Vistagen Therapeutics Reports Fiscal Year Results, Highlights Pherine Pipeline Focus

**Vistagen Therapeutics Reports Fiscal Year Results, Focuses on Pherine Pipeline**

Vistagen Therapeutics, Inc., a late clinical-stage biopharmaceutical company, announced its financial results for the fiscal year ended March 31, 2025, reporting sublicense and other revenue of $486,000, a decrease from $1.1 million in the prior fiscal year. The decrease was attributed to the timing of revenue recognized under the AffaMed Agreement. The company's net loss for the year was $51.4 million, compared to a net loss of $29.4 million for the year ended March 31, 2024. This increase in net loss was primarily driven by increased research and development expenses.

Research and development expenses for the year totaled $39.4 million, a significant increase from $20.0 million in the previous fiscal year. This rise was largely due to the advancement of the PALISADE Program for fasedienol, including manufacturing, nonclinical studies, and Phase 3 clinical trials, as well as manufacturing and nonclinical studies to support the planned PH80 U.S. Investigational New Drug Application (IND). General and administrative expenses also increased to $17.1 million from $14.1 million, primarily due to increased headcount and related costs.

The company's cash, cash equivalents, and marketable securities amounted to $80.5 million as of March 31, 2025, compared to $119.2 million the year prior. Management expressed uncertainty about the company's ability to fund operations beyond twelve months from the issuance date of the consolidated financial statements, leading to a conclusion that substantial doubt exists about the company's ability to continue as a going concern. The company plans to seek additional funding through various means, including equity offerings, debt financings, and strategic collaborations.

Vistagen is focused on developing its pherine pipeline, with fasedienol as its lead product candidate for the acute treatment of social anxiety disorder (SAD). The company anticipates topline data for the PALISADE-3 Phase 3 trial in the fourth quarter of 2025 and for PALISADE-4 and the Repeat Dose Study in the first half of 2026. The company is also planning for potential U.S. Phase 2B clinical development of itruvone for major depressive disorder. The company's future success is dependent on the successful development, regulatory approval, and commercialization of its product candidates.