Anebulo Pharmaceuticals Reports Fourth Quarter and Fiscal Year 2023 Financial Results and Recent Updates
20 September 2023 - 10:29PM
Business Wire
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 and twelve months ended June 30,
2023, and recent updates.
Fourth Quarter Fiscal Year 2023 and Subsequent
Highlights:
- Positive feedback from the Type B meeting with the FDA supports
advancing ANEB-001 to registrational studies.
- Dosing completed in Part C open-label extension of Phase 2
study evaluating up to a 60 mg challenge of THC with ANEB-001 given
simultaneously in healthy volunteers. Data readout anticipated in
Q4 2023.
- Observational PK study in patients reporting to the emergency
department with ACI is ongoing.
- The Company will present at the following scientific
conferences:
- North American Congress on Clinical Toxicology in Montreal,
Quebec: Oral Presentation on September 29 from 1 p.m. to 3 p.m.
ET.
- American Congress of Emergency Physicians in Philadelphia, PA:
Poster presentation on October 9 at 10:30 a.m. ET and oral
presentation on October 10, 2023, at 3:30 p.m. ET.
Management Commentary
“I am grateful for our team’s hard work and diligence in
transitioning Anebulo to a Phase 3-ready company, a very important
step in our mission to make ANEB-001 available to individuals who
present at emergency departments with cannabinoid intoxication,”
commented Simon Allen, Chief Executive Officer of Anebulo. “We
believe ANEB-001 can significantly reduce the treatment time of ACI
patients by several hours while providing superior patient
outcomes. We are targeting to initiate Phase 3 registrational
studies in the first half of 2024.”
Financial Results for the three months ended June 30,
2023
- Operating expenses in the fourth quarter of fiscal 2023 were
$2.5 million compared with $2.3 million in the same period in
fiscal 2022.
- Net loss in the fourth quarter of fiscal 2023 was $2.5 million,
or $(0.10) per share, compared with a net loss of $2.3 million, or
$(0.10) per share, in the fourth quarter of fiscal 2022.
- Cash was $11.2 million as of June 30, 2023.
Financial Results for the twelve months ended June 30,
2023
- Operating expenses in fiscal year 2023 were $11.8 million
compared with $6.8 million in the same period in fiscal 2022.
Research and Development increased approximately $2.6 million over
the prior year period, primarily due to increased pre-clinical and
clinical studies, and direct third-party costs, in the support of
ANEB-001. General and Administrative expenses increased
approximately $2.3 million over the prior year period, primarily
due to compensation and related benefits, and professional and
consultant fees, including legal and accounting fees.
- Net loss in fiscal year 2023 was $11.7 million, or $(0.47) per
share, compared with a net loss of $6.8 million, or $(0.29) per
share, in fiscal year 2022. The increase in the net loss was the
result of higher operating expenses in fiscal year 2023, as
explained above.
About Anebulo Pharmaceuticals, Inc.
Anebulo Pharmaceuticals, Inc. is a clinical-stage
biopharmaceutical company developing novel solutions for people
suffering from acute cannabinoid intoxication and substance abuse
disorder. Its lead product candidate, ANEB-001, 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. ANEB-001 is a competitive antagonist at
the human cannabinoid receptor type 1 (CB1). For further
information about Anebulo, please visit www.anebulo.com.
About ANEB-001
Our lead product candidate is ANEB-001, a potent, small molecule
cannabinoid receptor antagonist, under development to address the
unmet medical need for a specific antidote for ACI. ANEB-001 is an
orally bioavailable, readily absorbed treatment candidate that we
anticipate will rapidly reverse key symptoms of ACI. ANEB-001 is
protected by one issued patent and rights to one patent application
covering various methods of use of the compound and delivery
systems. We are targeting initiation of Phase 3 registrational
studies of ANEB-001 in the first half of 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.
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:
the potential for a single well-controlled study of ANEB-001 in ACI
patients presenting to the emergency department combined with a
larger THC challenge study in volunteers to provide substantial
evidence to support a new drug application; Anebulo’s intention to
file patent applications in the US and foreign jurisdictions to
further cover ANEB-001; the expected data read out in Q4 2023 for
Anebulo’s open-label Part C extension of its Phase 2 clinical
trial; intent to commence phase 3 registrational trials in the
first half of 2024; Anebulo’s intention to participate in and
present at certain conferences; the potential for ANEB-001 to
address an unmet medical need for a specific antidote for ACI; and
Anebulo's expectation that ANEB-001 will rapidly reverse key
symptoms of ACI. 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 Type B
feedback should not be relied on as an indication that ANEB-001
will ultimately be approved; the timing and success of clinical
trials and potential safety and other complications thereof; 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 March 31, 2023,
as filed with the SEC on May 11, 2023. 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
June 30,
2023
2022
Cash
$
11,247,403
$
14,548,471
Total assets
11,670,151
15,579,431
Total liabilities
1,068,801
512,531
Total stockholders’ equity
10,601,350
15,066,900
Condensed Statements of
Operations
Three months ended June
30,
Year ended June 30,
2023
2022
2023
2022
Research and development
$
1,417,159
$
1,118,141
$
5,600,197
$
2,961,538
General and administrative
1,077,230
1,207,343
6,183,402
3,869,636
Total operating expenses
2,494,389
2,325,484
11,783,599
6,831,174
Loss from operations
(2,494,389
)
(2,325,484
)
(11,783,599
)
(6,831,174
)
Other (income) expenses
Interest income
(6
)
(1,929
)
(92,407
)
(7,332
)
Other
1,197
(813
)
41,146
1,777
Total other (income) expenses, net
1,191
(2,742
)
(51,261
)
(5,555
)
Net loss
$
(2,495,580
)
$
(2,322,742
)
$
(11,732,338
)
$
(6,825,619
))
Weighted average common shares
outstanding, basic and diluted
25,633,217
23,344,567
25,074,481
23,344,567
Net loss per share, basic and diluted
$
(0.10
)
$
(0.10
)
$
(0.47
)
$
(0.29
)
View source
version on businesswire.com: https://www.businesswire.com/news/home/20230920248131/en/
Media Contact Ignacio Guerrero-Ros, Ph.D. Russo Partners (646)
942-5604 ignacio.guerrero-ros@russopartnersllc.com
Investor Relations Adanna Alexander, Ph.D. or Harrison Seidner,
Ph.D. (646) 942-5603 (646) 942-5599 Adanna@russopr.com
Harrison.seidner@russopartnersllc.com
Anebulo Pharmaceuticals, Inc. Sandra Gardiner Acting Chief
Financial Officer (512) 598-0931 Sandra@anebulo.com
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