Incannex Healthcare (IXHL) Appoints Douglas B. Kirsch to its Board

Incannex Healthcare Inc. (Nasdaq: IXHL) (“Incannex” or the “Company”), a clinical-stage biopharmaceutical company advancing combination drug therapies for high-impact indications, announces the appointment of Douglas B. Kirsch, M.D., FAAN, FAASM to its IHL-42X Obstructive Sleep Apnea (OSA) Clinical Advisory Board.

“We are honored to welcome Dr. Kirsch to the IHL-42X Clinical Advisory Board,” stated Dr. Lou Barbato, Incannex Chief Medical Officer. “His extensive clinical experience and leadership within the sleep medicine community will be instrumental as we advance IHL-42X through late-stage development. With his addition, our advisory board continues to strengthen its depth of expertise at a pivotal time for the program.”

Dr. Kirsch is a recognized authority in the field of sleep medicine with a long-standing track record of clinical, academic, and organizational leadership. He currently serves as Medical Director of Atrium Health Sleep Medicine, where he oversees clinical sleep medicine services across a large, multi-state hospital system while maintaining an active clinical practice. He is also a Clinical Professor in the Department of Neurology at the Wake Forest School of Medicine and has previously held faculty appointments at both the University of Michigan Medical School and Harvard Medical School.

Dr. Kirsch served as President of the American Academy of Sleep Medicine (AASM) from 2018 to 2019 and has played a leading role in national education efforts, including as Program Chair for the SLEEP Meeting (2012–2014) and Chair of the AASM Sleep Medicine Trends course (2023–2025). His current interests focus on emerging technologies in sleep medicine and demonstrating the value of sleep care across healthcare systems.

Dr. Kirsch joins recently announced advisors Scott A. Sands, Ph.D., Ali Azarbarzin, Ph.D., Nancy Collop, M.D., and Lora J. McGill, M.D., FAAN, in supporting the advancement of IHL-42X, an oral fixed-dose combination therapy designed to address obstructive sleep apnea by targeting the physiological mechanisms of intermittent hypoxia and hypercapnia. The Company expects to report topline Phase 2 data from its U.S. RePOSA study in July 2025, with Phase 3 initiation targeted for later in the year.

About IHL-42X
IHL-42X is designed to treat obstructive sleep apnea (“OSA”) by targeting its underlying pathophysiology. An oral fixed-dose combination of dronabinol and acetazolamide, IHL-42X is currently advancing through the RePOSA Phase 2/3 clinical trial, which is expected to enroll more than 560 patients at sites worldwide.

Designed to act synergistically, IHL-42X uniquely targets two physiological pathways associated with the intermittent hypoxia (“IH”) and hypercapnia that characterize OSA. In a prior Australian Phase 2 clinical trial, IHL-42X was shown to reduce the Apnea-Hypopnea Index (“AHI”) in all dosage strengths, with the lowest dose reducing AHI by an average of 51 percent relative to baseline. RePOSA, a global Phase 2/3 clinical trial is underway, evaluating IHL-42X in individuals with OSA who are either non-compliant, intolerant, or naïve to positive airway pressure devices, including CPAP, with the Phase 2 portion conducted in the United States. A topline readout from the U.S. Phase 2 portion is anticipated in July 2025.

Unlike weight loss therapies, IHL-42X is uniquely engineered to target two key physiological pathways, intermittent hypoxia (IH) and hypercapnia, that underlie the pathology of OSA. By targeting these core mechanisms, IHL-42X offers a differentiated approach that may benefit a wider range of patients, including the 67% of individuals with OSA who are not classified as obese. OSA affects an estimated 1 billion people globally and approximately 30 million people in the United States. Despite its high prevalence OSA remains significantly underdiagnosed and undertreated. IHL-42X has the potential to address this critical gap in care and improve outcomes for millions living with this serious, chronic condition.

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