{"schema_version":"secwatch.filing_event.v1","accession":"0001104659-23-128806","form_type":"8-K","ticker":"OTLK","cik":"0001649989","company_name":"Outlook Therapeutics, Inc.","filed_at":"2023-12-22T23:59:59+00:00","discovered_at":"2026-05-14T18:03:29.937406+00:00","generated_at":"2026-06-07T07:58:32.217384+00:00","sec_items":["2.02","9.01"],"event_type":"earnings","sentiment":"neutral","materiality_score":0.6,"calibrated_materiality_score":0.6,"confidence":"high","headline":"Outlook Therapeutics reports FY2023 net loss of $59M, reiterates ONS-5010 path with NORSE EIGHT trial start in Q1 2024","bullets":["Net loss of $59.0M ($0.24 per share) for FY2023, vs. $66.1M ($0.31 per share) prior year.","Cash and equivalents $23.4M as of Sept 30, 2023; extended convertible note maturity to April 1, 2024.","FDA response on NORSE EIGHT SPA expected early Feb 2024; trial start targeted Q1 2024.","MAA decision in EU for ONS-5010 (LYTENAVA) anticipated first half 2024; BLA resubmission expected by end of 2024.","Exploring expanded relationship with Cencora for international launch; Syntone partnership in China continues."],"urls":{"canonical":"https://secwatch.observer/filing/0001104659-23-128806","json":"https://secwatch.observer/filing/0001104659-23-128806.json","markdown":"https://secwatch.observer/filing/0001104659-23-128806.md","text":"https://secwatch.observer/filing/0001104659-23-128806.txt","edgar_index":"https://www.sec.gov/Archives/edgar/data/1649989/000110465923128806/0001104659-23-128806-index.htm","edgar_primary_document":"https://www.sec.gov/Archives/edgar/data/1649989/000110465923128806/tm2333600d1_8k.htm"},"model":{"generated_by":"deepseek-v4-flash:cloud@v2","generated_at":"2026-06-07T07:58:32.217384+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":"c012fb7fd31502b87caf06563215eff9e63e8ccd","claim":"Outlook Therapeutics, Inc. updated its guidance (reaffirmed).","evidence_excerpt":"Outlook Therapeutics® Reports Financial Results for Fiscal Year 2023 and Reiterates ONS-5010 Clinical and Regulatory Path Forward in the U.S. and EU","evidence_source":"SEC 8-K Item 2.02","evidence_url":"https://www.sec.gov/Archives/edgar/data/1649989/000110465923128806/0001104659-23-128806-index.htm","confidence":0.7,"family_label":"Earnings Releases","details":[{"label":"Guidance","value":"reaffirmed"},{"label":"Result","value":"guidance update"}],"fact_type":"earnings_release"}],"license":"Source filings: public domain (SEC EDGAR). Summaries (headline + bullets): CC-BY-4.0; attribute https://secwatch.observer"}