VALBIOTIS
10.1.2023 07:36:41 CET | Business Wire | Press release
Regulatory News:
Valbiotis (FR0013254851 – ALVAL, PEA / SME eligible), a commercially oriented Research and Development company committed to scientific innovation for preventing and combating metabolic and cardiovascular diseases, announces its roadmap for 2023. This year promises to be rich in strategic advances, with the completion of the clinical development of TOTUM•63 (prediabetes), the objective of signing a license and/or distribution agreement for TOTUM•070 (LDL hypercholesterolemia), and the preparation of commercial launches by 2024 for these two active substances.
On the R&D front, Valbiotis will continue its clinical development efforts for its plant-based active substances, to reinforce their scientific and medical value and obtain health claims. After the major success of the HEART Phase II clinical study in 2022, which demonstrated the efficacy of TOTUM•070 against excess LDL cholesterol in the blood (press releases of June 13, 2022 and October 3, 2022), 2023 will be marked by expected clinical advances, in particular for TOTUM•63, against prediabetes:
- The first major milestone, before the end of the first half of the year, will be the clinical results of Phase II/III REVERSE-IT, a large pivotal study conducted on 600 people with the primary endpoint of reducing fasting blood glucose levels with TOTUM•63. These results will represent the final step before marketing and the filing of a health claim. In parallel, clinical results on the mode of action of TOTUM•63 will be obtained and communicated this year.
- For TOTUM•854, a major milestone should be reached at the end of the first half of the year with the completion of enrollment in the first Phase II/III clinical study (INSIGHT studies) for blood pressure reduction. The results of the clinical bioavailability and mode of action study will be known early in the year.
- The latest clinical advance announced for 2023 is the launch of a clinical study with TOTUM•448 against the early stages of metabolic liver disease, or "fatty liver disease", which is growing rapidly worldwide.
Alongside these R&D advances, Valbiotis will accelerate the commercialization strategy announced last October (press release of October 7, 2022), based on two main priorities:
- Structuring the Company to support the global strategic agreement signed with Nestlé Health Science for TOTUM•63 and to conclude future licensing and/or distribution partnerships for TOTUM•070, TOTUM•448 and TOTUM•854.
- Direct marketing in France of TOTUM products (except TOTUM•63) in pharmacies, drugstores and via a dedicated e-commerce site.
On the industrial and manufacturing processes front, which are essential for supporting strategic partnerships and marketing active substances in France, Valbiotis is continuing to develop galenic forms and to set up the supply chain, from the sourcing of plant raw materials to market launch, with the internalization of specific skills.
A dedicated team has been set up to look for new agreements worldwide (except in France), bringing together AEC Partners and Valbiotis' Business Development department. At the heart of the first partnership with Nestlé Health Science concluded in February 2020, AEC Partners has already identified a panel of global or regional players in the world of health and nutrition and initiated the first exchanges. The goal remains the signature of a partnership for TOTUM•070 by the second half of 2023.
With regard to direct marketing in France, the second major focus of the strategy, Valbiotis is gearing up for the launch of TOTUM•070 in the first half of 2024, to be followed by TOTUM•448 and TOTUM•854. Market research with healthcare professionals and consumers has helped establish the commercial strategy, combining medical recommendation and open access for consumers. This strategy is based on in-house medical promotion officers (MPOs), whose main focus is on key prescribers such as general practitioners, certain specialists and pharmacists, and on an e-commerce site that is scheduled to go online in the first half of 2024.
Valbiotis enters this new fiscal year with a strengthened financial position thanks to the success of the recently finalized fundraising (press release of November 9, 2022), for an amount of 9.7 million euros (€M).
Sébastien PELTIER, Chairman of the Valbiotis Board of Directors, states: "After years devoted to R&D and the clinical advancement of our plant-based active substances, we are embarking on a new phase of development designed to make the most of our TOTUM products and rapidly generate sales. This goal is based on a two-pronged strategy: local, with our own revenues from direct marketing in France, and international, with worldwide revenues generated by partnerships. The year 2023 will bring us major clinical results for TOTUM•63, in particular for the Phase II/III REVERSE-IT study, the last step before market launch and health claim application. In 2023, we will also complete the first steps of our strategic acceleration with the signature of a license and/or distribution agreement for TOTUM•070, while we continue to structure the Company and ramp up our industrial operations to prepare for the launch of TOTUM•070 in France and the delivery of the first commercial batches of TOTUM•63 by the first half of 2024. With a consolidated financial situation thanks to the recent fundraising and a product portfolio with a high level of scientific evidence in the prevention of metabolic and cardiovascular diseases, Valbiotis is equipped to achieve its goals in the fast-growing food supplement market in France and abroad, estimated at €272 billion in 2028 1."
About Valbiotis
Valbiotis is a commercially oriented 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 and completed by an amendment on November 8, 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.
1www.grandviewresearch.com/industry-analysis/dietary-supplements-market
To view this piece of content from cts.businesswire.com, please give your consent at the top of this page.
View source version on businesswire.com: https://www.businesswire.com/news/home/20230109005534/en/
About Business Wire
Subscribe to releases from Business Wire
Subscribe to all the latest releases from Business Wire by registering your e-mail address below. You can unsubscribe at any time.
