Vistagen Therapeutics is making strides in its clinical programs, particularly with fasedienol, an investigational neuroactive pherine nasal spray for the acute treatment of social anxiety disorder (SAD). The company's PALISADE Phase 3 program is underway, with both PALISADE-3 and PALISADE-4 trials actively recruiting participants. Top-line results from these trials are anticipated in 2025.
Fasedienol for Social Anxiety Disorder
Fasedienol is designed to regulate the olfactory-amygdala neural circuits of fear and anxiety, potentially offering a novel mechanism of action (MOA) distinct from currently approved anxiety medications. It aims to attenuate the sympathetic autonomic nervous system without systemic absorption or direct binding to brain neurons. The FDA has granted Fast Track designation for fasedienol's development for acute SAD treatment.
Pipeline Expansion: Itruvone and PH80
Vistagen is also developing itruvone, an investigational pherine nasal spray for major depressive disorder (MDD). Itruvone is designed to regulate olfactory-to-amygdala neural circuitry, potentially increasing catecholamine release for antidepressant effects without systemic absorption or brain penetration. The FDA has also granted Fast Track designation for itruvone in MDD.
Additionally, PH80, a hormone-free investigational neuroactive pherine nasal spray, is being developed for vasomotor symptoms (hot flashes) due to menopause. PH80's proposed MOA does not require systemic absorption or binding to brain neurons, offering a potential non-hormonal treatment option.
Financial Update
Vistagen reported its financial results for the fiscal year 2025 second quarter, which ended September 30, 2024. Research and development (R&D) expenses increased to $10.2 million, compared to $3.9 million for the same period in 2023, primarily due to the PALISADE Phase 3 Program. General and administrative (G&A) expenses also rose to $4.2 million from $3.2 million. The net loss for the quarter was $13.0 million, compared to $6.6 million in the previous year. As of September 30, 2024, Vistagen's cash, cash equivalents, and marketable securities totaled $97.6 million.
