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. Figu...

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, i...

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...

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 expec...