Company: IXHL
Filing Date: 2025-09-29
Form Type: 10-K
Source: 0001213900-25-092837
Chunk: 55

Company: Incannex Healthcare Inc.
Filing Date: 2025-09-29
Form: 10-K
Item: Item 1
Chunk 55
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 improved daily functioning for patients with OSA.

●Polysomnography (“PSG”) Metrics: IHL-42X drastically improved objective sleep parameters as measured by PSG. 

●Wake After Sleep Onset: Reduced by 29.8% in the high-dose arm, meaning patients spent less time awake during the night.

●AHI During Supine Sleep: Decreased by 30.3% in the high-dose arm, a critical improvement given supine sleep exacerbates apneic
events.

6

●Rapid Eye Movement (“REM”) Sleep: IHL-42X did not reduce the proportion of time spent
in REM sleep, as measured in the PSGs. This distinguishes IHL-42X from many drugs that are approved for other sleep indications, which
are known to reduce the amount of time spent in REM sleep. REM is an important stage of sleep that contributes to memory consolidation,
emotional regulation and brain health.

IHL-42X was also observed to be well-tolerated
across both low- and high-dose cohorts. No serious adverse events were reported during the treatment period, and TEAEs were infrequent,
with the majority being mild or moderate in severity.

We are finalizing arrangements for our End of Phase
2 meeting with the FDA to get feedback on planned next steps, including a pivotal Phase 3 trial design.

General Anxiety Disorder

Generalized Anxiety Disorder or “GAD”

GAD is a chronic, often debilitating mental health
disorder that affects approximately 10% of U.S. adults in their lifetimes. Symptoms of GAD include excessive anxiety and worry that persist
for over six months, which can lead to significant impairments in social, occupational and other functioning, according to the National
Institute of Mental Health. GAD is the most common anxiety disorder seen in primary care settings. An estimated 6.8 million adults are
diagnosed with GAD in a given year in the United States.

Existing Treatments

There is a significant unmet need for new therapies
in GAD. Current recommendations for GAD treatment include selective serotonin reuptake inhibitors (“SSRIs”), serotonin and
noradrenaline reuptake inhibitors (“SNRIs”), and pregabalin as first-line options, with benzodiazepines as second-line options.
GAD is also treated with psychotherapy alone or in combination with pharmacotherapies. However, these treatments have significant limitations,
including a delayed