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

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Incannex Healthcare, Inc. 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 includes management of the organization, capital management, and management of resources. The company was founded on April 27, 2001 and is headquartered in New York, NY.

NEW YORK and MELBOURNE, Australia, May 30, 2024 (GLOBE NEWSWIRE) -- Incannex Healthcare Inc. (Nasdaq: IXHL), (‘Incannex' or the ‘Company'), a pharmaceutical company developing unique medicinal cannabinoid pharmacotherapies and psychedelic medicine therapies is pleased to announce that patient dosing has commenced in the Company's Phase 2/3 clinical trial to assess safety and efficacy of IHL-42X in patients with obstructive sleep apnea (‘OSA').

Patient dosing commenced in RePOSA Phase 2/3 Clinical Trial Protocol to Assess IHL-42X Drug in Patients with Obstructive Sleep Apnea

MELBOURNE, Australia and NEW YORK, May 07, 2024 (GLOBE NEWSWIRE) -- Incannex Healthcare Inc. (Nasdaq: IXHL), (Incannex or the Company), a leading cannabinoid and psychedelic medicine biotechnology company, is pleased to announce the successful completion of a pre-IND (Investigational New Drug) meeting with the U.S. Food and Drug Administration (FDA) regarding the development of CannQuit-O for treatment of Opioid Use Disorder (OUD).

Incannex Complete Successful Pre-IND Meeting with the FDA for CannQuit-O for treatment of opioid use disorder

Dallas, Texas--(Newsfile Corp. - May 1, 2024) - Stonegate Healthcare Partners is pleased to announce the publication of its latest report, titled "Potentially Transformative therapies for Generalized Anxiety Disorder (GAD)." This report explores the pervasive issue of GAD, a condition affecting millions worldwide, and potentially transformative therapies which will change the landscape of future treatments.

Stonegate Healthcare Partners Releases Report on Potentially Transformative Therapies for Generalized Anxiety Disorder (GAD)

MELBOURNE, Australia and NEW YORK, Feb. 16, 2024 (GLOBE NEWSWIRE) -- Incannex Healthcare Inc. (Nasdaq: IXHL), (Incannex or the Company), a leading cannabinoid and psychedelic medicine biotechnology company, is pleased to announce the successful completion of a pre-IND (Investigational New Drug) meeting with the U.S. Food and Drug Administration (FDA) regarding the development of CannQuit-N for tobacco smoking cessation and control of relapse.

Incannex Completes Successful Pre-IND Meeting with the FDA for CannQuit-N; a Novel Solution for Tobacco Smoking Cessation

Highlights: Clarion's Head of Psychiatry, Professor Suresh Sundram, has been approved by the TGA to prescribe MDMA for Post-traumatic Stress Disorder and psilocybin for Treatment-resistant Depression, alongside extensive psychotherapy. Clarion Clinics' built-for-purpose clinic in Melbourne is now open for treatment, and will begin screening patients immediately.

Clarion Clinics Open for Psychedelic-Assisted Treatments

MELBOURNE, Australia and NEW YORK, Jan. 24, 2024 (GLOBE NEWSWIRE) -- Incannex Healthcare Inc. (Nasdaq: IXHL), (‘Incannex' or the ‘Company'), a pharmaceutical company developing novel medicinal cannabinoid pharmacotherapies and psychedelic medicine therapies for unmet medical needs, is pleased to announce that patient dosing has commenced in the Phase 2 clinical trial assessing IHL-675A in patients with rheumatoid arthritis (RA).

Incannex Commences Dosing in Phase 2 Clinical Trial Assessing IHL-675A in Patients with Rheumatoid Arthritis

Highlights: 72 patients treated at purpose-built facilities within Monash University, Melbourne, Australia. Topline results from the trial anticipated within current Q1 2024.

Incannex Completes Dosing and Therapy in Phase 2 “PsiGAD” Clinical Trial Assessing Psilocybin-assisted Psychotherapy for Generalized Anxiety Disorder; Data Analysis Commences

MELBOURNE, Australia and NEW YORK, Jan. 17, 2024 (GLOBE NEWSWIRE) -- Incannex Healthcare Inc. (Nasdaq: IXHL), (‘Incannex' or the ‘Company'), a pharmaceutical company developing unique medicinal cannabinoid pharmacotherapies and psychedelic medicine therapies is pleased to announce that an independent Institutional Review Board (IRB) has approved the protocol for the Company's Phase 2/3 clinical trial to be conducted in the United States to assess safety and efficacy of proprietary combination drug candidate IHL-42X in patients with obstructive sleep apnea (OSA). IRB approval of the protocol is a key step in activation of clinical trial sites for the RePOSA study.

