CANNABINOID BASED MEDICINES LEADING THE NEXT EVOLUTION OF HEALTHCARE

Incannex Healthcare Limited  (IHL.ASX)

Incannex Healthcare Limited (ASX: IHL) is a clinical-stage pharmaceutical company focused on the development of unique medicines using cannabinoids and psychedelic compounds. The company is targeting major health problems for which there are limited or no effective treatments and therefore have enormous market potential. Incannex is the only ASX listed company focused on investigating psychedelics in combination with psychotherapy as a potential treatment for Generalised Anxiety Disorder.

 

Products and clinical programs have been designed to be consistent with the following ideals:

  • There is an established body of research evidence validating hypothesis for cannabinoids being efficacious in the chosen therapeutic areas.
  • No current registered pharmacotherapy (drug) options are available in the patient market to compete with IHL’s four candidates.
  • Strong patent opportunities and total addressable market of each therapeutic area is measured in the billions of dollars per annum.
  • Registered medications discovered may be eligible for public subsidies (eg. PBS in Australia, Medicare, and Medicaid in the USA).
  • Accelerated commercialisation pathways remain available, including the FDA 505b(2) new drug application for product registration to create prescription medicines and over which the market will have market exclusivity.
  • Early pre-registration sales opportunities exist under opening global medicinal cannabis access programs, including the Australian Special Access Scheme for Medicinal Cannabis.
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key investment insights

Clear Business Strategy

Incannex Healthcare Limited (IHL) is pursuing a strategy of combining existing off patent drugs with medicinal cannabis or cannabinoids and psychedelic medicine therapies to treat common major health issues for which there is no treatment currently available. The company is targeting Obstructive Sleep Apnoea (OSA), Traumatic Brain Injury (TBI), Lung Inflamation, Inflammatory Bowel Disease, Rheumatoid Arthritis and Generalised Anxiety Disorder (GAD). Each condition represents a major global market which currently has no or limited existing registered drug treatments available. This opens up the possibility of patients receiving government subsidies for products that demonstrate suitable safety and efficacy profiles in clinical trials. The Company has also announced that it is evaluating a further opportunity in the psychedelic medicine space.

Successful Management

Incannex has a highly credentialed and experienced specialist medical and scientific team including key global opinion leaders. Joel Latham is the CEO and Managing Director of Incannex Healthcare and is responsible for the Company’s commercial operations. He has an outstanding track record of success with over 13 years’ experience in management in multiple major blue-chip organisations.

Troy Valentine, Chairman of Incannex, is a finance professional with managerial and board experience spanning over 25 years. Mr Valentine is also the co-founder and director of the boutique corporate advisory group Alignment Capital. Dr Sud Agarwal is the Chief Medical Officer and Director responsible for strategic decision-making and oversight over the Company’s cannabinoid clinical program and pipeline of proprietary products.

Dr Agarwal is considered one of the most influential people in the medicinal cannabis sector.

Significant Investment Upside

Based on 1,060m shares on issue the current market capitalisation of the company is $275.7m. Success in developing a new medicine in any of the conditions which the company is targeting should provide significant upside from the current price of 26 cents. The company has approximately 347m in the money options on issue with 302m of them set to expire on 30th September, 2021. If the options expiring this year get exercised this will result in an additional $48.2m dollars in funding for the company.

SCALABLE BUSINESS MODEL

Incannex is developing new innovative medicines for conditions where no current pharmacotherapy options are available to treat patients. The company’s large project list means that the company is diversified, which is an attractive tenet of a biotech company. The markets it is targeting are very large so success in any one of the company’s pharmaceutical development programs provides significant upside from the current market capitalisation of the company.

Targeting Large Markets with Unmet Needs

Obstructive Sleep Apnoea (OSA) – US$5.9B in 2019, CAGR 7.4%

Traumatic Brain Injury (TBI) – US$2.7B in 2019, CAGR 7.3%

Lung Inflammation – Acute Respiratory Distress Syndrome (ARDS), SAARDS and Pulmonary Neutrophilia (Total combined market of US$44.7B per annum)

Inflammatory Bowel Disease (IBD) – US$22.4B in 2018, CAGR 4.4%

Rheumatoid Arthritis – $US57.9B per annum in 2019, CAGR 2.8%

Generalised Anxiety Disorder– US$7.5B by 2023, CAGR 2.5%

Incannex plans to expedite its products through the Special Access Scheme (SAS) in Australia and other regulatory bodies ahead of global registration and sales. IHL will develop multiple income streams from future drug sales post FDA registration.

