Company: IXHL
Filing Date: 2025-09-29
Form Type: 10-K
Source: 0001213900-25-092837
Chunk: 49

Company: Incannex Healthcare Inc.
Filing Date: 2025-09-29
Form: 10-K
Item: Item 1
Chunk 49
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 are well positioned for development
with the FDA. We may continue to conduct certain smaller studies in Australia to generate supportive data while advancing pivotal trials
under U.S. INDs.

3

IHL-42X

Obstructive Sleep Apnea or “OSA”

OSA is a disease of sleep disordered breathing
characterized by a narrowing or collapse of the upper airway during sleep, which interferes with breathing and reduces sleep quality.
Presentation of OSA often includes snoring and waking up gasping for air. Though OSA is recognized as a relatively common and chronic
disorder, it remains underdiagnosed and inadequately treated. Untreated OSA is associated with a wide range of serious long-term outcomes,
including cardiovascular disease, cognitive impairments such as memory loss, poor concentration and judgment, depression and increased
risk of death or injury due to traffic accidents resulting from excessive daytime sleepiness. The substantial patient and society costs
related to undiagnosed and diagnosed obstructive OSA include increased healthcare usage, reduced productivity, and diminished quality
of life.

A 2019 article published by The Lancet premised
on literature-based analysis of 17 studies across 16 countries, estimated that OSA affects some 936 million adults worldwide. This alarming
statistic is thought to be increasing due to the growing prevalence of obesity and an aging global population. Many people with OSA develop
high blood pressure (hypertension), which can increase the risk of cardiovascular disease. OSA is considered a serious medical condition;
the more severe the OSA, the greater the risk of coronary artery disease, heart attack, heart failure, stroke and shortened life span.

There are limited drug treatment options for OSA.
Certain drug products containing tirzepatide, a GLP-1 agonist, are approved for treatment of OSA in obese patients. Tirzepatide is also
approved to treat obesity, reducing body mass index. There is a well-established link between obesity and OSA risk, and one of the consequences
of reducing body mass index in obese patients with OSA is improvement of OSA severity. However, tirzepatide does not treat the pathophysiological
mechanisms of OSA outside of obesity and is not an available option for non-obese OSA patients, which is estimated to be greater than
67% of the OSA patient population.

Available non-pharmacological treatment options
for OSA include: the standard of care, positive air