TheraCryf this morning announced the successful GMP manufacture of 2.57 kg of clinical-grade drug substance for its lead orexin-1 (Ox-1) receptor antagonist, delivered in a single, first-pass manufacturing run, three weeks ahead of schedule. This is a decisive de-risking event for the programme and, in our view, materially strengthens the investment case ahead of the anticipated Phase 1 initiation. TCF is developing Ox-1 for substance use disorders (SUD), a large, underserved market projected to exceed US$70 billion by 2035. With current pharmacotherapies offering limited efficacy and significant side-effect burden, a well-tolerated, non-addictive Ox-1 antagonist addresses an acute gap in the treatment landscape. The Company's capital-light development model, targeting partnership with a major pharmaceutical company at or before proof-of-concept, provides a clearly defined route to value realisation. We maintain our recommendation and PT.
