DBV Technologies S.A. Q2 FY2023 earnings call

• Discussed Viaskin Peanut programs, including FDA feedback on supplemental safety studies for toddlers and children.
• Phase 3 study EPITOPE for toddlers in the 1-3 age group showed statistically significant results with 67% of subjects in the Viaskin Peanut arm meeting responder criteria, published in the New England Journal of Medicine.
• FDA requested supplemental safety studies for toddlers and children, both 6 months in duration, double-blind, placebo-controlled. The toddlers study will have ~400 subjects, the children's study ~270 subjects, both 3:1 randomization.
• VITESSE Phase 3 study for children aged 4-7 initiated in March 2023 with ongoing progress.
• Finalizing protocols for COMFORT safety studies in toddlers and children, expect to initiate once FDA reviews protocols.
• Cash as of June 30, 2023, was $174M, a net decrease from $209.2M on Dec 31, 2022; cash used in operating activities driven by clinical R&D, with $7.8M raised via ATM program in June 2023.

No specific product segment financial performance with revenue contribution % provided. Focus is on two Viaskin Peanut programs: Viaskin Peanut in toddlers (age 1-3) and Viaskin Peanut in children (age 4-7). The Phase 3 study EPITOPE for toddlers showed 67% of subjects in the Viaskin Peanut arm met treatment responder criteria after 12 months, and the VITESSE Phase 3 study for children (age 4-7) was initiated in March 2023 with ongoing progress.

• Anticipate ~1,400 subjects enrolled in Viaskin Peanut Phase 3 studies by next year.
• VITESSE Phase 3 trial for children aged 4-7 expected to have the last patient screened in the first half of next year, with top line results in the first half of 2025.
• Successful completion of the COMFORT Toddlers safety study is a step towards filing a BLA for marketing approval in peanut allergic toddlers.

• Forward-looking statements are subject to risks and uncertainties that could cause actual results to differ significantly from those suggested.
• Risks from the company's filings with the SEC and French AMF concerning factors that could materially affect actual results compared to expectations, including forward-looking statements made on the call.

Q: What other protocol details are being aligned with FDA and when could the COMFORT programs start?

A: For protocol details, it's about finalizing inclusion, exclusion, etc. The main points are 6-month duration and trial size. Working to finalize the protocol and submit to FDA, but no specific timeline given yet.

Q: Update on VITESSE enrollment and COMFORT Children timing?

A: VITESSE is enrolling as expected, guidance of last patient screened in first half of next year and top line results in first half 2025 remains. Expect to start COMFORT Children towards the end of VITESSE enrollment to not compete and use same sites.

Q: Does the FDA agreement change cash runway guidance for COMFORT Toddlers?

A: No, the feedback from FDA doesn't change clinical trial planning or cash runway guidance as the 6-month duration was already part of financial projections.