{"schema_version":"secwatch.filing_event.v1","accession":"0001193125-25-221704","form_type":"8-K","ticker":"IOBTQ","cik":"0001865494","company_name":"IO Biotech, Inc.","filed_at":"2025-09-29T23:59:59+00:00","discovered_at":"2026-05-14T18:02:45.435760+00:00","generated_at":"2026-05-17T05:26:53.401037+00:00","sec_items":["2.05","7.01","8.01","9.01"],"event_type":"regulatory","sentiment":"negative","materiality_score":0.85,"calibrated_materiality_score":0.85,"confidence":"high","headline":"FDA advises IO Biotech not to submit BLA for Cylembio; workforce cut by ~50%","bullets":["FDA recommends against BLA submission based on IOB-013 trial data (PFS improved but missed statistical significance).","Company plans new registrational study for first-line advanced melanoma; also engaging European regulators.","Restructuring reduces workforce ~50%; expects $1.0-1.5M severance charges in Q3 2025.","Cash runway extended into Q1 2026 to focus on regulatory path for Cylembio."],"urls":{"canonical":"https://secwatch.observer/filing/0001193125-25-221704","json":"https://secwatch.observer/filing/0001193125-25-221704.json","markdown":"https://secwatch.observer/filing/0001193125-25-221704.md","text":"https://secwatch.observer/filing/0001193125-25-221704.txt","edgar_index":"https://www.sec.gov/Archives/edgar/data/1865494/000119312525221704/0001193125-25-221704-index.htm","edgar_primary_document":"https://www.sec.gov/Archives/edgar/data/1865494/000119312525221704/d940102d8k.htm"},"model":{"generated_by":"deepseek-v4-flash:cloud@v2","generated_at":"2026-05-17T05:26:53.401037+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":"d6ad0ac6c51e01bc5a20d99808128de0fd1db62e","claim":"IO Biotech, Inc. announced a restructuring with charges of approximately $1.0 million to $1.5 million (approximately 50% of the Company’s workforce globally).","evidence_excerpt":"On September 25, 2025, the Board of Directors of IO Biotech, Inc. (the “Company”) approved a restructuring and workforce reduction plan (the “Plan”) to conserve capital to align the Company’s operations with its primary focus of advancing development of Cylembio ® (imsapepimut and etimupepimut, adjuvanted). The Plan is expected to result in a reduction of approximately 50% of the Company’s workforce globally. In connection with the implementation of the Plan, the Company expects to incur one-time charges and cash expenditures in a range of approximately $1.0 million to $1.5 million, primarily related to employee wages and severance payments, healthcare continuation, earned vacation time and related termination costs.","evidence_source":"SEC 8-K Item 2.05/2.06","evidence_url":"https://www.sec.gov/Archives/edgar/data/1865494/000119312525221704/0001193125-25-221704-index.htm","confidence":0.9,"family_label":"Restructurings & Charges","details":[{"label":"Type","value":"restructuring"},{"label":"Charge","value":"approximately $1.0 million to $1.5 million"},{"label":"Headcount","value":"approximately 50% of the Company’s workforce globally"}],"fact_type":"restructuring_charge"}],"license":"Source filings: public domain (SEC EDGAR). Summaries (headline + bullets): CC-BY-4.0; attribute https://secwatch.observer"}