Market Overview - U.S. stock index futures are showing mixed performance as investors react to a recent Federal Reserve interest rate cut and anticipate upcoming economic data [1][2] - Major indexes closed at record highs on Thursday, with the Dow Jones Industrial Average up 0.27%, S&P 500 rising 0.48%, and Nasdaq Composite increasing by 0.94% [3] Economic Indicators - The 10-year Treasury yield rose by 2 basis points to 4.13%, while the 2-year yield increased by 1 basis point to 3.58% [2] - Strong labor market data indicated a drop in U.S. Weekly Initial Jobless Claims to 231K for the week ending September 13, below expectations, which reassured investors about economic stability [3] Upcoming Economic Data - Key economic data releases include Flash Purchasing Managers' Index (PMI) surveys and the U.S. core Personal Consumption Expenditures (PCE) price index, scheduled for September 26, 2025 [5] - Other significant upcoming data includes revised GDP numbers, consumer confidence data, home sales figures, durable goods orders, and inventories [5] Corporate Earnings - Several companies are set to report earnings, including MoneyHero Limited, IperionX Limited ADR, and FedEx, which reported better-than-expected FQ1 earnings and projected 4%-6% revenue growth for fiscal year 2026 [6][11] - 22nd Century Group's shares surged 31% after announcing it is now debt-free, while 89bio's shares skyrocketed 85% following Roche's agreement to acquire the biotech firm for $14.50 per share [11] Key Corporate News - Nvidia shares advanced 3.5% after announcing a $5 billion investment in Intel, which saw its stock surge over 23% [7] - CoreWeave's shares rose 0.3% after Loop Capital initiated coverage with a "Buy" rating, highlighting its growing prominence among chip giants and AI labs [11] - FedEx's strong results positively impacted UPS, which saw its stock increase by 2% [11] Stock Movements - Red Cat Holdings' shares fell 12% after pricing an offering of 15.6 million shares at $9.60 each [11] - Nucor's shares slipped 4% after guiding its Q3 EPS to $2.05-$2.15, below the consensus estimate of $2.56 [11]

Group 1 - Anebulo Pharmaceuticals has announced an update regarding its going private transaction and strategic alternatives [1] - The company is exploring various strategic options to enhance shareholder value [1] - The update indicates ongoing discussions with potential investors and stakeholders [1]

[Special Note Regarding Forward-Looking Statements](index=4&type=section&id=Special%20Note%20Regarding%20Forward-Looking%20Statements) This section cautions readers that forward-looking statements are subject to risks and uncertainties, advising against undue reliance and referring to risk factors [Forward-Looking Statements Disclosure](index=4&type=section&id=Forward-Looking%20Statements%20Disclosure) This disclosure details the nature of forward-looking statements, their inherent risks, and the company's policy of not updating them, urging review of risk factors - The report contains forward-looking statements regarding future financial condition, business strategy, and operational objectives, identifiable by terms like 'believe,' 'may,' 'could,' 'will,' 'estimate,' 'continue,' 'anticipate,' 'intend,' 'seek,' 'plan,' 'expect,' 'should,' 'would,' 'potentially' or their negatives[9](index=9&type=chunk) - Key areas covered by forward-looking statements include capital requirements, regulatory submissions, clinical trial timing and conduct, clinical utility and approval likelihood of selonabant, future growth, intellectual property, licensing arrangements, commercial potential, supplier performance, competitive ability, economic/political impacts, and governmental regulations[12](index=12&type=chunk) - Readers are cautioned not to place undue reliance on these statements, as actual results may differ materially due to various factors, including those detailed in the 'Risk Factors' section[9](index=9&type=chunk)[11](index=11&type=chunk) [PART I. FINANCIAL INFORMATION](index=5&type=section&id=PART%20I.%20FINANCIAL%20INFORMATION) [Item 1. Financial Statements (Unaudited)](index=5&type=section&id=Item%201.%20Financial%20Statements%20(Unaudited)) This section presents the unaudited condensed financial statements, including balance sheets, statements of operations, stockholders' equity, and cash flows [Condensed Balance Sheets](index=5&type=section&id=Condensed%20Balance%20Sheets) This section provides a snapshot of the company's financial position, detailing assets, liabilities, and equity at specific points in time Condensed Balance Sheet Highlights | Metric | March 31, 2025 | June 30, 2024 | | :-------------------------- | :------------- | :------------ | | Cash and cash equivalents | $13,279,901 | $3,094,200 | | Total current assets | $13,807,935 | $3,507,990 | | Total assets | $14,008,484 | $4,073,114 | | Total liabilities | $546,032 | $260,583 | | Total stockholders' equity | $13,462,452 | $3,812,531 | - Cash and cash equivalents significantly increased to **$13.3 million** as of March 31, 2025, from **$3.1 million** as of June 30, 2024, primarily due to financing activities[14](index=14&type=chunk) - Total assets grew from **$4.1 million** to **$14.0 million**, while total liabilities increased from **$0.3 million** to **$0.5 million** over the same period[14](index=14&type=chunk) - Stockholders' equity saw a substantial increase from **$3.8 million** to **$13.5 million**, reflecting new capital infusions[14](index=14&type=chunk) [Condensed Statements of Operations](index=6&type=section&id=Condensed%20Statements%20of%20Operations) This section presents the company's financial performance over specific periods, detailing revenues, expenses, and net loss Condensed Statements of Operations Highlights | Metric | 3 Months Ended Mar 31, 2025 | 3 Months Ended Mar 31, 2024 | 9 Months Ended Mar 31, 2025 | 9 Months Ended Mar 31, 2024 | | :-------------------------- | :-------------------------- | :-------------------------- | :-------------------------- | :-------------------------- | | Research and development | $638,324 | $748,339 | $3,173,718 | $3,081,231 | | General and administrative | $1,253,998 | $915,912 | $3,718,879 | $3,887,157 | | Total operating expenses | $1,892,322 | $1,664,251 | $6,892,597 | $6,968,388 | | Net loss | $(1,676,169) | $(1,653,542) | $(6,339,935) | $(6,851,734) | | Net loss per share (basic & diluted) | $(0.04) | $(0.06) | $(0.20) | $(0.27) | - Net loss for the three months ended March 31, 2025, was **$(1.7) million**, a slight increase from **$(1.7) million** in the prior-year period[17](index=17&type=chunk) - For the nine months, net loss improved to **$(6.3) million** from **$(6.9) million**[17](index=17&type=chunk) - Research and development expenses decreased by **$0.11 million** for the three months ended March 31, 2025, but increased by **$0.09 million** for the nine months ended March 31, 2025, compared to the respective prior periods[17](index=17&type=chunk) - Grant income of **$0.36 million** and **$0.78 million** was recognized for the three and nine months ended March 31, 2025, respectively, with no comparable income in the prior year[17](index=17&type=chunk) [Condensed Statements of Stockholders' Equity](index=7&type=section&id=Condensed%20Statements%20of%20Stockholders'%20Equity) This section outlines changes in the company's equity accounts, reflecting capital transactions and net income or loss over time Stockholders' Equity Changes (Nine Months Ended March 31, 2025) | Item | Change in Shares | Change in Amount (Common Stock) | Change in Additional Paid-in Capital | Change in Accumulated Deficit | Change in Total Stockholders' Equity | | :---------------------------------- | :--------------- | :------------------------------ | :----------------------------------- | :---------------------------- | :----------------------------------- | | Balance at June 30, 2024 | 25,933,217 | $25,934 | $69,190,341 | $(65,403,744) | $3,812,531 | | Stock-based compensation expense | - | - | $1,106,520 | - | $1,106,520 | | Issuance of common stock, net | 15,151,514 | $15,152 | $14,947,251 | - | $14,962,403 | | Common stock offering costs | - | - | $(79,067) | - | $(79,067) | | Net loss | - | - | - | $(6,339,935) | $(6,339,935) | | Balance at March 31, 2025 | 41,084,731 | $41,086 | $85,165,045 | $(71,743,679) | $13,462,452 | - Total stockholders' equity increased from **$3.8 million** at June 30, 2024, to **$13.5 million** at March 31, 2025[20](index=20&type=chunk) - The increase was primarily driven by the issuance of **15,151,514 shares** of common stock, resulting in net proceeds of approximately **$14.9 million**, and stock-based compensation expense of **$1.1 million**, partially offset by a net loss of **$6.3 million**[20](index=20&type=chunk) - The accumulated deficit grew to **$(71.7) million** as of March 31, 2025, from **$(65.4) million** at June 30, 2024[20](index=20&type=chunk) [Condensed Statements of Cash Flows](index=8&type=section&id=Condensed%20Statements%20of%20Cash%20Flows) This section details the sources and uses of cash across operating, investing, and financing activities over specific periods Condensed Statements of Cash Flows Highlights (Nine Months Ended March 31) | Cash Flow Activity | 2025 | 2024 | | :----------------- | :------------ | :------------ | | Operating | $(4,697,635) | $(6,037,910) | | Financing | $14,883,336 | $(62,354) | | Net increase (decrease) in cash | $10,185,701 | $(6,100,264) | | Cash, end of period | $13,279,901 | $5,147,139 | - Net cash used in operating activities decreased to **$4.7 million** for the nine months ended March 31, 2025, from **$6.0 million** in the prior-year period[23](index=23&type=chunk)[106](index=106&type=chunk)[107](index=107&type=chunk) - Net cash provided by financing activities was **$14.9 million** for the nine months ended March 31, 2025, primarily from the issuance of common stock, a significant increase from net cash used of **$62,354** in the prior-year period[23](index=23&type=chunk)[106](index=106&type=chunk) - The company experienced a net increase in cash of **$10.2 million** for the nine months ended March 31, 2025, compared to a net decrease of **$6.1 million** in the prior-year period, resulting in cash and cash equivalents of **$13.3 million** at period end[23](index=23&type=chunk)[106](index=106&type=chunk) [Notes to Unaudited Condensed Financial Statements](index=9&type=section&id=Notes%20to%20Unaudited%20Condensed%20Financial%20Statements) This section provides detailed explanations and additional information supporting the unaudited condensed financial statements [Note 1. Nature of business and basis of presentation](index=9&type=section&id=Note%201.%20Nature%20of%20business%20and%20basis%20of%20presentation) This note describes the company's core business, its focus on drug development, and the basis for preparing the financial statements - Anebulo Pharmaceuticals, Inc. is a clinical-stage pharmaceutical company focused on developing treatments for cannabis-induced toxicity, including acute cannabis-induced toxicity in children and acute cannabinoid intoxication (ACI) in adults[26](index=26&type=chunk) - The company has incurred significant losses since inception, with a net loss of approximately **$6.3 million** for the nine-month period ended March 31, 2025, and an accumulated deficit of **$71.7 million**[27](index=27&type=chunk) - Management expects current cash and cash equivalents, along with available funding from the Loan Agreement, to be sufficient for operating expenses and capital expenditures for at least 12 months from the financial statements' issuance date[28](index=28&type=chunk) [Note 2. Summary of Significant Accounting Policies](index=10&type=section&id=Note%202.%20Summary%20of%20Significant%20Accounting%20Policies) This note outlines the key accounting principles and methods used in preparing the financial statements, including recent pronouncements - The company's significant accounting policies remain largely unchanged from the June 30, 2024, Annual Report on Form 10-K, except for the policy on accounting for research and development grants[35](index=35&type=chunk) - New accounting pronouncements include ASU No. 2023-07 (Segment Reporting), effective July 1, 2024, requiring incremental qualitative segment disclosures, and ASU 2023-09 (Income Taxes), effective for fiscal 2026, which is expected to be disclosure-only[36](index=36&type=chunk)[37](index=37&type=chunk) - ASU No. 2024-03 (Disaggregation of Income Statement Expenses), effective for annual periods beginning after December 15, 2026, is currently being evaluated for its impact[38](index=38&type=chunk) [Note 3. Prepaid Expenses](index=11&type=section&id=Note%203.%20Prepaid%20Expenses) This note details the composition and changes in the company's prepaid expenses, including insurance and research and development Prepaid Expenses Breakdown | Category | March 31, 2025 | June 30, 2024 | | :------------------------ | :------------- | :------------ | | Prepaid insurance | $54,197 | $95,871 | | Prepaid research and development | $332,899 | $274,879 | | Prepaid other | $140,938 | $43,040 | | Total prepaid expenses | $528,034 | $413,790 | - Total prepaid expenses increased to **$528,034** as of March 31, 2025, from **$413,790** as of June 30, 2024[39](index=39&type=chunk) - The increase was primarily driven by higher prepaid research and development (**$332,899** vs **$274,879**) and prepaid other expenses (**$140,938** vs **$43,040**), partially offset by a decrease in prepaid insurance[39](index=39&type=chunk) [Note 4. Accrued Expenses](index=11&type=section&id=Note%204.%20Accrued%20Expenses) This note provides a breakdown of accrued expenses, including payroll, research and development, and professional fees Accrued Expenses Breakdown | Category | March 31, 2025 | June 30, 2024 | | :------------------------ | :------------- | :------------ | | Accrued payroll related expenses | $18,658 | $29,512 | | Accrued research and development | $45,445 | $47,554 | | Accrued professional fees | $54,351 | $27,091 | | Total accrued expenses | $118,454 | $104,157 | - Total accrued expenses increased to **$118,454** as of March 31, 2025, from **$104,157** as of June 30, 2024[40](index=40&type=chunk) - This increase was mainly due to a rise in accrued professional fees (**$54,351** vs **$27,091**), partially offset by decreases in accrued payroll-related expenses and accrued research and development[40](index=40&type=chunk) [Note 5. Other Assets](index=11&type=section&id=Note%205.%20Other%20Assets) This note explains the nature of other assets, primarily loan commitment fees, and their amortization - Other assets primarily consist of loan commitment fees, which decreased from **$0.6 million** at June 30, 2024, to **$0.2 million** at March 31, 2025[41](index=41&type=chunk) - In connection with the refinancing of the Loan Agreement, approximately **$0.2 million** of unamortized loan commitment fees were written off and recognized as incremental interest expense[41](index=41&type=chunk) - Interest expense related to the amortization of loan commitment fees was **$36 thousand** for the three months and **$0.2 million** for the nine months ended March 31, 2025[41](index=41&type=chunk) [Note 6. License Agreement](index=11&type=section&id=Note%206.