Summary of VistaGen Therapeutics Conference Call Company Overview - **VistaGen Therapeutics** is a late clinical-stage biopharmaceutical company focused on neurocircuitry-focused drugs known as **Pherines**. The company has five assets in its pipeline targeting various conditions including social anxiety disorder, major depressive disorder, vasomotor symptoms, psychomotor impairment, and cancer cachexia [6][7][8]. Core Points and Arguments - **Unique Drug Mechanism**: The drug candidates are characterized by rapid onset, non-systemic effects, and a differentiated profile compared to traditional neuropsych drugs. They do not exhibit abuse liability, sexual side effects, weight gain, or sedation [6][7]. - **Phase III Studies**: The company is conducting multiple Phase III studies, including **PALISADE-3**, with results expected by the end of the calendar year. A fourth study is anticipated to read out in the first half of 2026 [7][8]. - **Study Design**: PALISADE-3 is designed to measure acute treatment effects in social anxiety disorder through a public speaking challenge, utilizing the Subjective Units of Distress Scale (SUDS) to assess anxiety levels [8][10]. - **Regulatory Alignment**: The company has engaged with the FDA to ensure that the study designs and endpoints are appropriate for potential New Drug Application (NDA) submissions. The PALISADE-2 study is considered robust and adheres to the Statistical Analysis Plan (SAP) [20][30]. - **Impact of COVID-19**: Variability in results from PALISADE-1 and PALISADE-2 is attributed to the pandemic, particularly the use of masks during public speaking challenges [18][20]. Additional Important Content - **Patient Engagement**: The drug aims to improve patient engagement in daily activities, potentially leading to better health outcomes in areas such as heart health and diabetes management [55][56]. - **Open-Label Studies**: Previous open-label studies indicated positive outcomes, with patients showing improvement over time. The company has confidence in the drug's efficacy based on these results [26][50]. - **Safety and Redosing**: The company is exploring the safety of redosing in real-world scenarios, with a focus on ensuring that patients can use the drug as needed without adverse effects [27][30]. - **Digital Psychiatry**: The rise of telehealth and digital psychiatry is seen as a favorable environment for the drug, which offers a non-invasive treatment option for social anxiety [54][56]. Conclusion VistaGen Therapeutics is positioned to potentially offer a groundbreaking treatment for social anxiety disorder and other conditions through its innovative drug candidates. The upcoming Phase III results and ongoing regulatory discussions will be critical in determining the future of these therapies in the market [53][56].

Company Overview - Acrivon Therapeutics is a clinical-stage biotech company focused on precision oncology, utilizing its proprietary Generative Phosphoproteomics AP3 platform to identify which patients are most likely to benefit from specific therapies [2][4] - The company has advanced two drug candidates into human clinical trials, with ACR-368 being its lead program [1][8] Drug Candidates - ACR-368 is a selective CHK1/CHK2 inhibitor currently in a registrational-intent Phase 2b trial for recurrent, high-grade endometrial cancer, showing encouraging early clinical readouts, particularly in OncoSignature-positive patients [1][7] - ACR-2316 is a dual WEE1/PKMYT1 inhibitor undergoing a Phase 1 monotherapy dose-escalation study, with preclinical data indicating strong single-agent activity and an ongoing confirmed partial response in a patient with endometrial cancer [8][10] Regulatory Designations - ACR-368 has received FDA Fast Track designation as a monotherapy for ovarian and endometrial cancer, while its companion diagnostic, OncoSignature, has been granted Breakthrough Device status [7][10] Market Potential - ACR-2316's positive emerging profile could potentially add approximately $150 million in market capitalization, with analysts noting its best-in-class potential due to its dual-targeting approach [10][11] - Acrivon’s stock, currently trading at $1.99, has a price target of $13, indicating a potential upside of 553% [9][12] Analyst Sentiment - The broader analyst consensus for Acrivon is a Strong Buy, with 6 Buy ratings and an average price target of $11.75, suggesting a potential upside of 490% over the next year [12]

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]

Industry Overview - The biotech industry has reached a market size of $1.55 trillion in 2023 and is projected to grow to $3.88 trillion by 2030, highlighting significant investment opportunities [1]. Company Profile: Vistagen Therapeutics - Vistagen Therapeutics, founded in 1998, is a clinical-stage biopharmaceutical company focused on developing pherine nasal sprays and CNS therapeutics for mental health disorders such as anxiety and depression [3]. - The company has been recognized for its commitment to workplace mental health, receiving the Platinum Bell Seal for Workplace Mental Health from Mental Health America for two consecutive years [3]. Financial Performance - Vistagen Therapeutics is currently valued at $104.5 million, with its stock up 15.9% year-to-date and 14% over the past 52 weeks [4]. Recent Developments - Janus Henderson, a leading biotech-focused investment firm, has made a significant investment in Vistagen, acquiring 4.1 million shares for a 13.6% stake, along with an additional 3.6 million shares through its Biotech Innovation Master Fund, representing an 11.7% stake [5]. - This investment reflects Janus Henderson's confidence in Vistagen, particularly as the Biotech Innovation fund has achieved annualized returns of over 50% since its inception in 2020 [5]. Clinical Trials - Vistagen is preparing for the PALISADES-3 Phase 3 trial readout for its investigational nasal spray fasedienol, aimed at treating social anxiety disorder (SAD) [6][7]. - The PALISADES-3 trial is a randomized, double-blind, placebo-controlled study evaluating the efficacy, safety, and tolerability of fasedienol in relieving anxiety triggered by public speaking challenges in adults with SAD, with top-line data expected in Q4 2025 [7].

