DBV Technologies (DBV) Corporate presentation summary

Mission and market overview

• Focused on developing novel treatments for pediatric food allergy, especially peanut allergy, using epicutaneous immunotherapy (EPIT) via the VIASKIN® patch technology.

• Over 1.1 million patches administered to 1,600+ children aged 1-7 years in clinical studies.

• Significant unmet need: ~670,000 children aged 1-7 in the US and 615,000 in the EU have peanut allergy.

• Annual economic impact of peanut allergy in the US is $25B, with high risk of accidental exposure and limited current treatment options.

Product pipeline and regulatory milestones

• VIASKIN® Peanut Patch is the lead product, with separate candidates for toddlers (1-3 years, square patch) and children (4-7 years, circular patch).

• BLA submission for 4-7 YO anticipated in 1H 2026, eligible for priority review; for 1-3 YO, submission expected in 2H 2026 under accelerated approval.

• EMA guidance supports a single MAA submission for 1-7 YO in Europe, requiring three studies including new safety data.

• FDA confirmed accelerated approval pathway for toddlers, with Phase 3 EPITOPE data accepted as an intermediate clinical endpoint.

Clinical efficacy and safety data

• VITESSE Phase 3 in 4-7 YO: 31.8% treatment effect, primary endpoint met, safety profile consistent with prior studies, low discontinuation and anaphylaxis rates.

• EPITOPE Phase 3 in 1-3 YO: 67% responders vs 33.5% placebo at 12 months, with sustained improvement and high compliance over 36 months.

• Safety profile in toddlers: mostly mild-to-moderate local skin reactions, with decreasing frequency over time and no serious treatment-related events after year one.