DBV Technologies S.A. Q2 FY2024 earnings call

• DBV is developing Viaskin for food allergy immunotherapy, with Viaskin Peanut as the most advanced candidate.
• VITESSE Phase 3 pivotal trial in 4 - 7 year olds: Enrollment ongoing with 86 sites, expect final subject screened by end of third quarter 2024, results and COMFORT Children study will form BLA basis.
• EPITOPE Phase 3 efficacy study in 1 - 3 year olds: Met primary endpoint, FDA requested COMFORT Toddlers supplemental safety study. Submitted protocol, engaged in dialogue with FDA on patch wear time, recently submitted draft labeling proposal.
• Cost - saving measures extended cash runway into Q1 2025.

DBV is developing Viaskin, an investigational proprietary technology platform for immunotherapy, particularly for peanut allergy. The most advanced candidate is Viaskin Peanut, with two development programs: one in 4 - 7 year olds (VITESSE Phase 3 pivotal trial) and one in 1 - 3 year olds (EPITOPE Phase 3 efficacy study and COMFORT Toddlers supplemental safety study). No specific absolute financial performance numbers for segments but focuses on these clinical programs.

• Anticipate completing enrollment in VITESSE Phase 3 trial by end of third quarter 2024.
• Await FDA feedback on draft labeling proposal for COMFORT Toddlers.
• Look forward to sharing year three results of EPITOPE open - label extension later this year.
• Note that OVRR at FDA has more bandwidth for interaction, which is encouraging.

Forward - looking statements based on assumptions subject to risks and uncertainties, including those in SEC and French AMF filings that could cause actual results to differ materially from expectations.

Q: Jon Wolleben asked about patch wear time experience, specifically whether it means how long the kids are wearing the patch or an interplay between concepts.

A: Daniel Tassé and Pharis Mohideen explained it relates to day - to - day variability in patch wear time, not just a simple number of hours, and there's a holistic experience with data to differentiate label - in and label - out subjects.

Q: Jon Wolleben asked about parameters for robust clinical efficacy response and percentage of EPITOPE patients label - in and label - out.

A: Daniel Tassé said they're in dialogue with FDA and can't disclose specific numbers yet, but mentioned a 67% overall response rate with label - in having a better response rate.

Q: Jon Wolleben asked about progress with COMFORT Children and its relation to COMFORT Toddlers.

A: Daniel Tassé said solving for toddlers first is job one, with children to follow in discussions with FDA.