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Mar 31, 2022
Vistagen Q4 2022 Earnings Report
VistaGen reported financial results for fiscal year 2022 and provided a corporate update.
Key Takeaways
VistaGen Therapeutics reported its financial results for the fiscal year ended March 31, 2022. The company highlighted the completion of the last patient out milestone for the PALISADE-1 Phase 3 clinical trial of PH94B in social anxiety disorder and the anticipation of topline results, as well as the FDA's consensus that data from studies of PH94B provide no signal of abuse potential.
Completed the last patient out milestone for PALISADE-1 Phase 3 clinical trial of PH94B in social anxiety disorder (SAD).
Topline results for PALISADE-1 are anticipated mid-2022.
PALISADE-2 is on track for topline readout in late 2022.
Received FDA consensus that data from nonclinical and clinical studies of PH94B completed to date provide no signal of abuse potential.
Vistagen
Vistagen
Forward Guidance
VistaGen is awaiting topline results from the PALISADE-1 Phase 3 clinical trial of PH94B in social anxiety disorder and continues to progress its nasal spray, pherine-based platform, and novel oral NMDA receptor programs.
Positive Outlook
- PALISADE-1 reached the last patient out milestone in June 2022, with topline data anticipated in mid-2022.
- PALISADE-2 is progressing, with topline results anticipated in late 2022.
- The FDA agreed that data from nonclinical and clinical studies of PH94B completed to date provide no signal of abuse potential.
- The Company and AffaMed Therapeutics completed regulatory preparations necessary to initiate PALISADE Global in the U.S. and China in the second half of 2022.
- Following positive results from the exploratory Phase 2A program of PH10 in major depressive disorder (MDD), the Company is conducting the necessary nonclinical studies to support the submission of an Investigational New Drug (IND) application to the FDA for further clinical development of PH10 in MDD in the U.S.
Challenges Ahead
- The completion and results of the Company’s PALISADE-1 and PALISADE-2 Phase 3 clinical trials
- The Company’s ability to submit a NDA to the FDA following the completion of PALISADE-1 and/or PALISADE-2 Phase 3 clinical trials
- Delays in launching, conducting and/or completing other ongoing and planned clinical trials, including delays due to the impact of the ongoing COVID-19 pandemic
- Fluctuating costs of materials and other resources required to conduct the Company’s ongoing and/or planned clinical and non-clinical trials
- Market conditions; the impact of general economic, industry or political conditions in the United States or internationally