Full Press Release Details
Pharmaceuticals Reports Second Quarter Fiscal Year 2024
Results and Recent Updates
Texas (February 13, 2024) - Anebulo Pharmaceuticals, Inc. (Nasdaq: ANEB), a clinical-stage biopharmaceutical company developing
novel solutions for people suffering from acute cannabinoid intoxication (ACI) and substance abuse (the "Company" or "Anebulo"),
today announced financial results for the three months ended December 31, 2023, and recent updates.
Quarter Fiscal Year 2024 and Subsequent Highlights:
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.
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," Cunningham continued. "Despite the high tolerability of cannabis in the majority
of users, a significant number of users who develop ACI may experience moderate to severe neuropsychiatric symptoms such as anxiety,
paranoia, and psychosis. In addition to poor patient outcomes, cannabis toxicity places a substantial burden on the healthcare system."
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."
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 $10 million. This facility reflects their on-going confidence and support as we continue to prepare for Phase
3 trials, a very important step in our mission."
Results for the three months ended December 31, 2023
| Operating expenses in the second quarter of fiscal 2024 were $2.8 million compared with $3.8 million in the same period in fiscal 2023. | |
| Net loss in the second quarter of fiscal 2024 was $2.7 million, or $(0.11) per share, compared with a net loss of $3.8 million, or $(0.15) per share, in the second quarter of fiscal 2023. | |
| Cash was $6.6 million as of December 31, 2023. |
Selonabant (ANEB-001)
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.
Anebulo Pharmaceuticals, Inc.
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.
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.
Pharmaceuticals, Inc.
Chief Financial Officer
| 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 |
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 | ) |