Vistagen Announces Q2 Fiscal 2025 Financial Results and Corporate Update

SOUTH SAN FRANCISCO, Calif.--(BUSINESS WIRE)--Vistagen (Nasdaq: VTGN), a company in the advanced stages of clinical development focused on neuroscience innovations through nose-to-brain neurocircuitry, has shared its financial outcomes for the fiscal quarter ending on September 30, 2024, and provided a recent corporate update.

Shawn Singh, the CEO of Vistagen, highlighted the commencement of the PALISADE-4 Phase 3 trial for fasedienol in the acute treatment of social anxiety disorder (SAD) during this quarter as a crucial advancement in their Phase 3 Program aimed at U.S. registration. Singh noted the ongoing recruitment efforts for both PALISADE-3 and PALISADE-4 trials, underscoring the company's commitment to execution. The company’s extensive neuroscience pipeline is built on unique non-systemic, neurocircuitry-focused treatments targeting several high-prevalence conditions with limited effective treatments currently available. Looking ahead to 2025, the company anticipates results from multiple Phase 3 trials in social anxiety disorder and further progress in Phase 2 programs for major depressive disorder (MDD) and hormone-free treatment of menopausal hot flashes, which hold the potential to redefine standard care.

### Neuroscience Pipeline Highlights

**Fasedienol for SAD:**
In the second quarter, Vistagen initiated the PALISADE-4 Phase 3 trial for fasedienol aimed at acute SAD treatment, with PALISADE-3 and PALISADE-4 trials expected to yield top-line results in 2025.

**Itruvone for MDD:**
Preparations are ongoing for the Phase 2B development of itruvone, a non-systemic treatment for MDD that avoids weight gain, sexual side effects, and safety concerns typically associated with existing depression therapies.

**PH80 for Menopausal Hot Flashes:**
The U.S. IND-enabling program for PH80 is designed to support further Phase 2 clinical development in the U.S. for PH80 as a novel non-systemic, hormone-free treatment for vasomotor symptoms (hot flashes) due to menopause.

### Corporate Highlight

**Raising Awareness at Nasdaq:**
On World Mental Health Day, Vistagen joined forces with The Goldie Hawn Foundation’s MindUP, participating in a Nasdaq Closing Bell ceremony in New York City to raise awareness about global mental health challenges and the potential of neuroscience-based innovations.

### Financial Results for Fiscal Year 2025 Second Quarter Ended September 30, 2024

**Research and Development Expense:**
R&D expenses rose to $10.2 million from $3.9 million in the same period the previous year, driven largely by costs associated with the PALISADE Phase 3 Program for fasedienol, increased staffing, and consulting fees.

**General and Administrative Expense:**
G&A expenses increased to $4.2 million from $3.2 million, primarily due to higher staffing costs and professional service fees.

**Net Loss:**
The net loss for the quarter was $13.0 million, up from $6.6 million in the previous year.

**Other Financial Highlights:**
As of September 30, 2024, Vistagen held $97.6 million in cash, cash equivalents, and marketable securities.

### Conference Call
Vistagen will host a conference call and live audio webcast in the afternoon at 5:00 p.m. Eastern Time to provide a further corporate update.

### About Vistagen’s Pherine Nasal Sprays

**Fasedienol for SAD:**
Fasedienol is an investigational neuroactive pherine nasal spray designed for rapid onset and novel action mechanism. It targets olfactory-amygdala neural circuits of fear and anxiety without systemic absorption, aiming to reduce sympathetic autonomic nervous system tone. It has shown no abuse potential in clinical trials and has received Fast Track designation from the FDA.

**Itruvone for MDD:**
Itruvone is an investigational pherine nasal spray with rapid onset, developed for MDD with a unique neurocircuitry-focused action mechanism. It aims to enhance limbic-hypothalamic sympathetic nervous system activity without the side effects tied to current antidepressants. The FDA has granted it Fast Track designation.

**PH80 for Menopausal Hot Flashes:**
PH80 is a hormone-free investigational neuroactive pherine nasal spray for hot flashes due to menopause. It operates through a unique neurocircuitry-focused mechanism without systemic absorption or brain neuron binding.

### About Vistagen
Based in South San Francisco, Vistagen is at a late clinical stage, focusing on neuroscience and nose-to-brain neurocircuitry to develop innovative intranasal treatments termed pherines. These products aim to activate neurocircuitry rapidly for therapeutic benefits without systemic absorption. The company seeks to offer new treatment options for several prevalent disorders, including social anxiety disorder, major depressive disorder, and menopausal hot flashes.