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GENETIC TECHNOLOGIES LIMITED — Investor Presentation 2020
Oct 29, 2020
65022_rns_2020-10-29_feb785b8-fc09-4577-acb0-04e0d2c9cb96.pdf
Investor Presentation
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Genetic based preventative health platform
Personalised, Precision medicine. ASX:GTG NASDAQ: GENE Investor Presentation October 2020
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Approved by the Board of Directors
Genetic Technologies Limited 60-66 Hanover Street Fitzroy, 3065 Australia T: +61 3 8412 7000
Coming soon
Notice: Forward looking statements The purpose of the presentation is to provide an update of the business of Genetic Technologies Limited ACN: 009 212 328 (ASX:GTG; NASDAQ:GENE). These slides have been prepared as a presentation aid only and the information they contain may require further explanation and/or clarification. Accordingly, these slides and the information they contain should be read in conjunction with past and future announcements made by Genetic Technologies and should not be relied upon as an independent source of information. Please refer to the Company’s website and/or the Company’s filings to the ASX and SEC for further information. The views expressed in this presentation contain information derived from publicly available sources that have not been independently verified. No representation or warranty is made as to the accuracy, completeness or reliability of the information. Any forward looking statements in this presentation have been prepared on the basis of a number of assumptions which may prove incorrect and the current intentions, plans, expectations and beliefs about future events are subject to risks, uncertainties and other factors, many of which are outside Genetic Technologies’ control. Important factors that could cause actual results to differ materially from assumptions or expectations expressed or implied in this presentation include known and unknown risks. Because actual results could differ materially to assumptions made and Genetic Technologies’ current intentions, plans, expectations and beliefs about the future, you are urged to view all forward looking statements contained in this presentation with caution. Additionally, the INSIGHT investigator sponsored clinical trial described in this presentation is controlled by the lead investigator and therefore Genetic Technologies has no control over this clinical trial. This presentation should not be relied on as a recommendation or forecast by Genetic Technologies. Nothing in this presentation should be construed as either an offer to sell or a solicitation of an offer to buy or sell shares in any jurisdiction.
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Genetic Technologies - Leader in Genomics F Over a decade developing polygenic risk scores - for major oncological, metabolic and degenerative diseases
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F – a pioneer in the development of polygenic risk scores
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Strong scientific leadership under Dr Richard Allman
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F Delivering better outcomes - at a lower cost to the patient and the medical system
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F Dual listed - ASX (GTG) and Nasdaq (GENE)
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Academic collaborations with some of the most prestigious academic institutions in the world 3
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In 2020 we will offer the most comprehensive suite of polygenic risk assessment tests on the market
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Background to Genomics - The Human Genome Project F In 2003 scientists mapped the human genome – the three-billion-plus base pairs of DNA that create a living person
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F Significant advances in genomics are influencing the way physicians practice medicine in the 21st century
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RISK PREDICTION RESEARCH
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17
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2008 2009 2010 2011 2012 2013 2014 2015 2016 2017 2018
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Polygenic predictors are now being used to identify individuals at risk of common complex diseases
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Our Platform - Polygenic Risk Score (PRS)
F
Most common complex diseases are a result of many genes acting in concert
F
Our tests predicts a patient’s risk of developing a specific disease by analysing DNA variants across a genome
F
Large genome-wide association study (GWAS) datasets are used to identify the specific variants (SNPs)
F
Polygenic risk is then determined by a mathematical algorithm indentifying risk from each of these variants
F
We are able to identify people with the average disease risk as well as people with as little as
five times
0.2
or one fifth the average disease risk
AVERAGE RISK
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RELATIVE RISK RELATIVE RISK
X 0.2 X 5.0
POLYGENIC RISK
ecancer.org, SABCS 2018, “Polygenic risk scores for breast cancer: ready or not?”
