Company: IXHL
Filing Date: 2025-09-29
Form Type: 10-K
Source: 0001213900-25-092837
Chunk: 54

Company: Incannex Healthcare Inc.
Filing Date: 2025-09-29
Form: 10-K
Item: Item 1
Chunk 54
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ol and acetazolamide, at equivalent doses, as well
as placebo. The endpoints, inclusion criteria and study procedures are similar across both component studies, which is designed to streamline
the transition process from Phase 2 to Phase 3.

The Phase 2 portion of the RePOSA Study was completed
in July 2025 and demonstrated statistically and clinically significant improvements across multiple key endpoints for patients receiving
IHL-42X compared to placebo, highlighting its potential to reduce OSA severity and enhance patient quality of life:

●AHI: 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.
                                            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% 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%—demonstrating a strong therapeutic
                                            response in a substantial subset of the population.

●Patient
                                            Global Impression of Change (“PGI-C”) Sleep Related Impairment: The low-dose
                                            IHL-42X group showed statistically significant improvement (p<0.05) in PGI-C, reflecting
                                            meaningful patient-perceived benefits.

●PGI-C
                                            Fatigue: Statistically significant improvement in PGI-C Fatigue was observed in the low-dose
                                            group, suggesting enhanced daytime alertness and reduced fatigue.

●ODI:
                                            Both low- and high-dose groups demonstrated statistically significant improvements in ODI,
                                            indicating better oxygenation during sleep.

●Patient-Reported
                                            Outcomes: IHL-42X led to clinically significant improvements in patient-reported outcome
                                            measures, including the Functional Outcomes of Sleep Questionnaire-10, Patient-Reported Outcomes
                                            Measurement Information System (“PROMIS”) Sleep-Related Impairment 8a, PROMIS
                                            Fatigue 7a, and ESS in both low- and high-dose groups, demonstrating enhanced sleep quality,
                                            reduced daytime fatigue, and