DBV Technologies (DBV) investor relations material

Key study results

• The Phase III VITESSE trial of the VIASKIN Peanut patch in 654 children aged 4–7 met its primary endpoint, with a 46.6% responder rate at 12 months versus 14.8% for placebo, yielding a statistically significant treatment effect of 31.8% and a lower bound 95% CI of 24.5%, exceeding the FDA threshold of 15%.

• The trial was conducted at 86 sites globally, with enrollment exceeding the original target and balanced baseline characteristics between arms.

• Responders achieved significant increases in eliciting dose of peanut protein, as measured by double-blind, placebo-controlled food challenge.

• Results are consistent with previous phase III data in one to three-year-olds, showing similar treatment effects across the one to seven-year-old age range.

• High compliance rate (96.2%) and robust patch adhesion were observed throughout the study.

Safety and tolerability

• Safety profile was favorable and consistent with prior studies, with most adverse events being mild to moderate local skin reactions at the patch site.

• Discontinuations due to adverse events were low: 3.2% in the treatment arm and 0.5% in placebo.

• Treatment-related anaphylaxis was rare at 0.5%, with both affected children continuing treatment.

• No treatment-related serious adverse events were reported.

Clinical and regulatory implications

• The results provide a clear regulatory path to BLA submission in the first half of 2026, with potential for priority review due to breakthrough designation.

• The responder definition was tailored for a younger, more sensitive population, focusing on clinically meaningful desensitization that reduces risk from accidental peanut exposure.

• The levels of desensitization achieved exceed typical accidental exposure amounts, supporting real-world clinical relevance.

• Open-label extension enrollment rates are in line with previous studies, and long-term efficacy and safety data are being collected.

• Full results will be presented at future medical congresses and submitted for peer-reviewed publication.