Announcement PDF Annual Report 2022 2021 - 2022 UPDATE CommenCed Human Trials for EMD-RX5 expanded MDMA Analogue Partnership with UWA awarded National Digital Disrupter Award Boosted Real-World Data with Palantir Foundry added Renowned Biopharma Executive to Board provided Personalised Care to 1000’s of Patients accelerating the development of new treatments for unmet medical needs WE ARE 2 E MYRIA AN NUA L R EPO RT 20 22 Emyria is... A clinical-stage biotech accelerating the development of new treatments for unmet medical needs. CONTACT INFORMATION Michael Winlo mwinlo@emyria.com Investors investors@emyria.com Media media@emyria.com General info@emyria.com ASX:EMD ABN 96 625 085 734 emyria.com 3 E MYRIA AN NUA L R EPO RT 20 22 Contents PART ONE Letter From the Chairman 04 The Year That Was 05 What are Emyria’s Drug Development Programs? 06 Drug Development Commencing Human Trials 07 Why is Emyria’s Ultra- Pure CBD Key To Sustainable Cannabis-Based Treatments? 08 New Drug Discovery Extending The Potential of MDMA 09 Innovation Boosting Emyria’s Real World Evidence 10 How Does Emyria’s Real-World Data Improve Treatment Development? 11 CBD - Bringing Hope To Families Living With Autism 12 PART TWO Directors’ Report 13 Financial Report 31 Consolidated Statement of Profit or Loss and Other Comprehensive Income 32 Consolidated Statement of Financial Position 33 Consolidated Statement of Changes in Equity 34 Consolidated Statement of Cash Flows 35 Notes to the Consolidated Financial Statements 36 Director’s Declaration 67 Auditor’s Declaration 68 Independent Auditor’s Report 69 Corporate Governance Statement 74 ASX Additional Information 83 Corporate Directory 86 Letter From The Chairman Our mission to create a more efficient system of drug development, powered by Real-World Data created with patients at our clinics, is coming to fruition in remarkable ways. EMD-RX5 PHASE 1 OTC Capsule shows strong results Vs. globally registered Epidyolex® In less than eight months, we have developed a proprietary, Ultra-Pure CBD capsule (EMD-RX5) and demonstrated its safety, tolerability and performance compared to the leading registered CBD medication in the world (Epidyolex®). EMD-RX5 will enter Phase Three clinical trials in FY22/23 before submitting for Australian registration and further global commercialisation plans are underway. We also have a second Ultra-Pure CBD capsule (EMD-RX7) progressing down the same path in FY23 and more on the way. Last year, we initiated a New Drug Development (NDD) Program by entering into a partnership with the University of Western Australia. We expanded our partnership with UWA in May 2022 and are excited about the possibilities it presents in the years to come. Our goal is to develop MDMA analogues that can be developed into next-generation psychedelic-assisted therapies for severe mental health disorders and treatments for other neurological disorders. As always, the milestones of the last twelve months have been guided by strategic and sustainable corporate governance. Step closer to pre clinical studies with our MDMA So far, our NDD program has created and successfully screened over 120 compounds, that are poised for further pre clinical studies. analogue program “ ... setting up FY23 to be the most exciting and momentous year ahead in Emyria’s history as we establish ourselves as a product company...” Emyria bolstered its board and international reach by adding global bio-pharmaceutical expert Dr Karen Smith to our board, and in the same month, we welcomed Tattarang as a strategic corporate investor who has shown great support for our future vision. Our trial partners, CMAX and Clinitrials, have helped us guide EMD-RX5 on its path to registration. These partnerships are recognition of Emyria’s growing influence in the biotech industry, as is our growing media presence, which included