Completion of PALISADE-3 Randomized Portion
The company completed the randomized portion of the PALISADE-3 Phase III trial in social anxiety disorder as guided and is analyzing results to inform PALISADE-4 and broader program strategy.
PALISADE-4 Enrollment On Track
PALISADE-4 (Phase III) enrollment and randomized portion remain ongoing and are reported to be on track with prior guidance; the open-label extension portions of PALISADE-3 and PALISADE-4 also remain active.
Advanced Analytical Work Using AI/ML
The company engaged third-party collaborators to apply proprietary AI and machine learning across PALISADE studies to identify nonspecific/placebo responses, potential predictors of drug response, and candidate covariates for enhanced statistical models.
Operational Enhancements Implemented
Following PALISADE-3, Vistagen implemented moderate refinements including retraining, site rationalization, centralized recruitment focus, audio monitoring and other placebo-mitigation operational measures for PALISADE-4.
Refisolone (PH80) USAN Adoption and IND Plans
PH80 received an official USAN adoption (refisolone). The company plans to submit a U.S. IND in the first half of 2026 to support potential Phase II development for moderate to severe vasomotor symptoms, building on a completed Phase IIa in Mexico that showed clinical benefit.
Cash Position and Cost Controls
As of December 31, 2025, Vistagen reported $61.8 million in cash, cash equivalents and marketable securities and implemented company-wide cash preservation measures to extend runway and enhance operational efficiency.
No Observable Enrollment Impact from PALISADE-3 Announcement
Management reported no discernible negative impact on PALISADE-4 enrollment rates after the December 17 public announcement regarding PALISADE-3 results.
Clarification on Share Count Disclosure
Management clarified end-of-quarter shares outstanding were 39.7 million versus a weighted average of 42.0 million for the quarter, noting the difference reflects prefunded warrants used in EPS calculations.