REG - Theracryf PLC - Key Ox-1 milestone & notice of investor webinar

TheracryfAnnouncement

05/01/2026 07:00

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RNS Number : 5502N  Theracryf PLC  05 January 2026

 

TheraCryf plc

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

 

Ox-1 addiction programme advances closer to clinical readiness on achievement
of key milestone

and

Notice of investor webinar

Manufacturing of drug substance successfully scaled up to supply 28-day
toxicology studies

Alderley Park, 5 January 2026 - TheraCryf plc (AIM: TCF), the clinical stage
drug development company focussing on brain disorders, has started 2026
positively, achieving a key milestone on the path to clinical readiness for
its Ox-1 orexin blocker potential treatment for addictive disorders.

·    Process for large-scale manufacturing of drug substance established

·    Scale-up achieved on schedule with a manufacturing yield in excess of
target

·    10.6kg produced to supply critical 28-day regulatory toxicology
studies

·  Dosing in two species has now commenced to identify maximum tolerated
dose for 28-day regulatory toxicology studies

·    These studies will begin in Q1/2 2026, depending on species

·    All studies on schedule to complete Q3 2026

Manufacturing scale-up and completion of 28-day toxicology studies were
highlighted, during the successful placing in March 2025, as the two key
milestones remaining in the Ox-1 programme to achieve clinical readiness.
Scale-up of the Ox-1 compound to 10kg has now been achieved on schedule and
with a yield in excess of expectations.

This drug substance will be used in the 28-day regulatory toxicology studies
scheduled to commence, in Q1 and Q2, this year in two species. These studies
will provide essential data for the planned regulatory submission later in the
year and represent the last major hurdle to achieving that goal.

Before starting the 28-day toxicology studies, the Maximum Tolerated Dose and
Dose Range Finding studies need to be completed. This work has now started.
These studies will identify the 'therapeutic index' of the orexin-1 blocker -
that 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.

Ox-1 is TheraCryf's lead asset, an orexin-1 blocker, being developed as a
potential treatment for addiction, blocks a pathway in the brain (orexin-1)
known to be over-active in individuals with addiction. This group of
conditions have significant human and economic impact globally. Blocking the
overactivity of this pathway is known to reduce aberrant substance seeking
behaviour in animal models. Drugs that can block this pathway have generated
significant commercial interest and Theracryf's orexin-1 blocker is the most
selective yet developed, indicating class leading potential.

Investor Webinar

Dr Huw Jones, Chief Executive Officer, and Dr Alastair Smith, Non-executive
Chair, will be presenting a webinar hosted by TheraCryf's joint broker, Turner
Pope Investments, at 6:00p.m. on Thursday, 8 January 2026.

The webinar will look at the progress made by TheraCryf in 2025 in driving its
lead Ox-1 orexin blocker programme towards clinical trial readiness and also
the potential milestones and value inflection points for TheraCryf coming up
in 2026, including manufacturing scale-up as described above. A Q&A
session will follow the main presentation.

The webinar is freely available for all existing and potential investors. To
register for the event and submit questions, please go to:
https://www.turnerpope.com/register/
(https://eur03.safelinks.protection.outlook.com/?url=https%3A%2F%2Fwww.turnerpope.com%2Fregister%2F&data=05%7C02%7CAndy.Thacker%40TurnerPope.com%7Caf1907486dd84b095c7008de41337b89%7Cff82bd738fe84a38a86994e58a240e55%7C0%7C0%7C639019886526800594%7CUnknown%7CTWFpbGZsb3d8eyJFbXB0eU1hcGkiOnRydWUsIlYiOiIwLjAuMDAwMCIsIlAiOiJXaW4zMiIsIkFOIjoiTWFpbCIsIldUIjoyfQ%3D%3D%7C0%7C%7C%7C&sdata=tOQmJteJyXei7af%2FQQR7z4MRyzSm37AivDw9X9lwasA%3D&reserved=0)

 

Dr Helen Kuhlman, COO of TheraCryf commented:

"We are pleased to have achieved this key milestone in the development of our
potentially class leading orexin blocker programme, on schedule. These
activities are critical to generating a robust data package to enable human
trials and we are on track to deliver them during 2026."

-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

 Andy Thacker / Guy McDougall

 Vigo Consulting                                     +44 (0)20 7390 0230

 Rozi Morris/ Melanie Toyne Sewell                   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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