10-K: Anebulo Shifts Focus to Pediatric Cannabis Toxicity IV Treatment

Anebulo Pharmaceuticals is prioritizing the development of an intravenous selonabant formulation for pediatric cannabis poisoning, while reporting continued operating losses and proposing a reverse stock split to go private.

Summary

• Anebulo Pharmaceuticals, a clinical-stage company, is developing selonabant (formerly ANEB-001) to treat cannabis-induced toxicity, including acute cannabinoid intoxication (ACI) in adults and unintentional cannabis poisoning in children.
• The company is shifting its primary focus to an intravenous (IV) formulation of selonabant for pediatric patients with unintentional cannabis poisoning, believing it offers a faster path to regulatory approval.
• The U.S. Food and Drug Administration (FDA) has acknowledged the unmet need for a pediatric treatment and proposed close collaboration for the selonabant program.
• A single ascending dose (SAD) study of IV selonabant in healthy adults was initiated in the third quarter of calendar 2025.
• Previous Phase 2 data from the Netherlands Trial (Part A and B, 134 subjects) showed oral selonabant significantly reduced key ACI symptoms, including 'feeling high' (p < 0.0001) and improved alertness (p < 0.01) at 50mg and 100mg doses.
• Part B of the Netherlands Trial demonstrated a single 10mg oral dose of selonabant, administered one hour after THC challenge (21mg or 30mg), rapidly and significantly reversed psychotropic effects (VAS feeling high p=<0.0001, VAS alertness p=0.0042, reduced body sway p=0.0196).
• Part C of the Netherlands Trial (20 subjects, open-label) showed 10mg selonabant with 40mg THC or 20mg selonabant with 60mg THC mitigated major THC effects, with all adverse events being mild and transient.
• The company reported a net loss of $8.48 million for the fiscal year ended June 30, 2025, compared to $8.20 million for the prior year.
• Research and development expenses increased to $4.30 million in fiscal 2025 from $3.55 million in fiscal 2024, driven by IV selonabant development.
• General and administrative expenses increased to $4.92 million in fiscal 2025 from $4.76 million in fiscal 2024, primarily due to increased stock-based compensation.
• Anebulo received $14.9 million in net proceeds from a private placement in December 2024 and was awarded a $0.9 million first tranche of a $1.9 million NIDA grant in July 2024.
• As of June 30, 2025, cash and cash equivalents totaled $11.6 million, with an accumulated deficit of $73.9 million.
• The company's board has approved a proposed reverse stock split (1-for-2,500 to 1-for-7,500) and plans to delist from Nasdaq and deregister its common stock to go private, subject to stockholder approval.
• Daniel George resigned as Chief Financial Officer, effective September 30, 2025, and Richard Anthony Cunningham, CEO, was appointed Interim CFO.

Sentiment

Score: 4

Explanation: The sentiment is moderately negative. While there are clear positives in clinical progress and a strategic shift towards a high-unmet-need pediatric indication with FDA collaboration, these are significantly overshadowed by persistent operating losses, the explicit need for future capital, and the highly impactful decision to go private and delist from Nasdaq, which is generally detrimental to public shareholders' interests.

Positives

• Positive Phase 2 clinical trial results for oral selonabant demonstrated significant reduction in key ACI symptoms and rapid reversal of THC effects.
• FDA acknowledged the unmet medical need for pediatric cannabis toxicity treatment and proposed close collaboration for the IV selonabant program, potentially accelerating approval.
• Secured a two-year cooperative grant of up to $1.9 million from the National Institute on Drug Abuse (NIDA) to support IV selonabant development, with $0.9 million received in fiscal 2025.
• Successfully scaled up the intravenous (IV) selonabant formulation for initial clinical safety studies.
• Initiated a single ascending dose (SAD) study of IV selonabant in healthy adults in Q3 calendar 2025.
• Proprietary position protected by three issued U.S. patents and rights to six additional patent applications, covering selonabant's use, aspects, and delivery systems, with protection extending through 2040 and 2042.
• The recent U.S. Department of Justice decision to reschedule marijuana from Schedule I to Schedule III is believed to increase cannabis use, potentially expanding the market for cannabis toxicity treatments.

