Anebulo Pharmaceuticals Announces Positive Regulatory Update for Selonabant in Acute Cannabis-Induced Toxicity in Children and Capital Raise
24 December 2024 - 1:15AM
Business Wire
Anebulo Pharmaceuticals, Inc. (Nasdaq: ANEB), a
clinical-stage biopharmaceutical company developing novel solutions
for people suffering from acute cannabinoid-induced toxicities (the
“Company” or “Anebulo”), today announced a positive regulatory
update and the close of a capital raise.
- In a Phase 2 proof-of-concept study, Anebulo enrolled 134 adult
subjects challenged with oral delta-9-tetrahydrocannabinoil
(“THC”), oral selonabant blocked or reversed key CNS effects of
THC, establishing the clinical path for intravenous selonabant for
a much-needed targeted therapy for rapidly reversing the serious
and life-threatening consequences of acute cannabis-induced
toxicity in children
- Anebulo met with FDA to discuss the development of intravenous
selonabant and the initial plan for clinical testing
- FDA acknowledged the unmet need for a treatment for children
exposed to cannabis toxicity, and proposed a close, ongoing
collaboration to efficiently advance the selonabant program for the
pediatric indication
- Anebulo plans to begin its Phase I SAD study of IV selonabant
in healthy adults in 1H25
- Anebulo entered into a definitive stock purchase agreement with
22NW, a company controlled by one of its directors, Nantahala
Capital and an additional existing investor for the issuance and
sale of 15.2 million shares of common stock for gross proceeds of
$15 million in a private placement offering priced at-the-market
under Nasdaq rules
- In exchange for purchasing $10 million of shares of common
stock in the private placement, Anebulo intends to modify the Loan
and Security Agreement (LSA) that was entered into with 22NW and
JFL Capital Management by reducing the maximum loan size to
approximately $3 million, which reduces the LSA to just under the
securitization threshold, and the removal of any
securitization
“We are grateful to have the continued support from current
investors. Having secured such meaningful financing without having
to issue stock at a discount to the market or include warrant
coverage is indicative of the confidence these highly respected
institutional investors have in the company’s future,” commented
Richie Cunningham, Chief Executive Officer of Anebulo.
Cunningham continued, “In 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. To validate this
market opportunity, we hired a top five pharmaceutical consulting
firm to complete a market assessment. This team of experts
evaluated and confirmed acute cannabis induced toxicity in children
as a viable commercial opportunity. In addition, based on an
incidence less than 200,000 cases per year we also believe this to
be a rare pediatric condition.”
The private placement is expected to close no later than
December 24th, subject to the satisfaction of customary closing
conditions. The private placement is being conducted in accordance
with applicable Nasdaq rules and was priced at $0.99 per share to
satisfy the “Minimum Price” requirement (as defined in the Nasdaq
rule).
In connection with the close of the private placement, the
Company will amend its LSA that was entered into in November 2023.
The LSA allowed the Company to borrow up to $10 million, and to
date, no funds have been borrowed. The amended loan agreement will
reduce the borrowing limit to approximately $3 million and will be
unsecured.
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 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:
plans to begin its Phase I SAD study of IV selonabant in healthy
adults in 1H25; plans to amend the LSA; the unmet need for a
treatment for children exposed to cannabis toxicity; the potential
for selonabant to offer a much-needed targeted therapy for rapidly
reversing the serious and life-threatening consequences of acute
cannabis-induced toxicity in children; acute cannabis induced
toxicity in children being a viable commercial market opportunity
and a rare pediatric condition; the closing of the private
placement on December 24, 2024; 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 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 close its private
placement as anticipated; pursue its regulatory strategy including;
commencement of the Phase 1 SAD study of IV selonabant in healthy
adults in 1H25, having acute cannabis induced toxicity in children
treated as a rare pediatric condition; 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.
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Anebulo Pharmaceuticals, Inc. Daniel George Part time Chief
Financial Officer (512) 598-0931 Dan@anebulo.com
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