Genetic Signatures Ltd. · ASX:GSS
Genetic Signatures — Investor Presentation (September 2023)
26 slides from Genetic Signatures's investor presentation, September 2023
Slide 1: 510(k) Filing in Preparation for US Commercial Launch
510(k) Filing in Preparation for US Commercial Launch September 2023
Slide 2: This presentation has been prepared by Genetic Signatures Limited ACN 095 913 205 (the
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 comprises written materials/slides for a verbal presentation concerning the Company and should be read in that context. This presentation is p
Slide 3: Investment highlights
Investment highlights Proprietary 3base® technology platform - a revolutionary approach to molecular diagnostic assays for infectious diseases Dramatically simplifies multiple pathogen testing from a single sample (multiplexing); more informative—simpler with fewer reagents Strong commercial adoptio
Slide 4: Company Snapshot
Company Snapshot Financial information Share price (1-September-23) A$0.445 Shares on issue 143.4m Share price (A$) Volume (m) 1.40 4.00 Market capitalisation A$63.8m 1.20 3.50 Cash (30-Jun-23) A$16.3m 3.00 1.00 Debt (30-Jun-23) Nil 2.50 0.80 Enterprise value A$47.5m 2.00 0.60 1.50 0.40 1.00 Top sha
Slide 5: How 3base simplifies molecular targets
How 3base® simplifies molecular targets Molecular diagnostic tests are based on DNA/RNA sequences • DNA/RNA is unique to each organism Genetic Signatures 3base® makes multiplex testing easier: • More informative – detect related pathogens/genes using fewer tests • Simpler – fewer reagents with bette
Slide 6: 3base simplifies syndromic testing – EasyScreen Kits
3base® simplifies syndromic testing – EasyScreen™ Kits Syndromic testing: simultaneously test for multiple pathogens that all can cause the same signs and symptoms • Respiratory infections: cough, runny nose, sore throat, headache • Gastrointestinal infections: nausea, diarrhea, vomiting, cramps, fe
Slide 7: Strong underlying growth in core revenue streams
Strong underlying growth in core revenue streams FY23 sales $16.9 million • Anticipated material decline in pathogen-specific molecular testing for SARS-CoV-2 experienced across the industry • Replaced with growing syndromic respiratory sales— long-term, durable market • Several Covid only customers
Slide 8: FY 2023 financial results
FY 2023 financial results Reduced SARS-CoV-2 molecular testing replaced with growing syndromic respiratory sales: • Sales revenue of $16.9 million compared to $35.4 million in FY22; • Non-COVID-19 only sales up 38% in FY23 and account for 75% of sales in FY23 • Gross margin on materials 60% compare
Slide 9: Robust pipeline with multiple products cleared for sale
Robust pipeline with multiple products cleared for sale DEVELOPMENT RESEARCH USE REGISTRATION TGA CE Mark FDA In clinical trials Submitted Converting to new protocol In development
Slide 10: Launching into Worlds Largest Molecular Diagnostic Market
Launching into Worlds Largest Molecular Diagnostic Market
Slide 11: 3base supports appropriate treatment for infection
3base® supports appropriate treatment for infection Protozoan Pathogen Symptoms Antibiotic Giardia lamblia/intestinalis Metronizadole, tinidazole, nitazoxanide Common set of symptoms from all gastric protozoan Cryptosporidium spp. Nitazoxanide (some patients) infections which include: Entamoeba hist
Slide 12: Current testing protocols are complex and inefficient
Current testing protocols are complex and inefficient This complex inefficient process has been replaced by a streamlined molecular assay 12 Sourced from Mayo Foundation for Medical Education and Research
Slide 13: North America represents 40% of diagnostic market
North America represents 40% of diagnostic market United States has a significant commercial opportunity for testing for gastrointestinal parasites • 5.5 million tests conducted in the US per annum • Primarily culture/microscopy: slow, labour intensive, unreliable • Detects leading clinically signif
Slide 14: Overview of molecular multiplex testing approach
Overview of molecular multiplex testing approach Rapid simultaneous testing for range of pathogens that cause a similar set of symptoms in presenting patients 14
Slide 15: Significant benefits from molecular multiplex testing
Significant benefits from molecular multiplex testing Higher sensitivity and specificity Able to combine multiple targets into single assay Workflow automation “Once ordering physicians have used molecular for parasite screening, they Quicker turnaround times become users. They are not going back to
Slide 16: EasyScreen Gastrointestinal Parasite Detection Kit
EasyScreenTM Gastrointestinal Parasite Detection Kit Underpinned by patented 3base technology
Slide 17: Positive feedback from users in testing laboratories
Positive feedback from users in testing laboratories “Molecular is going to impact patient management in three ways. Your results will come back quicker, they will potentially be more accurate, and they will also help redirect the evolving differential diagnosis by providing both positive and negati
Slide 18: Preparations for commercial sales once cleared
Preparations for commercial sales once cleared Focused prospects • Targeting the top 30-50 mid to high throughput laboratories in the US • 80/20 rule with majority of tests conducted by 20% of sites • Allows direct sales effort Direct sales model • Highly experienced sales team represented across th
Slide 19: Preparations for commercial sales once cleared
Preparations for commercial sales once cleared US market preparation activities underway • Delivery of an educational webinar series and white paper involving industry parasitology experts with global reach • US focus group executed with key opinion leaders to deep dive into product appeal and posit
Slide 20: Preparations for commercial sales once cleared
Preparations for commercial sales once cleared Commercial sales expected to start soon after FDA clearance • Positive forward indicators with many customer experience sites expected to transition to a purchasing customer • Solid opportunity pipeline supported by sales and marketing efforts in prepar
Slide 21: Global Growth
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Slide 22: Business development activity in expanding markets
Business development activity in expanding markets Recent Key appointments • Distributor Channel Manager – Europe • Regulatory Affairs and Quality Assurance Manager – Europe • Head of Clinical Operations – North America New channel partners appointed • Europe, Israel & Middle East Industry meetings
Slide 23: Growth initiatives
Growth initiatives Leverage experience in AU market to grow international sales • Europe – drive adoption of other 3base® products • US – build 3base® franchise once the Gastrointestinal Parasite Detection Kit is cleared Build & expand portfolio of EasyScreen™ products • Expand menu of 3base® tests
Slide 24: Next Generation, sample-to-answer Instrument
Prototype Next Generation Instrument Next Generation, “sample-to-answer” Instrument • Highly automated, little hands-on time • High-throughput Images are concepts only • Same testing parameters for all panels – 3base® • Can run multiple products in a single run • Highly flexible • Can run mixed spec
Slide 25: Upcoming milestones – 12 months
Upcoming milestones – 12 months US EasyScreenTM Gastrointestinal Parasite Detection Kit • 510(k) clearance • Launch product once clearance is granted Increase sales and presence in UK and EMEA markets • Contracts with new customers • Direct sales force and distributor appointments • Expansion of Bio
Slide 26: Contact Us
Contact Us Dr John Melki Managing Director & Chief Executive Officer E: john.melki@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
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