UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
Form 6-K
REPORT OF FOREIGN PRIVATE ISSUER PURSUANT TO RULE 13a-16 OR 15d-16 UNDER THE SECURITIES EXCHANGE ACT OF 1934
Date of Report: June 3, 2022
Commission File Number: 001-40377
Valneva SE
(Translation of registrant's name into English)
6 rue Alain Bombard
44800 Saint-Herblain, France
(Address of principal executive office)
Indicate by check mark whether the registrant files or will file annual reports under cover of Form 20-F or Form 40-F.
Form 20-F [ X ] Form 40-F [ ]
Indicate by check mark if the registrant is submitting the Form 6-K in paper as permitted by Regulation S-T Rule 101(b)(1):
Note: Regulation S-T Rule 101(b)(1) only permits the submission in paper of a Form 6-K if submitted solely to provide an attached annual report to security holders.
Indicate by check mark if the registrant is submitting the Form 6-K in paper as permitted by Regulation S-T Rule 101(b)(7):
Note: Regulation S-T Rule 101(b)(7) only permits the submission in paper of a Form 6-K if submitted to furnish a report or other document that the registrant foreign private issuer must furnish and make public under the laws of the jurisdiction in which the registrant is incorporated, domiciled or legally organized (the registrant's "home country"), or under the rules of the home country exchange on which the registrant's securities are traded, as long as the report or other document is not a press release, is not required to be and has not been distributed to the registrant's security holders, and, if discussing a material event, has already been the subject of a Form 6-K submission or other Commission filing on EDGAR.
On May 31, June 2, and June 3, 2022, the Registrant issued press releases, copies of which are attached hereto as Exhibits 99.1, 99.2 and 99.3, respectively, and are incorporated herein by reference.
| Exhibit | ||||
| 99.1 | Press release dated May 31, 2022 | |||
| 99.2 | Press release dated June 2, 2022 | |||
| 99.3 | Press release dated June 3, 2022 |
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned, thereunto duly authorized.
| Valneva SE | ||
| (Registrant) | ||
| Date: June 3, 2022 | /s/ Thomas Lingelbach | |
| Thomas Lingelbach | ||
| Chief Executive Officer and President | ||
EXHIBIT 99.1
Valneva Appoints Dr. Thomas Decker and Dr. Michael Pfleiderer to its Scientific Advisory Board
Saint-Herblain (France), May 31, 2022 – Valneva SE (Nasdaq: VALN; Euronext Paris: VLA), a specialty vaccine company, announced today the appointment of leading vaccine experts Dr. Thomas Decker and Dr. Michael Pfleiderer to its Scientific Advisory Board (SAB).
Dr. Thomas Decker is a professor of Immunobiology at the Max Perutz Labs of the University of Vienna. His experience as an immunobiologist stems from more than 30 years of research and teaching in Germany, Sweden, Austria and the USA, with a focus on the molecular aspects of immunity to infection. During his career, Dr. Decker also served as a consultant for several pharmaceutical companies. He was Chair of the Department of Microbiology and Genetics of the University of Vienna until 2009 and is the current president of the European Macrophage and Dendritic Cell Society (EMDS). He is also a member of the editorial boards for the scientific journals Molecular and Cellular Biology and Journal of Biological Chemistry.
Dr. Michael Pfleiderer is an internationally renowned expert in regulatory affairs and development of vaccines. He is a biologist by training and holds a Ph.D. in molecular virology. Since 1998, Dr. Pfleiderer had been the Head of the Human Viral Vaccines Section at the Paul-Ehrlich-Institut (PEI), German Federal Institute for Vaccines and Biomedicines. He was responsible for all issues related to vaccine licensing and regulation, for batch testing and release of vaccines as well as inspection-related aspects. As an ex-regulator, Dr. Pfleiderer has in-depth regulatory experience, including leading decision-making processes on the benefit-risk ratio of vaccines and on regulatory, legal and administrative issues related to vaccine applications. Dr. Pfleiderer significantly contributed to numerous EMA and WHO guidelines on scientific and regulatory issues related to vaccines.
Juan Carlos Jaramillo, M.D, Chief Medical Officer of Valneva, commented, “Dr. Decker and Dr. Pfleiderer’s significant expertise will be highly complementary to that of the existing SAB. We look forward to having them join this advisory group, whose skills and perspectives are extremely valuable to Valneva as we continue to enhance our future R&D strategy.”
