Ox-1 Addiction Programme Update

Best-in-class Ox-1 asset continues to be de-risked ahead of clinical readiness

TheraCryf plc (AIM: TCF), the biotech company developing new medicines for addiction and other disorders of the brain, is pleased to announce that it has received a Notice of Allowance from the Canadian Patent Office for its Orexin-1 (Ox-1) addiction programme, alongside a positive update on ongoing preclinical development.

The Canadian patent represents the final major market to grant for this intellectual property, completing broad protection across the US, Europe, Canada and key Asian territories. The patent provides Composition of Matter, the strongest form of patent cover available, conferring long-term exclusivity and significantly strengthening the commercial and partnering proposition for the programme.

The Group also reports continued progress on its Maximum Tolerated Dose (MTD) and Dose Range Finding (DRF) studies, which commenced earlier this month. The MTD have now been successfully completed, with two species dosed up to the regulatory maximum, 1g/kg of the orexin-1 blocker, with no adverse clinical observations reported. This favourable outcome further de-risks the programme and enables progression into repeat-dose DRF studies, the results of which will inform the dosing for the planned 28-day regulatory toxicity studies scheduled in Q1 and Q2 2026, depending on species. This is a near final step on the path to IND/CTA readiness targeted for 2026.

Ox-1, TheraCryf's lead programme, is a novel, best-in-class orexin-1 blocker, being developed as a potential treatment for addiction, including alcohol and other substance use disorders. The programme demonstrates class-leading selectivity and high receptor occupancy, characteristics which are expected to translate into improved tolerability and efficacy. Blocking the orexin-1 pathway has been shown to reduce aberrant substance-seeking behaviour in animal models, and the orexin pathway has attracted strong interest in the pharmaceutical sector.

Addiction represents a large and growing global market, with substantial unmet medical need and significant human, social and economic impact, making it an attractive indication for development and commercialisation.

Dr Helen Kuhlman, Chief Operating Officer of TheraCryf, commented:

"Securing the Canadian patent completes coverage across all major commercial markets for our Ox-1 programme and strengthens its long-term value. Completion of our maximum tolerated dose studies further de-risks our best-in-class lead asset as we progress towards clinical readiness.

We remain well positioned to generate key value inflection data and advance Ox-1 towards partnering opportunities."