---
schema_version: "secwatch.filing_event.v1"
accession: "0001999371-25-021194"
form_type: "8-K"
ticker: "TNXP"
cik: "0001430306"
company_name: "Tonix Pharmaceuticals Holding Corp."
filed_at: "2025-12-29T23:59:59+00:00"
generated_at: "2026-05-16T12:05:49.387761+00:00"
event_type: "other_material"
sentiment: "positive"
materiality_score: 0.7
calibrated_materiality_score: 0.7
confidence: "high"
source: SEC EDGAR
---

# Tonix announces TNX-4800 Phase 1 data, plans 2026 FDA meeting for Phase 2/3 Lyme disease prevention

## Summary
- Phase 1 study of TNX-4800 in 44 subjects showed mean half-life of 62-69 days; detectable up to 12 months.
- Company will meet with FDA in 2026 to explore Phase 2/3 development options including a controlled human infection model (CHIM).
- Expects GMP investigational product available for clinical testing in early 2027.
- TNX-4800 targets OspA of Borrelia burgdorferi; designed as annual seasonal prophylaxis for Lyme disease.
- Anti-drug antibodies in <10% of subjects with no impact on PK; most adverse events mild or moderate.

## SEC filing metadata
- accession: 0001999371-25-021194
- form_type: 8-K
- ticker: TNXP
- cik: 0001430306
- company_name: Tonix Pharmaceuticals Holding Corp.
- filed_at: 2025-12-29T23:59:59+00:00
- event_type: other_material
- sentiment: positive
- materiality_score: 0.7
- calibrated_materiality_score: 0.7
- confidence: high
- sec_items: 7.01, 8.01, 9.01
- EDGAR index: https://www.sec.gov/Archives/edgar/data/1430306/000199937125021194/0001999371-25-021194-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/1430306/000199937125021194/tonix-8k_122925.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001999371-25-021194
- JSON: https://secwatch.observer/filing/0001999371-25-021194.json
- Plain text: https://secwatch.observer/filing/0001999371-25-021194.txt

This AI-assisted summary is a reading aid. Review the linked SEC EDGAR filing before relying on any specific claim.