Anebulo Pharmaceuticals Reports Second Quarter Fiscal Year 2024 Financial Results and Recent Updates
- Appointment of Richie Cunningham as CEO.
- Adoption of selonabant as the generic name for ANEB-001 by the USAN Council.
- Advancement of a selonabant IV formulation for clinical safety studies.
- Securing a credit facility of up to $10 million.
- Focus on Phase 3 studies for selonabant to address acute cannabinoid intoxication.
- None.
The recent announcement by Anebulo Pharmaceuticals, Inc. indicates a strategic progression in their pipeline, particularly with the development of selonabant for acute cannabinoid intoxication (ACI). Observing the financial results, a reduction in operating expenses from $3.8 million to $2.8 million year-over-year for the same quarter is noteworthy. This suggests a more efficient allocation of resources or a strategic cut in spending, which could be perceived positively by investors.
The net loss reduction from $(0.15) to $(0.11) per share also signals a potential improvement in financial stability. However, the cash reserves of $6.6 million, while sufficient for short-term operations, will likely necessitate additional funding for long-term trials and commercialization efforts. The secured credit facility of up to $10 million provides some cushion, but the terms and potential dilution effects should be scrutinized.
Investors should monitor the company's burn rate and the progression towards Phase 3 trials, as these factors will be critical in assessing the company's ability to reach milestones without facing financial shortfalls.
ACI represents a growing concern with the increased legalization of cannabis, positioning Anebulo Pharmaceuticals as a potential front-runner in this new therapeutic area. The advancement of a selonabant IV formulation could address a significant unmet medical need, especially for pediatric patients. The safety and efficacy of this treatment have yet to be established in Phase 3 trials, which are pivotal in determining the drug's market potential.
The USAN's adoption of a generic name for ANEB-001 is a procedural milestone that contributes to the drug's identity and recognition in the medical community. However, the real value lies in the outcomes of the upcoming clinical studies and the drug's ability to safely and effectively mitigate the symptoms of ACI.
For healthcare stakeholders, the development of an effective treatment for ACI could alleviate the burden on emergency services and improve patient outcomes. The long-term implications hinge on the drug's approval and its adoption by healthcare providers, which will be determined by the clinical data and subsequent FDA discussions.
Second Quarter Fiscal Year 2024 and Subsequent Highlights:
- Richie Cunningham announced as Chief Executive Officer
- United States Adopted Names (USAN) adopted selonabant as the generic name for ANEB-001
- Advancing selonabant IV formulation as a second product
-
Secured a credit facility of up to
$10 million
- Bimal Shah announced as Board Member
“Anebulo continues to make progress towards our goal of becoming the first company to have an approved treatment for acute cannabinoid intoxication. Our current efforts are focused on completion of critical steps needed to support the future Phase 3 studies of selonabant, including efficient scale up of manufacturing, completion of remaining nonclinical activities, and finalizing the designs of our proposed registrational studies for further discussion with the FDA. One important development at Anebulo is the advancement of a selonabant IV formulation, which we are currently scaling-up for initial clinical safety studies as a potential treatment for patients where oral dosing is not an option, such as younger pediatric patients accidentally exposed to cannabis, who may experience serious outcomes like CNS depression, seizures, or coma,” commented Richie Cunningham, Chief Executive Officer of Anebulo.
“We find ourselves at a seminal moment to deliver a meaningfully constructive solution to healthcare providers and to their patients suffering with ACI and associated cannabis toxicities,”
“We are pleased to report that the USAN Council has adopted selonabant as the generic name for ANEB-001. This is just another step in the journey to delivering a much needed solution to patients.
“Lastly, the company has recently strengthened its capital structure by executing a credit facility with certain existing investors that will allow us access of up to
Financial Results for the three months ended December 31, 2023
-
Operating expenses in the second quarter of fiscal 2024 were
$2.8 million $3.8 million
-
Net loss in the second quarter of fiscal 2024 was
$2.7 million $(0.11) $3.8 million $(0.15)
-
Cash was
$6.6 million
About Selonabant (ANEB-001)
Our lead product candidate is selonabant (ANEB-001), a potent, small molecule antagonist of cannabinoid receptor type 1 (CB1), under development to address the unmet medical need for a specific antidote for cannabis toxicity, including ACI. Selonabant is an orally bioavailable, readily absorbed treatment candidate that we anticipate will rapidly reverse key symptoms of ACI. Selonabant is protected by two issued patents and rights to four pending patent applications covering various methods of use of the compound and delivery systems. We are targeting initiation of Phase 3 registrational studies of oral selonabant in the first half of calendar 2024. In addition, an observational study in patients presenting to Emergency Departments with ACI is currently ongoing. The study will determine concentrations of cannabinoids and metabolites in plasma and gather information on signs and symptoms, patients’ disposition and selected subjective assessments.
