Invion Ltd. · ASX:IVX
Invion — Corporate Update (February 2019)
35 slides from Invion's corporate update, Feb 28, 2019
Slide 1: Transforming Photodynamic Therapy for novel & effective treatments for cancer
INVION For personal use only Transforming Photodynamic Therapy: for novel & effective treatments for cancer Invion Limited (ASX: IVX)
Slide 2: Invion is developing Photosoft technology, the next-generation PDT
INVION IS DEVELOPING PHOTOSOFT™ TECHNOLOGY, THE NEXT-GENERATION PDT For personal use only Advancing Photosoft™ technology - a novel photosensitiser – with new formulations Lead products of (IVX- P02) for topical and intravenous use IVX-P02 is 15 times more effective in killing cancer cells in in vit
Slide 3: How does Photosoft Technology differ from existing PDT treatments
How does Photosoft™ Technology differ from For personal use only existing PDT treatments: The compound can be activated using PHOTOSOFT multiple wavelengths, allowing for both ™ diagnostic and therapeutic use TECHNOLOGY Water soluble – IVX-P02 compound doesn’t accumulate in the body ADVANTAGES Can b
Slide 4: Invion Team: Global Experts in Cancer
For personal use only INVION TEAM: GLOBAL EXPERTS IN CANCER
Slide 5: Strong Experienced Leadership
STRONG EXPERIENCED LEADERSHIP For personal use only Thian Chew Greg Collier PhD Chairman CEO and Managing Director • Managing Partner, Polar Ventures • 25+yrs experience in clinical drug development, corporate • Executive Director, Goldman Sachs proprietary investing (New management, strategic plann
Slide 6: Management Team: Global Experts in Drug Development
MANAGEMENT TEAM GLOBAL EXPERTS IN DRUG DEVELOPMENT For personal use only Alexander Bennett Louise White Technical Advisor Manufacturing and Quality Advisor • 35+ years experience in senior technical and • Over 35 years experience in the pharmaceutical industry management at Rofin and at ICI. • 13 ye
Slide 7: Scientific Advisors
SCIENTIFIC ADVISORS LEADING AUTHORITIES IN CANCER AND PDT For personal use only Dr Andrew Stephens Assoc. Professor Louis Irving Scientific Advisory Board member Scientific Advisory Board member • 15+ years experience in novel treatment research • Lung Cancer; Respiratory Physician, Peter MacCallum
Slide 8: 2018: A Year of Rapid Progress
2018 A YEAR OF RAPID PROGRESS For personal use only MANUFACTURING- HUDSON RESEARCH SKIN CANCER AGENT COLLOBARATION PROGRAM • Contract IVX-P02 FORMULATION • Dr Andrew Topical formulation manufacturer • Stephens • New formulation for skin cancer engaged appointed to Invion tested in vitro -15x Process
Slide 9: Invion PDT Mechanism of Action
For personal use only INVION PDT MECHANISM OF ACTION
Slide 10: Advantages of Photosoft Technology
ADVANTAGES OF PHOTOSOFT™ TECHNOLOGY For personal use only Absorbs light in wavelengths to PDT is a proven, effective Is inert without light and “light up” a tumour (diagnostic) or cancer therapy. Photosoft™ has rapidly clears from cells activate oxygen free radicals that been improved since inceptio
Slide 11: Photodynamic Therapy: A Novel Cancer Treatment
PHOTODYNAMIC THERAPY: A NOVEL CANCER TREATMENT For personal use only Photodynamic therapy (PDT) • Combines photosensitiser compound with light-induced activation • Generates reactive oxygen species causing damage to organic molecules • Direct cell death and induction of inflammatory response Light N
Slide 12: Photosoft Oral and IVX-P02: Next Generation PDTs
For personal use only PhotosoftTM Oral NEXT • Chlorin-e4 based photosensitiser, multiple GENERATION excitation peaks • Blue light – strong red fluorescence for lesion visualisation PDTs: • Red light – generation of ROS for directed tissue ablation PHOTOSOFT TM • Non-toxic and tolerated at high doses
Slide 13: Spectral Characteristics of Photosoft and IVX-P02
