{"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","discovered_at":"2026-05-14T18:03:34.557873+00:00","generated_at":"2026-06-12T22:04:34.440147+00:00","sec_items":["2.02","9.01"],"event_type":"regulatory","sentiment":"positive","materiality_score":0.75,"calibrated_materiality_score":0.75,"confidence":"high","headline":"FDA aligns with DBV on COMFORT safety study designs for toddlers (1-3) and children (4-7); cash $174M, H1 loss $44.8M","bullets":["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."],"urls":{"canonical":"https://secwatch.observer/filing/0001193125-23-199395","json":"https://secwatch.observer/filing/0001193125-23-199395.json","markdown":"https://secwatch.observer/filing/0001193125-23-199395.md","text":"https://secwatch.observer/filing/0001193125-23-199395.txt","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"},"model":{"generated_by":"deepseek-v4-flash:cloud@v2","generated_at":"2026-06-12T22:04:34.440147+00:00"},"review":{"review_status":"machine_generated","human_reviewed":false,"corrected":false,"correction_note":null,"correction_timestamp":null,"superseded_by":null,"related_filings":[]},"source_grounded_claims":[{"claim_id":"6a982c72b0e93c284c7ff1d06ff06dc827d59657","claim":"DBV Technologies S.A. reported financial results for the fiscal quarter ended June 30, 2023.","evidence_excerpt":"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_source":"SEC 8-K Item 2.02","evidence_url":"https://www.sec.gov/Archives/edgar/data/1613780/000119312523199395/0001193125-23-199395-index.htm","confidence":0.9,"family_label":"Earnings Releases","details":[{"label":"Period","value":"the fiscal quarter ended June 30, 2023"},{"label":"Result","value":"reported results"}],"fact_type":"earnings_release"}],"license":"Source filings: public domain (SEC EDGAR). Summaries (headline + bullets): CC-BY-4.0; attribute https://secwatch.observer"}