Anebulo Pharmaceuticals, Inc. (ANEB) Bundle
Could Anebulo Pharmaceuticals, Inc. hold the key to addressing unmet needs in substance intoxication treatment, despite reporting a net loss of $14.1 million for the fiscal year ending June 30, 2023?
This clinical-stage biopharmaceutical company is channeling significant resources, including $9.4 million in research and development during that same period, primarily into its lead candidate aimed at treating acute cannabinoid intoxication.
With a distinct focus and navigating the challenging path of drug development, how is this company positioned within the competitive biotech landscape?
What drives its operations, ownership structure, and mission, and how does it ultimately plan to generate value for stakeholders and achieve profitability?
Anebulo Pharmaceuticals, Inc. (ANEB) History
Understanding the journey of Anebulo Pharmaceuticals provides context for its current operations and strategic direction. The company emerged relatively recently, focusing on a specific unmet medical need.
Anebulo Pharmaceuticals, Inc.'s Founding Timeline
Year established
Anebulo Pharmaceuticals, Inc. was incorporated on January 2, 2020.
Original location
The company established its headquarters in Austin, Texas.
Founding team members
Key figures involved in the early stages included Daniel Schneeberger, serving as Chief Executive Officer.
Initial capital/funding
Prior to its public listing, the company secured initial funding through private placements, though specific early-stage amounts are not typically disclosed publicly. This initial capital was crucial for licensing its primary drug candidate and initiating preclinical work.
Anebulo Pharmaceuticals, Inc.'s Evolution Milestones
Year | Key Event | Significance |
---|---|---|
2020 | Company Incorporation & Licensing | Established operations and acquired rights to its lead development candidate, ANEB-001, targeting acute cannabinoid intoxication (ACI). |
2021 | Initial Public Offering (IPO) | Successfully listed on the Nasdaq stock exchange in May, raising gross proceeds of approximately $21 million, enabling funding for clinical trials. |
2021 | Phase 2 Trial Initiation | Commenced a Phase 2 proof-of-concept clinical trial for ANEB-001 in patients with ACI, a major step in clinical development. |
2022 | Positive Topline Phase 2a Data | Reported encouraging results from Part A of the Phase 2 trial, demonstrating potential efficacy and informing the design of Part B. |
2023 | Continued Clinical Development | Focused resources on advancing the ANEB-001 program through further clinical evaluation and regulatory interactions. Managed cash reserves, reporting approximately $16.2 million in cash and equivalents as of September 30, 2023. |
2024 | Ongoing Phase 2 Study & Operations | Continued the clinical development pathway for ANEB-001 while carefully managing operational expenditures. Cash and cash equivalents stood at approximately $11.8 million as of March 31, 2024. Explored strategic directions amidst the biotech funding environment. Exploring Anebulo Pharmaceuticals, Inc. (ANEB) Investor Profile: Who’s Buying and Why? provides more insight into shareholder perspectives during this period. |
Anebulo Pharmaceuticals, Inc.'s Transformative Moments
Securing Lead Asset ANEB-001
The licensing of ANEB-001 shortly after incorporation was foundational, providing the company with its primary focus and therapeutic candidate.
Transition to Public Company
The 2021 IPO marked a significant transformation, granting access to public capital markets essential for funding costly clinical trials and enhancing corporate visibility.
Demonstration of Clinical Potential
Achieving positive topline data in the Phase 2a trial in 2022 represented a critical validation point, bolstering confidence in the ANEB-001 program and guiding subsequent development efforts.
Anebulo Pharmaceuticals, Inc. (ANEB) Ownership Structure
Anebulo Pharmaceuticals operates as a publicly traded entity, meaning its shares are available for purchase by the general public on stock exchanges. This structure diversifies ownership among various groups, including company insiders, large financial institutions, and individual retail investors.
Anebulo Pharmaceuticals, Inc.'s Current Status
As of the end of 2024, Anebulo Pharmaceuticals, Inc. is listed on the Nasdaq Capital Market under the ticker symbol ANEB. Being a public company requires adherence to strict regulatory reporting standards set by the Securities and Exchange Commission (SEC), ensuring transparency for investors.
Anebulo Pharmaceuticals, Inc.'s Ownership Breakdown
The ownership distribution provides insight into who holds significant stakes and influence within the company. Understanding this breakdown is crucial for assessing potential alignment or conflicts of interest among shareholders.
