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INOVIQ LTD — AGM Information 2016
Nov 6, 2016
65112_rns_2016-11-06_12929e08-9c54-4823-9464-b4fa086accfd.pdf
AGM Information
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Transformin earl cancer detection & revention g y p
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ASX: BD1
AGM PRESENTATION 7[th] November 2016
Forward Statements
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This presentation has been prepared by BARD1 Life Sciences Limited (“BARD1” or the “Company”) based on information available to it as at the date of this presentation. The information in this presentation is provided in summary form and does not contain all information necessary to make an investment decision.
This presentation does not constitute an offer, invitation, solicitation or recommendation with respect to the purchase or sale of any security in BARD1, nor does it constitute financial product advice or take into account any individual’s investment objectives, taxation situation, financial situation or needs. An investor must not act on the basis of any matter contained in this presentation but must make its own assessment of BARD1 and conduct its own investigations. Before making an investment decision, investors should consider the appropriateness of the information having regard to their own objectives, financial situation and needs, and seek legal, taxation and financial advice appropriate to their jurisdiction and circumstances. BARD1 is not licensed to provide financial product advice in respect of its securities or any other financial products. Cooling off rights do not apply to the acquisition of BARD1 securities.
Although reasonable care has been taken to ensure that the facts stated in this presentation are accurate and that the opinions expressed are fair and reasonable, no representation or warranty, express or implied, is made as to the fairness, accuracy, completeness or correctness of the information, opinions and conclusions contained in this presentation. To the maximum extent permitted by law, none of BARD1 its officers, directors, employees and agents, nor any other person, accepts any responsibility and liability for the content of this presentation including, without limitation, any liability arising from fault or negligence, for any loss arising from the use of or reliance on any of the information contained in this presentation or otherwise arising in connection with it.
The information presented in this presentation is subject to change without notice and BARD1 does not have any responsibility or obligation to inform you of any matter arising or coming to their notice, after the date of this presentation, which may affect any matter referred to in this presentation.
The distribution of this presentation may be restricted by law and you should observe any such restrictions.
This presentation contains certain forward looking statements that are based on the Company’s management beliefs, assumptions and expectations and on information currently available to management. Such forward looking statements involve known and unknown risks, uncertainties, and other factors which may cause the actual results or performance of BARD1 to be materially different from the results or performance expressed or implied by such forward looking statements. Such forward looking statements are based on numerous assumptions regarding the Company’s present and future business strategies and the political and economic environment in which BARD1 will operate in the future, which are subject to change without notice. Past performance is not necessarily a guide to future performance and no representation or warranty is made as to the likelihood of achievement or reasonableness of any forward looking statements or other forecast. To the full extent permitted by law, BARD1 and its directors, officers, employees, advisers, agents and intermediaries disclaim any obligation or undertaking to release any updates or revisions to information to reflect any change in any of the information contained in this presentation (including, but not limited to, any assumptions or expectations set out in the presentation).
