• Expansion of Phase III insomnia trial with three new clinical sites activated
• Acceleration of trial recruitment with 131 participants on study medication
• Strategic planning commenced for TGA registration and commercialisation

Avecho Biotechnology Limited (ASX: AVE) has presented its Quarterly Activities Report and Appendix 4C for the quarter ended 30 June 2025. The company continues to advance the clinical development and commercialisation of its TPM®-enhanced cannabidiol (CBD) soft-gel capsule, which is currently under evaluation in a pivotal Phase III clinical trial for the treatment of insomnia. In March 2025, Avecho entered into a licensing agreement with Sandoz AG for the exclusive commercialisation rights of its TPM®-enhanced CBD product in Australia. Avecho and Sandoz have commenced planning the path toward TGA registration and commercialisation, with a focus on increasing the rate of recruitment on the Phase III clinical trial. Several initiatives have accelerated recruitment, and the company anticipates completing enrolment for the interim analysis cohort in the second half of 2025, with interim results expected in early 2026. Avecho has also broadened its business development efforts to target additional international markets, with licensing discussions active across multiple jurisdictions. During the quarter, the company received $1.66 million under the Australian Government's R&D Tax Incentive Scheme, which was used to support the ongoing Phase III trial, company operations, and the commercialisation strategy.

Avecho is targeting completion of enrolment for the interim analysis cohort of its Phase III insomnia trial in the second half of 2025, with interim results expected in early 2026. This interim readout will be a key milestone in Avecho's commercial strategy as it positions the company to be the first to secure over-the-counter registration of a CBD product for insomnia in Australia.

Avecho is well positioned to be first to market with an over-the-counter CBD pharmaceutical for insomnia in Australia, commercialized by Sandoz, with no other successful Phase III CBD trials in Australia to date. The company continues to pursue licensing agreements in additional international markets beyond Australia.