Anebulo Pharmaceuticals Inc
For the period ended Mar 31, 2024. Filed May 15, 2024.
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A company's report for each of its first three quarters. The financial statements are not audited. It shows how the business has moved since the last annual report, and what management says changed.
Mar 31, 2024 · Filed May 15, 2024
ANEB$0.34-1.8%Stored close · as of Jul 8, 2026
What changed in Management’s Discussion and Analysis?
Read the current filingPrevious report: 10-Q
Period ended 2023-12-31; filed 2024-02-13.
0001493152-24-006103
Item 2. Management’s Discussion and Analysis of Financial Condition and Results of OperationsCurrent report: 10-Q
Period ended 2024-03-31; filed 2024-05-15.
0001493152-24-019922
Item 2. Management’s Discussion and Analysis of Financial Condition and Results of OperationsThe baseline is this issuer’s latest earlier reporting period of the same form that was filed before the current report. A previous 10-Q is a different quarter, not a year-over-year comparison. Amendments are excluded.
Compared 70 previous paragraphs and 72 current paragraphs.
51 unchanged; 18 reworded; 3 added; 1 removed; 0 previous and 0 current paragraphs rearranged.
Tables are not compared: 7 previous and 7 current tables excluded. Dates, whitespace, punctuation and numbering changes are ignored; changes to financial figures remain significant.
A changed paragraph is not evidence that risk increased or decreased. An unchanged paragraph does not establish that risk stayed the same.
Added paragraphs (3)
Current report
The recent decision by the United States Department of Justice to support the rescheduling of marijuana from a schedule I to a schedule III-controlled substance is a move that we believe will ultimately lead to increased use of cannabis-containing products among US households. This potentially includes edible products that are often the cause of unintentional cannabis poisoning in children. We have evaluated the potential advantages of prioritizing a near-term solution for children with more serious symptoms over progressing our plans for clinical studies to support an adult oral ACI treatment and have decided to focus current efforts on the pediatric indication at this time. Our decision to prioritize the development of an intravenous treatment for children is driven by multiple factors. Our prior discussions with the FDA have highlighted the need for an alternative formulation of selonabant for treating younger patients. There is increasing recognition among clinicians that this is a growing, unmet medical need in a vulnerable population where there are no approved treatments. Our belief is that the path to approval for an oral treatment for adult ACI may be facilitated by an initial approval in the pediatric population. Furthermore, 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. Research has shown children are much more sensitive to the toxic effects of cannabis. Key factors such as a smaller body size, reduced ability to metabolize THC, and the fact that younger children have an underdeveloped endocannabinoid system with more CB1 receptors in the brain than adults all contribute to a much greater risk to children. The risk is also evident in how cannabis effects this population; in contrast to adults who are exposed to acute cannabis toxicity, children are at risk of serious and life-threatening outcomes such as CNS depression, seizures, and coma.
Current report
Prior to beginning the Phase 3 oral ACI studies in adults, we are now prioritizing the advancement of a selonabant 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. We are currently scaling up the intravenous formulation for initial clinical safety studies.
