IXHL

Psi-GAD delivers statistically significant and clinically meaningful improvements across validated measures of anxiety, mood, disability, and quality of life; results establish PSX-001 as a leading psilocybin-assisted therapy in development globally MELBOURNE, Australia and NEW YORK, Aug. 26, 2025 (GLOBE NEWSWIRE) -- Incannex Healthcare Inc. (Nasdaq: IXHL) (“Incannex” or the “Company”) is pleased to report positive data from its Phase 2 clinical trial of PSX-001 (formerly Psi-GAD), a psilocybin-assisted psychotherapy treatment for Generalised Anxiety Disorder (GAD). The results confirm statistically significant and clinically meaningful improvements across every key endpoint assessed in the study, reinforcing PSX-001’s potential as a best-in-class therapy for patients with moderate to severe GAD. Trial Design Overview The randomized, double-blind, placebo-controlled Phase 2 study enrolled 73 adult participants diagnosed with moderate to severe Generalised Anxiety Disorder. Participants were randomly assigned to complete two dosing sessions with either a 25 mg dose of synthetic psilocybin or placebo, administered in a controlled clinical setting as part of a proprietary psychotherapeutic protocol developed. All participants received equal hours of psychological support and preparation, ensuring that any treatment effect could be attributed to psilocybin itself and not therapeutic bias. Efficacy was assessed using a suite of validated clinical measures at multiple timepoints post-treatment, with the primary endpoint focused on change in HAM-A (Hamilton Anxiety Rating Scale) scores. Exceptional Efficacy Results: Statistically Significant and Clinically Meaningful Improvements Across All Key Measures The Phase 2 trial of Psi-GAD demonstrated a robust and consistent pattern of efficacy, delivering statistically significant and clinically meaningful improvements across all primary and secondary endpoints. • HAM-A (Hamilton Anxiety Rating Scale): Patients treated with Psi-GAD achieved an average 12.8-point reduction in HAM-A scores from baseline, compared to a 3.6-point reduction in the placebo group. This difference was statistically significant (p<0.0001) and sustained across the 11-week follow-up period, indicating a rapid onset and durable treatment effect. As the trial’s primary endpoint, the HAM-A outcome establishes a strong efficacy signal for Psi-GAD. Figure 1. Change from baseline in HAM-A scores showing statistically significant and durable reduction in anxiety symptoms with PsiGAD compared to placebo. • Clinical Response and Remission: Psi-GAD treatment resulted in a clinically meaningful response, corresponding to a reduction in HAM-A score from baseline of ≥50% in 44.1% of patients. A response rate more than four times higher than that of the placebo group. Of patients receiving PsiGAD treatment, 27% achieved full disease remission (HAM-A ≤7), five times higher than placebo. Figure 2. Rates of clinical response (≥50% reduction in HAM-A) and full remission (HAM-A ≤7) demonstrating substantial efficacy of PsiGAD vs. placebo. • GAD-7 (Generalised Anxiety Disorder 7-item scale): The Psi-GAD group recorded an average 7.4-point reduction in GAD-7 scores, compared to a 3.5-point reduction for placebo. This difference was statistically significant (p<0.0004), confirming Psi-GAD’s effect across multiple validated measures of anxiety severity. • SDS (Sheehan Disability Scale): Patients in the Psi-GAD group experienced a 6.0-point reduction in SDS scores, versus 1.3 points in the placebo group—a statistically significant improvement (p<0.007). These results demonstrate a marked improvement in functional impairment across work, social, and family domains, which are often severely impacted in GAD. • PHQ-9 (Patient Health Questionnaire-9): Psi-GAD also showed statistically significant antidepressant effects, with a 3.9-point reduction in PHQ-9 scores compared to just 0.3 points in the placebo group (p<0.005). This supports PSX-001’s broad therapeutic utility in mood-related comorbidities. • PWI (Personal Wellbeing Index): Quality of life, as measured by the PWI, improved by an average of 10.6 points in the Psi-GAD group versus 2.7 points for placebo—a statistically significant difference (p<0.002). These results reflect substantial and sustained enhancements in overall psychological wellbeing. Safety and Tolerability Treatment with Psi-GAD was well tolerated across the study population. No serious adverse events (SAEs) were reported, and only one of the 73 subjects withdrew from the trial during the 7 week treatment program. The majority of treatment-emergent adverse events (TEAEs) were transient, mild to moderate in nature, and consistent with the expected pharmacological effects of psilocybin. Importantly, there were no signs of increased suicidality, psychosis, or prolonged psychological