Anebulo Pharmaceuticals, Inc.

Anebulo Pharmaceuticals, Inc. is a clinical-stage pharmaceutical company focused on developing treatments for cannabis-induced toxicity, including acute cannabis-induced toxicity in children and acute cannabinoid intoxication (ACI) in adults, as well as broader acute cannabis-induced conditions. The company's lead product candidate, selonabant (formerly ANEB-001), is designed to rapidly reverse the negative effects of cannabis-induced toxicity and reduce recovery time. There are currently no approved medical treatments specifically for cannabis-induced toxicity, and Anebulo is not aware of any competing products further along in development for reversing the effects of cannabinoids like THC ¹. The company believes the market opportunity is growing, with cannabis-related emergency department visits increasing from an estimated 1.1 million in 2014 to approximately 1.8 million patients in 2021 ².

The core business model of Anebulo Pharmaceuticals is centered on the research, development, and eventual commercialization of selonabant. The company generates revenue through potential product sales, or payments from collaboration and license agreements, though it has not generated any revenue since its inception ³. Its primary customer segments, once products are approved, would be patients suffering from acute cannabis-induced toxicity and unintentional cannabis poisoning, with a current strategic focus on pediatric patients. The company aims for capital efficiency by outsourcing clinical and non-clinical research, manufacturing, and data management activities ⁴.

Selonabant is a potent, small molecule antagonist of cannabinoid binding receptor type-1 (CB1), the primary receptor involved in the psychotropic effects of cannabinoids ⁵. It is orally bioavailable, rapidly absorbed, and has also been formulated for intravenous (IV) administration ⁶. Both oral and IV selonabant are being designed to rapidly reverse the symptoms of cannabis toxicity and reduce the time to recovery ⁷. The company's proprietary position is protected by three issued US patents and rights to six additional patent applications, two pending Patent Cooperation Treaty (PCT) applications, and additional international patent applications, covering various methods of use, aspects of selonabant, and delivery systems ⁸.

For the fiscal year ended June 30, 2025, Anebulo Pharmaceuticals reported total operating expenses of $9,223,481 ⁹, resulting in a loss from operations of $(9,223,481) ¹⁰. The net loss for the period was $(8,484,763) ¹¹, leading to a basic and diluted EPS of $(0.25) ¹². As of June 30, 2025, the company had cash and cash equivalents of $11,627,849 ¹³ and an accumulated deficit of $73,888,507 ¹⁴. The company had no outstanding debt under its Loan Agreement as of June 30, 2025 ¹⁵.

Comparing the fiscal year ended June 30, 2025, to the prior year, total operating expenses increased by $914,726 ¹⁶. Research and development expenses rose to $4,299,941 ¹⁷ in 2025 from $3,548,937 ¹⁸ in 2024, an increase of $751,004 ¹⁹. General and administrative expenses increased by $163,722 ²⁰ to $4,923,540 ²¹ in 2025 from $4,759,818 ²² in 2024. Net loss increased by $283,060 ²³ from $(8,201,703) ²⁴ in 2024 to $(8,484,763) ²⁵ in 2025. Grant income of $864,014 ²⁶ was recognized in 2025, with no comparable income in the prior year ²⁷.

During the fiscal year, Anebulo Pharmaceuticals prioritized the advancement of a selonabant IV formulation for pediatric patients with unintentional cannabis poisoning, believing it offers a faster timeline to approval compared to the adult oral product ²⁸. The company initiated a single ascending dose (SAD) study of IV selonabant in healthy adults in the third quarter of calendar 2025 ²⁹. Anebulo also received the first tranche of a two-year cooperative grant totaling approximately $1.9 million ³⁰ from the National Institute on Drug Abuse (NIDA) in July 2024, with an initial award of $0.9 million ³¹ in the first year, to support the development of intravenous selonabant ³². The company closed a private placement offering in December 2024, receiving net proceeds of approximately $14.9 million ³³. In July 2025, the company announced a proposed going private transaction, including a reverse stock split at a ratio of not less than 1-for-2,500 and not greater than 1-for-7,500 ³⁴, subject to stockholder approval, with the primary purpose of maintaining fewer than 300 record holders of its common stock ³⁵.

Anebulo Pharmaceuticals expects to continue incurring significant operating losses and negative cash flows in the future as it advances the clinical development of its programs ³⁶. The company anticipates that its cash and cash equivalents, along with available funding under the Loan Agreement, will be sufficient to fund its operating expenses and capital expenditure requirements through at least 12 months from the issuance date of the financial statements ³⁷. However, it may exhaust its available capital resources sooner than expected due to the numerous risks and uncertainties associated with program development ³⁸.

The company's primary growth area is the development and commercialization of selonabant in the United States, with a current strategic prioritization of the intravenous (IV) formulation for pediatric patients with unintentional cannabis poisoning ³⁹. This prioritization is driven by the belief that it offers a faster timeline to approval relative to the adult oral product ⁴⁰, the recent development of a suitable IV selonabant formulation, prior discussions with the FDA highlighting the need for an alternative formulation for younger patients, and increasing recognition of this unmet medical need in a vulnerable population ⁴¹. The company believes that initial approval for intravenous treatment in the pediatric population may facilitate the path to approval for an oral treatment for adult ACI ⁴². Anebulo initiated a single ascending dose (SAD) study of IV selonabant in healthy adults in the third quarter of calendar 2025 ⁴³. The company also plans to pursue the adult oral ACI treatment market opportunity once it can provide a necessary treatment for pediatric patients ⁴⁴.

