Vistagen Therapeutics, Inc. Q4 FY2024 earnings call

• Shawn Singh highlighted positive results from PALISADE-2 Phase 3 study of fasedienol for social anxiety disorder, launched PALISADE-3 Phase 3 trial, and plans for PALISADE-4 Phase 3 trial. - Introduced the pherine pipeline, including itruvone for major depressive disorder and PH80 for women's health. - PH80 showed positive results in Phase 2A studies, with US IND-enabling studies ongoing and exclusive negotiation with Fuji Pharma for Japan. - Corporate awards received, including Mental Health America's Platinum Bell Seal Award and Great Place to Work certification. - Cindy Anderson reported financials: R&D expenses $20M (vs $44.4M in 2023), G&A expenses $14.1M (vs $14.7M in 2023), net loss $29.4M (vs $59.2M in 2023), cash and cash equivalents $119.2M as of March 31, 2024.

No detailed segment performance with revenue contribution provided as the transcript does not break down financials by specific product segments.

• PALISADE-3 on track for top-line data mid-2025, PALISADE-4 to initiate in H2 2024 and complete by end-2025. - Plan to initiate small placebo-controlled repeat dose study in H2 2024, completing in H2 2025 with top-line readout near end-2025. - Potential submission of U.S. new drug application for fasedienol in acute social anxiety disorder by H1 2026. - Ongoing preparations for US Phase 2B development of itruvone for major depressive disorder.

• Forward-looking statements involve risks and uncertainties; actual results may differ materially. - Risks detailed in Form 10-K filed with SEC, including factors affecting business and financial results.

Q: In PALISADE-3, how many patients have been enrolled so far, and is enrollment cadence looking stronger or slower than prior studies, and comment on screen failure rate?

A: No specific enrollment numbers or screen failure rate guidance given, but progress is on track with enhanced efficiencies in study execution.

Q: Could you provide more color on the enhancements in PALISADE-3 and PALISADE-4 and the purpose of the repeat dose study?

A: Enhancements focus on optimal subjects, precise screening/inclusion-exclusion criteria, and consistent protocol administration; repeat dose study to inform labeling regarding use of a second dose.

Q: How many sites are up and enrolling patients in PALISADE-3, and how many overlap with prior studies?

A: ~10 sites up, some overlap with prior studies, with high-quality sites due to study awareness and positive read-through of data.