Incannex Healthcare Inc.

We are a clinical-stage biopharmaceutical company dedicated to developing innovative medicines for patients living with serious chronic diseases and significant unmet needs. IHL-42X, our drug candidate in a pivotal Phase 2/3 clinical trial for the treatment of obstructive sleep apnea ( OSA ) is an oral fixed-dose combination of dronabinol and acetazolamide designed to act synergistically by targeting two different physiological pathways associated with the intermittent hypoxia and hypercapnia that characterize OSA. In a proof-of-concept study conducted in Australia, as well as in the Phase 2 portion of our RePOSA clinical trial, we observed that IHL-42X reduced apnea hypopnea index ( AHI ) and was well-tolerated in OSA patients. In the Phase 2 portion of the RePOSA clinical trial investigating, IHL-42X maximum reductions in AHI were observed at up to 83% for the high-dose group and up to 79% for the low-dose group. Notably, 33.3% of patients in the low-dose group and 41.2% of patients in the high-dose group achieved a greater than 30% reduction in AHI, while 13.9% (low-dose) and 14.7% (high-dose) experienced reductions exceeding 50%. Significant clinical improvement was observed across multiple secondary endpoints. Observed treatment-emergent adverse effects ( TEAEs ) were infrequent, with the majority being mild or moderate in severity. The low-dose and high-dose IHL-42X groups achieved a statistically significant reduction in percent change in AHI from baseline compared to placebo (p 0.05), the primary measure of OSA severity.