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Anebulo Pharmaceuticals Reports Second Quarter Fiscal Year 2025 Financial Results and Recent Updates AUSTIN, Texas (

Key Takeaway: Pharmaceuticals Reports Second Quarter Fiscal Year 2025 Results and Recent Updates Texas (February 14, 2025) - Anebulo Pharmaceuticals, Inc. (Nasdaq: ANEB), a clinical-stage pharmaceutical company developing novel solutions for people suffering from acute cannabis-induced toxi

Full Press Release Details

Pharmaceuticals Reports Second Quarter Fiscal Year 2025
Results and Recent Updates
Texas (February 14, 2025) - Anebulo Pharmaceuticals, Inc. (Nasdaq: ANEB), a clinical-stage pharmaceutical company developing
novel solutions for people suffering from acute cannabis-induced toxic effects (the "Company" or "Anebulo"),
today announced financial results for the three months ended
December 31, 2024, and recent updates.
Quarter Fiscal Year 2025 and Subsequent Highlights:
are grateful to have the continued support from current investors. Having secured such meaningful financing is indicative of the confidence
these highly respected institutional investors have in the Company's future," commented Richie Cunningham, Chief Executive
continued, "There is a significant and growing unmet medical need for an emergency antidote to acute cannabis-induced toxicity.
In particular, acute cannabis exposure in children can result in serious and potentially life-threatening consequences, including Central Nervous System ("CNS")
depression, respiratory depression, coma, and in rare cases death. Research has shown that children are much more sensitive to the
toxic effects of cannabis, due in part to age-related differences in the abundance of cannabis receptors in their brains. As a consequence,
cannabis ingestion in children can result in much more serious outcomes than in adults, and a much greater risk of hospitalization and
admission to intensive care.
recent interactions, FDA confirmed our belief that there is an unmet need for a treatment for children exposed to cannabis toxicity and
suggested a close collaboration with Anebulo to facilitate an efficient development plan for this important pediatric condition. If approved,
we believe selonabant has the potential to offer a much-needed targeted therapy for rapidly reversing the serious and life-threatening
consequences of acute cannabis-induced toxicity in children."
Results for the three months ended December 31, 2024
Operating expenses in the second quarter of fiscal 2025 were $2.6 million compared with $2.8 million in the same period in fiscal 2024.
Net loss in the second quarter of fiscal 2025 was $2.5 million, or $(0.09) per share, compared with a net loss of $2.7 million, or $(0.11) per share, in the second quarter of fiscal 2024.
Cash and cash equivalents were $15.0 million as of December 31, 2024. The Company also has access to an additional $3 million in cash through a Loan Agreement.
Selonabant (ANEB-001)
Company's lead product candidate is selonabant (ANEB-001), a potent, small molecule antagonist of the cannabinoid receptor type-1
("CB1"), under development to address the unmet medical need for a specific antidote for acute cannabis-induced toxicity,
including acute cannabinoid intoxication ("ACI") in adults and unintentional cannabis poisoning in pediatric subjects. The
Company anticipates that selonabant will rapidly reverse key symptoms of cannabis toxicity. Selonabant has been successfully formulated
for oral administration in clinical studies and as a potential intravenous treatment for clinical testing. In a Phase 2 proof-of-concept
study in adult subjects challenged with oral delta-9-tetrahydrocannabinol ("THC") (www.clinicaltrials.gov/ct2/show/NCT05282797),
oral selonabant blocked or reversed key CNS effects of THC. Selonabant was well tolerated in this study and there were no serious adverse
events. In the open-label extension of the study, THC challenge doses of 40 mg and 60 mg were well-tolerated when dosed in combination
with oral selonabant, and all treatment-related adverse events were mild and transient. The prior Phase 1 and Phase 2 studies of oral
selonabant have together enrolled a total of 250 subjects, of which 189 received selonabant. Selonabant is protected by two issued patents
covering various methods of use of the compound and composition of matter of the crystalline form of selonabant. Anebulo also has multiple
pending applications covering various methods of use of the compound and delivery systems. An observational study in patients presenting