Chaired by Dr. Ralf Clemens, PhD, Valneva’s SAB includes Dr. Norman Baylor, PhD; Dr. Anna Durbin, MD; Dr. George R. Siber, MD, PhD; and Dr. Alexander von Gabain, PhD. The advisory board was first formed in 2019.
About Valneva SE
Valneva is a specialty vaccine company focused on the development and commercialization of prophylactic vaccines for infectious diseases with significant unmet medical need. The Company takes a highly specialized and targeted approach to vaccine development and then applies its deep understanding of vaccine science to develop prophylactic vaccines addressing these diseases. Valneva has leveraged its expertise and capabilities both to successfully commercialize two vaccines and to rapidly advance a broad range of vaccine candidates into and through the clinic, including candidates against Lyme disease, the chikungunya virus and COVID-19.
| Media & Investor Contacts Laëtitia Bachelot-Fontaine VP Global Communications & European Investor Relations M +33 (0)6 4516 7099 laetitia.bachelot-fontaine@valneva.com | Joshua Drumm, Ph.D. VP Global Investor Relations M +001 917 815 4520 joshua.drumm@valneva.com |
EXHIBIT 99.2
Valneva Announces the Availability of Documentation for its Shareholder Meetings
Saint Herblain (France), June 2, 2022 – Valneva SE (Nasdaq: VALN; Euronext Paris: VLA), a specialty vaccine company, today announced the availability of documentation for its Combined General Meeting and Special Meeting of holders of Convertible Preferred Shares.
The Company’s Combined General Meeting will be held on June 23, 2022, at 2 p.m. CEST, at the Hotel InterContinental Paris Le Grand, 2 rue Scribe, 75009 Paris, and will follow a Special Meeting of holders of Convertible Preferred Shares1 to be held at the same location at 1:30 p.m. CEST on the same day.
The preliminary Notices of Meetings, containing the agenda, the draft resolutions and instructions for participation and voting, were published in the French Bulletin des Annonces Légales Obligatoires (BALO) on May 18, 2022.
Documents and information relating to the Meetings are available on Valneva’s website (www.valneva.com) in the “Investors/General Meetings” section. Shareholders can also obtain the Combined General Meeting and Special Meeting documents upon request to the Company by sending an email to the following address: assemblee.generale@valneva.com.
The Company also recommends that shareholders regularly consult the sections related to the the Combined General Meeting and Special Meeting on its website, www.valneva.com.
Contact Details, Legal Department
Valneva SE
Service Assemblée Générale
6 rue Alain Bombard, 44800 Saint-Herblain (France)
assemblee.generale@valneva.com
| Media & Investor Contacts Laëtitia Bachelot-Fontaine VP Global Communications & European Investor Relations M +33 (0)6 4516 7099 laetitia.bachelot-fontaine@valneva.com | Joshua Drumm, Ph.D. VP Global Investor Relations M +001 917 815 4520 joshua.drumm@valneva.com |
About Valneva SE
Valneva is a specialty vaccine company focused on the development and commercialization of prophylactic vaccines for infectious diseases with significant unmet medical need. The Company takes a highly specialized and targeted approach to vaccine development and then applies its deep understanding of vaccine science to develop prophylactic vaccines addressing these diseases. Valneva has leveraged its expertise and capabilities both to successfully commercialize two vaccines and to rapidly advance a broad range of vaccine candidates into and through the clinic, including candidates against Lyme disease, the chikungunya virus and COVID-19.
1 Convertible Preferred Shares are special instruments created in 2015 and held by Senior Management.
EXHIBIT 99.1
Valneva to Present and Hold Investor Meetings at the Jefferies US Healthcare Conference
Saint-Herblain (France), June 3, 2022 – Valneva SE (Nasdaq: VALN; Euronext Paris: VLA), a specialty vaccine company, today announced that its senior management will present and participate in 1-on-1 meetings with institutional investors at the Jefferies Healthcare Conference which will take place from June 8 to 10, 2022 in New York.
Valneva’s Chief Executive Officer Thomas Lingelbach and Chief Financial Officer Peter Bühler will notably discuss the Company’s late-stage vaccine candidates against Lyme disease (VLA15), chikungunya (VLA1553) and COVID-19 (VLA2001).