Current report
Critical Accounting Estimates
Removed paragraphs (1)
Previous report
Critical Accounting Policies and Significant Judgments and Estimates
Reworded paragraphs (18)
Previous wording
We are a clinical-stage biotechnology company developing novel solutions for people suffering from acute cannabinoid intoxication (“ACI”) and substance addiction. Our lead product candidate, selonabant (formerly ANEB-001), is intended to rapidly reverse the negative effects of ACI and reduce time to recovery. ACI is characterized by signs and symptoms that may include sedation, anxiety, panic attacks, agitation, psychosis, tachycardia, and in extreme cases, respiratory depression and coma. In pediatric subjects, exposure to high doses of THC can lead to severe complications, including profound sedation, seizures, coma, and death. There is no approved medical treatment currently available to specifically alleviate the symptoms of ACI, and we are not aware of any competing products that are further along in the development process than selonabant in reversing the effects of cannabinoids like delta-9-tetrahydrocannabinol, better known as THC, the principal psychoactive constituent of cannabis. Previous clinical trials completed by a third party have shown that selonabant is rapidly absorbed, well tolerated and, when repeatedly administered to obese subjects, leads to weight loss, an effect that is consistent with central antagonism of the cannabinoid receptor type-1 (“CB1”), the primary target of agonists like THC. In March 2021, our European clinical trial application (“CTA”), which is equivalent to an investigational new drug application in the United States, was accepted in the Netherlands to allow us to utilize selonabant in a randomized, double-blind, placebo-controlled Phase 2 human proof-of-concept clinical trial in the Netherlands for potential use as a treatment for ACI. The study was designed to evaluate the safety, tolerability, pharmacokinetics, and effectiveness of a single dose of selonabant in treating healthy adult subjects challenged with THC. We announced on January 3, 2022, that the first patient had been dosed in the Netherlands Trial. On May 11, 2022, we announced the dosing of all 60 subjects in Part A of the Netherlands Trial. On March 28, 2023, we announced complete results from Part A and Part B of the Netherlands Trial, in a total of 134 subjects. Dosing of an additional 20 subjects in an open-label extension of the study (“Part C”) was initiated in July 2023 and the study was completed in August 2023. We met with the FDA in July 2023 for a Type B meeting to discuss the Part A and B Phase 2 data and the potential path forward for Phase 3 development of selonabant and received the minutes of the meeting in August 2023. The FDA indicated that a single well-controlled study of selonabant in ACI patients presenting to the emergency department combined with a larger THC challenge study in volunteers could potentially provide substantial evidence to support a new drug application. In addition, an observational study in patients presenting to emergency departments with ACI is currently ongoing. The study will determine concentrati…
Excerpt shortened here; the source contains the full paragraph.
Current wording
We are a clinical-stage biotechnology company developing novel solutions for people suffering from acute cannabinoid intoxication (“ACI”) and unintentional cannabis poisoning. Our lead product candidate, selonabant (formerly ANEB-001), is intended to rapidly reverse the negative effects of ACI and unintentional cannabis poisoning and reduce time to recovery. ACI is characterized by signs and symptoms that may include anxiety, panic attacks, agitation, psychosis, and tachycardia. Unintentional cannabis poisoning primarily occurs in children. Pediatric patients accidentally exposed to cannabis are at risk of serious and life-threatening outcomes including Central Nervous System (“CNS”) depression, seizures, and coma. There is no approved medical treatment currently available to specifically treat ACI or unintentional cannabis poisoning, and we are not aware of any competing products that are further along in the development process than selonabant in reversing the effects of cannabinoids like delta-9-tetrahydrocannabinol, better known as THC, the principal psychoactive constituent of cannabis. Previous clinical trials completed by a third party have shown that selonabant is rapidly absorbed, well tolerated and, when repeatedly administered to obese subjects, leads to weight loss, an effect that is consistent with central antagonism of the cannabinoid receptor type-1 (“CB1”), the primary target of agonists like THC. In March 2021, our European clinical trial application (“CTA”), which is equivalent to an investigational new drug application in the United States, was accepted in the Netherlands to allow us to utilize selonabant in a randomized, double-blind, placebo-controlled Phase 2 human proof-of-concept clinical trial in the Netherlands for potential use as a treatment for ACI. The study (the “Netherlands Trial”) was designed to evaluate the safety, tolerability, pharmacokinetics, and effectiveness of a single dose of selonabant in treating healthy adult subjects challenged with THC. We announced on January 3, 2022, that the first patient had been dosed in the Netherlands Trial. On May 11, 2022, we announced the dosing of all 60 subjects in Part A of the Netherlands Trial. On March 28, 2023, we announced complete results from Part A and Part B of the Netherlands Trial, in a total of 134 subjects. Dosing of an additional 20 subjects in an open-label extension of the study (“Part C”) was initiated in July 2023 and the study was completed in August 2023. We met with the FDA in July 2023 for a Type B meeting to discuss the Part A and B Phase 2 data and the potential path forward for Phase 3 development of selonabant and received the minutes of the meeting in August 2023. The FDA indicated that a single well-controlled study of selonabant in ACI patients presenting to the emergency department combined with a larger THC challenge study in volunteers could potentially provide substantial evidence to support a new drug application. In addition, an observ…
Excerpt shortened here; the source contains the full paragraph.
