VistaGen Therapeutics(VTGN) - 2022 Q1 - Quarterly Report

PART I. FINANCIAL INFORMATION This section presents unaudited financial statements and management's analysis for the quarter ended June 30, 2021 Item 1. Condensed Consolidated Financial Statements (Unaudited) This section presents the unaudited condensed consolidated financial statements, including balance sheets, statements of operations and comprehensive loss, statements of cash flows, and statements of changes in stockholders' equity, along with accompanying notes. It provides a snapshot of the company's financial position and performance for the quarter ended June 30, 2021, and comparative periods Condensed Consolidated Balance Sheets This statement provides a snapshot of the company's assets, liabilities, and equity at specific points in time | Metric | June 30, 2021 ($) | March 31, 2021 ($) | | :-------------------------------- | :------------ | :------------- | | Cash and cash equivalents | $97,776,900 | $103,108,300 | | Total assets | $103,907,200 | $108,281,300 | | Total liabilities | $18,290,400 | $16,302,800 | | Accumulated deficit | $(227,586,200)| $(219,841,600) | | Total stockholders' equity | $85,616,800 | $91,978,500 | - Cash and cash equivalents decreased by approximately $5.3 million from March 31, 2021, to June 30, 2021[10] - Total liabilities increased by approximately $2.0 million from March 31, 2021, to June 30, 2021[10] Condensed Consolidated Statements of Operations and Comprehensive Loss This statement details the company's revenues, expenses, and net loss over specific reporting periods | Metric | Three Months Ended June 30, 2021 ($) | Three Months Ended June 30, 2020 ($) | | :------------------------------------ | :------------------------------- | :------------------------------- | | Sublicense revenue | $354,100 | $- | | Research and development expenses | $5,603,600 | $1,731,200 | | General and administrative expenses | $2,496,700 | $1,390,600 | | Net loss | $(7,744,500) | $(3,126,800) | | Net loss attributable to common stockholders | $(8,106,300) | $(3,462,600) | | Basic and diluted net loss per common share | $(0.04) | $(0.07) | - Sublicense revenue increased from $0 in Q2 2020 to $354,100 in Q2 2021[13] - Research and development expenses increased by approximately $3.87 million (223%) year-over-year[13] Condensed Consolidated Statements of Cash Flows This statement reports the cash generated and used by operating, investing, and financing activities | Metric | Three Months Ended June 30, 2021 ($) | Three Months Ended June 30, 2020 ($) | | :------------------------------------ | :------------------------------- | :------------------------------- | | Net cash used in operating activities | $(6,172,900) | $(2,806,700) | | Net cash used in investing activities | $(149,900) | $- | | Net cash provided by financing activities | $991,400 | $2,997,500 | | Net increase (decrease) in cash and cash equivalents | $(5,331,400) | $190,800 | | Cash and cash equivalents at end of period | $97,776,900 | $1,545,900 | - Net cash used in operating activities increased by approximately $3.37 million (120%) year-over-year[18] - Net cash provided by financing activities decreased by approximately $2.01 million (67%) year-over-year[18] Condensed Consolidated Statement of Changes in Stockholders' Equity (Deficit) This statement details changes in equity components, including common stock, additional paid-in capital, and accumulated deficit | Metric | March 31, 2021 ($) | June 30, 2021 ($) | | :------------------------------------ | :------------- | :------------ | | Common Stock Shares Issued | 180,751,234 | 191,632,008 | | Common Stock Amount | $180,800 | $191,600 | | Additional Paid-in Capital | $315,603,100 | $316,975,600 | | Accumulated Deficit | $(219,841,700) | $(227,586,200)| | Total Stockholders' Equity | $91,978,400 | $85,616,800 | - Total stockholders' equity decreased by approximately $6.36 million from March 31, 2021, to June 30, 2021[24] - The conversion of Series D Preferred stock into common stock resulted in an increase of 9,249,427 common shares[23] Notes to the Condensed Consolidated Financial Statements This section provides detailed explanations and disclosures for the condensed consolidated financial statements, covering business description, accounting policies, specific balance sheet and income statement items, capital stock activities, related party transactions, commitments, contingencies, and subsequent events Note 1. Description of Business This note outlines the company's core business, therapeutic focus, and key clinical-stage product candidates - VistaGen Therapeutics, Inc. is a biopharmaceutical company focused on developing new medicines for anxiety, depression, and other central nervous system (CNS) disorders[26] - The company's CNS