BARD1 Life Sciences (ASX:BD1)
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Life sciences company developing novel diagnostics and therapeutics for unmet needs in cancer
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Leverages proprietary BARD1 technology that is a tumour suppressor in healthy individuals and important tumour biomarker in cancer
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Focused on developing non-invasive diagnostic tests for early detection of cancer in US$100.9B cancer diagnostics market
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Lead product BARD1 Lung Cancer Test is a simple blood test in development for early detection of lung cancer with potential convenience, accuracy & cost advantages
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Completed POC Study validating BARD1 antibodies as biomarkers for detection of lung cancer and demonstrating high sensitivity and specificity of prototype BARD1 Test
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Commenced Analytical Validation to further develop, optimise and validate BARD1 Test for early-stage lung cancer on proven ELISA platform
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Planned Clinical Validation studies to prove the safety and performance of BARD1 Test as a screening test for early detection of lung cancer, expected to commence 2H17
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Future pipeline of high-value diagnostics and therapeutics at research-stage for multiple cancers
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Experienced leadership with track record in building successful companies, and international expertise in BARD1 biology, biomarker translation & respiratory medicine
Company Snapshot
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Biotech focused on fast-to-market diagnostics with significant upside from potential highvalue therapeutic pipeline for unmet needs in cancer
| KEY FINANCIALS | |
|---|---|
| Ticker | ASX:BD1 |
| Ordinary Shares | 551,996,586 |
| Performance Shares1 | 217,003,236 |
| Share Price (@4/11/16) | A$0.036 |
| Market Cap (@4/11/16) | A$19.87m |
| 52w Range | A$0.041-0.019 |
| Cash (@ 30/9/16) | A$2.67m |
| SUBSTANTIAL SHAREHOLDERS | # SHARES | % HOLDING |
|---|---|---|
| Irmgard Irminger | 108,252,420 | 19.61% |
| Tony Walker | 88,501,626 | 16.03% |
| Paul Sharbanee | 33,911,561 | 6.14% |
| Peter Lynton Gunzburg | 29,835,004 | 5.40% |
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- Escrowed until Jul-18
Leadership Team Experience & expertise
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Peter Gunzburg BCom | Executive Chairman
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•Public company director, stockbroker and technology investor, with 20+ years corporate advisory, capital raising, transaction & business management experience
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•Currently Chair of the Institute for Respiratory Health at UWA
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•Previously director of Resolute Ltd, Australian Stock Exchange Ltd, Eyres Reed Ltd, CIBC World Markets Australia Ltd, Fleetwood Corporation Ltd, Dragon Mining Ltd and Newzulu Ltd
Dr Irmgard Irminger-Finger PD PhD | Executive Director & Chief Scientific Officer
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•Founder and co-inventor of BARD1 and its technology, and internationally recognised expert in BARD1 biology with over 40 publications, 6 issued patents, 30 collaborations and 150 conference presentations
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•Currently Privat Docent at UNIGE, Head of the Molecular Gynaecology and Obstetrics Laboratory at HUG, and Adjoint Prof at UWA
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•Former Executive Director & founder of BARD1Ag
Brett Montgomery | Non-Executive Director
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•Extensive experience in public company management, leadership, corporate governance and risk management
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•Currently Non-Executive Director of Tanami Gold NL, and Magnum Gas and Power Ltd
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•Previously Managing Director of Kalimantan Gold NL, and Director of Grants Patch Mining Ltd and EZA Corporation Ltd
Prof Geoff Laurent PhD FRCP(Hon) FRCPath FMedSci | Non-Executive Director
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•Accomplished organisational leader, thought-leader, scientific editor, advisory board member, and award winning respiratory scientist with over 300 peer reviewed publications
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•Currently Director of the Institute for Respiratory Health, and Director of the Centre of Cell Therapy and Regenerative Medicine at UWA
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•Former Vice-Dean of Enterprise & Head of Department of Internal Medicine at University College London, Past President of the British Association for Lung Research
Dr Leearne Hinch BSc BVMS MBA | Chief Executive Officer
