A VISIONARY APPROACH TO MENTAL HEALTH CARE | --- | --- | |-------|-------| | | | | | | COMPANY HIGHLIGHTS • Three innovative CNS drug candidates advancing in clinical development • Unique mechanisms of action • Therapeutic potential in multiple anxiety, depression and neurology markets • Lead candidate in NDA-enabling Phase 3 development for acute treatment of anxiety in adults with Social Anxiety Disorder • FDA Fast Track Designation in Social Anxiety Disorder, Major Depressive Disorder and Neuropathic Pai ...

Financial Data and Key Metrics Changes - The company recognized $1.1 million in sublicense revenue for the fiscal year ended March 31, 2021, compared to no revenue in the previous year [50] - Research and development expenses decreased from $13.4 million to $12.5 million, primarily due to the completion of a Phase 2 study of AV-101 [51] - General and administrative expenses decreased to approximately $6.5 million from approximately $7.4 million, mainly due to the absence of non-cash warrant modification expense [52] - The net loss for the fiscal year ended March 31, 2021, was approximately $17.9 million, an improvement from a net loss of $20.8 million in the previous year [53] - As of March 31, 2021, the company had cash and cash equivalents of approximately $103.1 million [53] Business Line Data and Key Metrics Changes - The company entered a strategic collaboration for the clinical development and commercialization of PH94B in Greater China, South Korea, and Southeast Asia, receiving a non-dilutive upfront payment of $5 million [11][12] - The ongoing PALISADE Phase 3 program for PH94B is designed to demonstrate its potential as a fast-acting treatment for anxiety in adults with social anxiety disorder [26][28] Market Data and Key Metrics Changes - The prevalence of social anxiety disorder (SAD) affects over 23 million Americans, with a mean duration of the illness of about 20 years [27] - The company aims to commercialize PH94B in the U.S. and enter additional commercial collaborations in ex-U.S. markets if the PALISADE Phase 3 program is successful [13] Company Strategy and Development Direction - The company is focused on developing medicines that improve mental health, particularly for anxiety and depression disorders exacerbated by the COVID-19 pandemic [7][9] - The company plans to initiate multiple Phase 2a studies involving PH94B and a Phase 2b study of PH10 in major depressive disorder [17][41] - The addition of experienced personnel in CNS drug development is aimed at driving programs through important clinical and regulatory milestones [18][19] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the potential of the CNS pipeline to make meaningful changes in the lives of those impacted by mental illness [9][20] - The company is committed to advancing its clinical development programs and believes its current cash position is sufficient to support these efforts [15][49] Other Important Information - The company completed a $100 million capital raise, strengthening its balance sheet and institutional shareholder base [14] - PH94B has been granted Fast Track designation status by the FDA for the treatment of SAD [28] Q&A Session Summary Question: Will the adjustment disorder and procedural anxiety exploratory studies start by year-end? - Yes, the company expects to initiate both studies by the end of the year, with readouts anticipated in 2022 [62] Question: What is the expected patient population for PALISADE-1 and PALISADE-2? - The PALISADE-2 study will start before the readout of PALISADE-1, and the patient population will be excluded from those who have failed on two FDA-approved medicines for SAD [68][70] Question: Can you discuss the long-term safety study for PH94B? - The long-term safety study is expected to launch before the end of 2021, with an open-label treatment period following the use of PH94B [77] Question: What are the potential risks to the study regarding placebo response? - Historically, the placebo response for social anxiety disorder is lower than for generalized anxiety disorder, which bodes well for the company's studies [86][88] Question: Will PH94B be considered a scheduled drug? - Currently, there is no basis for PH94B to be scheduled, and the company will continue to track this closely [96][99] Question: How does the company plan to educate the market about PH94B? - The company plans to conduct extensive market education regarding the neurobiology and differentiation of PH94B from existing treatments [104]

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, 2021 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 ...

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, 2020 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 inc ...

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, 2020 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 in ...

