Anebulo Pharmaceuticals, Inc. (ANEB): History, Ownership, Mission, How It Works & Makes Money

Anebulo Pharmaceuticals, Inc. (ANEB): History, Ownership, Mission, How It Works & Makes Money

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How does a clinical-stage biotechnology company like Anebulo Pharmaceuticals, Inc. (ANEB) navigate a niche market with a laser-focus on a single, high-stakes drug candidate? You're looking at a company that closed its 2025 fiscal year with a net loss of $8.5 million, yet its valuation-a market capitalization of around $97.37 million as of November 2025-is driven almost entirely by the potential of its lead asset, Selonabant, to address acute cannabis-induced toxicity. Their strategy is a clear pivot: they are prioritizing the intravenous (IV) formulation of Selonabant for pediatric emergency use, a move they believe offers a faster path to approval than the adult oral version, and they are already backed by a collaborative grant from the National Institute on Drug Abuse (NIDA) for $994,300. This is a defintely a story of managing cash-they had $11.6 million in cash and equivalents as of June 30, 2025-while chasing a critical, unmet medical need, so you need to understand exactly how this model works and what the next clinical milestones mean for your investment thesis.

Anebulo Pharmaceuticals, Inc. (ANEB) History

You're looking for the foundational story of Anebulo Pharmaceuticals, Inc., and the key takeaway is this: the company quickly evolved from an adult-focused oral drug developer to a pediatric emergency treatment specialist, and is now facing a major corporate transformation with a proposal to go private in late 2025.

This is a young, clinical-stage biotechnology company that has made a sharp pivot to address an acute, unmet medical need-cannabis toxicity in children-which could accelerate its path to market. Still, the proposed reverse stock split and delisting from Nasdaq introduces significant risk for current public shareholders.

Given Company's Founding Timeline

Year established

Anebulo Pharmaceuticals, Inc. was founded on April 23, 2020, as a Delaware corporation.

Original location

The company's principal operations are located in Lakeway, Texas, a suburb of Austin.

Founding team members

While the initial small group is not explicitly named, the company was quickly assembled by industry veterans, including individuals who would become key leaders and board members, such as Dr. Kenneth C. Cundy, Ph.D. (Chief Scientific Officer), who is a coinventor of blockbuster drugs like tenofovir DF (Viread®), and Dr. Joseph F. Lawler, M.D., Ph.D. (Chairman of the Board).

Initial capital/funding

The company initially funded its operations through a private placement of Series A convertible preferred stock before its Initial Public Offering (IPO). A more recent capital injection was a $15 million Post IPO funding round in December 2024 from Merida Capital Partners.

Given Company's Evolution Milestones

Year Key Event Significance
2020 Company founded and licensed rights to its lead product candidate, selonabant (ANEB-001). Established the core asset, a CB1 receptor antagonist, for the pipeline.
2022-2023 Completed Phase 2 proof-of-concept study for oral selonabant in adults. Demonstrated that oral selonabant could block or reverse key central nervous system (CNS) effects of THC, validating the drug's mechanism of action.
2024 Strategic pivot to Intravenous (IV) formulation of selonabant for pediatric use. Shifted focus from oral adult acute cannabinoid intoxication (ACI) to a more serious, unmet need in children, aiming for a potentially faster regulatory path.
FY 2025 Secured $0.9 million in grant income from the National Institute on Drug Abuse (NIDA). Provided non-dilutive funding to support the development of the IV formulation.
Sep 2025 First subjects dosed in a Phase 1 Single Ascending Dose (SAD) study of IV selonabant. Initiated clinical testing of the new IV formulation, a critical step for the pediatric program.
Nov 2025 Proposed a massive Reverse Stock Split (1-for-2,500 to 1-for-7,500) to delist from Nasdaq. A fundamental corporate action signaling a move to terminate its public reporting status and go private, impacting shareholder liquidity.