Latest releases from Business Wire
IQM and Real Asset Acquisition Corp. to Host Conference Call/Webcast to Discuss Proposed Transaction27.2.2026 13:00:00 CET | Press release
IQM Finland Oy, a global leader in full-stack superconducting quantum computers (“IQM”, “IQM Quantum Computers” or the “Company”), and Real Asset Acquisition Corp. (Nasdaq: RAAQ), a special purpose acquisition company (“RAAQ”), announced that they will host a conference call to discuss their recently announced business combination, including certain transaction highlights. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260227472716/en/ IQM Radiance quantum computer As previously disclosed, on February 23, 2026, IQM and RAAQ announced they have entered into a definitive business combination agreement, which will result in IQM becoming a public company and listing American Depositary Shares on one of the two leading U.S. stock exchanges. The transaction provides funding with the aim to accelerate IQM’s technology and commercial development towards fault-tolerance quantum computing, further advancing its position as a leading p
HighRadius Launches $0 Implementation Fee, $0 Subscription Fee via Outcome Based Pricing for oCFO Software27.2.2026 12:00:00 CET | Press release
HighRadius launches Office of the CFO first Outcome Based Pricing with $0 Implementation fee and $0 Subscription until Go-Live. Customers only pay a fraction of realized gains based on P&L impact. Chapter 1: Outcome Based Pricing (OBP)Introduction of OBP: HighRadius, a provider of 190+ AI agents for Order-to-Cash, Accounts Payable, Record-to-Report, and Treasury introduces Outcome Based Pricing (OBP). Three Components of OBP: Customers pay a) $0 in Implementation fees, b) $0 in Subscription fees until Go Live, c) HighRadius earns a fraction of the actual savings realized by the client. Chapter 2: US GAAP & ASC 606 ConstraintsNot Designed for Innovation: The traditional ASC 606 model requires companies to standardize and recognize revenue based on contractual obligations. For a traditional SaaS subscription, the obligation is access to software over time. AI agents are designed to deliver quantifiable, real-time Business Outcomes that do not fit the traditional accounting framework. Cha
Kioxia Appoints Yoshihiko Kawamura as Chief Financial Officer27.2.2026 09:15:00 CET | Press release
Kioxia Holdings Corporation (TOKYO:285A), a world leader in memory solutions, today announced the appointment of Yoshihiko Kawamura as Chief Financial Officer (CFO), effective April 1, 2026. Mr. Kawamura brings extensive international experience to Kioxia, having held assignments at Mitsubishi Corporation’s U.S. headquarters, served as General Manager of its Chicago office, and completed a tenure at the World Bank. At Hitachi, Ltd., he held senior leadership positions, including Chief Strategy Officer (CSO), Chief Financial Officer (CFO), and Chief Risk Management Officer (CRMO), where he was instrumental in leading the company’s management reforms. Since joining Kioxia as Executive Vice President in June 2025, Mr. Kawamura has worked closely with the executive team to advance the business through strategic capital and financial planning. Following its initial public offering on the Prime Market of the Tokyo Stock Exchange in December 2024, Kioxia is entering a new phase of growth char
DNP Invests in Rapidus to Support the Establishment of Mass Production for Next-Generation Semiconductors27.2.2026 08:18:00 CET | Press release
Will accelerate the development and mass production of EUV lithography photomasks Dai Nippon Printing Co., Ltd. (DNP, TOKYO:7912) today announced that it has participated in Rapidus Corporation’s funding round as one of the round investors. This strategic funding initiative supports Rapidus’ plan to steadily progress from its current R&D phase to mass production of 2nm (10⁻⁹ meters) logic semiconductors by 2027. Through this initiative, DNP will advance the development and mass production of EUV lithography photomasks and support Rapidus as it establishes a mass production system for 2nm & next-generation semiconductors. Background In recent years, the rise in energy consumption, in line with increased data generation, has become a challenge, driving demand for next-generation semiconductors capable of improving device performance and reducing power consumption. Next-generation semiconductors manufactured using EUV lithography enable the formation of finer patterns on silicon wafers co
EdgeConneX Looks to Enter Swedish Market as Part of European Data Center Expansion Strategy27.2.2026 08:05:00 CET | Press release
Planned data center campus in Skellefteå would support future AI and cloud infrastructure needs EdgeConneX®, an EQT portfolio company with an extensive Pan-European data center footprint, looks to expand its presence with a new site located in Skellefteå, Sweden. The data center site will be acquired from Lyten, a global company that specializes in lithium-sulfur batteries and energy storage. The site would support EdgeConneX broader strategy to expand digital infrastructure capacity across the Nordics. Subject to the completion of applicable administrative and regulatory processes, EdgeConneX will look to develop a data center campus with potential capacity of up to one gigawatt in support of future AI and cloud computing workloads. Upon completion, the data center campus would be one of the largest facilities in Europe that would be primarily powered by renewable energy. “Sweden represents an attractive long‑term market for digital infrastructure investment. The country’s access to r
In our pressroom you can read all our latest releases, find our press contacts, images, documents and other relevant information about us.
Visit our pressroom