DBV Technologies S.A. Q3 FY2022 earnings call

• VITESSE Phase 3 pivotal trial update: Received partial clinical hold from FDA on September 21, not affecting other studies; focus on resolving hold to resume trial initiation.
• Financial results: As of September 30, 2022, cash and cash equivalents were $212.7 million; net cash used in operating activities for nine months was $31.8 million, a 35% decrease from 2021; cash runway guidance unchanged.
• Upcoming event: Looking forward to attending the American College of Allergy, Asthma and Immunology Annual Scientific Meeting.

No specific product segment financial performance data provided.

• Cash runway guidance remains unchanged.
• Continued focus on resolving VITESSE partial clinical hold.

• Uncertainties related to clinical holds and regulatory feedback affecting trial timelines and outcomes.
• Risks associated with forward-looking statements and potential differences between actual results and expectations.

Q: With the clinical hold and dialogue with FDA, how thinking about food challenge as primary endpoint?

A: Daniel Tassé says primary endpoint remains clinical response as defined by food challenge month 12 vs day 0, not a topic in clinical hold.

Q: FDA dialogue on adhesion criteria?

A: Daniel Tassé says adhesion and statistical criteria around adhesion, wear time flip are key discussion topics.

Q: Update on 1-3 year old population after EPITOPE trial?

A: Daniel Tassé says focus is on clinical hold first, then discuss with agency.

Q: R&D spend portion for VITESSE ramp-up and future spend with clinical hold?

A: Sébastien not immediately available, but cash guidance remains unchanged.

Q: Clarity on adverse event categorization and link to trial patients?

A: Pharis Mohideen says it's about how FDA wanted to bucket adverse events, no link to number of patients for efficacy.

Q: Timeline for FDA feedback on lifted hold?

A: Daniel Tassé explains regs: sponsor responds to clinical hold elements, agency has 30 days to respond after.

Q: Impact of clinical hold on cash burn?

A: Daniel Tassé says delay will affect cash burn, but cash runway guidance unchanged with $213M cash.

Q: More on adverse event categorization, timeline for hold lift, cash burn impact?

A: Pharis and Daniel Tassé address each part as above.

Q: Thoughts on quick clinical hold after trial initiation?

A: Daniel Tassé says surprised, but beneficial for enriching data before trial enrollment.