Full Press Release Details
Incannex Healthcare Announces Formation of Clinical
Advisory Board for PSX-001 Program
Strengthens clinical and regulatory guidance
as PSX-001 advances to its next phase of development
MELBOURNE, Australia and NEW YORK, USA - January 22, 2026
- Incannex Healthcare Inc. (Nasdaq: IXHL), a clinical-stage biopharmaceutical company developing innovative combination therapies,
announces the formation of a Clinical Advisory Board (CAB) to support the continued advancement of its PSX-001 development program in
generalized anxiety disorder.
The newly established CAB has been formed to provide independent clinical
and scientific guidance as the Company progresses PSX-001 into its next phase of clinical and regulatory development. The CAB gathers
leading experts in psychiatry, neurobiology, and psychopharmacology, strengthening the scientific rigor and patient-focused approach underpinning
the Company's development strategy. Ultimately, among its roles, the CAB will advise Incannex on clinical trial design, endpoint
selection, regulatory engagement, and broader strategic approach for PSX-001 as the program advances.
"The formation of this Clinical Advisory Board represents an
important step forward for the PSX-001 program," stated Incannex Healthcare Chief Medical Officer Dr. Lou Barbato. "As we
move PSX-001 forward, the collected perspectives of this Clinical Advisory Board will help inform key development decisions and support
disciplined execution across clinical and regulatory milestones. This reflects a strategic and intentional approach to drug development,
facilitating informed choices that strengthen execution, manage risk, and support long-term shareholder value."
The inaugural PSX-001 Clinical Advisory Board includes:
| C. Neill Epperson, M.D. | ||
| Robert Freedman Endowed Professor and Chair, Department of Psychiatry, University of Colorado School of Medicine |
Dr. Epperson is an internationally recognized leader in psychiatry and women's brain health, with more than 30 years of NIH-funded
research spanning neuroendocrinology, mood disorders, and sex-based differences in psychiatric illness. She has authored over 220 peer-reviewed
publications and has led multiple large-scale, interdisciplinary research initiatives focused on the biological and clinical impact of
stress and hormonal transitions.
| Charles B. Nemeroff, M.D., Ph.D. | ||
| Matthew P. Nemeroff Professor and Chair, Department of Psychiatry and Behavioral Sciences, The University of Texas at Austin, Dell Medical School |
Dr. Nemeroff is a globally recognized authority in the pathophysiology and treatment of mood and anxiety disorders, with a particular
focus on early life adversity. He has published more than 1,300 scientific articles and reviews, and his research has been continuously
supported by grants from the National Institutes of Health. He currently leads multiple academic and clinical research initiatives in
neuroscience and psychiatric medicine.
| Alan F. Schatzberg, M.D. | ||
| Kenneth T. Norris, Jr. Professor of Psychiatry (Emeritus), Stanford University School of Medicine; Director, Stanford Mood Disorders Center |
Dr. Schatzberg is a pioneer in the biology and psychopharmacology of depressive disorders, with more than 700 publications and decades
of leadership in academic psychiatry. He is a former President of the American Psychiatric Association, the American College of Neuropsychopharmacology,
and the Society of Biological Psychiatry, and is a member of the National Academy of Medicine.
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
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ability to execute on its objectives, prospects o 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 will be representative or consistent with 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
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standards within the applicable extended grace period or following the applicable extended grace period; that Incannex may fail to comply
with Nasdaq listing standards other than the bid price rule; the closing price of the common stock may fall below $0.10 for ten consecutive
trading days and be subject to Nasdaq's low bid price rules and subject to delisting or denial of compliance periods; the continued
availability of financing; Incannex's ability to raise capital to fund continuing operations 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 and to obtain necessary
regulatory approvals for commercialization of its product candidates; 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, 2025, filed with
the SEC on September 29, 2025, 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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