Dallas, Texas--(Newsfile Corp. - February 18, 2026) - Incannex Healthcare Inc. (NASDAQ: IXHL): Stonegate Capital Partners updates their coverage on Incannex Healthcare Inc. (NASDAQ: IXHL). Incannex continued to build the clinical and patient-reported evidence base for IHL-42X in obstructive sleep apnea (OSA), following full Phase 2 RePOSA data and exit-interview analyses. Both low and high-dose IHL-42X achieved statistically significant reductions in Apnea-Hypopnoea Index (AHI) versus placebo, with maximum ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended December 31, 2025 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 FOR THE TRANSITION PERIOD FROM___________ TO__________ Commission File Number 001-41106 Incannex Healthcare Inc. (Exact name of Registrant as specified in its Charter) | Delaware | 93-24 ...

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. is advancing its PSX-001 program for generalized anxiety disorder by forming a Clinical Advisory Board (CAB) to provide clinical and regulatory guidance [1][2] Group 1: Clinical Advisory Board Formation - The newly established CAB consists of leading experts in psychiatry, neurobiology, and psychopharmacology, aimed at enhancing the scientific rigor and patient-focused approach of the PSX-001 development strategy [2] - The CAB will advise on clinical trial design, endpoint selection, regulatory engagement, and broader strategic approaches as the PSX-001 program progresses [2] Group 2: Expert Profiles - Dr. C. Neill Epperson, an expert in psychiatry and women's brain health, has over 30 years of NIH-funded research experience and has authored more than 220 peer-reviewed publications [4] - Dr. Charles B. Nemeroff, a recognized authority in mood and anxiety disorders, has published over 1,300 scientific articles and leads multiple research initiatives in neuroscience and psychiatric medicine [5] - Dr. Alan F. Schatzberg, a pioneer in depressive disorders, has more than 700 publications and has held leadership roles in major psychiatric associations [6] Group 3: Company Overview - Incannex Healthcare is focused on developing combination medicines targeting chronic conditions, including obstructive sleep apnea, rheumatoid arthritis, and generalized anxiety disorder [7] - The company is advancing three clinical-stage product candidates, with PSX-001 being an oral synthetic psilocybin treatment for generalized anxiety disorder [8]

Core Insights - Incannex Healthcare Inc. has received the Research and Development Award in the Respiratory Disorders category at the 2025 Clinical Trials Arena Excellence Awards for its innovative work on IHL-42X, an oral fixed-dose combination therapy for obstructive sleep apnea (OSA) [1][2] Company Overview - Incannex Healthcare Inc. is a clinical-stage biopharmaceutical company focused on developing combination therapies targeting chronic conditions such as obstructive sleep apnea, rheumatoid arthritis, and generalized anxiety disorder [9][10] - The company's lead product candidate, IHL-42X, is a combination of dronabinol and acetazolamide aimed at treating adults with moderate-to-severe OSA [3][9] Product Development - IHL-42X is designed as a non-invasive pharmacologic alternative for patients who struggle with device-based therapies, addressing the significant unmet medical need in OSA management [3][6] - The development strategy for IHL-42X is supported by a robust Phase 2 clinical program that includes objective polysomnography outcomes and validated patient-reported measures [4][5] Recognition and Impact - The Clinical Trials Arena Excellence Awards recognize companies that drive positive change in the industry, highlighting Incannex's research-driven approach to addressing unmet needs in respiratory medicine [2][5] - The award reflects the company's commitment to evidence-based innovation and its broader pipeline strategy focused on combination medicines [5][6]

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]

Group 1 - Cannabis stocks are gaining attention from investors, with significant increases observed in various companies over the past week [1] - The year-to-date (YTD) returns of cannabis companies show a diverse performance, with approximately half trading down and the other half experiencing substantial gains [2] - Incannex Healthcare (IXHL) has notably increased by 22% in the past month and 86% over the last six months, driven by President Trump's executive order to reclassify marijuana as a less dangerous drug [3] Group 2 - Incannex operates as a clinical-stage biopharma company focused on advancing medicinal cannabis and psychedelic therapies, with ongoing research in Australia for conditions like rheumatoid arthritis and sleep apnea [4] - The potential opening of the U.S. market for medical cannabis research could significantly enhance the sector, providing opportunities for companies like Incannex to conduct more research domestically [5] - The fundamentals of Incannex reflect its early-stage status, making it challenging to assess based on traditional financial metrics, as the company primarily raises capital for research and development [7]

Core Insights - The U.S. FDA has granted Fast Track designation to Incannex Healthcare's IHL-42X, an oral fixed-dose combination product for treating obstructive sleep apnea (OSA) [1][3] Group 1: FDA Fast Track Designation - Fast Track designation is awarded to drug candidates that address serious conditions and unmet medical needs, facilitating quicker access to new therapies [3] - IHL-42X's Fast Track designation is supported by positive results from three clinical trials, including a Phase 2 study showing significant reductions in the Apnea-Hypopnea Index (AHI) by up to 83% and excellent safety profiles [2][3] Group 2: Company Statements - The Chief Scientific Officer expressed satisfaction with the FDA's decision, highlighting the potential of IHL-42X to meet the unmet needs of OSA patients [4] - The President & CEO emphasized that the Fast Track designation is a significant milestone for the company, aiming to close the gap in available oral pharmacotherapy for OSA, which affects millions globally [4] Group 3: Development and Future Plans - The company anticipates receiving detailed feedback from the FDA regarding its Phase 2 data and clinical development strategy, which will guide the next steps toward late-stage development [3] - The Fast Track designation allows for more frequent interactions with the FDA, eligibility for rolling review, and potential access to Accelerated Approval and Priority Review [6]

Core Viewpoint - Incannex Healthcare Inc. (IXHL) has been upgraded to a Zacks Rank 2 (Buy), indicating a positive outlook based on rising earnings estimates, which significantly influence stock prices [1][3]. Earnings Estimates and Stock Performance - The Zacks rating system emphasizes the importance of earnings estimate revisions, which are strongly correlated with near-term stock price movements [4][6]. - For Incannex Healthcare Inc., the Zacks Consensus Estimate has increased by 97.4% over the past three months, reflecting a positive trend in earnings expectations [8]. Zacks Rating System - The Zacks Rank system classifies stocks into five groups based on earnings estimates, with Zacks Rank 1 (Strong Buy) stocks historically generating an average annual return of +25% since 1988 [7]. - Incannex Healthcare Inc.'s upgrade to Zacks Rank 2 places it in the top 20% of Zacks-covered stocks, suggesting a strong potential for market-beating returns in the near term [10].

Core Insights - Stonegate Capital Partners has updated its coverage on Incannex Healthcare Inc. (NASDAQ: IXHL), highlighting significant clinical progress in the development of IHL-42X for obstructive sleep apnoea (OSA) [1][7] Clinical Development - In Q4 2025, Incannex reported that IHL-42X achieved statistically significant reductions in the Apnoea-Hypopnoea Index (AHI), with maximum reductions of up to 83% in the high-dose group and 79% in the low-dose group [1][7] - Exit interviews indicated that 57.6% of participants perceived an improvement in their OSA, with many describing the changes as meaningful to their daily lives, including better sleep quality and reduced fatigue [1][7] - IHL-42X was well tolerated, with no serious adverse events reported, suggesting its potential for broad use upon approval [1][7] Financial Overview - As of the quarter-end, Incannex reported cash reserves of $73.3 million, a net loss of $6.4 million, and operating expenses of $6.8 million, providing at least twelve months of financial runway [7]