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Polygenic predictors are now being used to identify individuals at risk of common complex diseases
FREQUENCY
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PRS and Risk Stratification
BREAST CANCER -
COLORECTAL CANCER -
WOMEN WITH FAMILY HISTORY PEOPLE WITH FAMILY HISTORY
<20 20-40 40-60 60-80 80+
2 FIRST DEGREE
RELATIVES WITH CRC
HIGH
HIGHEST QUINTILE SNP RISK
RISK
0.30 30%
AVERAGE SNP RISK
0.25 25%
LOWEST QUINTILE SNP RISK
0.20 20%
HIGHEST QUINTILE SNP RISK
0.15 15%
AVERAGE SNP RISK
0.10 LOW 10%
LOWEST QUINTILE SNP RISK
RISK
0.05 5% NO FAMILY HISTORY
0.00 0%
20 25 30 35 40 45 50 55 60 65 70 75 30 35 40 45 50 55 60 65 70 75 80
AGE - YEARS AGE - YEARS
Jenkins et al. (2019) Familial Cancer
Mavaddat et al. (2015) JNCI
CUMULATIVE RISK OF CRC
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- Introducing PRS to detect high risk groups and deliver better medical outcomes
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- Differences between PRS & Genetic Testing F Current genetic testing only captures hereditary forms of the disease (e.g. inherited cancer risk representing 5-15% of all Breast Cancer (BC)
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F PRS captures sporadic (non-inherited) disease - the most common form of all diseases (representing 85-90% of all cancers)
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F Allows for the implementation of preventative, personalised, precise medical strategies
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GeneType tests evaluate the risk of developing common complex diseases even without family history
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- GeneType for Breast Cancer
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- GeneType for Breast Cancer F 1 in 8 women will develop breast cancer in their lifetime
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BREAST CANCER
BRCA
VARIANT
(INHERITED)
NO BRCA
VARIANT
(FAMILIAL)
5%
10%
85%
NO FAMILY
HISTORY
(SPORADIC)
F
Only 5% of women with breast cancer
[have a pathogenic variant, such as BRCA]
F
10% have a family history but no
[high-penetrance mutation, such as BRCA]
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F It is the number 1 cancer in Australia with 3000
deaths per year and 20,000 diagnosed this
year alone
F
85% of women with breast cancer have
no family history (sporadic)
DIAGNOSIS OF BREAST CANCER IN PERSONS, AUSTRALIA 2020
25,000
20,000
15,000
10,000
5,000
0
Breast Prostate Skin CR Lung Non- Kidney Pancreatic Thyroid Uterine
Cancer Cancer Melanoma Cancer Cancer Hodgkin Cancer Cancer Cancer Cancer
Lymphoma
NUMBER OF NEW CASES
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GeneType’s technology covers 95% of women
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Screening compliance & breast density risks UP-TO-DATE MAMMOGRAM BREAST DENSITY 37% 43% NON-COMPLIANT DENSE BREAST TISSUE 63% 57%
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37%
NON-COMPLIANT
63%
COMPLIANT
Over 1/3 of women are
not screened
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Nearly half of all women have a significant risk factor - dense breast tissue
American Cancer Society. Breast Cancer Facts & Figures 2019-2020. Atlanta: American Cancer Society, Inc. 2019.
