GENETIC SIGNATURES LIMITED — AGM Information 2017

Nov 27, 2017

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ASX: GSS
AGM PRESENTATION
NOVEMBER 2017
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Genetic Signatures Limited Investor Presentation – November 2017

Investment highlights

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A REVENUE-STAGE HEALTHCARE COMPANY ACCELERATING THE GLOBAL COMMERCIALISATION OF ITS UNIQUE DIAGNOSTIC PRODUCTS

• Genetic Signatures (GSS) designs and manufactures Molecular Diagnostic products that have substantially greater efficacy than traditional solutions

• ― Domestic customer base generated A$2m+ revenue in FY17

• Scalable business model with high gross margins

• Strong revenue growth pipeline driven by sale of existing products to new customers and supported by complementary new product releases

• Sales expansion planned in FY18 across North America and Europe to capture part of the US$2bn addressable global market opportunity

• Valuable intellectual property portfolio with 100%-owned 3base[TM] technology and key patents issued, some expiring 2031

• Strong balance sheet with cash of A$11.3 million at 30 September 2017

Note: All Medical Diagnostics (MDx) tests are solely focussed on the identification of infectious diseases

Genetic Signatures Limited

Investor Presentation – November 2017

2

GSS snapshot

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All GSS products underpinned by proprietary 3base™ technology to enable customers to identify a wider array of infections than standard tests

3base™ unique approach optimises DNA analysis by simplifying the natural sequences resulting in faster and more accurate results

GSS manufactures a range of MDx tests[1] all branded EasyScreen™

Most advanced product is the EasyScreen™ Enteric (gastrointestinal) tests, detects 20+ causes of viral, protozoan and bacterial gastroenteritis

Revenue growth expected from new customers in Australia, EU and US and the release of new 3base[TM] products

Australian expansion in FY18 to set platform for international sales growth

Existing customers generated … A$2.0m revenue in FY17 from …

3 existing product groups, with … 4 new product groups in development

Historical revenues (A$m)

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2.0
1.8
1.1
0.7
0.3
FY13 FY14 FY15 FY16 FY17
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1: All MDx tests are solely focussed on the identification of infectious diseases

Genetic Signatures Limited

Investor Presentation – November 2017

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Significant operational progress since IPO in 2015

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Corporate

Apr-15 Nov-15 First installation of 3base[TM] Collaboration respiratory virus kits with UCLA announced

Aug-15 Mar-15 Distribution IPO deals in Ireland and Poland

Jun-16 Mar-17 Launch ASR Launch and first products in the sales of STI USA Genital Pathogen Detection Kit

Sep-16 A$14m placement announced

Sep-16 Trial of STI Kit commenced

Jul-15

FDA listing of EasyScreen[TM] clinical concentrators

Jun-16

UCLA completes trial of 3base[TM] technology with successful results

Oct-17

Beta-release 2[nd] -generation Respiratory Detection Kit

Clinical / regulatory

Genetic Signatures Limited

Investor Presentation – November 2017

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1Q FY18 trading update

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STRONG REVENUE GROWTH CONTINUES WITH SOME SEASONALITY

1Q FY18 Revenue Update

Quarterly revenue (A$000)

• Record quarterly revenues achieved in Q1 FY18 of A$754k

• Some seasonality in revenue due to strong demand for respiratory kits across the winter flu season

1Q performance continues consistent quarter-on-quarter revenue growth since listing in 2015

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754
575
540
495
463 460
442
423
410
Q1 Q2 Q3 Q4
FY16 FY17 FY18
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Genetic Signatures Limited

Investor Presentation – November 2017

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3base[TM] enables a step-change in MDx efficacy

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GSS owns the proprietary 3base™ technology

• Unique and innovative approach simplifies the DNA and RNA sequences of bacterial, viral, protozoan and fungal pathogens

• The resultant simplified genetic sequences enables a step-change in efficacy in molecular diagnostics ( MDx )

• Underlying 3base[TM] technology covered by multiple patents including workflow

3base[TM] MDx testing is focused solely on the detection of infectious diseases

• 3base[TM] MDx can identify a wider array of patient infections than current diagnostics

• Reduces time to results (5 vs 24 hours for conventional methods)

• Provides greater testing accuracy

Genetic Signatures Limited

Investor Presentation – November 2017

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EasyScreen[TM] products built on 3base[TM] technology