the ABC, West Australian, Sydney Morning Herald, Australian Financial Review, and many more in the last year. FY21 represented the building of a foundation - the establishment of a data-forward clinical service that learns from every patient. In FY22, we added world-class drug development capabilities, setting FY23 up to be the most exciting and momentous year in Emyria’s history. Particularly as we establish ourselves as a product company with multiple clinical programs, a deep pipeline and one of the most robust Real-World Data assets globally. Importantly, all this growth is in service of our ultimate goal – to help those with unmet needs. There are millions of people around the world that suffer from conditions without accessible treatments. Everything we do – our clinics, our data programs, our drug development and remote monitoring programs – aims to improve those patients’ lives. It’s a goal we share with you, our valued shareholders, and we cannot thank you enough. Dr Stewart Washer Emyria Chairman 4 2021 THE YEAR THAT WAS AUGUST SIGNED AGREEMENT with the University of Western Australia (UWA) to develop a drug discovery pipeline inspired by MDMA. EXECUTED AGREEMENT with Altasciences to develop, Ultra-Pure cannabinoid medicines for FDA and TGA registration. ENGAGED CALVERT LABS to conduct pre clinical studies for Emyria’s Drug Repurposing Programs. SEPTEMBER PUBLISHED PROMISING in vivo and in vitro results from the first round of screening MDMA analogues. Results to guide next batch of novel chemical entity generation. EXPANDED specialist psychiatry advisory team to help advance Emryia’s psychedelic-assisted therapy trials and novel MDMA-analogue development. OCTOBER SELECTED to join a cohort of emerging companies participating in Palantir’s Foundry Builders Program, which is expected to greatly boost Emyria’s data integration and analysis capabilities. NOVEMBER PARTNERED WITH TATTARANG STRATEGIC INVESTMENT to accelerate drug development programs. The Company issued 20 million shares to Tattarang Ventures Pty Ltd at A$0.25 per share, and 10 million options with an exercise price of $0.40 per option and an expiry date of 24 November 2023. RECEIVED $1,162,000 research and development tax incentive refund. DECEMBER RELEASED MDMA ANALOGUE SCREENING results showing 82 of 85 compounds passing initial safety screening. PUBLISHED POSITIVE ANIMAL DATA for Emyria’s first, Ultra-Pure CBD capsule (EMD-RX5). EXPANDED REAL-WORLD DATA monitoring technology via partnership with Cydelic. BEGAN INCORPORATING WEARABLE MONITORING into Emyria’s observational and clinical trials programs. APPOINT GLOBAL PHARMA EXPERT TO BOARD. Dr Karen Smith, former Chief Medical Officer and Global Head of Research and Development at Jazz Pharmaceuticals. 2022 JANUARY ANNOUNCED PLANS to commence Phase One human trials for Ultra-Pure CBD capsule, EMD-RX5. FEBRUARY ADDED 17 MDMA ANALOGUES to library that had been synthesised based off earlier positive screening. MARCH MAY RECEIVED ETHICS APPROVAL AND START OF RECRUITMENT for Phase 1 clinical trial evaluating safety and tolerability of EMD-RX5. ANNOUNCED POSITIVE SCREENING OF MDMA-ANALOGUES. 94% of compounds synthesised and screened demonstrated no interactions with selected ‘anti-targets’ linked to unwanted side effects. LAUNCHED EMD-RX7, Emyria’s second, proprietary and highly bio available, Ultra-Pure CBD capsule. APRIL COMMENCED DOSING for EMD-RX5 Phase One human clinical trial. PARTNERED WITH CLINITRIALS to lead a multi-site Phase Three trial required to register EMD-RX5 as an over-the-counter, Schedule 3 medication with the TGA. COMPLETED DOSING for EMD-RX5 Phase One human clinical trial. PUBLISHED CLINICAL PHASE ONE HUMAN TRIAL RESULTS for capsule medication EMD-RX5 which demonstrated: • • • • excellent safety and tolerability less patient variability, a sustained release profile excellent bio availability compared to the only registered CBD medicine Epidyolex®. EXPANDED MDMA-ANALOGUE New Drug Discovery program with the University of Western Australia. 