Vistagen Therapeutics Inc (NASDAQ:VTGN), a late clinical-stage biopharmaceutical company pioneering neuroscience, stock fell 8.82% (As on June 18, 11:33:42 AM UTC-4, Source: Google Finance) after the company has reported the adjusted revenue of $0.49 million in the fourth quarter of FY25, beating the analysts’ estimates for revenue of $0.32 million. Net loss was $51.4 million for the year ended March 31, 2025, as compared to $29.4 million for the year ended March 31, 2024. R&D expenses were $39.4 million and $20.0 million for the fiscal years ended March 31, 2025, and 2024, respectively. The increase in R&D expense was primarily due to an increase in research, clinical and nonclinical development, and contract manufacturing expenses and headcount related to the U.S. registration-directed PALISADE Program for fasedienol in SAD and U.S. IND-enabling program for PH80 in women’s health. G&A expenses were $17.1 million and $14.1 million for the fiscal years ended March 31, 2025, and 2024, respectively. The increase in G&A expense was primarily due to an increase in headcount and consulting and professional services fees.

Moreover, Vistagen is developing a broad and diverse pipeline of five clinical-stage intranasal pherine product candidates. The U.S. registration-directed PALISADE Program evaluating intranasal fasedienol for the acute treatment of SAD continues to progress. The PALISADE-3 Phase 3 trial remains on track for expected topline data in the fourth quarter of this year. Topline results for the PALISADE-4 Phase 3 trial are expected in the first half of 2026. Vistagen believes either PALISADE-3 or PALISADE-4, if successful, together with the positive results from PALISADE-2 reported in the second half of 2023, may establish substantial evidence of the effectiveness of fasedienol in support of a potential fasedienol New Drug Application (NDA) submission to the U.S. FDA for the acute treatment of SAD. Vistagen also continues to advance its US-registration-directed nonclinical, CMC, and human factors programs for fasedienol.

Furthermore, building on the positive results from a placebo-controlled exploratory Phase 2A clinical study of itruvone in MDD, Vistagen is currently planning for further Phase 2 development of itruvone under its now open U.S. Investigational New Drug Application (IND). Itruvone has the potential to be a novel, non-systemic, stand-alone treatment for MDD without the weight gain, sexual side effects, and safety concerns associated with currently available depression therapies. In addition, building on the positive results from placebo-controlled exploratory Phase 2A clinical studies of PH80 in vasomotor symptoms (hot flashes) due to menopause and premenstrual dysphoric disorder (PMDD), Vistagen is currently preparing its U.S. IND to facilitate further Phase 2 clinical development of PH80 for women’s health conditions.