GENE Genetic Technologies Ltd

Genetic Technologies Limited (ASX:GTG; NASDAQ:GENE, ”Company”, “GTG”), a global leader in guideline-driven genomics-based testing in health, wellness and serious diseases, is pleased to provide an update on the company activities for the quarter ending 30 September 2023.

Highlights:

• Partnership signed with the Gold Coast Private Hospital (a member of Healthscope), to establish a Precision Medicine Clinic at the hospital.
• GeneType Multi-Test granted approval for Pancreatic Cancer, Melanoma, and Atrial Fibrillation in Australia.
• Medical Research Future Fund (MRFF) grant names GTG as sole industry partner for trial to assess multi cancer genetic risk assessment in general practice.

• Receipts from customers was A$2.0 million, in line with the prior quarter and corresponding period (pcp).
• Peer-reviewed research paper validates geneType’s Pancreatic Cancer risk test, showing a nearly 50% improvement to the traditional clinical risk score in identifying patients at high risk of developing pancreatic cancer.
• Environmental, Social, and Governance (ESG) reporting commenced with the development of a baseline report addressing 21 core metrics set by the World Economic Forum (WEF).

Commenting on the Company’s quarterly performance, Chief Executive Officer Simon Morriss said: “the team has had an exceptionally busy quarter executing on key foundational objectives outlined in the comprehensive strategic review linked to our core revenue drivers and importantly our pathway to profitability.”

Key Achievements During the Quarter

Precision Medicine Pilot Partnership signed with The Gold Coast Private Hospital

GTG announced a partnership with the Gold Coast Private Hospital (GCPH), a member of Healthscope, to establish a Precision Medicine Clinic at the hospital. Gold Coast Private Hospital is a 336 bed, 22 theatre hospital and home to leading doctors and surgeons from around the world. The goal of precision medicine is to target the right treatments to the right patients at the right time. Utilising GTG’s geneType Multi-test and Pharmacogenomics (PGx) tests will be an important step in improving health outcomes for GCPH’s patients.

The partnership will be initiated with a 50-patient pilot study to establish workflow and patient reporting, with the study utilising geneType Multi-risk test combined with PGx tests, providing a comprehensive wellness profile for GCPH patients. Patient recruitment has commenced and positive outcomes could enable the rollout of additional Precision Medicine Clinics throughout the Healthscope network. Healthscope is Australia's only national private hospital operation and healthcare provider with a network of 42 hospitals that service every state and territory with approximately 19,000 employees.

geneType granted approval for Pancreatic Cancer, Melanoma, and Atrial Fibrillation in Australia

In September the Company announced that the expanded geneType Multi-Risk Test, to include pancreatic cancer, melanoma, and Atrial Fibrillation (AFib), was approved for sale in Australia by the National Association of Testing Authority (NATA). In March 2023, the expanded test was granted approval for sale by the Centers for Medicare & Medicaid (CMS) for the U.S. market.

The geneType Multi-Risk Test now performs a total of nine individual serious disease risk assessments, all from the one simple saliva sample. The risk assessment panel focuses on Oncology, Cardiovascular and Metabolic diseases, including: Breast Cancer, Ovarian Cancer, Pancreatic Cancer, Prostate Cancer, Melanoma, Colorectal Cancer, Diabetes, Coronary Artery Disease, and Atrial Fibrillation.

The expanded Multi-test panel caters for most ethnicities over the age of 301. Each of the new diseases recently approved cause significant mortality and morbidity. According to the Australian Institute of Health and Welfare, in 2023 there will be approximately 10,639 new cases of melanoma, Australia’s third most diagnosed cancer. The estimates for pancreatic cancer are even more dire. In Australia it is estimated that 2,355 people will be diagnosed with pancreatic cancer during 2023 and a staggering 87% of these people will die. For both of these cancers, identifying people at increased risk provides an opportunity for early diagnosis and early intervention, leading to a significant improvement in patient outcomes, extending life expectancy, and saving lives. In the case of AFib, surveys and studies on sections of the Australian population suggest that AFib affects approximately 2% of the general population, equivalent to more than 500,000 people.

MRFF Grant names GTG as Sole Industry Partner

During the quarter GTG were named as sole industry partner for a Medical Research Future Fund (MRFF) Genomics Health Futures Mission Grant. The grant is to be awarded to a group of renowned national and international research and charity organisations. The grant will provide funding for the CASSOWARY Trial: a randomised controlled trial of the clinical utility and cost-effectiveness of a multi-cancer polygenic risk score in general practice. GTG is the national research partner for the trial, which is to be led by Professor Jon Emery. Results from the trial are expected to change the way risk is assessed and reshape the standard of care in general practice for serious disease. The trial results will inform future policy including the 5-year goal for the Australian Cancer Plan to use genomics for risk-stratified cancer screening. Results of this study could lead to a revision of national guidelines and improve risk stratification for four of the most common cancers in Australia; breast, colorectal, prostate, and melanoma. The study will recruit nearly 600 participants from eight general practices across Victoria. As the sole industry partner, GTG will receive funding to cover the supply of test kits and the analysis of the sample returned.

Peer Reviewed Paper Publication: A Breakthrough for Early Detection of Pancreatic Cancer

During the quarter a further peer reviewed paper validating geneType as an invaluable risk assessment tool was published. 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. The paper is authored by GTG’s scientific team including Dr Erika Spaeth, Dr Gillian Dite and Dr Chi Kuen Wong along with co-authors Dr Richard Allman and Dr Nicholas Murphy. GeneType’s Pancreatic Cancer risk assessment test showed a nearly 50% improvement to the traditional clinical risk score of identifying patients at a high risk of developing pancreatic cancer.

Pancreatic cancer has a very high mortality rate, approximately 76%2 of those diagnosed will die within 1 year. The five-year survival rate is only 9%3. Identifying those at-risk will enable doctors and their patients to increase surveillance and be proactive in their efforts to prevent the development of cancer. Pancreatic cancer has the poorest 5-year survival rate of any major solid tumour, but when diagnosed at an early stage, survival rates improve.

Genetic Technologies commences ESG Reporting

Recognising the Company responsibility to contribute to good corporate citizenship, GTG is pleased to announce that it has commenced its Environmental, Social, and Governance (ESG) reporting with the development of a baseline report addressing 21 core metrics set by the World Economic Forum (WEF) in their standardised and globally recognised Stakeholder Capitalism Metrics ESG framework. The report is available on the company’s website at www.genetype.com/investor-centre/governance/. This is the start of the GTG ESG reporting journey. The Company will commence a quarterly review of the baseline report, with improvements in reporting to come as our experience grows.

Enquiries

Investor RelationsAdrian MulcahyAutomic MarketsM: +61 438 630 411E: Adrian.mulcahy@automicgroup.com.au

About Genetic Technologies Limited

Genetic Technologies Limited (ASX: GTG; Nasdaq: GENE) 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. GTG 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. For more information, please visit www.genetype.com

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1 Cardiovascular and metabolic risk assessments start at age 40; cancers start at age 30.2 https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6396775/3 https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6396775/