Company: IXHL
Filing Date: 2025-09-29
Form Type: 10-K
Source: 0001213900-25-092837
Chunk: 50

Company: Incannex Healthcare Inc.
Filing Date: 2025-09-29
Form: 10-K
Item: Item 1
Chunk 50
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way pressure (“PAP”), including continuous positive airway pressure (“CPAP”),
in which an external device pneumatically splints the airway open to prevent disruptions in breathing; oral appliances to advance the
mandible or to retain the tongue, putting the mouth in a position more conducive to breathing; surgery to remove physical obstructions
to airflow; and implantable electronic stimulators to activate muscles at the base of the tongue, opening the airway in synchrony with
respiration. An estimated 50% of patients discontinue CPAP treatment within one year. Patient compliance to PAP devices is low due to
discomfort and claustrophobia resulting from pressurized air being pumped into the patient’s nose and/or mouth via a mask or nasal
pillow during sleep. These available treatment options, in many cases, are poorly tolerated, inadequate, expensive, and for implantable
stimulators and surgery, invasive.

Despite these discomforts, the global annual market
for sleep apnea devices is over US$8.2 billion and growing. The estimated compound annual growth rate for the global market of OSA devices
from 2024 to 2029 is 7.33%.

IHL-42X in OSA

IHL-42X is an oral fixed-dose combination of acetazolamide,
a carbonic anhydrase inhibitor approved for various indications, and dronabinol, a synthetic form of delta-9-tetrahydrocannabinol (“THC”)
approved for the treatment of nausea, vomiting and loss of appetite. Both agents have been shown in clinical studies to reduce the AHI.
We believe that the activity of dronabinol on cannabinoid receptors causes dilation of the airway, and acetazolamide induces modest metabolic
acidosis, signaling to the body that there is excess CO2 in the blood, thus increasing respiration. By combining two agents with mechanisms
known to reduce AHI in one pharmaceutical formulation, we believe IHL-42X may have therapeutic benefit at lower doses of each constituent
drug that are safe and tolerable.

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Phase 2 Clinical Trial for IHL-42X for OSA

We completed a Phase 2 clinical trial in Australia
to investigate the safety and efficacy of IHL-42X for the treatment of OSA. This study established proof-of-concept, the combination reduced
AHI in patients with OSA.

The primary endpoint of this Australian Phase 2
clinical trial was the change