2021 Annual Business Report

2021 Highlights

In 2021, Valneva achieved several major milestones, further enhancing its unique value proposition.

2021 Highlights

A specialty vaccine company

R&D

Lyme disease vaccine candidate VLA15

  • Valneva and Pfizer initiated and completed recruitment for a further Phase 2 trial aiming to support acceleration of the vaccine candidate’s pediatric program
  • Valneva and Pfizer reported further positive Phase 2 results from their VLA15-202 trial, including booster response

COVID-19 vaccine candidate VLA2001

  • Valneva published positive Phase 3 results for its pivotal comparative immunogenicity trial Cov-Compare
  • Valneva reported positive homologous booster results, from its Phase 1/2 trial, between seven to eight months after primary vaccination
  • Valneva launched rolling reviews with the European Medicines Agency (EMA) as well as the UK and Bahraini agencies (MHRA and NHRA, respectively). The Bahraini emergency use authorization has been obtained in 2022.

Chikungunya vaccine candidate VLA1553

  • Valneva reported positive topline pivotal and lot-to-lot Phase 3 results
  • VLA1553 was awarded FDA Breakthrough Designation
  • Valneva signed an agreement with Instituto Butantan for the development, manufacturing and marketing of VLA1553 in Low and Middle Income Countries

Strategic

  • Valneva raised $209.6 million of combined gross proceeds from a successful Nasdaq Initial Public Offering (IPO) and European placement in May 2021, plus November 2021 follow-on offering

Commercial

  • Valneva signed purchase agreements with the European Commission (EC) and Kingdom of Bahrain for up to 60 million and one million doses, respectively, of VLA2001
  • Valneva announced a collaboration with IDT Biologika for the production of VLA2001
  • S. DoD exercised first year option on Valneva’s IXIARO® supply contract

Organizational

  • Appointment of Peter Bühler as Chief Financial Officer