Vistagen Therapeutics, Inc.

Primary Endpoint

The primary efficacy results showed numerical separation from placebo in mean SUDS change from V2 to V3:

•Pooled fasedienol (N=40):-15.0, p=0.10(Cohen’s d effect size=0.46)

•Repeat dose fasedienol (N=19): -15.4, p=0.17(Cohen’s d=0.44)

•Single dose fasedienol (N=21):-14.7, p=0.14, (Cohen’s d=0.47)

•Placebo (N=21): -6.8.

In the prespecified analysis of patients with very severe social anxiety disorder as defined by a baseline Liebowitz Social Anxiety Scale (LSAS) score of ≥ 95, fasedienol showed nominally 2 statistically significant responses for the single dose arm compared with placebo and as pooled:

•Pooled fasedienol (N=24):-16.2, p=0.04 (Cohen’s d=0.78)

•Repeat dose fasedienol (N=10): -17.5, p=0.08 (Cohen’s d=0.74)

•Single dose fasedienol (N=14):-15.3, p=0.05 (Cohen’s d=0.80)

•Placebo (N=13): -1.6

The treatment effect for repeat dose fasedienol was numerically larger, although the smaller sample size and variability resulted in a higher p-value. The findings in the very severe group of patients defined by LSAS ≥95 are consistent with results previously observed in the randomized portion of the Company’s PALISADE-4 Phase 3 trial for the acute treatment of social anxiety disorder, where in a post-hoc analysis of patients with very severe social anxiety defined by LSAS ≥95, fasedienol also demonstrated a nominally statistically significant improvement compared with placebo (p=0.036).