Special Note Regarding Forward-Looking Statements This section highlights that the report contains forward-looking statements subject to substantial risks and uncertainties that could cause actual results to differ materially - This Quarterly Report contains forward-looking statements subject to 'safe harbor' provisions, involving substantial risks and uncertainties that could cause actual results to differ materially from expectations6 - Forward-looking statements are based on current expectations, beliefs, estimates, and projections, many of which are inherently uncertain and beyond the company's control7 - Key areas of forward-looking statements include capital requirements, regulatory submissions, clinical trial timing and results, market opportunity for ANEB-001, intellectual property, and the impact of economic/political events7 Risk Factors Summary This section summarizes key risks including lack of revenue, dependence on ANEB-001, funding needs, and reliance on intellectual property licenses - The company has not generated revenue since inception, expects future losses, and may never become profitable9 - Business success is highly dependent on the lead product candidate, ANEB-001, requiring completion of clinical testing and regulatory approval10 - Substantial additional funding is required, and inability to raise capital could force delays or elimination of development programs10 - The company relies on intellectual property licensed from third parties, and termination of these licenses would harm the business10 - Clinical drug development is lengthy, expensive, and uncertain, with no guarantee of favorable results or regulatory approval12 PART I. FINANCIAL INFORMATION This part contains the unaudited condensed financial statements and management's discussion and analysis for the reporting period Item 1. Financial Statements (Unaudited) This section presents the unaudited condensed financial statements for Anebulo Pharmaceuticals, Inc., including the balance sheets, statements of operations, stockholders' equity, and cash flows, along with accompanying notes, for the period ended September 30, 2023 Condensed Balance Sheets This section presents the company's financial position, detailing assets, liabilities, and stockholders' equity as of specific dates | Assets/Liabilities/Equity | September 30, 2023 (USD) | June 30, 2023 (USD) | | :------------------------ | :----------------------- | :------------------ | | Cash and cash equivalents | $8,520,578 | $11,247,403 | | Total assets | $9,047,884 | $11,670,151 | | Total liabilities | $716,560 | $1,068,801 | | Total stockholders' equity| $8,331,324 | $10,601,350 | - Cash and cash equivalents decreased by $2.73 million from June 30, 2023, to September 30, 202316 - Total assets decreased by $2.62 million, and total liabilities decreased by $352,241 during the quarter16 Condensed Statements of Operations This section outlines the company's financial performance, including revenues, expenses, and net loss for the reported periods | Expense/Income Item | Three Months Ended Sep 30, 2023 (USD) | Three Months Ended Sep 30, 2022 (USD) | | :-------------------------- | :------------------------------------ | :------------------------------------ | | Research and development | $1,270,220 | $1,223,776 | | General and administrative | $1,273,458 | $1,388,271 | | Total operating expenses | $2,543,678 | $2,612,047 | | Net loss | $(2,480,823) | $(2,611,835) | | Net loss per share (basic & diluted) | $(0.10) | $(0.11) | - Net loss decreased to $2.48 million for the three months ended September 30, 2023, from $2.61 million in the prior year period19 - Total operating expenses slightly decreased by $68,369, primarily due to a reduction in general and administrative expenses19 Condensed Statements of Stockholders' Equity This section details changes in the company's equity components, including common stock, additional paid-in capital, and accumulated deficit | Item | Balance at June 30, 2023 (USD) | Stock-based Compensation Expense (USD) | Net Loss (USD) | Balance at Sep 30, 2023 (USD) | | :---------------------------------- | :----------------------------- | :------------------------------------- | :------------- | :---------------------------- | | Common Stock Amount | $25,634 | - | - | $25,634 | | Additional Paid-in Capital | $67,777,757 | $210,797 | - | $67,988,554 | | Accumulated Deficit | $(57,202,041) | - | $(2,480,823) | $(59,682,864) | | Total Stockholders' Equity | $10,601,350 | $210,797 | $(2,480,823) | $8,331,324 | - Total stockholders' equity decreased from $10.6 million at June 30, 2023, to $8.3 million at September 30, 2023, primarily due to the net loss21 - Stock-based compensation expense contributed $210,797 to additional paid-in capital during the quarter21 Condensed Statements of Cash Flows This section reports the cash inflows and outflows from operating, investing, and financing activities for the specified periods | Cash Flow Activity | Three Months Ended Sep 30, 2023 (USD) | Three Months Ended Sep 30, 2022 (USD) | | :-------------------------------- | :------------------------------------ | :------------------------------------ | | Net cash used in operating activities | $(2,726,825) | $(2,033,922) | | Net cash provided by financing activities | - | $6,699,148 | | Net (decrease) increase in cash | $(2,726,825) | $4,665,226 | | Cash and cash equivalents, end of period | $8,520,578 | $19,213,697 | - Net cash used in operating activities increased to $2.73 million for the three months ended September 30, 2023, compared to $2.03 million in the prior year22 - No cash was provided by financing activities in Q3 2023, a significant change from $6.7 million in Q3 2022 which included proceeds from common stock issuance22 Notes to Unaudited Condensed Financial Statements This section provides detailed explanations and additional information supporting the unaudited condensed financial statements Note 1. Nature of business and basis of presentation This note describes the company's business, its focus on ACI treatment, and its financial condition, including accumulated losses and future funding needs - Anebulo Pharmaceuticals, Inc. is a clinical-stage biotechnology company focused on developing treatments for Acute Cannabis Intoxication (ACI) and addiction25 - The company has incurred significant losses since inception, with an accumulated deficit of $59.7 million as of September 30, 2023, and expects continued operating losses26 - Current cash and access to a $10 million debt facility are expected to fund operations for at least 12 months, but additional funding will be sought for development and commercialization26 Note 2. Summary of Significant Accounting Policies This note outlines the key accounting principles and methods used in preparing the financial statements - No material changes to significant accounting policies have occurred since the audited financial statements for the year ended June 30, 202332 Note 3. Prepaid Expenses This note details the composition and changes in the company's prepaid expenses over the reporting period | Prepaid Expense Category | September 30, 2023 (USD) | June 30, 2023 (USD) | | :----------------------------- | :----------------------- | :------------------ | | Prepaid insurance | $274,225 | $391,750 | | Prepaid research and development | $220,168 | - | | Prepaid other | $32,913 | $30,998 | | Total prepaid expenses | $527,306 | $422,748 | - Total prepaid expenses increased by $104,558, primarily driven by new prepaid research and development expenses of $220,16834 Note 4. Accrued Expenses This note provides a breakdown and changes in the company's accrued expenses as of the reporting dates | Accrued Expense Category | September 30, 2023 (USD) | June 30, 2023 (USD) | | :----------------------------- | :----------------------- | :------------------ | | Accrued payroll related expenses | $116,200 | $190,121 | | Accrued professional fees | $34,411 | - | | Accrued research and development | - | $344,135 | | Total accrued expenses | $150,611 | $534,256 | - Total accrued expenses decreased significantly by $383,645, mainly due to the absence of accrued research and development expenses at quarter-end35 Note 5. License Agreement This note describes the key terms of the intellectual property license agreement with Vernalis Development Limited - The company licensed intellectual property, know-how, and clinical trial data from Vernalis Development Limited in May 202036 - The agreement includes potential development milestone payments up to $29.9 million and sales milestone payments up to $35.0 million, plus single-digit royalties36 - In May 2021, 192,857 shares of common stock were issued to Vernalis in lieu of approximately $1.4 million in future milestone payments, and no further milestone payments are considered probable as of September 30, 202337 Note 6. Stockholders' Equity This note outlines the company's authorized capital stock and significant equity transactions - The company's authorized capital stock consists of 40,000,000 shares of common stock and 2,000,000 shares of preferred stock38 - In September 2022, a private placement of 2,264,650 units (common stock and warrants) generated approximately $6.3 million in net proceeds39 Note 7. Stock-Based Compensation This note details the company's stock incentive plan, stock option activity, and unrecognized compensation expense - The 2020 Stock Incentive Plan authorizes the grant of up to 3,650,000 shares for stock options and other awards, with 588,607 shares available for future issuance as of September 30, 202340 | Stock Option Activity | Number of Shares | Weighted Average Exercise Price (USD) | | :------------------------------ | :--------------- | :------------------------------------ | | Outstanding at June 30, 2023 | 2,049,313 | $4.54 | | Granted | 10,000 | $3.27 | | Forfeited/cancelled | (4,420) | $6.00 | | Outstanding at September 30, 2023 | 2,054,893 | $4.53 | | Options exercisable at Sep 30, 2023 | 882,224 | $4.30 | - Unrecognized stock-based compensation expense totaled approximately $2.2 million as of September 30, 2023, to be recognized over a weighted average period of 2.4 years45 Note 8. Net Loss Per Share Attributable to Common Stockholders This note explains the calculation of net loss per share and the treatment of common stock equivalents | Common Stock Equivalents | September 30, 2023 | September 30, 2022 | | :----------------------- | :----------------- | :----------------- | | Stock options outstanding| 2,054,893 | 1,895,701 | | Warrants outstanding | 2,264,650 | 2,264,650 | | Total | 4,319,543 | 4,160,351 | - Stock options and warrants were excluded from diluted EPS calculation due to their anti-dilutive effect47 Note 9. Subsequent Events This note discloses significant events that occurred after the balance sheet date, including executive changes and a new loan agreement - Simon Allen was terminated as CEO on October 5, 2023, and Richard Anthony Cunningham was appointed as the new CEO and Board member on October 6, 20234950 - Mr. Cunningham was granted stock options to purchase 600,000 shares (quarterly vesting) and 140,000 performance-based shares50 - On November 13, 2023, the company entered into a Loan and Security Agreement (LSA) for up to $10 million, accruing 0.25% annual interest, collateralized by company assets upon drawing at least $3 million51 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 September 30, 2023, highlighting key developments, financial performance, and future outlook Overview This section provides a general description of the company's business, its lead product candidate ANEB-001, and its clinical development status - Anebulo is a clinical-stage biotechnology company developing ANEB-001 to rapidly reverse Acute Cannabinoid Intoxication (ACI) symptoms, with no approved medical treatment currently available for ACI54 - The company completed Part A and B of its Phase 2 Netherlands Trial in March 2023, with Part C dosing completed in August 2023, and received FDA feedback for Phase 3 development54 - ACI-related emergency department visits are increasing, reaching an estimated 1.7 million patients in 2019, indicating a significant unmet medical need56 - The company secured U.S. Patent No. 11,141,404 in October 2021, protecting ANEB-001 for treating acute cannabinoid overdose through 204060 Components of Results of Operations This section describes the primary drivers of the company's operating results, including revenue and expense categories - The company has not generated any revenue since inception and expects to incur significant operating losses in the future63 - Research and development expenses are expected to increase significantly as the company advances ANEB-001 and expands its product-candidate pipeline65 - General and administrative expenses primarily consist of professional fees, stock-based compensation, insurance, personnel costs, and rent67 Results of Operations This section analyzes the company's financial performance for the reported periods, focusing on changes in expenses and net loss | Item | 2023 (3 months ended Sep 30) (USD) | 2022 (3 months ended Sep 30) (USD) | Change (USD) | | :---------------------------------- | :--------------------------------- | :--------------------------------- | :----------- | | Research and development | $1,270,220 | $1,223,776 | $46,444 | | General and administrative | $1,273,458 | $1,388,271 | $(114,813) | | Total operating expenses | $2,543,678 | $2,612,047 | $(68,369) | | Loss from operations | $(2,543,678) | $(2,612,047) | $68,369 | | Net loss | $(2,480,823) | $(2,611,835) | $131,012 | - Research and development expenses increased by $46,444, primarily due to increased nonclinical and clinical study activities for ANEB-00171 - General and administrative expenses decreased by $114,813, mainly due to reduced compensation (decreased headcount) and lower directors' and officers' insurance premiums, partially offset by higher professional and consultant fees73 Liquidity and Capital Resources This section discusses the company's cash position, funding sources, and ability to meet its short-term and long-term financial obligations - As of September 30, 2023, the company had $8.5 million in cash and expects this, combined with a new $10 million Loan and Security Agreement (LSA), to fund operations for at least the next 12 months7480 - The LSA, entered into on November 13, 2023, allows for draws up to $10 million, accrues interest at 0.25% per annum, and will be collateralized by substantially all assets upon drawing at least $3 million5175 - The company issued 300,000 shares of common stock to 22NW upon signing the LSA and will issue additional shares based on advances, up to a maximum of 300,0005276 | Cash Flow Activity | Three Months Ended Sep 30, 2023 (USD) | Three Months Ended Sep 30, 2022 (USD) | | :-------------------------------- | :------------------------------------ | :------------------------------------ | | Net cash used in operating activities | $(2,726,825) | $(2,033,922) | | Net cash provided by financing activities | - | $6,699,148 | | Net (decrease) increase in cash | $(2,726,825) | $4,665,226 | - Contractual obligations include a license agreement with Vernalis (potential milestones up to $64.9 million and royalties), a manufacturing agreement for $0.9 million, and a CRO agreement for €2.8 million, both expected to be fully incurred by Q4 20238386 Critical Accounting Policies and Significant Judgments and Estimates This section outlines the accounting policies that require management's most difficult, subjective, or complex judgments and estimates - The