Company: IXHL
Filing Date: 2025-09-29
Form Type: 10-K
Source: 0001213900-25-092837
Chunk: 64

Company: Incannex Healthcare Inc.
Filing Date: 2025-09-29
Form: 10-K
Item: Item 1
Chunk 64
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 three lead drug candidates in the above indications, we are also exploring the development of 25 other
secondary assets where we believe proof-of-concept has been established in either preclinical studies, Phase 1 clinical trials or Phase
2 clinical trials.

These secondary drug candidates target a variety
of potentially high-value indications, including topical cannabinoid candidates for various skin conditions (estimated global market size
US$1.8 billion in 2021), a chewable candidate for smoking cessation (estimated global market size US$28.9 billion in 2024 with estimated
9.2% CAGR) and a candidate for the treatment of opioid addiction (estimated global market size of $4.59 billion in 2021). We also believe
our lead drug candidate, IHL-675A, may be able to treat inflammatory bowel disease (estimated U.S. market size US$21 billion in 2021)
and pulmonary inflammatory diseases such as COPD and asthma (estimated combined U.S. market size US$36.7 billion in 2022).

Intellectual Property

We strive to protect the proprietary know-how and
technology that we believe is important to our business, including seeking and maintaining patents intended to cover our drug candidates
and compositions, their methods of use and processes for their manufacture, and any other aspects of inventions that are commercially
important to the development of our business. In addition to pursuing patent protection for all our assets, we rely on unpatented trade
secrets, know-how and other confidential information as well as proprietary technological innovation and expertise that are protected
in part by confidentiality and invention assignment agreements with our employees, advisors and consultants.

11

We plan to continue to expand our intellectual
property estate by filing patent applications directed to compositions, methods of use, treatment and patient selection, formulations
and manufacturing processes created or identified from our ongoing development of our drug candidates. We have two primary patent families
in our lead drug candidates, including IHL-42X and IHL-675A. Our IHL-42X patent portfolio consists of 12 pending applications, and our
IHL-675A patent portfolio consists of 16 pending applications. If granted, the patent applications in the IHL-42X patent portfolio are
expected to expire as far out as 2041 to 2043, and the patent applications in the IHL-675A patent portfolio are expected to expire as
far out as 2041 to 2042 (in each case, subject to any