Expands clinical expertise to support disciplined advancement of the PSX-001 programMELBOURNE, Australia and NEW YORK, Jan. 29, 2026 (GLOBE NEWSWIRE) -- Incannex Healthcare Inc. (Nasdaq: IXHL), a clinical-stage biopharmaceutical company developing innovative combination therapies, today announced the appointment of three additional members to its recently established Clinical Advisory Board (“CAB”): Murray B. Stein, MD, MPH; Andrew Cutler, MD; and Amir Kalali, MD. The CAB was formed to provide independent c ...

Core Insights - Incannex Healthcare Inc. enters 2026 with over $70 million in cash, two positive Phase 2 programs, and FDA Fast Track designation, positioning the company for continued execution and growth [1][2] Financial Position and Capital Discipline - The company reported a strengthened balance sheet with over $70 million in cash, providing an operating runway well into 2027 [6] - Completed a $12.5 million private placement financing and eliminated all outstanding Series A warrants, removing legacy dilution overhang [6] - Authorized a $20 million share repurchase program and maintained disciplined use of its at-the-market (ATM) facility [6] Clinical and Regulatory Progress - Achieved two positive Phase 2 clinical readouts for IHL-42X (for obstructive sleep apnea) and PSX-001 (for generalized anxiety disorder) [4][6] - IHL-42X received FDA Fast Track designation, reflecting the unmet medical need for oral pharmacotherapy in obstructive sleep apnea [6] - Positive Phase 2 results for PSX-001 demonstrated statistically significant improvements on the primary efficacy endpoint (HAM-A) compared to placebo [6] Outlook for 2026 - The company plans to advance IHL-42X toward later-stage development following FDA Fast Track designation and progress PSX-001 through next-phase clinical and regulatory planning [9] - The strong cash position will allow the company to execute development priorities without near-term financing pressure [9] - Continued disciplined capital allocation is aligned with long-term shareholder value [9]

Core Points - Incannex Healthcare Inc. has received a 180-calendar-day extension from Nasdaq to regain compliance with the minimum bid price requirement, allowing until April 20, 2026, to maintain a closing bid price of at least US$1.00 per share for a minimum of ten consecutive business days [1][2] - The extension was granted as Incannex continues to meet all other continued listing criteria for the Nasdaq Capital Market and has indicated its intention to cure the deficiency, potentially through a reverse stock split [2][3] - The company has successfully delivered two Phase 2 clinical data packages this year, validating its development platform and positioning it for future growth [3] Company Overview - Incannex Healthcare is focused on developing combination medicines targeting chronic conditions such as obstructive sleep apnea, rheumatoid arthritis, and generalized anxiety disorder [4] - The lead clinical program, IHL-42X, is an oral fixed-dose combination of dronabinol and acetazolamide aimed at treating obstructive sleep apnea [4] - IHL-675A, another clinical-stage product, combines cannabidiol and hydroxychloroquine sulfate to alleviate inflammatory conditions like rheumatoid arthritis, while PSX-001 is an oral synthetic psilocybin treatment for generalized anxiety disorder [4]