Announcement PDF Investor presentation October 2020 Michael Winlo - MD & CEO ASX:EMD DRAFT Disclaimer and notices This presentation has been prepared by Emyria Limited ACN 625 085 734 (Company or Emyria). This presentation is not a financial product or investment advice or recommendation, offer or invitation by any person or to any person to sell or purchase securities in Emyria in any jurisdiction. This presentation contains general information only and does not consider the investment objectives, financial situation and needs of individual investors. Investors should make their own independent assessment of the information in this presentation and obtain their own independent advice from a qualified financial adviser having regard to their personal objectives, financial situation and needs before taking any action. 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This release may contain certain forward-looking statements with respect to matters including but not limited to the financial condition, results of operations and business of Emyria and certain of the plans and objectives of Emyria with respect to these items. These forward-looking statements are not historical facts but rather are based on Emyria's current expectations, estimates and projections about the industry in which Emyria operates, and its beliefs and assumptions. Words such as "anticipates," "expects," "intends," "plans," "believes," "seeks," "estimates", "guidance" and similar expressions are intended to identify forward looking statements and should be considered an at-risk statement. Such statements are subject to certain risks and uncertainties, particularly those risks or uncertainties inherent in the process of developing technology and in the endeavour of building a business around such products and services. These statements are not guarantees of future performance and are subject to known and unknown risks, uncertainties and other factors, some of which are beyond the control of Emyria, are difficult to predict and could cause actual results to differ materially from those expressed or forecasted in the forward looking statements. Emyria cautions shareholders and prospective shareholders not to place undue reliance on these forward-looking statements, which reflect the view of Emyria only as of the date of this release. The forward-looking statements made in this announcement relate only to events as of the date on which the statements are made. Emyria will not undertake any obligation to release publicly any revisions or updates to these forward-looking statements to reflect events, circumstances or unanticipated events occurring after the date of this announcement except as required by law or by any appropriate regulatory authority. Presentation release authorised by Michael Winlo, CEO and Managing Director Funding history & milestones in6first 6 months Funding history & milestones in first months History Milestones • Listed on the ASX, 12 February 2020 (ticker: EMD) • $1m+ total contract value of data deals • Last reported cash position (Q2, 2020): $3.7m • 2,500 patients referred to Emerald Clinics • Market cap: $17.76m (13 Oct 20) • Extending model to new diseases • Shares on issue 211.4m • Developing unique technology IP (Openly) • Options on issue 18.3m (strike $0.45) • Class 1 TGA registration for Openly • Strategic partnership with Mt Sinai Experienced board with medical focus Key Person Role Previous Experience Non-Executive Chairman / Founder 30 years of CEO and Board experience in medical and agrifood biotech companies. Chairman of Orthocell Ltd (ASX:OCC), regenera- tive medicine company, Founding Chairman and current Director of Cynata Therapeutics Ltd (ASX:CYP) stem cell therapies. Founder of AusCann Ltd (ASX:AC8), medical cannabis manufacturing, Cofounder of Zelda Therapeutics Ltd (ASX:ZLD) medical cannabis clinical studies and research. Stewart has held a number of Board positions in the past, including Chairman of Hatchtech that was sold in 2015 for A$279m and was a Director of iCeutica Inc. that was sold to a US Pharma. He was also a Senator with Murdoch University and was a Director of AusBiotech Ltd Chief Executive Officer / Managing Director Former CEO of rapid growth clinical trial organisation, Linear Clinical Research, serving biotech start-ups through to multinational pharmaceutical companies across the USA, Europe, Japan and China. Previously, Health Lead at Palantir (a Peter Thiel founded company based in