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INOVIQ LTD — Investor Presentation 2018
Mar 21, 2018
65112_rns_2018-03-21_f524f0b1-6b2e-4aac-90e6-3c0b19c6fd10.pdf
Investor Presentation
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BARD1 RELEASES CORPORATE PRESENTATION
Perth, Australia, 22 March 2018: BARD1 Life Sciences Limited (ASX:BD1), a biotechnology company developing non-invasive cancer diagnostics, is pleased to release to shareholders and investors its latest Corporate Presentation providing an overview of the Company, its technology, pipeline and commercialisation strategy.
A copy of the corporate presentation is appended to this announcement.
- ENDS -
FOR MORE INFORMATION PLEASE CONTACT:
Peter Gunzburg Dr Leearne Hinch Chairman CEO E [email protected] E [email protected] M +61 400 414 416
ABOUT BARD1 LIFE SCIENCES LTD
BARD1 Life Sciences Ltd (ASX:BD1) is an Australian-based biotechnology company focused on developing and commercialising non-invasive diagnostic tests for early detection of cancer. BARD1’s proprietary technology platform is based on novel tumour markers with potential diagnostic and therapeutic applications across multiple cancers. The development pipeline includes two BARD1 autoantibody tests in early development for early detection of lung and ovarian cancers, and a cancer vaccine project at research-stage for treatment of cancer. Additional diagnostic projects are being evaluated for prostate, breast and other cancers. BARD1 is committed to transforming the early detection and prevention of cancer to help improve patients' lives. For more information on BARD1, see www.bard1.com.
BARD1 Life Sciences Limited (ABN 58 009 070 384) Headquarters | Harry Perkins Institute, L2/QQ Block, 6 Verdun St, Nedlands WA 6009, Australia Registered Office | Suite B1, Tempo Building, 431 Roberts Road, Subiaco WA 6008, Australia P +618 9381 9550 | F +618 9388 7559 | E [email protected] | W www.bard1.com
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Transforming early cancer detection & prevention
CORPORATE PRESENTATION
2
Forward Looking Statements
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).
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BARD1 Life Sciences (ASX:BD1)
■ Medtech company focused on developing non-invasive diagnostics for early detection of cancer to save patients’ lives
■ Platform technology of BARD1 tumour markers with potential Dx and Rx applications across multiple cancers
■ Diagnostic tests in development for lung and ovarian cancers ■ Cancer vaccine project at research-stage
- Pilot studies demonstrating accuracy of BARD1 autoantibody panels for detection of lung and ovarian cancers with high sensitivity and specificity
■ Planned studies to further develop and validate the performance of BARD1 tests
■ Large market opportunities and diversified risk across 3 programs
Transforming early cancer detection and prevention Lung Ovarian Vaccine
4
Company Snapshot
| CORPORATE INFORMATION | |
|---|---|
| Listed | 20 June 2016 |
| Industry | Biotechnology |
| Products | Cancer diagnostics |
| Headquarters | Perth, Australia |
| Ticker | ASX:BD1 |
| Ordinary Shares | 742m |
| Market Cap (@13/3/18) | A$19.29m |
| Share Price (@13/3/18) | A$0.026 |
| 52w H/L Range | A$0.064-0.006 |
| Cash (@31/12/17) | A$1.2m |
| SHAREHOLDERS (@ 31/12/17) | # SHARES | % HOLDING |
|---|---|---|
| Irmgard Irminger* | 108,252,420 | 14.59% |
| Tony Walker* | 88,501,626 | 11.93% |
| Peter Lynton Gunzburg | 29,835,004 | 4.02% |
| Universite de Geneve* | 12,500,000 | 1.68% |
| Vendor Shares* | 229,503,236 | 30.93% |
| Top 20 Holders | 391,324,085 | 52.74% |
| TOTAL | 741,995,731 | 100.00% |
| *Escrowed until 20/6/18 |
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Platform Technology
-
Normal cells express FL BARD1 protein that functions as a tumour suppressor to prevent cancer
-
Cancer cells express abnormal BARD1 isoforms that drive oncogenesis and are correlated with cancer progression & poor prognosis
-
BARD1 isoforms are immunogenic and induce BARD1 autoantibodies reflecting the early immune response to cancer
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Antibodies against
Normal FL-BARD1 normal BARD1
Normal
BARD1
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Cancer BARD1
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Antibodies specific for cancer BARD1
- BARD1 Technology has potential applications as diagnostic markers & therapeutic targets for the diagnosis and treatment of various cancers
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Development Pipeline
■ Pipeline of BARD1 diagnostics and therapeutics in development to diversify product risk and expand market opportunities
| DIAGNOSTICS THERAPEUTICS |
PRODUCT |
INDICATION | **PLATFORM ** | USE | RESEARCH | ASSAY DEVELOPMENT |
CLINICAL VALIDATION |
MARKETING / APPROVAL |
|---|---|---|---|---|---|---|---|---|
| Lung Cancer | ELISA (Blood) |
Screening & Risk Assessment |
