Invex Therapeutics Ltd. · ASX:IXC
Invex Therapeutics — Investor Presentation (November 2022)
20 slides from Invex Therapeutics's investor presentation, Nov 22, 2022
Slide 1: Invex Therapeutics Investor Briefing Series
For personal use only Invex Therapeutics Investor Briefing Series: 22-24 November 2022 Professor Alex Sinclair Executive Director & Chief Scientific Officer “ Clinical Insights into Idiopathic Intracranial Hypertension (IIH) and the importance of the IIH EVOLVE Clinical Trial” ASX Code: IXC
Slide 2: Disclaimer
Disclaimer For personal use only 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 expecta
Slide 3: Company Snapshot
Company Snapshot Company Major Shareholders (as at 1 November 2022) For personal use only Repurposed, Proven Drug Presendin™ (SR-Exenatide) Directors / Management 16.8% Clinical Stage Phase III (Single Trial) Tattarang 11.8% Tisia Nominees Pty Ltd 5.3% Orphan Disease Focus Idiopathic Intracranial Hy
Slide 4: Today's Speaker
Today’s Speaker Professor Alexandra Sinclair For personal use only • Co-Founder of Invex Therapeutics and Executive Director / Chief Scientific Officer • Professor of Neurology, Clinician Scientist and Neurology Consultant leading the Translational Brain Science Group at The University of Birmingham
Slide 5: What is IIH
What is Idiopathic Intracranial Hypertension (IIH) For personal use only Patients typically present at A&E or to an optometrist with a combination of debilitating chronic daily headaches and visual 70-90% severe, daily headaches3 loss Definitive diagnostic criteria is raised intracranial hypertensio
Slide 6: IIH is a Rapidly Rising Cost to the Healthcare System
IIH is a Rapidly Rising Cost to the Healthcare System ▪ IIH is a rapidly growing orphan indication driven by changing demographics1 ▪ 90% of IIH patients are women of childbearing age1 For personal use only ▪ By 2030 IIH is projected to cost hospitals in England alone +£400m p.a1, similar trend in U
Slide 7: Urgent Need to Identify New Treatments
Urgent Need to Identify New Treatments For personal use only Idiopathic Intracranial Hypertension (IIH) is a growing neurological disorder ▪ No regulatory approved treatments ▪ No new therapeutic interventions in clinical trials ▪ For patients at risk of vision loss, invasive & high risk surgical in
Slide 8: Invex – The Story so Far
Invex – The Story so Far From Benchtop to Human Clinical Trials For personal use only ▪ My group was the first to identify that a GLP-1 agonist (Exenatide) could lower intracranial pressure (ICP) in patients via modulation of GLP-1R in choroid plexus cells that regulate cerebral spinal fluid secreti
Slide 9: IIH Pressure Trial - Strong Phase II Data – Primary Endpoint
IIH Pressure Trial - Strong Phase II Data – Primary Endpoint Brain pressure reduced For personal use only ▪ Exenatide achieved a significant reduction in Intracranial Pressure (ICP) ▪ Considered clinically meaningful Primary Endpoint ICP @ 2.5hr, 24hr & 12 weeks – Exenatide Reduces ICP in IIH Patien
Slide 10: IIH Pressure Trial - Strong Phase II Data – Secondary Endpoints
IIH Pressure Trial - Strong Phase II Data – Secondary Endpoints Headaches Reduced For personal use only ▪ A reduction of 7.7 days is clinically meaningful ▪ A reduction in Monthly Headache Days is a well recognised and validated endpoint by regulators in headache studies Vision Improved ▪ Clinically
Slide 11: IIH EVOLVE – Phase III Registration Trial
IIH EVOLVE – Phase III Registration Trial For personal use only Invex Therapeutics sponsored study utilising Presendin™ Presendin™ ▪ Modified release re-formulation of exenatide ▪ Single Phase III trial designed to support Presendin™ ▪ Once weekly sub-cut. injection ▪ Aiming for market approvals in
Slide 12: IIH EVOLVE - Design
IIH EVOLVE - Design Outcome measures Phase III Schematic For personal use only Primary Endpoint Change in Intracranial Pressure (ICP) from baseline at 24 weeks 1 week screening Secondary Change in Perimetric Mean Deviation Endpoint (PMD) from baseline over 24 weeks Placebo, Presendin™, s.c., 1x week
Slide 13: IIH EVOLVE Phase III
IIH EVOLVE Phase III For personal use only Manufacturing Clinical Sites Trial Steering Committee (TSC) United Kingdom (UK) South Korea - Peptron United States (US) Germany Israel Australia New Zealand TSC Members Presendin™ Manufacturing Clinical Sites 13
Slide 14: Reformulated Exenatide for Dedicated ICP Therapeutic Agent
Reformulated Exenatide for Dedicated ICP Therapeutic Agent ▪ Presendin™ once weekly sub-cutaneous injection For personal use only ▪ Sustained release formulation of exenatide in a poly(lactic-co-glycolic acid) microsphere (PLGA) ▪ Access to completed preclinical and Phase I & II clinical trials has
Slide 15: IIH EVOLVE Trial Steering Committee – Global Leaders in IIH
IIH EVOLVE Trial Steering Committee – Global Leaders in IIH For personal use only Professor Michael Wall – Chair Professor of Neurology and Ophthalmology at the University of Iowa. Director of the Iowa Visual Field Reading Center. Associate Professor Clare Fraser – Member Assoc. Professor Neuro-opht
Slide 16: IIH EVOLVE Success - First Available Licenced Treatment
IIH EVOLVE Success - First Available Licenced Treatment For personal use only Diagnosis Presendin™ Treatment Monitoring 16
Slide 17: De-risked Program
De-risked Program For personal use only • Partnered with Pepton Inc. for Presendin™ manufacturing • Single Phase III clinical trial with regulatory approvals – Australia TGA – United Kingdom MHRA – US IND approved 17
Slide 18: Confident Outlook
Confident Outlook ▪ Emerged from Pandemic For personal use only ▪ Cost efficient spending ▪ Overcome regulatory hurdles - majorly de-risked program ▪ Successfully opened IIH EVOLVE trial ▪ First patient randomised into trial on 21 November 2022 ▪ Success of IIH EVOLVE ▪ Presendin™ would be the first
Slide 19: Contacts
Contacts For personal use only 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
Slide 20: Invex Therapeutics - Executive Summary
Invex Therapeutics - Executive Summary Late-stage drug development company targeting the orphan disease Idiopathic Intracranial Hypertension (IIH) For personal use only Attractive Market Significant Barriers to Supportive Clinical Data Dynamics Competition ▪ IIH Total Addressable Market (TAM) in ▪ S
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