Strengthens clinical and regulatory guidance as PSX-001 advances to its next phase of development (Form 8-K)

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:

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.

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.

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.