Incannex Reports Positive Topline Results from RePOSA Phase 2 Trial of IHL-42X Statistically and clinically significant improvements across key clinical endpoints; IHL-42X reduced AHI by up to 83% from baseline. IHL-42X

Incannex Reports Positive Topline Results

from RePOSA Phase 2 Trial of IHL-42X

Statistically and clinically significant improvements

across key clinical endpoints; IHL-42X reduced AHI by up to 83% from baseline. IHL-42X demonstrates compelling clinical benefit and an

outstanding safety profile that exceeded expectations.

NEW YORK and MELBOURNE, Australia, July 30,

2025 - Incannex Healthcare Inc. (Nasdaq: IXHL) ("Incannex" or the "Company") is excited to share positive

topline results from its RePOSA Phase 2 clinical trial evaluating IHL-42X, a novel oral drug candidate for obstructive sleep apnoea (OSA).

With over 900 million people affected globally and no approved oral pharmaceutical treatments currently available, IHL-42X's robust

efficacy and exceptional safety profile position it as a potential transformative therapy for OSA patients worldwide. The results confirm

statistically significant and clinically meaningful improvements across key endpoints assessed in the study, reinforcing IHL-42x's

potential as a best-in-class therapy for patients with OSA.

Compelling Clinical Efficacy

The RePOSA Phase 2 trial demonstrated clear statistically

and clinically significant improvements across multiple key endpoints for patients receiving IHL-42X compared to placebo, highlighting

its potential to reduce OSA severity and enhance patient quality of life:

These results collectively demonstrate IHL-42X's

ability to address both objective and subjective aspects of OSA, offering compelling clinical benefits to patients.

Outstanding Safety Profile

IHL-42X was well tolerated across both low- and

high-dose cohorts. No serious adverse events were reported during the treatment period, and treatment-emergent adverse effects (TEAEs)

were infrequent, with the majority being mild or moderate in severity. This excellent safety profile supports IHL-42X's potential

for broad patient use.

Joel Latham, CEO and President of Incannex,

"We are extremely pleased with the RePOSA trial results. The combination of statistically significant improvements

across multiple endpoints and an outstanding safety profile positions IHL-42X as one of the most compelling drug candidates in the global

race to bring a pharmaceutical treatment for OSA to market. The depth of response seen in a defined subset of patients further reinforces

our belief in its clinical and commercial potential. These results are a clear signal of the strength of our development strategy and

a critical step forward in building long-term shareholder value. We continue to facilitate commercial discussions and look forward to

providing shareholders with an update in this regard soon."

Dr. Mark Bleackley, Chief Scientific Officer

"These findings highlight the statistically

significant treatment effects observed across multiple measures of disease severity and patient experience. Combined with an excellent

safety and tolerability profile, the results provide strong validation of IHL-42X's potential as an innovative and impactful therapy

for obstructive sleep apnea."

With positive Phase 2 data in hand, Incannex is

now focused on advancing IHL-42X toward commercial readiness. Preparations are in progress for the Company's End-of-Phase 2 meeting

with the FDA, where discussions will focus on identifying the most efficient and effective path to registration. This engagement is expected

to provide critical guidance for optimising the Phase 3 trial design and regulatory strategy.

In parallel, Incannex will continue to evaluate

all clinical data and complete the full Clinical Study Report in the coming months. These strategic activities mark a new phase of execution

for Incannex as it progresses toward late-stage development and possible future commercialisation.

RePOSA Phase 2 Trial Overview

The RePOSA Phase 2 trial was a randomized, double-blind,

placebo-controlled clinical study designed to evaluate the safety, tolerability, and efficacy of IHL-42X, a novel oral drug candidate

for the treatment of obstructive sleep apnoea (OSA). The study enrolled 121 adult participants with confirmed moderate to severe

OSA, who were randomized to receive either a high dose, low dose, or placebo version of IHL-42X for a 28-day treatment period. Efficacy

was assessed using both objective and patient-reported outcome measures aligned with FDA guidance, including the primary endpoint of change

in Apnea-Hypopnoea Index (AHI) as measured by polysomnography (PSG). Key secondary endpoints included the Oxygen Desaturation Index (ODI),

Patient Global Impression of Change (PGI-C), Epworth Sleepiness Scale (ESS), Functional Outcomes of Sleep Questionnaire (FOSQ-10), and

PROMIS fatigue and sleep-related impairment scores. The study was designed to generate high-quality clinical data to support the advancement

of IHL-42X into Phase 3 development and regulatory discussions.

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 apnea, rheumatoid

arthritis and generalized 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 apnea. In a Phase

2 development program, 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. Approved for Phase 2 clinical development, PSX-001 is an oral synthetic

psilocybin treatment for the treatment of generalized anxiety disorder. 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: Incannex's 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 of earlier clinical trials

or interim or topline results (such as the topline results of the RePOSA Phase 2 Study) will be representative or consistent with a full

Clinical Study Report, later clinical trials or their respective interim or final results; the potential benefits 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: the continued availability of financing; Incannex's ability to raise capital to fund

continuing operations, to complete capital raising transactions and to maintain or potentially further improve its capital structure;

Incannex's ability to maintain the listing of its shares of common stock on the Nasdaq Stock Market; the impact of any infringement

actions or other litigation brought against Incannex; the success of Incannex's development efforts, including Incannex's ability to progress

its drug candidates through clinical trials on the timelines expected (including its ability to successfully complete the Phase 3 trial

for IHL-42) and to obtain necessary regulatory approvals for commercialization of its product candidates, including IHL-42; the effects

of competition from other providers and products as currently existing or that may be developed in the future; that the market for its

drug candidates may not grow at the rates anticipated or at all or that estimates for these markets may ultimately be incorrect; that

Incannex may be unable to successfully execute upon any commercial discussions; Incannex's ability to comply with the various evolving

and complex laws and regulations applicable to its business and its industry; and Incannex's ability to protect its proprietary technology

and intellectual property; and other factors relating to Incannex's industry, its operations and results of operations. The forward-looking

statements made in this press release speak only as of the date of this press release, and Incannex assumes no obligation to update publicly

any such forward-looking statements to reflect actual results or changes in expectations, except as otherwise required by law. Incannex's

reports filed with the U.S. Securities and Exchange Commission (SEC) including its annual report on Form 10-K for the fiscal year ended

June 30, 2024, filed with the SEC on September 30, 2024, and the other reports it files from time to time, including subsequently filed

annual, quarterly and current reports, are made available on Incannex's website upon their filing with the SEC. These reports contain

more information about Incannex, its business and the risks affecting its business, as well as its results of operations for the periods

covered by the financial results included in this press release. For additional information on Incannex, please visit our website at www.incannex.com.

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