Vistagen Therapeutics, Inc.

Exploratory Endpoint

A prespecified exploratory analysis in V2 to V3 change of anticipatory anxiety prior to the beginning of the public speaking challenge showed a larger decrease in mean SUDS score for fasedienol compared with placebo, with the repeat dose and pooled fasedienol showing nominal statistical significance (where anticipatory anxiety is the average of SUDS measures taken 3 minutes and 4 minutes prior to the start of the speech):

•Pooled fasedienol (N=40): -13.8, p=0.03 (Cohen’s d=0.61)

•Repeat dose fasedienol (N=19): -19.3, p=0.01 (Cohen’s d=0.83)

•Single dose fasedienol (N=21): -8.7, p=0.2 (Cohen’s d=0.40) Placebo (N=21): -0.9

"We are encouraged by the directionally favorable efficacy signals observed in this FDA-informed study,” said Dr. Angel Angelov, Chief Medical Officer of Vistagen. “Although not designed to show statistical significance, the study showed consistent findings across multiple efficacy measures and contributes to our growing understanding of how patients may benefit from fasedienol, including its repeat dose use. As observed in the post-hoc analyses from our PALISADE-4 Phase 3 trial, the pronounced separation from placebo within the very severe social anxiety disorder subpopulation reflects an enhanced fasedienol signal and minimized placebo change in very severe social anxiety disorder patients. Together with the broad body of clinical evidence from Phase 2 and Phase 3 studies, these results will help inform our discussions with the FDA regarding a potential registrational pathway for fasedienol.”