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Dr. David Ribeiro, PhD Chief Executive Officer David.Ribeiro@proaxsis.com www.proaxsis.com @proaxsis
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Respiratory diagnostics company 2 Commercialising immunoassay kits and Point-of-Care (POC) tests for management of Cystic Fibrosis (CF) and Chronic Obstructive Pulmonary Disease (COPD) Patented proprietary ProteaseTag® technology for the capture, detection and measurement of active protease biomarkers – indicators of exacerbations Launching POC tests in EU 2017 Series A funding for final validation of POC and pan-European launch
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CF is a life-limiting inherited condition caused by a faulty gene Causes mucus to gather in the lungs and digestive system and creates a range of challenging symptoms 40,000 EU and 30,000 US Diagnosed 3
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19.9 million EU, 15.8 million US, 43 million China diagnosed 25% growth through 2033 COPD is an umbrella term used to describe progressive lung diseases Breathlessness, coughing, wheezing and chest tightness 4
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Patented novel technology ProteaseTags™ Irreversibly capture a specific active protease Tools for the detection and quantification of the activity of a single protease species within a complex biological sample ProteaseTags™ Irreversibly capture a specific active protease Tools for the detection and quantification of the activity of a single protease species within a complex biological sample ProteaseTag ™ Technology: Novel and rapid method of detecting active protease biomarkers ProteaseTag ™ Technology: Novel and rapid method of detecting active protease biomarkers Applications Potential to be incorporated into a number of technology platforms Multi-analyte Product pipeline Applications Potential to be incorporated into a number of technology platforms Multi-analyte Product pipeline 5
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NE is linked with exacerbation Moffitt et al, P102, British Thoracic Society, December 2015. NE measured in 20 matched sputum samples from COPD patients when stable and during exacerbation. * Sagel et al (2012) Am. J. Respir. Crit. Care Med., 186: p857-865. Sputum NE is the most informative biomarker to monitor disease activity* NE is also an effective biomarker to monitor decline in lung function 6
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Research market – Immunoassay kits Testing kit comprising of the necessary reagents to measure NE in lab Recent kit sales to UK, Ireland, Germany, Switzerland and Sweden CE Marking process initiated, submission target end Q2 Immunoassay accepted for use in a pharma company trial, and being validated by several others Research collaborations with number of universities Abstracts presented/accepted – ECFC, NACFC, BTS, ATS 7
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Clinical market - Point-of-care NEATstik Launch Strategy CE mark Launch first as general IVD for use in clinic – elevate clinician awareness Follow-up launch as point-of-care IVD for use by the patient at home Business Model Western/Northern Europe: Direct sales Rest of Europe/Asia/US: Seek commercial partners Reimbursement Strategy Health economic model prepared for launch, using third party provider 8
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Series A fundraising Use of Proceeds Complete NEATstik POC development programme and CE marking Build commercial team and launch across Europe Establish base sales in key EU markets Ongoing development and launch of further respiratory protease target assays Prospective pan-European COPD trial Funding plans 9
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Product pipeline 10 Proteases in disease AIDS (Resistant HIV protease) Alzheimer's (β and γ-secretases) Pulmonary embolsim (Thrombin, Fxa) Heart attack (Thrombin, Fxa) Stroke (Thrombin, Fxa) Asthma (Tryptase) Neurodegenerative disorders (Caspases) Cancer (Cathepsins) Osteoporosis (Cathepsins) COPD (Cathepsins) Hepatitis C (Hep. C protease) ARDS (Neutrophil elastase) Diabetes (DPP IV) Arthritis/Inflammation (TACE, MMPs) Hypertension (ACE/NEP/ECE) Angioedema Kallikrien Cystic fibrosis/COPD (Neutrophil elastase)
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Experts in diagnostics & respiratory disease Dr. David Ribeiro – CEO Senior management at Pfizer, Solvay Healthcare and Encysive Pharma. Most recently, at Pharmaxis, worked on a diagnostic test for assessing bronchial hyper-responsiveness in asthma, and a therapeutic product designed for the chronic treatment of patients with CF Prof. Brain Walker – CSO 30 years of experience in the design and synthesis of “Protease-Tags”. Chair of Biomedicinal Chemistry – School of Pharmacy QUB. World renowned thought leader in respiratory disease Sarah Ganniclefft – Sales and Marketing Manager Significant managerial sales and marketing experience in diagnostics at BD and Roche 11
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Dr. David Ribeiro, PhD Chief Executive Officer David.Ribeiro@proaxsis.com www.proaxsis.com @proaxsis
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