PH94B - (PALISADE-4)

June 15, 2026: Vistagen (NASDAQ: VTGN) reported fiscal year results (ended March 31, 2026) and provided pipeline updates highlighting multiple clinical/regulatory catalysts.

Fasedienol (social anxiety disorder, acute treatment): Completed the randomized portion of the PALISADE-4 Phase 3 trial; topline results are expected in June 2026. The company refined the PALISADE-4 statistical analysis plan to include baseline pre-dose SUDS as a prespecified covariate in the primary efficacy analysis. Vistagen also reported preliminary positive data from the ongoing open-label extension of PALISADE-3 Phase 3: fasedienol was well-tolerated with no new drug-related safety findings, and LSAS and SPIN scores improved over the first four months. Across the program, >1,500 individuals have been exposed (including >400 for 6 months and >100 for 12 months), meeting minimum ICH E1 exposure recommendations, though FDA alignment on NDA exposure requirements is still pending. A Phase 2 repeat-dose study’s randomized portion is complete; topline results are expected in Q3 2026.

Refisolone (menopausal vasomotor symptoms): Received an FDA “Study May Proceed” letter under its IND to support further U.S. development; data were presented at The Menopause Society 2025 Annual Meeting (Oct 2025).

Itruvone (major depressive disorder): Preparations continue for future clinical development.

Financials: Net loss $69.7M (FY2026); cash/cash equivalents/marketable securities $45.4M as of March 31, 2026; runway into 2027.