Charlotte's Web Updates on DeFloria's Phase 1 Autism Trial Results

Promising Findings Presented at the American College of Neuropsychopharmacology Annual Meeting

Charlotte's Web Holdings, Inc., a renowned leader in the cannabidiol (CBD) hemp extract wellness market, has shared significant progress in botanical pharmaceutical development through its collaboration with DeFloria LLC. This venture, established by AJNA BioSciences and Charlotte's Web, recently presented encouraging Phase 1 clinical trial results for their investigational drug, AJA001, at the American College of Neuropsychopharmacology Annual Meeting.

AJA001 is being developed as a novel treatment for symptoms associated with autism spectrum disorder (ASD). The drug is a botanical oral solution that includes a multi-compound hemp extract with a full range of cannabinoids, aiming to bridge the gap between natural wellness products and federally regulated medications, which typically focus on single compounds. The promising Phase 1 trial results were presented by Dr. Marcel Bonn-Miller, highlighting the drug's safety, tolerability, and pharmacokinetic and pharmacodynamic properties across a broad dosage range. These findings are pivotal in determining appropriate dosing for imminent Phase 2 trials.

The development of AJA001 aligns strategically with Charlotte's Web's vision of utilizing its proprietary hemp genetics for innovative treatments targeting neglected health conditions such as ASD. The multi-cannabinoid composition of AJA001 exemplifies the potential of botanical drug development, offering a new category of solutions that demonstrate broad therapeutic efficacy.

Dr. Marcel Bonn-Miller, Chief Scientific Officer at Charlotte's Web and a board member of DeFloria, emphasized the importance of these findings in integrating botanical hemp-based therapies into mainstream pharmaceutical medicine. He noted that AJA001 is not just an isolated project but a continuation of Charlotte's Web's longstanding mission to address diverse health needs. The positive safety and pharmacokinetic data from this trial support AJA001's potential, especially in an area with limited treatment options, bringing the company closer to offering real solutions for the underserved ASD community.

Furthermore, Bill Morachnick, CEO of Charlotte's Web, remarked that the successful Phase 1 results validate the company's strategic vision of advancing botanical science through pharmaceutical channels. This milestone demonstrates the value that can be created through Charlotte's Web's proprietary genetics and hemp cultivation expertise, potentially opening new markets and revenue streams for shareholders.

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). Pending the FDA's approval, DeFloria plans to progress to Phase 2 clinical trials, which will investigate the therapeutic potential of AJA001 in addressing behavioral symptoms and enhancing the quality of life for individuals with ASD. Successful results in these trials could lead to broader access to this groundbreaking therapy.

Charlotte's Web continues to prioritize quality, transparency, and innovation, positioning itself to capitalize on emerging opportunities within regulated botanical drug markets. The developments with DeFloria are in line with the company's long-term strategy to enhance shareholder value through diversified growth initiatives.

DeFloria LLC, jointly established by Charlotte's Web, AJNA BioSciences, and British American Tobacco PLC, aims to address critical healthcare needs through innovative multi-compound drugs derived from natural sources. Their collective expertise in regulatory, research, and quality-controlled manufacturing supports their ambitious goal of securing FDA approval for a novel botanical drug developed from Charlotte's Web's proprietary hemp genetics, targeting neurological conditions identified by DeFloria's leadership and research teams.

Charlotte's Web Holdings, Inc., based in Louisville, Colorado, is a Certified B Corporation that leads in the market of innovative hemp extract wellness products, including full-spectrum CBD extracts and products certified for sport. Their offerings, which include CBD oil tinctures, gummies, capsules, creams, lotions, and pet products, are created using proprietary hemp genetics cultivated with organic practices. Charlotte's Web maintains strict quality control from soil to shelf, ensuring the consistency and efficacy of their products distributed across the U.S.A.