{"filing":{"accession_number":"0001493152-26-035741","cik":"0001430306","ticker":"TNXP","company_name":"Tonix Pharmaceuticals Holding Corp.","form":"8-K","filing_date":"2026-08-03","report_date":"2026-08-03","primary_document":"form8-k.htm","primary_document_url":"https://www.sec.gov/Archives/edgar/data/1430306/000149315226035741/form8-k.htm"},"events":[{"id":23408,"run_id":21161,"accession_number":"0001493152-26-035741","anchor_item_number":null,"event_type":"operational_other","event_domain":"operational","is_material":true,"confidence":0.75,"summary":"The filing discloses receipt of official FDA minutes from a Type C meeting regarding alignment on the design of an adaptive Phase 2 field study for TNX-4800 (anti-OspA monoclonal antibody) for Lyme disease prevention. This represents a material regulatory milestone and clinical development advancement—the company has secured FDA agreement on key study design elements (3,300 participants, randomized placebo-controlled design, primary efficacy endpoint at six months) and plans to initiate the Phase 2 study in Q1 2027. While this is a significant operational and regulatory event for a clinical-stage biopharmaceutical company, it does not fit neatly into the specific event categories (not an earnings release, executive change, M\u0026A activity, restatement, auditor change, going concern, impairment, shareholder vote, delisting, bankruptcy, covenant breach, cybersecurity incident, dilutive issuance, litigation, debt issuance, dividend, or workforce reduction). The event is clearly operational/strategic in nature—a material product development milestone—making operational_other the most appropriate classification.","company_name":"Tonix Pharmaceuticals Holding Corp.","ticker":"TNXP","filing_date":"2026-08-03","form":"8-K","submitted_at":null,"items":null}],"classifications":[{"id":23625,"accession_number":"0001493152-26-035741","item_number":null,"item_title":null,"event_type":"operational_other","event_domain":"operational","is_material":true,"confidence":0.75,"reasoning":"The filing discloses receipt of official FDA minutes from a Type C meeting regarding alignment on the design of an adaptive Phase 2 field study for TNX-4800 (anti-OspA monoclonal antibody) for Lyme disease prevention. This represents a material regulatory milestone and clinical development advancement—the company has secured FDA agreement on key study design elements (3,300 participants, randomized placebo-controlled design, primary efficacy endpoint at six months) and plans to initiate the Phase 2 study in Q1 2027. While this is a significant operational and regulatory event for a clinical-stage biopharmaceutical company, it does not fit neatly into the specific event categories (not an earnings release, executive change, M\u0026A activity, restatement, auditor change, going concern, impairment, shareholder vote, delisting, bankruptcy, covenant breach, cybersecurity incident, dilutive issuance, litigation, debt issuance, dividend, or workforce reduction). The event is clearly operational/strategic in nature—a material product development milestone—making operational_other the most appropriate classification.","classifier_version":"claude-haiku-4-5-20251001+prompt-a85dd512","taxonomy_version":"v1.3","classified_at":"2026-08-04T02:26:28.206790+00:00","company_name":"Tonix Pharmaceuticals Holding Corp.","ticker":"TNXP","filing_date":"2026-08-03"}]}