Mr. Yaky Yanay was appointed as CEO of Pluri in June 2019 after serving as President from February 2014. Previously, Mr. Yanay served in a variety of executive positions at Pluri since 2006 including Co-CEO, Chief Financial Officer, Chief Operating Officer and Executive Vice President. He is also the former Co-Chairman and current board member of Israel Advanced Technology Industries (IATI), the largest umbrella organization representing Israel’s life science and high-tech industries. Mr. Yanay founded over the years several activities and organizations to promote and support the Israeli life science industry. Before joining Pluri, Mr. Yanay was the Chief Financial Officer of Elbit Vision Systems Ltd. a public, machine vision, high-tech company. Prior to that Mr. Yanay served as manager at Ernst & Young Israel. Mr. Yanay holds a bachelor’s degree with honors in business administration and accounting and is a Certified Public Accountant in Israel.
1. Pluri [NASDAQ: PLUR] is an innovative biotechnology company with unique flexibility to work across major sectors including regenerative medicine, foodtech and agtech fields. What is unique to Pluri’s technology that allows it to take a leading position in cell-based solutions?
Pluri’s innovation stems from our proprietary cell expansion technology that is supported by 140 patents and, by design, offers unique flexibility of purpose that allows us to develop solutions for some of humanity’s greatest challenges. Our proprietary 3D cell expansion technology mimics the cell’s natural environment by giving it the exact conditions it needs in order to expand and multiply, in a completely automated and controlled environment. By changing these conditions, we can grow different cell types and offer different cell-based solutions for multiple industries. For example, our biopharmaceutical research and development program for cell-based regenerative medicines is targeting acute radiation, inflammatory, and hematology conditions, and we are also hastening drug candidates to market through CDMO services. Our technology is also applicable to producing cost-effective, sustainable, and scalable cell-based cultivated meats, foods (like chocolate), and coffee products that reduce environmental impact and simplify logistics through predictable supply.
2. How does Pluri’s technology play a role in mitigating climate change and the anticipated agricultural crisis stemming from reduced availability of suitable land and other resources?
Our technology confronts the forthcoming agricultural crisis stemming from global warming by bringing the farm indoors and reducing the physical and environmental resources footprint needed to produce predictable, high-quality commodities that face increasing price and supply volatility. For example, at our coffee subsidiary Coffeesai, our 3D cell-expansion bioreactor system mimics the ideal growing conditions for coffee and requires only coffee plant leaves to produce the same amount of ground coffee as produced by 1,000 plants. We can also produce that same quantity of coffee in only three weeks compared to the much longer, traditional growing season.
This approach delivers authentic ground coffee through a process that slashes water usage across the entire supply chain by 98 percent, while also significantly reducing the footprint, time, and resources needed for traditional coffee cultivation. The state-of-the-art patented technology integrates cellular agriculture, eco-efficiency, and scalability to create cell-based coffee.
Similarly, our cultivated meat subsidiary, Ever After Foods, is using our technology to meet the demands of a growing world population, and we have several partnerships with international corporations who are exploring how our technology can produce other widely needed vegetable, grain, meat, and beverage ingredients.
3. You recently announced a $6.5 million strategic private investment and subsequent for 71 percent acquisition in Kokomodo payable in $4.5 million company common shares. What made Kokomodo a good fit with Pluri and how will you integrate it into your business model?
We believe that there are great synergies between Kokomodo’s advancements in cell line development specific to cacao and our ability at Pluri for industrial-scale production and supply chain logistics. Our acquisition of a leadership stake in Kokomodo will help us to set new benchmarks in cultivated cacao technologies and grow our ability at Pluri to demonstrate the value and importance of cultivated food production across different commodity and ingredient lines to meet the needs of our global population.
4. While Pluri has launched subsidiaries in cultivated meat (Ever After Foods), cell-based coffee (Coffeesai), and now will take a leadership position in cell-based cacao production, you also partner with large, international companies to research and scale other in-demand commodities and ingredients, on top of providing CDMO services to biopharmaceutical companies. How do you select your partners and what is key to offering scalable solutions?
At Pluri, we have over 20 years’ experience in developing and manufacturing cell therapies and cell-based products, and that experience and knowledge informs everything we do for our customers and for our partners. When it comes to partnerships, we seek out large and small companies similarly committed to innovation as the driving force to create valuable, marketable, but also, sustainable cell-based products that meet the needs of our growing population during a time of climate change.
At Pluri, we have over 20 years’ experience in developing and manufacturing cell therapies and cell-based products, and that experience and knowledge informs everything we do for our customers and for our partners. When it comes to partnerships, we seek out large and small companies similarly committed to innovation as the driving force to create valuable, marketable, but also, sustainable cell-based products that meet the needs of our growing population during a time of climate change.
5. What are the most critical factors when scaling up from early-stage clinical studies to late-stage development in cell therapy?
Cell-based therapy, as a therapeutic category, is still fairly new, which is why few companies can bring their products from early-stage development through commercialization without specialized technology support and expertise.
While early-stage clinical cell therapy manufacturing can be completed in a laboratory setting using research lab equipment to manufacture the small number of doses for a small initial clinical trial, larger scale Phase II, III and commercial -scale manufacturing demands a closed manufacturing process with minimal manual intervention and increased automation. Validation and outside auditing also is required to provide important data points to international regulating bodies. Hence, when companies progress to this stage, outsourcing to a CDMO, like Pluri, to avoid the immense investment in highly sophisticated machinery that requires specialized expertise becomes essential.
6. With support from the U.S. National Institute of Allergy and Infectious Diseases (NIAID) and U.S. Department of Defense, Pluri is developing PLX-R18 as a potential novel treatment for hematopoietic complications of the acute radiation syndrome (H-ARS). Why is this treatment a priority and what have you learned so far?
Pluri is developing PLX-R18 as a novel treatment for hematopoietic complications of ARS (H-ARS), caused by exposure to life-threatening amounts of ionizing radiation that might occur during a radiological or nuclear accident, terrorist activities, or warfare. Amid heightened geopolitical tensions, the relevance of this therapy has never been more critical, offering a pioneering solution to mitigate the devastating effects of radiation exposure and bolster global health and security.
To date, PLX-R18 has demonstrated a 68% survival rate compared to placebo in clinical studies and a significant increase in three critical blood lineages: platelets, white blood cells, and red blood cells. Already, PLX-R18 has been granted both Orphan Drug Designation and Investigational New Drug approval by the U.S. Food and Drug Administration, underscoring its potential as a life-saving treatment.
7. What is the market opportunity for cell-based solutions and is Pluri positioned to capitalize?
From a biopharmaceutical perspective, there are more than 1,300 active studies on cell and gene therapies in development on ClinicalTrials.gov, demonstrating the appetite for innovative medicines that address unmet treatment needs. Further, the U.S. cell-therapy market was valued at around $2.9 billion in 2023 and is projected to reach $19.7 billion by 2033, a compound annual growth rate of 21.2% between 2024 and 2033. The numbers are even larger internationally, of course.
Considering that Pluri works across sectors, our opportunity to capitalize as a company and to provide benefit to communities worldwide is immense.
With more than twenty years of investment to understand and leverage the potential of cells through its proprietary, 3D bioreactor technology, Pluri™ is pushing the boundaries of science and engineering to create cell-based products for commercial use, leading a biotech revolution that promotes global well-being and sustainability. The technology pioneered by Pluri allows us to work across diverse sectors to create and partner with companies working on cell-based regenerative medicines and cultivated food and beverage products that meet the needs of a growing population impacted by climate change.
