Molecular Diagnostics at the Point of Need

Transcription

1 Molecular Diagnostics at the Point of Need 24 November 2016 David Budd CEO

2 1 DOCUMENT INFORMATION The information contained in this document and made verbally to you (together the Presentation ) is confidential and is being supplied to persons with professional experience in matters relating to investments and/or to high net worth companies as described in Article 19(5) and 49(2) respectively of the Financial Services and Markets Act 2000 (Financial Promotion) Order 2001 (SI. 2001/No.1335) (as amended) made pursuant to section 21(5) of the Financial Services and Markets Act 2000 and, if permitted by applicable law, is being supplied outside the United Kingdom to professionals or institutions whose ordinary business involves them in investment activities. The information contained in this document is not intended to be viewed by, or distributed or passed on (directly or indirectly) to, any other class of persons. Accordingly, information contained in the Presentation is being supplied to you solely for your information and may not be copied, reproduced or further distributed to any person or published in whole or in part, for any purpose. In particular, the distribution of this document in jurisdictions other than the United Kingdom may be restricted by law and persons into whose possession this document comes should inform themselves about, and observe, any such restrictions. Any failure to comply with these restrictions may constitute a violation of laws of any such other jurisdiction. No representation or warranty, express or implied, is given as to the accuracy of the information or opinions contained in the Presentation and no liability is accepted for any such information or opinions by genedrive plc (the Company ) or any of its directors, members, officers, employees, agents or advisers. Notwithstanding this, nothing in this paragraph shall exclude liability for any representation or warranty made fraudulently. The Presentation does not constitute any part of an offer of, or invitation to apply for, securities in the Company.

3 2 COMPANY OVERVIEW GENEDRIVE PLC (LSE:GDR) Rapidly developing, commercial-stage molecular diagnostics business Company based in Manchester. Renamed genedrive plc July 2016 Refocusing on a Healthcare Diagnostics business model Raised c. 6.0m in July 2016 Develop test portfolio, clinical trials, expand commercialisation efforts, increase operational infrastructure New management team Diagnostics and commercial experience and track record Genedrive : a Point-of-Need, molecular diagnostic system Focus on market opportunities where DNA analysis can be used to diagnose and treat patients Large attractive markets exist (c.$1bn for infectious disease pipeline) But today are generally delivered from expensive, hospital based settings

4 3 COMPANY OVERVIEW GENEDRIVE PLC (LSE:GDR) Rapidly developing, commercial-stage molecular diagnostics business Genedrive Decentralised Molecular Diagnostics using handheld Genedrive system Contract Research Organisation Provides Services to Pharmaceutical Industry and Biotech to understand biochemical pathways during drug development Pharmacogenomics Organisation Provides Services to Pharmaceutical and Biotech to understand genetic modes of drug action & activation during drug development

5 4 MOLECULAR DIAGNOSTICS Molecular diagnostic tests detect specific sequences in human genes or the DNA of microbes, viruses and pathogens that may be associated with disease Use a technique called PCR, that takes a tiny amount of DNA from cells and replicates it to a quantity that we can analyst Understanding DNA can mean getting the most appropriate treatment as quickly as possible Historically provided almost exclusively from large hospital labs or specialised testing centres

6 5 GENEDRIVE TECHNOLOGY Technology platform brings the power of molecular diagnostics outside of the hospital Affordable System and test cost price point accessible world-wide Rapid results outside of a hospital environment Prompt clinical decisions are possible - sample to result typically in minutes Easy to use Single use disposable reagent cartridge (razor/ razor blade model) Limited training required for operation Real world robustness and reliability Battery pack permits use in poor infrastructure settings Operates in hot and humid conditions present outside laboratories Versatile Core technology across a range of applications, including human health, animal health, and environmental testing

7 6 APPLICATIONS BACTERIAL INFECTIONS - TB Tuberculosis (TB) is a global healthcare crisis with 9.6m new cases in 2014 TB is the largest single infectious cause of death among young people and adults Poor and inappropriate treatments historically has led to widespread drug resistance TB diagnosis in many countries is still reliant on old fashioned microscopy Variable by operator and can be less that 60% - 80% sensitive in correctly diagnosing TB It tells you nothing about drug resistance. Culture = 40 days Molecular testing with Genedrive 33% 13% 2% India 52% China South Africa Brazil Percent of New Active TB Cases in 2012 in the High Burden Countries Determine TB infection status and resistance to Rifampicin No operator interpretation Quick results at a Point of Need

8 7 Decentralising molecular diagnostics APPLICATIONS BACTERIAL INFECTIONS TB Predominantly public Fully automated Large Hospital KOLs Hospital High Throughput/ Low PoC usage Labs (n=500) Small/ Medium Labs (n=5,000) Small Out-Reach Labs (n=50,000) Predominantly private Manual Low Skill Level Medium Point of Need use Predominantly public Semi-automated Medium Skill Level High PoC usage Of the TB tests currently conducted, Genedrive has shown 95% sensitivity, and 94% specificity with respect to culture confirmed microscopy. This is fully aligned to the company s performance claims.these results show that Genedrive offers an acceptable, low cost and accessible alternative for facilities without the sophisticated infrastructure and equipment which we have in our main laboratory. Dr Bhavini Shah, Head of TB testing services at Supratech Inc, India Indian market launch Genedrive test launched under licence from Drug Controller General of India Commercial approach Market accessed through distribution partner Xcelris Laboratories Ltd Target market Simple market segmentation of laboratories in India Initially targeting small/medium laboratories in private sector

