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 19, 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 18, 2022, the Registrant issued press releases, a copy of each of which is attached hereto as Exhibits 99.1 and 99.2, respectively, and is incorporated herein by reference. The information contained in this Form 6-K, including Exhibits 99.1 and 99.2, 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 August 18, 2022 | |
| 99.2 | Press release dated August 18, 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 19, 2022 | /s/ Thomas Lingelbach | |
| Thomas Lingelbach | ||
| Chief Executive Officer and President | ||
EXHIBIT 99.1
Valneva Provides Update on IXIARO® Supply Contract with U.S. Department of Defense
Saint Herblain (France), August 18, 2022 – Valneva SE (Nasdaq: VALN; Euronext Paris: VLA) a specialty vaccine company, today announced that the U.S. Department of Defense (DoD) has decided not to exercise the second option year of the contract1 to supply Valneva’s Japanese encephalitis (JE) vaccine IXIARO®.
Due to the past and ongoing impact of the COVID-19 pandemic on its operations, the DoD considers its existing IXIARO® supply levels sufficient to meet current needs. The DoD has communicated an interest in negotiating a new supply contract in 2023, once inventory returns to standard levels. The Company expects no impact on its 2022 financial guidance as a result of this decision and will continue deliveries of IXIARO® pursuant to the terms of the first option year, which the DoD exercised with amended terms2, through the fourth quarter of 2022. The DoD has relied on IXIARO® since 2010 to help protect personnel who are deployed to JE endemic areas, for whom JE vaccination is recommended.
The total minimum value of the existing supply contract was approximately $118 million, assuming the exercise of the second option year, which had a minimum value of approximately $36 million for 250,000 doses.
Thomas Lingelbach, President and Chief Executive Officer of Valneva, commented: “We thank the DoD for their partnership and look forward to further contract negotiations in the future. In parallel, we continue to see significant recovery in the private travel market for IXIARO®, which more than tripled in the first half of this year compared to the first half of 2021.”
About IXIARO®/JESPECT®
Valneva’s Japanese encephalitis vaccine is indicated for active immunization for the prevention of the disease for people who travel to, or live in, endemic areas. It has received marketing approval in the U.S., Europe, Canada, Hong Kong, Singapore, and Israel under the trade name IXIARO® and in Australia and New Zealand where it is marketed as JESPECT®. It is the only vaccine available to the U.S. military for Japanese Encephalitis. IXIARO® is approved for use in individuals two months of age and older in the U.S. and EU member states, Canada, Norway, Liechtenstein, Iceland, Singapore, Hong Kong, Japan, the Republic of Korea and Israel. In all other licensed territories, IXIARO®/JESPECT® is indicated for use in persons aged 18 years or more.
About Japanese Encephalitis
Japanese encephalitis is a deadly infectious disease found mainly in Asia. About 70,000 cases of JE are estimated to occur in Asia each year, although the actual number of cases is likely much higher due to underreporting in rural areas. JE is fatal in approximately 30 percent of those who show symptoms, and leaves half of survivors with permanent brain damage. The disease is endemic in Southeast Asia, India and China, a region with a population of more than three billion. In 2005, JE killed more than 1,200 children in only one month during an epidemic outbreak in Uttar Pradesh, India, and Nepal.
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 prospects for future contracts. 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 sustained in the future. 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 largely 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, and the ability to obtain or maintain patent or other proprietary intellectual property protection. Success in preclinical
studies or earlier clinical trials may not be indicative of results in future clinical trials. 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 these materials as of this press release and disclaim 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 Announces New IXIARO® Supply Contract with the US Government worth
up to $166 million
2 Valneva: U.S. DoD Exercises First Year Option on IXIARO® Supply Contract
EXHIBIT 99.2
Valneva Initiates Rolling Submission of FDA Biologics License Application for its Single-Shot Chikungunya Vaccine Candidate
Saint-Herblain (France), August 18, 2022 – Valneva SE (Nasdaq: VALN; Euronext Paris: VLA), a specialty vaccine company, today announces that it has initiated rolling submission of the Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) seeking approval of the Company’s single-shot chikungunya vaccine candidate in persons aged 18 years and above.
This BLA submission follows final pivotal Phase 3 data reported in March 20221 and final lot-to-lot consistency results reported in May 20222. A clinical study of VLA1553 in adolescents is ongoing in Brazil3, which may support future regulatory submissions in this group if VLA1553 is approved in adults.
