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GENETIC TECHNOLOGIES LIMITED — AGM Information 2022
Nov 27, 2022
65022_rns_2022-11-27_5b3f4d5a-7a72-4c22-8971-940c8baaa17e.pdf
AGM Information
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Annual General Meeting November 28, 2022 Authorised by the Board of Directors of Genetic Technologies Limited
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ASX: GTG NASDAQ: GENE
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Agenda
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Chairman’s address – Mr Peter Rubinstein
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Business of the Meeting
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2022 Annual Report and auditors’ report
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Resolutions
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Remuneration report
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Re-elect Mr Nick Burrows
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Increased placement capacity
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Amendment to the Constitution
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CEO address – Mr Simon Morriss
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Q&A
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Chairman's Address Mr. Peter Rubinstein
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Items of business
First item of business: to receive and consider the financial statements and reports for the year ended 30 June 2022
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Resolution 1: Adoption of the Remuneration Report
“That for the purpose of Section 250R(2) of the Corporations Act and all other purposes the Remuneration Report as set out in the Directors’ report for the Company for the year ended 30 June 2022 be adopted.”
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Resolution 1: Adoption of the Remuneration Report
- Proxy Voting:
Vote type Voted % For 541,123,404 83.3% Against 101,153,924 15.6% Open-Usable 7,467,502 1.1% Abstain 85,254,478
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Resolution 2: Re-Election of Mr Nick Burrows
“To elect Mr Nick Burrows who retires by rotation in accordance with clause 20.3 of the Company’s Constitution and being eligible offers himself for re-election as a Director.”
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Resolution 2: Re-Election of Mr Nick Burrows
- Proxy Voting:
| Vote type | Voted | % |
|---|---|---|
| For | 739,948,815 | 86.7% |
| Against | 105,946,465 | 12.4% |
| Open-Usable | 7,977,502 | 0.9% |
| Abstain | 83,645,835 |
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Resolution 3: Approval of increased placement capacity
“That pursuant to and in accordance with Listing Rule 7.1A and for all other purposes, Shareholders approve the increase in capacity of the Company to 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 otherwise on the terms and conditions in the Explanatory Statement accompanying this Notice of Meeting.”
Resolution 3: Approval of increased placement capacity • Proxy Voting: Vote type Voted % For 783,009,659 83.8% Against 142,988,184 15.3% Open-Usable 7,967,502 0.9% Abstain 3,553,272
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Resolution 4: Amendment to the Constitution
“That for the of section of the purposes 136(2) Corporations Act, the existing constitution of the Company be amended as detailed in the Explanatory Memorandum, effective at the close of this meeting.”
Resolution 4: Amendment to the Constitution
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- Proxy Voting:
Vote type Voted % For 696,223,379 83.8% Against 126,326,114 15.2% Open-Usable 8,074,645 1.0% Abstain 106,894,479
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Chief Executive Officer Address Mr. Simon Morriss The Future: Unlocking personalised preventative medicine
World leading portfolio
Most comprehensive guideline driven portfolio for human and animal health.
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Patented GeneType Multi Risk Test
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Non-Invasive Prenatal Testing (NIPT)
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Carrier screen testing
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Pharmacogenomics
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Oncogenetic diseases
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Pet care
Revenues anchored by our 3 brands to seize a multi Billion-dollar opportunity.
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* Patents granted are specific to the GeneType portfolio of products
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Patented* Genetype tests Integrate polygenic risk and clinical risks for critical medical conditions
Genetype tests integrate individual’s familial, clinical and genetic information to actionable clinical insights.
A non-invasive saliva based test combines genetic and clinical risk models with cutting-edge research. We’re leading a personalised healthcare revolution.
Our medical practitioners, scientists and technicians have developed the next generation of integrated predictive genetic testing and assessment tools – empowering physicians and patients to proactively manage health.