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•Biotechnology executive and consultant with extensive experience in the life science industry in general management, strategy, fundraising, business development and commercialisation
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•Currently Director at Ingeneus Solutions
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•Previously CEO of Eustralis Pharmaceuticals Ltd and Immuron Ltd, and executive at OBJ Ltd, Holista CollTech Ltd, Chemeq Ltd and Virbac (Australia) Pty Ltd
Business Model
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Develop, validate, partner & profit
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Focus on developing fast-to-market diagnostic tests for early detection of cancer that are reliable, accurate and affordable
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Deliver clinical evidence to demonstrate medical value and enable medical device marketing or approval in Europe, Australia & USA
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Commercialise through licensing of laboratory tests (LDTs) to central laboratories, or of approved in vitro diagnostics (IVDs) to multinational partners for royalties
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Expand research to develop high-value therapeutic pipeline for unmet needs in cancer and partner early to biopharma partner for upfront fees, milestone payments & future royalties
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Create value for ASX:BD1 shareholders
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BARD1 Technology
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Science
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BARD1 gene (BRCA1-associated RING domain 1) is a tumour suppressor coding for the BARD1 protein □ BARD1 protein binds & stabilises the BRCA1 protein, otherwise unstable[1]
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BRCA1 is responsible for DNA repair, whereas BRCA mutations increase the risk for breast cancer
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BARD1 is important in mitosis and required for cytokinesis, whereas BARD1 depletion leads to cell cycle arrest[2]
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Cancer cells express a number of aberrant BARD1 isoforms generated by alternate gene splicing
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BARD1 isoforms antagonise the functions of ‘normal’ BARD1 and BRCA1 to drive oncogenesis[3]
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Different combinations of BARD1 molecules are specific for different cancers[4]
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BARD1 mutations identified in multiple non-coding & coding regions that predispose to cancer[5]
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BARD1 isoforms have been correlated with cancer progression & poor prognosis[6]
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BARD1 epitopes are novel and specific biomarkers for multiple cancers
Normal BARD1
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Antibodies
against regions
on normal
BARD1
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Wu et al 1996; Irminger-Finger et al 2016
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Ryser et al 2009; Zhang et al 2004; Delaval et al 2004; Daniels et al 2004
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Ryser et al 2009; Bosse et al 2012
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Wu et al 2006; Li et al 2007; Zhang et al 2012a; Zhang et al 2012b; Lepore et al 2013
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Nowakowska et al 2015; Ratajska et al 2015
Novel, proprietary & specific cancer biomarkers
- Zhang 2012a; Zhang 2012b; Wu et al 2006; Li 2007b
Biomarker Translation
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Scientific Rationale
■ BARD1 is potentially a diagnostic biomarker and therapeutic target for cancer
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Aberrant BARD1 proteins are released in large amounts by cancer cells and induce circulating BARD1 autoantibodies that can be detected early in the blood enabling early diagnosis of cancer[1]
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BARD1 cancer-specific RNA-isoforms result in diagnostic signatures that can be detected by liquid biopsy methods[1]
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Cancer-associated BARD1 isoforms can be targeted to inhibit their oncogenic potential enabling targeted therapies for prevention or treatment of cancer
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Potential applications for Lung, Breast, Ovarian, Prostate, Colorectal & other cancers
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Global cancer diagnostics market valued at US $100.9B in 2013 & $168.6B by 2020[2]
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Global cancer therapeutics market was valued at US $78.2B in 2013 & $111.9B by 2020[3]
Cancer BARD1
Antibodies specific for cancer BARD1
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Antibodies bind to small surface regions of BARD1 (epitopes). We use epitopes to capture antibodies.
Peptides are 10-15 amino acids long.
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Wu et al 2006; Li et al 2007; Zhang et al 2012a; Zhang et al 2012b
