<SEC-DOCUMENT>0001171843-24-005718.txt : 20241021
<SEC-HEADER>0001171843-24-005718.hdr.sgml : 20241021
<ACCEPTANCE-DATETIME>20241021160456
ACCESSION NUMBER:		0001171843-24-005718
CONFORMED SUBMISSION TYPE:	6-K
PUBLIC DOCUMENT COUNT:		2
CONFORMED PERIOD OF REPORT:	20241021
FILED AS OF DATE:		20241021
DATE AS OF CHANGE:		20241021

FILER:

	COMPANY DATA:	
		COMPANY CONFORMED NAME:			Valneva SE
		CENTRAL INDEX KEY:			0001836564
		STANDARD INDUSTRIAL CLASSIFICATION:	BIOLOGICAL PRODUCTS (NO DIAGNOSTIC SUBSTANCES) [2836]
		ORGANIZATION NAME:           	03 Life Sciences
		IRS NUMBER:				000000000
		STATE OF INCORPORATION:			I0
		FISCAL YEAR END:			1231

	FILING VALUES:
		FORM TYPE:		6-K
		SEC ACT:		1934 Act
		SEC FILE NUMBER:	001-40377
		FILM NUMBER:		241383426

	BUSINESS ADDRESS:	
		STREET 1:		6, RUE ALAIN BOMBARD
		CITY:			SAINT-HERBLAIN
		STATE:			I0
		ZIP:			44800
		BUSINESS PHONE:		33 2 28 07 37 10

