Genetic Technologies Signs Multi-Year US Distribution Agreement for COVID Risk Test

MELBOURNE, Australia, March 04, 2021 (GLOBE NEWSWIRE) -- Genetic Technologies Limited (ASX: GTG; NASDAQ: GENE, “Company”, “GTG”), a diversified Genomics and AI-driven preventative health business is pleased to announce a co-exclusive production and distribution rights and license agreement (‘Agreement’) with US-based Infinity BiologiX LLC (‘IBX’), a leading central laboratory providing sample collection and processing, storage, analytical services, and scientific and technical support, for the production, distribution and sale of the Company’s COVID-19 Serious Disease Risk (sdr) Test (‘COVID-19 Risk Test’) in the United States.

Highlights

• Initial three-year co-exclusive licence agreement between IBX and GTG for the production, distribution, sales and marketing of GTG’s COVID-19 Risk Test in the US, under the ‘powered by GeneType’ branding
• IBX is required to make minimum payments to GTG totaling US$2.9 million over the term to maintain exclusivity with an initial upfront payment of US$50k followed by minimum payments totaling US$850k in the first year and US$1.0 million in each of the second and third years¹
• IBX may terminate this agreement at any time and for any reason upon 60 days written notice to GTG with effect upon the expiry of the 60-day period
• IBX currently has the capacity to process over 100,000 COVID-19 Risk Tests per day across its two major labs and is well-positioned with an existing network of SARS-CoV-2 testing partners and associated medical practitioners across the US to be able to use GTG's COVID-19 Risk Test in conjunction with these existing third-party SARS-CoV-2 Tests
• Underlying royalty structure is on a per unit basis of US$10
• IBX will define and decide the sales and end-to-consumer pricing structure for the COVID-19 Risk Test

Genetic Technologies has secured a co-exclusive three-year agreement for the production, sale and distribution of its COVID-19 Risk Test across the United States with IBX, subject to IBX's rights to early termination on 60 days’ notice. The payment structure includes an initial upfront payment of US$50k followed by minimum payments totalling US$850k in the first year and US$1.0 million in each of the second and third years totalling a minimum US$2.9 million to maintain exclusivity.

IBX has three well-established labs, with two in New Jersey and one in Minnesota and a network of COVID-19 testing partners, with access to testing sites across the country providing a clear pathway for the sale and distribution of GTG’s COVID-19 Risk Test.

GTG’s COVID-19 Risk Test may enable the risk assessment of an individual developing a serious disease should they contract the COVID-19 virus. The COVID-19 Risk Test is intended to predict ‘disease severity’ using a combination of genetic and clinical information.

Simon Morriss, CEO of Genetic Technologies, stated: "We are excited to be partnering with IBX, to enable our COVID-19 Risk Test to be introduced commercially into the COVID-19 product landscape in the US. This agreement is a significant milestone for GTG representing the first multi-year commercial agreement the Company has entered into for the sale and distribution of one of its developed products.

“Our COVID-19 Risk Test is a crucial product that will provide individuals with the ability to understand their personal risk associated with contracting a serious case of this disease. Alongside existing treatment options and vaccines, we believe this test will enable more insightful decisions for states, workplaces and individuals on pathways forward in managing this pandemic.”

IBX is a market-disrupting central laboratory supporting academia, government, and industry. IBX provides global sample collection, processing, storage, and analytical services integrated with scientific and technical support in both the research and clinical arenas. As a leader in biomaterials, IBX provides support to the development of diagnostics, therapeutics, and research in the genomics, precision, and regenerative medicine arenas.

IBX launched its COVID-19 saliva-test in May 2020, after receiving FDA Emergency Use Authorization. It was the first test to utilize saliva as the primary biomaterial for SARS-CoV-2, and IBX subsequently became the first company to offer an at-home collection with this approach.

“We view this initial agreement for the sale and distribution of Genetic Technologies’ COVID-19 Risk Test as a critical collaboration in line with our mission to understand the genetic causes of common, complex diseases and to discover diagnoses, treatments and, eventually, cures for these diseases,” explained Robin Grimwood, IBX Chief Executive Officer, “We are uniquely and strategically positioned with our partners to deliver the test and provide remote telehealth services and reporting, utilizing our extensive array capability and capacity across a number of platforms. We were proud to offer the first COIVD-19 PCR saliva test last spring and now see the Risk Test as an important next step with providing patients with the information they need to make the best decisions possible for their own health, their family’s health and the health of their community.”

Peter Rubinstein, Chairman of GTG stated: “This agreement is a testament to the hard work of the team both at IBX and within GTG who have navigated challenges and a changing landscape to ensure we can deliver this product to market and provide a valuable resource in the fight against COVID-19. We look forward to a long and fruitful relationship with IBX as we collaborate to bring this valuable resource to market in the fight against COVID-19.

“Our head of strategic partnerships, Adam Kramer, was critical in driving this agreement through his strong relationships within IBX and his incredible passion to bring new, innovative, and transformative healthcare technologies and advancements to market.

“We also recognise and applaud the significant contribution of our Scientific Team, headed by Dr Richard Allman, our Medical Team now headed by Dr George Muchnicki and Kathy Koskiris heading our Regulatory Team for their ongoing dedication to refining and improving our COVID-19 Severity Predictor to enable us to be at this critical juncture for the Company.

“We value and recognise the long-term and significant support we have received from our shareholder base throughout these past months and years and are thrilled to be delivering on our strategic objective outlined to the market at the start of this COVID journey.”

The GTG team is in final stages to submit the COVID-19 Risk Test for clearance from Clinical Laboratory Improvement Amendments (CLIA) and will update the market when clearance is received.

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

About Infinity BiologiX LLC:

Infinity BiologiX (IBX) is a market-disrupting next-generation central laboratory supporting academia, government, and industry. IBX provides global sample collection, processing, storage, and analytical services integrated with scientific and technical support in both the research and clinical arenas. As a leader in biomaterials, IBX provides support to the development of diagnostics, therapeutics, and research in the genomics, precision, and regenerative medicine arenas. IBX previously operated as RUCDR Infinite Biologics before spinning off from Rutgers University-New Brunswick in August 2020

For more information, visit www.ibx.bio

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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¹Subject to certain payment provisions allowing IBX to average sales volumes over subsequent quarters