Company: IXHL
Filing Date: 2025-09-29
Form Type: 10-K
Source: 0001213900-25-092837
Chunk: 45

Company: Incannex Healthcare Inc.
Filing Date: 2025-09-29
Form: 10-K
Item: Item 1
Chunk 45
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Item 1. Business

Overview

We are a clinical-stage biopharmaceutical company
dedicated to developing innovative medicines for patients living with serious chronic diseases and significant unmet needs.

IHL-42X, our drug candidate in a pivotal Phase
2/3 clinical trial for the treatment of obstructive sleep apnea (“OSA”) is an oral fixed-dose combination of dronabinol and
acetazolamide designed to act synergistically by targeting two different physiological pathways associated with the intermittent hypoxia
and hypercapnia that characterize OSA. In a proof-of-concept study conducted in Australia, as well as in the Phase 2 portion of our RePOSA
clinical trial, we observed that IHL-42X reduced apnea hypopnea index (“AHI”) and was well-tolerated in OSA patients.

In the Phase 2 portion of the RePOSA clinical trial
investigating, IHL-42X maximum reductions in AHI were observed at up to 83% for the high-dose group and up to 79% for the low-dose group.
Notably, 33.3% of patients in the low-dose group and 41.2% of patients in the high-dose group achieved a greater than 30% reduction in
AHI, while 13.9% (low-dose) and 14.7% (high-dose) experienced reductions exceeding 50%. Significant clinical improvement was observed
across multiple secondary endpoints. Observed treatment-emergent adverse effects (“TEAEs”) were infrequent, with the majority
being mild or moderate in severity. The low-dose and high-dose IHL-42X groups achieved a statistically significant reduction in percent
change in AHI from baseline compared to placebo (p<0.05), the primary measure of OSA severity. Based on these results, we are finalizing
arrangements for our  End of Phase meeting with the U.S. Food and Drug Administration (the “FDA”) to obtain guidance on
planned next steps, including a pivotal Phase 3 trial design.

PSX-001, our drug candidate in Phase 2 clinical
development, is an oral synthetic psilocybin treatment, administered in combination with psychological therapy for patients with moderate-to-severe
generalized anxiety disorder (“GAD”). We completed a Phase 2 clinical trial, known as PsiGAD1, in the results of which we
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