distress—concerns often cited with psychedelic treatments. The controlled setting, comprehensive preparation, and therapist-supported integration sessions contributed to the overall safety of the intervention. These findings reinforce the strong risk-benefit profile of Psi-GAD and support its continued advancement into late-stage development. Dr. Lou Barbato, Chief Medical Officer of Incannex, commented: “These results speak for themselves—statistically significant, clinically meaningful, and consistent across every validated measure. Psi-GAD demonstrated a reduction in anxiety, improved mood, enhanced quality of life, and better day-to-day functioning. Importantly, the treatment effect was durable and observed across 11 weeks. These outcomes reinforce the power of our proprietary psychotherapeutic model and position Psi-GAD as a global leader in anxiety treatment innovation. We are also very pleased with the safety profile of Psi-GAD, particularly when considered alongside comparator programs in the market, which strengthens our confidence in both the clinical utility and scalability of this treatment.” Joel Latham, President and Chief Executive Officer of Incannex, commented: “These are outstanding results for Incannex and a major milestone for our clinical pipeline. Alongside our strong cash position, the success of PSX-001 significantly de-risks another of our lead assets and further validates our strategy of developing innovative combination and psychedelic-based therapies. To deliver back-to-back positive Phase 2 results for both PSX-001 and IHL-42X is an exceptional achievement, and one that gives us tremendous confidence as we progress towards late-stage development and continue to build value for patients and shareholders alike.” Next Steps The Company has an open Investigational New Drug (IND) application with the U.S. FDA and is preparing to initiate a multi-jurisdiction Phase 2 clinical trial. In parallel, Incannex continues to refine formulation strategies to ensure a robust and defensible intellectual property (IP) position. The Company is also exploring strategic partnerships to accelerate development and broaden global access to PSX-001 for patients with unmet needs. Figure 3. PsiGAD reduced anxiety scores to a greater extent than that reported for approved anxiety medications. 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 apnoea, rheumatoid arthritis, and generalised 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 apnoea. IHL-42X has successfully completed a Phase 2 clinical trial. PSX-001 is a synthetic psilocybin treatment for the treatment of generalised anxiety disorder. PSX-001 has recently completed a Phase 2 clinical trial with positive results, establishing it as a leading psilocybin-assisted therapy in development globally. 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. IHL-675A is currently in a Phase 2 clinical development program. 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. Forward Looking Statements This press release contains "forward-looking statements" within the meaning of the "safe harbor" provisions of the U.S. Private Securities Litigation Reform Act of 1995. Forward-looking statements are statements other than historical facts and relate to future events, future circumstances and Incannex's future performance. These statements are based on management's current assumptions, expectations, and beliefs. Examples of forward-looking statements in this press release include statements about, among other things: statements regarding potential future dilution; Incannex’s opinions and estimates about the fundamentals and underlying value of its business relative to the trading price of its common stock; business strategy, future operations; Incannex's ability to execute on its objectives, prospects, commercial discussions or plans; evaluations and judgments regarding Incannex's research and development efforts and potential future commercialization, including any implications that the results (including qualitative patient-reported outcomes) of earlier clinical trials or interim or topline results will be representative or consistent with later clinical trials or their respective interim or final results; the potential benefits (including qualitative patient-reported outcomes) and safety of Incannex's drug candidates and the market opportunity for these candidates; and potential shareholder value. These forward-looking statements are subject to a number of risks and uncertainties, which may cause the forward-looking events and circumstances described in this press release to not occur, and actual results to differ materially and adversely from those described in or implied by the forward-looking statements. These risks and uncertainties include, among others: that current expense and cash resource estimates which may be ultimately be inaccurate