Slide 1: genedrive plc
genedrive plc David Budd | Chief Executive Officer Presentation has been modified from original use to remove competitor names VOX Markets Presentation 12 June 2020
Slide 2: Genedrive: the Point-of-Need molecular diagnostic gene reader
GENEDRIVE – AIM:GDR Genedrive®: the Point-of-Need, molecular diagnostic gene reader • We develop highly accurate molecular diagnostic assays for use on our Genedrive® instrument • PCR is the base chemistry • Rapid results – in as little as 27 minutes • Single use, disposable reagent cartridge revenu
Slide 3: Genedrive – Commercial Stage Company
3 GENEDRIVE – COMMERCIAL STAGE COMPANY Antibiotic 96 SARS- 96 Induced Hepatitis C US Military Tuberculosis CoV-2 SARS-CoV-2 SARS-CoV-2 Hearing Loss (HCV) Detection World’s first Sole supplier to Rapid saliva High Throughput Blood-based, Sputum based rapid genetic test US military for based* POC in P
Slide 4: Decentralising molecular diagnostics
4 Decentralising molecular diagnostics
Slide 5: Genedrive SARS-CoV-2 Kit
Genedrive® 96 SARS-CoV-2 Kit Innovative PCR to meet the need for increased consistency, throughput, and ease of use in COVID-19 PCR • A Unique, one-step CE-IVD PCR assay designed to detect SARS-CoV-2 infection • Single PCR solid bead format eliminates the need for time-consuming, error prone reagent
Slide 6: Simple '1-step' Test
Simple ‘1-step’ Test Freeze dried reagents Load extracted RNA Run on Real-Time Time to result = 100 mins sample directly into the PCR machine (96 tests) plate, mix and centrifuge Load sample Run test View results 6
Slide 7: Performance Characteristics
Performance Characteristics Performance study data 180 clinical specimens, collected using various swab types (BD, Copan, Sterilab) and extraction kits/methods. Metric Result (%) 95% Confidence Interval (%) Sensitivity 100.0% 97.0 - 100.0 Specificity 98.2% 90.4 - 99.9 Diagnostic Accuracy 99.4% 96.9
Slide 8: Sample Comparison Workflow Summaries
Sample Comparison Workflow Summaries Comp A Comp B Comp C Step 1 – Add sample Step 1 - Add buffer to /controls to the lyophilised Step 1 - Mix master A + B Step 1 – Re-suspend lyophilised instrument plate liquid lyophilised mastermix plate Step 2 - Transfer to Step 2 – Add sample Step 2 - Transfer S
Slide 9: Competitor Comparison
Competitor Comparison Comp A Comp C Comp D Comp B Comp E Comp F Genedrive® Viasure COVID-19 TaqPath RealStar® Allplex STAT NAT Test Name 96 SARS- SARS-CoV- coronavirus COVID-19 SARS-CoV-2 2019-nCoV COVID-19 CoV-2 Kit 2 RTCR Kit test Combo Kit RT-PCR Kit assay Ambient shipping/storage Yes Yes No No N
Slide 10: A Global Market
10 | Presentation Title A Global Market WHO chief Tedros Adhanom warned on Tuesday against complacency ““Although the situation in Europe is improving, globally it is worsening”. https://ourworldindata.org/epi-curve-covid-19 10
Slide 11: Desired Distribution Channels
11 Regulatory Current / Distribution Agreements status Europe: Austria, Germany, United Kingdom, Switzerland, Turkey, Spain, Portugal, Belgium, The Netherlands, Luxembourg, Poland, Hungary, Czech CE Mark Republic, Slovakia, Sweden, Norway, Denmark, France, Cyprus 22 May Central East Europe: Romania,
Slide 12: Genedrive SARS-CoV-2 Summary
12 | Presentation Title Genedrive 96 SARS-CoV-2 Summary Huge market potential and currently limited price sensitivity • Unique product design with meaningful, valuable benefits to the user • Top tier clinical performance specifications • Temperature stable nature facilitates global distribution to g
Slide 13: Antibiotic Induced Hearing Loss
Antibiotic Induced Hearing Loss Genedrive® MT-RNR1 ID Kit First to Market Global Opportunity
Slide 14: First to market opportunity
First to market opportunity • Percentage of children (1/500) will suffer permanent deafness when given the drug gentamycin. • Given within 1 hour of admission to Neonatal Intensive Care. • Caused by a genetic mutation called MT-RNR1. • Use Genedrive test to give a rapid (27 min) genetic result in th
Slide 15: Genedrive Workflow
Genedrive Workflow Baby admitted to Nurse Run the 27 Get a positive NICU takes min test on result and With infection buccal Genedrive treat with swab alternative antibiotics 15
Slide 16: Clear Benefits in Health and in Cost
Clear Benefits in Health and in Cost UK Example • The current hospital tests used take 2-5 days for a result, therefore they are unsuitable for emergency care • The test provides a clear patient benefit by helping to prevent antibiotic related hearing loss in neonates • In the UK there are approx. 9
Slide 17: Market Opportunity
Market Opportunity • Approx 90,000 babies admitted each year to NICU in the UK • Assume ‘Western World” market opportunity 1.25M tests / year • Test economics - <£10 to make, £35 to distributors, £50-£85 direct depending on reimbursement / country • Approx 1:500 carry the mutation (Preliminary UK Bi
Slide 18: Clinical Performance
Clinical Performance Diagnostic accuracy of Genedrive MT-RNR1 ID Kit Reference Test Detected Not detected Index Test Detected 59 0 Not detected 0 244 • Sensitivity = 100% (93.9% to 100% CI) • Specificity = 100% (98.5% to 100% CI) 18
Slide 19: Genedrive AIHL Summary
19 | Presentation Title Genedrive AIHL Summary • World first product design with health economic benefits • Clinical performance specifications match best in class lab testing • Temperature stable cartridges contract manufactured by Cytiva • Competitive pricing with attractive margins • Launching au
Slide 20: Visit www.genedrive.com for more information
Visit www.genedrive.com for more information.