Summary: Incannex Healthcare Inc provided an update on its lead drug candidate, IHL-42X, an oral therapy in development for the treatment of obstructive sleep apnea (OSA), highlighting progress in its phase 2/3 clinical trial. The clinical trial aims to evaluate IHL-42X in OSA patients who struggle with or avoid using positive airway pressure therapy. The company also highlighted previously announced business updates, including a strategic financing agreement with Arena Investors and its redomiciliation to the United States, where it is now listed on Nasdaq.
Key Takeaways:
- Clinical Trial Progress: Incannex highlighted that it has begun dosing patients in its phase 2/3 RePOSA clinical trial for IHL-42X, targeting patients with OSA who are intolerant, non-compliant, or naïve to positive airway pressure therapy.
- Strategic Financing: The company secured up to $59 million in financing from Arena Investors to fund ongoing clinical trials and general corporate needs.
- US Redomiciliation: Incannex completed its transition from Australia to the US, listing its stock on the Nasdaq to access a broader investor base and enhance financial flexibility.
Incannex Healthcare Inc, a clinical-stage biopharmaceutical company advancing IHL-42X—its lead product—for the treatment of obstructive sleep apnea (OSA), provided full-year financial business updates.
Business highlights for the year include the announcement of strategic financings with Arena Investors, which may provide up to $59 million in gross proceeds to Incannex through a $50 million equity line of credit and the sale in future closings of convertible debentures with an aggregate principal amount of up to $9 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.
Incannex also 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 in Sleep Portfolio
IHL-42X is Incannex’s oral fixed dose combination of dronabinol and acetazolamide designed to act synergistically, targeting two different physiological pathways associated with the intermittent hypoxia and hypercapnia that characterize OSA.
Highlights for the drug candidate include:
- 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 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.
“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…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,” says Joel Latham, Incannex’s president and chief executive officer, in a release.
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