Negatives

• Continued to incur significant operating losses, with a net loss of $8.48 million for the fiscal year ended June 30, 2025.
• Accumulated deficit reached $73.9 million as of June 30, 2025, indicating a history of unprofitability.
• Will need to raise additional capital in the future, which may not be available on acceptable terms or may cause substantial dilution to existing stockholders.
• Proposed plan to go private, delist from Nasdaq, and deregister common stock, which will significantly reduce liquidity and public information for stockholders.
• The company has no product revenue since its inception and does not anticipate generating revenue from product sales in the near term.
• Reliance on third parties for manufacturing and clinical trials introduces risks of delays, increased costs, and potential data rejection by regulatory authorities.
• Daniel George, the part-time Chief Financial Officer, resigned effective September 30, 2025, potentially creating a leadership gap.

Risks

• We have not generated any revenue since our inception and expect to incur future losses and may never become profitable.
• We currently have no product revenue and will need to raise additional capital in the future, which may be unavailable to us or may cause dilution or place significant restrictions on our ability to operate.
• We have a limited operating history as a publicly traded company, and our inexperience could materially and adversely affect us and our stockholders.
• Our current and future operations substantially depend on our Founder, our Chief Executive Officer, and our ability to hire other key personnel, the loss of any of whom could disrupt our business operations.
• If we are unable to obtain and maintain sufficient patent protection for selonabant, or if the scope of the patent protection obtained is not sufficiently broad, our competitors could develop and commercialize products that are similar or identical to ours, and our ability to successfully commercialize our current or future product candidates may be adversely affected.
• If we do not obtain patent term extension and data exclusivity for any product candidates we may develop, our business may be materially harmed.
• We currently rely on a license from a third party, and in the future may rely on additional licenses from other third parties, in relation to our development of selonabant, and if we fail to comply with our obligations under our current or future intellectual property license agreements or otherwise experience disruptions to our business relationships with our current or any future licensors, we could lose intellectual property rights that are important to our business.
• We may not be able to protect our intellectual property rights throughout the world, which could negatively impact our business.
• The expiration or loss of patent protection may adversely affect our future revenues and operating earnings.
• Delays in the completion of, or the termination of, a clinical trial for selonabant, our lead drug candidate, could adversely affect our business.
• If we are not able to obtain regulatory approvals for selonabant, we will not be able to commercialize our lead drug candidate and our ability to generate revenue will be limited.
• Even if we receive regulatory approval for selonabant, our lead drug candidate we may not be able to successfully commercialize the product and the revenue that we generate from its sales, if any, may be limited.
• Interim, topline and preliminary data from our preclinical studies or clinical trials may change as more data become available, and are subject to audit and verification procedures that could result in material changes in the final data.
• Even if we obtain marketing approval for selonabant, we will be subject to ongoing obligations and continued regulatory review, which may result in significant additional expense. Additionally, selonabant could be subject to labeling and other restrictions and withdrawal from the market and we may be subject to penalties if we fail to comply with regulatory requirements or if we experience unanticipated problems with selonabant.
• Any products we develop may become subject to unfavorable pricing regulations, third-party coverage and reimbursement practices or healthcare reform initiatives, thereby harming our business.
• Current legislation may increase the difficulty and cost for us to commercialize selonabant and affect the prices we may obtain and our current and future relationships with healthcare professionals, clinical investigators, consultants, patient organizations, customers, CROs and third-party payors.
• Our lead drug candidate, selonabant, may face competition sooner than expected.
• Any termination or suspension of, or delays in the commencement or completion of, any necessary studies of selonabant, our lead drug candidate, for any indications could result in increased costs to us, delay or limit our ability to generate revenue and adversely affect our commercial prospects.
• Clinical drug development involves a lengthy and expensive process with an uncertain outcome, and results of earlier studies and trials may not be predictive of future trial results.
• We may be exposed to product liability risks, and clinical and preclinical liability risks, which could place a substantial financial burden upon us should we be sued.
• Selonabant, our lead product candidate, may have undesirable side effects which may delay or prevent marketing approval, or, if approval is received, require it to be taken off the market, require it to include safety warnings or otherwise limit sales of the product.
