Anebulo Pharmaceuticals, Inc. (ANEB) Business Model Canvas

Anebulo Pharmaceuticals, Inc. (ANEB): Business Model Canvas [Dec-2025 Updated]

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You're digging into Anebulo Pharmaceuticals, Inc.'s business model, and what you find is a pure-play, clinical-stage operation staked entirely on one asset: ANEB-001, their proposed intravenous antidote for acute cannabis-induced toxicity, especially in the pediatric segment. Honestly, this model is currently fueled by non-sales revenue, relying heavily on grants-like the recent tranche from NIDA-and equity infusions, evidenced by their $10.4 million in cash and equivalents as of September 30, 2025, to cover steep R&D and clinical trial costs. To get a clear picture of the near-term risks tied to their Phase 1 study and the long-term path to hospital adoption, you need to map out every building block, so let's break down the full canvas below.

Anebulo Pharmaceuticals, Inc. (ANEB) - Canvas Business Model: Key Partnerships

You're looking at the core relationships Anebulo Pharmaceuticals, Inc. relies on to push IV selonabant through the clinic, especially for the pediatric indication. These aren't just names on a slide; they represent concrete financial commitments and regulatory milestones that define the near-term path.

The funding structure is heavily supported by strategic capital raises and non-dilutive government grants. For instance, the $15 million gross proceeds from the December 2024 private placement, which included 22NW Fund, LP, provided the runway to start the Phase 1 study in 1H25 (or Q3 2025 according to a later update).

Here's a breakdown of the key external dependencies:

  • - National Institute on Drug Abuse (NIDA) grant for IV selonabant study
  • - Food and Drug Administration (FDA) for efficient pediatric development plan
  • - Contract Research Organizations (CROs) for managing clinical trials
  • - Contract Manufacturing Organizations (CMOs) for drug formulation scale-up
  • - Institutional investors like 22NW Fund for private placement financing

The NIDA support is significant validation. Anebulo Pharmaceuticals, Inc. secured a two-year cooperative grant, NIH award number 1U01DA059995-01, for up to approximately $1.9 million. The initial tranche was $0.9 million. By the first quarter of fiscal year 2026, the company announced receipt of the second-year tranche, specifically $994,300, under award number 5U01DA059995-02, to support the ongoing Phase 1 SAD study.

Regarding the FDA, Anebulo Pharmaceuticals, Inc. held discussions in December 2024 regarding the IV selonabant development plan for the pediatric indication. The FDA acknowledged the unmet need and proposed a close, ongoing collaboration. Furthermore, the randomized, double-blind, placebo-controlled design for the Phase 1 SAD study was officially cleared by the FDA.

The execution of clinical trials and manufacturing relies on specialized third parties. Research and development expenses for the twelve months ended June 30, 2025, increased by approximately $0.9 million, driven by costs under agreements with CROs and CMOs.

The financial commitments to these operational partners are detailed below:

Partner Type Specific Activity/Contract Approximate Total Contract Cost Expected Completion/Status as of Late 2025
Contract Research Organization (CRO) Assistance with Phase 1 SAD study $3.4 million Substantially completed by Q3 2026
Contract Manufacturing Organization (CMO) Manufacturing agreement for IV formulation $3.0 million Manufacturing aspect substantially complete as of June 30, 2024; stability study aspect expected in 2026

On the financing side, 22NW Fund, LP is a critical institutional partner. In December 2024, Anebulo Pharmaceuticals, Inc. closed a private placement raising $15 million in gross proceeds by selling 15.2 million shares at $0.99 per share. Separately, 22NW Fund, LP acquired an additional 10,101,010 shares at $0.99 per share on December 23, 2024, for about $9.99 million. Following these transactions, Anebulo Pharmaceuticals, Inc. amended its Loan and Security Agreement in February 2025 with 22NW and JFL Capital Management, reducing the maximum borrowing limit to approximately $3 million.

The relationship with 22NW Fund, LP also involved a lock-up agreement dated February 24, 2025, restricting the voting or transfer of acquired shares until stockholder approval was obtained.

Finance: draft 13-week cash view by Friday.

