DBV Technologies SA Q1 FY2022 earnings call

• Clinical and regulatory update on modified Viaskin Peanut patch: Announced plan to initiate pivotal Phase 3 clinical study VITESSE in December, completed VITESSE protocol and prepared for FDA submission, engaged in collaborative exchanges with FDA, expecting Type C meeting in Q2. - EPITOPE Phase 3 trial: Expect top-line results by end of Q2 2022, which will inform regulatory pathway for 1-3-year-olds. - Financials: Cash and cash equivalents as of March 31, 2022 were $74.1 million, expected to support operations into Q1 2023. - Established an at-the-market (ATM) program to sell up to $100 million of ADSs until June 2024, exploring non-dilutive financing strategies. - Near-term catalysts: FDA alignment on VITESSE protocol and EPITOPE top-line data, planning conference calls before releasing first half 2022 financial results targeted for early August.

• Near-term catalysts include FDA alignment on VITESSE protocol and EPITOPE top-line data. - Likely to host at least one conference call and possibly two before releasing first half 2022 financial results in early August.

• Forward-looking statements subject to risks and uncertainties that could cause actual results to differ significantly. - Refer to Company’s filings with SEC and French AMF for risk factors affecting actual results differing from forward-looking statements.

Q: Could you tell us any more about the broad strokes of the protocol you submit to FDA ahead of the Type C meeting?

A: We’re looking forward to sharing extensive details on the protocol but want to get FDA alignment first. The FDA has seen two previous pivotal studies from us, and we think the discussion will be healthy but prefer to finalize protocol and data alignment before sharing details with investors.

Q: Wondering why you’re thinking that there may be one or two interactions after the Type C meeting may be necessary?

A: The Type C meeting will provide answers, but we may need to go back to the agency to ensure everything is buttoned down given the healthy dynamic with them, prioritizing minimizing regulatory risk for speed.

Q: Looking forward to EPITOPE data, can you walk us through your expectations on assumed success and patch scenarios?

A: We are comfortable conceptually with two different patches but will wait for EPITOPE results and engage with FDA. The EPITOPE study lines are similar to PEPITES, and we think discussing regulatory pathway will be straightforward once data is in hand, but prefer not to speculate before having the data.