VistaGen Therapeutics(VTGN) - 2026 Q1 - Quarterly Results

Executive Summary Vistagen announced Q1 FY2026 financial results and company updates, with key fasedienol Phase 3 trial results expected in Q4 2025 and H1 2026 - Vistagen announced Q1 FY2026 financial results and company updates, with top-line results for fasedienol's PALISADE-3 and PALISADE-4 Phase 3 trials for social anxiety disorder anticipated in Q4 2025 and H1 2026, respectively[1][2] - The company continues to advance its diverse intranasal pherine pipeline across psychiatry, women's health, and cancer supportive care[1][3] - Research and development expenses increased, and net loss expanded this quarter, yet the company remains optimistic about fasedienol's potential and its pherine platform[2][9][11] Clinical-stage Neuroscience Product Candidates Vistagen is advancing a diverse pipeline of clinical-stage neuroscience product candidates, including fasedienol, PH80, and itruvone, targeting various psychiatric and women's health conditions Lead Program Highlights Vistagen's lead program, fasedienol for social anxiety disorder, is nearing key milestones with Phase 3 trial data anticipated in Q4 2025 and H1 2026, potentially supporting an FDA NDA submission Fasedienol for the Acute Treatment of Social Anxiety Disorder Vistagen's fasedienol, an acute treatment for social anxiety disorder, has upcoming Phase 3 trial readouts in Q4 2025 and H1 2026, which could support an NDA submission - Vistagen's lead clinical development program, fasedienol for the acute treatment of social anxiety disorder (SAD), expects top-line data from the PALISADE-3 Phase 3 trial in Q4 2025 and from the PALISADE-4 Phase 3 trial in H1 2026[1][2][4] - Successful results from PALISADE-3 or PALISADE-4, combined with positive results from PALISADE-2, could provide substantial evidence for submitting a New Drug Application (NDA) to the U.S. FDA for fasedienol for the acute treatment of SAD in adults[4] - There are currently no FDA-approved acute treatments for SAD, a condition affecting over 30 million U.S. adults with increasing prevalence[2][5] PH80 for Menopausal Hot Flashes and Other Women's Health Indications Following positive exploratory Phase 2A results for PH80 in women's health, Vistagen is preparing an IND submission to advance its Phase 2 clinical development for menopausal vasomotor symptoms - Vistagen achieved positive results in an exploratory Phase 2A study of PH80 for women's health conditions, including menopausal vasomotor symptoms (VMS), or hot flashes[13] - The company is preparing a U.S. IND submission to facilitate further Phase 2 clinical development of PH80 for the treatment of VMS[13] - Research indicates that approximately 60%-80% of menopausal women in the U.S. experience VMS[13] Itruvone for Major Depressive Disorder Vistagen plans to advance itruvone into Phase 2 development for Major Depressive Disorder under its US IND, following positive exploratory Phase 2A study results - Vistagen achieved positive results in an exploratory Phase 2A study of itruvone for Major Depressive Disorder (MDD)[13] - The company plans to advance itruvone into further Phase 2 development for MDD under its U.S. IND[13] - MDD is a leading cause of disability globally, affecting over 250 million people worldwide, with approximately 21 million U.S. adults (about 8.4% of the total adult population) experiencing at least one major depressive episode in 2020[13] Corporate Updates Vistagen announced a key management appointment in June 2025, strengthening its strategic and business development functions Management Appointments In June 2025, Vistagen appointed Elissa Cote as Chief Corporate Development Officer to oversee strategic, commercial, and business development functions - In June 2025, Vistagen announced the appointment of Elissa Cote as Chief Corporate Development Officer, responsible for overseeing strategic, commercial, and business development functions[8] Financial Results for Fiscal Year 2026 First Quarter Ended June 30, 2025 