secwatch.observer — SEC 8-K summary
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Issuer:     Tonix Pharmaceuticals Holding Corp. (TNXP)
CIK:        0001430306
Form:       8-K
Filed at:   2026-05-15T13:25:40+00:00
Accession:  0001999371-26-010790
Event type: other_material
Sentiment:  positive
Materiality: 0.70
Item codes: 7.01, 8.01, 9.01
LLM model:  deepseek-v4-flash:cloud@v2

Tonix reports Phase 1 PK data for TNX-4800 Lyme antibody; two-dose regimen supports 6-month protection
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- TNX-4800 Phase 1 PK data presented at Global Lyme Alliance; two-dose 350 mg SC regimen (Day 1, Day 56) modeled.
- Simulations predict days above MEC: 10 µg/mL (196 days), 15 µg/mL (161 days), 20 µg/mL (136 days), 5 µg/mL (265 days).
- Data supports maintaining serum level above 10 µg/mL for six months after initial dose, proposed Phase 2 primary endpoint.
- Adaptive Phase 2 field study planned for first half of 2027, pending FDA agreement.

Source:
  EDGAR index:    https://www.sec.gov/Archives/edgar/data/1430306/000199937126010790/0001999371-26-010790-index.htm
  Primary doc:    https://www.sec.gov/Archives/edgar/data/1430306/000199937126010790/tnxp-8k_051526.htm
  HTML page:      https://secwatch.observer/filing/0001999371-26-010790

License: Source filings: public domain (SEC EDGAR). Summaries (headline + bullets): CC-BY-4.0; attribute https://secwatch.observer