{"schema_version":"secwatch.filing_event.v1","accession":"0001999371-26-007254","form_type":"8-K","ticker":"TNXP","cik":"0001430306","company_name":"Tonix Pharmaceuticals Holding Corp.","filed_at":"2026-03-31T23:59:59+00:00","discovered_at":"2026-05-14T18:02:35.065902+00:00","generated_at":"2026-05-15T08:08:22.665964+00:00","sec_items":["7.01","8.01","9.01"],"event_type":"other_material","sentiment":"positive","materiality_score":0.75,"calibrated_materiality_score":0.75,"confidence":"high","headline":"Tonix reports Phase 1 data for Lyme prophylactic TNX-4800; Phase 2 field study planned for H1 2027","bullets":["Phase 1 data (N=44) showed no significant safety signals; mean half-life 62-69 days; serum levels at 5 mg/kg ~10 μg/ml at 4 months, ~2x in vitro MEC.","Planned Phase 2 field study: randomized, double-blind, placebo-controlled, 350 mg SC single dose; primary endpoint Lyme prevention at 4 months.","Phase 2 expected to initiate in H1 2027 pending FDA clearance; GMP product available early 2027.","TNX-4800 is a long-acting anti-OspA monoclonal antibody in-licensed from UMass Chan in 2025; no FDA-approved Lyme vaccine/prophylactic in US.","If needed, controlled human infection model study planned for 2028."],"urls":{"canonical":"https://secwatch.observer/filing/0001999371-26-007254","json":"https://secwatch.observer/filing/0001999371-26-007254.json","markdown":"https://secwatch.observer/filing/0001999371-26-007254.md","text":"https://secwatch.observer/filing/0001999371-26-007254.txt","edgar_index":"https://www.sec.gov/Archives/edgar/data/1430306/000199937126007254/0001999371-26-007254-index.htm","edgar_primary_document":"https://www.sec.gov/Archives/edgar/data/1430306/000199937126007254/tnxp-8k_033026.htm"},"model":{"generated_by":"deepseek-v4-flash:cloud@v2","generated_at":"2026-05-15T08:08:22.665964+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"}