DBV Technologies (DBV) Status Update summary

Regulatory and Clinical Development Updates

• Secured FDA agreement on safety exposure data, eliminating the need for a supplemental safety study for Viaskin Peanut in children aged 4–7, accelerating BLA submission to the first half of 2026.

• VITESSE Phase 3 study for Viaskin Peanut in 4–7-year-olds over-enrolled to 654 subjects, increasing statistical power above 90%, with top-line results expected in Q4 2025.

• Two independent Viaskin Peanut programs are advancing: one for toddlers (1–3 years) and one for children (4–7 years), each with separate BLA submissions.

• Accelerated approval pathway for 1–3-year-olds and expedited pathway for 4–7-year-olds provide regulatory clarity and potential for earlier market entry.

• Viaskin Peanut has breakthrough designation, making it eligible for priority review upon BLA acceptance.

Clinical Trial Design and Expectations

• VITESSE targets a younger, more sensitive population, with robust response rates observed in post-hoc analyses of prior studies.

• Inclusion criteria and responder definitions were adjusted to reflect more sensitive patients, aiming for a higher probability of meeting the primary endpoint.

• The study enrolled 654 subjects, exceeding the original power calculations, and included a higher proportion of younger children and those with lower IgE levels.

• Placebo response in prior trials was 9.6%; current design is expected to yield a more robust treatment effect.

• COMFORT Toddlers study is on track to start in Q2, with all preparations in place.

Financing Overview and Use of Proceeds

• Announced financing of up to $306.9 million (€284.5 million): $125.5 million upfront and up to $181.4 million via warrants, contingent on positive VITESSE results.

• Proceeds will fund working capital, Viaskin Peanut program development, BLA submission, and US commercial launch readiness if approved.

• If all warrants are exercised, financial visibility could extend into 2028, supporting potential US commercialization.

• Prior to the offering, cash was only sufficient to fund operations into April 2025; post-offering, funding is expected to last until June 2026.

• The financing includes a share capital increase and issuance of various warrants, resulting in immediate dilution of 22.4% and up to 73.7% if all warrants are exercised.