Incannex – Review of IND Application for IHL-42X by US FDA has been completed; Clinical Trial for Patients with Obstructive Sleep Apnoea May Proceed

Melbourne, Australia, August 22, 2023 – Incannex Healthcare Limited (Nasdaq: IXHL) (ASX: IHL),
(‘Incannex’ or the ‘Company’) a clinical-stage pharmaceutical company developing proprietary
medicinal cannabinoid products and psychedelic assisted psychotherapies for unmet needs, is pleased
to announce that it has received approval from the US Food and Drug Administration (‘FDA’) to conduct
the Company’s Investigational New Drug (‘IND’) opening pivotal IHL-42X Phase 2/3 clinical trial in the
United States as planned.