Given Company's Transformative Moments

The most significant shift for Anebulo Pharmaceuticals, Inc. involves two simultaneous, high-impact decisions: the strategic pipeline pivot and the corporate structure change. Here's the quick math on the financial reality underpinning these moves: the company reported a net loss of $8.5 million in fiscal year 2025, with operating expenses at $9.2 million. They are a clinical-stage company with no revenue, so cash management is defintely paramount.

  • The Pediatric Pivot: After the successful Phase 2 trial for the oral adult formulation, the company chose not to proceed directly to Phase 3. Instead, they prioritized the IV formulation for pediatric acute cannabis-induced toxicity, a decision strongly encouraged by the FDA. This focus on a severe, life-threatening condition in children offers the potential for an expedited regulatory timeline, which is a massive opportunity.
  • The Going-Private Proposal: The management's proposal in late 2025 to execute a massive reverse stock split and delist from Nasdaq is an existential corporate transformation. This move, which would terminate its SEC public reporting status, is intended to cut the significant General and Administrative (G&A) costs associated with being a public company. In the near term, this effort drove G&A expenses up, consuming capital that could have gone to R&D, but the long-term goal is a leaner operation.
  • Securing Non-Dilutive Funding: The continuing collaboration with the National Institute on Drug Abuse (NIDA) is a key de-risking factor. For instance, the company was awarded the second-year tranche of a grant, valued at $994,300, to support the IV formulation's Single Ascending Dose (SAD) study. This non-dilutive funding helps extend the cash runway, which stood at $10.4 million as of September 30, 2025.

To understand the implications of these changes on the company's investor base, you should read Exploring Anebulo Pharmaceuticals, Inc. (ANEB) Investor Profile: Who's Buying and Why?

Anebulo Pharmaceuticals, Inc. (ANEB) Ownership Structure

Anebulo Pharmaceuticals' ownership structure is heavily concentrated, with institutional investors and company insiders controlling over 95% of the total shares outstanding as of November 2025.

This high insider and institutional stake means that strategic decisions are defintely driven by a small group of large stakeholders, giving retail investors less direct influence over the company's direction.

Given Company's Current Status

Anebulo Pharmaceuticals, Inc. is a publicly held, clinical-stage biotechnology company, trading on the NASDAQ Capital Market under the ticker ANEB.

As a clinical-stage entity, the company currently reports no revenue, which is typical for its phase, and its focus is on advancing its lead product candidate, selonabant (ANEB-001), for acute cannabinoid intoxication. For the fiscal year 2025, the company reported an Earnings per Share (EPS) of -$0.26, reflecting its significant investment in research and development.

Given Company's Ownership Breakdown

The ownership breakdown clearly shows who holds the power. Institutional investors, like 22NW LP and Blackrock, Inc., hold the majority, while company insiders maintain a very strong position.

Here's the quick math based on the latest filings: Institutional ownership is nearly 55%, and insiders hold over 40%, leaving a small float for the general public.

Shareholder Type Ownership, % Notes
Institutional Investors 54.99% Includes hedge funds and asset managers like 22NW LP and Nantahala Capital Management.
Insiders (Executives/Directors) 40.54% This high percentage indicates strong alignment between management and shareholder interests.
Retail/General Public 4.47% The calculated remaining float; a small percentage for individual investors.

This structure means that institutions and insiders, who collectively own over 95%, effectively control the company's direction, including any decisions regarding a potential strategic transaction or a reverse stock split.

Given Company's Leadership

The company is steered by an experienced leadership team focused on navigating the complex regulatory and clinical landscape of biopharmaceuticals. The average tenure of the management team is approximately 2.8 years, which is solid for an emerging biotech.

  • Richie Cunningham: Chief Executive Officer (CEO) and Director. He was appointed in October 2023 and has over two decades of leadership experience in drug discovery and commercialization.
  • Daniel George: Acting Chief Financial Officer (CFO) and Secretary. Mr. George specializes in providing executive financial services to healthcare companies.
  • Dr. Kenneth Cundy, Ph.D.: Chief Scientific Officer (CSO). Dr. Cundy is a co-inventor of the approved drug Horizant and guides the clinical and scientific strategy.
  • Joseph F. Lawler, M.D., Ph.D.: Founder and Chairman of the Board. He brings a strong background as an analyst and portfolio manager in healthcare investment funds.

