DBV Technologies S.A.

DBV reported €66.2 million of cash on hand at the end of H1 2024 and said its cash runway now extends into Q1 2025, versus prior guidance of funding through year-end 2024. In H1, cash used in operations totaled $70 million, including $24 million of non-recurring costs, operating expenses were $65 million, operating income was $2.6 million, and net loss was $60.5 million. Management did not give revenue or EPS figures on the call. Looking ahead, DBV reiterated that VITESSE enrollment should complete by end-Q3 2024, with top-line results expected about 12 months after the last patient is screened; it also expects year-three EPITOPE open-label extension results later this year.

Daniel Tassé framed 2024 as a critical year, centering the story on two potential BLA filings: one for ages 4-7 based on VITESSE plus COMFORT Children, and one for toddlers based on EPITOPE plus COMFORT Toddlers. His tone was constructive but measured, emphasizing progress with FDA and saying the agency now appears to have more bandwidth for Viaskin Peanut-related interactions. He also highlighted that the company’s proposed labeling approach is designed to be pragmatic and rooted in EPITOPE data.

Virginie Boucinha focused on liquidity, spend discipline, and the drivers of cash use. She said cash on hand was €66.2 million and that cost-saving measures extended runway into Q1 2025; H1 cash used in operations was $70 million, with $24 million of that tied to non-recurring items such as COMFORT study startup, move projects, and supply chain activities. She also said operating expenses were $65 million, up 28% year over year, driven mainly by Viaskin Peanut clinical and CMC work, and that operating income of $2.6 million came entirely from research tax credits and the French CIF scheme after the Nestlé Health Sciences collaboration ended.

Analysts focused mainly on the proposed “label in/label out” approach and what exactly the patch-wear-time data means. Management said it refers to how long children wear the patch and the day-to-day variability in wear time, plus related tolerability factors such as itching and ease of use, not just simple adhesion. When asked for details on the size of the responder groups, management declined to give numbers while talks with FDA continue, but said the EPITOPE data show a clear separation and cited a 67% overall response rate as a reference point. Management also said COMFORT Toddlers is the first step, and that progress there should help set up COMFORT Children next year.