# EDGAR Filing Document

**Accession Number:** 0001836564
**File Stem:** 0001171843-23-001012
**Filing Date:** 2023-2
**Character Count:** 25619
**Document Hash:** 56b9414d63054bcbe3d221ef60409b33
**Contains OCR:** False
**Source Format:** 

## Filing Content

## Filing Summary
**0001171843-23-001012.hdr.sgml**: 20230216

**ACCESSION NUMBER**: 0001171843-23-001012

**CONFORMED SUBMISSION TYPE**: 6-K

**PUBLIC DOCUMENT COUNT**: 3

**CONFORMED PERIOD OF REPORT**: 20230216

**FILED AS OF DATE**: 20230216

**DATE AS OF CHANGE**: 20230216

**FILER**: 

**COMPANY DATA:**
- **COMPANY CONFORMED NAME:** Valneva SE
- **CENTRAL INDEX KEY:** 0001836564
- **STANDARD INDUSTRIAL CLASSIFICATION:** BIOLOGICAL PRODUCTS (NO DIAGNOSTIC SUBSTANCES) [2836]
- **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:** 23637239

**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: February 16, 2023**

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 ] &nbsp;&nbsp;&nbsp;&nbsp; Form 40-F [ ]

------

The Registrant issued press releases on February 14 and February 16, 2023, copies of which are attached hereto as Exhibit 99.1 and Exhibit 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).

---

| | |
|:---|:---|
| <u>**Exhibits**</u> |  |
| [99.1](exh_991.htm) | [Press release dated February 14, 2023](exh_991.htm) |
| [99.2](exh_992.htm) | [Press release dated February 16, 2023](exh_992.htm) |

---

------

**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.

---

| | |
|:---|:---|
|  | <u>**&nbsp;&nbsp;&nbsp;&nbsp;Valneva SE&nbsp;&nbsp;&nbsp;&nbsp;**</u> |
|  | (Registrant) |
| Date: February 16, 2023 | <u>&nbsp;&nbsp;&nbsp;&nbsp;/s/ Thomas Lingelbach&nbsp;&nbsp;&nbsp;&nbsp;</u> |
|  | Thomas Lingelbach |
|  | Chief Executive Officer and President |

---

## Exhibit 99.1

**EXHIBIT 99.1**

**Valneva Completes Enrollment for Adolescent Phase 3 Trial of Single-Shot Chikungunya Vaccine Candidate**

**Saint-Herblain (France), February 14, 2023** – Valneva SE (Nasdaq: VALN; Euronext Paris: VLA), a specialty vaccine company, today announced that it completed enrollment and vaccination for a Phase 3 trial in adolescents, VLA1553-321, of its single-shot chikungunya vaccine candidate, VLA1553. First results of the trial are expected mid-2023.

Funded by the Coalition for Epidemic Preparedness Innovations (CEPI), the VLA1553-321 adolescent trial is intended to support the label extension in this age group following a potential initial regulatory approval in adults from the Food and Drugs Administration (FDA) in the United States (U.S).

Valneva completed rolling submission of the Biologics License Application (BLA) to the U.S. FDA for approval of VLA1553 in persons aged 18 years and above in December 2022<sup>1</sup>. If BLA filing is accepted and approved, VLA1553 could become the first chikungunya vaccine to be marketed in the U.S. Valneva reported final pivotal Phase 3 data for VLA1553 in March 2022<sup>2</sup> and final lot-to-lot consistency results in May 2022<sup>3</sup>. The Company also recently reported positive antibody persistence data with a 99% seroresponse rate 12 months after a single-dose vaccination<sup>4</sup>.

The VLA1553-321 adolescent trial is also expected to support licensure of the vaccine in Europe and Brazil, which would be the first potential approval for use in endemic populations.

Conducted in collaboration between Instituto Butantan and Valneva, VLA1553-321 is a double-blinded, multi-center, randomized and placebo-controlled Phase 3 trial. 754 adolescents aged 12 to 17 years were vaccinated following randomization at a 2:1 ratio to receive either VLA1553 or placebo. The primary objective of the trial is to evaluate safety and immunogenicity 28 days following a single vaccination with VLA1553. Participants will be evaluated for the primary endpoint and followed up to twelve months. The study will also provide the first systematic safety and immunogenicity data in participants previously exposed to chikungunya.

