<SEC-DOCUMENT>0001628280-25-001948.txt : 20250121
<SEC-HEADER>0001628280-25-001948.hdr.sgml : 20250121
<ACCEPTANCE-DATETIME>20250121081056
ACCESSION NUMBER:		0001628280-25-001948
CONFORMED SUBMISSION TYPE:	6-K
PUBLIC DOCUMENT COUNT:		2
CONFORMED PERIOD OF REPORT:	20251231
FILED AS OF DATE:		20250121
DATE AS OF CHANGE:		20250121

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:		25540495

	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
</SEC-HEADER>
<DOCUMENT>
<TYPE>6-K
<SEQUENCE>1
<FILENAME>a6-kcoverpagetemplate.htm
<DESCRIPTION>COVER
<TEXT>
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<title>Document</title></head><body><div id="if383fd469a974d61b775fa2416f7e223_1"></div><div style="min-height:45.36pt;width:100%"><div style="margin-bottom:0.04pt;margin-top:0.04pt;text-align:justify"><font><br></font></div></div><div style="padding-left:5.3pt"><font><br></font></div><div style="margin-top:0.05pt"><font><br></font></div><div style="padding-left:0.15pt;padding-right:0.15pt;text-align:center"><font style="color:#000000;font-family:'Times New Roman',sans-serif;font-size:14pt;font-weight:700;line-height:100%">UNITED STATES</font></div><div style="margin-top:0.4pt;padding-left:0.15pt;padding-right:0.15pt;text-align:center"><font style="color:#000000;font-family:'Times New Roman',sans-serif;font-size:14pt;font-weight:700;line-height:100%">SECURITIES AND EXCHANGE COMMISSION</font></div><div style="margin-bottom:0.04pt;margin-top:0.04pt;text-align:center"><font style="color:#000000;font-family:'Times New Roman',sans-serif;font-size:14pt;font-weight:700;line-height:133%">Washington, D.C. 20549</font></div><div style="margin-bottom:0.04pt;margin-top:0.04pt;padding-left:117.17pt;padding-right:117.17pt;text-align:center"><font><br></font></div><div style="margin-bottom:0.04pt;margin-top:0.04pt;padding-left:117.17pt;padding-right:117.17pt;text-align:center"><font style="color:#000000;font-family:'Times New Roman',sans-serif;font-size:14pt;font-weight:700;line-height:133%">FORM 6-K</font></div><div style="margin-bottom:0.04pt;margin-top:0.04pt;padding-left:117.17pt;padding-right:117.17pt;text-align:center"><font><br></font></div><div style="margin-top:0.35pt;text-align:center"><font style="color:#000000;font-family:'Times New Roman',sans-serif;font-size:10pt;font-weight:700;line-height:100%">REPORT OF FOREIGN PRIVATE ISSUER PURSUANT TO RULE 13a-16 OR 15d-16 UNDER THE                </font></div><div style="text-align:center"><font style="color:#000000;font-family:'Times New Roman',sans-serif;font-size:10pt;font-weight:700;line-height:120%">SECURITIES EXCHANGE ACT OF 1934</font></div><div style="text-align:center"><font><br></font></div><div style="margin-bottom:0.04pt;margin-top:0.04pt;text-align:center"><font style="color:#000000;font-family:'Times New Roman',sans-serif;font-size:10pt;font-weight:700;line-height:133%">Date of Report&#58; January 21, 2025</font></div><div style="margin-bottom:0.04pt;margin-top:0.04pt;text-align:center"><font><br></font></div><div style="margin-bottom:0.04pt;margin-top:0.04pt;padding-left:114.85pt;padding-right:114.85pt;text-align:center"><font style="color:#000000;font-family:'Times New Roman',sans-serif;font-size:10pt;font-weight:700;line-height:133%"> </font><font style="color:#000000;font-family:'Times New Roman',sans-serif;font-size:10pt;font-weight:400;line-height:133%">Commission File Number&#58; </font><font style="color:#000000;font-family:'Times New Roman',sans-serif;font-size:10pt;font-weight:700;line-height:133%">001-40377</font></div><div style="margin-bottom:0.04pt;margin-top:0.04pt;padding-left:114.85pt;padding-right:114.85pt;text-align:center"><font><br></font></div><div style="margin-bottom:0.04pt;margin-top:0.04pt;padding-left:114.85pt;padding-right:114.85pt;text-align:center"><font style="color:#000000;font-family:'Times New Roman',sans-serif;font-size:12pt;font-weight:700;line-height:133%"> Valneva SE</font></div><div style="margin-top:0.8pt;padding-left:111.72pt;padding-right:111.72pt;text-align:center"><font style="color:#000000;font-family:'Times New Roman',sans-serif;font-size:10pt;font-weight:400;line-height:100%">(Translation of registrant's name into English)</font></div><div style="margin-top:0.55pt"><font><br></font></div><div style="padding-left:116.95pt;padding-right:116.95pt;text-align:center"><font style="color:#000000;font-family:'Times New Roman',sans-serif;font-size:8pt;font-weight:700;line-height:128%">6 rue Alain Bombard</font></div><div style="text-align:center"><font style="color:#000000;font-family:'Times New Roman',sans-serif;font-size:8pt;font-weight:700;line-height:120%">44800 Saint-Herblain, France</font></div><div style="text-align:center"><font style="color:#000000;font-family:'Times New Roman',sans-serif;font-size:8pt;font-weight:700;line-height:120%">(Address of principal executive office)</font></div><div style="text-align:justify"><font><br></font></div><div style="margin-top:0.5pt;text-align:justify"><font style="color:#000000;font-family:'Times New Roman',sans-serif;font-size:10pt;font-weight:400;line-height:100%">Indicate by check mark whether the registrant files or will file annual reports under cover of Form 20-F or Form 40-F. </font></div><div style="text-align:justify"><font><br></font></div><div