Core Insights - Vistagen is a late clinical-stage biopharmaceutical company focused on developing intranasal product candidates known as pherines [1] - The company will present data on its investigational pherine nasal spray, PH80, at The Menopause Society 2025 Annual Meeting [1] - PH80 is characterized as a novel, non-systemic, and non-hormonal treatment option [1] Company Overview - Vistagen specializes in neuroscience and aims to pioneer new therapeutic approaches through nose-to-brain neurocircuitry [1] - The company is publicly traded on Nasdaq under the ticker VTGN [1] Upcoming Events - The presentation of PH80 data is scheduled for October 23, 2025, in Orlando, Florida [1]

Thanks to the shrill buzz around artificial intelligence, the unmatched potential of the biotech industry largely goes unnoticed. Yet, the opportunity is huge, with the market already reaching a mammath $1.55 trillion in 2023. Experts project it will further grow to $3.88 trillion by 2030. Within this huge and growing opportunity, the savviest investors are looking for rare biotech companies that specialize in treating mental health conditions. One such biotech gem is California-based Vistagen Therapeutic ...

Summary of VistaGen Therapeutics FY Conference Call Company Overview - **Company**: VistaGen Therapeutics (NasdaqCM: VTGN) - **Focus**: Late-stage clinical-stage biotechnology company specializing in neuroactive pherines for neuropsychiatric disorders Industry Insights - **Industry**: Neuropsychiatry and Epilepsy - **Market Potential**: Approximately 30 million adults in the U.S. affected by Social Anxiety Disorder (SAD), with only about 30% currently treated, indicating significant room for growth in diagnosis and treatment options [42][43] Key Product and Pipeline - **Lead Product**: Fasedienol - **Indication**: Acute treatment of Social Anxiety Disorder - **Mechanism of Action**: Modulates olfactory-limbic-amygdala circuits without systemic absorption, providing rapid onset of action within 25 milliseconds [2][5][6] - **Clinical Trials**: - Positive Phase III study results from PALISADE-2, with expectations for PALISADE-3 readout in Q4 2025 and PALISADE-4 in the first half of 2026 [23][49] - PALISADE-1 faced challenges due to pandemic-related disruptions, resulting in higher placebo rates [9][10] Clinical Trial Design and Results - **PALISADE Study Design**: Focused on public speaking challenges to provoke anxiety, using the Subjective Units of Distress Scale (SUDS) as a primary endpoint [8][17] - **Results**: - PALISADE-2 showed significant efficacy with a 13.8-point drop in SUDS for the treated group compared to an 8-point drop in the placebo group [25] - The Clinical Global Impression Improvement (CGII) showed a 1.8 times greater improvement in the treated group compared to placebo [19] Safety and Efficacy - **Safety Profile**: Remarkable safety with low prevalence of treatment-emergent adverse events (TEAEs), primarily headaches [37][34] - **Open-Label Extension**: Encouraging results from previous open-label studies indicate improved patient engagement and reduced anxiety over time [33] Commercial Strategy - **Market Approach**: Emphasis on digital psychiatry and telehealth, targeting a broad market including general practitioners and psychiatrists [44] - **Consumer-Driven**: Anticipated demand for a non-scheduled drug with minimal side effects, addressing the needs of patients who prefer rapid onset without sedation or abuse liability [22][43] Future Catalysts - **Upcoming IND**: Expected for PH80, a non-hormonal treatment for menopausal hot flashes, in Q4 2025 [49] - **Additional Products**: iTRUVON for major depressive disorder, focusing on non-systemic rapid onset without common side effects [49] Conclusion - VistaGen Therapeutics is positioned to address significant unmet needs in the treatment of neuropsychiatric disorders with its innovative pipeline, particularly fasedienol for SAD, while leveraging a strong commercial strategy to capture market opportunities.

