{"schema_version":"secwatch.filing_event.v1","accession":"0000950170-25-106944","form_type":"8-K","ticker":"ATOS","cik":"0001488039","company_name":"ATOSSA THERAPEUTICS, INC.","filed_at":"2025-08-12T23:59:59+00:00","discovered_at":"2026-05-14T18:02:44.098216+00:00","generated_at":"2026-05-17T14:26:08.819047+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":"Atossa Q2 operating expenses $9M; FDA clears IND path for (Z)-endoxifen in metastatic breast cancer","bullets":["Total operating expenses $9.0M in Q2 2025, up 27% YoY from $7.1M; R&D spend rose 55% to $5.5M.","FDA feedback July 2025: no additional toxicity studies needed; Atossa plans IND submission in Q4 2025 for (Z)-endoxifen in metastatic breast cancer.","I-SPY2 pilot (20 patients): 95% completed ≥75% dosing; median Ki-67 dropped from 10.5% to 5%; functional tumor volume decreased 77.7% by MRI.","Issued U.S. Patent 12,281,056 with 58 claims covering (Z)-endoxifen enteric formulations; two other patents under post-grant challenge."],"urls":{"canonical":"https://secwatch.observer/filing/0000950170-25-106944","json":"https://secwatch.observer/filing/0000950170-25-106944.json","markdown":"https://secwatch.observer/filing/0000950170-25-106944.md","text":"https://secwatch.observer/filing/0000950170-25-106944.txt","edgar_index":"https://www.sec.gov/Archives/edgar/data/1488039/000095017025106944/0000950170-25-106944-index.htm","edgar_primary_document":"https://www.sec.gov/Archives/edgar/data/1488039/000095017025106944/atos-20250812.htm"},"model":{"generated_by":"deepseek-v4-flash:cloud@v2","generated_at":"2026-05-17T14:26:08.819047+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"}