• We currently have no marketing and sales organization and we have no direct experience marketing pharmaceutical products. If we are unable to establish our own marketing and sales capabilities, or enter into agreements with third parties to market and sell our products after approval, we may not be able to generate product revenues.
• New drugs, which may be developed by others, could impair our ability to maintain and grow our business and remain competitive.
• Recent changes implemented by the United States government, including changes to grant funding and trade policies, may have an adverse effect on our reputation, business, financial condition and results of operations.
• We depend on third parties in connection with our preclinical testing and clinical trials, which may result in costs and delays that prevent us from obtaining regulatory approval or successfully commercializing selonabant or future product candidates.
• We will be completely dependent on third parties to manufacture selonabant, and our commercialization of selonabant could be halted, delayed or made less profitable if those third parties fail to obtain manufacturing approval from the FDA or comparable foreign regulatory authorities, fail to provide us with sufficient quantities of selonabant or fail to do so at acceptable quality levels or prices.
• Our reliance on collaborations with third parties to develop and commercialize selonabant is subject to inherent risks and may result in delays in product development and lost or reduced revenues, restricting our ability to commercialize selonabant and adversely affecting our profitability.
• Legislative or regulatory reform of the healthcare system may affect our ability to sell our products profitably.
• Clinical trials for selonabant have and may in the future be conducted outside the United States and not under an IND, and where this is the case, the FDA may not accept data from such trials.
• We intend to seek stockholder approval of a reverse stock split, which is being proposed in connection with our proposed plan to go private and to delist our common stock from the Nasdaq Stock Market and deregister our common stock under the Exchange Act.
• The trading price and volume of our common stock in the public markets has experienced, and may in the future experience, volatility due to a variety of factors, many of which are beyond our control.
• Future sales, or the perception of future sales, of a substantial number of our shares of common stock could depress the trading price of our common stock.
• Our principal stockholders and management own a substantial majority of our stock and will be able to exert significant control over matters subject to stockholder approval.
• Anti-takeover provisions in our charter documents could discourage, delay or prevent a change in control of our company and may affect the trading price of our common stock.
• Our certificate of incorporation provides that the Court of Chancery of the State of Delaware will be the sole and exclusive forum for certain disputes and that federal district courts will be the sole and exclusive forum for Securities Act claims, which could limit our stockholders ability to obtain a favorable judicial forum.
• We do not expect to pay any dividends on our common stock.
• If we fail to establish and maintain proper and effective internal control over financial reporting, our operating results and our ability to operate our business could be harmed.
• We are incurring significantly increased costs as a result of operating as a public company, and our management is required to devote substantial time to compliance efforts.
• Changes in accounting principles or guidance, or in their interpretations, could result in unfavorable accounting charges or effects, including changes to our previously filed financial statements, which could cause our stock price to decline.
• We are an emerging growth company and our election to delay adoption of new or revised accounting standards applicable to public companies may result in our financial statements not being comparable to those of some other public companies; as a result, our securities may be less attractive to investors.
• Changes in tax laws or regulations that are applied adversely to us or our customers may have a material adverse effect on our business, cash flow, financial condition or results of operations.
• Our ability to use net operating loss carryforwards and certain other tax attributes to offset future taxable income may be limited.
• If securities or industry analysts do not publish or cease publishing research or reports about us, or if they change their recommendations adversely, or if our actual results differ significantly from our guidance, our stock price and trading volume could decline.
• Health epidemics or pandemics may adversely affect our business, financial condition and results of operations.
• Unstable market and economic conditions, geopolitical conditions, domestic and foreign trade policies, monetary policies and other factors beyond our control may have serious adverse consequences on our business, financial condition and stock price.
• Inflation may adversely affect us by increasing our costs.
• We are subject to stringent and evolving U.S. and foreign laws, regulations, rules, contractual obligations, policies and other obligations related to data privacy and security. Our actual or perceived failure to comply could lead to regulatory investigations or actions, litigation, fines and penalties, and other adverse consequences.
• If our internal information technology systems or sensitive information, or those of our third-party CROs or other contractors or consultants, are or were compromised, we could experience adverse consequences, including a material disruption of the development of our product candidates.

