DeFloria Advancing Charlotte's Web Legacy as Pioneer in Cannabinoid Health, with Phase 2 Clinical Trials for Autism Botanical Drug

LOUISVILLE, Colo. and WASHINGTON, Dec. 19, 2025 /PRNewswire/ - DeFloria Inc., a botanical drug development Company recognizes the Presidential Executive Order to reclassify cannabis from Schedule I to Schedule III, as a critical accelerator for cannabinoid medical innovation and regulatory reform. DeFloria is advancing a leading cannabinoid-based investigational new drug ("IND") through the FDA botanical drug pathway for autism-related irritability (AJA001 oral solution). The Executive Order represents pivotal federal acknowledgment of the therapeutic value of cannabinoids and validates a patient-centered movement that began more than a decade ago with the Stanley Brothers and their founding of Charlotte's Web (TSX: CWEB) (OTCQB: CWBHF).

"Charlotte's Web ignited the era of cannabinoid medicine, and DeFloria is the next chapter, elevating that mission with scientific rigor and FDA pathways," said Joel Stanley, Co-Founder of Charlotte's Web and Chair of the DeFloria Board. "Federal policy is finally catching up to what patients, academics, and clinicians have long understood: cannabinoids hold real therapeutic power. DeFloria exists to transform that promise into approved medicines that change lives."

Born from the founders of Charlotte's Web - the market leading brand that defined CBD and reshaped the national dialogue - DeFloria is leveraging years of real-world medicinal benefits and patient experience that sparked the early momentum that led to this moment. Building on legacy and data, DeFloria is driving an entirely new category of FDA-regulated botanical drug development.

Founders' Long-Standing Vision Gains Historic Federal Level Validation

Years before federal policy shifted, DeFloria's founders recognized the unmet medical need for autism spectrum disorder and the gap in the pharmaceutical market that the broad therapeutic cannabinoid-based formulations could potentially fill. They invested early in standardized pharmaceutical manufacturing, controlled dosing, and FDA-regulated science to pursue a botanical IND drug development pathway aligned with real clinical evidence.

DeFloria's early commitment now positions the Company years ahead of the industry as national policy aligns with the scientific path it has championed from the start.

DeFloria Is the Most Advanced Cannabinoid Drug Program Utilizing the FDA's Botanical Drug Pathway

As the federal government formally acknowledges accepted medical use for cannabinoids, DeFloria stands uniquely positioned with significant clinical and regulatory milestones already achieved:

• A cleared botancial IND application and "Study May Proceed" letter from the FDA;
• Completion of a Phase 1 PK/PD clinical trial, demonstrating safety and a well-tolerated dosing profile; and
• FDA authorization to initiate a Phase 2 clinical program evaluating AJA001 for irritability associated with autism.

These achievements now establish DeFloria at the forefront of developing an FDA-approved botanical cannabinoid drug.

A New Era of Research, Funding, and Collaboration

The shift to Schedule III is expected to unlock significant new opportunities across research, academia, and capital markets, including:

• Expanded federal research funding and reduced barriers for academic cannabinoid studies;
• Increased collaboration with medical institutions on controlled trials; and
• Greater institutional investment as regulatory and compliance risk decreases.

DeFloria, with its Phase 2-ready program and pharmaceutical-grade botanical formulation, is positioned to leverage this surge in momentum and interest.

Built for Next-Level Pharma Partnerships

Rescheduling reduces long-standing barriers for pharmaceutical companies evaluating cannabinoid-based drug candidates. DeFloria's standardized botanical composition, robust safety data, and advanced clinical status make it one of the most partnership-ready platforms in the emerging cannabinoid drug sector.

"This policy shift opens the door to an entirely new level of potential investment, partnership, and scientific collaboration," said Jared Stanley, CEO of DeFloria. "DeFloria is initiating the Phase 2 clinical program at exactly the right moment - as federal recognition of cannabinoid medicine can unlock capital inflows and strategic interest across the biopharmaceutical industry. This momentum strengthens our path toward an FDA-approved therapeutic and supports our mission to bring AJA001 to the patients and families who need it."

About DeFloria, Inc.
DeFloria, Inc. is an FDA 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, OTCQB: 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.

About Charlotte's Web Holdings, Inc.
Charlotte's Web Holdings, Inc., a Certified B Corporation headquartered in Louisville, Colorado, is a botanical wellness innovation company and market leader in hemp extract wellness. The Company's product categories include CBD oil tinctures (liquid products), CBD gummies (sleep, calming, exercise recovery), CBN gummies, CBG gummies, hemp-derived THC microdose gummies, functional mushroom gummies, CBD soft gels, 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 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.

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 changes; anticipated product development and sales; 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.

View original content to download multimedia:https://www.prnewswire.com/news-releases/presidential-executive-order-validates-deflorias-strategy-in-pharmaceutical-cannabinoid-drug-development-302647076.html

SOURCE Charlotte's Web Holdings, Inc.