company's critical accounting policies include estimating accrued research and development expenses, which involves reviewing contracts, communicating with personnel, and estimating service levels90 - Stock-based compensation expense is estimated using the Black-Scholes option pricing model, with key assumptions including expected stock price volatility, expected term, risk-free rate, and expected dividends93 - As an 'emerging growth company' under the JOBS Act, the company elects to use extended transition periods for new accounting standards, which may affect comparability with other public companies94 Item 3. Quantitative and Qualitative Disclosures About Market Risk As a smaller reporting company, Anebulo Pharmaceuticals, Inc. is not required to provide quantitative and qualitative disclosures about market risk in this report - The company is exempt from providing quantitative and qualitative disclosures about market risk due to its status as a smaller reporting company95 Item 4. Controls and Procedures Management, including the CEO and CFO, evaluated the effectiveness of the company's disclosure controls and procedures as of September 30, 2023, concluding they were effective at a reasonable assurance level. There were no material changes in internal control over financial reporting during the quarter - As of September 30, 2023, management concluded that the design and operation of the company's disclosure controls and procedures were effective at a reasonable assurance level97 - There were no changes in internal control over financial reporting during the three months ended September 30, 2023, that materially affected, or are reasonably likely to materially affect, internal control over financial reporting97 PART II. OTHER INFORMATION This part includes legal proceedings, risk factors, equity sales, and other disclosures Item 1. Legal Proceedings The company is not currently a party to any material legal proceedings, and management believes there are no pending claims or actions that could have a material adverse effect on its operations or financial condition - The company is not currently a party to any material legal proceedings99 - Management believes there are no claims or actions pending that could have a material adverse effect on results of operations or financial condition99 Item 1A. Risk Factors This section details various material risks that could negatively impact an investment in the company's common stock, covering business operations, financial condition, intellectual property, product development, regulatory approval, manufacturing, commercialization, reliance on third parties, government regulation, and common stock ownership Risks Related to our Business, Financial Condition and Capital Requirements This section outlines risks concerning the company's financial viability, funding needs, dependence on ANEB-001, and reliance on key personnel - The company has not generated revenue since inception, has an accumulated deficit of $59.7 million, and expects to incur future losses, potentially never achieving profitability101 - Future success is highly dependent on ANEB-001, requiring successful clinical testing, regulatory approval, and commercialization, with no guarantee of adequate financial resources or market acceptance103 - The company relies on a license from Vernalis Development Limited for ANEB-001, and failure to comply with obligations or termination of the license could result in loss of significant intellectual property rights107108 - Substantial additional funding is needed, and if unavailable on acceptable terms, the company may be forced to delay, reduce, or eliminate product development programs, leading to potential dilution for stockholders from equity financing or liens on assets from debt financing113115 - The Loan and Security Agreement (LSA) with 22NW and JFL may be secured by substantially all company assets, and a default could have material adverse consequences, including insolvency116 - The company's operations depend on its founder and CEO, Joseph F. Lawler and Richard Anthony Cunningham, and its ability to attract and retain other key personnel; loss of whom could disrupt business118 - Adverse developments in the financial services industry, such as bank failures, could impair the company's access to cash and liquidity, potentially delaying operations or leading to uninsured losses120122 Risks Related to Our Intellectual Property This section addresses risks associated with obtaining, maintaining, and enforcing patent protection for ANEB-001 and other intellectual property - Failure to obtain and maintain broad patent protection for ANEB-001 could allow competitors to commercialize similar products, adversely affecting the company's ability to commercialize its product candidates125127 - The patent prosecution process is expensive and time-consuming, with no assurance that pending applications will issue as granted patents or provide meaningful protection129130 - Issued patents may be challenged, narrowed, circumvented, or invalidated by third parties, potentially leading to loss of exclusivity or inability to stop competitors131132 - Failure to obtain patent term extension or a shorter extension