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INOVIQ LTD — AGM Information 2018
Nov 29, 2018
65112_rns_2018-11-29_825f49d2-a3aa-49a6-834c-d81ee59d8d2d.pdf
AGM Information
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Early cancer detection to save lives
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Agenda
■ AGM
- Chairman’s Opening
□ Business of meeting in including resolutions
□ Close of AGM
■ CEO Presentation
■ Questions
■ Tea/Coffee
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Business of Meeting
■ Annual Report
□ To table and consider the 2018 Annual Report including the Financial Report, Directors’ Report and Auditors’ Report for the period 1 July 2017 to 30 June 2018
No resolution is required for this item of business
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Business of Meeting
■ Adoption of Remuneration Report
□ To consider and if thought fit, to pass with or without amendment, as a non-binding advisory ordinary resolution:
Resolution 1:
“That for the purposes of section 250R(2) of the Corporations Act and for all other purposes, the Remuneration Report for the Company and its controlled entities for the year ended 30 June 2018 be approved and adopted”
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Business of Meeting
■ Re-Election of Dr Irmgard Irminger-Finger
□ To consider and if thought fit, to pass with or without amendment, as an : ordinary resolution
Resolution 2:
“That pursuant to, and in accordance with Listing Rule 14.4, article 6.3(b) and 6.3(c) of the Constitution and for all other purposes, Dr Irmgard Irminger-Finger Director retires and, being eligible, is reelected as a Director on the terms and conditions in the Explanatory Memorandum”
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Business of Meeting
■ Approval of 10% Placement Capacity
□ To consider and if thought fit, to pass with or without amendment, as a : special resolution
Resolution 3:
“That pursuant to, and in accordance with Listing Rule 7.1A and for all other purposes, Shareholders approve the issue of Equity Securities up to 10% of the issued capital of the Company (at the time of the issue) calculated in accordance with the formula prescribed in Listing Rule 7.1A.2 and on the terms and conditions in the Explanatory Memorandum”
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Business of Meeting
■ Ratification of Placement under Listing Rule 7.1
□ To consider and if thought fit, to pass with or without amendment, as an : ordinary resolution
Resolution 4:
“That pursuant to, and in accordance with Listing Rule 7.4 and for all other purposes, Shareholders approve and ratify the prior issue by the Company of 86,666,666 Placement Shares at an issue price of $0.015 on the terms and conditions in the Explanatory Memorandum”
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CEO PRESENTATION
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Disclaimer
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. This presentation contains general and background information about the Company's activities current as at the date of the presentation and should not be considered to be comprehensive or to comprise all the information that an investor should consider when making an investment decision and does not contain all information about the Company's assets and liabilities, financial position and performance, profits and losses, prospects, and the rights and liabilities attaching to the Company's securities necessary to make an investment decision. The information in this presentation should be read in conjunction with The Company's other periodic and continuous disclosure announcements lodged with the Australian Securities Exchange, available at www.asx.com.au. The information in this presentation is based on the Company's own information and estimates and has not been independently verified. The Company is not responsible for providing updated information and assumes no responsibility to do so. Any investment in the Company should be considered speculative and there is no guarantee that they will make a return on capital invested, that dividends would be paid, or that there will be an increase in the value of the investment in the future.
This presentation is not a prospectus, product disclosure document or other offering document under Australian law (and will not be lodged with ASIC) or any other law. This presentation is for information purposes only and should not be considered as, an offer or an invitation to acquire securities in the Company or any other financial products and neither this document nor any of its contents will form the basis of any contract or commitment. This presentation must not be disclosed to any other party and does not carry any right of publication. Neither this presentation nor any of its contents may be reproduced or used for any other purpose without the prior written consent of the company.
This presentation is not financial product, investment advice or a recommendation to acquire the Company's securities and has been prepared without taking into account the objectives, financial situation or needs of individuals. Before making an investment decision prospective 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. The Company 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 the Company's securities. Each investor must make its own independent assessment of the Company before acquiring any securities in the Company.
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. In particular, this presentation does not constitute, and shall not be relied upon as, a promise, representation, warranty or guarantee as to the past, present or the future performance of the Company.