SPECTRAL CHARACTERISTICS OF PHOTOSOFTTM AND IVX-P02 For personal use only Blue light excitation produces red fluorescence for cellular visualisation • Excitation maxima at 400nm, with additional peaks at 550 and 650nm • Single emission peak at 658nm With this ability to absorb light at two wavelengt
Slide 14: Photosoft and IVX-P02 Not Activated by Ambient Light
PHOTOSOFT AND IVX-P02 NOT ACTIVATED BY AMBIENT LIGHT For personal use only • Cancer cells incubated with increasing photosensitiser concentrations for 24hrs • No evidence of cytotoxicity prior to activation • The Photosoft™shows significantly lower “dark toxicity” than Temoporfin (FoscanTM) and HPPH
Slide 15: IVX-P02 Cytotoxicity Substantially Greater Than Other Photosensitisers
IVX-P02 CYTOTOXICITY SUBSTANTIALLY GREATER THAN OTHER PHOTOSENSITISERS For personal use only • Cytotoxicity in ovarian cancer cells tested at fixed concentration and total fluence • Cell death compared between multiple photosensitisers • IVX-P02 has the greatest cytotoxic effect after activation tha
Slide 16: IVX-P02 Induced Apoptosis via ER Calcium Flux and Caspase Activation
IVX-P02 INDUCED APOPTOSIS VIA ER CALCIUM FLUX AND CASPASE ACTIVATION For personal use only • Cell death pathways induced on IVX-P02 activation explored using antibody array • IVX-P02 treatment resulted in release of cytochrome C, caspase 3 cleavage, and altered abundance of multiple apoptosis-relate
Slide 17: IVX-P02 Localises to Tumor Tissue in Mouse Model of Ovarian Cancer
IVX-P02 LOCALISES TO TUMOR TISSUE IN MOUSE MODEL OF OVARIAN CANCER For personal use only Mice with advanced ovarian cancer administered IVX-P02 (intraperitoneally). Mice trial findings : • Clear and specific accumulation in tumour tissue • Both primary tumour and metastatic lesions detected – the IV
Slide 18: Invion's Priority Areas of Development
For personal use only INVION’S PRIORITY AREAS OF DEVELOPMENT
Slide 19: Skin Cancer Program: A Powerful New Treatment Option
SKIN CANCER PROGRAM A POWERFUL NEW TREATMENT OPTION For personal use only Invion will be pursuing superficial BCC (sBCC) Collaborations established: and Actinic Keratosis (AK). Formulytica • Engaged to develop topical formulation of IVX- Product Characteristics P02 • Therapeutic • Ready for human cl
Slide 20: IVX-SKIN: Using Invion's Topical PDT Product
IVX-SKIN: USING INVION’S TOPICAL PDT PRODUCT For personal use only Using Invion’s Topical PDT Product, IVX-SKIN, to treat skin cancers • Basal Cell Cancer (BCC) • Actinic Keratosis (pre-cancer) • Squamous Cell Cancer (SCC) Skin cancer is the most common cancer worldwide, with over 50 million cases o
Slide 21: For Skin: Potential for Unique Positioning
FOR SKIN: POTENTIAL FOR UNIQUE POSITIONING For personal use only METVIX / ALA Plus low pain…. GOOD Cosmesis SURGERY POOR FAIR Effectiveness GOOD
Slide 22: IVX-SKIN: Path to Success and Clinical Studies
IVX-SKIN: PATH TO SUCCESS AND CLINICAL STUDIES For personal use only Invion will optimise the IVX-SKIN drug/light combination to build clinical and commercial success Strategy: Target indications where we are differentiated by being less painful (eg vs Metvix) and better than surgery. Skin cancer Ph
Slide 23: IVX-SKIN: Non Melanoma Skin Cancer and Actinic Keratosis
IVX-SKIN: NON MELANOMA SKIN CANCER (NMSC) AND ACTINIC KERATOSIS(AK) For personal use only • 99% of skin cancers are non-melanoma. NMSC prevalence per 100,000s • BCC accounts for 70% of NMSC with SCC about 25%. • AK is a common pre-cancerous skin lesion which may progress to 3000 SCC. Australia has t
Slide 24: IVX-SKIN: Basal Cell Carcinoma Treatment Market
IVX-SKIN: NON MELANOMA SKIN CANCER (NMSC) AND ACTINIC KERATOSIS(AK) For personal use only Basal Cell Carcinoma Treatment Market (Market “Basal Cell Carcinoma Treatment Market Value - USD $ Millions) global report’ 12000 • Global basal cell carcinoma market was valued approximately USD 5390 million i
