Full Press Release Details
Healthcare March 2023 Quarterly Activities Report and Appendix 4C Cash Flow Statement
Australia, April 27, 2023 - 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 31 March 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.
of Psychedelic Assisted Psychotherapy Clinics in Collaboration with Australia's Foremost Psychedelic Assisted Psychotherapy Experts
March of 2023, Incannex announced that it had developed plans for the commercialisation of its psychedelic-assisted psychotherapy business
( Psychedelic Clinics'). The Company estimates that the addressable market for psychedelic assisted psychotherapy in Australia
will grow to over $2 billion per annum within 3 years.
Clinics Group, the collaboration between Australia's foremost clinical experts and IHL (84.5% owned by IHL subsidiary Psychennex
Pty Ltd), will provide treatment under the TGA regulated authorised prescriber scheme, for the use of psilocybin for treatment-resistant
depression (TRD) and the use of MDMA for Post-Traumatic Stress Disorder (PTSD). A number of other depression and anxiety related disorders
will be treated with ketamine-assisted psychotherapy.
through Clarion Clinics Group, plans to open multiple psychedelic-assisted psychotherapy clinics in Australia and overseas, with the
first model' clinic to open in Melbourne in Q3, 2023, followed by rapid expansion of much larger clinics to other Australian
major centres based on the development of sound operations at the model clinic.
model clinic will be a commercial scale prototype, capable of treating 600+ patients per year in normal working hours and substantially
more in extended hours of operation. The Company expects its inner-North Melbourne premises to be ready before September 2023, facilitating
first patient treatments shortly after.
Company has entered a collaboration agreement with Australia's leading clinical psychedelic professionals, all of whom have extensive
experience within clinical psychedelic research, treatment, and training. Dr. Paul Liknaitzky, Professor Suresh Sundram and Sean O'Carroll
have joined the Board of Directors of a Clarion Clinics Group Pty Ltd and Clarion Model Clinic Pty Ltd and taken key executive roles
within the business. The venture is being led by long time Incannex Director, Peter Widdows.
Healthcare Limited (ABN: 93 096 635 246)
39, Rialto South Tower, 525 Collins Street, Melbourne VIC 3000
Paul Liknaitzky: Co-Founder, Director, Chief Strategy Officer, and Chief Scientific Officer
has played a central role in establishing the clinical psychedelic field in Australia and leads the largest group of psychedelic researchers
and clinicians in the country. Paul is the Chief Principal Investigator on a program of psychedelic trials and collaborates on numerous
others nationally. He has led the development of psychedelic trial protocols, treatment design, trial coordination, therapist selection
and training, and has established active collaborations with an extensive network of international experts and organisations in the field.
Paul's work is focused on developing innovative psychedelic therapies, evaluating benefits, exploring potential drawbacks, predicting
treatment response, mitigating risks, understanding therapeutic mechanisms, and translating research into practice.
Suresh Sundram: Co-Founder, Director, Chief Medical Officer, and Head of Psychiatry
is a Fellow of the Royal Australian and New Zealand College of Psychiatrists and a consultant psychiatrist. He holds senior leadership
positions in academic and clinical psychiatry and has published more than 150 scientific articles, books, book chapters, and conference
abstracts. He has presented as plenary and invited speaker at international and national conferences, served as Deputy Editor for the
Asian Journal of Psychiatry, and as an advisor to the United Nations (UN), and to national and state governments. Prof. Sundram has led
over 50 clinical trials and studies in psychiatric disorders. He has extensive experience with the use of psychedelics within psychotherapy
and has overseen multiple research projects in this field.
O'Carroll: Co-Founder, Director, and Head of Psychotherapy
is an integrative psychotherapist and academic - specialising in experiential, relational, and transpersonal psychotherapy. Since
2019, he has developed and delivered psychedelic-assisted psychotherapy training for several clinical psychedelic research teams. He
has served as lead psychotherapist on two clinical research trials, continues to supervise one of these teams, and works as a psychedelic-assisted
psychotherapy consultant within industry, with an emphasis on psychotherapy training and protocol development. Sean began lecturing in
transpersonal psychology in 2011 and has over ten years' experience working with what he calls "psychedelic casualties".
Through the Wild Mind Institute, he offers training for mental health practitioners in psychedelic-assisted psychotherapy, "bad
trip" integration, and eco-psychotherapy.
Widdows: Co-Founder, Director, and Business Lead
has been a Director of Incannex since 2018 and is also the Chairman of Sunny Queen Ltd and a non-executive director of Youi Insurance.
He has extensive business experience in the FMCG sector and was the CEO for a large part of Asia and Australasia, responsible for 18,500
people and multi-billion-dollar revenues for H. J. Heinz Inc, an NYSE listed multinational food company. Peter has senior business experience
across multiple geographies, throughout Asia, Australasia, Europe, and North America. Peter Widdows has been driving this project since
its inception and will continue to lead the Incannex owned subsidiary for the foreseeable future.