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 “forward-looking statements” and “forward-looking information”, including statements and forecasts relating to the Company. Often, but not always, forward-looking information can be identified by the use of words such as “plans”, “expects”, “is expected”, “is expecting”, “budget”, “scheduled”, “estimates”, “forecasts”, “intends”, “anticipates”, or “believes”, or variations (including negative variations) of such words and phrases, or state that certain actions, events or results “may”, “could”, “would”, “might”, or “will” be taken, occur or be achieved. Such information is based on assumptions and judgements of management regarding future events and results. The purpose of forward-looking information is to provide the audience with information about management’s expectations and plans. Readers are cautioned that forward-looking information involves known and unknown risks, uncertainties and other factors which may cause the actual results, performance or achievements of the Company and/or its subsidiaries to be materially different from any future results, performance or achievements expressed or implied by the forward-looking information.
Forward-looking information and statements are based on the reasonable assumptions, estimates, analysis and opinions of management made in light of its experience and its perception of trends, current conditions and expected developments, as well as other factors that management believes to be relevant and reasonable in the circumstances at the date such statements are made, but which may prove to be incorrect. The Company believes that the assumptions and expectations reflected in such forward-looking statements and information are reasonable. Readers are cautioned that the foregoing list is not exhaustive of all factors and assumptions which may have been used. The Company does not undertake to update any forward-looking information or statements, except in accordance with applicable laws.
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).
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Investment Highlights
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Medtech company focused on developing non-invasive diagnostics for early detection of cancer to save lives
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Proprietary tumour marker platform with strong IP protecting biomarkers, methods and use
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Targeting unmet needs in burgeoning US$101B global cancer diagnostics market
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Case-control studies showing accuracy of BARD1 autoantibody panels for detection of breast, ovarian and lung cancers with high sensitivity & specificity
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Assay development underway to transfer, develop & validate BARD1 tests on Luminex[®] instrumentation
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Focus on commercializing BARD1-Ovarian and new BARD1-Breast cancer tests to take advantage of synergies in women with HBOC*
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Clinical studies expected to commence in 2H19 and market launch by 1H21
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■ Pipeline includes BARD1-Lung for the world’s deadliest cancer
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Exploring multiple partnering and corporate opportunities to deliver shareholder value
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Value-adding milestones and newsflow expected in next 6-12 months
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*Hereditary Breast and Ovarian Cancer (HBOC) syndrome
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Corporate Overview
| FINANCIAL INFORMATION | TOP SHAREHOLDERS (16/11/18) | # SHARES | % HOLDING | ||
|---|---|---|---|---|---|
| Ticker | ASX:BD1 | Irmgard Irminger-Finger | 108,252,420 | 13.06% | |
| Share Price (@29/11/18) | A$0.023 | Peter Gunzburg | 29,835,004 | 3.60% | |
| Ordinary Shares | 828.66m | Tony Walker | 26,501,626 | 3.20% | |
| Market Capitalisation (@29/11/18) | A$19.06m | Universite de Geneve | 12,500,000 | 1.51% | |
| 52w H/L Range | A$0.075-0.006 | Top 20 Holders | 266,489,434 | 32.16% | |
| Cash (@30/9/18) | A$1.13m | TOTAL | 828,662,398 | 100.00% | |
| Average Daily Volume (3mo) | 48.60m |
SHARE PRICE PERFORMANCE
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Behind BARD1’s diagnostic success
■ Proprietary tumour marker platform and diagnostic approach
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Autoantibodies enable early detection of cancers across all stages before symptoms appear
■ BARD1 blood tests measure autoantibodies to BARD1 proteins and use an algorithm to give a cancer score
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Physician ordered blood test with routine blood collection & processing in certified laboratories
■ Autoantibodies indicate the body’s early immune response to cancer, present in early stages before symptoms appear
Early detection
saves lives
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■ Existing blood tests often detect tumour-associated antigens, high in late stages after symptoms appear
Accurate detection of cancer with high sensitivity & specificity
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■ Targeting unmet need for early detection of cancer
Clinically relevant & actionable results to guide clinical decisions
■ Early detection enables earlier treatment, improves patient outcomes, save lives and reduces healthcare costs
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Focused on unmet needs in Global Cancer Diagnostics Market of US$101b[1]
$7b Ovarian Ca Global market $26b Lung Ca $20b Breast Ca US market opportunities for screening tests[2]
Breast & Ovarian Cancer
48.4m average-risk women 50-74 years[3]
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Lung Cancer 6.8m eligible current or former smokers 55-77y[4]
