Genetic Technologies Rapidly Accelerating Commercialization Plans

MELBOURNE, Australia, July 26, 2021 (GLOBE NEWSWIRE) — Genetic Technologies Limited (NASDAQ: GENE, “Company”, “GTG”), a global leader in Genomics based tests in health, wellness and serious disease, is pleased to provide its Quarterly Business Update to the market.

Highlights

• Revenues from customers of A$99k in the quarter (unaudited), up from A$6k in Q3, including receipt of first month IBX sales
• Confirmed launch of COVID-19 Risk Test by Infinity Biologix in the US
• Confirmed grant of US Patent No 11,031,098 – ‘Computer Systems and Methods for Genomic Analysis’ (ASX Announcement on 11 June 2021)
• Post quarter end acquisition of EasyDNA for US$4 million; strategically, this direct-to-consumer acquisition provides the foundation to grow the portfolio of serious disease tests across well-established websites in 40 countries
• Strong cash balance of A$20.8 million as at 30 June 2021 provides runway to fund commercialization opportunities and continued product development
• Net cash used for operations of A$2.12 million, an increase on the prior quarter (Q3 FY21: A$1.08 million) due mainly to the increase in R&D and operating expense of A$353k and receipt in Q3 of the R&D tax incentive receipt for A$763k
• Appointment of Carl Stubbings as Chief Commercial Officer and commencement of Mike Tonroe as Chief Financial Officer

Simon Morriss, CEO of Genetic Technologies, stated, “Genetic Technologies is moving rapidly into the commercialization of its products with the launch of its COVID-19 Risk Test in May and the post quarter end announcement of the acquisition of EasyDNA.”

“This acquisition provides a direct-to-consumer platform and strong alignment with GTG’s planned expansion into health and wellness testing across well-established websites in 40 countries. This alignment was critical to our decision to acquire the brand and assets of EasyDNA,” continued Morriss.

Commercialization Update

Launch of COVID-19 Serious Disease Risk Test

The three-year co-exclusive licence agreement between IBX and GTG was announced on 3 March 2021 for the production, distribution, sales and marketing of GTG’s COVID-19 Risk Test in the US with the product launch at the end of May 2021. Revenues in the quarter from the IBX agreement were A$95k.

Commercialization Strategy for Broader Product Portfolio

The Company has previously outlined its key avenues for commercialization which currently include the consumer-initiated online sales and marketing platform (CIT) available in Australia and the US. With the recent inclusion of EasyDNA the Company intends to leverage this direct-to-consumer (DTC) platform to enhance the visibility and awareness of its existing products globally.

Additionally, GTG is engaging in business to business (B2B) sales via medical professionals and now has distribution coverage of the Australian and US markets. The Company is assessing the CE certification requirements for its products and have identified Europe and the UK as the next regions the company intends to enter.

Product Overview and Regulatory Progress

GeneType Comprehensive Risk Assessment Test (Multitest)

GTG’s Polygenic Risk Score (PRS) products under development will ultimately be offered as part of the GeneType Multitest, which will provide risk assessment for greater than 70% of all morbidities including Breast Cancer, Colorectal Cancer, Cardiovascular Disease, Type 2 Diabetes, Melanoma and Prostate Cancer. The Multitest will leverage the foundational IP granted under US Patent 7,127,355 – ‘Methods for Genetic Analysis’. Recent advances in the Prostate Cancer and Melanoma Tests have identified informative polygenic risk scores that could enhance predictability with the Company intending to release initial findings by the end of CY21.

The overall strategy for the Multitest is focused on precise risk assessments for the most common preventable diseases. Future iterations of the test will include the Company’s germline hereditary cancer testing products which are currently under development.

GeneType Breast Cancer and Colorectal Cancer Screening and Germline Testing Platform

GTG continues to progress the development of its Germline Testing division for hereditary testing. The initial BRCA and Lynch Syndrome tests, that align with GTG’s GeneType products in market for Breast Cancer and Colorectal Cancer respectively, are anticipated to launch by the end of CY21. These hereditary tests increase coverage from 85% under standalone polygenic risk up to 100%¹ of known risk coverage when combined with GTG’s PRS testing. BRCA and Lynch Syndrome tests also have existing reimbursement codes, which provides a clear pathway to monetization and an opportunity to bundle with their associated PRS tests.