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GSS is commercialising a range of MDx tests based on 3base[TM] and branded EasyScreen[TM]

EasyScreen[TM] kits offer faster and more effective detection of infectious disease

• Three product families available covering enteric microorganisms, respiratory viruses, and STIs

• Target customers are highvolume hospitals and pathology laboratories

• Platform agnostic – compatible with common existing laboratory equipment

• High specificity – superior accuracy of results

• Rapid time to result (4 - 5 hours) – would have traditionally taken 4 - 5 days

• Common Workflow – all tests work under identical conditions

EASYSCREEN™ KITS IDENTIFY MORE PATHOGENS IN LESS TIME

Genetic Signatures Limited

Investor Presentation – November 2017

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3base[TM] offers significant benefits to all parties

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Saves lives

• More accurate test results

• Faster turnaround

• 4-5 hours (vs 4-5 days)

• Improved efficacy & breadth of detection

Saves costs

• More results per patient specimen

• Easy to use common workflow between tests

• Compatible with existing equipment (no CAPEX required)

Better system outcomes

• Reduces hospital stays through more effective infection detection

• Rapid detection reduces spread of infectious diseases

• Reduced repeat doctor visits

Genetic Signatures Limited

Investor Presentation – November 2017

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Powerful evidence of efficacy from clinical trials

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St Vincent’s Hospital Evaluation Study results

Clinical trials demonstrate efficacy

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|||||
|---|---|---|---|
|Pathogen|Conventional|EasyScreen|™|
|Methods*|
|Campylobacter|7|9|
|Salmonella|8|9|
|Shigella|5|6|
|C. Difficile|3|7|
|Yersinia|-|1|
|Cryptosporidium|-|1|
|Giardia|9|12|
|Dientamoeba fragalis|4|20|
|Blastocystis hominis|16|21|
|Entamoeba histolytica|1|1|
|Norovirus group 2|-|7|
|Adenovirus|-|1|
|Adenovirus 40/41|-|1|
|Sapovirus|-|1|
|Total|53|97|

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Evaluation study conducted at St Vincent’s Hospital, Sydney in 2014

221 patient samples tested and compared to traditional culture, microscopy, and antibody based tests

Results highlight the efficacy of 3base[TM ] technology and GSS products

• Faster screening: Generated results in 4 hours, compared to up to 120 hours for traditional testing methods

• Greater accuracy: Identified 44 infections that existing testing missed

Significantly greater efficacy

Genetic Signatures Limited

Investor Presentation – November 2017

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7 products underpinned by 3base[TM] technology

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	Product group Target pathogens Key highlights
	EasyScreen™ Enteric 20+ enteric pathogens Includes Salmonella,_C. difficile_Bacteria, Protozoan and Viral Detection Kits and _C. difficile_reflex kits All tests have full regulatory approval in Europe (10-20x the size of Aus market)
Three existing products groups Commercial sales underway
	EasyScreen™ Respiratory 15 respiratory pathogens(including influenza A & B, Rhinovirus and M. pneumonia) Approval in Australian and European markets currently in progress
	EasyScreen™ STI / Genital 12 most commonly encountered STIs (including chlamydia, gonorrhoea and syphilis) Offers superior test efficacy for pathogens contracted by 1m people daily1 (market worth ~US$550M2)
Four new product groups Trials underway
	EasyScreen™ Flavivirus / Alphavirus Multiple Flavivirus/Alphavirus viral families (including Zika and West Nile virus) Offers testing for complex viruses causing widespread morbidity and mortality but historically labour-intensive to detect
	EasyScreen™ ESBL & CPO Extended Spectrum Beta-Lactamase and Carbapenemase Producing Organisms Beta trials underway; rapid alternative for conventional antibiotic-resistant bacterial detection
	EasyScreen™ Meningitis (Viral and Bacterial) Multiple strains of Meningitis (viral and bacterial infections) In final development stages – offers rapid diagnosis for life-threatening bacterial meningitis
	EasyScreen™ Respiratory Atypical Pathogen Simultaneous detection ofleading causes of bacterial respiratory infection In development

Sources:

