Genetic Signatures Prepares for IPO: Prospectus now available

Exciting Australian Biotech offers Institutional & Retail Shareholders Access to Global $5.3B Molecular Diagnostics Market

Sydney, Australia – 18 November 2014: Genetic Signatures Ltd has launched its prospectus offering institutional and retail investors the opportunity to invest in the exciting growing global molecular diagnostics market prior to the Company’s listing on the Australian Stock Exchange on 23 December 2014.

Molecular diagnostics (MDx) is a modern technique increasingly used by hospitals and pathology labs to detect specific sequences of the genome, the DNA or RNA that define an organism. Founded in 2001 by the late Dr Geoffrey Grigg, the former Chief of Molecular Biology at CSIRO, Genetic Signatures’ proprietary MDx 3Base™ platform technology provides high-volume hospitals and pathology laboratories the ability to screen for a wide array of infectious pathogens with a high degree of specificity in a rapid throughput (time to result) environment, thereby saving time, money and lives in the process.

According to John Melki Ph.D, CEO of Genetic Signatures, the ability to screen quickly and accurately for a wide array of infectious diseases (or pathogens) is a critical requirement for hospitals and pathology laboratories globally. Genetic Signatures’ products have also been developed to be platform agnostic, thereby maximising the addressable market by reducing the need for capital expenditure by customers.

“Genetic Signatures’ tests have the ability to quickly and accurately screen patient samples for a wide array of pathogens that are most commonly associated with medical conditions such as gastroenteritis. A more effective clinical assessment allows better patient care and treatment, and is a critical step in infection control,” said Dr. Melki.

Whilst Genetic Signatures’ proprietary technology has applications in a number of areas, including cancer detection assays, food testing and other applications, the Company opted to focus on a test for enteric pathogens first because it was readily accessible, niche and offered greatest need. Subsequently Genetic Signatures developed and commercialised a suite of real-time Polymerase Chain Reaction (PCR) based products that are now in use by major hospitals in Australia for the routine detection of infectious pathogens that can cause gastroenteritis, such as Norovirus and C. difficile.

Gastroenteritis is a major widespread clinical problem and it has been estimated that there are 17.2 million gastroenteritis cases each year in Australia alone resulting in 250,000 visits to hospital emergency departments, 15,000 hospitalisations and 80 deaths[1]. Globally, there are nearly 1.7 billion cases of diarrhoeal disease every year and is responsible for killing around 760,000 children under 5 years of age every year[2].

“Through championing diagnostic change, Genetic Signatures is well positioned to capitalise on the significant global market opportunity with a business model that drives economic and health benefits for the community,” continued Dr Melki. “This is a significant opportunity for both institutional and retail investors to participate in the potential of a smart Australian company that has the proven ability to meet global problems.”

Genetic Signatures’ current target markets are major hospitals and pathology laboratories undertaking infectious disease screening and as the spread of infectious diseases around the world continues to grow, the Company plans to launch additional products for the detection of pathogens associated with respiratory diseases, sexual health infections, MRSA, tuberculosis and meningitis.

With initial sales in Australia and Europe, the Company now aims to expand its revenue base with additional customers, products, and other major geographies, including the USA where Genetic Signatures has recently established a senior management team. The senior management team in the USA includes Mike Aicher, founder of National Genetics Institute and recently responsible for more than US$1 billion in annual revenue for Laboratory Corporation of America.

The Company’s commercial plan is based on regulatory, market entry and intellectual property strategies and its products have been developed to meet existing and planned future requirements for customers in both its current and planned target markets of the US and the EU.

“Genetic Signatures is bridging the scientific and commercial void, an issue which combined with a lack of experience or revenue have typically held back many other Australian biotech companies,” added Dr Melki, who believes that the Company is now well positioned to achieve commercial scale and success in target markets.

“With our scalable and attractive business to business model and deep regulatory understanding, the proceeds of the Offer will primarily to be applied to increasing the Company’s business development and sales activities to help achieve rapid growth via a continued commercial rollout of our reagent products in Australia and entry into the US and further penetration into EU markets.”

Genetic Signatures operates in the global MDx market which had sales of USD5.3 billion in 2012 and grew at 13% per annum from 2009 to 2012 according to independent research firm Kalorama[3]. The addressable markets within the global MDx market that are covered by Company’s current infectious disease products and additional products in development and in Beta Testing with customers (covering respiratory and MRSA, meningitis, tuberculosis and sexual health infections) is expected by Kalorama to grow to an estimated USD1,770 million globally in 2017[4].

 

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About Genetic Signatures: Genetic Signatures is a specialist molecular diagnostics (MDx) company focused on the development and commercialisation of its proprietary platform technology, 3Base™. Genetic Signatures has released a suite of real-time PCR based products for the routine detection of infectious diseases under the EasyScreen™ brand. The Company’s proprietary MDx technology provides hospital and pathology laboratories with the ability to screen for a wide array of infectious pathogens in a rapid high-throughput environment.

Genetic Signatures’ suite of reagent products have been through extensive customer validation in Australia over the past 4 years, with several high profile customers leading the way, with 37,880 tests performed by customers in Australia in FY14 using the Company’s EasyScreen™ reagent products.

The Company established operations in the EU in 2013 with the appointment of a General Manager – EU Operations and has subsequently appointed an Italian distributor (in April 2014) and an Israeli distributor (in October 2014).

The Company established operations in the US in 2014 with the appointment of an experienced management team led by ex Laboratory Corporation of America, Inc. (LabCorp) executive Mr Mike Aicher.

About the Offer: Detailed information about the Offer and the financial and operating performance of the Company are set out in the Company’s Prospectus. It also includes a description of the key risks associated with an investment in the Company in Section 4 such as risks related to competition, product development, regulatory approvals, key staff, supplier dependence, manufacturing and production, foreign exchange, the Company’s expenditure program, sufficiency of funding and intellectual property. I encourage you to read it carefully and in its entirety before making your investment decision.

To apply for Shares, you will need to fill out the Application Form attached to this Prospectus.

If you have any questions about how to apply for Shares, please call the Genetic Signatures Offer Information Line on 1300 737 760 (within Australia) or +61 2 9290 9600 (outside Australia) from 8.30am until 5.30pm (AEDT) Monday to Friday during the Offer period. The Offer is expected to close at 5.00pm (AEDT) on Friday, 12 December 2014.

Genetic Signatures is at its most exciting phase and through this Offer is seeking to raise $12 million to $15 million primarily to fund the commercial expansion into the European and US markets and the development of additional products.

 

Media contact:

Simon Murphy, Market Eye:
0434 708 104
[email protected]

 

 

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[1] Australian Government Department of Health and Aging, “The Annual Cost of Food borne illness in Australia, March 2006
[2] World Health Organization, Diarrhoeal disease, Fact sheet no. 330, April 2013
[3] Kalorama MDx Report, page 7
[4] Kalorama MDx Report, page 168