**Juan Carlos Jaramillo, M.D., Chief Medical Officer of Valneva, commented**, "Recruitment completion in this study is an important milestone for the overall program. We reported compelling pivotal Phase 3 results in adults and in the elderly, and we are now looking forward to obtaining results in adolescents later this year. Chikungunya virus is a major, growing public health threat which has already impacted over 100 countries and affected millions worldwide, yet no vaccine or specific treatment is currently available to prevent this debilitating disease."

**Dr. Esper Georges Kallas, President of Instituto Butantan, which will develop, manufacture and market VLA1553 in Low- and Middle-Income Countries, commented,** "the achievement of this goal is a major milestone to expand the vaccine indication in adolescents. Based on a single-dose schedule, the VLA1553 chikungunya vaccine could become a key tool to prevent the chikungunya disease in endemics areas and fight the disease-induced public health burden."

**Dr. Melanie Saville, Director of Vaccine Research & Development at CEPI, which provided funding for this study, added, "**Millions of people have been affected by chikungunya and, today, over a billion people live in areas where chikungunya outbreaks occur. The progress Valneva has made to date brings the world one step closer towards a safe and effective vaccine against this debilitating disease, for which there is currently no specific treatment nor vaccine licenced for human use. Data from this Phase 3 study will help to ensure that the people most affected by this virus can benefit from this product and help regulators assess this important vaccine candidate."

To make VLA1553 more accessible to Low- and Middle-Income Countries (LMIC), Valneva and Instituto Butantan in Brazil signed an agreement in January 2021 for the development, manufacturing and marketing of VLA1553<sup>5</sup>. The collaboration falls within the framework of the agreement signed between CEPI and Valneva in July 2019<sup>6</sup>, which provides funding of up to $24.6 million with support from the European Union's Horizon 2020 program.

Brazil had an exponential increase of chikungunya cases in 2021 in comparison to 2020, according to data from the Brazilian Vigilance Health Secretary (SVS). At the beginning of December 2021, 90,147 chikungunya cases had been registered compared to 78,808 over the same period in the previous year. The three states that most registered cases of the disease were Pernambuco (29,700 cases), São Paulo (18,100 cases) and Paraíba (9,000 cases), respectively. In 2021, São Paulo which is the most populous state in the country, went from 468 cases to 18,156 cases compared to 2020<sup>7</sup>.

**About Chikungunya**

Chikungunya is a mosquito-borne viral disease caused by the chikungunya virus (CHIKV), a *Togaviridae* virus, transmitted by *Aedes* mosquitoes. Chikungunya virus often causes sudden large outbreaks with high attack rates, affecting one-third to three-quarters of the population in areas where the virus is circulating. There are no preventive vaccines or effective treatments available and, as such, chikungunya is considered to be a major public health threat. As of September 2020, there were more than 3 million reported cases in the Americas<sup>7</sup> and the economic impact is considered to be significant. The medical and economic burden is expected to grow as the CHIKV primary mosquito vectors continue to spread geographically. Infection leads to symptomatic disease in up to 97% of humans after three to seven days following the mosquito bite. While mortality with CHIKV is low, morbidity is high. Clinical symptoms include acute onset of fever, debilitating joint and muscle pain, headache, nausea, rash and chronic arthralgia. It is estimated that over three quarters of the world's population live in areas at-risk of CHIKV transmission<sup>8</sup>. High risk areas of infection are places where chikungunya virus-carrying mosquitos are currently endemic, including the Americas, parts of Africa, and Southeast Asia.

**About VLA1553**

VLA1553 is a live-attenuated, single dose investigational vaccine candidate targeting the chikungunya virus, which has spread to over 100 countries. It has been designed by deleting a part of the chikungunya virus genome.

Valneva reported final data from the pivotal Phase 3 trial of VLA1553 in March 2022<sup>9</sup> and final lot-to-lot consistency results in May 2022<sup>10</sup>.

If approved, VLA1553 would expand Valneva's existing commercial vaccines portfolio and as such, Valneva intends to commercialize this vaccine, leveraging its existing manufacturing and commercial operations.

