THERACRYF PLC - Update on the Ox-1 programme

TheraCryf PLC provided an investor update on its OX-1 programme, highlighting significant progress in the development of its selective orexin-1 receptor antagonist for addiction and impulse-control disorders, with an initial focus on binge eating disorder. CEO Dr Hugh Jones and COO Dr Helen Coleman discussed the successful completion of the preclinical toxicology programme, reporting encouraging safety and tolerability results, with no significant adverse findings even at doses substantially exceeding anticipated human exposure levels. The company is targeting an Australian ethics submission in mid-November 2026, with approval anticipated by year-end, paving the way for Phase 1 clinical trials to assess safety, pharmacokinetics and blood-brain barrier penetration in healthy volunteers. Management also highlighted improvements in manufacturing efficiency, successful production scale-up and additional intellectual property protection potentially extending to 2046, strengthening the programme's commercial prospects. TheraCryf's growth strategy centres on securing pharmaceutical partnerships, with potential partners particularly interested in clinical safety data, manufacturing scalability and efficacy. The company confirmed a cash runway until at least 31 March 2027, while exploring partnership funding, equity financing and co-development opportunities to support clinical progression. Management also discussed the evolving competitive landscape for selective orexin-1 antagonists, highlighting the discontinuation or limited advancement of competing programmes and TheraCryf's potentially differentiated clinical profile. The investor presentation reinforced the company's focus on advancing its lead asset towards human trials, reducing development risk and creating long-term shareholder value through strategic commercial partnerships.