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 ...

Strengthens clinical and regulatory guidance as PSX-001 advances to its next phase of developmentMELBOURNE, Australia and NEW YORK, Jan. 22, 2026 (GLOBE NEWSWIRE) -- Incannex Healthcare Inc. (Nasdaq: IXHL), a clinical-stage biopharmaceutical company developing innovative combination therapies, announces the formation of a Clinical Advisory Board (CAB) to support the continued advancement of its PSX-001 development program in generalized anxiety disorder. The newly established CAB has been formed to provide ...

MELBOURNE, Australia and NEW YORK, Jan. 15, 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). ...

Company enters 2026 with over $70 million in cash, two positive Phase 2 programs, FDA Fast Track Designation and runway well into 2027MELBOURNE, Australia and NEW YORK, Jan. 14, 2026 (GLOBE NEWSWIRE) -- 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 executi ...

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]

Revenue Performance - Revenue from customers for the three months ended September 30, 2025, was $0, a decrease of 100% compared to $74,000 in the same period in 2024[92]. - The company has not generated revenue and does not expect to do so until drug candidates are approved[93]. Expenses - Research and development expenses decreased by $1.8 million to $1.1 million for the three months ended September 30, 2025, a reduction of 61% compared to $2.9 million in 2024[92][96]. - General and administrative expenses increased by $2.2 million to $5.7 million for the three months ended September 30, 2025, a rise of 65% compared to $3.4 million in 2024[92][102]. - The company anticipates substantial increases in general and administrative expenses as it expands operations and prepares for potential commercialization of drug candidates[102]. - Stock-based compensation is recognized using a fair value method, with expenses recorded over the vesting period[121]. - Research and development costs are expensed as incurred, including salaries, benefits, and clinical trial costs[122]. - Nonrefundable advance payments for future research and development activities are deferred as prepaid expenses until services are performed[123]. - Accrued liabilities for estimated research and development costs are based on services provided but not yet invoiced[124]. - The company has not experienced material differences between accrued costs and actual costs incurred[125]. Financial Position - Total comprehensive loss for the three months ended September 30, 2025, was $6.2 million, compared to a loss of $5.1 million in 2024, representing an increase of 22%[92][110]. - Cash and cash equivalents as of September 30, 2025, were $73.3 million, an increase of $58.3 million from $15.0 million as of June 30, 2025[112]. - Net cash used in operating activities for the three months ended September 30, 2025, was $9.2 million, an increase of $7.0 million compared to $2.2 million in 2024[112][116]. - Cash provided by financing activities increased by $67.2 million for the three months ended September 30, 2025, due to share issuances under the ATM program[115][118]. - The accumulated deficit as of September 30, 2025, was $164.0 million[110]. Tax Credits and Market Risk - Benefit from R&D tax credit in Australia is recorded within other income, recognized once compliance conditions are met[126]. - As a smaller reporting company, the company omits certain market risk disclosures[127].

Core Insights - Incannex Healthcare Inc. is making significant progress in clinical, regulatory, and capital initiatives aimed at long-term growth [1] Recent Highlights - IHL-42X (OSA) Phase 2 trial showed statistically significant efficacy with up to 83% reduction in Apnea-Hypopnea Index (AHI) from baseline, indicating potential for improved treatment of obstructive sleep apnea [2] - Patient-reported outcomes were positive, with 57.6% of participants reporting perceived improvement, increasing to 78.6% in the low dose group, and 86.4% of those reporting improvement found it meaningful to daily life [2] Priorities for the Remainder of 2025 - The company is focusing on regulatory engagement and planning for late-stage development of IHL-42X and PSX-001, with ongoing discussions with the U.S. FDA to define optimal pathways for late-stage studies [3] - Further updates will be provided after FDA interactions are concluded [3] PSX-001 Phase 2 Results - PSX-001 demonstrated statistically significant improvements in anxiety symptoms compared to placebo, with sustained relief over 11 weeks and excellent safety profile [4] - The results indicate PSX-001's potential to address a significant unmet medical need in anxiety disorders [4] Financial Position - The company has not utilized its At-The-Market (ATM) facility since August 28, 2025, maintaining a stable share count of 347,705,507, reflecting strong capital efficiency [4] - This decision underscores the company's focus on long-term shareholder value creation and confidence in growth catalysts [4] Operational Readiness - Incannex is prioritizing activities to maintain clinical momentum, data integrity, and capital discipline as programs progress [5] - The company is evaluating opportunities for prudent capital deployment to support value-creating milestones [5] Strategic Collaborations - The company is exploring partnerships and co-development opportunities to advance its scientific initiatives and create long-term value for stakeholders [6] - The CEO emphasized the significance of the Phase 2 trial results for IHL-42X in transforming treatment for obstructive sleep apnea [6][7] Overall Positioning - With two successful Phase 2 trials completed and a Nasdaq extension secured, Incannex is positioned to capitalize on strong clinical validation and disciplined capital management as it advances toward late-stage development [8]