pipeline includes three clinical-stage product candidates: PH94B Nasal Spray (anxiety disorders), PH10 Nasal Spray (depression disorders), and AV-101 (neurological indications)[26] - PH94B Nasal Spray has initiated its Phase 3 development program (PALISADE Phase 3 Program) for the acute treatment of anxiety in adults with social anxiety disorder (SAD) and has been granted Fast Track designation by the FDA[26][27] Note 2. Basis of Presentation This note describes the financial statement preparation basis, including going concern considerations and funding sources - The company has an accumulated deficit of approximately $227.6 million from inception through June 30, 2021, and expects continued losses[34] - Operations have been financed primarily through equity and debt securities ($199.0 million) and government research grant awards, collaboration payments, and licensing ($22.7 million)[35] - Net proceeds from the December 2020 Public Offering were approximately $93.6 million, and an additional $1.1 million was received from warrant exercises during Q2 2021[36][37][40] Note 3. Summary of Significant Accounting Policies This note details the key accounting principles and methods applied in preparing the financial statements - Revenue is generated from collaborative research and development arrangements, licensing, and government grants, with the AffaMed Agreement being a primary source[49] - The AffaMed Agreement is treated as a single combined performance obligation, with revenue recognized on a straight-line basis over the expected service period (estimated to complete by end of calendar 2023)[52][58][119] | Metric | Three Months Ended June 30, 2021 ($) | Three Months Ended June 30, 2020 ($) | | :------------------------------------ | :------------------------------- | :------------------------------- | | Sublicense revenue recognized | $354,100 | $0 | | Total stock-based compensation expense | $590,400 | $674,600 | Note 4. Receivable from Collaboration Partner This note explains the nature and amounts of receivables from collaboration partners | Metric | June 30, 2021 ($) | March 31, 2021 ($) | | :------------------------------------ | :------------ | :------------- | | Receivable from collaboration partner | $44,000 | $40,600 | - These amounts reflect payments made to a contract manufacturing organization on behalf of a collaboration partner, which are subsequently reimbursed[87] Note 5. Prepaid Expenses and Other Current Assets This note details the composition and changes in prepaid expenses and other current assets | Metric | June 30, 2021 ($) | March 31, 2021 ($) | | :------------------------------------ | :------------ | :------------- | | Prepaid expenses and other current assets | $1,871,400 | $835,100 | | Clinical and nonclinical materials and contract services | $1,332,800 | $686,900 | | Insurance | $503,000 | $121,800 | - Total prepaid expenses and other current assets increased by over 124% from March 31, 2021, to June 30, 2021, primarily driven by clinical and nonclinical materials and insurance[88] Note 6. Property and Equipment This note provides information on the company's property and equipment, including changes and additions | Metric | June 30, 2021 ($) | March 31, 2021 ($) | | :------------------------------------ | :------------ | :------------- | | Property and equipment, net | $482,800 | $367,400 | | Construction in progress | $146,700 | $- | - Net property and equipment increased by approximately $115,400 from March 31, 2021, to June 30, 2021[89] - Construction in progress of $146,700 at June 30, 2021, relates to laboratory analytical equipment for PH94B drug product development[91] Note 7. Accrued Expenses This note details the components and changes in accrued expenses | Metric | June 30, 2021 ($) | March 31, 2021 ($) | | :------------------------------------ | :------------ | :------------- | | Accrued expenses | $2,150,000 | $1,562,700 | | Accrued compensation | $750,000 | $- | - Total accrued expenses increased by approximately $587,300 from March 31, 2021, to June 30, 2021, with a new accrual for compensation of $750,000[92] Note 8. Capital Stock This note describes changes in the company's capital stock, including equity offerings and conversions - The Lincoln Park Capital Fund (LPC) Agreement was terminated in June 2021, resulting in a $232,100 noncash expense for deferred offering costs[93] - All 402,149 outstanding shares of Series D Preferred Stock were converted into 9,249,427 shares of common stock in April 2021[94] - An At-The-Market (ATM) offering program was established in May 2021 with Jefferies LLC to sell up to $75.0 million of common stock[95] | Activity | Three Months Ended June 30, 2021 ($) | | :------------------------------------ | :------------------------------- | | Cash proceeds