High Barriers to Entry

IHL has a strong patent filing strategy to protect the markets for which it is developing new drugs. Patents have been filed for IHL-216A for TBI, IHL-42X for OSA and IHL-675A for lung inflammatory diseases, including SAARDS, ARDS asthma, as well as for IBD and rheumatoid arthritis. A patent application is currently being considered for psylocibin in combination with psychotherapy as a treatment regime for GAD.

By combining cannabinoids with existing drugs that have come off patent, Incannex has the potential to bring new medicines to market in a shorter space of time. Given the existing drugs have already been through the regulatory approval process, historical results from clinical trials can be used to speed up the registration process by eliminating the need for some trials and studies. This means that Incannex can commence clinical evaluation with phase 2 or even phase 2B trials, also potentially reducing the time to registration.

What are Cannabinoids?

Cannabinoids are compounds found in cannabis. The most notable cannabinoid is the phytocannabinoid tetrahydrocannabinol (THC), the primary psychoactive compound found in cannabis. Cannabinoids interact with specific cannabinoid receptors present on the surface of cells. These receptors are found in different parts of the central nervous system and the two main types of cannabinoid receptors in the body are CB1 and CB2. The most abundant of the cannabinoids is Cannabidiol (CBD), which is thought to have anti-anxiety effects, possibly counteracting the psychoactive effects of THC.

In 1992, a naturally occurring substance in the brain that binds to CB1 was discovered, called anandamide. This cannabinoid-like chemical and others that were later discovered are referred to as endocannabinoids. The effects of cannabinoids depends on the brain area involved. Effects on the limbic system, which is a complex system of nerves and networks in the brain involving several areas near the edge of the cortex may alter the memory, cognition and psychomotor performance. Effects on the mesolimbic pathway, which is a dopaminergic pathway in the brain, may affect the reward and pleasure responses and pain perception may also be altered.

Developing New Drugs Combining Cannabinoids with Existing Medicines

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Organisations Incannex Healthcare is Working With

Incannex is working with highly regarded organisations to progress its drug candidates through clinical trials and the regulatory approval process.

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Incannex have commissioned Camargo (leading regulatory FDA consultants) to undertake strategic assessments on the FDA approvals pathway for the company’s projects and they have confirmed that Incannex have commissioned Camargo (leading regulatory FDA consultants) to undertake strategic assessments on the FDA approvals pathway for the company’s projects and they have confirmed that IHL assets are candidates for the New Drug Approval (‘NDA’) pathway, reducing time and cost to commercialisation, subject to successful clinical assessment.

The Alfred Hospital has been engaged as a clinical trial site for the treatment of obstructive sleep apnoea using IHL-42X. The University of Western Australia Centre for Sleep Science has also been engaged as a second recruitment site for the phase 2b OSA trial.

Monash University and Incannex are working collaboratively together on the clinical development of psychedelics in combination with psychotherapy as a potential treatment for depression and anxiety. The study will be conducted at Brainpark which is a world first neuroscience research clinic dedicated to improving the physical, mental and brain health of Australians.

Pharmaceutical Development Plan

IHL is pursuing FDA registration of all new drugs being developed – all preclinical and clinical trials are geared towards this end.

  • FDA registration means that all doctors are entitled to prescribe the product and it also entitles the company to marketing exclusivity over its formulations over a period of time (minimum 5 years).
  • Once FDA registration is granted, IHL will pursue registration in other regions including Europe and Australia.
  • In addition to FDA marketing exclusivity, IHL is generating patent protection over its formulations and therapies. Granted patents provide the company with 20 years of exclusivity over its formulations and facilitates the opportunity to be the sole provider of a therapy, subject to ongoing clinical success.
  • Furthermore, as IHL receives more pre-clinical and clinical data on its assets as it pursues registration, the products will be eligible for sale under various global special medicines access schemes, including the Australian special access scheme. This will facilitate sales of its proprietary products even prior to registration, potentially creating a significant market opportunity.

Under the pathway IHL:

  • Plans to bring current drug assets to market in approximately 2.5 years, rather than up to 12 years for new molecular entities
  • Will generally not be required to complete pre-clinical and phase 1 clinical trials prior to commencing phase 2 studies for its FDA new drug application for its clinical assets. This is because there is extensive existing publicly available clinical information (including safety data) on the active ingredients in the drugs, allowing the company to bridge to the pre-existing data in its regulatory submissions
  • Will run animal toxicology bridging studies to run concurrently with Phase 2 “Factorial Study”
  • TBI, OSA and inflammatory lung conditions such as ARDS, SAARDS and Pulmonary Neutrophilia are all serious and life-threatening conditions with unmet medical needs, meaning there are no registered pharmaceutical treatments available – this affords IHL the opportunity to take advantage of the following programs – Breakthrough Designation, Accelerated Approval, Priority Review and Fast Track.