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, 2020 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. (State or other jurisdiction of incorporation or organization) Nevada 20-5093315 (I.R.S. Emplo ...

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, 2020 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) 343 Allerton Avenue South S ...

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, 2019 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 Nevada 20-5093315 (I.R.S. Employer Identification No.) 343 Allerton Avenue South San Francisco, CA 94080 (Address of p ...

PART I. FINANCIAL INFORMATION [Item 1. Condensed Consolidated Financial Statements (Unaudited)](index=4&type=section&id=Item%201.%20Condensed%20Consolidated%20Financial%20Statements%20(Unaudited)) Presents unaudited financial statements, including balance sheets, operations, cash flows, and notes, highlighting going concern uncertainty [Condensed Consolidated Balance Sheets](index=4&type=section&id=Condensed%20Consolidated%20Balance%20Sheets) Condensed Consolidated Balance Sheets (as of September 30, 2019 vs. March 31, 2019) | Metric | September 30, 2019 (Unaudited) (USD) | March 31, 2019 (USD) | | :--- | :--- | :--- | | **Assets** | | | | Cash and cash equivalents | $4,072,400 | $13,100,300 | | Total current assets | $4,676,900 | $13,651,200 | | Total assets | $8,735,500 | $14,011,700 | | **Liabilities & Equity** | | | | Total current liabilities | $4,117,300 | $2,800,900 | | Total liabilities | $12,365,900 | $6,936,500 | | Total stockholders' (deficit) equity | $(3,630,400) | $7,075,200 | [Condensed Consolidated Statements of Operations and Comprehensive Loss](index=6&type=section&id=Condensed%20Consolidated%20Statements%20of%20Operations%20and%20Comprehensive%20Loss) Operating Results Summary | Metric | Three Months Ended Sep 30, 2019 (USD) | Three Months Ended Sep 30, 2018 (USD) | Six Months Ended Sep 30, 2019 (USD) | Six Months Ended Sep 30, 2018 (USD) | | :--- | :--- | :--- | :--- | :--- | | Research and development | $4,205,200 | $5,261,100 | $8,519,100 | $8,004,800 | | General and administrative | $1,146,100 | $2,171,000 | $3,056,200 | $3,637,300 | | Loss from operations | $(5,351,300) | $(7,432,100) | $(11,575,300) | $(11,642,100) | | Net loss | $(5,335,900) | $(7,435,000) | $(11,545,800) | $(11,649,500) | | Net loss attributable to common stockholders | $(5,649,700) | $(7,718,600) | $(12,162,100) | $(12,206,600) | | Basic and diluted net loss per common share | $(0.13) | $(0.30) | $(0.29) | $(0.50) | [Condensed Consolidated Statements of Cash Flows](index=7&type=section&id=Condensed%20Consolidated%20Statements%20of%20Cash%20Flows) Cash Flow Summary (Six Months Ended September 30) | Metric | 2019 (USD) | 2018 (USD) | | :--- | :--- | :--- | | Net cash used in operating activities | $(8,898,200) | $(7,063,100) | | Net cash used in investing activities | $0 | $(169,800) | | Net cash (used in) provided by financing activities | $(129,700) | $4,686,200 | | **Net decrease in cash and cash equivalents** | **$(9,027,900)** | **$(2,546,700)** | | Cash and cash equivalents at end of period | $4,072,400 | $7,831,600 | [Notes to Condensed Consolidated Financial Statements](index=10&type=section&id=Notes%20to%20Condensed%20Consolidated%20Financial%20Statements) Detailed notes support financial statements, covering CNS product pipeline, going concern uncertainty, accounting policies, and subsequent private placement - The company is a clinical-stage biopharmaceutical firm focused on CNS diseases, with a portfolio including **AV-101** for Major Depressive Disorder (MDD), **PH10** for MDD, and **PH94B** for Social Anxiety Disorder (SAD)[22](index=22&type=chunk)[23](index=23&type=chunk)[25](index=25&type=chunk) - The company's financial statements have been prepared on a **going concern** basis, but recurring losses, negative cash flows, and a cash balance of **approximately $4.1 million** at September 30, 2019, raise **substantial doubt** about its ability to fund operations for the next twelve months without additional financing[32](index=32&type=chunk)[34](index=34&type=chunk) - On