Vistagen Therapeutics, Inc. Q2 FY2026 earnings call

• Last patient completed randomized double-blind phase of PALISADE 3 phase 3 trial for fascidinol in social anxiety disorder; preparing for top-line results by end of 2025. • Appreciates patients, investigators, etc., involved in PALISADE 3 study, including ongoing open-label extension. • Progress on broader farine pipeline, including itravone for major depressive disorder and PH80 for menopausal hot flashes. • As of September 30, 2025, had $77.2 million in cash, cash equivalents, and marketable securities. • Welcomed Paul Edick to Board of Directors; thanked Jerry Jin for service. • Mission to redefine neuroscience, restore emotional well-being, improve quality of life.

No detailed financial performance by product segment provided; as of September 30, 2025, cash, cash equivalents, and marketable securities were $77.2 million.

• Expect top-line results from PALISADE 3 by end of 2025. • Estimate NDA submission for PALISADE 3's positive data around 2026 if program is successful.

• Uncertainties related to clinical trial outcomes and regulatory approvals. • Potential differences between actual results and forward-looking statements due to various risks and uncertainties.

Q: When will the top-line results from PALISADE 3 be released?

A: Our guidance is we will see top-line results released before the end of this calendar quarter, so by the end of 2025.

Q: What about discontinuation rates, protocol violations, and safety profile in top-line analysis?

A: We will give top-line results on primary (CGII), secondary (PGIC), and safety data similar to PALISADE II.

Q: What are the top reasons for patient screen failures in PALISADE 3 and different from PALISADE II?

A: Enhancements made to PALISADE 3 and 4 to ensure high-quality subject eligibility assessment; details to be unpacked later, but comfortable with modeled expectations.

Q: Assuming one of PALISADE 3 or 4 works, what's gating registration?

A: Pivotal program data, repeat dose study, open-label data, human factor study, preclinical safety studies; will meet with FDA for NDA submission around 2026 if successful.

Q: Is tasadionol eligible for a commission's priority review voucher?

A: Aware of criteria, but currently don't expect fascidinol to fall within typical CMPV program scope, but will evaluate if pathways evolve.

Q: Why were sites in Arkansas and Kansas terminated?

A: Evaluation of site fit; some sites not enrolling appropriate patients, leading to termination; part of wind-down approach for study.

Q: Usage patterns of fascidinol in open-label?

A: More activity during the week, less on weekends; based on long-term safety study observations.

Q: Difference in open-label phase entry between PALISADE 2 and 3?

A: High throughput rate; reasons for not entering open-label often related to life-changing events.

Q: Clinically meaningful effect size for SODS or CGI?

A: Targeting to replicate clinically meaningful outcomes seen in PALISADE 2.

Q: Thoughts on commercialization?

A: Have commercial plan, consider optionality; excited about unique asset's potential in transformed market environment