Opthea Limited · ASX:OPT
Opthea — Circadian Technologies — Shareholder Meeting (November 2012)
43 slides from Opthea's shareholder meeting presentation, Nov 20, 2012
Slide 1: Annual General Meeting 20 November 2012
ANNUAL GENERAL MEETING 20 NOVEMBER 2012 Robert Klupacs, CEO & Managing Director Circadian Technologies (ASX.CIR)
Slide 2: Disclaimer
DISCLAIMER Investment in Circadian Technologies Limited (‘Circadian’) is subject to investment risk, including possible loss of income and capital invested. Neither Circadian nor any other member company of the Circadian Group guarantees any particular rate of return or performance, nor do they guar
Slide 3: 2012 AGM Presentation Outline
CIRCADIAN TECHNOLOGIES LIMITED- 2012 AGM PRESENTATION OUTLINE • Corporate Snapshot & Structure • Review of achievements since July 2011 • Therapeutic, Diagnostic & Reagent Development – Ceres Oncology Pty Ltd – Precision Diagnostics Pty Ltd – Opthea Pty Ltd • Expected milestones/value adding events
Slide 4: Corporate Snapshot
CORPORATE SNAP SHOT An Australian based emerging clinical stage company developing human therapeutic and diagnostic products from our extensive and worldwide dominant intellectual property platform in respect of VEGF-C, VEGF-D and VEGFR-3 and key relationships with leading cancer and eye research or
Slide 5: Our Corporate Structure
OUR CORPORATE STRUCTURE Circadian Technologies Limited 100% 100% 100% 100% 100% PolyChip 51.67% Listed Ceres Precision Pharmaceuticals Vegenics Opthea Syngene investment in Oncology Diagnostics Pty Pty Ltd OIL Pty Ltd Pty Ltd Limited Pty Ltd Ltd (ANP investment) ASX Listed DiMitech investments Techn
Slide 6: Circadian Technologies Limited
CIRCADIAN TECHNOLOGIES LIMITED 100% 100% 100% 100% 51.7% Excusive w/w licence to VGX-100 & CERES SYNGENE VEGF-C Abs as cancer therapies LIMITED ONCOLOGY PTY LTD VEGENICS PTY LTD VEGF Technology Excusive w/w licence to eye IP Holding & disease theraputics OPTHEA PTY LTD Management Co. Excusive w/w li
Slide 7: Review of Achievements Since July 2011
REVIEW OF ACHIEVEMENTS SINCE JULY 2011
Slide 8: Objectives We Set for 2011/2012
OBJECTIVES WE SET FOR 2011/2012 • Advance drug development pipeline toward human clinical trials • Develop partnerships for the commercialisation of our intellectual property • Release the value inherent in our IP assets
Slide 9: Progress Achieved in Executing Business Strategy
PROGRESS ACHIEVED IN EXECUTING BUSINESS STRATEGY Advancing our product pipeline • Phase 1 trials commenced in USA Jan 12 with VGX-100 (human anti- VEGF-C antibody) • Additional data generated in animal models showing combination effects with small molecule angiogenesis inhibitors • VGX-100 and VGX-3
Slide 10: Progress Achieved in Executing Business Strategy: Partnerships
PROGRESS ACHIEVED IN EXECUTING BUSINESS STRATEGY Partnerships • Healthscope-CUPGUIDE Test launched July 2012 • Cincinnati Children's Hospital Medical Centre – VEGF-D Diagnostic for women with respiratory disease: Product launched • Eli Lilly-IMC-3C5: Phase 1 trials continuing • Ark Therapeutics: Arb
Slide 11: Financial Position & Shareholder Base
FINANCIAL POSITION & SHAREHOLDER BASE Top 10 shareholders: 54.4% Financial Summary @ 16 November 2012 Investor % of issued shares (unaudited) BNP Paribas Noms Pty Ltd 17.10 Stock code: CIR Citicorp Nominees Pty Ltd 8.78 Share price: 37.5c (AUD) Ludwig Institute for Cancer 6.43 Shares issued: 48,481,
Slide 12: Key Financials (Consolidated)
KEY FINANCIALS (CONSOLIDATED) 30 June 12 16 Nov 2012 (unaudited) $000 $000 (excl Syngene) Cash 16,439 13,062 Listed investments (market value) 3,652 2,426 Net assets 20,197 Revenue 1,486 Operating expenses (incl. R&D, investment (9,048) related exp’s) Loss before tax (7,309) Net cash outflows (5,750
