VTGN · VistaGen Therapeutics, Inc.

This disclosure represents a high-materiality clinical development update for Vistagen’s lead candidate fasedienol, shifting focus from the failed single-dose primary endpoint in the randomized PALISADE-3 portion (announced December 2025) to compelling long-term, real-world evidence of safety and exploratory efficacy. The OLE data — derived from 341 patients using fasedienol as-needed in daily life for up to 12 months — demonstrate robust tolerability: low discontinuation rate (2.6%), absence of drug-related serious adverse events, and predominance of mild-to-moderate TEAEs (headache 10.9%, upper respiratory infection 11.4%). Critically, the observed improvements on both clinician-administered (LSAS) and patient-reported (SPIN) scales are clinically meaningful and progressive over four months, with increasing proportions of patients achieving threshold-defined responses (e.g., ≥20-point LSAS improvement rising from 38% at Month 1 to 56% at Month 4). These findings directly address a key regulatory and commercial concern — durability and real-world relevance — especially following the earlier negative single-dose challenge outcome. Management explicitly positions the OLE results as supportive of fasedienol’s potential clinical meaningfulness and as consistent with prior studies suggesting persistent neurocircuitry modulation. With PALISADE-4 topline data imminent in Q2 2026 and the Repeat Dose Study expected in Q3 2026, this update strengthens the near-term catalyst pipeline and reinforces the strategic rationale for pursuing an NDA based on a multi-study body of evidence rather than a single pivotal trial.