Vistagen Therapeutics, Inc. reported financial results for its fiscal year 2027 second quarter ended September 30, 2026, and provided an update on its clinical development programs. The company announced that it received constructive feedback from the U.S. Food and Drug Administration (FDA) regarding its potential Phase 3 study of fasedienol in adults with social anxiety disorder (SAD). The FDA recommended using the Liebowitz Social Anxiety Scale (LSAS) as the primary endpoint and suggested interim assessments to evaluate whether acute effects could lead to longer-term functional improvement. Based on this feedback, Vistagen plans to focus its future Phase 3 development on the overall treatment of SAD for the general population.
The company also presented preliminary positive data from the open-label extension (OLE) portion of its Phase 3 PALISADE-4 study. Data showed clinically relevant improvement in social anxiety over four months as measured by the LSAS on both clinician-administered and patient-reported scales. Additionally, Vistagen presented Phase 3 data at Psych Congress 2026 demonstrating a positive efficacy signal for fasedienol in participants with very severe social anxiety disorder.
On the corporate front, Vistagen appointed Douglas J. Williamson, MD, to its Board of Directors, bringing experience from Acadia Pharmaceuticals, Eli Lilly, Lundbeck, Avadel Pharmaceuticals, and QurAlis. The company implemented targeted cost-management initiatives to prioritize capital allocation and extend its operating runway.
Financially, for the three months ended September 30, 2026, Vistagen reported Research and Development (R&D) expense of $6.6 million, a decrease from $15.9 million in the prior year period. General and administrative (G&A) expense was $4.5 million, compared to $4.4 million in the prior year. The company reported a net loss of $10.7 million for the quarter. As of September 30, 2026, Vistagen held $20.0 million in cash, cash equivalents, and marketable securities. The company stated that these funds are expected to be sufficient to fund operations into 2027 but are not expected to extend the cash runway for more than one year.
