Valbiotis

Regulatory Filings • Jun 17, 2024

Press release

Valbiotis invited to present clinical results from the TOTUM•63 Phase II/III REVERSE-IT study in prediabetes and type 2 diabetes at the American Diabetes Association's 84th Scientific Sessions

• • Being invited to deliver an oral presentation at the world's leading diabetes congress (June 21-24) is a clear indication of clinical recognition.
• • Valbiotis has also been invited to present the results of the TOTUM•63 mode-of-action clinical study carried out with Laval University's Institute of Nutrition and Functional Foods (INAF), in association with the Institut Universitaire de Cardiologie et de Pneumologie de Québec (IUCPQ).
• • All these clinical data position TOTUM•63 as a non-drug, 100% plant-based innovation, unique in the fight against type 2 diabetes, helping the millions of people currently affected.

La Rochelle, le 17 juin 2024 (5:40 p.m. CEST) - Valbiotis (FR0013254851 – ALVAL, éligible PEA / PME), laboratoire français de recherches scientifiques, spécialisé dans l'élaboration et la commercialisation de compléments alimentaires pour la prévention et la lutte contre les troubles métaboliques à l'origine des maladies cardiovasculaires, announces that it has been invited to present the clinical results of the TOTUM•63 Phase II/III REVERSE-IT study in prediabetes and type 2 diabetes at the American Diabetes Association's 84th Scientific Sessions.

Full results from the Phase II/III REVERSE-IT study were published on September 11, 2023 (press release), highlighting TOTUM•63's remarkable efficacy against prediabetes and the early stages of type 2 diabetes.

Samy HADJADJ, Professor of Endocrinology, Diabetology and Metabolic Diseases, Hospital Practitioner at Nantes University Hospital and scientific advisor for the REVERSE-IT study, comments: "Data from the REVERSE-IT study illustrate the efficacy of TOTUM•63 on glucose homeostasis, right down to reducing glycated hemoglobin, which is an accepted biomarker for microvascular risk used in diabetes monitoring. Achieving such results in a population at a very early stage is a major clinical challenge. The availability of a clinically proven product that can be widely used as a preventive or early treatment option to limit the incidence of type 2 diabetes, a chronic disease which often has severe long-term complications and a major impact on patient quality of life, is extremely promising."

Valbiotis has also been invited to present the results of the TOTUM•63 mode-of-action clinical study carried out with the Institute of Nutrition and Functional Foods at Laval University, in association with the Institut Universitaire de Cardiologie et de Pneumologie de Québec. The results of this study, marking the final stage in TOTUM•63's clinical development, were released on November 7, 2023 (press release).

André MARETTE, Professor at the Faculty of Medicine, Laval University (Quebec) and researcher at the IUCPQ and INAF, explains: "We are very proud to have the chance to present these exciting results to the scientific community and diabetes specialists meeting in Orlando for the world's leading diabetes congress. Being invited to this prestigious event underscores the tremendous value of the clinical data collected on TOTUM•63. By focusing on understanding the mode-of-action of TOTUM•63, we have been able to demonstrate that the product exerts its beneficial effects through a multi-target effect in subjects at risk of type 2 diabetes, boosting the efficacy of energy metabolism, particularly after meals. The study's confirmation of efficacy on glycated hemoglobin rounds off TOTUM•63's exemplary clinical trajectory".

About Valbiotis

Valbiotis is a French scientific research laboratory specializing in the development and marketing of dietary supplements for preventing and combating metabolic disorders causing cardiovascular disease,

Valbiotis has adopted an innovative approach, aiming to revolutionize healthcare by developing a new class of health nutrition products designed to reduce metabolic disorders and cardiovascular risk factors, relying on a multi-target strategy enabled by the use of plant-based resources.

In France, Valbiotis is responsible for its own sales and marketing. Internationally, Valbiotis' products are the subject of licensing agreements.

Created at the beginning of 2014 in La Rochelle, the Company has forged numerous partnerships with leading academic centers. Valbiotis is a member of the "BPI Excellence" network and has been recognized as an "Innovative Company" by the BPI label. Valbiotis has also 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

Contacts

Corporate communication Valbiotis +33 5 46 28 62 58 media@valbiotis.com

Financial communication Seitosei Actifin Marianne PY +33 1 80 48 25 31 marianne.py@seitoseiactifin.com

Médias relations Agence Monet Victoire BEAU Alexandra DUNANT Mélanie DA RUI PONS +33 1 45 63 12 43 valbiotis@monet-rp.com

Name: Valbiotis ISIN code: FR0013254851 Ticker symbol : 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 Valbiotis at the present time. However, in no way does this constitute a guarantee of future performance, and these projections may be affected by changes in economic conditions and financial markets, as well as certain risks and uncertainties, including those described in Valbiotis' Universal Registration Document filed́ with the Autorité́ des marchés financiers (AMF) on April 26, 2023, under No. D.23-0347 as well as its Amendment filed with the AMF on December 11, 2023, under No. D. 23-0347.A01, available on the Company website (www.valbiotis.com). This press release and the information it contains do not constitute an offer to sell or subscribe, or a solicitation to purchase or subscribe to Valbiotis' shares or financial securities in any country.