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✓ 10 Patent families covering the GeneType products ✓ 4 Patents granted in the US
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✓ 2 Patents granted in China
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✓ 9 Patents pending Worldwide
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Global Overview
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57
25
Countries
Employees Countries Patents globally Granted (9 Pending Worldwide) 14 51 12 Test Tests Partner Categories Laboratories
- Patents granted are specific to the GeneType portfolio of products
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Delivering Revenue and Growth – Q1 FY23
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Cash Receipts (A$'000)
$6,789
145%
Growth
on LY
half-year ending December
31, 2021
$2,060
$89 $850
Full Year FY21 Full Year FY22 Q1 FY22 Q1 FY23
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CASH BALANCE A$7.9m* GROSS MARGIN 44%
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• Clinical utility demonstrated by the peer review publication of Genetype for Breast Cancer in the Journal of Precision Medicine
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Q1 CASH RECEIPTS
A$2.06m
GROSS MARGIN
A$0.9m
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Strategic & Operational Highlights:
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Cash receipts from customers A$2.06m with +145% on last year;
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Revenue A$1.93 million for the quarter, up 375% from (Q1 FY22)
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GeneType Risk Test outperforms traditional risk assessments for breast cancer in identifying risk by up to 9 times
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5 consecutive qtrs. of growth on prior year
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GeneType Multi-Risk Test is implemented in 64 clinics building our geneType hub strategy
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Material progress in USA with Alva10 and large payer engagement
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Promoting to over 10,000 General practitioners (GPs) across Australia by leveraging Breast Cancer Awareness Month
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New USA business manager is making great progress with concierge medicine groups and independent doctor network
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*Sept ’22 quarter end cash and cash equivalents of A$8.0 million as announced on ASX 25 October 2022 # All revenues for the period ‘21 & ‘22 are 'out of pocket' our strategy for reimbursement should become effective in 2023 FY
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Execute the B2B commercialisation of the geneType multi-risk test
Our FOCUS
Core ‘4’
Commercialisation of the geneType suite of multi-risk tests Commercialisation of the geneType suite of multi-risk tests Demonstrate clinical validity & clinical utility of geneType tests
EasyDNA & Affinity DNA Revenue Growth: Tests, Channels. & Markets
Innovation: Next Generation of capability – Starting with Epigenetics
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Our Innovation – Multi-Risk Test
GeneType can identify patients ’at risk’ before onset and aid in the early detection and treatment.
GeneType Risk assessment test for breast cancer has demonstrated improved early stage detection by 18% and saving approx. US$1.4B per annum[4 ] for the US payer
Oncology
Diseases Areas
Cardiovascular
GeneType Multitest covers >70% of mortality & morbidity
Atrial Fibrillation
Breast Cancer
[insert revenue structuColorectal Cancer Co r one a ry Artery nd agreement Prostate Cancer types]Disease Melanoma Product list Pancreatic Cancer Metabolic Ovarian Cancer
Type 2 Diabetes
Phase 1 Launch[2] Phase 2 Launch[3]
Guideline driven, Actionable results
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TGA, FDA and EU regulatory approval granted to the sponsor, DNA Genotek
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Commercial availability expected Q1 CY2022
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Commercial availability upon regulatory approval 4. Budget Impact Model prepared by Alva10
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GeneType Identifies up to 9 Times More Cancer Risk Patients Compared to Existing SoC Models[1]
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The paper, titled “Integrating Personalised Medicine into Preventative Care through Risk Stratification” Published in the Journal of Precision Medicine 1 https://www.thejournalofprecisionmedicine.com/wp-content/uploads/integrating-personalized-medicine-preventive-care.pdf
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Pathways to Market Executing a multi-brand strategy
Medical & Payer Business to Business (B2B)
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Oncology – GTG[insert revenue structure Cardiovascular Prenatal NIPT and agreement types] Carrier testingProduct list Clinical & Molecular Metabolic
Consumer initiated testing (CIT) with medical supervision
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Expanded Carrier testing & NIPT [insert revenue structure Oncology – MultiTest Cardiovascular – MultiTestand agreement types] Metabolic – MultiTestProduct list COVID Rick Test Pharmacogenomics
Direct to Consumer Testing (DTC)
with no medical supervision
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Ancestryand agreement types]Animal Paternity Product listDrug testing Health & Wellbeing Relationship Pharmacogenetics DNA Storage
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Pathways to Market – highest priority
Revenue
Drivers
Partners
Medical & Payer Business to Business (B2B)
Health Economic modeling completed by ALVA10*
- Certifying reimbursable testing platform: [insert revenue BRCA test & LYNCH Syndrome teststructure and
~~agreement types]~~
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A plan curated for: Payers / Insurers* Product list Primary Care Physicians, Specialists,
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Surgeons, Concierge Medicine Groups
Payer coverage is the key driver of revenues for geneType
Coverage from payers in the US will accelerate adoption of geneType Risk Assessment Tests more widely
Budget Impact Model (BIM) demonstrates significant health & economic benefits of implementing the geneType Breast Cancer Risk Assessment Test
11 Active conversations with payer groups in the US
US Payers include:
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Humana – 17 million lives covered
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Aetna – 22.1 million live covered
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Independence Blue Cross – 3 million lives covered
Products
geneType Multi-test
NGS platforms with Germline, Carrier Screening and NIPT
BRCA test & LYNCH Syndrome test
Smaller payers such as employer groups have potential to move quickly
BIM validates the benefits of implementing geneType
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- Corporates and Insurance market entry assessment in progress and Health Economic Model being completed by ALVA10.
