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GENETIC TECHNOLOGIES LIMITED — AGM Information 2023
Nov 21, 2023
65022_rns_2023-11-21_0e4b59ce-b5d2-4439-9aac-7982b9f26741.pdf
AGM Information
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Annual General Meeting November 22, 2023 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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2023 Annual Report and auditor’s report
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Resolutions
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Adoption of the Remuneration Report
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Re-election Mr Peter Rubinstein 3. Re-election Dr Lindsay Wakefield
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Approval of Increased Placement Capacity
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Share Consolidation
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Ratification of prior issue of Shares under ASX Listing Rule 7.1
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Ratification of prior issue of Shares under ASX Listing Rule 7.1A
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Issue of Warrants to H.C. Wainwright
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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 company’s financial statements, directors’ report, and auditor’s report for the year ended 30 June 2023
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Resolution 1: Adoption of the Remuneration Report
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“That for the of Section of the purpose 250R(2) Corporations Act and all other the Remuneration as set purposes report out in the Directors’ report for the Company for the year ended 30 June 2023be adopted.”
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| Resolution 1: Adoption of the Remuneration Report • Proxy Voting: Vote type Voted % For 713,423,619 74.36 Against 242,779,122 25.30 Open-Usable 3,314,995 0.34 Abstain 445,477,664 |
Resolution 1: Adoption of the Remuneration Report • Proxy Voting: Vote type Voted % For 713,423,619 74.36 Against 242,779,122 25.30 Open-Usable 3,314,995 0.34 Abstain 445,477,664 |
Resolution 1: Adoption of the Remuneration Report • Proxy Voting: Vote type Voted % For 713,423,619 74.36 Against 242,779,122 25.30 Open-Usable 3,314,995 0.34 Abstain 445,477,664 |
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|---|---|---|---|
| Vote type | Voted | % | |
| For | 713,423,619 | 74.36 | |
| Against | 242,779,122 | 25.30 | |
| Open-Usable | 3,314,995 | 0.34 | |
| Abstain | 445,477,664 |
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Resolution 2: Re-Election of Mr Peter Rubinstein
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“To elect Mr Peter Rubinstein 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 Peter Rubinstein • Proxy Voting: Vote type Voted % For 1,588,619,984 84.71 Against 283,473,919 15.12 Open-Usable 3,314,995 0.17 Abstain 22,324,800 |
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Resolution 3: Re-Election of Dr Lindsay Wakefield
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“To elect Dr Lindsay Wakefield 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 3: Re-Election of Dr Lindsay Wakefield • Proxy Voting: Vote type Voted % For 1,608,801,251 84.95 Against 281,311,852 14.86 Open-Usable 3,564,995 0.19 Abstain 4,055,600 |
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Resolution 4: Approval of Increased Placement Capacity
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“That pursuant to and in accordance with Listing Rule 7.1A and for all other Shareholders the purposes, approve increase in capacity of the Company to issue of Equity Securities to 10% of the issued of the up capital 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.”
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| Resolution 4: Approval of Increased Placement Capacity • Proxy Voting: Vote type Voted % For 1,314,827,290 69.86 Against 563,347,638 29.93 Open-Usable 4,064,995 0.21 Abstain 15,493,775 |
Resolution 4: Approval of Increased Placement Capacity • Proxy Voting: Vote type Voted % For 1,314,827,290 69.86 Against 563,347,638 29.93 Open-Usable 4,064,995 0.21 Abstain 15,493,775 |
Resolution 4: Approval of Increased Placement Capacity • Proxy Voting: Vote type Voted % For 1,314,827,290 69.86 Against 563,347,638 29.93 Open-Usable 4,064,995 0.21 Abstain 15,493,775 |
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|---|---|---|---|
| Vote type | Voted | % | |
| For | 1,314,827,290 | 69.86 | |
| Against | 563,347,638 | 29.93 | |
| Open-Usable | 4,064,995 | 0.21 | |
| Abstain | 15,493,775 |
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Resolution 5: Share Consolidation
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“That, pursuantto section 254H(1)ofthe Corporations Act and for all other the issued of the purposes, capital Company be consolidated on the basis that every 100 Shares be consolidated into 1 Share and, where this consolidation results in a fraction of a Share being held, the be authorised to round that fraction to Company up the nearest whole Share (as the case may be), with the consolidation to take effect in accordance with the timetable set out in the Explanatory Statement which accompanies and forms part of this Notice of Meeting.”
