Form 6-K - Report of foreign issuer [Rules 13a-16 and 15d-16]

 

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: November 13, 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 [   ]

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On November 12, 2024 and November 13, 2024, the Registrant issued press releases, copies of which are attached hereto as Exhibits 99.1 and 99.2 and are 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 November 12, 2024
99.2		Press release dated November 13, 2024

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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: November 13, 2024		/s/ Thomas Lingelbach
		Thomas Lingelbach
		Chief Executive Officer and President

EXHIBIT 99.1

Valneva to Present and Hold Investor Meetings at Upcoming U.S. and European Healthcare Conferences

Saint-Herblain (France), November 12, 2024 – Valneva SE (Nasdaq: VALN; Euronext Paris: VLA), a specialty vaccine company, today announced that its senior management will present and participate in 1-on-1 meetings with institutional investors at upcoming investor conferences in the United States and Europe.

Chief Executive Officer Thomas Lingelbach and Chief Financial Officer Peter Bühler will host moderated “fireside chat” presentations to discuss the Company’s key value drivers and upcoming catalysts, which include multiple clinical data events in 2025, most notably key Phase 3 conclusions for VLA15, the Company’s Lyme disease vaccine candidate, which is partnered with Pfizer. If successful, Pfizer aims to submit applications for U.S. and European market authorization in 2026.

Guggenheim Inaugural Healthcare Innovation Conference
Date/Time:                         November 12, 3:30pm EST
Format:                Fireside chat and investor meetings
Location:                Boston, Massachusetts        

Jefferies London Healthcare Conference

Date/Time:                 November 19, 8:00am GMT
Format:                 Fireside chat and investor meetings
Location:                London, United Kingdom
Webcast Link:        https://wsw.com/webcast/jeff315/valn/1852116
A replay of the webcast will be available following the live events in the “Investor” section of the Valneva website at www.valneva.com.

Institutional investors who would like to meet with Valneva management at any of the below conferences are asked to submit a request to their representative at the respective bank.

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 and European Investor Relations M [phone] [e-mail]

Joshua Drumm, Ph.D. VP, Global Investor Relations M +001 917 815 4520 [e-mail]

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 and regulatory approval of product candidates. 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 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.

EXHIBIT 99.2

Valneva and LimmaTech Announce First Vaccination in Phase 2b Human Challenge Study of Tetravalent Shigella Vaccine Candidate S4V2

Saint Herblain (France) and Schlieren (Zurich), November 13, 2024 – Valneva SE (Nasdaq: VALN; Euronext Paris: VLA), a specialty vaccine company, and LimmaTech Biologics AG, a clinical-stage biotech company developing vaccines for the prevention of life-threatening diseases, announced today that the first participant has been vaccinated in a Phase 2b controlled human infection model (CHIM) study of Shigella4V2 (S4V2), the world’s most clinically advanced tetravalent bioconjugate shigellosis vaccine candidate, for which Valneva obtained an exclusive worldwide license from LimmaTech¹.

In the CHIM study S4V03 (Identifier: NCT06615375), S4V2 will be tested for safety and preliminary efficacy in approximately 120 healthy Shigella-naïve participants aged 18 to 50 years at three sites in the United States. The study, sponsored and conducted by LimmaTech, is a parallel-group, randomized, double-blind, multicenter, placebo-controlled study and will include two steps. In a first step, the vaccine dose will be confirmed and, in a second step, participants will be challenged with the Shigella sonnei strain 53G one month after injection of S4V2 or placebo, in order to assess the ability of S4V2 to protect against the Shigella infection. The infection rate of shigellosis caused by the Shigella sonnei strain 53G in the group vaccinated with S4V2 will then be compared to the group of participants who received placebo injections.

Thomas Lingelbach, Chief Executive Officer of Valneva, commented, “Human challenge studies are unique in their ability to investigate and understand the onset and development of disease in a safe and highly controlled environment. This CHIM study forms part of our staggered and risk-mitigating development strategy for S4V2, as it should provide the first results on efficacy before potentially advancing to further CHIM and Phase 3 studies.”

Dr. Patricia Martin, Chief Operating Officer of LimmaTech, stated, “The start of this trial is a significant milestone for the S4V2 program and our combined efforts with Valneva to bring an effective vaccine against shigellosis to market. Today, we are an important step closer to LimmaTech’s vision of developing vaccines to fight against serious diseases and antimicrobial resistant pathogens.”

In addition to the CHIM study, LimmaTech will conduct a Phase 2 pediatric study in Low- and Middle-Income Countries expected to begin before the end of 2024. Valneva will assume all further development, including CMC (chemistry, manufacturing and controls) and regulatory activities, and be responsible for its commercialization worldwide, if approved.
Last month, the U.S. Food and Drug Administration (FDA) granted Fast Track designation to S4V2, recognizing its potential to address a serious condition and fill an unmet medical need².

Shigellosis is the second leading cause of fatal diarrheal disease worldwide. However, there is currently no approved Shigella vaccine and the development of Shigella vaccines has been identified as a priority by the World Health Organization (WHO)³.

About Shigellosis
Shigellosis is a global health threat caused by the Gram-negative Shigella bacteria. It is estimated that up to 165 million infections⁴ are due to Shigella of which 62.3 million occur in children younger than five years. Diarrheal infection is one of the major causes of morbidity and mortality in numerous countries as well as in travelers and deployed military personnel in endemic regions. There are an estimated 600,000 deaths attributed to Shigella each year and it is the second leading cause for diarrheal deaths⁵. The standard treatment for shigellosis is oral rehydration and antibiotic therapy, however, the bacteria have acquired resistance to many antibiotics with numerous reports of outbreaks of multidrug-resistant strains, making treatment extremely difficult. Currently, no licensed Shigella vaccine is available.

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.

About LimmaTech Biologics AG
LimmaTech Biologics is at the forefront of combating the global antimicrobial resistance epidemic based on its unparalleled track record in vaccine technology and clinical candidate development. The company is leveraging its proprietary self-adjuvanting and multi-antigen vaccine platform alongside additional disease-specific vaccine approaches to prevent increasingly untreatable microbial infections. With decades of expertise and an expanding, robust pipeline, the LimmaTech team is dedicated to generating protective solutions to deliver transformative value worldwide. LimmaTech Biologics is backed by specialist healthcare investors, including Adjuvant Capital, AXA IM Alts, Novo Holdings REPAIR Impact Fund, and Tenmile.
For more information, please visit www.lmtbio.com.

Valneva Investor and Media Contacts Laetitia Bachelot-Fontaine VP Global Communications & European Investor Relations M [phone] [e-mail]

Joshua Drumm, Ph.D. VP Global Investor Relations M +001 917 815 4520 [e-mail]

For LimmaTech
LimmaTech Biologics AG
Franz-Werner Haas, CEO
E-mail: [e-mail]

For media enquiries
Trophic Communications
Gretchen Schweitzer or Jacob Verghese
Phone: [phone]
E-mail: [e-mail]

Forward-Looking Statements

This press release contains certain forward-looking statements relating to the business of Valneva, including with respect to financial results for 2024; mid-term revenue and cash outlook; the progress, timing, results and completion of research, development and clinical trials for product candidates; regulatory approval of product candidates and requested label extensions; 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 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.

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1 LimmaTech Biologics AG
2 Valneva and LimmaTech Awarded FDA Fast Track Designation for Tetravalent Shigella Vaccine Candidate S4V - Valneva
3 Immunization, Vaccines and Biologicals (who.int)
4Shigellosis | CDC Yellow Book 2024
5 Shigellosis | CDC Yellow Book 2024

 

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