{"schema_version":"secwatch.filing_event.v1","accession":"0000950170-24-134779","form_type":"8-K","ticker":"ATOS","cik":"0001488039","company_name":"ATOSSA THERAPEUTICS, INC.","filed_at":"2024-12-10T23:59:59+00:00","discovered_at":"2026-05-14T18:03:08.568434+00:00","generated_at":"2026-05-29T05:08:52.569223+00:00","sec_items":["8.01","9.01"],"event_type":"other_material","sentiment":"positive","materiality_score":0.7,"calibrated_materiality_score":0.7,"confidence":"high","headline":"Atossa presents positive PK/tolerability data from Phase 2 EVANGELINE trial of (Z)-endoxifen","bullets":["50% of patients on 80 mg (Z)-endoxifen + goserelin met target plasma Css of 500-1,000 ng/mL.","Tissue Css levels >2x plasma; >90% of patients achieved target tissue levels >500 ng/g.","Ki-67 ≤10% response rate >85% across doses after 4 weeks, indicating antitumor activity.","(Z)-endoxifen well tolerated with no Grade 3-4 toxicities; four gynecologic events in 80 mg groups.","Randomized trial to compare 40 mg + OFS vs exemestane + OFS; recruitment expected to start 2025."],"urls":{"canonical":"https://secwatch.observer/filing/0000950170-24-134779","json":"https://secwatch.observer/filing/0000950170-24-134779.json","markdown":"https://secwatch.observer/filing/0000950170-24-134779.md","text":"https://secwatch.observer/filing/0000950170-24-134779.txt","edgar_index":"https://www.sec.gov/Archives/edgar/data/1488039/000095017024134779/0000950170-24-134779-index.htm","edgar_primary_document":"https://www.sec.gov/Archives/edgar/data/1488039/000095017024134779/atos-20241210.htm"},"model":{"generated_by":"deepseek-v4-flash:cloud@v2","generated_at":"2026-05-29T05:08:52.569223+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":[],"license":"Source filings: public domain (SEC EDGAR). Summaries (headline + bullets): CC-BY-4.0; attribute https://secwatch.observer"}