Pluri (US:PLUR)2025-09-17 20:22Acquisition and Partnerships - The company completed the acquisition of approximately 79% of Kokomodo, an innovative agfood startup focused on sustainable cacao production using cellular agriculture technology[27] - The company holds approximately 69% of Ever After Foods, which focuses on scalable production technologies for cultivated meat[31] - Ever After Foods entered a strategic collaboration with Bühler Group to advance scalable cultivated meat production systems, aiming to reduce costs and support global food security[55] - The company has established strategic partnerships, including with Tnuva and ICL Group, to enhance its product development and market reach[170] Funding and Financial Agreements - In June 2024, the company raised $10 million through a private placement offering for Ever After Foods, with the company investing $1.25 million, aiming to support its B2B technology platform for cultivated meat[30] - The company executed a finance agreement with EIB for non-dilutive funding of up to €50 million, intended to support R&D in the EU[71] - The company received a loan of up to €50 million from the EIB, with the first tranche of €20 million received in June 2021, due for repayment on June 1, 2026, with accrued interest of approximately €3.27 million as of June 30, 2025[133] - A €7.5 million non-dilutive grant was awarded to the PROTO project from the EU's Horizon program for treating knee osteoarthritis[78] Product Development and Technology - The company launched a novel allogenic immunotherapy platform utilizing MAIT cells in May 2024, designed to address solid tumors, which are currently a critical area in medicine[20] - The company established a new business division, PluriCDMO™, in January 2024, offering cell therapy manufacturing services and generating revenues from several client agreements[22] - The company is developing cell-cultured coffee through its subsidiary Coffeesai, addressing challenges in the traditional coffee industry and demonstrating a proof-of-concept beverage[25][26] - The company has a unique 3D cell expansion platform that enables high-quality cell production at commercially relevant volumes, applicable across various sectors including regenerative medicine and AgTech[34][36] - The company launched a cell-based coffee business, PluriAgTech, in January 2024 to meet the demand for sustainable coffee production[57] Clinical Trials and Regulatory Compliance - PLX-PAD and PLX-R18 products have been tested in clinical studies for various indications, with PLX-PAD being developed for knee osteoarthritis as part of an international collaboration[41][42] - The company has submitted an Investigational New Drug (IND) Application, which must be effective before clinical testing in humans can begin[96] - The in-house clinical manufacturing facility has been operational since February 2013, approved for producing PLX-PAD and PLX-R18 for clinical use[86] - The facility continues to comply with GMP standards and has been inspected by a European Union Qualified Person in December 2024[87] Intellectual Property and Patents - The company holds 193 issued patents and approximately 55 pending patent applications across multiple jurisdictions, including the U.S., Europe, and Asia[61] - A new patent approval from the Israel Patent Office in March 2024 represents a breakthrough in 3D bioreactor technology for efficient plant cell cultivation[58] - The patent portfolio includes claims for proprietary 3D cell expansion methods for both adherent and suspension cells, covering various therapeutic applications[63] - The expiration dates of the patents range from 2027 to 2044, with potential extensions based on regulatory delays[67] - The company emphasizes the importance of protecting its intellectual property through patents and confidentiality agreements[60] Financial Performance and Risks - The company has a history of losses and has not generated significant revenues to date, expecting future losses and potential difficulties in raising additional capital[119] - The independent registered public accounting firm has included an explanatory paragraph regarding the company's ability to continue as a going concern in its audited financial statements[119] - As of June 30, 2025, the company's cash balances totaled $21,914,000, which is insufficient to meet operating obligations for at least twelve months[124] - The company anticipates needing to raise significant additional capital in the future to support research, development, and manufacturing of cell-based products[126] - The company faces risks related to the development and commercialization of its products, which are currently in the development stage and require regulatory approvals[129] Market Competition and Challenges - The company is facing intense competition in the regenerative medicine field, with 2,096 cell-based therapies in development globally, including 820 gene-modified and cellular immunotherapies[106] - The company operates in a competitive landscape for cultivated meat, with a unique proprietary technology that allows for lower-cost and larger-scale production[109] - The cellular therapeutics industry is highly competitive, with many companies targeting the same diseases, which could render the company's products obsolete if it fails to keep pace with technological advancements[199] - The trend towards consolidation in the pharmaceutical and biotechnology industries may lead to increased competition and fewer collaboration opportunities for the company[198] Operational and Compliance Risks - The company is dependent on third-party suppliers for raw materials necessary for manufacturing, which poses risks to its ability to deliver products on time[204] - Cybersecurity incidents and technology disruptions could adversely affect the company's operations and reputation, particularly regarding compliance with privacy laws[210] - The company is exposed to fluctuations in currency exchange rates due to a significant portion of its business being conducted outside the United States[124] - The company has implemented a hedging strategy using options and forward contracts to mitigate currency exchange risks[195] Future Outlook and Strategic Initiatives - Ever After Foods has a limited operating history in the cultivated meat sector, making its future prospects difficult to predict[152] - The company is focused on developing industrial-scale cultivated meat technologies and processes, which are crucial for its market success[152] - The success of Ever After Foods' cultivated meat products will depend on consumer preferences, which are difficult to predict and may change[156] - The company is working with regulatory consultants to determine if its cultivated plant-based products can be classified as "Generally Recognized as Safe" (GRAS) under FDA regulations[166]