Future Outlook

Anebulo is prioritizing the advancement of an intravenous (IV) selonabant formulation as a potential treatment for pediatric patients with unintentional cannabis poisoning, anticipating a faster timeline to approval compared to the adult oral product. The company believes initial approval for the pediatric IV treatment may facilitate the path to approval for an oral treatment for adult ACI. An observational study in emergency department patients with acute cannabis-induced toxicity is ongoing to gather data supporting selonabant's development, with a modified focus on pediatric cannabis-induced toxicity. The company expects research and development expenses to increase as it completes the current IV selonabant SAD study and prepares for further clinical trials. Anebulo also plans to explore strategic collaborations to commercialize selonabant if approved, aiming for capital efficiency by outsourcing research, manufacturing, and data management. The company intends to seek stockholder approval for a reverse stock split as part of a plan to go private, delist from Nasdaq, and deregister its common stock, though it is also reviewing other strategic alternatives.

Management Comments

• We believe that the number of cannabis-related emergency department visits and health problems associated with unintentional cannabis poisoning and ACI will continue to increase substantially as more states pass laws legalizing cannabis for medical and recreational use.
• Given the consequences, there is an urgent need for a treatment to rapidly reverse the symptoms of cannabis-induced toxicity.
• We believe the data generated from the Netherlands Trial provide support for our development pathway.
• Rather than proceeding directly with the Phase 3 studies of oral selonabant in adults with ACI, we are prioritizing the advancement of a selonabant intravenous (IV) formulation as a potential treatment for pediatric patients with unintentional cannabis poisoning, which we believe offers the potential for a faster timeline to approval relative to the adult oral product.
• FDA acknowledged the unmet need for a treatment for children exposed to cannabis toxicity, and proposed a close, ongoing collaboration to efficiently advance the selonabant program for the pediatric indication.
• Our belief is that the path to approval for an oral treatment for adult ACI may be facilitated by an initial approval for intravenous treatment of unintentional cannabis poisoning in the pediatric population.
• With this unprecedented change in cannabis regulation, Anebulo is uniquely positioned to become a provider of a rapid and clinically impactful solution for Emergency Departments to treat pediatric patients suffering from unintentional cannabis poisoning.
• We expect that our cash and cash equivalents at June 30, 2025, along with access to funding under our loan agreement, will enable us to fund our operating expenses and capital expenditure requirements through at least 12 months from the issuance date of the financial statements.

Industry Context

The U.S. cannabis market is expanding rapidly due to increasing legalization for medical and recreational use across states. This trend is leading to a dramatic increase in cannabis-related emergency department visits, particularly due to unintentional ingestion of potent edible products by children. There is a significant unmet medical need for specific treatments to rapidly reverse cannabis-induced toxicity, as current medical practice relies on supportive care. The recent decision by the U.S. Department of Justice to support rescheduling marijuana from Schedule I to Schedule III is expected to further increase cannabis product use, exacerbating the need for such treatments. Anebulo aims to position selonabant as a first-in-class treatment in this growing market, initially targeting the vulnerable pediatric population where the need is particularly acute and the path to approval may be faster.

Comparison to Industry Standards

• Anebulo Pharmaceuticals is currently not aware of any competing products that are further along in the development process than selonabant to specifically reverse the symptoms of unintentional cannabis poisoning or ACI, positioning it as a potential 'First-in-Class Treatment'.
• Potential current competitors include Aelis Farma, which is developing a medication based on a pregnenolone derivative to treat cannabis use disorders in collaboration with Indivior PLC.
• Opiant Pharmaceuticals, Inc. (acquired by Indivior PLC in March 2023), is developing a drinabant injection to treat acute cannabis overdose, which could obtain regulatory approval before selonabant.
• The company's preclinical and clinical data for selonabant show rapid absorption and CB1 antagonist effects, consistent with the mechanism of action for other CB1 antagonists, but without the significant side effects observed with prolonged administration of a different CB1 antagonist that led to its discontinuation for weight loss.
• The FDA's evidentiary standard of efficacy generally relies on a p-value of less than or equal to 0.05; selonabant's Phase 2 results demonstrated highly statistically significant reductions in key ACI symptoms (p < 0.0001), meeting this standard for efficacy signals.

