2025 Annual Business Report

2025 Highlights

2025 demonstrated Valneva’s resilience and dedication to progress. We achieved significant milestones across our development pipeline, including our mid– and late-stage clinical assets.

2025 Highlights

A specialty vaccine company

In 2025, Valneva advanced its key R&D programs, including its late-stage Lyme disease vaccine candidate partnered with Pfizer, remained committed to growing its commercial brands and enhanced its financial flexibility by successfully refinancing its debt and continuing to substantially reduce operating cash burn.

R&D

Lyme disease vaccine candidate, VLA15

  • Announced completion of vaccinations in VALOR Phase 3 trial
  • Announced Positive final Phase 2 results for VLA15 vaccine candidate

Chikungunya vaccine, VLA1553 marketed under IXCHIQ®

  • Announced several regulatory approvals: IXCHIQ® is now approved for use in individuals 12 years of age and older in the European Union and Canada and in individuals 18 years to 59 years of age in the United Kingdom and Brazil
  • Reported positive long term antibody persistence data four years after a single dose of IXCHIQ®
  • Prepared Pilot Vaccination Campaign in Brazil with partner Instituto Butantan

Shigella vaccine candidate, S4V2

  • Vaccinated first participant in a Phase 2 infant safety and immunogenicity trial

Zika vaccine candidate, VLA1601

  • Reported positive Phase 1 results for second-generation Zika vaccine candidate

Strategic

  • Enhanced financial flexibility with successful debt refinancing
  • Signed exclusive agreement with CSL Seqirus, one of the world’s largest influenza vaccine companies, for the marketing and distribution of Valneva’s three proprietary vaccines in Germany