Rajan Sharma's questions to Valneva (VALN) leadership • Q2 2025
Question
Rajan Sharma of Goldman Sachs questioned the confidence in a 2025 Lyme disease data readout given a 2026 completion date on clinicaltrials.gov. He also asked about the efficacy bar for success and approvability compared to previous Lyme vaccines.
Answer
CEO Thomas Lingelbach clarified that the clinicaltrials.gov date includes follow-up periods and that Pfizer, who controls the process, reaffirmed the 2026 submission timeline. He stated there is no pre-aligned efficacy bar with regulators but noted that the trial was designed for success with a 3+1 dose schedule, and direct comparisons to older vaccines are challenging due to different study designs.