Incannex Healthcare (IXHL) investor relations material

Strategic focus and pipeline overview

• Focuses on developing innovative oral fixed-dose combination medicines for chronic conditions with unmet needs, including obstructive sleep apnea (OSA), generalized anxiety disorder (GAD), and rheumatoid arthritis (RA).

• Pipeline includes three late-stage clinical programs: IHL-42X (OSA), PSX-001 (GAD), and IHL-675A (RA), all in Phase 2 or 2/3 development.

• Positive Phase 2 data reported for both OSA and GAD programs in August 2025.

• Holds approximately $70 million in cash as of December 2025, supporting advancement to Phase 3 trials.

• Strategic advisory support and fast-track designation for IHL-42X enhance clinical and regulatory positioning.

Market opportunities and unmet needs

• Targets large, underserved patient populations: 936 million globally with OSA, 280 million with GAD, and 19 million with RA.

• OSA market valued at $4.5B globally; GAD at $1.8B; RA at $25B, with significant portions of patients unresponsive to current therapies.

• OSA: 50% of patients non-compliant with current gold-standard PAP therapy after 12 months.

• GAD: ~50% of patients unresponsive to first-line SSRI treatment, highlighting need for new options.

• RA: 40% discontinue first-line bDMARDs due to intolerance or insufficient response.

Clinical program highlights

• IHL-42X (OSA): First oral therapeutic targeting underlying disease pathways, showing up to 83% reduction in AHI and significant improvements in ODI, fatigue, and sleep quality; well-tolerated with no serious adverse events.

• PSX-001 (GAD): First oral synthetic psilocybin therapeutic, with 44% achieving ≥50% anxiety reduction and 27% remission; broad benefits in daily functioning and quality of life; strong safety profile.

• IHL-675A (RA): Oral combination of synthetic cannabidiol and hydroxychloroquine; Phase 1 showed good tolerability and bioavailability; targets inflammation and pain with a differentiated mechanism.