Invex Therapeutics Ltd. · ASX:IXC
Invex Therapeutics — Investor Presentation (November 2019)
23 slides from Invex Therapeutics's investor presentation, November 2019
Slide 1: Invex Therapeutics: Repurposing An Approved Drug
Invex Therapeutics Repurposing An Approved Drug Open Briefing November 2019 ASX Code: IXC 1
Slide 2: Disclaimer
Disclaimer This presentation (Presentation) is issued by Invex Therapeutics Ltd (ASX:IXC) (the Company or IXC). The information presented in this Presentation may contain predictions, estimates and other forward-looking statements. Although the company believes that its expectations are based on rea
Slide 3: Invex Therapeutics - ASX:IXC
Invex Therapeutics - ASX:IXC • Invex Therapeutics (Invex or the Company) was established March 2019 • Focused on repurposing Exenatide for neurological conditions involving raised intracranial pressure such as idiopathic intracranial hypertension (IIH) • Assignment of intellectual property from Univ
Slide 4: Investment Highlights
Investment Highlights • Completed proof-of-concept preclinical in-vitro and in-vivo studies – data published in world leading scientific journal • Orphan Drug Designations granted for IIH in Europe (EMA) and in the US (FDA) • Clinical study initiated in IIH • Lower development risk • Faster commerci
Slide 5: Capital Structure & Major Shareholders
Capital Structure & Major Shareholders Capital Structure Major Shareholders Shares on issue Directors / Management 20% 55 mil Minderoo Pty Ltd 9.1% Unlisted Options 3 mil @60c Kim Hogan 7.3% Cash ~$A11.3 mil Tony Grist 7.3% Market Cap $A42 mil Tom Henderson 7.3% Jason Peterson 4.5% University of Bir
Slide 6: Board and Management Team
Board and Management Team • Dr Jason Loveridge, Chairman – Experienced life science investor & CEO • Prof Alexandra Sinclair, Executive Director and Chief Scientific Officer – Global scientific & clinical leader in IIH • Mr David McAuliffe, Non Executive Director – Founder of numerous life science c
Slide 7: Professor Sinclair MBChB, FRCP, PhD
Professor Sinclair MBChB, FRCP, PhD • Clinician Scientist & Neurology Consultant • Leads a translational research program focused on defining the pathophysiological mechanisms of raised intracranial pressure and developing therapeutics strategies to take through to clinical trials • Leads the multid
Slide 8: Idiopathic Intracranial Hypertension (IIH)
Idiopathic Intracranial Hypertension (IIH) • Disease characterised by raised intracranial pressure & papilloedema • Symptoms – severe headaches – visual impairment, with ~25% of patients experiencing permanent loss of vision • 90% of IIH patients are obese women of childbearing age IIH peaks between
Slide 9: Cause of Raised Intracranial Pressure
Cause of Raised Intracranial Pressure Mollan S & Sinclair A JNNP 2016 9
Slide 10: Rising IIH Incidence Linked to Obesity
Rising IIH Incidence Linked to Obesity • IIH is a rapidly growing orphan indication – incidence of IIH has more than doubled in the last 10 years – incidence is strongly linked to obesity in women The expanding burden of idiopathic intracranial hypertension, Susan P. Mollan, Magda Aguiar, Felicity E
Slide 11: IIH Diagnosis: 5-steps, Standardised, Rapid
IIH Diagnosis: 5-steps, Standardised, Rapid A. Papilloedema 100% B. Normal neurological examination 95% of IIH patients present at either A&E or opticians and C. Normal Brain Imaging are referred to a neurologist for diagnosis & treatment D. Normal cerebrospinal fluid (CSF) composition E. Elevated l
Slide 12: IIH Treatment Guidelines
IIH Treatment Guidelines • Leading role played by Invex’s founder Prof Alexandra Sinclair • Currently no approved drugs for IIH 12
Slide 13: Current Therapeutic Options are Ineffective
Current Therapeutic Options are Ineffective All current medicines for IIH are unapproved*, outdated, work poorly and cause debilitating side effects Acetazolamide (1954) Most commonly used drug in IIH Cochrane review IIH in August 2015 concluded: “Insufficient evidence to recommend or reject the eff
Slide 14: Neurosurgery Is Currently Needed
Neurosurgery Is Currently Needed • CSF shunting (tube) – Drains fluid to reduce brain pressure – Can save vision, BUT • Shunts have serious issues – Over 50% require shunt revision • 63% are revised within 1 year – Over-drainage in >20% • AT BEST, a short-term fix! 14
Slide 15: Exenatide – Novel Approach to Raised ICP
Exenatide – Novel Approach to Raised ICP • Exenatide is a small peptide that binds the GLP-1 receptor • GLP-1 receptor agonists – like Exenatide – decrease fluid secretion in the kidney and are used extensively to treat diabetes • Prof Alexandra Sinclair has shown that GLP-1 receptors are also expre
Slide 16: Exenatide – Where Does It Come From?
Exenatide – Where Does It Come From? Exenatide is derived from a chemical found in the saliva of the Gila monster, a venomous lizard 16
Slide 17: Ongoing Clinical Trial in IIH
Ongoing Clinical Trial in IIH • Single centre study 16 patients active IIH • Randomised double blinded clinical study Randomised – 10 patients enrolled & completed to date – 6 additional patients now enrolled Exenatide – top-line dataset available 1H, 2020 Placebo s.c. 10mg twice a day Secondary •
Slide 18: Invex Proprietary Patented ICP Blocker
Invex Proprietary Patented* ICP Blocker • Exenatide - in its Byetta® form - was approved in 2005 for the treatment of type II diabetes in both the EU & US – administered as a twice-daily sub-cutaneous injection – commercialized by AstraZeneca – safe and well tolerated drug used in millions of diabet
Slide 19: Invex's Repurposed Pressure Blocker
Invex’s Repurposed Pressure Blocker • Proprietary and patented • Aim to be the first & only drug for IIH patients – approved for the disease (IIH) by EMA & FDA – safety and efficacy established by statistical significance in randomised, double blinded clinical trials – assigned unique National Drug
Slide 20: Repurposing Approved Drugs - An Established, Successful Business Model
Repurposing Approved Drugs - An Established, Successful Business Model Drug Original Disease New Orphan Disease Azathioprine Rheumatoid arthritis Renal transplant Bleomycin Various cancers Pleural effusion Colchicine Gout Mediteranien fever Cycloserine Urinary tract infection Tuberculosis Cyclospori
Slide 21: 5 Key Goals to Drive Value in 2020
5 Key Goals to Drive Value in 2020 1. Complete reformulation of Exenatide 2. Establish manufacturing for clinical studies and commercial sales 3. Complete ongoing clinical trial and publish top-line data in IIH 4. Define and initiate with key regulatory agencies – FDA & EMA – a registration study fo
Slide 22: Exenatide – out of this world
Exenatide – out of this world • Raised intracranial pressure occurs after 3 months space flight – Papilloedema – Cognitive slowing – No treatment • Mars expedition is 9 months away and NASA is looking for solutions • Ongoing discussions to plan a trial on the International Space Station 22
Slide 23: For more information please contact
For more information please contact David McAuliffe Dr Jason Loveridge Non Executive Director Non Executive Chairman +61 408 994 313 +49 152 23709246 dmcauliffe@invextherapeutics.com jloveridge@invextherapeutics.com www.invextherapeutics.com www.invextherapeutics.com 23
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