If you want to understand the core principles guiding these leaders, you should review the Mission Statement, Vision, & Core Values of Anebulo Pharmaceuticals, Inc. (ANEB).

Anebulo Pharmaceuticals, Inc. (ANEB) Mission and Values

Anebulo Pharmaceuticals, Inc.'s core purpose transcends standard drug development; it is centered on addressing a critical, escalating public health crisis: acute cannabis-induced toxicity, particularly in vulnerable pediatric populations. Their values are rooted in scientific urgency and a commitment to providing the first specific, rapid-acting antidote to a growing medical need.

Anebulo Pharmaceuticals, Inc.'s Core Purpose

The company operates with a clear, singular focus: to develop novel, targeted therapies that quickly reverse the serious and life-threatening effects of cannabinoid overdose and intoxication. This drive is evident in their strategic pivot to prioritize the most critical unmet need, which is a hallmark of a purpose-driven biotech firm.

The urgency of their work is underscored by the fact that National Poison Data System call volumes for pediatric cannabis exposure rose 40% in states post-legalization, demonstrating a clear market need for their lead candidate, selonabant (ANEB-001).

Official Mission Statement (Synthesized)

While Anebulo Pharmaceuticals, Inc. does not publish a traditional, one-sentence mission statement, its stated purpose is to be a clinical-stage pharmaceutical company:

  • Developing novel solutions for people suffering from acute cannabis-induced toxic effects.
  • Providing the first emergency antidote for acute cannabis-induced toxicity in children.
  • Advancing selonabant (a cannabinoid receptor type-1 antagonist) to rapidly reverse key symptoms of cannabis toxicity.

This mission is defintely supported by their financial decisions, including securing the second-year tranche of a collaborative grant from the National Institute on Drug Abuse (NIDA) amounting to $994,300 in the 2025 fiscal year to fund their IV formulation studies.

Vision Statement (Synthesized)

The company's vision is clearly articulated through its forward-looking goals and the potential impact of its lead therapeutic candidate. The vision is to establish selonabant as the essential, targeted therapy in emergency medicine for cannabinoid-related crises.

  • Offer a much-needed targeted therapy for rapidly reversing the serious and life-threatening consequences of acute cannabis-induced toxicity in children.
  • Address the unmet medical need for a specific antidote for acute cannabis-induced toxicity, including unintentional cannabis poisoning in pediatric subjects.
  • Achieve a faster timeline to approval for the intravenous (IV) formulation, prioritizing the most serious condition over the adult oral product.

To realize this vision, they have been working on operational efficiency; for example, net cash used in operating activities decreased 25% year-over-year to $1.3 million in the second quarter of fiscal year 2025, extending their operational runway. For more on the numbers, you should check out Breaking Down Anebulo Pharmaceuticals, Inc. (ANEB) Financial Health: Key Insights for Investors.

Anebulo Pharmaceuticals, Inc. Slogan/Tagline (Interpreted)

While an official, punchy slogan is not publicly used, the company's investor materials consistently frame their work with a powerful, action-oriented statement:

  • Reimagining the ways acute cannabinoid toxicities are treated by developing novel, best-in-class therapeutics.

This statement captures their commitment to innovation in a niche market, a commitment that led to an increase in General and Administrative expenses by $0.2 million in the fiscal year ended June 30, 2025, as they scaled up operations and prepared for the Phase 1 SAD study of IV selonabant.

Anebulo Pharmaceuticals, Inc. (ANEB) How It Works

Anebulo Pharmaceuticals, Inc. operates as a clinical-stage biopharmaceutical company, meaning it does not yet sell commercial products; instead, its value is driven by advancing its lead drug candidate, selonabant, through clinical trials to treat acute cannabis-induced toxic effects. The core of its business is the research, development, and eventual commercialization of this specific antidote, primarily focusing on the most vulnerable patient population, children.