Clinical Program Structure: 

    1. Phase 2b
    2. Phase 2 Factorial
    3. Phase 3
    4. FDA New Drug Approval (mid 2022 – early 2023)

Six Drug Development Programs Providing Multiple Chances of Success

Obstructive Sleep Apnoea

IHL-42X is a novel cannabinoid formulated to moderate disordered sleeping and reduce Obstructive Sleep Apnoea (OSA). OSA affects almost 1 billion people worldwide and is characterised by disordered breathing during sleep leading to poor quality sleep and decreased oxygen uptake. IHL-42X is currently in Phase 2b clinical trials and is intended to be the first-in-class and first-time treatment for mild-moderate OSA. IHL_42X has predicted earning capacity of >$5 Billion per annum in sales after approval.

Professor Terence O’Brien is the Independent Principal Investigator from The Alfred Hospital for the OSA study. Professor O’Brien (MB, BS, MD, FRACP, FRCPE, FAHMS, FAES) is The Van Cleef Roet Professor of Medicine (Neurology), Head, Departments of Neuroscience and Medicine, and Deputy Head of School, Central Clinical School, Monash University. He also heads the Neuroscience Clinical Trials Unit at The Alfred and has an experienced team of study coordinators and research nurses that are an integral part of the trials team. Professor O’Brien is a specialist in neurology and clinical pharmacology, with expertise in epilepsy and related brain diseases, including traumatic brain injury, brain tumours and neurodegenerative diseases, neuropharmacology and in-vivo imaging in animal models and humans. Professor O’Brien was formerly The University of Melbourne’s James Stewart Chair of Medicine and Head of the Department of Medicine at the Royal Melbourne Hospital (2008-17). He has been the Principal Investigator of more than 100 commercially sponsored and investigator-initiated trials and is Chair of the Australian Epilepsy Clinical Trial Network. He has published more than 395 peer reviewed papers in leading scientific and medical journals, which have been cited approx. 14,000 times.

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Traumatic Brain Injury

IHL is taking a novel approach in developing a cannabinoid neuroprotective drug to protect the brain against neuronal cell death amongst other negative consequences due Traumatic Brain Injury (TBI). IHL hypothesized that the combination of CBD and isoflurane would have benefit in improving recovery after TBI my minimizing secondary injury cascades. In December 2020, results from a preclinical study confirmed strong synergistic neuroprotective activity of IHL-216A after TBI.  IHL-216A outperformed either drug alone at improving motor and cognitive function 7 days post injury as well as at reducing neuronal damage and neuronal inflammation in post-mortem analysis of brain tissue. The CDC estimates that there are 1.6 – 3.8 million concussions in the US per year, but no approved drugs for the treatment of TBI exist. The drug presents potential sales revenue of $450m per annum in the seven major markets.

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Inflammatory Lung Conditions (ARDS, SAARDS, Pulmonary Neutrophilia)

Incannex held a Pre-Investigational New Drug meeting with the US Food & Drug Administration (FDA) in April 2021. They agreed that marketing applications for IHL-675A should be made under 505(b)(2) which contains the full safety and effectiveness reports but allows some of the information required for NDA approval, such as safety and efficacy information on the active ingredients, to originate from historical studies not conducted by Incannex.  This should result in an accelerated and less costly pathway to approval compared to the traditional route for a new clinical entity that has no history of human consumption.

Acute Respiratory Distress Syndrome happens when the lungs become severely inflamed from an infection or injury. The inflammation causes fluid from nearby blood vessels to leak into the tiny air sacs in your lungs, making breathing increasingly difficult. Sepsis Associated Acute Respiratory Distress Syndrome occurs when a widespread infection in the blood stream (Sepsis) causes fluid to build up in the lungs.

IHL-675A contains a combination of an original cannabidiol and hydroxychloroquine to treat SAARDS. The total addressable market for SAARDS is $675m in the US and extrapolates to a total addressable market of more than $2 billion in the 7 major markets. IHL-675A has also produced positive results when tested in vivo on other inflammatory lung conditions. Pulmonary Neutrophilia is the primary underlying cause of asthma, bronchitis, and chronic obstructive pulmonary disease (COPD) which are very common medical conditions with limited treatment options.

IHL-675A has the potential to become a multi-use pharmaceutical drug addressing lung inflammatory and other conditions.

