Anebulo Pharmaceuticals Reports First Quarter Fiscal Year 2025 Financial Results and Recent Updates

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AUSTIN, Texas, November 13, 2024--(BUSINESS WIRE)--Anebulo Pharmaceuticals, Inc. (Nasdaq: ANEB), a clinical-stage pharmaceutical company developing novel solutions for people suffering from acute cannabis-induced toxic effects (the "Company" or "Anebulo"), today announced financial results for the three months ended September 30, 2024, and recent updates.

First Quarter Fiscal Year 2025 and Subsequent Highlights:

  • Anebulo announced it has been 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"), part of the National Institutes of Health ("NIH"), under award number 1U01DA059995-01.

  • With the support of NIDA, Anebulo aims to complete IND-enabling activities and the scale up of its intravenous (IV) formulation of selonabant around calendar year end 2024 as it prepares for clinical studies and the Company expects to enroll the first healthy adult volunteer in the first half of calendar 2025.

"We are excited to have the support of NIDA to advance our development of a rapid and clinically impactful emergency treatment for acute cannabis-induced toxicities, including cannabis-induced Central Nervous System (CNS) depression in children," commented Richie Cunningham, Chief Executive Officer of Anebulo.

"We believe this important grant from NIDA recognizes the significant progress we have already made with the successful Phase 2 proof of concept study of oral selonabant. This grant, along with our access to an additional $10 million in cash through the recent Loan and Security Agreement, provides further momentum for advancing the intravenous formulation towards clinical testing. We also believe the grant further validates the significant and growing unmet medical need for an emergency antidote to acute cannabis-induced toxicity. In particular, acute cannabis exposure in children can result in serious and potentially life-threatening consequences, including CNS depression, respiratory depression, coma, and in rare cases death. Research has shown that children are much more sensitive to the toxic effects of cannabis, due in part to age-related differences in the abundance of cannabis receptors in their brains. As a direct consequence, cannabis ingestion in children can result in much more serious outcomes than in adults, and a much greater risk of hospitalization and admission to intensive care. If approved, we believe selonabant has the potential to offer a much-needed targeted therapy for rapidly reversing the serious and life-threatening consequences of accidental cannabis ingestion in children."