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Cannabinoid Based Medicines Leading the next evolution of healthcare

Welcome To Incannex

Incannex Healthcare Limited (IHL.ASX) is an innovator and developer of medicinal cannabinoid pharmaceutical products with global export capability.

IHL is currently undertaking 4 significant clinical programs to develop 4 uniquely formulated products in its relentless pursuit of FDA registration and market exclusivity over the following indications:

  • Obstructive Sleep Apnoea (‘OSA’)
  • Traumatic Brain Injury (‘TBI’)/Concussion
  • Sepsis Associated Acute Respiratory Distress Syndrome (‘SAARDS’)
  • Temporomandibular Joint Disorder (‘TMJD’).

AGM presentation from chief medical officer Dr Sud Agarwal

Unique cannabinoid-based products targeting major unmet markets

Incannex has established first-in-class, innovative cannabinoid-based pharmaceutical therapies. 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 exceeds $1 billion dollars per annum
  • Registered medications discovered may be eligible for public subsidies (e.g. 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 and market exclusivity
  • Early pre-registration sales opportunities exist under opening global medicinal cannabis access programs, including the Australian Special Access Scheme for Medicinal Cannabis.

THREE FOLD BUSINESS MODEL

A model to diversify clinical risk, create long term value and achieve immediate revenue streams.

1

Near term sales of patent protected cannabinoid medicines under Special Access Scheme (‘SAS’) prescriptions, in some cases after successful in-vivo and in-vitro pre-clinical, or other precursory, studies.

2

Mid-term out-licensing of specialist products for indications (revenue and lump sum milestone payment opportunities)

3

Long term development of targeted, scientifically validated products released to market globally via formal registration (e.g. FDA/EMA/TGA)

COMPETITIVE ADVANTAGE

The relaxation of laws around uses of cannabis in medicine has provided IHL its opportunity for novel cannabinoid drug evaluation and development. Within this advantaged framework, IHL has:

  • A credentialed medical advisory board of global key opinion leaders
  • An experienced regulatory affairs team
  • A clear go-to-market and FDA registration strategy for development of novel pharmaceuticals
  • Patent filing strategy over unique drug combinations
  • Multiple studies currently underway

COMMERCIAL DISTRIBUTION

Incannex has collaborations with multiple wholesale suppliers of cannabinoid oils and a cannabidiol pressurised metered dose inhaler to ensure that our products are high-quality and well-priced.

IHL has distributed pharmaceutical grade medicinal cannabis oils to 1000s of Australian patients who require various forms of care.

Cannabinoid products are primarily sold under Incannex’s unique product supply and distribution relationship with Cannvalate Pty Ltd, which is the largest network of cannabis medicine prescribers in Australia. The CEO of Cannvalate is Dr Sud Agarwal, who is also a Director and Chief Medical Officer of Incannex. Cannvalate and Dr Agarwal are major shareholders of IHL.

Our Medical Advisory Board

Dr Sud Agarwal

MBChB FANZCA

Chief Medical Officer

About Dr Sud Agarwal

Dr Sud Agarwal leads Incannex’s Medical Advisory Board, overseeing clinical trial programs, product commercialisation strategies, assistance with furthering defendable intellectual property and other matters. Dr Agarwal is an internationally recognised as an early mover and key opinion leader in the clinical use of cannabinoid medicines.

Sud is the current CEO and Managing Director of Cannvalate Pty Ltd; Australia’s largest network of medicinal cannabis prescribing doctors, which currently represents circa 40-50% of the total prescribing market. He is a qualified anaesthetist and the former Medical Director of Cann Group Limited (CAN:ASX)

Dr Mark Bleackley

PhD (Cell Biology and Genetics)

Chief Scientific Officer

About Dr Mark Bleackley

Dr Mark Bleakley was appointed to the role of Chief Scientific Officer in January of 2020, managing the clinical programs in conjunction with Dr Agarwal, other members of the advisory board and contracted clinical staff.

Dr Bleakley has a PhD in Cell Biology and Genetics from the University of British Columbia and has deep experience in clinical trial design and implementation; being named in 34 peer reviewed scientific publications during his career.

Mrs Rosemarie Walsh

B.Sc (App. Bio)

Clinical Research Manager

About Rosemarie Walsh

Rosemarie Walsh was appointed to the role of Clinical Research Manager in May 2020, managing the clinical trials program, together with Dr Bleackley.

With over 20 years of experience in clinical trials research, working in both pharma and global contract research organisations, Rosemarie brings a wealth of knowledge to the team.

Prior to entering the world of clinical research, Rosemarie worked in medical research, at the Ludwig Institute for Cancer Research and at AMRAD discovery Technologies natural products R&D.

Assoc. Professor Michael Stubbs

BDS MDS MDSc FRACDS

TMJ Disorder Specialist

About Associate Professor Michael Stubbs

Associate Professor Michael Stubbs is an oral medicine specialist practitioner based in Melbourne, Victoria, with a special interest in Temporomandibular Disorders for the  treatment of facial and jaw pain. He is an associate professor in oral medicine at Latrobe University and an editor of ‘Australasian Dentist’ Magazine with a multitude of research and professional education publications.

Prior to his current roles, Associate Professor Stubbs was Head of the Oral Medicine Unit at the Alfred Hospital in Melbourne between 2006 and 2015, national vice president of the Oral Medicine Society of Australia and New Zealand and a visiting lecturer at the School of Dental Science, University of Melbourne between 2003 and 2011.

Dr Rondhir (Ron) Jithoo

MBChB FRACS (Neuro) FCS(SA), FICS

Traumatic Brain Injury/Concussion/CTE Specialist

About Dr Rondhir Jithoo

Dr Rondhir Jithoo is a leading neurosurgeon based at the Alfred hospital in Melbourne, Victoria. He is also a research fellow at the National Trauma Research Institute, which is a partnership between Alfred Health and Monash University.

Prior to his current roles, Dr Jithoo was deputy chair of Neurosciences at Epworth Hospital, former Acting Head of Neurosurgery the Alfred Hospital and a reviewer for the Journal of Clinical Neuroscience.

Dr David Cunnington

MBBS MMedSc MAppMgt FRACP FCCP RPSGT DBSM

Obstructive Sleep Apnoea Specialist

About Dr David Cunnington

Dr David Cunnington is a specialist sleep physician, co-director of Melbourne Sleep Disorders Centre, and cofounder of the online sleep resource, Sleephub.com.au. David is a Fellow of the Royal Australasian College of Physicians, a diplomat of Behavioural Sleep Medicine (DBSM), registered Polysomnographic Technologist (RPSGT) and holds a master’s degrees in Medical Science
(Pharmaco-epidemiology and economics specialisation) and Applied Health  Management (Quality assurance specialisation).

David is an experienced investigator with original research, editorials and reviews published in leading medical journals on a range of sleep disorders. David appears regularly in traditional and social media as a commentator on sleep, promoting positive health messages about sleep and sleep
health and is an invited speaker at both national and international conferences on sleep.

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