Annual/Biennial Ave MMG screening $100 per test US$4.84b market potential for blood tests Current screening uptake >70% US$242m sales potential
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5% market share
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Annual Ave LDCT screening $255 per test
US$1.74b market potential for blood tests Current screening uptake <3.9% US$86.7m sales potential
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- Transparency Market Research 2014; 2. Company estimates; 3. Statista 2017; 4. ACS 2017
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Breast Cancer is the biggest cancer killer of women
■ Breast Cancer is the most common cancer in women worldwide
□ World: 2.1m new cases & 627k deaths pa
□ US: 266k new cases & 41k deaths pa
■ Risk factors include age, family history and inherited mutations (BRCA1/2)
■ Life-time risk
Ave-risk Family BRCA1 BRCA2 12.4% 24% 72% 69%
■ Good overall 5-year survival of 90% due to screening, awareness and treatments
■ Screening recommended with
mammograms in average-risk asymptomatic women aged 45+ years, annual MRI/ mammogram in high-risk women aged 30+
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Breast Cancer 5-Year Survival Rates
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Overall 90%
Stage 1 99%
Stage 2 93%
Stage 3 72%
Stage 4 22%
Survival
0% 20% 40% 60% 80% 100%
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Source: https://www.cancer.org/cancer/breast-cancer/understanding-a-breast-cancerdiagnosis/breast-cancer-survival-rates.html
■ No blood test approved for early detection
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BARD1-Breast a world-first solution
Blood test in development for early detection of breast cancer
■ Measures BARD1 autoantibodies in the blood to give a breast cancer score
■ Breakthrough case-control study in 174 samples shows 86% accurate for early detection of breast cancer in women across common subtypes and all stages with 70% sensitivity & 88% specificity
■ Accurately distinguishes malignant and benign lesions with 85% sensitivity & 76% specificity enabling risk assessment of malignancy following a suspicious mammogram
| Study | n (cancer:normal) | Model AUC | Test AUC | Sensitivity | Specificity |
|---|---|---|---|---|---|
| BC-001a (model) | 123 (61:64) | 0.94 | 0.86 | 70% | 88% |
| BC-001b (benign) | 110 (61:49) | 0.84 | 85% | 76% | |
| AUC is the accuracy of the test; Sensitivity is the % of people with cancer that correctly test positive; Specificity is the % people without cancer that correctly test negative. |
■ Same autoantibody test method and Luminex® instrumentation as BARD1-Ovarian enabling fast development & parallel clinical testing
■ Clinical studies expected to commence 2019 to evaluate clinical performance as a screening test for early detection of breast cancer in average-risk asymptomatic women
■ Potential to detect breast cancer early, increase screening uptake, improve survival and reduce healthcare costs
Breast
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Ovarian Cancer continues to devastate
■ Ovarian Cancer is the leading cause of gynecological cancer deaths
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World: 295k new cases & 185k deaths pa
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US: 22k new cases & 14k deaths pa
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Risk factors include age, family history and inherited mutations (BRCA1/2)
■ Life-time risk
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Ave-risk Family BRCA1 BRCA2
1.3% 4-7% 35-70% 10-30%
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Low overall 5-year survival of 47% since 65% diagnosed at late-stage since no screening program
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Early-detection saves lives increasing survival to 89%
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Ovarian Cancer 5-Year Survival Rates
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Overall 47%
Stage 1 89%
Stage 2 71%
Stage 3 41%
Stage 4 20%
Survival
0% 20% 40% 60% 80% 100%
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*All Epithelial subtypes (90% of all cases) Source: https://onlinelibrary.wiley.com/doi/full/10.3322/caac.21456
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Screening not recommended with TVUS or CA125 in average-risk asymptomatic women, whereas screening with TVUS and CA125 may be offered in women high-risk
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No blood test approved for early detection
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BARD1-Ovarian changes the landscape Blood test in development for early detection of ovarian cancer
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Measures BARD1 autoantibodies and CA125 in the blood to give an ovarian cancer score
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7 case-control studies in 743 samples show excellent diagnostic accuracy for early detection of ovarian cancer across all stages
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95% accurate in average-risk women with addition of CA125 biomarker achieving 88% sensitivity & 93% specificity
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97% accurate in high-risk women with family history of breast/ovarian cancer or carrying BRCA1/2 mutations achieving 89% sensitivity & 97% specificity
| Study | n (cancer:normal) | Model AUC | Test AUC | Sensitivity | Specificity |
|---|---|---|---|---|---|
| OC-CA125 | 400 (200:200) | 0.98 | 0.95 | 88% | 93% |
| OC-R001 | 261 (127:134) | 0.99 | 0.97 | 89% | 97% |
| AUC is the accuracy of the test; Sensitivity is the % of people with cancer that correctly test positive; Specificity is the % people without cancer that correctly test negative. |
AUC is the accuracy of the test; Sensitivity is the % of people with cancer that correctly test positive; Specificity is the % people without cancer that correctly test negative.
