VALBIOTIS
14.4.2021 17:42:06 CEST | Business Wire | Press release
Regulatory News:
Valbiotis (Paris:ALVAL) (FR0013254851 – ALVAL, PEA-PME eligible), a Research & Development company committed to scientific innovation for preventing and combating metabolic diseases, today announces the launch of a capital increase within the context of a private placement through an accelerated bookbuilding process for an amount of approximately 12 million euros. This capital increase, with the removal of shareholders’ preferential subscription rights in favor of a category of persons, will be reserved exclusively for qualified investors as referred to in article 2(e) of Regulation (EU) 2017/1129 of June 14, 2017.
Reasons for the offer
The net proceeds of the capital increase are intended primarily to finance the acceleration of the development of TOTUM•854 (prevention of arterial hypertension) with the launch of three clinical trials at the end of this year including a Phase II/III clinical trial, prior to a health claim application. In partnership with a major healthcare player, TOTUM•854 could then be marketed at the end of this study, up to 3 years ahead of the initial schedule.
This acceleration comes in the wake of the positive preclinical results obtained with this active substance, presented at the annual ESH – ISH congress (press release of April 12, 2021 ) and available on the Company website (www.valbiotis.com/en ). These results obtained in vivo on predictive models of human hypertension have shown that TOTUM•854 effectively prevents arterial hypertension, considered as the number one chronic disease worldwide with over 124 million people with moderately high blood pressure in the United States and the 5 main European countries (Germany, Spain, France, Italy, and the United Kingdom) alone. This represents an addressable market for Valbiotis worth an estimated 1.15 billion euros (source: AEC Partners, 2020).
The capital increase will also help to extend Valbiotis' funding horizon and enable the Company to reach the next steps in value creation of its various products:
- funding of preclinical research on the other products in the portfolio;
- reinforcement of staff, mainly clinical and supply chain teams, to prepare the upcoming marketing of TOTUM•63 in prediabetes by Nestlé Health Science;
- financing the Company’s overall costs until summer 2023.
Conditions of the offer
The transaction consists in a private placement and will be undertaken with the removal of shareholders’ preferential subscription rights in favor of a category of persons by using the delegation granted by the Shareholders’ Annual General Meeting held on May 28, 2020 (13th resolution). The issue price of the new shares will be determined in accordance with the said resolution.
The offer is reserved for “qualified investors” within the European Economic Area (including France) as defined in article 2(e) of Regulation (EU) 2017/1129 of the European Parliament and of the Council of June 14, 2017, and “Qualified Institutional Buyers” in the United States as defined in Rule 144A of the U.S. Securities Act of 1933 ("Securities Act") or “Institutional Accredited Investors” as defined in Regulation D of the Securities Act, based on the exemption from registration under the Securities Act.
The private placement will be executed through an accelerated bookbuilding process, following which the number and price of the new shares issued will be determined.
The accelerated bookbuilding process will begin immediately and should be concluded before the opening of the markets on April 15, 2021.
Valbiotis will announce the outcome of the private placement as soon as possible after the closure of the bookbuilding process in a press release specifying in particular the final number of new shares issued and the issue price.
The settlement of the new shares issued within the context of the capital increase should take place within 3 business days following the closure of the capital increase.
Pursuant to Article 1(4) of Regulation (EU) 2017/1129, a Prospectus approved by the French Financial Markets Authority (AMF) will not be published for the issuances envisaged.
Within the framework of the transaction, Invest Securities and TP ICAP Europe will act as Global Coordinators, Leaders, and Bookkeepers of the private placement.
Warning
Valbiotis (the “Company") draws the attention of the public to:
- The risk factors presented in the registration agreement approved by the French Financial Markets Regulator (AMF) on 31 July 2020 (application number R 20-018) the annual financial report for the financial year ending December 31, 2020 and the half-year financial report for the period ending June 30, 2020 (these documents are available on the Company's website (www.valbiotis.com )); the materialization of any or all of these risks is likely to have a detrimental effect on the activity, financial situation, or the results of Valbiotis or on its ability to achieve its objectives.
