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GENE Presentation

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RedChip Companies, Inc.
RedChip Companies, Inc.

Genetic Technologies is a diversified molecular diagnostics company. A global leader in genomics-based tests in health, wellness and serious disease through its geneType and EasyDNA brands. GENE offers cancer predictive testing and assessment tools to help physicians to improve health outcomes for people around the world. The Company has a proprietary risk stratification platform that has been developed over the past decade and integrates clinical and genetic risk to deliver actionable outcomes to physicians and individuals. Leading the world in risk prediction in oncology, cardiovascular and metabolic diseases, Genetic Technologies continues to develop risk assessment products.

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Genetic Technologies – Investor Webinar The Future: Unlocking personalised preventative medicine 27 April, 2023 Authorised by the Board of Directors of Genetic Technologies Limited ASX: GTG NASDAQ: GENE
2 World leading portfolio 2 Most comprehensive guideline driven portfolio for human and animal health. • Patented GeneType Multi Risk Test • Non-Invasive Prenatal Testing (NIPT) • Carrier screen testing • Pharmacogenomics • Oncogenetic diseases • Pet care Revenues anchored by our 3 brands to seize a multi Billion-dollar opportunity.
[insert revenue structure and agreement types] Product list [insert revenue structure and agreement types] Product list [insert revenue structure and agreement types] Product list 3 Comprehensive genomics-based testings via a multi-brand strategy Direct to Consumer Testing (DTC) with no medical supervision Consumer initiated testing (CIT) with medical supervision Medical & Payer Business to Business (B2B) Oncology – GTG Cardiovascular Prenatal NIPT Carrier testing Clinical & Molecular Metabolic Expanded Carrier testing & NIPT Oncology – MultiTest Cardiovascular – MultiTest Metabolic – MultiTest COVID Rick Test Pharmacogenomics Ancestry Paternity Health & Wellbeing Pharmacogenetics Animal Drug testing Relationship DNA Storage
Global Overview 57 Employees globally 40 Countries 25 Patents Granted* (9 Pending Worldwide*) 14 Test Categories 51 Tests 12 Partner Laboratories 4 * Patents granted are specific to the GeneType portfolio of products
Snapshot and Achievements last 12 months 5 ✓ 9 Tests NOW commercially available in the US the geneType Multi-Risk test ✓ >100 medical practices on-boarded launching the foundation of geneType Hubs in Australia ✓ Presentations by Dr Erika Spaeth at: ✓ ASCOGI Cancers Symposium Jan 2023 ✓ San Antonio Breast Cancer Symposium, ✓ Precision Medicines leaders summit ✓ Precision Medicine World Conference ✓ Completed 2 Acquisitions ✓ NEW EasyDNA Website ready for launch ✓ NEW eCommerce Platform ready launch ✓ Launch Carrier Testing and Non-Invasive Prenatal Tests (NIPT) into Europe ✓ Partnering in India with stud farms extending paternity infrastructure into the equine industry ✓ Launch DNA storage solution in GTG NATA approved facility ✓ Independently developed Budget Impact Model (BIM) identifies US$1.4 billion dollars in annual saving by ALVA 10 ✓ 11 Active payer conversations ✓ Progress on US Payer meetings to enable coverage across millions of lives ✓ 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 ✓ Partnerships with Australian Breast Care Centre and Dr Nicole Yap ✓ Launch of screening for breast cancer risk with Prof Bruce Mann at Royal Women’s Hospital in Melbourne ✓ 5 Peer reviewed publication in 6 months ✓ Published in PLOS ONE ✓ Published in Journal or Precision Medicine ✓ Published in European Journal of Cancer prevention ✓ Published in journal Breast Cancer Research and Treatment ✓ 25 Patents granted or pending ✓ 3 more papers under review ✓ Gained NATA and CMS-CLIA accreditation and certification for 6 polygenic risk score tests ✓ Successful ARTG notification to TGA for company IVDs for all tests on the multi- risk test GeneType commercialization EasyDNA & Affinity DNA Reimbursement activation Partnerships Clinical Validity and IP Strategy Laboratory Capability
