-shelf, without blood or tissue matching or additional manipulation prior to administration.

In May 2024, Pluri launched a novel allogenic immunotherapy platform utilizing Mucosal Associated Invariant T (MAIT) cells specifically designed to address solid tumors. The company believes its MAIT cells, isolated from the human placenta, offer substantial potential benefits compared to conventional T-cells.

The company's CDMO business division, PluriCDMO, launched in January 2024, offers cell therapy manufacturing services from early preclinical development through late-stage clinical trials and commercialization. This new division has already signed several agreements with clients and is currently generating revenues.

In the agtech and food tech sectors, Pluri is actively involved in initiatives leveraging its 3D cell expansion technology. This includes a cell-based coffee business through its PluriAgtech vertical, a proof-of-concept collaboration with ICL Group Ltd. to revolutionize bio-stimulant delivery, and a strategic agreement with a leading international agriculture corporation to boost global vegetable product supply, streamline supply chains, and combat climate change.

Future Outlook

Looking ahead, Pluri is poised to capitalize on the growing demand for its cell-based technologies across various industries. The company's CDMO business, which provides contract manufacturing services to other biotechnology firms, has gained significant traction and is expected to contribute to Pluri's revenue growth in the coming years. Additionally, the company's forays into food technology and agricultural technology, such as its cultivated coffee venture and collaborations with leading agricultural companies, hold promising long-term potential.

The regenerative medicine and cell therapy market is projected to grow at a CAGR of over 20% from 2023 to 2030, driven by increasing incidence of chronic diseases, advancements in technology, and rising investments. The cultivated meat market is also expected to grow rapidly, with a projected CAGR of over 30% from 2022 to 2030. These industry trends bode well for Pluri's diverse portfolio of cell-based solutions.

Despite the challenges posed by its accumulated deficit and the geopolitical risks in its operating environment, Pluri's diverse portfolio of cell-based solutions, robust partnerships, and a steadfast commitment to innovation position the company as a key player in the rapidly evolving biotechnology landscape. As Pluri continues to execute on its strategic priorities, investors will closely monitor the company's ability to translate its groundbreaking research into commercially viable products and services that deliver tangible value to its customers and shareholders.