vTv Therapeutics (VTVT) TD Cowen 46th Annual Health Care Conference summary

Key program highlights

• Cadisegliatin is in phase III as a potential first-in-class oral adjunctive therapy for type 1 diabetes, with top-line CATT1 trial data expected by year-end.

• 75% of U.S. T1D patients do not meet ADA glycemic targets; hypoglycemia is a major barrier to optimal management.

• No oral adjunctive therapy for T1D has been approved in the U.S. in over a century; KADI aims to fill this gap.

• KADI has shown clinically meaningful reductions in hypoglycemia and A1C in over 500 patients, with a strong safety profile and FDA breakthrough therapy designation.

• The company is well-capitalized, ending Q3 2025 with $99M in cash and raising an additional $20M in February 2026.

Clinical and mechanistic insights

• Cadisegliatin activates glucokinase in the liver, improving glucose uptake and glycogen synthesis, addressing both hyper- and hypoglycemia.

• Phase II studies showed a 0.36% A1C reduction and 50% fewer symptomatic hypoglycemic events versus insulin alone, with no increase in ketoacidosis or lipid disturbances.

• The Simplici-T1 study demonstrated continuous A1C improvement and reduced hypoglycemia, motivating FDA breakthrough status.

• Safety data show no difference in adverse events, liver signals, or lipid levels between KADI and control groups.

• The ongoing CATT1 phase III trial is double-blind, randomized, and powered to show a 30% reduction in hypoglycemia, with secondary endpoints including A1C.

Market and regulatory outlook

• The addressable market includes 1.5M Americans and 10M globally with T1D, expected to grow to 15M by 2040.

• KADI’s value proposition centers on reducing hypoglycemia and A1C, addressing a significant unmet need for both patients and payers.

• The FDA breakthrough designation enables expedited development and frequent regulatory engagement.

• Additional phase III studies may be required, especially to address closed-loop insulin systems and broader patient exposure.

• The company’s IP portfolio provides protection through 2041, potentially extending to 2046.