Company: IXHL
Filing Date: 2025-09-29
Form Type: 10-K
Source: 0001213900-25-092837
Chunk: 143

Company: Incannex Healthcare Inc.
Filing Date: 2025-09-29
Form: 10-K
Item: Item 1
Chunk 143
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of factors, including:

●timing
                                            of market introduction, number and clinical profile of competitive products;

●our
                                            ability to provide acceptable evidence of safety and efficacy and our ability to secure the
                                            support of key clinicians and physicians for our drug candidates;

●cost-effectiveness
                                            compared to existing and new treatments;

●availability
                                            of coverage, reimbursement and adequate payment from health maintenance organizations and
                                            other third-party payers;

●prevalence
                                            and severity of adverse side effects; and

●other
                                            advantages over other treatment methods.

As
controlled substances, the products may generate public controversy. Physicians, patients, payers or the medical community may be unwilling
to accept, 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