Here are the 10-K annual reports from Incannex Healthcare Limited (IXHL) in our archive since June 2025, newest first, and each one links through to the document itself with the summary and the scores our analysis gives it.
A 10-K covers the audited annual report, with the full financial statements, so if you follow IXHL and want that one kind of document rather than the whole filing history, this is the page to keep. The company's other filings, of every form, are on the full IXHL filings page.
Incannex Healthcare Inc. (IXHL) is a clinical-stage biopharmaceutical company advancing IHL-42X for obstructive sleep apnea (OSA), while evaluating next steps for PSX-001 in generalized anxiety disorder (GAD) and IHL-675A in inflammatory conditions. The FDA granted IHL-42X Fast Track designation in December 2025. Its DReAMzz Phase 2 dose-confirmation study is enrolling approximately 120 subjects at 14 U.S. sites and evaluates nine dose combinations; completion is estimated for mid-2027, with results expected to inform a planned Phase 3 design.
In RePOSA, the Phase 2 portion was completed in July 2025, and Incannex reported statistically significant AHI reductions and improvements in several patient-reported measures. In the completed PsiGAD1 Phase 2 trial, the company reported an average 12.8-point reduction in HAM-A anxiety scores sustained over an 11-week follow-up. The Australian Phase 2 trial of IHL-675A was terminated after recruitment challenges, and the company said the data were insufficient for conclusions on safety or efficacy. The USPTO granted a key patent for IHL-42X in June 2026.
Incannex Healthcare Inc. (IXHL) is an R&D-focused clinical-stage company developing three lead drug candidates: IHL-42X (for obstructive sleep apnea), PSX-001 (psilocybin-based therapy) and IHL-675A (inflammatory and autoimmune indications). Clinical data disclosed for IHL-42X show statistically significant reductions in AHI versus placebo (maximum reductions up to 83% high-dose, 79% low-dose) and clinically meaningful improvements in patient-reported outcomes including fatigue and sleep impairment. Financially the company reported continuing operating losses ($23.8M loss from operations) and net cash outflows from operations (~$12.5M for FY 2025). The company raised gross proceeds of ~$12.5M from an equity offering (9.687M shares at $1.08) and undertook financings, debenture repayments and warrant cancellations during the year. Material risks highlighted include dependence on R&D tax incentives, need for DEA scheduling and FDA/other regulatory approvals, potential listing risk on Nasdaq, and ongoing cash requirements to advance pivotal programs.