half-year ending December 31, 2021 Delivering Revenue and Growth – Q3 FY23 $1,967 $2,232 $4,626 $6,687 Q3 FY22 Q3 FY23 YTD FY22 YTD FY23 Cash Receipts (A$'000) Strategic & Operational Highlights: • March Quarter FY23 receipts A$4.22 million • Cash receipts from customers A$2.2m +13% on last year; • R&D Tax Incentive of A$1.96m was received in Q3 2023 • YTD receipts from customers A$6.69 million up 45% on prior year • 7 consecutive qtrs. of growth on prior year Q3 CASH RECEIPTS A$2.2m GROSS MARGIN A$1.13m March GROSS MARGIN 49% +2ppts 6 CASH BALANCE A$10.5m* *As at 31 March 2023 # All revenues for the period ‘21 & ‘22 are 'out of pocket' our strategy for reimbursement should become effective in 2023 FY 45% Growth on LY • Launched Melanoma, Pancreatic Cancer and Atrial Fibrillation in U.S. • Back to Back peer reviewed publications demonstrating Genetype for Breast cancer identifies MORE at risk patients then the current standards • Presentations at ASCO Gi Cancers Symposium in San Francisco
Commercialisation of the geneType suite of multi-risk tests Our FOCUS Core ‘4’ Commercialisation of the geneType suite of multi-risk tests Demonstrate clinical validity & clinical utility of geneType tests Innovation: Next Generation of capability – Starting with Epigenetics EasyDNA & Affinity DNA Revenue Growth: Tests, Channels. & Markets Execute the B2B commercialisation of the geneType multi-risk test 7
NEW Comprehensive Breast and Ovarian Cancer test Evaluates a woman’s risk of developing Breast and/or Ovarian Cancer in women 30 years+ • 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. (Announced Feb 3, 2023) • GTG’s unique approach “appends” the detection of the 13 major “actionable” Breast and Ovarian cancer susceptibility genes to the GeneType test platform. • Advances the goal of providing population-based genetic screening where up to 85% of cancers diagnosed do not have hereditary or family history • Showcase at BRCA 2023 in Montreal 1 https://www.breastcancer.org/facts-statistics Announcement - Globe Newswire 5% - Hereditary Cancer with known pathogenic variant BRCA1/2 85% - GeneType Patented integrated Breast and Ovarian Risk test 10% - Familial cancer with no known pathogenic variant
[insert revenue structure and agreement types] Product list NEW – 9 Diseases now available in the US 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 annum4 for the US payer 9 Phase 1 Launch 2 GeneType Multi- test covers >70% of mortality & morbidity Phase 2 Launched – US March 20233 1. TGA, FDA and EU regulatory approval granted to the sponsor, DNA Genotek 2. Commercial availability in Australia and the US since Q1 CY2022 3. Commercial availability in the US and waiting on NATA Approval for Australia 4. Budget Impact Model prepared by Alva10 Breast Cancer Colorectal Cancer Prostate Cancer Melanoma Pancreatic Cancer Ovarian Cancer Oncology Cardiovascular Atrial Fibrillation Coronary Artery Disease Metabolic Type 2 Diabetes Diseases Areas One report. Two risk scores. Actionable results