style="text-align:justify"><font style="color:#000000;font-family:'Times New Roman',sans-serif;font-size:10pt;font-weight:400;line-height:120%">Form 20-F &#9746; Form 40-F &#9744;</font></div><div style="margin-top:0.5pt;text-align:justify"><font><br></font></div><div style="text-align:justify"><font style="color:#000000;font-family:'Times New Roman',sans-serif;font-size:10pt;font-weight:400;line-height:100%">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)&#58;</font></div><div style="margin-top:0.55pt;text-align:justify"><font><br></font></div><div style="text-align:justify"><font style="color:#000000;font-family:'Times New Roman',sans-serif;font-size:10pt;font-weight:700;line-height:120%">Note</font><font style="color:#000000;font-family:'Times New Roman',sans-serif;font-size:10pt;font-weight:400;line-height:120%">&#58; 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. </font></div><div style="text-align:justify"><font><br></font></div><div style="text-align:justify"><font><br></font></div><div style="text-align:justify"><font style="color:#000000;font-family:'Times New Roman',sans-serif;font-size:10pt;font-weight:400;line-height:120%">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)&#58;</font></div><div style="margin-top:0.05pt;padding-right:7.85pt;text-align:justify"><font><br></font></div><div style="padding-right:7.85pt;text-align:justify"><font style="color:#000000;font-family:'Times New Roman',sans-serif;font-size:10pt;font-weight:700;line-height:120%">Note&#58; </font><font style="color:#000000;font-family:'Times New Roman',sans-serif;font-size:10pt;font-weight:400;line-height:120%">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 &#34;home country&#34;), 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.</font></div><div style="margin-top:0.55pt"><font><br></font></div><div style="margin-top:0.55pt;text-align:justify"><font><br></font></div><div style="margin-top:3.6pt;padding-left:5.3pt;padding-right:7.85pt;text-align:justify"><font><br></font></div><div style="padding-right:7.85pt;text-align:justify"><font style="color:#000000;font-family:'Times New Roman',sans-serif;font-size:10pt;font-weight:400;line-height:120%">On January 20, 2025, the Registrant issued a press release, a copy of which is attached hereto as Exhibit 99.1 and 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).</font></div><div style="padding-right:7.85pt;text-align:justify"><font><br></font></div><div style="padding-right:7.85pt"><table style="border-collapse:collapse;display:inline-table;margin-bottom:5pt;vertical-align:text-bottom;width:93.779%"><tr><td style="width:1.0%"></td><td style="width:13.529%"></td><td style="width:0.1%"></td><td style="width:1.0%"></td><td style="width:84.271%"></td><td style="width:0.1%"></td></tr><tr><td colspan="3" style="padding:2px 1pt;text-align:left;vertical-align:bottom"><font style="color:#000000;font-family:'Times New Roman',sans-serif;font-size:10pt;font-weight:700;line-height:133%;text-decoration:underline">Exhibit</font></td><td colspan="3" style="padding:0 1pt"></td></tr><tr style="height:5pt"><td colspan="3" style="padding:0 1pt"></td><td colspan="3" style="padding:0 1pt"></td></tr><tr><td colspan="3" style="padding:2px 1pt 2px 6.3pt;text-align:left;vertical-align:bottom"><font style="color:#000000;font-family:'Times New Roman',sans-serif;font-size:10pt;font-weight:400;line-height:125%">Exhibit 99.1</font></td><td colspan="3" style="padding:2px 1pt;text-align:left;vertical-align:bottom"><div style="margin-bottom:0.1pt;padding-left:5.3pt"><font style="color:#0000ff;font-family:'Times New Roman',sans-serif;font-size:10pt;font-weight:400;line-height:125%;text-decoration:underline"><a href="valnevapr20-1x25.htm" style="color:#0000ff;font-family:'Times New Roman',sans-serif;font-size:10pt;font-weight:400;line-height:125%;text-decoration:underline">Press release dated </a><a href="valnevapr20-1x25.htm" style="color:#0000ff;font-family:'Times New Roman',sans-serif;font-size:10pt;font-weight:400;line-height:125%;text-decoration:underline">Ja</a><a href="valnevapr20-1x25.htm" style="color:#0000ff;font-family:'Times New Roman',sans-serif;font-size:10pt;font-weight:400;line-height:125%;text-decoration:underline">nuary </a><a href="valnevapr20-1x25.htm" style="color:#0000ff;font-family:'Times New Roman',sans-serif;font-size:10pt;font-weight:400;line-height:125%;text-decoration:underline">20</a><a href="valnevapr20-1x25.htm" style="color:#0000ff;font-family:'Times New Roman',sans-serif;font-size:10pt;font-weight:400;line-height:125%;text-decoration:underline">, 202</a><a href="valnevapr20-1x25.htm" style="color:#0000ff;font-family:'Times New Roman',sans-serif;font-size:10pt;font-weight:400;line-height:125%;text-decoration:underline">5</a></font></div></td></tr></table></div><div style="margin-top:0.5pt;text-align:center"><font><br></font></div><div style="text-align:center"><font><br></font></div><div style="text-align:center"><font><br></font></div><div style="text-align:center"><font><br></font></div><div style="text-align:center"><font><br></font></div><div style="text-align:center"><font><br></font></div><div style="text-align:center"><font><br></font></div><div style="height:36pt;position:relative;width:100%"><div style="bottom:0;position:absolute;width:100%"><div