Core Insights - Vistagen Therapeutics reported Q1 FY2026 earnings with EPS at $(0.47), matching consensus estimates, while revenue of $0.24 million exceeded expectations of $0.0 million [1][5] - The company experienced a significant increase in R&D spending to support ongoing phase 3 trials, resulting in a net loss of $15.1 million for the quarter, up from $10.7 million in the same period last year [2][5] Financial Performance - EPS (GAAP) for Q1 FY2026 was $(0.47), a decrease of 34.3% from $(0.35) in Q1 FY2025 [2] - Revenue (GAAP) reached $0.24 million, a 185.7% increase from $0.08 million in Q1 FY2025 [2] - R&D expenses rose to $11.7 million, a 53.9% increase from $7.6 million in the previous year [2] - General and Administrative expenses slightly decreased to $4.4 million, down 4.3% from $4.6 million [2] - Net loss for the quarter was $15.1 million, compared to $10.7 million in Q1 FY2025, reflecting a 41.1% increase [2] Company Overview - Vistagen Therapeutics focuses on developing treatments for neuropsychiatric conditions, including social anxiety disorder, major depressive disorder, and menopause-related symptoms, utilizing novel intranasal therapies [3][4] - The lead program, fasedienol, is currently in pivotal phase 3 trials for social anxiety disorder, with results expected in late 2025 and early 2026 [4][7] Key Developments - The company is advancing its clinical programs, particularly fasedienol, through the PALISADE-3 and PALISADE-4 trials, with increased costs attributed to expanded clinical activities and research personnel [6][9] - PH80, another product targeting menopausal symptoms, has shown positive phase 2A results, and itruvone for major depressive disorder is preparing for new phase 2 trials [7][8] - The company appointed a new Chief Corporate Development Officer to enhance future commercial and partnership strategies [9] Future Outlook - Management did not provide specific financial guidance for FY2026, emphasizing the importance of clinical trial outcomes, particularly for fasedienol [10] - Key milestones will include announcements regarding trial completions and topline data, which are critical for potential New Drug Application submissions [11]

VistaGen Therapeutics, Inc. (VTGN) came out with a quarterly loss of $0.47 per share in line with the Zacks Consensus Estimate. This compares to a loss of $0.35 per share a year ago. These figures are adjusted for non-recurring items. A quarter ago, it was expected that this company would post a loss of $0.52 per share when it actually produced a loss of $0.43, delivering a surprise of +17.31%.Over the last four quarters, the company has surpassed consensus EPS estimates two times.VistaGen Therapeutics, whi ...

VistaGen Therapeutics (VTGN) Q1 2026 Earnings Call August 07, 2025 05:00 PM ET Speaker0Good day everyone and thank you for standing by. Welcome to Vistagen Therapeutics Fiscal Year twenty twenty six First Quarter Corporate Update Conference Call and Webcast. Please note that today's call is being recorded. At this time, I'd like to turn the call over to your host, Mark McPartland, Senior Vice President, Investor Relations at Vistagen. Mark, please go ahead.Speaker1Thank you, Justin. Good afternoon, everyone ...

Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, DC 20549 Form 10-Q (Mark One) þ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended June 30, 2025 or o TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from __________ to __________. Commission File Number: 001-37761 VISTAGEN THERAPEUTICS, INC. (Exact name of registrant as specified in its charter) ...

