REG - Theracryf PLC - Ox-1 Programme Achieves Manufacturing Milestone

TheracryfAnnouncement

03/11/2025 07:00

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RNS Number : 7892F  Theracryf PLC  03 November 2025

 

TheraCryf plc

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

 

Ox-1 Addiction Programme Achieves First Manufacturing Milestone

Scale up of drug quantity achieved ahead of schedule

 

Alderley Park, 3 November 2025 - TheraCryf plc (AIM: TCF), the clinical stage
drug development company focussing on brain disorders, provides an update on
key activity in its Ox-1 development programme.

·    0.5kg scale-up completed, ahead of schedule

·    Manufacturing of 2kg human grade material initiated

·    10kg manufacturing scale-up proceeding to plan

Successful achievement of compound scale-up, from small gram quantities to
0.5kg, is a significant milestone for the Company. This milestone was reached
ahead of schedule and with no issues. After formulation to the optimal dosage
form, the compound will be used in an in vivo study to identify the
'therapeutic index': this is the range between which the dose is expected to
have a therapeutic effect and the highest dose of compound reached before any
harmful effects are observed. Data from this study will inform dosing in the
key 28-day toxicology studies scheduled to commence in early 2026.

The 28-day toxicology studies will be supplied by the 10kg compound scale-up
which is currently proceeding to plan and schedule.

The Company have also now initiated work through its partner, Pharmaron, to
manufacture drug product for human use in the Ph1 healthy volunteer study.
This process is conducted under special conditions, referred to as GMP (Good
Manufacturing Practice), a regulatory standard to ensure safety and quality in
order that the product can be given to people. Data from this activity will
form part of the regulatory package required for the clinical trial
application.

 

Dr Helen Kuhlman, COO of TheraCryf commented:

"The achievement of this first stage of compound scale-up is testament to the
expertise and drive of the TheraCryf team and our colleagues at Pharmaron who
continue to deliver excellent progress on our Orexin programme.

"We stated in our previous update that we would inform the market of this key
milestone and it is very satisfying to be able to share that we got there
ahead of schedule.

"We anticipate updating the market over the coming weeks and months on
further substantial progress. This will include completion of the 10kg
manufacturing scale-up campaign, further dose range finding studies to enable
the initiation of the toxicology studies and the start and finish of the
regulatory standard 28-day toxicology studies. We will also provide updates
on the GMP manufacture of compound intended for human administration, along
with our interactions with appropriate regulatory agencies in preparation for
our clinical trial application.

"We remain confident that we are on target to achieve the data required to
support a clinical trial submission for this exciting programme according to
the plan we have outlined."

-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 / Oliver Platts / Patrick Weaver

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

 James Pope / Andy Thacker

 Vigo Consulting                                     +44 (0)20 7390 0230

 Rozi Morris                                         theracryf@vigoconsulting.com

About TheraCryf plc

TheraCryf is the clinical stage drug development company focussing on brain
disorders. The Company has a broad clinical and preclinical pipeline in
indications including addiction, anxiety, fatigue, narcolepsy, glioblastoma*
and neurodevelopmental disorders [*orphan indication].

The Company's strategy is to generate compelling data sets to preclinical
and/or clinical proof of concept and partner its clinical programmes with
mid-size to large pharma for larger trials and commercialisation. It also has
a number of industry partnerships with companies, including Stalicla SA, in
neurodevelopmental disorders.  The Company has sourced know-how for
programmes from companies such as Shire (now Takeda).

TheraCryf has worked with and has ongoing collaborations with major
universities and hospitals such as the University of Manchester, La Sapienza
(Università di Roma), the Erasmus Medical Centre, Rotterdam, Kings College
London and the University of Michigan.

The Company has its headquarters and registered office at Alderley
Park, Cheshire. It is quoted on AIM in London and trades under the
ticker symbol TCF. 

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