Previous wording
ACI has become a widespread health issue in the United States, particularly in the increasing number of states that have legalized cannabis for medical and recreational use. Excessive ingestion of THC via edible products such as candies and brownies, and intoxication from synthetic cannabinoids (also known as “synthetics,” including “K2” or “spice”), are two potential causes of THC-related emergency room visits. Synthetic cannabinoids are analogous to fentanyl for opioids insofar as they are more potent at the cannabinoid receptor than their natural product congener THC.
Current wording
ACI and unintentional cannabis poisoning have become a widespread health issue in the United States, particularly in the increasing number of states that have legalized cannabis for medical and recreational use. Excessive ingestion of THC via edible products such as candies and brownies, and intoxication from synthetic cannabinoids (also known as “synthetics,” including “K2” or “spice”), are two potential causes of THC-related emergency room visits. Synthetic cannabinoids are analogous to fentanyl for opioids insofar as they are more potent at the cannabinoid receptor than their natural product congener THC.
Previous wording
Hospital emergency rooms across the United States have seen a dramatic increase in patient visits with cannabis-related conditions. Before the legalization of cannabis, an estimated 450,000 patients visited hospital emergency rooms annually for cannabis-related conditions. In 2014, this number more than doubled to an estimated 1.1 million patients, according to data published in “Trends and Related Factors of Cannabis-Associated Emergency Department Visits in the United States: 2006-2014,” Journal of Addiction Medicine (May/June 2019), which provided a national estimate analyzing data from The Nationwide Emergency Department Sample (“NEDS”), the largest database of U.S. hospital-owned emergency department visits. Based on a published analysis of the most recent NEDS data, we believe that the number of emergency department visits grew to approximately 1.7 million patients in 2019 and was growing at an approximately 15% compounded annual growth rate between 2011 and 2019. We believe the number of cannabis-related emergency department visits and other health problems associated with ACIs such as depression, anxiety and mental disorders 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 ACI.
Current wording
Hospital emergency rooms across the United States have seen a dramatic increase in patient visits with cannabis-related conditions. Before the legalization of cannabis, an estimated 450,000 patients visited hospital emergency rooms annually for cannabis-related conditions. In 2014, this number more than doubled to an estimated 1.1 million patients, according to data published in “Trends and Related Factors of Cannabis-Associated Emergency Department Visits in the United States: 2006-2014,” Journal of Addiction Medicine (May/June 2019), which provided a national estimate analyzing data from The Nationwide Emergency Department Sample (“NEDS”), the largest database of U.S. hospital-owned emergency department visits. Based on our evaluation of a published analysis of the most recent NEDS data, we believe that the number of cannabis related emergency department visits grew to approximately 1.7 million patients in 2019 and was growing at an approximately 15% compounded annual growth rate between 2011 and 2019. We believe the number of cannabis-related emergency department visits and health problems associated with ACI and unintentional cannabis poisoning 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 ACI and unintentional cannabis poisoning.
Previous wording
In May 2020, we entered into a royalty-bearing license agreement with Vernalis Development Limited (“License Agreement”) to exploit its license compounds and licensed products to combat symptoms of ACI and substance addiction. We are currently developing our lead product candidate, selonabant to quickly, and effectively, combat symptoms of ACI.
Current wording
In May 2020, we entered into a royalty-bearing license agreement with Vernalis Development Limited (“License Agreement”) to exploit its licensed compounds and licensed products to combat symptoms of ACI and substance addiction. We are currently developing our lead product candidate, selonabant to quickly, and effectively, combat symptoms of ACI.
Previous wording
Our objective is to develop and commercialize new treatment options for patients suffering from ACI and substance addiction. Our lead product candidate is selonabant, a potent, small molecule cannabinoid receptor antagonist, to address the unmet medical need for a specific antidote for ACI. selonabant is an orally bioavailable, rapidly absorbed treatment that we anticipate will rapidly reverse the symptoms of ACI. Our proprietary position in the treatment of ACI is protected by rights to two patent applications covering various methods of use of the compound and delivery systems.
