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: August 2, 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 August 1, 2022, the Registrant issued a press release, a copy of which is attached hereto as Exhibit 99.1 and is incorporated herein by reference.
Exhibit | ||
99.1 | Press release dated August 1, 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: August 2, 2022 | /s/ Thomas Lingelbach | |
Thomas Lingelbach | ||
Chief Executive Officer and President | ||
EXHIBIT 99.1
Valneva Confirms Amendment of Advance Purchase Agreement with European Commission for Valneva’s Inactivated COVID-19 Vaccine
Saint-Herblain (France), August
1, 2022 – Valneva SE (Nasdaq: VALN; Euronext Paris:
VLA), a specialty vaccine company, today confirms the signing of the amendment to its Advance Purchase Agreement (APA)1 with
the European Commission (EC), following expiration of the Member States’ opt-out period, as announced by the Company on July 20,
20222. Under this amendment, the Member States’ purchases of VLA2001, Valneva’s inactivated whole-virus COVID-19
vaccine, consist of 1.25 million doses of VLA2001 in 2022, with the option to purchase an equivalent quantity later this year for delivery
in 2022.
The Company expects to deliver the first vaccine doses to participating EU Member States (Germany, Austria, Denmark, Finland, and Bulgaria) in the coming weeks.
About VLA2001
VLA2001 is the only whole virus, inactivated, adjuvanted COVID-19 vaccine which
has received marketing authorization in Europe for use as primary vaccination in people from 18 to 50 years of age. VLA2001 is produced
on Valneva’s established Vero-cell platform, leveraging the manufacturing technology for Valneva’s licensed Japanese encephalitis
vaccine, IXIARO®. VLA2001 consists of inactivated whole virus particles of SARS-CoV-2 with high S-protein density, in
combination with two adjuvants, alum and CpG 1018. This adjuvant combination has consistently induced higher antibody levels in preclinical
experiments than alum-only formulations and shown a shift of the immune response towards Th1. CpG 1018 adjuvant, supplied by Dynavax Technologies
Corporation (Nasdaq: DVAX), is a component of the US FDA- and EMA-approved HEPLISAV-B® vaccine. VLA2001’s manufacturing
process, which has already been upscaled to final industrial scale, includes chemical inactivation to preserve the native structure of
the S-protein. VLA2001 is expected to conform with standard cold chain requirements (2 to 8 degrees Celsius).
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 |
Forward-Looking Statements
This press release contains certain forward-looking statements relating
to the business of Valneva, including with respect to delivery schedules. 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, unexpected
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 and the impact of the COVID-19 pandemic. In
light of these risks and uncertainties, there can be no assurance that the forward-looking statements made in this press release 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 Signs Purchase Agreement with European Commission for its Inactivated COVID-19 Vaccine VLA2001
2 European
Commission Approves Purchase Agreement Amendment for Valneva’s Inactivated COVID-19 Vaccine