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| Resolution 5: Share Consolidation • Proxy Voting: Vote type Voted % For 1,296,603,927 68.43 Against 594,940,715 31.40 Open-Usable 3,314,995 0.17 Abstain 2,874,061 |
Resolution 5: Share Consolidation • Proxy Voting: Vote type Voted % For 1,296,603,927 68.43 Against 594,940,715 31.40 Open-Usable 3,314,995 0.17 Abstain 2,874,061 |
Resolution 5: Share Consolidation • Proxy Voting: Vote type Voted % For 1,296,603,927 68.43 Against 594,940,715 31.40 Open-Usable 3,314,995 0.17 Abstain 2,874,061 |
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|---|---|---|---|
| Vote type | Voted | % | |
| For | 1,296,603,927 | 68.43 | |
| Against | 594,940,715 | 31.40 | |
| Open-Usable | 3,314,995 | 0.17 | |
| Abstain | 2,874,061 |
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Resolution 6:
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Ratification of prior issue of Shares under ASX Listing Rule 7.1
That for the purposes of Listing Rule 7.4 and for all other purposes, approval is given for the prior issue by the Company of1,385,094,771Shares to U.S. institutionalinvestors on 7 February 2023, as detailed in the Company's announcements dated 6 to 8 February 2023, pursuant to Listing Rule 7.1andotherwise on the terms andconditions set out in the Explanatory Statement which accompanies and forms part of the Notice of Meeting.”
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| Resolution 6: Ratification of prior issue of Shares under ASX Listing Rule 7.1 • Proxy Voting: Vote type Voted % For 1,501,602,806 79.83 Against 376,181,712 20.00 Open-Usable 3,314,995 0.17 Abstain 16,634,185 |
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Resolution 7:
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Ratification of prior issue of Shares under ASX Listing Rule 7.1A
“That for the purposes of Listing Rule 7.4 and for all other purposes, approval is given for the prior issue by the Company of 922,598,229 Shares to U.S. institutional investors on 7 February 2023, as detailed in the Company's announcements dated 6 to 8 February 2023, pursuant to Listing Rule 7.1A and otherwise on the terms and conditions setoutin the Explanatory Statementwhich accompanies and forms part of the Notice of Meeting.”
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| Resolution 7: Ratification of prior issue of Shares under ASX Listing Rule 7.1A • Proxy Voting: Vote type Voted % For 1,501,443,806 79.82 Against 370,301,312 19.68 Open-Usable 9,514,995 0.50 Abstain 16,473,585 |
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Resolution 8: Issue of Warrants to H.C. Wainwright
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“That for the purposes of Listing Rule 7.1 and for all other purposes, approval is given for the issue of 250,000 Warrants to acquire ADSs, each representing 600 ordinary shares in the Company, to H.C. Wainwright & Co in part consideration for exclusive placement agent services provided to the Company on the terms and conditions set out in the Explanatory Statement which accompanies and forms part of the Notice of Meeting.”
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| Resolution 8: Issue of Warrants to H.C. Wainwright • Proxy Voting: Vote type Voted % For 1,295,718,687 78.25 Against 358,038,987 21.62 Open-Usable 2,202,995 0.13 Abstain 241,773,029 |
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Chief Executive Officer Address Mr. Simon Morriss The Future: Unlocking personalized preventative medicine
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Notice: Forward looking statements
The purpose of the presentation is to provide an update of the business of Genetic Technologies Limited (the Company) 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 the Company 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 the Company’s 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 the Company’s current intentions, plans, expectations and beliefs about the future, you are urged to view all forward looking statements contained in this presentation with caution. This presentation should not be relied on as a recommendation or forecast by the Company. 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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Key Messages
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Executing our Vision and Strategy to be leader in personalized predictive genomics
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Our journey from R&D Commercialization and the pathway to profitability
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Milestones include:
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Precision Medicine launch with Major Private Hospital
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• GeneType Multi-test with 3 NEW tests – Approved in Australia
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Ambassador to promote Melanoma this Summer
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Industry Partner in Multi Cancer Risk trial
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Major breakthrough - geneType Predicting Risk of Pancreatic Cancer
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A global operation, a comprehensive human and animal health portfolio
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New Market opportunities in S.E.A and UK
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Engaged with leading global collaborations
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Continuing our journey with a strong commitment to ESG principals
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Have a well-defined strategic plan to execute on a multi brand strategy in key regions
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VISION
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World leader in personalized predictive genomics. Empowering individuals to take control of their health.
UNIQUE VALUE PROPOSITION
Turning cutting-edge science into personalized, predictive tests driven by AI & machine learning techniques.
