Genetic Signatures Ltd. · ASX:GSS
Genetic Signatures — Investor Presentation (June 2024)
39 slides from Genetic Signatures's investor presentation, Jun 4, 2024
Slide 1: FDA Clearance and Capital Raising Presentation
Not for release to US wire services or distribution in the United States
Slide 2: Disclaimer
FDA Clearance and Capital Raising Presentation Disclaimer 4 June 2024 This presentation has been prepared by Genetic Signatures Limited ACN 095 913 205 (the Company or GSS) and approved by the Board of Directors for release. It provides general background information about the Company’s activities c
Slide 3: Executive Summary
FDA Clearance and Capital Raising Presentation Executive Summary 4 June 2024 • A differentiated approach to molecular diagnostic assays for infectious diseases Proprietary 3base® technology • Detects a wide range of clinically relevant targets, in one test – Syndromic Testing underpinning an automat
Slide 4: Executive Summary
FDA Clearance and Capital Raising Presentation Executive Summary 4 June 2024 • Allison Rossiter to serve as CEO commencing September 2024 New CEO announced adding to • Former MD of Roche Diagnostics Australia. Extensive experience in commercialisation of molecular diagnostics an experienced team pro
Slide 5: Allison Rossiter
Allison Rossiter FDA Clearance and Capital Raising Presentation 4 June 2024 Appointed as CEO to commence in September 2024 A highly experienced global molecular diagnostics executive to drive global commercialisation for Genetic Signatures • Ms Rossiter has extensive global experience in the diagnos
Slide 6: US Commercial Rollout for Gastrointestinal Parasite Test
US Commercial Rollout for Gastrointestinal Parasite Test
Slide 7: FDA approval - Compelling opportunity in the US
FDA Clearance and Capital Raising Presentation FDA approval - Compelling opportunity in the US 4 June 2024 EasyScreenTM Gastrointestinal Parasite Detection Kit cleared for sale by the FDA The product addresses an unmet need • Broadest molecular syndromic test for 8 clinically relevant GI parasites •
Slide 8: Benefits of the EasyScreen Gastrointestinal Parasite Detection Kit
Benefits of the EasyscreenTM FDA Clearance and Capital Raising Presentation 4 June 2024 Gastrointestinal Parasite Detection Kit Higher Improved sensitivity Increased pathogen coverage reliability and specificity Testing for 8 most clinically Testing is controlled and Traditional testing have relevan
Slide 9: Market opportunity
FDA Clearance and Capital Raising Presentation Market opportunity 4 June 2024 • Estimated ~65m GI parasitic infections per annum in US Estimated 9m • An estimated 9m patients1 with GI parasitic infections per annum infections seek medical attention in the United seeking medical attention States • Of
Slide 10: Sales strategy to grow the US market
FDA Clearance and Capital Raising Presentation Sales strategy to grow the US market 4 June 2024 B 7 customer experience sites established A with instruments and training prior to receiving FDA clearance. FDA clearance Convert customer experience sites Creating C further Increasing number of laborato
Slide 11: Four distinct customer segments – all targets
FDA Clearance and Capital Raising Presentation Four distinct customer segments – all targets 4 June 2024 *EP005 = EasyScreenTM Gastrointestinal Parasite Detection Kit Target GI parasite testing Potential TAM Share of targeted 2.2m Potential customers segments requirements = 5.5 m tests EP005* tests
Slide 12: Drivers leading laboratories to adopt approved tests
