Cannabis stocks are once again in the spotlight for investors, with a range of companies in this sector seeing big increases over the past week. www.barchart.com The list of cannabis companies shows extremely diverse year-to-date (YTD) returns, with roughly half the list currently trading down on the year and the other half seeing big gains. More News from Barchart However, among the most notable decliners on this list that's seen a big boost from President Trump's recently announced move to sign an e ...

MELBOURNE, Australia and NEW YORK, Dec. 03, 2025 (GLOBE NEWSWIRE) -- Incannex Healthcare Inc. (Nasdaq: IXHL), a clinical-stage biopharmaceutical company developing innovative combination therapies, announces that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation for IHL-42X, the Company’s oral fixed-dose combination product candidate for the treatment of obstructive sleep apnea (OSA). The Fast Track designation was supported by promising safety, efficacy, and pharmacokinetic res ...

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]

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]

Core Insights - Several biotech and healthcare stocks experienced significant after-hours gains on October 1, driven by technical momentum and recent clinical updates rather than new disclosures [1] Company Summaries - Zhongchao Inc. (ZCMD) saw a 14.04% increase in after-hours trading, rising to $1.30 from $1.14, despite no new filings or press releases [2] - AbCellera Biologics Inc. (ABCL) rose 11.41% in after-hours trading, closing at $6.64, following an 18.49% gain during the regular session, attributed to recent clinical trial progress [3][4] - Vor Biopharma Inc. (VOR) surged 9.53% in after-hours trading, recovering from a 19.42% drop during the regular session, with no new updates since a recent announcement regarding clinical data presentation [5] - Incannex Healthcare Inc. (IXHL) gained 6.48% in after-hours trading, partially recovering from a 6.94% drop, with the latest update showing positive Phase 2 trial results for PSX-001 [6] - Ovid Therapeutics Inc. (OVID) shares rose 8.03% in after-hours trading, building on a 5.38% gain during the regular session, with recent earnings report indicating a narrower net loss and higher revenue [7] - Bullfrog AI Holdings Inc. (BFRG) advanced 3.44% in after-hours trading, following a 3.57% rise during the regular session, after announcing an expansion of its sales and marketing team [8]

Financial Performance - The company reported total comprehensive losses of $46.7 million and $18.5 million for the fiscal years ended June 2024 and 2025, respectively, with accumulated comprehensive losses of $157.6 million as of June 30, 2025[245]. - The company has a history of operating losses and may not achieve profitability in the future, depending on the successful development of its drug candidates[244]. - The company has experienced negative cash flows from operating activities of $12.5 million and $5.8 million for the fiscal years ended June 2024 and 2025, respectively[245]. - The company anticipates substantial additional funding will be required to continue the development of its drug candidates, with no revenue generated from product sales to date[249]. Regulatory and Compliance Risks - The company is subject to ongoing regulatory obligations and may incur significant additional expenses if it receives marketing approval for its drug candidates[242]. - Regulatory approvals in one jurisdiction do not guarantee approvals in others, potentially limiting the market for drug candidates[268]. - Compliance with manufacturing regulations requires significant time and resources, and failure could lead to regulatory enforcement actions[288]. - The company must comply with extensive CSA requirements and DEA regulations for the importation, manufacturing, and distribution of drug candidates[343]. - The company faces potential delays in clinical trials if DEA researcher registrations are not granted in a timely manner[343]. - The company is subject to significant scrutiny regarding pharmaceutical pricing practices, which may lead to legislative changes affecting operations[352]. Clinical Development Challenges - The company relies on third parties for conducting preclinical and clinical trials, and any failure by these parties could substantially harm its business[237]. - Clinical trials are lengthy and expensive, with uncertain outcomes, and previous positive results do not guarantee future success[269]. - The company may encounter difficulties in enrolling patients for clinical trials, as evidenced by the termination of a Phase 2 trial due to recruitment challenges[276]. - Delays in clinical trials can arise from various factors, including recruitment challenges and regulatory compliance issues[270]. - Clinical trials may produce negative or inconclusive results, which could delay or prevent regulatory approvals[279]. Intellectual Property and Competition - The company is exploring a patent protection strategy for its candidate PSX-001, which is critical for protecting its intellectual property rights[244]. - The company’s success is dependent on the ability to protect its intellectual property rights globally, which may not be achievable[396][398]. - Third-party intellectual property rights could adversely affect the company's ability to commercialize drug candidates, leading to potential litigation[403][404]. - The company faces competition from major pharmaceutical and biotechnology firms, which may have greater resources and could develop superior products[318]. - The company may face challenges from third parties regarding the validity of its patents, which could adversely affect its business[422]. Market and Pricing Risks - Pricing regulations and reimbursement practices vary by country, potentially delaying product launches and impacting revenue[328]. - Coverage and reimbursement from payors are critical for the commercialization of drug candidates, with variability in the U.S. and Europe[329]. - Legislative changes, such as the IRA, may impose price controls and affect revenue from drug products[333]. - Price controls in non-U.S. markets, particularly in the EU, Japan, Australia, and Canada, may negatively impact future profitability due to governmental pricing negotiations[428]. Stock and Market Performance - The company's common stock has consistently closed below $1.00 per share since early March 2025, resulting in a notice from Nasdaq regarding non-compliance with the minimum bid price requirement[261]. - The trading price of the company's common stock has been highly volatile, influenced by various factors including quarterly financial results and revenue fluctuations[431]. - Broader market fluctuations unrelated to the company's performance may adversely affect the trading price of its common stock[433]. Cybersecurity and Data Protection - Cybersecurity threats pose significant risks to the company's operations, potentially leading to data breaches, regulatory investigations, and financial losses[366]. - The company is subject to evolving U.S. federal and state, and international laws regarding data protection, which could lead to significant fines and liability if compliance is not met[375]. - The California Consumer Privacy Act (CCPA) went into effect in January 2020, providing California residents with expanded rights and potential civil penalties for violations[375]. Operational and Management Risks - The company faces a scarcity of experienced professionals in the industry, which may hinder the company's ability to execute its business strategy effectively[388]. - High turnover rates among management personnel could significantly harm the company's ability to implement its business strategy successfully[389]. - The company may face material adverse effects from geopolitical events, accidents, and natural disasters, impacting operations and financial condition[390].