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Haber et al 2012
Kerlikowski et al 2015
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GeneType Age Coverage F Current Government screening starts at 50 years of age F Over 20% of women under the age of 50 are diagnosed with breast cancer DIAGNOSIS OF BREAST CANCER IN PERSONS BY AGE AT DIAGNOSIS, AUSTRALIA 2020
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3000
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2,816
2,782
2500
2,532
2,215
2000
1,969 2,139
1,742
1500
1000
1,070
1,053
931
580
500
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0 0 0 1 79
4
0
0-4 5-9 10-14 15-19 20-24 25-29 30-34 35-39 40-44 45-49 50-54 55-59 60-64 65-69 70-74 75-79 80-84 85+
AGE - YEARS
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GeneType test covers women from 35 years of age
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- GeneType test for Breast Cancer
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F First-to-market
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F Clinically validated
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F Covers up to 85% of all breast cancers
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F Simple cheek swab
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F Clinically actionable results with a 5 year and lifetime
- risk assessment
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F Validated for use in Caucasion women over 35
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GeneType accurately predicts risk of disease by combining PRS + family history + mammography data
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Better Medical Outcomes
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F Better compliance with screening
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F Enhanced surveillance of high-risk women
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F Up to 48% of interval cancers would be detected by stratified screening based on risk
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F Lifestyle interventions: Cessation of smoking, lowering BMI, increase activity
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F 5-year survival rate significantly improves with early detection
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- F Preventive Medication Selective estrogen receptor modulators (SERMs), or aromatase inhibitors (AIs)
Earlier risk assessment with GeneType tests saves lives
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Better Financial Outcomes STAGE ...................................................................... $55,000 1 Early diagnosis STAGE means lower ...................................................................... 2 $100,000 cost burden & better outcomes STAGE STAGE + ........................................ $150,000+ 3 4
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- GeneType for Colorectal Cancer
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Colorectal Cancer
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F
1 in 11 men and 1 in 16 women will contract colorectal cancer in their lifetime
F
Second deadliest cancer-responsible for an average 100 deaths per week in Australia
F
Current screening begins at 50 with approximately 10% developing the cancer earlier
F
Over 33% of the population is non-compliant with testing
F
More than 50% of colorectal cancer is first identified in late stage
F
5-year mortality rate of 31%
DIAGNOSIS OF COLORECTAL CANCER IN PERSONS, AUSTRALIA 2020
25,000
20,000
15,000
10,000
5,000
0
Breast Prostate Skin CR Lung Non- Kidney Pancreatic Thyroid Uterine
Cancer Cancer Melanoma Cancer Cancer Hodgkin Cancer Cancer Cancer Cancer
Lymphoma
NUMBER OF NEW CASES
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- GeneType for Colorectal Cancer
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F Covers 95% of colorectal cancer
F Improved screening compliance with an easy to use test
F Examines risk in individuals before they are eligible for routine screening
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F Simple cheek swab
F Clinically actionable results with a 5-year, 10-year and lifetime risk
F Validated for use in Caucasian men and women over 30
https://www.canceraustralia.gov.au/affected-cancer/cancer-types/bowel-cancer/statistics
- GeneType predicts the risk of disease by combining PRS + family history + age
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Better Medical Outcomes
BOWEL CANCER STAGE OF DISTRIBUTION 5-YEAR SURVIVAL RATES
NBCSP
UNSCREENED ESTIMATES
SCREENED
STAGE 1 43% 17% STAGE 1 87%
STAGE 2 STAGE 2
27% 37% 81%
STAGE 3 STAGE 3
27% 29% 64%
STAGE 4 STAGE 4
3% 18% 16%
F F
Earlier screening leads to greater detection of Stage 1 cancers.
Targeted screening leads to significantly higher survival rates.