The Company continues to engage in discussions with Medicare to enable the Company to secure a rebate for PRS tests conducted. This remains a longer-term objective and is expected to support distribution through the B2B channel.

Predictix by Taliaz

GTG highlighted the Predictix by Taliaz product at the General Practice Conference and Exhibition (GPCE) in Sydney in mid-May 2021 with solid feedback and are progressing discussions on partnerships to advance the distribution and sales of the product in Australia and New Zealand. In addition, the Taliaz product will be incorporated into GTG’s Multitest.

Research and Publications

GTG continues to focus on publications of relevant content for submission to peer-reviewed journals.

The Company confirms the below article, authored by GTG employees, was made available online by Cambridge University Press on 2 July 2021.

‘Development and validation of a clinical and genetic model for predicting risk of severe COVID-19’ authored by Dite, Murphy and Allman;

The Dite, Murphy and Allman article outlines the outcomes from the analysis of an updated dataset of 2,205 cases and 5,416 control patients. The increased sample numbers have enabled separation into test and validation datasets, a key requirement for commercialization.

Post quarter end acquisition of EasyDNA

GTG signed an agreement to acquire the brand and distribution rights for EasyDNA from BelHealth for US$4 million. The EasyDNA acquisition will provide GTG the platform to build its direct-to-consumer offerings and wellness division. This acquisition provides an established revenue stream with US$4.63 million in unaudited revenue for CY20 and the ability to leverage existing direct-to-consumer marketing avenues.

The agreement provides for the acquisition of all brands, websites and reseller agreements associated with EasyDNA. This includes over 70 websites in 40 countries and six brand identities. EasyDNA revenue contributions are strongly weighted to five countries: Australia, UK, France, Canada and the US, where it received 68% of its CY20 revenue, with the UK as the largest market contributing 20% of total revenue. EasyDNA has current agreements with 12 NATA and associated international certified laboratories.

Morriss commented, “We look forward to integrating the EasyDNA team into our business and working closely with them to continue to build upon their existing product portfolio and the brand recognition they have already achieved. EasyDNA is a leader in paternity testing and animal genomics, and their breadth of available products also extends into the important wellness category, providing multiple highly attractive growth opportunities for GTG moving forward.”

GTG will be onboarding EasyDNA’s existing team, retaining the skills and expertise of its employees based in Malta and Australia. This includes the retention of Kevin Camilleri, founder and CEO of EasyDNA, who will be heading up GTG’s Direct to Consumer Division following the completion of the acquisition expected to occur by 31 July 2021.

Corporate Update

The Company has recently appointed Carl Stubbings to the role of Chief Commercial Officer. Carl rounds out the leadership team for GTG with considerable experience commercialising diagnostic products. Based in the USA for 13 years, he served as Senior Vice President for Panbio USA Ltd and Vice-President of Sales and Marketing for Focus Diagnostics, a subsidiary of Quest Diagnostics, one of the world’s largest pathology laboratories. More recently he was Chief Operating Officer of ASX listed BARD1 Life Sciences having successfully facilitated the merger with Sienna Cancer Diagnostics as its CEO and Managing Director.

Investor Webinar

The Company will provide an update on its results and recent acquisition and hold an investor webinar on Tuesday 27 July 2021 at 7:30pm EDT.

To participate on the quarterly investor webinar, please register at:

https://us02web.zoom.us/webinar/register/WN_ntdVwrJPQkeM0XszdzUvXQ

After registering, you will receive a confirmation email containing information about joining the webinar.

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

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¹ Source: “An integrated clinical and genetic model for predicting risk of severe COVID-19” available at: https://www.medrxiv.org/content/10.1101/2020.09.30.20204453v1.full.pdf