Avecho Biotechnology (AVE) Status update summary

Trial overview and design

• Conducting the world's largest phase III CBD insomnia trial with 519 patients, using a proprietary TPM-enhanced cannabidiol capsule, testing 75mg and 150mg CBD versus placebo over eight weeks.

• Patients randomized into three arms: 75mg CBD, 150mg CBD, or placebo, with nightly treatment for eight weeks.

• Two primary endpoints: Insomnia Severity Index (ISI) and sleep efficiency; success on either is sufficient for trial success.

• Trial is fully blinded, placebo-controlled, with independent statistician and Data Monitoring Board (DMB) overseeing adaptive interim analysis.

• Designed to FDA, EMA, and TGA standards, with tight inclusion criteria and placebo-effect control mechanisms.

Interim analysis and process

• Interim analysis on 244 patients underway, with DMB to recommend: continue trial, stop for efficacy, or stop for futility.

• Most likely outcome is continuation with a confirmed sample size, aiming for 519 total patients.

• DMB findings delivered to Avecho and announced to ASX in late June 2026.

• Recruitment for additional patients expected to complete within 12 months with expanded trial sites.

• No serious adverse events reported to date, indicating strong safety profile.

Regulatory and commercial positioning

• TGA in Australia incentivizes OTC registration for oral CBD insomnia treatments; no products have succeeded yet.

• Sandoz is a key commercial partner, with a 10-year agreement and AUD 3 million investment.

• TGA reviewed and validated the trial design as robust, with no recommended changes.

• FDA may now accept a single phase III trial for approval due to recent regulatory changes.

• Potential for rapid expansion into overseas markets and licensing deals post-interim analysis.