style="margin-bottom:0.04pt;margin-top:0.04pt;text-align:justify"><font><br></font></div></div></div><hr style="page-break-after:always"><div style="min-height:45.36pt;width:100%"><div style="margin-bottom:0.04pt;margin-top:0.04pt;text-align:justify"><table style="border-collapse:collapse;display:inline-table;margin-bottom:5pt;vertical-align:text-bottom;width:59.089%"><tr><td style="width:1.0%"></td><td style="width:32.233%"></td><td style="width:0.1%"></td><td style="width:1.0%"></td><td style="width:32.233%"></td><td style="width:0.1%"></td><td style="width:1.0%"></td><td style="width:32.234%"></td><td style="width:0.1%"></td></tr><tr style="height:15pt"><td colspan="3" style="padding:0 1pt"></td><td colspan="3" style="padding:0 1pt"></td><td colspan="3" style="padding:0 1pt"></td></tr></table></div></div><div style="text-align:center"><font><br></font></div><div style="text-align:center"><font><br></font></div><div style="text-align:center"><font style="color:#000000;font-family:'Times New Roman',sans-serif;font-size:10pt;font-weight:700;line-height:120%">SIGNATURES</font></div><div><font><br></font></div><div style="padding-left:5.3pt"><font style="color:#000000;font-family:'Times New Roman',sans-serif;font-size:10pt;font-weight:400;line-height:100%">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.</font></div><div><font><br></font></div><div><table style="border-collapse:collapse;display:inline-table;margin-bottom:5pt;vertical-align:text-bottom;width:99.952%"><tr><td style="width:1.0%"></td><td style="width:13.507%"></td><td style="width:0.1%"></td><td style="width:1.0%"></td><td style="width:12.821%"></td><td style="width:0.1%"></td><td style="width:1.0%"></td><td style="width:12.821%"></td><td style="width:0.1%"></td><td style="width:1.0%"></td><td style="width:12.821%"></td><td style="width:0.1%"></td><td style="width:1.0%"></td><td style="width:12.821%"></td><td style="width:0.1%"></td><td style="width:1.0%"></td><td style="width:20.762%"></td><td style="width:0.1%"></td><td style="width:1.0%"></td><td style="width:6.747%"></td><td style="width:0.1%"></td></tr><tr><td colspan="3" style="padding:0 1pt"></td><td colspan="3" style="padding:0 1pt"></td><td colspan="3" style="padding:0 1pt"></td><td colspan="3" style="padding:0 1pt"></td><td colspan="3" style="padding:0 1pt"></td><td colspan="3" style="padding:2px 1pt;text-align:left;vertical-align:middle"><div style="margin-bottom:0.1pt;text-align:center"><font style="color:#000000;font-family:'Times New Roman',sans-serif;font-size:10pt;font-weight:700;line-height:133%;text-decoration:underline">Valneva SE</font><font style="color:#000000;font-family:'Times New Roman',sans-serif;font-size:10pt;font-weight:400;line-height:133%">                           (Registrant)</font></div></td><td colspan="3" style="padding:0 1pt"></td></tr><tr style="height:20pt"><td colspan="3" style="padding:0 1pt"></td><td colspan="3" style="padding:0 1pt"></td><td colspan="3" style="padding:0 1pt"></td><td colspan="3" style="padding:0 1pt"></td><td colspan="3" style="padding:0 1pt"></td><td colspan="3" style="padding:0 1pt"></td><td colspan="3" style="padding:0 1pt"></td></tr><tr><td colspan="3" style="padding:2px 1pt;text-align:center;vertical-align:middle"><font style="color:#000000;font-family:'Times New Roman',sans-serif;font-size:10pt;font-weight:400;line-height:133%">Date&#58;  January 7, 2025</font></td><td colspan="3" style="padding:0 1pt"></td><td colspan="3" style="padding:0 1pt"></td><td colspan="3" style="padding:0 1pt"></td><td colspan="3" style="padding:0 1pt"></td><td colspan="3" style="padding:2px 1pt;text-align:left;vertical-align:middle"><div style="margin-bottom:0.1pt;text-align:center"><font style="color:#000000;font-family:'Times New Roman',sans-serif;font-size:10pt;font-weight:400;line-height:133%;text-decoration:underline">&#47;s&#47; Thomas Lingelbach</font><font style="color:#000000;font-family:'Times New Roman',sans-serif;font-size:10pt;font-weight:400;line-height:133%">                 Thomas Lingelbach                          Chief Executive Officer and President</font></div></td><td colspan="3" style="padding:0 1pt"></td></tr></table></div><div style="margin-bottom:0.04pt;margin-top:0.04pt;padding-right:5.2pt;text-align:right"><font><br></font></div><div style="margin-bottom:0.04pt;margin-top:0.04pt;padding-right:5.2pt;text-align:right"><font><br></font></div><div style="height:36pt;position:relative;width:100%"><div style="bottom:0;position:absolute;width:100%"><div style="margin-bottom:0.04pt;margin-top:0.04pt;text-align:justify"><font><br></font></div></div></div></body></html>
</TEXT>
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<DOCUMENT>
<TYPE>EX-99.1
<SEQUENCE>2
<FILENAME>valnevapr20-1x25.htm
<DESCRIPTION>EX-99.1
<TEXT>