Economic Modeling in the US Payer System[1] The economic benefit to the payers in the US is US$1.4B per annum
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$73 69% - 74% 6.8%-9.2%
US Payor system overall increase in Supplemental
will save per women getting screening frequency
patient per year screened
14.8% - 8.8% 57% - 67%
Interval Cancers Early-stage cancer
drop detection
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3.6% in annual savings to a payer system in the screening and treatment of breast cancer.
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1 Corporates and Insurance market entry assessment - Health Economic Model completed by ALVA10 May 2022.
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Divisions of Operations
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Existing divisions
Emerging divisions
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NEW Universal collection test kit to support Multi Test Launch
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NEW Universal sample collection kit with TGA, FDA and EU regulatory approval[1]
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BC = Breast Cancer; CRC = Colorectal Cancer; PC = Prostate Cancer; CVD = Cardiovascular Disease; IHD = Ischemic Heart Disease; Atrial Fibrillation 1. TGA, FDA and EU regulatory approval granted to the sponsor, DNA Genotek
DTC - Growth strategy for EasyDNA
PHASE 1 Brand Re-Ignition
PHASE 2
Revenue and Growth Focus
[insert revenue structure and Brand Refresh agreement types] Website Refresh Product list Multi-brand Portfolio Website Development EasyDNA Brand Refresh First-party data collection Test Rationalization Targeted Messaging Improve User experience and engagement
[insert revenue structure and agreement types] Improved Lead Gen New Sales Channels Product list Google Ads Amazon store front Facebook Ads Target B2B customer Content & Email Marketing segments Influencer Marketing & New Markets Testimonials
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DTC - Growth strategy for EasyDNA
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Collaborations
Professor Bernard Rosner
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Channing Division of Network Medicine, Brigham and Women’s Hospital and Harvard Medical School, Boston, Massachusetts, USA – Principal Investigator of the Nurses’ Health Study [insert revenue structure (International expert in Biostatistics and breast cancer epidemiology).and agreement types]
Product list Collaborating on a project to improve the GeneType Breast Cancer Test and to Cross-validate the Ovarian cancer test in the Nurses Health Study
Professor Graham Colditz
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Deputy Director, Institute for Public Health. Washington University School of Medicine, St. Louis, Missouri (International expert in Biostatistics and breast cancer epidemiology). [insert revenue structure
Collaborating on a project to validate and agreement types] the GeneType for Breast Cancer Test in Product list African American patients
Professor John Hopper
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Professorial Fellow at the Centre for Epidemiology and Biostatistics in the School of Population Global Health, Melbourne University
Collaborating on a project to improv[insert revenue structur e the Genetype for Breast Cancer Test and agreement types] and on a joint project with Prof Emery Product list to develop clinical utility evidence for the GeneType tests
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Collaborations
Professor Jon Emery
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Professor of Primary Care Cancer Research at the University of Melbourne, and the Victorian Comprehensive Cancer Centre[insert revenue structure and agreement types] Collaborating on a joint project with Prof Hopper to develop cl nical utility Product l i st evidence for the GeneType tests
Memorial Sloane Kettering Cancer
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Collaborating on a project to investigate modification of risk in BRCApositive patients by polygenic risk scores[insert revenue structure
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Ohio State
University
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Collaborating on a project to investigate modification of risk in BRCApositive patients by polygenic risk scores[insert revenue structure
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Snapshot and Achievements last 12 months
GeneType commercialization
EasyDNA integration activities
Reimbursement activation
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✓ Phase 1 commercial release of the geneType Multi-Risk test in US
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✓ >90 medical practices on-boarded launching the foundation of geneType Hubs in Australia
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✓ AffinityDNA
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✓ Completed 2 Acquisitions – EasyDNA and
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✓ Presentations by Dr Erika Spaeth at:
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✓ San Antonio Breast Cancer Symposium,
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✓ NEW EasyDNA Website ready for launch
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✓ NEW eCommerce Platform ready launch
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✓ Launch Carrier Testing and Non-Invasive Prenatal Tests (NIPT) into Europe
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✓ Partnering in India with stud farms extending paternity infrastructure into the equine industry
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✓ Launch DNA storage solution in GTG NATA approved facility
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✓ Independently developed Budget Impact Model (BIM) identifies US$1.4 billion dollars in annual saving by ALVA 10