Incannex Receives IRB Approval for the RePOSA Phase 2/3 Clinical Trial Protocol to Assess IHL-42X Drug in Patients with Obstructive Sleep Apnea

Highlights: Incannex subsidiary, Clarion Clinics, has received Human Research Ethics Committee (HREC) endorsement for administration of psychedelic-assisted therapies for TRD and PTSD. HREC approval is required for the administration of psychedelic drugs in Australia.

Clarion Clinics Receives Ethics Board Endorsement for the First Dedicated Psychedelic-Assisted Therapy Clinic in Australia

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MELBOURNE, Australia and NEW YORK, Dec. 06, 2023 (GLOBE NEWSWIRE) -- Incannex Healthcare Inc. (Nasdaq: IXHL), (‘Incannex' or the ‘Company'), a pharmaceutical company developing unique medicinal cannabinoid pharmacotherapies and psychedelic medicine therapies for unmet medical needs, is pleased to provide the following update on its proprietary IHL-42X drug candidate.

Incannex Update on IHL-42X Drug Candidate in Phase 2/3 Clinical Trial in Obstructive Sleep Apnea

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MELBOURNE, Australia and NEW YORK, Nov. 29, 2023 (GLOBE NEWSWIRE) -- Incannex Healthcare Inc. (NASDAQ: IXHL) is pleased to announce that its previously announced transaction to redomicile Incannex Healthcare from Australia to the United States has been implemented as of yesterday, November 28, 2023 New York time (November 29, 2023 Melbourne time).

Incannex Healthcare Announces Completion of its Redomiciliation to the United States

MELBOURNE, Australia, Nov. 16, 2023 (GLOBE NEWSWIRE) -- Incannex Healthcare Limited (ASX: IHL) (NASDAQ: IXHL) (the “Company” or “Incannex”) is pleased to announce that the Federal Court of Australia (“Court”) has today made orders approving the scheme of arrangement in relation to the Company's proposed re-domiciliation from Australia to the United States (“Scheme”), under which Incannex Healthcare Inc. (“Holdco”) will become the ultimate parent company of Incannex Healthcare Limited following the implementation of the Scheme.

Federal Court of Australia Approves Incannex's Re-Domiciliation and Lodgement of Court Orders With ASIC

MELBOURNE, Australia, Sept. 08, 2023 (GLOBE NEWSWIRE) -- Incannex Healthcare Limited (Nasdaq: IXHL) (ASX: IHL), (‘Incannex' or the ‘Company') a pharmaceutical company developing cannabinoid pharmaceutical medicines 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 25th Annual Global Investment Conference - September 11-13, 2023. Incannex will be presenting and taking one on one meetings virtually. Mr Joel Latham, CEO and Managing Director of Incannex, will provide an overview of the Company's business during the presentation.

Incannex Announces Participation at the H.C. Wainwright 25th Annual Global Investment Conference - September 11-13, 2023

MELBOURNE, Australia, Aug. 24, 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 its subsidiary Psychennex Pty Ltd has commenced preparations of an investigational new drug (‘IND') application to the U.S. Food and Drug Administration (‘FDA') for the Company's psilocybin assisted psychotherapy development program (‘Psi-GAD').

Incannex to Prepare FDA IND Application for Psilocybin-assisted Psychedelic Psychotherapy Program, Known as Psi-GAD

MELBOURNE, Australia, Aug. 22, 2023 (GLOBE NEWSWIRE) -- Incannex Healthcare Limited (Nasdaq: IXHL) (ASX: IHL), (‘Incannex' or the ‘Company') a clinical-stage pharmaceutical company developing proprietary medicinal cannabinoid products and psychedelic assisted psychotherapies for unmet needs, is pleased to announce that it has received approval from the US Food and Drug Administration (‘FDA') to conduct the Company's Investigational New Drug (‘IND') opening pivotal IHL-42X Phase 2/3 clinical trial in the United States as planned.

Review of IND Application for IHL-42X by US FDA has been completed; Clinical Trial for Patients with Obstructive Sleep Apnoea May Proceed

Highlights: Incannex subsidiary, Clarion Clinics Group Pty Ltd (Clarion) begins accepting registrations of interest in its psychedelic-assisted therapy (PAT) treatments ahead of planned Q3 opening. First clinic in Abbotsford, Melbourne, nearing fit-out completion.

Clarion Clinics Begins Accepting Registrations for Psychedelic Treatment Interest as Part of Pre-Screening in Readiness for Opening

MELBOURNE, Australia, July 28, 2023 (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 June 2023. Incannex is undertaking a multitude of U.S. Food and Drug Administration (‘FDA') research and development (‘R&D') programs for cannabinoid pharmaceutical products and psychedelic medicine therapies administered by health professionals.

Incannex Healthcare June 2023 Quarterly Activities Report and Appendix 4C Cash Flow Statement

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')

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