PH94B - (PALISADE-4)

June 30, 2026: Vistagen (NASDAQ: VTGN) reported topline results from PALISADE-4, a U.S. randomized, double-blind, placebo-controlled Phase 3 trial of intranasal fasedienol for acute treatment of social anxiety disorder during a simulated public speaking challenge. In the overall population (n=238), fasedienol did not meet the primary endpoint on the Subjective Units of Distress Scale (SUDS): LS mean change -9.5 (SE 1.7) vs placebo -11.4 (SE 1.7); LS mean difference 1.9 (p=0.427). No treatment differences were seen on secondary endpoints. Safety/tolerability was favorable and consistent with prior trials.

In a post-hoc analysis of patients with very severe social anxiety (screening LSAS ≥95; n=123), fasedienol showed nominal statistical significance on the primary endpoint: SUDS LS mean change -12.8 (SE 3.4) vs placebo -3.7 (SE 3.4); LS mean difference -9.1 (p=0.036).

Vistagen plans to meet with FDA to discuss a potential registrational path centered on a single future multi-dose Phase 3 trial using the Liebowitz Social Anxiety Scale (LSAS) as the primary endpoint, with confirmatory evidence from the PALISADE program (including positive PALISADE-2) and other trials. A conference call/webcast was scheduled for June 30, 2026 at 8:30 a.m. ET.