AJNA BioSciences and Charlotte's Web to Spotlight Cannabis' Pharmaceutical Future at Benzinga Cannabis Capital Conference Featuring DeFloria

Rhea-AI Summary

DeFloria, in collaboration with AJNA BioSciences and Charlotte's Web (CWBHF), will participate in a key panel at the Benzinga Cannabis Capital Conference on June 9th, 2025, focusing on cannabis' transition from recreational to pharmaceutical applications. The panel, featuring industry leaders including Joel Stanley and Dr. Orrin Devinsky, will discuss DeFloria's groundbreaking AJA001 oral solution for autism spectrum disorder (ASD), which has received FDA clearance for Phase 2 clinical trials. The discussion will highlight the projected $1 trillion pharmaceutical cannabis market, DeFloria's first-mover advantage in botanical drug development, and their strategic positioning with Charlotte's Web's infrastructure. The company's AJA001 represents a paradigm shift by utilizing a multi-compound botanical approach rather than traditional single-molecule drugs, targeting a $50 billion global ASD therapeutic market.

Industry Leaders to Discuss the Transformative Shift from Recreational Cannabis to Pharmaceutical Applications

LITTLETON, Colo. and CHICAGO, June 3, 2025 /PRNewswire/ -- DeFloria, Inc., the botanical-drug developer advancing the first of its kind AJA001 oral solution for autism spectrum disorder (ASD), today announced it will be featured in a high-profile investor panel at the Benzinga Cannabis Capital Conference in Chicago on June 9th. Presented by AJNA BioSciences and Charlotte's Web (TSX: CWEB) (OTCQX: CWBHF), the session, "Evolving from Dispensaries to Pharmacies: Investing in the Future of Cannabis," will examine the multi-billion-dollar inflection point as cannabis investment migrates from the retail shelf to the prescription pad.

Global market forecasts project a dramatic shift from today's recreational-dominated market to a trillion-dollar pharmaceutical-centric future within the next decade¹. This shift represents the next major investment wave in cannabis, driven by regulatory oversight, clinical validation, and patient demand for FDA-approved therapeutic cannabinoid options free from the legal and scheduling hurdles of the recreational market. DeFloria stands at the forefront of this transformation, having achieved a historic milestone as the developer of the first orally administered botanical drug to receive FDA clearance for Phase 2 clinical trials.

"We are witnessing the evolution of cannabis from a fragmented recreational market to a sophisticated pharmaceutical sector," said Joel Stanley, CEO of AJNA BioSciences and founding CEO of Charlotte's Web. "DeFloria represents the vanguard of this transformation, leveraging decades of full spectrum cannabis sativa L. production expertise to develop targeted treatments for underserved conditions. These solutions are built for regulatory clarity, insurance accessibility, and scalable distribution through established healthcare systems."

The panel will feature four industry leaders who have collectively shaped the modern cannabis landscape:

• Joel Stanley – CEO, AJNA BioSciences; Founding CEO, Charlotte's Web
  Leader of AJNA's neuro-psychiatric pipeline, Mr. Stanley oversees the AJA001 clinical program and pharma-grade manufacturing built on a decade of proprietary hemp genetics.
  
  
• Jared Stanley – CEO, DeFloria; Co-Founder, Charlotte's Web
  Extensive expertise in cannabis operations and pharmaceutical-grade manufacturing. His instrumental role in developing the patented hemp genetics that served as the foundation for DeFloria's research and development has positioned the company years ahead of potential competitors.
  
  
• Dr. Orrin Devinsky – Chief Medical Advisor, AJNA BioSciences
  Principal architect of cannabis-based pharmaceutical development. As the lead investigator for Epidiolex™—the first FDA-approved cannabis-derived drug developed by GW Pharmaceuticals and acquired by Jazz Pharmaceuticals for $7.2 billion—Dr. Devinsky has established the regulatory pathway that DeFloria now follows.
  