%20License%20Agreement) This note describes the company's licensing agreement for selonabant, including milestone payments and royalty obligations - In May 2020, the Company licensed intellectual property, know-how, and clinical trial data from Vernalis Development Limited for selonabant, with initial consideration of **$0.15 million** recorded as R&D expense[42](index=42&type=chunk) - The agreement includes potential development milestone payments up to **$29.9 million** and sales milestone payments of **$10.0 million** and **$25.0 million**, plus annual single-digit royalties on net product sales[42](index=42&type=chunk) - As of March 31, 2025, no further milestone payments are considered probable, and no liability has been recorded, partly due to the issuance of **192,857 common shares** to Vernalis in lieu of future milestone payments of approximately **$1.4 million** during the IPO[43](index=43&type=chunk) [Note 7. Stockholders' Equity](index=12&type=section&id=Note%207.%20Stockholders'%20Equity) This note details changes in stockholders' equity, including authorized shares, stock issuances, and private placement activities - On November 20, 2023, the Company increased its authorized common stock from **40,000,000** to **50,000,000 shares**[44](index=44&type=chunk) - On December 22, 2024, the Company completed a private placement, issuing **15,151,514 shares** of common stock at **$0.99 per share**, generating approximately **$15.0 million** in gross proceeds (net **$14.9 million** after offering expenses)[47](index=47&type=chunk) - The private placement involved 22NW Fund, LP, a greater than 5% stockholder controlled by a director, and other institutional accredited investors[47](index=47&type=chunk) [Note 8. Stock-Based Compensation](index=12&type=section&id=Note%208.%20Stock-Based%20Compensation) This note explains the company's stock incentive plan, stock option activity, and the related compensation expense recognized - The 2020 Stock Incentive Plan, as amended, authorizes the grant of up to **3,650,000 shares** (increased to **6,150,000** post-March 31, 2025) for stock options and other awards to employees, officers, directors, advisors, and consultants[48](index=48&type=chunk)[65](index=65&type=chunk) - Stock-based compensation expense was approximately **$0.3 million** for the three months and **$1.1 million** for the nine months ended March 31, 2025, compared to **$0.2 million** and **$0.6 million** for the respective prior-year periods[55](index=55&type=chunk) Stock Option Activity (Nine Months Ended March 31, 2025) | Metric | Number of Shares | Weighted Average Exercise Price | | :------------------------ | :--------------- | :------------------------------ | | Outstanding at June 30, 2024 | 2,319,048 | $3.00 | | Granted | 254,433 | $1.56 | | Outstanding at March 31, 2025 | 2,573,481 | $2.85 | | Options exercisable at March 31, 2025 | 1,369,960 | $2.83 | - As of March 31, 2025, unrecognized stock-based compensation expense related to unvested stock options totaled approximately **$1.6 million**, to be recognized over a weighted average period of **2.1 years**[53](index=53&type=chunk) [Note 9. Net Loss Per Share Attributable to Common Stockholders](index=14&type=section&id=Note%209.%20Net%20Loss%20Per%20Share%20Attributable%20to%20Common%20Stockholders) This note details the calculation of net loss per share and identifies anti-dilutive common stock equivalents Anti-Dilutive Common Stock Equivalents | Item | March 31, 2025 | March 31, 2024 | | :------------------------ | :------------- | :------------- | | Stock options outstanding | 2,573,481 | 2,008,185 | | Warrants outstanding | 2,264,650 | 2,264,650 | | Total | 4,838,131 | 4,272,835 | - Stock options and warrants totaling **4,838,131 shares** as of March 31, 2025, were excluded from the net loss per share calculation due to their anti-dilutive effect[56](index=56&type=chunk) [Note 10. Loan Agreement](index=14&type=section&id=Note%2010.%20Loan%20Agreement) This note describes the company's loan and security agreement, including its terms, modifications, and outstanding balance - On November 13, 2023, the Company entered into a Loan and Security Agreement (LSA) with 22NW and JFL Capital Management LLC, allowing it to draw up to **$10 million**[57](index=57&type=chunk) - The LSA was modified on February 10, 2025, reducing the maximum loan advance to **$3 million**, removing securitization provisions, and assigning 22NW's rights to 22NW Fund, LP[59](index=59&type=chunk) - The Loan Agreement accrues interest at **0.25% per annum**, terminates on February 10, 2028, and requires the issuance of **0.03 shares** of common stock per dollar loaned, up to a maximum of **90,000 shares**[59](index=59&type=chunk) - No balance was outstanding under the Loan Agreement as of March 31, 2025, or under the LSA as of June 30, 2024[59](index=59&type=chunk) [Note 11. Research and Development Grant](index=14&type=section&id=Note%2011.%20Research%20and%20Development%20Grant) This note details the NIDA cooperative grant awarded to the company and the recognition of grant income for R&D activities - On July 16, 2024, the Company was awarded the first tranche of **$0.9 million** from a two-year cooperative grant of up to **$1.9 million** from the National Institute on Drug Abuse (NIDA) to support the development of intravenous selonabant for acute cannabis-induced toxicities in children[61](index=61&type=chunk) - The grant income is recognized as other income in the condensed statements of operations, derived from reimbursement of direct out-of-pocket expenses, salaries, fringe benefits, and direct materials costs[62](index=62&type=chunk)[63](index=63&type=chunk) - The Company recognized **$0.4 million** and **$0.8 million** in grant income for the three and nine months ended March 31, 2025, respectively, with no comparable income in the prior year[64](index=64&type=chunk) [Note 12. Subsequent Events](index=15&type=section&id=Note%2012.%20Subsequent%20Events) This note discloses significant events that occurred after the balance sheet date, such as changes in authorized shares - On April 4, 2025, stockholders approved an amendment to increase authorized common stock from **50,000,000** to **75,000,000 shares**[65](index=65&type=chunk) - Stockholders also approved an amendment to the 2020 Stock Incentive Plan, increasing shares available for awards from **3,650,000** to **6,150,000 shares**[65](index=65&type=chunk) [Item 2. Management's Discussion and Analysis of Financial Condition and Results of Operations](index=16&type=section&id=Item%202.%20Management's%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) Management discusses the company's financial condition, operational results, and liquidity, highlighting the strategic focus on IV selonabant and recent financing [Overview](index=16&type=section&id=Overview) This section provides a high-level summary of the company's business, drug development focus, and strategic priorities for selonabant - Anebulo is a clinical-stage pharmaceutical company developing selonabant (formerly ANEB-001) to rapidly reverse cannabis-induced toxicity, including acute cannabis-induced toxicity in children and acute cannabinoid intoxication (ACI) in adults[67](index=67&type=chunk) - The company is prioritizing the advancement of an intravenous (IV) selonabant formulation for pediatric patients with cannabis-induced CNS depression, believing it offers a faster timeline to approval compared to the adult oral product[71](index=71&type=chunk)[72](index=72&type=chunk) - The decision to prioritize the pediatric IV formulation is driven by the recent development of a suitable IV formulation, prior discussions with the FDA highlighting the unmet need in a vulnerable population, and the potential for initial pediatric approval to facilitate adult ACI treatment approval[72](index=72&type=chunk) - The company was awarded a **$1.9 million** cooperative grant from NIDA to support the development of IV selonabant and plans to initiate a single ascending dose (SAD) study in healthy adults in Q3 calendar 2025[61](index=61&type=chunk)[79](index=79&type=chunk) [Components of Results of Operations](index=19&type=section&id=Components%20of%20Results%20of%20Operations) This section explains the key elements contributing to the company's financial performance, including revenue, R&D, and G&A expenses - The company has not generated any revenue since inception and expects to incur significant operating losses and negative cash flows in the future[84](index=84&type=chunk) - Research and development expenses are expected to remain significant and increase as the company advances selonabant's clinical development, including direct third-party costs, consultant fees, and manufacturing costs[86](index=86&type=chunk)[87](index=87&type=chunk)[88](index=88&type=chunk) - General and administrative expenses primarily consist of professional fees, insurance, personnel costs (including stock-based compensation), and rent[89](index=89&type=chunk) [Results of Operations](index=21&type=section&id=Results%20of%20Operations) This section analyzes the company's financial performance over specific periods, comparing operating expenses and net loss Operating Expenses and Net Loss Comparison | Metric | 3 Months Ended Mar 31, 2025 | 3 Months Ended Mar 31, 2024 | Period to Period Change | 9 Months Ended Mar 31, 2025 | 9 Months Ended Mar 31, 2024 | Period to Period Change | | :-------------------------- | :-------------------------- | :-------------------------- | :---------------------- | :-------------------------- | :-------------------------- | :---------------------- | | Research and development | $638,324 | $748,339 | $(110,015) | $3,173,718 | $3,081,231 | $92,487 | | General and administrative | $1,253,998 | $915,912 | $338,086 | $3,718,879 | $3,887,157 | $(168,278) | | Total operating expenses | $1,892,322 | $1,664,251 | $228,071 | $6,892,597 | $6,968,388 | $(75,791) | | Net loss | $(1,676,169) | $(1,653,542) | $(22,627) | $(6,339,935) | $(6,851,734) | $511,799 | - Research and development expenses decreased by **$0.1 million** for the three months ended March 31, 2025, primarily due to timing of clinical studies, but increased by **$0.1 million** for the nine months, driven by contract manufacturing for the IV selonabant Phase I SAD study[93](index=93&type=chunk)[94](index=94&type=chunk) - General and administrative expenses increased by **$0.3 million** for the three months ended March 31, 2025, due to higher professional fees (debt refinancing, registration statement, proxy filing) and stock-based compensation[96](index=96&type=chunk) - For the nine months, G&A decreased by **$0.2 million** due to strategic cost reductions and lower compensation, partially offset by increased stock-based compensation[97](index=97&type=chunk) - Grant income of **$0.4 million** and **$0.8 million** was recognized for the three and nine months ended March 31, 2025, respectively, from the NIDA grant, with no comparable income in the prior year[100](index=100&type=chunk) [Liquidity and Capital Resources](index=23&type=section&id=Liquidity%20and%20Capital%20Resources) This section assesses the company's ability to meet its financial obligations and fund future operations, including cash position and financing needs - As of March 31, 2025, the company had **$13.3 million** in cash and cash equivalents, expecting this, along with the Loan Agreement, to fund operations for at least the next 12 months[101](index=101&type=chunk) - The company received net proceeds of approximately **$14.9 million** from a private placement offering on December 23, 2024[101](index=101&type=chunk) - Net cash used in operating activities was **$4.7 million** for the nine months ended March 31, 2025, a decrease from **$6.0 million** in the prior-year period[106](index=106&type=chunk) - The company will need to raise additional funding in the future through equity, debt, or collaboration agreements to support its development and commercialization objectives[102](index=102&type=chunk)[109](index=109&type=chunk) [Critical Accounting Estimates](index=27&type=section&id=Critical%20Accounting%20Estimates) This section discusses accounting estimates that require significant judgment and could materially impact the financial statements - Critical accounting estimates include accrued research and development expenses, which involve estimating services performed by CROs, investigative sites, vendors, and manufacturers when invoices are not yet received[119](index=119&type=chunk) - Stock-based compensation expense is estimated using the Black-Scholes option pricing model, relying on subjective assumptions such as expected stock price volatility, expected term, risk-free rate, and expected dividends[122](index=122&type=chunk) - The company, as an 'emerging growth company' under the JOBS Act, takes advantage of extended transition periods for new accounting standards, which may affect comparability with other public companies[124](index=124&type=chunk) [Item 3. Quantitative and Qualitative Disclosures About Market Risk](index=29&type=section&id=Item%203.%20Quantitative%20and%20Qualitative%20Disclosures%20About%20Market%20Risk) This item is not required for smaller reporting companies, and therefore, no disclosures are provided - The company is a smaller reporting company and is not required to provide quantitative and qualitative disclosures about market risk[125](index=125&type=chunk) [Item 4. Controls and Procedures](index=29&type=section&id=Item%204.%20Controls%20and%20Procedures) Management, with the participation of the CEO and CFO, evaluated the effectiveness of the company's disclosure controls and procedures as of March 31, 2025, concluding they were effective at a reasonable assurance level. No material changes in internal control over financial reporting occurred during the quarter - As of March 31, 2025, the CEO and CFO concluded that the design and operation of the company's disclosure controls and procedures were effective at a reasonable assurance level[126](index=126&type=chunk)[127](index=127&type=chunk) - No changes in internal control over financial reporting materially affected, or are reasonably likely to materially affect, the company's internal control over financial reporting during the three months ended March 31, 2025[128](index=128&type=chunk) [PART II. OTHER INFORMATION](index=30&type=section&id=PART%20II.%20OTHER%20INFORMATION) [Item 1. Legal Proceedings](index=30&type=section&id=Item%201.%20Legal%20Proceedings) The company is not currently a party to any material legal proceedings, and management believes no pending claims could have a material adverse effect on its operations or financial condition - The company is not currently a party to any material legal proceedings[130](index=130&type=chunk) - Management believes there are no claims or actions pending that could have a material adverse effect on the company's results of operations or financial condition[130](index=130&type=chunk) [Item 1A. Risk Factors](index=30&type=section&id=Item%201A.%20Risk%20Factors) This section details various risks that could materially impact the company's financial position, including lack of revenue, capital needs, and policy changes - The company has not generated any revenue since inception, has an accumulated deficit of **$71.7 million** as of March 31, 2025, and expects to incur future losses, with no assurance of profitability[132](index=132&type=chunk) - The company will need to raise additional capital beyond its current resources and the Loan Agreement, which may result in substantial dilution for existing stockholders through equity issuances or involve restrictive covenants if debt financing is obtained[135](index=135&type=chunk)[137](index=137&type=chunk)[138](index=138&type=chunk) - Changes in U.S. government policies, such as limitations on NIH grant funding or trade policies, could adversely affect the company's business, reputation, financial condition, and results of operations[140](index=140&type=chunk)[141](index=141&type=chunk) - The company faces risks related to maintaining its Nasdaq Capital Market listing standards, as evidenced by a recent non-compliance issue regarding a private placement, which was subsequently resolved[142](index=142&type=chunk) [Item 2. Unregistered Sales of Equity Securities and Use of Proceeds](index=34&type=section&id=Item%202.