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<title>Document</title></head><body><div id="ib55cfea55e044c2caebf7dcf4cabaa41_78"></div><div style="min-height:72pt;width:100%"><div style="margin-bottom:8pt"><font><br></font></div></div><div style="margin-bottom:8pt"><font><br></font></div><div id="ib55cfea55e044c2caebf7dcf4cabaa41_1"></div><div style="text-align:center"><font style="color:#000000;font-family:'Times New Roman',sans-serif;font-size:16pt;font-weight:700;line-height:120%">Valneva Reports High Sustained Immune Response in Adolescents One Year After Single Vaccination with its Chikungunya Vaccine</font></div><div style="margin-bottom:8pt"><font><br></font></div><div style="margin-bottom:8pt"><font style="color:#000000;font-family:'Times New Roman',sans-serif;font-size:11pt;font-weight:700;line-height:125%">January 20, 2025</font></div><div style="margin-bottom:8pt"><font style="color:#000000;font-family:'Times New Roman',sans-serif;font-size:11pt;font-weight:700;line-height:125%">Saint-Herblain (France), January 20, 2025</font><font style="color:#000000;font-family:'Times New Roman',sans-serif;font-size:11pt;font-weight:400;line-height:125%"> &#8211; Valneva SE (Nasdaq&#58; VALN&#59; Euronext Paris&#58; VLA), a specialty vaccine company, today reported further positive Phase 3 data in adolescents for its single-shot chikungunya virus (CHIKV) vaccine, IXCHIQ&#174;, which showed a sustained 98.3% sero-response rate one-year after single vaccination. These results support and strengthen the pivotal data previously reported for adolescents (12 to 17 years old) which supported filing for potential label extension to this age group in the U.S.</font><font style="color:#000000;font-family:'Times New Roman',sans-serif;font-size:7.15pt;font-weight:400;line-height:125%;position:relative;top:-3.85pt;vertical-align:baseline">1</font><font style="color:#000000;font-family:'Times New Roman',sans-serif;font-size:11pt;font-weight:400;line-height:125%">, Europe, and Canada</font><font style="color:#000000;font-family:'Times New Roman',sans-serif;font-size:7.15pt;font-weight:400;line-height:125%;position:relative;top:-3.85pt;vertical-align:baseline">2</font><font style="color:#000000;font-family:'Times New Roman',sans-serif;font-size:11pt;font-weight:400;line-height:125%">. Data from this trial are also expected to support licensure of IXCHIQ&#174; in Brazil, which would be the first potential approval for use in endemic populations.</font></div><div style="margin-bottom:8pt"><font style="color:#000000;font-family:'Times New Roman',sans-serif;font-size:11pt;font-weight:400;line-height:125%">The one-year VLA1553-321 data showed that a single-dose vaccination induced a high, sustained immune response in an immunogenicity subset of participants who were CHIKV negative at baseline, with a seroresponse rate of 98.3% (232 out of 236 participants) one year after vaccination (Day 360) compared to 99.1% (232 out of 234 participants) after six month</font><font style="color:#000000;font-family:'Times New Roman',sans-serif;font-size:7.15pt;font-weight:400;line-height:125%;position:relative;top:-3.85pt;vertical-align:baseline">3</font><font style="color:#000000;font-family:'Times New Roman',sans-serif;font-size:11pt;font-weight:400;line-height:125%"> (Day 180) and 98.8% (248 out of 251 participants) 28 days</font><font style="color:#000000;font-family:'Times New Roman',sans-serif;font-size:7.15pt;font-weight:400;line-height:125%;position:relative;top:-3.85pt;vertical-align:baseline">4,5</font><font style="color:#000000;font-family:'Times New Roman',sans-serif;font-size:11pt;font-weight:400;line-height:125%"> after vaccination. The results complement the long-term persistence data previously reported for adults</font><font style="color:#000000;font-family:'Times New Roman',sans-serif;font-size:7.15pt;font-weight:400;line-height:125%;position:relative;top:-3.85pt;vertical-align:baseline">6</font><font style="color:#000000;font-family:'Times New Roman',sans-serif;font-size:11pt;font-weight:400;line-height:125%">, confirming a strong and long-lasting antibody response to the vaccine.</font></div><div style="margin-bottom:8pt"><font style="color:#000000;font-family:'Times New Roman',sans-serif;font-size:11pt;font-weight:400;line-height:125%">Geometric mean antibody titers (GMTs) consistently surpassed the seroresponse threshold defined with the U.S. Food and Drug Administration (FDA)</font><font style="color:#000000;font-family:'Times New Roman',sans-serif;font-size:7.15pt;font-weight:400;line-height:125%;position:relative;top:-3.85pt;vertical-align:baseline">7</font><font style="color:#000000;font-family:'Times New Roman',sans-serif;font-size:11pt;font-weight:400;line-height:125%"> as the surrogate of protection in baseline seronegative participants who received a single dose of the vaccine.</font></div><div style="margin-bottom:8pt"><font style="color:#000000;font-family:'Times New Roman',sans-serif;font-size:11pt;font-weight:400;line-height:125%">Additionally, the one-year data confirmed that a single dose of the vaccine was generally well tolerated in adolescents. Throughout the trial, an Independent Data Safety Monitoring Board (IDSMB) consistently assessed safety data and found no safety issues.</font></div><div style="margin-bottom:8pt"><font style="color:#000000;font-family:'Times New Roman',sans-serif;font-size:11pt;font-weight:400;line-height:125%">Juan Carlos Jaramillo M.D., Chief Medical Officer of Valneva, said, &#8220;These additional adolescent data confirm IXCHIQ&#174;&#8217;s ability to induce a robust, long-lasting antibody response in both younger people and adults with a single vaccination. Given the substantial risk that chikungunya presents to individuals residing in or traveling to endemic regions, it&#8217;s imperative to ensure the vaccine is available to all age groups and has the potential to offer long-term protection, particularly in low- and middle-income countries (LMICs) where vaccine access is often limited. We are now looking forward to the first data in children which we expect to report imminently.