  
• Dr. Marcel Bonn-Miller – Chief Scientific Officer, Charlotte's Web; Board Member, DeFloria
  Contributes more than 20 years of cannabinoid research experience, with 150+ publications and three patents related to CBD's therapeutic applications. His guidance of U.S. Congress on CBD safety studies underscores his authority in translating botanical science into regulatory frameworks.

Moderator: Kelly D. Fair, Partner, Dentons LLP – Former U.S. General Counsel, Canopy Growth, specializing in cannabis policy and FDA-regulated pathways.

Panel Focus
The panel discussion will address the compelling investment thesis underlying botanical pharmaceuticals, highlighting why sophisticated investors are positioning for the sector's explosive growth. The discussion will detail:

• The $1 trillion global forecasted market¹ as pharmaceutical applications eclipse recreational sales over the next decade;
• Mechanistic advantages of multi-compound ("entourage") formulations versus single-molecule synthetics;
• Manufacturing and CMC hurdles unique to botanical drugs—and how DeFloria's cGMP infrastructure provides a multi-year head start;
• Unmet clinical need in ASD where only two FDA-approved treatments exist, both associated with significant metabolic risk;
• Capital efficiency of the FDA's Botanical Drug Pathway and why first movers are positioned for outsized returns.

DeFloria's first-mover advantage in botanical drug development, combined with its advanced clinical progress and manufacturing capabilities, positions the company to capture a significant market share. The company's initial focus on autism spectrum disorder enables the company to serve a vast, overlooked patient population while tapping into a high-growth therapeutic market projected at $50 billion globally. 

DeFloria's AJA001 oral solution represents a paradigm shift in pharmaceutical development, utilizing a multi-compound botanical approach rather than traditional single-molecule synthetic drugs, opening the door for multi-indications for commercialization. This full-spectrum formulation leverages the entourage effect, where multiple cannabinoids work synergistically to enhance therapeutic efficacy while minimizing side effects.

Dr. Bonn-Miller emphasized the scientific rationale: "Multi-compound botanical formulations harness the full therapeutic potential of the cannabis plant, delivering enhanced efficacy through synergistic mechanisms that single-compound drugs cannot replicate. This approach also opens pathways to multiple indications not typically available from a single-compound drug platform."

DeFloria Progress
DeFloria's lead candidate AJA001 oral solution is the first systemically absorbed, full-spectrum hemp drug to receive FDA clearance to enter Phase 2 clinical trials in adolescents and adults with ASD, planned to begin later this year. Phase 1 data demonstrated safety, tolerability and predictable pharmacokinetics, establishing dose rationale for the next stage.

By leveraging Charlotte's Web's patented hemp cultivars and decade-long, pharma-grade cGMP extraction platform—capabilities unavailable to most early-stage biotech companies—DeFloria can scale drug-quality material under existing U.S.-based manufacturing agreements. Charlotte's Web currently owns approximately one-third of DeFloria and holds exclusive commercial supply rights should AJA001 reach market approval.

Conference Details and Attendance
The Benzinga Cannabis Capital Conference brings together leading investors, entrepreneurs, and industry experts to explore emerging opportunities in the evolving cannabis landscape. DeFloria's panel on June 9th at 3:15 PM ET will provide attendees with exclusive insights into the botanical pharmaceutical opportunity and the company's strategic positioning for growth. Company executives will be available for one-on-one meetings with attendees during the event.

For attendance information and conference details, interested parties may contact IR@defloria.bio or visit the  Benzinga Cannabis Capital Conference website.

About Charlotte's Web Holdings, Inc.
Charlotte's Web Holdings, Inc. (TSX: CWEB) (OTCQX: CWBHF), a Certified B Corporation headquartered in Louisville, Colorado, is a botanical wellness innovation company and a market leader in hemp extract wellness that includes Charlotte's Web whole-plant full-spectrum CBD extracts as well as broad-spectrum CBD and cannabinoid isolates.  The Company's hemp extracts have naturally occurring botanical compounds including cannabidiol ("CBD"), CBN, CBC, CBG, THC, 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, hemp-derived THC microdose gummies, functional mushroom 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 are available online through the Company's website at www.charlottesweb.com.

