Loading...
•
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.
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.
Historical Earnings Impact
Analyze how earnings announcements historically affect stock price performance
Avg. Return Before/After Earnings
Loading earnings performance data...
Loading earnings reaction data...