Tonix Pharmaceuticals (TNXP) investor relations material

Addressing the public health challenge of Lyme disease

• Lyme disease incidence is rising in the U.S., with actual prevalence estimated 8–12 times higher than reported and 95% of cases in high-incidence areas.

• No FDA-approved vaccines or prophylactics are currently available for Lyme disease prevention in the U.S.

• Current prevention relies on tick avoidance; post-exposure prophylaxis is limited to antibiotics, which have side effects and do not prevent long-term sequelae in all patients.

TNX-4800 product profile and mechanism

• TNX-4800 is a long-acting, human monoclonal antibody targeting OspA of Borrelia burgdorferi, the main cause of Lyme disease in the U.S.

• Engineered Fc domain extends half-life, enabling a two-dose subcutaneous regimen (Day 1 and Day 85) for at least 6 months of protection.

• Acts inside the tick to kill Borrelia and block transmission to humans, providing rapid protection within 2 days of administration.

• Binds a specific OspA epitope, avoiding the arthritogenic region linked to autoimmune concerns in previous vaccines.

Clinical development and safety data

• Phase 1 study in healthy adults showed favorable safety, tolerability, immunogenicity, and pharmacokinetics, with rapid absorption and long half-life (62–69 days).

• No significant clinical or laboratory safety signals; most adverse events were mild or moderate.

• Nonclinical studies in animals showed high protection rates and no significant cross-reactivity or toxicity.