Invex Therapeutics Ltd. · ASX:IXC
Invex Therapeutics — Investor Presentation (May 2020)
34 slides from Invex Therapeutics's investor presentation, May 22, 2020
Slide 1: Invex Therapeutics: Phase II Clinical Results & Capital Raise
Invex Therapeutics Phase II Clinical Results & Capital Raise Investor Presentation May 2020 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: Invex Therapeutics - Executive Summary
Invex Therapeutics - Executive Summary ▪ Clinical stage drug development company targeting the orphan disease Idiopathic Intracranial Hypertension (IIH) ▪ Repurposed Exenatide (Presendin™) formulation ▪ Large, growing market for IIH, Total Addressable Market of up to ~A$1.6 billion annually in the U
Slide 4: Phase II Trial Design
Phase II Trial Design Randomised double blinded placebo controlled clinical study1 ▪ n=16 ▪ Female, 18-60 years old 12 weeks ▪ Confirmed IIH diagnosis 1:1 ▪ Real-time ICP measurement Placebo, 2x day Exenatide, s.c. 10g, 2x day Primary endpoints 80% statistically powered to Change in intracranial pr
Slide 5: Phase II Trial - Design Considerations
Phase II Trial - Design Considerations ▪ Measuring ICP by lumbar puncture is inaccurate and highly variable ▪ Reliable & stable baseline data established through substantial lead-in data collection ▪ Participants completed a daily headache diary in the month before visits 1 and 2 ▪ IIH patients enro
Slide 6: Primary Endpoints – Exenatide Reduces ICP in IIH Patients
Primary Endpoints – Exenatide Reduces ICP in IIH Patients ▪ The primary endpoints of the study assessed differences in intracranial pressure (ICP) between the Exenatide treatment arm and placebo at (A) 2.5 hours, (B) 24 hours and at (C) 12 weeks ▪ Exenatide reduced ICP at all three time points in a
Slide 7: Secondary Endpoint – Exenatide Reduces Headache Frequency
Secondary Endpoint – Exenatide Reduces Headache Frequency ▪ Headache frequency data shown in the figure below (A) highlights a statistically significant beneficial reduction in Monthly Headache Days in Exenatide treated patients ▪ Analgesic use (B) also shows a reduction in the use of pain medicatio
Slide 8: Secondary Endpoint – Exenatide Improves Visual Acuity
Secondary Endpoint – Exenatide Improves Visual Acuity ▪ Visual acuity was assessed using a Logarithm of the Minimum Angle of Resolution Chart – LogMAR assessment ▪ Despite not being powered, the improvement in VA in the Exenatide arm was large enough to show a statistically significant and clinicall
Slide 9: Exenatide Improved Visual Acuity in Majority of IIH Patients
Exenatide Improved Visual Acuity in Majority of IIH Patients ▪ LogMAR improved in all but one of the Exenatide treated patients, and in only a single patient on placebo, further supporting the breadth and certainty of this observed improvement in vision with Exenatide Placebo Exenatide 0.2 ● ● ● ● ●
Slide 10: Exenatide Benefit Not Due to Weight Loss
Exenatide Benefit Not Due to Weight Loss ▪ IIH patients on Exenatide did not lose weight during the course of the study ▪ Patients on Placebo lost a small amount of weight equivalent to 0.5 BMI units ▪ The benefit of Exenatide use could not be explained by these patients losing weight 10
Slide 11: Safety & Adverse Events
Safety & Adverse Events ▪ No serious adverse events (AE) were observed related to the use of Exenatide ▪ Overall, adverse events were relatively low, with nausea the most common seen in >85% of patients treated with Exenatide ▪ Nausea is a known and the most frequent AE of sub-cutaneous administrati
Slide 12: Patient Baseline Characteristics
Patient Baseline Characteristics Exenatide Placebo Differences Wilcoxon rank chi-squared Median (range) Mean (SD) Median (range) Mean (SD) sum p p Despite the relatively small number of participants, the study was well balanced at Number 7 8 Age 25 (18, 57) 28 (13) 26 (23, 38) 28 (6) 0.560 Gender (%
Slide 13: Timeline – Key Milestones to Market Entry
Timeline – Key Milestones to Market Entry Complete Complete animal Results of human PK animal PK study tolerability for study for Presendin™ for Presendin ™ Presendin™ 2Q 4Q 1Q 2020 2020 2021 1H 3Q 4Q 2021 2020 2020 Initiate Phase III Finalise key Commence human registration study for manufacturing
Slide 14: Summary - Exenatide in IIH Clinical Study
Summary - Exenatide in IIH Clinical Study ▪ Phase II data strongly supports moving Presendin™ into Phase III clinical development in 1H 2021 ▪ Met all Primary Endpoints for a >10% reduction of Intracranial Pressure1 (ICP) at 2.5 hours (p<0.048), 24 hours (p<0.03) and 12 weeks (p<0.058) ▪ Statistical
Slide 15: Capital Raising
Capital Raising ▪ $26.2 million Share Placement to Sophisticated and Pro-Forma Capital Structure - $26.2 million placement Professional Investors at $1.30 per share Current Shares on Issue 55 million ▪ The offer price represents: Placement shares issued (Tranche 1) 12.5 million ▪ 13% discount to las
Slide 16: Use of Funds
Use of Funds ▪ Seeking to raise $26.2 million in a two tranche share placement $26.2 million Completion of Presendin™ pre-Phase III development $1.3 million Presendin™ Phase III registration study in IIH $16.0 million Drug manufacture and supply for Phase III & $3.5 million commercialisation Clinica
Slide 17: Timetable
Timetable* Event Date Trading Halt Monday 18 May 2020 ASX Announcement – Clinical Trial results Wednesday 20 May 2020 Placement Bookbuild Commences Wednesday 20 May 2020 Allocations and Signed Acceptances Thursday 21 May 2020 ASX Announcement – Placement, Investor Presentation, Trading Halt Lifted F
