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Mar 31, 2023
Vistagen Q4 2023 Earnings Report
Vistagen reported fiscal year 2023 financial results and provided a corporate update.
Key Takeaways
Vistagen reported a net loss of $59.2 million for fiscal year 2023, with cash and cash equivalents of $16.6 million as of March 31, 2023. The company highlighted positive results from its Phase 3 open label study of fasedienol in social anxiety disorder and positive FDA feedback on the use of the LSAS as the primary efficacy endpoint in future Phase 3 studies.
Positive results were achieved in the Phase 3 open label study of fasedienol (PH94B) for social anxiety disorder (SAD).
The FDA provided positive feedback on using the Liebowitz Social Anxiety Scale (LSAS) as the primary efficacy endpoint in future Phase 3 studies of fasedienol in SAD.
A successful itruvone (PH10) U.S. Phase 1 study supports previous studies and facilitates the next-step U.S. Phase 2B development in major depressive disorder (MDD).
The clinical-stage pipeline has expanded to include six differentiated product candidates targeting multiple large CNS markets.
Vistagen
Vistagen
Forward Guidance
Vistagen is pursuing multiple global and regional strategic development and commercialization partnerships to accelerate clinical and regulatory milestones across the CNS pipeline.
Positive Outlook
- Advancing therapeutics with the potential to be faster-acting.
- Advancing therapeutics with fewer side effects and safety concerns.
- Expanding the intellectual property portfolio.
- Pursuing partnering and non-dilutive grant opportunities.
- Aiming to transform the treatment landscape for individuals living with anxiety, depression and other CNS disorders.
Challenges Ahead
- Risks and uncertainties relating to the Company’s ability to secure adequate financing for its operations.
- Risks and uncertainties related to the Company’s ability to secure successful strategic global and/or regional development and commercialization partnerships.
- Risks and uncertainties related to delays in launching, conducting and/or completing ongoing and planned clinical trials.
- Fluctuating costs of materials and other resources and services required to conduct the Company’s ongoing and/or planned clinical and non-clinical trials.
- Other technical and unexpected hurdles in the development, manufacture and commercialization of the Company’s product candidates.