REG - Theracryf PLC - Successful GMP Manufacture Advances Ox-1 to Clinic

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RNS Number : 0094B  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 billion(1) 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
$70bn(1) 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
(https://www.futuremarketinsights.com/reports/substance-use-disorder-treatment-market)

 

-Ends-

 

Enquiries

 

 TheraCryf plc                                      +44 (0)1625 315 090

 Dr Huw Jones, CEO                                  enquiries@theracryf.com

 Toni Hänninen, CFO

 Dr Helen Kuhlman, COO

 Singer Capital Markets (NOMAD & Joint Broker)      +44 (0)20 7496 3000
 Phil Davies / Patrick Weaver

 Turner Pope Investments (Joint Broker)             +44 (0)20 3657 0050

 Guy McDougall / Andy Thacker

 Northstar Communications (Investor Relations)      +44 (0)113 730 3896

 Sarah Hollins                                      sarah@northstarcommunications.co.uk
                                                    (mailto:sarah@northstarcommunications.co.uk)

 

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 (https://theracryf.com)

 

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