Anebulo Pharmaceuticals(ANEB) - 2025 Q2 - Quarterly Results

Report Overview and Recent Highlights 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][2] CEO Commentary 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][5] - Research indicates children are more sensitive to cannabis toxicity, leading to more serious outcomes and higher hospitalization risk[5] - FDA confirmed the unmet need for pediatric cannabis toxicity treatment and suggested close collaboration for selonabant's development in this indication[6] Second Quarter Fiscal Year 2025 and Subsequent Highlights Anebulo provided key updates including progress in clinical development for intravenous selonabant, particularly for pediatric cannabis toxicity, and significant financing activities Clinical Development Updates 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] - Anebulo plans to begin its Phase 1 single ascending dose (SAD) study of intravenous selonabant in healthy adults in 1H25[7] Financing and Corporate Updates 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] - 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] Financial Results for Q2 FY2025 Summary of Financial Performance 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] Condensed Balance Sheets 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 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) Product Overview and Clinical Status 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] - 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] - 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][11] - An observational study is ongoing in Emergency Departments to gather data on cannabinoid concentrations, signs/symptoms, and patient disposition[9] About Anebulo Pharmaceuticals, Inc. Company Profile and Strategic Focus 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] - 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] - Selonabant is a competitive antagonist at the human CB1 receptor[11] Legal and Contact Information Forward-Looking Statements 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] - 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] 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]