Opthea Limited · ASX:OPT
Opthea — Circadian Technologies — Shareholder Meeting (November 2011)
39 slides from Opthea's shareholder meeting presentation, Nov 24, 2011
Slide 1: Annual General Meeting 24 November 2011
ANNUAL GENERAL MEETING 24 NOVEMBER 2011 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: 2011 AGM Presentation Outline
CIRCADIAN TECHNOLOGIES LIMITED- 2011 AGM PRESENTATION OUTLINE • Corporate Snapshot & Structure • Review of achievements since June 2010 • Therapeutic Development – Oncology – Ophthamology • Diagnostics Development • Expected milestones/value adding events next 6-18 months • Circadian – the investmen
Slide 4: Corporate Snapshot
CORPORATE SNAPSHOT Developing human therapeutic and diagnostic products from our extensive intellectual property assets in respect of VEGF-C, VEGF-D and VEGFR-3 and key relationships with leading cancer and ocular research organisations.
Slide 5: Circadian Technologies Limited
Circadian Technologies Limited Cash Approx $19M at 22 November 2011 Staff 100% 100% 100% Cancer Polychip Vegenics Pty Ltd Therapeutics Limited Limited Oncology Ophthalmology Diagnostics Investments VGX-100 (PI Trials Dec ’11) VGX-100 VEGF-C ASX:ANP (Approx 11%) Front of eye EIA (Blood test) VGX-200
Slide 6: Review of Achievements Since June 2010
REVIEW OF ACHIEVEMENTS SINCE JUNE 2010
Slide 7: Objectives We Set for 2010/2011
OBJECTIVES WE SET FOR 2010/2011 • Advance drug development pipeline toward human clinical trials • Develop partnerships for the commercialisation of our intellectual property • Further strengthen and add skill-sets to our management team
Slide 8: Progress Achieved in Executing Business Strategy
PROGRESS ACHIEVED IN EXECUTING BUSINESS STRATEGY Advancing our product pipeline VGX-100: (human anti-VEGF-C antibody): - Completed IND enabling studies - IND Filed and cleared by FDA for studies in cancer patients - Phase 1 trials to commence in USA December - MD Anderson collaboration identified ke
Slide 9: Progress Achieved in Executing Business Strategy
PROGRESS ACHIEVED IN EXECUTING BUSINESS STRATEGY Advancing our product pipeline IMC-035: (VEGFR-3 Antibody being developed by Eli Lilly): - Phase 1 Clinical Trials commenced. Results expected Q3’12 VGX-300: (recombinant VEGFR-3) - CSIRO alliance has generated second generation molecules with signifi
Slide 10: Progress Achieved in Executing Business Strategy
PROGRESS ACHIEVED IN EXECUTING BUSINESS STRATEGY Partnerships – Healthscope-CUP Test: Good progress. On track for launch in Q1 2012 – Cincinnati Childrens Hospital Medical Centre – VEGF-D Diagnostic for women with respiratory disease: Product launched – Eli Lilly-IMC-3C5: Phase 1 trials commenced –
Slide 11: Financial Position & Shareholder Base
FINANCIAL POSITION & SHAREHOLDER BASE Top 10 shareholders: 52.8% Financial Summary @ 22 November 2011 Investor % of issued shares (unaudited) HSBC Custody Nominees 18.88 (Australia) Limited Stock code: CIR Licentia Ltd 6.79 Share price: 50.0c (AUD) Ludwig Institute for Cancer 6.73 Shares issued: 46,
Slide 12: Key Financials (Consolidated)
KEY FINANCIALS (CONSOLIDATED) 30 June 11 22 Nov 2011 (unaudited) $000 $000 Cash 22,104 19,100 Listed investments (market value) 1,432 3,548 Net assets 21,824 Revenue 1,850 Operating expenses (incl. R&D, investment (12,893) related exp’s) Loss before tax (11,043) Net cash outflows (9,477) NTA per sha