Slide 25: IVX-SKIN: Actinic Keratosis Treatment Market
IVX-SKIN: NON MELANOMA SKIN CANCER (NMSC) AND ACTINIC KERATOSIS(AK) For personal use only "Actinic Keratosis (AK) Treatment Market “Actinic Keratosis Market By Treatments (Market Value USD $ Millions) Growth, Share, Opportunities & Competitive Analysis, 2016 – 2022”: • Global actinic keratosis marke
Slide 26: IVX-SKIN: Timeline to Product Registration Submission
IVX-SKIN: TIMELINE TO PRODUCT REGISTRATION SUBMISSION For personal use only Invion’s expected product development timeline to regulatory submission: 2019 2020 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 IVX-SKIN PRE-CLINICALS PHASE Ib HUMAN TRIAL PHASE III HUMAN TRIALS PRODUCT REGISTRATION
Slide 27: IVX Solid Cancer Program: Exploring Intravenous Treatment Formulations
IVX SOLID CANCER PROGRAM: EXPLORING INTRAVENOUS TREATMENT FORMULATIONS For personal use only Invion is undertaking an initial IV development to support future clinical studies. Invion will begin clinical studies of IV formulations in solid cancer treatments with a small, controlled orphan indication
Slide 28: IVX-MES: For Solid Cancers - Mesothelioma
IVX-MES: FOR SOLID CANCERS - MESOTHELIOMA For personal use only There are over 18 million cases of cancer every year worldwide, with nearly 10 million deaths. Surgery, radiotherapy and chemotherapy are the usual treatments – all have their side-effects. There are many cancers where new treatment opt
Slide 29: IVX-MES: Mesothelioma - A Growing Cancer Market
IVX-MES: MESOTHELIOMA – A GROWING CANCER MARKET For personal use only Lung cancer accounts for 54–75 per cent of all occupational cancer. Comparison of Global Burden of Asbestos related cancer accounts for 55–85 per cent of lung cancer and causes other Mesothelioma Deaths for leading o cancers cou
Slide 30: IVX-MES: Mesothelioma - Potential Market
IVX-MES: MESOTHELIOMA – POTENTIAL MARKET For personal use only Global Market Study on Malignant Mesothelioma “Global Market Study on Malignant ($ US Million) Mesothelioma’ – Market research: 750.00 • Global malignant mesothelioma market was valued approximately USD 338 625.00 million in 2017 and is
Slide 31: IVX-MES: Timeline to Product Registration Submission
IVX-MES: TIMELINE TO PRODUCT REGISTRATION SUBMISSION For personal use only Invion’s expected product development timeline to approval: 2019 2020 2021 2022 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 IVX-MES PHASE 1 TRIAL MESOTHELIOMA PHASE III TRIAL PRODUCT REGISTRATION
Slide 32: Clinical Development Program: Multiple Programs, Accelerated Approach
CLINICAL DEVELOPMENT PROGRAM MULTIPLE PROGRAMS, ACCELERATED APPROACH For personal use only 2019 2020 2021 2022 IVX-SKIN Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Pre-Clinicals Skin Cancer(BCC) Phase IB Trial Skin Cancer(BCC) Phase III Trial Skin Cancer(AK) Registration and Approval Submission Phase
Slide 33: Upcoming Milestones: Expected Newsflow 2019
UPCOMING MILESTONES EXPECTED NEWSFLOW 2019 For personal use only Program / Milestone 2019 2020 IVX Skin Q1 Q2 Q3 Q4 Q1 Pre-clinical studies commence Clinical site and CRO appointed Phase Ib (BCC) trial to commence Pre-clinical studies – results Phase I complete / results readout Phase III trials – c
Slide 34: Market Overview
MARKET OVERVIEW 7,000,000 Price and Volume 0.045 For personal use only 6,000,000 0.04 0.035 5,000,000 0.03 4,000,000 0.025 $0.015 (At 25th February 2019) Focus Clinical-stage life sciences company 3,000,000 2,000,000 0.02 0.015 0.01 1,000,000 0.005 0 0 Market Cap Issued Shares 5,492,272,967 06 06 06
Slide 35: For personal use only
For personal use only