Valneva Announces Publication of 2020 Universal Registration Document and Provides Business Updates
Saint-Herblain (France), April 10, 2021 – Valneva SE (“Valneva” or the "Company”), a specialty vaccine company focused on the development and commercialization of prophylactic vaccines for infectious diseases with significant unmet medical need, announces today the publication of its 2020 Universal Registration Document filed with the French Financial Markets Authority on April 9, 2021 under the filing number D.21-0286.
Valneva’s 2020 Universal Registration Document notably includes the Company’s 2020 Annual Financial Report, Management Board Report, the Supervisory Board’s report on Corporate Governance including information on the conditions of preparation and organization of the Supervisory Board’s work and on the internal control and risk management procedures, information on the amount of fees paid to the Statutory Auditors (as included in the Consolidated Financial Statements), as well as the Group’s Corporate Social Responsibility Report.
This 2020 Universal Registration Document also provides a presentation of the Company’s preclinical programs and an enhanced description of the Company’s material agreements.
This document is available on the Company’s corporate website (https://valneva.com/investors/financial-reports/) and on the AMF's website (www.amf-france.org). A hard copy of the document may be obtained from the Company, free of charge, upon request at the following address: 6 rue Alain Bombard, 44800 Saint-Herblain, France.
Valneva also announces that the Food and Drug Administration (FDA) has allowed the use of a surrogate marker to demonstrate the efficacy of its chikungunya vaccine candidate VLA1553 in the Company’s ongoing Phase 3 trial, VLA1553-301. Surrogate endpoints are generally allowed for serious diseases or conditions where there is a significant unmet need. Enrollment for this Phase 3 trial is close to completion.
Valneva has publicly filed a form F-1 with the Securities and Exchange Commission (SEC) in the United States. This document refers to a potential public offering of shares in the United States, subject to the further approval of the SEC, and discloses what would be the potential use of proceeds in the event of the completion of such offering. The proceeds of the potential public offering would be used to fund further development of Valneva’s vaccine candidates (VLA15 against Lyme disease, VLA1533 against chikungunya and VLA2001 against COVID-19) as well as for working capital and other general corporate purposes.