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) |

Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 Form 10-K x Annual Report Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 For the fiscal year ended: March 31, 2024 or o Transition Report Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 Commission file number: 001-37761 Vistagen Therapeutics, Inc. (Exact name of registrant as specified in its charter) Nevada 20-5093315 (State or other jurisdiction of incorporation or organ ...

Vistagen Therapeutics, Inc. (NASDAQ:VTGN) Q3 2024 Earnings Conference Call February 13, 2024 5:00 PM ET Company Participants Mark McPartland - Senior Vice President, Investor Relations Shawn Singh - Chief Executive Officer Cindy Anderson - Chief Financial Officer Josh Prince - Chief Operating Officer Conference Call Participants Andrew Tsai - Jefferies Tim Lugo - William Blair Operator Greetings and welcome to Vistagen Therapeutics' Fiscal Year 2024 Third Quarter Financial Results and Corporate Update. At t ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, DC 20549 Form 10-Q (Mark One) ☑ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended December 31, 2023 or ☐ 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) (Address of principal executive of ...

Vistagen Therapeutics, Inc. (NASDAQ:VTGN) Q2 2024 Earnings Conference Call November 9, 2023 5:00 PM ET Company Participants Mark McPartland - Senior Vice President, Investor Relations Shawn Singh - Chief Executive Officer Cindy Anderson - Chief Financial Officer Josh Prince - Chief Operating Officer Conference Call Participants Andrew Tsai - Jefferies Tim Lugo - William Blair Operator Good day, everyone and welcome to today's Vistagen Fiscal Year 2024 Second Quarter Corporate Update Conference Call. [Operat ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, DC 20549 Form 10-Q (Mark One) ☑ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended September 30, 2023 or ☐ 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) Nevada 20-5093315 (I.R.S. Employer ...

Vistagen Therapeutics, Inc. (NASDAQ:VTGN) Q1 2024 Earnings Conference Call August 10, 2023 4:30 PM ET Company Participants Mark Flather - VP of IR Shawn Singh - CEO Josh Prince - SVP of Business Operations Conference Call Participants Andrew Tsai - Jefferies Joanne Lee - Maxim Group Operator Greetings, and welcome to the Vistagen Therapeutics Fiscal Year 2024 First Quarter Corporate Update Conference Call. [Operator Instructions] And as a reminder, this conference is being recorded, Thursday, August 10, 202 ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, DC 20549 Form 10-Q (Mark One) ☑ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended June 30, 2023 or ☐ 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) (State or other jurisdiction of incorpo ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 Form 10-K ☒ Annual Report Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 For the fiscal year ended: March 31, 2023 or ☐ Transition Report Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 Commission file number: 001-37761 Vistagen Therapeutics, Inc. (Exact name of registrant as specified in its charter) (State or other jurisdiction of incorporation or organization) Nevada 20-5093315 (I.R.S. E ...