Genetic Technologies Reports Q1 FY22 Results

Genetype MultiTest submitted for regulatory approval as commercialization plans gather momentum increase in cash receipts over prior quarter

MELBOURNE, Australia, Oct. 25, 2021 (GLOBE NEWSWIRE) — Genetic Technologies Limited (ASX: GTG; NASDAQ: GENE, “Company”, “GTG”), a global leader in Genomics based tests in health, wellness and serious disease provides its results for its first quarter of fiscal year 2022, ended September 30, 2021.

Highlights

• Cash receipts of A$850k, a material increase on the prior quarter
• Acquired, settled and integrated the acquisition of EasyDNA, the primary channel for the increase in cash receipts for the quarter, for US$4 million in cash and scrip
• Completed and submitted NATA validation pack for the Multi-Test; a final step prior to the commercial launch. The Multi-Test is a Predictive Panel Risk Test to cover six common cancers which account for ~70% of annual morbidities. Phase one launch to include Breast Cancer, Colorectal Cancer, Prostate Cancer, Ovarian Cancer, Coronary Artery Disease and Type-2 Diabetes.
• Invested in collaborative study to enable expanded Breast Cancer risk testing for populations of African American descent addressing underlying and underserved need to include diverse population studies within risk testing protocols and applications
• Published peer-reviewed paper titled “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) on PLoS
• Strong cash balance of A$15.7 million providing 24 months of runway post the integration and revenue contribution from EasyDNA
• Net cash used for operations of A$1.9 million, due mainly to the increase in R&D and operating expenses as the Company executes on its commercialisation strategy

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

Over the quarter, the Company has continued to invest in its product development through the self-funded study in collaboration with the Institute of Public Health in St Louis, and continued progress with the Multi-Test with the post period end completion of the validation pack which has been submitted to NATA for approval. This is one of the final steps prior to commercial release of the test.

Commenting on the quarter, CEO Simon Morriss stated: “This past quarter demonstrates the forward trajectory and momentum Genetic Technologies has established. We have built our product roadmap and our deliverables and are now positioned to execute on driving sales and product awareness in the months and years ahead. With the acquisition of EasyDNA we can fast track consumer awareness of our product portfolio with the ability to include consumer-initiated testing products on these platforms, subject to local jurisdictions restrictions and requirements.

“We continue to innovate and have engaged with a number of notable institutions over the quarter which will pay rewards in the coming periods as we nurture these initiatives and relationships. Additionally, we are pleased to report the delivery of our preliminary revenue generation from the acquisition of EasyDNA contributing A$850k in customer receipts for the quarter. Alongside the established relationship with IBX we are confident that we are well resourced and appropriately positioned to drive forward with our objectives. We continue to demonstrate our transition from a pure R&D company to execute on commercialisation and deliver revenue growth in the coming periods.”

Commercialization and Product Overview

The Company’s strategy to commence commercialization and enhance the 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.

Additionally, GENE are engaging in sales via medical professionals for business-to-business (B2B) purposes and direct-to-consumer (DTC) testing requiring no medical supervision for products under consideration including non-medical based genetic and gut microbiome testing, subject to regulatory approval and target market assessment.

GENE now have distribution coverage of the Australian and US geographies and have identified Europe and the UK as the next regions the Company intends to enter. 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.

The core products for release include GENE’s geneType for Breast Cancer, geneType for Colorectal Cancer and the COVID-19 Risk Test. The 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 as part of the first phase is on track for release later this calendar year.

The three-year co-exclusive licence agreement between IBX and GENE was announced on March 3, 2021 for the production, distribution, sales and marketing of GENE’s COVID-19 Risk Test in the US continues with further discussions underway. This includes discussions on opportunities to expand the products offered and consideration of further geographical opportunities given IBXs extensive network.

Research and Publications

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 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.

Additionally, GENE have committed to fund a collaborative study with Professor Graham Colditz, Deputy Director of the Institute for Public Health, Washington University in St. Louis. The purpose of the study is to incorporate further research and data on women of African descent to provide expanded testing capabilities for the geneType for Breast Cancer product. Polygenic risk models are required to be validated for use with multiple ethnicities and therefore GENE will be validating samples which have both genotype information and the relevant clinical information to cover this expanded population.

This investment will be self-funded by GENE with costs estimated to be A$110k which will be partially offset by an R&D tax rebate estimated to be 43.5% of the costs associated with the study. The initial sample set will contain ~1,000 samples and it is anticipated to require around nine months of research and processing at GENE’s Melbourne laboratory.

Professor Colditz is a world-renowned figure in breast cancer epidemiology and risk modelling, with notable genotype datasets on the African American population held by the Institute for Public Health. Given the multi-ethnic landscape (particularly in the USA) in which risk models may be used in clinical practice, it is important to understand how the risk model performs in these populations. The lifetime probability of developing non-hereditary breast cancer is 11.5% (1 in 9) for the African American population in the USA¹.

The Company remains committed to investing in product development and enhancement through continued research and validation through peer-reviewed publications. GENE continues to advance its strategic objective to provide the most comprehensive preventative risk tests for common complex disease.

Outlook

Commenting on the outlook, Simon Morriss stated: “In one quarter we have transformed the business and are positioned to drive significant revenue growth in the coming months and years. We are only at the beginning of this journey and have the right team, platform and resources to execute on our growth plans.

“The challenging operating environment in Australia is coming to a close and we are grateful to be able to start operating on a more wholistic basis and invest in our marketing and sales initiatives globally. We are well placed to relaunch the geneType branding globally ahead of more normal trading conditions allowing us to accelerate our commercialisation plans.”

We expect revenue growth in the December 2021 quarter will continue to show a material uplift with the Company scheduled to commercially release its Multi-Test at the end of the calendar year.

Authorised for release by the Board of Genetic Technologies Limited.

About Genetic Technologies Limited

Genetic Technologies Limited (ASX: GTG; Nasdaq: GENE) is a diversified molecular diagnostics company. GTG 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.gtglabs.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.

Investor Relations Contact:
Dave Gentry / CEO
RedChip Companies Inc.
1-800-RED-CHIP (733-2447) or 407-491-4498 (cell)
Dave@redchip.com

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1} Cancer Facts & Figures for African Americans 2019-2021, American Cancer Society