Incannex has reported positive interim safety data from its ongoing Phase II PsiGAD study. A review by an independent Data Safety Monitoring Board (DSMB) identified no safety concerns from the first 37 patients enrolled (expected to recruit 72 in total) in the trial and has recommended no changes to the study design. Additionally, based on the interim analysis of 29 patients who have completed the study protocol, the company projects a more than 85% probability that the psilocybin treatment arm will provide a statistically significant benefit over the placebo treatment arm of the study. While we advise caution in the interpretation of modelling projections to predict trial outcomes, these early observations of safety and potential efficacy, in our view, support the continuation of Incannex’s psilocybin-assisted psychotherapy program for generalized anxiety disorder (GAD). We see trial completion (expected by Q423) as a key upcoming catalyst.