Appendix 4C & Quarterly Business Update – March 2024

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Launching our most comprehensive test and expanding into new global markets

MELBOURNE, Australia, April 30, 2024 (GLOBE NEWSWIRE) -- Genetic Technologies Limited (ASX:GTG; NASDAQ:GENE, ”Company”, “GTG”), a global leader in guideline-driven genomics-based testing in health, wellness and serious diseases, releases its Appendix 4C and Quarterly business update for the quarter ending 30 March 2024 (Q3 FY24).

Key highlights:
  • Cash Receipts totalling A$1.8m for the quarter ending March 2024.
  • Launched targeted digital strategy for geneType CIT Sales in the United States, driving the highest level of brand engagement ever seen.
  • Demonstrating clinician adoption – the Company has seen an increase commercial samples for the geneType portfolio of over 500%, compared to the prior corresponding 6 month period.
  • Initiated a pilot study which includes geneType Breast Cancer Risk Assessment Test in Breast Imaging Centres across the U.S.
  • Shareholders approved the Company to raise up to $15 million at the Extraordinary General Meeting held on 20 March 2024.
  • Launching “Know Your Risk” event in Pasadena California in May co-hosted by world renowned Breast Surgeon Dr Kristi Funk and CEO Humanise Health Krystal Barter.
  • Announced the development of the geneType Comprehensive Risk Assessment Test building on the success of the Comprehensive Hereditary Breast and Ovarian Cancer (HBOC) test including more than 200 high penetrant genes.
  • Post quarter activities - Closed US$2M registered direct offering subsequent to the end of the quarter, issuing 30 million shares in accordance with prior shareholder approval.

Commenting on the Company’s quarterly performance, Chief Executive Officer Simon Morriss said:

“The team is making remarkable progress, especially in unlocking areas such as the pathway to profitability, largely driven by the growing acceptance of geneType in Australia and the USA.

Additionally, our new digital marketing efforts are delivering unprecedented levels of consumer engagement, and we are poised to significantly boost sales in the near future.

The continuous rise in geneType adoption, coupled with enhanced brand engagement, is not only steering the company towards our profitability goals, but also positively impacting lives by identifying individuals at risk of diseases earlier, improving health outcomes for millions worldwide.”

Operational HighlightsSignificant Increase in Volume of Commercial Sales and Volume of GeneType Tests GTG is seeing the growing adoption of geneType with Health Care Practitioners (HCPs) in more than 12 U.S. states, Canada and nationally in Australia. Commercial tests received for the 6 months ending March 31, 2024 increased by more than 500%, when compared with the same period last year, demonstrating the company is well on the pathway to profitability. This adoption and clinical utility demonstrate clinicians’ commitment to offering an improved standard of care to patients and willingness to adopt new technology into clinical practice.

U.S Customer Digital Media Sales Campaign In February the Company announced the launch of a wide-reaching Direct to Consumer (DTC) digital advertising campaign in the United States. This comprehensive program will drive Consumer Initiated Testing (CIT) for the company’s geneType Risk Assessments Tests. The campaign commenced at end of March 2024 and will scale up throughout the remainder of the year. The U.S. DTC wellness testing market is projected to reach $4.9 billion by 2032 from $878.9 million in 2022 with annual growth rate of 18.86%1. GTG’s strategy ensures the company’s geneType Risk Assessment test portfolio will be able to access this rapidly growing market segment in the U.S.

Established GeneType Pilot Study in US Breast Screen Imaging CentresGTG is establishing a clinical implementation study with leading breast imaging centres in New York, Miami and Houston. The initiative will pilot the integration of the geneType into breast imaging centres, assisting in the streamlining of care and moving the geneType Breast Cancer Risk Assessment Test into routine use in these centres.

Launch of Comprehensive Risk Assessment TestIn March the Company announced the development of the company’s most advanced risk assessment test for serious diseases, building on the success of the Comprehensive Hereditary Breast and Ovarian Cancer (HBOC) test. This innovation will be a world first, including over 200 high penetrant genes to unlock the hereditary disease risk added to its current multi-test associated with the most common cancers, cardiovascular disease and type 2 diabetes. The new test enables doctors to identify nearly 100% of people at risk of disease going; beyond family history, which is only responsible for 5-15%. Importantly, the test includes sporadic non-hereditary disease which is linked to the remaining 85% of people.

Capital Management

At an extraordinary general meeting of the Company held on 20 March 2024, shareholders provided approval for the Company to raise up to $15 million by the issue of securities to institutional and otherwise exempt investors.

On 26 March 2024, the Company announced it had secured a $600k short-term loan facility with Radium Capital to provide additional working capital. This represented 80% of the estimated R&D Tax Incentive for the six months to 31 December 2023. The loan is secured against the R&D Tax Incentive refund for the 2024 financial year and will attract an interest charge of 1.33% per month.

Subsequent to the end of the quarter, on 23 April 2024 the Company announced the closing of a US$2 million registered direct offering for the purchase and sale of 1,000,000 American Depositary Shares (“ADSs”), each representing 30 ordinary shares of the Company, at a purchase price of US$2.00 per ADS. In addition, the Company issued warrants to purchase up to 1,000,000 ADSs. The warrants have an exercise price of US$2.00 per ADS, are exercisable upon issuance and will expire five years following issuance.

Financial and Cashflow Overview

At the end of March 2024, the Company had A$1.8 million in cash and cash equivalents. Cash receipts from customers for the quarter were A$1.83 million. Cash outflow for operating activities was A$2.6 million.

During the quarter, the Company made A$98k of payments to related parties of the entity, and their associates, disclosed at item 6.1 of the Appendix 4C. The payments related to director and consulting fees (inclusive of GST) on normal commercial terms.

Authorised for release by the Board of Genetic Technologies Limited

Enquiries

Simon MorrissChief Executive OfficerE: investors@genetype.com

About Genetic Technologies Limited

Genetic Technologies Limited (ASX: GTG; Nasdaq: GENE) 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. GTG offers cancer predictive testing and assessment tools to help physicians to improve health outcomes for people around the world. The company has a proprietary risk stratification platform that has been developed over the past decade and integrates clinical and genetic risk to deliver actionable outcomes to physicians and individuals. Leading the world in risk prediction in oncology, cardiovascular and metabolic diseases, Genetic Technologies continues to develop risk assessment products. For more information, please visit www.geneType.com

Forward Looking Statements

This announcement 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. As 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 with the ASX 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 https://www.businesswire.com/news/home/20230308005478/en/United-States-DTC-Direct-to-Consumer-Wellness-Testing-Market-Report-2023-A-4.946-Billion-Market-by-2032---The-Shift-from-Physician-Focused-to-a-Consumer-Focused-Healthcare-Industry-Bodes-Well---ResearchAndMarkets.com 

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Source: Genetic Technologies Ltd

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