Anebulo Pharmaceuticals aims to be capital efficient in its development of selonabant by outsourcing clinical and non-clinical research, manufacturing, and data management activities, anticipating this will lower clinical development costs and improve efficient commercialization if approved ⁴⁵. The company also intends to explore strategic collaborations to widely commercialize selonabant, if approved, potentially partnering with companies that possess a direct sales force and sales representatives ⁴⁶. Furthermore, Anebulo plans to introduce promising product candidate extensions, having developed an IV selonabant formulation and investigating additional potential routes of administration alongside the oral formulation ⁴⁷.

The company expects its research and development expenses to be significant over the next several years as it advances its current clinical development program and prepares to seek regulatory approval ⁴⁸. For the fiscal year ended June 30, 2025, research and development expenses were $4,299,941 ⁴⁹, and the company expects these expenses to increase as it completes the current study and prepares for further clinical trials ⁵⁰. The company was awarded the first tranche of $0.9 million ⁵¹ of a two-year cooperative grant of up to approximately $1.9 million ⁵² from NIDA in July 2024 to support the development of intravenous selonabant ⁵³. The second year's funding of approximately $1.0 million ⁵⁴ is subject to certain conditions and milestones, specifically that the Investigational New Drug Application to the FDA for a Phase 1 SAD study of IV selonabant in healthy adults is permitted to proceed or an FDA clinical hold is imposed that cannot be successfully addressed with available time and resources ⁵⁵.

Anebulo Pharmaceuticals has identified several structural headwinds and execution risks. The company currently has no product revenue and will need to raise additional capital in the future, which may be unavailable or cause dilution ⁵⁶. The Loan Agreement with 22NW and JFL Capital Management LLC allows for borrowing up to $3 million ⁵⁷, but even if fully drawn, additional funding will be required ⁵⁸. The company is completely dependent on third parties to manufacture selonabant, and commercialization could be halted, delayed, or made less profitable if these third parties fail to obtain manufacturing approval, provide sufficient quantities, or meet quality levels or prices ⁵⁹. Reliance on collaborations with third parties for development and commercialization is also subject to inherent risks, potentially leading to delays and lost or reduced revenues ⁶⁰.

Geographic, regulatory, and macro factors also pose constraints. The recent decision by the United States Department of Justice to support the rescheduling of marijuana from a schedule I to a schedule III-controlled substance is believed to ultimately lead to increased use of cannabis-containing products, including edibles that cause unintentional cannabis poisoning in children ⁶¹. Clinical trials for selonabant have been and may in the future be conducted outside the United States and not under an IND, and the FDA may not accept data from such trials, requiring additional costly and time-consuming trials ⁶². The company is subject to stringent and evolving U.S. and foreign laws, regulations, rules, contractual obligations, policies, and other obligations related to data privacy and security, with actual or perceived failure to comply potentially leading to regulatory investigations, litigation, fines, and penalties ⁶³.

Anebulo Pharmaceuticals faces several material risks, including the fundamental challenge of not having generated any revenue since inception and the expectation of future losses, with an accumulated deficit of $73.9 million ⁶⁴ as of June 30, 2025. The company will require additional capital beyond its current cash and cash equivalents of $11.6 million ⁶⁵ and the $3 million ⁶⁶ available under its Loan Agreement, and there is no assurance that such financing will be available on acceptable terms or at all, potentially leading to delays or elimination of product development ⁶⁷. Delays or termination of clinical trials for selonabant, which are expensive, time-consuming, and unpredictable, could adversely affect the business, shorten patent protection periods, and allow competitors to enter the market sooner ⁶⁸. The company is entirely dependent on third parties for manufacturing selonabant, and any failure by these manufacturers to obtain regulatory approval, provide sufficient quantities, or maintain quality could significantly impact commercialization ⁶⁹. Furthermore, the company's reliance on third-party licensors for intellectual property rights, such as the exclusive license agreement with Vernalis Development Limited, carries the risk of losing critical rights if obligations are not met or agreements are terminated ⁷⁰. Legislative or regulatory reforms in the healthcare system, including pricing regulations, third-party coverage, and reimbursement practices, could unfavorably impact the commercial viability and profitability of any approved products ⁷¹. The company is also exposed to product liability risks inherent in testing, manufacturing, and marketing pharmaceutical products, with potential claims or losses exceeding insurance coverage ⁷². Cybersecurity threats, including cyberattacks and data breaches, pose a risk to internal information technology systems and sensitive information, potentially causing material disruption to product development, regulatory investigations, litigation, and financial losses ⁷³.

Management's message to shareholders emphasizes the urgent and growing unmet medical need for treatments for cannabis-induced toxicity, particularly in pediatric patients, which is driving the company's strategic focus. The company has decided to prioritize the advancement of a selonabant intravenous (IV) formulation as a potential treatment for pediatric patients with unintentional cannabis poisoning, believing this offers the potential for a faster timeline to approval relative to the adult oral product ⁷⁴. This decision is supported by the recent development of a suitable IV formulation and prior discussions with the FDA, which acknowledged the unmet need for children exposed to cannabis toxicity and proposed close, ongoing collaboration ⁷⁵. Anebulo initiated a single ascending dose (SAD) study of IV selonabant in healthy adults in the third quarter of calendar 2025 ⁷⁶. Management also highlighted the recent decision by the United States Department of Justice to support the rescheduling of marijuana, which they believe will ultimately lead to increased use of cannabis-containing products and consequently, an increase in unintentional cannabis poisoning in children ⁷⁷. The three strategic priorities emphasized are: developing and commercializing selonabant in the United States with a focus on the pediatric IV formulation, exploring strategic collaborations to widely commercialize selonabant if approved, and striving for capital efficiency by outsourcing research, manufacturing, and data management activities ⁷⁸.