Anebulo Pharmaceuticals, Inc. (ANEB) - Canvas Business Model: Key Activities

You're looking at the core actions Anebulo Pharmaceuticals, Inc. is taking right now to move its pipeline forward, especially as it navigates a major corporate structure change. Here's the breakdown of what they are actively doing, grounded in the numbers from their latest filings.

Conducting Phase 1 SAD study of intravenous selonabant (ANEB-001)

The company's primary clinical activity centers on advancing the intravenous (IV) formulation of selonabant, prioritizing pediatric acute cannabis-induced toxicity. Anebulo Pharmaceuticals announced the first subjects were dosed in this Phase 1 single ascending dose (SAD) study on September 25, 2025. This study is designed to check the safety, tolerability, and pharmacokinetics of IV selonabant in healthy adult subjects, specifically those aged between 18 to 30 years. The study is being conducted at a single Phase 1 clinical study site. This key activity is directly supported by external funding.

  • - NIDA collaborative grant awarded the second-year tranche of $994,300 to support the ongoing SAD study.
  • - The study design received clearance from the FDA.

Research and development (R&D) for acute cannabis-induced toxicity antidote

Research and development activities are focused on preparing the IV formulation for potential pediatric use, a shift from earlier plans for adult oral studies. The financial commitment to R&D shows up clearly in the operating expenses. For the three months ended September 30, 2025, the company reported total operating expenses of $2.3 million. The R&D spend is a significant component of that burn rate, though specific R&D expense for that quarter isn't isolated in the top-line operating expense figure provided.

Looking at the full fiscal year ended June 30, 2025, Research and development expenses increased approximately $0.9 million from the prior year. As of September 30, 2025, the balance sheet showed accrued Research and development expenses of $105,263. The company recorded a net loss of $2.2 million, or $(0.05) per share, for the three months ended September 30, 2025.

Regulatory submissions and ongoing collaboration with the FDA

A critical activity is managing the regulatory pathway, which includes securing necessary clearances before starting trials. The company's Phase 1 SAD study design for IV selonabant received clearance by the FDA. Furthermore, the ongoing research is supported by a collaborative grant from the National Institute on Drug Abuse (NIDA) of the National Institutes of Health (NIH), under award number 5U01DA059995-02, which provided $994,300 for the second year of support.

Manufacturing and scaling up the intravenous drug formulation

Anebulo Pharmaceuticals has been actively engaged in the necessary steps to prepare the drug product for clinical use. The company has scaled up the intravenous formulation of selonabant specifically for these initial clinical safety studies. This manufacturing scale-up is a key activity that precedes and supports the initiation of the Phase 1 SAD study.

Reviewing strategic alternatives, including a potential reverse stock split

The company is undertaking significant corporate activity to manage its public reporting status and costs. The Board of Directors approved a plan for a reverse stock split in July 2025, which is intended to terminate the company's registration as a public reporting company. This move is part of a broader review of strategic alternatives, which also includes considering a potential sale of assets or a merger transaction. The proposed reverse stock split ratio is set between 1-for-2,500 and 1-for-7,500. Under this plan, stockholders holding fewer than the minimum threshold of shares (between 2,500 and 7,500 shares, depending on the final ratio) would receive $3.50 in cash per pre-split share, which represented a 91% premium over the closing stock price on July 22, 2025. The primary goal is to reduce record holders below 300.

Here are some key financial metrics surrounding this corporate action as of late 2025:

Metric Value as of September 30, 2025 Context/Period
Cash and Cash Equivalents $10.4 million Balance Sheet
Loan Agreement Availability Additional $3.0 million Liquidity
Shares Outstanding 41,084,731 As of September 30, 2025
Net Loss $2.2 million Three Months Ended September 30, 2025
Net Loss Per Share $(0.05) Three Months Ended September 30, 2025
Accumulated Deficit $76.0 million As of September 30, 2025

The company stated that its cash position, along with the Loan Agreement availability, is expected to fund operating expenses through at least 12 months from the issuance date of the financial statements.

Anebulo Pharmaceuticals, Inc. (ANEB) - Canvas Business Model: Key Resources

You're looking at the core assets Anebulo Pharmaceuticals, Inc. (ANEB) relies on to drive its clinical-stage drug development, especially as they push the IV formulation forward. Honestly, for a company at this stage, the IP and the cash runway are what analysts watch most closely.

