Anebulo Pharmaceuticals(ANEB) - 2024 Q4 - Annual Results

Executive Summary & Recent Highlights 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 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] - 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] - 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] Financial Results 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) 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] - The Company has access to an additional $10 million in cash through a Loan and Security Agreement executed on November 13, 2023[4] Financial Results for the Twelve Months Ended June 30, 2024 (FY2024) 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] - General and Administrative expenses decreased $1.4 million from the prior period, primarily due to reductions in compensation, professional fees, and insurance premiums[5] Condensed Financial Statements 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 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 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 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) 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] - 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][8] - Selonabant is protected by two issued patents covering methods of use and composition of matter, with multiple pending applications[7] About Anebulo Pharmaceuticals, Inc. 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] - 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] Additional Information This section outlines the company's forward-looking statements, emphasizing inherent risks and uncertainties, and provides essential contact information Forward-Looking Statements 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] - 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] - 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] 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]