DBV Technologies (DBV) investor relations material

Strategic focus and product development

• Focused on epicutaneous immunotherapy (VIASKIN) for food allergies, primarily peanut allergy in young children, addressing significant unmet needs in efficacy, safety, and practicality.

• Two separate BLAs planned: one for 4–7-year-olds (submission in first half of this year), and one for 1–3-year-olds (submission following completion of the COMFORT safety study).

• FDA considers the two age groups as different products, providing two market opportunities.

• Rich clinical milestone agenda over the next 18 months, including BLA submissions, approvals, and launches for both age groups.

Clinical data and efficacy

• Over 1,600 patients treated with VIASKIN Peanut, with strong efficacy: 47% responder rate in active arm vs. 15% placebo at one year, meeting FDA criteria.

• Open-label extensions show improved outcomes with longer treatment duration (3–5 years).

• Early treatment (ages 1–7) yields the most profound benefit, with similar treatment effects across this age range.

• Product is non-invasive, patch-based, and designed for daily home use, offering an alternative to oral immunotherapy.

Safety and regulatory pathway

• Safety profile is consistent, with very low anaphylaxis rates (0.5%) and mostly mild to moderate local site reactions.

• COMFORT study in 1–3-year-olds is the final requirement for BLA submission, with no new safety signals expected.

• BLA for 4–7-year-olds to be filed before end of Q2; team is actively preparing regulatory documents.