Charlotte's Web Provides Update on DeFloria's Phase 1 Results Targeting Autism Spectrum Disorder

Promising Findings Presented at the American College of Neuropsychopharmacology Annual Meeting

LOUISVILLE, Colo., Dec. 12, 2024  /CNW/ - (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.

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Forward-Looking Information

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SOURCE Charlotte's Web Holdings, Inc.

For more information: Cory Pala | Director of Investor Relations, [phone], [email protected]