Company: IXHL
Filing Date: 2025-09-29
Form Type: 10-K
Source: 0001213900-25-092837
Chunk: 286

Company: Incannex Healthcare Inc.
Filing Date: 2025-09-29
Form: 10-K
Item: Item 1A
Chunk 286
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 use or recommend our drug candidates which would adversely affect our potential revenues and future profitability. Adverse
publicity or public perception regarding cannabis and psilocybin to our investigational therapies using these substances may negatively
influence the success of these therapies.

We
face competition from entities that may develop drug candidates for our target disease indications and from entities currently providing
treatment to our target disease indications.

The development and commercialization of drug candidates
is highly competitive. We face or may face potential competition from many different sources, including major pharmaceutical, biopharmaceutical,
specialty pharmaceutical and biotechnology companies, academic institutions, governmental agencies and medical research organizations.
Many of our competitors may have significantly greater financial, manufacturing, marketing, drug
development, technical and human resources than we do. There are a number of products that are currently under development and
may become commercially available in the future, for the treatment of conditions for which we are developing, and may in the future try
to develop, drug candidates. For instance, Zepbound (tirzepatide) was recently approved for the treatment of OSA in obese patients. .
In addition, Apnimed’s lead product candidate for OSA, AD109, has completed both Phase 2b and Phase 3 trials with topline results
from its Phase 3 trial announced in July 2025. These and other potential competitors may succeed in obtaining FDA or other regulatory
approval for alternative or superior products. Any drug candidates that we successfully develop will compete with the standard of care
and new therapies that may become available in the future. Competing products could present superior treatment alternatives, including
by being more effective, safer, less expensive or marketed and sold more effectively than any products we may develop and may make any
products we develop obsolete or non-competitive before we recover the expense of developing and commercializing our drug candidates.

Our
competitors also may compete with us in recruiting and retaining qualified scientific and management personnel, in establishing clinical
trial sites and enrolling subjects for our clinical trials and in acquiring technologies complementary to, or necessary for, our programs.
These competitors could also recruit our employees, which could negatively affect our level of expertise and our ability to execute our
business plan.

Our
drug candidates for which we obtain approval may face competition sooner than anticipated.

Even
if we are successful in achieving regulatory approval to commercialize a drug candidate ahead of a potential competitor, our future approved
products may face direct competition from generic and other follow-on drug