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]

Core Insights - VistaGen Therapeutics, Inc. reported a quarterly loss of $0.47 per share, matching the Zacks Consensus Estimate, compared to a loss of $0.35 per share a year ago [1] - The company generated revenues of $0.24 million for the quarter ended June 2025, missing the Zacks Consensus Estimate by 62.46%, but showing an increase from $0.08 million year-over-year [2] - The stock has underperformed the market, gaining about 0.7% year-to-date compared to the S&P 500's gain of 7.9% [3] Earnings Outlook - The current consensus EPS estimate for the upcoming quarter is -$0.51 on revenues of $0.49 million, and for the current fiscal year, it is -$1.66 on revenues of $1.77 million [7] - The estimate revisions trend for VistaGen Therapeutics was mixed ahead of the earnings release, resulting in a Zacks Rank 3 (Hold) for the stock, indicating expected performance in line with the market [6] Industry Context - The Medical - Biomedical and Genetics industry, to which VistaGen belongs, is currently in the top 41% of over 250 Zacks industries, suggesting a favorable outlook compared to the bottom 50% [8] - Empirical research indicates a strong correlation between near-term stock movements and trends in earnings estimate revisions, which can be tracked by investors [5]

Financial Data and Key Metrics Changes - Research and development expenses increased to $11.7 million for the quarter compared to $7.6 million for the same period last year, reflecting continued investment in the PALISADE program [10] - General and administrative expenses were $4.4 million, slightly down from $4.6 million in the same period last year, consistent with the company's growing organizational needs [10] - Net loss attributable to common stockholders for the quarter was $15.1 million, compared to $10.7 million in the same period last year [10] - As of June 30, 2025, the company had $63.2 million in cash, cash equivalents, and marketable securities [11] Business Line Data and Key Metrics Changes - The lead product candidate, Intranasal Facadeinol, is advancing through late Phase III development for the acute treatment of social anxiety disorder (SAD), with over 30 million adults affected in the US [5] - The company expects to report top-line data from the PALISADE III Phase III trial in Q4 of this year, which is a critical potential value inflection point [6] - The company is also advancing further Phase II development of Itruvone for major depressive disorder and PH80 for menopausal hot flashes, with an IND submission expected in Q4 [8] Market Data and Key Metrics Changes - The company is addressing significant unmet clinical needs in depression and women's health, which remain among the most underserved areas in medicine [8] - The PALISADE program is designed to meet the needs of patients with social anxiety disorder, a condition with currently suboptimal standards of care [5] Company Strategy and Development Direction - The company aims to redefine possibilities in neuroscience by delivering transformative therapies that harness nose-to-brain neurocircuitry [12] - The focus remains on advancing the neuroscience pipeline and preparing for potential commercialization of Facadeinol for SAD [9] - The company is optimistic about delivering long-term value to patients and stockholders with multiple near-term catalysts on the horizon [9] Management's Comments on Operating Environment and Future Outlook - Management expressed enthusiasm for the PALISADE program, reinforcing the significant unmet clinical need for innovation in treating social anxiety disorder [6] - The company is confident in its ability to execute efficiently on clinical trials and maintain rigorous adherence to protocols [42] - Management highlighted the importance of the open-label phase in capturing safety and efficacy data, which will inform future commercial forecasts [55] Other Important Information - The company welcomed Alissa Cote as the new Chief Corporate Development Officer, bringing extensive experience in strategic planning and corporate development [9] - The management emphasized the importance of patient engagement and the potential for transformative changes in patients' lives through their therapies [54] Q&A Session Summary Question: Plans for announcing study enrollment completion and dropout rates - Management confirmed they will announce enrollment completion and noted encouraging conversion rates from the randomized study into the open label, with over 80% of subjects moving into the open label [15][18] Question: Details on top-line data to be shared in Q4 - Management indicated that the press release will include primary and secondary endpoints similar to previous trials, including PGIC and LSAS scores [23][24] Question: Expected efficacy differences between genders - Management expects similar efficacy between male and female participants, as previous studies did not show statistically significant differences [25][26] Question: Enrollment status of PALISADE IV - Both PALISADE III and IV are currently enrolling, with no anticipated protocol adjustments needed at this stage [38][39] Question: Measurement in the open label phase - The primary focus is on safety, with additional measures including the Leibowitz Social Anxiety Scale (LSAS) to assess the severity of social anxiety over time [46][51] Question: Opinion on competing trials - Management acknowledged the existence of a competing trial but emphasized the unique advantages of Facadeinol's non-systemic delivery and rapid onset [48][49]