Slide 13: Financials: Cash and Expenditure
FINANCIALS CASH AND EXPENDITURE As of 30 June $ Million 9.4 A focus on funds going to R&D 8.4 value generating activity and 7.7 7.2 continued streamlining of 6.2 5.5 business activities to reduce Administrative expenses 3.4 2.7 2.1 2010 2011 2012 Cash Used in Operating Activities R&D Expenditure Adm
Slide 14: Financials: Total Operating Costs
FINANCIALS TOTAL OPERATING COSTS 12% Our goal is to have a ratio of R&D/IP 22% Expense to Administrative/Other 60% better than 80/20 on an annual basis 6% Research & Development 60% Patents 6% Administrative 22% Other 12%
Slide 15: Financials – Cash Flows
FINANCIALS – CASH FLOWS • Current Cash - $13m (Unaudited) excluding Syngene • Value of Listed Holdings - $2.4M (Unaudited) • Conservative Cash Burn 2011/12 and 2012/13 - $6.0M p.a • Well positioned to achieve key value adding milestones • Does not take into consideration: Increased R&D Tax Credit
Slide 16: Therapeutic, Diagnostics & Research Reagent Development
THERAPEUTIC, DIAGNOSTICS & RESEARCH REAGENT DEVELOPMENT Ceres Oncology Pty Ltd Precision Diagnostics Pty Ltd Opthea Pty Ltd
Slide 17: Mark Sullivan, Chief Executive Officer
Mark Sullivan Chief Executive Officer
Slide 18: Executive Summary
Executive Summary Anti-angiogenic therapies: $30B market (2011) - Proven efficacy - Limited by escape and relapse VGX-100: new treatment to block VEGF-C - Targets both blood and lymph vessel growth Blocks a treatment escape route for Avastin® (anti-VEGF-A) Enhances existing therapies - Fully hum
Slide 19: Multiple Indications with Important Advantages
Multiple Indications with important advantages Lymphedema Recurrent Recurrent Metastatic Glioblastoma Ovarian colorectal multiforme cancer Rationale ++ +++ ++ +++ Feasibility +++ ++ +++ ++ Opportunity ++ ++ + +++ (13-65% of breast (n=22,910 (n=22,280 (n=149,600 cancer survivors) new cases in 2012) n
Slide 20: Phase Ia and Ib in a Single Study
Phase Ia and Ib in a single study Monotherapy and Avastin® combination evaluation VGX100 1 mg/kg N=4 VGX100 Solid tumour 2.5mg/kg (advanced or N=3 VGX100 Current metastatic) 5mg/kg N=3 VGX100 No further 10mg/kg treatment N=3 options VGX100 20mg/kg N=3 MD Anderson Bev + VGX100 VGX100 30mg/kg UCLA 5 +
Slide 21: Forecast Timeline of Potential Value Creating Events
Forecast Timeline of Potential Value Creating Events 2012 2013 2014 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Last subject enrolled Solid Tumors Phase I (fully funded) 2o lymphedema VGX-100 in lymphedema Proof of concept Phase 2 In Breast Cancer Standard of care +/- VGX-100 Pivotal Phase 3 (orphan) Early read CA12
Slide 22: A Research Reagents and Molecular Diagnostics Company
A research reagents and molecular diagnostics company Precision Diagnostics A Circadian Company
Slide 23: Precision Diagnostics
PDPL REAGENTS / MOLECULAR IP LICENSING BIOMARKERS TOOLS DIAGNOSTICS VEGF-C / D / R3 VEGF-C , D, R3 antibodies VEGF-C , EIA (In Development) CUP Test reagent deals Rec human VEGF-C VEGF-D EIA (Cincinnati) Other tests in development Rec human VEGF-D Acquisitions Launch expected Jan 2013 Precision Diag
Slide 24: Gene Expression Based Assay for Carcinomas of Unknown Primary
Development of a Gene Expression Based Assay to Determine the Origin of Metastatic Carcinomas of Unknown Primary. Keith Byron1, Lisa Paiman1, Richard Tothill2, Evangeline Buela1, Fan Shi3, Adam Kowalczyk3, Robert Klupacs4, David Bowtell2 1.Healthscope Advanced Pathology, Clayton, Vic, Australia, 2.P
Slide 25: Precision Diagnostics
Precision Diagnostics A Circadian Company
Slide 26: LAM Diagnostic Test Launched Jan 2011
LAM DIAGNOSTIC TEST launched Jan 2011 in the USA under CAP/CLIA waiver.
