VistaGen Therapeutics(VTGN) - 2023 Q3 - Earnings Call Transcript

Financial Data and Key Metrics Changes - Revenue for Q3 2023 was $179,600, a decrease from $357,900 in Q3 2022, with both periods reflecting non-cash revenue [32] - Research and development expenses decreased by $0.9 million from $7.9 million in Q3 2022 to $6.9 million in Q3 2023, primarily due to reduced expenses related to the PALISADE Phase III program [33] - Net loss attributable to common stockholders for Q3 2023 was approximately $9.8 million, compared to a net loss of approximately $10.7 million in Q3 2022 [34] - Cash and cash equivalents at the end of Q3 2023 were approximately $25.0 million [34] Business Line Data and Key Metrics Changes - The PALISADE Phase III program for PH94B is under review, with protocol amendments submitted to the FDA to address unexpected results from previous studies [15][16] - The PALISADE Open Label Study, which evaluates the safety and tolerability of PH94B, has shown encouraging preliminary results from nearly 400 subjects [21] Market Data and Key Metrics Changes - The company is focusing on the significant unmet need in mental healthcare, particularly for anxiety and depression disorders, which are growing areas of concern globally [7] Company Strategy and Development Direction - The company aims to shift the treatment paradigm for anxiety and depression disorders by developing differentiated treatments [7] - Plans to meet with the FDA to discuss a broader Phase III development plan for PH94B, including a potential randomized double-blind placebo-controlled study using the Liebowitz social anxiety scale (LSAS) as the primary measure [16][17] - The acquisition of Pherin Pharmaceuticals has eliminated future royalty and milestone payment obligations for PH94B and PH10, enhancing the commercial profile of these assets [28][29] Management's Comments on Operating Environment and Future Outlook - Management acknowledges the challenges posed by the COVID-19 pandemic on study designs and patient responses, but remains confident in the potential of PH94B as a treatment for social anxiety disorders [15][16] - The company is optimistic about the upcoming data readouts and the potential for PH10 to address major depressive disorder, especially with the FDA's Fast Track designation [25][26] Other Important Information - The company has completed a small Phase IIa trial for PH94B in adjustment disorder with anxiety and anticipates announcing topline data soon [22] - The ongoing Phase I study for PH10 is expected to complete by the end of Q1 2023, which will inform future Phase IIb development plans [23][24] Q&A Session Summary Question: Upcoming FDA meeting regarding Phase III design pivot - Management discussed the potential scenarios depending on FDA feedback regarding the PALISADE-2 study and the possibility of unblinding data from interim analysis [39][40] Question: Open label study data expectations - Management indicated that the topline release will provide significant insights into the efficacy of PH94B, despite the absence of a control group [44][45] Question: Adjustment disorder study dosing and placebo rates - Management confirmed that subjects in the adjustment disorder study are taking PH94B four times a day, but historical placebo rates in this disorder are not well-documented [54][55] Question: Competitors' SAD topline data and FDA considerations - Management expressed confidence in the LSAS as a primary endpoint, citing historical success in registrational studies, while acknowledging the challenges of scaling methodologies for larger studies [61][62] Question: Timeline for Phase III studies - Management estimated that if funding is secured, Phase III studies could commence within six months, with data readouts expected by the end of Q4 2024 [67]