---
schema_version: "secwatch.filing_event.v1"
accession: "0001193125-23-199395"
form_type: "8-K"
ticker: "DBVT"
cik: "0001613780"
company_name: "DBV Technologies S.A."
filed_at: "2023-07-31T23:59:59+00:00"
generated_at: "2026-06-12T22:04:34.440147+00:00"
event_type: "regulatory"
sentiment: "positive"
materiality_score: 0.75
calibrated_materiality_score: 0.75
confidence: "high"
source: SEC EDGAR
---

# FDA aligns with DBV on COMFORT safety study designs for toddlers (1-3) and children (4-7); cash $174M, H1 loss $44.8M

## Summary
- FDA agreed on COMFORT Toddlers design: 6-month, 3:1 randomization, ~400 subjects, ages 1-3, no oral food challenge required.
- FDA feedback on COMFORT Children (ages 4-7) consistent with Dec 2022 agreement; studies target ~600 on active treatment per group.
- Cash and equivalents $174M as of June 30, 2023 (down from $209.2M at Dec 31, 2022); H1 net loss $44.8M ($0.48/share).
- Operating expenses $50.7M in H1 (+$6.1M YoY); R&D up to $33.6M driven by VITESSE trial initiation in March 2023.
- Company raised $7.8M via ATM in June 2023; EPITOPE data published in NEJM in May 2023.

## SEC filing metadata
- accession: 0001193125-23-199395
- form_type: 8-K
- ticker: DBVT
- cik: 0001613780
- company_name: DBV Technologies S.A.
- filed_at: 2023-07-31T23:59:59+00:00
- event_type: regulatory
- sentiment: positive
- materiality_score: 0.75
- calibrated_materiality_score: 0.75
- confidence: high
- sec_items: 2.02, 9.01
- EDGAR index: https://www.sec.gov/Archives/edgar/data/1613780/000119312523199395/0001193125-23-199395-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/1613780/000119312523199395/d533459d8k.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001193125-23-199395
- JSON: https://secwatch.observer/filing/0001193125-23-199395.json
- Plain text: https://secwatch.observer/filing/0001193125-23-199395.txt

## Key facts
- Earnings Releases
  DBV Technologies S.A. reported financial results for the fiscal quarter ended June 30, 2023.
  - Period: the fiscal quarter ended June 30, 2023
  - Result: reported results
  source text: On July 31, 2023, DBV Technologies S.A. (the “Company”) issued a press release announcing financial results and business highlights for the fiscal quarter ended June 30, 2023.
  evidence_url: https://www.sec.gov/Archives/edgar/data/1613780/000119312523199395/0001193125-23-199395-index.htm

This AI-assisted summary is a reading aid. Review the linked SEC EDGAR filing before relying on any specific claim.