Company: IXHL
Filing Date: 2025-09-29
Form Type: 10-K
Source: 0001213900-25-092837
Chunk: 66

Company: Incannex Healthcare Inc.
Filing Date: 2025-09-29
Form: 10-K
Item: Item 1
Chunk 66
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in the scientific or patent literature often lags behind actual discoveries, we cannot be certain of the priority of inventions covered
by our issued patents, our pending patent applications or of patent applications we may file in the future. Moreover, we may have to participate
in interference proceedings or derivation proceedings declared by the U.S. Patent and Trademark Office (“USPTO”), or similar
proceedings outside the United States, to determine priority of invention.

We also own trademark registrations in Australia
and the United States to distinguish and/or protect our brand, including our company name and logo.

12

Competition

We are targeting indications that have limited,
inadequate, or no approved pharmaceutical treatment options. The table below outlines existing drugs and therapies used to treat the illnesses
we aim to treat with our drug candidates and what believe are some of the associated pitfalls for patients with these existing drugs and
therapies.

    IHL Drug Candidate
     
    Indication
     
    Existing Drugs and
Therapies
     
    Existing Drug and Therapy Pitfalls
  
    IHL-42X
     
    Obstructive Sleep Apnea
     
    - PAP device, dental device, surgery, Zepbound (tirzepatide)

    - Noisy mechanical device worn during sleep.
    - Potential poor patient compliance due to discomfort.
    - Surgery is invasive
    -Tirzepatide is only approved for the treatment of obese OSA patients,
and these obese patients represent approximately 33% of all OSA patients worldwide.

    IHL-675A
     
    Rheumatoid Arthritis
     
    - Corticosteroids 
- DMARDS 
- Biologic agents
     
    - High expense, significant side effect profiles. 
- Lack of efficacy or tolerability in certain patient cohorts.

    IHL-675A
     
    Lung Inflammation
     
    - Corticosteroids 
- Ventilator
     
    - Corticosteroids reduce immune system activity. 
- Ventilators are associated with a high rate of mortality.

    IHL-675A
     
    Inflammatory Bowel Disease
     
    - Corticosteroids 
- Immune system suppressors (ISSs) 
- Biologic agents
     
    - Corticosteroids can reduce immune system activity. 
- ISSs can damage the digestive tract lining.

    PSX-001