1. A clinical-stage Sage Therapeutics, focused on developing treatments for anxiety disorders.

2. Like an earlier-stage Axsome Therapeutics, but specializing in new therapies for anxiety and other CNS conditions.

• Fasedienol (PH94B): An investigational pherine nasal spray designed for the acute treatment of anxiety in adults with Social Anxiety Disorder (SAD).
• PH10: An investigational pherine nasal spray currently being developed for the acute treatment of Major Depressive Disorder (MDD).
• PH80: An investigational pherine nasal spray focused on the acute treatment of perimenopausal anxiety.
• PH15: An investigational pherine nasal spray being developed for the acute treatment of adjustment disorder with anxiety.

Vistagen Therapeutics (symbol: VTGN) is a clinical-stage biopharmaceutical company focused on developing novel therapeutics for anxiety, depression, and other central nervous system (CNS) disorders. Their lead product candidates are investigational and have not yet received regulatory approval for commercial sale.

As a clinical-stage biopharmaceutical company, Vistagen Therapeutics does not currently have any approved products available on the market for sale. Therefore, the company does not have "major customers" in the traditional sense of companies or individuals purchasing its therapeutic products.

The company primarily funds its research and development operations through:

• Equity financing (the sale of shares to institutional and individual investors)
• Research grants from government agencies or non-profit organizations
• Historically, through collaboration agreements with other pharmaceutical companies for specific development programs, though these are not ongoing major revenue-generating customer relationships in the context of product sales.

Should Vistagen's product candidates receive regulatory approval in the future, the company would then establish commercialization strategies, which could involve partnerships with larger pharmaceutical companies or direct sales to healthcare providers (such as hospitals, clinics, and pharmacies), who would then become their primary customers for the approved therapeutics.

Shawn K. Singh, J.D. President, Chief Executive Officer, and Director

Mr. Singh has served as President and Chief Executive Officer of Vistagen Therapeutics since August 2009, and he joined its Board of Directors in 2000. He has over 30 years of experience with private and public biotechnology, medical device, and pharmaceutical companies, a venture capital firm, and a contract research and development organization (CRO). Prior to Vistagen, he served as President of Artemis Neuroscience (which Vistagen acquired), Managing Principal of Cato BioVentures (a healthcare-focused venture capital firm), Chief Business Officer and General Counsel of Cato Research Ltd (now Allucent), and Chief Business Officer of SciClone Pharmaceuticals. He assisted with the IPO of SciClone Pharmaceuticals. Mr. Singh began his career as a corporate finance attorney in Silicon Valley.

Chief Financial Officer

The position of Chief Financial Officer is currently vacant. Cynthia L. Anderson, C.P.A., previously served as Chief Financial Officer, appointed effective August 21, 2023. Ms. Anderson resigned effective October 15, 2025, and the company is currently searching for her successor. Prior to joining Vistagen, Ms. Anderson held the role of Chief Accounting Officer for Alnylam Pharmaceuticals, Inc. from 2019 to 2023. From 2011 to 2019, she held senior financial reporting roles at Alexion Pharmaceuticals, Inc. Her experience also includes serving as an Audit Senior Manager at Ernst & Young LLP and various audit roles at PricewaterhouseCoopers LLP.

Joshua Prince, MBA Chief Operating Officer

Mr. Prince serves as the Chief Operating Officer of Vistagen Therapeutics.

Elissa Cote Chief Corporate Development Officer

Ms. Cote holds the title of Chief Corporate Development Officer at Vistagen Therapeutics. She was recently appointed to this role.

Reid G. Adler, J.D. Chief Legal Officer

Mr. Adler serves as the Chief Legal Officer for Vistagen Therapeutics.

Key Risks to Vistagen Therapeutics (VTGN)

1. Regulatory Approval and Clinical Trial Success: As a late clinical-stage biopharmaceutical company, Vistagen Therapeutics' future is heavily dependent on the successful completion of clinical trials and obtaining regulatory approvals from authorities such as the FDA for its product candidates. The approval processes are lengthy, time-consuming, and inherently unpredictable. Any failure to achieve regulatory approval for its product candidates, such as fasedienol, would substantially harm the business. This risk was recently underscored by a Phase 3 trial for fasedienol not achieving its primary endpoint.
2. Need for Additional Capital and Profitability Concerns: Vistagen Therapeutics is currently unprofitable and has experienced increasing net losses. The company requires substantial additional financing to execute its business plan, and its ability to raise capital through equity-based financing could lead to significant dilution for existing stockholders. The company has implemented cost-saving measures to extend its cash runway.
3. Dependence on Third-Party Collaborators: Vistagen Therapeutics is significantly reliant on third-party collaborators for conducting its nonclinical studies and clinical trials. Unsatisfactory performance by these collaborators could lead to delays in regulatory approval or the commercialization of its product candidates.