The most critical tangible asset is the drug candidate itself, Selonabant (ANEB-001), a potent, small molecule antagonist of the cannabinoid receptor type-1 (CB1). This compound is the foundation for their entire strategy, which is currently prioritizing the intravenous (IV) formulation for pediatric acute cannabis-induced toxicity over the previously studied oral version for adults.

Intellectual property (IP) protection is key here. Anebulo Pharmaceuticals, Inc. has solid patent coverage on this compound.

  • - Selonabant (ANEB-001) compound and related intellectual property (IP): Protection includes two issued patents covering various methods of use and the composition of matter of the crystalline form, with one patent providing protection through the year 2040. Anebulo Pharmaceuticals, Inc. also maintains multiple pending applications covering different methods of use and delivery systems.

Financial resources provide the necessary runway to execute clinical plans. You need to know the latest liquidity position.

  • - Cash and equivalents of $10.4 million as of September 30, 2025.
  • - The company also has access to an additional $3.0 million in cash via a Loan Agreement.

Non-dilutive funding from government sources helps extend that cash runway significantly. The National Institute on Drug Abuse (NIDA) has been a key supporter for the IV formulation development.

  • - NIDA grant funding, including a $994,300 tranche for the ongoing Single Ascending Dose (SAD) study of IV selonabant.
  • - The total cooperative grant from NIDA is for up to approximately $1.9 million, with the initial tranche being $0.9 million.

The human capital-the management team-is another vital resource, given their focus on navigating clinical-stage drug development with the FDA.

  • - Experienced management team in clinical-stage drug development.

Finally, the existing clinical evidence forms a crucial resource base, validating the mechanism of action before advancing the IV candidate.

  • - Clinical data from completed Phase 2 oral ACI trial in adults.

Here's a quick look at the numbers supporting the efficacy demonstrated in that completed oral Phase 2 proof-of-concept study, which involved challenging healthy adults with delta-9-tetrahydrocannabinol (THC).

Trial Component/Metric Dose/Result Detail Subject Count/Context
Total Subjects Enrolled (Parts A & B) 134 healthy subjects Total enrollment for the Phase 2 study
Part A Efficacy (Low Dose THC) Single oral dose of 50 mg or 100 mg ANEB-001 reduced effects of 10.5 mg THC Positive protective effects demonstrated
Part B Efficacy (High Dose THC) Single oral dose of 10 mg ANEB-001 reduced key symptoms of ACI Induced by 30 mg challenge dose of oral THC
Part B Efficacy (Higher THC Dose) 10 mg or 30 mg ANEB-001 led to significant reduction in VAS feeling high score (p < 0.001) vs placebo after 21 mg THC challenge
Placebo Response Rate (High THC Dose) 100% of subjects met the VAS threshold for feeling high (>20 mm) Compared to only 1 subject per group treated with ANEB-001
Tolerability Well tolerated; no serious adverse events reported Across the Phase 2 study

Also, remember that Anebulo Pharmaceuticals, Inc. can point to data showing delayed dosing of ANEB-001 rapidly reversed pre-existing THC effects, which is a strong point for an emergency antidote candidate.

Anebulo Pharmaceuticals, Inc. (ANEB) - Canvas Business Model: Value Propositions

The core value proposition for Anebulo Pharmaceuticals, Inc. centers on delivering the first targeted, rapid-acting therapeutic for acute cannabis-induced toxicity (ACI), with a primary focus on the vulnerable pediatric population.

The company is prioritizing the development of an intravenous (IV) formulation of selonabant as a potential treatment for pediatric patients experiencing cannabis-induced Central Nervous System (CNS) depression. This focus is driven by the FDA acknowledging the unmet need for a treatment specifically for children exposed to cannabis toxicity, suggesting a close collaboration to advance this indication (Source 1, 10).