and the Company may need to raise capital, including through the ATM, sooner than it presently anticipates; the continued availability of financing; Incannex's ability to raise capital to fund continuing operations and to maintain or potentially further improve its capital structure; Incannex’s ability to maintain the listing of its shares of common stock on the Nasdaq Stock Market; the impact of any infringement actions or other litigation brought against Incannex; the success of Incannex's development efforts, including Incannex's ability to progress its drug candidates through clinical trials on the timelines expected and to obtain necessary regulatory approvals for commercialization of its product candidates; the effects of competition from other providers and products as currently existing or that may be developed in the future; that the market for its drug candidates may not grow at the rates anticipated or at all or that estimates for these markets may ultimately be incorrect; that Incannex may be unable to successfully execute upon any commercial discussions; Incannex's ability to comply with the various evolving and complex laws and regulations applicable to its business and its industry; and Incannex's ability to protect its proprietary technology and intellectual property; and other factors relating to Incannex's industry, its operations and results of operations. The forward-looking statements made in this press release speak only as of the date of this press release, and Incannex assumes no obligation to update publicly any such forward-looking statements to reflect actual results or changes in expectations, except as otherwise required by law. Incannex's reports filed with the U.S. Securities and Exchange Commission (SEC) including its annual report on Form 10-K for the fiscal year ended June 30, 2024, filed with the SEC on September 30, 2024, and the other reports it files from time to time, including subsequently filed annual, quarterly and current reports, are made available on Incannex's website upon their filing with the SEC. These reports contain more information about Incannex, its business and the risks affecting its business, as well as its results of operations for the periods covered by the financial results included in this press release. For additional information on Incannex, please visit our website at www.incannex.com. Investor & Media Contacts CORE IR (212) 655-0924 [email protected] [email protected] Photos accompanying this announcement are available at https://www.globenewswire.com/NewsRoom/AttachmentNg/84e5d4b1-226c-4436-ac47-6e860bd7bacf https://www.globenewswire.com/NewsRoom/AttachmentNg/3e07b30a-ecdd-4aa4-a6a5-5e569f791016 https://www.globenewswire.com/NewsRoom/AttachmentNg/f7109e12-d50d-4407-a1d4-7587681f151f

Statistically and clinically significant improvements across key clinical endpoints; IHL-42X reduced AHI by up to 83% from baseline. IHL-42X demonstrates compelling clinical benefit and an outstanding safety profile that exceeded expectations. NEW YORK and MELBOURNE, Australia, July 30, 2025 (GLOBE NEWSWIRE) -- Incannex Healthcare Inc. (Nasdaq: IXHL) (“Incannex” or the “Company”) is excited to share positive topline results from its RePOSA Phase 2 clinical trial evaluating IHL-42X, a novel oral drug candidate for obstructive sleep apnoea (OSA). With over 900 million people affected globally and no approved oral pharmaceutical treatments currently available, IHL-42X’s robust efficacy and exceptional safety profile position it as a potential transformative therapy for OSA patients worldwide. The results confirm statistically significant and clinically meaningful improvements across key endpoints assessed in the study, reinforcing IHL-42x’s potential as a best-in-class therapy for patients with OSA. Compelling Clinical Efficacy The RePOSA Phase 2 trial demonstrated clear statistically and clinically significant improvements across multiple key endpoints for patients receiving IHL-42X compared to placebo, highlighting its potential to reduce OSA severity and enhance patient quality of life: Apnoea-Hypopnoea Index (AHI): The low-dose and high-dose IHL-42X groups achieved a statistically significant reduction in percent change in AHI from baseline compared to placebo (p<0.05), the primary measure of OSA severity. Maximum reductions in AHI were observed at up to 83% for the high-dose group and up to 79% for the low-dose group. Notably, 33.3% of patients in the low-dose group and 41.2% in the high-dose group achieved a greater than 30% reduction in AHI, while 13.9% (low-dose) and 14.7% (high-dose) experienced reductions exceeding 50%—demonstrating a strong therapeutic response in a substantial subset of the population. Patient Global Impression of Change (PGI-C) Sleep related impairment: The low-dose IHL-42X group showed statistically significant improvement (p<0.05), reflecting meaningful patient-perceived benefits. PGI-C Fatigue: Statistically significant improvement in the low-dose group, suggesting enhanced daytime alertness and reduced fatigue. Oxygen Desaturation Index (ODI): Both low- and high-dose groups demonstrated statistically significant improvements, indicating better oxygenation during sleep. Patient-Reported Outcomes: IHL-42X led to clinically significant improvements in patient-reported outcome measures, including the Functional Outcomes of Sleep Questionnaire-10 (FOSQ-10), PROMIS Sleep-Related Impairment 8a (PROMIS-SRI 8a), PROMIS Fatigue 7a, and Epworth Sleepiness Scale (ESS) in both low- and high-dose groups, demonstrating enhanced sleep quality, reduced daytime fatigue, and improved daily functioning for patients with OSA. Polysomnography (PSG) Metrics: IHL-42X drastically improved objective sleep parameters as measured by PSG. Wake After Sleep Onset (WASO): Reduced by 29.8% in the high-dose arm, meaning patients spent less time awake during the night. AHI During Supine Sleep: Decreased by 30.3% in the high-dose arm, a critical improvement given supine sleep exacerbates apneic events. These results collectively demonstrate IHL-42X’s ability to address both objective and subjective aspects of OSA, offering compelling clinical benefits to patients. Outstanding Safety Profile IHL-42X was well tolerated across both low- and high-dose cohorts. No serious adverse events were reported during the treatment period, and treatment-emergent adverse effects (TEAEs) were infrequent, with the majority being mild or moderate in severity. This excellent safety profile supports IHL-42X’s potential for broad patient use. Joel Latham, CEO and President of Incannex, commented: "We are extremely pleased with the RePOSA trial results. The combination of statistically significant improvements across multiple endpoints and an outstanding safety profile positions IHL-42X as one of the most compelling drug candidates in the global race to bring a pharmaceutical treatment for OSA to market. The depth of response seen in a defined subset of patients further reinforces our belief in its clinical and commercial potential. These results are a clear signal of the strength of our development strategy and a critical step forward in building long-term shareholder value. We continue to facilitate commercial discussions and look forward to providing shareholders with an update in this regard soon." Dr. Mark Bleackley, Chief Scientific Officer of Incannex, added: “These findings highlight the statistically significant treatment effects observed across multiple measures of disease severity and patient experience. Combined with an excellent safety and tolerability profile, the results provide strong validation of IHL-42X’s potential as an innovative and impactful therapy for obstructive sleep apnea.” Next Steps With positive Phase 2 data in hand, Incannex is now focused on advancing IHL-42X toward commercial readiness. Preparations are in progress for the Company’s End-of-Phase 2 meeting with the FDA, where discussions will focus on identifying the most efficient and effective path to registration. This engagement is expected to provide critical guidance for optimising the Phase 3 trial design and regulatory strategy. In parallel, Incannex will continue to evaluate all clinical data and complete the full Clinical Study Report in the coming months. These strategic activities mark a new phase of execution for Incannex as it progresses toward late-stage development and possible future commercialisation. RePOSA Phase 2 Trial Overview The RePOSA Phase 2 trial was a randomized, double-blind, placebo-controlled clinical study designed to evaluate the safety, tolerability, and efficacy of IHL-42X, a novel oral drug candidate for the treatment of obstructive sleep apnoea (OSA). The study enrolled 121 adult participants with confirmed moderate to severe OSA, who were randomized to receive either a high dose, low dose, or placebo version of IHL-42X for a 28-day treatment period. Efficacy was assessed using both objective and patient-reported outcome measures aligned with FDA guidance, including the primary endpoint of change in Apnea-Hypopnoea Index (AHI) as measured by polysomnography (PSG). Key secondary endpoints included the Oxygen Desaturation Index (ODI), Patient Global Impression of Change (PGI-C), Epworth Sleepiness Scale (ESS), Functional Outcomes of Sleep Questionnaire (FOSQ-10), and PROMIS fatigue and sleep-related impairment scores. The study was designed to generate high-quality clinical data to support the advancement of IHL-42X into Phase 3 development and regulatory discussions. 