Incannex Healthcare Inc

Incannex Healthcare Ltd. is a clinical stage pharmaceutical development company, which engages in the research and development associated with medicinal cannabinoid and psychedelic pharmaceutical products and therapies. It operates through the following segments: Psychedelic Products, Cannabinoid Products, and Corporate. The Psychedelic Products segment is involved in the use of psychedelic medicine and therapies for the treatment of mental health disorders. The Cannabinoid Products segment focuses on the use of medicinal cannabinoid products. The Corporate segment consists of management of the organization, capital management, and management of resources. The company was founded on April 27, 2001 and is headquartered in Melbourne, Australia.

Earnings data Q3 2024

Earnings data Q4 2024

Earnings data Q3 2025

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Incannex Healthcare, Inc. is a biotech company, which engages in developing cannabinoid and psychedelic compound medicines. It focuses on the research and development for medicinal cannabis pharmaceutical products and psychedelic medicine therapies for treatment of a range of indications. The company was founded on July 5, 2023 and is headquartered in Norwest, Australia.

MELBOURNE, Australia, July 26, 2023 (GLOBE NEWSWIRE) -- Incannex Healthcare Limited (Nasdaq: IXHL) (ASX: IHL), (‘Incannex' or the ‘Company') a clinical-stage pharmaceutical company developing unique medicinal cannabinoid pharmaceutical products and psychedelic medicine therapies for unmet medical needs, is pleased to announce that it has completed a constructive pre-Investigational New Drug Application (‘pre-IND') meeting with the U.S. Food and Drug Administration (‘FDA') for its proprietary drug product IHL-675A for treatment of rheumatoid arthritis (‘RA').

Incannex Completes Positive Pre-IND Meeting with US FDA on IHL-675A for Treatment of Rheumatoid Arthritis

MELBOURNE, Australia, July 21, 2023 (GLOBE NEWSWIRE) -- Incannex Healthcare Limited (Nasdaq: IXHL) (ASX: IHL), (‘Incannex' or the ‘Company') a clinical-stage pharmaceutical company developing unique medicinal cannabinoid pharmaceutical products and psychedelic medicine therapies for unmet medical needs, is pleased to announce that it has successfully submitted an Investigational New Drug (‘IND') application to the US Food and Drug Administration (‘FDA') for IHL-42X for treatment of obstructive sleep apnoea.

Incannex Submits IND Application to the US FDA for IHL-42X for Obstructive Sleep Apnoea

Highlights: Incannex has engaged Fortrea as the contract research organisation (‘CRO') to manage the IND opening Phase 2/3 clinical trial investigating IHL-42X for treatment of OSA. The Phase 2/3 clinical trial will assess the safety and efficacy of IHL-42X in people with OSA who are intolerant, non-compliant, or naïve to continuous positive airway pressure (‘CPAP').

Incannex engages Fortrea to Manage its FDA IND Opening Phase 2/3 Clinical Trial Investigating IHL-42X for Treatment of Obstructive Sleep Apnoea

Highlights: Incannex to redomicile to the United States via a Scheme of Arrangement pursuant to Australian law A newly formed Delaware corporation (Incannex Healthcare Inc.) will become the ultimate parent company of the group, following implementation of the Scheme of Arrangement The shares of common stock issued by Incannex Healthcare Inc. in exchange for all outstanding ordinary shares of Incannex, pursuant to the Scheme of Arrangement, will be listed on Nasdaq Incannex will have greater access to capital market more cognisant of IHL's value proposition with peer comparison companies trading at significantly higher market valuations The Incannex Board also anticipates: Improved access to large pools of lower cost equity capital over the long term Increased alignment with prominent pharmaceutical companies A simplified corporate structure for any future potential merger or acquisition transactions Enhanced access to FDA resources Incannex shareholders and optionholders will be given the opportunity to vote on redomiciling to the US in October 2023; if approved, the change in nature of the shares in Incannex can be implemented rapidly. If approved, Incannex will assist shareholders to seamlessly transfer their holdings to US shares tradable on Australia broking platforms to ensure little to no disruption to shareholders.

