Avecho Biotechnology (AVE) Q2 2025 TU earnings summary

Executive summary

• Phase III insomnia trial expanded with three new clinical sites in Sydney and the Gold Coast, accelerating recruitment to 131 participants, with interim results expected in early 2026.

• Strategic planning for TGA registration and commercialisation underway following Avecho-Sandoz meetings.

• TPM®-enhanced CBD capsule positioned to be the first registered OTC cannabidiol product for insomnia in Australia.

• Licensing agreement with Sandoz AG for exclusive Australian rights; business development efforts expanded to international markets.

Financial highlights

• Cash balance of A$5.9 million as at 30 June 2025.

• Received A$1.66 million under the Australian Government's R&D Tax Incentive Scheme, used to repay A$1.04 million in R&D tax advances and support operations.

• Net cash used in operating activities for the quarter was A$680,000.

• Payments to related parties and associates during the quarter totaled approximately A$67,000.

Outlook and guidance

• Interim analysis cohort enrolment expected to complete in H2 2025, with interim results anticipated in early 2026.

• Continued focus on regulatory readiness and commercialisation, with active licensing discussions in multiple jurisdictions.

• Positioned to capitalize on Australia's OTC CBD market, projected to exceed US$125 million annually.