Valneva SE 6-K, filed Sep 20, 2022
Valneva SE (VALN)
About this 6-K
Valneva SE filed this 6-K on September 20, 2022.
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: September 20, 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 September 16, 2022, the Registrant issued a press release, a copy of which is attached hereto as Exhibit 99.1 and is incorporated herein by reference. The information contained in this Form 6-K, including Exhibit 99.1, is hereby incorporated by reference into the registrant's Registration Statement on Form F-3 (File No. 333-266839).
| Exhibit | ||
| 99.1 | Press release dated September 16, 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: September 20, 2022 | /s/ Thomas Lingelbach | |
| Thomas Lingelbach | ||
| Chief Executive Officer and President | ||
EXHIBIT 99.1
Valneva and IDT Biologika Agree on Termination of their COVID-19 Collaboration
Saint-Herblain (France) and Dessau-Roßlau (Germany), September 16, 2022 – Valneva SE (Nasdaq: VALN; Euronext Paris: VLA), a specialty vaccine company, and IDT Biologika today announced they have agreed to terminate their collaboration following the delivery of inactivated COVID-19 bulk vaccine to Valneva, and considering the current order levels and existing inventories.
As per the commercial manufacturing services agreement signed in November 20211, IDT Biologika produced VLA2001 bulk vaccine at its Biosafety Level 3 facilities in Germany, and Valneva bought the batches that were manufactured so far by IDT. In light of the reduced European Commission order2, Valneva has suspended manufacturing of the vaccine and, as compensation, will pay IDT up to €36.2 million in cash and the equivalent of €4.5 million in kind, in the form of specified equipment purchased by Valneva.
Valneva has started to deliver doses of VLA2001 to the European Member States who ordered the vaccine and is retaining inventory for potential additional supply to these Member States should demand increase. In parallel, the Company is continuing discussions with various other governments around the world, with the aim to deploy approximately eight to ten million doses of remaining inventory into international markets in the next six to twelve months.
About VLA2001
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).
VLA2001 is the first COVID-19 vaccine to receive a standard marketing
authorization in Europe3 and the only whole virus, inactivated, adjuvanted COVID-19 vaccine to receive marketing authorization
in Europe for use as primary vaccination in people from 18 to 50 years of age. The vaccine was also granted conditional marketing authorization
in the United Kingdom4 and emergency use authorization in the United Arab Emirates5 and Kingdom of Bahrain6.
Valneva currently has agreements to supply VLA2001 to certain EU Member States7 and the Kingdom of Bahrain8. In
August 2022, the World Health Organization (WHO) issued recommendations for use of VLA20019.
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 commercialize three vaccines and to rapidly advance a broad
range of vaccine candidates into and through the clinic, including candidates against Lyme disease and the chikungunya virus.
About IDT Biologika
IDT Biologika is an innovative biotech company with a successful
history dating back 100 years. On the basis of modern technologies and high levels of expertise, we support customers in the development
and manufacture of innovative virus vaccines, gene and immune therapy products as well as biologics employed worldwide as protection against
diseases. German sites are the BioPharmaPark in Dessau-Roßlau and Magdeburg. In the US, the IDT Corporation has a manufacturing site
for clinical test samples in Rockville, Maryland.
| Valneva Investor and Media Contacts Laetitia Bachelot-Fontaine VP, Global Communications and European Investor Relations M +33 (0)6 4516 7099 investors@valneva.com |
Joshua Drumm, Ph.D. VP, Global Investor Relations M +001 917 815 4520 joshua.drumm@valneva.com |
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Forward-Looking Statements
This press release contains certain forward-looking statements relating
to the business of Valneva, including with respect to the manufacturing and commercialization plans for VLA2001. 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, the cancellation of existing contracts, including but not limited to the HMG Supply Agreement, 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 and IDT Biologika Announce Collaboration for Production of Inactivated COVID-19 Vaccine VLA2001
- Valneva
2 Valneva Confirms Amendment of Advance Purchase Agreement with European Commission for Valneva’s
Inactivated COVID-19 Vaccine - Valneva
3 Valneva Receives Marketing Authorization in Europe for Inactivated
Whole-Virus COVID-19 Vaccine VLA2001
4 Valneva Receives Conditional Marketing Authorization from UK MHRA for its Inactivated
COVID-19 Vaccine
5 Valneva Receives Emergency Use Authorization from the United Arab Emirates for its Inactivated
COVID-19 Vaccine
6 Valneva Receives Emergency Use Authorization from Bahrain for its Inactivated COVID-19 Vaccine VLA2001
7
European Commission Approves Purchase Agreement Amendment for Valneva’s Inactivated COVID-19 Vaccine
8 Valneva
Signs Advance Purchase Agreement with Bahrain for Inactivated COVID-19 Vaccine VLA2001
9 Valneva Confirms WHO Recommendations
for its Inactivated COVID-19 Vaccine