Silicon Valley) working on complex data integration and analysis for Fortune 50 companies; as well as the US and UK Governments. Holds multiple patents in data analysis as well as a Bachelor of Medicine and Bachelor of Surgery (MBBS) and an MBA from Stanford University Graduate School of Business. Member of AICD and has completed director’s course. Dr Alistair Vickery Chief Medical Officer / Executive Director Specialist general practitioner with >30 years’ experience in general practice. Associate Professor of Primary Health Care at the University of Western Australia and Deputy Chair of the Postgraduate Medical Council of WA and the clinical lead of the research group CHASM (The Collaborative for Health Care Analysis and Statistical Modelling) providing high-level analysis and statistical modelling to inform clinical service evaluation and planning for WA Health. Chair of Black Swan Health, one of the largest primary health care service providers in WA and Fellow of the Australasian College of Health Service Management and AICD graduate. Matt Callahan Non-Executive Director / Founder Founder of Botanix Pharmaceuticals (ASX:BOT), iCeutica Inc. and Orthocell (ASX:OCC). Successfully developed 4 products through FDA approval. More than 20 years’ legal, intellectual property and investment management experience. Former investment director for 2 venture capital firms in life sciences and was GM and general counsel with technology and licensing company Ipernica Limited, now Nearmap Limited (ASX:NEA), where he was responsible for licensing programs that generated more than $120M in revenue. Professor Sir John Tooke Independent NonExecutive Director Senior Independent Director, BUPA Chile, Chair of Collaboration for the Advancement of Sustainable Medical Innovation (CASMI), UCL. Sir Tooke was Head of the School of Life and Medical Sciences at University College London (UCL) as Vice Provost (Health) and Academic Director of UCL Partners. Immediate past President of the Academy of Medical Sciences in the UK where he Chaired a report titled Enhancing the use of scientific evidence to judge the potential benefits and harms of medicine. Previous member of Google DeepMind Health’s Independent Review Board. Leading advisor to the UK Government regarding health policy and was knighted in the United Kingdom in the 2007 New Year Honours for Services to Medicine. Dr Stewart Washer Dr Michael Winlo Deliver great care and insights Drivers of change in health care Typical model today Care access Care decision making Care payment model Emyria today Potential future model What’s needed? How Emyria is investing Doctor sees patient in “brick & mortar” clinics or via telehealth “Doctor-in-your-pocket” Building remote clinical smartphones facilitate self-care monitoring Apps and programs with a clinical team at the ready Doctor leads decisions based on training & published evidence Doctor + patient decide together considering patient’s health Capturing patient-centric goals + real-time analysis of health goals and investing in similar patients to develop clinical decision support tools personalised health plans Health providers paid on a fee-for-service basis Health services rewarded for delivering great health outcomes Care Randomised control innovation trials are gold standard model (10+ years, $1B+) Collecting pharmacoeconomic data and patient-reported outcomes Evidence-generating care Ensuring high quality and models constantly evaluate the ethically-sourced data is safety and efficacy of treatment, captured in all clinical choices, both standard and encounters to build robust realnovel world data and evidence Emyria creates data products and technologies that accelerate novel drug development and elevate care for patients with unmet medical needs Emyria’s data products Novel treatments Emyria product registration Emyria Patients with unmet medical needs Care Emyria Data Emyria pharmacovigilance Emyria Tech Personalised care plans DRAFT Emyria’s leading products Emyria Care Emyria Tech Emyria Data Emyria product registration Emyria pharmacovigilance * Australia-wide, independent clinical service * Cutting-edge remote monitoring technology * Unique clinical data of value to drug developers Emyria accelerates novel drug development Novel treatments We partner with research-focused Sponsors to safely administer novel and unregistered treatments where evidence is lacking but the clinical need is great Revenue generation Emyria treatment pipeline