Incannex Announces Intention to Redomicile to United States, List all Shares on Nasdaq

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Highlights: Incannex has received approval from Bellberry Human Research Ethics Committee (‘HREC') to commence the bioavailability/bioequivalence (‘BA/BE') clinical trial to assess the pharmacokinetics and tolerability of IHL-42X The trial will include 116 participants at CMAX Clinical Research in South Australia and will be managed by Novotech Data from the clinical trial will be a critical component of future marketing submissions for IHL-42X for treatment of OSA The trial will be conducted in parallel to the IND opening and pivotal Phase 2/3 clinical trial OSA is highly prevalent, affecting approximately 30 million adults in the United States alone and there are no registered prescription drugs available to patients for the treatment of OSA The design of the BA/BE trial is consistent with FDA recommendations as part of the required research required to undertake a new drug application. MELBOURNE, Australia, July 06, 2023 (GLOBE NEWSWIRE) -- Incannex Healthcare Limited (Nasdaq: IXHL) (ASX: IHL), (‘Incannex' or the ‘Company') a clinical-stage pharmaceutical company developing unique medicinal cannabinoid pharmaceutical products and psychedelic medicine therapies for unmet medical needs, is pleased to announce that Incannex has received approval from Bellberry Human Research Ethics Committee to commence a bioavailability/bioequivalence (‘BA/BE') clinical trial on IHL-42X, the Company's proprietary drug product for treatment of obstructive sleep apnoea.

Incannex Receives Ethics Approval for Bioequivalence/Bioavailability Clinical Trial for IHL-42X, the Company's Proprietary Drug for Treatment of Obstructive Sleep Apnoea (‘OSA')

MELBOURNE, Australia, June 23, 2023 (GLOBE NEWSWIRE) -- Incannex Healthcare Limited (Nasdaq: IXHL) (ASX: IHL), (‘Incannex' or the ‘Company') a pharmaceutical company developing medicinal cannabinoid pharmaceutical products and psychedelic therapies for unmet medical needs, is pleased to announce that it will be featured as a presenting company at the H.C. Wainwright 4th Annual Neuropsychiatry Virtual Conference. The conference is being held virtually on September 26, 2023.

Incannex Announces Participation at the H.C. Wainwright 4th Annual Neuropsychiatry Virtual Conference June 26, 2023

MELBOURNE, Australia, June 16, 2023 (GLOBE NEWSWIRE) -- Incannex Healthcare Limited (Nasdaq: IXHL) (ASX: IHL), (‘Incannex' or the ‘Company') a clinical-stage pharmaceutical company developing unique medicinal cannabinoid pharmaceutical products and psychedelic medicine therapies for unmet medical needs, is pleased to announce that it has recruited two highly experienced lead principal investigators (PIs) for the IND opening Phase 2/3 clinical trial investigating IHL-42X for treatment of obstructive sleep apnoea (‘OSA'). Dr John D Hudson of FutureSearch Trials of Neurology, Austin, Texas and Dr Russell Rosenberg of Neurotrials Research Inc, Atlanta, Georgia.

Incannex Appoints Principal Investigators for IHL-42X Phase 2/3 Clinical Trial

Highlights: Three world-leading clinical psychedelics experts join Clarion Clinics Advisory Board. Dr. Bill Richards is among the world's best known psychedelic researchers and practitioners.

World Renowned International Psychedelics Experts Join Clarion Clinics Advisory Board

MELBOURNE, Australia, May 16, 2023 (GLOBE NEWSWIRE) -- Incannex Healthcare Ltd (Nasdaq: IXHL) (ASX: IHL) (‘Incannex' or ‘the Company') is pleased to announce a company presentation which details activities of its psychedelic therapies subsidiary company, called Psychennex.

Incannex Company Presentation – Presentation of Psychennex, Psychedelic Therapies Subsidiary Company

MELBOURNE, Australia, May 05, 2023 (GLOBE NEWSWIRE) -- Incannex Healthcare Ltd (Nasdaq: IXHL) (ASX: IHL) (‘Incannex' or ‘the Company'), a medicinal cannabinoid and psychedelic pharmaceutical development company, is delighted to announce that its subsidiary company, Clarion Clinics Group Pty Ltd, has entered a lease for riverfront premises in Abbottsford, Melbourne.

Incannex enters a lease for first psychedelic-assisted psychotherapy clinic

MELBOURNE, Australia, May 03, 2023 (GLOBE NEWSWIRE) -- Incannex Healthcare Ltd (Nasdaq: IXHL) (ASX: IHL) (‘Incannex' or ‘the Company') is pleased to announce a company presentation containing data and analysis of the results from the Phase 1 clinical trial undertaken to assess safety and pharmacokinetics of IHL-675A as an anti-inflammatory drug candidate.

