Avecho Biotechnology (AVE) investor relations material

Product and clinical progress

• Synthetic CBD capsule enhanced with TPM; pharmaceutical product, not a medicinal-cannabis product; IP protection to ~2043.

• Pivotal Phase III insomnia trial is 8 weeks, double-blind and once-daily, with 150 mg, 75 mg and placebo arms; planned enrollment is 519.

• Trial has two primary endpoints, Insomnia Severity Index and subjective sleep efficiency; either endpoint can support success.

• Interim analysis at 244 participants; independent DMB unanimously recommended continuing to 519, with sample size unchanged.

• No serious adverse events among 244 participants at either dose; interim safety described as benign and competitive with approved sleep drugs.

Market and commercial position

• Australia’s Schedule 3 pathway allows registered CBD medicines to be sold OTC through pharmacies; no product is registered yet, and 9.5 million Australians experience insomnia symptoms.

• Australian consumers spend ~A$5bn annually on OTC medicines; initial forecasts for OTC CBD exceed US$125m annually.

• Sandoz licensed exclusive Australian rights for US$3m upfront, received on signing, US$16m in pre-commercial development milestones and tiered royalties of 14–19% on net sales; includes a right of first refusal for ex-Australia territories.

• Global insomnia market was valued at US$5.2bn in 2024; more than 850 million people have clinically significant insomnia.

Execution and financial snapshot

• Dosing is scheduled to recommence in H2 2026; ~320 patients, including spares, are to complete, with ~10 sites identified and ready and ~12 months to trial completion once all sites are open.

• 2027 priorities include completing Phase III dosing, manufacturing work for a TGA submission, compiling the submission dossier and engaging overseas regulators including the FDA and EMA.

• Further ex-Australia licensing deals, manufacturing scale-up and development with international partners are planned.

• End-June 2026 cash was A$6.6m; shares on issue were 3.86bn and market capitalization was A$77.27m as of COB 6 September 2026.