{"schema_version":"secwatch.filing_event.v1","accession":"0001493152-24-038718","form_type":"8-K","ticker":"CLDI","cik":"0001855485","company_name":"Calidi Biotherapeutics, Inc.","filed_at":"2024-09-30T23:59:59+00:00","discovered_at":"2026-05-14T18:03:14.960688+00:00","generated_at":"2026-05-31T00:53:58.689979+00:00","sec_items":["7.01","9.01"],"event_type":"regulatory","sentiment":"positive","materiality_score":0.65,"calibrated_materiality_score":0.65,"confidence":"high","headline":"FDA clears IND for Calidi's CLD-101 Phase 1b/2 trial in high-grade glioma","bullets":["FDA cleared Northwestern University's IND for CLD-101, a stem cell-based oncolytic virus therapy for high-grade glioma.","Phase 1b/2 trial will evaluate safety/feasibility of multiple doses in newly diagnosed patients; expected to start Q1 2025.","Prior Phase 1 trial showed median overall survival 18.4 months and no dose-limiting toxicity (Lancet Oncology 2021).","Additional Phase 1 trial in recurrent high-grade glioma at City of Hope with interim data expected H1 2025."],"urls":{"canonical":"https://secwatch.observer/filing/0001493152-24-038718","json":"https://secwatch.observer/filing/0001493152-24-038718.json","markdown":"https://secwatch.observer/filing/0001493152-24-038718.md","text":"https://secwatch.observer/filing/0001493152-24-038718.txt","edgar_index":"https://www.sec.gov/Archives/edgar/data/1855485/000149315224038718/0001493152-24-038718-index.htm","edgar_primary_document":"https://www.sec.gov/Archives/edgar/data/1855485/000149315224038718/form8-k.htm"},"model":{"generated_by":"deepseek-v4-flash:cloud@v2","generated_at":"2026-05-31T00:53:58.689979+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"}