Incannex provides shareholder update including 2025 priorities

The company said, “Recent Highlights: IHL-42X Phase 2 – Statistically significant efficacy, outstanding patient-reported outcomes, and strong safety profile – Incannex (IXHL) reported Phase 2 data for IHL-42X demonstrating statistically significant and clinically meaningful reductions in Apnea-Hypopnea Index of up to 83% from baseline, confirming the potential of IHL-42X to meaningfully improve disease severity in obstructive sleep apnea. The study also showed significant improvements across multiple sleep-quality and fatigue instruments, accompanied by an outstanding safety and tolerability profile. Structured exit interviews reinforced the objective findings, with 57.6% of participants across the study, increasing to 78.6% of those assigned to the low dose group, reporting perceived improvement in their OSA. Of participants reporting an improvement in their OSA, 86.4% described the benefit as meaningful to daily life. Together, we believe these results demonstrate a potential consistent and meaningful treatment effect across both quantitative and qualitative measures PSX-001 Phase 2: Positive Topline Results – The Company reported statistically significant and clinically meaningful improvements versus placebo across the primary endpoint and multiple secondary measures, demonstrating both the robust efficacy and breadth of therapeutic impact of PSX-001. Participants experienced sustained symptom relief over 11 weeks, highlighting the durability of the treatment effect. The study also confirmed excellent tolerability and safety, with no serious adverse events reported. We believe these results underscore PSX-001’s potential to set a new standard in the treatment of anxiety disorders, addressing a large unmet medical need with an innovative, well-tolerated therapy that could transform the lives of millions of patients worldwide. At-The-Market Offering – The Company has not utilized its ATM facility since August 28, 2025, with the total number of shares on issue remaining unchanged at 347,705,507, as reported in the Company’s Form 10-K. We believe this highlights the Company’s strong balance sheet and capital efficiency, enabling the continued advancement of its lead clinical programs without the current need for further equity dilution. The decision reflects management’s strategic discipline and unwavering focus on its goal of long-term shareholder value creation, reinforcing the strength of the Company’s financial position and its confidence in near-term growth catalysts. Priorities for the Remainder of 2025: Regulatory engagement and late-stage advancement – Following two successful Phase 2 readouts, Incannex is prioritizing regulatory engagement and next-phase planning to support the advancement of IHL-42X and PSX-001 into pivotal development. The Company is actively working through the next steps of engagement with the U.S. Food and Drug Administration, including preparation for formal interactions and related development planning activities. These discussions are focused on defining the optimal pathway for late-stage studies, clinical design considerations, and potential regulatory designations to support expedited review. Incannex expects to provide the market with a further update once these FDA interactions have concluded and the forward development strategy for each asset is confirmed. Operational readiness and study execution – The Company is prioritizing activities that maintain clinical momentum, data integrity, and capital discipline as programs progress. Capital allocation discipline – Incannex continues to evaluate opportunities to deploy capital prudently in support of value-creating milestones, including, as appropriate, utilization of the previously authorized repurchase program. Strategic collaboration and partnership exploration – The Company also intends to evaluate partnership, co-development, and joint-venture opportunities with aligned organizations to advance its science, expand platform applications, and build tangible long-term value for all stakeholders.”