Opthea Limited · ASX:OPT
Opthea — Circadian Technologies — Shareholder Meeting (November 2010)
36 slides from Opthea's shareholder meeting presentation, Nov 11, 2010
Slide 1: Annual General Meeting 11 November 2010
ANNUAL GENERAL MEETING 11 NOVEMBER 2010 Robert Klupacs, 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: 2010 AGM Presentation Outline
CIRCADIAN TECHNOLOGIES LIMITED- 2010 AGM PRESENTATION OUTLINE • Corporate Snapshot • Review of achievements since June 2009 • Circadian – a developer of biologics based cancer therapies • Cancer therapies/diagnostic pipeline – product development overview • Expected p milestones/value addingg events
Slide 4: Corporate Snapshot
CORPORATE SNAPSHOT DEVELOPER OF BIOLOGICAL CANCER THERAPIES TARGETED TO BLOCK ANGIOGENESIS AND LYMPHANGIOGENESIS • Breakthrough g technology gy based on tumour starvation and metastasis inhibition • Lead program: VGX-100 – Fully human, high affinity, neutralizing monoclonal antibody for VEGF-C – P P
Slide 5: Review of Achievements Since June 2009
REVIEW OF ACHIEVEMENTS SINCE JUNE 2009
Slide 6: Objectives We Set for 2009/2010
OBJECTIVES WE SET FOR 2009/2010 • Extend and strengthen core intellectual property covering VEGF- based therapeutics • Advance drug development pipeline toward human clinical trials • Develop partnerships for the commercialisation of our intellectual property • Further strengthen and add skill-sets
Slide 7: Progress Achieved in Executing New Business Strategy – To Date
PROGRESS ACHIEVED IN EXECUTING NEW BUSINESS STRATEGY – TO DATE E t di Extending and d strengthening t th i our IP position iti – Japanese VEGF-C patent granted – Major US patent covering cancer treatment till September 2023 – European patent covering cancer treatment to be granted Nov 24 2010 – US V
Slide 8: Progress Achieved in Executing Business Strategy: VGX-100
PROGRESS ACHIEVED IN EXECUTING BUSINESS STRATEGY Advancing our product pipeline VGX-100: (human anti-VEGF-C antibody): - cGMP manufacturing g of clinical trial material commenced and to be available Jan 2011 -Major results showing efficacy in animal models of cancer published at AACR. Further promis
Slide 9: Progress Achieved in Executing Business Strategy: IMC-035, VGX-200, VGX-300
PROGRESS ACHIEVED IN EXECUTING BUSINESS STRATEGY Advancing our product pipeline IMC-035: (VEGFR-3 Antibody being developed by Eli Lilly): - Advised that on track for IND Filing before end 2010 VGX-200: (humanised anti-VEGF-D antibodies) - Multi-gram batches made - Currently being assessed in a range
Slide 10: Progress Achieved: Partnerships and Advisory Team
PROGRESS ACHIEVED IN EXECUTING BUSINESS STRATEGY P t Partnerships hi – Healthscope – Good progress. On track for launch in H1 2011 – Cincinnati Childrens Hospital p Medical Centre – VEGF-D Diagnostic g for women with respiratory disease B ildi the Building th managementt and d advisory d i team t –
Slide 11: Financial Position & Shareholder Base
FINANCIAL POSITION & SHAREHOLDER BASE Top 10 shareholders: 54.5% Financial Summary @ 10 November 2010 Investor % of issued shares (unaudited) Packer and Co Limited 16.66 Licentia Ltd 6.79 Stock code: CIR Share price: 60c (AUD) Ludwig Institute for Cancer 6.73 Research Shares issued + 46,396,928 defe
Slide 12: Key Financials (Consolidated)
KEY FINANCIALS (CONSOLIDATED) 30 June 10 9 Nov 2010 (unaudited) $000 $000 Cash 31,855 27,482 Listed investments (market value) 1,922 1,356 N t assets Net t 31 820 31,820 Revenue 2,265 Operating expenses (incl. R&D, investment (12,015) related exp’s) Loss before tax (6,839) Net cash outflows (6,936)
Slide 13: Circadian – A Developer of Biologics Based Cancer Therapies
CIRCADIAN – A DEVELOPER OF BIOLOGICS BASED CANCER THERAPIES
Slide 14: Mechanism of Circadian's Drugs (1)
MECHANISM OF CIRCADIAN’S DRUGS (1)
Slide 15: Mechanism of Circadian's Drugs (2)
MECHANISM OF CIRCADIAN’S DRUGS (2)
Slide 16: Our Strategy: A Cash Generating Entity Undertaking Biologicals Drug Development
OUR STRATEGY: A CASH GENERATING ENTITY WHICH UNDERTAKES HIGH VALUE BIOLOGICALS DRUG DEVELOPMENT Technology & Cash Partnered Product Internal Product Development Development VGX‐100 VGX 200 VGX‐200 Research VGX‐300 Reagents Diagnostics Therapeutics •Millipore •R&D systems •Healthscope •Cincinatti •El
Slide 17: Circadian's Deep Product Pipeline
CIRCADIAN’S DEEP PRODUCT PIPELINE
Slide 18: Improving Anti-Angiogenesis: A Major Commercial Opportunity
IMPROVING ANTI-ANGIOGENESIS A MAJOR COMMERCIAL OPPORTUNITY • Avastin®: 2009 Sales $US5.7B • Effective but not in all patients – Not all patients respond to therapy (30-50% response rate) – 25-50% of responders become “resistant” within 12 to 18 months – Potential reasons: • Tumour growth due to fact