Vistagen reported increased R&D expenses and net loss for Q1 FY2026, primarily due to higher investment in the fasedienol PALISADE program Summary of Financial Performance Vistagen's Q1 FY2026 saw increased R&D expenses and net loss, driven by fasedienol program investments, with cash and equivalents decreasing to $63.2 million - For Q1 FY2026 (ended June 30, 2025), both research and development expenses and net loss increased[9][11] - The increase in R&D expenses was primarily due to higher research and development, contract manufacturing, and personnel costs related to the fasedienol PALISADE program for social anxiety disorder[9] 2026 Fiscal Year First Quarter Key Financial Data (Ended June 30, 2025) | Metric | June 30, 2025 (Q1 FY2026) | June 30, 2024 (Q1 FY2025) | Change (YoY) | | :--- | :--- | :--- | :--- | | R&D Expense | $11.7 million | $7.6 million | Increase $4.1 million | | G&A Expense | $4.4 million | $4.6 million | Decrease $0.2 million | | Net Loss | $(15.1) million | $(10.7) million | Increase $(4.4) million | | Basic and Diluted Net Loss Per Share | $(0.47) | $(0.35) | Increase $(0.12) | Research and development (R&D) expense R&D expenses for Q1 FY2026 increased by 53.9% to $11.7 million, primarily due to higher costs associated with the fasedienol PALISADE program Research and Development Expense Comparison | Metric | June 30, 2025 (Q1 FY2026) | June 30, 2024 (Q1 FY2025) | Change Amount | Change Rate (YoY) | | :--- | :--- | :--- | :--- | :--- | | R&D Expense | $11.7 million | $7.6 million | Increase $4.1 million | 53.9% | - The increase in R&D expenses was primarily attributable to higher research and development, contract manufacturing, and personnel costs associated with the U.S. registration-directed PALISADE program for fasedienol in social anxiety disorder[9] General and administrative (G&A) expense G&A expenses for Q1 FY2026 slightly decreased by 4.3% to $4.4 million compared to the prior year's quarter General and Administrative Expense Comparison | Metric | June 30, 2025 (Q1 FY2026) | June 30, 2024 (Q1 FY2025) | Change Amount | Change Rate (YoY) | | :--- | :--- | :--- | :--- | :--- | | G&A Expense | $4.4 million | $4.6 million | Decrease $0.2 million | -4.3% | Net loss Net loss for Q1 FY2026 expanded by 41.1% to $15.1 million, resulting in a basic and diluted net loss per share of $(0.47) Net Loss and Earnings Per Share Comparison | Metric | June 30, 2025 (Q1 FY2026) | June 30, 2024 (Q1 FY2025) | Change Amount | Change Rate (YoY) | | :--- | :--- | :--- | :--- | :--- | | Net Loss | $(15.1) million | $(10.7) million | Increase $(4.4) million | 41.1% | | Basic and Diluted Net Loss Per Share | $(0.47) | $(0.35) | Increase $(0.12) | 34.3% | Cash, cash equivalents, and marketable securities As of June 30, 2025, Vistagen held $63.2 million in cash, cash equivalents, and marketable securities, a decrease from the previous quarter Cash, Cash Equivalents, and Marketable Securities | Metric | June 30, 2025 (USD) | March 31, 2025 (USD) | Change Amount (USD) | Change Rate (QoQ) | | :--- | :--- | :--- | :--- | :--- | | Cash and Cash Equivalents | $48,985 thousand | $67,131 thousand | Decrease $18,146 thousand | -27.0% | | Marketable Securities | $14,195 thousand | $13,351 thousand | Increase $844 thousand | 6.3% | | Total | $63,180 thousand | $80,482 thousand | Decrease $17,302 thousand | -21.5% | CONDENSED CONSOLIDATED BALANCE SHEETS As of June 30, 2025, total assets decreased to $68.92 million, with total liabilities at $12.16 million and total stockholders' equity at $56.77 million Condensed Consolidated Balance Sheets Summary (in thousands of USD) | Metric | June 30, 2025 (Unaudited) | March 31, 2025 | Change (QoQ) | | :--- | :--- | :--- | :--- | | Assets | | | | | Total Current Assets | $66,716 | $82,076 | Decrease $15,360 | | Total Assets | $68,924 | $84,341 | Decrease $15,417 | | Liabilities and Stockholders' Equity | | | | | Total Current Liabilities | $11,155 | $12,612 | Decrease $1,457 | | Total Liabilities | $12,159 | $13,951 | Decrease $1,792 | | Total Stockholders' Equity | $56,765 | $70,390 | Decrease $13,625 | CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS For Q1 FY2026, total revenue was $0.24 million, primarily from sublicense and other income, resulting in an operating loss of $15.80 million and a net loss of $15.10 million Condensed Consolidated Statements of Operations and Comprehensive Loss Summary (in thousands of USD) | Metric | June 30, 2025 (Q1 FY2026) | June 30, 2024 (Q1 FY2025) | Change (YoY) | | :--- | :--- | :--- | :--- | | Sublicense and Other Revenue | $244 | $84 | Increase $160 | | Total Revenue | $244 | $84 | Increase $160 | | Total Operating Expenses | $16,048 | $12,215 | Increase $3,833 | | Operating Loss | $(15,804) | $(12,131) | Increase $(3,673) | | Net Interest Income | $711 | $1,398 | Decrease $687 | | Net Loss | $(15,095) | $(10,733) | Increase $(4,362) | | Comprehensive Loss | $(15,099) | $(10,731) | Increase $(4,368) | | Basic and Diluted Net Loss Per Share | $(0.47) | $(0.35) | Increase $(0.12) | | Weighted Average Common Shares Outstanding | 31,930,665 | 30,603,435 | Increase 1,327,230 | Company Information This section provides details on Vistagen's pherine platform, company overview, investor relations, forward-looking statements, and contact information About Pherines Vistagen's pherine products utilize a novel mechanism of action, activating nasal-brain neural circuits without systemic absorption, offering a potentially safer therapeutic option - Vistagen's neuroscience pipeline includes five clinical-stage intranasal pherine product candidates, each with a novel mechanism of action[15] - Pherines activate peripheral receptors in human nasal chemosensory neurons, rapidly engaging nasal-brain neural circuits to modulate brain regions for therapeutic benefits without systemic absorption or entering the brain[15][16] - This mechanism of action is expected to make pherines a potentially safer alternative to other pharmacological options[16] About Vistagen Vistagen is a late clinical-stage biopharmaceutical company focused on developing novel intranasal pherine products for unmet medical needs in psychiatric and women's health conditions - Vistagen is a late clinical-stage biopharmaceutical company based in South San Francisco, leveraging a deep understanding of nasal-brain neural circuits to develop and commercialize novel intranasal pherine products[16] - The company is dedicated to developing transformative treatments to improve the lives of patients with unmet medical needs, including social anxiety disorder, major depressive disorder, and various women's health conditions[17] Conference Call and Webcast Vistagen will host a conference call and webcast on August 7, 2025, at 5:00 PM ET to provide company updates, with an archived recording available - Vistagen will host a conference call and webcast on August 7, 2025, at 5:00 PM ET to provide company updates[14] - The webcast link can be found under "Events" in the Investors section of Vistagen's website and will be archived for at least 90 days[14] Forward-looking Statements This press release contains forward-looking statements subject to known and unknown risks and uncertainties, and the company disclaims any obligation to update them - This press release contains forward-looking statements involving known and unknown risks and uncertainties, where actual results or developments may differ materially from those projected or implied[18] - Risk factors include the completion of clinical trials, regulatory approvals, commercial success, reliance on third-party collaborators, and macroeconomic conditions[18] - Vistagen expressly disclaims any obligation to update any forward-looking statements, except as required by law[18] Investor and Media Inquiries This section provides contact information for investor and media inquiries, including specific email addresses for relevant personnel - Investor Contact: Mark A. McPartland (markmcp@vistagen.com)[19] - Media Contact: Michelle P. Wellington (mwellington@vistagen.com)[19]