Current wording
Our objective is to develop and commercialize new treatment options for patients suffering from ACI and unintentional cannabis poisoning. Our lead product candidate is selonabant, a potent, small molecule cannabinoid receptor type 1 (CB1) antagonist, that is under development to address the unmet medical need for a specific antidote for ACI and unintentional cannabis poisoning. Selonabant is an orally bioavailable, rapidly absorbed treatment that we anticipate will rapidly reverse the symptoms of ACI. Our proprietary position in the treatment of ACI and unintentional cannabis poisoning is protected by two issued patents covering various methods of use of the compound and composition of matter of the crystalline form of selonabant. We also have multiple pending applications covering various methods of use of the compound and delivery systems.
Previous wording
On January 31, 2024, the United States Adopted Names (USAN) Council has adopted selonabant as the generic name for ANEB-001.
Current wording
On January 31, 2024, the United States Adopted Names (USAN) Council adopted selonabant as the generic name for ANEB-001.
Previous wording
We expect to continue incurring significant research and development costs related to selonabant. Our research and development expenses for the three and six months ended December 31, 2023 and 2022 included research and development consulting expenses, nonclinical and clinical study costs, and other costs associated with development of our lead product candidate, selonabant.
Current wording
We expect to continue incurring significant research and development costs related to selonabant. Our research and development expenses for the three and nine months ended March 31, 2024 and 2023 included research and development consulting expenses, nonclinical and clinical study costs, and other costs associated with development of our lead product candidate, selonabant.
Previous wording
We anticipate that our research and development activities will account for a significant portion of our operating expenses and these costs are expensed as incurred. We expect to significantly increase our research and development efforts as we continue to develop selonabant and conduct additional clinical trials with volunteers and with ED patients suffering from symptoms of ACI, as well as continue to expand our product-candidate pipeline. Research and development expenses include:
Current wording
We anticipate that our research and development activities will account for a significant portion of our operating expenses and these costs are expensed as incurred. We expect to significantly increase our research and development efforts as we continue to develop selonabant and conduct additional clinical trials with volunteers and with ED patients suffering from symptoms of ACI and unintentional cannabis poisoning, as well as continue to expand our product-candidate pipeline. Research and development expenses include:
Previous wording
General and administrative expenses for the three and six months ended December 31, 2023 and 2022 consisted primarily of professional fees, stock-based compensation, insurance, personnel costs and rent.
Current wording
General and administrative expenses for the three and nine months ended March 31, 2024 and 2023 consisted primarily of professional fees, stock-based compensation, insurance, personnel costs and rent.
Previous wording
Comparison of the Three and Six Months Ended December 31, 2023 and 2022
Current wording
Comparison of the Three and Nine Months Ended March 31, 2024 and 2023
Previous wording
The overall decrease in research and development expenses was primarily attributable to the completion of our Phase 2 proof of concept trial for ACI and awaiting the start of Phase 3.
Current wording
The overall decrease in research and development expenses was primarily attributable to the completion of our Phase 2 proof of concept trial for ACI and awaiting the start of the next clinical study.
Previous wording
The overall decrease in general and administrative expenses was primarily attributable to a decrease in professional and consultant fees, including legal and accounting fees, resulting from strategic cost reductions, a decrease in directors’ and officers’ insurance resulting from a decrease in yearly premium amount. This was partially offset by an increase in compensation and related benefits due to severance accrued related to our former CEO.
Current wording
The overall decrease in general and administrative expenses was primarily attributable to a decrease in professional and consultant fees, including legal and accounting fees, resulting from strategic cost reductions and a decrease in directors’ and officers’ insurance resulting from a decrease in yearly premium amount.
Previous wording
Since our inception in April 2020, we have incurred significant operating losses. We expect to incur significant expenses and operating losses in the future as we advance the clinical development of our programs. In May 2021, we completed our IPO in which we received net proceeds of approximately $19.8 million. As noted above, on September 28, 2022, we closed the Private Placement, in which we received net proceeds of approximately $6.3 million. As of December 31, 2023, we had cash of approximately $6.6 million. As and if necessary, we will seek to raise additional funds through various potential sources, such as equity and debt financings or through collaboration, license and development agreements. We can give no assurances that we will be able to secure such additional sources of funds to support our operations on acceptable terms or at all, or, if such funds are available to us, that such additional financing will be sufficient to meet our needs.
