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Gene Presentation October 2019
Genetic Technologies Limited is a company focused on developing genetic risk prediction platforms for major diseases, utilizing collaborations with esteemed universities and medical institutions. Their clinically validated tests, such as for breast and colon cancer, aim to enhance patient outcomes through targeted screening and prevention strategies. With a strong IP portfolio and partnerships with leading research organizations, they are positioned to advance precision medicine and improve health care efficiency.
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Gene Presentation October 2019
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- 2. Forward looking statements Thispresentation may contain forward-looking statements within the meaning of Section 27A of the U.S. Securities Act of 1933 and Section 21E of the U.S. Securities Exchange Act of 1934 with respect to the financial condition, results and business achievements/performance of Genetic Technologies Limited and certain of the plans and objectives of its management. These statements are statements that are not historical facts. Words such as “should”, “expects”, “anticipates”, “estimates”, “believes” or similar expressions, as they relate to Genetic Technologies Limited, are intended to identify forward-looking statements. By their nature, forward-looking statements involve risk and uncertainty because they reflect Genetic Technologies’ current expectations and assumptions as to future events and circumstances that may not prove accurate. There is no guarantee that the expected events, trends or results will actually occur. Any changes in such assumptions or expectations could cause actual results to differ materially from current expectations. 2
- 3. Who we are •Spun out of the human genome project • Developing risk prediction platforms for major Oncological, Metabolic and degenerative diseases. • In collaboration with some the world’s most prestigious Universities and medical institutes. 3 Research and Development leader in the genomics sector • Delivering better outcomes at a lower cost to the patient and the medical system. • Specializing in Public Health initiatives and mass screening programmes • Supported by a robust IP portfolio Dual listed on the ASX (GTG) and Nasdaq (GENE)
- 4. Our vision 4 • Toidentify and manage patients who are at high risk of developing major life threatening diseases • To implement protective medical strategies through targeted screening, life style changes, chemoprophylaxis or surgical intervention where indicated • To utilise our powerful predictive / indicative technology as the cornerstone of a preventative medical system where early detection leads to cost effective and life saving outcomes
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- 6. Our genetic testpredicts a woman’s risk of developing breast cancer 6 GeneType for Breast Cancer is a first-to-market, clinically validated genetic risk assessment for non-hereditary (sporadic) breast cancer Simple cheek swab that helps determine a woman’s risk of developing breast cancer First test of its kind to be clinically validated to evaluate risk for sporadic breast cancer Validated for use in Caucasian, African American and Hispanic women over age 35
- 7. 7 Polygenic risk stratifiesrisk for women with or without family history
- 8. 8 Impact of polygenicrisk on Lifetime risk of breast cancer
- 9. Precision medicine 9 • 1in eight women will get breast cancer in their lifetime • Early detection leads to 99% survival with late stage IV having a 27% survival rate • Screening programs that test all women at the same intervals will be overscreening 7 women and underscreening 1 woman • Our risk assessment test offers health policy regulators and clinicians the potential for more efficient use of screening resources
- 10. Early detection =better outcomes 10 5 year survival rates dramatically improve when breast cancer is diagnosed before spreading to other parts of the body https://www.cancer.org/cancer/breast-cancer/understanding-a-breast-cancer-diagnosis/breast-cancer-survival-rates.html
- 11. Early diagnosis =less expensive treatment 11 Stage I $ 55,000 Stage II $103,000 Stage III and IVup to $150,000 First year treatment costs for breast cancer https://journals.plos.org/plosone/article/figure?id=10.1371/journal.pone.0207993.t001 USD, study based on US patients, 2003-2010
- 12. Targeted screening andprevention 12 More frequent mammograms or MRIs Selective estrogen receptor modulators (SERMs) or aromatase inhibitors (AIs) Weight loss, alcohol consumption, physical activity GeneTypeBC enables the targeting of limited resources to women who are most likely to develop breast cancer. Screening Medication Lifestyle
