VistaGen Therapeutics(VTGN) - 2021 Q4 - Earnings Call Transcript

Financial Data and Key Metrics Changes - The company recognized $1.1 million in sublicense revenue for the fiscal year ended March 31, 2021, compared to no revenue in the previous year [50] - Research and development expenses decreased from $13.4 million to $12.5 million, primarily due to the completion of a Phase 2 study of AV-101 [51] - General and administrative expenses decreased to approximately $6.5 million from approximately $7.4 million, mainly due to the absence of non-cash warrant modification expense [52] - The net loss for the fiscal year ended March 31, 2021, was approximately $17.9 million, an improvement from a net loss of $20.8 million in the previous year [53] - As of March 31, 2021, the company had cash and cash equivalents of approximately $103.1 million [53] Business Line Data and Key Metrics Changes - The company entered a strategic collaboration for the clinical development and commercialization of PH94B in Greater China, South Korea, and Southeast Asia, receiving a non-dilutive upfront payment of $5 million [11][12] - The ongoing PALISADE Phase 3 program for PH94B is designed to demonstrate its potential as a fast-acting treatment for anxiety in adults with social anxiety disorder [26][28] Market Data and Key Metrics Changes - The prevalence of social anxiety disorder (SAD) affects over 23 million Americans, with a mean duration of the illness of about 20 years [27] - The company aims to commercialize PH94B in the U.S. and enter additional commercial collaborations in ex-U.S. markets if the PALISADE Phase 3 program is successful [13] Company Strategy and Development Direction - The company is focused on developing medicines that improve mental health, particularly for anxiety and depression disorders exacerbated by the COVID-19 pandemic [7][9] - The company plans to initiate multiple Phase 2a studies involving PH94B and a Phase 2b study of PH10 in major depressive disorder [17][41] - The addition of experienced personnel in CNS drug development is aimed at driving programs through important clinical and regulatory milestones [18][19] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the potential of the CNS pipeline to make meaningful changes in the lives of those impacted by mental illness [9][20] - The company is committed to advancing its clinical development programs and believes its current cash position is sufficient to support these efforts [15][49] Other Important Information - The company completed a $100 million capital raise, strengthening its balance sheet and institutional shareholder base [14] - PH94B has been granted Fast Track designation status by the FDA for the treatment of SAD [28] Q&A Session Summary Question: Will the adjustment disorder and procedural anxiety exploratory studies start by year-end? - Yes, the company expects to initiate both studies by the end of the year, with readouts anticipated in 2022 [62] Question: What is the expected patient population for PALISADE-1 and PALISADE-2? - The PALISADE-2 study will start before the readout of PALISADE-1, and the patient population will be excluded from those who have failed on two FDA-approved medicines for SAD [68][70] Question: Can you discuss the long-term safety study for PH94B? - The long-term safety study is expected to launch before the end of 2021, with an open-label treatment period following the use of PH94B [77] Question: What are the potential risks to the study regarding placebo response? - Historically, the placebo response for social anxiety disorder is lower than for generalized anxiety disorder, which bodes well for the company's studies [86][88] Question: Will PH94B be considered a scheduled drug? - Currently, there is no basis for PH94B to be scheduled, and the company will continue to track this closely [96][99] Question: How does the company plan to educate the market about PH94B? - The company plans to conduct extensive market education regarding the neurobiology and differentiation of PH94B from existing treatments [104]