REG - Theracryf PLC - Positive Ox-1 tox data in addiction programme

TheracryfAnnouncement

14/05/2026 07:01

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RNS Number : 2198E  Theracryf PLC  14 May 2026

 

 

14 May 2026

TheraCryf plc

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

 

Positive top line data from first toxicology species in lead Ox-1 addiction
programme

 

Clinical trial enabling work progressing ahead of plan

On track to deliver the major value infection point of all clinical trial
application data in 2026

Progress to date is attracting incoming interest from potential partners

Phase 1 clinical stage assets attract up-front payments in the range
US$26m-US$49m(1)

 

TheraCryf plc, the biotech company developing new medicines for addiction and
other neuropsychiatric disorders, is pleased to announce that dosing of the
first toxicology species in the Ox-1 blocker clinical trial enabling work
completed in early May and initial analysis shows that it is well tolerated at
very high doses.

TheraCryf's Ox-1 blocker is aimed at treating substance use disorders, a
market already valued at over US$70bn(2) per annum. Preclinical data has shown
that the Ox-1 blocker has potential class leading performance including
proof-of-efficacy in a rodent model of binge eating disorder.

 

The clinic enabling programme was fully funded in May 2025 to deliver the data
to support an application for Phase 1 human clinical trials before the end of
2026. The key outstanding work packages required to make this application
were:

 

1.    Drug manufacturing improvements and scale-up

2.    Development of the methods of analysis for animal and human clinical
samples

3.    Toxicology studies in two species

 

The Company has now successfully scaled-up manufacturing and produced over 2Kg
of drug that can be used in human trials. Improvements in the manufacturing
process have led to a manufacturing patent application being submitted which,
when granted, will provide considerable increased commercial protection until
2046, increasing the value of future licensing deals.

 

Dosing is now complete in the rodent toxicology study, and using the analysis
methods that have been developed, initial analysis shows that the drug is well
tolerated at doses up to 100 times the expected requirements for human
therapeutic use, which is well in excess of the tenfold safety margin
requirements in the FDA guidelines.

 

All remaining activities are due to complete on schedule by the end Q3 2026
when an application for human phase 1 trials can be submitted - a significant
value inflection point for any biotech.

 

Dr Huw Jones, Chief Executive Officer, commented:

 

"I am very proud of the team that has delivered this preclinical development
programme on budget and ahead of schedule with such outstanding results. Our
Ox-1 blocker continues to demonstrate class leading potential and is now
clearing the final toxicology hurdles to allow us to apply for a Phase 1 study
in healthy human volunteers.

 

Assets that are at the Phase 1 clinical stage attract up-front payments alone
in the range US$26m-US$49m in the neuroscience field which is why reaching
clinical stage is such a significant value driver for the Company.  We have
recently rejected an approach which undervalued the assets in our pipeline and
we continue to work proactively with other partners including following up on
other incoming approaches with a view to maximising value for shareholders
through a licensing deal.

We look forward to continuing to report on strong progress towards clinic
readiness over the next few months."

Dr Alastair Smith, Chairman, added:

 

"TheraCryf is approaching a very exciting inflection point as it moves its
lead programme, the Ox-1 blocker, from preclinical development into human
trials. Not only does our Ox-1 blocker demonstrate class leading performance,
but addiction and the broader neuropsychiatric space is a current focus for
large pharma and is generating a lot of commercial activity and M&A, such
as the recent acquisition of Centessa by Eli Lily for up to US$7.8bn.

 

I joined the TheraCryf board last year because it was clear to me that the
Company was considerably undervalued given the assets it has in its pipeline,
the many recent transactions in the neuroscience space and the obvious near
term value inflection points for the Company. I have been impressed by the
team's delivery of the final preclinical stages over the past year on schedule
and to budget and remain very excited indeed about the potential value uplift
for TheraCryf as we head into the clinic."

 

1.        Licensing deals in the therapeutic space (2020-2025)
globally, curated to relevant Pre-Clinical and Phase I CNS deals (excluded
M&A, platform deals, research projects and deals where public information
was unavailable). Most deals also have a royalty component, which is not
reflected in the total value. Pre-Clinical: n=17, Phase 1: n=13. Source:
Evaluate, Singer Capital Markets, TheraCryf management curation.

2.        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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