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TMR. Cancer Diagnostics Market. 2014
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Allied Analytics. Global Oncology Drugs Market. 2015
Pipeline Balanced risk profile
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■ Developing a pipeline of cancer diagnostic & therapeutic products based on its proprietary BARD1 technology
■ Lead product is BARD1 Lung Cancer Test for early detection of lung cancer ■ Research-stage pipeline targeting unmet needs in multiple cancers
| DIAGNOSTICS THERAPEUTICS |
PRODUCT |
INDICATION |
**PLATFORM ** | USE |
RESEARCH |
ANAYTICAL VALIDATION |
CLINICAL VALIDATION |
MARKETABLE / APPROVAL |
|---|---|---|---|---|---|---|---|---|
| BARD1 Lung Cancer Test |
Lung Cancer |
ELISA1 (Blood) |
Screening & Diagnosis |
2H17 | ||||
| BARD1 Ovarian Cancer Test |
Ovarian Cancer |
ELISA (Blood) |
Detection & Monitoring |
|||||
| BARD1 RNA Test |
Cancer |
RT-PCR (Blood) |
Diagnosis & Monitoring |
|||||
| PRODUCT |
INDICATION |
RESEARCH |
PRE- CLINICAL |
PHASE I | PHASE II | PHASE III | APPROVAL | |
| BARD1 Vaccine |
Cancer | |||||||
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1ELISA = Enzyme Linked ImmunoSorbent Assay
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2RT-PCR = Reverse Transcriptase Polymerase Chain Reaction
Lung Cancer Facts
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Lung Cancer is the leading cause of cancer death worldwide[1]
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Incidence: 1.82m new cases pa
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Mortality: 1.59m deaths pa
■ Cancer types
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NSCLC (Non-Small Cell Lung Cancer): 85% cases
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SCLC (Small Cell Lung Cancer): 15% cases
■ Risk factors
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Smoking: 90% cases
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Other: age (>65y), second-hand smoke, radon exposure, occupational exposure, cancer history, family history, lung disease
■ 5-year survival is linked to stage at detection[2]
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Average 5-year survival 17.4% in US & 5.8% worldwide[1]
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Late-detection is deadly: majority of patients diagnosed at late-stage with <1% survival
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Early-detection saves lives: potentially >50% survival rate if diagnosed early
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Early diagnosis is linked to improved prognosis & reduced mortality[2,3]
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Global lung cancer diagnostics market US$26.0B in 2013 & US$42.2B by 2020, with 7.1% CAGR[4]
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5-Year Survival Rate by Stage at Detection
It takes 10-20 years for lung cancer symptoms to appear and
only 3-4 years for cancer to progress from Stage 1 to 4
Stage 1 49%
Stage 2 30%
Stage 3 14%
Stage 4 1%
Survival
0% 20% 40% 60% 80% 100%
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GLOBOCAN 2012
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ACS 2016
Early detection saves lives!
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NCI 2014
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TMR. Cancer Diagnostics Market. 2014
Lung Cancer Unmet need for early detection
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■ Current diagnostic options are limited
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Chest X-ray: standard diagnostic tool in symptomatic patients, but not specific for LC
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CT scan: ‘gold standard’ screening & diagnostic tool, but routine use limited by high false positives, additional diagnostic confirmation, radiation exposure & cost
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Biopsy: ‘ definitive diagnostic’ to determine cancer type & stage, but invasive & expensive
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No simple blood test currently available
■ Treatment advances in surgery, radiotherapy & chemotherapy have not improved Overall Survival
■ However, early diagnosis has improved 5-year survival
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Low dose CT screening has shown a reduction in RR of mortality by 20% over chest X-ray[1]
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Clinical guidelines recommend annual screening for lung cancer with LDCT[2]
NCCN Guidelines recommend “annual screening for lung cancer with low-dose computed tomography (LDCT) in high-risk asymptomatic adults aged 55-74 years with a greater than 30 packyear smoking history that either continue to smoke or have quit within the past 15 years”
■ Cancer screening is critical to enable early detection, improve prognosis & help inform treatment options
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NCI 2014
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NCCN, Guidelines 2016
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TMR. Cancer Diagnostics Market. 2014 LC = Lung Cancer