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. Forward Looking Statements This press release contains "forward-looking statements" within the meaning of the "safe harbor" provisions of the U.S. Private Securities Litigation Reform Act of 1995. Forward-looking statements are statements other than historical facts and relate to future events, future circumstances and Incannex's future performance. These statements are based on management's current assumptions, expectations, and beliefs. Examples of forward-looking statements in this press release include statements about, among other things: Incannex's business strategy, future operations; Incannex's ability to execute on its objectives, prospects, commercial discussions or plans; evaluations and judgments regarding Incannex's research and development efforts and potential future commercialization, including any implications that the results of earlier clinical trials or interim or topline results (such as the topline results of the RePOSA Phase 2 Study) will be representative or consistent with a full Clinical Study Report, later clinical trials or their respective interim or final results; the potential benefits and safety of Incannex's drug candidates and the market opportunity for these candidates; and potential shareholder value. These forward-looking statements are subject to a number of risks and uncertainties, which may cause the forward-looking events and circumstances described in this press release to not occur, and actual results to differ materially and adversely from those described in or implied by the forward-looking statements. These risks and uncertainties include, among others: the continued availability of financing; Incannex's ability to raise capital to fund continuing operations, to complete capital raising transactions and to maintain or potentially further improve its capital structure; Incannex’s ability to maintain the listing of its shares of common stock on the Nasdaq Stock Market; the impact of any infringement actions or other litigation brought against Incannex; the success of Incannex's development efforts, including Incannex's ability to progress its drug candidates through clinical trials on the timelines expected (including its ability to successfully complete the Phase 3 trial for IHL-42) and to obtain necessary regulatory approvals for commercialization of its product candidates, including IHL-42; the effects of competition from other providers and products as currently existing or that may be developed in the future; that the market for its drug candidates may not grow at the rates anticipated or at all or that estimates for these markets may ultimately be incorrect; that Incannex may be unable to successfully execute upon any commercial discussions; Incannex's ability to comply with the various evolving and complex laws and regulations applicable to its business and its industry; and Incannex's ability to protect its proprietary technology and intellectual property; and other factors relating to Incannex's industry, its operations and results of operations. The forward-looking statements made in this press release speak only as of the date of this press release, and Incannex assumes no obligation to update publicly any such forward-looking statements to reflect actual results or changes in expectations, except as otherwise required by law. Incannex's reports filed with the U.S. Securities and Exchange Commission (SEC) including its annual report on Form 10-K for the fiscal year ended June 30, 2024, filed with the SEC on September 30, 2024, and the other reports it files from time to time, including subsequently filed annual, quarterly and current reports, are made available on Incannex's website upon their filing with the SEC. These reports contain more information about Incannex, its business and the risks affecting its business, as well as its results of operations for the periods covered by the financial results included in this press release. For additional information on Incannex, please visit our website at www.incannex.com. Investor & Media Contacts CORE IR (212) 655-0924 [email protected] [email protected]

MELBOURNE, Australia and NEW YORK, May 28, 2025 (GLOBE NEWSWIRE) -- Incannex Healthcare Inc. (Nasdaq: IXHL), a clinical-stage biopharmaceutical company advancing combination drug therapies for high-impact indications, today announced that it has entered into a binding agreement to cancel the remaining 172 million Series A Warrants issued under a previous financing arrangement contingent upon Incannex paying the Series A Warrant holders a cancellation payment of up to $12.2 million. When combined with the earlier tranche canceled earlier this month, this agreement will result in the elimination of up to 347.2 million shares from potential future dilution, pending final execution. This strategic step follows the company’s earlier warrant cancellation transaction announced on May 20, 2025, which removed the first 175.2 million dilution-linked shares. With this second agreement