[Executive Summary](index=1&type=section&id=Executive%20Summary) 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](index=1&type=chunk)[2](index=2&type=chunk) - The company continues to advance its diverse intranasal pherine pipeline across psychiatry, women's health, and cancer supportive care[1](index=1&type=chunk)[3](index=3&type=chunk) - 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](index=2&type=chunk)[9](index=9&type=chunk)[11](index=11&type=chunk) [Clinical-stage Neuroscience Product Candidates](index=1&type=section&id=Clinical-stage%20Neuroscience%20Product%20Candidates) 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](index=1&type=section&id=Lead%20Program%20Highlights) 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](index=1&type=section&id=Fasedienol%20for%20the%20Acute%20Treatment%20of%20Social%20Anxiety%20Disorder) 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](index=1&type=chunk)[2](index=2&type=chunk)[4](index=4&type=chunk) - 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](index=4&type=chunk) - There are currently no FDA-approved acute treatments for SAD, a condition affecting over **30 million** U.S. adults with increasing prevalence[2](index=2&type=chunk)[5](index=5&type=chunk) [PH80 for Menopausal Hot Flashes and Other Women's Health Indications](index=2&type=section&id=PH80%20for%20Menopausal%20Hot%20Flashes%20and%20Other%20Women's%20Health%20Indications) 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](index=13&type=chunk) - The company is preparing a U.S. IND submission to facilitate further Phase 2 clinical development of PH80 for the treatment of VMS[13](index=13&type=chunk) - Research indicates that approximately **60%-80%** of menopausal women in the U.S. experience VMS[13](index=13&type=chunk) [Itruvone for Major Depressive Disorder](index=2&type=section&id=Itruvone%20for%20Major%20Depressive%20Disorder) 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](index=13&type=chunk) - The company plans to advance itruvone into further Phase 2 development for MDD under its U.S. IND[13](index=13&type=chunk) - 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](index=13&type=chunk) [Corporate Updates](index=2&type=section&id=Corporate%20Updates) Vistagen announced a key management appointment in June 2025, strengthening its strategic and business development functions [Management Appointments](index=2&type=section&id=Management%20Appointments) 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](index=8&type=chunk) [Financial Results for Fiscal Year 2026 First Quarter Ended June 30, 2025](index=2&type=section&id=Financial%20Results%20for%20Fiscal%20Year%202026%20First%20Quarter%20Ended%20June%2030%2C%202025) 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](index=2&type=section&id=Summary%20of%20Financial%20Performance) 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](index=9&type=chunk)[11](index=11&type=chunk) - 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](index=9&type=chunk) 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](index=2&type=section&id=Research%20and%20development%20(R%26D)%20expense) 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](index=9&type=chunk) [General and administrative (G&A) expense](index=2&type=section&id=General%20and%20administrative%20(G%26A)%20expense) 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](index=2&type=section&id=Net%20loss) 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](index=2&type=section&id=Cash%2C%20cash%20equivalents%2C%20and%20marketable%20securities) 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](index=5&type=section&id=CONDENSED%20CONSOLIDATED%20BALANCE%20SHEETS) 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](index=6&type=section&id=CONDENSED%20CONSOLIDATED%20STATEMENTS%20OF%20OPERATIONS%20AND%20COMPREHENSIVE%20LOSS) 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](index=3&type=section&id=Company%20Information) This section provides details on Vistagen's pherine platform, company overview, investor relations, forward-looking statements, and contact information [About Pherines](index=3&type=section&id=About%20Pherines) 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](index=15&type=chunk) - 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](index=15&type=chunk)[16](index=16&type=chunk) - This mechanism of action is expected to make pherines a potentially safer alternative to other pharmacological options[16](index=16&type=chunk) [About Vistagen](index=3&type=section&id=About%20Vistagen) 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](index=16&type=chunk) - 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](index=17&type=chunk) [Conference Call and Webcast](index=3&type=section&id=Conference%20Call%20and%20Webcast) 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](index=14&type=chunk) - 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](index=14&type=chunk) [Forward-looking Statements](index=4&type=section&id=Forward-looking%20Statements) 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](index=18&type=chunk) - Risk factors include the completion of clinical trials, regulatory approvals, commercial success, reliance on third-party collaborators, and macroeconomic conditions[18](index=18&type=chunk) - Vistagen expressly disclaims any obligation to update any forward-looking statements, except as required by law[18](index=18&type=chunk) [Investor and Media Inquiries](index=4&type=section&id=Investor%20and%20Media%20Inquiries) 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](index=19&type=chunk) - Media Contact: Michelle P. Wellington (mwellington@vistagen.com)[19](index=19&type=chunk)

Financial Data and Key Metrics Changes - Research and development expenses increased to $39.4 million for the fiscal year ended March 31, 2025, compared to $20 million for the same period last year, primarily due to increases in research, clinical and nonclinical development, and contract manufacturing expenses [14] - General and administrative expenses rose to $17.1 million for the fiscal year ended March 31, 2025, compared to $14.1 million for the same period last year, mainly due to increased headcount and consulting fees [15] - The net loss attributable to common shareholders was $51.4 million for the fiscal year ended March 31, 2025, compared to $29.4 million for the same period last year [16] - As of March 31, 2025, the company had $80.5 million in cash, cash equivalents, and marketable securities [16] Business Line Data and Key Metrics Changes - The lead product candidate, Fascidinol, is in Phase III development for the acute treatment of social anxiety disorder (SAD), with ongoing trials expected to provide substantial evidence for a new drug application [8][9] - Itruvone, another product candidate, is being advanced for the standalone treatment of major depressive disorder (MDD), with promising results from a Phase 2a study [10] - PH-80, focused on women's health, is progressing towards additional Phase II clinical development, with an IND submission anticipated in the second half of the year [10] Market Data and Key Metrics Changes - The company is addressing a significant unmet need in the treatment of social anxiety disorder, which affects over 31 million adults in the U.S. [8] - The evolving regulatory landscape is seen as encouraging, with the FDA focusing on improving communication and guidance for drug development [12][13] Company Strategy and Development Direction - The company aims to deliver transformative treatment options for patients while building shareholder value through its innovative neuroscience pipeline [7] - The focus remains on advancing clinical-stage product candidates that utilize non-systemic intranasal delivery mechanisms, which are differentiated from existing treatments [6][17] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about the potential of their clinical-stage product candidates and the upcoming data readouts, particularly from the PALISADE III trial [13] - The company is committed to rigorous operational execution and believes that the enhancements made to the PALISADE trials will improve outcomes [26][27] Other Important Information - The company participated in the FDA's CEO Listening Tour, which aimed to foster a more collaborative regulatory environment [12][13] - Management highlighted the importance of maintaining a strong review team at the FDA, with no changes reported in their review team [23] Q&A Session Summary Question: Changes with FDA leadership and impact on the review process - Management noted that there were no changes in their review team and that the FDA is hiring additional reviewers with domain expertise [22][23] Question: Timing for PALISADE IV and patient demand - Management explained that the modest delay in PALISADE IV was due to stringent subject eligibility requirements and improvements made to study execution [26][27] Question: Enrollment completion and data reporting timeline for PALISADE III - Management confirmed that they would announce enrollment completion once subjects completed their safety follow-up, with top-line data expected six to eight weeks thereafter [30] Question: Variability in placebo response in PALISADE studies - Management indicated that they designed PALISADE III and IV to replicate the success of PALISADE II while limiting variability through enhanced controls [32] Question: Screening and eligibility criteria for PALISADE studies - Management clarified that the slowdown in patient enrollment was primarily due to rigorous screening processes to ensure appropriate subject selection [44]