To make VLA1553 more accessible to Low- and Middle-Income Countries (LMIC), Valneva and Instituto Butantan in Brazil signed an agreement in January 2021 for the development, manufacturing and marketing of VLA1553<sup>11</sup>. The collaboration falls within the framework of the agreement signed between CEPI and Valneva in July 2019<sup>12</sup>, which provides funding of up to $24.6 million with support from the European Union's Horizon 2020 program.

**About Phase 3 study VLA1553-321**

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. VLA1553 or placebo will be administered as a single intramuscular immunization to participants who will be randomized into two study groups at a 2:1 ratio. The primary objective is to evaluate the immunogenicity and safety of the adult dose of VLA1553 28 days following a single vaccination. Secondary objectives of the trial will include assessment of safety and immunogenicity up to twelve months following a single vaccination with VLA1553. The study will also provide safety and immunogenicity data in participants previously exposed to chikungunya.

Additional information, including a detailed description of the study design, eligibility criteria and investigator sites, is available at ClinicalTrials.gov (Identifier: NCT04650399).

**About Valneva SE**

Valneva is a specialty vaccine company focused on the development, manufacturing and commercialization of prophylactic vaccines for infectious diseases with significant unmet medical need. The Company takes a highly specialized and targeted approach to vaccine development and then applies its deep understanding of vaccine science to develop prophylactic vaccines addressing these diseases. Valneva has leveraged its expertise and capabilities both to commercialize three vaccines and to rapidly advance a broad range of vaccine candidates into and through the clinic, including candidates against Lyme disease and the chikungunya virus.

**About Instituto Butantan**

Instituto Butantan is the main producer of immunobiological products and vaccines in Brazil. Instituto Butantan carries out scientific missions domestically and abroad through the Pan American Health Organization, the World Health Organization, UNICEF and the United Nations. The Institute collaborates with other agencies of the São Paulo State Secretariat of Health and the Brazilian Ministry of Health for the improvement of overall health in Brazil. It acts in partnership with various universities and entities such as the Bill & Melinda Gates Foundation for the achievement of its institutional objectives. For more information please visit the Institute website at www.butantan.gov.br or contact the press office at (+55 11) 2627-9606 / 9428 or email to imprensa@butantan.gov.br

**About CEPI**

CEPI is an innovative partnership between public, private, philanthropic, and civil organizations, launched at Davos in 2017, to develop vaccines to stop future epidemics. Before the emergence of COVID-19 CEPI's priority diseases included Ebola virus, Lassa virus, Middle East Respiratory Syndrome coronavirus, Nipah virus, Rift Valley Fever and chikungunya virus. CEPI also invested in platform technologies that can be used for rapid vaccine and immunoprophylactic development against unknown pathogens (Disease X).

CEPI has moved with great urgency and in coordination with WHO in response to the emergence of COVID-19. CEPI has initiated 9 partnerships to develop vaccines against the novel coronavirus. The programmes will leverage rapid response platforms already supported by CEPI as well as new partnerships. The aim is to advance COVID-19 vaccine candidates into clinical testing as quickly as possible.

CEPI, alongside Gavi and the World Health Organisation, co-leads the vaccines pillar of the ACT Accelerator – known as COVAX – which is working to develop, distribute and deploy COVID-19 vaccines to the world. Learn more at **http://www.cepi.net**. Follow CEPI at **@CEPIvaccines**.

---

| | |
|:---|:---|
| **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;&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 |

---

**Forward-Looking Statements**

This press release contains certain forward-looking statements relating to the business of Valneva, including with respect to the progress, timing, results and completion of research, development and clinical trials for product candidates, to regulatory approval of product candidates and review of existing products. In addition, even if the actual results or development of Valneva are consistent with the forward-looking statements contained in this press release, those results or developments of Valneva may not be sustained in the future. In some cases, you can identify forward-looking statements by words such as "could," "should," "may," "expects," "anticipates," "believes," "intends," "estimates," "aims," "targets," or similar words. These forward-looking statements are based largely on the current expectations of Valneva as of the date of this press release and are subject to a number of known and unknown risks and uncertainties and other factors that may cause actual results, performance or achievements to be materially different from any future results, performance or achievement expressed or implied by these forward-looking statements. In particular, the expectations of Valneva could be affected by, among other things, uncertainties involved in the development and manufacture of vaccines, unexpected clinical trial results, unexpected regulatory actions or delays, competition in general, currency fluctuations, the impact of the global and European credit crisis, and the ability to obtain or maintain patent or other proprietary intellectual property protection. Success in preclinical studies or earlier clinical trials may not be indicative of results in future clinical trials. In light of these risks and uncertainties, there can be no assurance that the forward-looking statements made during this presentation will in fact be realized. Valneva is providing the information in these materials as of this press release, and disclaim any intention or obligation to publicly update or revise any forward-looking statements, whether as a result of new information, future events, or otherwise.

