• Phase 1 Results to Inform Phase 2 studies in 1H24

DENVER, Dec. 13, 2023 /CNW/ - (TSX: CWEB) (OTCQX: CWBHF), Charlotte's Web Holdings, Inc. ("Charlotte's Web," "CW" or the "Company"), the market leader in full-spectrum hemp extract wellness products, and AJNA BioSciences PBC ("AJNA"), a botanical drug development company focused on mental health and neurological disorders, announced today that DeFloria LLC ("DeFloria") commenced its First-in-Human Phase 1 clinical trial for AJA001, a full-spectrum botanical drug.

Dr. Orrin Devinsky Ph.D., the Chief Medical Advisor at AJNA Biosciences stated, "Our phase 1 entrance marks a critical milestone in AJA001's clinical timeline and advances a full-spectrum cannabinoid formulation into rigorous clinical trials that are essential to advance medical science. We are proud of our team's hard work reach this point, and I am excited to help develop the Phase 2 program for this new drug." 

AJA001's initial research is dedicated to the examination of the safety, tolerability, pharmacokinetics, and pharmacodynamics in fasted and fed healthy participants of a full spectrum hemp oil extracted from one of Charlotte's Web's patented hemp cultivars ("AJA-001"). The study includes single ascending dose and a seven-day multiple ascending dose administration phases. The study is expected to involve around 64 participants. The first cohort was dosed in early September and Defloria expects preliminary results in the first quarter of 2024. The study is being conducted with Nucleus Networks in Brisbane, Australia.

"The initiation of the AJA001 clinical program serves as an important milestone for DeFloria. Data from this study will help us better understand the safety profile of AJA001 and position us to move into Phase 2 studies with greater dosing accuracy," remarked Dr. Marcel Bonn-Miller Ph.D., Chief Scientific Officer at Charlotte's Web.

AJA001, an investigational full-spectrum cannabinoid drug, leverages Charlotte's Web's proprietary hemp genetics. As an innovative multi-cannabinoid formulation, it may provide a more complete therapeutic action relative to single-molecule alternatives. Its full-spectrum composition has potential therapeutic applications across various medical conditions due to its varied mechanisms of action. 

"This achievement shows the commitment and excellence of our top-tier team. At DeFloria, we have united the early leaders in CBD with the finest minds in clinical and biotechnological research. This milestone is a big one for early adopters in botanical drug development, and especially for those of us that have known cannabinoid therapies would become very important in modern medicine. As we approach Phase 2 efficacy trials in the new year, DeFloria is establishing itself as a key player and leader in the new field of botanical drugs," noted Joel Stanley, Co-Founder of AJNA BioSciences."

Following completion of this Phase 1 study, DeFloria plans to submit an Investigational New Drug (IND) application to the Food and Drug Administration (FDA) to commence the Phase 2 clinical program for AJA001. AJA001 is being developed through the FDA's botanical drug pathway, which serves as a specialized regulatory framework, streamlining the development and approval of pharmaceutical products derived from plants or plant-based substances, acknowledging their unique properties. This approach aims to strike a balance between harnessing existing knowledge about botanicals and ensuring that these products adhere to the same stringent quality, safety, and efficacy standards as conventional pharmaceuticals.

About DeFloria LLC
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. Visit www.defloria.bio

About AJNA BioSciences PBC
AJNA BioSciences PBC is a botanical drug development company based in Denver, Colorado, focused on natural pharmaceuticals that address mental health and neurological disorders. The Company's strategy encompasses selecting plant and fungi species with a well-established history of therapeutic use, which streamlines drug discovery, mitigates late-stage clinical trial risk, to advance unprecedented medicinal breakthroughs. AJNA's unique platform is designed for rapid development of investigational new drugs by combining specialized laboratory infrastructure and CMC capabilities with top-tier clinical and regulatory expertise. AJNA's commercialization strategy is flexibly designed for co-development partnerships, IP licensing, and vertically integrated drug products in a broad range of botanical species and clinical indications. As a public benefit corporation, AJNA's business model maximizes profitability and sustainability for both people and the planet. Visit www.AjnaBiosciences.com

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 under a family of brands that includes Charlotte's Web™, ReCreate™, CBD Medic™, and CBD Clinic™. Charlotte's Web whole-plant CBD extracts come in full-spectrum and broad-spectrum options, including ReCreate™ by Charlotte's Web, broad-spectrum CBD certified NSF for Sport^®. ReCreate is the official CBD of Major League Baseball©, Angel City Football Club and the Premier Lacrosse League. 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"), 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), 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 health care 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

Certain information provided herein constitutes forward-looking statements or information (collectively, "forward-looking statements") within the meaning of applicable securities laws. Forward-looking statements are typically identified by words such as "may", "will", "should", "could", "anticipate", "expect", "project", "estimate", "forecast", "plan", "intend", "target", "believe" and similar words suggesting future 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 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. Specifically, this news release contains forward-looking statements relating to, among others, the ability of DeFloria to achieve its purpose, including obtaining FDA approval of a new CBD-based botanical drug.

The material factors and assumptions used to develop the forward-looking statements herein include, but are not limited to: regulatory regime change and including but not limited to 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, 2022 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.

Any forward-looking statement in this press release is based only on information currently available to the Company and speaks only as of the date on which it is made. Except as required by applicable law, the Company assumes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events, or otherwise. All forward-looking statements, whether written or oral, attributable to the Company or persons acting on the Company's behalf, are expressly qualified in their entirety by these cautionary statements.