DBV Technologies S.A. Q3 FY2023 earnings call

• DBV is advancing 2 Viaskin Peanut programs: for toddlers (1-3 years) and children (4-7 years).
• For toddlers, the FDA requested a supplemental safety study (COMFORT Toddlers) to increase active treatment subjects to ~600. For children (4-7), a supplemental safety study (COMFORT Children) to increase active treatment subjects to ~600.
• Received FDA feedback clarifying remaining protocol design elements for both safety studies. Protocols will have harmonized language regarding product use.
• COMFORT Toddlers will use EPITOPE study eligibility criteria; COMFORT Children will align with Phase III efficacy study. Anticipate COMFORT Toddlers enrollment in Q1 2024, COMFORT Children after Toddlers.

As of September 30, 2023, cash and cash equivalents were $149.1 million, a net decrease of $60.1 million from $209.2 million as of December 31, 2022. Operating activities used $66 million, mainly due to clinical work and initiation of the VITESSE trial. $7 million of net proceeds came from the issuance and sale of new ordinary shares in June 2023.

• Anticipate ~1,400 patients enrolled in Viaskin Peanut Phase III studies by next year.
• Expect to submit finalized COMFORT Toddlers protocol in the next few weeks and initiate COMFORT Toddlers study in Q1 2024.
• COMFORT Children enrollment will occur after COMFORT Toddlers and in alignment with VITESSE recruitment.

Q: What impact do the need for food challenging COMFORT Toddlers have on anticipated timeline?

A: Pharis Mohideen said they anticipate first patient enrollment in Q1 2024, expecting food challenge could add some time through recruitment but sites are familiar with food challenges and confident they can get it done.

Q: Does the food challenge requirement impact the potential cost of the trial and whether sufficient run rate to fund through to completion?

A: Daniel Tassé said the addition of the food challenge will not add significantly to the cost of the trial. They have sufficient cash to go into 2025 and will look at raising capital in due time but no rush at the moment.