Company: IXHL
Filing Date: 2025-09-29
Form Type: 10-K
Source: 0001213900-25-092837
Chunk: 56

Company: Incannex Healthcare Inc.
Filing Date: 2025-09-29
Form: 10-K
Item: Item 1
Chunk 56
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 onset of action, poor therapy adherence rates and substantial treatment side effects. In particular, the side effects
associated with long-term use of these pharmacotherapies include emotional numbness, reduced positivity, weight gain, sexual dysfunction,
and suicidal thoughts.

Psychedelic-Assisted Psychotherapy as a Treatment in Mental Health

Psychedelic-assisted psychotherapy may provide
rapid, significant, and lasting benefits in treating unipolar depression, depression and anxiety symptoms associated with a terminal illness,
and substance misuse. Psilocybin is a psychoactive molecule that occurs naturally in several genera of mushrooms, which primarily acts
on the serotonin receptor system, and can modulate states of consciousness, cognition, perception, and mood.

Over the past decade, there has been an accumulating
body of evidence that psilocybin may have beneficial effects in anxiety, depression, and other mental health conditions. In these studies,
administration of psilocybin with psychological support from trained therapists provided a rapid reduction in anxiety and depression symptoms
on the day of administration with generally maintained treatment effects at follow-up assessments many months later. These studies have
shown psilocybin to be generally well-tolerated. Most studies do not report serious adverse events.

Two psilocybin third-party research programs for
depression have received breakthrough therapy designation from the FDA. A small number of other psilocybin treatment development programs
are underway globally. Should the results from any of these research programs be positive, approval of psilocybin-assisted psychotherapy
as a prescription treatment could occur within the next five years.

7

PSX-001 for GAD

Our oral psilocybin lead candidate, PSX-001 is
designed to be used in combination with psychological therapy from trained therapists that has been specifically designed for patients
diagnosed with GAD. The therapy is designed to optimize patient safety and therapeutic outcomes in GAD with specific support before, during
and after PSX-001 dosing sessions.

Our psilocybin treatment includes administration
of two therapeutic doses of our drug candidate, PSX-001, with psychological support from trained therapists before, during and after each
dose session. The psychotherapy comprises three distinct phases:

●Preparation psychotherapy: conducted following full enrollment and prior to the first dosing session with a key focus on explaining
the concept of the trial and principles of the psychotherapy program to the patient, gaining and understanding of the patient’s
presenting problem(s), establishing a safety