Cancer Prevention Research Validation of an abridged breast cancer risk prediction model for the general population1. Spaeth EL, Dite GS, Hopper JL, Allman R. European Journal of Cancer Prevention A combined clinical and genetic model for predicting risk of ovarian cancer2 Dite GS, Spaeth E, Murphy NM, Allman R. Breast Cancer Research and Treatment Validation of a breast cancer risk prediction model based on the key risk factors: family history, mammographic density and polygenic risk3 Allman R, Mu Y, Dite GS, Spaeth E, Hopper JL, Rosner BA. NEW – 3 Peer Review Publications Released Our Scientific team continues to achieve scientific publication milestones, with 3 publications accepted in three peer-reviewed journals during the quarter 10 1. https://pubmed.ncbi.nlm.nih.gov/36862830/ 2. https://pubmed.ncbi.nlm.nih.gov/36503897 3. https://pubmed.ncbi.nlm.nih.gov/36749458/ Guideline driven, Actionable results 3 NEW Peer reviewed Publications in the latest Qtr
NEW Strategic Alliance with Qiagen The alliance will establish and develop a ‘Centre of Excellence’ facility in Australia QIAGEN will support the enhancement of GTG capabilities through software, hardware, consumable and technical solutions, including: • Reagents and QIAGEN’s proprietary QCII software to complete Next Generation Sequencing (NGS) validation in house. • The rollout will include QIAGEN’s QIAseq targeted DNA Pro Sample to Insight solutions for NGS Oncology and customized inhouse data analysis tools to provide sample to result service for GTG customers Announcement – Globe Newswire Feb 1 2023
[insert revenue structure and agreement types] Product list Medical & Payer Business to Business (B2B) GeneType Priority Pathway to Market Health Economic modeling completed by ALVA10* Certifying reimbursable testing platform: BRCA test & LYNCH Syndrome test A plan curated for: Payers / Insurers* Primary Care Physicians, Specialists, Surgeons, Concierge Medicine Groups geneType Multi-test NGS platforms with Germline, Carrier Screening and NIPT BRCA test & LYNCH Syndrome test Revenue Drivers Partners Products * Corporates and Insurance market entry assessment in progress and Health Economic Model being completed by ALVA10. 12 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: • Humana – 17 million lives covered • Aetna – 22.1 million live covered • Independence Blue Cross – 3 million lives covered Smaller payers such as employer groups have potential to move quickly BIM validates the benefits of implementing geneType
Economic Modeling in the US Payer System1 The economic benefit to the payers in the US is US$1.4B per annum $73 US Payor system will save per patient per year 69% - 74% overall increase in women getting screened 6.8%-9.2% Supplemental screening frequency 14.8% - 8.8% Interval Cancers drop 57% - 67% Early-stage cancer detection 1 Corporates and Insurance market entry assessment - Health Economic Model completed by ALVA10 May 2022. 3.6% in annual savings to a payer system in the screening and treatment of breast cancer. 13
[insert revenue structure and agreement types] Product list [insert revenue structure and agreement types] Product list PHASE 1 Brand Re-Ignition DTC - Growth strategy for EasyDNA Brand Refresh Multi-brand Portfolio EasyDNA Brand Refresh Test Rationalization Website Refresh Website Development First-party data collection Targeted Messaging Improve User experience and engagement PHASE 2 Revenue and Growth Focus Improved Lead Gen Google Ads Facebook Ads Content & Email Marketing Influencer Marketing & Testimonials New Sales Channels Amazon store front Target B2B customer segments New Markets 14
eCommerce Growth strategy for EasyDNA 15
Thank you Investor Relations Adrian Mulcahy Market Eye – Automic Group M: +61 438 630 422 E: adrian.mulcahy@automicgroup.com.au 16 www.linkedin.com/company/genetype-limited www.genetype.com
Appendices 17
Dr. Lindsay Wakefield MBBS Non – Executive Director Mr. Peter Rubinstein BEc, LLB Chairman Non – Executive Director Dr. Jerzy “George” Muchnicki MBBS Non-Executive Director Mr Nick Burrows B.Comm, FAICD, FCA, FGIA, FTIA, F Fin Non – Executive Director Simon Morriss GAICD Chief Executive Officer Richard Allman BSc, PhD Scientific Advisor Tony Di Pietro B. Comm, CA, AGIA, MAICD CFO & Company Secretary Carl Stubbings Chief Commercial Officer Erika Spaeth PhD Director of Clinical & Scientific Affairs Board and Management: Sales and Scientific expertise leading GTG 18
