vTv Therapeutics (VTVT) investor relations material

Pipeline and clinical development

• Lead asset cadisegliatin (CADI) is in phase III for type 1 diabetes, targeting a major unmet need with no new adjunctive treatments in over a century.

• Phase III CATT1 trial is on track to complete enrollment in Q3, with top-line data expected in 2027.

• Simplici-T1 phase II trial showed a 50% reduction in hypoglycemia and HbA1c lowering, leading to breakthrough therapy status.

• Additional phase III studies are anticipated to meet regulatory requirements for size and duration.

• A phase II-A hybrid CATT1 trial will assess CADI in hybrid closed-loop system users, with recruitment starting in Q3.

Mechanism of action and differentiation

• CADI is a liver-selective glucokinase activator, designed to avoid hypoglycemia and fat overproduction seen with earlier non-selective GKAs.

• The liver-selective approach leverages the organ's unique glucose handling and feedback mechanisms.

• CADI does not bind outside the liver, reducing risks associated with pancreatic stimulation.

Clinical trial design and endpoints

• CATT1 is a randomized, placebo-controlled, three-arm study (two CADI doses, one insulin-only control), powered to show a 30% reduction in hypoglycemia.

• Key secondary endpoint is HbA1c non-inferiority, with additional metrics including time in range, insulin dose, and patient-reported outcomes.

• All subjects use CGM sensors, enabling robust glycemic control data collection.