Invex Therapeutics Ltd. · ASX:IXC
Invex Therapeutics — Shareholder Meeting (November 2022)
13 slides from Invex Therapeutics's shareholder meeting presentation, Nov 22, 2022
Slide 1: Invex Therapeutics 2022 Annual General Meeting
For personal use only Invex Therapeutics 2022 Annual General Meeting 22 November 2022 ASX Code: IXC
Slide 2: Chairman Address and Presentation
For personal use only Invex Therapeutics Chairman Address and Presentation Dr Jason Loveridge
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: 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 A Potential Solution ▪ Dysregulation of cerebral spinal fluid ▪ Invasive surgical and/or device ▪ Exenat
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 Attractive Market Significant Barriers to Supportive Clinical Data Dynamics Competition ▪ IIH Total Addressable Market (TAM) in ▪
Slide 6: 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. $27.
Slide 7: 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 8: 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 8
Slide 9: 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 10: 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 11: 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 12: 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 13: 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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