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

Key Takeaway: Pharmaceuticals Reports First Quarter Fiscal Year 2025 Results and Recent Updates Texas (November 13, 2024) - Anebulo Pharmaceuticals, Inc. (Nasdaq: ANEB), a clinical-stage pharmaceutical company developing novel solutions for people suffering from acute cannabis-induced toxic

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Pharmaceuticals Reports First Quarter Fiscal Year 2025
Results and Recent Updates
Texas (November 13, 2024) - 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.
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
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.
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."
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.
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 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.
Anebulo Pharmaceuticals, Inc.
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.
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.
Pharmaceuticals, Inc.
time Chief Financial Officer
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
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 )
Last updated: Nov 13, 2024