Table of Contents Title of each class Trading Symbol(s) Name of each exchange on which registered Common Stock, par value $0.001 per share VTGN Nasdaq Capital Market Large accelerated filer o Accelerated filer o Non-Accelerated filer x Smaller reporting company x Emerging growth company o 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 September ...

Vistagen (NASDAQ: VTGN ) is continuing on with phase 3 development of its nasal spray containing fasedienol for social anxiety disorder. I haven't looked at VTGN since April, when I considered the name a hold, as the Scientist and trader of biotech stock. Focus on trading around events such as trial results and NDA/BLA approvals. Also covering companies in industries regulated by the FDA. Articles present my opinion on stocks, but don't constitute investment advice. Analyst's Disclosure: I/we have no stock, ...

Core Viewpoint - VistaGen Therapeutics, Inc. (VTGN) has been upgraded to a Zacks Rank 2 (Buy) due to an upward trend in earnings estimates, which is a significant factor influencing stock prices [1][3]. Earnings Estimates and Stock Price Movement - The Zacks rating system is based on the consensus measure of EPS estimates from sell-side analysts, reflecting the company's changing earnings picture [1][2]. - Changes in future earnings potential, as indicated by earnings estimate revisions, are strongly correlated with near-term stock price movements, influenced by institutional investors [4]. Company Performance and Outlook - The upgrade for VistaGen Therapeutics signifies an improvement in the company's underlying business, which is expected to positively affect its stock price [5]. - Over the past three months, the Zacks Consensus Estimate for VistaGen Therapeutics has increased by 14.2%, indicating a positive trend in earnings estimates [8]. Zacks Rank System - The Zacks Rank system classifies stocks into five groups based on earnings estimates, with a strong historical performance, particularly for Zacks Rank 1 stocks, which have generated an average annual return of +25% since 1988 [7]. - VistaGen Therapeutics' upgrade to Zacks Rank 2 places it in the top 20% of Zacks-covered stocks, suggesting potential for market-beating returns in the near term [10].

VistaGen Therapeutics, Inc. (VTGN) could be a solid addition to your portfolio given its recent upgrade to a Zacks Rank #2 (Buy). This rating change essentially reflects an upward trend in earnings estimates -- one of the most powerful forces impacting stock prices. The sole determinant of the Zacks rating is a company's changing earnings picture. The Zacks Consensus Estimate -- the consensus of EPS estimates from the sell-side analysts covering the stock -- for the current and following years is tracked by ...

Financial Data and Key Metrics Changes - Research and development expenses increased to $7.6 million for Q1 FY2025 from $4.2 million in the same period last year, primarily due to clinical and development expenses related to PALISADE-3 and preparation for PALISADE-4 [14] - General and administrative expenses rose to $4.6 million from $3 million year-over-year, driven by increased headcount and professional service expenses [14] - Net loss attributable to common shareholders was $10.7 million for the quarter, compared to $6.9 million in the prior year [14] - As of June 30, 2024, the company had cash, cash equivalents, and marketable securities totaling $108.4 million [14] Business Line Data and Key Metrics Changes - The company is focused on three lead clinical development programs targeting social anxiety disorder, major depressive disorder, and menopausal hot flashes, with a unique non-systemic approach [5][6] - Fasedienol for social anxiety disorder is the primary focus, with ongoing Phase 3 trials (PALISADE-3 and PALISADE-4) aimed at establishing it as the first FDA-approved acute treatment for this condition [8][10] Market Data and Key Metrics Changes - The target market for social anxiety disorder affects approximately 12% of adults in the U.S., representing a significant and underserved population [8] - The company aims to address the unmet medical needs in large markets with current standards of care that are primarily oral medications associated with side effects [5][6] Company Strategy and Development Direction - The company is committed to advancing its lead programs in neurocircuitry-focused pherine drug candidates, with a focus on achieving FDA approval for Fasedienol [11][16] - Plans for further Phase II development of Itruvone for major depressive disorder and PH80 for menopausal hot flashes are underway, building on positive Phase IIa results [11][12] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the ongoing PALISADE Phase III program for Fasedienol, highlighting the growing prevalence of social anxiety disorder post-pandemic [16][17] - The company is optimistic about the potential for FDA approval and the impact of its products on patient lives [16][17] Other Important Information - The company has achieved Fast Track designation for Fasedienol, which is significant for its development pathway [25] - The PALISADE-2 trial results are expected to be published in a suitable journal, reflecting the historic nature of the findings [25] Q&A Session Summary Question: Types of patients enrolling for Phase III trials for Fasedienol - The enrolled patients are primarily those with a primary diagnosis of social anxiety disorder, with specific inclusion and exclusion criteria to ensure appropriate chronicity and severity [18][21] Question: Higher screen failure rates in PALISADE-3 compared to previous trials - Screen failure rates are consistent with projections, indicating that the study is progressing as expected [22][23] Question: Timeline for PALISADE-2 publication and breakthrough designation filing - The company is preparing a manuscript for publication and is optimistic about the potential for breakthrough designation beyond Fast Track [25] Question: Discussions with the FDA regarding self-administration versus HCP administration - The protocols have been submitted to the FDA, and the company does not anticipate any negative impact on dosing language in the label [28][29] Question: Gating steps to the MDD Phase IIb trial - The protocol for the Phase IIb trial is being finalized, with plans to submit to the FDA before the end of the year [31][36]