- The main risks associated with the capital increase are the following:
- the market price of the Company shares may fluctuate and fall below the subscription price of the new shares;
- due to stock market fluctuations, the volatility and liquidity of the Company shares may vary significantly;
- the sale of Company shares may occur on the secondary market, after the capital increase, and have a negative impact on the Company share price;
- regarding the use of the expected proceeds of the issuance within the context of the present capital increase, the Company has room for maneuver as to the use of the funds raised and could use them in a way that the shareholders may not adhere to or that would not increase the value of their investment in the short term;
- a new market-based call by the Company, after the capital increase, could result in further dilution for the investors.
About Valbiotis
Valbiotis is a Research & Development company committed to scientific innovation for 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
Warning
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 mentioned in this press release. 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.
As a reminder, pursuant to the provisions of Article 211-3 of the General Regulations of the Autorité des marchés financiers and Article 1, 4 of Regulation (EU) 2017/1129, the offer of the Company's shares in the context of the capital increase carried out for the benefit of a category of persons meeting specific characteristics, in particular qualified French and international investors, will not give rise to a prospectus subject to the visa of the Autorité des marchés financiers .
Detailed information about Valbiotis, including its business, results and risk factors, has been presented in the annual financial report for the financial year ending December 31, 2020, in the half-year financial report for the period ending June 30, 2020 and in the registration agreement approved by the French Financial Markets Regulator (AMF) on 31 July 2020 (application number R 20-018). These documents, as well as other regulated information and press releases, can be consulted on the Company's website (www.valbiotis.com ).
This press release is for information purposes only. This press release does not constitute and shall not be deemed to constitute an offer to the public, an offer to subscribe, an offer to sell or a solicitation of interest to the public in connection with any transaction by way of public offering of securities in any jurisdiction.
Securities may be offered or sold in the United States only pursuant to registration under the U.S. Securities Act of 1933, as amended (the "Securities Act"), or pursuant to an exemption from such registration requirement. The securities of the Company that are the subject of this press release have not been and will not be registered under the Securities Act, and the Company does not intend to conduct a public offering of the securities that are the subject of this press release in the United States.
The release, publication or distribution of this press release in certain countries may violate applicable laws. The information contained in this press release does not constitute an offer of securities in France, the United States, Canada, Australia, Japan or any other country. This press release may not be published, transmitted or distributed, directly or indirectly, in the United States, Canada, Australia or Japan. This document does not constitute an offer to sell or a public offering of Valbiotis shares in the United States or in any other country.
View source version on businesswire.com: https://www.businesswire.com/news/home/20210414005616/en/
Link:
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
Bending Spoons S.p.A. announces pricing of initial public offering1.7.2026 01:56:00 CEST | Press release
Bending Spoons S.p.A. (“Bending Spoons”), a leading technology company, today announces the pricing of its initial public offering (“IPO”) at $29.00 per share. A total of 57,971,015 ordinary shares are being offered, of which 34,398,640 shares are being offered by Bending Spoons and 23,572,375 shares are being offered by certain selling shareholders (the “Selling Shareholders”). Bending Spoons will not receive any proceeds from any sale of shares by the Selling Shareholders. The shares are expected to begin trading on the Nasdaq Global Select Market under the ticker symbol “BSP” on July 1, 2026. The offering is expected to close on July 2, 2026, subject to customary closing conditions. In addition, Bending Spoons and the Selling Shareholders granted the underwriters an option to purchase up to an additional 5,244,026 ordinary shares from Bending Spoons and up to an additional 3,451,626 ordinary shares from the Selling Shareholders at the initial public offering price, less underwriting
