Anebulo Pharmaceuticals Reports First Quarter Fiscal Year 2025 Financial Results and Recent Updates
13 Novembro 2024 - 6:05PM
Business Wire
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 September 30, 2024, and recent updates.
First Quarter Fiscal Year 2025 and Subsequent
Highlights:
- Anebulo announced it has been awarded the first tranche of a
two-year cooperative grant of up to approximately $1.9 million from
the National Institute on Drug Abuse (“NIDA”), part of the National
Institutes of Health (“NIH”), under award number
1U01DA059995-01.
- With the support of NIDA, Anebulo aims to complete IND-enabling
activities and the scale up of its intravenous (IV) formulation of
selonabant around calendar year end 2024 as it prepares for
clinical studies and the Company expects to enroll the first
healthy adult volunteer in the first half of calendar 2025.
“We are excited to have the support of NIDA to advance our
development of a rapid and clinically impactful emergency treatment
for acute cannabis-induced toxicities, including cannabis-induced
Central Nervous System (CNS) depression in children,” commented
Richie Cunningham, Chief Executive Officer of Anebulo.
“We believe this important grant from NIDA recognizes the
significant progress we have already made with the successful Phase
2 proof of concept study of oral selonabant. This grant, along with
our access to an additional $10 million in cash through the recent
Loan and Security Agreement, provides further momentum for
advancing the intravenous formulation towards clinical testing. We
also believe the grant further validates the 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 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 direct 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. 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
accidental cannabis ingestion in children.”
Financial Results for the three months ended September 30,
2024
- Operating expenses in the first quarter of fiscal 2025 were
$2.4 million compared with $2.5 million in the same period in
fiscal 2024.
- Net loss in the first quarter of fiscal 2025 was $2.2 million,
or $(0.08) per share, compared with a net loss of $2.5 million, or
$(0.10) per share, in the first quarter of fiscal 2024.
- Cash and cash equivalents were $1.4 million as of September 30,
2024. The Company has access to an additional $10 million in cash
through the Loan and Security Agreement executed on November 13,
2023.
About Selonabant (ANEB-001)
The 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 t as a potential IV
treatment. 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.
About Anebulo Pharmaceuticals, Inc.
Anebulo Pharmaceuticals, Inc. is a clinical-stage pharmaceutical
company developing novel solutions for people suffering from acute
cannabinoid intoxication and unintentional cannabis intoxication.
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 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:
completion of IND-enabling activities and the scale up of Anebulo’s
intravenous formulation of selonabant around year end 2024 as
Anebulo prepares for clinical studies; enrollment of the first
healthy adult volunteer in the first half of 2025; the grant from
NIDA recognizing the significant progress the Company has already
made with the successful Phase 2 proof of concept study of oral
selonabant; the grant further validating the significant and
growing unmet medical need for an emergency antidote to acute
cannabis-induced toxicity; the potential of selonabant to offer a
much-needed targeted therapy for rapidly reversing the serious and
life-threatening consequences of accidental cannabis ingestion in
children; 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 advancement 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. 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: the Company’s ability to pursue its regulatory strategy
including completion of IND enabling activities and scale up of the
intravenous formulation of selonabant around year end 2024 and
enrolling the first healthy adult volunteer in the first half of
2025, its ability to obtain regulatory approvals for
commercialization of product candidates or to comply with ongoing
regulatory requirements, the Company’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,
the Company’s ability to maintain its license agreements, the
continued maintenance and growth of its patent estate and the
Company’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 the Company’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.
Condensed Balance
Sheets
September 30, 2024
June 30,
2024
Cash and cash equivalents
$
1,404,211
$
3,094,200
Total assets
2,467,940
4,073,114
Total liabilities
569,225
260,583
Total stockholders’ equity
1,898,715
3,812,531
Condensed Statements of
Operations
Three months ended September
30,
2024
2023
Research and development
$
1,314,859
$
1,270,220
General and administrative
1,097,265
1,273,458
Total operating expenses
2,412,124
2,543,678
Loss from operations
(2,412,124
)
(2,543,678
)
Other (income) expenses:
Interest expense
59,697
-
Interest income
(26,006
)
(55,198
)
Grant income
(245,362
)
-
Other
283
(7,657
)
Total other income, net
(211,388
)
(62,855
)
Net loss
$
(2,200,736
)
$
(2,480,823
)
Weighted average common shares
outstanding, basic and diluted
25,933,217
25,633,217
Net loss per share, basic and diluted
$
(0.08
)
$
(0.10
)
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Anebulo Pharmaceuticals, Inc. Daniel George Part time Chief
Financial Officer (512) 598-0931 Dan@anebulo.com
Anebulo Pharmaceuticals (NASDAQ:ANEB)
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