Current wording
Since our inception in April 2020, we have incurred significant operating losses. We expect to incur significant expenses and operating losses in the future as we advance the clinical development of our programs. In May 2021, we completed our IPO in which we received net proceeds of approximately $19.8 million. As noted above, on September 28, 2022, we closed the Private Placement, in which we received net proceeds of approximately $6.3 million. As of March 31, 2024, we had cash and cash equivalents of approximately $5.1 million. As and if necessary, we will seek to raise additional funds through various potential sources, such as equity and debt financings or through collaboration, license and development agreements. We can give no assurances that we will be able to secure such additional sources of funds to support our operations on acceptable terms or at all, or, if such funds are available to us, that such additional financing will be sufficient to meet our needs.
Previous wording
During the six months ended December 31, 2023, we used cash in operating activities of approximately $4.5 million primarily resulting from our net loss of $5.2 million, partially offset by the non-cash related stock-based compensation and loan commitment amortization totaling approximately $0.5 million, and a change in operating assets and liabilities of approximately $0.2 million.
Current wording
During the nine months ended March 31, 2024, we used cash in operating activities of approximately $6.0 million primarily resulting from our net loss of $6.9 million, partially offset by the non-cash related stock-based compensation and loan commitment amortization totaling approximately $0.7 million, and a change in operating assets and liabilities of approximately $0.1 million.
Previous wording
During the six months ended December 31, 2022, we used cash in operating activities of approximately $4.6 million primarily resulting from our net loss of approximately $6.4 million partially offset by the non-cash related stock-based compensation of approximately $0.4 million, and a change in operating assets and liabilities of approximately $1.3 million. We received cash from financing activities of approximately $6.5 million primarily resulting from the issuance of common stock and warrants of approximately $6.6 million, net of offering costs of approximately $0.3 million.
Current wording
During the nine months ended March 31, 2023, we used cash in operating activities of approximately $6.8 million primarily resulting from our net loss of approximately $9.2 million partially offset by the non-cash related stock-based compensation of approximately $0.7 million, and a change in operating assets and liabilities of approximately $1.7 million. We received cash from financing activities of approximately $6.5 million primarily resulting from the issuance of common stock and warrants of approximately $6.6 million, net of offering costs of approximately $0.3 million.
Previous wording
Until such time, if ever, as we can generate substantial product revenue from sales of any of our current or future product candidates, we expect to finance our cash needs through a combination of equity offerings, debt financings and potential collaboration, license or development agreements. Debt financing and preferred equity financing, if available, may involve agreements that include covenants limiting or restricting our ability to take specific actions, such as incurring additional debt, making capital expenditures, or declaring dividends. We have no current agreements or understandings with investors to provide such capital.
Current wording
Until such time, if ever, as we can generate substantial product revenue from sales of our current or any of our future product candidates, we expect to finance our cash needs through a combination of equity offerings, debt financings and potential collaboration, license or development agreements. Debt financing and preferred equity financing, if available, may involve agreements that include covenants limiting or restricting our ability to take specific actions, such as incurring additional debt, making capital expenditures, or declaring dividends. We have no current agreements or understandings with investors to provide such capital.
Previous wording
We have a manufacturing agreement with a third-party CMO. The total cost for the current contract is approximately $2.9 million. The manufacturing aspect of this contract is expected to be fully incurred by the end of the first calendar quarter of 2024. The stability study aspect of the contract is expected to be fully incurred during calendar 2026.
Current wording
We have a manufacturing agreement with a third-party CMO. The total cost for the current contract is approximately $3.0 million. The manufacturing aspect of this contract is expected to be fully incurred by the end of the second calendar quarter of 2024. The stability study aspect of the contract is expected to be fully incurred during calendar 2026.
Previous wording
There were no significant changes to assumptions used to value options using the Black Scholes option pricing model during the six months ended December 31, 2023, with the exception of the stock and exercise prices.
Current wording
There were no significant changes to assumptions used to value options using the Black Scholes option pricing model during the nine months ended March 31, 2024, with the exception of the stock and exercise prices.