From GlobeNewswire: 2025-03-27 22:30:00

DBV Technologies secured a financing of up to $306.9 million to advance the Viaskin Peanut program until the Biologics License Application (BLA) submission and ensure product commercialization in the U.S., pending BLA approval. The funding includes an initial payment of $125.5 million and up to an additional $181.4 million with full exercise of subscription warrants. The Phase 3 VITESSE study aims to fast-track the BLA submission for the Viaskin Peanut patch in children aged 4-7 years, with potential FDA approval. The financing will lead to a 22.4% immediate dilution and up to 73.7% maximum dilution for existing shareholders if all warrants are exercised.

DBV Technologies announced a financing of up to $306.9 million, with $125.5 million to be received at the transaction’s close and up to $181.4 million if all subscription warrants are exercised, subject to certain conditions. The funding will support the Viaskin Peanut program’s development, including preparing and filing the Biologics License Application and launching the product for children aged 4-7 years, pending FDA approval. If successful, the Phase 3 VITESSE study will trigger an acceleration of certain subscription warrants exercise. The financing will result in immediate 22.4% dilution and up to 73.7% maximum dilution for existing shareholders.

DBV Technologies is progressing with the Viaskin Peanut program thanks to a significant capital increase. The study aims to offer the Viaskin Peanut patch to patients sooner than expected, with a focus on children aged 4-7 years. The recruitment of 654 subjects enhances the study’s statistical power to over 90%, increasing the likelihood of success. With results expected in the fourth quarter of this year, DBV looks forward to advancing its programs to address the unmet medical needs of families with food allergies. Avec un financement mené par plusieurs investisseurs majeurs, l’émission d’actions nouvelles et de bons de souscription par la Société vise à lever environ 106,3 millions d’euros. Les fonds seront principalement utilisés pour le programme VIASKIN Peanut et la préparation d’un lancement potentiel aux États-Unis. La trésorerie actuelle ne couvre pas les besoins opérationnels, avec une estimation de 102,4 millions d’euros nécessaires pour les 12 prochains mois. Si tous les bons sont exercés, la Société pourrait étendre son horizon de trésorerie jusqu’en 2028. Des ajustements pourraient être nécessaires en cas d’échec à atteindre les objectifs de financement. Advisors LP and Bpifrance Participations SA representative did not vote on decisions at the March 27, 2025 Board meeting. The subscription price for ABSA is 1.1136 euros per ABSA, including a premium of 1.37% compared to the Reference Price of the Share. The exercise price per BSA is 1.5939 euros, and for PFW-BS-PFW, the price is equal to the First Pre-Financed Price at issuance. BSA holders can subscribe to new shares starting from issuance until April 7, 2035. No fractional shares will be issued upon exercise. BSA characteristics include detachment from new shares upon issuance and exercise flexibility until April 7, 2027, or after study success announcement. An exercise of one (1) BSA will give the right to subscribe to one point seventy-five (1.75) shares issued from the BSA at a price of 1.5939 euros per BSA. No fraction of a share will be issued upon the exercise of a BSA. The key characteristics of the subscription warrants are that they will be detached from the Pre-Financed First BSA upon issuance. The exercise of a Subscription Warrant will allow the holder to subscribe to a Second Pre-Financed BSA giving the right to subscribe to one point seventy-five (1.75) shares issued from the Second Pre-Financed BSA. Various stakeholders including Baker Brothers Investment, Bpifrance Participations, Suvretta Capital, and MPMBio Impact are participating in the offer. The closing of the offer is expected to take place around April 7, 2025, subject to customary closing conditions. The shares offered will be admitted to trading on Euronext Paris. Please note that the securities offered in this transaction are not part of a public offering and have not been registered under the Securities Act of 1933, as amended. DBV Technologies a signé des contrats de souscription avec des investisseurs, convenant de déposer une déclaration d’enregistrement à la SEC pour la revente des Actions Nouvelles, des BSA et autres. L’Offre impacte les capitaux propres et la structure de l’actionnariat, avec des pourcentages spécifiques avant et après l’émission de nouvelles actions. Les résultats financiers audités pour 2024 seront publiés d’ici le 15 avril 2025. L’Offre bénéficie d’une exemption de prospectus et des informations détaillées sont disponibles en ligne. Une conférence téléphonique et webcast pour les investisseurs est prévue le 31 mars 2025 pour discuter du financement et des activités de la FDA. DBV Technologies is focusing on studying the use of its VIASKIN technology platform to treat food allergies, which affect millions of people, including young children. The platform is designed to introduce microgram quantities of a biologically active compound into the immune system through intact skin, aiming to desensitize the individual to the allergen. The company is committed to transforming the treatment of food allergies, with ongoing clinical trials on VIASKIN Peanut for young children and children allergic to peanuts. DBV Technologies is headquartered in France and has operations in New Jersey, trading on Euronext Paris and Nasdaq Capital Market.

The company’s immunotherapy platform, EPIT™, leverages the skin’s immune tolerance properties to potentially modify an individual’s allergy. While DBV Technologies aims to close an offering, it is subject to various factors and risks, including financing, research and development uncertainties, regulatory approvals, and successful budgetary measures. Investors are urged to exercise caution with forward-looking statements, as the sale of the company’s products has not been authorized in any country. This press release is not an offer to sell securities and may be subject to local restrictions. In France, the securities are restricted to qualified investors as defined by the French Monetary and Financial Code. This press release outlines regulations regarding the public offering of securities in the European Economic Area, specifying criteria for qualified investors and limitations on the number of individuals who can participate in the offering. It also clarifies the definition of a public offering in each member state. In the UK, the press release is directed only towards investment professionals, high net worth individuals, and other specified groups. The document emphasizes that it is not an offer to sell securities in the United States and that any such sale would need to comply with US securities laws. 1. The stock market saw a sharp decline today, with the Dow Jones Industrial Average dropping 500 points due to concerns over rising inflation rates and potential interest rate hikes by the Federal Reserve.

2. A new study shows that over 80% of Americans are concerned about the rising cost of healthcare, with many reporting that they have skipped necessary medical care due to financial constraints.

3. The United Nations reported that global carbon dioxide emissions reached a record high in 2021, despite efforts to reduce greenhouse gas emissions and combat climate change.

4. The FDA announced a recall of certain infant formula products due to potential contamination with harmful bacteria, urging parents to check their products and stop using them immediately.

5. In sports news, the NBA All-Star Game saw Team LeBron defeat Team Durant in a high-scoring game, with Giannis Antetokounmpo winning MVP honors for his standout performance.



Read more at GlobeNewswire: DBV Technologies Annonce un Financement pouvant atteindre