FDA Clearance and Capital Raising Presentation Drivers leading laboratories to adopt approved tests 4 June 2024 5.5 Million tests per year Conventional process Genetic Signatures solution FDA cleared Highly manual and complex workflow, slow time to result, O&P high labour and time costs with Microsc
Slide 13: Preparations for launch in the United States
FDA Clearance and Capital Raising Presentation Preparations for launch in the United States 4 June 2024 Genetic Signatures has invested prior to launch in the United States to accelerate commercialisation post FDA clearance. Scale & prepare for Product availability Regulatory Reimbursement Sales & M
Slide 14: Team with significant experience commercialising diagnostics
Team with significant experience commericalising diagnostics FDA Clearance and Capital Raising Presentation 4 June 2024 Nick Samaras Michael Aicher Allison Rossiter Non Executive Chairman Executive Director Incoming CEO • Significant experience leading • Currently based in the US with • Former MD of
Slide 15: Other growth initiatives and catalysts
§ senctic Signatures Ps | ay Other growth initiatives and catalysts
Slide 16: Next Generation Instrument development
FDA Clearance and Capital Raising Presentation Next Generation Instrument development 4 June 2024 Fully automated customer driven multi-year instrument development program Sample-to-result” Instrument Value Proposition • Highly automated • Further differentiate and automate • High-throughput (~400 s
Slide 17: EMEA growth initiatives to accelerate revenue
FDA Clearance and Capital Raising Presentation EMEA growth initiatives to accelerate revenue 4 June 2024 Highly experienced direct sales and support team in place • Located in the United Kingdom and Germany • Market transitioning to broader syndromic testing Channel partnerships in place in select E
Slide 18: US commercialisation and growth initiatives
FDA Clearance and Capital Raising Presentation 4 June 2024 • US EasyScreenTM Gastrointestinal Parasite Detection Kit • 510(k) clearance now received • First revenue anticipated early FY25 • Targeting to convert pre-qualified customer experience sites to initial customers, post clearance • Additional
Slide 19: Offer Details
nsforming Molecular Diagnosti G senetic Signatures Offer Details
Slide 20: Offer Details
FDA Clearance and Capital Raising Presentation 4 June 2024 Genetic Signatures is conducting a capital raising of up to approximately A$30.0 million comprising an institutional placement and a fully underwritten pro rata accelerated non-renounceable entitlement offer (together, the ‘Offer’) ▪ A capit
Slide 21: Use of funds
FDA Clearance and Capital Raising Presentation Use of funds 4 June 2024 Funds raised to increase global revenue through instrument and product development $30m raised • Additional sales, field services and marketing resources to support new Support US Commercialisation $7.5m commercialisation activi
Slide 22: Offer timetable
FDA Clearance and Capital Raising Presentation Offer timetable1 4 June 2024 Key events Sydney, Australia time Back-to-back trading halt Friday, 31 May 2024 Announcement of the Offer Tuesday, 4 June 2024 Institutional Entitlement Offer Opens Tuesday, 4 June 2024 Announcement of results of Institution
Slide 23: Appendix
forming Mol Appendix
Slide 24: Company snapshot - Pre-Offer
FDA Clearance and Capital Raising Presentation Company snapshot - Pre-Offer 4 June 2024 Financial information 1.00 Share price (30-May-24) A$0.73 0.90 Shares on issue 186.5m 2.00mm 0.80 Market capitalisation A$136.1m 0.70 1.50mm Cash (31-Mar-24) A$20.4m Share Price (A$) 0.60 Volume (m) Debt (31-Mar-
Slide 25: What does Genetic Signatures do?
