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Sep 30, 2023
Vistagen Q2 2024 Earnings Report
Vistagen reported financial results for the second quarter of fiscal year 2024 and provided a corporate update.
Key Takeaways
Vistagen reported positive Phase 3 results for fasedienol and is preparing to initiate potential NDA-enabling Phase 3 studies in 2024. The company secured $137.7 million in gross proceeds since the beginning of the fiscal 2024 second quarter and has a strong financial position to fund operations through a potential fasedienol U.S. NDA submission.
Fasedienol (PH94B) PALISADE Phase 3 Program for acute treatment of social anxiety disorder (SAD) advancing to build on recent positive PALISADE-2 Phase 3 results.
Preparations to initiate potential fasedienol NDA-enabling Phase 3 studies in 2024 are underway.
Itruvone (PH10) is staged for potential Phase 2B clinical development in the second half of 2024.
PH80 positive exploratory Phase 2A trial data was reported in two separate women’s health indications – vasomotor symptoms (hot flashes) due to menopause and premenstrual dysphoric disorder (PMDD).
Vistagen
Vistagen
Forward Guidance
Vistagen is preparing for multiple milestones in 2024 across its pipeline, including initiating Phase 3 studies for fasedienol, a Phase 2B study for itruvone, and finalizing U.S. IND-enabling studies for PH80.
Positive Outlook
- Initiate PALISADE-3 Phase 3 study in the first half of 2024.
- Initiate PALISADE-4 Phase 3 study in the second half of 2024.
- Initiate fasedienol Phase 2B repeat dose study in the second half of 2024.
- Initiate Itruvone Phase 2B study in the second half of 2024.
- Finalize U.S. IND-enabling studies for PH80 in the second half of 2024 to facilitate potential Phase 2B development in the U.S. for the acute treatment of vasomotor symptoms (hot flashes) due to menopause in the first half of 2025