Vistagen Therapeutics, Inc. is a late-stage clinical biopharmaceutical company developing and commercializing non-systemic intranasal drug candidates called pherines for psychiatric and neurological disorders.

# Company Summary: Vistagen Therapeutics, Inc.

## Business Overview
- **Type:** Late-stage clinical biopharmaceutical company
- **Focus:** Developing and commercializing non-systemic intranasal drug candidates called **pherines** that target nose-to-brain neurocircuitry for psychiatric and neurological disorders.
- **Core Technology:** Pherines specifically bind to peripheral receptors in nasal chemosensory neurons, rapidly activating neural circuits connected to brain regions involved in anxiety, depression, and other neurological conditions without requiring systemic absorption or crossing the blood-brain barrier.

## Current Product Pipeline
- **Primary Candidate:** 
  - **Fasedienol** for **acute treatment of Social Anxiety Disorder (SAD)**
  - **Status:** Phase 3 clinical trials, with positive topline results from the second trial (PALISADE-2) in August 2023.
  - **Upcoming Data:** Results for PALISADE-3 and PALISADE-4 expected in late 2025 and early 2026.
  - **Regulatory Path:** FDA granted Fast Track designation; potential NDA submission supported by multiple successful phase trials.
- **Other Candidates:**
  - **Itruvone:** For **Major Depressive Disorder (MDD)**; demonstrated promising Phase 2A results; planning U.S. Phase 2B trials.
  - **PH80:** For **Vasomotor Symptoms (hot flashes)** due to menopause; Phase 2A trials showed significant reduction in hot flashes.
  - **PH15:** For **psychomotor impairment due to mental fatigue**; Phase 2A showed reaction time improvements.
  - **PH284:** For **cancer cachexia**; Phase 2A indicated increased feelings of hunger with a good safety profile.

## Employees and Operations
- **Employees:** 56 full-time and 1 part-time (as of May 31, 2025)
  - 40 employees in research and development
  - 16 employees in management, legal, corporate support, and communications
- **Facilities:** No owned manufacturing facilities; relies on third-party contract development and manufacturing organizations (CDMOs).

## Financials
- **Market Capitalization:** Approximately **$81.2 million** as of September 30, 2024
- **Shares Outstanding:** 29,157,733 shares as of June 10, 2025
- **Cash and Equivalents:** $80.5 million as of March 31, 2025
- **Net Losses:**
  - **FY2025:** $51.4 million
  - **FY2024:** $29.4 million
- **Revenue:** None (company is in development stage, no products approved for sale)
- **Funding:** Needs additional capital; substantial doubt about continuing as a going concern noted as of June 17, 2025 due to cash reserves being insufficient beyond 12 months.

## Business Focus
- Developing transformative treatments for **high unmet needs** in neuropsychiatric and neurological disorders.
- Partnering and licensing for global development, especially in Greater China and Southeast Asia through collaborations like the **AffaMed Therapeutics** license agreement.

**Note:** The company’s operations are focused on clinical trial development and regulatory approvals for its pipeline; no commercial products have been launched or sold to date.

Vistagen Therapeutics, Inc. is a neuroscience-focused biopharmaceutical company dedicated to developing innovative therapies for psychiatric and neurological disorders using a unique nose-to-brain drug delivery system.

# Vistagen Therapeutics, Inc. Overview

## Company Profile
- **Name**: Vistagen Therapeutics, Inc.
- **Incorporation**: Nevada Corporation
- **Focus**: Neuroscience-focused biopharmaceutical company 
- **Headquarters**: South San Francisco, California

## Business Model
Vistagen is dedicated to developing and commercializing innovative therapies for psychiatric and neurological disorders through a pioneering approach to nose-to-brain drug delivery. The company's product candidates are classified as pherines, a new class of potential neuroscience therapies designed exclusively as **intranasal sprays**. These products aim to activate chemosensory neurons in the nasal cavity to impact neurocircuitry without requiring systemic absorption.

## Clinical Pipeline
### Key Product Candidates
1. **Fasedienol**: 
   - Intended for the acute treatment of Social Anxiety Disorder (SAD).
   - Currently in **Phase 3 clinical development**.
   - Received **Fast Track designation** from the FDA.
  
2. **Itruvone**: 
   - Targeting Major Depressive Disorder (MDD).
   - In preparation for **U.S. Phase 2B clinical development**.
   - Also granted **Fast Track designation**.

3. **PH80**: 
   - Investigated for the treatment of vasomotor symptoms (hot flashes) due to menopause.
   - Recent exploratory Phase 2A study reported positive results.

4. **PH15 & PH284**: 
   - Other clinical-stage programs targeting cognitive impairment due to mental fatigue and cachexia (wasting syndrome), respectively.

### Research & Development
- R&D expenses for the year ended March 31, 2024: **$20.0 million**.
- R&D expenses for the year ended March 31, 2023: **$44.4 million**.
- Total net losses for the year ended March 31, 2024: **$29.4 million**.

## Workforce
- **Employees**: As of June 10, 2024: **39 full-time employees** and **1 part-time employee**.
   - Breakdown:
     - 25 employees in research and development.
     - 14 employees in management, corporate development, legal, and general administrative roles.

## Customers
- **Target Markets**: The company aims to address multiple highly prevalent neuroscience indications like social anxiety disorder, major depressive disorder, and hot flashes associated with menopause.
- **Potential Patient Base**:
   - An estimated **31 million adults** in the U.S. affected by SAD.
   - Approximately **21 million adults** in the U.S. had at least one major depressive episode in 2020.
   - Around **20 million women** in the U.S. experience vasomotor symptoms due to menopause.

## Financial Overview
- Vistagen has incurred **significant net losses** since its inception with no revenue from approved product sales to date.
- The company is in need of substantial additional financing to execute its long-term business plans, including further development and potential commercialization of its product candidates.

## Conclusion
Vistagen Therapeutics is committed to addressing significant unmet needs in the field of neuroscience by leveraging its unique intranasal drug delivery system and remains focused on advancing its diverse clinical pipeline, though it faces substantial financial and operational challenges.

Vistagen Therapeutics, Inc.

10-K / June 17, 2025

10-K / June 11, 2024

10-K / June 17, 2025

Company Summary: Vistagen Therapeutics, Inc.

Business Overview

Current Product Pipeline

Employees and Operations

Financials

Business Focus