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 Strong Scientific Leadership: Advisory Board 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. 19
• Net cash outflow of A$7.2 million for the nine months to 31 March 2023. We continue to grow EasyDNA and Affinity DNA brand sales and develop and commercialise our geneType tests • Cash reserves will be directed to: • to support the commercialisation of the GeneType Multi Risk test through the B2B channels with payers, insurers and employers in the United States and expand into Europe; • to drive new market opportunities in reimbursable categories by leveraging our strategic relationship with QIAGEN; • for funding product research and development; • to increase our sales and marketing presences and drive of its tests via the consumer-initiated testing platforms; • to execute the go to market, sales and marketing to launch the Comprehensive Hereditary Breast and Ovarian Cancer Risk Test as part of our germline genetic testing division; and • for other working capital and general corporate purposes. A$’000 31-March-23 31-March-22 Change Net operating cashflow (7,249) (6,152) -18% Receipts from customers 6,687 4,626 45% Cash 10,481 11,350 -8% 1 Based on cashflow projections 20 Financial Overview
BNY Mellon, 71% Board & Management , 5%, Other, 24% BNY Mellon Board & Management Other Top 50 share registry breakdown Financial Information Share price (AUD) as at 25 April 2023 0.3c ADR price (USD) as at 25 February 2023 $1.06 Ord Shares on Issue (M) 11,542 ASX 52-week trading (AUD low/high) 0.2/1.3c Nasdaq 52-week trading (USD low/high) 0.86/1.82 Market Cap (A$M/US$M) 34.6/19.0 Cash at 31 March 2023 A$10.5m Cash at 30 June 2022 A$11.7m Debt (30 June 2022 and 31 March 2023) nil Dual Listed on the ASX and Nasdaq Corporate Overview 21
4 Patents granted in the US • Patent No: US 11,257,569, Methods of assessing risk of developing a severe response to Coronavirus infection • Patent No: US 11,072,830, Methods for breast cancer risk assessment • Patent No: US 10,683,549, Methods for assessing risk of developing breast cancer • Patent No: US 10,920,279, Methods for assessing risk of developing breast cancer 2 Patents granted in PRC (China & HK) • Patent No. 201080033130.5 Methods for Breast Cancer Risk Assessment • Patent No. 201580063966.2 Methods for assessing risk of developing breast cancer 9 Patent families pending • Breast cancer risk assessment • Methods for assessing risk of developing prostate cancer • Methods for assessing risk of developing ovarian cancer • Methods of assessing risk of developing a severe response to Coronavirus infection • Methods of assessing risk of developing a disease • Methods for assessing risk of developing breast cancer • Improved methods for assessing risk of developing breast cancer • Methods of assessing risk of developing breast cancer • Methods for assessing risk of developing colorectal cancer Our Intellectual Property 22 * Patents granted are specific to the GeneType portfolio of products
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 23

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GENE Presentation

  • 1. Genetic Technologies – Investor Webinar The Future: Unlocking personalised preventative medicine 27 April, 2023 Authorised by the Board of Directors of Genetic Technologies Limited ASX: GTG NASDAQ: GENE
  • 2. 2 World leading portfolio 2 Most comprehensive guideline driven portfolio for human and animal health. • Patented GeneType Multi Risk Test • Non-Invasive Prenatal Testing (NIPT) • Carrier screen testing • Pharmacogenomics • Oncogenetic diseases • Pet care Revenues anchored by our 3 brands to seize a multi Billion-dollar opportunity.
