Company: IXHL
Filing Date: 2025-09-29
Form Type: 10-K
Source: 0001213900-25-092837
Chunk: 67

Company: Incannex Healthcare Inc.
Filing Date: 2025-09-29
Form: 10-K
Item: Item 1
Chunk 67
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 Generalized Anxiety Disorder
     
    - Antidepressants (SSRI/SNRI classes)
     
    - Non-curative, poor side effect profile. 
- Some patients become treatment resistant.

However, the biopharmaceuticals
industry is highly competitive. While we believe that our investigational synthetic cannabinoid-combination and psychedelic-assisted treatments
represent a fundamental shift in the treatment paradigm relative to other treatments for these serious, chronic diseases, 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. Accordingly,
our 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.

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. In addition, competitors may have higher name recognition
and more extensive collaborative relationships. Mergers and acquisitions in the pharmaceutical, biotechnology and diagnostic industries
may result in even more resources being concentrated among a smaller number of competitors. Smaller or emerging earlier stage companies
may also prove to be significant competitors, particularly if they have collaborations with larger, established companies. Competitors
in the OSA drug development space include Apnimed, Inc. and Mineralys Therapeutics. In particular, Apnimed’s lead product candidate
for OSA, AD109, has completed both Phase 2b and Phase 3 trials with topline results from its Phase 3 trials announced in May and July
2025. A number of companies are developing drug candidates intended for the treatment of GAD, including Cybin Inc., Otsuka Pharmaceutical
Development & Commercialization, Inc., Sunovion Pharmaceuticals Inc., Mind Medicine Inc., and others. Competitors working on novel
biopharmaceuticals focused on modulation of the serotonin and dopamine systems include Atai Life Sciences N.V., Compass Pathways plc,
GH Research plc and others. There are a large number of existing pharmaceutical companies marketing drugs for the treatment of rheumatoid
arthritis, including Pfizer Inc., Abbvie Inc., Am