VALBIOTIS SA: Valbiotis announces positive results from the Cardio-Liver clinical study - Commercial launch of ValbiotisPRO® Foie on September 23

Press Release

Valbiotis announces positive results from the Cardio-Liver
clinical study

Commercial launch of ValbiotisPRO® Foie on September 23

• The Cardio-Liver study demonstrates positive effects on various metabolic parameters and, in particular, a reduction in liver fat content. It brings to a close the clinical development program of the active substance Steadrive®.

• ValbiotisPRO® Foie, based on the patented Steadrive® formulation, will be marketed from September 23 across all channels in France: pharmacies and e-commerce.
   
• The ValbiotisPRO® range now comprises four solutions dedicated to managing the risk factors of cardiometabolic imbalances, all based on clinically tested active substances.

La Rochelle, September 22, 2026 (5:40 PM CEST) - Valbiotis (FR0013254851 - ALVAL, PEA / PME eligible), a French laboratory specializing in cardiometabolic health, announces the completion of the Cardio-Liver clinical study. The results demonstrate the positive effects of Steadrive® (formerly Totum•448) in a context of excess liver fat associated with various metabolic disorders. These results enable the commercial launch of ValbiotisPRO® Foie in France, from September 23.

Cardio-Liver: positive results bringing the Steadrive® clinical program to a close

Cardio-Liver is a randomized, placebo-controlled, double-blind clinical study conducted in 71 volunteers presenting with hepatic steatosis (without significant associated fibrosis) and overweight or obesity. Participants were divided into two arms and supplemented for 4 months with either Steadrive® (4.28 g per day) or a placebo.

The results obtained confirm the positive effects of Steadrive® on the accumulation of fat in the liver as well as on various associated metabolic parameters. The Cardio-Liver study included a very large number of measurements, providing additional information on the effects of Steadrive® and its mechanisms of action in a context of hepatic steatosis. This study reinforces the entire body of data accumulated on Steadrive®, which has already been the subject of 4 publications in scientific journals and 14 communications at international congresses. Cardio-Liver, the detailed results of which will be presented at an international scientific congress, thereby completes the clinical development program of Steadrive®.

The study was conducted in partnership with Université Laval in Quebec City, within the framework of a Research Chair in "translational research on the mechanisms of action of plant-based compounds on metabolic hepatic steatosis", led by Professor André Marette.

André Marette, principal investigator of the study, full professor at the Faculty of Medicine of Université Laval and researcher at the Quebec Heart and Lung Institute (Institut universitaire de cardiologie et de pneumologie de Québec), said: "We are very pleased to have the first results of this clinical study on Steadrive®, which shows a reduction in the accumulation of liver fat and will also help us better understand the mechanisms of action involved. Indeed, the initial analyses highlight very promising results not only on the liver but also on the various metabolic parameters measured in the subjects of this clinical study. We now look forward to sharing more detailed data with the scientific community at an upcoming congress."

Pascal Sirvent, Medical and Scientific Director of Valbiotis, added: "The Cardio-Liver results reinforce the scientific data already accumulated around Steadrive® and confirm its value in the context of excess liver fat. They are consistent with Valbiotis's commitment to rigorous clinical research and further strengthen the scientific foundation underpinning the development of the ValbiotisPRO® range, dedicated to cardiometabolic health."

ValbiotisPRO® Foie: a natural, scientifically tested response to a major public health challenge

In France, nearly one adult in two is overweight with associated metabolic imbalances[1], and 20% of the population has an excessive accumulation of fat in the liver[2]. These imbalances remain insufficiently identified, even though early, appropriate prevention would help better preserve liver health.

This is precisely the challenge that ValbiotisPRO® Foie addresses. Based on Steadrive®, a patented plant-derived formulation backed by more than 10 years of research, it acts directly on liver health and fat metabolism. It thus provides support addressing various imbalances affecting liver function, ranging from digestive discomfort linked to an over-rich diet or occasional excess through to the chronic accumulation of fat in the liver.

A launch across all channels from September 23

ValbiotisPRO® Foie will be available from September 23 in pharmacies, in pillbox format, in pharmacies as well as on the online store www.valbiotis.com.

Its launch will draw on the multichannel commercialization approach deployed for the ValbiotisPRO® range: promotion to pharmacists and partner pharmacy groups, training of pharmacy teams, point-of-sale and shelf display materials, and targeted digital marketing campaigns.

A complete ValbiotisPRO® range, backed by leading scientific credentials

Following ValbiotisPRO® Cholestérol (May 2024), ValbiotisPRO® Santé métabolique (February 2025) and ValbiotisPRO® Cardio-circulation (June 2025), the launch of ValbiotisPRO® Foie completes, in line with the announced schedule, a range of four solutions dedicated to maintaining cardiometabolic balance, each based on an active substance with clinically demonstrated efficacy.

Backed by intellectual property covering more than 60 countries, this range benefits from an unrivalled clinical foundation (13 studies in total) and leading scientific validation, with 69 selections at benchmark international congresses and 17 scientific publications in international peer-reviewed journals.

The high point of this scientific recognition: the results of REVERSE-IT, a randomized study showing a significant reduction in fasting blood glucose after 6 months with Totum•63 (ValbiotisPRO® Santé métabolique), were published this past July in Nature Communications, a journal renowned for its editorial and methodological rigor (press release of July 22, 2026).

About Valbiotis

Valbiotis is a French laboratory specializing in the development and distribution of scientifically tested first-line nutritional solutions designed to prevent cardiometabolic imbalances. Through an innovative approach combining scientific excellence, plant expertise and a wealth of natural ingredients, Valbiotis develops high -quality formulations based on patented active ingredients validated by rigorous clinical studies, designed to provide long-term support for cardiometabolic health and address associated functional issues such as sleep, fatigue, mood management, immunity and vitality. Created at the beginning of 2014 in La Rochelle, France, Valbiotis 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 received major financial support from the European Union for its research programs via the European Regional Development Fund (ERDF). Valbiotis is a PEA PME eligible company.

Contacts

Corporate Communication / Valbiotis

Caroline LAMBERTI

+ 33 6 77 82 56 88

caroline.lamberti@valbiotis.com

Financial communication / Seitosei.Actifin 

Marianne PY

+33 6 85 52 76 93

marianne.py@seitosei-actifin.com

Press Relations / LJ Com by JIN

Valentine MARTIN

+33 6 32 29 43 82
v.martin@ljcom.net

Name: Valbiotis
ISIN code: FR0013254851

Ticker symbol: ALVAL

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This press release contains forward-looking statements regarding Valbiotis' objectives. Valbiotis considers that these projections are based on information currently available to Valbiotis and on reasonable assumptions. However, they in no way constitute guarantees of future performance and may be affected by changes in the economic environment, financial markets and by a number of risks and uncertainties, available on the Company's website (www.valbiotis.com).

This press release and the information it contains do not constitute an offer to sell or subscribe, nor the solicitation of an order to buy or subscribe for shares or financial securities of Valbiotis in any country.

[1] Ligue nationale contre l'Obésité — Observatoire Français d'Épidémiologie de l'Obésité (OFÉO), 2024 — overweight (30.8%) + obesity (17.9%) combined.

[2] Metabolic dysfunction-associated steatotic liver disease (MASLD/NAFLD) | SNFGE. (n.d.). Retrieved September 7, 2026.