VTGN

Shawn Singh discussed the completion of the randomized portion of the PALISADE-3 Phase III trial in social anxiety disorder, implemented refinements in PALISADE-4, worked with collaborators on data analysis using AI/ML, ongoing open-label extensions of PALISADE-3 and -4. The women's health program saw refisolone receive USAN adoption, with plans to submit an IND for refisolone in the first half of 2026. As of December 31, 2025, had $61.8 million in cash, cash equivalents, and marketable securities, and is positioned to complete PALISADE-4 and advance Pherin pipeline preparations.

On track with PALISADE-4 and advancing preparations for the Pherin pipeline.

Forward-looking statements involve risks and uncertainties; actual results could differ. Modifying the SAP plan for PALISADE-4 requires resubmission and alignment with the FDA before database lock and top line results.

Q: About PALISADE-3 data curves, was there separation at any time points with fasedienol vs placebo?

A: Top line results released, individual curves not public yet, analysis continues looking at individual respondents and subgroups.

Q: Modifying SAP plan for PALISADE-4, would it require notifying FDA and risk of modifying SAP plan?

A: Any future changes to SAP require resubmission and FDA alignment before database lock and top line results.

Q: Enrollment in PALISADE-4, any impact since December 17?

A: Enrollment has continued as planned and projected.

Q: Regulatory path forward and confidence with PALISADE-4 success or failure?

A: Regulatory outcomes depend on totality of data, weight of evidence, FDA regulations; focused on evolving AI in agency and weight of evidence across program.

Q: How PALISADE-3 outcome could differ PALISADE-4 by amending SAP?

A: Looking at covariates via AI/ML, need FDA alignment for SAP changes, considering all PALISADE studies.

Q: Shares outstanding at end of December vs weighted average?

A: Includes prefunded warrants, weighted average accounts for such factors