{"schema_version":"secwatch.filing_event.v1","accession":"0001493152-26-045260","form_type":"8-K","ticker":"AZTR","cik":"0001701478","company_name":"Azitra, Inc.","filed_at":"2026-10-01T12:10:36+00:00","discovered_at":"2026-10-01T12:15:00.348669+00:00","generated_at":"2026-10-12T14:16:11.732755+00:00","sec_items":["8.01","9.01"],"event_type":"other_material","sentiment":"positive","materiality_score":0.5,"calibrated_materiality_score":0.5,"confidence":"high","headline":"Azitra clears ATR-04 safety review, advances Phase 1/2 trial to Cohort 2 enrollment","bullets":["Safety review committee cleared ATR-04 after reviewing Cohort 1 data; seven patients received a single 4g topical application to face, chest and back, then 28 days of once-daily dosing.","Cohort 2 will enroll approximately 24 patients receiving 4g once daily for 28 days at six clinical sites, including MD Anderson Cancer Center and Yale University.","The multicenter, randomized, double-blind, vehicle-controlled Phase 1/2 study (NCT06830863) uses 3:1 randomization comparing ATR04-484 to vehicle.","ATR04-484 holds FDA Fast Track designation for EGFRi-associated rash, which affects roughly 50-80% of EGFR inhibitor patients and ~150,000 people annually in the U.S.","CEO Francisco Salva said ATR-04 could become the first live biotherapeutic specifically developed for cancer treatment-associated rash."],"urls":{"canonical":"https://secwatch.observer/filing/0001493152-26-045260","json":"https://secwatch.observer/filing/0001493152-26-045260.json","markdown":"https://secwatch.observer/filing/0001493152-26-045260.md","text":"https://secwatch.observer/filing/0001493152-26-045260.txt","edgar_index":"https://www.sec.gov/Archives/edgar/data/1701478/000149315226045260/0001493152-26-045260-index.htm","edgar_primary_document":"https://www.sec.gov/Archives/edgar/data/1701478/000149315226045260/form8-k.htm"},"model":{"generated_by":"deepseek-v4.1-flash:cloud@v2","generated_at":"2026-10-12T14:16:11.732755+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"}