Backed by over 20 years of experience, our scientific and clinical teams are translating genetics and clinical information into absolute risk tests that predict risk of chronic diseases before onset.
Empowering physicians to improve health outcomes for people around the world enabling a new era of personalised 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 & Monogenic diseases
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Pet care
Revenues anchored by our 3 brands to seize a multi Billion-dollar opportunity.
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Global Overview
60 40 25
Employees Countries Patents Granted
(FTE) globally (9 Pending
Worldwide)
14 51 12
Test Tests Partner
Categories Laboratories
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- Patents granted are specific to the GeneType portfolio of products
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Delivering Revenue and Growth – year ending 30 June
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29%
Growth CASH RECEIPTS
on LY CASH BALANCE
$8,771
Cash Receipts (A$'000)
FY23 A$8.8m
A$7.9m
+29%
$6,789
GROSS MARGIN GROSS MARGIN
A$4.2m 47%
$89
Full Year FY21 Full Year FY22 Full Year FY23
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Strategic & Operational Highlights:
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Group receipts from customers A$8.8m to 30 June 2023, up 29%.
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June Quarter FY23 receipts were A$2.1 million.
- Launched a National Television campaign in the U.S. for Genetype
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Presented at The American Society of Clinic Oncologists (ASCO) in Chicago
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GeneType test growth +250% growth in commercial samples
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Attended the Biotechnology Innovation Organisation (BIO) conference in Boston
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20 Medical practices in the U.S. and Australia now repeatedly referring samples for geneType testing – growing weekly
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Publications validating the use of geneType; identifying those at elevated risk
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Melanoma, Pancreatic, and Prostate Cancer
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*Jun 2023 Quarter end cash and cash equivalents of A$7.9 million as announced on ASX 28 July 2023
Our Pathway to Profitability
Our Journey from Extensive R&D to Revenue and Profitability Research, Development and Commercialisation and Pathway to Profitability Innovation Revenue Generation 2000 - 2024 - 2021 2022 2023 ~~2021 2025~~ Pioneers in Genomics, Launched Patented Acquired Affinity DNA Global Developing Building the US Our Pathway to profitability participating in the very 1[st] Genetype Multi Risk Test Direct to consumer genomics and Australian B2B markets Executing on our 5 strategic International Human covering 9 diseases and up for GeneType Pillars Genome. to 70 annual Mortalities and Developed commercial Morbidities Pathways for the whole Delivering group revenues of People and Culture Investing more than 20 portfolio AUD $8.7m year ending 30 Whole of Life Portfolio years in extensive R&D and Acquired EasyDNA Global June 2023 Engaging our Stakeholders Innovation Direct to consumer Delivering group revenues of Sales and Marketing Excellence genomics AUD $6.8m year ending 30 Systems and Processes June 2022
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Revenue Drivers and our Pathway to Profitability
Q4 CY2024
Launch UK Pharmacy April 2024
Cash Flow positive*
12 months worth of self funding cash
Q4 FY2024
H1 FY2024
Q3 FY2024 Launch BD, License agreement or Payer
Q3 CY2024
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BD, License Agreement
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- Coding strategy & payment June’24
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- NCCN guideline pathway to inclusion
Cashflow positive January 2025
Launch Launch Launch Launching UNITY Small Pilot HBOC Epigenetics* 2024
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Q1 Q2 Q3 Q4 Q1FY25 Q2 FY24 FY24 FY24 FY24 FY25 Easy DNA & AfinityDNA Genetype Multi Test & HBOC Prenatal Category B2B Distributor and Payer
This excludes ANY NEW Markets e.g. India, SEA or UAE *Cash Flow positive will rely on the execution of a large payer group in the US within the next 12 months HBOC – Hereditary Breast and Ovarian Cancer
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Genetic Technologies ASX:GTG - ESG Focus Areas
Environmental, Social & Governance
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Highlights:
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Board and Executive teams clearly defined our vision and purpose
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• Introduced updated Maternity Leave Policy exceeding mandatory level, addressing Pay Equity
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Conducted Cybersecurity Training, addressing Risks and Opportunities
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Focus areas for H1 FY24
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Board Composition
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Ethical Behaviour (policy review) • Code of conduct
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Whistle Blower
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Antibribery
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Diversity & Inclusion
- Culture and Engagement Survey
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Stakeholder Capitalism Metrics ESG Framework
Major Milestones Precision Medicine Launch with Major Private Hospital
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Pioneering Precision Medicine - Prestigious initiative for the hospital
Pilot study will utilise:
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Patented geneType Multi-risk test Combining Clinical and Genetic risk
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• 9 Diseases - Oncology, Cardiovascular, and Metabolic risk assessment
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• Combined with; Pharmacogenomics (PGx) tests,
Providing a comprehensive risk and wellness profile for Gold Coast Private Hospital
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Major Milestones Expanded geneType Multi-test Approved
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Announced that the expanded geneType MultiRisk Test is now available to order in Australia. GTG announced the launch of the expanded test in the U.S., to include three new diseases, in March 2023. The three new diseases
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Pancreatic Cancer
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Melanoma
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Atrial Fibrillation
Approved for sale in Australia by the National Association of Testing Authority (NATA).
