Leiden, Netherlands and Saint-Herblain, France, June 15, 2020 – Batavia Biosciences (“Batavia”) and Valneva Sweden AB, the Swedish subsidiary of Valneva SE (“Valneva”), today announced that they have entered into a collaboration agreement to accelerate market-access of a low-cost inactivated polio vaccine (IPV). This work is supported under GPEI.[1]

In 2019, Batavia received a grant from the Bill & Melinda Gates Foundation to use its novel, low-cost vaccine manufacturing process HIP-Vax™, in combination with Nevoline™ manufacturing equipment developed by Univercells, to deliver clinical grade IPV bulks to selected Developing Country Vaccine Manufacturers (DCVMs) for phase I/II clinical studies. The IPV vaccine is based on the Sabin vaccine strains (sIPV), which Batavia has successfully obtained from the World Health Organization (WHO).

Under the terms of the agreement, Valneva will manufacture the sIPV vaccine for clinical trial purposes in its state-of-the-art GMP polio manufacturing facility operated under GAPIII[2] polio containment in Solna, Sweden, using Batavia’s process. In return, Valneva will receive an upfront payment and monthly service fees.

Batavia will remain responsible for release and supply of the GMP vaccine to the DCVMs. The know-how generated will be made available to the DCVMs to facilitate transfer of the technology and manufacture of the vaccine under GAPIII conditions in the future.

Thomas Lingelbach, CEO, Valneva, commented, “As a company focusing on high unmet medical needs, Valneva is proud to make another important contribution to polio eradication through this agreement with Batavia. Our site and team in Sweden has significant experience working with poliovirus. This new contract underscores Valneva’s technical expertise in clinical manufacturing and bio-risk management.”

Chris Yallop, COO, Batavia Biosciences, added, “We are excited to be working with Valneva, who can leverage their GAPIII polio facility and polio know-how to accelerate the development of this important vaccine as well as offering an important step forward in the application of our HIP-Vax™ technology for vaccine manufacture.”

Über Valneva SE

Valneva is a specialty vaccine company focused on prevention against diseases with major unmet needs. Valneva’s portfolio includes two commercial vaccines for travelers: IXIARO® /JESPECT® indicated for the prevention of Japanese encephalitis and DUKORAL® indicated for the prevention of cholera and, in some countries, prevention of diarrhea caused by ETEC. The Company has various vaccines in development including unique vaccines against Lyme disease and chikungunya. Valneva has operations in Austria, Sweden, the United Kingdom, France, Canada and the US with over 500 employees. For more information, visit www.valneva.com and follow the Company on LinkedIn.

About Batavia Biosciences

Batavia Biosciences significantly contributes to ease human suffering from infectious diseases and cancer by improving the success rate in the translation of candidate medicines from discovery to the clinic. We offer our innovative technologies and in-depth know-how in order to help our partners to complete preclinical phases in biopharmaceutical product development at higher speed, reduced costs and increased success. The company focuses on the early stages of product development including cell line generation, upstream process development, purification development, product characterization and clinical manufacturing. Headquartered in Leiden, the Netherlands, with a subsidiary in Woburn, Massachusetts, and offices in Hong Kong, Batavia Biosciences is privileged to have strong strategic partners worldwide.

Investor and Media Contacts

Valneva

Laetitia Bachelot-Fontaine

Director of Investor Relations &

Corporate Communications

M +33 (0)6 4516 7099

investors@valneva.com

Batavia Biosciences

Chris Yallop

COO

T +31 (0)88 9950600

c.yallop@bataviabiosciences.com

 

Zukunftsgerichtete Aussagen

This press release contains certain forward-looking statements relating to the business of Valneva, including with respect to the progress, timing and completion of research, development and clinical trials for product candidates, the ability to manufacture, market, commercialize and achieve market acceptance for product candidates, the ability to protect intellectual property and operate the business without infringing on the intellectual property rights of others, estimates for future performance and estimates regarding anticipated operating losses, future revenues, capital requirements and needs for additional financing. 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 performance. In some cases, you can identify forward-looking statements by words such as “könnte,” “sollte,” “könnte” “erwartet,” “antizipiert,” “glaubt,” “beabsichtigt,” “schätzt,” “strebt an,” “zielt darauf ab,” 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. 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] The Global Polio Eradication Initiative is a public-private partnership led by national governments with six core partners – the World Health Organization (WHO), Rotary International, the US Centers for Disease Control and Prevention (CDC), the United Nations Children’s Fund (UNICEF), the Bill & Melinda Gates Foundation and Gavi, the Vaccine Alliance. Its goal is to eradicate polio worldwide.

[2] The Global Action Plan, third edition (GAPIII) was established by the World Health Organization in December 2014 to minimize the risk of reestablishing the circulation of poliovirus from potentially infectious samples stored in facilities, including laboratories.