VistaGen Therapeutics, Inc. (VTGN) came out with a quarterly loss of $0.35 per share versus the Zacks Consensus Estimate of a loss of $0.41. This compares to loss of $0.94 per share a year ago. These figures are adjusted for non-recurring items. This quarterly report represents an earnings surprise of 14.63%. A quarter ago, it was expected that this company would post a loss of $0.34 per share when it actually produced a loss of $0.25, delivering a surprise of 26.47%. Over the last four quarters, the compan ...

Financial Performance - Net loss for the first quarter of FY2025 was $10.7 million, an increase from $6.9 million in the same period last year[8]. - Total revenues for June 2024 were $84 million, a decrease of 52.7% compared to $177 million in June 2023[17]. - The net loss for June 2024 was $10,733 million, compared to a net loss of $6,903 million in June 2023, reflecting a 55.5% increase in losses[17]. - Basic and diluted net loss per common share improved to $(0.35) in June 2024 from $(0.94) in June 2023[17]. - Total stockholders' equity decreased to $104,803 million as of June 30, 2024, down from $114,286 million[16]. - Total liabilities and stockholders' equity amounted to $113,548 million, a decrease from $123,653 million[16]. - Accumulated deficit increased to $(366,947) million as of June 30, 2024, compared to $(356,214) million[16]. Expenses - Research and development (R&D) expenses increased to $7.6 million for Q1 FY2025, up from $4.2 million in Q1 FY2024, primarily due to clinical trial costs for PALISADE-3 and PALISADE-4[7]. - General and administrative (G&A) expenses rose to $4.6 million in Q1 FY2025, compared to $3.0 million in Q1 FY2024, driven by increased headcount and professional service expenses[7]. - Research and development expenses increased to $7,648 million in June 2024, up 82.5% from $4,197 million in June 2023[17]. - General and administrative expenses rose to $4,567 million, a 53.3% increase from $2,978 million in the same period last year[17]. - Total operating expenses for June 2024 were $12,215 million, representing a 70.1% increase compared to $7,175 million in June 2023[17]. Clinical Trials and Development - PALISADE-3 Phase 3 trial for fasedienol is on track to produce top-line results in 2025, with PALISADE-4 trial preparations also progressing as planned[3]. - Itruvone is advancing towards a Phase 2B trial in the U.S. after successful IND-enabling programs, aiming to provide a novel treatment for major depressive disorder[5]. - PH80 is undergoing an IND-enabling program to support its Phase 2 clinical development for menopausal hot flashes, following positive Phase 2A trial results[6]. - Vistagen aims to establish substantial evidence for fasedienol's effectiveness through PALISADE-3 and PALISADE-4 trials, potentially leading to a New Drug Application submission[4]. - The company is focused on developing non-systemic treatments that avoid common side effects associated with current therapies for anxiety and depression[10]. - Vistagen's pipeline includes innovative nasal sprays designed to activate chemosensory neurons, with favorable safety profiles observed in clinical studies[12].

