Incannex Healthcare Inc. Reports Fiscal Full Year 2024 Financial Results and Business Updates

About this update from Incannex Healthcare Inc.

Announced strategic financing with Arena Investors , providing access to up to $59.0 million USD in gross proceeds to Incannex Announced positive top-line results from our Phase 2 proof-of-concept clinical trial of PSX-001, known as the PsiGAD1 study, in which synthetic psilocybin in combination with psychotherapy was observed to significantly reduce anxiety scores and to be well tolerated in patients with generalised anxiety disorder (GAD) Commenced dosing in the RePOSA Phase 2/3 clinical trial of IHL-42X, an oral investigational treatment for patients with obstructive sleep apnea Received Investigational New Drug (IND) application clearance from the U.S. Food and Drug Administration (FDA) to initiate PsiGAD2, a Phase 2 clinical trial of PSX-001 Successfully completed redomiciliation to the United States and listing shares of Incannex common stock on Nasdaq under the ticker “IXHL” in late 2023 NEW YORK and MELBOURNE, Australia , Sept. 30, 2024 (GLOBE NEWSWIRE) -- Incannex Healthcare Inc. (Nasdaq: IXHL), (Incannex), a clinical-stage biopharmaceutical company developing innovative medicines for people with serious chronic diseases and significant unmet medical needs, today reported fiscal full year financial results and provided business updates. “The past year has been transformative for Incannex as we successfully completed our transition to the Nasdaq as a company domiciled in the United States , reported positive top-line data from our proof-of-concept clinical trial of PSX-001, known as PsiGAD1, and initiated dosing in our Phase 2/3 IHL-42X RePOSA trial. These achievements demonstrate our commitment to advancing new oral cannabinoids and psychedelic treatments. With our recent strategic financing and clinical trials underway for three programs, we are excited to share updates later this year,” said Joel Latham , Incannex’s President and Chief Executive Officer. “We are grateful to all of the physicians, investigators and patients involved in our U.S. and Australian clinical trials for their support of our investigational synthetic cannabinoid and psilocybin-based therapeutic programs.” Operational Highlights Announced strategic financings with Arena Investors , which may provide up to $59.0 million USD in gross proceeds to Incannex through a $50 million USD equity line of credit and the sale in future closings of convertible debentures with an aggregate principal amount of up to $9.0 million USD . Incannex intends to use the proceeds from this strategic financing to support the ongoing clinical trials of its drug candidates, and for working capital and other general corporate purposes. Drawdown of the capital will be determined according to the Incannex’s strategic needs. Announced the opening of Clarion Clinics , one of the first psychedelic-assisted psychotherapy clinics in Australia , which will serve as a model for potential future sites. Incannex believes this first clinic will provide real-world experience in treating mental health patients utilizing psychedelic-assisted psychotherapy. Assuming regulatory approval of PSX-001, the Clarion Clinics model has the potential to provide insight into the potential commercialization of PSX-001. Completed the redomiciliation of Incannex from Australia to the United States , effective November 28, 2023 and listing our common stock on the Nasdaq Global Market under the ticker “IXHL.” With no material changes to its operations, Incannex believes this will provide access to a broader set of investors, streamline financial reporting comparably with industry peers, and provide greater flexibility in accessing capital. Clinical Highlights Commenced dosing in the RePOSA Phase 2/3 clinical trial of IHL-42X, an oral fixed dose combination of dronabinol and acetazolamide for the treatment of patients with obstructive sleep apnea (OSA). RePOSA, a randomized, double-blind trial, is designed to assess the safety and efficacy of IHL-42X in patients with OSA who are intolerant, non-compliant, or naïve to positive airway pressure. The Phase 2 portion of this clinical trial is being conducted in the United States , and the expanded Phase 3 portion will include sites in the United Kingdom and European Union . Incannex plans to recruit 560 subjects, with an estimated 355 participants in the active study arms, and anticipates reporting top-line data from the Phase 2 portion of this clinical trial in the first half of 2025. Completed dosing of 115 subjects in a bioavailability/bioequivalence (BA/BE) clinical trial conducted in Australia assessing the pharmacokinetics and tolerability of IHL-42X, our drug product for the treatment of obstructive sleep apnea. Data analysis is underway, with no serious adverse events reported to date. Incannex expects to release top-line results from this BA/BE clinical trial in 2024. Announced positive results from its proof-of-concept Australian Phase 2 clinical trial, PsiGAD1, of PSX-001. In the PsiGAD2 trial the combination of an oral synthetic psilocybin with psychotherapy was observed to significantly reduced anxiety scores and was well tolerated in patients with generalized anxiety disorder (GAD). The reduction in HAM-A from baseline, the trial’s primary endpoint, in the psilocybin group was 12.8 points from baseline, representing a 9.2-point improvement over psychotherapy with placebo (p

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