April 1, 2019, the company adopted the new lease accounting standard (**ASC 842**), resulting in the recognition of **approximately $4.3 million** in total lease liabilities and **approximately $3.9 million** in right-of-use assets on the balance sheet[57](index=57&type=chunk) - Subsequent to the quarter's end, between **October 30 and November 6, 2019**, the company completed a private placement, selling **600,000 units** for **$1.00** each, raising aggregate cash proceeds of **$600,000**[79](index=79&type=chunk) [Management's Discussion and Analysis of Financial Condition and Results of Operations](index=26&type=section&id=Item%202.%20Management's%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) Management analyzes financial performance, detailing operating expense changes driven by clinical trials and reiterating liquidity challenges and going concern doubts [Results of Operations](index=29&type=section&id=Results%20of%20Operations) Net loss decreased for three months due to a 2018 non-cash expense, while six-month net loss was stable, with R&D and G&A changes detailed Comparison of Operating Expenses (Three Months Ended Sep 30) | Expense Category | 2019 (USD) | 2018 (USD) | Change (USD) | Reason for Change | | :--- | :--- | :--- | :--- | :--- | | Research & Development | $4.2M | $5.3M | $(1.1M) | Decrease primarily due to a $2.25M non-cash expense in 2018 for PH94B/PH10 license acquisition, partially offset by increased 2019 costs for the ELEVATE Study. | | General & Administrative | $1.1M | $2.2M | $(1.1M) | Decrease due to lower stock-based compensation and absence of bonus payments made in 2018. | Comparison of Operating Expenses (Six Months Ended Sep 30) | Expense Category | 2019 (USD) | 2018 (USD) | Change (USD) | Reason for Change | | :--- | :--- | :--- | :--- | :--- | | Research & Development | $8.5M | $8.0M | $0.5M | Increase driven by higher costs for the ELEVATE Study and PH94B/PH10 development, offsetting the non-recurring $2.25M license acquisition cost from 2018. | | General & Administrative | $3.1M | $3.6M | $(0.5M) | Decrease due to lower stock-based compensation and non-recurring 2018 bonus payments. | [Liquidity and Capital Resources](index=39&type=section&id=Liquidity%20and%20Capital%20Resources) Cash of **$4.1 million** is insufficient for future operations, raising substantial doubt about going concern, necessitating additional capital - Cash and cash equivalents decreased to **$4.1 million** at September 30, 2019, from **$13.1 million** at March 31, 2019[146](index=146&type=chunk)[150](index=150&type=chunk) - The company explicitly states that its current cash position is **not sufficient** to fund planned operations for the next twelve months, which raises **substantial doubt** about its ability to continue as a **going concern**[146](index=146&type=chunk)[149](index=149&type=chunk) - Future capital requirements depend on many factors, including the costs of pivotal **Phase 3 trials** for **PH94B** and **AV-101**, and **Phase 2b trials** for **PH10**[148](index=148&type=chunk)[250](index=250&type=chunk) [Controls and Procedures](index=41&type=section&id=Item%204.%20Controls%20and%20Procedures) Management concluded disclosure controls were effective but identified two material weaknesses in internal control over financial reporting - Management concluded that disclosure controls and procedures were **effective** as of the end of the period[155](index=155&type=chunk) - The company identified **two ongoing material weaknesses** in internal control over financial reporting: **lack of segregation of duties** and **inadequate accounting software functionality**[156](index=156&type=chunk) PART II. OTHER INFORMATION [Legal Proceedings](index=42&type=section&id=Item%201.%20Legal%20Proceedings) The company reports no legal proceedings during the period - The company had **no legal proceedings** to report[158](index=158&type=chunk) [Risk Factors](index=42&type=section&id=Item%201A.