than requested could allow competitors to enter the market sooner, harming the business139 - Protecting intellectual property rights globally is expensive and challenging, as foreign laws may offer less protection, potentially allowing competitors to sell infringing products142143 - Changes in patent laws, such as the America Invents Act, increase uncertainties and costs in patent prosecution and enforcement, potentially diminishing the value of patents145146 - The expiration or loss of patent protection could adversely affect future revenues and operating earnings by opening the market to generic competition148 Risks Related to Product Development, Regulatory Approval, Manufacturing and Commercialization This section covers risks inherent in the development, regulatory approval, manufacturing, and market acceptance of ANEB-001 - Clinical trials for ANEB-001 are expensive, time-consuming, and unpredictable; delays or termination could significantly increase costs and affect product development plans150 - The company relies on third-party clinical trials for ANEB-001, and regulatory authorities may not accept this data, leading to delays in approval152 - Failure to obtain required regulatory approvals for ANEB-001 would prevent commercialization and limit revenue generation, as success in early trials does not guarantee later success154155 - Even with marketing approval, commercial success depends on acceptance by the medical community, pricing, reimbursement, and competition, which may be limited161163 - Interim, topline, and preliminary data from studies may change upon full review, and adverse differences could harm business prospects166168 - Post-approval, ANEB-001 will be subject to ongoing regulatory review, potentially leading to restrictions, costly post-market studies, or withdrawal from the market if problems arise169172 - Unfavorable pricing regulations, third-party coverage, and reimbursement practices or healthcare reform initiatives could harm the business by limiting market access and profitability174176 - New drugs developed by competitors, such as Aelis Farma and Opiant Pharmaceuticals, could obtain regulatory approval before ANEB-001, impairing the company's competitive position197 - ANEB-001 may have undesirable side effects, either during clinical development or after marketing, which could delay or prevent approval, require safety warnings, or limit sales192193 - The company lacks a marketing and sales organization and direct experience; inability to establish these capabilities or partner with third parties could prevent product revenue generation195196 Risks Related to Our Reliance on Third Parties This section discusses risks arising from the company's dependence on third parties for clinical trials, manufacturing, and collaborations - The company depends on third parties for preclinical testing and clinical trials, and their failure to perform timely or adequately could result in increased costs, delays, or rejection of data199200 - Complete dependence on third parties for ANEB-001 manufacturing means commercialization could be halted or delayed if manufacturers fail to obtain regulatory approval, provide sufficient quantities, or meet quality/price standards204206 - Reliance on collaborations with third parties carries inherent risks, including potential termination of agreements, reduced payments, or loss of control over product development, which could delay development and reduce revenues211213 Risks Related to Government Regulation of our Industry This section addresses risks stemming from healthcare legislative reforms and regulatory requirements impacting the pharmaceutical industry - Legislative or regulatory reforms of the healthcare system, such as the ACA and IRA, could impact the company's ability to sell products profitably, affecting pricing, coverage, and relationships with healthcare professionals218219221 - Clinical trials conducted outside the United States and not under an IND may not be accepted by the FDA, potentially requiring additional costly and time-consuming trials222223 Risks Related to Ownership of Our Common Stock This section details risks associated with the company's common stock, including price volatility, future sales, and corporate governance provisions - The trading price and volume of the common stock have experienced and may continue to experience volatility due to various factors beyond the company's control, including quarterly results, analyst expectations, and industry developments224 - Future sales, or the perception of future sales, of a substantial number of common shares by the company or its stockholders could depress the stock's trading price and make future equity financing more difficult227228 - Principal stockholders and management own a substantial majority of the stock, enabling them to exert significant control over stockholder approval matters, potentially discouraging acquisition proposals229 - Anti-takeover provisions in charter documents and Delaware law could discourage, delay, or prevent a change in control, potentially affecting the common stock's trading price230232 - The company's certificate of incorporation designates Delaware courts as the