%20Unregistered%20Sales%20of%20Equity%20Securities%20and%20Use%20of%20Proceeds) There were no unregistered sales of equity securities or issuer purchases/repurchases of equity securities during the quarter ended March 31, 2025, that were not previously disclosed - No unregistered sales of equity securities occurred during the quarter ended March 31, 2025, that were not previously disclosed[143](index=143&type=chunk) - There were no issuer purchases or repurchases of equity securities during the quarter[144](index=144&type=chunk)[145](index=145&type=chunk) [Item 3. Defaults Upon Senior Securities](index=34&type=section&id=Item%203.%20Defaults%20Upon%20Senior%20Securities) The company reported no defaults upon senior securities during the period - There were no defaults upon senior securities[146](index=146&type=chunk) [Item 4. Mine Safety Disclosures](index=34&type=section&id=Item%204.%20Mine%20Safety%20Disclosures) This item is not applicable to the company - Mine safety disclosures are not applicable to the company[147](index=147&type=chunk) [Item 5. Other Information](index=34&type=section&id=Item%205.%20Other%20Information) No directors or officers adopted or terminated Rule 10b5-1 or non-Rule 10b5-1 trading arrangements during the three months ended March 31, 2025 - No director or officer adopted or terminated a 'Rule 10b5-1 trading arrangement' or 'non-Rule 10b5-1 trading arrangement' during the three months ended March 31, 2025[148](index=148&type=chunk) [Item 6. Exhibits](index=35&type=section&id=Item%206.%20Exhibits) This section lists all exhibits filed with the Quarterly Report on Form 10-Q, including corporate governance documents and certifications - Exhibits include various amendments to the company's Certificate of Incorporation and Amended and Restated Bylaws, reflecting changes such as the increase in authorized common stock and board declassification[150](index=150&type=chunk)[152](index=152&type=chunk) - A Lock-Up Agreement and Irrevocable Instruction Letter, both dated February 24, 2025, related to 22NW Fund, LP, are filed as exhibits[152](index=152&type=chunk) - Certifications from the Principal Executive Officer and Principal Financial Officer, pursuant to the Securities Exchange Act of 1934 and the Sarbanes-Oxley Act of 2002, are included[152](index=152&type=chunk) [Signatures](index=36&type=section&id=Signatures) [Report Signatures](index=36&type=section&id=Report%20Signatures) The report is duly signed on behalf of Anebulo Pharmaceuticals, Inc. by Richard Anthony Cunningham, Chief Executive Officer, and Daniel George, Chief Financial Officer, on May 13, 2025 - The report was signed by Richard Anthony Cunningham, Chief Executive Officer (Principal Executive Officer), and Daniel George, Chief Financial Officer (Principal Financial and Accounting Officer), on May 13, 2025[155](index=155&type=chunk)

[FORM 8-K Filing Information](index=1&type=section&id=FORM%208-K%20Filing%20Information) This section provides essential details about Anebulo Pharmaceuticals, Inc. as the registrant and specifics of the Form 8-K filing [Registrant Information](index=1&type=section&id=Registrant%20Information) This section identifies Anebulo Pharmaceuticals, Inc. as the registrant, detailing its state of incorporation, principal executive offices, and contact information - Registrant: **Anebulo Pharmaceuticals, Inc.**, incorporated in Delaware[2](index=2&type=chunk) - Principal Executive Offices: 1017 Ranch Road 620 South, Suite 107, Lakeway, TX 78734[2](index=2&type=chunk) - Registrant's Telephone Number: (512) 598-0931[3](index=3&type=chunk) [Filing Details](index=1&type=section&id=Filing%20Details) This subsection specifies the filing date of the Form 8-K, lists the company's registered securities, and confirms its status as an emerging growth company - Date of Report (Date of earliest event reported): May 13, 2025[2](index=2&type=chunk) Securities Registered | Title of each class | Trading Symbol(s) | Name of each exchange on which registered | | :------------------ | :---------------- | :---------------------------------------- | | Common Stock, $.0.001 par value per share | ANEB | The Nasdaq Stock Market LLC | - **Anebulo Pharmaceuticals, Inc.** is an emerging growth company[4](index=4&type=chunk) [Item 2.02 Results of Operations and Financial Condition](index=3&type=section&id=Item%202.02%20Results%20of%20Operations%20and%20Financial%20Condition) This section details the announcement of Anebulo Pharmaceuticals, Inc.'s financial results and business update for the quarter ended March 31, 2025 [Financial Results Announcement](index=3&type=section&id=Financial%20Results%20Announcement) Anebulo Pharmaceuticals, Inc. announced its financial results for the quarter ended March 31, 2025, and provided a business update through a press release issued on May 13, 2025, which is furnished as Exhibit 99.1 - **Anebulo Pharmaceuticals, Inc.** issued a press release on May 13, 2025[5](index=5&type=chunk) - The press release announced financial results for the quarter ended March 31, 2025, and provided a business update[5](index=5&type=chunk) - The press release is furnished as Exhibit 99.1 to this Current Report on Form 8-K[5](index=5&type=chunk) [Item 9.01 Financial Statements and Exhibits](index=3&type=section&id=Item%209.01%20Financial%20Statements%20and%20Exhibits) This section provides a comprehensive list of all exhibits included in the Form 8-K filing, such as the press release and interactive data file [Exhibits List](index=3&type=section&id=Exhibits%20List) This section lists the exhibits accompanying the Form 8-K filing, including the press release detailing financial results and the interactive data file cover page List of Exhibits | Exhibit Number | Description | | :------------- | :---------- | | 99.1 | Press Release dated May 13, 2025 | | 104 | Cover Page of Interactive Data File (embedded within the Inline XBRL document). | [Signatures](index=4&type=section&id=SIGNATURES) This section formally documents the authorization and signing of the Form 8-K report by the Chief Executive Officer [Authorization and Signatory](index=4&type=section&id=Authorization%20and%20Signatory) This section confirms the official signing of the Form 8-K report by Richard Anthony Cunningham, Chief Executive Officer of Anebulo Pharmaceuticals, Inc., on May 13, 2025 - The report was signed on behalf of **Anebulo Pharmaceuticals, Inc.** on May 13, 2025[11](index=11&type=chunk) - Signed by **Richard Anthony Cunningham**, Chief Executive Officer (Principal Executive Officer)[11](index=11&type=chunk)

[Special Note Regarding Forward-Looking Statements](index=4&type=section&id=SPECIAL%20NOTE%20REGARDING%20FORWARD-LOOKING%20STATEMENTS) This section highlights forward-looking statements in the report, subject to risks and uncertainties that could cause actual results to differ materially - This section highlights that the Quarterly Report contains forward-looking statements subject to 'safe harbor' provisions, which involve substantial risks and uncertainties that could cause actual results to differ materially from expectations. Readers are cautioned not to place undue reliance on these statements and to review the 'Risk Factors' section[9](index=9&type=chunk)[10](index=10&type=chunk)[11](index=11&type=chunk) - Forward-looking statements include expectations regarding capital requirements, regulatory submissions, clinical trial timing and conduct, clinical utility and approval likelihood of selonabant, future growth, intellectual property, licensing arrangements, commercial potential, supplier performance, competition, economic/political impacts, and governmental regulations[12](index=12&type=chunk) [PART I. FINANCIAL INFORMATION](index=5&type=section&id=PART%20I.%20FINANCIAL%20INFORMATION) This part presents the unaudited condensed financial statements and management's discussion and analysis for the reported periods [Item 1. Financial Statements (Unaudited)](index=5&type=section&id=Item%201.%20Financial%20Statements%20%28Unaudited%29) This section presents Anebulo Pharmaceuticals, Inc.'s unaudited condensed financial statements for periods ended December 31, 2024, and June 30, 2024 [Condensed Balance Sheets](index=5&type=section&id=Condensed%20Balance%20Sheets) This statement provides a snapshot of the company's financial position, detailing assets, liabilities, and stockholders' equity at specific points in time Condensed Balance Sheets Data | Metric | December 31, 2024 ($) | June 30, 2024 ($) | Change ($) | % Change | | :-------------------------- | :------------------ | :---------------- | :------- | :------- | | Cash and cash equivalents | $14,998,467 | $3,094,200 | $11,904,267 | 384.7% | | Total current assets | $15,395,489 | $3,507,990 | $11,887,499 | 338.9% | | Total assets | $15,841,220 | $4,073,114 | $11,768,106 | 289.0% | | Total liabilities | $878,799 | $260,583 | $618,216 | 237.2% | | Total stockholders' equity | $14,962,421 | $3,812,531 | $11,149,890 | 292.4% | - The **significant increase** in **cash and cash equivalents**, total assets, and total stockholders' equity is **primarily due to** net proceeds of approximately **$15.0 million** from a **private placement offering** in **December 2024**[14](index=14&type=chunk)[27](index=27&type=chunk)[95](index=95&type=chunk) [Condensed Statements of Operations](index=6&type=section&id=Condensed%20Statements%20of%20Operations) This statement reports the company's revenues, expenses, and net loss over specific reporting periods, reflecting operational performance Condensed Statements of Operations Data | Metric | Three Months Ended Dec 31, 2024 ($) | Three Months Ended Dec 31, 2023 ($) | Change (YoY) ($) | Six Months Ended Dec 31, 2024 ($) | Six Months Ended Dec 31, 2023 ($) | Change (YoY) ($) | | :-------------------------- | :------------------------------ | :------------------------------ | :----------- | :---------------------------- | :---------------------------- | :----------- | | Research and development | $1,220,535 | $1,062,672 | $157,863 | $2,535,394 | $2,332,892 | $202,502 | | General and administrative | $1,367,616 | $1,697,787 | $(330,171) | $2,464,881 | $2,971,245 | $(506,364) | | Total operating expenses | $2,588,151 | $2,760,459 | $(172,308) | $5,000,275 | $5,304,137 | $(303,862) | | Net loss | $(2,463,030) | $(2,717,369) | $254,339 | $(4,663,766) | $(5,198,192) | $534,426 | | Net loss per share (basic & diluted) | $(0.09) | $(0.11) | $0.02 | $(0.17) | $(0.20) | $0.03 | | Grant income | $(177,703) | $- | $(177,703) | $(423,065) | $- | $(423,065) | - Net loss **decreased by** **$254,339** for the three months and **$534,426** for the six months ended **December 31, 2024**, **primarily due to a decrease** in general and administrative expenses and the **recognition of grant income**, **partially offset by increased** research and development expenses[17](index=17&type=chunk)[86](index=86&type=chunk)[91](index=91&type=chunk)[94](index=94&type=chunk) [Condensed Statements of Stockholders' Equity](index=7&type=section&id=Condensed%20Statements%20of%20Stockholders%27%20Equity) This statement details changes in the company's equity accounts, including common stock, additional paid-in capital, and accumulated deficit, over the reporting period Condensed Statements of Stockholders' Equity Data | Metric | Balance at June 30, 2024 ($) | Balance at December 31, 2024 ($) | Change ($) | | :-------------------------- | :----------------------- | :--------------------------- | :----- | | Common Stock Shares | 25,933,217 | 41,084,731 | 15,151,514 | | Common Stock Amount | $25,934 | $41,086 | $15,152 | | Additional Paid-in Capital | $69,190,341 | $84,988,845 | $15,798,504 | | Accumulated Deficit | $(65,403,744) | $(70,067,510) | $(4,663,766) | | Total Stockholders' Equity | $3,812,531 | $14,962,421 | $11,149,890 | - The **significant increase** in **common stock shares** and additional paid-in capital is **primarily due to** the issuance of **15,151,514 shares** in a private placement in **December 2024**, **generating approximately** **$15.0 million** in gross proceeds[20](index=20&type=chunk)[47](index=47&type=chunk) - Stock-based compensation expense recognized during the six months ended **December 31, 2024**, was **$851,253**, **contributing to the increase** in additional paid-in capital[20](index=20&type=chunk)[54](index=54&type=chunk) [Condensed Statements of Cash Flows](index=8&type=section&id=Condensed%20Statements%20of%20Cash%20Flows) This statement summarizes cash inflows and outflows from operating, investing, and financing activities for the reporting periods Condensed Statements of Cash Flows Data | Cash Flow Activity ($) | Six Months Ended Dec 31, 2024 ($) | Six Months Ended Dec 31, 2023 ($) | Change ($) | | :-------------------------- | :---------------------------- | :---------------------------- | :----- | | Net cash used in operating activities | $(3,095,733) | $(4,540,532) | $1,444,799 | | Net cash provided by (used in) financing activities | $15,000,000 | $(62,354) | $15,062,354 | | Net increase (decrease) in cash | $11,904,267 | $(4,602,886) | $16,507,153 | | Cash, end of the period | $14,998,467 | $6,644,517 | $8,353,950 | - The company experienced a **significant net increase in cash** during the six months ended **December 31, 2024**, **primarily driven by** **$15.0 million** in proceeds from the **issuance of common stock** through a private placement[23](index=23&type=chunk)[100](index=100&type=chunk) - Net cash used in operating activities **decreased by approximately** **$1.4 million** compared to the prior year period, mainly due to a **lower net loss and favorable changes** in operating assets and liabilities[23](index=23&type=chunk)[100](index=100&type=chunk)[101](index=101&type=chunk) [Notes to Unaudited Condensed Financial Statements](index=9&type=section&id=Notes%20to%20Unaudited%20Condensed%20Financial%20Statements) These notes provide essential context for the condensed financial statements, covering business nature, liquidity, accounting policies, and specific financial line items - Anebulo Pharmaceuticals, Inc. is a clinical-stage pharmaceutical company developing treatments for cannabis-induced toxicity, with its principal operations in Lakeway, Texas[26](index=26&type=chunk) - The company has incurred an accumulated deficit of **$70.1 million** as of **December 31, 2024**, and **expects to continue generating operating losses**, **necessitating additional funding** for its development and commercialization objectives[27](index=27&type=chunk)[29](index=29&type=chunk)[127](index=127&type=chunk) - In **December 2024**, the company completed a private placement, issuing **15,151,514 shares of common stock** for **approximately $15.0 million** in gross proceeds, **significantly boosting its cash and cash equivalents**[47](index=47&type=chunk)[79](index=79&type=chunk) - The company was **awarded a two-year cooperative grant** of up to **$1.9 million** from NIDA in **July 2024** to **support the development of intravenous selonabant** for pediatric cannabis-induced toxicities, **recognizing** **$0.4 million** in grant income for the six months ended **December 31, 2024**[59](index=59&type=chunk)[61](index=61&type=chunk)[78](index=78&type=chunk)[94](index=94&type=chunk) - The **Loan and Security Agreement (LSA)** with 22NW, LP and JFL Capital Management LLC, initially allowing up to **$10 million**, was **modified in February 2025** to **reduce the maximum advance to** **$3 million**, **remove securitization provisions**, and **assign 22NW's interest to** 22NW Fund, LP. **No balance was outstanding** as of **December 31, 2024**, or **February 14, 2025**[56](index=56&type=chunk)[62](index=62&type=chunk)[63](index=63&type=chunk)[77](index=77&type=chunk)[96](index=96&type=chunk)[97](index=97&type=chunk) - Stock-based compensation expense for the six months ended **December 31, 2024**, was **approximately $0.9 million**, an **increase from $0.4 million** in the prior year, due to grants of options with immediate vesting terms in June and **December 2024**[54](index=54&type=chunk)[91](index=91&type=chunk) [Item 2. Management's Discussion and Analysis of Financial Condition and Results of Operations](index=16&type=section&id=Item%202.