Anebulo Pharmaceuticals, Inc. (Nasdaq: ANEB) Reports Second Quarter Fiscal Year 2025 Financial Results and Provides Business Updates
Anebulo Pharmaceuticals, Inc. (Nasdaq: ANEB), a clinical-stage pharmaceutical company dedicated to developing innovative treatments for individuals suffering from acute cannabis-induced toxic effects, has released its financial results for the three months ended December 31, 2024. The Company has also provided significant updates on recent developments, including regulatory interactions, clinical progress, and financing activities.
Addressing an Urgent and Growing Medical Need
The increasing prevalence of cannabis use has led to a substantial rise in cases of acute cannabis toxicity, particularly among children. This alarming trend underscores the urgent need for an effective emergency antidote. Cannabis toxicity in children can have severe and potentially life-threatening consequences, including Central Nervous System (CNS) depression, respiratory depression, coma, and in rare cases, death. Due to the developmental differences in cannabis receptor distribution in young brains, children are far more susceptible to severe adverse effects compared to adults, often requiring hospitalization and intensive medical intervention.
Richie Cunningham, Chief Executive Officer of Anebulo, emphasized the significance of the company’s mission, stating:
“There is a 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. Research has shown that children are much more sensitive to the toxic effects of cannabis, which increases their risk of hospitalization and intensive care unit admission. If approved, we believe selonabant has the potential to provide a much-needed targeted therapy to rapidly counteract the serious and life-threatening effects of acute cannabis toxicity.”
Second Quarter Fiscal Year 2025 and Subsequent Business Highlights
Regulatory and Clinical Progress
In December 2024, Anebulo met with the U.S. Food and Drug Administration (FDA) to discuss the development of its lead investigational drug, intravenous selonabant, and to outline an initial clinical testing plan. The FDA acknowledged the critical need for a treatment specifically designed to address cannabis toxicity in pediatric populations. Moreover, the agency proposed a close and ongoing collaboration with Anebulo to facilitate the efficient advancement of selonabant for this pediatric indication.
As part of this initiative, Anebulo is set to commence its Phase 1 single ascending dose (SAD) study of intravenous selonabant in healthy adult participants during the first half of 2025 (1H25). This study will assess the safety, tolerability, and pharmacokinetic properties of the drug in preparation for subsequent pediatric trials.
Strategic Financing and Corporate Development
In December 2024, Anebulo successfully entered into a definitive stock purchase agreement with 22NW Fund, LP (“22NW”), a firm controlled by one of its directors, along with participation from existing investors. The agreement involves the issuance and sale of 15.2 million shares of common stock, generating gross proceeds of $15 million through a private placement offering. This strategic investment reflects strong investor confidence in Anebulo’s mission and potential to bring a novel cannabis toxicity antidote to market.
Furthermore, in February 2025, Anebulo announced amendments to its Loan and Security Agreement (LSA) with 22NW and JFL Capital Management. The revised agreement reduces the maximum loan size to approximately $3 million and removes all securitization provisions, optimizing the company’s financial flexibility and reducing its debt burden.
CEO Richie Cunningham expressed gratitude for investor support, noting:
“We are grateful for the continued backing from our investors. Securing this substantial financing demonstrates the confidence that highly respected institutional investors have in Anebulo’s future. This funding positions us well to advance our clinical programs and execute our strategic initiatives.”
Financial Results for the Three Months Ended December 31, 2024
Operating Expenses and Net Loss
- Anebulo reported total operating expenses of $2.6 million in the second quarter of fiscal 2025, compared to $2.8 million in the same period of fiscal 2024.
- The company incurred a net loss of $2.5 million, or $(0.09) per share, for the second quarter of fiscal 2025, compared to a net loss of $2.7 million, or $(0.11) per share, in the second quarter of fiscal 2024. The reduction in losses reflects Anebulo’s disciplined approach to financial management while continuing to invest in critical development programs.
Cash Position and Liquidity
- As of December 31, 2024, Anebulo had cash and cash equivalents totaling $15.0 million, providing the company with a solid financial foundation to support ongoing research and development activities.
- Additionally, the company retains access to an additional $3 million in cash through its amended Loan Agreement, further bolstering its liquidity.
Advancing a Promising Treatment for Cannabis Toxicity
Anebulo’s investigational drug, selonabant, is designed to act as a targeted therapy for acute cannabis toxicity. The drug’s mechanism of action involves blocking cannabinoid receptors in the brain, potentially reversing the toxic effects of excessive cannabis consumption. By swiftly mitigating CNS and respiratory depression, selonabant could offer a life-saving intervention for patients experiencing severe cannabis toxicity.
With the increasing availability and potency of cannabis products, particularly edibles that appeal to children, the number of accidental exposures has surged. According to recent studies, pediatric cannabis toxicity cases have risen dramatically over the past decade, necessitating the development of effective medical countermeasures.
Looking Ahead: Future Milestones
Anebulo is poised to achieve several key milestones in 2025, including:
- Initiation of Phase 1 SAD Study: The company plans to launch its Phase 1 clinical trial in healthy adults in the first half of 2025, marking a crucial step in advancing selonabant toward regulatory approval.
- FDA Engagement for Pediatric Studies: Continued collaboration with the FDA to ensure a streamlined and efficient path for pediatric clinical trials.
- Exploring Additional Funding Opportunities: Anebulo remains committed to securing additional resources to support its clinical development programs and regulatory submissions.
- Building Awareness and Advocacy: The company aims to increase awareness of the dangers of acute cannabis toxicity and the urgent need for effective medical interventions through partnerships with healthcare professionals and public health organizations.
