Vistagen Therapeutics, Inc. Q1 FY2025 earnings call

• The company is a neuroscience company with clinical-stage product candidates in Phase 2 and 3 development, targeting social anxiety disorder, depression, and menopausal hot flashes with novel neurocircuitry-focused pherine drug candidates.
• The lead program is the PALISADE Phase 3 program for fasedienol in acute social anxiety disorder treatment, with PALISADE-3 enrollment on track and PALISADE-4 to initiate in the second half of the year.
• Planning for Phase IIb development of itruvone for major depressive disorder based on positive Phase IIa results, and ongoing nonclinical work for PH80 in menopausal hot flashes to enable US IND for Phase II development.
• Cindy Anderson highlighted R&D and G&A expense increases due to clinical development activities and headcount growth.

Research and development expenses for the quarter ending June 30, 2024 were $7.6 million, compared to $4.2 million in the same period last year. General and administrative expenses were $4.6 million for the quarter ended June 30, 2024, versus $3 million in the prior year. There are no traditional product segments with revenue contribution as the company is focused on clinical-stage drug development programs.

• On-track progress in the PALISADE Phase 3 program for fasedienol, with PALISADE-3 and -4 studies set to read out in 2025.
• Staging of itruvone for Phase IIb development in the US based on positive Phase IIa results.
• Ongoing nonclinical work for PH80 to enable US IND for Phase II development in menopausal hot flashes.

Q: Can you provide color on the types of patients currently enrolling for the Phase III trials for fasedienol?

A: Patients are similar to those in PALISADE-2 study, with LSAS scores >70, primary SAD diagnosis, no other primary health or mental health disorders, and exclusion of excessive smoking/vaping. High scrutiny on chronicity and severity of the disorder.

Q: For PALISADE-3, are you seeing higher screen failure rates compared to PALISADE-1 and 2, and any confidence in study execution?

A: Screen failure rates have been consistent with projections, and progress of the study is in-line with expectations.

Q: Discussions with FDA about self-administration in PAL-1 and PAL-2 versus HCP administration in PAL-3 and PAL-4 and impact on label?

A: Protocols submitted to the agency, HCP administration consistent with Phase II, and no expected impact on label if studies 3 or 4 combined with 2 are successful.

Q: Gating steps to MDD Phase IIb trial and dose efficacy curve for itruvone?

A: Finalizing protocol with KOLs, and expecting to land on a 6.4 microgram dose for a double-blind, placebo-controlled 6-week study with HAMD-17 as the primary endpoint