from warrant exercises | $1,109,700 | | Cash proceeds from stock option exercises | $12,900 | | Proceeds from ESPP purchases | $31,600 | Note 9. Related Party Transactions This note discloses transactions with related parties and their financial impact - In Q2 2020, the company engaged a consulting firm led by a then-independent Board member for market research, incurring $15,000 in R&D expense[104] - The Board member ceased to be independent in May 2021 upon accepting a position as Chief Commercial Officer[104] Note 10. Commitments and Contingencies This note outlines the company's contractual commitments and potential contingent liabilities - The company leases its headquarters office and laboratory space in South San Francisco, California, with the lease expiring on July 31, 2022, and an option to renew for an additional five years[106] | Metric | As of June 30, 2021 ($) | As of March 31, 2021 ($) | | :------------------------------------ | :------------------ | :------------------- | | Right of use asset – operating lease | $3,125,300 | $3,219,600 | | Total operating lease liability | $3,631,100 | $3,715,600 | | Operating lease cost (Q2) | $235,700 | $212,800 | - The assumed remaining lease term is 6.08 years with an assumed discount rate of 8.54% as of June 30, 2021[107] Note 11. Sublicensing and Collaborative Agreements This note details the terms and financial implications of sublicensing and collaborative agreements - The company entered into the AffaMed Agreement in June 2020, granting an exclusive license to develop and commercialize PH94B in Greater China, South Korea, and Southeast Asia[110] - Under the AffaMed Agreement, the company received a non-refundable upfront license payment of $5.0 million in August 2020 and is eligible for up to $172.0 million in milestone payments and royalties on net sales[115] - Sublicense revenue of $354,100 was recognized in Q2 2021 under the AffaMed Agreement, with $3,556,400 allocated to the remaining performance obligation at June 30, 2021[119] Note 12. Subsequent Events This note discloses significant events that occurred after the reporting period but before the financial statements were issued - From July 1, 2021, through the report date, warrant holders exercised warrants to purchase 1,330,931 common shares, generating approximately $923,000 in cash proceeds[121] - Options to purchase 400,000 common shares were granted to newly-hired employees and two newly-appointed independent directors from July 1, 2021, through the report date[122] Item 2. Management's Discussion and Analysis of Financial Condition and Results of Operations This section provides management's perspective on the company's financial condition, results of operations, and liquidity for the three months ended June 30, 2021, compared to the prior year. It highlights key financial trends, operational developments, and future outlook, including discussions on revenue, expenses, cash flows, and capital resources Cautionary Note Regarding Forward-Looking Statements This note advises readers that the report contains forward-looking statements subject to various risks and uncertainties - The report contains forward-looking statements subject to significant risks, including financing, R&D results, regulatory effects, competition, and product development difficulties[123] - Future events and trends may differ materially from expectations due to the competitive and rapidly changing environment and unforeseen risks[124] - The company is under no duty to update any forward-looking statements after the report date[125] Business Overview This section provides an overview of the company's biopharmaceutical focus and its clinical-stage product pipeline - VistaGen is a biopharmaceutical company developing medicines for anxiety, depression, and other CNS disorders, with three clinical-stage product candidates: PH94B, PH10, and AV-101[126] - The PH94B Phase 3 development program (PALISADE Phase 3 Program) has been initiated for social anxiety disorder (SAD), and PH10 is preparing for Phase 2B clinical development for major depressive disorder (MDD)[126][127][128] - AV-101 is preparing for Phase 1B clinical development in combination with probenecid for neurological indications involving the NMDA receptor[126][129] Financial Operations Overview and Results of Operations This section provides an executive summary of the company's financial performance, highlighting the net loss, key operational advancements in its CNS pipeline, and the impact of recent financing activities. It also details the company's strategic focus on managing costs while accelerating clinical development Summary This summary highlights the company's net loss, accumulated deficit, and ongoing investment in its clinical pipeline - The company reported a net loss