National Bowel Cancer Screening Program https://www.cancervic.org.au/about/media-releases/2010-media-releases/june-2010-media/bowel-treatment-costs.html
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Risk stratification enables personalised screening and improved outcomes
- Better Channelling of Resources
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Screening
Resources targeted to those at a higher risk of developing colorectal cancer
More frequent & potentially earlier screening Colonoscopy for high-risk Preventive Medication Low-dose aspirin (100-300 mg/day)
Lifestyle Weight management, alcohol consumption, physical activity, smoking cessation
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Better Financial Outcomes
F
Bowel cancer treatment costs have soared by over $50K per advanced case
BOWEL CANCER COST INCREASE
CURRENT PREVIOUS ESTIMATES (1999
INCREASE
ESTIMATES COSTS)
STAGE 1
$30,890 $17,148 46%
STAGE 2 $47,534 $33,364 17%
STAGE 3
$74,225 $25,771 180%
STAGE 4
$61,423 $6,264 710%
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https://www.cancervic.org.au/about/media-releases/2010-media-releases/june-2010-media/bowel-treatment-costs.html Precision screening leads to earlier detection and lower treatment costs
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Coming Soon
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Prostate Type 2 Diabetes Cardiovascular Disease COVID-19 SDR Melanoma
genetype.com 21
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COVID-19 SDR (Serious disease risk)
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World first genetic risk test that predicts your risk of hospitalisation & life threatening complications SDR
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Genetype for COVID-19
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F World first
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F Combines genetic risk with clinical risk
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F Up to 111% better at identifying risk than clinical risk models on their own*
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F Simple oral swab test
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F Allows for remote screening
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F It’s accurate and low cost*
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F Designed to protect the vulnerable and first responders
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F Has the potential to be an alternative to a one size fits all
- lockdown strategy
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F Fully developed, currently undergoing technical validation in
- GTG’s laboratory
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F Expected to be market ready Q4 2020
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F In discussion with US labs who are able to scale up & distribute
- to whole of USA**
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Expansion/Growth Roadmap
GENETICS
RISK
Lifestyle
Stratification
Disease Microbiome testing
Prediction and ancestry
Disease
Diagnosis/
Therapeutic
recurrence
screening
Cell-Free DNA (cfDNA) Genetically inspired
Circulating Tumor Cells (CTC)
medical therapies
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Product Development
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Between 2010 - 2019 F Developed PRS Test Kits for BC (Breast Cancer) & CRC (Colorectal Cancer)
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F 2 to 5 years per test to develop
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F Average cost per test in excess of $2M AUD
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2020 onwards F Collaborate with world class medical groups such as MSK, University of Melbourne, T gen.
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F Acquire or license best in class genomic risk stratification technology
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F Offer germline testing for monogenic mutations in combination with PRS Testing
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F Market /Commercialise
F Sales & Distribution
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F Integrate into existing health systems
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F Relationships with large, commercial genetic laboritories
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Expansion/Growth/Market Size
ONCOLOGY GENETIC Lifestyle
Ancestry
BC, CRC, PC,
Melanoma /Microbiome
TECHNOLOGIES
(Genetype)
CVD
Pharmoco-
(Heart Disease)
genetics
IHD, AF
Metabolic
COVID-19 SDR
Diseases
Diabetes
Mental
Health
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SALES & DISTRIBUTION by Region CLIA to sell into
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• Certified by US regulators the USA
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NATA , to sell
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• Certified by Australian regulators: into the Australian market
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Looking to commence CE certification with the
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view of entering the European market with our novel genetic risk tests in 2021
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- SALES & DISTRIBUTION by Method
• CIT (Consumer initiated testing and online sales and marketing platform with medical supervision) due for launching in Australia & the USA in Q4 2020
• DTC (Direct to consumer testing with no medical supervision) including ancestry and gut microbiome testing scheduled Q2 2021
• BtoB sales via the medical profession
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- Corporate • Dual listed on ASX and the Nasdaq the worlds largest biotech exchange Listings In 2001 and 2005 respectively • 600 shares on the ASX equate to 1 ADR (American Depository Receipts) in the USA which are interchangeable via custodian bank of Mellon with 70% of stock held in the USA • 10 million ADR’s with extremely low float • Last 3 months average trade in USD $1.1m shares per day at USD $3.40 current ADR price and .008c on ASX • Market cap of approximately AUD $70m • Current mandate with HC Wainright as USA bankers • Presented at JPMorgan biotech conference in January in San Francisco and HC Wainright virtual conference in July 2020 • Approximately AUD $18m cash with 24 months runway
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Our Board
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Dr. Jerzy “George” Muchnicki MBBS Executive Director & Chief Executive Officer (Interim
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Mr. Peter Rubinstein BSc, BEc, LLB Chairman & Non-Executive Director
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Dr. Lindsay Wakefield MBBS Non-Executive Director
Mr Nick Burrows BSc, BEc, LLB B.Com, FAICD, FCA, FGIA, FTIA, F Fin Non-Executive Director
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