Incannex Reports Positive Results from Phase 2 Clinical Trial of PSX-001 (Psi-GAD) for Generalised Anxiety Disorder Psi-GAD delivers statistically significant and clinically meaningful improvements across validated measu

Incannex Reports Positive Results from Phase

2 Clinical Trial of PSX-001 (Psi-GAD) for Generalised Anxiety Disorder

Psi-GAD delivers statistically significant and

clinically meaningful improvements across validated measures of anxiety, mood, disability, and quality of life; results establish PSX-001

as a leading psilocybin-assisted therapy in development globally

MELBOURNE, Australia and NEW YORK, USA - August 26 - Incannex Healthcare

Inc. (Nasdaq: IXHL) ("Incannex" or the "Company") is pleased to report positive data from its Phase 2 clinical

trial of PSX-001 (formerly Psi-GAD), a psilocybin-assisted psychotherapy treatment for Generalised Anxiety Disorder (GAD). The results

confirm statistically significant and clinically meaningful improvements across every key endpoint assessed in the study, reinforcing

PSX-001's potential as a best-in-class therapy for patients with moderate to severe GAD.

Trial Design Overview

The randomized, double-blind, placebo-controlled

Phase 2 study enrolled 73 adult participants diagnosed with moderate to severe Generalised Anxiety Disorder. Participants were randomly

assigned to complete two dosing sessions with either a 25 mg dose of synthetic psilocybin or placebo, administered in a controlled clinical

setting as part of a proprietary psychotherapeutic protocol developed. All participants received equal hours of psychological support

and preparation, ensuring that any treatment effect could be attributed to psilocybin itself and not therapeutic bias. Efficacy was assessed

using a suite of validated clinical measures at multiple timepoints post-treatment, with the primary endpoint focused on change in HAM-A

(Hamilton Anxiety Rating Scale) scores.

Exceptional Efficacy Results: Statistically Significant and Clinically

Meaningful Improvements Across All Key Measures

The Phase 2 trial of Psi-GAD demonstrated a robust and consistent pattern

of efficacy, delivering statistically significant and clinically meaningful improvements across all primary and secondary endpoints.

HAM-A (Hamilton Anxiety Rating Scale): Patients

treated with Psi-GAD achieved an average 12.8-point reduction in HAM-A scores from baseline, compared to a 3.6-point reduction in the

placebo group. This difference was statistically significant (p<0.0001) and sustained across the 11-week follow-up period, indicating

a rapid onset and durable treatment effect. As the trial's primary endpoint, the HAM-A outcome establishes a strong efficacy signal

Figure 1. Change from baseline in HAM-A scores showing

statistically significant and durable reduction inanxiety symptoms with PsiGAD compared to placebo.

Clinical Response and Remission: Psi-GAD

treatment resulted in a clinically meaningful response, corresponding to a reduction in HAM-A score from baseline of 50% in 44.1%

of patients. A response rate more than four times higher than that of the placebo group. Of patients receiving PsiGAD treatment, 27% achieved

full disease remission (HAM-A 7), five times higher than placebo.

Figure 2. Rates of clinical response ( 50% reduction

in HAM-A) and full remission (HAM-A 7) demonstrating substantial efficacy of PsiGAD vs. placebo.

GAD-7 (Generalised Anxiety Disorder 7-item

scale): The Psi-GAD group recorded an average 7.4-point reduction in GAD-7 scores, compared to a 3.5-point reduction for placebo.

This difference was statistically significant (p<0.0004), confirming Psi-GAD's effect across multiple validated measures of anxiety

SDS (Sheehan Disability Scale): Patients

in the Psi-GAD group experienced a 6.0-point reduction in SDS scores, versus 1.3 points in the placebo group-a statistically significant

improvement (p<0.007). These results demonstrate a marked improvement in functional impairment across work, social, and family domains,

which are often severely impacted in GAD.

PHQ-9 (Patient Health Questionnaire-9): Psi-GAD

also showed statistically significant antidepressant effects, with a 3.9-point reduction in PHQ-9 scores compared to just 0.3 points in

the placebo group (p<0.005). This supports PSX-001's broad therapeutic utility in mood-related comorbidities.

PWI (Personal Wellbeing Index): Quality

of life, as measured by the PWI, improved 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). These results reflect substantial and sustained enhancements in overall psychological wellbeing.

