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: October 21, 2024
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 [ ]
On October 21, 2024, 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).
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: October 21, 2024 | | /s/ Thomas Lingelbach |
| | Thomas Lingelbach |
| | Chief Executive Officer and President |
| | |
EXHIBIT 99.1
Valneva
to Present on Chikungunya at Several Leading Scientific Conferences
Saint-Herblain (France), October 21, 2024 – Valneva SE (Nasdaq: VALN; Euronext Paris:
VLA), a specialty vaccine company, announces today that members of its senior leadership team will present datasets on the world’s
first and only approved chikungunya vaccine, IXCHIQ®, at several leading scientific conferences during the fourth
quarter of 2024.
At
the International Society of Vaccines Annual Congress taking place in Seoul, South
Korea, Valneva will present on the two-year antibody persistence and safety data of its single-dose
chikungunya vaccine in adults aged 18 years and above today at 5:00 pm Korea Standard Time
(KST). The Company will also display a poster at the event complementing the presentation.
At
the American Society of Tropical Medicine and Hygiene (ASTMH) 2024 Annual Meeting in
New Orleans, Louisiana, Valneva will hold a presentation on the pivotal Phase 3 six-month
safety and immunogenicity data of its single-dose chikungunya vaccine in adolescents in Brazil
on November 16, 2024, at 11:15 am Central Daylight Time (CDT). The Company will also display
four posters: “Chikungunya: Ongoing Dose-Response, Safety, and Immunogenicity Phase
2 Trial of Single-dose Live-attenuated Vaccine (VLA1553) in Children aged 1 to 11 years”,
“Modelling of 5 Year Antibody Persistence after Vaccination with Live Attenuated Chikungunya
Vaccine VLA1553 (IXCHIQ®)”, “The Global Health Burden of Chikungunya
from 2011 to 2020: A Model-Driven Analysis on the Impact of an Emerging Vector-Borne Disease”
and “Predicting Chikungunya in Miami: Outbreak Impact and Effectiveness of Vaccine
Intervention with IXCHIQ®”.
Finally,
during the International Society for Pharmacoeconomics and Outcomes Research (ISPOR) European
Congress taking place November 17 - 20, 2024 in Barcelona, Spain, Valneva will present
a poster on the cost-effectiveness of IXCHIQ® vaccination in Puerto Rico.
About
Chikungunya
Chikungunya virus (CHIKV) is a mosquito-borne viral disease spread by
the bites of infected Aedes mosquitoes which causes fever, severe joint and muscle
pain, headache, nausea, fatigue and rash. Joint pain is often debilitating and can persist
for weeks to years.1
In 2004, the disease began to spread quickly, causing
large-scale outbreaks around the world. Since the re-emergence of the virus, CHIKV has now
been identified in over 110 countries in Asia, Africa, Europe and the Americas.2
Between 2013 and 2023, more than 3.7 million cases were reported in the Americas3
and the economic impact is considered to be significant. The medical and economic burden
is expected to grow with climate change as the mosquito vectors that transmit the disease
continue to spread geographically. As such, the World Health Organization (WHO) has highlighted
chikungunya as a major public health problem.4
About
Valneva SE
We are a specialty vaccine company that develops, manufactures, and commercializes
prophylactic vaccines for infectious diseases addressing unmet medical needs. We take a highly
specialized and targeted approach, applying our deep expertise across multiple vaccine modalities,
focused on providing either first-, best- or only-in-class vaccine solutions.
We have
a strong track record, having advanced multiple vaccines from early R&D to approvals,
and currently market three proprietary travel vaccines, including the world’s first
and only chikungunya vaccine, as well as certain third-party vaccines.
Revenues from our
growing commercial business help fuel the continued advancement of our vaccine pipeline.
This includes the only Lyme disease vaccine candidate in advanced clinical development, which
is partnered with Pfizer, the world’s most clinically advanced Shigella vaccine candidate,
as well as vaccine candidates against the Zika virus and other global public health threats.
More information is available at www.valneva.com.
Valneva
Investor and Media Contacts Laetitia 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 the progress, timing, results and completion of research, development
and clinical trials for product candidates, to regulatory approval of product candidates
and review of existing products. 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 and delays 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
https://jvi.asm.org/content/jvi/88/20/11644.full.pdf
2 https://cmr.asm.org/content/31/1/e00104-16
3
PAHO/WHO data: Number of reported cases of chikungunya fever in the Americas (Cumulative
Cases 2018-2023 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 01 Aug 2023.
4 Geographical expansion of cases of dengue and chikungunya
beyond the historical areas of transmission in the Region of the Americas (who.int)
Valneva (PK) (USOTC:INRLF)
過去 株価チャート
から 10 2024 まで 11 2024
Valneva (PK) (USOTC:INRLF)
過去 株価チャート
から 11 2023 まで 11 2024