Valbiotis Announces the Publication of the First Scientific Papers on TOTUM•63 in Three International Journals, Elucidating Its Multitarget Mode of Action

Regulatory News:

Valbiotis (FR0013254851 – ALVAL, PEA / SME eligible), a Research and Development company committed to scientific innovation for preventing and combating metabolic diseases, announces the first publication of preclinical and clinical Phase I/II data on TOTUM•63 in three peer-reviewed international scientific journals: the American Journal of Physiology-Endocrinology and Metabolism, the International Journal of Obesity and Nutrients. These papers bring together a first set of results from the development of this active substance for the reduction of the risk of type 2 diabetes. They represent a first and comprehensive elucidation of mechanisms of action, to prepare for further scientific communications as part of a strategy of TOTUM•63, developed in collaboration with Nestlé Health Science as part of the global strategic partnership. This plan includes the publication of all TOTUM•63 preclinical and clinical results to accompany subsequent marketing of this active substance.

Pascal SIRVENT, Chief Scientific Officer, member of the Valbiotis Board of Directors, comments: ‘These three publications by leading journals constitute a major scientific recognition of our R&D work on TOTUM•63 for the prevention of type 2 diabetes. They represent a very powerful endorsement of the TOTUM•63 results, already presented at international congresses, on carbohydrate homeostasis and weight, on the pleiotropic mode of action of this active substance on several tissues, and on its safety of use. New preclinical data on the benefit of TOTUM•63 in combination with physical activity has also been published. This first publishing success kicks off our scientific promotion strategy for this program, which is being carried out alongside our partner Nestlé Health Science and will lead to the comprehensive publication of the results obtained with TOTUM•63. This strategy reflects our high scientific standards. But above all, it is a decisive factor for the successful marketing of TOTUM•63 throughout the world.’

Hans-Juergen WOERLE, Chief scientific and chief medical officer at Nestlé Health Science, states: ‘Comprehensive scientific publications for TOTUM•63 ensure high scientific validity of the quality of results for this active substance. This is instrumental for a health product, where often times a comprehensive understanding of mechanisms are lacking, and will pave the way for anticipated use of TOTUM•63 in prediabetes and blood glucose disorders. We are delighted with these first publications, working alongside the Valbiotis teams and its highly reputable academic partners.’

First three publications in leading international peer-reviewed journals

The three papers have been accepted and published in the following three journals:

• The American Journal of Physiology, published since 1898 by the American Physiology Society, the main American scientific society dedicated to physiology and all its disciplines. 5-year Impact Factor: 4.209.

• The International Journal of Obesity, published by the Nature group, one of the world's most respected scientific publishers. It promotes the study of obesity through a multidisciplinary approach. 5-year Impact Factor: 5.336.

• Nutrients, a journal of the MDPI Group, a pioneer in online scientific publishing. It is supportedby a consortium of several national and international learned societies in the field of nutrition. 5-year Impact Factor: 5.089.

The research work on which these publications are based was carried out by the Valbiotis R&D platform and through close collaboration between the Company and its French and international academic partners. The University of Clermont Auvergne, the Clermont Auvergne Clinical Investigation Center (Centre d’investigation clinique Clermont Auvergne), La Rochelle University, Claude Bernard University in Lyon, INRA, INSERM, CNRS, Vanderbilt University in Nashville (USA) and Leiden University (Netherlands) are among the co-authors.

Citations:

- Chavanelle V et al., Effects of TOTUM•63 on glucose homeostasis and post‐prandial glycemia: a translational study, American journal of Physiology – Endocrinology and metabolism, 2021.
journals.physiology.org/doi/abs/10.1152/ajpendo.00629.2020

- Van der Zandea H. et al., Effects of a novel polyphenol-rich plant extract on body composition, inflammation, insulin sensitivity and glucose homeostasis in obese mice, International Journal of Obesity, 2021.
www.nature.com/articles/s41366-021-00870-x

- Dupuit M. et al., The TOTUM•63 Supplement and High-Intensity Interval Training Combination Limits Weight Gain, Improves Glycemic Control, and Influences the Composition of Gut Mucosa-Associated Bacteria in Rats on a High Fat Diet, Nutrients, 2021.
www.mdpi.com/2072-6643/13/5/1569

About TOTUM•63
TOTUM•63 is a unique and patented combination of 5 plant extracts, with high potential to target the physiopathological mechanisms of Type 2 Diabetes.
TOTUM•63 has already been proven safe and effective in healthy human volunteers during a Phase I/II clinical study. The results of the international randomized, placebo-controlled Phase II study showed that TOTUM•63 reduced fasting and 2-hour blood sugar levels, two risk factors for Type 2 Diabetes, in prediabetics compared to placebo. In these subjects, who also had abdominal obesity, TOTUM•63 significantly reduced body weight and waist circumference.
TOTUM•63 benefits from intellectual property granted in the main markets worldwide: Europe (covering 39 countries), the United States, Russia, China, Japan, Mexico, Indonesia, Israel, South Africa, New-Zealand and national phases are underway in more than 10 countries including Brazil and Australia. The ability to produce TOTUM•63 industrially, in compliance to North American and European standards, has been validated. TOTUM•63 already has marketing authorizations related to its status in Europe.
In 2020, Valbiotis has signed a global and long-term partnership with Nestlé Health Science for the development and worldwide commercialization of TOTUM•63. This unique partnership in the field of Nutrition Health plans that TOTUM•63 will be put on the market by Nestlé Health Science at a global level, possibly before obtaining a health claim, depending on the areas. It will also provide funding for the latest development stages of TOTUM•63.

About Valbiotis
VALBIOTIS is a Research & Development company committed to scientific innovation preventing and combating metabolic diseases in response to unmet medical needs.
VALBIOTIS has adopted an innovative approach, aiming to revolutionize healthcare by developing a new class of health nutrition products designed to reduce the risk of major metabolic diseases, based on a multi-target approach enabled by the use of plant-based ingredients.
Its products are intended to be licensed to players in the health sector.
Created at the beginning of 2014 in La Rochelle, the Company has forged numerous partnerships with leading academic centers. The Company has established three sites in France: Périgny, La Rochelle (17) and Riom (63).
Valbiotis is a member of the "BPI Excellence" network and has been recognized as an "Innovative Company" by the BPI label. Valbiotis has also been awarded "Young Innovative Company" status and has received major financial support from the European Union for its research programs via the European Regional Development Fund (ERDF). VALBIOTIS is a PEA-SME eligible company.
For more information about VALBIOTIS, please visit: www.valbiotis.com.

Name: Valbiotis
ISIN code: FR0013254851
Mnemonic code: ALVAL
EnterNext© PEA-PME 150

This press release contains forward-looking statements about Valbiotis' objectives. Valbiotis considers that these projections are based on rational hypotheses and the information available to the company at the present time. However, in no way does this constitute a guarantee of future performance, and these projections may be reconsidered based on changes in economic conditions and financial markets, as well as a certain number of risks and uncertainties, including those described in the Valbiotis registration document, approved by the French Financial Markets Regulator (AMF) on 31 July 2020 (application number R 20-018). This document is available on the Company's website (www.valbiotis.com).
This press release, as well as the information contained herein, does not constitute an offer to sell or subscribe to, or a solicitation to purchase or subscribe to, Valbiotis' shares or securities in any country.

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Contact information

Corporate communication / Valbiotis
Carole Rocher / Marc Delaunay
+33 5 46 28 62 58
media@valbiotis.com

Financial communication / Actifin
Stéphane Ruiz
+33 1 56 88 11 14
sruiz@actifin.fr