Incannex Healthcare Inc.

We are a clinical-stage biopharmaceutical company developing oral fixed-dose combination therapies and psychedelic-assisted treatments for serious chronic conditions. Our principal development priority is IHL-42X for obstructive sleep apnea. We are also evaluating the next clinical development plan for PSX-001 in generalized anxiety disorder and the potential for further development of IHL-675A in inflammatory conditions. Our aim is to offer patients additional treatment options where existing care does not adequately meet their needs. IHL-42X, our lead drug candidate 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. We completed the Phase 2 portion of our RePOSA Phase 2/3 clinical trial (the "RePOSA Study") in July 2025, in which we observed that IHL-42X reduced apnea hypopnea index ( AHI ), improved patient reported outcome measures and was well-tolerated in OSA patients. In December 2025, the U.S. Food and Drug Administration ( FDA ) granted Fast Track designation for IHL-42X for the treatment of OSA. We have determined to conduct an additional dose confirmation study, the DReAMzz Study, to further optimize the ratio of dronabinol and acetazolamide prior to advancing into a Phase 3 clinical trial of IHL-42X.