Slide 18: Reformulation & Regulatory Update
Reformulation & Regulatory Update ✓ Patent applications on the new formulation of Exenatide (Presendin™) filed in March 2020 ✓ Pharmacokinetic (PK) evidence obtained in mouse models has shown that Invex’s novel proprietary formulation (Presendin™) provides the targeted PK – i.e. immediate onset with
Slide 19: Likely Second Orphan Indication: IIH-WOP
Likely Second Orphan Indication: IIH-WOP ▪ Idiopathic Intracranial Hypertension (IIH) – Without Papilloedema (WOP) ▪ Rare sub-population of IIH patients, representing 5.7% of IIH patients1 ▪ 1,225 patients in the EU/USA, representing a TAM of A$95 million per annum ▪ Invex to initiate Phase II clini
Slide 20: Summary
Summary ▪ Large, growing market for IIH with no approved (regulatory cleared) or efficacious drug-based interventions ▪ 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 u
Slide 21: Contacts
Contacts INVESTORS MEDIA Dr Tom Duthy Margie Livingston Nemean Group Ignite Communications +61 402 493 727 +61 438 661 131 tduthy@nemean.com.au margie@ignitecommunications.com.au 21
Slide 22: International Offer Restrictions
International Offer Restrictions This document does not constitute an offer of New Shares of the Company in any jurisdiction in which it would be unlawful. In particular, this document may not be distributed to any person, and the New Shares may not be offered or sold in the Placement, in any countr
Slide 23: International Offer Restrictions (cont.)
International Offer Restrictions (cont.) United Kingdom Neither this document nor any other document relating to the offer has been delivered for approval to the Financial Conduct Authority in the United Kingdom and no prospectus (within the meaning of section 85 of the Financial Services and Market
Slide 24: Company Overview
Company Overview 24
Slide 25: Company snapshot
Company snapshot Company Major Shareholders Repurposed Proven Drug Presendin™ (Exenatide) Directors / Management 20% Clinical Stage Phase II Minderoo Group 9.1% JK Nominees Pty Ltd 7.3% Orphan Disease Focus IIH^ + Other Tisia Nominees Pty Ltd 7.2% Orphan Designation Granted USA + EU Oaktone Nominees
Slide 26: Current treatments for IIH are limited
Current treatments for IIH are limited Idiopathic Intracranial Hypertension – Treatment Guidelines1 Non-Surgical / Device Surgical / Device (Severe cases) Acetazolamide is used ‘off label’ No immediate threat to vision Vision threatened (not regulatory cleared) for IIH, has limited efficacy & poor C
Slide 27: Total addressable market (TAM) – expected to grow
Total addressable market (TAM) – expected to grow 39,8061 Annual incidence of IIH in Invex markets 3.4% Estimated growth in incidence per annum 5 (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 surgical
Slide 28: Repurposing Exenatide for IIH
Repurposing Exenatide for IIH ▪ Exenatide was approved in 2005 in the US & 2006 in the EU for the treatment of Type II diabetes] ▪ Currently marketed by AstraZeneca in two dosage formulations ▪ In its Byetta® form Exenatide is administered as a twice-daily, sub-cutaneous injection or as Bydureon®, a
Slide 29: Exenatide reformulation strategy
Exenatide reformulation strategy Current dose not optimal to treat Exenatide @ current IIH diabetic dose1 tested Current formulations have either Risk for off label use of in Phase II to insufficient half life2 or too slow Invex is developing a Byetta® or Bydureon ® is demonstrate proof of onset3 &
Slide 30: Reformulation – Clinical and regulatory requirements
Reformulation – Clinical and regulatory requirements ▪ Ex-AstraZeneca’s Exenatide formulation team engaged to help work on Presendin™ repurposing ▪ Pharmacokinetic (PK) evidence obtained in mouse models has shown that Invex’s novel 24 hour proprietary formulation of Exenatide (i.e. Presendin™) provi
Slide 31: How the Phase II Achieves Sufficient Statistical Power to Observe an Effect on ICP
How the Phase II Achieves Sufficient Statistical Power to Observe an Effect on ICP Surgically implanted Telemetric Intracranial Pressure Monitor ICP VARIABILITY CONTROLLED ▪ IIH patients enrolled with >25cm H2O (>19mm Hg) ICP [as per IIH diagnostic criteria] ▪ Normal range: 7.5–20cm H2O (5-15 mm Hg)
Slide 32: Benefits of orphan drug designation
Benefits of orphan drug designation Designation granted for treating rare diseases: <200k Orphan Drug Designation granted in 2017 by EMA (EU) & patients in USA, < 5/10,000 in the EU1 FDA (USA) Single pivotal Phase III registration study required for High patient need will facilitate rapid recruitmen
Slide 33: Indicative Phase III design
Indicative Phase III design1 Randomised double blinded placebo controlled Criteria multi-centre clinical study World class Medical Advisory ▪ >18 years old Board established by Invex to ▪ Sig. raised ICP & confirmed IIH diagnosis by Updated Modified Dandy criteria provide input on trial design as ▪
Slide 34: Invex scientific data validates approach for IIH
Invex scientific data validates approach for IIH Intracranial pressure % - exenatide vs saline 1 120% 100% ▪ Treatment was given daily for 5 days, and ICP was recorded on days 2, 4, and 6, before and ICP - % of baseline on day 2 after the rats received a subcutaneous (SC) 80% injection of either sal
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