  • First specific emergency antidote for acute cannabis-induced toxicity (ACI)
  • Rapid reversal of severe symptoms like CNS depression in pediatric patients
  • Intravenous (IV) formulation for use in emergency settings and hospitals
  • Addressing a growing, significant unmet medical need in children

The urgency of this value proposition is underscored by the market context. The global Cannabinoid Intoxication Treatment Drug market is projected to reach approximately $750 million by 2025 (Source 6). Furthermore, the general antidote market, where injectable treatments are a major segment, was valued at $2.16 billion in 2023, with the injectable segment alone accounting for $1.5 billion in 2023 (Source 12, 13). Anebulo Pharmaceuticals, Inc. is targeting a specific, high-acuity subset of this need.

The shift to the IV formulation represents a strategic value proposition enhancement, aiming for a potentially faster regulatory pathway compared to the prior oral development track. The company previously demonstrated selonabant's potential in a Phase 2 trial using an oral formulation in adults challenged with oral THC (Source 2, 3).

Here's a quick comparison of the development focus:

Development Focus Prior Oral Formulation Current IV Formulation
Target Population Adults with ACI Pediatric patients with ACI
Clinical Status (as of late 2025) Completed Phase 2 trial Initiated Phase 1 SAD study on September 25, 2025 (Source 2, 3)
Phase 1 Study Subjects N/A Healthy adults aged 18 to 25 years or 18 to 30 years (Source 1, 3)
Regulatory Advantage Potential for a slower timeline to approval Believed to offer the potential for a faster timeline to approval relative to the adult oral product (Source 2, 3)

The company's operational funding reflects the investment required to support this clinical advancement. As of September 30, 2025, Anebulo Pharmaceuticals, Inc. held cash and cash equivalents of $10.4 million, with access to an additional $3.0 million via a Loan Agreement (Source 3). This work is partially supported by grant funding, including the second-year tranche of $994,300 from the National Institute on Drug Abuse (NIDA) (Source 2, 3). The net loss for the fiscal year ending June 30, 2025, was $8.5 million (Source 2).

The IV formulation is designed for immediate use in emergency settings, which is critical given that the injectable segment of the broader antidote market is favored in hospitals, which accounted for the highest end-use share of 37.24% in 2023 (Source 12, 13). The company's market capitalization was near $97.77 million as of early December 2025 (Source 8).

The primary value is the potential to rapidly reverse life-threatening consequences of acute cannabis toxicity in children, a condition where current treatment is often supportive care using agents like naloxone in off-label scenarios (Source 1, 14).

Anebulo Pharmaceuticals, Inc. (ANEB) - Canvas Business Model: Customer Relationships

You're managing a clinical-stage biotech, so your relationships with regulators and capital providers are everything right now. Here's the breakdown of how Anebulo Pharmaceuticals, Inc. (ANEB) handles its key external stakeholders as of late 2025.

High-touch, collaborative relationship with the FDA for pediatric indication

The relationship with the Food and Drug Administration (FDA) is centered on advancing selonabant as a treatment for acute cannabis-induced toxicity in children. The FDA has confirmed the unmet need for this pediatric condition and suggested a close collaboration with Anebulo Pharmaceuticals, Inc. to streamline the development plan. This focus is strategic, as Anebulo Pharmaceuticals, Inc. believes the IV formulation for pediatrics offers a potentially faster timeline to approval compared to the oral product for adults. You saw this collaboration in action when the FDA cleared the design for the Phase 1 Single Ascending Dose (SAD) study. Furthermore, Anebulo Pharmaceuticals, Inc. held a Pre-Investigational New Drug (IND) application interaction with the FDA in December 2024 specifically to discuss the IV selonabant development plan.

Key regulatory milestones and interactions include:

  • FDA suggested a close, ongoing collaboration for the pediatric indication.
  • Phase 1 SAD study design was cleared by the FDA.
  • Pre-IND meeting with FDA held in December 2024.
  • Prior Type B meeting with FDA regarding oral data occurred in July 2023.

Investor relations focused on financing and strategic review updates

Investor relations activity in 2025 has been dominated by capital needs and a significant strategic shift. The company reported cash and cash equivalents of $10.4 million as of September 30, 2025, with access to an additional $3.0 million via a Loan Agreement. This follows a December 2024 private placement that brought in gross proceeds of $15 million. More recently, investor focus shifted to the July 23, 2025 announcement of a plan to go private, involving a reverse stock split with a ratio between 1-for-2,500 and 1-for-7,500. The Board is now reviewing all strategic alternatives, including the going private transaction, following inbound interest from potential partners received after the July 2025 announcement.

