Successful GMP Manufacture Advances Ox-1 to Clinic

Theracryf PLC

20 April 2026

 

20 April 2026

TheraCryf plc

("TheraCryf", the "Company" or the "Group")

Lead Asset Ox-1 Advances Towards Clinic With Successful GMP Manufacture For Human Use

Over 2kg of clinical-grade material produced to support Phase 1 trials

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."

1.     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

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Enquiries

TheraCryf plc Dr Huw Jones, CEO Toni Hänninen, CFO Dr Helen Kuhlman, COO	[phone] [e-mail]
Singer Capital Markets (NOMAD & Joint Broker) Phil Davies / Patrick Weaver	[phone]
Turner Pope Investments (Joint Broker) Guy McDougall / Andy Thacker	[phone]
Northstar Communications (Investor Relations) Sarah Hollins	[phone] [e-mail]

About TheraCryf

TheraCryf plc is a biotechnology company developing new medicines for addiction and other neuropsychiatric disorders, areas of significant unmet medical need within central nervous system (CNS) disorders.

The Group's lead programme is a novel, best-in-class orexin-1 receptor antagonist being developed as a potential treatment for addiction, including binge eating, alcohol and other substance use disorders.

The programme has already been heavily de-risked for both safety/tolerability and efficacy in previous testing and is fully funded through final pre-clinical trials to clinical readiness, with regulatory submissions for first in man studies targeted for 2026.

TheraCryf also has a dopamine transporter (DAT) modulator programme addressing fatigue of brain origin, including fatigue associated with multiple sclerosis, chemotherapy and narcolepsy. The Group also has a legacy, grant-funded, oncology programme in glioblastoma with SFX-01.

The Group operates a capital-light, virtual development model advancing programmes to early clinical or proof-of-concept stage before partnering with commercially focused pharmaceutical and biotechnology companies.

TheraCryf's headquarters and registered office are at Alderley Park, Cheshire.

For further information, visit: https://theracryf.com

 

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