■ Assay development by Thermo Fisher underway to transfer test to Luminex® instrumentation
- Clinical studies expected to commence 2019 to evaluate clinical performance as a
screening test for early detection of ovarian cancer in high-risk women with HBOC
- Potential to detect ovarian cancer early, save women’s lives and avoid unnecessary surgery
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Ovarian
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Lung Cancer remains the biggest cancer killer
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Lung Cancer is the leading cause of cancer deaths worldwide
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World: 2.1m new cases & 1.8m deaths pa
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US: 234k new cases & 154k deaths pa
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Risk factors include age and smoking
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Poor overall 5-year survival of 18.6% since over 57% diagnosed at late-stage
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Early-detection saves lives increasing survival to over 77%
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Screening recommended with annual CT scan in high-risk asymptomatic adults aged 55-80 years with >30 pack-year smoking history (USPSTF 2014)
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No blood test approved for early detection
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Lung Cancer 5-Year Survival Rates
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Overall 19%
Stage 1A3 77%
Stage 2B 53%
Stage 3C 13%
Stage 4B 1%
Survival
0% 20% 40% 60% 80% 100%
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Source: https://www.cancer.org/cancer/non-small-cell-lung-cancer/detection-diagnosisstaging/survival-rates.html
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BARD1-Lung test
Blood test in development for early detection of lung cancer
■ Measures BARD1 autoantibodies in the blood to give a lung cancer score
■ 2 case-control studies in 628 samples shows high accuracy for early detection of lung cancer with up to 80% sensitivity and 77% specificity, and promising results for genders ecific al orithms p g
| Study | n (cancer:normal) | Model AUC | Test AUC | Sensitivity | Specificity |
|---|---|---|---|---|---|
| LC-POC | 187 (94:93) | 0.96 | 0.86 | 80% | 77% |
| LC-600 | 628 (395:233) | 0.85 | 0.80 | 80% | 68% |
| AUC is the accuracy of the test; Sensitivity is the % of people with cancer that correctly test positive; Specificity is the % people without cancer that correctly test negative. |
■ Publication of POC results and diagnostic method in peer-reviewed journal PloS ONE
■ Assay development planned for 2H19 to optimise and validate test on Luminex® instrumentation using additional biomarkers & gender-specific algorithms
■ Clinical studies required to evaluate clinical performance as a screening test for early detection of lung cancer in high-risk asymptomatic individuals
■ Potential to detect lung cancer early, save lives and reduce healthcare costs
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Lung
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BARD1-Vaccine
Exploratory research program for a potential cancer vaccine
- OBJECTIVE: POC study to evaluate BARD1 peptide vaccine formulations for cancer prevention and/or treatment in murine cancer models to assess in vivo effectiveness for reducing tumour size, inhibiting tumour growth and/or inducing an effective immune response
■ PRELIMINARY RESULTS:
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Malignant mesothelioma: Encouraging initial results showing delayed tumour growth
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Lung and colon cancers: Analysis incomplete
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ONGOING ANALYSIS:
□ Breast cancer
- Tumour inflammatory cell profile
■ FINAL RESULTS: Expected Dec-18
■ FUTURE RESEARCH:
□ Determine methods to improve immune response
- Determine effectiveness of BARD1-Vaccine in combination with therapies
Vaccine
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BARD1 Ke Milestones y
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CY 2018 2019 2020 2021
Q3 Q4 Q1 Q2 Q3 Q4
Assay Dev
Clinical Validation
Ovarian
Launch
Assay Dev
Clinical Validation
Breast
Launch
Assay Dev
Lung
R&D to advance other Dx for early cancer detection
Research