Here's a quick look at recent financial positioning and strategic actions:

Metric/Event Value/Date Context
Cash & Equivalents (as of Sep 30, 2025) $10.4 million Q1 Fiscal Year 2026 balance
Additional Loan Availability (as of Sep 30, 2025) $3.0 million Amended Loan Agreement
Gross Proceeds from Dec 2024 Private Placement $15 million Sale of 15.2 million shares
Reverse Split Ratio Range (July 2025 Plan) 1-for-2,500 to 1-for-7,500 To facilitate deregistration
Cash Payout for Small Shareholders (Go-Private) $3.50 per share For stockholders below the minimum share threshold
Operating Expenses (Q1 FY2026) $2.3 million Three months ended September 30, 2025

Professional relationship with clinical investigators and sites

The relationship with clinical investigators is currently focused on the Phase 1 SAD study for IV selonabant, which commenced dosing subjects on September 25, 2025. This study is being conducted at a single Phase 1 clinical study site. The study involves healthy adult subjects aged 18 to 30 years. This clinical work is supported by external scientific partners, specifically Anebulo Pharmaceuticals, Inc. secured the second-year tranche of an ongoing collaborative grant from the National Institute on Drug Abuse (NIDA) of the National Institutes of Health (NIH) amounting to $994,300. The study itself operates under award number 5U01DA059995-02.

Clinical relationship metrics include:

  • Phase 1 SAD study initiated dosing on September 25, 2025.
  • Study conducted at a single Phase 1 clinical study site.
  • NIDA grant second-year tranche awarded: $994,300.
  • Study subjects are healthy adults aged 18 to 30 years.

Direct communication with institutional shareholders for private placement

Direct communication with key shareholders was critical during the financing activities of late 2024 and early 2025. The December 2024 definitive stock purchase agreement for the $15 million private placement involved 22NW Fund, LP, a company controlled by one of its directors, alongside existing investors. The CEO noted that securing this financing was indicative of the confidence held by highly respected institutional investors in the company's future. Following this, in February 2025, the Loan and Security Agreement with 22NW and JFL Capital Management was amended, reducing the maximum loan size to approximately $3 million.

Shareholder engagement highlights:

  • Private placement involved one director-controlled company (22NW Fund, LP).
  • Financing secured from existing investors.
  • The CEO referenced confidence from highly respected institutional investors.

Anebulo Pharmaceuticals, Inc. (ANEB) - Canvas Business Model: Channels

You're looking at how Anebulo Pharmaceuticals, Inc. gets its product, selonabant, from the lab bench to the potential end-user, which is a process heavily reliant on regulatory milestones and clinical execution right now. The channels are less about direct sales and more about proving the science and getting the green light from the Food and Drug Administration (FDA).

The most immediate channel for data generation is the clinical trial network. As of late 2025, Anebulo Pharmaceuticals, Inc. is running a Phase 1 single ascending dose (SAD) study for the intravenous (IV) formulation of selonabant, which began dosing subjects on September 25, 2025. This critical study is being managed through a single Phase 1 clinical study site. The subjects in this trial are healthy adults aged 18 to 30 years. This contrasts with their earlier Phase 2 proof-of-concept work, which was conducted in the Netherlands by the CHDR.

The regulatory pathway itself acts as a crucial, non-physical channel. Anebulo Pharmaceuticals, Inc. is focused on advancing the IV formulation for pediatric acute cannabis-induced toxicity, believing this path offers a faster timeline to approval than the oral adult product. The company had previously aimed to complete IND-enabling activities around calendar year end 2024. The design for the current Phase 1 SAD study was cleared by the FDA. The FDA has indicated that a combination of a single well-controlled study in Acute Cannabinoid Intoxication (ACI) patients presenting to the emergency department and a larger THC challenge study could potentially provide substantial evidence to support a New Drug Application (NDA). The most recent reported regulatory event was a Dose Update on September 25, 2025.