%20Risk%20Factors) Extensive risks include dependence on clinical-stage candidates, regulatory uncertainty, third-party reliance, significant losses, and need for additional financing [Risks Related to Product Development, Regulatory Approval and Commercialization](index=42&type=section&id=Risks%20Related%20to%20Product%20Development%2C%20Regulatory%20Approval%20and%20Commercialization) Success hinges on clinical-stage candidates, facing uncertain regulatory approval, reliance on third-party manufacturing and trials, and market acceptance challenges - The business depends heavily on the successful development, regulatory approval, and commercialization of its three clinical-stage candidates: **AV-101**, **PH94B**, and **PH10**[160](index=160&type=chunk) - The company relies **completely on third-party Contract Manufacturing Organizations (CMOs)** for the manufacturing of its product candidates and has **no internal manufacturing capabilities**[182](index=182&type=chunk) - The company relies on **third parties** such as **Contract Research Organizations (CROs)** to conduct its clinical trials, leading to **less direct control** over timing and execution[177](index=177&type=chunk)[178](index=178&type=chunk) [Risks Related to Our Financial Position](index=62&type=section&id=Risks%20Related%20to%20Our%20Financial%20Position) History of significant net losses, need for substantial additional financing, going concern doubts, and material weaknesses in internal controls are key risks - The company has incurred **significant net losses** since inception, with an **accumulated deficit of approximately $192.7 million** as of September 30, 2019, and may **never achieve profitability**[244](index=244&type=chunk) - The company requires **additional financing** to continue as a **going concern**, as its auditors have indicated that continuing losses and negative cash flows raise **substantial doubt** about this ability[248](index=248&type=chunk) - **Material weaknesses** in internal control over financial reporting have been identified related to **segregation of duties** and **accounting software**, which could harm the business and stock price if not addressed[256](index=256&type=chunk) [Risks Related to Our Intellectual Property Rights](index=71&type=section&id=Risks%20Related%20to%20Our%20Intellectual%20Property%20Rights) Success depends on obtaining and maintaining patent protection, with risks of invalidation or loss of licensed IP rights for key product candidates - The company's success depends on its ability to obtain and maintain **patent and other proprietary protection** for its technology and product candidates[276](index=276&type=chunk)[277](index=277&type=chunk) - The company is dependent on **licensed intellectual property** for **PH10**, **PH94B**, and certain stem cell technologies. Breaching these license agreements could result in the **loss of rights** to develop and commercialize these candidates[317](index=317&type=chunk)[318](index=318&type=chunk) [Unregistered Sales of Equity Securities and Use of Proceeds](index=85&type=section&id=Item%202.%20Unregistered%20Sales%20of%20Equity%20Securities%20and%20Use%20of%20Proceeds) A post-quarter private placement raised **$600,000** by selling **600,000 units** of common stock and warrants for general corporate purposes Fall 2019 Private Placement Details | Metric | Detail | | :--- | :--- | | Date | October 30 - November 6, 2019 | | Securities Sold | 600,000 units (1 common share + 0.5 warrant per unit) | | Price Per Unit | $1.00 | | Warrants Issued | 300,000 | | Warrant Exercise Price | $2.00 per share | | Gross Proceeds | $600,000 | | Use of Proceeds | General corporate purposes | [Defaults Upon Senior Securities](index=85&type=section&id=Item%203.%20Defaults%20Upon%20Senior%20Securities) The company reports no defaults upon senior securities during the period - The company had **no defaults** upon senior securities to report[354](index=354&type=chunk) [Exhibits](index=85&type=section&id=Item%206.%20Exhibits) Exhibits filed with Form 10-Q include private placement agreements and officer certifications - Exhibits filed include forms for the **Fall 2019 Private Placement**, **officer certifications (302 and 906)**, and **XBRL instance documents**[355](index=355&type=chunk)

