Tonix Pharmaceuticals (TNXP) Investor presentation summary

Background and scientific rationale

• Mpox (monkeypox) and smallpox are caused by orthopoxviruses, with significant historical and current public health impact.

• Smallpox eradication was achieved using vaccines derived from cowpox, horsepox, and vaccinia viruses.

• TNX-801 is a live attenuated, minimally replicative horsepox-based vaccine candidate targeting mpox and smallpox.

Vaccine design and attenuation

• TNX-801 is genetically similar to historical horsepox strains used in early vaccines, with a core genome nearly identical to MNR-76.

• Demonstrates small plaque phenotype and up to 100-fold lower replication in vitro compared to vaccinia-based vaccines.

• In vivo, TNX-801 is up to 100,000-fold less virulent than older smallpox vaccines, showing minimal disease even in immunocompromised models.

• Limited replication at the site of delivery and improved safety profile in multiple animal models.

Immunogenicity and efficacy

• Single-dose TNX-801 elicits strong IgG and neutralizing antibody responses in mice, rabbits, and non-human primates.

• Provides 100% protection against mpox lesions and lethal challenge in animal models, including both clade I and IIa monkeypox and rabbitpox.

• Durable protection demonstrated for at least six months post-vaccination in rabbitpox challenge studies.

• Effective via multiple administration routes: percutaneous, subcutaneous, and intramuscular.