Viking Therapeutics (VKTX) investor relations material

Pipeline and clinical development

• Lead compound VK2735, a dual GLP-1/GIP agonist, is in Phase 3 for obesity with both subcutaneous and oral formulations advancing in trials.

• Oral VK2735 achieved up to 12% weight loss in Phase 2, with strong dose response and promising maintenance data.

• Subcutaneous VK2735 showed nearly 15% weight loss in Phase 2, with over 90% of efficacy maintained at week 17.

• Amylin agonist program is expected to enter clinical trials late this year or early next year.

• Additional thyroid beta receptor programs are available for licensing but not prioritized for near-term focus.

Safety, tolerability, and dosing strategy

• Both oral and subcutaneous VK2735 demonstrated favorable safety profiles, with most adverse events mild to moderate and transient.

• GI adverse events were most common early in titration and resolved quickly; slower titration is expected to further improve tolerability.

• Maintenance regimens at lower doses are supported by data, showing continued or sustained weight loss.

• Future studies will focus on optimized titration and maintenance strategies to balance efficacy and tolerability.

Regulatory and trial design considerations

• Phase 3 trials are placebo-controlled as required by current regulatory guidance, with active comparators considered for future studies.

• BMI inclusion criteria for Phase 3 allow for 30+ or 27+ with comorbidities, aligning with industry standards.

• End-of-Phase 2 FDA meeting for the oral program is planned for Q4 to determine next steps toward Phase 3.

• No regulatory path exists for maintenance-only approval; all studies are designed for weight change endpoints.