of approximately $7.7 million for the three months ended June 30, 2021, compared to $3.1 million for the same period in 2020, with an accumulated deficit of approximately $227.6 million[132] - Substantial resources have been devoted to research, development, and contract manufacturing of PH94B, PH10, and AV-101, including the initiation of the PALISADE Phase 3 Program for PH94B[132] - The company expects losses to continue for the foreseeable future due to ongoing research, development, and commercialization activities[132] Summary of the Three Months Ended June 30, 2021 This summary outlines key operational and financial developments during the quarter, including clinical trial progress and financing activities - A strong cash position, primarily from the December 2020 public offering ($93.6 million net proceeds), has enabled the acceleration of the CNS pipeline, including the PALISADE Phase 3 Program for PH94B[132] - PALISADE-1, a Phase 3 clinical trial for PH94B in SAD, commenced in May 2021, with topline results anticipated in mid-2022[134] - The company expanded its employee infrastructure and Board of Directors, and entered into an At-The-Market (ATM) offering program for up to $75.0 million of common stock[135][137] Results of Operations This section provides a detailed comparison of the company's financial performance for the three months ended June 30, 2021, versus June 30, 2020, breaking down changes in revenue, research and development expenses, general and administrative expenses, and interest and other expenses Revenue This section analyzes the company's revenue sources and changes for the reporting period - Sublicense revenue of $354,100 was recognized in Q2 2021 from the AffaMed Agreement, compared to none in Q2 2020[141] - The company expects to continue recognizing revenue from the $5.0 million upfront payment of the AffaMed Agreement in future periods[141] Research and Development Expense This section details the changes and drivers of research and development expenses | Metric | Three Months Ended June 30, 2021 ($) | Three Months Ended June 30, 2020 ($) | | :------------------------------------ | :------------------------------- | :------------------------------- | | Total R&D expense | $5,604,000 | $1,731,000 | | Salaries and benefits | $1,307,000 | $348,000 | | PH94B and PH10 development expenses | $3,439,000 | $635,000 | - R&D expense increased by $3.9 million, primarily due to the commencement of the PALISADE Phase 3 Program for PH94B and increased salaries and benefits from new hires and compensation accruals[141][142] - PH94B and PH10 project expenses significantly increased, reflecting development, manufacturing, and regulatory initiatives, with PH94B costs exceeding PH10 due to its later development stage[148] General and Administrative Expense This section analyzes the changes and components of general and administrative expenses | Metric | Three Months Ended June 30, 2021 ($) | Three Months Ended June 30, 2020 ($) | | :------------------------------------ | :------------------------------- | :------------------------------- | | Total G&A expense | $2,496,000 | $1,391,000 | | Salaries and benefits | $951,000 | $348,000 | | Write off of deferred offering costs | $232,000 | $- | - G&A expense increased by approximately $1.1 million, driven by higher salaries and benefits from new senior management hires, pre-commercialization market studies, and a $232,000 noncash write-off of deferred offering costs[151][153][158][163] - Insurance expense increased due to market-rate increases for directors' and officers' liability insurance[159] Interest and Other Expenses This section details the company's interest income, interest expense, and other non-operating financial items | Metric | Three Months Ended June 30, 2021 ($) | Three Months Ended June 30, 2020 ($) | | :------------------------------------ | :------------------------------- | :------------------------------- | | Interest income (expense), net | $5,100 | $(3,200) | | Accrued dividends on Series B Preferred Stock | $(361,800) | $(335,800) | - Net interest income was $5,100 in Q2 2021, a positive change from net interest expense of $3,200 in Q2 2020, due to cash deposits in interest-bearing accounts and repayment of the Payroll Protection Program loan[164][166] Liquidity and Capital Resources This section assesses the company's ability to meet its short-term and long-term financial obligations and fund future operations - The company had approximately $97.8 million in cash and cash equivalents at June 30, 2021, which is believed sufficient to fund planned operations for well beyond the next twelve months[173] - Future plans include continuing the PH94B PALISADE Phase 3 Program, initiating PH94B Phase 2A, PH10 Phase 2B, and AV-101 Phase 1B studies, and