Invex Therapeutics Ltd. · ASX:IXC
Invex Therapeutics — Investor Presentation (June 2021)
16 slides from Invex Therapeutics's investor presentation, Jun 21, 2021
Slide 1: Invex Therapeutics Investor Presentation
For personal use only Invex Therapeutics Investor Presentation June 2021 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 For personal use only 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) Anthony Grist 4.
Slide 4: Invex Therapeutics - Executive Summary
Invex Therapeutics - Executive Summary Clinical stage drug development Company targeting the orphan disease Idiopathic Intracranial Hypertension (IIH) For personal use only Attractive Market Dynamics ▪ IIH Total Addressable Market (TAM) in the US and Europe of A$1.6 billion per annum and growing at
Slide 5: Q1/Q2 2021 Highlights
Q1/Q2 2021 Highlights Dr Megan Baldwin Appointed to the Board of Directors For personal use only ▪ Dr Baldwin is CEO and Managing Director of Opthea Limited (ASX:OPT; NASDAQ:OPT) ▪ Opthea included into the S&P/ASX 300 in June 2020 ▪ Opthea raised $180 million and listed on NASDAQ Exchange in October
Slide 6: FDA Response Type C Meeting – June
FDA Response Type C Meeting – June 21 For personal use only ▪ Filing to Division of Neurology, based on finalised protocol assistance from European Medicines Agency (EMA) in December 2020 – aim to harmonise a single Current Status of Phase III Clinical Trial Phase III study across both EMA & FDA: ▪
Slide 7: What is Idiopathic Intracranial Hypertension (IIH)?
What is Idiopathic Intracranial Hypertension (IIH)? The Disease1 For personal use only ▪ >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
Slide 8: Current treatments for IIH are limited
Current treatments for IIH are limited ▪ Diagnostic criteria (2013) and treatment guidelines (2017/8) now well defined For personal use only ▪ IIH consensus guidelines written by Prof. Alex Sinclair & colleagues ▪ Treatment guidelines highlight the lack of a standard drug therapy in IIH and opportun
Slide 9: IIH Total addressable market (TAM)
IIH Total addressable market (TAM) 39,8061 3.4% Estimated growth in incidence per annum 5 For personal use only Annual incidence of IIH in Invex markets (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 s
Slide 10: Key clinician pathways in the management of IIH
Key clinician pathways in the management of IIH Optometrists For personal use only 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 ophthalmolo
Slide 11: Invex Phase II trial – design & outcomes
Invex Phase II trial – design & outcomes Study Purpose For personal use only ▪ 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 (r
Slide 12: Lead-In Activities Ahead of Planned Phase III Trial
Lead-In Activities Ahead of Planned Phase III Trial Reformulation Tolerability* For personal use only ▪ Successfully completed a series of animal pharmacokinetic (PK) ▪ All Presendin™ formulation excipient(s) have been used in already studies in CY2020 with proprietary formulations approved drugs an
Slide 13: Negative Impact of COVID-19 Lockdown in the UK on IIH
Negative Impact of COVID-19 Lockdown in the UK on IIH For personal use only Prospective Evaluation Study Showed 4.7 Fold Increase in Emergency Surgical Interventions to Avoid Permanent Vision Loss ▪ Study (n=139 over 10 weeks) showed increased risk of disease deterioration and CSF shunting in those
Slide 14: Summary & Outlook
Summary & Outlook ▪ Large, growing market for IIH with no approved medical interventions For personal use only ▪ 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 7
Slide 15: Thank you
For personal use only Thank you 15
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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