{"schema_version":"secwatch.filing_event.v1","accession":"0001193125-26-229153","form_type":"8-K","ticker":"IBRX","cik":"0001326110","company_name":"ImmunityBio, Inc.","filed_at":"2026-05-18T21:20:47+00:00","discovered_at":"2026-05-18T21:22:00.570106+00:00","generated_at":"2026-05-18T21:25:17.802120+00:00","sec_items":["1.01","7.01","9.01"],"event_type":"other_material","sentiment":"positive","materiality_score":0.85,"calibrated_materiality_score":0.85,"confidence":"high","headline":"ImmunityBio signs exclusive U.S. supply agreement with Japan BCG Laboratory for Tokyo strain of BCG","bullets":["Agreement grants ImmunityBio exclusive U.S. rights to develop and commercialize Tokyo-172 BCG for 10 years after FDA approval.","Positive Phase III SWOG S1602 trial demonstrated non-inferiority of Tokyo strain vs TICE BCG in high-grade NMIBC (HR 0.82; 95.8% CI 0.63–1.08).","ImmunityBio plans to engage FDA for BLA submission as sole applicant; no payment due until FDA approval; vials for regulatory submission provided at no cost.","Agreement provides second BCG source alongside Serum Institute's rBCG; rBCG remains available to eligible patients under FDA Expanded Access Program."],"urls":{"canonical":"https://secwatch.observer/filing/0001193125-26-229153","json":"https://secwatch.observer/filing/0001193125-26-229153.json","markdown":"https://secwatch.observer/filing/0001193125-26-229153.md","text":"https://secwatch.observer/filing/0001193125-26-229153.txt","edgar_index":"https://www.sec.gov/Archives/edgar/data/1326110/000119312526229153/0001193125-26-229153-index.htm","edgar_primary_document":"https://www.sec.gov/Archives/edgar/data/1326110/000119312526229153/d75270d8k.htm"},"model":{"generated_by":"deepseek-v4-flash:cloud","generated_at":"2026-05-18T21:25:17.802120+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":[{"claim_id":"dd11d5e24351943d01102421a9e2fe7b071e32e6","claim":"ImmunityBio, Inc. entered into Exclusive Development and Supply Agreement with Japan BCG Laboratory valued at No payment due prior to FDA approval; minimum 2 batches per year after approval (effective 2026-05-14).","evidence_excerpt":"On May 14, 2026, ImmunityBio, Inc., a Delaware corporation (“ImmunityBio” or the “Company”), entered into an exclusive development and supply agreement (the “Agreement”) with Japan BCG Laboratory, a Japanese corporation (“JBL”).","evidence_source":"SEC 8-K Item 1.01/1.02","evidence_url":"https://www.sec.gov/Archives/edgar/data/1326110/000119312526229153/0001193125-26-229153-index.htm","confidence":0.95,"family_label":"Material Agreements","details":[{"label":"Action","value":"entry"},{"label":"Agreement","value":"supply"},{"label":"Counterparty","value":"Japan BCG Laboratory"},{"label":"Value","value":"No payment due prior to FDA approval; minimum 2 batches per year after approval"},{"label":"Effective","value":"2026-05-14"}],"fact_type":"material_agreement"}],"license":"Source filings: public domain (SEC EDGAR). Summaries (headline + bullets): CC-BY-4.0; attribute https://secwatch.observer"}