Promising Findings Presented at the American
College of Neuropsychopharmacology Annual Meeting
LOUISVILLE, Colo., Dec. 12,
2024 /PRNewswire/ - (TSX: CWEB) (OTCQX: CWBHF)
Charlotte's Web Holdings, Inc. ("Charlotte's Web" or the "Company")
the market leader in cannabidiol (CBD) hemp extract wellness
products, is pleased to share an update on the progress of DeFloria
LLC's ("DeFloria") botanical pharmaceutical development, an entity
established by AJNA BioSciences and Charlotte's Web. Promising
findings from DeFloria's Phase 1 clinical trial results for AJA001
were presented by Dr. Marcel
Bonn-Miller at the American College of
Neuropsychopharmacology Annual Meeting on December 11, 2024. AJA001 is being developed for
the treatment of symptoms of autism spectrum disorder (ASD).
About AJA001 Oral Solution
AJA001 Oral Solution is being developed by DeFloria as an
innovative new botanical drug containing a multi-compound hemp
extract with a full spectrum of cannabinoids, bridging the gap
between natural wellness products and FDA-regulated medicines that
are generally single-compound drugs. Leveraging a proprietary
hemp cultivar patented by Charlotte's Web, the Phase 1 trial,
designed to evaluate the safety, tolerability, pharmacokinetics,
and pharmacodynamics of AJA001, demonstrated that the
investigational drug was well-tolerated across a wide dose range.
The study provides critical data for determining appropriate dosing
protocols that will be used in Phase 2 trials.
Strategic Alignment with Charlotte's Web's Vision
As a co-founder of DeFloria, Charlotte's Web is proud to see its
proprietary hemp genetics being utilized to advance innovative
therapies for underserved health conditions, such as ASD. The
multi-cannabinoid composition of AJA001 underscores the potential
of botanical drug development, paving a new category of solutions
that provide broad therapeutic efficacy.
"DeFloria's Phase 1 findings represent a significant step toward
integrating botanical hemp-based therapies into modern
pharmaceutical medicine," said Dr. Marcel
Bonn-Miller, Chief Scientific Officer at Charlotte's Web and
DeFloria Board Member. "AJA001 isn't just a standalone initiative;
it continues Charlotte's Web's long-standing mission grounded in
addressing the diverse needs of individuals and families. The
safety and pharmacokinetic data from this trial affirm AJA001's
potential particularly in a space with limited treatment options.
These positive Phase 1 results bring us closer to creating real
solutions for this underserved community."
Expanding Charlotte's Web's Leadership in Botanical
Science
"DeFloria's Phase 1 results validate our strategic vision of
advancing botanical science through pharmaceutical pathways," said
Bill Morachnick, CEO of Charlotte's
Web. "This milestone demonstrates how our proprietary genetics and
expertise in hemp cultivation can create significant value beyond
our core wellness business, potentially opening new markets and
revenue opportunities for our shareholders."
Clinical and Commercial Opportunities
DeFloria is preparing to submit the Phase 1 trial data as part
of its Investigational New Drug (IND) application to the U.S. Food
and Drug Administration (FDA) for review. If the FDA raises no
objections, DeFloria plans to advance to Phase 2 clinical
trials.
DeFloria's planned Phase 2 trials in ASD will explore the
therapeutic potential of AJA001 in addressing behavioral symptoms
and improving quality of life for individuals with the condition.
These trials represent a significant step toward potential FDA
approval, which would pave the way for broader access to this
groundbreaking therapy.
Charlotte's Web continues to prioritize its focus on quality,
transparency, and innovation, positioning itself to capitalize on
emerging opportunities in regulated botanical drug markets. The
progress with DeFloria aligns with the Company's long-term strategy
to enhance shareholder value through diversified growth
initiatives.
About DeFloria
DeFloria LLC, a collaboration between
Charlotte's Web, Inc., AJNA BioSciences PBC, and British American
Tobacco PLC (BAT), is on a mission to address crucial healthcare
needs through groundbreaking innovations from multi-compound drugs
originating in nature. With a combined century of experience in
regulatory, research, and quality-controlled standardized
manufacturing, DeFloria's ambitious endeavor aims to secure FDA
approval for a novel cutting-edge botanical drug developed from
Charlotte's Web proprietary hemp genetics that targets a
neurological condition identified by the DeFloria leadership and
research teams.
About Charlotte's Web Holdings, Inc.
Charlotte's Web Holdings, Inc., a Certified B Corporation
headquartered in Louisville,
Colorado, is the market leader in innovative hemp extract
wellness products that include Charlotte's Web whole-plant
full-spectrum CBD extracts as well as broad-spectrum CBD certified
NSF for Sport®. Charlotte's Web is the official CBD of Major League
Baseball©. Charlotte's Web branded premium quality products start
with proprietary hemp genetics that are North American farm-grown
using organic and regenerative cultivation practices. The Company's
hemp extracts have naturally occurring botanical compounds
including cannabidiol ("CBD"), CBN, CBC, CBG, terpenes, flavonoids,
and other beneficial compounds. Charlotte's Web product categories
include CBD oil tinctures (liquid products), CBD gummies (sleep,
calming, exercise recovery, immunity), CBN gummies, CBD capsules,
CBD topical creams, and lotions, as well as CBD pet products for
dogs. Through its substantially vertically integrated business
model, Charlotte's Web maintains stringent control over product
quality and consistency with analytic testing from soil to shelf
for quality assurance. Charlotte's Web products are distributed to
retailers and healthcare practitioners throughout the U.S.A. and online through the Company's
website at www.charlottesweb.com.
© Major League Baseball trademarks and copyrights are used
with permission of Major League Baseball. Visit MLB.com.
Forward-Looking Information
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forward-looking statements or information (collectively,
"forward-looking statements") within the meaning of applicable
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outcomes or statements regarding an outlook. Forward-looking
statements are not guarantees of future performance and readers are
cautioned against placing undue reliance on forward-looking
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statements. By their nature, these statements involve a
variety of assumptions, known and unknown risks and uncertainties,
and other factors which may cause actual results, levels of
activity, and achievements to differ materially from those
expressed or implied by such statements. The forward-looking
statements contained in this press release are based on certain
assumptions and analysis by management of the Company in light of
its experience and perception of historical trends, current
conditions and expected future development and other factors that
it believes are appropriate and reasonable.
The material factors and assumptions used to develop the
forward-looking statements herein include material risk factors
that could cause actual results to differ materially from the
forward-looking statements including, among others, general
economic and market risks, cyber-security risks and those risks and
uncertainties discussed under the heading "Risk Factors" in the
Company's Annual Report on Form 10-K for the year ending
December 31, 2023, and other risk
factors contained in other filings with the Securities and Exchange
Commission available on www.sec.gov and filings with Canadian
securities regulatory authorities available on www.sedarplus.ca.
The impact of any one risk, uncertainty, or factor on a particular
forward-looking statement is not determinable with certainty as
these are interdependent, and the Company's future course of action
depends on management's assessment of all information available at
the relevant time.
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only on information currently available to the Company and speaks
only as of the date on which it is made. Except as required by
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information, future events, or otherwise. All forward-looking
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persons acting on the Company's behalf, are expressly qualified in
their entirety by these cautionary statements.
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SOURCE Charlotte's Web Holdings, Inc.