conducting nonclinical studies[174] - Additional capital may be raised through public/private equity offerings, strategic licensing/development collaborations, or government grants, with an ATM program available for up to $75.0 million[175][176][178] Cash and Cash Equivalents This section analyzes the sources and uses of cash across operating, investing, and financing activities | Metric | Three Months Ended June 30, 2021 ($) | Three Months Ended June 30, 2020 ($) | | :------------------------------------ | :------------------------------- | :------------------------------- | | Net cash used in operating activities | $(6,173,000) | $(2,807,000) | | Net cash used in investing activities | $(150,000) | $- | | Net cash provided by financing activities | $992,000 | $2,998,000 | | Cash and cash equivalents at end of period | $97,777,000 | $1,546,000 | - The increase in cash used in operations during Q2 2021 resulted from the initiation of the PALISADE Phase 3 Program and preparations for other clinical and nonclinical studies[182] - Cash provided by financing activities in Q2 2021 was primarily from warrant exercises, while Q2 2020 included proceeds from the LPC Agreement and a Payroll Protection Program loan[182] Off-Balance Sheet Arrangements This section discloses any material off-balance sheet arrangements that could impact the company's financial position - The company has no off-balance sheet arrangements[183] Recent Accounting Pronouncements This section refers to disclosures regarding the impact of recently issued accounting standards - Information relating to recent accounting pronouncements and their expected impact is provided in Note 3 of the Notes to Condensed Consolidated Financial Statements[184] Item 4. Controls and Procedures This section addresses the effectiveness of the company's disclosure controls and procedures and outlines the identified material weaknesses in internal control over financial reporting, along with the steps being taken to remediate them Disclosure Controls and Procedures This section reports on the effectiveness of the company's disclosure controls and procedures - Management, with the participation of the CEO and CFO, concluded that the company's disclosure controls and procedures were effective as of June 30, 2021[185] Internal Control over Financial Reporting This section discusses the identified material weaknesses in internal control over financial reporting and remediation efforts - The company identified two material weaknesses in internal control over financial reporting: (i) lack of appropriate segregation of duties due to staff size and (ii) accounting software functionality that did not prevent erroneous or unauthorized changes and lacked an adequate audit trail[186] - Remediation steps, initiated in April 2021, include retaining additional accounting staff for appropriate review and implementing state-of-the-art accounting software[186] - The company believes these weaknesses have not resulted in deficient financial reporting due to the CEO and CFO's awareness and personal certification of financial reports[187] PART II. OTHER INFORMATION This section includes legal proceedings, risk factors, equity sales, defaults, and exhibits Item 1. Legal Proceedings The company reports no legal proceedings for the period - The company is not currently involved in any legal proceedings[188] Item 1A. Risk Factors This section outlines the significant risks and uncertainties that could materially affect the company's business, financial condition, and operating results. It covers risks related to the COVID-19 pandemic, product development, regulatory approval, commercialization, financial position, general company operations, and intellectual property rights Risk Factor Summary This summary highlights primary risks: pandemic impact, development stage, product dependence, competition, and financial challenges - Key risks include the impact of the COVID-19 pandemic, the company's development stage status with no recurring revenues, heavy dependence on the success of current CNS product candidates (PH94B, PH10, AV-101), and significant competition[189][190][197] - Other material risks involve failures or delays in clinical trials, inability to adequately protect proprietary technology, significant net losses since inception, identified material weaknesses in internal control over financial reporting, and the need for additional financing[197] COVID-19 Pandemic Impact This section details the adverse impacts of the COVID-19 pandemic on the company's operations, clinical programs, and financial stability - The COVID-19 pandemic has caused and may continue to cause delays and disruptions to ongoing development programs for PH94B, PH10, and AV-101, including potential delays in recruitment and enrollment for