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VistaGen Therapeutics (VTGN) investor relations material

VistaGen Therapeutics Q2 2026 earnings summary

Complete event summary combining all related documents: earnings call transcript, report, and slide presentation.
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Q2 2026 earnings summary13 Nov, 2025

Executive summary

  • Achieved a major milestone with the last patient completing the randomized double-blind portion of the PALISADE 3 phase III trial for fasedienol in social anxiety disorder; top-line results expected by year-end 2025.

  • PALISADE 4 phase III trial remains on track for top-line results in the first half of 2026, both using a public speaking challenge design and primary efficacy endpoint as in PALISADE 2.

  • Advancing a broader neuroscience pipeline, including Itruvone for major depressive disorder and PH80 for menopausal hot flashes, with five clinical-stage product candidates.

  • Welcomed Paul Edick to the board, bringing significant experience in FDA approvals and commercial launches.

  • Company has not achieved revenue-generating status from product sales and expects continued operating losses as development progresses.

Financial highlights

  • Cash, cash equivalents, and marketable securities totaled $77.2 million as of September 30, 2025.

  • Net loss was $19.4 million for the quarter and $34.5 million for the six months ended September 30, 2025, compared to $13.0 million and $23.7 million for the same periods in 2024.

  • Research and development expenses increased to $15.9 million for the quarter and $27.7 million for the six months, mainly due to expanded clinical activity for fasedienol.

  • General and administrative expenses were $4.4 million for the quarter and $8.7 million for the six months.

  • Revenue was $0.3 million for the quarter and $0.5 million for the six months, primarily from the AffaMed license agreement.

Outlook and guidance

  • Top-line results from PALISADE 3 to be released before the end of calendar year 2025; PALISADE 4 top-line results anticipated in the first half of 2026.

  • NDA submission for fasedienol possible around mid-2026 if PALISADE 3 is positive and all required studies are completed.

  • Expects research and development expenses to increase as clinical programs advance and headcount grows.

  • Uncertainty exists regarding whether current cash resources will fund operations beyond twelve months from the financial statement issuance date.

  • Plans to seek additional capital through equity, debt, grants, or strategic partnerships as needed.

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Frequently asked questions

VistaGen Therapeutics Inc. is a clinical-stage biopharmaceutical company focused on developing innovative therapies for central nervous system (CNS) disorders. The company's pipeline includes drug candidates designed to address mental health conditions such as anxiety, depression, and social anxiety disorder. VistaGen’s lead programs aim to provide rapid-acting treatments that target specific CNS pathways, offering potential alternatives to traditional therapies. The company is headquartered in South San Francisco, California, and its shares are listed on the NASDAQ.

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