&#8221;</font></div><div style="margin-bottom:8pt"><font style="color:#000000;font-family:'Times New Roman',sans-serif;font-size:11pt;font-weight:400;line-height:125%">Conducted in collaboration with Instituto Butantan in Brazil and funded by the Coalition for Epidemic Preparedness Innovations (CEPI) with support from the European Union (EU)&#8217;s Horizon 2020 program, the VLA1553-321 trial represents the first clinical trial conducted in an endemic area and with individuals previously infected with CHIKV. This trial supported the submission of label extension applications to the U.S. Food and Drug Administration (FDA)</font><font style="color:#000000;font-family:'Times New Roman',sans-serif;font-size:7.15pt;font-weight:400;line-height:125%;position:relative;top:-3.85pt;vertical-align:baseline">8</font><font style="color:#000000;font-family:'Times New Roman',sans-serif;font-size:11pt;font-weight:400;line-height:125%">, the European Medicines Agency (EMA) and Health Canada</font><font style="color:#000000;font-family:'Times New Roman',sans-serif;font-size:7.15pt;font-weight:400;line-height:125%;position:relative;top:-3.85pt;vertical-align:baseline">9</font><font style="color:#000000;font-family:'Times New Roman',sans-serif;font-size:11pt;font-weight:400;line-height:125%"> to potentially extend the use of IXCHIQ&#174; to adolescents aged 12 to 17 years. Data from this trial may support regulatory approval of the vaccine in Brazil and other countries in Latin America.</font></div><div style="margin-bottom:8pt"><font style="color:#000000;font-family:'Times New Roman',sans-serif;font-size:11pt;font-weight:400;line-height:125%">Valneva expanded its partnership with CEPI, with support from the EU&#8217;s Horizon Europe programme, in the third quarter of 2024</font><font style="color:#000000;font-family:'Times New Roman',sans-serif;font-size:7.15pt;font-weight:400;line-height:125%;position:relative;top:-3.85pt;vertical-align:baseline">10</font><font style="color:#000000;font-family:'Times New Roman',sans-serif;font-size:11pt;font-weight:400;line-height:125%"> through a $41.3 million grant to advance broader access to the vaccine in LMICs, including outbreak-affected countries, post-marketing studies and potential </font></div><div style="height:72pt;position:relative;width:100%"><div style="bottom:0;position:absolute;width:100%"><div style="margin-bottom:8pt"><font><br></font></div></div></div><hr style="page-break-after:always"><div style="min-height:72pt;width:100%"><div style="margin-bottom:8pt"><font><br></font></div></div><div style="margin-bottom:8pt"><font style="color:#000000;font-family:'Times New Roman',sans-serif;font-size:11pt;font-weight:400;line-height:125%">label extensions in children, adolescents and pregnant women. Within the framework of this agreement, Valneva recently announced the signing of an exclusive license agreement with the Serum Institute of India (SII), the world&#8217;s largest manufacturer of vaccines by number of doses</font><font style="color:#000000;font-family:'Times New Roman',sans-serif;font-size:7.15pt;font-weight:400;line-height:125%;position:relative;top:-3.85pt;vertical-align:baseline">11</font><font style="color:#000000;font-family:'Times New Roman',sans-serif;font-size:11pt;font-weight:400;line-height:125%">, enabling the supply of the vaccine in Asia, with a commitment to priority supply of the chikungunya vaccine at an affordable price to public health markets in LMICs.</font></div><div style="margin-bottom:8pt"><font style="color:#000000;font-family:'Times New Roman',sans-serif;font-size:11pt;font-weight:400;line-height:125%">IXCHIQ&#174; is the world&#8217;s first and only licensed chikungunya vaccine available to address this significant unmet medical need. The vaccine is currently approved in the U.S.</font><font style="color:#000000;font-family:'Times New Roman',sans-serif;font-size:7.15pt;font-weight:400;line-height:125%;position:relative;top:-3.85pt;vertical-align:baseline">12</font><font style="color:#000000;font-family:'Times New Roman',sans-serif;font-size:11pt;font-weight:400;line-height:125%">, Europe</font><font style="color:#000000;font-family:'Times New Roman',sans-serif;font-size:7.15pt;font-weight:400;line-height:125%;position:relative;top:-3.85pt;vertical-align:baseline">13</font><font style="color:#000000;font-family:'Times New Roman',sans-serif;font-size:11pt;font-weight:400;line-height:125%">, and Canada</font><font style="color:#000000;font-family:'Times New Roman',sans-serif;font-size:7.15pt;font-weight:400;line-height:125%;position:relative;top:-3.85pt;vertical-align:baseline">14</font><font style="color:#000000;font-family:'Times New Roman',sans-serif;font-size:11pt;font-weight:400;line-height:125%"> for the prevention of disease caused by the chikungunya virus in individuals 18 years of age and older. In addition to Brazil, Valneva also expects to receive marketing approval in the United Kingdom in the first quarter of the year.