Anebulo Pharmaceuticals Q3 FY 2024 Financial Results and Updates

Anebulo Pharmaceuticals, Inc. (Nasdaq: ANEB), a clinical-stage biopharmaceutical company, recently released its financial results for the quarter ending on March 31, 2024. The company, which focuses on developing treatments for acute cannabinoid toxicities such as acute cannabinoid intoxication (ACI) and unintentional cannabis poisoning, has made significant strides in the past few months.

In response to increasing medical needs and potential changes in DEA scheduling, Anebulo has prioritized the development of an intravenous (IV) formulation of their lead drug, selonabant, specifically for children who suffer from unintentional cannabis poisoning. This decision has been influenced by the United States Department of Justice's announcement on April 30, 2024, to consider reclassifying marijuana as a less dangerous drug, potentially increasing its household presence and the risk of accidental consumption by children.

Children exposed to cannabis face severe health risks including Central Nervous System (CNS) depression, seizures, and even coma. According to Richie Cunningham, the CEO of Anebulo, this reclassification could lead to increased use of cannabis products, particularly edibles, which are a common cause of unintentional poisoning in children. Discussions with the United States Food and Drug Administration have highlighted an urgent need for alternative formulations of selonabant to treat younger patients. The company sees an opportunity for faster approval of their drug for pediatric use, which could pave the way for subsequent approval for adult treatments.

Cunningham emphasized the higher sensitivity of children to cannabis toxicity due to smaller body size, reduced metabolic ability, and an underdeveloped endocannabinoid system, which increases the density of cannabinoid receptor type 1 (CB1) in the brain. These factors contribute to more severe and life-threatening outcomes in children compared to adults. Recent media coverage has brought attention to the risks, underscoring the urgent need for effective treatments.

Cunningham added that Anebulo is uniquely positioned to provide a rapid and clinically effective solution for emergency departments dealing with pediatric cannabis poisoning. As a result, the company is focusing on advancing the selonabant IV formulation, which they believe could quickly counteract THC effects, offering a quicker path to regulatory approval than adult treatments. While the annual incidence of pediatric cannabis poisoning is under 50,000 cases, the number has been rising, according to data from America’s Poison Centers.

Financially, Anebulo reported operating expenses of $1.7 million in the third quarter of fiscal 2024, down from $2.9 million in the same quarter of the previous fiscal year. The net loss was $1.7 million, or $0.06 per share, compared to a net loss of $2.8 million, or $0.11 per share, in the third quarter of fiscal 2023. The company had $5.1 million in cash and cash equivalents as of March 31, 2024.

Anebulo's lead product candidate, selonabant (ANEB-001), is a potent, small molecule antagonist of the CB1 receptor. It is designed to address the unmet medical need for an antidote to cannabis toxicity, including ACI and unintentional cannabis poisoning. Selonabant is available in oral form and is being developed as a parenteral treatment. The compound is protected by patents covering its usage and composition, with ongoing studies determining its efficacy in emergency settings.

Anebulo Pharmaceuticals remains dedicated to developing innovative solutions for those suffering from cannabinoid intoxication, with selonabant showing promise in both adult and pediatric applications.