DBV Technologies Announces Financing of up to $306.9 Million (€284.5 Million) to Advance Viaskin® Peanut Patch Through Biologics License Application Submission and U.S. Commercial Launch, if Approved

Core Viewpoint - DBV Technologies announced a financing of up to $306.9 million (€284.5 million) to support the development and potential commercialization of its Viaskin Peanut patch for treating pediatric peanut allergies, contingent upon FDA approval and successful completion of clinical trials [1][3][4]. Financing Details - The financing includes gross proceeds of$125.5 million (€116.3 million) upon closing and up to $181.4 million (€168.2 million) if all warrants are exercised, with an immediate dilution of 22.4% and a maximal dilution of up to 73.7% for existing shareholders [1][4][7]. - The financing was led by several prominent investors, including MPM BioImpact and Adage Capital Management LP, among others [2]. Development and Regulatory Updates - DBV is advancing the Viaskin peanut patch, having aligned with the FDA on safety exposure data required for a Biologics License Application (BLA) for children aged 4 to 7 years, which accelerates the timeline for submission [3][4]. - The VITESSE Phase 3 study, which is the largest study conducted for peanut allergy in this age range, has enrolled 654 subjects, exceeding the original target of 600, enhancing the study's statistical power to over 90% [3][4]. Use of Proceeds - The proceeds from the financing will be allocated for working capital, continued development of the Viaskin Peanut program, preparation and submission of the BLA, and readiness for a potential U.S. launch [1][5][6]. Financial Position and Future Outlook - The company anticipates that the financing will provide sufficient net working capital to meet obligations over the next 12 months and extend financial visibility into 2028, contingent on the successful commercialization of Viaskin Peanut [11][13]. - Current cash reserves are insufficient to cover operating needs for the next 12 months, highlighting the importance of this financing [8][10]. Shareholder Impact - The financing will significantly alter the shareholding structure, with existing shareholders facing substantial dilution if all warrants are exercised [40][41][43]. - Baker Brothers Investments, a major shareholder, will see its ownership change from 22.82% to 17.14% on a non-diluted basis post-offering, and potentially to 25.15% if all warrants are exercised [32][41][43]. Investor Engagement - DBV Technologies will host an investor conference call to discuss the financing and FDA updates, indicating proactive communication with stakeholders [4][49].