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Valneva Announces Major COVID-19 Vaccine Partnership With VLA: UK Government Paris Stock Exchange

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The UK government secured 60 million supply between 2022 and 2025 with more than 130 million options and at a cost of 470 million.

The UK government invests in the Valnevas manufacturing facility in Livingston, Scotland to support scale-up and establish a major vaccine facility in the UK. Inactivated adjuvant 2nd SARS-COV-2 vaccine candidate due to enter its first clinical study in December 2020 Combining proven approach of Valnevas with Dynavax CpG 1018 adjuvant

Saint-Herblain (France), September 14, 2020 Valneva SE, a specialized vaccine company focused on preventing major unmet diseases, today announced a vaccine partnership with the UK government for the inactivated COVID-19 vaccine, VLA2001.

If the vaccine development is successful by agreement, Valneva will provide 60 million shots to the UK government in the second half of 2021. The UK government has a capacity of more than 40 million in 2022, with a total capacity of 30 to 90 million or more. , From 2023 to 2025. Revenues from these options can reach nearly 900 million. The Valnevas-inactivated SARS-CoV-2 vaccine is expected to have a two-dose regimen. The UK government is also making upfront investments in the expansion and development of vaccines, and is paying back investments in vaccine supply under the partnership. The agreement follows the UK government’s initial intention to participate in the COVID-19 vaccine response, announced in July.

David Lawrence, Valneva’s Chief Financial Officer, said Scotland’s proven track record and manufacturing capabilities support this partnership. Through recent discussions, we have built a great partnership with the UK government. I am grateful for the contributions of the British Government Task Force and colleagues, as well as other stakeholders including West Lothian, Scottish and British politicians who are supporting the work in progress. We show a fantastic spirit to all stakeholders to make this partnership a success.

Thomas Lingelbach, CEO of Valneva, said: “With this partnership we have made an initial decision to opt for a more proven, well-established, inactivated vaccine approach that is more proven. We are honored to have been selected by the British government and would like to work with them to tackle this terrible epidemic. This is another phase of change for Valneva, following the Lyme partnership we signed earlier this year and the Chikun Gunya vaccine, which started phase 3 clinical trials last week.

British Business Secretary Alok Sharma said: When I visited Valneva last month, I saw firsthand the amazing things they are doing to develop and manufacture a Covid-19 vaccine. This new contract will not only help us vaccinate millions of people across the U.S., but also to speed up access to potential Covid-19 candidates and increase the nation’s resilience to future pandemics. Can help you create.

The Valnevas vaccine candidate, VLA2001, is based on a proven approach and will leverage the company’s existing manufacturing platform used for Japanese encephalitis (JE) vaccines approved by the US FDA and EMA. VLA2001 is expected to enter clinical research at the end of 2020, and if clinical development is successful, it could get its first regulatory approval in the second half of 2021.

Valneva had previously agreed in principle with the UK government on the supply of vaccine doses 1 and announced a binding preliminary agreement to support expansion of UK-based manufacturing facilities.

Regarding the novel coronavirus SARS-CoV-2 and COVID-19 diseases, SARS-CoV-2 is a novel coronavirus identified at the end of 2019 and belongs to the group of enveloped RNA viruses including MERS and SARS, both of which are severe human respiratory infections. Caused. system. The virus that causes the disease COVID-19 has never been found in humans before. Since the outbreak was first reported at the end of 2019, the virus has infected more than 29 million people and has caused more than 900,000 deaths worldwide (as of September 13, 2020). Declared infectious disease by the World Health Organization (WHO). There is currently no vaccine against COVID-19.

About VLA 2001 VLA2001 utilizes the manufacturing technology of the Valnevas Japanese encephalitis vaccine as a highly purified, inactivated vaccine candidate against the Vero cell-based SARS-COV-2 virus. The company has designed a process that primarily uses this platform with respect to the upstream and downstream process steps, plug-and-play with moderate adjustments. This process involves inactivation with BPL to preserve the basic structure of the S protein. Combination with CpG 1018 is expected to elicit a strong immune response and has the potential to generate high titers of neutralizing antibodies. VLA2001 is expected to comply with standard low temperature chain requirements (2 to 8 degrees Celsius).

About Valneva SEValneva is a professional vaccine company focused on preventing diseases with major unmet needs. The Valnevas portfolio includes two commercial vaccines for travelers. IXIARO/JESPECT for the prevention of Japanese encephalitis and DUKORAL for the prevention of cholera, in some countries it is used to prevent diarrhea caused by ETEC. The company is developing a variety of vaccines, including its own vaccine against Lyme disease, Chikungunya, and COVID-19. Valneva has over 500 employees in Austria, Sweden, the UK, France, Canada and the USA. For more information, please visit www.valneva.com and follow the company on LinkedIn.

Valneva Investor and Media Contact David Lawrence Chief Financial Officer +447908627213

Laetitia Bachelot-Fontaine Director Investor Relations and Corporate Communications M +33 (0) 6 4516 [email protected]

Valneva forward-looking statements

This press release contains certain forward-looking statements related to Valneva’s business with respect to the progress, timing and completion of research, development and clinical trials of product candidates, manufacturing, marketing, commercialization, and achievement of market capacity for the product. . Future performance and estimates of product candidates, the ability to protect intellectual property rights and operate a business without infringing on the intellectual property rights of others, expected operating losses, future revenues, capital requirements and requirements for additional financing. Additionally, although Valneva’s actual results or developments are consistent with the forward-looking statements contained in this press release, Valneva’s results or developments may not be indicative of the future. In some cases, words such as “can”, “must”, “can”, “expect”, “expect”, “believe”, “intention”, “estimate”, “goal” To identify forward-looking statements. “”targets” or a similar word. These forward-looking statements are based primarily on Valneva’s current expectations as of the date of this press release, and a number of known and unknown risks and uncertainties that could materially result in actual results, performance or performance, and It is affected by other factors.It differs from the future results, performance or performance expressed or implied by these forward-looking statements.In particular, Valneva’s expectations are the uncertainties associated with the development and manufacture of vaccines, unexpected clinical trial results, May be affected by regulatory actions or delays, general competition, currency fluctuations, global and global corporate influences, European credit crisis and the ability to obtain or maintain patents or other proprietary intellectual property protections. In the light of uncertainty, there is no guarantee that any forward-looking statements made during this presentation will actually be realized. You disclaim any intention or obligation to update or modify it publicly.

1 Valneva Confirms Participation in UK Government COVID-19 Vaccine Response Program

2 Valneva reports H1 results in terms of key corporate performance and strong cash positions

2020_09_14_VLA_COVID-19_Contract_UKGov_PR_EN_FINAL

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