Ox-1 Preclinical Data Package Complete

TheraCryf plc, the biotech company developing new medicines for addiction and other neuropsychiatric disorders, announces the successful completion and final reporting of the 28-day regulatory toxicology studies in two species for its lead orexin-1 (Ox-1) receptor antagonist programme. These provide the final preclinical data required to support the application in November 2026 to conduct a first-in-human Phase 1 study in Australia.

The studies produced results that substantially exceeded the Company’s expectations and support progression towards a first-in-human Phase 1 study. Ox-1 was extremely well tolerated, with no adverse findings at any dose tested. The highest dose tested was approximately 70 times the dose anticipated for human therapeutic use, substantially exceeding the tenfold safety margin regarded as the ‘gold standard’ for drug development and well above that generally considered acceptable by regulatory authorities.

Data from the preclinical development programme, delivered on schedule and within budget over the past 18 months, are now being compiled into the Australian clinical trial submission package.

As announced on 2 October 2026, TheraCryf’s Australian subsidiary has appointed Avance Clinical to support preparations for ethics review and the subsequent clinical trial notification. The Company expects to submit the application in November 2026 and continues to target the necessary approvals by 31 December 2026.

Dr Huw Jones, Chief Executive Officer, commented:

“These toxicology results exceed our expectations and mark an important milestone for our Ox-1 programme. The compound was very well tolerated at all doses tested. With the final preclinical data now collected, we are preparing our submission to conduct the first human clinical study of Ox-1 in Australia and reiterate our expectation of approval for human trials by the end of the calendar year.

“Human safety data is key for any biotech aiming to partner its assets, and we know that there is considerable commercial interest in our Ox-1 programme that is waiting to see Phase 1 data. We now have a clear pathway to regulatory approval in Australia for this important study, which would provide key value inflection points.”

Dr Helen Kuhlman, Chief Operating Officer, added:

“Our team and partners have delivered the preclinical package in line with our high level of confidence in the programme and our previous guidance. In addition to these excellent toxicology results, our manufacturing optimisation has delivered yields comfortably ahead of expectations and new intellectual property with potential patent protection to 2046. We are now focused on submitting the application and securing the approvals required to progress into a Phase 1 study in Australia.”

Investor webinar

Dr Huw Jones, Chief Executive Officer and Dr Helen Kuhlman, Chief Operating Officer, will provide an update on TheraCryf’s Ox-1 programme, including the final preclinical results and next steps towards a first-in-human Phase 1 study in Australia, via Investor Meet Company at 1.00 pm BST on Tuesday, 20 October 2026.

The webinar is open to all existing and potential shareholders. Questions can be submitted via the Investor Meet Company dashboard up to 24 hours before the event or during the live presentation.

Investors can register at https://www.investormeetcompany.com/theracryf-plc/register-investor.

Investors who already follow TheraCryf on the platform will automatically be invited.