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UNITED
STATES
SECURITIES
AND EXCHANGE COMMISSION
WASHINGTON,
D.C. 20549
FORM
8-K
CURRENT
REPORT
Pursuant
to Section 13 or 15(d) of the Securities Exchange Act of 1934
Date
of Report (Date of earliest event reported): September 25, 2024
ANEBULO
PHARMACEUTICALS, INC
(Exact
name of Registrant as Specified in Its Charter)
Delaware |
|
001-40388 |
|
85-1170950 |
(State
or Other Jurisdiction
of
Incorporation) |
|
(Commission
File
Number) |
|
(IRS
Employer
Identification
No.) |
Anebulo
Pharmaceuticals, Inc.
1017
Ranch Road 620 South, Suite 107
Lakeway,
TX |
|
78734 |
(Address
of Principal Executive Offices) |
|
(Zip
Code) |
Registrant’s
Telephone Number, Including Area Code: (512) 598-0931
Not
Applicable
(Former
Name or Former Address, if Changed Since Last Report)
Check
the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under
any of the following provisions:
☐ |
Written
communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425) |
|
|
☐ |
Soliciting
material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12) |
|
|
☐ |
Pre-commencement
communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b)) |
|
|
☐ |
Pre-commencement
communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c)) |
Securities
registered pursuant to Section 12(b) of the Act:
Title
of each class |
|
Trading
Symbol(s) |
|
Name
of each exchange on which registered |
Common
Stock, $0.001 par value per share |
|
ANEB |
|
The
Nasdaq Stock Market LLC |
Indicate
by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§ 230.405
of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§ 240.12b-2 of this chapter).
Emerging
growth company ☒
If
an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying
with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act.
Item
2.02 Results of Operations and Financial Condition.
On
September 25, 2024, Anebulo Pharmaceuticals, Inc., a Delaware corporation (the “Company”), issued a press release announcing
its financial results for the quarter and fiscal year ended June 30, 2024 and providing a business update. A copy of the press release
is furnished as Exhibit 99.1 to this Current Report on Form 8-K.
The
information in this Current Report on Form 8-K (including Exhibit 99.1) shall not be deemed “filed” for purposes of Section
18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise subject to the liabilities of that
section, nor shall it be deemed incorporated by reference in any filing under the Securities Act of 1933, as amended, or the Exchange
Act, except as expressly set forth by specific reference in such a filing.
Item
9.01 Financial Statements and Exhibits.
(d)
Exhibits
SIGNATURES
Pursuant
to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by
the undersigned hereunto duly authorized.
|
ANEBULO
PHARMACEUTICALS, INC. |
|
|
|
Date:
September 25, 2024 |
By: |
/s/
Richard Anthony Cunningham |
|
|
Richard
Anthony Cunningham |
|
|
Chief
Executive Officer (Principal Executive Officer) |
Exhibit
99.1
Anebulo
Pharmaceuticals Reports Fourth Quarter and Fiscal Year 2024
Financial
Results and Recent Updates
AUSTIN,
Texas (September 25, 2024) – Anebulo Pharmaceuticals, Inc. (Nasdaq: ANEB), a clinical-stage biopharmaceutical company developing
novel solutions for people suffering from acute cannabis-induced toxic effects (the “Company” or “Anebulo”),
today announced financial results for the three and twelve months ended June 30, 2024, and recent updates.
