Tonix Pharmaceuticals (TNXP) Corporate presentation summary

Addressing the public health challenge of Lyme disease

• Lyme disease prevalence is rising in the U.S., with actual cases estimated to be 8–12 times higher than reported due to expanded surveillance criteria and underreporting.

• No vaccine is currently available; prevention focuses on tick avoidance and post-exposure antibiotics, which have side effects and limited efficacy.

• About 10–20% of patients experience long-term effects, including Post-Treatment Lyme Disease Syndrome.

TNX-4800 mechanism and differentiation

• TNX-4800 is a long-acting, human monoclonal antibody targeting OspA, designed for pre-exposure prophylaxis against Lyme disease.

• A single subcutaneous dose is expected to provide at least four months of protection, with rapid onset within two days.

• The antibody binds a specific OspA epitope, avoiding regions associated with autoimmune risk, unlike previous vaccines.

• Engineered Fc mutations extend half-life, supporting seasonal protection with one dose.

Preclinical and clinical data

• In vitro, TNX-4800 demonstrated potent bactericidal activity (EC50 ≈ 0.56 µg/mL); in vivo, it provided 95% protection in primate tick challenge models at serum levels >21 µg/mL.

• Nonclinical safety studies in rats and monkeys showed no significant adverse findings; observed effects were mild, reversible, and non-aversive.