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- **Trial Milestone**: PALISADE-3 Phase III trial completed; top-line results expected by end of 2025.
- **Cash Position**: $77.2 million in cash to support U.S. registration efforts.
- **Pipeline Expansion**: itruvone and PH80 in Phase III, targeting depression and menopause.
- **Commercial Focus**: Exploring partnerships for U.S. launch, leveraging digital health trends.
- **FDA Readiness**: Preparing for potential NDA submission in early 2026.

**【CEO Summary Section】**
- **PALISADE-3 Trial Completion**: Last patient completed the randomized double-blind phase of the Phase III trial for fasedienol, targeting social anxiety disorder (SAD). Top-line results expected by end of 2025.
- **Pipeline Progress**: PALISADE-4 Phase III trial ongoing; itruvone (major depressive disorder) and PH80 (menopausal hot flashes) in Phase III development.
- **Financial Position**: $77.2 million in cash as of September 30, 2025, sufficient to cover U.S. registration-directed PALISADE program costs.
- **Board Update**: Paul Edick joined the Board, bringing FDA and commercial launch expertise.

**【Q&A Highlights】**
- **PALISADE-3 Timeline**: Top-line results to be released by end of 2025; safety and efficacy data from the public speaking challenge (primary endpoint) and secondary endpoints (CGI-I, PGI-C) will be reported.
- **Site Management**: 1-2 sites terminated due to enrollment challenges; others wound down as the trial concluded.
- **Commercial Strategy**: Considering partnerships for U.S. launch; leveraging digital health trends and consumer engagement for patient access.
- **FDA Interaction**: Planning for NDA submission if PALISADE-3 is positive, with interactions expected in early 2026.
- **Usage Patterns**: Open-label data shows weekday utilization, aligning with real-world social stressors.


Vistagen Therapeutics, Inc. (VTGN) Q2 2026 Earnings Call Transcript

Revenue

Sales and Services Revenue

Financing Services Revenue

Other Revenue

Cost of Revenue

Cost of Goods and Services

Cost of Financing Services

Other Cost

Gross Profit

Other Operating Income

Operating Expenses

Selling, General and Administrative Expenses

Selling and Marketing Expenses

General and Administrative Expenses

Research and Development Expenses

Loss on Bad Debts

Loss on Impairment of Other Assets

Loss on Disposal of Assets

Other Operating Expenses

Operating Income

Non-Operating Income (Loss)

Income (Loss) from Affiliates

Income (Loss) from Associates

Income (Loss) from Joint ventures

Gain (Loss) on Other Investment

Gain (Loss) on Change in Fair Value

Gain (Loss) on Foreign Currency Exchange

Other Non-Operating Income (Loss)

Net Interest Expense

Interest Expense

Interest Income

Pretax Income From Continuing Operations

Income Tax Expense

Current Income Tax

Deferred Income Tax

Income Tax Adjustments

Net Income from Continuing Operations

Income from Discontinued Operations

Other Items Before Net Income

Net Income

Net Income Attributable to Minority Interests

Net Income Attributable to Owners of the Company

Preferred Stock Dividends

Other Adjustments

Net Income Attributable to Common Stockholders

Other Comprehensive Income

Total Comprehensive Income

Total Comprehensive Income Attributable to Minority Interests

Total Comprehensive Income Attributable to Owners of the Company

Basic EPS

Basic EPS from Continuing Operations

Basic EPS from Discontinued Operations

Diluted EPS

Diluted EPS from Continuing Operations

Diluted EPS from Discontinued Operations

VTGN

VTGN fundamentals

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