The emergence and FDA approval of rapid-acting oral therapies for depression, most notably Sage Therapeutics and Biogen's Zuranolone (Zurzuvae) for major depressive disorder (MDD) and postpartum depression (PPD), poses a clear emerging competitive threat. While Vistagen Therapeutics' lead candidate, Fasedienol (PH94B), is a nasal spray primarily targeting social anxiety disorder (SAD) and generalized anxiety disorder (GAD) with a novel pherine-based, non-systemic mechanism, Zuranolone's success establishes a strong market precedent for rapid-onset mental health treatments. This could significantly impact the market landscape for rapid-acting anxiolytics and antidepressants, potentially shifting physician and patient preferences towards oral, convenient, and proven rapid-acting options. This could make it more challenging for Vistagen's differentiated approach to gain significant market share and investor confidence, especially if Zuranolone or similar oral rapid-acting treatments expand their indications to other anxiety disorders.

Vistagen Therapeutics (VTGN) is developing a pipeline of "pherines" for neuropsychiatric and neurological disorders. The addressable markets for their main product candidates are as follows:

• Fasedienol (PH94B): This investigational pherine nasal spray is in Phase III clinical trials for the acute treatment of anxiety in adults with Social Anxiety Disorder (SAD).

  • The global Social Anxiety Disorder market is projected to grow from approximately USD 1.50 billion in 2024 to USD 2.60 billion by 2034.
  • In North America, the market for Social Anxiety Disorder was valued at approximately USD 0.80 billion in 2024 and is forecasted to reach USD 1.40 billion by 2034.
  • The European market for Social Anxiety Disorder was valued at approximately USD 0.40 billion in 2024 and is projected to reach USD 0.70 billion by 2034.
  • The Asia Pacific market for Social Anxiety Disorder was valued at approximately USD 0.20 billion in 2024 and is forecasted to reach USD 0.50 billion by 2034.

• Itruvone (PH10): This investigational pherine nasal spray is in Phase II clinical trials for Major Depressive Disorder (MDD).

  • The global Major Depressive Disorder treatment market size was approximately USD 6.84 billion in 2024 and is expected to reach USD 14.57 billion by 2033.
  • Another estimate indicates the global Major Depressive Disorder treatment market, valued at USD 5.61 billion in 2025, is projected to reach USD 13.16 billion by 2035.
  • North America is expected to hold a significant position in the global major depressive disorder treatment market.

• Other Products: Vistagen Therapeutics is also developing PH80 for vasomotor symptoms (including hot flashes due to menopause), PH15 for cognitive impairment, and PH284 for loss of appetite and cachexia. Market sizes for these specific products or the addressable markets for these specific pherine applications are not readily available in the provided information.

  • null

1. Advancement and Potential Approval of Fasedienol (PH94B) for Social Anxiety Disorder (SAD): Vistagen's lead product candidate, fasedienol, an intranasal pherine, is in late-stage Phase III clinical development for the acute treatment of social anxiety disorder. Top-line data from the PALISADE-3 Phase III trial is anticipated in the fourth quarter of 2025, with results from PALISADE-4 expected in the first half of 2026. Successful trial outcomes and subsequent regulatory approval could position fasedienol as a first-in-class acute treatment for SAD, a market with no currently FDA-approved acute options and a potential opportunity of $500 million to $1 billion.
2. Progress of PH80 for Menopausal Hot Flashes: Vistagen is developing PH80 as a hormone-free alternative for menopausal hot flashes. The product is currently in IND-enabling studies, with plans to advance to a Phase 2 trial. Positive progress in clinical development for PH80 could unlock new market opportunities within women's health.
3. Development of Itruvone (PH10) for Major Depressive Disorder (MDD): Itruvone, another investigational neuroactive pherine nasal spray, is in Phase II clinical trials for the treatment of major depressive disorder. Successful progression through clinical trials could lead to a differentiated treatment option for MDD and contribute to future revenue.
4. Expansion of the Pherine Pipeline and Platform Technology: Vistagen's strategic focus on its neuroscience pipeline, which includes five clinical-stage pherine product candidates, represents a broader growth driver. The company's unique nose-to-brain delivery mechanism for these neuroactive steroids could address various neuropsychiatric and neurological disorders, indicating future potential for additional product launches and market expansion beyond its current lead candidates.

Share Issuance

• Vistagen Therapeutics conducted a $100 million public offering in December 2020.
• In August 2020, VistaGen issued 17,868,250 shares of common stock in an underwritten public offering, generating approximately $14.29 million in gross proceeds, intended for CNS pipeline development, general research and development, and working capital.
• VistaGen closed an underwritten public offering in August 2020, issuing 15,625,000 shares of common stock at $0.80 per share, which yielded $12.5 million in gross proceeds.

Inbound Investments

• Lead investors including Acuta Capital, New Enterprise Associates (NEA), OrbiMed, and Venrock Healthcare Capital Partners participated in Vistagen's $100 million public offering in December 2020.
• As of August 17, 2025, institutional investors collectively held 23% of Vistagen Therapeutics.
• Hedge funds held 19% of Vistagen Therapeutics as of August 17, 2025.

Capital Expenditures

• Specific significant dollar values for traditional capital expenditures (property, plant, and equipment) are not readily available for the last 3-5 years.
• A substantial portion of capital is directed towards biopharmaceutical product development, which includes significant upfront expenditures and risk associated with clinical development.
• Research and development (R&D) expenses, which function as investments in the company's pipeline, were $39.4 million for the fiscal year ended March 31, 2025, an increase from $20.0 million in the prior fiscal year, primarily for the PALISADE Program and PH80 program.