Clinical Development - The company is in the late clinical stage of developing a new class of non-systemic intranasal product candidates called pherines, with five clinical-stage candidates currently in its neuroscience pipeline[76]. - Fasedienol, the company's lead product candidate, is being investigated for the acute treatment of social anxiety disorder (SAD) and has received positive topline results from the PALISADE-2 Phase 3 trial[77]. - The ongoing PALISADE Program includes PALISADE-3 and PALISADE-4 Phase 3 trials, with topline data for PALISADE-3 expected in Q4 2025 and for PALISADE-4 in the first half of 2026[77]. - Fasedienol has been granted Fast Track designation by the FDA, positioning it to potentially be the first FDA-approved acute treatment for SAD[78]. - The PALISADE Program includes randomized, double-blind, placebo-controlled trials designed to evaluate the efficacy and safety of fasedienol during anxiety-provoking situations[85]. - The PALISADE-1 trial did not meet its primary endpoint, while PALISADE-2 successfully met its primary efficacy endpoint, indicating variability in trial outcomes[85]. - The PALISADE-2 Phase 3 trial of fasedienol for treating anxiety in adults with SAD showed a statistically significant mean change in SUDS scores of -5.8 (p=0.015) compared to placebo[86]. - 37.7% of fasedienol-treated patients were identified as responders on the CGI-I scale, compared to 21.4% for placebo (p=0.033)[86]. - The PALISADE-2 trial also reported that 40.6% of fasedienol-treated patients were responders on the PGI-C scale, versus 18.6% for placebo (p=0.003)[86]. - Fasedienol-treated patients showed a 35.7% improvement in SUDS scores, compared to 18.6% in the placebo group (p=0.020)[86]. - The company reported positive results from exploratory Phase 2A trials for itruvone and PH80, targeting major depressive disorder and vasomotor symptoms, respectively[79]. - Itruvone demonstrated a significant reduction in depressive symptoms as early as one week, with a p-value of 0.022 in a Phase 2A trial[96]. - Itruvone was well-tolerated with no serious adverse events reported in the Phase 1 trial[96]. - PH80 significantly reduced the mean daily number of hot flashes from 7.7 (baseline) to 2.8 after one week, compared to 6.4 for placebo (p<0.001)[102]. - After four weeks of PH80 treatment, the mean daily number of hot flashes dropped to 1.5, compared to 5.1 for placebo (p<0.001)[102]. - PH80 was well-tolerated with no serious adverse events, and all subjects completed the four-week treatment[103]. - PH80 demonstrated a statistically significant improvement in managing PMDD symptoms with a p-value of 0.015 for the Penn Daily Symptom Report and 0.016 for the Premenstrual Tension Scale[106][107]. - In a Phase 2A pilot study, PH15 showed a statistically significant improvement in reaction time compared to placebo and caffeine, with p-values less than 0.001[111][112]. - PH284 induced a 71% improvement in Subjective Feeling of Hunger scores prior to dinner on Day 7 compared to baseline, while placebo showed less than 1% improvement[117]. - AV-101 has received Fast Track designation from the FDA for the treatment of neuropathic pain and as an adjunctive treatment for major depressive disorder[121]. - PH15 and PH284 have demonstrated excellent safety profiles in clinical trials, with no serious adverse events reported[113][118]. - The company is evaluating the potential path forward for PH15 and PH284, including necessary programs to support U.S. IND applications for further clinical development[114][118]. Financial Performance - The company reported an accumulated deficit of approximately $422.7 million as of June 30, 2025, with a net loss of approximately $51.4 million for the fiscal year ended March 31, 2025[125]. - The net loss for the three months ended June 30, 2025, was approximately $15.1 million, indicating ongoing financial challenges[125]. - The company has not yet achieved revenue-generating status from any product candidates, impacting its ability to sustain operations[125]. - Total revenues for the three months ended June 30, 2025, were $0.244 million, an increase from $0.084 million in the same period of 2024, reflecting a growth of 190%[136]. - Research and development expenses rose to $11.678 million for the three months ended June 30, 2025, compared to $7.648 million in 2024, marking an increase of 53.0%[139]. - The increase in research and development expenses was primarily due to a $4.0 million rise related to the U.S. registration-directed PALISADE Program for fasedienol[139]. - General and administrative expenses decreased slightly to $4.370 million in Q2 2025 from $4.567 million in Q2 2024, a reduction of 4.3%[141]. - Net loss for the three months ended June 30, 2025, was $15.095 million, compared to a net loss of $10.733 million in the same period of 2024, representing an increase in loss of 40.5%[136]. - Cash and cash equivalents at the end of the period were approximately $48.985 million, down from $102.918 million at the end of June 2024[151]. - Net cash used in operating activities for the three months ended June 30, 2025, was $18.846 million, compared to $10.869 million in the same period of 2024, indicating a 73.5% increase in cash outflow[152]. - The company has financed operations primarily through equity securities, raising approximately $342.2 million since inception, along with $22.7 million from government research grants[144]. - As of June 30, 2025, the company had approximately $63.2 million in cash, cash equivalents, and marketable securities, raising concerns about its ability to continue as a going concern[147]. - The company plans to seek additional capital through equity and/or debt securities to fund operations and advance product candidates[148].

[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)