Valneva (VLA) investor relations material

Company overview and R&D pipeline

• Fully integrated specialty vaccine company with a strong travel vaccine business and promising R&D assets, including Lyme (partnered with Pfizer), Shigella, EBV, and ETEC programs.

• Lyme vaccine program is the most significant, with other assets in earlier stages of development.

Lyme vaccine program status and regulatory path

• Phase III VALOR study in over 9,000 participants showed >70% efficacy but narrowly missed the per-protocol primary endpoint due to fewer adjudicated cases.

• Pre-submission meetings with EMA and FDA are ongoing; filing acceptance anticipated in autumn.

• Approval could enable vaccine launch in autumn 2027, with Pfizer leading regulatory strategy.

• Full data presentation expected at the first major conference after filing acceptance, likely in 2026.

• Market opportunity for Lyme vaccine estimated at over $1 billion, with significant upside in Europe due to rising incidence.

Commercial and market outlook

• U.S. and European high-risk populations for Lyme are substantial, with over 80 million in the U.S. and 200 million in Europe.

• Initial commercial models focus on high-incidence regions and risk-based recommendations.

• Expectation of a favorable ACIP recommendation for high-risk groups if approved.