Anebulo Pharmaceuticals(ANEB) - 2025 Q4 - Annual Results

Executive Summary & Recent Developments Anebulo Pharmaceuticals is advancing an IV selonabant formulation for pediatric acute cannabis toxicity, supported by FDA and NIDA, alongside a proposed reverse stock split Fourth Quarter Fiscal Year 2025 and Subsequent Highlights Anebulo Pharmaceuticals made significant progress in Q4 FY2025 and subsequently, focusing on the development of an intravenous (IV) selonabant formulation for pediatric acute cannabis-induced toxicity, supported by FDA collaboration and NIDA grants. The company also announced a proposed reverse stock split as part of a potential going private transaction - Prioritized advancement of selonabant IV formulation as a potential treatment for pediatric patients with acute cannabis-induced toxicity, believing it offers a faster timeline to approval relative to the adult oral product[4] - FDA has suggested close collaboration with Anebulo to facilitate the development of selonabant for pediatric cannabis toxicity, confirming a significant and growing unmet need[4] - Initiated a Phase 1 single ascending dose (SAD) study of an intravenous (IV) formulation of selonabant in healthy adult subjects aged 18 to 25 years on September 25, 2025[5] - Awarded the second-year tranche ($994,300) of an ongoing collaborative grant from the National Institute on Drug Abuse (NIDA) to support the SAD study[5] - A Special Committee recommended, and the Board approved, a reverse stock split as part of a proposed going private transaction, aiming to maintain fewer than 300 record holders to avoid SEC public reporting requirements[4] Product and Company Overview Anebulo Pharmaceuticals develops selonabant, a CB1 receptor antagonist, focusing on an IV formulation for pediatric acute cannabis toxicity About Selonabant Selonabant (ANEB-001) is Anebulo's lead product candidate, a potent CB1 receptor antagonist designed to reverse acute cannabis-induced toxicity. While an oral formulation showed promise in adult Phase 2 studies, the company is now prioritizing an IV formulation for pediatric patients, with an observational study also being amended to focus on this population - Selonabant (ANEB-001) is a potent, small molecule antagonist of the cannabinoid receptor type-1 (CB1), under development as a specific antidote for acute cannabis-induced toxicity[8] - Successfully formulated for oral administration in clinical studies and as a potential intravenous treatment for clinical testing[8] - A Phase 2 proof-of-concept study in adults challenged with oral THC demonstrated that oral selonabant blocked or reversed key CNS effects of THC and was well tolerated[8] - An observational study in patients presenting to Emergency Departments with cannabis toxicity is ongoing and being amended to focus on pediatric patients[8] About Anebulo Pharmaceuticals, Inc. Anebulo Pharmaceuticals is a clinical-stage company focused on developing selonabant for cannabis-induced toxicity. Following successful Phase 2 oral trials in adults, the company has shifted its strategic focus to an intravenous formulation for pediatric patients, initiating a Phase 1 SAD study in September 2025 - Anebulo Pharmaceuticals, Inc. is a clinical-stage pharmaceutical company developing novel solutions for people suffering from cannabis-induced toxicity[10] - Prioritizing the advancement of a selonabant IV formulation as a potential treatment for pediatric patients with acute cannabis-induced toxicity, believing it offers the potential for a faster timeline to approval[10] - Initiated a Phase 1 SAD study of IV selonabant in September 2025[10] Financial Results Anebulo reported increased operating expenses and net losses for Q4 and FY2025, driven by R&D, while cash and equivalents significantly improved Fourth Quarter Fiscal Year 2025 Financial Summary For the fourth quarter of fiscal year 2025, Anebulo reported a significant increase in operating expenses and a higher net loss compared to the same period in fiscal year 2024. Cash and cash equivalents stood at $11.6 million as of June 30, 2025 Fourth Quarter Fiscal Year 2025 Financial Highlights: | Metric | Q4 FY2025 | Q4 FY2024 | Change | | :----------------------- | :---------- | :---------- | :---------- | | Operating