21:20:05 EST Fri 19 Dec 2025
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or Name
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Charlotte's Web Holdings Inc
Symbol CWEB
Shares Issued 159,420,141
Close 2025-12-19 C$ 0.285
Market Cap C$ 45,434,740
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Charlotte's DeFloria talks U.S. pot reclassification

2025-12-19 18:21 ET - News Release

Mr. Joel Stanley reports

PRESIDENTIAL EXECUTIVE ORDER VALIDATES DEFLORIA'S STRATEGY IN PHARMACEUTICAL CANNABINOID DRUG DEVELOPMENT

Charlotte's Web Holdings Inc.'s DeFloria Inc. has recognized 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 (U.S. Food and Drug Administration) 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-centred movement that began more than a decade ago with the Stanley Brothers and their founding of Charlotte's Web.

"Charlotte's Web ignited the era of cannabinoid medicine, and DeFloria is the next chapter, elevating that mission with scientific rigour 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 (cannabidiol) 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 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 (pharmacokinetics/pharmacodynamics) clinical trial, demonstrating safety and a well-tolerated dosing profile;
  • 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, financing and collaboration

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

  • Expanded federal research financing and reduced barriers for academic cannabinoid studies;
  • Increased collaboration with medical institutions on controlled trials;
  • 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, chief executive officer 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 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, 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, a certified B corporation headquartered in Louisville, Colo., 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 and exercise recovery), CBN (cannabinol) gummies, CBG (cannabigerol) gummies, hemp-derived THC (tetrahydrocannabinol) 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 health care practitioners throughout the United States and are available on-line through the company's website.

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