• 1: http://www.who.int/mediacentre/factsheets/fs110/en/

• 2: World Market for Molecular Diagnostics, 5th. Edition (Infectious Disease, Oncology, Blood Screening, Pre-Natal and Other Areas) Kalorama Information, Published: 1/9/2013, page 168

Genetic Signatures Limited

Investor Presentation – November 2017

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Clear path to global commercialisation for all products

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Australia EU US
Product Trials Pilot stage Approvals Ready for Approvals Ready for FDA trials Approval
Products development underway revenue [2] and sales trials and sales ASR trials underway and sales
Existing EasyScreen™ 2018 2019
products Enteric
EasyScreen™ Q1 CY18
Respiratory
EasyScreen™ Q1 CY18
STI / Genital
New EasyScreen™ Q2 CY18
Flavivirus / Alphavirus
products
EasyScreen™ Q4 CY17 Q2 CY18
ESBL & CPO
EasyScreen™
Meningitis 1H 2018
(Viral/Bacterial)
EasyScreen™
2019
Atypical Respiratory
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Notes:

1: Each of the product suites may contain multiple different individual products, indicating that multiple regulatory approval applications and approvals may be required for a suite of products

1. Pilot stage revenue generated from sales for research use only (medical professionals may use products for diagnosis only where they validate results with independent testing)

2. Sold as individual Analyte Specific Reagents (ASR) for a number of pathogens in the USA

GSS HAS MADE SUBSTANTIAL PROGRESS ON ALL PRODUCTS SINCE IPO

Genetic Signatures Limited

Investor Presentation – November 2017

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EasyScreen[TM] customers are strong advocates

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“We use EasyScreen[TM] at ACL for its robust user friendly automation, higher levels of specificity for clinical samples and our confidence in delivering clinically significant results to our clinicians.

Tony Field Operations Manager Australian Clinical Labs

“Same day results and triage options for urgent requests help potentially save lives . And we get a high level of service and support from the GSS team!”

“I find that the fast turnaround time and the number of targets tested in the EasyScreen[TM] assays allow me to more rapidly identify highly infectious agents , potentially stopping the spread to other healthy individuals and thereby saving the health system money .”

Dr Damien Stark

KOL and Senior Microbiologist St Vincent’s Hospital Sydney

Genetic Signatures Limited

Investor Presentation – November 2017

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GSS has multiple levers to grow revenues

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New customer growth

Illustrative GSS revenue trajectory

• Continue to acquire new customers in Australia

• European sales recently enabled by key regulatory CE-IVD approvals

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High velocity,
compounding
revenue growth
Year 1
Year 1 Year 2
New Retention of Existing
customers existing customer
customers revenue
growth
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• In US, multiple products now seeking regulatory approvals to enable sales to USbased customers

Existing customer growth

• Further product sales to be driven by the commercial release of 3 new products in development

• Sales team to leverage established customer network and relationships

• Offers a high gross margin revenue growth opportunity

Existing customers

• Continue to retain and serve existing customer base in Australia

Genetic Signatures Limited

Investor Presentation – November 2017

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Executing a global strategy for commercialisation

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12+ TRIALS PLANNED GLOBALLY INCLUDING 3 DOMESTIC TRIALS

2

• Europe: Building out distributor model Trials underway

• Distributors appointed (Italy, Israel, Ireland and Poland)

• CE-IVD approvals granted (4 products)

• Direct Sales and Support Staff established

• Plan to appoint additional distributors in short term Product trials underway

3 North America: Accelerate direct sales approach Trials underway

• Head of US sales appointed

• Sales permitted through US FDA listing and ASRs

• Sales approval granted in Canada

Immediate focus on securing trials with larger pathology labs, ASR Product trials underway

1 Australia: Continued rapid growth

• Small base of customers with a number of trials underway

• Establish foothold

• Proven product traction

• Rapid customer acquisitions planned in 2018

US$0.1bn (Australia)

Estimated MDx market size (2017)

Source: World Market for Molecular Diagnostics, 5th. Edition (Infectious Disease, Oncology, Blood Screening, Pre-Natal and Other Areas) Kalorama Information, Published: 1/9/2013, page 94 .

