Tonix presents Phase 1 data for Lyme disease candidate TNX-4800, targets Phase 2 trial in H1 2027

Filed May 15, 2026 · Period ending May 15, 2026 · ~1 min read

Key Changes

• high

  Pharmacokinetic simulations show two-dose regimen maintains therapeutic levels above 10 µg/mL for 196 days, supporting six-month protection endpoint for planned Phase 2 field study.

  Item 8.01 verify on EDGAR →
• high

  Company plans adaptive Phase 2 field study for TNX-4800 in first half of 2027, pending FDA agreement on trial design and endpoints.

  Item 8.01 verify on EDGAR →
• medium

  Phase 1 trial data for TNX-4800, a monoclonal antibody Lyme disease prevention candidate, presented at Global Lyme Alliance conference on May 15, 2026.

  Item 8.01 verify on EDGAR →