VistaGen Therapeutics (VTGN) investor relations material

Pipeline overview and mechanisms

• Five clinical-stage neuroactive pherine assets target indications including social anxiety disorder, major depressive disorder, menopausal hot flashes, psychomotor impairments, and cancer cachexia.

• Intranasal therapies act as agonists to peripheral nasal receptors, enabling rapid onset of action without systemic absorption.

• Fasedienol modulates olfactory-limbic-amygdala circuits, providing acute relief in social anxiety disorder by enhancing GABAergic activity in the amygdala without benzodiazepine-like effects.

• Safety profile is favorable, with minimal systemic side effects and low abuse liability.

• The platform aims for rapid, episodic treatment tailored to patient needs.

Clinical trial design and results

• PALISADE-1 and PALISADE-2 used a public speaking challenge and SUDS as primary endpoint; PALISADE-2 showed statistically significant results, while PALISADE-1 was impacted by pandemic-related variability.

• Enhancements in PALISADE-3 and PALISADE-4 include stricter subject selection, increased sample size, and internal psychometrician oversight to reduce variability.

• PALISADE-3 readout expected in Q4 this year; PALISADE-4 in the first half of 2026.

• Open-label extension studies indicate improved patient engagement in daily activities and no evidence of abuse liability.

• Repeat dose Phase II study is ongoing to support safety data for regulatory submission.

Commercial landscape and future plans

• Current acute treatment options for social anxiety disorder are limited; about 30% of affected adults receive treatment, often suboptimal.

• Digital psychiatry and telehealth are increasingly important for patient outreach and potential drug adoption.

• The product profile emphasizes rapid onset, lack of sedation, and minimal side effects, differentiating it from existing therapies.

• Pre-commercial efforts are underway, with a focus on education and digital engagement.

• IND for PH80 (menopausal hot flashes) expected in Q4, and iTRUVON for major depressive disorder is advancing, both offering non-systemic, rapid-onset alternatives.