------

1 *Valneva Completes BLA Submission to U.S. FDA for its Single-Shot Chikungunya Vaccine Candidate - Valneva*

*2* <u>Valneva Successfully Completes Pivotal Phase 3 Trial of Single-Shot Chikungunya Vaccine Candidate</u>

*3* <u>Valneva Successfully Completes Lot-to-Lot Consistency Trial for its Single-Shot Chikungunya Vaccine Candidate</u>

*4 Valneva Reports Positive 12-Month Antibody Persistence Data for Single-Shot Chikungunya Vaccine Candidate - Valneva*

*5 Valneva and Instituto Butantan Sign Final Agreement on Single-Shot Chikungunya Vaccine for Low and Middle Income Countries*

<sup>*6*</sup> *CEPI awards up to $23.4 million to Valneva for late-stage development of a single-dose Chikungunya vaccine*

<sup>*7*</sup> *https://www.gov.br/saude/pt-br/assuntos/noticias/2021-1/novembro/sao-paulo-e-o-estado-com-o-maior-aumento-do-numero-de-casos-de chikungunya.*

*7 PAHO/WHO data: Number of reported cases of chikungunya fever in the Americas. https://www.paho.org/data/index.php/en/mnu-topics/chikv-en/550-chikv-weekly-en.html. Last accessed 13 Oct 2020.*

*8* CDC 2022, Puntasecca CJ 2021

9 *<u>Valneva Successfully Completes Pivotal Phase 3 Trial of Single-Shot Chikungunya Vaccine Candidate</u>*

10 *<u>Valneva Successfully Completes Lot-to-Lot Consistency Trial for its Single-Shot Chikungunya Vaccine Candidate</u>*

11 *<u>Valneva and Instituto</u> <u>Butantan</u> <u>Sign Final Agreement on Single-Shot Chikungunya Vaccine for Low and Middle Income Countries</u>*

12 *<u>CEPI awards up to $23.4 million to Valneva for late-stage development of a single-dose Chikungunya vaccine</u>*

## Exhibit 99.2

**EXHIBIT 99.2**

**Valneva Reports Full Year 2022 Revenue and Cash, Provides First 2023 Guidance**

**Total revenues of €361.3 million in 2022 were ahead of previously communicated guidance of €340 million to €360 million<sup>1</sup>** **(compared to €348.1 million in 2021)**

* Driven by Product Sales of €114.8 million (82.3% increase compared to 2021), including €85.2
million of travel vaccine sales and €29.6 million of COVID-19 vaccine sales

* €246.5 million of Other Revenues mainly driven by revenue recognition related to previous COVID-19
vaccine supply agreements

**Strong cash position of €289.4 million at December 31, 2022**

* Raised over €190 million in equity:

€102.9 million of gross proceeds from an upsized global offering<sup>2</sup> in a challenging economic
environment
€90.5 ($95) million equity investment by Pfizer 

* Included drawing of a total of $40 million from Deerfield & OrbiMed loan agreement<sup>3</sup>

**Full year 2023 sales guidance** 

* €130 million to €150 million product sales, including marginal COVID-19 vaccine sales under
an existing supply agreement with the Kingdom of Bahrain

**Saint-Herblain (France), February 16, 2023** – Valneva SE (Nasdaq: VALN; Euronext Paris: VLA) a specialty vaccine company, today reported its revenue and cash balance for the full year 2022 and provided first full year 2023 sales guidance. The Company will report its 2022 audited consolidated financial statements on March 23, 2023.

