-
Research and Development Expenses: $39.4 million for the fiscal year ended March 31, 2025, up from $20 million the previous year.
-
General and Administrative Expenses: $17.1 million for the fiscal year ended March 31, 2025, compared to $14.1 million the previous year.
-
Net Loss: $51.4 million for the fiscal year ended March 31, 2025, compared to $29.4 million the previous year.
-
Cash, Cash Equivalents, and Marketable Securities: $80.5 million as of March 31, 2025.
Release Date: June 17, 2025
For the complete transcript of the earnings call, please refer to the full earnings call transcript.
-
Vistagen Therapeutics Inc (NASDAQ:VTGN) has five clinical-stage pherine product candidates with differentiated mechanisms of action, showing positive results in controlled trials.
-
The company’s lead product candidate, Fasedienol, is in Phase III development for social anxiety disorder (SAD), aiming to become the first FDA-approved acute treatment for SAD.
-
Vistagen is advancing Itruvone for major depressive disorder (MDD), showing promise without common side effects of traditional antidepressants.
-
PH80, a pherine product candidate for women’s health, is progressing as a potential hormone-free treatment for menopausal hot flashes and premenstrual dysphoric disorder (PMDD).
-
The company has $80.5 million in cash, cash equivalents, and marketable securities as of March 31, 2025, providing a solid financial position to support ongoing development.
-
Research and development expenses increased significantly to $39.4 million for the fiscal year ended March 31, 2025, compared to $20 million the previous year.
-
General and administrative expenses rose to $17.1 million, up from $14.1 million, due to increased headcount and professional fees.
-
The net loss attributable to common shareholders was $51.4 million, a substantial increase from $29.4 million the previous year.
-
The timeline for PALISADE-4 trial results has been modestly delayed due to stringent subject eligibility requirements and operational adjustments.
-
There is uncertainty regarding the FDA’s evolving regulatory landscape and its impact on Vistagen’s product approvals, despite positive interactions with the agency.
Q: Have you noticed any changes in FDA interactions due to leadership turnover, and what caused the timing adjustment for PALISADE-4? A: Shawn Singh, CEO, noted that no FDA reviewers were affected by the recent staff changes, and they are hiring more experts. The timing adjustment for PALISADE-4 was due to stringent subject eligibility requirements and enhanced study execution, which are now showing positive results in screening visits.