||||||
| Ovarian Cancer | ELISA (Blood) |
Detection & Monitoring |
||||||
| PRODUCT |
INDICATION | **RESEARCH ** | PRE- CLINICAL |
PHASE I | PHASE II | PHASE III | APPROVAL | |
| Cancer | ||||||||
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Large Market Opportunities
■ Global cancer diagnostics market US$101B[1]
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$24B Lung Ca
$7B Ovarian Ca
US market opportunities for screening tests[2]
Lung Cancer screening test
6.8M eligible current / former smokers 55-77y[3]
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Ovarian Cancer screening test
43.2M average-risk women 50-74 years[4]
Ave reimbursement LDCT $255 per test
Ave $100 per test x
10% uptake
US$1.74B market potential
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~US$432M market potential for blood tests
5% market share
US$86.7M sales potential
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US$21.6M sales potential
■ Global cancer vaccines market US$3.5B[5]
- Transparency Market Research 2014; 2. Company estimates; 3. ACS 2017; 4. ACS 2015; 5. BCC 2016
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BARD1 Diagnostics
- BARD1 autoantibody (AAb) tests detect BARD1 AAbs against BARD1 isoforms in human blood
■ BARD1 algorithm combines multiple AAb measurements into a cancer score that identifies the presence or absence of a specific cancer
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Autoantibodies enable early detection of early to late-stage cancers before symptoms appear
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Simple blood test with routine blood collection & processing in certified laboratories
Early detection saves lives
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Accurate detection of cancer with high sensitivity & specificity
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Clinically relevant & actionable results to guide clinical decisions
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Lung Cancer
■ Lung Cancer is the leading cause of cancer deaths worldwide
-
World: 1.82m new cases & 1.59m deaths pa
-
US: 222,500 new cases & 155,870 deaths pa
-
Smoking is major risk factor in 85% cases
-
Poor overall 5-year survival of 18% since 80% diagnosed at late-stage
-
Early-detection saves lives increasing survival to over 49%
-
Current Dx: chest X-ray → CT scan → bronchoscopy, MRI/PET imaging → biopsy
-
Inaccurate, expensive, invasive or radiation exposure
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Annual CT screening recommended in high-risk asymptomatic adults aged 55-80 years with >30 pack-year smoking history (USPSTF 2014)
Lung Cancer 5-Year Survival Rates
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Overall 18%
Stage 1 49%
Stage 2 30%
Stage 3 14%
Stage 4 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
Unmet need for accurate, reliable & affordable blood test for early detection
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BARD1-Lung
BARD1-Lung is an ELISA-based blood test in development for early detection of lung cancer
- Pilot studies completed showing high accuracy for detection of lung cancer with up to 80% sensitivity & 77% specificity, and promising results for gender-specific algorithms
| Study | n | Model AUC | Test AUC | Sensitivity | Specificity |
|---|---|---|---|---|---|
| LC-POC | 187 | 0.96 | 0.86 | 80% | 77% |
| LC-600 | 628 | 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. |
■ Assay Development planned for 2H18 to further develop, optimise and technically validate the test on a commercial platform
ROC curve for BARD1-Lung
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■ Clinical Validation required to demonstrate clinical performance for intended use
-
Risk assessment of malignancy in patients with indeterminate pulmonary nodules following CT
-
Screening test for early detection of lung cancer in high-risk asymptomatic individuals
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Lung
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Ovarian Cancer
■ Ovarian Cancer is the leading cause of gynecological cancer deaths
-
World: 239K new cases & 152K deaths pa
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□ US: 22,440 new cases & 14,080 deaths pa
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Highest risk in post-menopausal women over 50 years & family history
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Low overall 5-year survival of 46% since 61% diagnosed at late-stage
-
Early-detection saves lives increasing survival to over 90%
-
Current Dx: pelvic exam + TVUS → CA125, ROCA or OVA1 blood tests → CT/MRI/PET imaging → Sx biopsy
-
Inaccurate, unreliable, expensive or invasive
-
Annual screening not recommended in averagerisk asymptomatic women (USPSTF 2012)
Ovarian Cancer 5-Year Survival Rates
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Overall 46%
Stage 1 90%
Stage 2 70%
Stage 3 39%
Stage 4 17%
