Viking Therapeutics (VKTX) investor relations material

Pipeline and clinical development updates

• Two phase III trials for obesity (VANQUISH-1 and VANQUISH-2) are fully enrolled, with data expected in the second half of 2027.

• Oral formulation of the GLP-1/GIP co-agonist is moving into two phase III trials later this year, with timelines about 12-18 months behind the injectable.

• Maintenance study exploring less frequent dosing (every other week/monthly) will read out in Q3, potentially informing phase III extension arms.

• IND filed for a novel amylin agonist; single ascending dose (SAD) study to start this quarter, with data expected late this year or early next.

• Multiple dosing regimens are being explored to optimize efficacy and tolerability for long-term obesity treatment.

Regulatory and trial design insights

• FDA alignment allows direct progression from phase II to phase III for the oral formulation, leveraging safety data from the injectable program.

• Oral phase III trials will be smaller and shorter than injectable, with fewer titration steps and about 75% fewer participants.

• Maintenance study results may be incorporated into the one-year extension of the VANQUISH phase III trials.

• Selection of maintenance regimens for extension will depend on efficacy, tolerability, and weight maintenance within a 5% threshold.

Commercial strategy and market positioning

• Having both injectable and oral formulations of the same molecule is seen as a commercial advantage, reducing risk and supporting brand synergy.

• Oral GLP-1/GIP dual agonist could be first-in-class, with strong uptake expected in the growing oral obesity drug market.

• Evolving direct-to-consumer and employer channels are lowering barriers for market entry, with Medicare coverage expected from July.

• Company is preparing for both standalone launch and potential partnerships, targeting a 5-10% market share.