Vistagen Therapeutics, Inc. Q4 FY2025 earnings call

• Shawn Singh discussed the company's neuroscience focus with 5 clinical-stage pherine product candidates. Fasedienol is in Phase III for acute SAD, itruvone is for MDD, PH80 is for women's health indications. - Mentioned progress in U.S. IND preparation for PH80. - Cindy Anderson provided financial results: R&D expenses increased due to clinical development, G&A expenses increased due to headcount and fees, net loss widened, and cash position was noted.

No specific product segments with detailed financial performance in terms of revenue contribution % were provided. Research and development expenses for the fiscal year ended March 31, 2025 were $39.4 million, general and administrative expenses were $17.1 million, net loss attributable to common shareholders was $51.4 million, and cash, cash equivalents and marketable securities as of March 31, 2025 were $80.5 million.

• PALISADE-3 is on track for top line data readout in Q4 2025. - PALISADE-4 anticipates top line results in H1 2026. - Anticipates submitting PH80's U.S. IND in H2 2025.

• Forward-looking statements involve risks and uncertainties where actual results could differ materially. - Risks detailed in Form 10-K and future SEC filings. - FDA reviewer turnover and hiring of additional reviewers with domain expertise were discussed as potential factors.

Q: You alluded to changes with FDA leadership and PALISADE-4 timing. Have you noticed changes with FDA and what led to PALISADE-4 timing slip?

A: At the FDA CEO listening forum, FDA leadership stated no reviewers/inspectors involved in layoffs and they're hiring reviewers. For PALISADE-4, timing slip is due to more stringent eligibility criteria and internal secondary eligibility review team to limit variability.

Q: Can we expect placebo response similar to PALISADE-2 in PALISADE-3/4?

A: Designed to replicate PALISADE-2 success, but variability will be limited through enhanced study execution, but exact placebo response to be seen.

Q: Thoughts on FDA alignment with fasedienol and PALISADE-3/4 criteria?

A: FDA is open to beneficial patient outcomes with negligible risk. PALISADE-3/4 slowdown is due to pre-Visit 1 screening with stringent eligibility inclusion/exclusion criteria