Slide 13: Financials
FINANCIALS A focus on funds going to R&D value generating activity and continued streamlining of business activities to reduce Administrative expenses
Slide 14: Financials
FINANCIALS Our goal is to have a ratio of R&D/IP Expense to Administrative/Other better than 80/20 on an annual basis
Slide 15: Financials – Cash Flows
FINANCIALS – CASH FLOWS • Current Cash - $19.1m (Unaudited) • Value of Listed Holdings - $3.5M (Unaudited) • Conservative Cash Burn 2011/12 and 2012/13 - $9.0M p.a • Well positioned to achieve key value adding milestones • Does not take into consideration: Increased R&D Tax Credit Royalties on S
Slide 16: Therapeutic Development: Oncology & Eye Disease
THERAPEUTIC DEVELOPMENT Oncology & Eye Disease
Slide 17: Combination Therapy of Targeted Agents Is the New Paradigm in Cancer Therapy
COMBINATION THERAPY OF TARGETED AGENTS IS BECOMING THE NEW PARADIGM IN CANCER THERAPY
Slide 18: Improving Anti-Angiogenesis a Major Commercial Opportunity
IMPROVING ANTI-ANGIOGENESIS A MAJOR COMMERCIAL OPPORTUNITY • Avastin®: 2010 Sales $US7.2B • 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: VEGF-C May Be a Predictive Biomarker for Avastin Resistance
HAVE NOW SHOWN THAT VEGF-C MAY BE A PREDICTIVE BIOMARKER FOR AVASTIN RESISTANCE * * VEGF-C levels begin to rise Significantly BEFORE tumours Stop responding to Avastin. Highlights major potential for improving therapy by combining VEGF-A and VEGF-C blockade C.Lieu et al., "The Association of Alterna
Slide 20: VGX-100 Reduces Metastasis in Orthotopic Prostate Cancer Model
VGX-100 REDUCES METASTASIS IN AN ORTHOTOPIC PROSTATE CANCER MODEL 20
Slide 21: VGX-100 Oncology Clinical Development
VGX-100 ONCOLOGY CLINICAL DEVELOPMENT 21
Slide 22: VGX-100 Target Product Profile in Oncology
VGX-100 TARGET PRODUCT PROFILE IN ONCOLOGY • Indication: – Co-administered with anti-angiogenic agent eg (Sutent®, Nexavar®, Avastin® ) and standard of care – Targeting glioblastoma and colorectal cancer as first indications – To develop through collaborations at least one of breast, lung, renal and
Slide 23: Glioblastoma - A Major Unmet Clinical Need
GLIOBLASTOMA - A MAJOR UNMET CLINICAL NEED • In the US in 20101 – Estimated diagnosed: 22,020 – Estimated fatalities: 13,140 • The most aggressive malignant primary brain tumor in adults • Nearly always fatal • Possibility for fast track registration based on Phase 2b study. • Phase 2b study aim to
Slide 24: Phase I and II Clinical Program
PHASE I AND II CLINICAL PROGRAM VGX-100 and Phase I VGX-100 + Avastin® Arm A (mono), Arm B (combo) Phase II VGX-100 + Avastin® + selected standards of care Part A Metastatic Lung Breast Renal cell Glio- colorectal cancer cancer cancer blastoma cancer Non- Metastatic Phase II Phase II squamous HER2 L
Slide 25: VGX-100 Ocular Development Opportunity
VGX-100 OCULAR DEVELOPMENT OPPORTUNITY LEVERAGING VGX-100 ONCOLOGY DEVELOPMENT 25
Slide 26: Development Opportunity
DEVELOPMENT OPPORTUNITY • Significant development opportunity for VGX-100 as a treatment for ‘front of the eye’ disease. • Initial indications: • Corneal Neovascularisation (CNV) • Estimated that up to 4-5% of patients at eye clinics have CNV • Potential market >$1B p.a • Very limited competition •