%20Management%27s%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) This section provides management's perspective on financial condition, results of operations, business developments, liquidity, and critical accounting estimates [Overview](index=16&type=section&id=Overview) This overview introduces Anebulo Pharmaceuticals, Inc.'s focus on developing selonabant for cannabis-induced toxicity, prioritizing an intravenous formulation for pediatric patients - Anebulo is a clinical-stage pharmaceutical company focused on developing selonabant (formerly ANEB-001) to rapidly reverse cannabis-induced toxicity, including unintentional poisoning in children and acute cannabinoid intoxication (ACI) in adults[65](index=65&type=chunk)[73](index=73&type=chunk) - The company is **prioritizing the advancement** of an intravenous (IV) selonabant formulation for pediatric patients with cannabis-induced CNS depression, believing it offers a **faster path to approval** compared to the adult oral product[70](index=70&type=chunk)[71](index=71&type=chunk)[89](index=89&type=chunk) - The FDA has acknowledged the **unmet need** for pediatric cannabis toxicity treatment and proposed close collaboration. A Phase I single ascending dose (SAD) study of IV selonabant in healthy adults is planned for 1H25[70](index=70&type=chunk) - The company holds U.S. Patent No. **11,795,146** for crystalline forms of selonabant and methods of use, providing **patent protection through** **2042**[75](index=75&type=chunk)[76](index=76&type=chunk) [Components of Results of Operations](index=19&type=section&id=Components%20of%20Results%20of%20Operations) This section describes primary components influencing financial performance, including R&D, G&A expenses, and the absence of revenue - The company has **not generated any revenue since inception** and **expects to continue generating operating losses** and negative cash flows as it advances clinical development[80](index=80&type=chunk) - Research and development expenses, which are expensed as incurred, are **expected to significantly increase** as the company develops selonabant and conducts clinical trials, particularly for the IV formulation[82](index=82&type=chunk)[83](index=83&type=chunk)[84](index=84&type=chunk)[89](index=89&type=chunk) - General and administrative expenses primarily consist of professional fees, insurance, personnel costs (including stock-based compensation), and rent[85](index=85&type=chunk) [Results of Operations](index=20&type=section&id=Results%20of%20Operations) This section analyzes the company's financial performance for the reported periods, focusing on changes in operating expenses, grant income, and net loss Results of Operations Data | Metric | Three Months Ended Dec 31, 2024 ($) | Three Months Ended Dec 31, 2023 ($) | Change (YoY) ($) | Six Months Ended Dec 31, 2024 ($) | Six Months Ended Dec 31, 2023 ($) | Change (YoY) ($) | | :-------------------------- | :------------------------------ | :------------------------------ | :----------- | :---------------------------- | :---------------------------- | :----------- | | Research and development | $1,220,535 | $1,062,672 | $157,863 | $2,535,394 | $2,332,892 | $202,502 | | General and administrative | $1,367,616 | $1,697,787 | $(330,171) | $2,464,881 | $2,971,245 | $(506,364) | | Net loss | $(2,463,030) | $(2,717,369) | $254,339 | $(4,663,766) | $(5,198,192) | $534,426 | | Grant income | $(177,703) | $- | $(177,703) | $(423,065) | $- | $(423,065) | - Research and development expenses **increased by** **$0.2 million** for the six months ended **December 31, 2024**, driven by increased pre-clinical, nonclinical, and clinical studies expenses as the company **prioritizes the IV selonabant formulation**[89](index=89&type=chunk) - General and administrative expenses **decreased by** **$0.5 million** for the six months ended **December 31, 2024**, **primarily due to** reduced compensation and professional/consultant fees, **partially offset by higher** stock-based compensation[91](index=91&type=chunk) - The company **recognized** **$0.4 million** in grant income for the six months ended **December 31, 2024**, from the NIDA grant, with no comparable income in the prior year[94](index=94&type=chunk) [Liquidity and Capital Resources](index=22&type=section&id=Liquidity%20and%20Capital%20Resources) This section discusses the company's ability to meet financial obligations, detailing cash position, funding sources, and future capital requirements - As of **December 31, 2024**, the company had **$15.0 million** in **cash and cash equivalents**, **significantly bolstered by a $15.0 million private placement offering** in **December 2024**[95](index=95&type=chunk) - The company **expects its current cash** and available funding under the Loan Agreement to **fund operations and capital expenditures for at least the next 12 months** from the filing date[102](index=102&type=chunk) - Future funding will be required through equity/debt financings or collaboration agreements, with **potential risks of dilution** for existing stockholders and restrictions from debt financing[103](index=103&type=chunk)[130](index=130&type=chunk)[132](index=132&type=chunk)[133](index=133&type=chunk) Liquidity and Capital Resources Data | Cash Flow Activity ($) | Six Months Ended Dec 31, 2024 ($) | Six Months Ended Dec 31, 2023 ($) | Change ($) | | :-------------------------- | :---------------------------- | :---------------------------- | :----- | | Net cash used in operating activities | $(3,095,733) | $(4,540,532) | $1,444,799 | | Net cash provided by (used in) financing activities | $15,000,000 | $(62,354) | $15,062,354 | | Net increase (decrease) in cash | $11,904,267 | $(4,602,886) | $16,507,153 | [Contractual Obligations and Commitments](index=24&type=section&id=Contractual%20Obligations%20and%20Commitments) This section outlines the company's significant contractual obligations, including licensing agreements and manufacturing commitments, and their potential financial impact - The company has an exclusive worldwide royalty-bearing license agreement with Vernalis Development Limited for selonabant, involving **potential development milestone payments** up to **$29.9 million** (of which **$0.4 million** paid) and **sales milestone payments** up to **$35.0 million**, plus **single-digit royalties**[106](index=106&type=chunk) - A manufacturing agreement with a third-party CMO for **approximately $3.0 million** was **substantially completed** as of **June 30, 2024**, with the stability study aspect expected to be incurred during calendar **2026**[109](index=109&type=chunk) [Critical Accounting Estimates](index=26&type=section&id=Critical%20Accounting%20Estimates) This section describes accounting policies requiring management's most difficult judgments and estimates, such as accrued R&D and stock-based compensation - Key accounting estimates include **accrued research and development expenses**, which involve estimating services performed by CROs, investigative sites, and vendors when invoices are not yet received[113](index=113&type=chunk)[114](index=114&type=chunk)[115](index=115&type=chunk) - **Stock-based compensation expense is estimated** using the Black-Scholes option pricing model, relying on subjective assumptions such as expected stock price volatility, expected term, risk-free rate, and expected dividends[117](index=117&type=chunk) - The company, as an 'emerging growth company' under the JOBS Act, **elects to use extended transition periods** for new or revised accounting standards, which **may affect comparability** with other public companies[119](index=119&type=chunk) [Item 3. Quantitative and Qualitative Disclosures About Market Risk](index=28&type=section&id=Item%203.%20Quantitative%20and%20Qualitative%20Disclosures%20About%20Market%20Risk) This item is not required for smaller reporting companies, thus no disclosures regarding quantitative and qualitative market risk are provided - The company is a smaller reporting company and is **not required to provide** quantitative and qualitative disclosures about market risk[120](index=120&type=chunk) [Item 4. Controls and Procedures](index=28&type=section&id=Item%204.%20Controls%20and%20Procedures) This section details management's evaluation of disclosure controls and procedures and reports on any changes in internal control over financial reporting [Evaluation of Disclosure Controls and Procedures](index=28&type=section&id=Evaluation%20of%20Disclosure%20Controls%20and%20Procedures) This section presents management's conclusion on the effectiveness of the company's disclosure controls and procedures as of the reporting period - As of **December 31, 2024**, management, including the CEO and CFO, concluded that the design and operation of the company's disclosure controls and procedures were **effective at a reasonable assurance level**[121](index=121&type=chunk)[122](index=122&type=chunk) [Changes in Internal Control over Financial Reporting](index=28&type=section&id=Changes%20in%20Internal%20Control%20over%20Financial%20Reporting) This section reports on any material changes in the company's internal control over financial reporting during the most recent fiscal quarter - There were **no changes in internal control over financial reporting** during the three months ended **December 31, 2024**, that materially affected, or are reasonably likely to materially affect, the company's internal control over financial reporting[123](index=123&type=chunk) [PART II. OTHER INFORMATION](index=29&type=section&id=PART%20II.%20OTHER%20INFORMATION) This part provides additional non-financial information, including legal proceedings, risk factors, equity sales, and other material disclosures [Item 1. Legal Proceedings](index=29&type=section&id=Item%201.%20Legal%20Proceedings) This section confirms the company is not currently a party to any material legal proceedings that could adversely affect its financial condition - The company is **not currently a party to any material legal proceedings**, and management believes there are no claims or actions pending that could have a material adverse effect on its results of operations or financial condition[125](index=125&type=chunk) [Item 1A. Risk Factors](index=29&type=section&id=Item%201A.%20Risk%20Factors) This section outlines various risks that could materially impact the company's financial position, results of operations, or cash flows - The company has **not generated any revenue since inception** and has an accumulated deficit of **$70.1 million** as of **December 31, 2024**, **expecting to incur significant future operating losses and negative cash flows**[127](index=127&type=chunk) - The company **will need to raise additional capital** to fund operations and development, which may not be available on acceptable terms or at all, potentially leading to **substantial dilution** for existing stockholders through equity issuances[130](index=130&type=chunk)[131](index=131&type=chunk)[132](index=132&type=chunk) - Changes in U.S. government policies, including **potential limits on NIH research funding** for 'indirect costs' and **trade policies, could adversely affect** the company's ability to realize grant benefits and obtain future funding[135](index=135&type=chunk)[136](index=136&type=chunk)[137](index=137&type=chunk) - The **future success of the business is uncertain**, with **challenges including inadequate financial resources**, **inability to manufacture commercially**, **delays in clinical testing**, and **difficulties in obtaining regulatory approval and market acceptance** for its product candidates[128](index=128&type=chunk)[129](index=129&type=chunk) [Item 2. Unregistered Sales of Equity Securities and Use of Proceeds](index=33&type=section&id=Item%202.%20Unregistered%20Sales%20of%20Equity%20Securities%20and%20Use%20of%20Proceeds) This section reports on the company's unregistered sales of equity securities and any issuer purchases or repurchases during the quarter - The company **did not sell any equity securities in unregistered transactions** during the quarter ended **December 31, 2024**, other than previously disclosed filings[138](index=138&type=chunk) - There were **no issuer purchases or repurchases of equity securities** during the reported period[139](index=139&type=chunk)[140](index=140&type=chunk) [Item 3. Defaults Upon Senior Securities](index=33&type=section&id=Item%203.%20Defaults%20Upon%20Senior%20Securities) This item confirms that the company has not defaulted on any senior securities during the reported period - The company reported **no defaults upon senior securities**[141](index=141&type=chunk) [Item 4. Mine Safety Disclosures](index=33&type=section&id=Item%204.%20Mine%20Safety%20Disclosures) This item is not applicable to the company's operations - This item is **not applicable to the company**[142](index=142&type=chunk) [Item 5. Other Information](index=33&type=section&id=Item%205.%20Other%20Information) This section discloses material events not otherwise reported, specifically a modification to the Loan and Security Agreement and insider trading arrangements - On **February 10, 2025**, the **Loan and Security Agreement (LSA)** was **modified**, **reducing the maximum loan advance to** **$3 million**, **removing all securitization provisions**, and **assigning 22NW's interest to** 22NW Fund, LP. The loan will accrue interest at **0.25%** per annum and is due **February 10, 2028**[143](index=143&type=chunk) - As of **December 31, 2024**, and **February 14, 2025**, there was **no balance outstanding** under the LSA or the **amended Loan Agreement**[143](index=143&type=chunk) - **No director or officer adopted or terminated** a 'Rule 10b5-1 trading arrangement' or 'non-Rule 10b5-1 trading arrangement' during the three months ended **December 31, 2024**[144](index=144&type=chunk) [Item 6. Exhibits](index=34&type=section&id=Item%206.%20Exhibits) This section lists all exhibits filed as part of the Form 10-Q, including corporate governance documents, material agreements, and certifications - The exhibits include corporate documents (e.g., Certificate of Incorporation, Bylaws), material agreements (e.g., Securities Purchase Agreement, Amended and Restated Loan Agreement), and **certifications pursuant to Sarbanes-Oxley Act**[146](index=146&type=chunk) [Signatures](index=35&type=section&id=Signatures) This section contains the required signatures of the registrant's authorized officers, certifying the filing of the report - The report is **signed by Richard Anthony Cunningham, Chief Executive Officer, and Daniel George, Chief Financial Officer**, on **February 14, 2025**, **certifying its submission**[149](index=149&type=chunk)[150](index=150&type=chunk)

