Vistagen — Fiscal Year 2027 Second Quarter Earnings Summary

Financial Performance:

• Total revenues were $0.138 million for the three months ended September 30, 2026, a decrease from $0.258 million in the same period of 2025.
• Research and development (R&D) expense was $6.6 million for the three months ended September 30, 2026, compared to $15.9 million in the prior year period, driven by lower clinical development expenses and reduced headcount.
• General and administrative (G&A) expense was $4.5 million for the three months ended September 30, 2026, compared to $4.4 million in the prior year period, primarily due to higher legal and professional fees offset by lower compensation costs.
• Net loss was $10.7 million for the three months ended September 30, 2026, compared to $19.4 million in the prior year period.
• Cash, cash equivalents, and marketable securities totaled $20.0 million as of September 30, 2026, down from $45.4 million (calculated as $30.8M cash + $14.6M securities) as of March 31, 2026.
• Deferred revenue was $0.1 million as of September 30, 2026, down from $1.7 million as of March 31, 2026.
• Total liabilities were $8.4 million as of September 30, 2026, compared to $13.0 million as of March 31, 2026.
• Accumulated deficit increased to $(501.1) million as of September 30, 2026, from $(477.3) million as of March 31, 2026.

Guidance and Future Outlook:

• Management believes current cash resources will be sufficient to fund operations into 2027 but are not expected to extend the cash runway for more than one year from the date of the press release.
• Vistagen plans to focus future Phase 3 clinical development of fasedienol on the overall treatment of social anxiety disorder (SAD) for the general SAD population, rather than solely acute treatment.
• The company intends to execute its plan to advance programs in social anxiety disorder and menopausal hot flashes while maintaining strategic flexibility to create long-term shareholder value.

Business Segments and Product Lines:

• Fasedienol (Social Anxiety Disorder): The FDA provided constructive feedback regarding a potential Phase 3 study, recommending the use of the Liebowitz Social Anxiety Scale (LSAS) as the primary endpoint and interim assessments to measure long-term functional improvement.
• PALISADE-4 Open-Label Extension (OLE): Preliminary positive data showed clinically relevant improvement in social anxiety over four months on clinician-administered and patient-reported scales.
• Pipeline: The pherine pipeline consists of five investigational product candidates targeting social anxiety disorder, major depressive disorder, and vasomotor symptoms (hot flashes) due to menopause.
• Cost Management: Targeted cost-management initiatives were implemented to prioritize capital allocation across clinical-stage programs and extend the operating runway.

Market and Competitive Landscape:

• The FDA recognized fasedienol's reported safety profile and its potential to benefit a broad population of patients with SAD.
• Vistagen presented Phase 3 data demonstrating a positive efficacy signal for fasedienol in participants with very severe social anxiety disorder at Psych Congress 2026.

Risks and Challenges:

• There is no assurance that FDA feedback will result in a successful registrational pathway or that future clinical trials will demonstrate safety and efficacy.
• The company faces risks regarding its ability to secure adequate financing for operations and continued clinical development.
• Vistagen is dependent on third-party collaborators for development, regulatory approval, and/or commercialization of its product candidates.
• Risks include the scope and enforceability of patents, fluctuating costs of materials and services, and general economic or political conditions.

Management Commentary and Tone:

• Shawn Singh, President and CEO, stated the company has clarity on potential regulatory pathways for fasedienol following extensive data evaluation and FDA feedback.
• Management emphasized alignment of operating structure and capital resources with late-stage development opportunities to maintain flexibility.

Other Key Points:

• Douglas J. Williamson, MD, was appointed to the Board of Directors, bringing experience from Acadia Pharmaceuticals, Eli Lilly, Lundbeck, Avadel Pharmaceuticals, and QurAlis.
• The company has a new class of intranasal product candidates called "pherines" designed to achieve therapeutic benefits without absorption into the blood or uptake into the brain.
• Weighted average common shares outstanding were 44,440,372 for the three months ended September 30, 2026, compared to 35,749,160 in the prior year period.
• Basic and diluted net loss per common share was $(0.24) for the three months ended September 30, 2026, compared to $(0.54) in the prior year period.