For future distribution to hospitals and emergency departments, the company is laying groundwork by studying the real-world setting. An observational study focusing on patients presenting to Emergency Departments with cannabis toxicity is currently ongoing and is being amended to focus specifically on pediatric patients. This focus aligns with the significant unmet need, which was underscored by the 1.7 million cannabinoid-related emergency department visits reported in the U.S. in 2018. The IV formulation is prioritized because acute cannabis exposure in children can lead to serious, life-threatening consequences.

Investor relations and public communication channels are managed through required SEC filings and regular financial updates. Anebulo Pharmaceuticals, Inc. filed its 2025 Form 10-K with the SEC on September 29, 2025. As of November 7, 2025, there were 41,084,731 shares of common stock outstanding. The most recent financial data available is for the first quarter of fiscal year 2026, covering the three months ended September 30, 2025.

Here's a quick look at the latest reported financial position as of the end of the first quarter of fiscal year 2026:

Financial Metric Amount/Value Date/Period
Cash and Cash Equivalents $10.4 million September 30, 2025
Additional Loan Availability $3.0 million As of September 30, 2025
Net Loss (Q1 FY2026) $2.2 million Three months ended September 30, 2025
Net Loss Per Share (Q1 FY2026) $(0.05) Three months ended September 30, 2025
Operating Expenses (Q1 FY2026) $2.3 million Three months ended September 30, 2025
NIDA Grant Award (Second Year Tranche) $994,300 Awarded for ongoing SAD study

The company continues to secure non-dilutive funding to support these clinical channels. For instance, the Phase 1 SAD study is supported by the second-year tranche of a collaborative grant from the National Institute on Drug Abuse (NIDA), amounting to $994,300 under award number 5U01DA059995-02.

The intellectual property portfolio also forms a channel for value protection and potential future licensing or collaboration. Selonabant is protected by three issued US patents and rights to six additional patent applications, plus two pending Patent Cooperation Treaty (PCT) applications and other international applications.

The key operational channel right now is the execution of the Phase 1 study, which involves these specific parameters:

  • - Phase 1 SAD study initiated on September 25, 2025.
  • - Study design cleared by the FDA.
  • - Study subjects are healthy adults aged 18 to 30 years.
  • - Study is randomized, double-blind, and placebo-controlled.
  • - Study is supported by a $994,300 NIDA grant tranche.

Finance: review the cash burn rate against the $10.4 million cash on hand as of September 30, 2025, and draft a 13-week cash flow projection by next Tuesday.

Anebulo Pharmaceuticals, Inc. (ANEB) - Canvas Business Model: Customer Segments

The customer segments for Anebulo Pharmaceuticals, Inc. center on the acute care setting for cannabis-induced toxic effects, with a clear prioritization for the pediatric population.

Pediatric patients suffering from acute cannabis-induced toxicity/poisoning represent the primary segment, as Anebulo Pharmaceuticals, Inc. is prioritizing the advancement of the intravenous (IV) formulation of selonabant for this indication.

The severity driving this segment is quantified by the potential outcomes:

  • - Serious and potentially life-threatening consequences, including CNS depression, respiratory depression, coma, and in rare cases death.
  • - Children are much more sensitive to the toxic effects of cannabis.
  • - Greater risk of hospitalization and admission to intensive care compared to adults.

Emergency room physicians and hospital staff administering the antidote are the direct users and key influencers for adoption within the healthcare system.

The scale of the problem for this group, based on historical data reflecting the growing need, includes:

  • - Cannabis-associated emergency department visits reached 1.7 million in 2018.
  • - The number of cannabis-associated ED visits surpassed 1.8 million in 2021.
  • - The annual growth rate (CAGR) for cannabis-associated ED visits was 15% between 2012 and 2018.
  • - In a 2020 survey, physicians saw an average of 10.5 patients with cannabis intoxication per month, with a range up to 45.
  • - Physicians surveyed scored the need for a cannabinoid antagonist at an average of 7.52 on a scale of 0 to 10.

