Vistagen Therapeutics, Inc. Q2 FY2025 earnings call

• Shawn Singh discussed the neuroscience pipeline with pherine products: fasedienol for social anxiety disorder, itruvone for major depressive disorder, and PH80 for menopausal hot flashes. - PALISADE-3 and PALISADE-4 Phase 3 trials for fasedienol were initiated on time; targeting mid-2025 for PAL-3 data and end-2025 for PAL-4. - Itruvone is preparing for Phase 2b development in the U.S. based on Phase 2a data. - PH80 is advancing through nonclinical programs and CMC requirements for a U.S. IND submission next year. - Cindy Anderson discussed financial results, highlighting R&D, G&A, and net loss figures.

For the fiscal year 2025 second quarter ended September 30, 2024: Research and development expenses were $10.2 million, compared to $3.9 million in the same period last year. General and administrative expenses were $4.2 million, compared to $3.2 million last year. Net loss attributable to common stockholders was $13 million, compared to $6.6 million last year. As of September 30, 2024, cash, cash equivalents, and marketable securities totaled $97.6 million. R&D expenses increase was due to clinical/development expenses for PALISADE Phase 3, headcount, and consulting. G&A increase was due to headcount and professional services fees.

• Targeting mid-2025 for PALISADE-3 data and end-2025 for PALISADE-4 data. - Phase 2b protocol for itruvone in MDD is on track, likely hitting target with possible slight extension into January. - PH80 aiming for U.S. IND submission in the second quarter next year.

Forward-looking statements involve risks and uncertainties; actual results could differ materially. Additional risk factors are detailed in the Form 10-Q and future SEC filings.

Q: Could you provide color on enrollment pace, site details, and timing for PALISADE-3 and -4?

A: Shawn mentioned 16 sites activated for PALISADE-3 and 12 for PALISADE-4, no site overlap, tracking towards mid-2025 for PAL-3 and end-2025 for PAL-4 data.

Q: If PALISADE-3 doesn't hit stats, will you still proceed with PALISADE-4?

A: Yes, both studies will be run to completion as the program is fully funded.

Q: Are you on track for submitting the Phase 2b protocol in MDD by year-end?

A: Working closely on the protocol, intention to hit target with possible slight extension into January.

Q: In healthy subject data, was dosing self-administered or physician-administered?

A: Physician-administered due to precision needed for electrogram measurements.

Q: What's gating the PH80 study and about headcount?

A: PH80 is advancing through nonclinical and CMC work for U.S. IND; headcount increase is R&D-related, enabling more work across lead programs.