Clinical Development - The company is focused on developing fasedienol, a synthetic investigational neuroactive pherine nasal spray, for the acute treatment of social anxiety disorder (SAD) and is currently in Phase 3 clinical development[68]. - The PALISADE-2 Phase 3 trial of fasedienol met its primary efficacy endpoint, showing a statistically significant mean change from baseline in SUDS scores of -5.8 (p=0.015) compared to placebo[72]. - In the PALISADE-2 trial, 37.7% of fasedienol-treated patients were rated as responders on the CGI-I scale, compared to 21.4% for placebo (p=0.033)[72]. - The trial also demonstrated that 40.6% of fasedienol-treated patients were rated as responders on the PGI-C scale, compared to 18.6% for placebo (p=0.003)[72]. - Fasedienol was well-tolerated in the PALISADE-2 trial, with no serious adverse events reported and treatment-emergent adverse events comparable between fasedienol and placebo[72]. - The company plans to launch the PALISADE-3 Phase 3 trial in March 2024 and the PALISADE-4 trial in the second half of 2024, both designed to evaluate the efficacy and safety of fasedienol[73]. - The PALISADE Phase 3 Program includes open-label extension safety studies and a small Phase 2 repeat dose study planned for the second half of 2024[74]. - Fasedienol's proposed mechanism of action is fundamentally differentiated from currently approved anti-anxiety medications, as it does not require systemic absorption[69]. - The company emphasizes the potential of fasedienol to provide rapid-onset anxiolytic effects on an as-needed basis, reducing the risk of unwanted side effects associated with current oral medications[69]. - Fasedienol has received Fast Track designation from the FDA for the acute treatment of Seasonal Affective Disorder (SAD) and may support a New Drug Application (NDA) submission[75][82]. - In a Phase 2A clinical trial, Itruvone significantly reduced depressive symptoms as early as one week, with a p-value of 0.022, demonstrating its potential as a treatment for Major Depressive Disorder (MDD)[81]. - PH80 demonstrated a significant reduction in the daily number of hot flashes from 7.7 (baseline) to 2.8 after one week of treatment, compared to 6.4 in the placebo group (p<0.001)[85]. - In the same study, after four weeks of treatment, the number of hot flashes dropped to 1.5 for PH80 compared to 5.1 for placebo (p<0.001)[85]. - PH80 showed statistically significant improvement in symptoms of Premenstrual Dysphoric Disorder (PMDD) as early as Day 4 (p=0.008) and Day 6 (p=0.006) in a Phase 2A study[89]. - PH15 demonstrated a statistically significant improvement in reaction time compared to placebo and caffeine in sleep-deprived participants, with p-values less than 0.001[95]. - The FDA has granted Fast Track designation for Itruvone for the treatment of MDD, indicating its potential for expedited development[82]. Financial Performance - The company reported a net loss of approximately $10.7 million for the three months ended June 30, 2024, compared to a net loss of $6.9 million for the same period in 2023, reflecting an increase in operating expenses[106]. - Total revenues for the three months ended June 30, 2024, were $0.1 million, a decrease from $0.2 million in the same period in 2023[107]. - Research and development expenses increased to $7.6 million for the three months ended June 30, 2024, up from $4.2 million in the same period in 2023, primarily due to the initiation of the PALISADE-3 Phase 3 clinical trial[108]. - The company has an accumulated deficit of approximately $366.9 million as of June 30, 2024[104]. - The company had cash and cash equivalents of approximately $108.4 million at June 30, 2024, which is expected to fund operations for more than twelve months[114]. - General and administrative expenses rose to $4.6 million for the three months ended June 30, 2024, compared to $3.0 million for the same period in 2023, driven by increased headcount and consulting fees[110]. - The company has not generated any revenue from product sales since inception and has incurred significant operating losses[112]. - The company expects research and development expenses to increase substantially over the next several years as it advances its pipeline of product candidates[109]. - Interest income, net, increased to $1.4 million for the three months ended June 30, 2024, compared to $0.1 million in the same period in 2023, due to higher interest rates and larger cash balances[111]. - The company plans to seek additional financing to support its operations and product development, including equity-based capital and non-dilutive funding sources[116]. - Net cash used in operating activities for Q2 2024 was $10.9 million, compared to $7.9 million in Q2 2023, reflecting an increase of approximately 38%[118]. - Net cash used in investing activities for Q2 2024 was $5.5 million, while it was immaterial in Q2 2023[119]. - Net cash provided by financing activities in Q2 2024 was immaterial, compared to $0.9 million in Q2 2023[121]. - The net decrease in cash and cash equivalents for Q2 2024 was $16.2 million, compared to a decrease of $7.0 million in Q2 2023, indicating a significant increase in cash outflow[120]. - Cash and cash equivalents at the end of Q2 2024 were $102.9 million, down from $119.2 million at the beginning of the period[120]. - Cash and cash equivalents at the end of Q2 2023 were $9.6 million, showing a substantial increase year-over-year[120]. - The company reported a net loss of $10.7 million for Q2 2024, compared to a net loss of $6.9 million in Q2 2023, representing an increase in losses of approximately 55%[118]. - Non-cash charges in Q2 2024 included $1.3 million primarily related to stock-based compensation and amortization of operating lease right-of-use assets[118]. - There were no material changes in contractual obligations during the three months ended June 30, 2024[122]. - There were no material changes to critical accounting policies and estimates during the three months ended June 30, 2024[123]. Market Need - The company aims to address the unmet needs of patients with SAD, a disorder affecting approximately 12% of adults in the U.S.[64]. - Cachexia affects more than five million people in the U.S., with an estimated prevalence of 1% of the population, highlighting a significant unmet medical need[97].

