Successful GMP Manufacture Advances Ox-1 to Clinic

TheraCryf plc (AIM: TCF), the biotech company developing new medicines for addiction and other neuropsychiatric disorders, today announces the successful manufacture of over 2kg of drug substance for its lead orexin-1 (Ox-1) receptor antagonist to Good Manufacturing Practice (GMP) standard. Generating human-grade material that meets regulatory standards is the vital next step following the Company's manufacturing update on 5 January 2026. As planned, this latest product batch is suitable for use in human clinical trials.

This critical milestone enables a seamless transition from preclinical to clinical activity, allowing initiation of dosing in humans after approval to conduct the Phase 1 study, without introducing programme delays due to further manufacturing.

TheraCryf's manufacturing partner successfully produced 2.57kg of human-grade drug substance in an efficient process with a higher yield than anticipated, delivering three weeks ahead of schedule and confirming the scalability and robustness of the Company's optimised manufacturing process, which is the subject of a recent patent filing.

Efficient GMP manufacturing is often a key bottleneck in drug development, leading to delays and higher product costs. In contrast, TheraCryf's Ox-1 antagonist has been successfully manufactured at scale, with clinical trial material meeting all required quality standards on first pass, supporting the planned Phase 1 study in human volunteers. This demonstrates strong process reliability, further de-risking the programme as it advances towards clinic readiness.

The drug substance is now ready for formulation into the final drug product that will be given to the Phase 1 volunteers. Completion of the preclinical package, including delivery of the 28-day toxicology study results, the final step to enable a regulatory submission and clinic readiness, remains on schedule for Q3 2026.

Ox-1 is being developed for the treatment of substance use disorders, a large and growing global market projected to exceed US$70 billion1 by 2035, where there remains a significant unmet medical need for new, effective and non-addictive therapies.

Dr Huw Jones, Chief Executive Officer of TheraCryf, commented:

"Achieving successful GMP manufacture of human-grade Ox-1 drug substance is an important milestone that further de-risks the programme as we move towards the clinic. The fact that the manufacturing process has proven robust and reliable, with good yields, enhances the commercial attractiveness of our Ox-1 antagonist.

Combined with our recent positive preclinical data and the filing of a new patent, this progress reinforces our confidence in Ox-1 as a potentially best-in-class treatment for addiction, a market that will be worth over $70bn1 by 2035.

With toxicology studies underway and on schedule, we remain focused on advancing towards first-in-human studies and moving the programme towards accretive partnership opportunities with commercially focused pharmaceutical companies."

• Substance Use Disorder Treatment Market Size and Share Forecast Outlook 2025 to 2035. Future Market Insights Inc, November 2025: https://www.futuremarketinsights.com/reports/substance-use-disorder-treatment-market