Safety and Tolerability

Treatment with Psi-GAD was well tolerated

across the study population. No serious adverse events (SAEs) were reported, and only one of the 73 subjects withdrew from the trial

during the 7 week treatment program. The majority of treatment-emergent adverse events (TEAEs) were transient, mild to moderate in nature,

and consistent with the expected pharmacological effects of psilocybin. Importantly, there were no signs of increased suicidality, psychosis,

or prolonged psychological distress-concerns often cited with psychedelic treatments. The controlled setting, comprehensive preparation,

and therapist-supported integration sessions contributed to the overall safety of the intervention. These findings reinforce the strong

risk-benefit profile of Psi-GAD and support its continued advancement into late-stage development.

Dr. Lou Barbato, Chief Medical Officer of Incannex, commented:

results speak for themselves-statistically significant, clinically meaningful, and consistent across every validated measure. Psi-GAD

demonstrated a reduction in anxiety, improved mood, enhanced quality of life, and better day-to-day functioning. Importantly, the treatment

effect was durable and observed across 11 weeks. These outcomes reinforce the power of our proprietary psychotherapeutic model and position

Psi-GAD as a global leader in anxiety treatment innovation. We are also very pleased with the safety profile of Psi-GAD, particularly

when considered alongside comparator programs in the market, which strengthens our confidence in both the clinical utility and scalability

Joel Latham, President and Chief Executive Officer of Incannex,

"These are outstanding results for Incannex and a major milestone for our clinical pipeline. Alongside our strong cash position,

the success of PSX-001 significantly de-risks another of our lead assets and further validates our strategy of developing innovative

combination and psychedelic-based therapies. To deliver back-to-back positive Phase 2 results for both PSX-001 and IHL-42X is an exceptional

achievement, and one that gives us tremendous confidence as we progress towards late-stage development and continue to build value for

patients and shareholders alike."

The Company has an open Investigational New Drug

(IND) application with the U.S. FDA and is preparing to initiate a multi-jurisdiction Phase 2 clinical trial. In parallel, Incannex continues

to refine formulation strategies to ensure a robust and defensible intellectual property (IP) position. The Company is also exploring

strategic partnerships to accelerate development and broaden global access to PSX-001 for patients with unmet needs.

Figure 3. PsiGAD reduced anxiety scores to a greater extent than that

reported for approved anxiety medications.

About Incannex Healthcare Inc.

Incannex is leading the way in developing combination

medicines that target the underlying biological pathways associated with chronic conditions, including obstructive sleep apnoea, rheumatoid

arthritis, and generalised anxiety disorder. The company is advancing three clinical-stage product candidates based on evidence-based

innovation, and supported by streamlined operations.Incannex's lead clinical program, IHL-42X, is an oral fixed-dose combination

of dronabinol and acetazolamide designed to target underlying mechanisms and act synergistically in the treatment of obstructive sleep

apnoea. IHL-42X has successfully completed a Phase 2 clinical trial. PSX-001 is a synthetic psilocybin treatment for the treatment

of generalised anxiety disorder. PSX-001 has recently completed a Phase 2 clinical trial with positive results, establishing it as a leading

psilocybin-assisted therapy in development globally. IHL-675A is an oral fixed-dose combination of cannabidiol and hydroxychloroquine

sulfate designed to act synergistically to alleviate inflammatory conditions, such as rheumatoid arthritis. IHL-675A is currently in a

Phase 2 clinical development program. Incannex's programs target disorders that have limited, inadequate, or no approved pharmaceutical

treatment options. For additional information on Incannex, please visit our website at www.incannex.com.

Forward Looking Statements

This press release contains "forward-looking

statements" within the meaning of the "safe harbor" provisions of the U.S. Private Securities Litigation Reform Act of

1995. Forward-looking statements are statements other than historical facts and relate to future events, future circumstances and Incannex's

future performance. These statements are based on management's current assumptions, expectations, and beliefs. Examples of forward-looking

statements in this press release include statements about, among other things: statements regarding potential future dilution; Incannex's

opinions and estimates about the fundamentals and underlying value of its business relative to the trading price of its common stock;

business strategy, future operations; Incannex's ability to execute on its objectives, prospects, commercial discussions or plans; evaluations

and judgments regarding Incannex's research and development efforts and potential future commercialization, including any implications

that the results (including qualitative patient-reported outcomes) of earlier clinical trials or interim or topline results will be representative

or consistent with later clinical trials or their respective interim or final results; the potential benefits (including qualitative patient-reported

outcomes) and safety of Incannex's drug candidates and the market opportunity for these candidates; and potential shareholder value. These

forward-looking statements are subject to a number of risks and uncertainties, which may cause the forward-looking events and circumstances

described in this press release to not occur, and actual results to differ materially and adversely from those described in or implied

by the forward-looking statements. These risks and uncertainties include, among others: that current expense and cash resource estimates