Financial Data and Key Metrics Changes - Research and development expenses increased to $39.4 million for the fiscal year ended March 31, 2025, compared to $20 million for the same period last year, primarily due to increases in research, clinical and nonclinical development, and contract manufacturing expenses [14] - General and administrative expenses rose to $17.1 million for the fiscal year ended March 31, 2025, compared to $14.1 million for the same period last year, mainly due to increased headcount and consulting fees [15] - The net loss attributable to common shareholders was $51.4 million for the fiscal year ended March 31, 2025, compared to $29.4 million for the same period last year [16] - As of March 31, 2025, the company had $80.5 million in cash, cash equivalents, and marketable securities [16] Business Line Data and Key Metrics Changes - The lead product candidate, Fascidinol, is in Phase III development for the acute treatment of social anxiety disorder (SAD), with ongoing trials expected to provide substantial evidence for a new drug application [7][9] - Itruvone, another product candidate, is being developed for major depressive disorder (MDD) and has shown promising results in a Phase 2a study [10] - PH-80, focused on women's health, is advancing towards additional Phase II clinical development, with an IND submission anticipated in the second half of the year [10] Market Data and Key Metrics Changes - The company is targeting a large market for social anxiety disorder, with over 31 million adults in the U.S. affected by this condition [7] - The regulatory landscape is evolving positively, with the FDA showing interest in expediting approvals for innovative treatments addressing unmet medical needs [12][13] Company Strategy and Development Direction - The company aims to deliver transformative treatment options for patients while building shareholder value through its innovative pipeline of non-systemic intranasal product candidates [6][17] - The focus remains on advancing clinical trials and preparing for regulatory submissions to support the development of its product candidates [10][11] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about the potential of its clinical stage product candidates and the positive regulatory environment, emphasizing the importance of effective communication with the FDA [12][13] - The company is committed to rigorous operational execution in its clinical trials to ensure successful outcomes [9][27] Other Important Information - The company participated in the FDA's CEO Listening Tour, which aimed to improve communication and guidance between the FDA and industry leaders [12] - Management highlighted the importance of innovative mechanisms of action in addressing public health needs, particularly in the context of social anxiety disorder [44] Q&A Session Summary Question: Changes with FDA leadership and impact on interactions - Management noted that there have been no changes in their review team and expressed hope for improved communication with the FDA [22][23] Question: Timing for PALISADE IV - The modest delay in PALISADE IV was attributed to stringent subject eligibility requirements and enhancements made to improve study execution [26][27] Question: Enrollment completion for PALISADE III - Management confirmed that they would announce enrollment completion once the last patients complete their safety follow-up, with top-line data expected six to eight weeks thereafter [30] Question: Variability in placebo arm results - Management indicated that efforts have been made to limit variability in PALISADE III and IV, aiming to replicate the success seen in PALISADE II [31][32] Question: Screening and eligibility criteria - The slowdown in recruitment was primarily due to rigorous screening and eligibility criteria, ensuring that only suitable candidates are enrolled [46][47]