Vistagen Announces FY 2025 Q1 Financial Results and Corporate Update

Vistagen, a neuroscience-focused biopharmaceutical company based in South San Francisco, California, has disclosed its financial results for the first quarter of its fiscal year 2025, which concluded on June 30, 2024. The company also provided updates on its ongoing corporate activities and clinical trials.

According to Shawn Singh, CEO of Vistagen, the company's main focus continues to be advancing its U.S. registration-directed PALISADE Phase 3 program for fasedienol, a rapid-onset, non-systemic pherine nasal spray designed for the acute treatment of social anxiety disorder (SAD). Singh emphasized the importance of their PALISADE-3 Phase 3 trial, which is progressing as scheduled, and mentioned that preparations for the PALISADE-4 Phase 3 trial are also on track.

In addition to fasedienol, Vistagen is making significant strides with two other lead pherine development programs: itruvone, aimed at treating major depressive disorder (MDD), and PH80, designed to alleviate menopausal hot flashes. Each of these programs employs novel, non-systemic mechanisms that leverage nose-to-brain neural circuits, potentially transforming existing treatment paradigms and improving the lives of many individuals who are currently underserved by available therapies.

For fasedienol, Vistagen's PALISADE-3 Phase 3 trial is expected to yield top-line results in 2025, consistent with earlier guidance. The PALISADE-4 Phase 3 trial is set to start in the latter half of 2024, also targeting top-line results in 2025. Notably, there is currently no FDA-approved acute treatment for SAD. Vistagen’s PALISADE-3 and PALISADE-4 trials are designed in a manner similar to the company's successful PALISADE-2 Phase 3 trial, which reported positive outcomes in 2023. Vistagen believes that success in either the PALISADE-3 or PALISADE-4 trials, combined with the positive results from PALISADE-2, could provide substantial evidence to support a New Drug Application (NDA) submission to the FDA for fasedienol for the acute treatment of anxiety in adults with SAD.

For itruvone, after achieving positive results in an exploratory Phase 2A trial in Mexico, Vistagen has completed its U.S. Investigational New Drug (IND)-enabling program, paving the way for further Phase 2 development in the U.S. Preparations for a Phase 2B trial are ongoing, with the primary objective being the development of itruvone as a standalone treatment for MDD that avoids the sexual side effects, weight gain, and safety concerns common with current depression therapies.

PH80, another investigational pherine nasal spray, is being developed as a hormone-free treatment option for vasomotor symptoms (hot flashes) due to menopause. Following positive results from a Phase 2A trial in Mexico, Vistagen is progressing with its U.S. IND-enabling program. This program aims to support a U.S. IND submission to facilitate the further Phase 2 clinical development of PH80, which could provide a novel, non-systemic treatment option for millions of women affected by menopausal hot flashes.

Financially, Vistagen reported a rise in research and development (R&D) expenses to $7.6 million for the three months ended June 30, 2024, compared to $4.2 million for the same period in 2023. This increase is attributed to higher clinical and development costs linked to the company’s ongoing Phase 3 trials, an uptick in headcount costs, and elevated consulting and professional fees. General and administrative expenses also increased, from $3.0 million to $4.6 million, primarily due to increased headcount and professional service costs necessary for supporting the company’s expanding administrative activities. Vistagen’s net loss for the quarter was $10.7 million, up from $6.9 million in the previous year.

As of June 30, 2024, Vistagen reported cash, cash equivalents, and marketable securities amounting to $108.4 million. These financial resources are expected to support the company’s ongoing and planned clinical trials and other corporate activities.

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