  • 3. [insert revenue structure and agreement types] Product list [insert revenue structure and agreement types] Product list [insert revenue structure and agreement types] Product list 3 Comprehensive genomics-based testings via a multi-brand strategy Direct to Consumer Testing (DTC) with no medical supervision Consumer initiated testing (CIT) with medical supervision Medical & Payer Business to Business (B2B) Oncology – GTG Cardiovascular Prenatal NIPT Carrier testing Clinical & Molecular Metabolic Expanded Carrier testing & NIPT Oncology – MultiTest Cardiovascular – MultiTest Metabolic – MultiTest COVID Rick Test Pharmacogenomics Ancestry Paternity Health & Wellbeing Pharmacogenetics Animal Drug testing Relationship DNA Storage
  • 5. Snapshot and Achievements last 12 months 5 ✓ 9 Tests NOW commercially available in the US the geneType Multi-Risk test ✓ >100 medical practices on-boarded launching the foundation of geneType Hubs in Australia ✓ Presentations by Dr Erika Spaeth at: ✓ ASCOGI Cancers Symposium Jan 2023 ✓ San Antonio Breast Cancer Symposium, ✓ Precision Medicines leaders summit ✓ Precision Medicine World Conference ✓ Completed 2 Acquisitions ✓ NEW EasyDNA Website ready for launch ✓ NEW eCommerce Platform ready launch ✓ Launch Carrier Testing and Non-Invasive Prenatal Tests (NIPT) into Europe ✓ Partnering in India with stud farms extending paternity infrastructure into the equine industry ✓ Launch DNA storage solution in GTG NATA approved facility ✓ Independently developed Budget Impact Model (BIM) identifies US$1.4 billion dollars in annual saving by ALVA 10 ✓ 11 Active payer conversations ✓ Progress on US Payer meetings to enable coverage across millions of lives ✓ 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 ✓ Partnerships with Australian Breast Care Centre and Dr Nicole Yap ✓ Launch of screening for breast cancer risk with Prof Bruce Mann at Royal Women’s Hospital in Melbourne ✓ 5 Peer reviewed publication in 6 months ✓ Published in PLOS ONE ✓ Published in Journal or Precision Medicine ✓ Published in European Journal of Cancer prevention ✓ Published in journal Breast Cancer Research and Treatment ✓ 25 Patents granted or pending ✓ 3 more papers under review ✓ Gained NATA and CMS-CLIA accreditation and certification for 6 polygenic risk score tests ✓ Successful ARTG notification to TGA for company IVDs for all tests on the multi- risk test GeneType commercialization EasyDNA & Affinity DNA Reimbursement activation Partnerships Clinical Validity and IP Strategy Laboratory Capability
  • 6. half-year ending December 31, 2021 Delivering Revenue and Growth – Q3 FY23 $1,967 $2,232 $4,626 $6,687 Q3 FY22 Q3 FY23 YTD FY22 YTD FY23 Cash Receipts (A$'000) Strategic & Operational Highlights: • March Quarter FY23 receipts A$4.22 million • Cash receipts from customers A$2.2m +13% on last year; • R&D Tax Incentive of A$1.96m was received in Q3 2023 • YTD receipts from customers A$6.69 million up 45% on prior year • 7 consecutive qtrs. of growth on prior year Q3 CASH RECEIPTS A$2.2m GROSS MARGIN A$1.13m March GROSS MARGIN 49% +2ppts 6 CASH BALANCE A$10.5m* *As at 31 March 2023 # All revenues for the period ‘21 & ‘22 are 'out of pocket' our strategy for reimbursement should become effective in 2023 FY 45% Growth on LY • Launched Melanoma, Pancreatic Cancer and Atrial Fibrillation in U.S. • Back to Back peer reviewed publications demonstrating Genetype for Breast cancer identifies MORE at risk patients then the current standards • Presentations at ASCO Gi Cancers Symposium in San Francisco
  • 7. Commercialisation of the geneType suite of multi-risk tests Our FOCUS Core ‘4’ Commercialisation of the geneType suite of multi-risk tests Demonstrate clinical validity & clinical utility of geneType tests Innovation: Next Generation of capability – Starting with Epigenetics EasyDNA & Affinity DNA Revenue Growth: Tests, Channels. & Markets Execute the B2B commercialisation of the geneType multi-risk test 7
  • 8. NEW Comprehensive Breast and Ovarian Cancer test Evaluates a woman’s risk of developing Breast and/or Ovarian Cancer in women 30 years+ • 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. (Announced Feb 3, 2023) • GTG’s unique approach “appends” the detection of the 13 major “actionable” Breast and Ovarian cancer susceptibility genes to the GeneType test platform. • Advances the goal of providing population-based genetic screening where up to 85% of cancers diagnosed do not have hereditary or family history • Showcase at BRCA 2023 in Montreal 1 https://www.breastcancer.org/facts-statistics Announcement - Globe Newswire 5% - Hereditary Cancer with known pathogenic variant BRCA1/2 85% - GeneType Patented integrated Breast and Ovarian Risk test 10% - Familial cancer with no known pathogenic variant