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Major Milestones Sole Industry Partner in Multi Cancer Risk trial
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Medical Research Future Fund (MRFF) Genomics Health Futures Mission Grant has been awarded.
The grant will provide funding for a randomized controlled trial of the clinical utility and cost-effectiveness of a multi-cancer polygenic risk score in general practice.
GENE is the sole industry partner for trial which is to be led by Professor Jon Emery.
Successful outcomes from the trial could lead to the implementation of geneType into routine use in General Practice in Australia.
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Major Milestones Publication GeneType Predicting Risk of Pancreatic Cancer
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GeneType’s Pancreatic Cancer risk assessment showed nearly 50% improvement in identifying patients at high risk.
The study evaluated close to 380,000 adults aged 40 to 69 years from the UK Biobank, identifying 851 incident cases of pancreatic cancer, providing a very powerful validation.
The paper entitled “Predicting 10-year risk of pancreatic cancer using a combined genetic and clinical model” was published in the journal Gastro Hep Advances.[1]
GeneType’s Pancreatic Cancer risk assessment will help doctors diagnose pancreatic cancer earlier, intervene earlier and help reduce this cancer’s appalling mortality.
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Ambassador - GeneType for Melanoma Campaign to promoted the Early Detection of Melanoma
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Driving awareness of Melanoma in the Summer of 2023 focusing on TV, Radio and Print media
Deborah revealed that the two cancers on her face were undetectable to the naked eye.
Deborah's shares a graphic shot is a poignant reminder to all Australians to have their skin checked, even if nothing is evident on the surface.
As for post-surgery scarring, Deborah revealed: “My skin will heal and in the coming months you’ll hardly see the scar.
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Exploring NEW markets – Southeast Asia Exclusive networking event in Jakarta, Indonesia - Uniting innovation
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The keynote address was by Budi Sadikin, Minister of Health, Ministry of Health of the Republic of Indonesia
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Southeast Asian healthcare market projected to reach USD 270 Billion by 2027
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Partnering to construct an MoU
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Licence agreement for Indonesian Healthcare System
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Longevity Bio Bank
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Exploring NEW markets - UK Pharmacy Expansion EasyDNA / Affinity DNA and Genetype
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Across 10,000 geared at helping patients increase their general health and wellbeing.
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The focus areas being disseminated through the NPA's 10,000+ pharmacies is Home Testing, where geneType / EasyDNA / Affinity DNA will feature prominently
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These brands will be featured as the thought leader, giving us a way to speak directly to the public:
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Launch dates:
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April 2024 (digital guides), with a guaranteed minimum of 3 million* distribution for 12 months.
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April 2024 (hard copies), with a minimum of 400,000* hard copies for 12 months.
