DBV Technologies (DBV) Goldman Sachs 45th Annual Global Healthcare Conference summary

Company overview and product platform

• Focuses on immunology, specifically food allergies in children, using epicutaneous immunotherapy via a patch called viaskin.

• The patch delivers microgram amounts of peanut protein to induce desensitization through the skin, leveraging Langerhans cells.

Clinical development and regulatory strategy

• Two parallel BLAs are being pursued: one for toddlers (1-3 years) with the original patch, and one for children (4-7 years) with a modified patch.

• Efficacy in toddlers demonstrated in the EPITOPE study, published in NEJM, showing significant clinical response and continued improvement in year two.

• FDA requires supplemental safety studies (COMFORT Toddlers and COMFORT Children), each with 600 patients, to be run in parallel with efficacy trials.

• Both safety and efficacy studies are expected to read out in the second half of 2025, with BLA submissions following shortly after.

Regulatory alignment and agency engagement

• Recent delays were mainly due to FDA resource constraints during the COVID-19 pandemic, but the backlog has now been resolved.

• Active discussions with the agency have led to agreement on key trial elements, with protocol minutiae for both COMFORT studies expected to align.

• A new Chief Regulatory Officer with extensive FDA experience was appointed to ensure smooth regulatory navigation.