Announcement • 14h
Incannex Healthcare Receives Additional AUD 5.1 Million R&D Tax Incentive Refund, Completing More Than AUD 11.2 Million In Non-Dilutive Capital Received In 2026 Incannex Healthcare Inc. had received the final AUD 5,102,788.30 refund under the Australian Government's Research and Development Tax Incentive Program following approval of the Company's overseas findings and amendment of its Fiscal year 2025 income tax return. Together with the previously announced AUD 6,039,162.43 refund, Incannex has now received more than AUD 11.2 million in non-dilutive capital during 2026. The receipt further enhances Incannex's already strong cash position and debt-free balance sheet, providing additional financial flexibility to advance its clinical pipeline while continuing to pursue shareholder-focused capital allocation initiatives. The refund recognizes the significant eligible Australian research and development activities undertaken by the Company in developing therapeutic regimens designed to address challenging chronic conditions during the financial year ended June 30, 2025. Total Fiscal year 2025 R&D Tax Incentive proceeds now exceed AUD 11.2 million. Entire amount received as non-dilutive capital, with no shareholder dilution. Further strengthens the Company's already robust balance sheet and financial flexibility. Supports continued advancement of key clinical assets, including IHL-42X and PSX-001. Reinforces disciplined capital management and shareholder-focused capital allocation strategy. The Australian Government's Research and Development Tax Incentive Program is designed to encourage innovation by providing eligible companies with cash refunds for qualifying research and development activities. Following approval of the Company's overseas findings, Incannex amended its Fiscal year 2025 income tax return, resulting in the additional refund announced. This outcome reflects the Company's successful execution of its strategy to maximize eligible R&D incentives while continuing to invest in the advancement of its clinical pipeline. These proceeds are entirely non-dilutive, enabling Incannex to recover a substantial portion of eligible research and development expenditure without issuing additional equity or taking on debt. Announcement • Jul 23
Incannex Healthcare Inc. Commences Participant Screening In Dreamzz Phase 2 Study Of IHL-42X For Obstructive Sleep Apnea Incannex Healthcare Inc. announce that participant screening has commenced in the Company's DReAMzz Phase 2 dose confirmation study evaluating IHL-42X for the treatment of obstructive sleep apnea (“OSA”). IHL-42X has previously been granted Fast Track designation by the U.S. Food and Drug Administration (“FDA”), underscoring its potential to address the significant unmet medical need in OSA and providing opportunities for more frequent interactions with the FDA throughout the development process, supporting a potentially expedited pathway towards regulatory review. The first tranche of clinical trial sites have now received approval to commence screening potential participants for the DReAMzz study, marking another important milestone in the advancement of Incannex's lead clinical program towards Phase III development. Additional clinical sites are expected to commence screening activities as they receive the necessary approvals. Potential participants will be identified through site patient databases and public outreach initiatives before undergoing screening assessments against the study's predefined inclusion and exclusion criteria. The commencement of screening represents the transition of the DReAMzz study into active clinical recruitment and follows significant operational progress made by the Company, including the appointment of a global CRO, completion of drug product manufacturing activities, finalization of import and export permits, and the establishment of clinical and drug distribution infrastructure required to support the study. The DReAMzz study has been strategically designed to optimize the dosing profile of IHL-42X while further evaluating the relationship between objective sleep metrics and patient-reported outcomes. The additional data generated from the study is expected to strengthen both the regulatory package and commercial positioning of IHL-42X ahead of the Company's planned Phase III development program. Importantly, patient-reported outcomes are becoming increasingly relevant in both regulatory review and commercialization strategies for therapies targeting chronic diseases such as OSA, particularly where improvements in quality of life, fatigue and overall patient wellbeing represent meaningful treatment objectives alongside objective clinical endpoints. Announcement • Jun 26
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. 
