Company: IXHL
Filing Date: 2025-09-29
Form Type: 10-K
Source: 0001213900-25-092837
Chunk: 59

Company: Incannex Healthcare Inc.
Filing Date: 2025-09-29
Form: 10-K
Item: Item 1
Chunk 59
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 for the development and cGMP manufacture of Incannex’s oral psilocybin drug candidate, PSX-001.
This drug candidate will be used in our planned clinical trials.

Model Mental Health Clinic for Psychedelic-Assisted Psychotherapy

On June 17, 2025, we announced our 50:50 joint
venture with Mind Medicine Australia (“MMA”) to operate a psychedelic-assisted therapies services clinic in Melbourne, Australia.
The new entity, MMA Clinics, represents a strategic advancement in our commercialization model. The joint venture will deliver a fully
integrated suite of services including clinical operations, governance, medicine supply, medical oversight, and marketing support to a
growing network of aligned authorized prescribers across Australia.

IHL-675A

We are developing IHL-675A, an oral fixed-dose
combination drug candidate that contains synthetic CBD and hydroxychloroquine sulphate (“HCQ”) for the treatment of inflammatory
conditions, with an initial focus on rheumatoid arthritis. Inflammatory conditions occur when the body’s immune system attacks its
own tissues and organs causing inflammation, pain, discomfort, and damage to the affected tissues.

IHL-675A comprises a combination of hydroxychloroquine
sulphate, an approved anti-rheumatic drug, and synthetic CBD. HCQ is a disease modifying antirheumatic drug that regulates the activity
of the immune system, which may be overactive in some conditions. HCQ can modify the underlying disease process, rather than simply treating
the symptoms. In our in vitro studies and disease model experiments, we demonstrated that IHL-675A components, CBD and HCQ, act synergistically
to inhibit production of key inflammatory cytokines as well as other key measures of disease severity. Based on the results of these experiments,
we believe IHL-675A also has the potential for use in rheumatoid arthritis and other inflammatory conditions, such as acute respiratory
distress syndrome, COPD, asthma, bronchitis and inflammatory bowel diseases, e.g. colitis and Crohn’s disease. The rheumatoid arthritis
market in the United States is growing rapidly with sales for rheumatoid arthritis treatments reaching US$25.37 billion in 2023. This
market is expected to exceed US$31.58 billion by 2033.

Manufacturing Arrangements

We engaged Procaps for the manufacture of a specific
oral, fixed-dose formulation of IHL-675