• Avecho successfully completes recruitment of ~210-patient interim analysis cohort
• Interim analysis results anticipated in June 2026, a major value-defining milestone
• Avecho positioned to capitalize on the TGA's over-the-counter CBD registration pathway

Avecho Biotechnology Limited has announced the completion of recruitment for the interim analysis cohort of participants for its pivotal Phase III clinical trial evaluating its TPM-enhanced cannabidiol (CBD) capsule for insomnia. The Company has successfully enrolled the approximately 210 participants required for the planned interim analysis, which will provide the first indication of the product's efficacy, de-risk the program moving forward and confirm the number of participants required to complete the trial. The interim analysis results are anticipated in June 2026 and represent a major value-defining milestone for Avecho's insomnia program. The Phase III study is designed to support registration of the CBD capsule with the Therapeutic Goods Administration (TGA) in Australia, where the Company is positioned to be one of the first to capitalize on the TGA's unique over-the-counter (OTC) CBD registration pathway, estimated to be worth more than US$125M per year. Avecho has already received major commercial validation for the CBD capsule, having licensed the commercial rights for Australia to Sandoz AG in 2025. The Company's worldwide licensing strategy continues to progress, as it holds discussions with potential partners for countries and regions outside of Australia.

Avecho has forecasted the Australian over-the-counter CBD market to be worth over US$125M per year. The global insomnia market was valued at US$5.22B in 2024.

A positive outcome from the interim analysis would materially de-risk Avecho's insomnia program and increase its attractiveness to prospective partners around the world. The Company is focused on executing the interim analysis and preparing for the final Phase III results.