Pluri Inc. (NASDAQ:PLUR) is a leading biotechnology company that has developed a unique three-dimensional (3D) technology platform for cell expansion with an industrial scale in-house Good Manufacturing Practice (GMP) cell manufacturing facility. The company is leveraging its advanced cell-based technology to create a collaborative network of ventures across various industries, from regenerative medicine and immunotherapy to food technology and agricultural technology.
Business Overview and Company History
Pluri Inc. was incorporated on May 11, 2001, as Pluristem Therapeutics Inc. and is headquartered in Haifa, Israel. The company changed its name to Pluri Inc. in July 2022. Pluri has a wholly-owned subsidiary, Pluri Biotech Ltd. (formerly known as Pluristem Ltd.), which is incorporated under the laws of the State of Israel. In January 2020, Pluri Biotech Ltd. established a wholly-owned German subsidiary, Pluristem GmbH. In January 2022, it established a new subsidiary, Ever After Foods Ltd. (formerly known as Plurinuva Ltd.), to collaborate with Tnuva Food Industries Agricultural Co-Operative in Israel Ltd. on cultivated meat products. Most recently, in March 2024, the company established a new wholly-owned subsidiary, Coffeesai Ltd., to develop cultivated coffee.
Pluri's core focus is on the research, development, and manufacturing of cell-based products, as well as the business development of cell therapeutics and cell-based technologies that can provide potential solutions for various industries. The company's unique 3D technology platform enables it to expand cells at an industrial scale, addressing the growing demand for advanced cell-based therapies and technologies.
In 2020, Pluri entered into a finance contract with the European Investment Bank (EIB) for non-dilutive funding of up to 50 million euros to support the company's R&D activities in the European Union. However, Pluri is currently in discussions with the EIB regarding a potential restructuring of the terms of this loan, as there is no certainty that such a restructuring will be achieved.
More recently, in November 2024, Pluri received a deficiency letter from the Nasdaq Stock Market notifying the company that it was not in compliance with the Nasdaq's continued listing requirements regarding minimum stockholders' equity. Pluri submitted a plan to regain compliance, and Nasdaq granted the company an extension of time until May 2025 to do so, but there is no assurance that Pluri will ultimately regain compliance with all applicable requirements for continued listing.
The company operates in three main product segments: Cell Therapy, Immunotherapy, and AgTech. Pluri currently uses its technology in the field of regenerative medicine, food technology, agricultural technology and has launched a Contract Development and Manufacturing Organization (CDMO) business.
Financial Performance and Ratios
Due to the company's focus on research and development, Pluri has not yet generated significant revenues from the sale of products. For the six-month period ended December 31, 2024, the company reported revenues of $511,000, up from $159,000 in the same period of the prior year. This increase was mainly attributed to the launch of new business verticals, specifically in the Contract Development and Manufacturing Organization (CDMO) field and an increase related to a proof-of-concept collaboration with a leading international agriculture corporation in the agtech field.
For the most recent quarter ended December 31, 2024, Pluri reported revenues of $185,000, compared to $105,000 in the same quarter of the previous year. The company's net income for the quarter was $1,847,000, a significant improvement from the net loss of $4.99 million in the same period of the prior year. Operating cash flow for the quarter was $730,000, and free cash flow was $447,000.
Pluri's net loss for the six-month period ended December 31, 2024, was $9.15 million, compared to a net loss of $10.09 million in the same period of the prior year. The decrease in net loss was due to a reduction in general and administrative expenses and research and development expenses, as part of the company's strategy to optimize its operations and the launch of new business initiatives.
As of December 31, 2024, Pluri had a working capital surplus of $17.93 million, total equity deficit of $2.92 million (after deduction of $5.11 million attributed to the non-controlling interest in Ever After Foods), and an accumulated deficit of $429.31 million. The company's cash and cash equivalents and restricted cash amounted to $7.49 million as of December 31, 2024, compared to $5.84 million as of December 31, 2023.
Liquidity
Pluri's financial ratios, as of December 31, 2024, include a current ratio of 5.04, a quick ratio of 5.04, and a cash ratio of 1.63, indicating a strong liquidity position. The company's debt-to-equity ratio is -0.68, suggesting a negative equity position due to accumulated losses.
As of December 31, 2024, Pluri had total current assets of $22.37 million and total current liabilities of $4.44 million. The company's cash and cash equivalents, short-term bank deposits, restricted cash, and restricted bank deposits totaled $22.37 million.
The company has a loan outstanding from the European Investment Bank (EIB) with a principal balance of $20.82 million and accrued interest of $2.98 million as of December 31, 2024. Pluri is currently in discussions with the EIB regarding a potential restructuring of the terms of the loan.
Operational Highlights and Key Developments
Cell Therapy and Immunotherapy Pluri's cell-based technology platform has been utilized in the field of regenerative medicine to develop placenta-based cell therapy product candidates for the treatment of inflammatory, muscle injuries, and hematologic conditions. The company's PLX cells are adherent stromal cells that are expanded using Pluri's proprietary 3D platform. These PLX cells can be administered to patients off-the-shelf, without the need for blood or tissue matching or additional manipulation prior to administration.
Pluri has conducted several studies evaluating its PLX cell product candidates for indications such as muscle recovery following hip fracture surgery, incomplete recovery following bone marrow transplantation, critical limb ischemia, chronic graft versus host disease, and hematopoietic acute radiation syndrome. Some of these studies have been completed, while others are still ongoing.