IRH cancer vaccine research
BD and partnerships
Commercial
New patents & publications
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Timelines subject to change according to clinical and regulatory advice
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Commercialisation Strategy
Assay Clinical Marketing/ Research Development Validation Approval
✓ POC studies ✓ Product • Clinical testing completed validating development planned for 2H19 to biomarker platform in underway to demonstrate clinical breast, ovarian & lung standardise BARD1 sensitivity and cancers autoantibody test on specificity of both ✓Multiple case-control Luminex® platform BARD1-Breast and studies completed BARD1-Ovarian in demonstrating high patient populations sensitivity & specificity for early detection of cancer
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Product launch of BARD1-Breast/ Ovarian anticipated by 1H21
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Market first as Laboratory Developed Test (LDT) to achieve early revenues and gain real-world product validation
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Secure regulatory approval later as In Vitro Diagnostic (IVD) in US, EU and AU to drive clinical adoption
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Commercialise through partnering LDTs with certified laboratories and IVDs with key distributors or trade sale
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Significant Achievements 2018
Date Announcements
9/1/18 ✓ OC-400 results showing 82% sensitivity & 79% specificity for detection of ovarian cancer
2/2/18 ✓ JP Divisional Patent granted providing broader protection for lung & colorectal cancer 6/3/18 ✓ OC-400V results showing 89% sensitivity & 82% specificity in independent test set 21/3/18 ✓ IL Patent granted covering BARD1-Lung 22/3/18 ✓ Capital Raising of $1.3m to institutional and professional investors
- 18/5/18[✓][Contract Development Agreement signed with TF to transfer research assay to ] Luminex® instrumentation
19/6/18[✓][OC-CA125 results with addition of CA125 showing 88% sensitivity & 93% specificity in ] average-risk women 12/7/18 ✓ US Patent granted covering BARD1-Ovarian & BARD1-Breast 6/9/18 ✓ OC-R001 results showing 89% sensitivity & 97% specificity in high-risk women
23/10/18[✓][NEW][BC-001][results][showing][high][accuracy][of][BARD1-Breast][for][detection][of][breast] cancer with 70% sensitivity & 88% specificity 24/10/18 ✓ Chinese Divisional Patent granted covering BARD1-Lung
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Expected newsflow in next 12 months
• Complete Assay Development and technical validation on Luminex® BARD1instrumentation – 1Q19 Ovarian • Commence clinical studies for BARD1-Breast and BARD1-Ovarian for early detection of breast and ovarian cancers – 2H19
- ✓Results from research studies for other cancers (breast) – 4Q18
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Pipeline • Results from BARD1-Vaccine mouse studies – 4Q18
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Initiate further product development for BARD1-Lung – 2H19
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Additional patents and publications – 1H19
-
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Commercial • Progress corporate and partnering discussions – 1H19
- Strengthen Board and management – 1H19
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Investment Summary: Building a successful Australian diagnostics company
Early cancer diagnostics targeting unmet needs in US$101B global Large Markets market
Industry leading results for early detection of breast, ovarian & lung Compelling Results cancers with high sensitivity & specificity
Assay development on Luminex ® platform underway, clinical studies Development Underway expected to commence in 2H19 and market launch by 1H21
Potential to enable earlier treatment, improve patient outcomes, save Diagnostic Advantages lives and reduce healthcare costs
Future Pipeline Pipeline of cancer diagnostics for early detection of other cancers
Solid IP Granted & pending patents covering biomarkers, methods and uses
Strong Newsflow Multiple value-adding milestones expected over next 6 - 12 months
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Contacts
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 | Chairman E [email protected]
Dr Leearne Hinch | CEO E [email protected] M 0400414418