FDA Clearance and Capital Raising Presentation What does Genetic Signatures do? 4 June 2024 Genetic Signatures develops and markets differentiated molecular diagnostic testing kits for syndromic testing for infectious diseases used by clinical laboratories Infectious diseases are a leading cause of
Slide 26: Proprietary 3base technology simplifies molecular targets
FDA Clearance and Capital Raising Presentation Proprietary 3base® technology simplifies molecular targets 4 June 2024 3base® converts the original 4-base microbial genome to 3-base simplifying the overall genetic sequence C→T most common mutation By simplifying the sequence 3base® allows laboratorie
Slide 27: Robust pipeline with multiple products cleared for sale
FDA Clearance and Capital Raising Presentation Robust pipeline with multiple products cleared for sale 4 June 2024 DEVELOPMENT RESEARCH USE REGISTRATION TGA CE Mark FDA Converting to new protocol In development 27
Slide 28: Key Risks
FDA Clearance and Capital Raising Presentation Key Risks 4 June 2024 1. KEY RISKS Investors should be aware that an investment in Genetic Signatures involves risks. The key risks identified by Genetic Signatures are set out in the "Key Risks" section of the Investor Presentation (below), but these a
Slide 29: Key Risks
FDA Clearance and Capital Raising Presentation Key Risks 4 June 2024 COUNTRY/REGION SPECIFIC RISKS IN NEW AND/OR UNFAMILIAR MARKETS Genetic Signatures has operations in a number of overseas jurisdictions and is exposed to a range of different legal and regulatory regimes, including in new jurisdicti
Slide 30: Key Risks
FDA Clearance and Capital Raising Presentation Key Risks 4 June 2024 LOSS OF ADOPTION BY CUSTOMERS Genetic Signatures is reliant on pathology laboratories purchasing its products. Healthcare practitioners play a significant role in influencing the types of tests and products used by patients. To ach
Slide 31: Key Risks
FDA Clearance and Capital Raising Presentation Key Risks 4 June 2024 GENERAL REGULATORY RISKS The Company operates and intends to operate in regulated industries (including but not limited to medical devices, diagnostics and therapeutics) in Australia and internationally. Given Genetic Signatures’ i
Slide 32: Key Risks
FDA Clearance and Capital Raising Presentation Key Risks 4 June 2024 INSURANCE RISK Genetic Signatures maintains a level of insurance coverage. If Genetic Signatures’ third-party providers fail to perform their obligations and/or its third-party insurance cover is insufficient for a particular matte
Slide 33: Key Risks
FDA Clearance and Capital Raising Presentation Key Risks 4 June 2024 2. OFFER AND GENERAL RISKS MARKET PRICE OF ORDINARY SHARES WILL FLUCTUATE Ordinary shares trade on ASX. The market price of ordinary shares on ASX may fluctuate due to various factors, including: • Australian and international gene
Slide 34: Key Risks
FDA Clearance and Capital Raising Presentation Key Risks 4 June 2024 LIQUIDITY RISK Genetic Signatures Shareholders who wish to sell their ordinary shares may be unable to do so at an acceptable price, or at all, if insufficient liquidity exists in the market for ordinary shares. Genetic Signatures
Slide 35: International Offer Restrictions
FDA Clearance and Capital Raising Presentation International Offer Restrictions 4 June 2024 International Offer Restrictions This Presentation does not constitute an offer of new ordinary shares (‘New Shares’) of the Company in any jurisdiction in which it would be unlawful. In particular, this Pres
Slide 36: Summary of Underwriting Arrangements
FDA Clearance and Capital Raising Presentation Summary of Underwriting Arrangements 4 June 2024 The Company has entered into an underwriting agreement (‘Underwriting Agreement’) with Bell Potter Securities Limited and Taylor Collison Limited (each a ‘Joint Lead Manager’, and together the ‘Joint Lead
Slide 37: Summary of Underwriting Arrangements
FDA Clearance and Capital Raising Presentation Summary of Underwriting Arrangements 4 June 2024 Key terms of the Underwriting Agreement (continued) • (Future matters) any estimate or expression of opinion, belief, expectation or intention, or statement relating to future matters (including any forec
Slide 38: Summary of Underwriting Arrangements
FDA Clearance and Capital Raising Presentation Summary of Underwriting Arrangements 4 June 2024 Key terms of the Underwriting Agreement (continued) • *(Political or economic conditions) the occurrence of any adverse change or disruption to financial, political or economic conditions, currency exchan
Slide 39: Contact Us
Contact Us Dr Neil Gunn Interim Chief Executive Officer E: neil.gunn@geneticsignatures.com P: +61 (0)2 9870 7580 Karl Pechmann Chief Financial & Operating Officer & Company Secretary E: karl.pechmann@geneticsignatures.com Visit us www.geneticsignatures.com Follow us 39
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