Core Insights - Incannex Healthcare Inc. reported positive results from its Phase 2 clinical trial of PSX-001, a psilocybin-assisted therapy for Generalised Anxiety Disorder (GAD), indicating its potential as a leading treatment globally [1][12] Trial Design Overview - The Phase 2 study was randomized, double-blind, and placebo-controlled, enrolling 73 adults with moderate to severe GAD, who received either a 25 mg dose of synthetic psilocybin or placebo [2] - Participants underwent two dosing sessions with equal psychological support, ensuring treatment effects were attributable to psilocybin [2] Efficacy Results - The trial demonstrated statistically significant improvements across all primary and secondary endpoints, with a notable 12.8-point reduction in HAM-A scores for the Psi-GAD group compared to a 3.6-point reduction in the placebo group (p<0.0001) [4] - A clinically meaningful response was observed in 44.1% of patients treated with Psi-GAD, achieving a ≥50% reduction in HAM-A scores, significantly higher than the placebo group [5] - The Psi-GAD group also showed a 7.4-point reduction in GAD-7 scores versus 3.5 points for placebo (p<0.0004) [7] - Improvements in functional impairment were noted with a 6.0-point reduction in SDS scores for Psi-GAD compared to 1.3 points for placebo (p<0.007) [8] - Statistically significant antidepressant effects were observed with a 3.9-point reduction in PHQ-9 scores for Psi-GAD versus 0.3 points for placebo (p<0.005) [9] - Quality of life, measured by the PWI, improved by 10.6 points in the Psi-GAD group compared to 2.7 points for placebo (p<0.002) [10] Safety and Tolerability - Treatment with Psi-GAD was well tolerated, with no serious adverse events reported and only one withdrawal from the trial [11] - Most treatment-emergent adverse events were mild to moderate and transient, with no increased risks of suicidality or psychosis noted [11] Company Statements - Dr. Lou Barbato, Chief Medical Officer, emphasized the statistically significant and durable treatment effects observed across multiple measures, positioning Psi-GAD as a leader in anxiety treatment innovation [12] - Joel Latham, President and CEO, highlighted the results as a major milestone for Incannex, reinforcing confidence in their clinical pipeline and strategy [13] Next Steps - Incannex is preparing to initiate a multi-jurisdiction Phase 2 clinical trial and is refining formulation strategies to strengthen its intellectual property position [14][16]