About Anebulo Pharmaceuticals, Inc.
Anebulo Pharmaceuticals, Inc. is a clinical-stage biopharmaceutical company developing novel solutions for people suffering from acute cannabinoid intoxication and, longer term, for substance use disorders. Its lead product candidate, selonabant, has completed dosing in a Phase 2 clinical trial (www.clinicaltrials.gov/ct2/show/NCT05282797) evaluating its utility in blocking and reversing the negative effects of acute cannabinoid intoxication. Selonabant is a competitive antagonist at the human cannabinoid receptor type 1 (CB1). For further information about Anebulo, please visit www.anebulo.com.
Forward-Looking Statements
Statements contained in this press release that are not statements of historical fact are forward-looking statements as defined in Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. In some cases, these forward-looking statements can be identified by words such as "anticipate," "designed," "expect," "may," "will," "should" and other comparable terms. Forward-looking statements include statements regarding Anebulo's intentions, beliefs, projections, outlook, analyses or current expectations regarding: the targeted commencement of phase 3 registrational trials for selonabant in the first half of calendar 2024; the advancement of a selonabant IV formulation; the observational study of selonabant; pending patent applications; the potential for selonabant to address an unmet medical need for a specific antidote for ACI; Anebulo becoming the first company to have an approved treatment for ACI; and Anebulo's expectation that selonabant will rapidly reverse key symptoms of ACI or related cannabis toxicities . You are cautioned that any such forward-looking statements are not guarantees of future performance and are subject to a number of risks, uncertainties and assumptions, including, but not limited to: initial and interim results from clinical studies are not necessarily indicative of results that may be observed in the future; the ability to obtain regulatory approval; the timing and success of development efforts and clinical trials may be impacted by various factors, including safety and other complications; any negative effects on the Company's business and product development plans caused by or associated with health crises or geopolitical issues; and Anebulo's need for additional capital. These and other risks are described under the "Risk Factors" heading of Anebulo's Quarterly Report on Form 10-Q for the quarter ended September 30, 2023, as filed with the SEC on November 14, 2023, and in Anebulo's Quarterly Report on Form 10-Q for the quarter ended December 31, 2023, being filed with the SEC on February 13, 2024. All forward-looking statements made in this press release speak only as of the date of this press release and are based on management's assumptions and estimates as of such date. Except as required by law, Anebulo undertakes no obligation to update or revise forward-looking statements to reflect new information, future events, changed conditions or otherwise after the date of this press release.
Condensed Balance Sheets |
||||||||
|
|
December 31, |
|
June 30, |
||||
|
|
2023 |
|
2023 |
||||
Cash |
|
$ |
6,644,517 |
|
|
$ |
11,247,403 |
|
Total assets |
|
|
7,500,773 |
|
|
|
11,670,151 |
|
Total liabilities |
|
|
1,013,556 |
|
|
|
1,068,801 |
|
Total stockholders’ equity |
|
|
6,487,217 |
|
|
|
10,601,350 |
|
Condensed Statements of Operations |
||||||||
|
|
Three Months Ended December 31, |
||||||
|
|
2023 |
|
2022 |
||||
Research and development |
|
$ |
1,062,672 |
|
|
$ |
1,869,920 |
|
General and administrative |
|
|
1,697,787 |
|
|
|
1,943,202 |
|
Total operating expenses |
|
|
2,760,459 |
|
|
|
3,813,122 |
|
Loss from operations |
|
|
(2,760,459 |
) |
|
|
(3,813,122 |
) |
Other (income) expenses: |
|
|
|
|
|
|
|
|
Interest income |
|
|
(75,522 |
) |
|
|
(8,816) |
|
Other |
|
|
32,432 |
|
|
|
22,646 |
|
Total other (income) expenses, net |
|
|
(43,090 |
) |
|
|
13,830 |
|
Net loss |
|
$ |
(2,717,369 |
) |
|
$ |
(3,826,952 |
) |
Weighted average common shares outstanding, basic and diluted |
|
|
25,789,739 |
|
|
|
25,633,217 |
|
Net loss per share, basic and diluted |
|
$ |
(0.11 |
) |
|
$ |
(0.15 |
) |
View source version on businesswire.com: https://www.businesswire.com/news/home/20240213596703/en/
Anebulo Pharmaceuticals, Inc.
Daniel George
Acting Chief Financial Officer
(512) 598-0931
Dan@anebulo.com
Source: Anebulo Pharmaceuticals, Inc.
FAQ
What were Anebulo Pharmaceuticals' financial results for the three months ended December 31, 2023?
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What is the generic name adopted for ANEB-001?
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