The company generates its current financial resources from capital raises and non-dilutive grant funding, not product sales. For the fiscal year 2025, Anebulo Pharmaceuticals reported a net loss of approximately $8.5 million, with operating expenses at $9.2 million, which is typical for a biotech company in the clinical development phase.

Anebulo Pharmaceuticals, Inc.'s Product/Service Portfolio

The company's portfolio is concentrated on a single, potent small molecule drug candidate called selonabant, which acts as a competitive antagonist at the cannabinoid receptor type-1 (CB1). This mechanism is designed to block and reverse the psychoactive and toxic effects of Tetrahydrocannabinol (THC), the primary intoxicating compound in cannabis.

Product/Service Target Market Key Features
Selonabant (IV Formulation) Pediatric patients with acute cannabis-induced toxicity (cannabis poisoning) Intravenous (IV) delivery for emergency settings; potential rapid reversal of CNS depression and respiratory issues; currently in Phase 1 clinical testing.
Selonabant (Oral Formulation) Adults with Acute Cannabinoid Intoxication (ACI) Oral capsule for non-emergency use; demonstrated potential in a Phase 2 trial to block and reverse negative effects; development is currently secondary to the IV pediatric program.

Anebulo Pharmaceuticals, Inc.'s Operational Framework

The company's operational framework is built around the rigorous, multi-stage process of clinical drug development, which is defintely a long and expensive road. Since Anebulo Pharmaceuticals is a clinical-stage company, its primary value-creation process is managing and executing these trials efficiently to meet regulatory milestones set by the U.S. Food and Drug Administration (FDA).

Here's the quick math on their operations: the majority of the $9.2 million in fiscal year 2025 operating expenses went toward research and development (R&D) and general and administrative costs related to clinical studies and corporate activities.

  • Clinical Trial Management: Design, fund, and manage studies-like the Phase 1 Single Ascending Dose (SAD) study for IV selonabant initiated in September 2025-using Contract Research Organizations (CROs).
  • Non-Dilutive Funding: Secure and manage grants, like the second-year tranche of $994,300 from the National Institute on Drug Abuse (NIDA) awarded in 2025, which helps offset R&D costs.
  • Formulation and Manufacturing: Scale up and produce the drug substance and final product (e.g., the IV formulation) under Good Manufacturing Practice (GMP) standards for use in clinical trials.

You can see more on their financial runway and burn rate in Breaking Down Anebulo Pharmaceuticals, Inc. (ANEB) Financial Health: Key Insights for Investors.

Anebulo Pharmaceuticals, Inc.'s Strategic Advantages

Anebulo Pharmaceuticals' market success hinges on its ability to be the first-mover with an approved, specific treatment for cannabis toxicity. Its strategic advantages are rooted in the drug's mechanism and the current market vacuum.

  • Targeting an Unmet Medical Need: The FDA has acknowledged the significant and growing unmet need for an emergency antidote for cannabis toxicity, especially in children, which can lead to life-threatening CNS depression. This focus offers a potential faster path to regulatory approval compared to the adult indication.
  • Specific Mechanism of Action: Selonabant is a competitive CB1 receptor antagonist, directly targeting the receptor responsible for cannabis's effects. This is a crucial advantage over current supportive care treatments, which only manage symptoms.
  • Government Support and Validation: The ongoing collaborative grant funding from the NIDA, with the second-year tranche of nearly $1.0 million awarded in 2025, provides external validation and financial support for the IV formulation development.
  • Strong Liquidity for Near-Term Operations: As of September 30, 2025, the company had $10.4 million in cash and cash equivalents, plus access to an additional $3.0 million loan facility, giving it a runway to fund operations for at least 12 months while it explores strategic alternatives.

