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INOVIQ LTD AGM Information 2017

Nov 27, 2017

65112_rns_2017-11-27_44744fdd-db76-4799-a9c8-6a7205968dbd.pdf

AGM Information

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Transforming early cancer detection & prevention

AGM 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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3

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 (@24/11/17) A$5.94m
Share Price (@24/11/17) A$0.008
52w H/L Range A$0.064-0.007
Cash (@ 30/9/17) A$1.71m
SHAREHOLDERS (@ 24/11/17) # 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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5

FY2017 Highlights

Financial Results FY2017 (AUD)
Revenue & other income $44,028
Operating expenses $2,218,320
Other non-cash expenses $129,879
Net Loss before and after tax $2,604,171
Loss per share (cps) 0.45
Cash balance @ 30/6/17 $650,051

Contracted MSD for assay feasibility on multiplex platform

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15/07/16

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BARD1 lists on ASX & raises $3M 20/06/16

CEO appointment 07/11/16

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Signed LC Diagnostic collaboration with UNIGE

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01/08/16

Promising result for Ovarian Cancer 22/09/16

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Results of Lung Cancer Study in 628 samples 15/05/17

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Signed Cancer Vaccine collaboration with IRH 05/04/17

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Appointed Advisory Board member

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20/07/17

Successful capital raising of A$1.5m

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04/08/17

Australian patent granted covering lung cancer Dx 07/08/17

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Published Lung Cancer POC study results 08/08/17

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Successful Assay Feasibility results

08/02/17

US patent granted covering lung cancer Dx 23/03/17

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Results of OC Study in 348 samples 23/03/17

Commenced OC400 Study 01/09/17

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Jun

Aug Oct

Dec

Feb

Apr

Jun Aug

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2016

2017

6

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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7

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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8

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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9

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

  • 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 simple, accurate & affordable blood test for early detection

10

BARD1 Lung Cancer Test

BARD1 Lung Cancer Test 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

11

Ovarian Cancer

■ Ovarian Cancer is the leading cause of gynecological cancer deaths

  • World: 239K new cases & 152K deaths pa

  • □ US: 22,440 new cases & 14,080 deaths pa

  • Highest risk in post-menopausal women over 50 years & hereditary predisposition

  • 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 simple, accurate & affordable blood test for early detection

12

BARD1 Ovarian Cancer Test

BARD1 Ovarian Cancer Test 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 up to 92% sensitivity & 84% specificity

Study n Model AUC Test AUC Sensitivity 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%
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.

OC400 study commenced in 400 OC & healthy controls to optimise BARD1 panel & algorithm with results expected Dec17

ROC curve for BARD1-Ovarian

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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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13

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

14

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]

  1. Transparency Market Research 2014; 2. Company estimates; 3. ACS 2017; 4. ACS 2015; 5. BCC 2016

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15

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 OvarianCommercialise 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

16

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
6
Pending
20
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, CN,
AU
US, JP, CN
(divisionals), EP,
CA, IL, 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*

*Plus any extension of term in the US due to prosecution delay

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17

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.

18

Anticipated Milestones

Date Events
(CY)
4Q17 oResults of OC400 Study
1H18 oInitiate additional development studies for BARD1 Ovarian
Cancer Test
2H18 oInitiate additional development studies for BARD1 Lung Cancer
Test
oComplete Technical Validation of BARD1 Test
oResults of Cancer Vaccine animal efficacy studies
2019 oCommence first Clinical Validation study for BARD1 Test
STUDY
PUBLIC-
ATIONS
PARTNERS
CATALYSTS
RESULTS
COLLABOR-
TECHNICAL
VALIDATION
CLINICAL
VALIDATION
ATIONS

19

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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20

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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] Dr Irmgard Irminger-Finger | CSO | E [email protected]

21

Income Statement for year ended 30 June 2017

30-Jun-17
30-Jun-16
30-Jun-17
30-Jun-16
Revenue & other income
44,028
Employee benefits expense
(701,669)
(13,673)
R&D expense
(1,089,976)
Patent expenses
(131,187)
Administration costs
(575,252)
(109,763)
Depreciation expense
(8,008)
(4,253)
Movement in fair value of investments
(8,990)
Impairment of available assets for sale
(56,458)
Foreign exchange gain/(loss)
13,754
Share based payments
(25,000)
Provision for grant repayment
(65,413)
Listing expense of acquisition of BARD1
(2,463,404)
Loss arising from remeasurement fin liabilities
(250,000)
Loss before income tax expense
(2,604,171)
(2,841,093)
(2,604,171)
(2,841,093)
Income tax expense
Loss after income tax expense
0
0
(2,604,171)
(2,841,093)

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22

Balance Statement for year ended 30 June 2017

30-Jun-17
30-Jun-16
Current Assets
Cash & cash equivalents
Trade & other receivables
Held for trading assets
650,051
3,097,751
31,956
76,412
16,659
25,649
Total Current Assets 698,666
3,199,812
Non-Current Assets
Property, plant & equipment
Financial assets availble for sale
Total Non-Current Assets
TOTAL ASSETS
Current Liabilities
Trade and other payables
Provisions
Convertible notes
Total Current Liabilities
TOTAL LIABILITIES
NET ASSETS
EQUITY
Issued capital
Distribution reserve
Foreign exchange translation reserve
Accumulated losses
TOTAL EQUITY
8,008
28,230
84,689
28,230
92,697
726,896
3,292,509
422,946
368,977
46,013
20,224
69,387
468,959
458,588
468,959
458,588
257,937
2,833,921
6,645,495
6,620,495
(309,421)
(309,421)
(38,085)
(41,272)
(6,040,052)
(3,435,881)
257,937
2,833,921

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23

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