Introduction
Anebulo Pharmaceuticals, Inc. is a clinical-stage pharmaceutical company dedicated to developing innovative solutions for individuals suffering from the acute toxic effects of cannabis consumption. As the landscape of cannabis legalization continues to evolve, Anebulo stands at the forefront, determined to address the growing public health concern surrounding unintentional cannabis poisoning and acute cannabinoid intoxication (ACI).
Company Background
Founded on April 23, 2020 as a Delaware corporation, Anebulo Pharmaceuticals has rapidly established itself as a leading player in the emerging field of cannabis toxicity treatment. The company's principal operations are located in Lakeway, Texas, and since its inception, Anebulo's activities have consisted primarily of performing research and development to advance its product candidates. The company's primary focus is the development of its lead product candidate, selonabant, a potent, small-molecule cannabinoid receptor antagonist designed to quickly and effectively combat the symptoms of cannabis toxicity.
Strategic Partnerships
In May 2020, Anebulo entered into a royalty-bearing license agreement with Vernalis Development Limited to exploit its licensed compounds and licensed products to combat symptoms of acute cannabinoid intoxication (ACI) and substance addiction. This strategic partnership laid the foundation for the company's research and development efforts, as it set out to advance selonabant through the clinical trial process.
Financials and Liquidity
Prior to its initial public offering (IPO) in May 2021, Anebulo funded its operations through a private placement of its series A convertible preferred stock and issuance of two promissory notes to a related party. The company's IPO raised net proceeds of approximately $19.8 million. On September 28, 2022, Anebulo closed a private placement offering, receiving net proceeds of approximately $6.3 million.
As a clinical-stage pharmaceutical company, Anebulo has faced challenges with no revenue generation since inception. The company has incurred losses, including a net loss of approximately $8.2 million for the fiscal year ended June 30, 2024. As of June 30, 2024, Anebulo had an accumulated deficit of $65.4 million. The company expects to continue generating operating losses as it advances its development programs.
For the fiscal year ended June 30, 2024, Anebulo reported no revenue, a net loss of $8,201,703, operating cash flow (OCF) of -$8,090,849, and free cash flow (FCF) of -$8,090,849. In the most recent quarter ended September 30, 2024, the company again reported no revenue, with a net loss of $2,200,736, OCF of -$1,689,989, and FCF of -$1,689,989. Notably, the company's net loss decreased by 11.3% year-over-year, from $2,480,629 in Q1 2023 to $2,200,736 in Q1 2024. This improvement was primarily attributed to a decrease in general and administrative expenses resulting from strategic cost reductions.
Anebulo's financial position, as of September 30, 2024, reflects the company's commitment to advancing its research and development efforts. The company reported cash and cash equivalents of $1.4 million and access to additional funding through a Loan and Security Agreement (LSA) with 22NW, LP and JFL Capital Management LLC, which allows Anebulo to draw up to $10 million as needed to fund future operations. As of September 30, 2024, there was no balance outstanding under the LSA.
The company's liquidity position is further illustrated by its debt-to-equity ratio of 0, as Anebulo has no debt as of September 30, 2024. The current ratio and quick ratio both stand at 3.447692915806579, indicating a strong ability to meet short-term obligations.
For the three months ended September 30, 2024, Anebulo reported total operating expenses of $2.41 million, consisting of $1.31 million in research and development expenses and $1.10 million in general and administrative expenses.
Clinical Trials and Development
In March 2021, Anebulo's European clinical trial application was accepted in the Netherlands, allowing the company to initiate a randomized, double-blind, placebo-controlled Phase 2 human proof-of-concept clinical trial for the potential use of selonabant in treating ACI. This study, known as the Netherlands Trial, was designed to evaluate the safety, tolerability, pharmacokinetics, and efficacy of a single oral dose of selonabant in healthy adult subjects challenged with tetrahydrocannabinol (THC), the primary psychoactive constituent of cannabis.
The results of the Netherlands Trial, announced in March 2023, demonstrated that selonabant was well-tolerated and showed promising signals of efficacy in reversing the acute effects of THC intoxication. These findings provided Anebulo with valuable insights and set the stage for the company's next steps in the development of selonabant.
Strategic Focus
Rather than proceeding directly with Phase 3 studies of oral selonabant in adults with ACI, Anebulo has made the strategic decision to prioritize the advancement of an intravenous (IV) formulation of selonabant as a potential treatment for pediatric patients with unintentional cannabis poisoning. This decision was driven by several factors, including the recent development of a suitable IV formulation and the recognition of the significant unmet medical need in the pediatric population, where the consequences of cannabis toxicity can be particularly severe.
Government Support
In July 2024, Anebulo was awarded 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), to support the development of the IV formulation of selonabant. On July 16, 2024, the company received the first tranche of $0.90 million from this grant. With this support, Anebulo aims to complete IND-enabling activities and scale up the manufacturing of the IV formulation, preparing for future clinical studies and the potential path to regulatory approval.
Intellectual Property
Anebulo's proprietary position in the treatment of cannabis toxicity is protected by rights to two patent applications covering various methods of use of selonabant and delivery systems. The company licensed the intellectual property, know-how, and clinical trial data for selonabant from Vernalis Development Limited in May 2020.
Future Outlook
Looking ahead, Anebulo's strategic priorities include the successful completion of IND-enabling activities and the scale-up of the IV formulation of selonabant, with the goal of initiating clinical studies in the first half of calendar year 2025. The company remains committed to addressing the significant unmet medical need in the treatment of unintentional cannabis poisoning and ACI, particularly in the pediatric population, where the consequences can be life-threatening.
Conclusion
Anebulo's journey has been marked by both challenges and opportunities. As the company navigates the uncharted territory of cannabis-induced toxicities, it remains steadfast in its mission to develop innovative solutions that can make a meaningful impact on the lives of those affected. With the support of the NIDA grant, a strong intellectual property portfolio, and a seasoned management team, Anebulo is well-positioned to continue its pursuit of regulatory approval and commercialization of selonabant, potentially becoming a game-changer in the emerging field of cannabis toxicity treatment.
The company currently operates only in the United States, focusing its efforts on advancing selonabant through the necessary clinical and regulatory processes. As Anebulo progresses with its development programs, it will need to carefully manage its financial resources and potentially seek additional funding to support its ongoing research and development activities.