GENE Genetic Technologies Ltd

Genetic Technologies Limited (ASX: GTG; NASDAQ: GENE, ‘Company’, ‘GENE’, ‘geneType’), a diversified Genomics and AI driven preventative health business, provides its results for the quarter ended December 31, 2021.

Highlights:

• Solid cash balance of A$13.5 million and increased customer receipts of A$1.8 million further extending runway for growth
• ‘One company two brands’ approach leverages EasyDNA acquisition with launch of the Multi-Test product
• Multi-Test technical validation complete and submitted to NATA1 and CMS2 for final regulatory approval ahead of the commercial release
• Multi-Test to address a burgeoning market determining personal risk of developing a range of serious diseases including:
  • breast cancer
  • colorectal cancer
  • ovarian cancer
  • prostate cancer
  • coronary artery disease
  • type 2 diabetes

• US patent application for novel geneType COVID-19 Risk Test has been accepted and cross validation study completed in independent cohort confirming test performance and utility
• Study of 200,000 participants presented at 2021 San Antonio Breast Cancer Symposium validating the risk model with an expanded panel of 313 Single Nucleotide Polymorphisms (SNPs)

• EasyDNA distribution network provides access to a significant addressable market with 70 websites in 40 countries and further engagement with IBX on the COVID-19 Risk Test
• COVID-19 Risk Test – expanded US patient access with new partnership agreement signed with 1Health and IBX. Cross validation study completed, independent cohort confirms test performance and utility. Emergence of new strains of COVID-19, such as Omicron, highlight the importance and utility of GENE’s COVID-19 Risk Test.

EasyDNA Acquisition and geneType Brand Launch

GENE announced the acquisition of EasyDNA in July 2021 and completed the settlement process in August 2021. The four months since settlement focused on the integration of our people, products and EasyDNA platform to deliver a “One Company-Two Brand” approach for GENE. This will drive a clearer marketing and engagement structure for new and existing products coming to market. Importantly, further integration will continue over the coming quarters as the Company works to further leverage and grow the existing network of 70 websites across 40 countries.

Overall, the Company is in a strong position with a portfolio of high-quality products both in the market and under development and a substantial international platform for the distribution of the Direct-to-Consumer product base via EasyDNA.

As part of the EasyDNA integration, the Company announced the launch of the geneType rebrand in November 2021. The geneType brand is the overarching business and brand, while the EasyDNA brand with its existing network, will represent the consumer facing brands and products and drive increased awareness of GENE’s product portfolio.

Total cash receipts for the quarter from EasyDNA were A$1.8 million in line with acquisition expectations. The Company is focused on further embedding the acquisition with the inclusion of the Multi-Test and expects to see continued solid growth in revenue across all brands and products.

Commercialization and Product Overview

The Company’s strategy to commence commercialization and enhance the product distribution network is well underway. Key avenues for commercialization of launched products currently include the consumer-initiated testing and online sales and marketing platform (CIT) available in Australia and the US. With the recent inclusion of the EasyDNA business the Company intends to leverage this platform to enhance the visibility and awareness of its existing products.

Core products for release include GENE’s geneType for Breast Cancer, geneType for Colorectal Cancer and the COVID-19 Risk Test with the commercial release of the Company’s Multi-Test to cover both Colorectal Cancer and Breast Cancer in addition to Prostate Cancer, Ovarian Cancer, Coronary Artery Disease and Type 2 Diabetes.

GENE now has distribution coverage in Australia and the US and has identified Europe and the UK as further expansion opportunities for the Company. The Company is assessing the European CE certification requirements for its products and will update the market on its progress within these regions as further clarity on timing is obtained. An Asian market entry for relevant products will also be assessed in due course.

Multi-Test Product Commercial Release

In late December 2021, the Company confirmed it is set to release phase one of its Multi-Test, subject to receiving final regulatory approval and confirms that all regulatory submissions to NATA and CMS have been completed. NATA completed their onsite audit of GENE’s Melbourne laboratory on December 15, 2021. The certifying body is preparing their final documentation on the audit in the coming weeks.

The phase one launch is the culmination of 10+ years of research and development and include Breast Cancer, Colorectal Cancer, Ovarian Cancer, Prostate Cancer, Coronary Artery Disease and Type 2 diabetes. The Company is now focused on finalizing commercial distribution opportunities via our EasyDNA brand and through our existing partner network with IBX, 1 Health and Vitagene.

The direct-to-consumer genetic testing market represents a significant growth opportunity for GENE, the total worldwide market is expected to grow from US$1.2 billion in 2020 to US$2.6 billion3 in 2025, an increase of US$1.4 billion. The growth of the DTC segment is driven by a number of factors including a broader understanding of the growing demand for disease risk analysis.

Of particular relevance to GENE’s Multi-Test development is the emergence of Precision Medicine and its ability to classify individuals into subpopulations that differ in their susceptibility to a particular disease. GENE’s Risk Assessment Tests are an important part of eliminating the traditional “one size fits all” approach, enabling preventive or therapeutic measures to be concentrated on patients who will gain the most benefit, significantly improving patient outcomes and health economics.

COVID-19 Risk Test

In December 2021, the Company announced a new partnership to expand access to the COVID-19 Risk Test in the US through its agreement with IBX and 1health on their ‘Vitagene’ platform directly from https://genetype.com/for-individuals/COVID-19/.

1health is a leading US-based cloud platform service provider for diagnostic test management. 1health has built infrastructure that helps laboratories, such as IBX and their customers, connect patients to testing and care. 1health’s services will be managed in partnership with IBX under our three-year co-exclusive licence agreement previously announced on March 3, 2021.

