{"filing":{"accession_number":"0001104659-26-080962","cik":"0000894158","ticker":"TOVX","company_name":"Theriva Biologics, Inc.","form":"8-K","filing_date":"2026-07-07","report_date":null,"primary_document":"tm2619846d1_8k.htm","primary_document_url":"https://www.sec.gov/Archives/edgar/data/894158/000110465926080962/tm2619846d1_8k.htm"},"events":[{"id":16322,"run_id":14573,"accession_number":"0001104659-26-080962","anchor_item_number":"8.01","event_type":"operational_other","event_domain":"operational","is_material":true,"confidence":0.85,"summary":"Theriva Biologics announced regulatory authorization from the Spanish Agency of Medicines and Medical Devices (AEMPS) to initiate the VIRAGE2 Phase 2a clinical trial for VCN-01 in metastatic pancreatic cancer. This represents a material clinical development milestone, with the trial designed to refine dosing regimens based on positive prior VIRAGE trial data and regulatory feedback from the EMA and FDA.","company_name":"Theriva Biologics, Inc.","ticker":"TOVX","filing_date":"2026-07-07","form":"8-K","submitted_at":null,"items":[{"id":14388,"accession_number":"0001104659-26-080962","item_number":"7.01","item_title":"Regulation FD Disclosure.","event_type":"operational_other","event_domain":"operational","is_material":true,"confidence":0.75,"reasoning":"The disclosure announces regulatory authorization from the Spanish Agency of Medicines and Medical Devices (AEMPS) to initiate the VIRAGE2 Phase 2a clinical trial for VCN-01 in metastatic pancreatic cancer. This is a material operational and clinical milestone for a clinical-stage biotech company—it represents progress in the development pathway of the company's lead candidate and builds on positive VIRAGE trial results. While this is clearly an operational/clinical event rather than a financial, governance, or legal matter, it does not fit neatly into a specific named category; it is best classified as an operational milestone or regulatory approval event.","classifier_version":"claude-haiku-4-5-20251001+prompt-a85dd512","taxonomy_version":"v1.3","classified_at":"2026-07-07T19:13:51.727623+00:00","company_name":"","ticker":null,"filing_date":""},{"id":14390,"accession_number":"0001104659-26-080962","item_number":"8.01","item_title":"Other Events.","event_type":"operational_other","event_domain":"operational","is_material":true,"confidence":0.85,"reasoning":"The disclosure announces regulatory authorization from AEMPS to initiate the VIRAGE2 Phase 2a clinical trial for VCN-01 in metastatic pancreatic cancer patients. This is a material operational and clinical milestone for a clinical-stage biotech company—it represents regulatory approval to proceed with an exploratory trial designed to refine dosing regimens based on positive prior VIRAGE trial results, which would inform a future pivotal Phase 3 trial. While this is clearly an operational/clinical event rather than a specific financial, governance, or legal matter, it does not fit neatly into the predefined categories and represents a significant development milestone for the company's lead candidate.","classifier_version":"claude-haiku-4-5-20251001+prompt-a85dd512","taxonomy_version":"v1.3","classified_at":"2026-07-07T19:13:51.727623+00:00","company_name":"","ticker":null,"filing_date":""}]}],"classifications":[{"id":14388,"accession_number":"0001104659-26-080962","item_number":"7.01","item_title":"Regulation FD Disclosure.","event_type":"operational_other","event_domain":"operational","is_material":true,"confidence":0.75,"reasoning":"The disclosure announces regulatory authorization from the Spanish Agency of Medicines and Medical Devices (AEMPS) to initiate the VIRAGE2 Phase 2a clinical trial for VCN-01 in metastatic pancreatic cancer. 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While this is clearly an operational/clinical event rather than a financial, governance, or legal matter, it does not fit neatly into a specific named category; it is best classified as an operational milestone or regulatory approval event.","classifier_version":"claude-haiku-4-5-20251001+prompt-a85dd512","taxonomy_version":"v1.3","classified_at":"2026-07-07T19:13:51.727623+00:00","company_name":"Theriva Biologics, Inc.","ticker":"TOVX","filing_date":"2026-07-07"},{"id":14390,"accession_number":"0001104659-26-080962","item_number":"8.01","item_title":"Other Events.","event_type":"operational_other","event_domain":"operational","is_material":true,"confidence":0.85,"reasoning":"The disclosure announces regulatory authorization from AEMPS to initiate the VIRAGE2 Phase 2a clinical trial for VCN-01 in metastatic pancreatic cancer patients. This is a material operational and clinical milestone for a clinical-stage biotech company—it represents regulatory approval to proceed with an exploratory trial designed to refine dosing regimens based on positive prior VIRAGE trial results, which would inform a future pivotal Phase 3 trial. While this is clearly an operational/clinical event rather than a specific financial, governance, or legal matter, it does not fit neatly into the predefined categories and represents a significant development milestone for the company's lead candidate.","classifier_version":"claude-haiku-4-5-20251001+prompt-a85dd512","taxonomy_version":"v1.3","classified_at":"2026-07-07T19:13:51.727623+00:00","company_name":"Theriva Biologics, Inc.","ticker":"TOVX","filing_date":"2026-07-07"}]}