FDA Issues Modified Risk Tobacco Product Orders for 20 ZYN Nicotine Pouch Products30.6.2026 18:19:00 CEST | Press release
FDA’s decision makes ZYN the first nicotine pouch product to receive MRTP orders authorizing reduced-risk claims versus cigarettes Philip Morris International Inc. (PMI) (NYSE: PM) today announced that the U.S. Food and Drug Administration (FDA) issued Modified Risk Tobacco Product (MRTP) orders for 20 variants of ZYN nicotine pouch products. These are the first MRTP orders granted for nicotine pouches, allowing PMI U.S. to market the following claim for the authorized ZYN products: “Using ZYN instead of cigarettes puts you at a lower risk of mouth cancer, heart disease, lung cancer, stroke, emphysema, and chronic bronchitis.” “FDA’s decision is an important moment for the more than 45 million legal-age nicotine consumers in America,” saidStacey Kennedy, PMI U.S. CEO. “Today’s news ensures these adultshave access to accurate, science-based information, including FDA-authorized evidence that switching from cigarettes to ZYN reduces the risk of smoking-related diseases like heart disease
Caidya Announces Strategic Combination with Simbec-Orion Bridging Early Scientific Insight and Global Clinical Execution30.6.2026 17:00:00 CEST | Press release
Caidya today announced a strategic combination with Simbec-Orion designed to close the divide between early scientific insight and global clinical execution. The combination of Caidya and Simbec-Orion creates a differentiated specialty clinical CRO platform that enables programs to scale, maintaining focus, speed, and accountability. The strategic combination brings together complementary strengths to create a more complete development partner for innovative biopharma companies. With established operations across Europe, the Americas, APAC, and China, the combined organization provides meaningful expertise and execution capabilities in the regions that matter most. Simbec-Orion brings early-phase clinical pharmacology capabilities alongside deep therapeutic expertise for later stage complex oncology and rare disease trials, helping sponsors shape critical decisions early in the development lifecycle. Together, the organizations strengthen their ability to support complex, cross-border
Archer® Proves Purpose-Built AI Beats General-Purpose LLMs on Regulatory Change Management: 95% Verified Accuracy, 80x Faster, 92% Lower Cost30.6.2026 16:13:00 CEST | Press release
In a head-to-head benchmark, a leading general-purpose LLM was confidently wrong 35% of the time on regulatory dates. Archer Evolv™ shipped zero errors. For enterprises deploying AI in compliance, a wrong date is a missed deadline. The more dangerous failure is a wrong answer the model returns with high confidence, one that flows silently into a compliance calendar and is only discovered after the window has passed. Archer® today released results showing purpose-built AI beats a general-purpose large language model (LLM) on regulatory work, and it’s not close. This head-to-head test compared Archer’s purpose-built, vertical-specific AI and proprietary data sets against a leading general-purpose LLM, on a core compliance task: determining the publication, effective and comment-close dates of regulatory documents across six jurisdictions. General-purpose models are a genuine breakthrough, and this is no referendum on their quality. The question Archer set out to answer is narrower and mo
Altasciences Supports Key Development Milestone for Steel Therapeutics’ Lead Therapeutic Candidate, Fizurex™30.6.2026 16:08:00 CEST | Press release
Altasciences, a leading drug development organization, today announced a significant milestone in the development of Steel Therapeutics, Inc.’s pivotal toxicology study for its lead product candidate, Fizurex™, for the treatment of anal fissures. The successful completion of the study plays a significant role in the advancement of Fizurex™ toward first-in-human trials. The GLP-compliant study demonstrated a favorable safety profile, which has advanced Steel Therapeutics' plans to submit an Investigational New Drug (IND) application for Fizurex™ to the FDA in Q3 2026. Fizurex™, a patent-pending, single-use topical wipe, was designed to provide a standardized, accessible treatment option for a painful and often undertreated medical condition. The product builds on years of use through compounding pharmacy prescriptions and is now advancing toward clinical development and regulatory review. "We are proud to have supported Steel Therapeutics with the generation of the high-quality safety d
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