Survival
0% 20% 40% 60% 80% 100%
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Source: www.cancer.org/cancer/ovarian-cancer/detection-diagnosis-staging/survivalrates.html
Unmet need for accurate, reliable & affordable blood test for early detection
12
BARD1-Ovarian
BARD1-Ovarian is an ELISA-based blood test in development for early detection of ovarian cancer
■ Pilot studies completed showing high accuracy for detection of ovarian cancer with over 82% sensitivity & 79% specificity
| OC-POC 1 | 116 | 0.86 |
0.75 |
68% | 65% |
|---|---|---|---|---|---|
| OC-POC 2 | 88 | 0.96 | 0.89 | 92% | 84% |
| OC-300 | 348 | 0.92 | 0.85 | 78% | 78% |
| OC-400 | 400 | 0.92 | 0.88 | 82% | 79% |
| 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. |
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ROC curve for BARD1-Ovarian
auc = 0.92
0.0 0.2 0.4 0.6 0.8 1.0
False positive rate
1.0
0.8
0.6
True positive rate 0.4
0.2
0.0
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■ Assay Development planned for 1H18 to standardise and validate technical performance of the test on a commercial platform
■ Clinical Validation required to demonstrate clinical performance for intended use in risk assessment or screening
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Ovarian
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BARD1 Research
Expand BARD1 diagnostic pipeline for other cancers
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-
•Evaluate BARD1 autoantibody (AAb) tests for other cancers including prostate & breast cancers
-
•Investigate BARD1 RNA test for prediction of cancer progression in premalignant human specimens
Evaluate BARD1 therapeutic applications for cancer
- •Entered cancer vaccine collaboration with IRH to evaluate a potential BARD1 vaccine for prevention or treatment of cancer in animal models
Explore future opportunities in companion diagnostics for patient selection and treatment monitoring
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Commercialisation Strategy
▪ Technical Validation on a commercial platform to demonstrate technical performance ▪ Lung Clinical Validation to demonstrate clinical performance ▪ Market first as laboratory developed tests (LDTs), then as invitro diagnostic (IVD) kits in US, EU and elsewhere Ovarian ▪ Commercialise through partnering LDTs with central laboratories, and IVDs with distributors or trade sale ▪Demonstrate POC of BARD1-specific immune response and anti-tumour activity in animal models ▪ Complete preclinical safety/toxicology studies in animals ▪ Vaccine Conduct Phase 1 clinical studies in healthy human volunteers in AU, followed by Phase 2a under IND in US ▪ License at early clinical-stage to biopharma partner for upfront fees, milestone payments and royalties
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Intellectual Property Portfolio
■ 5 patent families covering various BARD1 DNA & protein sequences, methods of diagnosis & treatment, and use in multiple cancers
| Patent Family 5 |
Title | Granted 7 |
Pending 21 |
Expiry |
|---|---|---|---|---|
| PCT/FR01/02731 | Truncated BARD1 protein and its diagnostic and therapeutic uses |
US, JP | 2023* | |
| PCT/IB2011/053635 | BARD1 isoforms in lung and colorectal cancer and use thereof |
US, JP, JP (div), CN, AU |
US, CN (divisionals), EP, CA, IL, BR, SG, HK |
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, HK |
2034* | |
| EP14002398.7 | Novel non-coding RNA, cancer target and compounds for cancer treatment |
US | 2035* |
*Plus any extension of term in the US due to prosecution delay
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Leadership Team
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PETER GUNZBURG BCom | Chairman
Public company director, stockbroker & technology investor, with 20+ years corporate advisory, capital raising, transaction & business management experience. Currently Chair of the Institute for Respiratory Health at UWA. 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.
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DR IRMGARD IRMINGER-FINGER PD PhD | Executive Director & Chief Scientific Officer
Founder and co-inventor of BARD1 and its technology, European Woman Entrepreneur Award finalist (2014), and internationally recognised expert in tumour biology with over 100 publications, several patents, and multiple international collaborations and keynote conference presentations. Currently Privat Docent at UNIGE and Adjunct Prof at UWA. Former Executive Director and founder of BARD1AG SA.
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BRETT MONTGOMERY | Non-Executive Director
Public company director with extensive experience in leadership, mining company management, corporate governance and risk management. Currently Non-Executive Director of Tanami Gold NL. Previously Managing Director Kalimantan Gold NL, and Director of Magnum Gas and Power Ltd, Grants Patch Mining Ltd, and EZA Corporation Ltd.