to Emergency Departments with cannabis toxicity is currently ongoing. The study is intended to 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 pharmaceutical company developing novel solutions for people suffering from cannabis-induced
toxicity. Its lead product candidate, selonabant, has completed a Phase 2 clinical trial evaluating its utility in blocking and reversing
the negative effects of acute cannabinoid intoxication in healthy adults challenged with oral THC. Rather than proceeding directly with
Phase 3 studies of oral selonabant in adults with ACI, the Company is prioritizing the advancement of a selonabant IV formulation as
a potential treatment for pediatric patients with acute cannabis-induced toxicity, which it believes offers the potential for a faster
timeline to approval relative to the adult oral product. Anebulo is currently scaling up the intravenous formulation for initial clinical
safety studies. Selonabant is a competitive antagonist at the human CB1 receptor. For further information about Anebulo, please visit
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: plans to begin its Phase 1 single ascending dose
("SAD") study of intravenous selonabant in healthy adults in 1H25; securing such meaningful financing being indicative of
the confidence these highly respected institutional investors have in the company's future; the belief that there is an unmet need
for a treatment for children exposed to cannabis toxicity; selonabant having the potential to offer a much-needed targeted therapy for
rapidly reversing the serious and life-threatening consequences of acute cannabis-induced toxicity in children; selonabant rapidly reversing
key symptoms of cannabis toxicity; the observational study determining concentrations of cannabinoids and metabolites in plasma and gathering
information on signs and symptoms, patients' disposition and selected subjective assessments; and a selonabant IV formulation as
a potential treatment for pediatric patients with acute cannabis-induced toxicity, offering the potential for a faster timeline to approval
relative to the adult oral product. 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: Anebulo's ability to pursue
its regulatory strategy including the ability to begin the Phase 1 single ascending dose ("SAD") study of intravenous selonabant
in healthy adults in 1H25; , the ability of selonabant to rapidly reverse key symptoms of cannabis toxicity; the ability of a selonabant
IV formulation as a potential treatment for pediatric patients with acute cannabis-induced toxicity, offering the potential for a faster
timeline to approval relative to the adult oral product; Anebulo's ability to obtain regulatory approvals for commercialization
of product candidates or to comply with ongoing regulatory requirements, Anebulo's ability to obtain or maintain the capital or
grants necessary to fund its research and development activities, its ability to complete clinical trials on time and achieve desired
results and benefits as expected, regulatory limitations relating to the ability to promote or commercialize product candidates for specific
indications, acceptance of product candidates in the marketplace and the successful development, marketing or sale of Anebulo's
products, Anebulo's ability to maintain its license agreements, the continued maintenance and growth of its patent estate and Anebulo's
ability to retain its key employees or maintain its Nasdaq listing. These risks should not be construed as exhaustive and should be read
together with the other cautionary statements included in Anebulo's Annual Report on Form 10-K for the year ended June 30, 2024,
and its subsequent filings with the Securities and Exchange Commission, including subsequent periodic reports on Quarterly Reports on
Form 10-Q and Current Reports on Form 8-K. 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.
December 31, 2024 June 30, 2024
Cash and cash equivalents $ 14,998,467 $ 3,094,200
Total assets 15,841,220 4,073,114
Total liabilities 878,799 260,583
Total stockholders' equity 14,962,421 3,812,531
Statements of Operations
Three months ended December 31,
2024 2023
Research and development $ 1,220,535 $ 1,062,672
General and administrative 1,367,616 1,697,787
Total operating expenses 2,588,151 2,760,459
Loss from operations (2,588,151 ) (2,760,459 )
Other (income) expenses:
Interest expense 59,696 31,838
Interest income (7,067 ) (75,522 )
Grant income (177,703 ) -
Other (47 ) 594
Total other income, net (125,121 ) (43,090 )
Net loss $ (2,463,030 ) $ (2,717,369 )
Weighted average common shares outstanding, basic and diluted 27,415,430 25,789,739
Net loss per share, basic and diluted $ (0.09 ) $ (0.11 )
Last updated: Feb 14, 2025