Valbiotis announced the implementation of the TOTUM•63 mode of action clinical study by the Institute of nutrition and functional foods (INAF) at Laval University in Quebec City, in partnership with Nestlé Health Science. This study, co-designed by Valbiotis in conjunction with INAF and Nestlé Health Science experts as part of the global strategic partnership, will include 20 volunteers and will explore the mechanism of action of TOTUM•63 in humans. It will provide additional data to strengthen the scientific communication and support the commercialization of TOTUM•63. Scheduled to begin in the 4th quarter of 2021, it will be conducted under the scientific supervision of André MARETTE, Professor at the Laval University Faculty of Medicine and researcher at INAF. The TOTUM•63 mode of action clinical study will explore, in humans, the main mode of action hypotheses resulting from preclinical work. It will include 20 overweight or obese volunteers with associated metabolic abnormalities. With a large number of scientific objectives, the protocol will evaluate the effect of TOTUM•63 administration for 8 weeks on numerous mechanistic parameters involved in the pathophysiology of prediabetes and type 2 diabetes, through in-depth physiological investigations: mainly intestinal absorption of nutrients, metabolomics, inflammation, composition of the intestinal microbiota and gastrointestinal hormones (incretins, including GLP-1). The study, designed to boost the scientific and commercial value of TOTUM•63, is part of the development plan established with Nestlé Health Science under the global strategic partnership for TOTUM•63. It will be the subject of milestone payments, dedicated in particular to its financing. Its launch is planned for the fourth quarter of 2021. To support this scientific collaboration and the development of Valbiotis' R&D activities in North America, the Company is opening a subsidiary, with a full-time employee responsible for scientific coordination starting in September. The research project carried out under this collaboration will be eligible for the Canadian Scientific Research and Experimental Development (SR&ED) program (system equivalent to the French research tax credit). About INAF: Created in the early 2000s to address the challenges of sustainable nutrition and the prevention of metabolic diseases, INAF brings together some 100 researchers in bio-food, health and social sciences from 14 universities and scientific institutions in Québec. Its multidisciplinary approach and the quality of the projects it coordinates have earned it a reputation for scientific excellence on the North American continent. About TOTUM•63: TOTUM•63 is a unique and patented combination of 5 plant extracts that targets the pathophysiological mechanisms of type 2 diabetes. TOTUM•63 has already been shown to be safe and effective in healthy volunteers in a Phase I/II clinical study. Results from a randomized, placebo-controlled, international Phase II study showed that when compared to the placebo, TOTUM•63 reduced fasting blood glucose and 2-hour blood glucose levels, two risk factors for type 2 diabetes. In these subjects, who were also abdominally obese, TOTUM•63 also significantly reduced body weight and waist circumference. TOTUM•63 benefits from intellectual property validated by patents in the world's leading markets: Europe (covering 39 countries), the United States, Russia, China, Japan, Mexico, Indonesia, Israel, South Africa, New Zealand and national phases are still underway in a dozen other countries including Brazil and Australia. Production capacity for TOTUM•63 has been validated in accordance with North American and European standards. TOTUM•63 already has marketing authorizations related to its status in Europe. In February 2020, Valbiotis signed a long-term global strategic partnership with Nestlé Health Science for the development and worldwide commercialization of TOTUM•63. This unique partnership in the field of Health Nutrition foresees the marketing of TOTUM•63 by Nestlé Health Science on a worldwide scale, possibly before obtaining a medical clearance depending on the area. They will also fund the final stages of development of TOTUM•63.