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✓ 11 Active payer conversations
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✓ Progress on US Payer meetings to enable coverage across millions of lives
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✓ Precision Medicines leaders summit
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✓ Precision Medicine World Conference
Partnerships
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✓ Launch with A/Prof Charles Siles providing immediate access to more than 1,000 referring primary care physicians and 15,000 patients annually in Australia
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✓ Partnerships with Australian Breast Care Centre and Dr Nicole Yap
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✓ Launch of screening for breast cancer risk with Prof Bruce Mann at Royal Women’s Hospital in Melbourne
Clinical Validity and IP Strategy
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✓ Published in Journal or Precision Medicine
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✓ Published in European Journal of Cancer prevention
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✓ 10 Patents granted
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✓ 5 new provisional patents filed
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✓ 4 papers published
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✓ 3 papers under review
Laboratory Capability
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✓ Gained NATA and CMS-CLIA accreditation and certification for 6 polygenic risk score tests
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✓ Successful ARTG notification to TGA for company IVDs for all tests on the multirisk test
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Thank you
Investor Relations Adrian Mulcahy Market Eye – Automic Group M: +61 438 630 422 E: [email protected]
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www.linkedin.com/company/genetype-limited www.genetype.com
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Appendices
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Corporate Overview
Top 50 share registry breakdown
BNY Mellon Board & Management Other Other, 25% Board & Management , 6%, BNY Mellon, 69%
Dual Listed on the ASX and Nasdaq
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|---|---|
|Financial Information|
|Share price (AUD) as at 25 October 2022|0.3c|
|ADR price (USD) as at 25 October 2022|$1.20|
|Ord Shares on Issue (M)|9,234|
|ASX 52-week trading (AUD low/high)|0.3/0.8c|
|Nasdaq 52-week trading (USD low/high)|0.95/3.04|
|Market Cap (A$M/US$M)|32.31/18.47|
|Cash at 30 September 2022|A$7.9m|
|Cash at 30 June 2022|A$11.7m|
|Debt (30 June 2022 and 30 September 2022)|nil|
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Financial Overview
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Net cash outflow of A$3.4 million in Q1 FY’22 (compared to Q4 FY’22 inflow of: A$197k) as we continue to grow EasyDNA and Affinity DNA brand sales and develop and commercialize our geneType tests
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Cash reserves of A$7.9 million at 30 September 2022 will be directed to:
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Drive the commercialization of geneType products in United States, Europe and Australia
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Develop the direct-to-consumer sales channel through EasyDNA and AffinityDNA
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US Payer model development for geneType for breast cancer;
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General product research and development; and
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For general working capital.
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A$’000 30-Sep-22 30-Jun-22 Change
Net operating cashflow (3,410) 197 -1831%
Receipts from customers 2,056 2,013 2%
Research and Development and
(2,126) (1,429) 49%
Staff costs
Cash 7,495 11,733 -32%
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1 Based on cashflow projections
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Board and Management: Sales and Scientific expertise leading GTG
Mr. Peter Rubinstein BEc, LLB Chairman Non – Executive Director
Dr. Lindsay Wakefield MBBS Non – Executive Director
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Mr Nick Burrows B.Comm, FAICD, FCA, FGIA, FTIA, F Fin Non – Executive Director
Simon Morriss GAICD Chief Executive Officer
Dr. Jerzy “George” Muchnicki MBBS Non-Executive Director
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Erika Spaeth PhD Director of Clinical & Scientific Affairs
Richard Allman BSc, PhD Scientific Advisor
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Tony Di Pietro B. Comm, CA, AGIA, MAICD CFO & Company Secretary
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Carl Stubbings Chief Commercial Officer
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Strong Scientific Leadership: Advisory Board
Professor Jon Emery
MBBCh MA DPhil FRACGP MRCGP Research & Education Lead, Primary Care Integration, Victorian Comprehensive Cancer Centre Herman Chair of Primary Care Cancer Research, University of Melbourne
Professor Finlay Macrae AO
MBBS, MD, FRACP, FRCP, AGAF MWGO is Principal Fellow and Professor, Department of Medicine, University of Melbourne, and Head of Colorectal Medicine and Genetics, The Royal Melbourne Hospital
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Ora K. Gordon, M.D.
MD, MS, FACMG
Regional Medical Director, Center for Clinical Genetics & Genomics. Clinical Director, PSJH Population Health Genomics Program. Chair, Integrated Network Cancer Program, Professor of Genetics, St John Cancer Institute
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A.Prof Ron Dick
MBBS, FRACP, FCSANZ, Chairman of Cardiovascular Institute at Epworth Healthcare, an Honorary Cardiologist at the Alfred Hospital and Bendigo Healthcare Group.
