{"schema_version":"secwatch.filing_event.v1","accession":"0001104659-24-062054","form_type":"8-K","ticker":"OTLK","cik":"0001649989","company_name":"Outlook Therapeutics, Inc.","filed_at":"2024-05-15T23:59:59+00:00","discovered_at":"2026-05-14T18:03:19.423777+00:00","generated_at":"2026-06-01T23:15:21.663886+00:00","sec_items":["2.02","9.01"],"event_type":"earnings","sentiment":"positive","materiality_score":0.75,"calibrated_materiality_score":0.75,"confidence":"high","headline":"Outlook Therapeutics reports Q2 FY2024 net loss of $114.3M; positive CHMP opinion for ONS-5010 in EU","bullets":["Net loss of $114.3M ($8.01/sh); adjusted net loss of $22.1M ($1.55/sh) vs $6.7M loss year ago.","CHMP issued positive opinion for ONS-5010/LYTENAVA in EU; EC decision expected within ~67 days.","NORSE EIGHT trial >30% enrolled; topline readout planned in Q4 CY2024; BLA resubmission by end of CY2024.","UK MAA submitted under International Recognition Procedure.","Company believes sufficient capital to fund potential FDA approval and commercial launch assuming warrant exercise."],"urls":{"canonical":"https://secwatch.observer/filing/0001104659-24-062054","json":"https://secwatch.observer/filing/0001104659-24-062054.json","markdown":"https://secwatch.observer/filing/0001104659-24-062054.md","text":"https://secwatch.observer/filing/0001104659-24-062054.txt","edgar_index":"https://www.sec.gov/Archives/edgar/data/1649989/000110465924062054/0001104659-24-062054-index.htm","edgar_primary_document":"https://www.sec.gov/Archives/edgar/data/1649989/000110465924062054/tm2414392d1_8k.htm"},"model":{"generated_by":"deepseek-v4-flash:cloud@v2","generated_at":"2026-06-01T23:15:21.663886+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":"2cdbae6f30f8e3914204bf224e32ac77211f66db","claim":"Outlook Therapeutics, Inc. reported financial results for second quarter of fiscal year 2024.","evidence_excerpt":"Outlook Therapeutics, Inc. (the “Company”) issued a press release announcing its financial results for its second fiscal quarter ended March 31, 2024","evidence_source":"SEC 8-K Item 2.02","evidence_url":"https://www.sec.gov/Archives/edgar/data/1649989/000110465924062054/0001104659-24-062054-index.htm","confidence":0.9,"family_label":"Earnings Releases","details":[{"label":"Period","value":"second quarter of fiscal year 2024"},{"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"}