DBVT: FDA agrees on safety data for Viaskin BLA in 4-7 yr olds; cash only into Apr 2025

DBV Technologies S.A.

FDA aligns: safety data from VITESSE Phase 3 and OLE sufficient for BLA; no COMFORT Children study needed; BLA filing 1H 2026, potential launch acceleration ~1 year.
VITESSE Phase 3 topline results on track for Q4 2025; 654 participants enrolled, largest peanut allergy trial in 4-7 age group.
Cash $32.5M at Dec 31, 2024 (vs $141.4M); net loss $113.9M ($1.17 diluted EPS); operating expenses $120.7M.
Going concern: cash expected only into April 2025; company actively seeking additional capital and reviewing financing options.

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