Unmet need for a non-invasive, simple, accurate & affordable screening test for early detection of lung cancer
LDCT = Low Dose Computed Tomography RR = Relative Risk
BARD1 Lung Cancer Test
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Simple, accurate & affordable non-invasive blood test
■ BARD1 Test is a non-invasive blood test in development for early detection of lung cancer
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ELISA-assay detecting BARD1 autoantibodies in blood serum
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BARD1 antibodies detectable from early-stage tumours (improves accuracy for early-stage lung cancer)
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Specific BARD1 epitopes are used to capture anti-BARD1 antibodies specific for lung cancer
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Results are measured by electrochemiluminescence (ECL) in a dynamic-range system
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Meso Scale Diagnostics (MSD) engaged to optimise BARD1 Test on proven instrument platform to enable fast, accurate & reliable testing at low cost
■ Intended use
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Screening test for early detection of lung cancer in high-risk asymptomatic individuals
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Diagnostic test for detection of lung cancer in symptomatic patients, or as a diagnostic aid to confirm CT scan
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Parallel development of BARD1 Test for marketing or approval in Europe first then USA may speed development, reduce cost & lower regulatory hurdles
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BARD1 Test offers potential advantages over other methods
Convenient Simple blood collection, standard lab methods & fast results
Safe Non-invasive blood test can be repeated regularly & complements other diagnostic methods Accurate Expected high sensitivity >90% and false positives <10% Affordable Estimated $200 per test
Potential new first-line screening and diagnostic test for lung cancer
Doctor receives result Order blood Take blood Lab results in to inform patient & test sample (<1mL) 3-5 days follow-up
Proof of Concept Study Results
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STUDY DESIGN: Controlled POC study in ~200 samples of lung cancer & healthy controls to determine the utility of circulating BARD1 antibodies as biomarkers for early detection of lung cancer
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RESULTS: BARD1 diagnostic models accurately :
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discriminated lung cancer from healthy controls[1] □ Training sets: Average AUC=0.96, Sensitivity >95%, False Positives <5%
□ Validation set: Sensitivity >90%, False Positives <10%
■ CONCLUSION: High AUCs demonstrate POC that selected models accurately detect lung cancer with high specificity and sensitivity
Typical ROC curve for CT Scan[2]
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ROC curve for BARD1 Test
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BARD1. Results on file. 2016
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Hiroaki Nomori et al. 2004 AUC = Area Under Curve ROC = Receiver Operating Characteristic
BARD1 Test more accurate than current gold standard LDCT
Analytical Validation Commenced
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■ CONFIRMATION STUDY: Internal study to further develop & optimise prototype BARD1 Lung Cancer Test in over 450 samples of lung cancer and healthy controls for sensitivity & specificity of lung cancer in multiple cohorts comprising lung cancers of different types and stages, age, gender & ethnicity
■ ANALYTICAL VALIDATION STUDY: External study to transfer, optimise & validate the BARD1 Lung Cancer Test on proven instrument platform for reproducibility, repeatability, stability, precision, interference and limits if detection
- RESULTS: expected 1Q17
Clinical Validation Planned
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■ PROSPECTIVE CLINICAL STUDY:
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Design: Prospective, multicentre clinical study of ~1000 high-risk asymptomatic adults aged 55-74 years with a 30-pack year smoking history to demonstrate the safety and performance (sensitivity & specificity) of the BARD1 Lung Cancer Test compared to LDCT Scan for early detection of lung cancer
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Objective: Verify that the BARD1 Lung Cancer Test achieves a lung cancer detection rate of greater than 90% and a false positive rate of less than 10%
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□ Commencement: Expected 2H17
■ POST-MARKETING TRIALS:
- Additional studies may be required to demonstrate the clinical utility (reduced mortality & improved quality of life) and health economic benefits of annual screening with the BARD1 Test compared to LDCT Scan over multiple years
Enable marketing or approval of laboratory tests under CE Mark in EU, ARTG Listing in AU, and CLIA-certified LDT test followed by FDA-cleared IVD in US
Ongoing BARD1 Research
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- Advance diagnostic pipeline for multiple cancers
