Avecho Biotechnology (AVE) Investor Presentation summary

Market opportunity and unmet need

• Insomnia affects 10–30% of the global population, with up to 237 million people impacted worldwide.

• Chronic insomnia affects 10–15% of the population, with 3.6 million chronic cases in Australia alone.

• The global insomnia market is valued at $5.22B in 2024, while the mental health market is $375.2B.

• Insomnia costs the US economy $63 billion annually.

• Existing medications have safety concerns and impair next-day function.

Product innovation and clinical development

• TPM technology increases oral CBD absorption by 400% compared to Epidiolex.

• No pharmaceutical CBD products are approved for sleep, despite high demand.

• Ongoing Phase III trial is the largest randomized, placebo-controlled study of CBD for insomnia, targeting 519 patients.

• Interim analysis expected in H1 2026, with TGA supportive of the protocol.

Regulatory and commercial strategy

• TGA allows oral CBD products to be registered as OTC medicines, providing a significant commercial advantage.

• Australians spend approximately $5B per year on OTC medicines.

• Sandoz acquired exclusive rights for the insomnia CBD capsule in Australia, with right of first refusal for other regions.

• Upfront payment of $3M USD, up to $16M USD in milestones, and tiered royalties of 14–19% on net sales.