Healthcare Limited (ABN: 93 096 635 246)
39, Rialto South Tower, 525 Collins Street, Melbourne VIC 3000
Psychotherapy for Generalised Anxiety Disorder (Psi-GAD): Interim Review of Phase 2 Clinical Trial
the quarter, Incannex completed a confidential and blinded review of the interim data from the first 29 participants to complete the
Psi-GAD treatment protocol. The Company also completed a conditional power analysis using the interim data to model and project total
the strong results to date, the Company found that there is a high probability (greater than 85%, alpha error 0.05 or 95% confidence
level) that, at completion, the clinical trial will show a statistically significant benefit for the psilocybin treatment arm over the
placebo treatment arm. This projection is made by assuming the effect size observed in the interim analysis for 29 participants is representative
of the effect size through the remaining 43 participants. The end point used in this modelling was a reduction in Hamilton Anxiety Rating
Scale (HAM-A) score at 11 weeks relative to baseline, which is the primary endpoint in the trial.
review was also conducted by an independent DSMB, which reviewed the available data from the first 37 out of 72 participants. The DSMB
recommended no adjustments to the original study design or sample size. The study design is based on the hypothesis that psilocybin-assisted
psychotherapy will show a large treatment effect, as measured by a reduction in HAM-A scores compared to the control condition (active-placebo-assisted
trial continues to progress well and on time, with retention of all participants who have been enrolled. As at the 27th April,
2023 a total of 55 participants have been enrolled in the trial. The trial team have identified no safety concerns to date. The interim
results from the trial gave the Company the confidence to proceed with engaging Catalent for development and cGMP manufacture of Incannex's
psilocybin drug products for use in future clinical trials and the psychedelic clinics.
2 Clinical Trial to Assess IHL-675A in Patients with Rheumatoid Arthritis Commences
February, Incannex commenced a Phase 2 clinical trial to assess IHL-675A for use in the treatment of pain and function associated with
rheumatoid arthritis ( RA'). IHL-675A is a fixed dose combination drug comprising cannabidiol ( CBD') and hydroxychloroquine
( HCQ'), both drugs are currently prescribed or taken to treat the symptoms of RA.
Phase 2 trial follows a successful Phase 1 trial, where IHL-675A was observed to be well tolerated in patients, and animal studies whereby
IHL-675A was observed to reduce RA inflammatory disease scores to a greater extent than CBD or HCQ when taken alone.
trial is being managed by Avance Clinical, an Australian and US contract research organisation, who will engage a total of 8-10 clinical
trial sites across Australia and New Zealand, recruiting 120 patients in total. The results of the trial will establish the safety and
efficacy of IHL-675A and contribute to the combination rule assessment in a FDA505(b)2 new drug application dossier.
parallel with the preparations for the Phase 2 trial in Australia and New Zealand the company is also preparing for a pre-IND meeting
with the FDA regarding the development of IHL-675A for treatment of pain and function in patients with rheumatoid arthritis to facilitate
the conduct of future clinical trials with sites in the US.
Healthcare Limited (ABN: 93 096 635 246)
39, Rialto South Tower, 525 Collins Street, Melbourne VIC 3000
Development Update for IHL-42X for Obstructive Sleep Apnoea ( OSA')
the quarter, Incannex continued development activities associated with the dosing of trial participants in the bioavailability and bioequivalence
( BA/BE") clinical trial. The BA/BE study is assessing the pharmacokinetics and tolerability of the two active pharmaceutical
ingredients ( APIs') in IHL-42X, dronabinol ( THC') and acetazolamide, compared to the respective FDA reference
listed drugs, as well as the effect of food on pharmacokinetics of the two APIs.
BA/BE study includes 116 participants who will each complete four (4) single dose treatment periods, being dosed with IHL-42X, dronabinol
and acetazolamide under fasted conditions as well as IHL-42X under fed conditions. Blood samples will be collected over 48 hours and
the concentrations of the APIs and their major metabolites in the samples will be analysed. The study will be conducted at CMAX Clinical
Research in Adelaide, South Australia and managed by Novotech. The design of the BA/BE study is consistent with FDA recommendations.
to the BA/BE clinical trial, Incannex is targeting submission of an IND application with FDA in the current June quarter of 2023. The
company has developed the study protocol for the proposed IND opening Phase 2/3 clinical trial, commenced the process of engaging US
based investigators and clinical trial sites for the IND opening clinical trial, finalised the modules on the pharmacology and toxicology
of the IHL-42X drug product and are finalising the chemistry and manufacturing controls module.
March 31, 2023, Incannex recorded A$37.1M in cash at bank. A$4.29M was recorded as cash outflows associated with R&D activities.
Notably, Incannex is eligible to receive an annual cash rebate equivalent to approximately 43.5% of all monies spent on research and