Financial Performance - The company reported a net loss of approximately $6.2 million for the quarter ended June 30, 2019, compared to a net loss of $4.2 million for the same quarter in 2018, with an accumulated deficit of approximately $187.3 million[90]. - Total operating expenses increased to $6.2 million for the quarter ended June 30, 2019, compared to $4.2 million for the same period in 2018, representing a 48% increase[101]. - The company reported a net loss of $6.2 million for the quarter ended June 30, 2019, compared to a net loss of $4.2 million for the same period in 2018, indicating a 47% increase in net loss[101]. - The company had no revenue for the quarters ended June 30, 2019, and 2018, with no recurring revenue-generating arrangements currently in place[102]. - Interest income for the quarter ended June 30, 2019, was $19,000, compared to no interest income in the same quarter of 2018, marking a significant improvement[119]. - Cash and cash equivalents at June 30, 2019, were approximately $8.3 million[122]. - The company recognized a cumulative dividend of $302,500 on Series B Preferred Stock for Q2 2019, compared to $273,500 for Q2 2018, a 10.6% increase[120]. - As of June 30, 2019, the company reported cash and cash equivalents of $8.297 million, down from $13.1 million at the beginning of the period, reflecting a net decrease of $4.803 million[128]. - Net cash used in operating activities for the three months ended June 30, 2019, was $4.761 million, compared to $3.135 million for the same period in 2018, indicating an increase in operational cash outflows[128]. - The increase in cash used in operations is attributed to the ELEVATE Study and increased employee compensation and investor relations initiatives[129]. - The company has substantial doubt about its ability to continue as a going concern without additional financing, which may impact its business and financial condition[127]. Clinical Development - The company is advancing the Phase 2 clinical development of AV-101 for major depressive disorder (MDD) and anticipates top-line results from the ELEVATE Study in the second half of the calendar year[84]. - PH94B, a neuroactive nasal spray, has shown significant efficacy in reducing social anxiety disorder (SAD) symptoms in a Phase 2 clinical trial, positioning it as a potential first FDA-approved on-demand treatment for SAD[83]. - The company is preparing for Phase 2b clinical development of PH10, another neuroactive nasal spray for MDD, following positive results from a small exploratory Phase 2a study[86]. - The Baylor Study, a collaboration with Baylor College of Medicine, is ongoing to evaluate the potential anti-suicidal effects of AV-101 in U.S. Military Veterans[85]. Research and Development - The company continues to pursue a broad portfolio of patent protection for AV-101, covering multiple CNS indications and unit dose formulations[93]. - The company has secured exclusive licenses for the patent assets related to PH94B and PH10, with patents issued in multiple countries including the U.S., Australia, and Europe[95][96]. - The company is exploring research and development collaborations that could provide non-dilutive funding for product candidates such as AV-101, PH94B, and PH10[125]. Capital and Financing - The company generated $11.5 million in gross proceeds from a public offering completed in February 2019, with no additional financing transactions during the period ended June 30, 2019[99]. - The company has financed operations through approximately $79.0 million in equity and debt securities and $17.7 million in government research grants since inception[121]. - The company plans to raise additional capital primarily through the sale of equity securities, with the potential for private placements or public offerings, to support ongoing operations and clinical studies[124]. - Future working capital requirements will depend on the success of clinical trials and the ability to secure government grants and collaborations[126]. Operating Expenses - Research and development expenses rose to $4.3 million in Q2 2019 from $2.7 million in Q2 2018, a 57% increase, primarily due to ongoing ELEVATE Study costs and AV-101 nonclinical activities[103]. - General and administrative expenses increased to approximately $1.9 million in Q2 2019 from approximately $1.5 million in Q2 2018, reflecting a 30% increase[111]. - Stock-based compensation expense increased to $1.1 million in Q2 2019 from $612,000 in Q2 2018, reflecting an 80% increase due to new grants and vesting schedules[112]. - The company remains committed to managing routine operating costs, including employee headcount and regulatory consulting expenses, to support its strategic initiatives[126]. - The company has no off-balance sheet arrangements that could impact its financial position[130].