Board Change • May 21
Less than half of directors are independent Following the recent departure of a director, there are only 2 independent directors on the board. The company's board is composed of: 2 independent directors. 3 non-independent directors. Independent Non-Executive Chair David Alastair Smith was the last independent director to join the board, commencing their role in 2025. The company's minority of independent directors is a risk according to the Simply Wall St Risk Model. 공시 • Jan 27
Theracryf plc Receives Notice of Allowance from the Canadian Patent Office for Its Orexin-1 Addiction Programme TheraCryf plc announced that it has received a Notice of Allowance from the Canadian Patent Office for its Orexin-1 (Ox-1) addiction programme, alongside a positive update on ongoing preclinical development. The Canadian patent represents the final major market to grant for this intellectual property, completing broad protection across the US, Europe, Canada and key Asian territories. The patent provides Composition of Matter, the strongest form of patent cover available, conferring long-term exclusivity and significantly strengthening the commercial and partnering proposition for the programme. The Group also reports continued progress on its Maximum Tolerated Dose (MTD) and Dose Range Finding (DRF) studies, which commenced earlier this month. The MTD have now been successfully completed, with two species dosed up to the regulatory maximum, 1g/kg of the orexin-1 blocker, with no adverse clinical observations reported. This favourable outcome further de-risks the programme and enables progression into repeat-dose DRF studies, the results of which will inform the dosing for the planned 28-day regulatory toxicity studies scheduled in First Quarter and Second Quarter 2026, depending on species. This is a near final step on the path to IND/CTA readiness targeted for 2026. TheraCryf's lead programme, is a novel, best-in-class orexin-1 blocker., being developed as a potential treatment for addiction, including alcohol and other substance use disorders. The programme demonstrates class-leading selectivity and high receptor occupancy, characteristics which are expected to translate into improved tolerability and efficacy. Blocking the orexin-1 pathway has been shown to reduce aberrant substance-seeking behaviour in animal models, and the orexin pathway has attracted strong interest in the pharmaceutical sector. Addiction represents a large and growing global market, with substantial unmet medical need and significant human, social and economic impact, making it an attractive indication for development and commercialisation. 공시 • Jan 05
Theracryf Plc Starts 2026 Positive, A Key Milestone on the Path to Clinical Ready for Its Ox-1 Orexin Bladder Potential Treatment for Addiction Disorders TheraCryf plc 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 study. These studies will begin in first quarter of 2026, depending on species. All studies on schedule to complete third quarter of 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 projects scheduled to commence, in first quarter and second quarter of 2020 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. 공시 • Nov 24
Theracryf Plc to Report First Half, 2026 Results on Dec 03, 2025 Theracryf Plc announced that they will report first half, 2026 results on Dec 03, 2025 공시 • Nov 05
TheraCryf plc Provides an Update on Key Activity in its Ox-1 Development Programme TheraCryf plc provided 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. 공시 • Jun 17
Theracryf Plc, Annual General Meeting, Jul 09, 2025 Theracryf Plc, Annual General Meeting, Jul 09, 2025. Location: the royal society of medicine, 1 wimpole street, w1g 0ae, london United Kingdom 