About DeFloria, Inc.
DeFloria is a Phase 2 clinical-stage botanical pharmaceutical company developing AJA001 oral solution for irritability associated with autism spectrum disorder. Formed in 2023 by AJNA BioSciences PBC and Charlotte's Web Holdings, Inc. (TSX: CWEB, OTCQX: CWBHF) with a subsidiary of British American Tobacco plc as lead investor, DeFloria harnesses proprietary full-spectrum hemp genetics, FDA-compliant manufacturing, and deep cannabinoid science to deliver safe, effective and accessible therapies through the FDA Botanical Drug Pathway.

(1)   Autism Spectrum Disorder Treatment Market Size Report, 2032. Report ID: GMI11087, Aug 2024, and https://www.precedenceresearch.com/cannabis-pharmaceuticals-market

Forward-Looking Statements
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, expected future development, and other factors that it believes are appropriate and reasonable. This press release includes forward-looking statements including: the future performance or achievements of DeFloria, Inc., future dose trial results, therapeutic efficacy, or approvals of AJA001 oral solution the results of which may be materially different from those expressed or implied by the forward-looking statements contained in this press release.

The material factors and assumptions used to develop the forward-looking statements herein include, but are not limited to: regulatory regime changes; anticipated product development and sales; the success of sales and marketing activities; product development and production expectations; outcomes from R&D activities; the Company's ability to deal with adverse growing conditions in a timely and cost-effective manner; the availability of qualified and cost-effective human resources; compliance with contractual and regulatory obligations and requirements; availability of adequate liquidity and capital to support operations and business plans; and expectations around consumer product demand. In addition, the forward-looking statements are subject to risks and uncertainties pertaining to, among other things: supply and distribution chains; the market for the Company's products; revenue fluctuations; regulatory changes; loss of customers and retail partners; retention and availability of talent; competing products; share price volatility; loss of proprietary information; product acceptance; internet and system infrastructure functionality; information technology security; available capital to fund operations and business plans; crop risk; economic and political considerations; 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, 2024, 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 at 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.

Investor & Media Contacts:

DeFloria Investor Relations – IR@defloria.bio
Charlotte's Web Investor Relations – IR@charlottesweb.com 

Tiberend Strategic Advisors, Inc.
Jonathan Nugent (investors)
205-566-3026
jnugent@tiberend.com

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SOURCE DeFloria, LLC

FAQ

What is the focus of DeFloria's presentation at the 2025 Benzinga Cannabis Capital Conference?

DeFloria will participate in a panel discussing the transformation of cannabis from recreational to pharmaceutical applications, highlighting their AJA001 oral solution for autism spectrum disorder and the projected $1 trillion pharmaceutical cannabis market.

What is DeFloria's AJA001 and what stage of development is it in?

AJA001 is the first systemically absorbed, full-spectrum hemp drug for autism spectrum disorder that has received FDA clearance to enter Phase 2 clinical trials, with Phase 1 showing safety, tolerability, and predictable pharmacokinetics.

What is Charlotte's Web's (CWBHF) relationship with DeFloria?

Charlotte's Web owns approximately one-third of DeFloria and holds exclusive commercial supply rights for AJA001, providing patented hemp cultivars and pharma-grade cGMP extraction platform for drug manufacturing.

Who are the key speakers at the DeFloria cannabis panel?

The panel features Joel Stanley (AJNA BioSciences CEO), Jared Stanley (DeFloria CEO), Dr. Orrin Devinsky (AJNA Chief Medical Advisor), Dr. Marcel Bonn-Miller (Charlotte's Web CSO), and moderator Kelly D. Fair from Dentons LLP.

What is the market potential for DeFloria's autism spectrum disorder treatment?

The global therapeutic market for autism spectrum disorder treatments is projected at $50 billion, with only two FDA-approved treatments currently available.