Invex Therapeutics Ltd. · ASX:IXC
Invex Therapeutics — Argonaut Biotech Briefing (October 2022)
16 slides from Invex Therapeutics's conference presentation, Oct 26, 2022
Slide 1: Upcoming Presentation at Argonaut Biotech Briefing
ASX / Media Release 26 October 2022 For personal use only Upcoming Presentation at Argonaut Biotech Briefing Invex Therapeutics Ltd (Invex, ASX:IXC, or the Company) a clinical-stage biopharmaceutical company focused on the development and commercialisation of Presendin™ (sustained release Exenatide)
Slide 2: Invex Therapeutics - Argonaut Biotech Briefing
For personal use only Invex Therapeutics Argonaut Biotech Briefing Dr Tom Duthy, Executive Director David McAuliffe, Non-Executive Director 26 October 2022 ASX Code: IXC
Slide 3: 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 4: Company Snapshot
Company Snapshot Company Major Shareholders (as at 1 October 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 Hyp
Slide 5: 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 The Disease1 The Impact2 The Solution ▪ Dysregulation of cerebral spinal fluid ▪ Invasive surgical and/or device ▪ Exenatide: a wel
Slide 6: 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
Slide 7: IIH Total Addressable Market (TAM)
IIH Total Addressable Market (TAM) Key Inputs1-5 Market Size (Annual)6 Market Drivers For personal use only ~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
Slide 8: Critical Components for Success
Critical Components for Success For personal use only REGULATORY AU registration via TGA, UK registration via MHRA, 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.
Slide 9: Manufacturing
Manufacturing STRATEGIC PARTNER PEPTRON For personal use only FINANCIAL Established 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 c
Slide 10: IIH EVOLVE Phase III
IIH EVOLVE Phase III Randomised double-blinded, placebo controlled multi-centre For personal use only 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 End
Slide 11: IIH EVOLVE Phase III
IIH EVOLVE Phase III For personal use only Manufacturing Clinical Sites Trial Steering Committee (TSC) United Kingdom (UK) South Korea United States (US) Germany Israel Australia New Zealand TSC Members Presendin™ Manufacturing Clinical Sites 10
Slide 12: Trial Steering Committee – Global Leaders in IIH
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-ophthalmology,
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) For personal use only First Phase CY21 Critical Regulatory Advice Second Phase: late 2H CY21-CY22 Targeted Regulatory Submissions & Approvals Third
Slide 14: Milestones for Q4 CY22
Milestones for Q4 CY22 For personal use only ▪ Completion of additional regulatory filings and/or approvals: ▪ Investigational New Drug Application (IND) with the US Food and Drug Administration (FDA) – achieved August 2022 ▪ HREC approval (public hospital) Australia – achieved September 2022 ▪ Meds
Slide 15: Summary & Outlook
Summary & Outlook For personal use only ▪ 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
Slide 16: 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
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