Completed his MBBS in 1979 and became a Fellow of the Australian College of Physicians in 1986. His interventional cardiology fellowship was from the University of Michigan Medical Centre USA.
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Our Intellectual Property
4 Patents granted in the US
9 Patent families pending
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Patent No: US 11,257,569, Methods of assessing risk of developing a severe response to Coronavirus infection
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Patent No: US 11,072,830, Methods for breast cancer risk assessment
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Patent No: US 10,683,549, Methods for assessing risk of developing breast cancer
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Patent No: US 10,920,279, Methods for assessing risk of developing breast cancer
2 Patents granted in PRC (China & HK)
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Patent No. 201080033130.5 Methods for Breast Cancer Risk Assessment
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Breast cancer risk assessment
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Methods for assessing risk of developing prostate cancer
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Methods for assessing risk of developing ovarian cancer
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Methods of assessing risk of developing a severe response to Coronavirus infection
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Methods of assessing risk of developing a disease
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Methods for assessing risk of developing breast cancer
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Improved methods for assessing risk of developing breast cancer
- Methods of assessing risk of developing breast cancer
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Methods for assessing risk of developing colorectal cancer
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Patent No. 201580063966.2 Methods for assessing risk of developing breast cancer
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- Patents granted are specific to the GeneType portfolio of products
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Defined Terms
Common Complex Diseases (CCP) – A complex disease is caused by the interaction of multiple genes and environmental factors. Complex diseases are also called multifactorial. Examples of common complex diseases include cancer and heart disease.
Polygenic risk score - a number associated with one’s disease risk based on the aggregated effects of individual risk variants through a multiplicative algorithm.
Variant - Single Nucleotide polymorphism (SNP), an alteration in DNA that may be a common or rare event.
Genomic - pertaining to function of genetics from structure to relationship between genetic events.
Genetic - pertaining to a gene.
GWAS - genome-wide association studies are large population level studies which enable scientists to identify genes and genetic markers involved in human disease. This method searches the genome for SNPs that occur more frequently in people with a particular disease than in people without the disease. Each study can look at hundreds or many thousands of SNPs at the same time. Researchers use data from this type of study to pinpoint genetic variations that may contribute to a person’s risk of developing a certain disease.
SNP - Single nucleotide polymorphisms, frequently called SNPs (pronounced “snips”), are the most common type of genetic variation among people. Each SNP represents a difference in a single DNA building block, called a nucleotide. For example, a SNP may replace the nucleotide cytosine (C) with the nucleotide thymine (T) in a certain stretch of DNA.
- Serious Disease Risk (SDR) Risk associated with acquiring COVID-19 and requiring hospitalisation withs its associated morbidities and mortalities.
Germline Testing – Germline testing is done on cells that do not have cancer. It is done to see if a person has a gene mutation that is known to increase the risk of developing cancers and other health problems. This test uses cells (such as blood or skin cells) that do not have any cancer cells. Germline mutations can sometimes be passed down from parents.
Clinical Laboratory Improvement Amendments (CLIA) - Regulates laboratory testing and require clinical laboratories to be certified by the Center for Medicare and Medicaid Services (CMS) before they can accept human samples for diagnostic testing
National Association of Testing Authorities (NATA) - the authority responsible for the accreditation of laboratories, inspection bodies, calibration services, producers of certified reference materials and proficiency testing scheme providers throughout Australia. It is also Australia's compliance monitoring authority for the OECD Principles of GLP. NATA provides independent assurance of technical competence through a proven network of best practice industry experts for customers who require confidence in the delivery of their products and services.
Next Generation Sequencing ( NGS) – Next-generation sequencing (NGS), also known as high-throughput sequencing, is the catch-all term used to describe a number of different modern sequencing technologies. These technologies allow for sequencing of DNA and RNA much more quickly and cheaply than the previously used Sanger sequencing, and as such revolutionised the study of genomics and molecular biology.
Laboratory Developed Tests (LDT) – A type of in vitro diagnostic test that is designed, manufactured and used within a single laboratory.
Consumer Initiated Tests (CIT) - laboratory testing that is initiated by the consumer without a physician order but reviewed and communicated back to the consumer via a physician.
Direct to Consumer (DTC) – laboratory testing that is initiated by the consumer without a physician order. The results are reported back directly to the consumer.
Health Care Professionals (HCP) – physician, GP, or specialist authorized to receive the patient results
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