Invex Therapeutics Ltd. · ASX:IXC
Invex Therapeutics — Investor Presentation (November 2020)
18 slides from Invex Therapeutics's investor presentation, Nov 5, 2020
Slide 1: ASX Announcement: Investor Presentation
ASX Announcement 5 November 2020 Investor Presentation Invex Therapeutics Ltd (Invex, ASX: IXC, or the Company) a clinical-stage biopharmaceutical company focused on the development and commercialisation of Presendin™ (Exenatide) for neurological conditions relating to raised intracranial pressure,
Slide 2: Invex Therapeutics Investor Presentation
Invex Therapeutics Investor Presentation 5 November 2020 ASX Code: IXC
Slide 3: 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 4: Company Snapshot
Company Snapshot Company Major Shareholders Repurposed Proven Drug Presendin™ (Exenatide) Directors / Management 16.8% Clinical Stage Entering Phase III Tattarang 11.8% Tisia Nominees Pty Ltd 5.3% Orphan Disease Focus Idiopathic Intracranial Hypertension (IIH) JK Nominees Pty Ltd 5.0% Orphan Designa
Slide 5: Invex Therapeutics - Executive Summary
Invex Therapeutics - Executive Summary Clinical stage drug development Company targeting the orphan disease Idiopathic Intracranial Hypertension (IIH) Attractive Market Dynamics ▪ IIH Total Addressable Market (TAM) in the US and Europe of A$1.6 billion per annum and growing at 3.4% per annum ▪ Unenc
Slide 6: What is Idiopathic Intracranial Hypertension (IIH)?
What is Idiopathic Intracranial Hypertension (IIH)? The Disease1 ▪ >90% of cases are overweight women of childbearing age, with no known cause (idiopathic): approx. 4.7 per 100,000 ▪ >90% suffer headaches that are progressively more severe and frequent: major cause of morbidity ▪ Up to 25% suffer pe
Slide 7: Current treatments for IIH are limited
Current treatments for IIH are limited ▪ Diagnostic criteria (2013) and treatment guidelines (2017/8) now well defined ▪ Recent IIH consensus guidelines written by Prof. Alex Sinclair & colleagues ▪ Treatment guidelines highlight the lack of a standard drug therapy in IIH and opportunity for rapid i
Slide 8: IIH Total addressable market (TAM)
IIH Total addressable market (TAM) 39,8061 Annual incidence of IIH in Invex markets 3.4% Estimated growth in incidence per annum 5 (60% - EU, 40% - USA) 55,000 Estimated annual incidence in 2030 >A$2.3bn Implied TAM in 2030 40% remain undiagnosed2 60% diagnosed2 10% emergency surgical intervention 9
Slide 9: Key clinician pathways in the management of IIH
Key clinician pathways in the management of IIH Optometrists No Immediate Threat to Vision ▪ Often patients with vision issues consult an optometrist, who in turn are primary referrers to ophthalmologists ▪ ~37,000 optometrists in the USA1 Ophthalmologists ▪ ~19,000 ophthalmologists in the USA1 ▪ ~2
Slide 10: Invex Phase II trial – design & outcomes
Invex Phase II trial – design & outcomes Study Purpose ▪ Obtain first clinical proof of concept for Exenatide in IIH and provide a basis to move into pivotal Phase III trial by leveraging orphan drug status in Europe and the United States Efficacy Outcomes ▪ Primary Endpoint (reduction in ICP) Met –
Slide 11: Invex Phase II Trial results (reported Q2 2020)
Invex Phase II Trial results (reported Q2 2020) Primary Endpoint ICP @ 2.5hr, 24hr & 12 weeks – Exenatide Reduces ICP in IIH Patients (pre-specified sig. level of p<0.10) ▪ Exenatide achieved a reduction in ICP of between 18.1%-20.8% in IIH patients versus placebo over the study duration ▪ The obser
Slide 12: Reformulation and re-purposing strategy
Reformulation and re-purposing strategy Exenatide - IIH ▪ Invex has demonstrated GLP-1 receptors are expressed in the choroid plexus region of the brain and that in animal models: • Exenatide can bind to these receptors • Provides fast onset of action (within 60 mins) • 50% reduction in ICP over 6 d
Slide 13: Reformulation & manufacturing update
Reformulation & manufacturing update Reformulation ▪ Successfully completed a series of animal pharmacokinetic (PK) studies in CY2020 with proprietary formulations ▪ Final formulation decision delayed due to COVID-19 impacts on access to laboratory personnel and testing facilities ▪ Current expectat
Slide 14: Tolerability and human PK trial update
Tolerability and human PK trial update Tolerability* ▪ All Presendin™ formulation excipient(s) have been used in already approved drugs and have a well-established safety profile - hence Invex only required to undertake one additional safety study to assess local tolerability at the injection site (
Slide 15: Regulatory update
Regulatory update Strength of the outcomes for both primary & key secondary clinical endpoints from the Phase II study implies a clear & strong drug effect in the IIH population & supports progression to a Phase III clinical trial for registration in the USA and Europe European Medicines Agency (EMA
Slide 16: Summary & Outlook
Summary & Outlook ▪ Large, growing market for IIH with no approved medical interventions ▪ Orphan Drug Designation in the USA and EU provides expedited, cost-effective clinical trial recruitment, reporting and approval/registration as well as commercial exclusivity for up to 10 years ▪ Strong Phase
Slide 17: Thank you
cue Thank you invex THERAPEUTICS
Slide 18: Contacts
Contacts INVESTORS MEDIA Dr Tom Duthy Margie Livingston Executive Director Ignite Communications +61 402 493 727 +61 438 661 131 tduthy@invextherapeutics.com margie@ignitecommunications.com.au To subscribe to Invex email alerts, please visit www.invextherapeutics.com Follow us on Twitter @InvexThera
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