Genetic Signatures Limited

Investor Presentation – November 2017

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1 Australia: continue rapid growth

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AUSTRALIA IS THE PLATFORM FOR INTERNATIONAL SALES

Commercialisation progress

Next steps

Established foothold

Rapid customer acquisitions

• Secured relationships with top tier customers in NSW and Victoria

• New Australian Sales Marketing and Support manager appointed

• Established customer relationships increase ease of new product sales

• Platform in NSW and Victoria has driven strong revenue growth over last 4 years

Australian revenue (A$m)

• Focus on new customer acquisitions

• Target customers include pathology labs, hospitals and large research laboratories

• Targeting trials with the largest hospitals and clinical labs in Australia to provide significant domestic revenue growth

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2.0
Strong recent growth in 1.8
other product sales
1.0
0.7
0.3
2013 2014 2015 2016 2017
Enteric Other products
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Existing sales
presence
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Expansion area focus (target for new customers)

Genetic Signatures Limited

Investor Presentation – November 2017

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2 Europe: building out distributor model

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STRONG PROGRESS ON MULTIPLE FRONTS TO ACCESS VALUABLE MARKET

Commercialisation progress

Next steps

Distributors hired and testing underway

Strategic market with large opportunity

• Full distributors appointed in Italy, Ireland, Israel and Poland

• Recently received key patent approvals in Spain and Israel

• Currently in discussions with a number of potential strategic commercial partners for product distribution

• Europe has an addressable MDx market of approximately US$435m - c.20% of the global market[1]

• GSS continues to participate in industry forums to increase its European profile

• Advanced discussions with new distributors in several European countries

• Enteric product suite has CE-IVD approval allowing for unrestricted sales in 31 countries

• Awaiting receipt of regulatory registration for STI and respiratory products in Europe

Genetic Signatures is developing a mix of direct sales and partnerships with distributors across Europe to optimise the sales network

European MDx market potential (US$m)

Respiratory STI's Hospital acquired infections Gastroenteritis Other

Sources:

• 1: World Market for Molecular Diagnostics, 5th. Edition (Infectious Disease, Oncology, Blood Screening, Pre-Natal and Other Areas) Kalorama Information, Published: 1/9/2013, page 94.

Genetic Signatures Limited

Investor Presentation – November 2017

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3 North America: accelerate direct sales approach

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SALES STRATEGY TO ACCELERATE FOLLOWING FDA APPROVAL

Commercialisation progress

Next steps

Foothold established

Largest market for MDx globally

• Hired US Sales Director in November 2016

• Partnership with UCLA for trials and research publication

• Initial trials established with local clinical labs using GSS supplied products in FY17

• Initial trials now progressing

• Addressable market of approximately US$1,265m, c.55% of the global market

• Over 5,600 registered hospitals in the USA and 11,000 CLA certified laboratories

• FDA listings of Clinical Concentrators in place to allow initial sales

• Focused on securing FDA approval leading to significant revenue growth

• 3base[TM ] technology has patents issued in the US

North American MDx potential[1] (US$m)

Respiratory STI's Hospital acquired infections Gastroenteritis Other

Genetic Signatures Limited

Investor Presentation – November 2017

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Financial performance

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A$000 Year ending 30 June 2016 Year ending 30 June 2017 Sales revenue 1,825 2,038 Other income 1,533 1,757 Total revenue 3,358 3,795 Cost of goods sold (462) (602) Employee benefits expense (3,393) (3,056) Other expense items (2,130) (2,846) EBITDA (2,627) (2,709) Depreciation and amortization (399) (479) EBIT (3,026) (3,188) Finance costs (1) (0) (Loss) / profit before tax expenses (3,027) (3,188) Income tax benefit / (expense) - - Net (loss) / profit after tax (3,027) (3,188) Basic and diluted earnings per share (Acps) (4.2) (3.3) Other income includes R&D rebates received (A$1.5m in FY2017) and interest received Total amount of unused tax losses for which no deferred tax asset has been recognised is A$11.0m (A$3.3m at tax effected rate of 30%) Other expense items includes scientific consumables (A$1.1m in FY2017), directors and consultancy fees (A$0.4m), rental expenses (A$0.2m), travel and other expenses Primarily staff salaries No interest bearing liabilities on balance sheet Charged across useful lives of 2.5-13.5 years

Genetic Signatures Limited

Investor Presentation – November 2017

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Near terms focus on product range and sales growth

