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Mar 31, 2021
Vistagen Q4 2021 Earnings Report
VistaGen reported financial results for fiscal year 2021 and provided a corporate update.
Key Takeaways
VistaGen Therapeutics reported sublicense revenue of $1.1 million for the year ended March 31, 2021, stemming from their collaboration agreement with EverInsight Therapeutics. The company's cash and cash equivalents stood at approximately $103.1 million as of March 31, 2021. Net loss for the fiscal year was approximately $17.9 million.
Reached consensus with the FDA on key aspects of Phase 3 clinical trials of PH94B for acute treatment of anxiety in adults with SAD.
Entered into a strategic licensing and collaboration agreement with EverInsight Therapeutics for clinical development and commercialization of PH94B in Greater China, South Korea and Southeast Asia, receiving a $5 million upfront payment.
Reported positive preclinical data differentiating the mechanism of action of PH94B and PH10 from benzodiazepines.
Raised $127.5 million gross proceeds from partnering and corporate finance transactions.
Vistagen
Vistagen
Forward Guidance
VistaGen anticipates topline data from PALISADE-1 in mid-2022 and expects to launch PALISADE-2 later this year. The company also expects to prepare for and initiate several exploratory Phase 2A clinical trials of PH94B in additional anxiety disorders, advance preparations necessary to initiate a U.S. multi-center Phase 2B clinical trial of PH10 as a potential rapid-onset, stand-alone treatment for major depressive disorder, and initiate a Phase 1B clinical trial of AV-101 with probenecid.
Positive Outlook
- Topline data from PALISADE-1 expected in mid-2022.
- Launch of PALISADE-2 expected later this year.
- Initiation of Phase 2A clinical trials of PH94B in additional anxiety disorders.
- Advancement of preparations for a Phase 2B clinical trial of PH10 for major depressive disorder.
- Initiation of a Phase 1B clinical trial of AV-101 with probenecid.
Challenges Ahead
- Delays in launching and/or conducting planned clinical trials, including delays due to the impact of the COVID-19 pandemic.
- Fluctuating costs of materials and other resources required to conduct planned clinical and non-clinical trials.
- Impact of general economic, industry or political conditions in the United States or internationally.
- Adverse healthcare reforms and changes of laws and regulations.
- Manufacturing and marketing risks, including unavailability of or delays in delivery of raw materials for manufacture of CNS drug candidates and difficulty in initiating or conducting clinical trials.