Valneva announces settlement agreement with UK

Holy-Grasslying (France), June 15, 2022 – Valneva SE, (Nasdaq: VALN; Euronext Paris: VLA), a specialist vaccine company, today announced that it has reached a settlement agreement with the United Kingdom Government (“HMG”) regarding the termination of the supply agreement for Valneva’s COVID-19 vaccine candidate, VLA2001.

The Company announced on September 13, 2021 that it had received notice of termination from HMG, and the termination, which Valneva accepted based on HMG’s discretionary right to terminate for convenience, became effective on October 10. 2021.

The settlement agreement resolves certain issues relating to the Company’s and HMG’s obligations following the termination of the supply agreement and in relation to the separate UK clinical trial agreement for VLA2001, which remains in effect.

The Company continues to have certain other obligations under the terms of the Supply Agreement which will survive its termination.

About VLA2001
VLA2001 is currently the only whole virus, inactivated and adjuvanted vaccine candidate in clinical trials against COVID-19 in Europe. It is intended for active immunization of at-risk populations to prevent carriage and symptomatic infection with COVID-19 during the ongoing pandemic and potentially later for routine vaccination, including control of new variants. VLA2001 may also be suitable for boosting, as repeated booster vaccinations have been shown to work well with inactivated whole virus vaccines. VLA2001 is produced on Valneva’s established Vero-cell platform, leveraging Valneva’s licensed Japanese encephalitis vaccine manufacturing technology, IXIARO®. VLA2001 consists of inactivated SARS-CoV-2 whole virus particles with high protein S density, in combination with two adjuvants, alum and CpG 1018. This combination of adjuvants consistently induced higher antibody levels in preclinical experiments than alum-only formulations and showed a shift in immune response towards Th1. CpG adjuvant 1018, supplied by Dynavax Technologies Corporation (Nasdaq: DVAX), is a component of HEPLISAV-B approved by the US FDA and EMA.® vaccine. The manufacturing process for VLA2001, which has already been scaled up to final industrial scale, includes chemical inactivation to preserve the native protein S structure. VLA2001 is expected to meet standard cold chain requirements (2 to 8 degrees Celsius).

About Valneva SE
Valneva is a vaccines company focused on the development and commercialization of prophylactic vaccines for infectious diseases with significant unmet medical needs. The Company takes a highly specialized and targeted approach to vaccine development, then applies its extensive knowledge of vaccine science to develop prophylactic vaccines against these diseases. Valneva has leveraged its expertise and capabilities both to successfully commercialize two vaccines and to rapidly advance a wide range of candidate vaccines in and through the clinic, including candidates against Lyme disease, chikungunya and COVID-19.

Media and investor contacts
Laetitia Bachelot-Fontaine
Vice President of Global Communications and European Investor Relations
M +33 (0)6 4516 7099
[email protected]

Joshua Drumm, Ph.D.
Vice President of Global Investor Relations
M +001 917 815 4520
[email protected]

Forward-looking statements
This press release contains certain forward-looking statements relating to Valneva’s business, including with respect to the progress, timing, design, reading of data, expected results and completion of clinical trials for VLA2001. Furthermore, even if the actual results or developments of Valneva are consistent with the forward-looking statements contained in this press release, such results or developments of Valneva may not be indicative of future results. In some instances, you can identify forward-looking statements by words such as “could”, “should”, “may”, “expect”, “anticipate”, “believe”, “intend”, “estimates”, “aims”, “targets” or similar words. These forward-looking statements are based on Valneva’s current expectations as of the date of this press release and are subject to a number of known risks and uncertainties and unknowns and other factors that may cause actual results, performance or achievements to differ materially from any future results, performance or achievements expressed or implied by such forward-looking statements. Valneva’s expectations could be affected by, among other things, uncertainties related to the development and manufacturing of vaccines, unexpected clinical trial results, unexpected regulatory actions or delays, general competition, currency fluctuations, impa ct of the global market and credit crisis in Europe, the ability to obtain or maintain patent or other proprietary intellectual property protection, the cancellation of existing contracts, including, but not limited to, the agreement supply chain, and the impact of the COVID-19 pandemic, the occurrence of which could materially adversely affect 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 in this presentation will actually materialize. 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.

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Edward L. Robinett