  • 9. [insert revenue structure and agreement types] Product list NEW – 9 Diseases now available in the US 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 annum4 for the US payer 9 Phase 1 Launch 2 GeneType Multi- test covers >70% of mortality & morbidity Phase 2 Launched – US March 20233 1. TGA, FDA and EU regulatory approval granted to the sponsor, DNA Genotek 2. Commercial availability in Australia and the US since Q1 CY2022 3. Commercial availability in the US and waiting on NATA Approval for Australia 4. Budget Impact Model prepared by Alva10 Breast Cancer Colorectal Cancer Prostate Cancer Melanoma Pancreatic Cancer Ovarian Cancer Oncology Cardiovascular Atrial Fibrillation Coronary Artery Disease Metabolic Type 2 Diabetes Diseases Areas One report. Two risk scores. Actionable results
  • 10. Cancer Prevention Research Validation of an abridged breast cancer risk prediction model for the general population1. Spaeth EL, Dite GS, Hopper JL, Allman R. European Journal of Cancer Prevention A combined clinical and genetic model for predicting risk of ovarian cancer2 Dite GS, Spaeth E, Murphy NM, Allman R. Breast Cancer Research and Treatment Validation of a breast cancer risk prediction model based on the key risk factors: family history, mammographic density and polygenic risk3 Allman R, Mu Y, Dite GS, Spaeth E, Hopper JL, Rosner BA. NEW – 3 Peer Review Publications Released Our Scientific team continues to achieve scientific publication milestones, with 3 publications accepted in three peer-reviewed journals during the quarter 10 1. https://pubmed.ncbi.nlm.nih.gov/36862830/ 2. https://pubmed.ncbi.nlm.nih.gov/36503897 3. https://pubmed.ncbi.nlm.nih.gov/36749458/ Guideline driven, Actionable results 3 NEW Peer reviewed Publications in the latest Qtr
  • 11. NEW Strategic Alliance with Qiagen The alliance will establish and develop a ‘Centre of Excellence’ facility in Australia QIAGEN will support the enhancement of GTG capabilities through software, hardware, consumable and technical solutions, including: • Reagents and QIAGEN’s proprietary QCII software to complete Next Generation Sequencing (NGS) validation in house. • The rollout will include QIAGEN’s QIAseq targeted DNA Pro Sample to Insight solutions for NGS Oncology and customized inhouse data analysis tools to provide sample to result service for GTG customers Announcement – Globe Newswire Feb 1 2023
  • 12. [insert revenue structure and agreement types] Product list Medical & Payer Business to Business (B2B) GeneType Priority Pathway to Market Health Economic modeling completed by ALVA10* Certifying reimbursable testing platform: BRCA test & LYNCH Syndrome test A plan curated for: Payers / Insurers* Primary Care Physicians, Specialists, Surgeons, Concierge Medicine Groups geneType Multi-test NGS platforms with Germline, Carrier Screening and NIPT BRCA test & LYNCH Syndrome test Revenue Drivers Partners Products * Corporates and Insurance market entry assessment in progress and Health Economic Model being completed by ALVA10. 12 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: • Humana – 17 million lives covered • Aetna – 22.1 million live covered • Independence Blue Cross – 3 million lives covered Smaller payers such as employer groups have potential to move quickly BIM validates the benefits of implementing geneType
  • 13. Economic Modeling in the US Payer System1 The economic benefit to the payers in the US is US$1.4B per annum $73 US Payor system will save per patient per year 69% - 74% overall increase in women getting screened 6.8%-9.2% Supplemental screening frequency 14.8% - 8.8% Interval Cancers drop 57% - 67% Early-stage cancer detection 1 Corporates and Insurance market entry assessment - Health Economic Model completed by ALVA10 May 2022. 3.6% in annual savings to a payer system in the screening and treatment of breast cancer. 13
