Company: IXHL
Filing Date: 2025-09-29
Form Type: 10-K
Source: 0001213900-25-092837
Chunk: 58

Company: Incannex Healthcare Inc.
Filing Date: 2025-09-29
Form: 10-K
Item: Item 1
Chunk 58
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) an average 7.4-point reduction
in Generalized Anxiety Disorder 7-item scale scores, compared to a 3.5-point reduction for placebo (p<0.0004), (ii) a 6.0-point reduction
in Sheehan Disability Scale scores, versus 1.3 points in the placebo group (p<0.007), (iii) a 3.9-point reduction in Patient Health
Questionnaire-9 scores compared to just 0.3 points in the placebo group (p<0.005), and (iv) an improvement in Personal Wellbeing Index,
also known as “quality of life,” by an average of 10.6 points in the Psi-GAD group versus 2.7 points for placebo—a statistically
significant difference (p<0.002). PSX-001, within the context of psychotherapy, was observed to be well-tolerated with no serious adverse
events reported. The majority of TEAEs were transient, mild to moderate in nature and consistent with the expected pharmacological effects
of psilocybin. Only one of the 73 participants withdrew from the trial during the 7-week treatment program. No signs of increased suicidality,
psychosis, or prolonged psychological distress, concerns often cited with psychedelic treatments, were observed.

8

Next Steps in PSX-001 Clinical Development

The FDA has completed its review of and cleared
our IND and gave its authorization for us to proceed with a Phase 2b clinical trial investigating PSX-001 in patients diagnosed with GAD.
We are preparing to initiate this trial in 2026. This Phase 2b trial is expected to include approximately 94 subjects (including those
currently treated with SSRIs who meet the study inclusion and exclusion criteria), evaluate change in the HAM-A anxiety score and other
measures of efficacy and be conducted at multiple sites in the United States and the United Kingdom. The required review of the trial
dossier by the UK’s Medicines and Healthcare products Regulatory Agency (“MHRA”) has also been completed. We have designed
the follow-up Phase 2b clinical trial with the assistance of Clerkenwell Health, a UK-based contract research organization (“CRO”)
specializing in psychiatry and central nervous system treatments.

Development and Manufacture of Current Good Manufacturing Practices
(“cGMP”) Psilocybin Drug Product

We have engaged Ardena US LLC (formerly
Catalent Pharma Solutions LLC)