Tonix Pharmaceuticals (TNXP) Investor presentation summary

Disease background and unmet need

• Gastric and colorectal cancers are among the leading causes of cancer deaths in the US, with over 1.4 million living with colorectal and 140,000 with gastric cancer.

• Five-year survival rates remain low: 37.9% for gastric and 65.4% for colorectal cancer.

• Standard PD-1 blockade therapy has limited response rates, especially in gastric cancer, highlighting a significant unmet need.

TNX-1700 mechanism and design

• TNX-1700 is a fusion protein combining human trefoil factor 2 (TFF2) and human serum albumin (HSA) for half-life extension.

• Acts as a partial agonist for CXCR4, distinct from SDF-1a, and modulates the tumor microenvironment by suppressing myeloid-derived suppressor cells (MDSCs).

• Promotes differentiation of MDSCs to non-immunosuppressive cells and enhances anti-cancer CD8+ T cell activity.

• Albumin fusion extends circulatory half-life, leveraging established pharmacokinetic strategies.

Preclinical efficacy and safety

• Preclinical studies show TNX-1700 inhibits tumor growth and reduces MDSCs in both gastric and colorectal cancer models.

• No observable toxicity at efficacious doses in mouse studies; no impact on WBC count or body weight.

• Overexpression or adenoviral delivery of TFF2 reduces tumor burden and MDSC levels in vivo.