Arcis solutions for saliva sample prep Simplified prep

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Arcis solutions for saliva sample prep Simplified prep for lateral flow and PCR analysis

Arcis solutions for saliva sample prep Simplified prep for lateral flow and PCR analysis Arcis Biotechnology Limited T: +44 1925 607101 E: info@arcisbio. com W: www. arcisbio. com

Move to less invasive rapid-testing Limitations of swab and blood-based testing: • • Sampling

Move to less invasive rapid-testing Limitations of swab and blood-based testing: • • Sampling Requires healthcare professionals Patient discomfort with invasive sampling Cost and availability of lancets and swabs Limits expansion of test programs Saliva enables: • • Avoidance of assisted sample collection No patient discomfort Elimination of lancets and swabs Rapid expansion of test programs Arcis enables: • • Conversion of lateral flow from swab or blood to saliva No lances, swabs, or technician-assisted sample collection 25/11/2020 Arcis Bio. Technology - Commercial in confidence 2

Simplify protein preparation Antigen/Antibody preparation for immunoassay Replace loading buffer to enable saliva ●

Simplify protein preparation Antigen/Antibody preparation for immunoassay Replace loading buffer to enable saliva ● Effective protein stabilization + Arcis Buffer ● Non-hazardous chemistry

Convert blood lateral flow assays to saliva with enhanced sensitivity Assay Specificity 100% 95%

Convert blood lateral flow assays to saliva with enhanced sensitivity Assay Specificity 100% 95% 90% 85% 80% 75% 70% 65% 60% 55% 50% 93% Blood Saliva + Arcis % Concordance with RT-q. PCR* Assay Sensitivity 100% 95% 90% 85% 80% 75% 70% 65% 60% 55% 50% 100% Blood Saliva + Arcis Results from 30 positive samples (Left) and 30 negative samples (Right) analysed with Leccurate SARS-COV-2 Antibody LF Test. Blood samples tested using kit manufacturers instructions. Saliva samples tested by replacing manufacturers sample buffer with Arcis reagent. Results confirmed by RT-q. PCR performed using Applied Biosystems Taq. Path COVID-19 CE-IVD RT-PCR Kit. Converted assay shows greater sensitivity than original format without affecting specificity Arcis Bio. Technology - Commercial in confidence 4

Antibody detection with Arcis mirrors immune response Tracking of Ig. M and Ig. G

Antibody detection with Arcis mirrors immune response Tracking of Ig. M and Ig. G response with Leccurate Blood lateral flow test converted to Saliva with Arcis reagent Days Post PCR 0 -5 days 6 -10 days 11 -20 days 21 -30 days >30 days Ig. M Ig. G Number of Samples 6 6 15 15 10 10 7 7 13 13 Positive Samples 6 3 15 15 9 10 3 6 0 3 100 50 100 90 100 43 86 0 23 Antibody PPA% combined‡ ‡ PPA 100 100 86 23 determined relative to RT Q-PCR performed using Applied Biosystems Taq. Path COVID-19 CE-IVD RT-PCR Kit 100% detection concordance with RT Q-PCR up to 20 days post diagnosis (31 positive samples) Arcis Bio. Technology - Commercial in confidence 5

Conversion of Antigen test from swab to Saliva (Proof of Concept) Fluorecare™ SARS-Co. V-2

Conversion of Antigen test from swab to Saliva (Proof of Concept) Fluorecare™ SARS-Co. V-2 Spike Protein Test Kit converted to Saliva samples with Arcis Immunoassay reagent No of samples RTq. PCR* Rapid Saliva Protein Test (SARS-Co. V-2 Spike Protein) 6 6 positive Concordance 100% *Applied Biosystems Taq. Path COVID-19 CE-IVD RT-PCR Kit Preliminary data indicates successful conversion of swab lateral flow device to saliva with Arcis Immunoassay Reagent Arcis Bio. Technology - Commercial in confidence 6

Summary of ability to prep saliva for antigen and antibody testing Arcis results indicate

Summary of ability to prep saliva for antigen and antibody testing Arcis results indicate ability to: • • • Convert lateral flow rapid tests from swab or blood to saliva Lyse virus without denaturing proteins No sacrifice of sensitivity Seeking partner for advancing the application • Arcis Biotechnology founded 2010 • Patented chemistry • Scalable manufacturing facility 7