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Pathways to Market Executing a multi-brand strategy
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Medical & Payer Consumer initiated Direct to Consumer Business to testing (CIT) Testing (DTC) Business (B2B) with medical supervision with no medical supervision Oncology – GTG Expanded Carrier testing & NIPT Cardiovascular[insert revenue structure Oncology – Multi-test[insert revenue structure [insert revenue structure Prenatal NIPT and agreement types] Cardiovascular – Multi-testand agreement types] Ancestryand agreement types]Animal Carrier testing Metabolic – Multi-test Paternity Drug testing Product list Product list Product list Clinical & Molecular Pharmacogenomics Health & Wellbeing Relationship Metabolic Pharmacogenetics DNA Storage
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B2B - US Enterprise model; market segmentation critical Driving our Revenue Pipeline
| 1. Current geneType CRM Contacts (~1,000) | ||||
| HCP Clinics | 2. Functional Medicine | |||
| Patient Pay | 3. Concierge Medicine | |||
| (3-6 months) | 4. Longevity Clinics | |||
| 5. Anti-Aging Clinics | ||||
| HCP-Centric | 6. Academic Precision Medicine Programs 7. Academic medical center based high risk Women’s Health Centers; |
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| (KOL/Influencer) | 8. Imaging Centers (National, regional and health system based) | |||
| (6-12 months) | 9. Nutraceutical / Supplement Industry 10. Health Systems |
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| 11. Self-Insured Employers | ||||
| Employer Ecosystem (6-24 months) |
12. Worksite Health Centers(WHC) 13. Employer Healthcare Coalitions 14. Employee Wellbeing/ Wellness Vendors |
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| 15. EBC/Broker | ||||
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Our Innovation – Multi-Risk Test
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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
Diseases Areas
GeneType Multitest covers >70% of mortality & morbidity
Oncology Cardiovascular
Breast Cancer Atrial Fibrillation
[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]
- TGA, FDA and EU regulatory approval granted to the sponsor, DNA Genotek 2. Commercial availability
Guideline driven, Actionable results
- Commercial availability in the US and Australia 4. Budget Impact Model
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NEW Comprehensive Breast and Ovarian Cancer test Evaluates a woman’s risk of developing Breast and/or Ovarian Cancer in women 30 years+
5% - Hereditary Cancer with known pathogenic variant BRCA1/2
10% - Familial cancer with no known pathogenic variant
- 85% - geneType Patented integrated Breast and Ovarian Risk test
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The test evaluates a women’s risk of developing Breast and/or Ovarian Cancer either from a hereditary genetic mutation or from the far more common familial or sporadic cancer.
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GTG’s unique approach “appends” the detection of the 13 major “actionable” Breast and Ovarian cancer susceptibility genes to the GeneType test platform.
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Advances the goal of providing population-based genetic screening where up to 85% of cancers diagnosed do not have hereditary or family history
1 https://www.breastcancer.org/facts-statistics Announcement - Globe Newswire
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DTC - Growth strategy for EasyDNA
PHASE 1 Brand Re-Ignition
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----- Start of picture text -----
PHASE 2
Revenue and Growth Focus
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[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 & 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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Collaborations
| ProfessorBernard Rosner |
Professor Graham Colditz |
Professor John Hopper |
Professor Jon Emery |
Memorial Sloane Kettering Cancer |
Ohio State University |
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|---|---|---|---|---|---|---|---|---|---|---|---|
| [insert revenue structure and agreement types] Product list Brigham & Women’s Hospital and Harvard Medical School, Boston, Massachusetts, USA – Principal Investigator of the Nurses’ Health Study (International expert in Biostatistics and breast cancer epidemiology). Collaborating on a project to improve the GeneType Breast Cancer Test and to |
[insert revenue structure and agreement types] Product list Deputy Director, Institute for Public Health. Washington University School of Medicine, St. Louis, Missouri (International expert in Biostatistics and breast cancer epidemiology). Collaborating on a project to validate the GeneType for Breast Cancer Test in African |
[insert revenue structure and agreement types] Product list Professorial Fellow at the Centre for Epidemiology and Biostatistics in the School of Population Global Health, Melbourne University Collaborating on a project to improve the Genetype for Breast Cancer Test and on a joint project with Prof Emery to develop |
[insert revenue structure and agreement types] Product list Professor of Primary Care Cancer Research at the University of Melbourne, and the Victorian Comprehensive Cancer Centre Collaborating on a joint project with Prof Hopper to develop clinical utility evidence for |
[insert revenue structure and agreement types] Product list Collaborating on a project to investigate modification of risk in BRCA-positive patients by polygenic risk scores |
[insert revenue structure and agreement types] Product list Collaborating on a project to investigate modification of risk in BRCA-positive patients by polyg nic risk scores |
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| Cross-validate the | American patients | clinical utility evidence | the GeneType tests | ||||||||
| Ovarian cancer test in the Nurses Health Study |
for the GeneType tests | ||||||||||
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Snapshot and Achievements last 12 months
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GeneType & Commercialization
EasyDNA & Affinity DNA
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Reimbursement activation
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FY23 Group Receipts A$8.8 million, up 29%
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GeneType risk test: +250% in commercial samples received in June quarter
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9 geneType Multi-Risk tests NOW commercially available in the US and Australian Markets
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100 medical practices on-boarded launching the foundation of geneType Hubs
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Launched U.S TV campaign
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Integrated 2 Acquisitions
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NEW EasyDNA Website
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NEW eCommerce Platform
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Launch Carrier Testing and Non-Invasive Prenatal Tests (NIPT) into Europe
