Avecho Biotechnology (AVE) Q3 2025 TU earnings summary

Executive summary

• Recruitment in the pivotal Phase III CBD TPM® insomnia trial reached 160 patients, with interim analysis results expected in H1 2026.

• Three new clinical sites were activated, accelerating recruitment and supporting regulatory milestones.

• Collaboration with Sandoz AG led to a revised statistical analysis plan, enhancing trial robustness.

• The trial aims to support TGA submission for over-the-counter registration of the CBD TPM® soft-gel capsule for insomnia.

Financial highlights

• Cash balance at 30 September 2025 was $4.6 million.

• Operational cash outflows for the quarter were $1.33 million, primarily for R&D and trial activities.

• Receipts from customers for the quarter totaled $28,000; year-to-date receipts were $6.14 million.

• Government grants and tax incentives contributed $652,000 during the quarter.

• Payments to related parties and associates totaled $67,000 for the quarter.

Outlook and guidance

• Focus remains on completing Phase III trial recruitment and preparing for TGA submission.

• $2.5 million capital raise post-quarter will accelerate manufacturing scale-up and regulatory preparations.

• International licensing discussions are ongoing, leveraging the Sandoz AG agreement as a benchmark.