VistaGen Therapeutics (NASDAQ: VTGN) Featured Research Report
2 A EGIS C APITAL C ORP. Summary VistaGen Therapeutics (VTGN) is a clinical-stage biopharmaceutical company developing medicines focused on anxiety, depression, and other central nervous system (“CNS”) disorders. VistaGen’s clinical-stage candidates include PH94B, PH10, and AV-101. VistaGen Therapeutics is based in South San Francisco, CA, and trades on the Nasdaq exchange with the ticker symbol VTGN. VistaGen is pursuing several psychiatric indications with its diverse, multi-faceted pipeline. For example, VistaGen’s proprietary, differentiated neuroactive nasal spray (PH94B) is being developed for Social Anxiety Disorder, Adjustment Disorder with Anxiety, Generalized Anxiety Disorder, and other indications. VistaGen’s PH10, an additional pipeline asset with a different API formulated as a neuroactive nasal spray, is being developed for Major Depressive Disorder, among other indications. Finally, VistaGen’s AV-101, an oral drug, is being developed for multiple indications as well, including Major Depressive Disorder and other CNS indications. Key investment points: • VistaGen is developing medicines focused on psychiatric indications including anxiety and depression, as well as other CNS indications. In particular, VistaGen is focused on epidemic- level indications such as Social Anxiety Disorder (SAD) with an estimated 7.1% of US adults suffering from the condition in the last year, and Major Depressive Disorder (MDD), which impacts an estimated 17.3mm US adults, and which has high remission rates for existing standards of care. • PH94B, which has Fast Track Designation, is currently the most advanced asset in VistaGen’s portfolio, moving into Phase 3 trials, expected in 1H:21, for Social Anxiety Disorder. Phase 2 trials (n=91) for PH94B in SAD indicated a high degree of safety, with headache the only (mild) AE, and efficacy, including statistically meaningful (p=0.002) benefit vs placebo on the Subjective Units of Distress (SUDS) scale, which will also comprise the primary endpoint of the Phase 3 trials. • PH94B, as well as PH10 – which are pherines (synthetic neuroactive steroids) – offer unique mechanisms of action via differentiated (intranasal) administration pathways, thereby engaging nasal chemosensory receptors, and have shown compelling Phase 2 data which underpin our confidence in an investment in VistaGen. • PH10 is being developed for MDD, among other indications. We foresee PH10 moving into a Phase 2B trial in MDD in 2H:21. In a Phase 2A trial in patients (n=30) with MDD, PH10 led to a statistically meaningful (p=0.022 at the 6.5ug dose) reduction in the Hamilton Depression Rating Scale (HAM D). • Additional value could accrue from successful data from Phase 2 trials of PH10 in Major Depressive Disorder, among other indications, additional Phase 2 trials of PH94B in indications beyond SAD, such as adjustment disorder with anxiety, and AV-101 in Major Depressive Disorder, among other indications, including in CNS indications, discussed further in this report. VistaGen Therapeutics, Inc. October 8, 2020
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