Vistagen Announces FY 2024 Financial Results and Corporate Update

Vistagen, a neuroscience-focused biopharmaceutical company, has showcased significant advancements in its mission to develop innovative therapies for psychiatric and neurological disorders. For the fiscal year ending March 31, 2024, Vistagen marked notable achievements, particularly in the treatment of social anxiety disorder (SAD) through its lead investigational drug, fasedienol.

In a breakthrough moment, Vistagen successfully reported positive results from its PALISADE-2 Phase 3 trial of fasedienol for the acute treatment of SAD. This disorder affects over 30 million adults in the U.S., and currently, no FDA-approved acute treatment exists. The PALISADE-2 trial was a multi-center, randomized, double-blind, placebo-controlled study that demonstrated the efficacy, safety, and tolerability of fasedienol. The treatment's efficacy was measured using the Subjective Units of Distress Scale (SUDS) during an anxiety-provoking public speaking challenge.

Fasedienol, administered as a rapid-onset nasal spray, activates olfactory and brain neural circuits without systemic uptake or neuron binding in the brain. Its mechanism of action (MOA) is distinct from other anxiety disorder treatments, making it a potentially groundbreaking therapy. With the positive results from PALISADE-2, Vistagen initiated its PALISADE-3 Phase 3 trial and is preparing for the PALISADE-4 Phase 3 trial scheduled to start in the second half of 2024. Both trials are designed similarly to PALISADE-2 and include an open-label extension allowing subjects to use fasedienol in their daily lives up to six times per day.

In addition to its progress with fasedienol, Vistagen has made headway with itruvone for major depressive disorder (MDD). The company completed a successful U.S. Phase 1 trial, which followed promising results from previous Phase 1 and 2A studies conducted outside the U.S. The data demonstrated favorable safety and tolerability, paving the way for Phase 2B development. Preclinical data further supported itruvone’s unique MOA, which involves binding to chemosensory neurons in the nasal cavity without entering the central nervous system, thereby minimizing systemic exposure.

For women's health, Vistagen’s PH80 nasal spray showed positive results in exploratory Phase 2A trials for treating vasomotor symptoms (hot flashes) due to menopause. The hormone-free, rapid-onset treatment exhibited statistically significant efficacy compared to a placebo. Additionally, PH80 demonstrated significant results in the treatment of premenstrual dysphoric disorder (PMDD). These trials, conducted outside the U.S., support further Phase 2 development within the country.

Corporate updates included Vistagen receiving Mental Health America’s Platinum Bell Seal for workplace mental health, recognizing the company's commitment to mental health in the workplace. The company also appointed Cindy Anderson as Chief Financial Officer, bringing extensive financial and operational expertise to the team. Moreover, Vistagen entered into an Exclusive Negotiation Agreement with Fuji Pharma to potentially develop and commercialize PH80 in Japan for menopausal hot flashes.

Financially, Vistagen reported a net loss of $29.4 million for the fiscal year ended March 31, 2024, a significant improvement from the $59.2 million net loss the previous year. R&D expenses were reduced to $20.0 million from $44.4 million, largely due to the timing of clinical trial expenses. General and administrative expenses slightly decreased to $14.1 million.

Vistagen’s cash and cash equivalents stood at $119.2 million as of March 31, 2024, providing a runway to execute key milestones in its ongoing and planned trials. The company issued 27,029,731 shares of common stock and had 3,577,240 pre-funded warrants outstanding as of June 10, 2024.

In summary, Vistagen’s fiscal year 2024 was marked by significant progress in its clinical programs, financial management, and corporate development, positioning it well for future advancements in treating psychiatric and neurological disorders.