In July 2023, Pluri signed a three-year, $4.2 million contract with the U.S. National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (NIH), to collaborate with the U.S. Department of Defense's Armed Forces Radiobiology Research Institute and the Uniformed Services University of Health Sciences to further advance the development of Pluri's PLX-R18 cell therapy as a potential novel treatment for hematopoietic acute radiation syndrome (H-ARS).
In May 2024, Pluri launched a novel allogenic immunotherapy platform utilizing MAIT (Mucosal Associated Invariant T) cells, which are specifically designed to address solid tumors. Pluri believes that its MAIT cells, isolated from the human placenta, offer substantial potential benefits compared to conventional T-cells. MAIT cells are potent effector cells that can potentially target tumors through multiple mechanisms while expressing high levels of various chemokine receptors, which facilitate their migration directly to tumor sites.
In April 2024, the company unveiled a novel method for the expansion of immune cells using proprietary technology and announced the granting of a new U.S. patent titled "System and Methods for Immune Cells Expansion and Activation in Large Scale." This innovation ensures that the produced immune cells retain their integrity, functionality, and therapeutic efficacy, offering a promising solution for advanced cell-based therapies for immune disorders and neurodegenerative diseases.
PluriCDMO In January 2024, Pluri launched a new business division, PluriCDMO, offering cell therapy manufacturing services as a contract development and manufacturing organization (CDMO). PluriCDMO leverages Pluri's 47,000 square foot GMP cell production facility to provide CDMO services to companies from early preclinical development through late-stage clinical trials and commercialization.
In July 2024, Pluri announced that PluriCDMO was selected to manufacture Kadimastem Ltd.'s novel cell therapy product candidates, further establishing the division as a leading manufacturing partner offering scalability and mass-scale production to a growing number of innovative life science companies.
AgTech and Food Tech Pluri is actively involved in several agtech initiatives, including a cell-based coffee business activity through its PluriAgtech business vertical, a proof-of-concept collaboration with ICL Group Ltd. to revolutionize biostimulant delivery and enhance yield sustainably, and a strategic proof-of-concept agreement with a leading international agriculture corporation to boost the global vegetable product supply, streamline supply chains, and combat global climate change.
In March 2024, the company announced the approval of a new patent from the Israel Patent Office that represents a major breakthrough in its proprietary 3D bioreactor technology, enabling efficient cultivation of plant cells across various applications, from sustainable agriculture to critical healthcare solutions.
Pluri's food tech initiatives include the establishment of a joint venture with Tnuva Food Industries Agricultural Co-Operative in Israel Ltd., called Ever After Foods, to develop cultivated meat products. In June 2024, Ever After Foods secured a $10 million strategic investment from U.S. and EU investors to accelerate the growth and development of its scalable production platform for cultivated meat, fish, and seafood.
Recent Financing and Strategic Transactions
On January 23, 2025, Pluri entered into a securities purchase agreement with global investor and entrepreneur Alejandro Weinstein, who invested $6.5 million in the company. Concurrently, Pluri announced the acquisition of a 71% stake in Kokomodo Ltd., an Israeli agtech company specializing in cultivated cacao production, for $4.5 million payable in Pluri's common shares.
On February 3, 2025, Pluri entered into an additional securities purchase agreement with Merchant Adventure Fund L.P., an existing investor, for a private placement offering of $3.5 million.
These recent financing and strategic transactions, totaling $10 million, are intended to support Pluri's growth and execution strategy as a global leader in cell-based technology, expand its presence in the sustainable food technology market, and strengthen its strategic and operational capabilities.
Risks and Challenges
Pluri operates in a highly competitive and rapidly evolving biotechnology and life sciences industry, which presents various risks and challenges:
1. Regulatory Approvals: Obtaining regulatory approvals for the company's cell-based therapies and technologies is a complex and time-consuming process, which could delay or prevent the commercialization of Pluri's products.
2. Intellectual Property Protection: The company's ability to protect its proprietary technologies and intellectual property is crucial, and any failure to do so could harm its competitive position.
3. Funding and Capital Requirements: Pluri's operations and research and development activities are capital-intensive, and the company may need to raise additional funding to support its growth and execute its business strategy.
4. Reliance on Key Personnel: The loss of key personnel, including the company's executive team and scientific experts, could adversely impact Pluri's operations and the development of its technologies.
5. Geopolitical and Military Risks: Pluri's principal research, development, and manufacturing facilities are located in Haifa, Israel, which exposes the company to potential disruptions due to military conflicts and geopolitical tensions in the region.
Outlook and Conclusion
Pluri is well-positioned to capitalize on the growing demand for advanced cell-based therapies, technologies, and sustainable food solutions. The company's unique 3D cell expansion platform, coupled with its expanding portfolio of cutting-edge initiatives in regenerative medicine, immunotherapy, agtech, and food tech, provide a solid foundation for long-term growth and value creation.
The cell-based therapy industry is experiencing significant growth, with a compound annual growth rate (CAGR) of over 20% expected in the coming years, driven by advancements in technology and increasing demand for regenerative medicine solutions. This trend bodes well for Pluri's future prospects and market opportunities.
The recent $10 million in strategic financing, along with the acquisition of a majority stake in Kokomodo, demonstrate Pluri's ability to execute on its growth strategy and solidify its position as a global leader in cell-based solutions. As the company continues to advance its pipelines, forge strategic partnerships, and expand its technological capabilities, Pluri is poised to play a transformative role in promoting global wellbeing and sustainability across diverse industries.
However, the company faces ongoing challenges, including the need to achieve profitability, manage its cash burn rate, and secure additional funding to support its research and development efforts. Pluri's ability to successfully navigate these challenges while capitalizing on the growing market opportunities in cell-based therapies and technologies will be crucial to its long-term success and value creation for shareholders.