Valneva was recently granted Conditional Marketing Authorization in the United Kingdom for its inactivated COVID-19 vaccine candidate VLA20011 and filed a Marketing Authorization Application with the European Medicines in May 20222. The Company also recently commenced the pre-submission process with the US Food and Drug Administration for its single-shot chikungunya vaccine candidate VLA1553 after reporting final positive pivotal Phase 3 results3 and lot-to-lot data4. Additionally, in April 2022, Valneva and its partner Pfizer reported first positive pediatric results for their Lyme disease vaccine candidate VLA155. These positive data build on the strong immunogenicity profile reported for adult participants (18-65 years old) in February 2022, and the two companies expect to proceed with a Phase 3 clinical trial in participants age 5-65, which is planned to start in the third quarter of 2022.
The fireside chat at the Jefferies conference will take place on June 9, 2022 at 11:30am EDT (17:30 CEST) and will be accessible live via the following link, https://wsw.com/webcast/jeff240/valn/1848225. A replay of the webcast will be available following the live events in the “Investor” section of the Valneva website at www.valneva.com.
To request a meeting at the event, please contact your representative at Jefferies.
About Valneva SE
Valneva is a specialty vaccine company focused on the development and commercialization of prophylactic vaccines for infectious diseases with significant unmet medical need. The Company takes a highly specialized and targeted approach to vaccine development and then applies its deep understanding of vaccine science to develop prophylactic vaccines addressing these diseases. Valneva has leveraged its expertise and capabilities both to successfully commercialize two vaccines and to rapidly advance a broad range of vaccine candidates into and through the clinic, including candidates against Lyme disease, the chikungunya virus and COVID-19.
| Valneva Investor and Media Contacts Laetitia Bachelot-Fontaine VP, Global Communications and European Investor Relations M +33 (0)6 4516 7099 communications@valneva.com | Joshua Drumm, Ph.D. VP, Global Investor Relations M +001 917 815 4520 joshua.drumm@valneva.com | | |
Forward-Looking Statements
This press release contains certain forward-looking statements relating to the business of Valneva, including but not limited to the initiation of clinical trials and product approvals. In addition, even if the actual results or development of Valneva are consistent with the forward-looking statements contained in this press release, those results or developments of Valneva may not be indicative of future results. In some cases, you can identify forward-looking statements by words such as "could," "should," "may," "expects," "anticipates," "believes," "intends," "estimates," "aims," "targets," or similar words. These forward-looking statements are based on the current expectations of Valneva as of the date of this press release and are subject to a number of known and unknown risks and uncertainties and other factors that may cause actual results, performance or achievements to be materially different from any future results, performance or achievement expressed or implied by these forward-looking statements. In particular, the expectations of Valneva could be affected by, among other things, uncertainties involved in the development and manufacture of vaccines, unexpected clinical trial results, regulatory actions or delays, competition in general, currency fluctuations, the impact of the global and European credit crisis, the ability to obtain or maintain patent or other proprietary intellectual property protection, the cancellation of existing contracts, including but not limited to the VLA2001 supply agreement with the UK government, and the impact of the COVID-19 pandemic, the occurrence of any of which could substantially harm Valneva’s business, financial condition, prospects and results of operations. In light of these risks and uncertainties, there can be no assurance that the forward-looking statements made during this presentation will in fact be realized. Valneva is providing the information in this press release as of the date hereof and disclaims any intention or obligation to publicly update or revise any forward-looking statements, whether as a result of new information, future events, or otherwise.
1 Valneva Receives Conditional Marketing Authorization from UK MHRA for its Inactivated COVID-19 Vaccine – Valneva
2 EMA accepts filing of marketing authorization application for Valneva’s inactivated COVID-19 Vaccine Candidate – Valneva
3 Valneva Successfully Completes Pivotal Phase 3 Trial of Single-Shot Chikungunya Vaccine Candidate – Valneva
4 Valneva Successfully Completes Lot-to-Lot Consistency Trial for its Single-Shot Chikungunya Vaccine Candidate – Valneva
5 Valneva and Pfizer Report Positive Phase 2 Pediatric Data for Lyme Disease Vaccine Candidate – Valneva