Saint-Herblain (France), April 10, 2021 – Valneva SE (“Valneva” or the “Company”), a specialty vaccine organization concentrated on the growth and commercialization of prophylactic vaccines for infectious conditions with important unmet professional medical need, announces nowadays the publication of its 2020 Common Registration Doc submitted with the French Financial Markets Authority on April 9, 2021 underneath the filing selection D.21-0286.
Valneva’s 2020 Universal Registration Document notably incorporates the Company’s 2020 Annual Economical Report, Administration Board Report, the Supervisory Board’s report on Company Governance including details on the problems of planning and organization of the Supervisory Board’s get the job done and on the inside management and threat management procedures, data on the total of costs paid out to the Statutory Auditors (as provided in the Consolidated Economical Statements), as nicely as the Group’s Corporate Social Duty Report.
This 2020 Universal Registration Doc also gives a presentation of the Company’s preclinical systems and an improved description of the Company’s content agreements.
This document is out there on the Company’s company site (https://valneva.com/buyers/money-studies/) and on the AMF’s internet site (www.amf-france.org). A difficult copy of the doc could be attained from the Company, cost-free of cost, on request at the subsequent deal with: 6 rue Alain Bombard, 44800 Saint-Herblain, France.
Valneva also announces that the Food stuff and Drug Administration (Food and drug administration) has authorized the use of a surrogate marker to display the efficacy of its chikungunya vaccine candidate VLA1553 in the Company’s ongoing Phase 3 trial, VLA1553-301. Surrogate endpoints are usually permitted for really serious conditions or circumstances where by there is a important unmet require. Enrollment for this Stage 3 trial is near to completion.
Valneva has publicly submitted a form F-1 with the Securities and Exchange Commission (SEC) in the United States. This doc refers to a potential public providing of shares in the United States, matter to the more approval of the SEC, and discloses what would be the likely use of proceeds in the occasion of the completion of these offering. The proceeds of the likely general public featuring would be employed to fund more progress of Valneva’s vaccine candidates (VLA15 towards Lyme disease, VLA1533 towards chikungunya and VLA2001 towards COVID-19) as nicely as for working funds and other standard company reasons.
About Valneva SE
Valneva is a specialty vaccine firm centered on the enhancement and commercialization of prophylactic vaccines for infectious disorders with sizeable unmet health-related want. Valneva has leveraged its abilities and capabilities both to effectively commercialize two vaccines and to swiftly advance a broad selection of vaccine candidates into and by means of the clinic, such as candidates towards Lyme illness, the chikungunya virus and COVID-19.
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Valneva Investor and Media Contacts |
Dan Sharp |
Forward-Seeking Statements
This push launch has particular ahead-searching statements relating to the business of Valneva, such as with respect to the progress, timing, benefits and completion of exploration, improvement and clinical trials for item candidates, the capacity to manufacture, market place, commercialize and obtain sector acceptance for merchandise candidates, the capacity to defend intellectual house and work the small business without the need of infringing on the intellectual home legal rights of many others, estimates for upcoming performance and estimates pertaining to expected operating losses, foreseeable future revenues, capital prerequisites and desires for additional financing. In addition, even if the real results or enhancement of Valneva are regular with the ahead-seeking statements contained in this push release, people outcomes or developments of Valneva might not be sustained in the upcoming. In some cases, you can establish ahead-on the lookout statements by phrases these kinds of as “could,” “should,” “may well,” “expects,” “anticipates,” “believes,” “intends,” “estimates,” “aims,” “targets,” or identical terms. These forward-hunting statements are dependent largely on the current expectations of Valneva as of the day of this push launch and are matter to a quantity of known and not known challenges and uncertainties and other factors that might bring about genuine success, effectiveness or achievements to be materially different from any potential final results, overall performance or accomplishment expressed or implied by these ahead-seeking statements. In certain, the expectations of Valneva could be influenced by, amid other matters, uncertainties concerned in the growth and manufacture of vaccines, unexpected scientific demo effects, unexpected regulatory actions or delays, competitiveness in typical, forex fluctuations, the effect of the global and European credit crisis, and the means to get or maintain patent or other proprietary intellectual residence security. In gentle of these pitfalls and uncertainties, there can be no assurance that the forward-wanting statements created during this presentation will in point be recognized. Valneva is providing the data in these products as of this push release, and disclaim any intention or obligation to publicly update or revise any ahead-looking statements, whether as a end result of new details, foreseeable future situations, or otherwise.
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