The Company has continued to expand and develop the geneType COVID-19 Risk Test, having recently completed a cross-validation study on a European data set confirming the test performance metrics. A paper describing the study has now been submitted to a peer-reviewed journal and will be released upon publication. The emergence of the Omicron variant underscores the importance of being able to identify those patients, whether vaccinated or not, who are at greater risk of developing severe disease.

The geneType COVID-19 Risk Test is designed to predict disease severity in people aged 18 and older, using genetic and clinical information providing a risk score that can be used to understand a person’s risk of contracting a serious case of COVID-19. In addition, employers, governments, and other public health entities may use the data to make informed decisions about disease risk, treatment options, and importantly guiding vaccination and booster priorities. According to the Centers for Disease Control and Prevention, as of January 15, 2022, only 74.9% of the US population had received at least one shot of a COVID-19 vaccine, leaving approximately 83 million Americans unvaccinated. The geneType COVID-19 Risk Test could assist these people to better understand their risk of severe disease, while providing those who are vaccinated (approximately 249 million people) with an incentive to obtain a booster if they are at high risk of severe disease.

Research and Publications

Over the quarter, the Company has continued to invest in its product development supporting a self-funded study in collaboration with the Institute of Public Health in St Louis, and continued progress with the Multi-Test slated for release in the coming months.

In December 2021, GENE’s Director of Clinical Affairs, Dr Erika Spaeth presented a poster at the San Antonio Breast Cancer Symposium. In her presentation, Dr Spaeth released new data that demonstrated a next generation version of the Company’s geneType Breast Cancer Test with an expanded panel of 313 SNPs showed improved discrimination and calibration over traditional clinical models. The study included over 200,000 women and highlighted GENE’s commitment to the ongoing development of geneType Breast Cancer Risk Test.

The Company is pleased to report a further peer-reviewed research publication entitled “Ability of known colorectal cancer susceptibility SNPs to predict colorectal cancer risk: A cohort study within the UK Biobank” Gafni A, Dite GS, Spaeth Tuff E, Allman R, Hopper JL (2021) was published on PLOS.

The study describes how the addition of a polygenic risk score to a family history model improves the stratification and discriminatory performance of both 10 year and full lifetime risk using a prospective population-based cohort within the UK Biobank.

Current screening guidelines in the UK, USA and Australia focus solely on family history and age for risk prediction, even though the vast majority of the population do not have any family history. The results support the view that a combined polygenic risk score and first-degree family history model could be used to improve risk stratified population screening programs.

Outlook

The Company remains focused on the commercialization opportunities for the Multi-Test, continued leveraging the EasyDNA brand and product suite to grow the revenue base, further investment in R&D to enhance our Multi-Test offering and COVID-19 Risk Test and continuing to remain at the cutting edge of genetic testing and preventative health.

Commenting on the forward outlook, Simon Morriss stated: “We are pleased with the progress made over this quarter and with the integration of the EasyDNA team while continuing to advance our product commercialization pathway opportunities.

Investor Webinar

The Company will provide an investor webinar to discuss the quarterly results. To register please follow the link below.

Date: Friday January 21, 2022Time: 9:30am AEDTRegistration Link: https://us02web.zoom.us/webinar/register/WN_YLLED0yxRHGiDMX6htX8jg

Investor Relations (AUS)	Investor Relations and Media (US)
Stephanie Ottens	Dave Gentry
Market Eye	1 800 RED CHIP (733 2447)
M: +61 434 405 400	Cell: 407 491 4498
E: stephanie.ottens@marketeye.com.au	E: dave@redchip.com

About Genetic Technologies Limited

Genetic Technologies Limited (ASX: GTG; Nasdaq: GENE) is a diversified molecular diagnostics company. GENE offers cancer predictive testing and assessment tools to help physicians proactively manage patient health. The Company’s lead products geneType for Breast Cancer for non-hereditary breast cancer and geneType for Colorectal Cancer are clinically validated risk assessment tests and are first in class. Genetic Technologies is developing a pipeline of risk assessment products.

For more information, please visit www.genetype.com

Forward-Looking Statements

This press release may contain forward-looking statements about the Company's expectations, beliefs or intentions regarding, among other things, statements regarding the expected use of proceeds. In addition, from time to time, the Company or its representatives have made or may make forward-looking statements, orally or in writing. Forward-looking statements can be identified by the use of forward-looking words such as "believe," "expect," "intend," "plan," "may," "should" or "anticipate" or their negatives or other variations of these words or other comparable words or by the fact that these statements do not relate strictly to historical or current matters. These forward-looking statements may be included in, but are not limited to, various filings made by the Company with the U.S. Securities and Exchange Commission, press releases or oral statements made by or with the approval of one of the Company's authorized executive officers. Forward-looking statements relate to anticipated or expected events, activities, trends or results as of the date they are made. Because forward-looking statements relate to matters that have not yet occurred, these statements are inherently subject to risks and uncertainties that could cause the Company's actual results to differ materially from any future results expressed or implied by the forward-looking statements. Many factors could cause the Company's actual activities or results to differ materially from the activities and results anticipated in such forward-looking statements as detailed in the Company's filings with the Securities and Exchange Commission and in its periodic filings in Australia and the risks and risk factors included therein. In addition, the Company operates in an industry sector where securities values are highly volatile and may be influenced by economic and other factors beyond its control.  The Company does not undertake any obligation to publicly update these forward-looking statements, whether as a result of new information, future events or otherwise, except as required by law.

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1 National Association of Testing Authorities, Australia2 Centers for Medicare & Medicaid Services3 https://www.technavio.com/report/direct-to-consumer-genetic-testing-market-size-industry-analysis&nowebp