Tonix receives FDA alignment on Phase 2 study design for TNX-4800 Lyme disease prevention

Tonix Pharmaceuticals Holding Corp.

• FDA aligned on adaptive Phase 2 field study of TNX-4800 enrolling 3,300 adults over two seasons.
• Primary efficacy endpoint: Lyme disease prevention at 6 months; key secondary at 3 months.
• Manufacturing of investigational product on track for delivery to study sites in Q1 2027.
• TNX-4800 is a long-acting human monoclonal antibody targeting OspA, with potential advantages over vaccines.
• Majority of enrollment expected in 2028 season; may extend to 2029 if attack rate lower.