GENE Genetic Technologies Ltd

Genetic Technologies Limited (ASX:GTG; NASDAQ:GENE,” Company”, “GTG”), a global leader in guidance-driven genomics-based tests in health, wellness and serious diseases releases its Quarterly business update for the quarter ended 31 December 2022 (Q2 FY23).

Highlights:

Qtr 2 Receipts from customers were A$2.4 million, up 15% compared to prior quarter and up 32% compared to prior year
YTD Receipts from customers total A$4.45 million up 67% on prior year
Revenue of A$2.2 million for the quarter, underpinned by the introduction of new distribution channels in the U.S.
6 consecutive quarters of revenue growth on the prior year for EasyDNA & AffinityDNA
R&D Tax Incentive of A$1.96 million expected Q3 2023
Ten active engagements with U.S. payer groups, with a combined coverage of 42 million lives, including insurers, payers, and Key Opinion Leaders (‘KOL’s)
Invited to India as guests of MedAchievers to explore GeneType MultiTest launch strategy
Advancing Innovation; Epigenetics and precision oncology collaboration with the University of Melbourne on track

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

“The continued momentum in our business is exciting with 6 consecutive quarters of growth where today we have presence in more than 40 countries with more than 50 tests on offer via our global network of partner laboratories.

Looking ahead we remain focussed on securing further growth and revenue uplift for our core brands, GeneType, EasyDNA and AffinityDNA. We see the combination of KOL support, the progress with commercialization plans in Australia and success with our engagement with the key payer groups in the U.S. as important underpinning revenue drivers. We are building a strong presence and support with KOL’s as we push to develop our new channels to market. Further, we continue to meet important milestones both from a scientific point of view, but importantly from a commercial perspective.

Importantly, we are continuing to challenge our go to market strategies for all our brands, to continue our revenue growth and improve profitability.”

Growing EasyDNA & AffinityDNA

EasyDNA & AffinityDNA’s revenue base continues to grow, achieving a sixth consecutive quarter of prior year revenue growth to record A$2.2 million in Q2 FY23, an increase of 15% on the previous quarter. This result reflects the early success of commercial initiatives during the past year, but importantly the growing market presence in the U.S.

Further, EasyDNA has focused on expanding the Direct-to-Consumer channel, with our new EasyDNA website and eCommerece platform the targeted to launch in February 2023. The relaunch of EasyDNA’s website will streamline the purchasing process, improve overall customer experience, increase brand awareness, and boost online sales revenue.

GeneType commercial progress

GTG has a core focus on initiatives that will be key to growing the adoption of the company’s GeneType platform and securing commercial success for GTG’s Business to Business (B2B) strategy. The GeneType platform is underpinned by 27 patents, 18 of which are granted patents, ensuring maximum protection of GeneType sales in key markets.

We have actively engaged with U.S. payer groups to gain reimbursement, this is key to obtaining wider adoption in the U.S. market and accelerating a step change in GTG’s revenue growth of GeneType’s risk assessment test. The Company is leveraging its’ Budget Impact Model (BIM), which demonstrates substantial health economic benefits from the implementation of GeneType, as a core initiative underpinning this B2B strategy. Currently, GTG has more than ten active engagements underway with U.S. payers. These payers have total coverage of 42 million people. GTG is also targeting smaller niche payers such as employer groups, with the goal of developing commercial pilot studies with one or more of these groups during the second half of FY 2023. These commercial pilot studies have the goal of highlighting the benefits of adopting the GeneType test. Executing one or more commercial pilot programs will be a significant milestone and will represent an important value inflection point for the Company.

Critical to the clinical implementation has been the deliberate focus of engaging with Key Opinion Leaders (KOL) in the U.S., who are leaders in their relative field and actively supporting the implementation of risk assessment tests. GTG believes their support will help build partnerships with new medical practices, accessing a wider group of patients. These KOL’s include:

• Dr Joel Evans - MD, a board certified obstetrician- gynaecologist (‘OB/GYN’) and international lecturer, is the director of The Center for Functional Medicine in Stamford, CT. He has a special interest in breast cancer, and, is the medical director of the “Keep A Breast Foundation” which brings the latest information on cancer risk assessment and prevention to his patients. 
• Dr Carolyn Young is an OB/GYN in Rockville, Maryland and is affiliated with multiple hospitals in the area, including Johns Hopkins Medicine-Suburban Hospital and Adventist Healthcare Shady Grove Medical Center.
• Dr Lisa Larkin is a board-certified internist practicing internal medicine and women’s health since 1991. She is the Founder and CEO of Ms. Medicine, LLC, a national membership organization for women’s health clinicians and a concierge women’s health primary care network.