Shareholder Type | Ownership, % (Approx. End 2024) | Notes |
---|---|---|
Individual Insiders | ~35% | Includes shares held by executives, directors, and significant private holders. |
Institutional Investors | ~12% | Represents holdings by mutual funds, pension funds, hedge funds, and other large investment entities. |
General Public | ~53% | Consists of shares held by individual retail investors. |
Anebulo Pharmaceuticals, Inc.'s Leadership
The strategic direction and day-to-day operations of the company are guided by its executive leadership team and board of directors. These individuals bring industry experience crucial for navigating the complex biopharmaceutical landscape and driving towards the company's objectives, which you can explore further here: Mission Statement, Vision, & Core Values of Anebulo Pharmaceuticals, Inc. (ANEB). Key figures leading the company at the close of 2024 included:
- Daniel Schneeberger, MD: Chief Executive Officer
- Simon Allen: Chief Financial Officer
- Joseph Stauffer, DO, MBA: Chief Medical Officer
The Board of Directors provides oversight and governance, ensuring management acts in the best interest of shareholders.
Anebulo Pharmaceuticals, Inc. (ANEB) Mission and Values
Anebulo Pharmaceuticals centers its efforts on addressing critical unmet medical needs, particularly in the area of substance use disorders. Their underlying values guide their approach to developing novel treatments aimed at improving patient outcomes.
Anebulo Pharmaceuticals, Inc.'s Core Purpose
Official mission statement
While not always formally articulated in a single public statement, Anebulo's operational mission is clearly focused on the development and commercialization of innovative treatments. Their primary drive is to bring solutions to market for conditions lacking effective therapies, with a strong initial emphasis on managing acute cannabinoid intoxication (ACI).
Vision statement
The company envisions becoming a key player in the biopharmaceutical space by successfully advancing its pipeline candidates through clinical trials and regulatory approval. Their long-term aspiration involves establishing treatments like ANEB-001 as standard care, thereby significantly impacting patient lives and addressing specific public health challenges. Understanding their strategic direction is crucial, as explored further in Breaking Down Anebulo Pharmaceuticals, Inc. (ANEB) Financial Health: Key Insights for Investors.
Company slogan
Anebulo Pharmaceuticals does not appear to utilize a widely publicized company slogan at this time. Their communication typically emphasizes their scientific approach and therapeutic focus directly.
Anebulo Pharmaceuticals, Inc. (ANEB) How It Works
Anebulo Pharmaceuticals operates as a clinical-stage biotechnology company focused exclusively on the development and potential commercialization of treatments for substance abuse and addiction. Its core function involves advancing its lead drug candidate through rigorous clinical trials to obtain regulatory approval.
Anebulo Pharmaceuticals, Inc.'s Product/Service Portfolio
Product/Service | Target Market | Key Features |
---|---|---|
ANEB-001 | Patients experiencing Acute Cannabinoid Intoxication (ACI) in emergency departments and potentially other settings. | A potent, small molecule cannabinoid receptor 1 (CB1) antagonist designed to rapidly reverse the symptoms of ACI. Currently in clinical development (Phase 2 completed). |
Anebulo Pharmaceuticals, Inc.'s Operational Framework
The company's operations center heavily on research and development (R&D) activities, primarily managing clinical trials for ANEB-001. This involves designing trial protocols, selecting and overseeing clinical research organizations (CROs), patient recruitment, data analysis, and navigating the regulatory landscape with bodies like the FDA. Manufacturing is typically outsourced to specialized contract manufacturing organizations (CMOs). As a pre-revenue company, its operations are funded through equity financing and managing cash reserves, which stood at approximately $11.8 million as of September 30, 2024. Operational spending is dominated by R&D, which amounted to roughly $6.1 million for the first nine months of 2024, and general administrative costs, around $4.6 million for the same period. Breaking Down Anebulo Pharmaceuticals, Inc. (ANEB) Financial Health: Key Insights for Investors offers more detail on the financial structure supporting these operations. The ultimate goal is achieving successful trial outcomes leading to regulatory submission and potential approval.
Anebulo Pharmaceuticals, Inc.'s Strategic Advantages
Anebulo Pharmaceuticals possesses several key strategic advantages driving its potential value.
- Focus on Unmet Need: ANEB-001 targets Acute Cannabinoid Intoxication, a growing concern with limited specific treatment options, potentially offering a first-mover advantage if approved.
- Novel Mechanism: The drug candidate utilizes a specific mechanism (CB1 antagonism) tailored to counteract the effects of cannabinoids directly.
- Intellectual Property: The company holds patents and pending applications related to its technology, providing a barrier to entry for potential competitors.
- Lean Operational Model: By outsourcing non-core functions like manufacturing, Anebulo maintains a relatively lean structure, focusing capital on clinical development milestones.
- Experienced Leadership: The management team possesses experience in drug development and navigating the biopharmaceutical industry.
Anebulo Pharmaceuticals, Inc. (ANEB) How It Makes Money
As a clinical-stage biopharmaceutical company, Anebulo Pharmaceuticals currently generates minimal to no revenue from product sales, focusing instead on advancing its lead drug candidate through clinical trials. Its financial model relies heavily on securing capital through equity financing and potential future collaboration or licensing agreements to fund research and development activities.
