DBV Technologies (DBVT) Q2 Earnings call transcript Jul 30, 2024

DBV Technologies recently held its second quarter financial results and business update conference call, providing investors and stakeholders with an overview of the company's progress and future outlook. The call, led by CEO Daniel Tassé, highlighted the company's focus on its Viaskin Peanut development program, clinical trial updates, and financial highlights.

Viaskin Peanut Development Program: A Promising Prospect

The discussion revolved around DBV's Viaskin Peanut, an investigational proprietary technology platform designed for immunotherapy, specifically in food allergy treatment. Viaskin Peanut is based on epicutaneous immunotherapy (EPIT), which delivers biologically active compounds through intact skin to induce immune tolerance. The most advanced candidate, Viaskin Peanut, is being developed for children aged one to seven, particularly those with peanut allergies, where there is a significant unmet medical need.

The company shared updates on its two Viaskin Peanut development programs. The first is for children aged four to seven, who are currently enrolled in the VITESSE Phase 3 pivotal trial using the modified larger circular patch. The second program is for toddlers aged one to three, who have successfully completed the Phase 3 efficacy study known as EPITOPE.

Clinical Trial Updates: VITESSE and EPITOPE

The VITESSE Phase 3 pivotal trial in children aged four to seven is progressing well, with a clear focus on enrolling participants and completing the study by the end of the third quarter of 2024. The company also announced that it has identified two groups within the Viaskin Peanut treatment arm, referred to as 'label in' and 'label out', based on patch wear time experience. These groups reflect differences in immune physiology, with the former group showing a robust efficacy response and the latter group less likely to respond. This differentiation is expected to provide prescribers with a pragmatic way to discuss patch wear time experience with parents and caregivers.

The EPITOPE study, which focused on toddlers aged one to three, showed successful results, meeting its primary endpoint and being published in the New England Journal of Medicine. The FDA requested a supplemental safety study, COMFORT Toddlers, to increase the number of subjects in the one- to three-year-old safety database. DBV has submitted a draft labeling proposal to the FDA, focusing on user experience during the first 90 days of treatment, to address the agency's concerns related to patch wear time. The company is now awaiting a response from the FDA.

Financial Highlights: Cash Runway and Operating Expenses

The call also included financial highlights, with DBV announcing a cash runway extension into Q1 of 2025, up from prior communications. This extension is attributed to cost-saving measures implemented by the company. The first semester of 2024 saw a net loss of €60.5 million, with operating expenses totaling €65 million, largely driven by Viaskin Peanut clinical and CMC activities.

In conclusion, DBV Technologies' second quarter earnings call provided valuable insights into the company's progress with its Viaskin Peanut development program, clinical trial updates, and financial highlights. With a focus on addressing the unmet medical needs in food allergies, particularly in children, DBV is working towards achieving significant milestones in 2024 and beyond.