VALBIOTIS

Regulatory News:

Valbiotis (FR0013254851 – ALVAL, PEA / SME eligible), a Research and Development company committed to scientific innovation for preventing and combating metabolic and cardiovascular diseases, is accelerating its marketing strategy.

Sébastien PELTIER, Chairman of the Valbiotis Board of Directors, states: "Today, we are embarking on a complementary development cycle to commercialize our innovative active substances, with the aim of providing breakthrough solutions for reducing the risk factors of cardio-metabolic diseases. Our new strategy aims to accelerate the growth of Valbiotis and to boost its capacity for innovation using two main levers: firstly, the signing of international partnerships (global or regional) with major players in the nutrition and healthcare sectors, supported by the specialist firm AEC Partners¹, and secondly, the company's own marketing of its products on the French market. This dual strategy, creating value, will enable Valbiotis to rapidly target the global food supplement market, estimated at 250 billion euros in 2025, with annual growth of 9.6%, including 3.2 billion euros for France, with annual growth of 7.3%². The exponential demand for natural, non-drug preventive products, market studies³ conducted with healthcare professionals and patients/consumers, combined with our recent positive Phase II clinical results for TOTUM•070, have led us to adapt our marketing strategy."

Committed to preventing and fighting metabolic and cardiovascular diseases through the development of unique combinations of plant-based molecules since 2014, Valbiotis now has a portfolio of four active substances in late-stage development with TOTUM•63 in prediabetes, TOTUM•070 in LDL hypercholesterolemia ("bad cholesterol"), TOTUM•854 in the reduction of blood pressure, and TOTUM•448 in the management of metabolic liver disease (NAFL and NASH). This solid pipeline of four products with proven efficacy based on preclinical and clinical data is the result of eight years of sustained R&D activities. Today, Valbiotis is entering a new phase of its development focused on revenue generation and structuring the Company to give this product portfolio every chance of success on a global scale.

Organization around three strategic priorities for Valbiotis

• First, the search for international licensing or distribution agreements for TOTUM•070, TOTUM•448 and TOTUM•854 with major nutrition and health players, in addition to the global strategic partnership already signed for TOTUM•63 in February 2020 with Nestlé Health Science. This key activity is supported by AEC Partners, the firm that has already worked on the partnership with Nestlé Health Science on behalf of Valbiotis, and by the creation of an internal business development and co-leadership team.
• Second, the direct marketing in France of TOTUM•070, TOTUM•448 and TOTUM•854 will ensure that Valbiotis can rapidly and independently develop its turnover and maximize its profitability in the medium term.
• Third, Valbiotis will continue its structuring to secure the supply chain for future commercializations, and will maintain its research efforts to prepare tomorrow's pipeline and complete clinical processes to obtain proprietary health claims for the majority of them.

Marketing of the TOTUM active substances prior to obtaining these proprietary health claims will allow to address significant needs, currently not appropriately met, in the prevention of cardio-metabolic diseases as soon as possible. In the United States and Europe alone (TOP 5⁴), 174 million adults are affected by moderate hypercholesterolemia, 124 million by moderate elevated blood pressure and 130 million by metabolic liver disease⁵. In these target populations, the demand for both effective preventive products and plant-based substances is driven by powerful underlying trends.

Internationally, the signing of licensing or distribution agreements
With its portfolio of four TOTUM active substances that have demonstrated their efficacy in these widely occurring pathologies, Valbiotis is confident in its ability to enter into licensing or distribution agreements with major nutrition and healthcare players in the near future, with a view to marketing them internationally. The consulting firm AEC Partners is supporting Valbiotis in this search for new large-scale partnerships, following the one signed in February 2020 with Nestlé Health Science worldwide for TOTUM•63, now in the final phase of clinical studies (Phase II/III). The new licensing or distribution partnerships will be global (except for France) or regional. Valbiotis' ambition is to finalize the signature of international licensing or distribution agreements for TOTUM•070 by the second half of 2023.

In France, the deployment of a direct marketing model
In France, apart from TOTUM•63 which benefits from a 100% worldwide partnership with Nestlé Health Science, the other three active substances will be marketed directly by Valbiotis. The marketing strategy will be based on in-house medical promotion officers (APMs) who will focus on key prescribers such as general practitioners, certain specialists and pharmacists. The latter will recommend the TOTUM active substances based on the cardiometabolic profile of their patients. At the same time, consumers/patients will be targeted directly through an adapted digital marketing strategy. The distribution channels envisaged will be pharmacies, drugstores and online sales.

TOTUM•070, whose Phase II clinical study was highly successful, will be the first product marketed by Valbiotis in France. It is scheduled to be launched in the first half of 2024, followed by TOTUM•448 and TOTUM•854 in 2024-2025.

Continued structuring and research efforts
The third strategic priority is to continue structuring the company with the aim of optimizing the value chain for the supply of TOTUM•63, as provided for in the contract with Nestlé Health Science, but also to develop capabilities for the other products in the portfolio.

At the same time, innovation efforts will continue. Valbiotis' proprietary R&D platform, specifically designed for plant research, will remain at the heart of the company's DNA, in order to feed the pipeline of the coming years, including the exploration of micro-algae produced in New Caledonia, through an exclusive agreement with ADECAL-Technopole and IFREMER (press release of September 24, 2021).

The execution of the strategy will be financed by Valbiotis' cash flow and the expected revenues from the partnership with Nestlé Health Science (which has already generated 8 million euros in cash since its signature). It is also conditional on obtaining additional financing, the terms of which are currently being studied.

About Valbiotis
Valbiotis is a Research & Development company committed to scientific innovation for preventing and combating metabolic and cardiovascular 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, relying on a multi-target strategy enabled by the use of plant-based terrestrial and marine resources.

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) – and a subsidiary in Quebec City (Canada).

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
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 the Valbiotis Universal Registration Document filed to the French Financial Markets Regulator (AMF) on May 19, 2022. This document is 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, or a solicitation to purchase or subscribe to Valbiotis’ shares or financial securities in any country.

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¹ AEC Partners: a life sciences firm specializing in market access, licensing and strategy consulting.
² Panorama of the food supplements market 2020-2021, Nutrikeo.
³ Medical-marketing studies conducted in 2022 by IFOP and A+A at the request of Valbiotis, in France, Germany and the United States.
⁴ France, Germany, Italy, Spain, United Kingdom
⁵ Elevated LDL, pre-HTA and NAFL preliminary market estimation, AEC Partners, 2020

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