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PRODUCTS New releases

• Commercial release of Flavivirus and ESBL/CPO kits initially in Australia

• Regulatory registrations for STI and respiratory kits

• AU Sales Strong focus of securing new customers New customers ― Additional hospital and pathology lab customers

• Targeting sales growth with conversion of trials

• EU Sales and new distributors/agents appointed

• New distributors ― New product trials announced in FY18

• Maiden sales of Analyte Specific Reagents (ASRs)

• US Sales ― First products preparing for full FDA approval

• FDA approvals ― Clinical trials for full FDA listing

Genetic Signatures Limited

Investor Presentation – November 2017

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Board of Directors

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WELL CREDENTIALED BOARD WITH SUCCESS IN COMMERCIALISATION

Management team with a proven track record in molecular diagnostics industry and extensive experience in bringing products from clinical development to commercialisation

Nickolaos Samaras	•	Significant experience in leading international sales expansions of biotech companies
	•	Former Managing Director ofApplied Biosystems(acquired by ThermoFisher, US$76.8bn market cap)
Non-Executive Chairman	•	Held senior roles withPerkin ElmerandAMRAD Corporation(now part of CSL)
John Melki	•	Led global commercialisation efforts of GSS since 2011and the product development team since 2003
	•	Successfullycommercialised two worldwide and five international products
Managing Director & CEO	•	Authored 20 peer-reviewed articles and listed as an inventor on eight patent applications
	•	Founder and former CEO ofNational Genetics Institute(subsidiary of LabCorp, US$15.3bn market cap)
Michael Aicher	•	Led Lab-Corp’s Esoteric Business Units which generated over US$1b revenue p.a.
Executive Director	•	Former executive roles atCentral Diagnostics Laboratory
	•	Recipient of Ernst & Young “Entrepreneur of the Year” award for emerging technologies
Anthony Radford	• •	Former Co-Founder and CEO ofCellestis(ASX:CST, acquired by QIAGEN for c.A$350m in 2011) Former member of CSIRO team that invented QuantiFERON
Non-Executive Director	•	Former Head of Development atAMRAD(later acquired by CSL)
	•	Former Managing Director of Australian subsidiary ofTechnicon Equipment
Phillip Isaacs	•	Former Managing Director ofBeckman Instrumentsin Australia
Non-Executive Director	•	Vice President of Asia Pacific forCytyc Corporation
	•	Founding Chairman of Australian Proteome Analysis Facility

Genetic Signatures Limited

Investor Presentation – November 2017

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Appendix – the science behind 3base[TM] technology

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3base[TM ] technology in summary

3base[TM] technology in the detection process

• 3base[TM ] platform technology converts original 4- base microbial genome to 3-base,

• Reducing complexity in molecular testing

• Conversion occurs during standard procedures and there are no additional steps for the technician

Regular cell Lysis and preparation steps

Original genome

3base[TM ] technology influenza example

• The sequence required to detect all sub-types of influenza as a naturally occurring 4-base nucleic acid is comprised of 768 combinations

• The corresponding sequence after applying 3base[TM ] technology to form a 3base[TM] nucleic acid has 24 combinations

• Therefore, there is a 32 fold reduction in complexity of the primers required to screen patient samples

3base conversion

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Converted
3Base [TM ]
genome
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Standard Real-Time PCR instrument

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Disclaimer

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This presentation was prepared by Genetic Signatures Limited known as “Genetic Signatures“, (“GSS” or “the Company”), in order to discuss its business with various interested parties. This presentation in its entirety has been released to the market via the Australian Securities Exchange Limited (“ASX”).

This presentation contains statements that involve estimates, risks and uncertainties. Although the Company believes these statements to be reasonable at this time, Genetic Signatures can give no guarantee that the expectations reflected in these statements will prove to be accurate. Actual results could differ materially from those expected for any of a multitude of risks including, but not limited to, those inherent in regulatory or market environments or more generally. In preparing this presentation, the Company has relied upon and assumed, without independent verification, the accuracy and completeness of all information available from public sources, or which was otherwise reviewed by it.

The presentation is proprietary to Genetic Signatures and may not be disclosed to any third party or used for any other purpose without the prior written consent of the Company.

This document does not constitute an offer, solicitation or recommendation in relation to the subscription, purchase or sale of securities in any jurisdiction and does not and will not form part of any securities subscription, purchase or sale contract.

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Investor Presentation – November 2017

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