Product selection QA checks Clinical service design Patient care Data products AUS Cannabinoids UK (in planning) Psychedelics * Others Active In planning * Under Australia’s Therapeutic Goods Administration (TGA), psychedelic medications such as psilocybin and MDMA are currently Schedule 9 of the Uniform Scheduling of Medicines and Poisons (which deals with Prohibited Substances). They are only available via approved research trials that include oversight by an institutional research ethics committee and careful monitoring and reporting of efficacy and safety outcomes. There is an active rescheduling proposal before TGA so that they can be more easily used as clinical therapies for the treatment of mental illnesses. The rescheduling would move these medicines to Schedule 8 (which deals with Controlled Medicines), the same category as THC-containing cannabinoid medicines. For more information : https://www.tga.gov.au/consultation-invitation/consultation-proposed-amendments-poisons-standard-acms-accs-and-joint-acmsaccs-meetings-november-2020 Emyria elevates care for patients with unmet medical needs DRAFT Emyria Care Emyria trains and develops our own clinical experts Dr Alistair Vickery Dr Jennifer Morgan Dr Nelson Lau Dr Jennifer Tai Pictured: Some of Emyria’s clinical team. For more details on our care team, please visit www.Emyria.com Dr Phil Finch Dr David Gunn Dr Ben Addison Creates creates Emyria Care Emyria Data Emyria data Emyria care Informs informs Emyria Care creates We evaluate and provide individualised care for patients who have failed “standard of care” Emyria Data We collect robust and ethicallysourced clinical evidence with each consenting patient • 4 clinicsEmyria across Australia care • Regulator-grade evidence Emyria data • Over 2,500 patients* • Validated clinical endpoints • Over 54 therapeutic indications • Patient-reported outcomes informs * An active patient is defined as an individual who has received a referral for a clinical evaluation at Emerald Clinics Emyria generates revenues from care and insights Emyria Unmet medical needs Data insights revenue Data Collect data Insights Clinical trials Registration Insomnia Chronic non-cancer pain Chemotherapy symptoms Autism Irritable Bowel Syndrome Emyria Care Cancer Pain Epilepsy Neurological Spasticity Clinical services revenue Parkinson's Disease Migraine (headache) PTSD Alzheimer's Disease Anorexia & wasting chronic illness Dementia Inflammatory Bowel Disease Others Completed In progress/ planning Monitoring Case Study - Bob • Vietnam Veteran | injured by fall in 1969 | multiple fractures • Chronic back pain | peripheral neuropathy from Agent Orange | PTSD • At initial visit: oxycontin | buprenorphine | pregabalin | gabapentin | PEA duloxetine – with little relief and side effects. • Now: Stable at 15mg 1:1 THC/CBD | ceased all opiates, pregabalin and PEA Scores Initial assessment Visit 5 BPI Pain severity score 5.0 1.75 BPI Pain interference score 5.29 0.86 Visual analogue scale 5.0 1.0 Insomnia severity score 12.0 1.0 DASS 42 Depression 14 4 DASS 42 Anxiety 16 2 DASS 42 Stress 16 12 Emyria creates data products Traditional drug development process Product registration Pharmacovigilance Initial market authorisation Potential indication expansion Preclinical Studies Preclinical studies Phase 1, 2, 3 clinical trials Post authorisation monitoring what is the drug? how might it work? is it safe? does it work? what is the target disease? is it still safe? does it work for anything else? is it cost effective? Emyria data products accelerate drug development Emyria product registration • Strategic trial design • Faster initial authorisations • Indication expansions Emyria pharmacovigilance • Safety monitoring • Payer coverage decisions Emyria product registration Data insights + services to help drug developers obtain market authorisation (i.e. a “label claim”) Emyria product registration Global product registration indication-specific dose response insights strategic trial design support using anonymised real-world evidence clinical trial execution registration and repurposing submission support Emyria product registration Case Study - Zelira Therapeutics Emyria was approached in 2019 and provided insomnia-related outcome insights from Emyria’s real-world data. These insights supported a Phase 2 trial. In parallel, Emyria conducted a home-based Phase 1 clinical trial via our national network - Emerald Clinics Emyria is now supporting registration