</font></div><div style="margin-bottom:8pt"><font><br></font></div><div style="margin-bottom:8pt"><font style="color:#000000;font-family:'Times New Roman',sans-serif;font-size:11pt;font-weight:700;line-height:125%">About Phase 3 Study VLA1553-321</font></div><div style="margin-bottom:8pt"><font style="color:#000000;font-family:'Times New Roman',sans-serif;font-size:11pt;font-weight:400;line-height:125%">VLA1553-321 is a prospective, double-blinded, multicenter, randomized, placebo-controlled pivotal Phase 3 trial conducted in 754 adolescents aged 12 to 17 years old in Brazil. The VLA1553-321 clinical trial was initiated in January 2022 and Valneva reported immunogenicity and safety data 28 days and six months after a single vaccination in 2023</font><font style="color:#000000;font-family:'Times New Roman',sans-serif;font-size:7.15pt;font-weight:400;line-height:125%;position:relative;top:-3.85pt;vertical-align:baseline">15, 16 </font><font style="color:#000000;font-family:'Times New Roman',sans-serif;font-size:11pt;font-weight:400;line-height:125%">and 2024</font><font style="color:#000000;font-family:'Times New Roman',sans-serif;font-size:7.15pt;font-weight:400;line-height:125%;position:relative;top:-3.85pt;vertical-align:baseline">17</font><font style="color:#000000;font-family:'Times New Roman',sans-serif;font-size:11pt;font-weight:400;line-height:125%">, respectively. Valneva&#8217;s chikungunya vaccine or placebo was administered as a single intramuscular immunization to participants who were randomized into two study groups at a 2&#58;1 ratio. The primary objective was to evaluate the immunogenicity and safety of the adult dose of the vaccine in adolescents 28 days following a single vaccination. Secondary objectives of the trial included assessment of safety and immunogenicity up to twelve months following a single vaccination with the vaccine. Additional information, including a detailed description of the study design, eligibility criteria and investigator sites, is available at ClinicalTrials.gov (Identifier&#58; NCT04650399).</font></div><div style="margin-bottom:8pt"><font><br></font></div><div style="margin-bottom:8pt"><font style="color:#000000;font-family:'Times New Roman',sans-serif;font-size:11pt;font-weight:700;line-height:125%">About Chikungunya</font></div><div style="margin-bottom:8pt"><font style="color:#000000;font-family:'Times New Roman',sans-serif;font-size:11pt;font-weight:400;line-height:125%">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</font><font style="color:#000000;font-family:'Times New Roman',sans-serif;font-size:7.15pt;font-weight:400;line-height:125%;position:relative;top:-3.85pt;vertical-align:baseline">18</font><font style="color:#000000;font-family:'Times New Roman',sans-serif;font-size:11pt;font-weight:400;line-height:125%">.</font></div><div style="margin-bottom:8pt"><font style="color:#000000;font-family:'Times New Roman',sans-serif;font-size:11pt;font-weight:400;line-height:125%">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</font><font style="color:#000000;font-family:'Times New Roman',sans-serif;font-size:7.15pt;font-weight:400;line-height:125%;position:relative;top:-3.85pt;vertical-align:baseline">19</font><font style="color:#000000;font-family:'Times New Roman',sans-serif;font-size:11pt;font-weight:400;line-height:125%">. Between 2013 and 2023, more than 3.7 million cases were reported in the Americas</font><font style="color:#000000;font-family:'Times New Roman',sans-serif;font-size:7.15pt;font-weight:400;line-height:125%;position:relative;top:-3.85pt;vertical-align:baseline">20</font><font style="color:#000000;font-family:'Times New Roman',sans-serif;font-size:11pt;font-weight:400;line-height:125%"> 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.</font><font style="color:#000000;font-family:'Times New Roman',sans-serif;font-size:7.15pt;font-weight:400;line-height:125%;position:relative;top:-3.85pt;vertical-align:baseline">21</font></div><div style="margin-bottom:8pt"><font><br></font></div><div style="margin-bottom:8pt"><font style="color:#000000;font-family:'Times New Roman',sans-serif;font-size:11pt;font-weight:700;line-height:125%">About Valneva SE</font></div><div style="margin-bottom:8pt"><font style="color:#000000;font-family:'Times New Roman',sans-serif;font-size:11pt;font-weight:400;line-height:125%">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.</font></div><div style="margin-bottom:8pt"><font style="color:#000000;font-family:'Times New Roman',sans-serif;font-size:11pt;font-weight:400;line-height:125%">We have a strong track record, having advanced multiple vaccines from early R&#38;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.