now in place, Incannex has taken firm action to fully eliminate the overhang posed by its Series A Warrants. “This is a significant milestone in strengthening our capital structure,” said Joel Latham, President and CEO of Incannex. “Subject to final execution, this transaction ensures that up to 347 million shares will no longer be eligible to enter the market, providing clarity and confidence for our shareholders. It is a strong endorsement of our forward strategy and a clear demonstration that we are actively managing dilution risk with the best interests of our investors in mind.” The agreement comes at a pivotal time for Incannex, as the company approaches the release of topline data from its Phase 2 RePOSA trial of IHL-42X for obstructive sleep apnea, expected in July 2025. IHL-42X is being developed as a potential first-in-class oral pharmaceutical treatment for a condition affecting millions globally, with no current FDA-approved drug therapy available. “We’ve worked quickly and strategically to eliminate overhang and deliver a clean cap table, heading into one of the most important data readouts in the company’s history,” Joel Latham added. “This transaction reflects our proactive approach to value creation and governance.” For more information, please refer to the Form 8-K filed with the SEC on May 28, 2025, including the Letter Agreements referenced therein. About IHL-42X IHL-42X is designed to treat obstructive sleep apnea (“OSA”) by targeting its underlying pathophysiology. An oral fixed-dose combination of dronabinol and acetazolamide, IHL-42X is currently advancing through the RePOSA Phase 2/3 clinical trial, which is expected to enroll more than 560 patients at sites worldwide. Designed to act synergistically, IHL-42X uniquely targets two physiological pathways associated with the intermittent hypoxia (“IH”) and hypercapnia that characterize OSA. In a prior Australian Phase 2 clinical trial, IHL-42X was shown to reduce the Apnea-Hypopnea Index (“AHI”) in all dosage strengths, with the lowest dose reducing AHI by an average of 51 percent relative to baseline. RePOSA, a global Phase 2/3 clinical trial is underway, evaluating IHL-42X in individuals with OSA who are either non-compliant, intolerant, or naïve to positive airway pressure devices, including CPAP, with the Phase 2 portion conducted in the United States. A topline readout from the U.S. Phase 2 portion is anticipated in July 2025. 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. Forward Looking Statements This press release contains "forward-looking statements" within the meaning of the "safe harbor" provisions of the U.S. Private Securities Litigation Reform Act of 1995. Examples of forward-looking statements in this press release include statements about, among other things: Incannex's business strategy, future operations; Incannex's ability to execute on its objectives, prospects, or plans, evaluations and judgments regarding Incannex's research and development efforts, including any implications that the results of earlier clinical trials will be representative or consistent with later clinical trials or final results; the expected timing of enrollment for these trials and the availability of data or results of these trials, and the potential benefits, safety or of Incannex's drug candidates. Forward-looking statements are statements other than historical facts and relate to future events or circumstances or Incannex's future performance, and they are based on management's current assumptions, expectations, and beliefs concerning future developments and their potential effect on Incannex's business; Incannex’s ability to obtain the requisite stockholder approval for the exercise of the Series A Warrants; Incannex’s ability to potentially improve its capital structure in the future. These forward-looking statements are subject to a number of risks and uncertainties, which may cause the forward-looking events and circumstances described in this press release to not occur, and actual results to differ materially and adversely from those described in or implied by the forward-looking statements. These risks and uncertainties include, among others: the continued availability of financing; Incannex's ability to raise capital to fund continuing operations, to complete capital raising transactions and to potentially improve its capital structure; the impact of any infringement actions or other litigation brought against Incannex; the success of Incannex's development efforts, including Incannex's ability to progress its drug candidates through clinical trials on the timelines expected; competition from other providers and products; that the market for its drug candidates may not grow at the rates anticipated or at all; Incannex's compliance with the various evolving and complex laws and regulations applicable to its