VistaGen Therapeutics(VTGN) - 2020 Q1 - Quarterly Report

Financial Performance - The company reported a net loss of approximately $6.2 million for the quarter ended June 30, 2019, compared to a net loss of $4.2 million for the same quarter in 2018, with an accumulated deficit of approximately $187.3 million[90]. - Total operating expenses increased to $6.2 million for the quarter ended June 30, 2019, compared to $4.2 million for the same period in 2018, representing a 48% increase[101]. - The company reported a net loss of $6.2 million for the quarter ended June 30, 2019, compared to a net loss of $4.2 million for the same period in 2018, indicating a 47% increase in net loss[101]. - The company had no revenue for the quarters ended June 30, 2019, and 2018, with no recurring revenue-generating arrangements currently in place[102]. - Interest income for the quarter ended June 30, 2019, was $19,000, compared to no interest income in the same quarter of 2018, marking a significant improvement[119]. - Cash and cash equivalents at June 30, 2019, were approximately $8.3 million[122]. - The company recognized a cumulative dividend of $302,500 on Series B Preferred Stock for Q2 2019, compared to $273,500 for Q2 2018, a 10.6% increase[120]. - As of June 30, 2019, the company reported cash and cash equivalents of $8.297 million, down from $13.1 million at the beginning of the period, reflecting a net decrease of $4.803 million[128]. - Net cash used in operating activities for the three months ended June 30, 2019, was $4.761 million, compared to $3.135 million for the same period in 2018, indicating an increase in operational cash outflows[128]. - The increase in cash used in operations is attributed to the ELEVATE Study and increased employee compensation and investor relations initiatives[129]. - The company has substantial doubt about its ability to continue as a going concern without additional financing, which may impact its business and financial condition[127]. Clinical Development - The company is advancing the Phase 2 clinical development of AV-101 for major depressive disorder (MDD) and anticipates top-line results from the ELEVATE Study in the second half of the calendar year[84]. - PH94B, a neuroactive nasal spray, has shown significant efficacy in reducing social anxiety disorder (SAD) symptoms in a Phase 2 clinical trial, positioning it as a potential first FDA-approved on-demand treatment for SAD[83]. - The company is preparing for Phase 2b clinical development of PH10, another neuroactive nasal spray for MDD, following positive results from a small exploratory Phase 2a study[86]. - The Baylor Study, a collaboration with Baylor College of Medicine, is ongoing to evaluate the potential anti-suicidal effects of AV-101 in U.S. Military Veterans[85]. Research and Development - The company continues to pursue a broad portfolio of patent protection for AV-101, covering multiple CNS indications and unit dose formulations[93]. - The company has secured exclusive licenses for the patent assets related to PH94B and PH10, with patents issued in multiple countries including the U.S., Australia, and Europe[95][96]. - The company is exploring research and development collaborations that could provide non-dilutive funding for product candidates such as AV-101, PH94B, and PH10[125]. Capital and Financing - The company generated $11.5 million in gross proceeds from a public offering completed in February 2019, with no additional financing transactions during the period ended June 30, 2019[99]. - The company has financed operations through approximately $79.0 million in equity and debt securities and $17.7 million in government research grants since inception[121]. - The company plans to raise additional capital primarily through the sale of equity securities, with the potential for private placements or public offerings, to support ongoing operations and clinical studies[124]. - Future working capital requirements will depend on the success of clinical trials and the ability to secure government grants and collaborations[126]. Operating Expenses - Research and development expenses rose to $4.3 million in Q2 2019 from $2.7 million in Q2 2018, a 57% increase, primarily due to ongoing ELEVATE Study costs and AV-101 nonclinical activities[103]. - General and administrative expenses increased to approximately $1.9 million in Q2 2019 from approximately $1.5 million in Q2 2018, reflecting a 30% increase[111]. - Stock-based compensation expense increased to $1.1 million in Q2 2019 from $612,000 in Q2 2018, reflecting an 80% increase due to new grants and vesting schedules[112]. - The company remains committed to managing routine operating costs, including employee headcount and regulatory consulting expenses, to support its strategic initiatives[126]. - The company has no off-balance sheet arrangements that could impact its financial position[130].