GENE Genetic Technologies Ltd

Genetic Technologies Limited (NASDAQ: GENE, ASX: GTG) (“GENE” or the “Company”), a global leader in genomics-based tests in health, wellness and serious disease provides its year to date results for the nine months ended March 31, 2022.

Key Highlights

• Year to date growth in revenue of 475%
• Cash receipts of A$2 million in quarter 3, an increase of 9% on the prior quarter, and mainly comprising EasyDNA product sales
• GeneType Multi-Risk Test received NATA accreditation and CMS certification
• Phase 1 of geneType Multi-Risk Test launched for physicians targeting 50% of annual mortalities and morbidities in six serious diseases including: breast cancer, colorectal cancer, prostate cancer, ovarian cancer, coronary artery disease and type-2 diabetes
• US Patent granted for COVID-19 Risk Test, enabling GENE to expand commercialization opportunities
• Leveraging EasyDNA acquisition by progressing a ‘One company two brands’ strategy
• Launched our Virtual Sales Rep (VSR) with Hahn Healthcare in Australian General Practice with sales supporting the creation of our geneType Hubs
• Sound cash balance of A$11.43 million, providing 21 months runway for investing in growth initiative

Genetic Technologies is in a strong position, with important progress made during the March ’22 quarter on two of the Company’s core geneType growth products. The geneType Multi-Risk Test receiving approval for commercial release, while the US Patent Office granted a US patent for the geneType COVID-19 Risk Test.

CEO Simon Morriss stated: “These approvals mark an important step for the Company to initiate the commercialization of the Multi-Risk Test to physicians in Australia and the USA. We are also very pleased to announce the granting of a US patent for our COVID-19 Risk Test, which provides a strong foundation for the ongoing commercialization of this test to provide improved outcomes for patients at risk of developing severe COVID-19 disease.”

The Future of Precision Medicine – Genetic Multi-Risk TestDuring February 2022, the Company’s geneType Multi-Risk Test received simultaneous NATA accreditation and CLIA certification from the US Centers for Medicare and Medicaid Services (CMS). These critical approvals have enabled the commercial launch of Multi-Risk Test and represents an important step towards the development of personalized, preventative healthcare, enabling patients and their healthcare professionals to develop a long-term health plan.

The Company’s strategy to commence commercialization and enhance the product distribution network is well underway. The initial launch phase will focus on risk assessments for six serious diseases that together represent around half of all annual morbidities in the US5: Breast Cancer, Colorectal Cancer, Prostate Cancer, Ovarian Cancer, Coronary Artery Disease and Type-2 Diabetes. The tests will be available to purchase individually or as a bundle. Additional disease candidates will follow in planned future phases.

Game-Changing Commercialization and Reimbursement Strategies for GeneTypeReimbursement - USAGENE has engaged US based consulting company, ALVA10, to determine the level of evidence required for US payers (e.g. Medicare and large US employer groups) to provide coverage for diagnostic tests. ALVA10 is in the final stages of developing a Budget Impact Model (BIM) that can translate our geneType breast cancer risk assessment test into a format that can be assessed within the US healthcare system. This is our first step towards obtaining US payers coverage, which would be a ‘game-changing’ achievement for GENE, facilitating and accelerating broad adoption of geneType.

Initial feedback from the BIM shows implementation of the geneType breast cancer risk assessment test increases supplemental screening and an increase in early-stage detection from 54% to 61% of cases, with potential savings of US$83k per patient by moving from a cancer stage (2b or later) to earlier stage diagnosis. The BIM will be completed in the coming quarter, including the drafting of a manuscript in support of reimbursement and commercialization model for payers and insurers to review.

Australian Sales StrategyHahn Healthcare has been engaged and launched our Virtual Sales Rep (VSR) in the Australian General Practice with sales management support targeting 2,000 general practice clinics with > 6 GPs which represent > 80% of all consultations. Our goal is to develop clinical practices into 40-50 “geneType Hubs”. With the support of our clinical and medical team, we have developed an “Early Access Program” enabling clinical practices to offer their first 10 patients testing at no-charge. GENE is optimistic that the combination of geneType’s strong predictive clinical utility and Hahn Healthcare’s deep reach into Australian medical centers will accelerate adoption and drive growth of the test in the Australian market.

US Patent Office Grants Patent for COVID-19 Risk TestDuring the March 2022 quarter, GENE was granted a US patent for the geneType COVID-19 Risk Test covering the proprietary technology incorporated in the test. This marks an important step for the Company to secure commercial opportunities for the geneType COVID-19 Risk Test, which predicts disease severity by using genetic and clinical information to provide a risk score that can be used to understand a person’s risk of contracting a serious case of COVID-19.

According to the Centers for Disease Control and Prevention, only 71.2% of the US population is fully vaccinated, leaving approximately 95 million Americans partially or completely unvaccinated. The test could assist people to better understand their risk of severe disease, while providing those who are vaccinated with an understanding of the necessity to obtain a booster if they are at high risk of severe disease. In the coming quarter, our Scientific team is preparing manuscripts for publication to support clinical validity for each of the tests in the phase 1 launch of the Multi-Risk Test.

OutlookCommenting on the forward outlook, Simon Morriss stated, “We are very pleased with the progress made over the last quarter in achieving approvals for Multi-Risk Test and the patent for the COVID-19 Risk Test. Quarter four focus will be on the significant opportunity of our geneType product suite; continuing to demonstrate the clinical validity and utility of the geneType tests in the healthcare sector; and EasyDNA sales growth by expanding our product offering through new markets and channels.”

Investor Relations                                 Hugh Morgan                                        Market Eye                                         M: +61 407 453 109                                 E: hugh.morgan@marketeye.com.au                

About Genetic Technologies Limited Genetic Technologies Limited (NASDAQ: GENE; ASX: GTG) 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’s Polygenic Risk Scores (PRS) platform is a proprietary risk stratification platform developed over the past decade integrating clinical and genetic risk delivering actionable outcomes from physicians and individuals. Leading the world in risk prediction in Oncology, Cardiovascular and Metabolic diseases. Genetic Technologies continues to develop a pipeline of risk assessment products.

For more information, please visit www.genetype.com

______________________________1 National Association of Test Authorities, Australia2 US Centers for Medicare and Medicaid Services3 Excludes A$1.44m R&D Tax Incentive received on April 2, 20224 Based on latest Company cashflow projections5 https://www.cdc.gov/nchs/fastats/leading-causes-of-death.htm