- 13. We are developingnew genetic risk assessment tests 13 * Tests are developed and market launch is scheduled. 2Q 2019 1Q 2020 3Q 2020 4Q 2020
- 14. 14 Product development strategyfocused on increasing population coverage for polygenic risk testing Targeted screening and prevention strategies are also appropriate for Type 2 Diabetes and Cardiovascular Disease
- 15. GTG’s enhanced breastcancer test covers 95% of women • 85% of women have no family history of breast cancer • 10% have a family history but no pathogenic variants, such as BRCA 15 Only 5% of women with breast cancer have a pathogenic variant, such as BRCA * Pathogenic variants include those in moderate and high penetration, including but not limited to ATM, BRCA1/2, BRIP1, CDH1, CHEK2, PALB2, PTEN, TP53. Our test covers 95% of women
- 16. GTG has developeda world-first polygenic risk test for colon cancer 16 Easy-to-use test solves the compliance problem Simple cheek swab test Report sent to your doctor Clinically actionable results Informs screening and health monitoring for those most at risk Risk stratification enables precision screening and personalised prevention 5-year, 10-year and lifetime risk
- 17. 17 Cumulative impact ofSNPs on colorectal cancer risk Jenkins MA, Makalic E, Dowty JG, et al: Quantifying the utility of single nucleotide polymorphisms to guide colorectal cancer screening. Future Oncol 12:503-513, 2016
- 18. 18 Distribution of lifetimeCRC risk stratified by polygenic risk and family history Jenkins MA, Win AK, Dowty JG, et al: Ability of known susceptibility SNPs to predict colorectal cancer risk for persons with and without a family history. bioRxiv:267666, 2018
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- 20. Development of CommercializationStrategy with TGen GTG and TGen will cooperate in the development of a commercialisation strategy and infrastructure development for a suite of polygenic risk tests to be made available in the US market. The collaboration will be wide in scope prioritising: • Phase 1 • Clinical Utility – Pilot Implementation Studies • Reimbursement Strategy • Phase 2 • Distribution Opportunities 20 MOU Signed
- 21. 21 Translational Genomics ResearchInstitute (TGen): Collaborative Network Collaborations with 427academic, medical, and industry partners worldwide (28 countries & U.S. territories) Spun out 16 companies Other: Government: Local, State (ADHS, CDPH), Federal (NIH, FDA, CDC), Philanthropy, Patients Health Care Partners: Community hospitals, health care systems, and oncology networks; >1000 physicians (Primary Care, Specialists, Medical Oncology, Surgeons) Background - Est. 2002 - Non-profit (501c3) - Patient-focused clinical & basic research - Pioneers in precision genomic medicine - Expertise includes: Clinicians, laboratory and computer scientists, data analysts, and business development - Joined City of Hope in Nov. 2016 Highlights - Performing personalized cancer treatment since circa 2008 - 1st polygenic risk score paper published in 2008 (NEJM) - Performing whole genome sequencing to inform cancer therapy since circa 2010 - 1st precision medicine trial for children’s cancer published in 2014 - Regularly conduct 1st in human clinical trials - Supercomputer built specifically for genomic applications - Developer and early adopter of paradigm shifting technologies Areas of Disease Focus - Oncology - Neurology - Rare Childhood Disorders - Diabetes - Infectious Disease Research Specialties - Population Genetics - Cancer Prevention and Early Detection - Rare (Childhood) Disease - Circulating Biomarkers - Quantitative Medicine - Infectious Disease - Tumor Profiling/Drug Selection - Clinical Trials Basic Computing to High Performance Computing Basic Data Analysis to Quantitative Medicine www.tgen.org
- 22. The Distribution Channel I.Major US Healthcare Systems Distribution opportunity: Health care system test availability II. National Cancer Centers Distribution opportunity: Testing of cancer patients an family members III. Physician networks Distribution opportunity: Physician test ordering IV. Large employers/Self-insured Distribution opportunity: Employee health and wellness programs 22 The TGen collaboration opens up a number of potential distribution channels:
- 23. V. Disease consortiums Distributionopportunity: Clinical validity and clinical utility studies VI. State Government Distribution opportunity: Public health department “endorsement;” Public policy; Clinical utility studies VII. Federal Government Distribution opportunity: Regulatory and or policy filings, requirements, or changes 23 The Distribution Channel
- 24. The Tgen ClinicalLaboratory 24 • Founded in 2011 • CLIA certified in 2013 • CAP certified 2014 • Provided some of the world’s first clinical studies for personalized cancer treatment • Spun out from TGen in 2014, provides commercial access to personalized cancer treatment via genomic profiling of DNA from tumor and normal biospecimens • Provides genomic testing for cancer centers across the US • In 2018, began serving City of Hope (Duarte, CA) Oncologists and Patients • Serves >70 U.S. cancer centers, hospitals, universities and laboratories
