Incannex Provides Shareholder Update Highlighting Clinical Progress, Capital Discipline, and EOY 2025 Strategic Focus

Core Insights - Incannex Healthcare Inc. is making significant progress in clinical, regulatory, and capital initiatives aimed at long-term growth [1] Recent Highlights - IHL-42X (OSA) Phase 2 trial showed statistically significant efficacy with up to 83% reduction in Apnea-Hypopnea Index (AHI) from baseline, indicating potential for improved treatment of obstructive sleep apnea [2] - Patient-reported outcomes were positive, with 57.6% of participants reporting perceived improvement, increasing to 78.6% in the low dose group, and 86.4% of those reporting improvement found it meaningful to daily life [2] Priorities for the Remainder of 2025 - The company is focusing on regulatory engagement and planning for late-stage development of IHL-42X and PSX-001, with ongoing discussions with the U.S. FDA to define optimal pathways for late-stage studies [3] - Further updates will be provided after FDA interactions are concluded [3] PSX-001 Phase 2 Results - PSX-001 demonstrated statistically significant improvements in anxiety symptoms compared to placebo, with sustained relief over 11 weeks and excellent safety profile [4] - The results indicate PSX-001's potential to address a significant unmet medical need in anxiety disorders [4] Financial Position - The company has not utilized its At-The-Market (ATM) facility since August 28, 2025, maintaining a stable share count of 347,705,507, reflecting strong capital efficiency [4] - This decision underscores the company's focus on long-term shareholder value creation and confidence in growth catalysts [4] Operational Readiness - Incannex is prioritizing activities to maintain clinical momentum, data integrity, and capital discipline as programs progress [5] - The company is evaluating opportunities for prudent capital deployment to support value-creating milestones [5] Strategic Collaborations - The company is exploring partnerships and co-development opportunities to advance its scientific initiatives and create long-term value for stakeholders [6] - The CEO emphasized the significance of the Phase 2 trial results for IHL-42X in transforming treatment for obstructive sleep apnea [6][7] Overall Positioning - With two successful Phase 2 trials completed and a Nasdaq extension secured, Incannex is positioned to capitalize on strong clinical validation and disciplined capital management as it advances toward late-stage development [8]