{"schema_version":"secwatch.filing_event.v1","accession":"0001193125-26-455436","form_type":"8-K","ticker":"MGX","cik":"0001785279","company_name":"Metagenomi Therapeutics, Inc.","filed_at":"2026-11-10T21:07:15+00:00","discovered_at":"2026-11-10T21:09:00.342451+00:00","generated_at":"2026-11-10T21:09:23.912873+00:00","sec_items":["2.02","9.01"],"event_type":"regulatory","sentiment":"positive","materiality_score":0.78,"calibrated_materiality_score":0.78,"confidence":"high","headline":"Metagenomi wins FDA IND clearance for MGX-001 in hemophilia A; Q3 cash $101.7M runway into 2028","bullets":["FDA cleared the IND for MGX-001; the INTEGR8 Phase 1/2 trial in adults with moderately severe to severe hemophilia A is planned to start in 1H 2027.","Initial safety, tolerability and Factor VIII activity data are expected in 2H 2027; additional preclinical data will be presented at ASH on Dec. 14, 2026 (Abstract 952).","Cash, cash equivalents and available-for-sale marketable securities were $101.7 million as of Sept. 30, 2026, with runway expected into 2028.","Q3 R&D expense was $17.5 million vs. $25.3 million a year earlier; G&A was $6.9 million, including a $1.2 million one-time net litigation settlement, vs. $6.2 million."],"urls":{"canonical":"https://secwatch.observer/filing/0001193125-26-455436","json":"https://secwatch.observer/filing/0001193125-26-455436.json","markdown":"https://secwatch.observer/filing/0001193125-26-455436.md","text":"https://secwatch.observer/filing/0001193125-26-455436.txt","edgar_index":"https://www.sec.gov/Archives/edgar/data/1785279/000119312526455436/0001193125-26-455436-index.htm","edgar_primary_document":"https://www.sec.gov/Archives/edgar/data/1785279/000119312526455436/mgx-20261110.htm"},"model":{"generated_by":"deepseek-v4.1-flash:cloud@v2","generated_at":"2026-11-10T21:09:23.912873+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"}