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PROF GEOFF LAURENT PhD FRCP(Hon) FRCPath FMedSci | Non-Executive Director
Accomplished organisational leader, thought-leader, scientific editor, advisory board member & award winning respiratory scientist with over 300 peer reviewed publications. Currently Emeritus Professor at UWA, and Scientific Advisor/Consultant at Helmholtz Zentrum München. Previously Director of the Institute for Respiratory Health and Director of the Centre of Cell Therapy & Regenerative Medicine at UWA, Director of Centre for Respiratory Research, Vice-Dean of Enterprise, and Head of Department of Internal Medicine at University College London, and Past President British Association for Lung Research.
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DR LEEARNE HINCH BVMS MBA | Chief Executive Officer
Biotechnology executive and consultant with extensive leadership, strategy, fundraising, operational, business development and commercial experience. Founder and director of Ingeneus Solutions Pty Ltd delivering commercialisation advice across drugs, devices, diagnostics & animal health. Previously CEO Eustralis Pharmaceuticals Ltd, CEO Immuron Ltd, COO OBJ Ltd, GM Holista CollTech Ltd, and CMO Chemeq Ltd.
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Investment Highlights
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STUDY
RESULTS
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TECHNICAL
PARTNERS
VALIDATION
CATALYSTS
PATENTS & CLINICAL
PUBLICATIONS VALIDATION
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Cancer Vaccine collaboration with IRH 5/4/17
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LC-600 Study results Appointed Advisory Board member 15/5/17 20/7/17
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COLLABOR-
ATIONS
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Additional BARD1-Ovarian results 6/3/18
OC-300 Study results Capital raising of A$1.5m 23/3/17 4/8/17
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JP patent granted 1/2/18
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2017
Q1 Q1 Q2 Q3 Q4 Q2 Q3 Q4 2018 2018 Today 8/8/17 Published LC-POC Study Technical Validation 23/3/17 7/8/17 9/1/18 results US patent granted AU patent granted OC-400 Study results Cancer Vaccine study results Assay Development studies Cancer Vaccine research
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Investment Summary
Compelling Opportunity Non-invasive cancer diagnostics targeting unmet needs in US$101B global market
BARD1 autoantibody tests demonstrated as highly sensitive and specific for POC Completed detection of lung and ovarian cancers
BARD1 tests undergoing further development and validation for early detection of Development Underway lung and ovarian cancers
Potential to enable earlier treatment, improve patient outcomes, save lives and Diagnostic Advantages reduce healthcare costs
Future Pipeline Additional high-value diagnostic and therapeutic applications under evaluation
Solid IP Patents covering technology, products and uses extending beyond 2031
Strong Newsflow Multiple value-adding milestones expected over next 12-18 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
Dr Leearne Hinch | CEO E [email protected]
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Acronyms
| Accuracy | Percentage of true results correctly identified by a diagnostic test |
|---|---|
| AUC | Area Under the Curve is an index of the accuracy of a diagnostic test to discriminate between diseased and healthy states |
| Biomarker | Biological marker of disease state |
| CE Mark | Conformite Européene mark certifying that a product has met EU consumer safety, health or environmental requirements |
| CLIA | Clinical Laboratory Improvement Amendment of 1988 |
| CT | Computed Tomography |
| ELISA | Enzyme-Linked Immunosorbent Assay |
| FDA | Food and Drug Administration is the US regulatory authority for medical drugs and devices |
| HBOC | Hereditary breast and ovarian cancer |
| Incidence | Number of new cases of a disease in a population during a given time period |
| IND | Investigational New Drug |
| IVD | In Vitro Diagnostic |
| IP | Intellectual Property |
| FL | Full Length |
| LDT | Laboratory Developed Test |
| MRI | Magnetic Resonance Imaging |
| Pack-year | Packs per day x number of years smoking |
| PCT | Patent Cooperation Treaty |
| PET | Positron Emission Tomography |
| Prevalence | Number of total cases of a disease in a population over a given time period |
| ROC | Receiver Operating Characteristics |
| RT-PCR | Reverse Transcriptase Polymerase Chain Reaction |
| Sensitivity | Probability that a diagnostic test will yield a positive result when the disease is present |
| Specificity | Probability that a diagnostic test will yield a negative result when the disease is absent |
| TGA | Therapeutic Goods Administration is the Australian agency for evaluation of medical goods |
| TVUS | Transvaginal Ultrasound |