Press Release of Incannex Healthcare Inc., dated January 15, 2026 (Form 8-K)

Incannex Healthcare Wins Research and Development Award for Obstructive Sleep Apnea Program in the 2025
Clinical Trials Arena Excellence Awards

MELBOURNE, Australia and NEW YORK - January 15^th, 2026 - (GLOBE NEWSWIRE) - Incannex Healthcare Inc. (Nasdaq: IXHL), a clinical-stage biopharmaceutical company developing innovative combination therapies, today announced that it has been honored with the Research and Development Award in the Respiratory Disorders category of the 2025 Clinical Trials Arena Excellence Awards for its work advancing IHL-42X, the Company's oral fixed-dose combination product candidate for the treatment of obstructive sleep apnea (OSA).

The Clinical Trials Arena Excellence Awards is an independent recognition program powered by GlobalData's business intelligence, in which researchers, journalists, and artificial intelligence analyze more than one billion datasets annually to identify and rank leading companies and achievements across more than 200 countries. Recognition in this program reflects the industry-wide relevance of Incannex's research-driven approach to addressing unmet needs in respiratory medicine.

IHL-42X is an oral fixed-dose combination of dronabinol and acetazolamide in development for adults with moderate-to-severe OSA, a chronic disorder that is still predominantly managed with device-based therapies such as positive airway pressure (PAP). In real-world practice, many patients remain untreated or undertreated due to intolerance, poor adherence, or reluctance to use nightly devices. Incannex's development strategy is grounded in established sleep-respiratory physiology, with a dual-component regimen designed to stabilize ventilatory control and improve upper airway muscle function, offering a potential standalone, non-invasive pharmacologic alternative for patients who are unable or unwilling to persist with device-based therapy.

The Company's late-stage development strategy for IHL-42X is supported by a robust Phase 2 clinical program that integrated objective polysomnography outcomes, validated patient-reported measures, and structured exit interviews in adults with moderate-to-severe OSA. The favorable safety and tolerability profile observed to date supports the continued development of IHL-42X for potential chronic use, if approved.

This recognition aligns with the core mission of the Clinical Trials Arena Excellence Awards, which focuses on identifying forward-thinking, innovative companies driving positive change across 12 key Areas of Excellence, including Research and Development. It also reflects Incannex's broader pipeline strategy, which centers on combination medicines and advanced therapeutics targeting underlying biological pathways in chronic conditions such as obstructive sleep apnea, rheumatoid arthritis, and generalized anxiety disorder. Across its clinical-stage programs - IHL-42X, IHL-675A, and PSX-001 - the Company remains focused on evidence-based innovation, streamlined operations, and outcomes that are meaningful to patients.

"We are honored to be recognized by the Clinical Trials Arena Excellence Awards for the deliberate, science-driven approach we have taken with IHL-42X," said Joel Latham, President and CEO of Incannex. "Obstructive sleep apnea continues to be an area of significant unmet medical need, particularly for patients who struggle with long-term adherence to device-based therapies. Our goal with IHL-42X has been to develop a purpose-built, oral combination therapy grounded in established sleep-respiratory physiology and supported by rigorous clinical and patient-reported evidence. This award underscores the importance of that approach as we advance IHL-42X into late-stage development."

About the Clinical Trials Arena Excellence Awards

The Clinical Trials Arena Excellence Awards is an independent recognition program powered by the business intelligence of GlobalData. Each year, GlobalData's team of researchers and journalists, supported by artificial intelligence, analyze more than one billion datasets to recognize, endorse, and rank top-tier companies and achievements across more than 200 countries. The program highlights forward-thinking organizations driving positive change across 12 Areas of Excellence, including Research and Development, Innovation, Safety, and Product Launches.
For more information, visit Clinical Trials Arena.

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.