[Report Overview and Recent Highlights](index=1&type=section&id=Report%20Overview%20and%20Recent%20Highlights) [Introduction](index=1&type=section&id=Introduction) Anebulo Pharmaceuticals announced financial results for the second quarter of fiscal year 2025, which ended December 31, 2024, along with key recent updates regarding its clinical development and financing activities - Anebulo Pharmaceuticals, a clinical-stage company, reported Q2 FY2025 financial results and recent updates[1](index=1&type=chunk)[2](index=2&type=chunk) [CEO Commentary](index=1&type=section&id=CEO%20Commentary) CEO Richie Cunningham expressed gratitude for continued investor support, highlighting confidence in the company's future, and emphasized the significant unmet medical need for an emergency antidote to acute cannabis-induced toxicity, particularly in children - CEO Richie Cunningham acknowledged strong investor confidence and the significant unmet medical need for an emergency antidote to acute cannabis-induced toxicity, especially in children[4](index=4&type=chunk)[5](index=5&type=chunk) - Research indicates children are more sensitive to cannabis toxicity, leading to more serious outcomes and higher hospitalization risk[5](index=5&type=chunk) - FDA confirmed the unmet need for pediatric cannabis toxicity treatment and suggested close collaboration for selonabant's development in this indication[6](index=6&type=chunk) [Second Quarter Fiscal Year 2025 and Subsequent Highlights](index=1&type=section&id=Second%20Quarter%20Fiscal%20Year%202025%20and%20Subsequent%20Highlights) Anebulo provided key updates including progress in clinical development for intravenous selonabant, particularly for pediatric cannabis toxicity, and significant financing activities [Clinical Development Updates](index=1&type=section&id=Clinical%20Development%20Updates) Anebulo met with the FDA to discuss the development of intravenous selonabant, receiving acknowledgment of the unmet need for pediatric cannabis toxicity treatment and a proposal for close collaboration, and plans to initiate a Phase 1 SAD study in 1H25 - In December 2024, Anebulo met with the FDA to discuss intravenous selonabant development, with the FDA acknowledging the unmet need for pediatric cannabis toxicity treatment and proposing close collaboration[7](index=7&type=chunk) - Anebulo plans to begin its Phase 1 single ascending dose (SAD) study of intravenous selonabant in healthy adults in 1H25[7](index=7&type=chunk) [Financing and Corporate Updates](index=1&type=section&id=Financing%20and%20Corporate%20Updates) The company secured $15 million in gross proceeds from a private placement offering in December 2024 and amended its Loan and Security Agreement in February 2025, reducing the maximum loan size to $3 million and removing securitization provisions - In December 2024, Anebulo completed a private placement offering, issuing **15.2 million shares** of common stock for gross proceeds of **$15 million**[7](index=7&type=chunk) - In February 2025, the Loan and Security Agreement with 22NW and JFL Capital Management was amended, reducing the maximum loan size to approximately **$3 million** and removing all securitization provisions[7](index=7&type=chunk) [Financial Results for Q2 FY2025](index=2&type=section&id=Financial%20Results%20for%20the%20three%20months%20ended%20December%2031%2C%202024) [Summary of Financial Performance](index=2&type=section&id=Summary%20of%20Financial%20Performance) For Q2 FY2025, Anebulo's operating expenses decreased slightly to $2.6 million, leading to a reduced net loss of $2.5 million, or $(0.09) per share, while cash and cash equivalents significantly increased to $15.0 million, with an additional $3 million available via a loan agreement Key Financial Highlights (Q2 FY2025 vs. Q2 FY2024) | Metric | Q2 FY2025 (3 months ended Dec 31, 2024) | Q2 FY2024 (3 months ended Dec 31, 2023) | Change | | :----------------------- | :-------------------------------------- | :-------------------------------------- | :----- | | Operating Expenses | $2.6 million | $2.8 million | -7.1% | | Net Loss | $(2.5) million | $(2.7) million | -7.4% | | Net Loss per Share | $(0.09) | $(0.11) | -18.2% | - Cash and cash equivalents were **$15.0 million** as of December 31, 2024, with an additional **$3 million** accessible through a Loan Agreement[10](index=10&type=chunk) [Condensed Balance Sheets](index=4&type=section&id=Condensed%20Balance%20Sheets) As of December 31, 2024, Anebulo's cash and cash equivalents significantly increased to nearly $15.0 million from $3.1 million at June 30, 2024, driving a substantial increase in total assets and stockholders' equity Condensed Balance Sheet Data (as of Dec 31, 2024 vs. Jun 30, 2024) | Metric | Dec 31, 2024 ($) | Jun 30, 2024 ($) | Change | | :---------------------- | :----------- | :----------- | :----- | | Cash and cash equivalents | $14,998,467 | $3,094,200 | +384.7% | | Total assets | $15,841,220 | $4,073,114 | +288.9% | | Total liabilities | $878,799 | $260,583 | +237.3% | | Total stockholders' equity | $14,962,421 | $3,812,531 | +292.5% | [Condensed Statements of Operations](index=4&type=section&id=Condensed%20Statements%20of%20Operations) For the three months ended December 31, 2024, Anebulo reported a net loss of $2.46 million, an improvement from $2.72 million in the prior year, primarily due to decreased general and administrative expenses and the recognition of grant income Condensed Statements of Operations (3 months ended Dec 31) | Metric | 2024 ($) | 2023 ($) | Change | | :-------------------------- | :----------- | :----------- | :----- | | Research and development | $1,220,535 | $1,062,672 | +14.8% | | General and administrative | $1,367,616 | $1,697,787 | -19.4% | | Total operating expenses | $2,588,151 | $2,760,459 | -6.2% | | Loss from operations | $(2,588,151) | $(2,760,459) | -6.2% | | Interest expense | $59,696 | $31,838 | +87.5% | | Interest income | $(7,067) | $(75,522) | -90.7% | | Grant income | $(177,703) | $- | N/A | | Total other income, net | $(125,121) | $(43,090) | +190.4% | | Net loss | $(2,463,030) | $(2,717,369) | -9.4% | | Weighted average common shares outstanding | 27,415,430 | 25,789,739 | +6.3% | | Net loss per share | $(0.09) | $(0.11) | -18.2% | [About Selonabant (ANEB-001)](index=2&type=section&id=About%20Selonabant%20%28ANEB-001%29) [Product Overview and Clinical Status](index=2&type=section&id=Product%20Overview%20and%20Clinical%20Status) Selonabant (ANEB-001) is Anebulo's lead product candidate, a CB1 receptor antagonist, being developed as an antidote for acute cannabis-induced toxicity in both adults and pediatric subjects, showing promise in Phase 2 studies for oral administration and now being developed as an intravenous treatment with a strategic focus on the pediatric indication - Selonabant (ANEB-001) is a potent, small molecule antagonist of the cannabinoid receptor type-1 (CB1), developed as an antidote for acute cannabis-induced toxicity[9](index=9&type=chunk) - Oral selonabant successfully blocked or reversed key CNS effects of THC in a Phase 2 proof-of-concept study in adults and was well tolerated[9](index=9&type=chunk) - The company is developing selonabant for intravenous administration, with a strategic focus on pediatric patients with acute cannabis-induced toxicity, believing this offers a faster timeline to approval[9](index=9&type=chunk)[11](index=11&type=chunk) - An observational study is ongoing in Emergency Departments to gather data on cannabinoid concentrations, signs/symptoms, and patient disposition[9](index=9&type=chunk) [About Anebulo Pharmaceuticals, Inc.](index=3&type=section&id=About%20Anebulo%20Pharmaceuticals%2C%20Inc.) [Company Profile and Strategic Focus](index=3&type=section&id=Company%20Profile%20and%20Strategic%20Focus) Anebulo Pharmaceuticals is a clinical-stage company focused on developing novel solutions for cannabis-induced toxicity, strategically prioritizing the development of an intravenous formulation of selonabant for pediatric patients, aiming for a faster regulatory pathway compared to the adult oral product - Anebulo Pharmaceuticals is a clinical-stage company developing solutions for cannabis-induced toxicity[11](index=11&type=chunk) - The company is prioritizing the advancement of an IV formulation of selonabant for pediatric patients with acute cannabis-induced toxicity, expecting a faster approval timeline than the adult oral product[11](index=11&type=chunk) - Selonabant is a competitive antagonist at the human CB1 receptor[11](index=11&type=chunk) [Legal and Contact Information](index=3&type=section&id=Legal%20and%20Contact%20Information) [Forward-Looking Statements](index=3&type=section&id=Forward-Looking%20Statements) The forward-looking statements caution investors about risks and uncertainties related to Anebulo's regulatory strategy, clinical trial success, funding, regulatory approvals, market acceptance, intellectual property, and ability to retain key employees or maintain Nasdaq listing - Statements regarding future performance are subject to risks and uncertainties, including Anebulo's ability to pursue its regulatory strategy, complete clinical trials, obtain funding, and achieve regulatory approvals[12](index=12&type=chunk) - Key risks include the ability of selonabant to rapidly reverse cannabis toxicity symptoms, the IV formulation's potential for faster approval, and maintaining license agreements and patent estate[12](index=12&type=chunk) [Contacts](index=3&type=section&id=CONTACTS) Contact information for Anebulo Pharmaceuticals' Chief Financial Officer, Daniel George, is provided for inquiries - For inquiries, contact Daniel George, Chief Financial Officer of Anebulo Pharmaceuticals, Inc[13](index=13&type=chunk)

[Special Note Regarding Forward-Looking Statements](index=4&type=section&id=Special%20Note%20Regarding%20Forward-Looking%20Statements) The report contains forward-looking statements regarding future financial condition, business strategy, plans, and management objectives, which are subject to substantial risks and uncertainties - The report contains forward-looking statements regarding future financial condition, business strategy, plans, and management objectives, which are subject to substantial risks and uncertainties[5](index=5&type=chunk) - Key areas of forward-looking statements include capital requirements, timing/outcome of regulatory submissions, clinical trial conduct, clinical utility and approval likelihood of selonabant, future growth, intellectual property, licensing, commercial potential, supplier performance, competition, economic/political impacts, and governmental regulations[6](index=6&type=chunk) [PART I. FINANCIAL INFORMATION](index=5&type=section&id=PART%20I.%20FINANCIAL%20INFORMATION) [Item 1. Financial Statements (Unaudited)](index=5&type=section&id=Item%201.%20Financial%20Statements%20(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 detailed notes explaining the nature of business, accounting policies, and specific financial line items [Condensed Balance Sheets as of September 30, 2024 and June 30, 2024](index=5&type=section&id=Condensed%20Balance%20Sheets%20as%20of%20September%2030,%202024%20and%20June%2030,%202024) The balance sheets show a decrease in total assets from **$4.07 million** at June 30, 2024, to **$2.47 million** at September 30, 2024, primarily driven by a reduction in cash and cash equivalents. Total liabilities increased significantly from **$0.26 million** to **$0.57 million**, while total stockholders' equity decreased from **$3.81 million** to **$1.90 million** Condensed Balance Sheet Highlights | Metric | Sep 30, 2024 | Jun 30, 2024 | Change | | :------------------------- | :----------- | :----------- | :----- | | Cash and cash equivalents | $1,404,211 | $3,094,200 | $(1,689,989) | | Total current assets | $1,962,513 | $3,507,990 | $(1,545,477) | | Total assets | $2,467,940 | $4,073,114 | $(1,605,174) | | Total liabilities | $569,225 | $260,583 | $308,642 | | Total stockholders' equity | $1,898,715 | $3,812,531 | $(1,913,816) | [Condensed Statements of Operations for the Three Months Ended September 30, 2024 and September 30, 2023](index=6&type=section&id=Condensed%20Statements%20of%20Operations%20for%20the%20Three%20Months%20Ended%20September%2030,%202024%20and%20September%2030,%202023) For the three months ended September 30, 2024, the company reported a net loss of **$2.20 million**, an improvement from **$2.48 million** in the prior year period, primarily due to decreased general and administrative expenses and increased grant income Condensed Statements of Operations Highlights | Metric | Sep 30, 2024 | Sep 30, 2023 | Change | | :---------------------------------- | :----------- | :----------- | :----- | | Research and development | $1,314,859 | $1,270,220 | $44,639 | | General and administrative | $1,097,265 | $1,273,458 | $(176,193) | | Total operating expenses | $2,412,124 | $2,543,678 | $(131,554) | | Loss from operations | $(2,412,124) | $(2,543,678) | $131,554 | | Interest expense | $59,697 | $0 | $59,697 | | Interest income | $(26,006) | $(55,198) | $29,192 | | Grant income | $(245,362) | $0 | $(245,362) | | Net loss | $(2,200,736) | $(2,480,823) | $280,087 | | Net loss per share, basic and diluted | $(0.08) | $(0.10) | $0.02 | [Condensed Statements of Stockholders' Equity for the Three Months Ended September 30, 2024 and September 30, 2023](index=6&type=section&id=Condensed%20Statements%20of%20Stockholders'%20Equity%20for%20the%20Three%20Months%20Ended%20September%2030,%202024%20and%20September%2030,%202023) Total stockholders' equity decreased from **$3.81 million** at June 30, 2024, to **$1.90 million** at September 30, 2024, primarily due to the net loss incurred, partially offset by stock-based compensation expense Condensed Statements of Stockholders' Equity Highlights | Metric | Jun 30, 2024 | Sep 30, 2024 | Change | | :--------------------------- | :----------- | :----------- | :----- | | Common Stock Amount | $25,934 | $25,934 | $0 | | Additional Paid-in Capital | $69,190,341 | $69,477,261 | $286,920 | | Accumulated Deficit | $(65,403,744) | $(67,604,480) | $(2,200,736) | | Total Stockholders' Equity | $3,812,531 | $1,898,715 | $(1,913,816) | [Condensed Statements of Cash Flows for the Three Months Ended September 30, 2024 and September 30, 2023](index=8&type=section&id=Condensed%20Statements%20of%20Cash%20Flows%20for%20the%20Three%20Months%20Ended%20September%2030,%202024%20and%20September%2030,%202023) Net cash used in operating activities decreased significantly to **$1.69 million** for the three months ended September 30, 2024, compared to **$2.73 million** in the prior year, driven by lower net loss and favorable changes in operating assets and liabilities Condensed Statements of Cash Flows Highlights (Operating Activities) | Metric | Sep 30, 2024 | Sep 30, 2023 | Change | | :---------------------------------- | :----------- | :----------- | :----- | | Net loss | $(2,200,736) | $(2,480,823) | $280,087 | | Stock-based compensation | $286,920 | $210,797 | $76,123 | | Amortization of loan commitment fee | $59,697 | $0 | $59,697 | | Grant receivable | $(245,362) | $0 | $(245,362) | | Prepaid expenses | $100,850 | $(104,558) | $205,408 | | Accounts payable | $95,716 | $31,404 | $64,312 | | Accrued expenses | $212,926 | $(383,645) | $596,571 | | Net cash used in operating activities | $(1,689,989) | $(2,726,825) | $1,036,836 | | Cash, end of period | $1,404,211 | $8,520,578 | $(7,116,367) | [Notes to Unaudited Condensed Financial Statements](index=8&type=section&id=Notes%20to%20Unaudited%20Condensed%20Financial%20Statements) This section provides detailed explanations and disclosures for the unaudited condensed financial statements, covering the company's nature of business, accounting policies, and specific financial line items [Note 1. Nature of business and basis of presentation](index=8&type=section&id=Note%201.