exclusive forum for most disputes and federal district courts for Securities Act claims, potentially limiting stockholders' ability to choose a favorable judicial forum233234235 - The company does not expect to pay dividends on its common stock, retaining earnings for operations, expansion, and debt repayment, meaning stockholders may only realize a return through stock sales236 General Risk Factors This section covers broad risks such as internal control effectiveness, public company costs, accounting changes, and macroeconomic conditions - Failure to establish and maintain effective internal control over financial reporting could harm operating results and business operations, leading to potential sanctions or stock price decline238239 - Operating as a public company incurs significantly increased costs and requires substantial management time for compliance efforts, potentially diverting attention from business management241 - Changes in accounting principles or interpretations could result in unfavorable accounting charges or effects, including retroactive changes to financial statements, causing stock price decline242 - As an 'emerging growth company,' the company utilizes reduced reporting requirements, which may make its financial statements less comparable and its securities less attractive to some investors243244 - Changes in tax laws or regulations, such as the Tax Cuts and Jobs Act, could adversely affect the business, cash flow, and financial condition, including limitations on net operating loss carryforwards248251 - If securities or industry analysts cease publishing research or change recommendations adversely, or if actual results differ from guidance, the stock price and trading volume could decline252253 - Health epidemics or pandemics, like COVID-19, may adversely affect business, financial condition, and results of operations through operational disruptions, supply chain issues, and economic instability254255 - Unstable market and economic conditions, including inflation, may seriously affect the business by increasing costs, making financing more difficult, and potentially delaying or abandoning clinical development plans257258259 - The company is subject to stringent and evolving data privacy and security laws (e.g., HIPAA, CCPA, GDPR), and actual or perceived failure to comply could lead to regulatory actions, litigation, fines, and business disruptions260261262263268 - Compromise of internal IT systems or sensitive information, or those of third-party contractors, could lead to material disruption of product development, regulatory investigations, litigation, and reputational harm271275278 Item 2. Unregistered Sales of Equity Securities and Use of Proceeds This section confirms no unregistered sales of equity securities and details the use of net proceeds from the company's Initial Public Offering (IPO) - No unregistered sales of equity securities occurred during the reporting period281 - The company received approximately $19.8 million in net proceeds from its May 2021 IPO281 - Through September 30, 2023, approximately $17.6 million of IPO net proceeds were used for research and development expenses for ANEB-001, working capital, and general corporate purposes282 Item 3. Defaults Upon Senior Securities This section indicates that there are no reported defaults upon senior securities - No defaults upon senior securities are reported282 Item 4. Mine Safety Disclosures This section indicates that there are no mine safety disclosures required for the company - No mine safety disclosures are applicable to the company282 Item 5. Other Information This section provides additional information, specifically detailing the Loan and Security Agreement (LSA) entered into on November 13, 2023, with 22NW, LP and JFL Capital Management LLC - On November 13, 2023, the company entered into a Loan and Security Agreement (LSA) allowing it to draw up to $10 million to fund future operations until November 13, 2026283 - The LSA accrues interest at 0.25% per annum, with no fee on the unused balance, and will be collateralized by substantially all company assets upon drawing at least $3 million283 - The company issued 300,000 shares of common stock to 22NW upon signing the LSA and will issue additional shares (0.03 shares per dollar loaned) up to an aggregate maximum of 300,000 for each advance284 Item 6. Exhibits This section lists all exhibits filed as part of the Quarterly Report on Form 10-Q, including corporate documents, agreements, and certifications - The report includes various exhibits such as the Second Amended and Restated Certificate of Incorporation, Amended and Restated Bylaws, Specimen Stock Certificate, Investors' Rights Agreement, Securities Purchase Agreement, Form of Common Stock Purchase Warrant, Executive Employment Agreement, Offer Letter, Loan and Security Agreement, and certifications285287 Signatures This section contains the official signatures of the company's executive officers, certifying the report's accuracy - The report is signed by Richard Anthony Cunningham, Chief Executive Officer, and Daniel George, Chief Financial Officer, on November 14, 2023291
Anebulo Pharmaceuticals(ANEB) - 2024 Q1 - Quarterly Report