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

DBV Technologies S.A.

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.

item 2.02 item 9.01

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Extracted from this filing and checked against the source text.

Earnings Releases SEC 8-K Item 2.02 confidence 0.9

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

Exact text from the filing

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.

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DBV Technologies S.A. filing history →

Source: SEC EDGAR

accession 0001193125-23-199395

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