%20Nature%20of%20business%20and%20basis%20of%20presentation) Anebulo Pharmaceuticals, Inc. is a clinical-stage company developing treatments for cannabis toxicity, with an accumulated deficit of **$67.6 million** as of September 30, 2024, and expects to require additional funding for long-term development - Anebulo Pharmaceuticals, Inc. is a clinical-stage pharmaceutical company developing treatments for cannabis toxicity, including unintentional cannabis poisoning and acute cannabinoid intoxication (ACI)[14](index=14&type=chunk) - The company has incurred a net loss of approximately **$2.2 million** for the three months ended September 30, 2024, and an accumulated deficit of **$67.6 million** as of September 30, 2024[15](index=15&type=chunk) - The company expects its cash and cash equivalents, along with available funding under the Loan and Security Agreement (LSA), to fund operations and capital expenditures for at least **12 months** from the financial statements' issuance date[15](index=15&type=chunk) - Future funding will be sought through equity and debt financings or collaboration agreements, with risks of dilution or inability to secure funding on acceptable terms, potentially delaying or eliminating product development[16](index=16&type=chunk) [Note 2. Summary of Significant Accounting Policies](index=10&type=section&id=Note%202.%20Summary%20of%20Significant%20Accounting%20Policies) The company's unaudited interim condensed financial statements are prepared in accordance with U.S. GAAP and SEC rules, with no material changes to significant accounting policies since June 30, 2024, except for research and development grants - Unaudited interim condensed financial statements are prepared in accordance with U.S. GAAP and SEC rules, with certain information and footnote disclosures omitted as permitted[19](index=19&type=chunk)[20](index=20&type=chunk) - No material changes to significant accounting policies have occurred since June 30, 2024, other than the policy for accounting for research and development grants[22](index=22&type=chunk) [Note 3. Prepaid Expenses](index=11&type=section&id=Note%203.%20Prepaid%20Expenses) Prepaid expenses decreased from **$413,790** at June 30, 2024, to **$312,940** at September 30, 2024, primarily due to a decrease in prepaid research and development, partially offset by an increase in prepaid insurance Prepaid Expenses | Category | Sep 30, 2024 | Jun 30, 2024 | | :------------------------- | :----------- | :----------- | | Prepaid insurance | $155,507 | $95,871 | | Prepaid research and development | $118,893 | $274,879 | | Prepaid other | $38,540 | $43,040 | | **Total prepaid expenses** | **$312,940** | **$413,790** | [Note 4. Accrued Expenses](index=11&type=section&id=Note%204.%20Accrued%20Expenses) Accrued expenses significantly increased from **$104,157** at June 30, 2024, to **$317,083** at September 30, 2024, primarily driven by a substantial increase in accrued research and development costs Accrued Expenses | Category | Sep 30, 2024 | Jun 30, 2024 | | :------------------------- | :----------- | :----------- | | Accrued payroll related expenses | $32,843 | $29,512 | | Accrued research and development | $248,685 | $47,554 | | Accrued professional fees | $35,555 | $27,091 | | **Total accrued expenses** | **$317,083** | **$104,157** | [Note 5. Other Assets](index=11&type=section&id=Note%205.%20Other%20Assets) Other assets, primarily loan commitment fees, decreased from **$0.6 million** at June 30, 2024, to **$0.5 million** at September 30, 2024, due to amortization, resulting in **$0.1 million** interest expense - Loan commitment fees, included in other assets, decreased from **$0.6 million** at June 30, 2024, to **$0.5 million** at September 30, 2024, due to amortization over a three-year loan term[26](index=26&type=chunk) - Interest expense related to the amortization of loan commitment fees was **$0.1 million** for the three months ended September 30, 2024, compared to zero in the prior year period[26](index=26&type=chunk) [Note 6. License Agreement](index=11&type=section&id=Note%206.%20License%20Agreement) The company licensed selonabant intellectual property from Vernalis Development Limited, involving potential development milestone payments up to **$29.9 million** and sales milestone payments up to **$35.0 million**, plus single-digit royalties - The company licensed intellectual property for selonabant from Vernalis Development Limited in May 2020, involving potential development milestone payments up to **$29.9 million** and sales milestone payments up to **$35.0 million**, plus single-digit royalties[27](index=27&type=chunk) - As part of the May 2021 IPO, **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, 2024[28](index=28&type=chunk) [Note 7. Stockholders' Equity](index=11&type=section&id=Note%207.%20Stockholders'%20Equity) The company's authorized common stock increased to **50,000,000 shares** in November 2023, with **25,933,217 shares** issued and outstanding as of September 30, 2024, following a **$6.3 million** private placement and issuance of **300,000 shares** for a Loan and Security Agreement - The authorized common stock was increased from **40,000,000** to **50,000,000 shares** in November 2023[28](index=28&type=chunk) - As of September 30, 2024, **25,933,217 shares** of common stock were issued and outstanding[9](index=9&type=chunk)[10](index=10&type=chunk) - A private placement in September 2022 generated approximately **$6.3 million** in net proceeds from the issuance of **2,264,650 units**, each comprising one common share and a warrant[29](index=29&type=chunk) - **300,000 shares** of common stock were issued in November 2023 in connection with a Loan and Security Agreement[30](index=30&type=chunk) [Note 8. Stock-Based Compensation](index=12&type=section&id=Note%208.%20Stock-Based%20Compensation) The 2020 Stock Incentive Plan has **324,452 shares** available for future issuance, with stock-based compensation expense of approximately **$0.3 million** for the three months ended September 30, 2024, and **$2.1 million** in unrecognized expense - The 2020 Stock Incentive Plan has **324,452 shares** available for future issuance as of September 30, 2024, out of a total authorized **3,650,000 shares**[31](index=31&type=chunk) - Stock-based compensation expense was approximately **$0.3 million** for the three months ended September 30, 2024, compared to **$0.2 million** for the same period in 2023[37](index=37&type=chunk) - As of September 30, 2024, unrecognized stock-based compensation expense related to unvested stock options totaled approximately **$2.1 million**, to be recognized over a weighted average period of **2.3 years**[37](index=37&type=chunk) Stock Option Activity (Three Months Ended September 30, 2024) | Metric | Number of Shares | Weighted Average Exercise Price | Weighted Average Remaining Contractual Term (Years) | | :-------------------------- | :--------------- | :------------------------------ | :------------------------------------------ | | Outstanding at June 30, 2024 | 2,319,048 | $3.00 | 6.0 | | Granted | - | - | - | | Exercised | - | - | - | | Forfeited/cancelled | - | - | - | | Outstanding at Sep 30, 2024 | 2,319,048 | $3.00 | 5.8 | | Options exercisable at Sep 30, 2024 | 903,994 | $3.15 | 3.0 | [Note 9. Net Loss Per Share Attributable to Common Stockholders](index=14&type=section&id=Note%209.%20Net%20Loss%20Per%20Share%20Attributable%20to%20Common%20Stockholders) Net loss per share was **$(0.08)** for the three months ended September 30, 2024, an improvement from **$(0.10)** in the prior year, with **4,583,698** common stock equivalents excluded due to anti-dilutive effect Common Stock Equivalents Excluded from EPS Calculation | Category | Sep 30, 2024 | Sep 30, 2023 | | :-------------------- | :----------- | :----------- | | Stock options outstanding | 2,319,048 | 2,054,893 | | Warrants outstanding | 2,264,650 | 2,264,650 | | **Total** | **4,583,698** | **4,319,543** | - Net loss per share, basic and diluted, was **$(0.08)** for the three months ended September 30, 2024, compared to **$(0.10)** for the same period in 2023[11](index=11&type=chunk) [Note 10. Loan and Security Agreement](index=14&type=section&id=Note%2010.%20Loan%20and%20Security%20Agreement) The company entered into a Loan and Security Agreement (LSA) on November 13, 2023, providing access to up to **$10 million** at **0.25%** annual interest, with **300,000 shares** issued upon signing and no outstanding balance as of September 30, 2024 - The company entered into a Loan and Security Agreement (LSA) on November 13, 2023, allowing it to draw up to **$10 million** at **0.25%** annual interest, due on November 13, 2026[39](index=39&type=chunk) - **300,000 shares** of common stock were issued to 22NW upon signing the LSA, with additional shares (**0.03** per dollar loaned, up to **300,000** aggregate) to be issued upon advances[40](index=40&type=chunk) - As of September 30, 2024, there was no outstanding balance under the LSA[40](index=40&type=chunk) [Note 11. Research and Development Grant](index=14&type=section&id=Note%2011.%20Research%20and%20Development%20Grant) The company received the first tranche of **$0.9 million** from a **$1.9 million** NIDA grant in July 2024, supporting IV selonabant development for pediatric cannabis toxicity, recognizing **$0.2 million** in grant income and a **$0.2 million** grant receivable - On July 16, 2024, the company was awarded the first tranche of **$0.9 million** from a two-year NIDA grant totaling up to **$1.9 million** to support the development of intravenous selonabant for pediatric cannabis toxicity[42](index=42&type=chunk) - The company recognized **$0.2 million** in grant income and recorded a **$0.2 million** grant receivable for the three months ended September 30, 2024, with no comparable income in the prior year[44](index=44&type=chunk) [Item 2. Management's Discussion and Analysis of Financial Condition and Results of Operations](index=14&type=section&id=Item%202.%20Management's%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) This section provides management's perspective on the company's financial condition and results of operations, highlighting its focus on developing selonabant for cannabis toxicity, recent financial performance, liquidity, capital resources, and critical accounting estimates [Overview](index=15&type=section&id=Overview) Anebulo Pharmaceuticals is a clinical-stage company developing selonabant for cannabis toxicity, prioritizing an IV formulation for pediatric use due to faster approval, and recently secured a U.S. patent and a **$1.9 million** NIDA grant - Anebulo Pharmaceuticals is a clinical-stage company developing selonabant (formerly ANEB-001) to rapidly reverse the negative effects of cannabis toxicities, including unintentional cannabis poisoning in children and ACI in adults[46](index=46&type=chunk) - The company is prioritizing the advancement of an intravenous (IV) selonabant formulation for pediatric patients with unintentional cannabis poisoning, believing it offers a faster timeline to approval compared to the adult oral product[51](index=51&type=chunk)[52](index=52&type=chunk) - A U.S. patent (No. **11,795,146**) was issued on October 24, 2023, covering crystalline forms of selonabant and methods of use to treat acute cannabinoid overdose, providing patent protection through **2042**[56](index=56&type=chunk) - On July 16, 2024, the company was awarded the first tranche of **$0.9 million** from a two-year NIDA grant totaling up to **$1.9 million** to support the development of intravenous selonabant for emergency treatment of acute cannabis-induced toxicities in children[59](index=59&type=chunk) [Components of Results of Operations](index=18&type=section&id=Components%20of%20Results%20of%20Operations) This section outlines the company's key operational components: Revenue, Research and Development Expenses, and General and Administrative Expenses, noting no revenue generation since inception and expected significant operating losses [Revenue](index=18&type=section&id=Revenue) The company has not generated any revenue since its inception and expects to continue incurring significant operating losses and negative cash flows, with future revenue contingent on successful product development or collaboration agreements - The company has not generated any revenue since inception and expects to incur significant operating losses and negative cash flows in the future[60](index=60&type=chunk) - Future revenue is dependent on successful development and marketing approval of selonabant or other product candidates, or through collaboration/license agreements[60](index=60&type=chunk) [Research and Development Expenses](index=19&type=section&id=Research%20and%20Development%20Expenses) Research and development expenses are a significant portion of operating costs, expensed as incurred, and are expected to increase as the company advances selonabant's clinical development and expands its pipeline - Research and development expenses are expected to significantly increase as the company continues to develop selonabant and conduct clinical trials for cannabis toxicity, and expand its product-candidate pipeline[63](index=63&type=chunk)[64](index=64&type=chunk) - R&D expenses include employee costs, third-party CRO/CMO costs, consultant fees, other direct third-party expenses, and amortization for asset purchases[63](index=63&type=chunk) [General and Administrative Expenses](index=19&type=section&id=General%20and%20Administrative%20Expenses) General and administrative expenses primarily consist of professional fees, stock-based compensation, insurance, personnel costs, and rent - General and administrative expenses primarily include professional fees, stock-based compensation, insurance, personnel costs, and rent[65](index=65&type=chunk) [Results of Operations (Comparison of the Three Months Ended September 30, 2024 and 2023)](index=19&type=section&id=Results%20of%20Operations%20(Comparison%20of%20the%20Three%20Months%20Ended%20September%2030,%202024%20and%202023)) The company's net loss decreased by **$280,087** to **$2.20 million** for the three months ended September 30, 2024, compared to **$2.48 million** in the prior year, driven by decreased general and administrative expenses and recognized grant income [Research and Development Expenses](index=20&type=section&id=Research%20and%20Development%20Expenses_Results) Research and development expenses increased slightly by **$44,639** to **$1.31 million** for the three months ended September 30, 2024, mainly due to increased contract manufacturing costs, and are expected to increase further for IV selonabant formulation and clinical safety studies Research and Development Expenses | Category | Sep 30, 2024 | Sep 30, 2023 | Change | | :------------------------------------- | :----------- | :----------- | :----- | | Pre-clinical, nonclinical and clinical studies | $833,861 | $841,133 | $(7,272) | | Contract manufacturing | $215,466 | $143,302 | $72,164 | | Other research and development | $265,532 | $285,785 | $(20,253) | | **Total research and development expenses** | **$1,314,859** | **$1,270,220** | **$44,639** | - Research and development expenses are expected to increase as the company scales up the IV selonabant formulation and commences clinical safety studies, following the completion of Phase 2 oral ACI trials[68](index=68&type=chunk) [General and Administrative