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Avecho Biotechnology (AVE) investor relations material

Avecho Biotechnology Q3 2025 TU earnings summary

Complete event summary combining all related documents: earnings call transcript, report, and slide presentation.
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Q3 2025 TU earnings summary30 Oct, 2025

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.

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Frequently asked questions

Avecho Biotechnology Limited is an Australian pharmaceutical company focused on drug delivery systems. The company develops proprietary formulations that enhance the solubility and absorption of active pharmaceutical ingredients using lipid-based delivery platforms. Its technologies are applied in human health, animal health, and topical therapeutics. The company is headquartered in Melbourne, Australia, and its shares are listed on the ASX.

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