Invex Therapeutics Ltd. · ASX:IXC
Invex Therapeutics — Investor Presentation (July 2022)
16 slides from Invex Therapeutics's investor presentation, July 2022
Slide 1: Invex Therapeutics Investor Presentation
Invex Therapeutics Investor Presentation Dr Tom Duthy, Executive Director July 2022 ASX Code: IXC
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: Company Snapshot
Company Snapshot Company Major Shareholders (as at 1 July 2022) 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 Hypertension (IIH) Anthony G
Slide 4: Invex Therapeutics - Executive Summary
Invex Therapeutics - Executive Summary Late-stage drug development Company targeting the orphan disease Idiopathic Intracranial Hypertension (IIH) Attractive Market Dynamics ▪ IIH Total Addressable Market (TAM) in the US and EU/UK of A$1.6 billion per annum (~A$1 billion EU/UK, ~A$0.6 billion US) an
Slide 5: What is Idiopathic Intracranial Hypertension (IIH)?
What is Idiopathic Intracranial Hypertension (IIH)? The Disease1 ▪ Dysregulation of cerebral spinal fluid secretion in the brain, leading to increased intracranial (brain) pressure (ICP) ▪ >90% of cases are overweight women of childbearing age, with no known cause (idiopathic): approx. 4.7 per 100,0
Slide 6: Recent Highlights / Milestones
Recent Highlights / Milestones Major Scientific Dissemination of Phase II “PRESSURE” Trial Data ▪ The results of the PRESSURE trial have undergone peer review and presented at major, relevant medical conferences: ▪ North American Neuro-Ophthalmology Society (NANOS) ▪ European Neuro-Ophthalmology Soc
Slide 7: IIH Total Addressable Market (TAM)
IIH Total Addressable Market (TAM) Key Inputs1-5 Market Size (Annual)6 Market Drivers ~24,000 EU/UK patients ~A$1.0 Billion Increasing obesity rates ~16,000 US patients ~A$0.6 Billion Increasing awareness ~A$1.6 Billion 10% in diagnosis rate = 60% Diagnosed A$300 million in TAM 90% Drug Treatabl
Slide 8: 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 Focussed target ~40 market of ▪ ~19,000 oph
Slide 9: Critical Components for Success
Critical Components for Success REGULATORY European Registration via EMA, U.S. Clinical sites via FDA. MANUFACTURING Exclusive Agreement with Peptron, Inc. for 1x per week Presendin™ clinical FUNDING and commercial supply. $29.3 million cash – fully funds Phase III trial to registration. CLINICAL Si
Slide 10: Manufacturing
Manufacturing STRATEGIC PARTNER PEPTRON FINANCIAL Establishes a long term strategic Strong economics partner for Invex (Sep 2021) - fixed price per dose Listed on South Korean KOSDAQ - no royalties Exchange (KS:087010) - no milestone payments TIME & RISK REDUCTION Significant clinical and non-clinic
Slide 11: IIH EVOLVE Phase III
IIH EVOLVE Phase III Manufacturing Clinical Sites Trial Steering Committee (TSC) United Kingdom (UK) South Korea United States (US) France Germany Israel Australia New Zealand TSC Members Presendin™ Manufacturing Clinical Sites 11
Slide 12: IIH EVOLVE Phase III
IIH EVOLVE Phase III Randomised double-blinded, placebo controlled multi-centre clinical trial to determine safety and efficacy of Presendin™ in IIH Phase III Schematic 40 centres across EU, UK, Australia, NZ, Israel and the US 240 patients 24 months recruitment Primary Endpoint Change in Intrac
Slide 13: Regulatory
Regulatory Phase III IIH EVOLVE clinical trial for Presendin™ is intended to initially support: EMA, TGA, MHRA approval for treatment of IIH ($1Bn TAM) Initial Phase (CY21) ▪ Seek Scientific / Protocol Advice from European Medicines Agency (EMA) and FDA ▪ Assimilate feedback into a complete regulato
Slide 14: Milestones for 2H CY22
Milestones for 2H CY22 ▪ Completion of additional regulatory approvals: ▪ Investigational New Drug Application (IND) with the US Food and Drug Administration (FDA) ▪ HREC approval (public hospital) Australia ▪ Medsafe Approval New Zealand ▪ Hospital Clearance / Ministry of Health Approval Israel ▪ N
Slide 15: Summary & Outlook
Summary & Outlook ▪ Single Phase III trial designed to support Presendin™ market approvals in the EU, UK and Australia - $1 billion+ unencumbered TAM ▪ Potential for rapid incorporation of Presendin™ into IIH treatment guidelines ▪ IIH EVOLVE includes an economic evaluation to facilitate the health
Slide 16: 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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