Slide 27: Rejected Corneas Over-Express VEGF-C and VEGFR-3
REJECTED CORNEAS ARE INFILTRATED BY BLOOD AND LYMPHATIC VESSELS AND OVER-EXPRESS VEGF-C and VEGFR-3 Transplanted Corneas: 3 wks Post-Transplant ACCEPTED REJECTED Photomicrographs Flat-mount IHC stained corneas: VEGF-C expression LYVE-1 (lymphatics) increased 2-fold in CD31 (blood vessels) rejected v
Slide 28: VGX-100 Promotes Corneal Transplant Survival
VGX-100 PROMOTES CORNEAL TRANSPLANT SURVIVAL Our Goal is to commence clinical studies by Q1 ‘13 with fast track approval application lodged by H2’15 ARVO Annual Meeting 2010. Program#/Poster#1554/D995 28
Slide 29: Our Diagnostics Portfolio
OUR DIAGNOSTICS PORTFOLIO 29
Slide 30: Diagnostics – A Source of Near Term Revenue
DIAGNOSTICS – A SOURCE OF NEAR TERM REVENUE • VEGF-D Diagnostics • VEGF-C Diagnostics • Cancers of Unknown Primaries 30
Slide 31: Diagnostics – VEGF-D Diagnostics
DIAGNOSTICS – A SOURCE OF NEAR TERM REVENUE VEGF-D Diagnostics – Marketed as biomarker test for LAM (degenerative lung disease in women) in USA by Cincinatti Children’s – Market expected to expand to 25-50,000 tests p.a within 2-3 years – $10-20M market (with 20-25% royalty) – Sales significantly in
Slide 32: Diagnostics – VEGF-C Diagnostics
DIAGNOSTICS – A SOURCE OF NEAR TERM REVENUE VEGF-C Diagnostics – Development accelerated – Based on MD Anderson study appears to be a major biomarker to monitor anti-angiogenic therapy “resistance” – Key product requirement for US re-imbursement agencies – Possible market 250,000 tests worldwide at
Slide 33: Diagnostics – Cancers of Unknown Primary Origin
DIAGNOSTICS – A SOURCE OF NEAR TERM REVENUE Cancers of Unknown Primary Origin » Market launch in Aust, NZ, Malaysia, Singapore expected Q1 2012 » Market size 10,000 tests p.a » Pricing at $1000-1500/test (Royalty > 15%) » Circadian retains rights to test to ROW » Partnership discussions ongoing » Ex
Slide 34: Expected Near Term Milestones
EXPECTED NEAR TERM MILESTONES
Slide 35: Near Term Milestones H1 2012
NEAR TERM MILESTONES • VGX-100 Phase 1 trials H1 commenced • CUP molecular diagnostic 2012 market launch • VGX-100 monotherapy safety demonstrated
Slide 36: Near Term Milestones H2 2012
NEAR TERM MILESTONES • VGX-100 & Avastin combination H2 safety and acceptable toxicity demonstrated • VGX-100 Phase 1 studies complete 2012 • IMC-3C5 Phase 1 studies complete • VEGF-C CLIA waivered diagnostic available • VGX-100 corneal allograft IND lodged
Slide 37: Near Term Milestones H1 2013
NEAR TERM MILESTONES • VGX-100 Phase 2 H1 oncology studies commence • VGX-100 Phase ½ 2013 corneal allograft studies commenced • CUP Test ROW partnership in place
Slide 38: An Investment with Significant Upside
AN INVESTMENT WITH SIGNIFICANT UPSIDE Research Report from van Leeuwenhoeck Research 7 October 20100 “…Based on sum-of-the-parts valuation, we believe Circadian is gravely undervalued at the current share price of AUD 0.47. Using our valuation model, the Company’s total value is AUD 91 million, or A
Slide 39: Thank You! Q&A
THANK YOU! Q&A
Circadian Technologies — Shareholder Meeting (November 2011) on 6ix