Incannex Company Presentation – Results from Phase 1 Clinical Trial to Assess Proprietary IHL-675A

MELBOURNE, Australia, May 02, 2023 (GLOBE NEWSWIRE) -- Incannex Healthcare Limited (Nasdaq: IXHL) (ASX: IHL), (‘Incannex' or the ‘Company') a clinical-stage pharmaceutical company developing unique medicinal cannabinoid pharmaceutical products and psychedelic medicine therapies for unmet medical needs, is pleased to announce that it has received final results from the Phase 1 clinical trial undertaken to assess pharmacokinetics and safety of the anti-inflammatory drug IHL-675A.

Incannex Announces Final Results from Phase 1 Clinical Trial Assessing Safety and Pharmacokinetics of IHL-675A

MELBOURNE, Australia, April 14, 2023 (GLOBE NEWSWIRE) -- Incannex Healthcare Ltd (Nasdaq: IXHL) (ASX: IHL) (‘Incannex' or ‘the Company') a pharmaceutical company developing proprietary medicinal cannabinoid products and psychedelic assisted psychotherapies for unmet medical needs, is pleased to announce that is has appointed Quest Pharmaceutical Services (‘QPS') to provide regulatory advice and manage clinical trials for the development of CannQuit™ and ReneCann™ products for addiction and immune-disordered skin diseases.

Incannex Appoints QPS to Advance CannQuit-N™ (Nicotine), CannQuit-O™ (Opioid) and Renecann™ Products in the USA and EU

Incannex to Commercialise its Psychedelic Clinics Business in Collaborative Partnership with Leading Psychedelic Experts

Interim review of proprietary PsiGAD clinical trial data indicates no safety concerns and projects a statistically significant benefit for the psilocybin arm versus the placebo arm in those participants who have completed the treatment

Incannex Engages Catalent for Development and cGMP Manufacture of Psilocybin Drug Product for Clinical Trials and Potential Commercial Use

Incannex Commences Phase 2 Clinical Trial Assessing IHL-675A for use in Treatment of Pain and Function in Rheumatoid Arthritis

MELBOURNE, Australia, Nov. 29, 2022 (GLOBE NEWSWIRE) -- Incannex Healthcare Limited (Nasdaq: IXHL) (ASX: IHL), (‘Incannex' or the ‘Company') a clinical-stage pharmaceutical company developing medicinal cannabinoid and psychedelic therapies for unmet medical needs, is delighted to announce that it has engaged multinational contract development and manufacturing organisation (CDMO) Eurofins Scientific (‘Eurofins') to manufacture ReneCann therapeutic for topical applications.

Incannex Engages Eurofins to Manufacture ReneCann Therapeutic Topical Application for Immune Disordered Skin Diseases

MELBOURNE, Australia, Nov. 28, 2022 (GLOBE NEWSWIRE) -- Incannex Healthcare Limited (Nasdaq: IXHL) (ASX: IHL), (‘Incannex' or the ‘Company') a clinical-stage pharmaceutical company developing medicinal cannabinoid and psychedelic therapies for unmet medical needs, is delighted to announce that it has engaged multinational contract development and manufacturing organisation (CDMO) Eurofins Scientific (‘Eurofins') to manufacture Incannex's two distinct medicated chewable products designed to treat nicotine and opioid addiction disorders.

Incannex Engages Eurofins to Manufacture Novel Addiction Treatments CannQuit-N and CannQuit-O

Incannex Development Update for IHL-42X for Obstructive Sleep Apnoea (‘OSA')

MELBOURNE, Australia, Oct. 28, 2022 (GLOBE NEWSWIRE) -- Clinical stage pharmaceutical development company, Incannex Healthcare Limited (ASX: IHL) (NASDAQ: IXHL), (‘Incannex' or the ‘Company'), is pleased to provide its quarterly activities report and appendix 4C for the period ended 30 September 2022. Incannex is undertaking a multitude of U.S. Food and Drug Administration (‘FDA') programs for cannabinoid pharmaceutical products and psychedelic medicine therapies administered by health professionals.

Incannex Healthcare Quarterly Activities Report and Appendix 4C Cash Flow Statement

Incannex Completes Dosing in Phase 1 Clinical Trial to Assess Multi-Use, Anti-Inflammatory Drug IHL-675A; Proceeds to Phase 2 Clinical Trials

MELBOURNE, Australia, Sept. 08, 2022 (GLOBE NEWSWIRE) -- Incannex Healthcare Limited (Nasdaq: IXHL) (ASX: IHL), (‘Incannex' or the ‘Company') a pharmaceutical company developing medicinal cannabinoid pharmaceutical products and psychedelic therapies for unmet medical needs, is pleased to announce that it will be featured as a presenting company at the H.C. Wainwright 24th Annual Global Investment Conference.

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