  • 14. [insert revenue structure and agreement types] Product list [insert revenue structure and agreement types] Product list PHASE 1 Brand Re-Ignition DTC - Growth strategy for EasyDNA Brand Refresh Multi-brand Portfolio EasyDNA Brand Refresh Test Rationalization Website Refresh Website Development First-party data collection Targeted Messaging Improve User experience and engagement PHASE 2 Revenue and Growth Focus Improved Lead Gen Google Ads Facebook Ads Content & Email Marketing Influencer Marketing & Testimonials New Sales Channels Amazon store front Target B2B customer segments New Markets 14
  • 15. eCommerce Growth strategy for EasyDNA 15
  • 16. Thank you Investor Relations Adrian Mulcahy Market Eye – Automic Group M: +61 438 630 422 E: adrian.mulcahy@automicgroup.com.au 16 www.linkedin.com/company/genetype-limited www.genetype.com
  • 18. Dr. Lindsay Wakefield MBBS Non – Executive Director Mr. Peter Rubinstein BEc, LLB Chairman Non – Executive Director Dr. Jerzy “George” Muchnicki MBBS Non-Executive Director Mr Nick Burrows B.Comm, FAICD, FCA, FGIA, FTIA, F Fin Non – Executive Director Simon Morriss GAICD Chief Executive Officer Richard Allman BSc, PhD Scientific Advisor Tony Di Pietro B. Comm, CA, AGIA, MAICD CFO & Company Secretary Carl Stubbings Chief Commercial Officer Erika Spaeth PhD Director of Clinical & Scientific Affairs Board and Management: Sales and Scientific expertise leading GTG 18
  • 19. 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 Strong Scientific Leadership: Advisory Board 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. 19
  • 20. • Net cash outflow of A$7.2 million for the nine months to 31 March 2023. We continue to grow EasyDNA and Affinity DNA brand sales and develop and commercialise our geneType tests • Cash reserves will be directed to: • to support the commercialisation of the GeneType Multi Risk test through the B2B channels with payers, insurers and employers in the United States and expand into Europe; • to drive new market opportunities in reimbursable categories by leveraging our strategic relationship with QIAGEN; • for funding product research and development; • to increase our sales and marketing presences and drive of its tests via the consumer-initiated testing platforms; • to execute the go to market, sales and marketing to launch the Comprehensive Hereditary Breast and Ovarian Cancer Risk Test as part of our germline genetic testing division; and • for other working capital and general corporate purposes. A$’000 31-March-23 31-March-22 Change Net operating cashflow (7,249) (6,152) -18% Receipts from customers 6,687 4,626 45% Cash 10,481 11,350 -8% 1 Based on cashflow projections 20 Financial Overview
  • 21. BNY Mellon, 71% Board & Management , 5%, Other, 24% BNY Mellon Board & Management Other Top 50 share registry breakdown Financial Information Share price (AUD) as at 25 April 2023 0.3c ADR price (USD) as at 25 February 2023 $1.06 Ord Shares on Issue (M) 11,542 ASX 52-week trading (AUD low/high) 0.2/1.3c Nasdaq 52-week trading (USD low/high) 0.86/1.82 Market Cap (A$M/US$M) 34.6/19.0 Cash at 31 March 2023 A$10.5m Cash at 30 June 2022 A$11.7m Debt (30 June 2022 and 31 March 2023) nil Dual Listed on the ASX and Nasdaq Corporate Overview 21
  • 22. 4 Patents granted in the US • Patent No: US 11,257,569, Methods of assessing risk of developing a severe response to Coronavirus infection • Patent No: US 11,072,830, Methods for breast cancer risk assessment • Patent No: US 10,683,549, Methods for assessing risk of developing breast cancer • Patent No: US 10,920,279, Methods for assessing risk of developing breast cancer 2 Patents granted in PRC (China & HK) • Patent No. 201080033130.5 Methods for Breast Cancer Risk Assessment • Patent No. 201580063966.2 Methods for assessing risk of developing breast cancer 9 Patent families pending • Breast cancer risk assessment • Methods for assessing risk of developing prostate cancer • Methods for assessing risk of developing ovarian cancer • Methods of assessing risk of developing a severe response to Coronavirus infection • Methods of assessing risk of developing a disease • Methods for assessing risk of developing breast cancer • Improved methods for assessing risk of developing breast cancer • Methods of assessing risk of developing breast cancer • Methods for assessing risk of developing colorectal cancer Our Intellectual Property 22 * Patents granted are specific to the GeneType portfolio of products
  • 23. 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 23