The development supporting this segment is financed, in part, by external validation, such as the second-year tranche of a collaborative grant from the National Institute on Drug Abuse (NIDA) of $994,300 awarded for the ongoing Phase 1 study. The company's operating expenses for the three months ended September 30, 2025, were $2.3 million.

The following table summarizes the primary and secondary patient populations Anebulo Pharmaceuticals, Inc. is targeting with selonabant:

Customer Segment Focus Indication Target Clinical Status/Context Financial Metric Context (as of Sep 30, 2025)
Primary Pediatric acute cannabis-induced toxicity Phase 1 Single Ascending Dose (SAD) study of IV formulation initiated September 2025 Cash and cash equivalents: $10.4 million
Secondary Adult patients with acute cannabinoid intoxication (ACI) Oral formulation completed a Phase 2 clinical trial Net loss for Q1 Fiscal Year 2026: $2.2 million

Regulatory bodies (FDA) that approve the drug for market access serve as a critical gatekeeper segment, whose collaboration is essential for the prioritized pediatric indication.

  • - The FDA cleared the design for the current Phase 1 SAD study.
  • - The FDA acknowledged the unmet need for a treatment for children exposed to cannabis toxicity and suggested a close, ongoing collaboration.

Adult patients with acute cannabinoid intoxication (ACI) remain a secondary focus, as the oral formulation of selonabant previously demonstrated potential for blocking and reversing negative effects in a Phase 2 clinical trial. The company shifted priority to the IV formulation for pediatrics, believing it offers a potential faster timeline to approval relative to the adult oral product.

As of November 7, 2025, Anebulo Pharmaceuticals, Inc. had a market capitalization of $99M with 41.1M shares outstanding.

Anebulo Pharmaceuticals, Inc. (ANEB) - Canvas Business Model: Cost Structure

You're managing a clinical-stage biotech, so you know the cost structure is dominated by the science-the cash burn is directly tied to getting that lead candidate, selonabant, through the clinic. For Anebulo Pharmaceuticals, Inc., the costs are almost entirely focused on Research and Development (R&D) until they hit commercialization, which is still a ways off since they are pre-revenue.

The total Operating expenses for the first quarter of fiscal year 2026 (the three months ended September 30, 2025) clocked in at $2.3 million. This was a slight improvement, down from $2.4 million in the same period of fiscal year 2025. Still, this burn rate is what you watch closely, especially with cash and cash equivalents at $10.4 million as of September 30, 2025, plus access to an additional $3.0 million via a Loan Agreement.

Research and development (R&D) expenses, the largest cost driver, are where the bulk of that $2.3 million goes. This category covers everything from lab work to running the actual trials. For the full fiscal year 2025, R&D expenses increased by approximately $0.9 million from the prior year, driven by activities related to pre-clinical and clinical studies, and direct third-party costs incurred under agreements with Contract Research Organizations (CROs) and Contract Manufacturing Organizations (CMOs) for selonabant. This increase reflects the shift in focus and the costs associated with advancing the IV formulation.

The Clinical trial expenses for the Phase 1 IV selonabant study are a major component of that R&D spend. Anebulo Pharmaceuticals, Inc. initiated the Phase 1 Single Ascending Dose (SAD) study of the intravenous formulation in September 2025. To help offset these development costs, the Company secured the second-year tranche of an ongoing collaborative grant from the National Institute on Drug Abuse (NIDA) of the National Institutes of Health (NIH), which amounted to $994,300. That's non-dilutive cash helping fund the safety and pharmacokinetics investigation.

The costs related to Contract manufacturing and formulation scale-up costs are embedded within the R&D third-party expenses mentioned above. Anebulo scaled up the intravenous formulation for these initial clinical safety studies. The dependency on third parties for manufacturing means these CMO costs are a critical, variable part of the R&D budget, and the Company notes that higher-than-expected commercial-scale manufacturing costs could significantly impact future operating results.

Finally, General and administrative (G&A) costs, including public company burdens, are the other major bucket. While the specific G&A figure for Q1 FY2026 isn't broken out from the $2.3 million total operating expense, we can see the impact of public company life. For the three months ended September 30, 2025, G&A expenses increased by $0.4 million from the comparable prior year period, specifically due to increased professional and consultant fees recognized in connection with the potential going private transaction. This shows how strategic activities, like exploring alternatives, add a layer of non-core, yet necessary, expense on top of standard compliance and overhead.