</font></div><div style="height:72pt;position:relative;width:100%"><div style="bottom:0;position:absolute;width:100%"><div style="margin-bottom:8pt"><font><br></font></div></div></div><hr style="page-break-after:always"><div style="min-height:72pt;width:100%"><div style="margin-bottom:8pt"><font><br></font></div></div><div style="margin-bottom:8pt"><font style="color:#000000;font-family:'Times New Roman',sans-serif;font-size:11pt;font-weight:400;line-height:125%">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></div><div style="margin-bottom:8pt"><font><br></font></div><div style="margin-bottom:8pt"><table style="border-collapse:collapse;display:inline-table;margin-bottom:5pt;vertical-align:text-bottom;width:100.000%"><tr><td style="width:1.0%"></td><td style="width:57.221%"></td><td style="width:0.1%"></td><td style="width:1.0%"></td><td style="width:40.579%"></td><td style="width:0.1%"></td></tr><tr><td colspan="3" style="padding:2px 1pt;text-align:left;vertical-align:top"><div style="margin-bottom:8pt"><font style="color:#000000;font-family:'Times New Roman',sans-serif;font-size:12pt;font-weight:700;line-height:109%">Valneva Investor and Media Contacts</font></div><div style="margin-bottom:8pt"><font style="color:#000000;font-family:'Times New Roman',sans-serif;font-size:12pt;font-weight:400;line-height:109%">Laetitia Bachelot-Fontaine</font></div><div style="margin-bottom:8pt"><font style="color:#000000;font-family:'Times New Roman',sans-serif;font-size:12pt;font-weight:400;line-height:109%">VP Global Communications &#38; European Investor Relations</font></div><div style="margin-bottom:8pt"><font style="color:#000000;font-family:'Times New Roman',sans-serif;font-size:12pt;font-weight:400;line-height:109%">M +33 (0)6 4516 7099</font></div><div style="margin-bottom:8pt"><font style="color:#000000;font-family:'Times New Roman',sans-serif;font-size:12pt;font-weight:400;line-height:109%">laetitia.bachelot-fontaine&#64;valneva.com</font></div></td><td colspan="3" style="padding:2px 1pt;text-align:left;vertical-align:top"><div style="margin-bottom:8pt"><font><br></font></div><div style="margin-bottom:8pt"><font style="color:#000000;font-family:'Times New Roman',sans-serif;font-size:12pt;font-weight:400;line-height:109%">Joshua Drumm, Ph.D.</font></div><div style="margin-bottom:8pt"><font style="color:#000000;font-family:'Times New Roman',sans-serif;font-size:12pt;font-weight:400;line-height:109%">VP Global Investor Relations</font></div><div style="margin-bottom:8pt"><font style="color:#000000;font-family:'Times New Roman',sans-serif;font-size:12pt;font-weight:400;line-height:109%">M +001 917 815 4520</font></div><div style="margin-bottom:8pt"><font style="color:#000000;font-family:'Times New Roman',sans-serif;font-size:12pt;font-weight:400;line-height:109%">joshua.drumm&#64;valneva.com</font></div></td></tr></table></div><div style="margin-bottom:8pt"><font><br></font></div><div style="margin-bottom:8pt"><font style="color:#000000;font-family:'Times New Roman',sans-serif;font-size:11pt;font-weight:700;line-height:125%">Forward-Looking Statements</font></div><div style="margin-bottom:8pt"><font><br></font></div><div style="margin-bottom:8pt"><font style="color:#000000;font-family:'Times New Roman',sans-serif;font-size:11pt;font-weight:400;line-height:125%">This press release contains certain forward-looking statements relating to the business of Valneva, including with respect to business partnerships and the progress, timing, results and completion of technology transfer and regulatory approvals in additional markets. 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 in this press release will in fact be realized. Valneva is providing this information as of the date of this press release 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.</font></div><div style="margin-bottom:8pt"><font style="color:#000000;font-family:'Times New Roman',sans-serif;font-size:11pt;font-weight:400;line-height:125%">_____________________</font></div><div style="margin-bottom:8pt"><font><br></font></div><div style="margin-bottom:8pt"><font style="color:#000000;font-family:'Times New Roman',sans-serif;font-size:11pt;font-style:italic;font-weight:400;line-height:125%">1 Valneva Submits Label Extension Application for its Chikungunya Vaccine, IXCHIQ&#174;, to the U.S. FDA &#8211; Valneva</font></div><div style="margin-bottom:8pt"><font style="color:#000000;font-family:'Times New Roman',sans-serif;font-size:11pt;font-style:italic;font-weight:400;line-height:125%">2 Valneva Submits Label Extension Applications for its Chikungunya Vaccine, IXCHIQ&#174;, to EMA and Health Canada &#8211; Valneva</font></div><div style="height:72pt;position:relative;width:100%"><div style="bottom:0;position:absolute;width:100%"><div style="margin-bottom:8pt"><font><br></font></div></div></div><hr style="page-break-after:always"><div style="min-height:72pt;width:100%"><div style="margin-bottom:8pt"><font><br></font></div></div><div style="margin-bottom:8pt"><font style="color:#000000;font-family:'Times New Roman',sans-serif;font-size:11pt;font-style:italic;font-weight:400;line-height:125%">3 Valneva Reports Further Positive Pivotal Phase 3 Data in Adolescents for its Single-Shot Chikungunya Vaccine &#8211; Valneva</font></div><div style="margin-bottom:8pt"><font style="color:#000000;font-family:'Times New Roman',sans-serif;font-size:11pt;font-style:italic;font-weight:400;line-height:125%">4 Valneva Reports Positive Pivotal Phase 3 Immunogenicity Data in Adolescents for its Single-Shot Chikungunya Vaccine Candidate</font></div><div style="margin-bottom:8pt"><font style="color:#000000;font-family:'Times New Roman',sans-serif;font-size:11pt;font-style:italic;font-weight:400;line-height:125%">5 Valneva Reports Positive Initial Phase 3 Safety Data in Adolescents for its Single-Shot Chikungunya Vaccine