Company: IXHL
Filing Date: 2025-09-29
Form Type: 10-K
Source: 0001213900-25-092837
Chunk: 48

Company: Incannex Healthcare Inc.
Filing Date: 2025-09-29
Form: 10-K
Item: Item 1
Chunk 48
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 collaboration opportunities
as they arise, with the objective of maximizing the value of our pipeline and approved drug candidates. These efforts are aligned with
our commitment to delivering long-term value for our stockholders.

2

Lead Drug Candidates

The estimated addressable global market opportunity
for OSA medical devices is approximately US$8.2 billion, with an estimated compound annual growth rate (“CAGR”) of 7.33% from
2024 to 2029. Sales for GAD treatments in the United States reached approximately US$21 billion in 2023. The rheumatoid arthritis market
in the United States reached US$25.37 billion in 2023 and is expected to exceed US$31.58 billion by 2033. We believe our drug candidate,
IHL-675A, also has potential applications in other inflammatory conditions, such as inflammatory bowel disease, chronic obstructive pulmonary
disease (“COPD”), and asthma. Sales for these other inflammatory conditions in the United States totaled US$3.6 billion in
2022.

Clinical Approach

Through our internal research and collaborations with leading medical
institutions in Australia, we identified significant opportunities to pursue combination drug strategies targeting synthetic cannabinoids
and psychedelic agents to address unmet medical needs. Combination therapy allows for lower doses than monotherapy, which may reduce the
likelihood of unwanted side effects while enhancing efficacy.

●IHL-42X and IHL-675A: In these programs, we are developing oral fixed-dose combinations in which the active agents target different
components of disease pathophysiology. Having two drugs with independent mechanisms of action increases the likelihood of synergistic
benefit beyond what either drug could achieve alone. Clinical data  supports these synergistic advantages.

●PSX-001: Our psilocybin treatment comprises administration of PSX-001 with psychological support from trained therapists. Evidence
suggests psilocybin may have beneficial effects across several mental health conditions, and the combination with structured therapy is
designed to optimize outcomes and safety.

●Regulatory strategy: The development path for our cannabinoid programs enables pursuit of the FDA’s 505(b)(2) pathway. This
approach may substantially reduce time from drug concept to in-human trials by leveraging existing nonclinical toxicology data for the
individual agents.

●Geographic execution: Initial preclinical and early-stage clinical development was conducted primarily in Australia, providing cost
efficiency and access to the Australian R&D rebate program. With this foundation, we believe we