# EDGAR Filing Document

**Accession Number:** 0001836564
**File Stem:** 0001628280-25-059180
**Filing Date:** 2025-12
**Character Count:** 12593
**Document Hash:** f62e0ca9fb6defec812a615162fe9324
**Contains OCR:** False
**Source Format:** 

## Filing Content

## Filing Summary
**0001628280-25-059180.hdr.sgml**: 20251231

**ACCESSION NUMBER**: 0001628280-25-059180

**CONFORMED SUBMISSION TYPE**: 6-K

**PUBLIC DOCUMENT COUNT**: 2

**CONFORMED PERIOD OF REPORT**: 20251231

**FILED AS OF DATE**: 20251231

**DATE AS OF CHANGE**: 20251231

**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
- **EIN:** 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:** 251616398

**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

**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: December 31, 2025**

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 ☒ Form 40-F ☐

On December 31, 2025, the Registrant issued a press release, a copy of which is attached hereto as Exhibit 99.1. The information contained in this Form 6-K is hereby incorporated by reference into the registrant's registration Statement on Form F-3 (File No. 333-268071).

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| | |
|:---|:---|
| **<u>Exhibit</u>** | |
| &nbsp;&nbsp;Exhibit 99.1 | &nbsp;&nbsp;<u>[Press release dated December 31, 2025](december312025pr.htm)</u> |

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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.

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| | |
|:---|:---|
| | **<u>Valneva SE</u>** (Registrant) |
| Date: December 31, 2025 | <u>/s/ Thomas Lingelbach</u>  |
| | Thomas Lingelbach |
| | Chief Executive Officer and President |

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## Exhibit 99.1

*&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;*

 **Valneva and Serum Institute of India Announce Discontinuation of Chikungunya Vaccine License Agreement**

**Saint-Herblain (France), Pune, (India), December 31, 2025** – <u>Valneva SE</u> ("Valneva" or "the Company"), a specialty vaccine company, and Serum Institute of India (SII), a Cyrus Poonawalla Group company today announced that they have mutually agreed to discontinue their license agreement for Valneva's single-shot chikungunya vaccine.

Valneva´s strategic intent in regaining full rights is to assume direct control over its supply chain and commercialization for endemic high-risk countries, thereby accelerating access for regions most affected by the disease.

Supporting access to the vaccine in low-and-middle-income countries (LMICs) falls within the framework of the funding agreement Valneva signed with the Coalition for Epidemic Preparedness Innovations (CEPI) in July 2024 with co-funding from the European Union<sup>1</sup>.

**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<sup>1</sup>.

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>

**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.

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

<sup>1</sup> *<u>https://jvi.asm.org/content/jvi/88/20/11644.full.pdf</u>* 

<sup>2</sup> *<u>https://cmr.asm.org/content/31/1/e00104-16</u>*

<sup>3</sup> *PAHO/WHO data: Number of reported cases of chikungunya fever in the Americas (Cumulative Cases 2018-2023 and Cases per year 2013-2017). <u>https://www.paho.org/data/index.php/en/mnu-topics/chikv-en/550-chikv-weekly-en.html</u>. Last accessed 01 Aug 2023.*

<sup>4</sup> *<u>Geographical expansion of cases of dengue and chikungunya beyond the historical areas of transmission in the Region of the Americas (who.int)</u>*

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vaccine candidate, as well as vaccine candidates against other global public health threats. More information is available at <u>www.valneva.com.</u>

**About CEPI**

CEPI was launched in 2017 as an innovative partnership between public, private, philanthropic and civil organisations. Its mission is to accelerate the development of vaccines and other biologic countermeasures against epidemic and pandemic disease threats and enable equitable access to them. CEPI has supported the development of more than 70 vaccine candidates or platform technologies against multiple known high-risk pathogens and is advancing the development of rapid response platforms for vaccines against a future Disease X. Central to CEPI's pandemic-beating five-year plan for 2022-2026 is the '100 Days Mission' to compress the time taken to develop safe, effective, globally accessible vaccines against new threats to just 100 days.

**About Horizon Europe**

Horizon Europe — #HorizonEU — is the European Union's flagship Research and Innovation programme, part of the EU-long-term Multiannual Financial Framework (MFF) with a budget of €95,5 billion to spend over a seven-year period (2021-2027). Under Horizon Europe, health research will be supported with the aim to find new ways to keep people healthy, prevent diseases, develop better diagnostics and more effective therapies, use personalised medicine approaches to improve healthcare and wellbeing, and take up innovative health technologies, such as digital ones.

**About Serum Institute of India Private Limited** 

Serum Institute of India Pvt. Ltd, part of Cyrus Poonawalla Group is a global leader in vaccine manufacturing, dedicated to providing affordable vaccines worldwide. Present across 170+ countries, including the US, UK, and Europe, SIIPL holds the distinction of being the world's largest vaccine manufacturer. SIIPL's multifunctional production and one-of-the-largest facilities in Hadapsar & Manjari, Pune, with an annual capacity of 4 billion doses, has saved over 30 million lives over the years.

Founded in 1966, SIIPL's primary mission is to produce life-saving immunobiological drugs, with a particular emphasis on affordability and accessibility. Guided by a strong commitment to improving global health, the company has played a pivotal role in reducing the prices of essential vaccines, such as Diphtheria, Tetanus, Pertussis, HIB, BCG, r-Hepatitis B, Measles, Mumps, and Rubella. Notably, they are the manufacturers of 'Pneumosiil,' the world's most affordable PCV, 'Cervavac' the first indigenous qHPV vaccine in India, and R21/Matrix-M™, the second Malaria vaccine to be authorized for use in children in malaria-endemic regions, 'MenFive', the first in the world Pentavalent (ACYWX) Meningococcal Polysaccharide Conjugate Vaccine, approved and WHO-prequalified for use in the pediatric population. Moreover, SIIPL has been at the forefront of the global fight against COVID-19, delivering over 2 billion doses of the COVID-19 vaccine worldwide.

To further expand its global presence and ensure widespread vaccine availability, SIIPL has established Serum Life Sciences Ltd, a subsidiary in the UK and Serum Inc., a subsidiary in the US. Through relentless pursuit of innovation, SII continues to champion the cause of affordable vaccines, making a positive impact on the lives of millions worldwide. <u>www.seruminstitute.com</u> 

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| | |
|:---|:---|
| **Valneva Investor and Media Contacts**<br>Laetitia Bachelot-Fontaine<br>VP Global Communications & European Investor Relations<br>M +33 (0)6 4516 7099<br>laetitia.bachelot-fontaine@valneva.com&nbsp;&nbsp;&nbsp;&nbsp; | <br>Joshua Drumm, Ph.D.<br>VP Global Investor Relations<br>M +001 917 815 4520<br>joshua.drumm@valneva.com |

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**Forward-Looking Statements**

This press release contains certain forward-looking statements relating to the business of Valneva, including with respect to use and regulatory 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 or new adverse events, 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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