Here's a quick look at a recent period's operating expense breakdown to show you where the money typically flows:

Expense Category Q2 Fiscal Year 2025 (Three Months Ended December 31, 2024) Amount FY 2025 Total Operating Expenses
Research and development $1,220,535 $9.2 million
General and administrative $1,367,616
Total operating expenses $2,588,151 (approx. $2.6 million) $9.2 million

Anebulo Pharmaceuticals, Inc. (ANEB) - Canvas Business Model: Revenue Streams

You're looking at the revenue streams for Anebulo Pharmaceuticals, Inc. as of late 2025. For a clinical-stage company like Anebulo Pharmaceuticals, Inc., the immediate cash flow is heavily reliant on non-sales sources while the lead candidate, selonabant (ANEB-001), moves through trials. Here's the quick math on where the money is coming from right now, and where it's projected to come from later.

Grant funding from the National Institute on Drug Abuse (NIDA)

Non-dilutive funding from the National Institute on Drug Abuse (NIDA) is a key, current revenue component, validating the science behind selonabant for acute cannabis-induced toxicities. Anebulo Pharmaceuticals, Inc. secured a two-year cooperative grant from NIDA, part of the National Institutes of Health (NIH), totaling up to approximately $1.9 million under award number 1U01DA059995-01. This was structured in tranches; the initial award was $0.9 million, with the remaining $1 million contingent on hitting certain milestones. More recently, for the first quarter of fiscal year 2026 (the quarter ended September 30, 2025), Anebulo Pharmaceuticals, Inc. announced it was awarded the second-year tranche of $994,300 under award number 5U01DA059995-02 to support the ongoing Phase 1 single ascending dose (SAD) study.

Equity financing and private placements from institutional investors

Since Anebulo Pharmaceuticals, Inc. is pre-commercial, equity financing and debt facilities are critical for funding operations, which currently run at a net loss. You can see a few significant recent capital raises that bolster the balance sheet:

  • - In December 2024, the company secured net proceeds of approximately $14.9 million from a securities purchase agreement.
  • - Also in December 2024, Anebulo entered a definitive stock purchase agreement for gross proceeds of $15 million by issuing 15.2 million shares of common stock in a private placement offering.
  • - Back in September 2022, a private placement raised aggregate gross proceeds of approximately $6.6 million by selling 2,264,650 units at $2.935 per Unit.

As of September 30, 2025, Anebulo Pharmaceuticals, Inc. reported cash and cash equivalents of $10.4 million, plus access to an additional $3.0 million through a Loan Agreement. This funding is what keeps the lights on while they advance development.

Future milestone payments from potential licensing or partnership deals (speculative)

The structure for potential future revenue from licensing selonabant is detailed in the existing License Agreement, though as of June 30, 2025, the company determined no further milestone payments were probable, so no liability was recorded. Still, the potential structure is clear:

Payment Type Trigger/Threshold Amount/Rate
Development Milestones Clinical trials and granting of marketing authorization Ranging from $0.4 million to $3.0 million, up to a total of $29.9 million
Sales Milestones (First Year) Cumulative annual net sales exceed $500.0 million $10.0 million
Sales Milestones (First Year) Cumulative annual net sales exceed $1.0 billion $25.0 million
Pre-IPO Milestone Settlement In lieu of certain milestones 192,857 shares issued instead of $1.4 million payment

The agreement also specifies ongoing payments after commercialization begins.

Future product sales of selonabant (ANEB-001) post-approval (long-term)

The ultimate long-term revenue stream relies on the commercial success of selonabant (ANEB-001) following regulatory approval, particularly for the prioritized pediatric indication. While specific sales forecasts aren't public here, the financial obligation structure for the company to its licensor, Vernalis, sets the baseline for royalty expectations. Anebulo Pharmaceuticals, Inc. is required to pay annual single-digit royalties on net product sales over the term of the License Agreement. That single-digit royalty rate is what the company will be paying out of future net sales.

Finance: draft 13-week cash view by Friday.


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