DBV Technologies (DBV) H.C. Wainwright 4th Annual BioConnect Investor Conference summary

Company overview and technology

• Focuses on immunology for pediatric food allergies, using a unique skin-based desensitization platform called VIASKIN, with the lead product targeting peanut allergy.

• VIASKIN Peanut is nearing its first BLA filing within six weeks, aiming to address a significant unmet need for parents of allergic children.

Market opportunity and commercial strategy

• Peanut allergy is a major concern for parents due to its unpredictability and prevalence, with current treatments limited and one approved product leaving the market soon.

• VIASKIN targets children aged one to seven, offering a non-invasive, easy-to-use alternative to monoclonal antibodies and oral immunotherapy.

• Market segmentation will focus on parental willingness to adopt new treatments, with initial emphasis on allergists before expanding to pediatricians.

Regulatory pathway and data highlights

• Regulatory process was prolonged due to the novel drug-device combination and initial lack of certain data, but a clear path is now established for children aged four to seven, with expansion to ages one to three by end of 2026.

• Key FDA concerns about patch adhesion were addressed by focusing on clinical response rather than wear time, leading to a mutual understanding with regulators.

• The company holds breakthrough designation and will seek priority review for a faster FDA decision.