Invex Therapeutics Ltd. · ASX:IXC
Invex Therapeutics — NWR Small Caps Virtual Conference March 2021
17 slides from Invex Therapeutics's conference presentation, Mar 18, 2021
Slide 1: ASX Media Release: Investor Presentation – March 2021
ASX / Media Release 18 March 2021 For personal use only Investor Presentation – March 2021 Invex Therapeutics Ltd (Invex, ASX:IXC, or the Company) a clinical-stage biopharmaceutical company focused on the development and commercialisation of Presendin™ (Exenatide) for neurological conditions relatin
Slide 2: Invex Therapeutics – NWR Small Caps Virtual Conference
For personal use only Invex Therapeutics NWR Small Caps Virtual Conference March 2021 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 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) JK Nominees Pty
Slide 5: 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 6: Q1 2021 Highlights to Date
Q1 2021 Highlights to Date 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) ▪ Experienced biotechnology executive, having over 20 years’ experience working on therapeutic drug development prog
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: Regulatory update
Regulatory update Strength of the outcomes for both primary & key secondary clinical endpoints from the Phase II study implies a clear & strong drug For personal use only effect in the IIH population & supports progression to a Phase III clinical trial for registration in the USA and EU European Med
Slide 14: 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 15: 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 10
Slide 16: Thank you
For personal use only Thank you 15
Slide 17: 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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