Charlotte's Web Holdings, Inc.

Phase 2 Clinical Program Update

DeFloria has been actively preparing for entry into its Phase 2 clinical program, with key elements including clinical site selection, protocol optimization, and manufacturing readiness now substantially advanced. Building on the favorable safety and pharmacokinetic data from Phase 1, which established the dosing parameters for Phase 2 evaluation, the Company expects to initiate its Phase 2 trial in mid-2026, subject to the completion of customary development activities and the alignment of required resources.

Phase 2 represents a pivotal milestone for AJA001, designed to evaluate safety, tolerability, and early signals of therapeutic effectiveness in adolescents and adults with ASD. Drawing on Charlotte’s Web’s extensive real-world experience within the ASD community and the consistency of outcomes observed with similar cannabinoid profiles, the Company is optimistic about AJA001’s potential to address irritability associated with ASD—an area with significant unmet need and limited well-tolerated treatment options.

“Our partnership with Ajna and BAT through DeFloria demonstrates our leadership in advancing hemp-derived compounds from consumer wellness into FDA-regulated pharmaceutical development, and it reflects the same commitment to science-backed innovation that drives our core business,” said Mr. Morachnick.