Juan Carlos Jaramillo, MD, Chief Medical Officer of Valneva, commented, “This is an extremely important milestone for our VLA1553 program and we are very proud to be the first company worldwide that has begun submission of a BLA for a chikungunya vaccine candidate. Chikungunya is a major public health threat that continues to grow, and no vaccine or specific treatments are currently available for this debilitating disease. We will continue to work assiduously to bring VLA1553 to market as soon as possible.”
Valneva is currently targeting the end of 2022 for completion of the BLA submission. Once all portions of the application have been submitted and if the filing is accepted, the FDA will determine priority review eligibility and the action date which the FDA will target to complete its evaluation.
This rolling BLA submission is part of the accelerated approval pathway agreed upon with the FDA in 20204. The program received FDA Fast Track and Breakthrough Therapy designations in 2018 and 2021, respectively. VLA1553 was also granted PRIority MEdicine (PRIME) designation by the European Medicines Agency (EMA) in 2020, and Valneva plans to make regulatory submissions for VLA1553 in Europe in the first half of 2023.
About Chikungunya
Chikungunya is a mosquito-borne viral disease caused by the chikungunya virus
(CHIKV), a Togaviridae virus, transmitted by Aedes mosquitoes. Infection leads to symptomatic disease in 72-92% of humans after four to
seven days following the mosquito bite. While mortality with CHIKV is low, morbidity is high, and the global market for vaccines against
chikungunya is estimated to exceed $500 million annually by 20325. Clinical symptoms include acute onset of fever, debilitating
joint and muscle pain, headache, nausea, rash and chronic arthralgia. Chikungunya virus often causes sudden large outbreaks with high
attack rates, affecting one-third to three-quarters of the population in areas where the virus is circulating. The high-risk areas of
infection for travelers are places where chikungunya virus-carrying mosquitos are endemic, including the Americas, parts of Africa, and
Southeast Asia, and the virus has spread to more than 100 countries. As of July 2022, more than three million cases have been reported
in the Americas6 and the economic impact is considered to be significant. The medical and economic burden is expected to grow
as the CHIKV primary mosquito vectors continue to spread geographically. There are no preventive vaccines or effective treatments available
and, as such, chikungunya is considered to be a major public health threat.
About VLA1553
VLA1553 is a live-attenuated, single dose investigational vaccine
candidate targeting the chikungunya virus, which has spread to over 120 countries. It has been designed by deleting a part of the chikungunya
virus genome.
Valneva reported final data from the pivotal Phase 3 trial of VLA1553 in March 20227 and final lot-to-lot
consistency results in May 20228.
If approved, VLA1553 would expand Valneva’s existing commercial vaccines portfolio
and as such, Valneva intends to commercialize this vaccine, leveraging its existing manufacturing and commercial operations.
To
make VLA1553 more accessible to Low- and Middle-Income Countries (LMIC), Valneva and Instituto Butantan in Brazil signed an agreement
in January 2021 for the development, manufacturing and marketing of VLA15539. The collaboration falls within the framework
of the agreement signed between CEPI and Valneva in July 201910, which provides funding of up to $23.4 million with support
from the European Union’s Horizon 2020 program.
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 regulatory approval of VLA1553, timing and plans for clinical programs and product
candidates and revenue forecasts. 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 Successfully Completes Pivotal Phase 3 Trial of Single-Shot Chikungunya Vaccine Candidate
2
Valneva Successfully Completes Lot-to-Lot Consistency Trial for its Single-Shot Chikungunya Vaccine Candidate
3
Valneva Announces Initiation of Adolescent Phase 3 Trial for its Single-Shot Chikungunya Vaccine Candidate – Valneva
4
Valneva Reports Positive End-of-Phase 2 Chikungunya Meeting with the U.S. FDA; Sets Stage for Phase 3 Study
5 VacZine
Analytics Chikungunya virus vaccines Global demand analysis. February 2020
6 PAHO/WHO data: Number of reported
cases of chikungunya fever in the Americas (Cumulative Cases 2018-2022 and Cases per year 2013-2017). https://www.paho.org/data/index.php/en/mnu-topics/chikv-en/550-chikv-weekly-en.html.
Last accessed 25 Jul 2022.
7 Valneva Successfully Completes Pivotal Phase 3 Trial of Single-Shot Chikungunya
Vaccine Candidate
8 Valneva Successfully Completes Lot-to-Lot Consistency Trial for its Single-Shot Chikungunya
Vaccine Candidate
9 Valneva and Instituto Butantan Sign Final Agreement on Single-Shot Chikungunya Vaccine
for Low and Middle Income Countries
10 CEPI awards up to $23.4 million to Valneva for late-stage development
of a single-dose Chikungunya vaccine