- 25. Collaboration is akey market advantage 25 The University of Melbourne • Australia’s peak research-intensive institution, ranked 32nd globally Professor John Hopper • PhD in Mathematical Statistics • NHMRC Senior Principal Research Fellow • Director (Research) of the Centre for Epidemiology and Biostatistics in the School of Population Global Health at The University of Melbourne • Published more than 700 papers Our collaboration with The University of Melbourne was awarded an NHMRC grant • Research investigation to assess the improvement in breast cancer risk prediction using polygenic risk • Led by Professor John Hopper • National Health and Medical Research Council is Australia’s peak funding body for cutting-edge research This work established GTG as a global leader in polygenic risk research and development
- 26. Research into clinicalapplications 26 GTG has an agreement in place with Memorial Sloan Kettering (MSK) and University of Cambridge • The research is led by Mark E. Robson, MD, Chief of Breast Medicine Service, Memorial Sloan Kettering • MSK is the world’s oldest and largest cancer treatment and research institution • Memorial Sloan Kettering was ranked second among hospitals specialising in cancer treatment in the US • The University of Cambridge’s UK Institute is a world leading cancer biotech centre GTG partners with world-leading research hospitals to develop the clinical use of polygenic risk scores in treatment decisions
- 27. Other key partnerships 27 OhioState University (Columbus, Ohio) • Research collaboration exploring polygenic risk as a means to more informed decision-making for women with BRCA mutations • Led by Amanda Toland, Director of Clinical Genetics and a leader in the field of breast cancer risk assessment Nurses’ Health Study • Harvard University prospective study of the risk factors for major chronic diseases in women • Collaborating with principle investigators to validate new risk models for breast cancer
- 28. Intellectual property isour advantage 5 Patents granted in the US • Patent Nos. 9,051,617; 9,068,229 and 9,702,011 covering three of the core genetic markers included in the BREVAGenplus® risk assessment test • Patent No. 7,127,355 offering broad protection re: methods of genetic analysis (the concept of combining clinical risk assessment with genetic risk factors to improve predictability over clinical risk assessment alone) • Patent No. 6,969,589 covering the identification of informative SNPs 28 GTG has a strong patent portfolio covering the breast cancer risk assessment test 5 Patents granted in China • Patent Nos. 200680051710.0; 201310524782.4; 201310524916.2 and 201310524765.0 “Markers for Breast Cancer” • Patent No. 201080033130.5 Methods for Breast Cancer Risk Assessment 5 Patents granted in Hong Kong • Patent Nos. 09101235.4; 12112875.1; 12112368.5 and 12112874.2 “Markers for Breast Cancer” • Patent No. 12109000.5 Methods for Breast Cancer Risk Assessment 7 Patent families pending • Methods for breast cancer risk assessment • Methods for assessing risk of developing breast cancer • Improved methods for assessing risk of developing breast cancer • Markers for breast cancer • Methods for genetic analysis • Methods for genomic analysis • Methods for assessing risk of developing colorectal cancer
- 29. Scientific authority 29 Dr. RichardAllman, Chief Scientific Officer • Strong publication record in genetic epidemiology across multiple disease categories • Collaboration for peer review and statistical validation BSc Microbiology, PhD Microbiology Honorary Fellow, Centre for Epidemiology and Biostatistics, The University of Melbourne • Over 20 years of scientific and research experience • Academic and commercial experience in research leadership, innovation management, and intellectual property strategy • Academic career encompassed oncology research, drug development, and assay design, with a particular interest in the linkage between onco-genetic profile and treatment response
- 30. Product strategy inChina 30 GTG has appointed Pacific Bridge Medical to advise on: • China market entry strategy • Chinese FDA Approval (Now known as National Medical Products Administration) • Distribution opportunities.
- 31. Next Steps inChina Develop collaborative relationships • Clinical validation • Regulatory approval • Commercial channels • Laboratory testing 31 Deliver the benefits of genetic screening • Go-to-market plan for additional genetic screening tests • Engagement with key opinion leaders • Collaboration with Chinese research organisations
- 32. 32 Thank you Dr GeorgeMuchnicki Executive Director and Interim CEO [email protected] www.gtglabs.com