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Jun 30, 2021
Vistagen Q1 2022 Earnings Report
Reported financial results for its fiscal year 2022 first quarter and provided a corporate update.
Key Takeaways
VistaGen Therapeutics reported financial results for its fiscal year 2022 first quarter ended June 30, 2021. The company recognized $0.4 million in sublicense revenue. Research and development expense increased by $3.9 million, and general and administrative expense increased to approximately $2.5 million. Net loss for the quarter was approximately $7.7 million. The Company had cash and cash equivalents of approximately $97.8 million at June 30, 2021.
Initiated PALISADE Phase 3 Program with PALISADE-1.
Expects to initiate PALISADE-2 in the second half of calendar 2021.
Received notice from the FDA allowing commencement of its exploratory Phase 2A clinical study of PH94B in adults experiencing AjDA.
Preparing to initiate a Phase 1B clinical study to evaluate AV-101 in combination with probenecid during the second half of calendar 2021.
Vistagen
Vistagen
Vistagen Revenue by Segment
Revenue by Segment
Sublicense and other Revenue
CapyFin.com Forward Guidance
VistaGen is focused on advancing its clinical-stage programs through multiple development and regulatory milestones. They are preparing for exploratory Phase 2A clinical studies of PH94B in adults experiencing other anxiety disorders, including postpartum anxiety, post-traumatic stress disorder and pre-procedural anxiety. They are also preparing to initiate a Phase 2B multi-center study to evaluate the efficacy, safety and tolerability of PH10 as a potential rapid-onset treatment for MDD in mid-2022.
Positive Outlook
- Initiation of PALISADE-2 expected in the second half of calendar 2021.
- Exploratory Phase 2A clinical study of PH94B in adults experiencing AjDA expected to start by the end of 2021.
- Preparation for exploratory Phase 2A clinical studies of PH94B in adults experiencing other anxiety disorders.
- Preparation to initiate a Phase 2B multi-center study to evaluate PH10 as a potential rapid-onset treatment for MDD in mid-2022.
- Phase 1B clinical study to evaluate AV-101 in combination with probenecid during the second half of calendar 2021.
Challenges Ahead
- Delays in launching and/or conducting planned clinical trials 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.
- 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.