□ Accelerate development of new Diagnostic Tests for Ovarian and other cancers
□ Initiate research to develop Liquid Biopsy products for diagnosis and treatment monitoring of cancer from blood and/or tissue samples □ Partner to co-develop Companion Diagnostics for patient selection and monitoring of specific cancer treatments
■ Progress therapeutic pipeline for BARD1 positive cancers □ Collaborate to research and evaluate development of targeted therapies for prevention or treatment of cancer
Intellectual Property Portfolio
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■ Strong IP portfolio with 5 patent families covering various BARD1 peptide sequences, methods of diagnosis & treatment, and use in multiple cancers
| Patent Family | Title | Status Granted Pending |
Status Granted Pending |
Expiry |
|---|---|---|---|---|
| PCT/FR01/02731 | Truncated BARD1 proteins and its diagnostic and therapeutic uses |
US, JP | 2023 | |
| PCT/IB2011/053635 | BARD1 isoforms in lung and colorectal cancer and use thereof |
US, EP, CA, JP, IL, CN, AU, BR, SG |
2031 | |
| PCT/IB2011/054194 | Kits for detecting breast or ovarian cancer in a body fluid sample and use thereof |
US, EP | 2032 | |
| PCT/EP2014/073834 | Lung Cancer Diagnosis | US, EP, CA, JP, IL,CN, AU, SG, KR |
2034 | |
| EP14002398.7 | Novel non-coding RNA, cancer target and compounds for cancer treatment |
US | 2035 |
Future Milestones Multiple value-adding milestones & newsflow
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| Events | Date (CY) |
|---|---|
| Commencement of Analytical Validation studies of BARD1 Lung Cancer Test for Lung Cancer | 3Q16 |
| Appointment of CEO | 4Q16 |
| Publish POC Study results in international peer-reviewed journal | 1Q17 |
| Expand R&D team | 1Q17 |
| Results of Analytical Validation studies of additional 450 samples | 1Q17 |
| Appoint Advisory Board | 1H17 |
| Commence Clinical Validation study of BARD1 Lung Cancer Test for early detection of Lung Cancer | 2H17 |
| Preliminary results of Clinical Validation study of BARD1 Lung Cancer Test | 2018 |
| CE Mark for marketing of BARD1 Lung Cancer Test in Europe | 2019* |
| ARTG Listing for marketing of BARD1 Lung Cancer Test in Australia | 2019* |
| Marketing of CLIA-certified LDT in USA | 2019* |
*Regulatory advice being sought on optimal regulatory strategy to firm up timelines
Investment Highlights
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Commercially Compelling Potential cancer diagnostics targeting unmet needs in US$101B global market Multiple publications validating BARD1 as a potential diagnostic marker & therapeutic target in Proven Science multiple cancers POC Completed BARD1 biomarkers demonstrated as highly sensitive and specific for detection of Lung Cancer BARD1 Lung Cancer Test undergoing validation studies to develop, optimize & clinically validate Commenced Validation the test for early detection of lung cancer Diagnostic Advantages Non-invasive blood tests for early detection of cancer that are simple, accurate & affordable Future Pipeline Additional high-value diagnostic & therapeutic applications being evaluated for development Solid IP Broad patents covering technology, products and uses extending to 2035 Scientific, clinical research & commercialisation expertise committed to delivering cancer Experienced Leadership detection & prevention solutions to improve patients’ lives Strong Newsflow Multiple milestone announcements & valuation inflection points over next 12-24 months
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Contact details
BARD1 Life Sciences Ltd Ground, Tempo Building, 431 Roberts Rd Subiaco WA 6008 Australia P +61 8 9381 9550 | E [email protected] | W www.bard1.com
Peter Gunzburg Dr Leearne Hinch Executive Chairman CEO E [email protected] E [email protected] M +61 412 927 773
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Acronyms
| AUC | Area Under the Curve is an index of the accuracy of a diagnostic test to discriminate between diseased and healthy states |
|---|---|
| Biomarker | Serum marker of disease state |
| CE Mark | Communaute/Conformite European mark certifying that a product has met EU consumer safety, health or environmental requirements |
| CLIA | Clinical Laboratory Improvement Amendment of 1988 |
| CMC | Chemistry, Manufacturing & Controls |
| CRO | Contract Research Organisation |
| ctDNA | Circulating tumour DNA in a Liquid Biopsy test |
| ELISA | Enzyme-Linked Immunosorbent Assay |
| FDA | Food and Drug Administration is the US regulatory authority for medical drugs and devices |
| Incidence | Number of new cases of a disease in a population during a given time period |
| IVD | In Vitro Diagnostic |
| IP | Intellectual Property |
| LDCT | Low Dose Computed Tomography |
| LDT | Laboratory Developed Test |
| PCT | Patent Cooperation Treaty |
| Prevalence | Number of total cases of a disease in a population over a given time period |
| QOL | Quality of Life |
| ROC | Receiver Operating Characteristics |
| RR | Relative Risk |
| RT-PCR | Reverse Transcriptase Polymerase Chain Reaction |
| TGA | Therapeutic Goods Administration is the Australian agency for evaluation of medical goods |