Anebulo Pharmaceuticals, Inc.'s Revenue Breakdown
As of late 2024, the company is pre-revenue regarding commercial product sales. Its reported revenue, if any, typically stems from non-operational sources or early-stage collaborations, which can be variable.
Revenue Stream | % of Total (TTM ending Q3 2024) | Growth Trend |
---|---|---|
Product Sales | 0% | N/A |
Collaboration/Grant Revenue | 100% (if applicable, often $0) | Variable/Project Dependent |
Anebulo Pharmaceuticals, Inc.'s Business Economics
The economic engine of Anebulo is driven by research and development investment, not current sales. Key cost drivers include:
- Clinical Trial Expenses: Costs associated with designing, executing, and analyzing results from human studies for its drug candidates.
- Personnel Costs: Salaries and benefits for research, clinical, and administrative staff.
- Regulatory Affairs: Expenses related to interacting with regulatory bodies like the FDA.
- General & Administrative (G&A): Overhead costs including legal, accounting, and executive management.
Profitability is a long-term goal, contingent upon successful drug development, regulatory approval, and subsequent market launch or lucrative licensing deals. The company's operational viability depends on its ability to manage cash burn and secure ongoing funding until revenue generation begins. Understanding the Mission Statement, Vision, & Core Values of Anebulo Pharmaceuticals, Inc. (ANEB). provides context for their strategic focus.
Anebulo Pharmaceuticals, Inc.'s Financial Performance
Reflecting its clinical-stage status, financial performance as of late 2024 is characterized by expenses outpacing revenues. Key indicators include:
- Net Loss: The company consistently reports net losses due to significant R&D and G&A spending without offsetting product revenue. For the trailing twelve months (TTM) ending Q3 2024, the net loss was approximately $13 million.
- Research & Development Expenses: Constituting the largest expense category, R&D costs were around $8.5 million for the TTM ending Q3 2024.
- General & Administrative Expenses: G&A costs were approximately $4.5 million for the TTM ending Q3 2024.
- Cash Position: Maintaining sufficient cash reserves is critical. As of September 30, 2024, cash and cash equivalents were essential for funding ongoing operations, with the cash burn rate dictating the company's operational runway.
Future financial health hinges on clinical trial success, regulatory milestones, and the ability to either commercialize its product or secure favorable partnerships.
Anebulo Pharmaceuticals, Inc. (ANEB) Market Position & Future Outlook
Anebulo Pharmaceuticals operates as a clinical-stage biotechnology company focused on developing treatments for substance use disorders, positioning it in a niche but growing market segment. Its future outlook hinges significantly on the successful clinical development and regulatory approval of its lead candidate, ANEB-001, for acute cannabinoid intoxication (ACI).
Competitive Landscape
As a clinical-stage company with no approved products as of early 2025, Anebulo's market share is effectively 0%. Competition comes primarily from the existing standard of care (supportive care for ACI) and potentially other companies developing specific antagonists, though the direct competitive landscape for an ACI antidote is still evolving.
Company/Approach | Market Share, % | Key Advantage |
---|---|---|
Anebulo Pharmaceuticals (ANEB) | 0% (Clinical Stage) | Focus on novel antagonist (ANEB-001) for ACI. |
Standard of Care (Supportive Care) | 100% (Current Practice) | Established practice in emergency departments; no drug cost. |
Other Potential Developers (Various) | 0% (Clinical/Pre-clinical) | Potential alternative mechanisms or formulations in development. |
Opportunities & Challenges
Opportunities | Risks |
---|---|
First-mover advantage for a specific ACI antidote. | Clinical trial failures or delays for ANEB-001. |
Increasing prevalence of cannabis use and related ACI incidents potentially expanding the market. | Regulatory hurdles from the FDA or other agencies. |
Potential application of core technology to other indications. | Securing adequate funding for continued development and commercialization. |
Partnership or acquisition interest from larger pharmaceutical companies upon positive data. | Market acceptance and adoption challenges post-approval. |
Industry Position
Within the biotechnology sector focusing on substance use disorders, Anebulo is a specialized player targeting an unmet need in ACI treatment. Its position is defined by its lead candidate's progress through clinical trials. Success would elevate its standing significantly, while failure could necessitate strategic shifts. The company's strategy aligns with its stated goals, viewable here: Mission Statement, Vision, & Core Values of Anebulo Pharmaceuticals, Inc. (ANEB). As of 2024 reporting, the company's research and development expenses reflect its clinical-stage focus, representing a major portion of its operating costs, with R&D expenses reported at approximately $9.8 million for the fiscal year ended June 30, 2024. Its industry standing is currently that of a speculative development company dependent on future clinical and regulatory outcomes.
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