Slide 27: VEGF-D Diagnostics – Respiratory Disease
VEGF-D Diagnostics – Respiratory Disease VEGF-D Diagnostics VEGF-D is increased in Serum VEGF-D levels distinguishable from other serum of patients with cystic and chylous lung diseases LAM Young et al. NEJM., 358(2), 199-200, 2008 Seyama et al. Lymphatic Res & Biol., Vol 4, #3, 143-152, 2006
Slide 28: VEGF-D - A Biomarker for mTOR Therapy?
VEGF-D - A biomarker for mTOR therapy? OPEN QACCESS Freely available online @ PLOS one Multicenter Phase 2 Trial of Sirolimus for Tuberous Sclerosis: Kidney Angiomyolipomas and Other Tumors Regress and VEGF- D Levels Decrease Sandra L. Dabora’*, David Neal Franz‘, Stephen Ashwal®, Arthur Sagalowsky®
Slide 29: Expected Near Term Milestones
EXPECTED NEAR TERM MILESTONES
Slide 30: Near Term Milestones H1 2013
NEAR TERM MILESTONES H1 • VGX-100 Phase 1 trials completed 2013 • Ceres Oncology partnership • Reagents Launch
Slide 31: Near Term Milestones H2 2013
NEAR TERM MILESTONES • Opthea Partnership H2 • VGX-100 Phase 2 studies commenced • IMC-3C5 Phase 1 studies complete 2013 • VEGF-C CLIA waivered diagnostic launched • CUPGUIDE Northern Hemisphere registrations lodged
Slide 32: Near Term Milestones H1 2014
NEAR TERM MILESTONES • VGX-100 Phase 2 H1 oncology studies initial results • VGX-300 IND Filed for “back of eye” 2014 • CUPGUIDE FDA approval, CE Mark • VEGF-D Diagnostic FDA approval
Slide 33: Development Opportunity for VEGF-C Inhibitors in Wet AMD
Development Opportunity for VEGF-C Inhibitors in Wet AMD Megan Baldwin, PhD megan.baldwin@circadian.com.au
Slide 34: Opthea Pty Ltd
Opthea Pty Ltd • Opthea Pty Ltd is a 100% owned subsidiary of Circadian Technologies, developing VEGF-C/-D/VEGFR-3 assets for eye disease. • ‘Seed’ investment from Circadian Technologies • Actively seeking partnership/s • Developing biologic VEGF-C inhibitors for ‘wet’ AMD – Lead candidate: VGX-300
Slide 35: Wet (neovascular) AMD
Wet (neovascular) AMD The Angiogenesis Foundation
Slide 36: Improving Anti-Angiogenesis: A Major Commercial Opportunity
IMPROVING ANTI-ANGIOGENESIS A Major Commercial Opportunity “Age-related macular degeneration (wet AMD) is a worldwide epidemic with an estimated prevalence of 30-50 million that rivals that of Alzheimer’s disease and that of all cancers combined.” J.Ambati. The Cogan Lecture. IOVS, April 2011 Estima
Slide 37: The Normal Retina and 'Wet' AMD
The Normal Retina and ‘Wet’ (neovascular) AMD Normal Retina ‘Wet’ AMD Choroid The Angiogenesis Foundation
Slide 38: Improving Anti-Angiogenesis: A Major Commercial Opportunity
IMPROVING ANTI-ANGIOGENESIS A Major Commercial Opportunity Existing therapies for wet AMD target VEGF-A but not VEGF-C: • Only one-third of patients recover driving vision* • One-sixth progress to registered blindness* We are targeting ‘sub’ responders that experience no gain in vision & continue to
Slide 39: Opthea Pty Ltd
Opthea Pty Ltd • By combining inhibition of VEGF-C with anti-VEGF-A therapies we aim to improve patient responses: – Vision gains – Reduce vascular leakage – Reduced dosing and visits to doctor • Relatively short time (3.5 yrs) to clinical proof of concept: Defined clinical endpoints & efficacy meas
Slide 40: VEGF-C is Required for Retinal Vascular Development
VEGF-C is Required for Retinal Vascular Development Retinas from P5 VEGF-C+/- mice have reduced vascularity. Tammela et al., Nature Cell Biology, 2011.
Slide 41: VEGF-C Induces Vascular Permeability
VEGF-C Induces Vascular Permeability - Contribution to Retinal Vessel Leakage Cao et al,. Circ Res., 2004
Slide 42: Development Activities
Development Activities • We have demonstrated activity in rodent model of AMD • We have shown comparable ocular biodistribution and PK profile in rabbits to marketed agents – potential for increased dosing interval in clinic • Fewer clinic visits & increased compliance • Key driver of market use • C
Slide 43: Thank-you
0 OPTHEA Thank-you
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