Viking Therapeutics (VKTX) Stifel 2024 Healthcare Conference summary

Product development strategy

• Injectable formulation is positioned as the primary therapy for initial weight loss, with weekly dosing envisioned for 6–9 months or until target weight is reached.

• Transition options include moving to a monthly or oral formulation for maintenance, offering flexibility and convenience without new side effects.

• Oral formulation is unique as a dual GLP-1/GIP agonist, potentially improving tolerability and reducing GI side effects compared to monoagonists.

• Data from ObesityWeek highlighted strong tolerability and durability of effect, with over 80% of weight loss maintained seven weeks post-treatment.

• Lower maintenance doses may suffice for long-term weight management, reducing supply concerns and broadening patient options.

Clinical data and trial design

• VENTURE study update showed long exposure time and durable weight loss with injectable; regression from prediabetic to non-diabetic state favored treatment arms.

• Oral formulation study demonstrated over 8% body weight reduction at 100 mg over 28 days, with muted rebound at lower doses.

• Dose reduction experiments suggest high initial doses can be tapered to lower maintenance doses without significant rebound.

• Phase 3 trial planning is underway, with end-of-phase-2 meeting expected later this quarter; studies will follow regulatory guidance for size and duration.

• Monthly dosing regimens will be explored in separate studies to avoid statistical complexity in registration trials.

Manufacturing and supply chain

• Manufacturing scalability for oral formulation is being addressed, with multiple global vendors engaged to ensure future supply.

• API supply is the current focus, with plans to finalize a long-term supplier arrangement by year-end.

• Autoinjector manufacturing will follow API agreements, ideally consolidating supply in-house.

• Catalent is not a key supplier for autoinjectors, and was excluded from consideration after recent industry acquisitions.

• Three years are available to resolve supply challenges before commercial launch.