Expenses](index=20&type=section&id=General%20and%20Administrative%20Expenses_Results) General and administrative expenses decreased by **$176,193** to **$1.10 million** for the three months ended September 30, 2024, primarily due to strategic cost reductions in professional and consultant fees General and Administrative Expenses | Category | Sep 30, 2024 | Sep 30, 2023 | Change | | :---------------------------------- | :----------- | :----------- | :----- | | Compensation and related benefits | $306,613 | $264,710 | $41,903 | | Professional and consultant fees | $315,794 | $613,960 | $(298,166) | | Stock-based compensation expense | $286,920 | $210,797 | $76,123 | | Directors' and officers' insurance | $117,158 | $117,525 | $(367) | | Facilities, fees and other costs | $70,780 | $66,466 | $4,314 | | **Total general and administrative expenses** | **$1,097,265** | **$1,273,458** | **$(176,193)** | - The decrease in general and administrative expenses was primarily due to strategic cost reductions in professional and consultant fees[69](index=69&type=chunk) [Interest Expense](index=20&type=section&id=Interest%20Expense_Results) Interest expense was **$0.1 million** for the three months ended September 30, 2024, attributed to the amortization of loan commitment fees related to the Loan and Security Agreement, which was not in effect in the prior year - Interest expense was **$0.1 million** for the three months ended September 30, 2024, due to the amortization of loan commitment fees from the LSA, which was not in effect in the prior year period[70](index=70&type=chunk) [Interest Income](index=20&type=section&id=Interest%20Income_Results) Interest income decreased to approximately **$26,000** for the three months ended September 30, 2024, from approximately **$55,000** in the prior year, due to lower cash balances and interest rates - Interest income decreased to approximately **$26,000** for the three months ended September 30, 2024, from **$55,000** in the prior year, attributed to lower cash balances and interest rates[71](index=71&type=chunk) [Grant Income](index=20&type=section&id=Grant%20Income_Results) The company recognized **$0.2 million** in grant income for the three months ended September 30, 2024, from the NIDA research and development grant, with no comparable income in the prior year period - Grant income of **$0.2 million** was recognized for the three months ended September 30, 2024, from the NIDA research and development grant, with no comparable income in the prior year period[72](index=72&type=chunk) [Liquidity and Capital Resources](index=20&type=section&id=Liquidity%20and%20Capital%20Resources) The company has incurred significant operating losses and expects this trend to continue, with **$1.4 million** in cash as of September 30, 2024, and anticipates needing additional funding beyond the next **12 months** despite access to a **$10 million** LSA [Overview](index=20&type=section&id=Overview_Liquidity) The company has incurred significant operating losses since inception and expects to continue doing so, with **$1.4 million** in cash as of September 30, 2024, and plans to seek additional funding through equity, debt, or collaboration agreements - The company has incurred significant operating losses since inception and expects to continue incurring significant expenses and operating losses in the future[73](index=73&type=chunk) - As of September 30, 2024, cash and cash equivalents were **$1.4 million**[73](index=73&type=chunk) - The company plans to seek additional funding through equity and debt financings or collaboration agreements, with no assurance of securing funds on acceptable terms[73](index=73&type=chunk) [Loan and Security Agreement](index=21&type=section&id=Loan%20and%20Security%20Agreement_Liquidity) The LSA, entered into on November 13, 2023, provides access to up to **$10 million** at **0.25%** annual interest until November 13, 2026, with **300,000** common shares issued upon signing and no outstanding balance as of September 30, 2024 - The LSA provides access to up to **$10 million** for future operations until November 13, 2026, with an interest rate of **0.25%** per annum[74](index=74&type=chunk) - **300,000** common shares were issued to 22NW upon signing the LSA, and **0.03 shares** per dollar loaned (up to **300,000** aggregate) will be issued upon advances[75](index=75&type=chunk) - As of September 30, 2024, there was no outstanding balance under the LSA[75](index=75&type=chunk) [Cash Flows](index=22&type=section&id=Cash%20Flows_Liquidity) Net cash used in operating activities for the three months ended September 30, 2024, was approximately **$1.7 million**, a significant decrease from **$2.7 million** in the prior year, due to lower net loss and favorable changes in operating assets and liabilities Net Cash Used in Operating Activities | Period | Net Cash Used in Operating Activities | | :------------------------- | :---------------------------------- | | Three Months Ended Sep 30, 2024 | $(1,689,989) | | Three Months Ended Sep 30, 2023 | $(2,726,825) | - The decrease in cash used in operating activities for the three months ended September 30, 2024, was primarily due to a lower net loss and favorable changes in operating assets and liabilities, partially offset by non-cash stock-based compensation and loan commitment amortization[78](index=78&type=chunk)[79](index=79&type=chunk) [Funding and Material Cash Requirements](index=22&type=section&id=Funding%20and%20Material%20Cash%20Requirements) The company expects current cash and LSA access to fund operations for at least the next **12 months**, but future funding needs are substantial and depend on clinical trial progress, regulatory approvals, and operational expansion, potentially leading to dilution or restrictive covenants - Current cash and LSA access are expected to fund operations for at least the next **12 months**, but estimates are imprecise, and capital resources may be exhausted sooner[80](index=80&type=chunk) - Future funding requirements depend on clinical trial progress, regulatory approvals, operational expansion, intellectual property costs, and new product candidates[81](index=81&type=chunk) - Additional equity or debt financing, or collaboration agreements, will be needed, potentially causing stockholder dilution, liens on assets, or relinquishing rights to products[82](index=82&type=chunk) [Contractual Obligations and Commitments](index=22&type=section&id=Contractual%20Obligations%20and%20Commitments) The company has contractual obligations including a license agreement with Vernalis for selonabant, requiring potential milestone payments and royalties, an office lease, manufacturing contract, and CRO contracts, with the **$3.0 million** manufacturing contract substantially completed by June 30, 2024 [License Agreement with Vernalis Development Limited](index=22&type=section&id=License%20Agreement%20with%20Vernalis%20Development%20Limited) The exclusive worldwide royalty-bearing license agreement with Vernalis for selonabant includes a **$0.2 million** signature fee, potential development milestone payments up to **$29.9 million**, sales milestone payments up to **$35.0 million**, and low to mid-single digit royalties - The license agreement with Vernalis for selonabant includes a **$0.2 million** signature fee, potential development milestone payments up to **$29.9 million** (**$0.4 million** paid), sales milestone payments up to **$35.0 million**, and low to mid-single digit royalties[83](index=83&type=chunk)[84](index=84&type=chunk) - The company has sole discretion and responsibility for selonabant's development and commercialization, including regulatory approvals and associated costs[86](index=86&type=chunk) [Office Lease, Manufacturing Contract and CRO Contract](index=24&type=section&id=Office%20Lease,%20Manufacturing%20Contract%20and%20CRO%20Contract) The company leases office space for approximately **$400** per month, and a **$3.0 million** manufacturing agreement was substantially completed by June 30, 2024, with stability study costs expected through **2026**, alongside cancellable CRO contracts - The company leases its principal executive office for approximately **$400** per month[87](index=87&type=chunk) - A manufacturing agreement for approximately **$3.0 million** was substantially completed by June 30, 2024, with stability study costs expected to be fully incurred during calendar **2026**[88](index=88&type=chunk) - The company enters into cancellable contracts with clinical trial sites and clinical supply manufacturers[89](index=89&type=chunk) [Critical Accounting Estimates](index=24&type=section&id=Critical%20Accounting%20Estimates) This section discusses critical accounting estimates requiring significant judgment, including accrued research and development expenses and stock-based compensation expense, and notes the company's election to use the extended transition period for new accounting standards under the JOBS Act [Accrued Research and Development Expenses](index=24&type=section&id=Accrued%20Research%20and%20Development%20Expenses) The company estimates accrued research and development expenses by reviewing contracts, communicating with personnel, and estimating service levels and costs for unbilled services, with potential adjustments for variations in service timing or effort - The company estimates accrued R&D expenses by reviewing contracts, communicating with personnel, and estimating service levels and costs for unbilled services from CROs, investigative sites, vendors, and manufacturers[92](index=92&type=chunk) - Estimates are made at each balance sheet date, and while not expected to be materially different, variations in actual service timing or effort may require adjustments[93](index=93&type=chunk) [Stock-Based Compensation Expense](index=25&type=section&id=Stock-Based%20Compensation%20Expense_Critical) Stock-based compensation expense is estimated using the Black-Scholes option pricing model, relying on subjective assumptions like expected stock price volatility and expected term, with no significant changes to these assumptions during the three months ended September 30, 2024 - The fair value of stock options is estimated using the Black-Scholes option pricing model, which depends on subjective assumptions including expected stock price volatility, expected term, risk-free rate, and expected dividends[95](index=95&type=chunk) - No significant changes to the assumptions used in the Black-Scholes model occurred during the three months ended September 30, 2024[96](index=96&type=chunk) [JOBS Act Accounting Election](index=25&type=section&id=JOBS%20Act%20Accounting%20Election) As an "emerging growth company," the company has elected to use the extended transition period for new accounting standards under the JOBS Act, which may affect comparability and investor attractiveness - As an "emerging growth company," the company has elected to use the extended transition period for complying with new or revised accounting standards under the JOBS Act[97](index=97&type=chunk) - This election may make the company's financial statements less comparable to those of other public companies and could potentially reduce investor attractiveness[97](index=97&type=chunk) [Item 3. Quantitative and Qualitative Disclosures About Market Risk](index=26&type=section&id=Item%203.%20Quantitative%20and%20Qualitative%20Disclosures%20About%20Market%20Risk) This item is not required for smaller reporting companies - This item is not required for smaller reporting companies[99](index=99&type=chunk) [Item 4. Controls and Procedures](index=26&type=section&id=Item%204.%20Controls%20and%20Procedures) This section details the evaluation of the company's disclosure controls and procedures and reports on any changes in internal control over financial reporting [Evaluation of Disclosure Controls and Procedures](index=26&type=section&id=Evaluation%20of%20Disclosure%20Controls%20and%20Procedures) As of September 30, 2024, management concluded that the design and operation of the company's disclosure controls and procedures were effective at a reasonable assurance level - As of September 30, 2024, management, including the CEO and CFO, concluded that the design and operation of disclosure controls and procedures were effective at a reasonable assurance level[100](index=100&type=chunk)[101](index=101&type=chunk) [Changes in Internal Control over Financial Reporting](index=26&type=section&id=Changes%20in%20Internal%20Control%20over%20Financial%20Reporting) There were no material changes in the company's internal control over financial reporting during the three months ended September 30, 2024 - No material changes in internal control over financial reporting occurred during the three months ended September 30, 2024[102](index=102&type=chunk) [PART II. OTHER INFORMATION](index=27&type=section&id=PART%20II.%20OTHER%20INFORMATION) [Item 1. Legal Proceedings](index=27&type=section&id=Item%201.%20Legal%20Proceedings) The company is not currently a party to any material legal proceedings, and management believes no pending claims could materially adversely affect its operations or financial condition - The company is not currently a party to any material legal proceedings, and management believes no pending claims could materially adversely affect its operations or financial condition[104](index=104&type=chunk) [Item 1A. Risk Factors](index=27&type=section&id=Item%201A.%20Risk%20Factors) The company faces various risks, including its inability to generate revenue, an accumulated deficit of **$67.6 million**, expected future losses, clinical trial delays, regulatory hurdles, competition, and the need for substantial additional capital - The company has not generated any revenue since inception and has an accumulated deficit of **$67.6 million** as of September 30, 2024, expecting to incur future losses[106](index=106&type=chunk) - Future success is uncertain due to potential clinical trial delays, regulatory challenges, competition, and the need for substantial additional capital, which may not be available on acceptable terms[106](index=106&type=chunk)[107](index=107&type=chunk)[109](index=109&type=chunk) - Raising additional capital through equity or equity-linked securities may result in substantial dilution for existing stockholders, and debt financing may involve liens on assets and restrictive covenants[111](index=111&type=chunk)[112](index=112&type=chunk) [Item 2. Unregistered Sales of Equity Securities and Use of Proceeds](index=30&type=section&id=Item%202.%20Unregistered%20Sales%20of%20Equity%20Securities%20and%20Use%20of%20Proceeds) The company did not sell any equity securities in unregistered transactions during the quarter ended September 30, 2024, and there were no issuer purchases or repurchases of equity securities - No unregistered sales of equity securities occurred during the quarter ended September 30, 2024[115](index=115&type=chunk) - There were no issuer purchases or repurchases of equity securities during the quarter[115](index=115&type=chunk) [Item 3. Defaults Upon Senior Securities](index=30&type=section&id=Item%203.%20Defaults%20Upon%20Senior%20Securities) There were no defaults upon senior securities - No defaults upon senior securities were reported[115](index=115&type=chunk) [Item 4. Mine Safety Disclosures](index=30&type=section&id=Item%204.%20Mine%20Safety%20Disclosures) This item is not applicable to the company - This item is not applicable[115](index=115&type=chunk) [Item 5. Other Information](index=30&type=section&id=Item%205.%20Other%20Information) No director or officer adopted or terminated a Rule 10b5-1 or non-Rule 10b5-1 trading arrangement during the three months ended September 30, 2024 - No director or officer adopted or terminated a Rule 10b5-1 or non-Rule 10b5-1 trading arrangement during the three months ended September 30, 2024[115](index=115&type=chunk) [Item 6. Exhibits](index=30&type=section&id=Item%206.%20Exhibits) This section lists the exhibits filed with the Form 10-Q, including various certificates of incorporation, bylaws, certifications of principal executive and financial officers, and Inline XBRL documents - The exhibits include various corporate governance documents (certificates of incorporation, bylaws), officer certifications (302 and 906), and Inline XBRL documents for financial data[116](index=116&type=chunk) [Signatures](index=32&type=section&id=Signatures) - The report was signed on November 13, 2024, by Richard Anthony Cunningham (CEO) and Daniel George (CFO)[119](index=119&type=chunk)