Fourth
Quarter Fiscal Year 2024 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”) |
|
|
|
|
● |
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 |
|
|
|
|
● |
Anebulo
prioritizes development of selonabant IV formulation for unintentional cannabis poisoning in children in response to the growing
medical need and impending change in Drug Enforcement Agency scheduling of marijuana from a Schedule I to a Schedule III controlled
substance supported by the United States Department of Justice |
“The
recently awarded grant from NIDA further enables our efforts to provide 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 progress we have already made with the successful Phase 2 proof of concept study
of oral selonabant and provides further momentum for advancing the intravenous formulation towards clinical testing. We also believe
this awarded grant further validates the significant and growing unmet medical need for an emergency antidote to cannabis toxicity. In
particular, acute cannabis exposure in children is a serious and potentially life-threatening condition that can result in 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,
pediatric cannabis ingestion 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 June 30, 2024
|
● |
Operating
expenses in the fourth quarter of fiscal 2024 were $1.3 million compared with $2.5 million in the same period in fiscal 2023. |
|
|
|
|
● |
Net
loss in the fourth quarter of fiscal 2024 was $1.3 million, or $(0.05) per share, compared with a net loss of $2.5 million, or $(0.10)
per share, in the fourth quarter of fiscal 2023. Cash and cash equivalents were $3.1 million as of June 30, 2024. |
|
|
|
|
● |
The
Company has access to an additional $10 million in cash through the Loan and Security Agreement executed on November 13, 2023. |
Financial
Results for the twelve months ended June 30, 2024
|
● |
Operating
expenses in fiscal year 2024 were $8.3 million compared with $11.8 million in the same period in fiscal 2023. Research and Development
expenses decreased approximately $2.1 million from the prior year, primarily due to the completion of the Company’s Phase 2
proof of concept clinical trial for acute cannabinoid intoxication (“ACI”) during the first half of the fiscal year ended
June 30, 2024, and prioritizing the advancement of a selonabant IV formulation, which resulted in a reduction in activities related
to pre-clinical, clinical studies, and direct third-party costs. General and Administrative expenses decreased $1.4 million from
the prior period, primarily due to an overall reduction in compensation and related benefits, including stock-based compensation,
professional and consultant fees, and a decrease in directors’ and officer’s insurance premiums. |
|
|
|
|
● |
Net
loss in fiscal year 2024 was $8.2 million, or $(0.32) per share, compared with a net loss of $11.7 million, or $(0.47) per share,
in fiscal year 2023. The decrease in the net loss and resulting net loss per share was the result of decreased operating expenses
as discussed above. |
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 cannabis toxicity, including
ACI and unintentional cannabis poisoning. Selonabant is an orally bioavailable, readily absorbed treatment candidate that the Company
anticipates will rapidly reverse key symptoms of cannabis toxicity. Selonabant is also under development as an IV treatment for unintentional
cannabis poisoning. 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 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 unintentional cannabis intoxication. 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. Rather than proceeding directly with the 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 unintentional
cannabis poisoning, 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. 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 decision by the United States Department of Justice to support
the change in Drug Enforcement Agency scheduling of marijuana from a schedule I to a schedule III controlled substance; 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; providing a rapid and clinically impactful emergency treatment for acute cannabis-induced toxicities,
including cannabis-induced CNS depression in children; the NIDA grant providing further momentum for advancing the intravenous formulation
of selonabant towards clinical testing and validating the significant and growing unmet medical need for an emergency antidote to cannabis
toxicity. 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 SEC, 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.
CONTACTS:
Anebulo
Pharmaceuticals, Inc.
Daniel
George
Part
time Chief Financial Officer
(512)
598-0931
Dan@anebulo.com
Condensed
Balance Sheets
| |
June 30, | |
| |
2024 | | |
2023 | |
Cash and cash equivalents | |
$ | 3,094,200 | | |
$ | 11,247,403 | |
Total assets | |
| 4,073,114 | | |
| 11,670,151 | |
Total liabilities | |
| 260,583 | | |
| 1,068,801 | |
Total stockholders’ equity | |
| 3,812,531 | | |
| 10,601,350 | |
Condensed
Statements of Operations
| |
Three months ended June 30, | | |
Year ended June 30, | |
| |
2024 | | |
2023 | | |
2024 | | |
2023 | |
Research and development | |
$ | 467,706 | | |
$ | 1,417,159 | | |
$ | 3,548,937 | | |
$ | 5,600,197 | |
General and administrative | |
| 872,661 | | |
| 1,077,230 | | |
| 4,759,818 | | |
| 6,183,402 | |
Total operating expenses | |
| 1,340,367 | | |
| 2,494,389 | | |
| 8,308,755 | | |
| 11,783,599 | |
Loss from operations | |
| (1,340,367 | ) | |
| (2,494,389 | ) | |
| (8,308,755 | ) | |
| (11,783,599 | ) |
Other (income) expenses: | |
| | | |
| | | |
| | | |
| | |
Interest expense | |
| 59,696 | | |
| - | | |
| 151,230 | | |
| - | |
Interest income | |
| (50,218 | ) | |
| (6 | ) | |
| (249,022 | ) | |
| (92,407 | ) |
Other | |
| 124 | | |
| 1,197 | | |
| (9,260 | ) | |
| 41,146 | |
Total other (income) expenses, net | |
| 9,602 | | |
| 1,191 | | |
| (107,052 | ) | |
| (51,261 | ) |
Net loss | |
$ | (1,349,969 | ) | |
$ | (2,495,580 | ) | |
$ | (8,201,703 | ) | |
$ | (11,732,338 | ) |
Weighted average common shares outstanding, basic and diluted | |
| 25,933,217 | | |
| 25,633,217 | | |
| 25,822,258 | | |
| 25,074,481 | |
Net loss per share, basic and diluted | |
$ | (0.05 | ) | |
$ | (0.10 | ) | |
$ | (0.32 | ) | |
$ | (0.47 | ) |
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