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Rheumatoid Arthritis

In a preclinical study concluded in March 2021, IHL-675A outperformed existing treatment for arthritis with increased effectiveness ranging from 1.06x to 3.52x. IHL has initiated an additional program to target rheumatoid arthritis exclusively which has a global addressable market of US$57 billion per annum thus further expanding the revenue generating potential of IHL-675A. Initial results demonstrate that IHL-675A, which combines CBD and HCQ, has the potential to permit a ten-fold reduction in HCQ dose, without sacrificing efficacy in treatment of arthritis with a reduction in the risk of side effects to patients. HCQ is approved and widely used in the treatment of this Rheumatoid Arthritis in the form of hydroxychloroquine sulphate under the brand name Plaquenil. The Company is hopeful that its drug will become a suitable replacement for HCQ in patients taking HCQ for rheumatoid arthritis.

Inflammatory Bowel Disease

In a mouse model of colitis, a form of inflammatory bowel disease, IHL-675A has been shown to outperform cannabidiol (CBD) and Hydroxychloroquine (HCQ) highlighting the synergistic nature between the two. The results indicate that IHL-675A has superior anti-inflammatory activity compared to CBD and HCQ alone. IBD is a growing problem which requires new and cost effective treatments. The global market for treatments for IBD is expected to reach US$22.4B by 2026, growing at a CAGR of 4.4% from 2018 to 2026.

Generalised Anxiety Disorder (GAD)

In December 2020, Incannex entered into a partnership agreement with Monash University to conduct a psychotherapy trial to treat Generalised Anxiety Disorder. The trial will be led by renowned psychedelic medicine expert Dr Paul Liknaitzky.

Dr Liknaitzky is the Principal Investigator, Psi-GAD-1 and Psychedilic Lead and works as a Research Fellow at Monash University, and has Adjunct or Honorary appointments at St Vincent’s Hospital, Macquarie University, Deakin University, and the University of Melbourne. He earned an Honours in Neuroscience and a PhD in Psychology from the University of Melbourne. His work examines mechanisms of mental illness and treatment development, primarily within mood disorders and addiction research. Dr Liknaitzky is Principal Investigator across a number of Australia’s first clinical psychedelic trials and is the only full time psychedelic medicine researcher in Australia. He is currently establishing a rigorous program of research in psychedelic medicine at Monash University in conjunction with Incannex that seeks to evaluate therapeutic effects, innovate on treatment design, mitigate known risks, explore potential drawbacks, and understand therapeutic mechanisms.

Monash will sponsor the trial, ensuring rigorous scientific independence as well as the highest standards in ethical and safe research. The phase 2 randomised double-blind active-placebo-controlled trial will recruit at least 72 patients, making it the largest psychedelic R&D project in Australia. The treatment will include psilocybin dosing sessions alongside a program of specialised psychotherapy in the treatment of Generalised Anxiety Disorder. This world-first clinical trial is expected to have a substantial impact on the field globally.

Generalised Anxiety Disorder is relatively common with an approximately 6-9% lifetime prevalence and a 3% 12 month prevalence in countries like Australia and the United States.

key people

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Joel Latham – CEO and Managing Director

Joel Latham is the CEO and Managing Director of Incannex Healthcare and is responsible for the Company’s commercial operations. Mr Latham is widely experienced in management and operational matters, having over 13 years’ experience in management in multiple major blue-chip organisations.

Prior to his appointment to CEO and Managing Director, Joel was the General Manager of Impression Healthcare for three years. During this time, he was instrumental negotiation and procurement of many contracts and collaborations, including with Cannvalate, AFL and NRL.

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Troy Valentine – Chairman

Troy Valentine is a finance professional with managerial and board experience spanning over 25 years. Originally from Perth, Troy began his career with Hartley Poynton in 1994, before moving to Paterson’s Securities in 2000 where he was appointed associate director of private clients. Mr Valentine has significant corporate advisory and capital raising experience, specifically with small to mid-cap size companies, and is currently co-founder and director of the boutique corporate advisory group Alignment Capital, based in Melbourne.

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Dr Sud Agarwal – CMO and Director

Dr Agarwal is the Chief Medical Officer of Impression Healthcare, responsible for strategic decision-making and oversight over the Company’s cannabinoid clinical program and pipeline of proprietary products.
Dr Agarwal is a qualified anaesthetist and is considered one of the most influential people in the medicinal cannabis sector, as evidenced by being a recent keynote speaker at the World Cannabis Congress (held in Canada).
He is also the current CEO of Cannvalate Pty Ltd, which is Australia’s largest distributor of medicinal cannabis products. Before Impression Healthcare, Sud was the Medical Director of ASX-listed, Cann Group Limited.

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