Candidate</font></div><div style="margin-bottom:8pt"><font style="color:#000000;font-family:'Times New Roman',sans-serif;font-size:11pt;font-style:italic;font-weight:400;line-height:125%">6 Valneva Reports Positive Three-Year Antibody Persistence Data for its Single-Shot Chikungunya Vaccine IXCHIQ&#174; &#8211; Valneva</font></div><div style="margin-bottom:8pt"><font style="color:#000000;font-family:'Times New Roman',sans-serif;font-size:11pt;font-style:italic;font-weight:400;line-height:125%">7 Defined as &#181;PRNT50 antibody titer &#8805; 150 agreed with the FDA as surrogate of protection to support accelerated approval</font></div><div style="margin-bottom:8pt"><font style="color:#000000;font-family:'Times New Roman',sans-serif;font-size:11pt;font-style:italic;font-weight:400;line-height:125%">8 Valneva Submits Label Extension Application for its Chikungunya Vaccine, IXCHIQ&#174;, to the U.S. FDA &#8211; Valneva</font></div><div style="margin-bottom:8pt"><font style="color:#000000;font-family:'Times New Roman',sans-serif;font-size:11pt;font-style:italic;font-weight:400;line-height:125%">9 Valneva Submits Label Extension Applications for its Chikungunya Vaccine, IXCHIQ&#174;, to EMA and Health Canada &#8211; Valneva</font></div><div style="margin-bottom:8pt"><font style="color:#000000;font-family:'Times New Roman',sans-serif;font-size:11pt;font-style:italic;font-weight:400;line-height:125%">10 CEPI Expands Partnership with Valneva with a $41.3 Million Grant to Support Broader Access to the World&#8217;s First Chikungunya Vaccine &#8211; Valneva</font></div><div style="margin-bottom:8pt"><font style="color:#000000;font-family:'Times New Roman',sans-serif;font-size:11pt;font-style:italic;font-weight:400;line-height:125%">11 Valneva Successfully Expands Access to Asia for its Chikungunya Vaccine with Serum Institute of India &#8211; Valneva</font></div><div style="margin-bottom:8pt"><font style="color:#000000;font-family:'Times New Roman',sans-serif;font-size:11pt;font-style:italic;font-weight:400;line-height:125%">12 Valneva Announces U.S. FDA Approval of World&#8217;s First Chikungunya Vaccine, IXCHIQ&#174; &#8211; Valneva</font></div><div style="margin-bottom:8pt"><font style="color:#000000;font-family:'Times New Roman',sans-serif;font-size:11pt;font-style:italic;font-weight:400;line-height:125%">13 Valneva Receives Marketing Authorization in Europe for the World&#8217;s First Chikungunya Vaccine, IXCHIQ&#174; &#8211; Valneva</font></div><div style="margin-bottom:8pt"><font style="color:#000000;font-family:'Times New Roman',sans-serif;font-size:11pt;font-style:italic;font-weight:400;line-height:125%">14 Valneva Announces Health Canada Approval of the World&#8217;s First Chikungunya Vaccine, IXCHIQ&#174; &#8211; Valneva</font></div><div style="margin-bottom:8pt"><font style="color:#000000;font-family:'Times New Roman',sans-serif;font-size:11pt;font-style:italic;font-weight:400;line-height:125%">15 Valneva Reports Positive Pivotal Phase 3 Immunogenicity Data in Adolescents for its Single-Shot Chikungunya Vaccine Candidate</font></div><div style="margin-bottom:8pt"><font style="color:#000000;font-family:'Times New Roman',sans-serif;font-size:11pt;font-style:italic;font-weight:400;line-height:125%">16 Valneva Reports Positive Initial Phase 3 Safety Data in Adolescents for its Single-Shot Chikungunya Vaccine Candidate</font></div><div style="margin-bottom:8pt"><font style="color:#000000;font-family:'Times New Roman',sans-serif;font-size:11pt;font-style:italic;font-weight:400;line-height:125%">17 Valneva Reports Further Positive Pivotal Phase 3 Data in Adolescents for its Single-Shot Chikungunya Vaccine &#8211; Valneva</font></div><div style="margin-bottom:8pt"><font style="color:#000000;font-family:'Times New Roman',sans-serif;font-size:11pt;font-style:italic;font-weight:400;line-height:125%">18 https&#58;&#47;&#47;jvi.asm.org&#47;content&#47;jvi&#47;88&#47;20&#47;11644.full.pdf</font></div><div style="margin-bottom:8pt"><font style="color:#000000;font-family:'Times New Roman',sans-serif;font-size:11pt;font-style:italic;font-weight:400;line-height:125%">19 https&#58;&#47;&#47;cmr.asm.org&#47;content&#47;31&#47;1&#47;e00104-16</font></div><div style="margin-bottom:8pt"><font style="color:#000000;font-family:'Times New Roman',sans-serif;font-size:11pt;font-style:italic;font-weight:400;line-height:125%">20 PAHO&#47;WHO data&#58; Number of reported cases of chikungunya fever in the Americas (Cumulative Cases 2018-2023 and Cases per year 2013-2017). https&#58;&#47;&#47;www.paho.org&#47;data&#47;index.php&#47;en&#47;mnu-topics&#47;chikv-en&#47;550-chikv-weekly-en.html. Last accessed 01 Aug 2023.</font></div><div style="margin-bottom:8pt"><font style="color:#000000;font-family:'Times New Roman',sans-serif;font-size:11pt;font-style:italic;font-weight:400;line-height:125%">21 Geographical expansion of cases of dengue and chikungunya beyond the historical areas of transmission in the Region of the Americas (who.int)</font></div><div style="margin-bottom:8pt"><font><br></font></div><div style="height:72pt;position:relative;width:100%"><div style="bottom:0;position:absolute;width:100%"><div style="margin-bottom:8pt"><font><br></font></div></div></div></body></html>
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