strategies with insights and trial support for multiple indications. product registration paid activities Indication Data insights Opioid Sparing A global medicinal cannabis company pursuing multiple, large clinical indications = Market capitalisation $87M (Oct 7, 20) Insomnia For more details, please see ASX announcements dated 27 FEB 2020 and 30 SEP 2020 Proof-of-concept trials Late phase trials Registration submissions Global regulatory environment for cannabinoids TGA (Australia) (USA) MHRA (UK) [09-Sep-20] TGA releases proposal to [05-Mar-20] FDA releases statement: [13-Oct-16] “We have come to the down schedule “low dose” CBD “To address the questions and opinion that products containing (< 60mg) to “Schedule 3” concerns…(re: CBD), we’re seeking cannabidiol (CBD) used for medical reliable and high-quality data.” purposes are a medicine. Licensed Would allow registered, “low dose” medicinal products have to meet CBD to become PHARMACIST-ONLY FDA showing it is interested in safety, quality and efficacy medicine regulating CBD like all other standards to protect public health.” medicines Registration requires product specific evidence on quality, safety and THC illegal at a Federal level in USA. efficacy for a specific indication Source: https://www.tga.gov.au/consultation-invitation/ consultation-proposed-amendments-poisons-standardjoint-acmsaccs-meetings-june-2020 Source: https://www.fda.gov/news-events/public-healthfocus/fda-regulation-cannabis-and-cannabis-derivedproducts-including-cannabidiol-cbd Source: https://www.gov.uk/government/news/mhrastatement-on-products-containing-cannabidiol-cbd Establishes primacy of registration and need for clinical evidence for cannabinoids in major markets = supports Emyria’s model For more details, please see ASX announcements dated 11 SEP 2020 Emyria pharmacovigilance Data insights to monitor how a drug performs in the real-world Emyria pharmacovigilance additional clinical indications Near real-time pharmacovigilance for novel products providing real-world safety / adverse events product use patterns evidence cost effectiveness Emyria pharmacovigilance Case Study - Spectrum Therapeutics Emyria approached in 2019 to develop a pharmacovigilance product registry to include safety data for Australian patients taking Spectrum products seen through Emerald Clinics. After just 6 months, Emyria’s PV services were expanded to include UK. Total contract values over $1M (AUD) pharmacovigilance paid activities Location Australia Medicinal Cannabis arm of Canopy Growth, Largest cannabis company in the world with market capitalisation = $6.94B USD (Oct 7, 20) UK For more details, please see ASX announcement dated 10 AUG 2020 Development Quality assurance Regular data reports Emyria creates technologies Emyria technology Emyria is investing in the future of care patient-centric care in the home improve clinical efficiency and evidence capture helps clinical team stay connected to patients supports delivery of datadriven care plans Emyria technology Health screening, powered by your smartphone and backed by a clinical team Emyria’s Openly App is registered with the TGA as a Class 1 Medical Device please see ASX announcement dated 15 SEP 2020 Emyria has a strategic partnership with Mt Sinai’s Precision Recovery Team to develop Openly please see ASX announcement dated 17 SEP 2020 Openly workflow Simple, Scalable Deployed to a person’s mobile device, Openly is quickly deployed to large populations Screening in Seconds Actionable Insights Openly is easy to use, enabling Openly aggregates population frequent screenings and health data to manage risk and objective clinical measurements provide decision support Future development of Emyria’s lead products Emyria Care Emyria Tech Emyria Data Emyria product registration Emyria pharmacovigilance * Clinical service in new geography (UK) * Increase diversity of therapies used across network * Develop health screening service * Technology development * More data deals * Emyria insights that are patentable or can become products Upcoming speaking engagements 15 OCT 29 OCT ARCS Conference Thursday 15 October 09.00 - 10.30am, AEDT AusBiotech 2020 Thursday 29 October 11.45am - 12.30pm, AEDT “Real World Evidence & its impact on clinical, regulatory and market access” “Evidence based medicine and precision dosing” Contact Information Michael Winlo: mwinlo@emyria.com Investors: investors@emyria.com Media: media@emyria.com General: info@emyria.com ASX:EMD DRAFT