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Jun 30, 2023
Vistagen Q1 2024 Earnings Report
Vistagen reported positive Phase 3 trial results and fiscal year 2024 first quarter financial results.
Key Takeaways
Vistagen reported positive top-line results from the Phase 3 PALISADE-2 trial of fasedienol nasal spray in social anxiety disorder (SAD). The company is preparing for Phase 3 PALISADE-3 and FEARLESS trials. Net loss for the quarter was $6.9 million, with cash and cash equivalents at $9.6 million as of June 30, 2023.
Phase 3 PALISADE-2 trial of fasedienol nasal spray achieved statistically significant top-line results for acute treatment of anxiety in adults with SAD.
Itruvone nasal spray is now staged for Phase 2B clinical development as a stand-alone, non-systemic treatment for major depressive disorder (MDD).
Positive exploratory Phase 2A trial of PH80 nasal spray shows optimism for acute treatment of moderate to severe vasomotor symptoms (hot flashes) in women due to menopause.
The company is preparing for Phase 3 PALISADE-3 and FEARLESS trials for fasedienol in SAD, with potential initiation in the first and second halves of calendar 2024, respectively.
Forward Guidance
Vistagen is advancing its Phase 3 program for fasedienol in SAD and planning for initiation of additional Phase 3 studies in 2024.
Positive Outlook
- Positive Phase 3 PALISADE-2 study results for fasedienol.
- Preparation for Phase 3 PALISADE-3 trial with potential initiation in the first half of calendar 2024.
- Preparation for Phase 3 FEARLESS trial with potential initiation in the second half of calendar 2024.
- Successful U.S. Phase 1 study of itruvone stages Phase 2B development in MDD.
- Positive exploratory Phase 2A trial of PH80 nasal spray for vasomotor symptoms.
Challenges Ahead
- Reliance on securing adequate financing for operations.
- Dependence on successful strategic global and/or regional development and commercialization partnerships.
- Risk of delays in launching, conducting, and/or completing clinical trials.
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