Through increasing sales efforts and general practitioner (GP) partnerships in Australia, with the sales efforts of GTG’s Virtual Sales Rep (VSR) and face-to-face engagements, via the MedLab Medical Science Liaison personnel, GTG has established over 90 medical practices in Australia who are actively evaluating the GeneType platform with their patients. Some of these medical practices have initiated the referral of patients on a commercial basis, with the Company expecting revenue growth from these initiatives to continue as more of these practices move to routine implementation of GeneType tests.

In addition, GTG is also continuing to build partnerships with other key users including:

• Dr Nicole Yap at the The Australian Breast Care Centre
• A/Prof Charles Siles, providing immediate access to more than 1,000 referring primary care physicians
• Prof Bruce Mann at Royal Women’s Hospital for the Melbourne Launch of screening for breast cancer risk

GTG showcasing the clinical validity and clinical utility of GeneType risk assessment tests

In the past quarter, the Company has published three separate peer-reviewed papers in scientific journals and presented at prestigious medical conferences. These events increase the awareness among medical physicians, validate the benefits of the GeneType tests, and ultimately support the adoption of the GeneType platform.

GTG’s Director of Clinical and Scientific Affairs, Dr Erika Spaeth, presented at the prestigious American Society of Clinical Oncology Gastroenterology Cancer Symposium (ASCOGI) in January 2023. Her presentation demonstrated significant improvement in identifying patients at risk of colorectal cancer by expanding the number of Single Nucleotide Polymorphisms (SNPs) genetic markers, a key component in GeneType risk assessment tests for colorectal cancer.

In addition, GTG released several publications showing GeneType as an enabling predictor of breast cancer, ovarian cancer, cardiovascular disease (CVD) and type 2 diabetes.

These publications were:

• “Polygenic risk scores for cardiovascular diseases and type 2 diabetes” published in PLOS ONE1  
• “A combined clinical and genetic model for predicting risk of ovarian cancer” published in the European Journal of Cancer Prevention2
• “Integrating Personalized Medicine into Preventative Care through Risk Stratification” published in the Journal of Precision Medicine 3

Building our GeneType Brand

A number recent of media events have been undertaken to continue to build the brand awareness of geneType. These included a segment on channel 7 News http://youtu.be/21SoDP8PTxg, a Webinar in which GTG’s Director of Medical Affairs, Dr Erika Spaeth, interviewed Associate Professor Charles Siles on the utility of geneType Breast Cancer Risk Assessment Test https://www.youtube.com/watch?v=Xmwn-WYFIeE, and an interview with GTG’s CEO, Simon Morriss, that aired on Bloomberg US https://youtu.be/YPBOPf8tPDE.

Financial and cashflow overview

At the end of December 2022, GTG had A$5.0 million in cash and cash equivalents. Cash outflows used in operating activities were A$2.8 million. Cash receipts from customers for the quarter were A$2.4 million, primarily driven by EasyDNA and AffinityDNA product sales. At the end of December 2022, GTG had 1.86 quarters of cash. The December cash balance does not include receipt of the R&D Tax Incentive for the 2022 financial year which is expected to result in a refund of A$1.96 million. Adding this to the December cash balance, the company’s cash runway extends to 2.5 quarters.

Payments to related parties of the entity and their associates for the quarter were $68k as disclosed in Item 6.1 of the Appendix 4C.

To support the Company’s continued investment in its core brands, GeneType, EasyDNA and AffinityDNA, and to secure further revenue growth, the Company expects to raise further equity. The Board are currently in discussions with equity advisors and will provide a further update to the market as appropriate.

Authorized 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. 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.

1 https://journals.plos.org/plosone/article?id=10.1371/journal.pone.02787642 https://journals.lww.com/eurjcancerprev/Fulltext/9900/A_combined_clinical_and_genetic_model_for.27.aspx   3 https://www.thejournalofprecisionmedicine.com/wp-content/uploads/integrating-personalized-medicine-preventive-care.pdf

A photo accompanying this announcement is available at https://www.globenewswire.com/NewsRoom/AttachmentNg/5822605b-29d2-4899-a78f-879bdf77da53

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