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Sep 30, 2021
Vistagen Q2 2022 Earnings Report
VistaGen reported financial results for the fiscal year 2022 second quarter and provided a corporate update.
Key Takeaways
VistaGen Therapeutics reported a net loss of $12.8 million for the quarter ended September 30, 2021, compared to a net loss of $3.3 million for the same quarter in the previous year. The company's research and development expenses increased to $10.1 million, driven by the PALISADE Phase 3 Program for PH94B in SAD and the Phase 2A study of PH94B in AjDA. As of September 30, 2021, the company had cash and cash equivalents of approximately $93.6 million.
Advanced PALISADE Phase 3 Program in social anxiety disorder with the initiation of PALISADE-2 and the PALISADE Long-term Safety Study.
Launched Phase 2A clinical program for PH94B to assess its therapeutic potential in anxiety indications beyond SAD, including a study in adjustment disorder with anxiety (AjDA).
Reported preclinical data supporting PH94B's potential mechanism of action, suggesting rapid-onset anti-anxiety effects without systemic uptake or benzodiazepine-like side effects.
Expanded the Board of Directors with the additions of Mary L. Rotunno and Maggie Fitzpatrick, bringing patient-focused mental health and healthcare consumer engagement expertise.
Vistagen
Vistagen
Forward Guidance
VistaGen anticipates several milestones through 2022 and beyond, including topline data from PALISADE-1 and PALISADE-2 studies, potential NDA submission for PH94B in mid-2023, topline results from the Phase 2A clinical trial evaluating PH94B in adults experiencing AjDA in the second half of 2022, initiation of a Phase 2B multi-center study for PH10 in mid-2022, and initiation of a Phase 1B clinical study to evaluate AV-101 in combination with probenecid during the current quarter.
Positive Outlook
- Topline data for PALISADE-1 expected in mid-2022.
- Topline data for PALISADE-2 expected in the second half of 2022.
- Potential NDA submission for PH94B in mid-2023, pending successful Phase 3 Program.
- Topline results from Phase 2A trial of PH94B in AjDA anticipated in the second half of 2022.
- Preparing regulatory submissions to initiate a Phase 2B study for PH10 in mid-2022.
Challenges Ahead
- Delays in launching and/or conducting 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 planned clinical and non-clinical trials.
- Market conditions could impact the company's plans.
- Adverse healthcare reforms and changes of laws and regulations could impact the company's plans.
- Manufacturing and marketing risks, including unavailability or delays in delivery of raw materials for manufacture of the Company’s CNS drug candidates and difficulty in initiating or conducting clinical trials due to the ongoing COVID-19 pandemic or otherwise.