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Published byNoreen Conley Modified over 8 years ago
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Momentum Bioscience Ltd April 2016
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Summary Creating high-value hospital microbiology diagnostics Backed by VCs, angel groups, HNWs Technology platform allows universal detection of living bacteria/fungi Cognitor® products give next day results for 95% of blood cultures First product ‘Cognitor minus’ CE marked Now starting clinical utility & cost effectiveness studies Additional Cognitor products in development
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Problem Sepsis is expensive and deadly £2.5bn in UK; $24bn in US; kills more than lung cancer Identifying sepsis infection uses 100 year old technology Blood culture still used worldwide ‘Query sepsis’ patients kept on intravenous antibiotics until lab reports Some positives are fast but some take days to appear Negatives take 5 days 90% of blood cultures are negative Rapid molecular tests only look for positives – the 10%
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Opportunity Create products that deliver rapid results for all specimens Potential market 62m blood culture sets p.a, 16m in Europe Early negative results help stop unnecessary antibiotic use Lowers pressure on antibiotic resistance Better for the patient Saves money Early positive results lead to more effective therapy and better clinical outcomes Significantly lower morbidity and mortality Greatly reduced costs
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Current blood culture workflow Day 1Day 2345 Bottles enter blood culture cabinet 90% negative after 5 days 10% positive Gram stain Action point – 5 days Action point – 1-5 days Action point – 2-7 days Deals with all patients but takes 5 days for negatives and 2-7 days for positives Identification & antimicrobial susceptibility
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Rapid test workflow (e.g Verigene) Day 1Day 2345 90% negative after 5 days 10% positive Identification & resistance markers Action point – 1-2 days faster Action point – 5 days Only deals with the 10% positive blood cultures Bottles enter blood culture cabinet
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Rapid test workflow (Iridica) Day 1Day 2345 Blood samples enter lab 90% negative after 5 days ~15% positive Identification & resistance markers Action point – up to 6 days faster Action point – 5 days Fast and picks up more positives but does not deal with negatives
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Cognitor workflow Day 1Day 2 Bottles enter blood culture cabinet 80% confirmed negative 6% early positives Action point – 15-27hr Action point – 17-29hr Cognitor Minus 14% preliminary positive Cognitor Confirm Cognitor allows reporting on 95% of patients next day 9% confirmed positive with group differentiation
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Technology ETGA platform detects microorganisms by measuring nucleic acid-modifying enzymes (e.g. DNA polymerase) within these organisms via qPCR Detects all viable species – hence can determine negatives Highly sensitive – hence rapid results
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Products Cognitor® minus Reports negative blood cultures the day after specimen reaches the laboratory Negative predictive value (NPV) 99.5% vs 5 day culture and detects clinical positives missed by blood culture The only product available for rapid reporting of negative blood cultures Saves net £160 for each reported negative in antibiotic costs alone Clinical interest in limiting AMR, patient benefits and freeing beds Cognitor® confirm For use on samples identified as likely positive by Cognitor minus 90min result with differentiation of organism groups
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Products Cognitor® HT Automation of sample preparation with minimal hands-on time Dry instrument with all reagents in disposable cartridge Throughput sufficient for entire laboratory needs Cognitor® AST Rapid, phenotypic antimicrobial susceptibility result before the blood culture turns positive Feasibility demonstrated; not in active development
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Leadership Chairman: Bill Moffitt – Ex CEO Nanosphere; built I-Stat (sold to Abbott 2004); now NED/chair on several boards Founder/CEO: Bill Mullen PhD - Founder/CEO Acolyte Biomedica (sold to 3M Healthcare 2007). Ex Abbott Labs. Commercial Director: James Collier BSc FIBMS MCIM - Ex NHS, bioMerieux, IDG, BioQuell & 3M Healthcare. Head of R&D: Matt Crow PhD - Ex DNA Research Innovations, Invitrogen & Oxford Gene Technology. Head of Operations: John Hockley BSc PGDip - Ex Merial, 3M, Acolyte; experienced diagnostics manufacturer. Head of Clinical Studies: Gill Morgan PhD (consultant). Clinical trials and regulatory with Bayer Healthcare and Siemens Medical.
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Creating value for shareholders We have a technology and product offering unique in rapid microbiology. Turning this into a high-value trade sale requires Product acceptance: Clinical utility and health economic data Customer and KOL support Scalability (High throughput system) Product pipeline (Confirm; Confirm extensions; AST) Intellectual property (1 granted; 2 pending; 3 licensed; more to be filed) Defined regulatory pathway especially for US
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Market development activities Customer service evaluations currently active Establish a base of KOL activity in Europe and the US to support market development Clinical utility studies commencing in: Neonates; high need to prevent second dose of gentamicin at 36hr Intensive care; high need to prevent multiple-resistant organisms in ITU Medical assessment; many patients started on antibiotics just in case. Workflow mapping; health economic modelling
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Fundraising Funds raised to date: £5.4m in equity, £1.4m in grants 2016 internal round providing funds to: Support market development activities Progress R&D programme In early 2017 the Company will seek Series B funds to Roll out new products including automation Expand commercial activity On current plan, take Company to exit via trade sale
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Summary Much value is yet to be captured in rapid clinical microbiology Momentum has a unique technology and market approach Cognitor minus is the only product available for fast reporting of blood culture negatives 2016 will see first clinical utility data
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