VistaGen Therapeutics(VTGN) - 2023 Q1 - Earnings Call Transcript

Financial Data and Key Metrics Changes - Research and development expenses increased by $9.8 million from $5.5 million to $15.3 million for the quarter ended June 30, 2022, primarily due to expenses related to the PALISADE Phase 3 program for PH94B [22] - General and administrative expenses rose to approximately $4.8 million for the quarter ended June 30, 2022, compared to approximately $2.6 million for the same quarter in the previous year, mainly due to the addition of senior management and prelaunch commercialization studies [23] - Net loss attributable to common stockholders for the quarter ended June 30, 2022, was approximately $19.8 million, compared to a net loss of approximately $8.1 million for the same quarter in 2021 [24] - As of June 30, 2022, the company had cash and cash equivalents of approximately $52 million, anticipating a considerable reduction in external spending to conserve cash for at least the next 12 months [24] Business Line Data and Key Metrics Changes - The company is focused on developing three central nervous system therapies aimed at treating anxiety and depression, with a particular emphasis on PH94B for social anxiety disorder [8][9] - The ongoing randomized double-blind placebo-controlled exploratory Phase 2a study in adjustment disorder with anxieties involves daily use of PH94B for 28 days [17] Market Data and Key Metrics Changes - The prevalence of anxiety and depression disorders has significantly increased since the beginning of the pandemic, highlighting the need for new treatment options [8] Company Strategy and Development Direction - The company aims to radically change the trajectory of mental health care and improve the lives of millions suffering from mental health challenges [29] - There is a focus on late-stage clinical development of PH94B, with plans to meet with the FDA to discuss a clearly defined development plan for further Phase 3 development [16][29] - The company is also advancing other CNS candidates, including PH10 for major depressive disorder and AV-101 in combination with probenecid [18][20] Management's Comments on Operating Environment and Future Outlook - Management acknowledges recent setbacks but remains confident in the potential of PH94B to transform the treatment of social anxiety disorder and other anxiety disorders [9][29] - The company is assessing different study designs for submission to the FDA, emphasizing the importance of LSAS as a primary efficacy endpoint [10][16] Other Important Information - The company has conducted extensive new data analysis since its last meeting with the FDA, reinforcing confidence in PH94B's potential [12] - Preliminary data from nearly 200 subjects in the PALISADE open-label safety study suggest significant functional improvement in social anxiety disorder severity [13][14] Q&A Session Summary Question: Clarification on preliminary results from the open-label extension - Management confirmed that the improvement observed is significant, with a notable percentage of subjects showing a 20-point reduction in LSAS scores after one month of treatment [35] Question: Details on the interim PALISADE-2 analysis - Management stated that it is still too early to draw conclusions from PALISADE-1 and that they are awaiting more data from the interim analysis [40][41] Question: Performance of drug in placebo arms relative to Phase 2 - Management indicated that they are not ready to disclose specific data regarding the performance of the drug versus placebo at this time [47]