Slide 19: Cancer Therapies/Diagnostic Pipeline - Product Development Overview
CANCER THERAPIES/DIAGNOSTIC PIPELINE - PRODUCT DEVELOPMENT OVERVIEW
Slide 20: VGX-100 Single-Agent & Combination Therapy in PC-3 Prostate Cancer Xenografts
VGX-100 SINGLE-AGENT & COMBINATION THERAPY IN PC-3 PC 3 PROSTATE CANCER XENOGRAFTS 2200 Negative isotype Control 2000 Avastin g) +/- SE 1800 VGX-100 1600 Docetaxel Burden (mg Avastin + Docetaxel 1400 VGX-100 + Docetaxel 1200 VGX-100 + Avastin 1000 000 VGX-100 VGX 100 + Avastin + Doce ean Tumor B 800
Slide 21: U87MG Glioblastoma Tumor Xenografts: VGX-100 Combination with Avastin
U87MG GLIOBLASTOMA TUMOR XENOGRAFTS: VGX VGX-100 100 COMBINATION WITH AVASTIN 2600 Negative Isotype Control 2400 Avastin mg) +/- SE 2200 2000 VGX-100 1800 or Burden (m 1600 1400 1200 1000 Mean Tumo VGX-100 + Avastin 800 600 400 200 0 0 10 20 30 40 Days Post-Tumor Implant At Day 49, VGX‐100 + Avastin
Slide 22: VEGF-C – Potential in Front of the Eye Disease
VEGF‐C‐ Potential in front of the eye disease
Slide 23: VGX-100 Improves Corneal Transplant Survival
VGX-100 IMPROVES CORNEAL TRANSPLANT SURVIVAL (COLLABORATION WITH HARVARD UNI., SCHEPENS) • >50000 corneal transplants/yr in USA. • High‐rate High rate (~50%) of rejection when transplanted into ‘high high‐risk risk’ inflammed and vascularised beds. • Post‐operative growth of blood and lymphatic vess
Slide 24: VGX-100 Promotes Corneal Transplant Survival
VGX 100 PROMOTES CORNEAL VGX-100 TRANSPLANT SURVIVAL ARVO Annual Meeting 2010. Program#/Poster#1554/D995
Slide 25: Building our Revenues
Building our Revenues
Slide 26: Near Term Revenue Generating Assets: CUP Diagnostic
NEAR TERM REVENUE GENERATING ASSETS Cancers of Unknown Primaries (CUP) Molecular Diagnostic – Development partnered with Healthscope (ASX:HSP) – US incidence of CUP 60,000 to 100,000 per annum – Test to sell for between US$2-4K due to significant health cost savings – CIR retains ownership and exclu
Slide 27: Near Term Revenue Generating Assets: CUP Diagnostic Progress
NEAR TERM REVENUE GENERATING ASSETS Cancers of Unknown Primaries (CUP) Molecular Diagnostic – Internal Developments throughout the year focused on improving the platform and gene set as well as the analytical software – Data looks promising with key experiments expected to be completed early 2011 –
Slide 28: Near Term Revenue Generating Assets: VEGF-D Diagnostic for Respiratory Disease
NEAR TERM REVENUE GENERATING ASSETS VEGF-D VEGF D DIAGNOSTIC FOR RESPIRATORY DISEASE VEGF-D a specific serum biomarker for Lymphangioleiomyomatosis (LAM) • Lymphangioleiomyomatosis (LAM): A disease causing cystic lung lesions in women and has also been linked to g genetic disease TSC • Often degener
Slide 29: VEGF-D Diagnostics – Respiratory Disease
VEGF-D Diagnostics – Respiratory disease VEGF‐D is increased in Serum VEGF‐D 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 30: Existing Revenue Generating Assets
EXISTING REVENUE GENERATING ASSETS • Imclone/Eli Lilly (VEGFR-3 Antibody) –Annual Licence Fees • Research Reagent suppliers - Merck Millipore - R&D Systems - Reliatech - Perkin P ki Elmer El • Lymphatix Ltd (VEGF-C and VEGF-D gene therapy)-Annual Licence Fees and royalties (will be affected by ongoi
Slide 31: Expected Near Term Milestones
EXPECTED NEAR TERM MILESTONES
Slide 32: Near Term Milestones H1 2011
NEAR TERM MILESTONES • VGX‐100 IND Filingg with FDA H1 • VGX‐100 toxicology completion • VGX‐100 cGMP manufacture completion • IMC‐3C5 IMC 3C5 IND filing (ImClone/Eli Lilly) 2011 • CUP molecular diagnostic market launch • VEGF‐D Diagnostic Sales Commence
Slide 33: Near Term Milestones H2 2011
NEAR TERM MILESTONES • VGX‐100 non‐cancer indications development commenced H2 • CUP molecular diagnostic USA and European partnerships in place • VEGF‐D Diagnostic Partnerships in 2011 Europe and Japan • VEGF‐C Clinical Diagnostic Development Partnered • Further Reagent Supply partnerships
Slide 34: Near Term Milestones 2012
NEAR TERM MILESTONES • VGX‐100 VGX 100 FiFirstt Cli Clinical i l HI Studies completed g • VGX‐300 Designated Product Development Candidate 2012 • IMC‐3C5 (ImClone/Eli Lilly) Phase 1 clinical studies completed;
Slide 35: An Investment with Significant Upside
AN INVESTMENT WITH SIGNIFICANT UPSIDE Research Report from Morningstar/Huntley’s 3 May 2010 Fair value $2.20/share $2 20/share "CIR is now focused on the development of VEGF-based therapies for the t t treatmentt off cancers and d other th diseases. di Li Licencing i deals d l already l d iin place
Slide 36: Thank You! Q&A
THANK YOU! Q&A
Circadian Technologies — Shareholder Meeting (November 2010) on 6ix