VistaGen Therapeutics Inc

Vistagen Therapeutics reported a narrower first-quarter fiscal 2027 net loss of $13.0 million, or $0.30 per share, compared with $15.1 million, or $0.47 per share, a year earlier. Revenue was $1.2 million, primarily from the expiration of the exclusivity period under its agreement with Fuji Pharma. The company said it is preparing to engage with the FDA during the current quarter regarding a potential future Phase 3 registration-directed development pathway for fasedienol in social anxiety disorder. Vistagen also received an FDA "Study May Proceed" letter for refisolone for moderate-to-severe menopausal vasomotor symptoms. Cash, cash equivalents and marketable securities totaled $31.7 million as of June 30, 2026, which the company expects to fund operations into 2027 but not for more than one year.

VistaGen Therapeutics reported a narrower-than-expected first-quarter loss and revenue that beat estimates. The company posted a GAAP loss of $0.30 per share, beating expectations by $0.06, while revenue of $1.48 million, up 516.7% year-over-year, beat by $1.31 million. Cash, cash equivalents, and marketable securities totaled $31.7 million as of June 30, 2026. VistaGen said its cash runway is expected to fund operations into 2027 but not for more than a year from now.

Vistagen announced topline results from an exploratory Phase 2 repeat-dose study of fasedienol nasal spray for the acute treatment of social anxiety disorder, demonstrating favorable safety and tolerability similar to single-dose administration. The three-arm, multicenter, randomized, double-blind, placebo-controlled study enrolled 61 adults and assessed two 3.2 µg doses given ten minutes apart versus a single 3.2 µg dose and placebo during a public speaking challenge. While the primary endpoint of change in subjective units of distress score did not reach statistical significance, both active arms showed numerical separation from placebo, with pooled fasedienol achieving a mean change of -15.0 compared to -6.8 for placebo. In a prespecified analysis of patients with very severe social anxiety disorder, defined by a baseline Liebowitz Social Anxiety Scale score of 95 or higher, single-dose fasedienol demonstrated nominally statistically significant improvement versus placebo, and the pooled fasedienol group also showed nominally significant results. Responder rates on secondary endpoints were directionally higher for fasedienol, with repeat-dose rates more than double those of placebo in the total population and four times or greater in the very severe subgroup. Vistagen plans to discuss these findings with the FDA regarding a potential registrational pathway for fasedienol.