VistaGen Therapeutics (VTGN) Stifel 2024 Healthcare Conference summary

Program and pipeline updates

• Advanced a neuroscience pipeline with multiple clinical-stage programs, including phase 2 and 3 trials for non-systemic, neurocircuitry-focused drug candidates targeting anxiety, depression, and menopausal hot flashes.

• Lead asset fasedienol is being developed for acute treatment of social anxiety disorder (SAD), with additional programs in major depressive disorder and menopausal hot flashes.

• Solid cash position supports completion of ongoing pivotal studies and potential NDA submission in early 2026.

Clinical trial progress and design

• PALISADE-3 and PALISADE-4 studies for SAD are progressing well, with 16 and 12 sites launched, respectively.

• Both studies use a public speaking challenge and the SUDS scale to assess acute treatment effects, focusing on severely affected patients.

• PALISADE-3 is expected to read out in the early second half of next year, and PALISADE-4 at the end of the second half.

• At least one of these studies needs to be positive to complement the prior successful PALISADE-2 study for NDA submission.

Addressing prior trial variability and protocol improvements

• PALISADE-1 failed due to pandemic-related disruptions, protocol adherence issues, and high placebo response.

• Enhanced training, direct investigator administration, and increased surveillance have been implemented in current studies.

• Main advisor Dr. Michael Liebowitz provides protocol guidance and site engagement.