Company: IXHL
Filing Date: 2025-09-29
Form Type: 10-K
Source: 0001213900-25-092837
Chunk: 57

Company: Incannex Healthcare Inc.
Filing Date: 2025-09-29
Form: 10-K
Item: Item 1
Chunk 57
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 plan and dosing day plan and conducting experiential exercises.

●Dosing sessions: the patients will be administered PSX-001 orally. Prior to dosing, the safety and dosing day plan are reviewed. Once
the patient is deemed ready for dosing the dose will be administered and the study team will provide support for navigating the experience.

●Integration psychotherapy: conducted following the dosing sessions, with a key focus on reviewing the dosing session, identifying
and exploring experiential avoidance that emerged in the dosing session and values-based actions.

Phase 2 Exploratory Proof-of-Concept Clinical Trial

We conducted an Australian Phase 2 exploratory,
proof-of-concept clinical trial, known as PsiGAD1, pursuant to an approval from the Human Research Ethics Committee.

The trial was a Phase 2 randomized triple-blind
active-placebo-controlled trial to assess the safety and efficacy of psilocybin-assisted psychotherapy for GAD. Participants experienced
two psilocybin or active-placebo dosing sessions and up to 11 non-drug, specialist psychotherapy sessions over a period of ten weeks.

Primary outcomes were safety, efficacy and tolerability,
and secondary outcomes included quality of life, functional impairment, and comorbidities. Safety was assessed by monitoring adverse events
including but not limited to liver function tests and scores on the Ultra Brief Checklist of Suicidality. Efficacy was assessed by comparing
the change in HAM-A scores from baseline between the placebo and treatment group. Tolerability was assessed by comparing the proportion
of participants who complete both dosing sessions in the placebo and treatment groups. Secondary endpoints were assessed by monitoring
disability, comorbidity, productivity and quality of life using patient reported outcome measures.

In August 2025, we reported full results which
demonstrated that the trial met its primary endpoint, supporting a clinical effect in the psilocybin treatment group compared to the placebo
group. Statistically meaningful reductions in HAM-A scores were observed, with patients being treated with PSX-001 achieving an average
12.8-point reduction from baseline that was sustained for an 11-week follow-up period. A greater than 50% reduction in HAM-A scores was
observed in 44.1% of patients receiving treatment, and 24% of patients receiving treatment achieved full disease remission, a number five
times higher than placebo. Improvements were also observed in secondary endpoint measures including, (i