9 8 APPLICATIONS VIRAL INFECTIONS HCV Hepatitis C (HCV) is a growing global healthcare crisis with c.170m people infected globally Historically treatment was very expensive and only effective on a subset of patients Required molecular testing and different treatments based on their DNA and the DNA of the virus China India Egypt Pakistan Indonesia Russia USA New Direct Activing Antiviral drugs are very effective and in most cases curative D.R. Congo Nigeria Japan New demand for molecular testing to determine if someone is infected with HCV virus Diagnosis rate in some countries is <10% Cameroon Brazil Uganda Ukraine Molecular Testing with Genedrive Italy Phillipines Genedrive HCV-ID can be used in decentralised laboratories to provide testing to those that don t have access Rapid result in <90 minutes Uzbekistan Thailand Ethiopia Turkey

10 9 APPLICATIONS HUMAN GENOTYPING Molecular diagnostic applied to individual genetics Determine if a person is likely to respond to treatment. Some new cancer drugs are only effective on a subset of patients, requiring the use of a Companion Diagnostics product Out of 45 new drugs approved by the FDA in 2015, 13 require a companion diagnostic test 30% of all treatments in late clinical development rely on biomarker data Molecular Testing with Genedrive genedrive plc s first human genotyping test, IL28B, was CE certified in November 2016 IL28B companion diagnostic validates Genedrive platform for use in pharmacogenomics/companion diagnostics

11 10 APPLICATIONS BIO-DEFENSE PATHOGEN ID Agreement with the US Department of Defense to develop Genedrive as a handheld bio-agent identifier testing system Identification of biological agents and pathogens in a military setting US DoD began assessing Genedrive for biodefence use in 2011 Positive review was followed up by US$7.8m in milestone funding due over 5 years (US$2.4m in 2016) $2.9m extension was confirmed in March 2016 Molecular Testing with Genedrive Specific Application of Genedrive is Confidential but it is anticipated it could be deployed in laboratory, non laboratory, or field applications

12 11 APPLICATIONS AGRICULTURE CROP LOSS Collaboration with Centre for Environment, Fisheries & Aquaculture Sciences (CEFAS) Point-of-need aquaculture test for diagnosis of pathogens Main target identified: White Spot Syndrome Virus Point of need aquaculture test for diagnosis of pathogens Affects shrimps/ crustaceans and can wipe out entire shrimp farms within days Estimated at ~$US 1B annual loss Molecular Testing with Genedrive 0.4m grant funding for test development from Innovate UK Determination of White Spot infection on-site in less than 60 minutes

13 12 DE-RISKED AND DIVERSE APPLICATIONS

14 13 COMMERCIAL OPPORTUNITIES AND STRATEGY Genedrive is an effective, low cost, molecular solution across a broad range of applications Genedrive - Internally Develop and Drive Proprietary Menu MTB/RIF > $120m in top 4 markets HCV > $500m diagnostics market broad application to other blood borne viruses (HIV, HEP B) Genedrive - Externally Develop and Drive Open or Proprietary Menu Migrate established assays to Genedrive platform Leverage Open Innovation Partnerships Critical or competitive menu item BD opportunities with DX and Pharma

15 OPERATIONAL HIGHLIGHTS Initial launch of the Genedrive Tuberculosis (MTB/RIF) assay in India in April/May 2016 Early days but Interest from the market has been encouraging Development programme of the Genedrive Hepatitis C (HCV) accelerated CE-IVD approval of the HCV test scheduled for March/April 2017 Successful progress in US Department of Defense Programme Develop Genedrive biohazard identification tests triggered by successful progress

16 OPERATIONAL HIGHLIGHTS (CONTINUED) Successful Genedrive validation for aquaculture Detection of White spot disease in shrimps in collaboration with the Centre for Environment, Fisheries and Aquaculture Science (CEFAS). Currently in field validation in Thailand Successful Genedrive validation for Human Genotyping Successful clinical trial results of Genedrive IL28B genotyping test in conjunction with Institut Pasteur and adoption of the Genedrive IL28B test in clinical trials being conducted by STOP- HCV campaign CE-IVD marked November 2016 Review and redirection of Group management organisation focussing the Company on the Genedrive molecular diagnostics opportunities Detailed strategic review of the Company s Preclinical & Pharmacogenomics Services operations commenced

17 16 FINANCIAL REVIEW PRELIMINARY RESULTS 2016 Full year revenues at 5.0m, up from 4.5m driven by Genedrive development income Revenues 5.0m 4.5m Preclinical Research revenues at 2.0m, down from 2.3m Pharmacogenomic revenues of 1.1m from 1.2m Contract costs 3.3m 3.9m Diagnostics Genedrive revenues of 1.9m up from 0.9m, based on development revenues from US DoD. Net Genedrive development investment of 2.9m Discovery, development and admin expenses 7.2m 4.6m Full year Operating loss of 5.4m reflecting increased Administrative costs of 2.4m End June cash balance 1.1m, bolstered in July 2016 by 6.0m net proceeds of Placing Operating loss for the full year (5.4)m (4.0)m Cash reserves 1.1m 30 June 2016 With Placing proceeds 4.9m 7.1m

18 17 SUMMARY Rapidly developing commercial-stage molecular diagnostics business 1 Genedrive is a disruptive point-of-need molecular diagnostic system 2 Strong management team with diagnostics and commercial experience and track record 3 Addressing multiple large markets ($1bn for infectious disease pipeline) 4 Plan to accelerate menu development through in house programmes and an actively seeking Partnerships 5 Newsflow: TB progress in India, HCV approval and roll out EU, Distribution, Corporate Partnerships

19 18 THANK YOU