VistaGen Therapeutics(VTGN) - 2024 Q4 - Annual Results

Corporate Highlights and Pipeline Update Vistagen achieved significant FY2024 pipeline progress, highlighted by positive Phase 3 fasedienol results for SAD and advancements in MDD and women's health - Vistagen's primary focus is the execution of its registration-directed PALISADE Phase 3 program for fasedienol in social anxiety disorder, alongside advancing its other pherine development programs for depression and menopausal hot flashes[3] - The company achieved a significant milestone by reporting the first-ever positive Phase 3 trial results (PALISADE-2) for an acute treatment of social anxiety disorder[3] Fasedienol for the Acute Treatment of Social Anxiety Disorder (SAD) Vistagen achieved positive PALISADE-2 Phase 3 results for fasedienol in SAD, initiating PALISADE-3 and planning PALISADE-4 for NDA support - Announced positive top-line results from the PALISADE-2 Phase 3 trial, marking the first positive Phase 3 trial for a drug candidate for the acute treatment of SAD[7] - The PALISADE-3 Phase 3 trial was initiated in the fourth quarter of fiscal 2024[5] - The PALISADE-4 Phase 3 trial is anticipated to be launched in the second half of calendar 2024[5] Itruvone for Major Depressive Disorder (MDD) Vistagen completed a U.S. Phase 1 trial for itruvone, enabling Phase 2B MDD development, with preclinical data supporting its non-systemic action - Successfully completed a U.S. Phase 1 trial, with preparations underway for U.S. Phase 2B development of itruvone as a stand-alone treatment for MDD[6] - Preclinical data for itruvone showed it was essentially undetectable in the brain and blood, supporting its unique proposed mechanism of action involving peripheral chemosensory neurons in the nasal cavity without systemic exposure[8] PH80 for Women's Health Indications Vistagen's PH80 showed positive Phase 2A results for menopausal hot flashes and PMDD, advancing to IND-enabling studies - Announced positive data from an exploratory Phase 2A trial where PH80 demonstrated statistically significant efficacy versus placebo for treating vasomotor symptoms (hot flashes) due to menopause[12] - Announced positive data from an exploratory Phase 2A trial where PH80 showed statistically significant efficacy versus placebo for treating Premenstrual Dysphoric Disorder (PMDD)[12] Corporate Updates In FY2024, Vistagen received a Platinum Bell Seal, appointed a new CFO, secured a PH80 negotiation agreement, and completed a public offering - Appointed Cindy Anderson as Chief Financial Officer in the second quarter of fiscal 2024[12] - Entered into an Exclusive Negotiation Agreement with Fuji Pharma Co., Ltd. for the potential development and commercialization of PH80 in Japan for menopausal hot flashes[12] - Closed an underwritten public offering in the third quarter of fiscal 2024, providing cash runway to execute on its PALISADE Phase 3 program and other pipeline developments[12] - Awarded Mental Health America's Platinum Bell Seal for workplace mental health[12] Financial Results for Fiscal Year 2024 Vistagen significantly reduced its FY2024 net loss to $29.4 million, driven by lower R&D expenses, ending with $119.2 million cash | Financial Metric | FY 2024 | FY 2023 | Change | | :--- | :--- | :--- | :--- | | Research & Development (R&D) Expenses | $20.0 million | $44.4 million | -55.0% | | General & Administrative (G&A) Expenses | $14.1 million | $14.7 million | -4.1% | | Net Loss | $29.4 million | $59.2 million | -50.3% | | Cash and cash equivalents (at period end) | $119.2 million | $16.6 million | +618.1% | Consolidated Financial Statements The consolidated financial statements for FY2024 show increased cash and total assets, alongside a reduced net loss compared to the prior fiscal year Consolidated Balance Sheets As of March 31, 2024, Vistagen's total assets increased to $123.7 million, driven by cash, with stockholders' equity rising to $114.3 million | Balance Sheet (in thousands) | March 31, 2024 | March 31, 2023 | | :--- | :--- | :--- | | Assets | | | | Cash and cash equivalents | $119,166 | $16,638 | | Total current assets | $120,672 | $17,507 | | Total assets | $123,653 | $21,089 | | Liabilities & Equity | | | | Total current liabilities | $5,123 | $4,574 | | Total liabilities | $9,367 | $9,009 | | Total stockholders' equity | $114,286 | $12,080 | | Total liabilities and stockholders' equity | $123,653 | $21,089 | Consolidated Statements of Operations and Comprehensive Loss For FY2024, Vistagen reported a net loss of $29.4 million or ($1.52) per share, a significant improvement from FY2023, due to reduced R&D expenses | Statement of Operations (in thousands) | Year Ended March 31, 2024 | Year Ended March 31, 2023 | | :--- | :--- | :--- | | Total revenues | $1,064 | $(227) | | Research and development | $20,022 | $44,377 | | General and administrative | $14,063 | $14,664 | | Loss from operations | $(33,021) | $(59,268) | | Net loss and comprehensive loss | $(29,362) | $(59,248) | | Basic and diluted net loss per common share | $(1.52) | $(8.51) |