Pluri Inc. (NASDAQ:PLUR) is a leading biotechnology company that is pioneering a biotech revolution through its innovative cell-based technology platform. The company's mission is to transform cells into solutions that promote global wellbeing and sustainability across various industries, including regenerative medicine, foodtech, and agtech.

Business Overview

Pluri 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's advanced cell-based technology platform enables it to develop and manufacture cell-based products for commercial use, addressing a wide range of challenges from medicine and climate change to food scarcity and animal cruelty.

Pluri's technology platform is highly versatile, accurate, scalable, cost-effective, and consistent from batch to batch. The company currently operates in the field of regenerative medicine, where it uses its PLX cells (adherent stromal cells) to develop cell therapy product candidates for the treatment of various inflammatory, muscle, and hematologic conditions. Pluri has also expanded its operations to the foodtech and agtech sectors, leveraging its 3D cell expansion technology to develop innovative solutions for the global food and agriculture industries.

In January 2024, Pluri launched its Contract Development and Manufacturing Organization (CDMO) division, PluriCDMO™, which offers services related to early preclinical development, late-stage clinical trials, and commercialization of cell-based products. PluriCDMO™ has already secured a significant manufacturing agreement with Kadimastem Ltd., a clinical-stage biotechnology company developing cell therapies for ALS and diabetes.

Financial Performance

Pluri's financial performance has been mixed in recent years. For the fiscal year ended June 30, 2023, the company reported annual revenue of $287,000, a significant decrease from the previous year's revenue of $1,023,000. The company's annual net loss for the same period was $28,321,000, compared to a net loss of $27,893,000 in the prior year.

The company's annual operating cash flow and free cash flow for the fiscal year ended June 30, 2023, were -$22,857,000 and -$23,119,000, respectively, reflecting the company's continued investment in research and development activities and the expansion of its operations.

In the most recent quarter ended December 31, 2023, Pluri reported quarterly revenue of $105,000, up from $2,000 in the same quarter of the previous year. The company's quarterly net loss for the period was $4,994,000, compared to a net loss of $8,254,000 in the same quarter of the prior year. The improvement in the company's quarterly financial performance was primarily due to a decrease in research and development expenses and general and administrative expenses, as well as an increase in other financial income.

Liquidity and Capital Resources

As of December 31, 2023, Pluri had a strong liquidity position, with $31,638,000 in cash and cash equivalents, short-term bank deposits, restricted cash, and restricted bank deposits. The company's working capital surplus as of the same date was $27,722,000, and its total equity stood at $6,617,000, of which $2,218,000 was attributed to the non-controlling interest in its subsidiary, Ever After Foods Ltd.

Pluri has been actively seeking non-dilutive sources of funding to support its operations and research and development activities. In April 2020, the company's subsidiary, Pluristem GmbH, executed a finance agreement with the European Investment Bank (EIB) for up to €50 million in non-dilutive funding, of which €20 million was received in June 2021. The company has also received grants from the Israeli Innovation Authority (IIA), the European Union's Horizon programs, and the National Institutes of Health (NIH) to support its research and development efforts.

Operational Highlights

During the fiscal year 2023, Pluri made significant progress in advancing its cell-based product candidates and expanding its business operations:

1. Regenerative Medicine

: Pluri continued the development of its PLX-PAD cell therapy for the treatment of various conditions, including critical limb ischemia, chronic graft-versus-host disease, and muscle recovery following hip fracture surgery. The company also announced a $4.2 million contract with the NIH to further advance the development of its PLX-R18 cell therapy as a potential treatment for hematopoietic acute radiation syndrome.

2. Foodtech and Agtech

: Pluri's subsidiary, Ever After Foods Ltd., successfully completed a proof-of-concept for the development of cultivated meat products using the company's 3D cell expansion technology. Additionally, Pluri announced a €1 million proof-of-concept agreement with a leading international agriculture corporation to develop innovative production methods to increase the global availability of vegetables, shorten supply chains, and promote sustainable agriculture.

3. CDMO Services

: The launch of Pluri's CDMO division, PluriCDMO™, has been a significant milestone for the company. PluriCDMO™ has already secured a manufacturing agreement with Kadimastem Ltd. to produce cell therapy product candidates for the treatment of ALS and diabetes.

Outlook and Guidance

Pluri's management remains cautiously optimistic about the company's future prospects. While the company has faced some challenges in recent years, it believes that its innovative cell-based technology platform and diversified business strategy will continue to drive growth and create value for its shareholders.

The company expects to generate revenue from its CDMO services, as well as potential licensing and collaboration agreements in the regenerative medicine, foodtech, and agtech sectors. Pluri also anticipates receiving additional non-dilutive funding from grants and other sources to support its ongoing research and development activities.

However, the company acknowledges that it may require additional liquidity resources in the future to support the commercialization of its products and maintain its research and development efforts. Pluri's management is actively exploring various funding options, including collaborations, partnerships, and the potential sale of its equity securities.

Risks and Challenges

Pluri faces several risks and challenges that could impact its future performance, including:

1. Regulatory Approvals: The company's ability to successfully develop and commercialize its cell-based products is subject to regulatory approvals, which can be a lengthy and uncertain process.

2. Technological Validation: Pluri's technology platform and methods must continue to be validated by the scientific community and accepted by regulatory agencies as the company progresses with its research and development efforts.

3. Competition: Pluri operates in highly competitive industries, and it may face pressure on pricing and market share from competitors with similar or alternative technologies.

4. Geopolitical Risks: Pluri's operations are based in Israel, and the company may be affected by political, economic, and military conditions in the region, including the ongoing conflict between Israel and Hamas, Hezbollah, and other terrorist organizations.

5. Liquidity and Funding: The company's ability to secure adequate funding to support its operations and research and development activities is crucial to its long-term success.

Conclusion

Pluri Inc. is a pioneering biotechnology company that is leveraging its innovative cell-based technology platform to address a wide range of global challenges. The company's diversified business strategy, which spans regenerative medicine, foodtech, and agtech, positions it well to capitalize on emerging opportunities in these rapidly evolving industries.

While Pluri has faced some financial and operational challenges in recent years, the company's strong liquidity position, ongoing research and development efforts, and strategic partnerships provide a solid foundation for future growth. As Pluri continues to execute on its ambitious plans, investors will be closely watching the company's ability to successfully commercialize its cell-based products, secure additional funding, and navigate the various risks and challenges that come with operating in the dynamic biotechnology sector.