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Valneva SE

Regulatory Filings Jan 23, 2012

1739_iss_2012-01-23_7fbaa208-169b-40b6-a4b2-1e83bda7586d.pdf

Regulatory Filings

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OPENING OF A NEW LABORATORY DEDICATED TO THE VIVA|SCREEN ANTIBODY DISCOVERY PLATFORM

Nantes & Lyon (France), Toyama (Japan) announced today the opening of a new programs in the Lyon Gerland Biotech advantages of a centralized, world health. Resident companies include research institutions such as the French - 23 January 2012 - VIVALIS (NYSE Euronext facility for partnered VIVA|Screen™ antibody Biotechnology Cluster. The Gerland biotechnology world-class research and production environment in human and animal the likes of Sanofi Pasteur, Merial, and Genzyme Institute for Protein Biology and Chemistry Euronext: VLS) discovery nology district offers the Genzyme along with Chemistry.

With this new state-of-the-art laboratory, VIVALIS will be able to capacity and strengthen the VIVA|Screen expand its research and development VIVA|Screen™ platform in current and future industrial collaborations collaborations.

Franck Grimaud, CEO, and Majid Mehtali, CSO, co implementing the microarray technology partnered activities and research into continually improving the technology has been at the forefront of our discovery efforts. Our capacity to engage in new becomes central to the success of VIVALIS as a whole and this new facility gives us the resources and power to do so." co-managers of VIVALIS jointly stated into our antibody discovery platform, the demand for ur new clients programs and advance the platform e stated, "Since

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Next Financial Press Release

January 24, 2012, after NYSE Euronext market closing: 2011 fourth anuary fourth-quarter sales

About the VIVA|Screen™ Platform

A Fully Human Monoclonal Antibody Discovery Platform

The VIVA|Screen™ technology is an innovative process for rapid generation of high value therapeutic antibodies that are fully human by nature by relying humoral immune responses against exogenous or self French Blood Transfusion Center (EFS), Vivalis benefits from access to a large pa the screening of individuals with past and present conditions of therapeutic interest on the principle that humans spontaneously and naturally develop self-antigens. Thanks to a close partnership with the national panel of human donors allowing interest. nel isolating and

The VIVA|Screen™ platform is a sequential process consisting of expanding target b-lymphocytes, screening recovering single b-lymphocytes using a high throughput microarray sequences and the characterization of methods (Figure 1). of selecting proper donors, screening secreted antibodies via functional and/or binding assays lymphocytes system. Further recovery of these human monoclonal antibodies are performed using well established assays, and . antibody formed

Figure 1: The VIVA|Screen™ antibody discovery process.

The VIVA|Screen™ microarray technology lymphocyte out of 200,000,000 peripheral blood mononuclear cells can "finding a needle in a haystack" is now possible (Figure 2). is what powers the isolation of individual b-lymphocytes be screened and chosen lymphocytes. A single bchosen. The proverbial

Figure 2: Detail of the VIVA|Screen™ microarray microarray.

In addition to human b-lymphocytes, cells from immunized mice, rabbits or other species can also entire platform is a highly efficient method for the including tumor and viral antigens. lymphocytes, discovery of antibodies against virtually any antigen of interest, be used. The

VIVA|Screen™ Technology Benefits

  • Discovery of fully human antibodies molecular changes to help ensure specificity, activity and potential increased safety. that have been naturally selected by the host immune syste system having no
  • Efficient, high-throughput screening benefiting from Vivalis isolation of extremely rare b-lymphocyte reening Vivalis's proprietary microarray format that allows the lymphocytes.
  • Functional screening for the identification of biologically relevant evaluation of candidates lacking b-lymphocytes avoids king therapeutic value. s time-consuming
  • A multiplexed approach resulting in against both the human and species used in the pre cross-reactive antibody candidates, including antibodies that react pre-clinical studies.
  • Generation of all classes of antibodies restricted to specific isotypes. – IgA, IgD, IgE, IgG, and IgM – as the VIVA|Screen™ platform is not reactive cell-based solutions to

About VIVALIS (www.vivalis.com)

VIVALIS (NYSE Euronext: VLS) is a biopharmaceutical company that provides innovative cell the pharmaceutical industry for the manufacture of vaccines and proteins, and develops drugs for the prevention and treatment of unmet medical needs. areas: VIVALIS' expertise and intellectual property are leveraged in three main

EB66® Cell Line

VIVALIS offers research and commercial licenses for its EB66 to pharmaceutical and biotechnology companies for the production of therapeutic and prophylactic viral vaccines, virosomes, VLP's, and recombinant proteins (with a focus on monoclonal antibodies having enhanced cytotoxic activity). EB66® cell line based vaccines are currently in clinical trials in programs VIVALIS receives upfront, clinical stage miles ® cell line, derived from duck embryonic stem cells, the USA and Japan. milestone payments along with royalties on licensees net sales. Japan. Through these

VIVA|ScreenTM Human Antibody Discovery Platform

Customized solutions for the discovery, development, and production of fully human monoclonal antibodies are now offered by VIVALIS. Through these along with royalties on licensees net sales. programs VIVALIS receives upfront, clinical stage milestone payments tone clinical molecules

3D-ScreenTM Drug Discovery Platform

VIVALIS performs discovery and development, up to pre identified with its proprietary platform, 3D molecules that alter the three-dimensional structure of a target protein, thus modulating its biological function through an innovative mode of action. treatment of hepatitis-C virus infection. customized 3D-ScreenTM HTS assays directed agains pre-clinical evaluation, of original small chemical 3D-ScreenTM . This unique screening platform is designed to identify original dimensional novative VIVALIS is building a portfolio of proprietary new chemical entities for the C infection. VIVALIS also offers on a service basis to develop ready against target proteins of interest. ready-to-use Based in Nantes & Lyon (France) and in Toyama (Japan) VIVALIS was founded in 1999 by the Grimaud Group (ca. 1,500 employees), a worldwide leader in animal genetic selection. VIVALIS has established more than 30 partnerships and licenses with world leaders in this sector, including Sanofi Pasteur, GlaxoSmithKline, Transgene, Pfizer Animal Health, Kaketsuken, Kitasato Daiichi Sankyo Vaccine, Merial, Merck Animal Health, and SAFC Biosciences. VIVALIS is a member of the French ATLANTIC BIOTHERAPIES and LYON BIOPOLE bioclusters and a member of the Japanese OKURIKU INNOVATION CLUSTER FOR HEALTH SCIENCE in Toyama.

VIVALIS Listed on Euronext Paris – Compartment B of NYSE Euronext Reuters: VLS.PA – Bloomberg: VLS FP Included in NYSE Euronext's SBF 250, CAC Small 90 and Next Biotech indexes

This document contains forward-looking statements and comments on the company's objectives and strategies. No guarantee can be given as to any of the events anticipated by the forward-looking statements, which are subject to inherent risks, including the risk factors described in the company's registration document (document de référence), changes in economic conditions, the financial markets or the markets in which the company operates.

Contacts

VIVALIS

Franck Grimaud, CEO Email: [email protected]

NewCap

Communication financière Axelle Vuillermet / Pierre Laurent Tél.: +33 (0) 1 44 71 94 91 Email : [email protected]

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