business and its industry; and Incannex's ability to protect its proprietary technology and intellectual property; and other factors relating to Incannex's industry, its operations and results of operations. The forward-looking statements made in this press release speak only as of the date of this press release, and Incannex assumes no obligation to update publicly any such forward-looking statements to reflect actual results or to changes in expectations, except as otherwise required by law. Incannex's reports filed with the U.S. Securities and Exchange Commission (SEC) including its annual report on Form 10-K for the fiscal year ended June 30, 2024, filed with the SEC on September 30, 2024, and the other reports it files from time to time, including subsequently filed annual, quarterly and current reports, are made available on Incannex's website upon their filing with the SEC. These reports contain more information about Incannex, its business and the risks affecting its business, as well as its results of operations for the periods covered by the financial results included in this press release. For additional information on Incannex, please visit our website at www.incannex.com. Contact Information Jennifer Drew-Bear Edison Group for Incannex [email protected]

NEW YORK and MELBOURNE, Australia, May 15, 2025 (GLOBE NEWSWIRE) -- Incannex Healthcare Inc. (Nasdaq: IXHL), (Incannex), a clinical-stage biopharmaceutical company leading the way in developing oral combination medicines, today reported fiscal second quarter financial results and provided business highlights for the quarter ended March 31, 2025. “The third quarter of 2025 represents a pivotal period of progress for Incannex as we continue to execute on our IHL-42X development program,” said Joel Latham, President and CEO of Incannex. “With the rapid completion of Phase 2 enrollment in the Phase 2/3 RePOSA, recent positive and confirmatory PK and safety clinical results, and the addition of expert sleep medicine clinical advisory leadership, we are well-positioned to deliver on key upcoming milestones and to advance IHL-42X as a potential treatment for millions of underserved patients living with OSA.” Operational Highlights Secured $12.5 million USD in private placement funding, priced at-the-market under Nasdaq rules. Proceeds will support the ongoing IHL-42X Phase 2/3 obstructive sleep apnea (OSA) clinical program, including completion of the Phase 2 study, topline data readout, and expansion into Phase 3. Announced the formation of an OSA Clinical Advisory Board and the appointment of Alison Wimms, Ph.D., representing ResMed. Dr. Wimms brings over 20 years of sleep medicine industry and research expertise. The establishment of this new advisory board marks an important step in advancing collaboration and the late-stage clinical development of IHL-42X for the treatment of OSA, as the Incannex progresses its ongoing Phase 2/3 RePOSA clinical study. Clinical Highlights Completed dosing of more than 120 patients across 11 clinical trials sites in the Phase 2 portion of the RePOSA Phase 2/3 study of IHL-42X, an oral once-daily treatment for OSA. The trial is evaluating two doses of IHL-42X (2.5 mg dronabinol/125 mg acetazolamide and 5 mg dronabinol/250 mg acetazolamide) compared to placebo over a four-week treatment period. The results from this study will inform the selection of the optimal dose to advance into the larger, pivotal Phase 3 study. The study is structured to support potential regulatory submissions, including a future 505(b)(2) New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA). End-of-study follow-up assessments are expected to conclude May 17, 2025 and topline data is anticipated in July 2025. RePOSA Phase 3 planning is underway and will be conducted exclusively at U.S. sites to improve operational efficiency. This decision was supported by U.S. clinical site and patient enthusiasm. Reported positive topline results from a pharmacokinetics (PK) and safety study of IHL-42X. The data demonstrated that both active components in the fixed-dose combination were bioavailable, with pharmacokinetic profiles comparable to their respective reference listed drugs—further de-risking the program and establishing a clear scientific bridge to existing safety and toxicology data. Financial Results General and Administration (G&A) expenses for the three months ended March 31, 2025 were $2.27 million USD, compared to $4.14 million USD for the same period in 2024, due to cost-saving initiatives and reduced overhead expenditures. Research and Development (R&D) expenses for the three months ended March 31, 2025 totaled $2.74 million USD, compared to $3.28 million USD for the same period in 2024. Net loss for the three-month period ended March 31, 2025 was $3.97 million USD, compared to $6.03 million USD for the three months ended