What this estimate hides is the risk that the company is currently exploring strategic alternatives, including a potential going-private transaction and a reverse stock split, which could fundamentally change its public status and capital structure.

Anebulo Pharmaceuticals, Inc. (ANEB) How It Makes Money

As a clinical-stage biopharmaceutical company, Anebulo Pharmaceuticals, Inc. does not generate revenue from commercial product sales; instead, it primarily funds its operations and drug development through capital raises, like equity offerings, and non-dilutive funding, such as government research grants. Its financial engine is currently focused on capital deployment to advance its lead drug candidate, selonabant (ANEB-001), through clinical trials toward potential regulatory approval.

Given Company's Revenue Breakdown

For the fiscal year ended June 30, 2025, Anebulo Pharmaceuticals' revenue is almost entirely comprised of grant income, as it has no approved products on the market.

Revenue Stream % of Total Growth Trend
Grant Income (NIDA) ~100% Increasing
Product Sales 0% Not Applicable

The company recorded grant income of approximately $0.9 million in fiscal year 2025, which represents nearly all of its reported revenue. This income is tied to a collaborative grant from the National Institute on Drug Abuse (NIDA) and supports the development of the intravenous (IV) formulation of selonabant. The growth trend is classified as Increasing because the company was awarded a second-year tranche of the NIDA grant, valued at approximately $994,300, which will be recognized in the subsequent fiscal year.

Business Economics

The core economic model for Anebulo Pharmaceuticals is a high-risk, high-reward biotech play, entirely dependent on the successful clinical development and eventual commercialization of selonabant, its competitive cannabinoid receptor type-1 (CB1) antagonist.

  • Pricing Power: The potential market for an emergency antidote to acute cannabis-induced toxicity, especially in children, is an unmet medical need, which historically supports premium pricing for an approved, first-in-class treatment.
  • Target Market: The company is prioritizing an IV formulation of selonabant for pediatric patients with cannabis-induced Central Nervous System (CNS) depression, a serious condition that requires emergency room intervention. This focus targets a critical, high-value segment of the market.
  • Cost Structure: The business is heavily weighted toward Research and Development (R&D) expenses, which were a significant driver of the total operating expenses of $9.2 million in fiscal year 2025. R&D costs are primarily third-party expenses for clinical trials, contract research organizations (CROs), and contract manufacturing organizations (CMOs).
  • De-Risking Strategy: Securing non-dilutive funding, like the NIDA grant, is a crucial financial strategy. This grant helps fund the Phase 1 Single Ascending Dose (SAD) study for IV selonabant without requiring the company to issue new shares, which protects existing shareholder value.

The entire economic value proposition rests on the FDA approval pathway, which the company believes is more streamlined for the pediatric IV formulation due to the severity of the condition and the lack of an approved treatment. You can read more about the company's long-term goals in its Mission Statement, Vision, & Core Values of Anebulo Pharmaceuticals, Inc. (ANEB).

Given Company's Financial Performance

Anebulo Pharmaceuticals' financial performance in fiscal year 2025 reflects the typical profile of a clinical-stage biotech: substantial investment in R&D leading to a net loss, while maintaining a sufficient cash runway to fund ongoing trials.

  • Net Loss: The company reported a net loss of $8.5 million for the fiscal year ended June 30, 2025, compared to a net loss of $8.2 million in the prior fiscal year. This slight increase in loss is directly tied to the ramp-up of clinical and pre-clinical study activities.
  • Operating Expenses: Total operating expenses for FY2025 were $9.2 million, up from $8.3 million in the previous year. This increase of approximately $0.9 million was mainly due to increased research and development activities for selonabant.
  • Liquidity Position: As of June 30, 2025, the company held $11.6 million in cash and cash equivalents. This cash position, plus access to an additional $3 million through a Loan Agreement, is what provides the company with its near-term financial runway.
  • Cash Burn Rate: For the first quarter of the subsequent fiscal year (Q1 FY2026, ended September 30, 2025), net cash used in operating activities was approximately $1.3 million, which management believes provides a runway for at least 12 months. That's the quick math on their current burn rate.