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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 savings in the treatment of breast cancer
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Active payer and distribution conversations
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Progress on US Payer meetings to enable coverage across millions of lives
Partnerships and Conferences
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Partnerships with Australian Breast Care Centre and Dr Nicole Yap
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Screening for breast cancer risk with Prof Bruce Mann at Royal Women’s Hospital in Melbourne
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The American Society of Clinic Oncologists (ASCO) in Chicago
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Biotechnology Innovation Organisation (BIO) conference in Boston
Clinical Validity and IP Strategy
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9 Peer reviewed publication in 12 months
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Submitted geneType risk test to NCCN Guidelines
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Publications:
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PLOS ONE
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Journal or Precision Medicine
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European Journal of Cancer prevention
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Journal Breast Cancer Research and Treatment
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 multi-risk test
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International Congress of Genomics (ICG)
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25 Patents granted or pending
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Summary
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Developed a clear Vision and Strategy to be leader in personalized predictive genomics
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Identified the Drivers of Revenue and pathway to profitability by the middle of FY25
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• Strong momentum in commercial operations with +29% growth in customer receipts
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We have a global operation, a comprehensive human and animal health portfolio
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Engaged with leading global collaborations
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Begun a journey with a strong commitment to ESG principals
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Have a well-defined strategic plan to execute on a multi brand strategy in key regions
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Thank you & Questions
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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Return to the Chairman
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Appendices
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Board and Management: Sales and Scientific expertise leading GTG
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Dr. Lindsay Wakefield MBBS Non – Executive Director
Mr Nick Burrows B.Comm, FAICD, FCA, FGIA, FTIA, F Fin Non – Executive Director Erika Spaeth PhD Director of Clinical & Scientific Affairs
Mr. Peter Rubinstein BEc, LLB Chairman Non – Executive Director Simon Morriss GAICD Chief Executive Officer Richard Allman BSc, PhD Scientific Advisor
Dr. Jerzy “George” Erika Spaeth Muchnicki PhD MBBS Director of Clinical & Non-Executive Director Scientific Affairs Tony Di Pietro Carl Stubbings B. Comm, CA, AGIA, MAICD Chief Commercial CFO & Company Secretary Officer
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Strong Scientific Leadership: Advisory Board
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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
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
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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Financial Overview
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- Net cash outflow of A$4.1 million for the 12 months to 30 June 2023. We continue to grow EasyDNA and Affinity DNA brand sales and develop and commercialize our geneType tests
• Cash reserves will be directed:
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to support the commercialization of the GeneType Multi Risk test through the B2B channels with payers, insurers and employers in the United States and expand into Europe;
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to drive new market opportunities in reimbursable categories by leveraging our strategic relationship with QIAGEN;
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for funding product research and development;
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to increase our sales and marketing presences and drive of its tests via the consumer-initiated testing platforms;
| A$’000 | 30-June-23 | 30-June-22 | Change |
|---|---|---|---|
| Net operating cashflow1 | (9,723) | (5,659) | 72% |
| Receipts from customers2 | 8,771 | 6,789 | 29% |
| Cash | 7,853 | 11,733 | -33% |
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to execute the go to market, sales and marketing to launch the Comprehensive Hereditary Breast and Ovarian Cancer Risk Test as part of our germline genetic testing division; and
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for other working capital and general corporate purposes.
1 Based on Consolidated Statement of Cash Flows per the 2023 Annual Report 2 Based on Receipts from Customers reported in the company’s Appendix 4C
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Corporate Overview
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Top 50 share registry breakdown
BNY Mellon Board & Management Other
Other, 25%
Board &
Management ,
5%,
BNY Mellon, 70%
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| Dual Listed on the ASX and Nasdaq | |
|---|---|
| Financial Information | |
| Share price (AUD) as at 23 October 2023 | 0.2c |
| ADR price (USD) as at 23 October 2023 | $0.70 |
| Ord Shares on Issue (M) | 11,542 |
| ASX 52-week trading (AUD low/high) | 0.2/1.3c |
| Nasdaq 52-week trading (USD low/high) | 0.67/2.40 |
| Market Cap (A$M/US$M) | 23.1/13.5 |
| Cash at 30 June 2023 | A$7.9m |
| Cash at 30 June 2022 | A$11.7m |
| Debt (30 June 2022 and 30 June 2023) | nil |
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Note - BNY is the nominee holder for ADS Shareholders in the US
Our Intellectual Property
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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
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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
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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
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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 hospitalization 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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