• Recruitment continues in Avecho's pivotal Phase III CBD TPM® insomnia trial, with 160 patients dosed
• Results from the interim analysis remain anticipated in H1 2026
• $2.5 million capital raise completed post-quarter to accelerate manufacturing and regulatory preparations

Avecho Biotechnology Limited (ASX: AVE) has provided its Quarterly Activities Report and Appendix 4C for the quarter ended 30 September 2025. The key highlights include:Phase III CBD Clinical Trial Recruitment Update:- Recruitment in Avecho's pivotal Phase III clinical trial evaluating the CBD TPM® soft-gel capsule for the treatment of insomnia has continued, with 160 participants now dosed with study medication.- Recruitment during the third quarter was moderately slower than previous months, primarily due to an increase in seasonal winter illness across clinical trial sites, but activity levels have since normalised.- Avecho has revised its planned statistical analysis to enhance the sensitivity and robustness of the trial's primary outcome measures.- The multicentre, double-blind, placebo-controlled trial is the largest of its kind, assessing the efficacy and safety of nightly doses of 75 mg and 150 mg of CBD TPM® against placebo over eight weeks.Operational Outlook:- Avecho's primary focus remains the successful execution and completion of the pivotal Phase III insomnia trial, in collaboration with Sandoz AG.- The company has begun preparations for the next stage of manufacturing and regulatory work that will support a TGA submission, including validation of scaled manufacturing processes and production of registration batches.- Internationally, the licensing agreement with Sandoz AG has continued to attract interest from additional pharmaceutical partners seeking opportunities to license the CBD TPM® capsule in other territories.Corporate and Financial Update:- Avecho held a cash balance of $4.6 million as of 30 September 2025.- Following the quarter, the company announced the successful completion of a $2.5 million capital raise, which was strongly supported by institutional and sophisticated investors.

Avecho has not provided any high-importance, price-sensitive forward-looking financial metrics in the announcement.

Avecho's primary operational focus remains the successful execution and completion of the pivotal Phase III insomnia trial. The company continues to collaborate closely with Sandoz AG to ensure strong alignment across regulatory, manufacturing, and commercial planning. With the statistical analysis plan finalised and recruitment approaching completion for the interim analysis cohort, Avecho has begun preparations for the next stage of manufacturing and regulatory work that will support a TGA submission.