March 31, 2024. Cash and cash equivalents as of March 31, 2025 were $6.71 million USD, compared to $2.09 million USD as of December 31, 2024, including proceeds from financing activities and R&D tax incentive receivables. About IHL-42X IHL-42X is designed to treat OSA by targeting its underlying pathophysiology. An oral fixed-dose combination of dronabinol and acetazolamide, IHL-42X is currently advancing through the RePOSA Phase 2/3 clinical trial, which is expected to enroll more 560 patients at sites worldwide. Designed to act synergistically, IHL-42X uniquely targets two physiological pathways associated with the intermittent hypoxia (IH) and hypercapnia that characterize OSA. In a prior Australian Phase 2 clinical trial, IHL-42X was shown to reduce the Apnea-Hypopnea Index (AHI) in all dosage strengths, with the lowest dose reducing AHI by an average of 51 percent relative to baseline. RePOSA, a global Phase 2/3 clinical trial is underway, evaluating IHL-42X in individuals with OSA who are either non-compliant, intolerant, or naïve to positive airway pressure devices, including CPAP, with the Phase 2 portion conducted in the United States. A topline readout from the U.S. Phase 2 portion is anticipated in July 2025. 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. Forward Looking Statements This press release contains "forward-looking statements" within the meaning of the "safe harbor" provisions of the U.S. Private Securities Litigation Reform Act of 1995. Examples of forward-looking statements in this press release include statements about, among other things: Incannex's business strategy, future operations; Incannex's ability to execute on its objectives, prospects, or plans, the skills and experience of the newly appointed officer of Incannex and expectations with respect to his future contributions to the Company and statements, evaluations and judgments regarding Incannex's research and development efforts, including any implications that the results of earlier clinical trials will be representative or consistent with later clinical trials or final results; the expected timing of enrollment for these trials and the availability of data or results of these trials, and the potential benefits, safety or of Incannex's drug candidates. Forward-looking statements are statements other than historical facts and relate to future events or circumstances or Incannex's future performance, and they are based on management's current assumptions, expectations, and beliefs concerning future developments and their potential effect on Incannex's business. These forward-looking statements are subject to a number of risks and uncertainties, which may cause the forward-looking events and circumstances described in this press release to not occur, and actual results to differ materially and adversely from those described in or implied by the forward-looking statements. These risks and uncertainties include, among others: the continued availability of financing; Incannex's ability to raise capital to fund continuing operations and to complete capital raising transactions; the impact of any infringement actions or other litigation brought against Incannex; the success of Incannex's development efforts, including Incannex's ability to progress its drug candidates through clinical trials on the timelines expected; competition from other providers and products; that the market for its drug candidates may not grow at the rates anticipated or at all; Incannex's compliance with the various evolving and complex laws and regulations applicable to its business and its industry; and Incannex's ability to protect its proprietary technology and intellectual property; and other factors relating to Incannex's industry, its operations and results of operations. The forward-looking statements made in this press release speak only as of the date of this press release, and Incannex assumes no obligation to update publicly any such forward-looking statements to reflect actual results or to changes in expectations, except as otherwise required by law. Incannex's reports filed with the U.S. Securities and Exchange Commission (SEC) including its annual report on Form 10-K for the fiscal year ended June 30, 2024, filed with the SEC on September 30, 2024, and the other reports it files from time to time, including subsequently filed annual, quarterly and current reports, are made available on Incannex's website upon their filing with the SEC. These reports contain more information about Incannex, its business and the risks affecting its business, as well as its results of operations for the periods covered by the financial results included in this press release. For additional information on Incannex, please visit our website at www.incannex.com. Contact Information Jennifer Drew-Bear Edison Group for Incannex [email protected]