Barron Amon

Barron Amon inquired about FDA agreement on patient numbers and duration for the oral VK2735 Phase 3 trials, and whether oral VK2735 supply is a gating factor for the Q3 trial start. He also asked for an update on the autoinjector's introduction into the VANQUISH studies and the expected timeline for the amylin program's Phase 1 initiation and data release.

Answer

Brian Lian, President and CEO, confirmed comfort with FDA feedback on the oral Phase 3 design and stated that oral VK2735 supply is not anticipated to be a significant challenge. He announced the successful completion of the autoinjector bioequivalence study, with introduction into VANQUISH expected this quarter. For the amylin agonist, the IND filing is planned for later this quarter, with first dosing likely in Q2 and single ascending dose (SAD) data potentially available in late 2026.