The company is defintely focused on conserving cash while advancing its lead program, which is further evidenced by the initiation of a strategic review process, including the exploration of a potential going-private transaction, as of late 2025.

Anebulo Pharmaceuticals, Inc. (ANEB) Market Position & Future Outlook

Anebulo Pharmaceuticals, Inc. is positioned as a high-risk, high-reward clinical-stage biotech, entirely focused on developing the first emergency antidote for acute cannabinoid intoxication (ACI). Its future trajectory is singularly tied to the success of its lead candidate, selonabant, particularly the intravenous (IV) formulation for pediatric use, which the company believes offers a faster path to market.

Competitive Landscape

Anebulo currently holds 0% of the commercial drug market for ACI treatment, as its lead product, selonabant (ANEB-001), is still in clinical development. The market is effectively dominated by generic symptomatic care. Here's how the competitive landscape looks as of November 2025:

Company Market Share, % Key Advantage
Anebulo Pharmaceuticals, Inc. 0% (Clinical-Stage) Developing Selonabant (ANEB-001): A specific CB1 receptor antagonist, a potential first-in-class antidote for ACI.
Generic Benzodiazepine Manufacturers (e.g., Pfizer, Roche) ~100% (Current SoC) Established, generic drugs (e.g., lorazepam) used for symptomatic treatment (agitation, seizures).
Indivior (Opiant) 0% (Pipeline) Broader focus on substance use disorders; early-stage program for acute cannabinoid overdose.

Opportunities & Challenges

The company's strategy is to capture the unmet need for a specific antidote, shifting away from the current supportive care model.

Opportunities Risks
Pediatric IV Formulation Priority: The FDA has acknowledged the significant unmet need for a pediatric treatment, potentially expediting the approval timeline. Clinical Trial Failure/Delays: Selonabant IV is only in Phase 1 as of September 2025; failure in any phase is a catastrophic event for a single-asset company.
NIDA Grant Funding: Secured the second-year tranche of a collaborative grant totaling $994,300 from the National Institute on Drug Abuse, providing non-dilutive capital for the IV program. Going Private/Reverse Split Risk: The plan to terminate public registration and execute a reverse stock split (announced July 2025) creates significant uncertainty and liquidity risk for investors.
Large, Untapped Market: Targeting the Cannabinoid Intoxication Treatment Drug market, which was valued at $1.2 billion in 2023 and is projected to reach $2.7 billion by 2032. CB1 Antagonist Safety History: Previous CB1 antagonists (like rimonabant) were withdrawn in the EU due to unacceptable psychiatric side effects, creating a regulatory hurdle and safety perception challenge.

Industry Position

Anebulo Pharmaceuticals, Inc. is a small-cap, clinical-stage biotechnology company with a market capitalization of approximately $97.37 million as of November 2025. It operates in a niche but rapidly expanding segment of the central nervous system (CNS) disorder market, driven by the increasing legalization and use of cannabis in the US. The company's financial position is typical for a pre-revenue biotech, reporting $0.00 in revenue for the fiscal year ended June 30, 2025, and a net loss of $8.48 million.

The company's strategic focus on a specific antidote for ACI, rather than the broader supportive care, gives it a unique competitive position. They are defintely trying to own the emergency room segment for this indication.

  • Core Asset Focus: Selonabant (ANEB-001) is a potent, selective CB1 receptor antagonist, which is the direct mechanism needed to reverse the effects of THC.
  • Liquidity: The company reported cash and cash equivalents of $10.4 million as of September 30, 2025, which is critical runway capital for clinical trials.
  • Regulatory Alignment: Close collaboration with the FDA and the NIDA grant support indicates regulatory and public health alignment on the need for this specific pediatric treatment.

To understand the foundational principles guiding this focused strategy, you should review the Mission Statement, Vision, & Core Values of Anebulo Pharmaceuticals, Inc. (ANEB).

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