Announcement • 16h
Incannex Healthcare Inc Secures U.S. Patent Grant for IHL-42X in Obstructive Sleep Apnea Incannex Healthcare Inc. announced that the United States Patent and Trademark Office (USPTO) has granted a key patent titled 'Compositions and Methods of Treatment for Obstructive Sleep Apnea.' The granted patent includes claims directed to the proprietary IHL-42X composition and its associated therapeutic methods for the treatment of Obstructive Sleep Apnea (OSA). The patent is expected to have a baseline expiry date of 9 July 2040 and the Company is exploring its eligibility for patent term extension following potential U.S. Food and Drug Administration (FDA) approval, with a view to further enhancing the long-term exclusivity of the asset. The grant of this patent represents a significant milestone in the advancement of IHL-42X and materially strengthens Incannex's intellectual property portfolio supporting its lead clinical program. The Company continues to actively review data generated across the IHL-42X development program with the objective of filing additional patent applications to further expand and protect the commercial and strategic value of the asset. IHL-42X is being developed as a novel oral combination therapy for the treatment of OSA, a condition with substantial unmet medical need, where long-term patient compliance and treatment effectiveness remain key challenges. The strengthened U.S. patent position significantly enhances the commercial value of IHL-42X by protecting the Company's proprietary oral combination therapy and supporting long-term market exclusivity. Together with FDA Fast Track designation, positive Phase II clinical data and ongoing advancement into the DReAMzz dose optimisation study, the patent further strengthens the strategic positioning of IHL-42X as a potentially differentiated pharmaceutical treatment for OSA. Incannex is nearing the commencement of patient recruitment in the DReAMzz Phase 2 study. The study has received central IRB approval along with the first tranche of site-specific IRB approvals. Study-specific Schedule I researcher registrations with the DEA are underway. The first site has received all necessary approvals and will commence screening in the near future, with additional sites to follow as the required approvals are received. Study drug supply has been shipped from the manufacturer to the distribution partner for secondary packaging and clinical trial labelling in preparation for patient dosing. The DReAMzz study is designed as a crossover dose optimisation study intended to further refine the dosing profile of IHL-42X and strengthen the design of the planned Phase III development program. The study is expected to generate additional data evaluating the relationship between dose optimisation, objective sleep metrics, and patient-reported outcomes, which are becoming increasingly important in both regulatory review and commercial positioning within the OSA market. Announcement • Apr 24
Incannex Healthcare Inc. Announces Incannex’s Completed Phase 2 Clinical Trial, PSX-001 Demonstrated Statistically Significant and Clinically Meaningful Improvements Across All Primary and Secondary Endpoints Incannex Healthcare Inc.believes its PSX-001 development program aligns with the goals outlined in the Executive Order and believes the data demonstrated to date, along with a more amenable regulatory environment, may provide significant hope for those suffering from anxiety disorders. PSX-001 is an oral, fixed-dose synthetic psilocybin formulation in development for Generalized Anxiety Disorder (GAD), a condition affecting an estimated 280 million people globally and approximately 6,800,000 in the United States. In Incannex’s completed Phase 2 clinical trial, PSX-001 demonstrated statistically significant and clinically meaningful improvements across all primary and secondary endpoints: 12.8-point reduction in HAM-A anxiety scores versus 3.6 points for placebo (p), 44% rate of clinically meaningful response (=50% anxiety reduction) — four times the placebo rate, 27% remission rate (HAM-A =7) — five times the placebo rate, sustained through 11 weeks, No serious adverse events and a single discontinuation across 73 patients. The Executive Order’s direction to the FDA to prioritize review of psychedelic compounds with Breakthrough Therapy designations create Right to Try pathways for investigational psychedelics, and initiate DEA rescheduling upon successful Phase 3 completion. The move also addresses systemic barriers that have historically constrained the development and commercialization of this entire therapeutic category. Incannex views these measures as meaningfully reducing regulatory and commercial risk for the psilocybin class broadly. PSX-001 is an investigational oral synthetic psilocybin therapeutic in development for Generalized Anxiety Disorder. Incannex completed a 73-patient Phase 2 clinical trial in Australia in 2025, reporting statistically significant and durable improvements in anxiety, functioning, depression, and quality of life measures. PSX-001 is the first oral synthetic psilocybin therapeutic in development for GAD. Announcement • Mar 17
Incannex Healthcare Regains Compliance with Nasdaq Minimum Bid Price Requirement On March 16, 2026, Incannex Healthcare Inc. (the Company) received a letter from the Listing Qualifications Department of The Nasdaq Stock Market LLC (Nasdaq) notifying the Company that the bid price deficiency under Nasdaq Listing Rule 5550(a)(2) (the Minimum Bid Price Rule), which the Company previously reported on in its Current Reports on Form 8-K filed on April 23, 2025 and Form 8-K filed on October 21, 2025, has been cured, and that the Company is now in compliance with the Minimum Bid Price Rule. 