Management Changes

Corporate Governance

Legal Proceedings

• The company is not currently a party to any material legal proceedings.

Related Party Transactions

• Entered into a Loan and Security Agreement (LSA) on November 13, 2023, with 22NW, LP and JFL Capital Management LLC (related parties). Joseph F. Lawler (founder/director) is Managing Member of JFL, and Aron R. English (director) and Nathaniel Calloway (director) are associated with 22NW.
• The LSA was modified on February 10, 2025, into an Amended and Restated Loan Agreement, reducing the maximum loan advance to $3 million and removing securitization provisions. No balance has been drawn on this agreement since inception.
• In connection with the L LSA, 300,000 shares of common stock were issued to 22NW upon signing.
• In December 2024, the company entered into a private placement with 22NW Fund, LP (a greater than 5% stockholder controlled by Aron English, a director) and other institutional accredited investors. 22NW Fund purchased 10,101,010 shares, contributing approximately $10.0 million of the total $15.0 million gross proceeds.
• The company manages its principal executive office in leased space under a sublease with JFL Capital Management LLC, a company controlled by Joseph F. Lawler, paying approximately $400 per month since July 2023.

Stakeholder Impact

• **Shareholders:** Will experience significant dilution if additional equity financing is pursued. The proposed reverse stock split and delisting will severely reduce liquidity and public information, making trading more difficult and potentially decreasing share value. Principal stockholders and management will maintain significant control.
• **Employees:** The company's future viability depends on attracting and retaining highly qualified personnel. Stock-based compensation is used to incentivize and retain employees.
• **Patients (Pediatric):** The strategic shift to an IV formulation for unintentional cannabis poisoning in children addresses a growing, unmet medical need in a vulnerable population, potentially offering a rapid and clinically impactful solution.
• **Patients (Adult ACI):** Development of an oral treatment for adult ACI is being de-prioritized, potentially delaying a specific treatment option for this population.
• **Regulatory Authorities (FDA):** The company is engaging in close, ongoing collaboration with the FDA for the pediatric IV selonabant program, which could streamline the approval process.
• **Third-Party Payors:** Future commercial success depends on obtaining favorable coverage and reimbursement, which is uncertain and subject to increasing scrutiny on price and cost-effectiveness.
• **Licensors (Vernalis):** The company relies on its exclusive license agreement with Vernalis for selonabant, with ongoing obligations for milestone payments and royalties upon commercialization.

Next Steps

• Hold a special meeting of stockholders to approve the proposed reverse stock split.
• If stockholder approval is obtained and the board determines to proceed, give notice to Nasdaq of intent to voluntarily delist common stock.
• File a Form 25 Notification of Removal From Listing with the SEC, followed by a Form 15 to suspend reporting obligations under the Exchange Act.
• Continue the single ascending dose (SAD) study of IV selonabant in healthy adults.
• Prepare for further clinical trials for IV selonabant, particularly for the pediatric indication.
• Continue the observational study in emergency department patients with acute cannabis-induced toxicity, with a modified focus on pediatric cases.
• Review all strategic alternatives, including the proposed going private transaction, a sale of assets, and/or a merger transaction.
• Assess the impact of the One Big Beautiful Bill Act (OBBBA) on consolidated financial statements and recognize effects in the period of enactment.

Key Dates

Recommendation

The proposed plan to go private, delist from Nasdaq, and deregister the common stock is a highly negative development for public shareholders. This action will drastically reduce the liquidity of the stock, eliminate public reporting, and make it significantly more difficult for investors to buy or sell shares. While the company has promising clinical data and a strategic shift to a high-unmet-need pediatric indication, the corporate governance decision to exit public markets fundamentally changes the investment thesis, making it unsuitable for most public investors. The continued operating losses and ongoing need for capital further compound the risk for any remaining public shareholders. Therefore, a seasoned investor would likely recommend selling to avoid the illiquidity and lack of transparency associated with a private company.

Keywords

Anebulo Pharmaceuticals, selonabant, cannabis toxicity, acute cannabinoid intoxication, pediatric cannabis poisoning, CB1 antagonist, drug development, clinical trials, biopharmaceutical, SEC filing, 10-K, Nasdaq delisting, reverse stock split, NIDA grant, FDA collaboration