Financial Results - Anebulo Pharmaceuticals reported its financial results for Q3 2024 on November 13, 2024[2] - The financial results announcement includes a business update alongside the earnings report[2] - The report does not specify detailed financial metrics or performance indicators in the provided content[3] Company Classification - The company is classified as an emerging growth company under the Securities Act[2] Stock Information - Anebulo Pharmaceuticals' common stock is traded on The Nasdaq Stock Market under the symbol ANEB[1] Press Release - The press release detailing the financial results is included as Exhibit 99.1[4]

Cannabis Treatment Development - The company is developing selonabant, a treatment for cannabis toxicity, with a focus on pediatric patients suffering from unintentional cannabis poisoning [115]. - Cannabis-related emergency room visits in the U.S. increased from an estimated 450,000 annually before legalization to approximately 1.8 million in 2021, highlighting the urgent need for effective treatments [115]. - The company has completed a Phase 2 clinical trial for oral selonabant, with results from 134 subjects indicating safety and tolerability [115]. - An intravenous formulation of selonabant is being prioritized for pediatric use, with initial clinical safety studies planned [116]. - The company received a $0.9 million grant from the National Institute on Drug Abuse to support the development of intravenous selonabant, with a total potential grant of approximately $1.9 million [117]. - The company aims to enroll the first healthy adult volunteer for intravenous selonabant clinical studies in the first half of 2025 [117]. Financial Performance and Projections - The company has not generated any revenue since inception and expects to continue incurring significant operating losses [118]. - Research and development expenses are anticipated to significantly increase as the company advances clinical trials and expands its product pipeline [120]. - The net loss for the fiscal year ended June 30, 2024, was $8,201,703, an improvement of $3,530,635 compared to the net loss of $11,732,338 in the previous year [121]. - Cash and cash equivalents as of June 30, 2024, were approximately $3.1 million, expected to fund operations for at least 12 months [124]. - The company entered into a Loan and Security Agreement on November 13, 2023, allowing for up to $10 million in funding to support future operations [125]. - During the fiscal year ended June 30, 2024, the company used cash and cash equivalents of $8.2 million, primarily due to operating activities [126]. - The company anticipates an increase in research and development expenses as it commences its next clinical trial [121]. - The company expects its cash resources will be sufficient to fund operations into the fourth quarter of calendar year 2025, but may need additional financing [128]. Research and Development Expenses - Research and development expenses decreased to $3,548,937 for the fiscal year ended June 30, 2024, down from $5,600,197 in the previous year, a reduction of $2,051,260 [121]. - The company estimates accrued research and development expenses based on open contracts and purchase orders, with significant costs related to CROs and clinical trials [132]. - The company has a manufacturing agreement with a third-party CMO costing approximately $3.0 million, with substantial completion expected by June 30, 2024 [131]. - A CRO agreement for managing a Phase 2 clinical trial for selonabant in the Netherlands has a total cost of approximately €2.8 million (about USD $3.1 million), substantially completed as of December 31, 2023 [131]. Corporate Governance and Management - Dr. Joseph F. Lawler founded the company in April 2020 and has been a board member since then [139]. - Richard Anthony Cunningham became the Chief Executive Officer in October 2023, bringing over 20 years of experience in the healthcare and biopharmaceutical industry [139]. - The company has a focus on clinical drug development and has been expanding its board with experienced professionals from the biopharmaceutical sector [140]. - The board includes members with extensive backgrounds in investment, regulatory affairs, and healthcare, enhancing the company's strategic capabilities [141]. - The company is actively involved in biotechnology and pharmaceutical investments, with board members having significant experience in these fields [142]. - The board diversity matrix will be reviewed annually, reflecting the company's commitment to diversity and inclusion [143]. - The Board of Directors consists of 8 male and 1 female directors, with 1 director not disclosing gender [144]. - All current directors, except Mr. Cunningham, are determined to be independent according to Nasdaq listing standards [144]. - The Audit Committee met four times during the fiscal year and is composed of three independent directors [145]. - The Compensation Committee met three times during the last fiscal year and is also composed of three independent directors [146]. - The Nominating and Corporate Governance Committee typically meets once a year and consists of three independent directors [148]. - The company has adopted a written code of business conduct and ethics applicable to all directors, officers, and employees [149]. - The Insider Trading Policy prohibits employees and directors from engaging in speculative transactions involving the company's equity securities [150].

[Executive Summary & Recent Highlights](index=1&type=section&id=Executive%20Summary%20%26%20Recent%20Highlights) Anebulo Pharmaceuticals secured a NIDA grant to prioritize the IV formulation of selonabant for unintentional cannabis poisoning in children, targeting clinical studies by early 2025 [Fourth Quarter Fiscal Year 2024 and Subsequent Highlights](index=1&type=section&id=Fourth%20Quarter%20Fiscal%20Year%202024%20and%20Subsequent%20Highlights) Anebulo Pharmaceuticals received a significant grant from NIDA to advance its intravenous (IV) formulation of selonabant, prioritizing its development for unintentional cannabis poisoning in children - Anebulo was awarded the first tranche of a two-year cooperative grant of up to approximately **$1.9 million** from the National Institute on Drug Abuse (NIDA)[2](index=2&type=chunk) - The Company prioritizes the development of selonabant IV formulation for unintentional cannabis poisoning in children, in response to growing medical need and impending DEA scheduling change for marijuana[2](index=2&type=chunk) - Anebulo aims to complete IND-enabling activities and scale up its IV formulation of selonabant around calendar year-end 2024, with the first healthy adult volunteer expected to be enrolled in clinical studies in the first half of calendar 2025[2](index=2&type=chunk) [Financial Results](index=2&type=section&id=Financial%20Results) The company reported significant reductions in operating expenses and net losses for both Q4 and full fiscal year 2024, maintaining a stable cash position [Financial Results for the Three Months Ended June 30, 2024 (Q4 FY2024)](index=2&type=section&id=Financial%20Results%20for%20the%20three%20months%20ended%20June%2030%2C%202024) Anebulo Pharmaceuticals reported a significant reduction in operating expenses and net loss for the fourth quarter of fiscal year 2024 compared to the prior year, alongside a cash balance of $3.1 million Q4 Fiscal Year 2024 Financial Highlights | Metric | Q4 FY2024 (USD) | Q4 FY2023 (USD) | Change (YoY) | | :----------------- | :-------------- | :-------------- | :----------- | | Operating Expenses | $1,300,000 | $2,500,000 | -48.0% | | Net Loss | $(1,300,000) | $(2,500,000) | -48.0% | | Net Loss Per Share | $(0.05) | $(0.10) | -50.0% | - Cash and cash equivalents were **$3.1 million** as of June 30, 2024[4](index=4&type=chunk) - The Company has access to an additional **$10 million** in cash through a Loan and Security Agreement executed on November 13, 2023[4](index=4&type=chunk) [Financial Results for the Twelve Months Ended June 30, 2024 (FY2024)](index=2&type=section&id=Financial%20Results%20for%20the%20twelve%20months%20ended%20June%2030%2C%202024) For the full fiscal year 2024, Anebulo Pharmaceuticals significantly reduced its operating expenses and net loss, primarily due to the completion of its Phase 2 clinical trial and a strategic shift in development focus Fiscal Year 2024 Financial Highlights | Metric | FY2024 (USD) | FY2023 (USD) | Change (YoY) | | :----------------- | :-------------- | :-------------- | :----------- | | Operating Expenses | $8,300,000 | $11,800,000 | -29.66% | | Net Loss | $(8,200,000) | $(11,700,000) | -30.00% | | Net Loss Per Share | $(0.32) | $(0.47) | -31.91% | - Research and Development expenses decreased approximately **$2.1 million** from the prior year, mainly due to the completion of the Phase 2 proof of concept clinical trial for ACI and prioritizing the selonabant IV formulation[5](index=5&type=chunk) - General and Administrative expenses decreased **$1.4 million** from the prior period, primarily due to reductions in compensation, professional fees, and insurance premiums[5](index=5&type=chunk) [Condensed Financial Statements](index=4&type=section&id=Condensed%20Financial%20Statements) The condensed financial statements provide a detailed breakdown of Anebulo's financial position and operational performance for the periods ended June 30, 2024 and 2023, reflecting reduced expenses and net losses [Condensed Balance Sheets](index=4&type=section&id=Condensed%20Balance%20Sheets) Anebulo's balance sheet as of June 30, 2024, shows a decrease in cash and total assets compared to the prior year, alongside a significant reduction in total liabilities and stockholders' equity Condensed Balance Sheet (as of June 30) | Metric | 2024 (USD) | 2023 (USD) | Change (YoY) | | :---------------------- | :------------ | :------------- | :----------- | | Cash and cash equivalents | $3,094,200 | $11,247,403 | -72.53% | | Total assets | $4,073,114 | $11,670,151 | -65.09% | | Total liabilities | $260,583 | $1,068,801 | -75.61% | | Total stockholders' equity| $3,812,531 | $10,601,350 | -64.04% | [Condensed Statements of Operations](index=4&type=section&id=Condensed%20Statements%20of%20Operations) The statements of operations detail the company's reduced operating expenses and net losses for both the fourth quarter and the full fiscal year 2024, driven by lower R&D and G&A costs Condensed Statements of Operations (Q4 and FY Ended June 30) | Metric | Q4 2024 (USD) | Q4 2023 (USD) | FY 2024 (USD) | FY 2023 (USD) | | :-------------------------- | :------------ | :------------ | :------------ | :------------ | | Research and development | $467,706 | $1,417,159 | $3,548,937 | $5,600,197 | | General and administrative | $872,661 | $1,077,230 | $4,759,818 | $6,183,402 | | Total operating expenses | $1,340,367 | $2,494,389 | $8,308,755 | $11,783,599 | | Loss from operations | $(1,340,367) | $(2,494,389) | $(8,308,755) | $(11,783,599) | | Net loss | $(1,349,969) | $(2,495,580) | $(8,201,703) | $(11,732,338) | | Net loss per share | $(0.05) | $(0.10) | $(0.32) | $(0.47) | [Product and Company Information](index=2&type=section&id=Product%20and%20Company%20Information) This section details Selonabant (ANEB-001) as the lead product candidate for cannabis toxicity and provides an overview of Anebulo Pharmaceuticals' strategic development focus [About Selonabant (ANEB-001)](index=2&type=section&id=About%20Selonabant%20%28ANEB-001%29) Selonabant (ANEB-001) is Anebulo's lead product candidate, a potent CB1 receptor antagonist being developed as a specific antidote for cannabis toxicity, including acute cannabinoid intoxication (ACI) and unintentional cannabis poisoning, with a strategic focus on an IV formulation for pediatric patients - Selonabant (ANEB-001) is a potent, small molecule antagonist of the cannabinoid receptor type-1 (CB1), developed to address unmet medical needs for cannabis toxicity[7](index=7&type=chunk) - It is under development as both an orally bioavailable and an intravenous (IV) treatment, with the IV formulation being prioritized for unintentional cannabis poisoning in children[7](index=7&type=chunk)[8](index=8&type=chunk) - Selonabant is protected by two issued patents covering methods of use and composition of matter, with multiple pending applications[7](index=7&type=chunk) [About Anebulo Pharmaceuticals, Inc.](index=3&type=section&id=About%20Anebulo%20Pharmaceuticals%2C%20Inc.) Anebulo Pharmaceuticals is a clinical-stage biopharmaceutical company focused on developing novel solutions for acute cannabinoid intoxication and unintentional cannabis intoxication, strategically shifting its primary development focus to an IV formulation of selonabant for pediatric patients - Anebulo Pharmaceuticals, Inc. is a clinical-stage biopharmaceutical company developing novel solutions for acute cannabinoid intoxication and unintentional cannabis intoxication[8](index=8&type=chunk) - The company has completed dosing in a Phase 2 clinical trial for oral selonabant but is prioritizing the advancement of an IV formulation for pediatric patients with unintentional cannabis poisoning, believing it offers a faster timeline to approval[8](index=8&type=chunk) [Additional Information](index=3&type=section&id=Additional%20Information) This section outlines the company's forward-looking statements, emphasizing inherent risks and uncertainties, and provides essential contact information [Forward-Looking Statements](index=3&type=section&id=Forward-Looking%20Statements) This section provides a cautionary statement regarding forward-looking statements, highlighting that future performance is subject to various risks, uncertainties, and assumptions, and Anebulo undertakes no obligation to update these statements - Statements in the press release that are not historical facts are forward-looking statements, identifiable by words such as 'anticipate,' 'expect,' 'may,' 'will,' and 'should'[9](index=9&type=chunk) - Forward-looking statements are not guarantees of future performance and are subject to risks and uncertainties, including the ability to pursue regulatory strategy, obtain approvals, secure funding, complete clinical trials, and maintain patents[9](index=9&type=chunk) - Anebulo undertakes no obligation to update or revise forward-looking statements to reflect new information, future events, or changed conditions, except as required by law[9](index=9&type=chunk) [Contacts](index=3&type=section&id=CONTACTS) Contact information for Anebulo Pharmaceuticals' Chief Financial Officer is provided for inquiries - Contact for Anebulo Pharmaceuticals, Inc.: Daniel George, Part-time Chief Financial Officer, (512) 598-0931, Dan@anebulo.com[10](index=10&type=chunk)