Financial Data and Key Metrics Changes - The net loss attributed to common stockholders was $29.4 million for the year ended March 31, 2024, compared to $59.2 million for the year ended March 31, 2023, indicating a significant reduction in losses [8] - Research and development expenses decreased to $20 million for the year ended March 31, 2024, from $44.4 million for the year ended March 31, 2023, primarily due to timing of expenses related to Phase 3 trials [56] - General and administrative expenses slightly decreased to $14.1 million for the year ended March 31, 2024, from $14.7 million for the year ended March 31, 2023, mainly due to reduced professional fees and stock-based compensation [56] Business Line Data and Key Metrics Changes - The company is advancing its registration-directed PALISADE-Phase 3 program for fasedienol targeting the acute treatment of social anxiety disorder (SAD), with the PALISADE-3 trial recently launched and expected to provide top-line data by mid-2025 [42] - The company is also preparing for the PALISADE-4 trial, which is anticipated to be initiated in the second half of 2024 and completed by the end of calendar 2025 [42] Market Data and Key Metrics Changes - The market for social anxiety disorder is significant, with over 30 million adults in the U.S. affected, yet there are currently no FDA-approved acute treatments available [5][14] - The company is exploring the therapeutic potential of PH80, a nasal spray candidate for women's health, which has shown statistically significant results in managing menopausal hot flashes and premenstrual dysphoric disorder [12] Company Strategy and Development Direction - The company aims to develop and commercialize a diversified pipeline of neuroactive pherines for multiple high-prevalence CNS disorders, focusing on conditions with limited treatment options [5] - The strategic focus includes enhancing clinical trial designs and operational efficiencies to optimize patient enrollment and data quality in ongoing studies [11][64] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the execution of the PALISADE-3 and PALISADE-4 trials, highlighting a more favorable clinical research environment compared to the pandemic period [11][64] - The company anticipates that successful outcomes from the ongoing trials could support a potential U.S. new drug application for fasedienol for the acute treatment of SAD in the first half of 2026 [54] Other Important Information - Vistagen received the Platinum Bell Seal Award from Mental Health America and the Great Place to Work certification, reflecting its commitment to workplace practices that support mental health [7] - The company has entered into an exclusive negotiation agreement with Fuji Pharma for the potential development and commercialization of PH80 in Japan [55] Q&A Session Summary Question: How many sites are up and enrolling patients for PALISADE-3? - Management indicated that approximately 10 sites are currently up and running for PALISADE-3, with some overlap from previous studies [33][34] Question: What enhancements have been made to PALISADE-3 and PALISADE-4? - Enhancements include operational changes, improved surveillance, and rigorous protocol adherence to optimize patient enrollment and data quality [11][64] Question: What is the purpose of the repeat dose study? - The repeat dose study aims to evaluate the effects of a second dose of fasedienol administered shortly after the first, primarily to inform labeling and provide guidance for physicians [85]

[Corporate Highlights and Pipeline Update](index=1&type=section&id=Corporate%20Highlights%20and%20Pipeline%20Update) 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](index=3&type=chunk) - 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](index=3&type=chunk) [Fasedienol for the Acute Treatment of Social Anxiety Disorder (SAD)](index=1&type=section&id=Fasedienol%20for%20the%20Acute%20Treatment%20of%20Social%20Anxiety%20Disorder%20%28SAD%29) 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](index=7&type=chunk) - The **PALISADE-3 Phase 3 trial** was initiated in the fourth quarter of fiscal 2024[5](index=5&type=chunk) - The **PALISADE-4 Phase 3 trial** is anticipated to be launched in the second half of calendar 2024[5](index=5&type=chunk) [Itruvone for Major Depressive Disorder (MDD)](index=1&type=section&id=Itruvone%20for%20Major%20Depressive%20Disorder%20%28MDD%29) 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](index=6&type=chunk) - 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](index=8&type=chunk) [PH80 for Women's Health Indications](index=2&type=section&id=PH80%20for%20Women%27s%20Health%20Indications) 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](index=12&type=chunk) - Announced **positive data from an exploratory Phase 2A trial** where PH80 showed **statistically significant efficacy** versus placebo for treating Premenstrual Dysphoric Disorder (PMDD)[12](index=12&type=chunk) [Corporate Updates](index=2&type=section&id=Corporate%20Updates) 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](index=12&type=chunk) - 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](index=12&type=chunk) - 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](index=12&type=chunk) - Awarded **Mental Health America's Platinum Bell Seal** for workplace mental health[12](index=12&type=chunk) [Financial Results for Fiscal Year 2024](index=2&type=section&id=Financial%20Results%20for%20Fiscal%20Year%202024) 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](index=5&type=section&id=Consolidated%20Financial%20Statements) 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](index=5&type=section&id=Consolidated%20Balance%20Sheets) 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](index=6&type=section&id=Consolidated%20Statements%20of%20Operations%20and%20Comprehensive%20Loss) 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) |