Company enters 2026 with over $70 million in cash, two positive Phase 2 programs, FDA Fast Track Designation and runway well into 2027
MELBOURNE, Australia and NEW YORK, USA - January 14, 2026 - Incannex Healthcare Inc. (Nasdaq: IXHL), a clinical-stage biopharmaceutical company developing innovative combination therapies, provides a 2025 corporate year-in-review and outlook for 2026, highlighting substantial clinical, regulatory and financial progress that positions the Company for continued execution.
"The year 2025 was a defining one for Incannex," stated Joel Latham, Incannex Healthcare Chief Executive Officer. "We delivered two independent, positive Phase 2 clinical readouts across distinct CNS programs, achieved FDA Fast Track designation for our lead OSA candidate, and materially strengthened our balance sheet. Importantly, we enter 2026 with more than $70 million in cash with runway extending well into 2027, allowing us to focus primarily on execution. With clinical validation, regulatory momentum and financial flexibility now in place, we are in a very exciting position as we advance our programs toward later-stage development and continue building long-term value for patients and shareholders."
2025 Corporate Highlights
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Two Positive Phase 2 Clinical Readouts across distinct CNS programs
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FDA Fast Track Designation granted for lead obstructive sleep apnea candidate IHL-42X
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Strengthened balance sheet with over $70 million in cash on hand, providing operating runway well into 2027
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Capital structure optimization, including elimination of legacy warrant overhang and authorization of a share repurchase program
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Formation and expansion of OSA Clinical Advisory Board
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Clinical and Regulatory Progress
IHL-42X (Obstructive Sleep Apnea)
During 2025, Incannex advanced IHL-42X, its oral combination therapy for obstructive sleep apnea, through several critical milestones:
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Positive Phase 2 RePOSA topline data demonstrating statistically significant reductions in apnea-hypopnea index (AHI), with reductions of up to 83%
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Clinically meaningful improvements in patient-reported outcomes, reinforcing clinical relevance and potential real-world benefit
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FDA Fast Track designation reflecting unmet medical need for oral pharmacotherapy in OSA and the potential of IHL-42X to address it
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PSX-001 (Psi-GAD - Generalized Anxiety Disorder)
In parallel, Incannex reported positive Phase 2 clinical results for PSX-001, its psilocybin-assisted therapy for generalized anxiety disorder:
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Statistically significant and clinically meaningful improvement on the primary efficacy endpoint (HAM-A) compared to placebo
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Favorable secondary endpoint outcomes and tolerability profile, which are supportive of continued development
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Clinical Advisory Board Expansion
To support advancing programs toward later-stage development, Incannex established a dedicated Obstructive Sleep Apnea Clinical Advisory Board comprised of leading experts in sleep medicine and respiratory disorders.
Financial Position and Capital Discipline
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Reported cash and cash equivalents exceeding $70 million, providing operating runway well into 2027
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Completed a $12.5 million private placement financing
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Eliminated all outstanding Series A warrants, removing legacy dilution overhang
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Authorized a $20 million share repurchase program
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Maintained disciplined and limited use of its at-the-market (ATM) facility
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Outlook for 2026
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Advance IHL-42X toward later-stage development following FDA Fast Track designation
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Progress PSX-001 through next-phase clinical and regulatory planning
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Leverage strong cash position and runway into 2027 to execute development priorities without near-term financing pressure
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Continue disciplined capital allocation aligned with long-term shareholder value
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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.