Expenses | $2.3 million | $1.3 million | +$1.0 million | | Net Loss | $2.1 million | $1.3 million | +$0.8 million | | Net Loss Per Share | $(0.05) | $(0.05) | 0 | - Cash and cash equivalents were $11.6 million as of June 30, 2025, with access to an additional $3 million through a Loan Agreement[9] Fiscal Year 2025 Financial Summary Anebulo's fiscal year 2025 saw an increase in operating expenses, primarily driven by higher research and development costs for pre-clinical and clinical studies of the IV selonabant formulation. This resulted in a higher net loss, partially mitigated by $0.9 million in grant income from NIDA Fiscal Year 2025 Financial Highlights: | Metric | FY2025 | FY2024 | Change | | :----------------------- | :---------- | :---------- | :---------- | | Operating Expenses | $9.2 million | $8.3 million | +$0.9 million | | Net Loss | $8.5 million | $8.2 million | +$0.3 million | | Net Loss Per Share | $(0.25) | $(0.32) | +$0.07 | - Research and development expenses increased by approximately $0.9 million, primarily due to increased activities for pre-clinical and clinical studies and direct third-party costs for selonabant[9] - Grant income of $0.9 million was recognized in connection with the research and development grant with NIDA[9] Condensed Balance Sheets As of June 30, 2025, Anebulo's cash and cash equivalents significantly increased to $11.6 million from $3.1 million in the prior year, leading to a substantial rise in total assets and stockholders' equity Condensed Balance Sheet Data (as of June 30): | Metric | 2025 | 2024 | | :----------------------- | :---------- | :---------- | | Cash and cash equivalents | $11,627,849 | $3,094,200 | | Total assets | $12,145,616 | $4,073,114 | | Total liabilities | $487,688 | $260,583 | | Total stockholders' equity | $11,657,928 | $3,812,531 | Condensed Statements of Operations The condensed statements of operations show a net loss of $2.1 million for Q4 FY2025 and $8.5 million for FY2025, driven by increased research and development and general and administrative expenses, partially offset by grant income Condensed Statements of Operations Data: | Metric | Three months ended June 30, 2025 | Three months ended June 30, 2024 | Year ended June 30, 2025 | Year ended June 30, 2024 | | :--------------------------------- | :------------------------------- | :------------------------------- | :----------------------- | :----------------------- | | Research and development | $1,126,223 | $467,706 | $4,299,941 | $3,548,937 | | General and administrative | $1,204,661 | $872,661 | $4,923,540 | $4,759,818 | | Total operating expenses | $2,330,884 | $1,340,367 | $9,223,481 | $8,308,755 | | Loss from operations | $(2,330,884) | $(1,340,367) | $(9,223,481) | $(8,308,755) | | Grant income | $(81,343) | - | $(864,014) | - | | Net loss | $(2,144,828) | $(1,349,969) | $(8,484,763) | $(8,201,703) | | Net loss per share | $(0.05) | $(0.05) | $(0.25) | $(0.32) | Other Information This section details cautionary forward-looking statements on drug development and regulatory processes, and provides company contact information Forward-Looking Statements This section contains forward-looking statements regarding Anebulo's drug development, regulatory strategy, and potential market for selonabant, particularly for pediatric acute cannabis-induced toxicity. It highlights the inherent risks and uncertainties associated with clinical trials, regulatory approvals, funding, and market acceptance, cautioning that these statements are not guarantees of future performance - Forward-looking statements include intentions, beliefs, projections, and expectations regarding selonabant as an emergency antidote for acute cannabis-induced toxicity in children and its potential for faster approval[11] - Cautionary statements emphasize risks and uncertainties, including the ability to pursue regulatory strategy, obtain approvals, secure funding, complete trials, and achieve desired results[11] - 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[11] Contacts This section provides the contact information for Anebulo Pharmaceuticals, Inc. for inquiries - Contact information for Anebulo Pharmaceuticals, Inc. is provided: (512) 598-0931, ir@anebulo.com[12]