	MAIL ADDRESS:	
		STREET 1:		6, RUE ALAIN BOMBARD
		CITY:			SAINT-HERBLAIN
		STATE:			I0
		ZIP:			44800
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<TYPE>6-K
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<FILENAME>f6k_102124.htm
<DESCRIPTION>FORM 6-K
<TEXT>
<html><head><title></title></head><body style="FONT-FAMILY: Times New Roman; FONT-SIZE: 10pt"><div align="center"><div style="margin-top: 3pt; margin-bottom: 12pt;"><div style="font-size: 1pt; border-top: Black 2.5pt solid; border-bottom: Black 1.1pt solid; width: 100%;">&#160;</div></div><p style="font-size: 14pt;" align="center"><strong>UNITED STATES</strong><br /><strong>SECURITIES AND EXCHANGE COMMISSION</strong><br /><strong>Washington, D.C. 20549</strong></p><p style="font-size: 14pt; text-transform: uppercase;" align="center"><strong>Form 6-K</strong></p><p style="text-align: center;"><strong></strong></p><p style="text-align: center;"><strong>REPORT OF FOREIGN PRIVATE ISSUER PURSUANT TO RULE 13a-16 OR 15d-16 UNDER THE SECURITIES EXCHANGE ACT OF 1934</strong></p><p style="text-align: center;"><strong></strong><strong>Date of Report: October 21, 2024</strong></p><p style="text-align: center;">Commission File Number: <strong>001-40377</strong></p><p style="text-align: center;"><font style="font-size: 12pt;"><strong>Valneva SE</strong></font><br />(Translation of registrant's name into English)</p><p style="text-align: center;"><strong><!--6 rue Alain Bombard-->6 rue Alain Bombard<br />44800 Saint-Herblain, France<br />(Address of principal executive office)</strong></p></div><p>Indicate by check mark whether the registrant files or will file annual reports under cover of Form 20-F or Form 40-F.<br />Form 20-F [&#160;X ] &#160;&#160;&#160;&#160;&#160;Form 40-F [&#160;&#160; ]</p><!--<p>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): <u>&#160;&#160;&#160;&#160;&#160;&#160;</u></p><p><strong>Note:&#160;</strong>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.</p><p>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): <u>&#160;&#160;&#160;&#160;&#160;&#160;</u></p><p><strong>Note:&#160;</strong>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.&#160;</p>--><hr style="page-break-after: always;" noshade="noshade" /><p> <p>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.&#160;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).</p><table style="font-size: 10pt;" border="0" cellspacing="0" cellpadding="0"><tr><td style="text-decoration-line: underline;" valign="bottom"><font><strong>Exhibit</strong></font></td><td width="20"><font>&#160;</font></td><td>&#160;</td></tr><tr><td>&#160;</td><td width="20"><font>&#160;</font></td><td><font>&#160;</font></td></tr><tr><td><a href="exh_991.htm">99.1</a></td><td width="20"><font>&#160;</font></td><td><a href="exh_991.htm"><font>Press release dated October 21, 2024 </font></a></td></tr></table></p><p /><hr style="page-break-after: always;" noshade="noshade" /><p style="text-align: center;"><strong>SIGNATURES</strong></p><p>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.</p><table style="font-family: Times New Roman; font-size: 10pt;" border="0" width="100%" cellspacing="0" cellpadding="0"><tr valign="top"><td width="47%">&#160;</td><td width="6%">&#160;</td><td style="text-decoration: underline;" align="center" width="47%"><strong>&#160;&#160;&#160;&#160;Valneva SE&#160;&#160;&#160;&#160;</strong></td></tr><tr valign="top"><td width="47%">&#160;</td><td width="6%">&#160;</td><td align="center" width="47%">(Registrant)</td></tr><tr valign="top"><td width="47%">&#160;</td><td width="6%">&#160;</td><td align="center" width="47%">&#160;</td></tr><tr valign="top"><td width="47%">&#160;</td><td width="6%">&#160;</td><td align="center" width="47%"></td></tr><tr valign="top"><td width="47%">Date: October 21, 2024</td><td width="6%">&#160;</td><td style="text-decoration: underline;" align="center" width="47%">&#160;&#160;&#160;&#160;/s/ Thomas Lingelbach&#160;&#160;&#160;&#160;</td></tr><tr valign="top"><td width="47%">&#160;</td><td width="6%">&#160;</td><td align="center" width="47%">Thomas Lingelbach</td></tr><tr valign="top"><td width="47%">&#160;</td><td width="6%">&#160;</td><td align="center" width="47%">Chief Executive Officer and President</td></tr><tr valign="top"><td width="47%">&#160;</td><td width="6%">&#160;</td><td align="center" width="47%"></td></tr></table></body></html>
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<TYPE>EX-99.1
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<FILENAME>exh_991.htm
<DESCRIPTION>PRESS RELEASE
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<p ></p><p style="text-align: right;"><FONT STYLE="font-size: 10pt"><B>EXHIBIT 99.1</B></FONT></p><p style="text-align: center;"><FONT STYLE="font-size: 10pt"><B>Valneva
                                            to Present on Chikungunya at Several Leading Scientific Conferences</B></FONT></p><p style="text-align: center;" ></p><p><p><FONT STYLE="font-size: 10pt"><B>Saint-Herblain (France), October 21, 2024</B> &#8211; 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&#8217;s
     first and only approved chikungunya vaccine, IXCHIQ<SUP>&#174;</SUP>, at several leading scientific conferences during the fourth
     quarter of 2024.</FONT></p>  <p align="justify"><FONT STYLE="font-size: 10pt">At
                                            the <B>International Society of Vaccines Annual Congress</B> 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.</FONT></p>  <p align="justify"><FONT STYLE="font-size: 10pt">At
                                            the <B>American Society of Tropical Medicine and Hygiene (ASTMH) 2024 Annual Meeting </B>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: &#8220;Chikungunya: Ongoing Dose-Response, Safety, and Immunogenicity Phase
                                            2 Trial of Single-dose Live-attenuated Vaccine (VLA1553) in Children aged 1 to 11 years&#8221;,
                                            &#8220;Modelling of 5 Year Antibody Persistence after Vaccination with Live Attenuated Chikungunya
                                            Vaccine VLA1553 (IXCHIQ<SUP>&#174;</SUP>)&#8221;, &#8220;The Global Health Burden of Chikungunya
                                            from 2011 to 2020: A Model-Driven Analysis on the Impact of an Emerging Vector-Borne Disease&#8221;
                                            and &#8220;Predicting Chikungunya in Miami: Outbreak Impact and Effectiveness of Vaccine
                                            Intervention with IXCHIQ<SUP>&#174;</SUP>&#8221;.</FONT></p>  <p align="justify"><FONT STYLE="font-size: 10pt">Finally,
                                            during the <B>International Society for Pharmacoeconomics and Outcomes Research (ISPOR) European
                                            Congress</B> taking place November 17 - 20, 2024 in Barcelona, Spain, Valneva will present
                                            a poster on the cost-effectiveness of IXCHIQ<SUP>&#174;</SUP> vaccination in Puerto Rico.</FONT></p>  <p align="justify"><FONT STYLE="font-size: 10pt"><B>About
                                            Chikungunya</B><BR>Chikungunya virus (CHIKV) is a mosquito-borne viral disease spread by
                                            the bites of infected <I>Aedes</I> 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.<SUP>1</SUP><BR>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.<SUP>2</SUP>
                                            Between 2013 and 2023, more than 3.7 million cases were reported in the Americas<SUP>3</SUP>
                                            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.<SUP>4</SUP></FONT></p>  <p align="justify"><FONT STYLE="font-size: 10pt"><B>About
                                            Valneva SE</B><BR>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.<BR>We have
                                            a strong track record, having advanced multiple vaccines from early R&amp;D to approvals,
                                            and currently market three proprietary travel vaccines, including the world&#8217;s first
                                            and only chikungunya vaccine, as well as certain third-party vaccines.<BR>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&#8217;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.</FONT></p> <table style="width:510.25pt; border-collapse:collapse !important;;border-collapse: collapse; "><tr><td style="width:396.94px;;vertical-align: top ; "><FONT STYLE="font-size: 10pt"><B>Valneva
                                            Investor and Media Contacts</B><BR>Laetitia Bachelot-Fontaine<BR>VP Global Communications
                                            &amp; European Investor Relations<BR>M +33 (0)6 4516 7099<BR>laetitia.bachelot-fontaine@valneva.com&#160;&#160;&#160;&#160;&#160;&#160;&#160;&#160;</FONT></td><td style="width:283.4px;;vertical-align: top ; "><FONT STYLE="font-size: 10pt">&#160;<BR><BR>Joshua
                                            Drumm, Ph.D.<BR>VP Global Investor Relations<BR>M +001 917 815 4520<BR>joshua.drumm@valneva.com</FONT></td></tr></table> <p><FONT STYLE="font-size: 10pt"><B>Forward-Looking
                                            Statements</B></FONT></p>  <p align="justify"><FONT STYLE="font-size: 10pt">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 &#8220;could,&#8221; &#8220;should,&#8221;
                                            &#8220;may,&#8221; &#8220;expects,&#8221; &#8220;anticipates,&#8221; &#8220;believes,&#8221;
                                            &#8220;intends,&#8221; &#8220;estimates,&#8221; &#8220;aims,&#8221; &#8220;targets,&#8221;
                                            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.</FONT></p>  <hr >  <p><FONT STYLE="font-size: 10pt"><I>1
                                            https://jvi.asm.org/content/jvi/88/20/11644.full.pdf</I><BR><I>2 https://cmr.asm.org/content/31/1/e00104-16</I><BR><I>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.</I><BR><I>4 Geographical expansion of cases of dengue and chikungunya
                                            beyond the historical areas of transmission in the Region of the Americas (who.int)</I></FONT></p>  <p><FONT STYLE="font-size: 10pt">&#160;</FONT></p>
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