**Peter Bühler, Valneva's Chief Financial Officer**, commented, "In 2022, Valneva successfully executed on key strategic objectives despite a difficult economic environment. After achieving clinical and regulatory success, we decided to wind-down our COVID-19 activities and focus on our lead programs. We were agile in reactivating production of our commercial vaccines to capitalize on the travel industry recovery. We also managed to strengthen our cash and our shareholder base, attracting leading investors and maintaining the support of our existing shareholders. With close to €290 million in cash, we entered 2023 in a strong position to support expected commercial growth and R&D programs."

**Revenues**

Valneva's total revenues were €361.3 million in 2022 compared to €348.1 million in 2021, an increase of 3.8%.

Valneva's total product sales reached €114.8 million in 2022 compared to €63.0 million in 2021, an increase of 82.3%. This was driven by a continued recovery of travel vaccine sales that surpassed expectations (€85.2 million vs. guidance of €70 to €80 million) complemented by COVID-19 vaccine sales in Europe and Bahrain (€29.6 million). On a constant exchange rate (CER) basis, product sales increased by 66.7% in 2022 as compared to 2021.

IXIARO<sup>®</sup>/JESPECT<sup>®</sup> sales were €41.3 million in 2022 compared to €45.1 million in 2021, a decrease of 8.4% (18.6% at CER), driven by lower sales to the U.S. Department of Defense. This decrease was partly offset by the significant recovery of the private travel markets, with IXIARO<sup>®</sup>/JESPECT<sup>®</sup> private sales reaching €28.8 million in 2022 compared to €7.1 million in 2021.

DUKORAL<sup>®</sup> sales were €17.3 million in 2022 compared to €2.4 million in 2021, an increase of 610.3% (629.2% at CER), also benefitting from the significant recovery in the private travel markets.

Third Party product sales grew to €26.5 million in 2022 compared to €15.4 million in 2021, an increase of 72.1%.

Other Revenues, including revenues from collaborations, licensing and services, amounted to €246.5 million in 2022 compared to €285.1 million in 2021. These were mainly driven by revenue recognition related to previous COVID-19 vaccine supply agreements.

**Liquidity** 

Cash and cash equivalents were €289.4 million as of December 31, 2022, compared to €346.7 million as of December 31, 2021. This included €102.9 million of gross proceeds from an upsized global offering completed in October 2022, €90.5 ($95) million from an equity investment by Pfizer completed in June 2022 as well as drawing of a total of $40 million from the Deerfield & OrbiMed loan agreement.

**About Valneva SE**

Valneva is a specialty vaccine company focused on the development, manufacturing and commercialization of prophylactic vaccines for infectious diseases with significant unmet medical need. The Company takes a highly specialized and targeted approach to vaccine development and then applies its deep understanding of vaccine science to develop prophylactic vaccines addressing these diseases. Valneva has leveraged its expertise and capabilities both to commercialize three vaccines and to rapidly advance a broad range of vaccine candidates into and through the clinic, including candidates against Lyme disease and the chikungunya virus.

---

| | |
|:---|:---|
| <br>**Valneva Investor and Media Contacts**<br>Laetitia Bachelot-Fontaine<br>VP, Global Communications and European Investor Relations<br>M +33 (0)6 4516 7099<br>investors@valneva.com<br>&nbsp;&nbsp;&nbsp;&nbsp;&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<br>|

---

**Forward-Looking Statements**

This press release contains certain forward-looking statements relating to the business of Valneva, including with respect to expected total revenues and product sales for full fiscal year 2023. 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 indicative of future results. 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 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 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, the ability to obtain or maintain patent or other proprietary intellectual property protection, the cancellation of existing contracts, including but not limited to the HMG Supply Agreement, and the impact of the COVID-19 pandemic, the occurrence of any of which could substantially harm Valneva's business, financial condition, prospects and results of operations. 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 this press release as of the date hereof 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.

------

*1 Valneva Reports Nine-Month 2022 Results and Provides Corporate Updates - Valneva*

*2 Valneva Announces Closing of Upsized €102.9 Million Global Offering - Valneva*

*3 Valneva Announces Upsized Financing Arrangement with Leading US Healthcare Funds Deerfield and OrbiMed - Valneva*