clinical studies[198] - Supply chain disruptions have led to delays in the delivery of active pharmaceutical product (API) for PH94B and PH10, which could materially disrupt clinical development[198] - The pandemic has created significant volatility in financial markets, potentially limiting access to capital and increasing cybersecurity risks due to remote working arrangements[195][198] Product Development, Regulatory Approval and Commercialization Risks This section outlines risks associated with developing, obtaining regulatory approval for, and commercializing the company's drug candidates - The company heavily depends on the successful development, manufacturing, regulatory approval, and commercialization of its CNS drug candidates (PH94B, PH10, AV-101), with no assurance of achieving regulatory approval or marketability[196][199] - Clinical trials face risks of delays or failures due to regulatory holds, recruitment challenges, supply shortages, or unexpected adverse events, which could significantly impact development timelines and commercial prospects[215][217][218] - Reliance on third-party contract research organizations (CROs) and contract manufacturing organizations (CMOs) for clinical trials and manufacturing exposes the company to risks related to their performance, compliance, and ability to meet deadlines[220][221][227][228] Financial Position Risks This section addresses risks related to the company's financial health, including historical losses, funding needs, and internal control weaknesses - The company has incurred significant net losses since inception, with an accumulated deficit of approximately $227.6 million at June 30, 2021, and expects to continue incurring substantial operating losses[280] - Additional financing is required to execute the long-term business plan, including development and commercialization of CNS product candidates, and future financing may result in substantial dilution or restrictive covenants[286][289][296] - Identified material weaknesses in internal control over financial reporting, including segregation of duties and accounting software functionality, could lead to financial statement errors if not adequately addressed[294][295] General Company-Related Risks This section covers broader operational risks, including personnel dependency, product liability, and business continuity threats - The company's success depends on attracting and retaining highly qualified senior management and key scientific personnel; the loss of such individuals could delay product development[299] - Product liability lawsuits are an inherent risk during clinical testing and commercialization, potentially leading to substantial liabilities, commercialization limitations, and diversion of resources[304][306] - Operations are vulnerable to natural disasters, power outages, cybersecurity attacks, and system failures, which could materially disrupt development programs and harm business[308][309][310] Intellectual Property Rights Risks This section addresses risks related to protecting intellectual property, patent enforceability, and potential infringement claims - Inability to adequately protect proprietary technology or obtain and maintain sufficient patents could lead to direct competition and materially adverse business impacts[313] - The issuance, scope, validity, and enforceability of patents are uncertain due to complex legal and factual questions, prior art, and varying international standards, making patent protection unpredictable[319][320][321] - Third parties may allege infringement of their intellectual property rights, leading to costly legal proceedings, potential development delays, and increased commercialization costs[333][335] Item 2. Unregistered Sales of Equity Securities and Use of Proceeds The company reports no unregistered sales of equity securities or use of proceeds for the period - There were no unregistered sales of equity securities or use of proceeds to report for the period[392] Item 3. Defaults Upon Senior Secured Securities The company reports no defaults upon senior secured securities for the period - There were no defaults upon senior secured securities to report for the period[393] Item 6. Exhibits This section lists the exhibits filed with the Form 10-Q, including agreements, certifications, and XBRL taxonomy files - Key exhibits include the Open Market Sale Agreement with Jefferies LLC, Indemnification Agreements, Certifications of Principal Executive and Financial Officers, and Inline XBRL Taxonomy files[394] SIGNATURES This section contains the required signatures for the Form 10-Q, certifying its submission by authorized officers - The report was signed by Shawn K. Singh, Chief Executive Officer, and Jerrold D. Dotson, Chief Financial Officer, on August 12, 2021[398]