DBV Technologies (DBV) investor relations material

Regulatory and clinical development updates

• BLA submission for VIASKIN Peanut in children ages 4–7 is planned for the end of Q3, following productive discussions with the agency regarding data organization and regulatory requirements.

• BLA submission for toddlers (ages 1–3) is targeted for year-end, with pre-BLA discussions to follow the initial submission.

• Ongoing Phase II THRIVE study is evaluating VIASKIN Peanut in infants aged 6–12 months, aiming to demonstrate long-term benefits and potential for label extension.

• The goal is to show that early, non-invasive immunotherapy can enable children to live with peanuts similarly to non-allergic peers after several years of treatment.

Market opportunity and unmet needs

• Peanut allergy significantly impacts family quality of life, with early diagnosis now occurring as young as 18 months due to earlier peanut introduction.

• Immunotherapy is most effective in younger children due to greater immune system plasticity, making this population a key target.

• VIASKIN Peanut aims to address the need for a safe, easy-to-use, long-term therapy that improves daily life and reduces anxiety for families.

Competitive landscape and differentiation

• Previous oral immunotherapy (Palforzia) failed commercially due to cumbersome administration and lifestyle limitations, despite strong physician and payer support.

• VIASKIN Peanut differentiates itself with a simple, non-invasive patch that integrates easily into daily routines and has a favorable safety profile.

• XOLAIR, an IgE-blocking therapy, is rarely used in young children; immunotherapy remains the preferred approach for this age group.