5 WHAT are EMYRIA’S DRUG DEVELOPMENT PROGRAMS ? Emyria’s pace of drug development is unusually quick. It demonstrates the effectiveness of the unique harmony between our clinics, our Real-World Data and our drug development programs. Our focus is to create innovative forms of existing treatments where evidence is lacking, like Ultra-Pure cannabinoids. And to develop new drugs inspired by promising compounds like MDMA. This isn’t just a short-term advantage. Our distinct capabilities allow us to provide personalised care for patients and rapidly develop new technologies and treatments with the potential to help address major unmet medical needs. It’s a tremendously exciting prospect. OUR LATEST DEVELOPMENT PROGRAMS DRUG DEVELOPMENT Powered By Real World Evidence ULTRA - PURE CANNABINOIDS NOVEL FORMULATION MEDICAL INDICATION EMD-RX5 OVER THE COUNTER Psychological Distress EMD-RX5 OVER THE COUNTER Irritable Bowel Syndrome EMD-RX7 PRESCRIPTION Multiple Medical Conditions OTHERS IN DEVELOPMENT PRESCRIPTION Multiple Medical Conditions DOSE OPTIMISATION SAFETY TRIALS PIVOTAL TRIALS APPROVAL NEW DRUG DISCOVERY MDMA - LIKE MEDICINE PROGRAMS PROGRAM MEDICAL INDICATION PROGRAM 01 HIGHER POTENCY MDMA e.g. Drug-Assisted Psychotherapy PROGRAM 02 SELECTED BRAIN TARGETS e.g. Parkinson’s PROGRAM 03 SELECTED NON-BRAIN TARGETS e.g. Fibrotic Disease Ongoing Library Expansion DISCOVERY PRE - CLINICAL PHASE 1 PIVOTAL TRIALS APPROVAL CONCEPT DESIGN SUBMISSION APPROVAL LAUNCH INNOVATION TECHNOLOGY DESCRIPTION OPENLY REMOTE HEALTH TRACKER Vital Signs Tracked Via Smartphone Camera 6 DRUG DEVELOPMENT COMMENCING HUMAN TRIALS EMD-RX5 Phase One Clinical Trial Emyria’s Phase One clinical trial tested our first Ultra-Pure CBD capsule, EMD-RX5, against Epidyolex® oil to see how it measured up in terms of safety, bio availability and drug delivery profile. An achievement recognised in 2021 with a US $7.2 billion acquisition by Jazz Pharmaceuticals. It’s the standard we want EMD-RX5 to meet, and it’s why the Phase One trial results were so exciting. We picked Epidyolex® because it is the only CBD medicine in the world that’s achieved registration in Europe, the USA and Australia (via EMA, FDA and TGA). Testing our capsule against the only FDA-registered CBD oil ensures that Emyria’s drug development program is well set to obtain multiple global registrations. And be the first of its kind in capsule form. Backed by years of development and hundreds of millions of dollars, Epidyolex® has changed the lives of thousands of patients. EMD-RX5 passed its first test with flying colours. EMD-RX5 & EPIDYOLEX® AVERAGE CANNABIDIOL (CBD) DOSING PROFILE at 150mg dose CBD Amount EMD-RX5 & EPIDYOLEX AVERAGE CANNABIDIOL (CBD) DOSING PROFILE at 150mg dose EMD-RX5 delivers higher CBD amount 3-8 hours after dosing FDA-registered CBD OIL FDA-registered EMD-RX5 CBD OIL CBD CAPSULE EMD-RX5 CBD CAPSULE 0 3 8 24 Hours after taking dose The results demonstrated excellent safety and tolerability, statistically equivalent bio availability to Epidyolex®, higher drug levels 3-8 hours after dosing and less variability in dose between patients, which should enable doctors and patients to use it with confidence. And as a capsule, it will be more convenient for patients and doctors alike, with improvements in dosing profile, consistency and measurement. Now, it’s on to Phase Three, with the ultimate goal of global registration as an over-the-counter medication. 7 WHY is EMYRIA’S ULTRA-PURE CBD KEY TO SUSTAINABLE CANNABIS-BASED TREATMENTS CBD is promising as a medical treatment globally for conditions such as chronic pain, psychological distress, gut health conditions and autism. And while the interest in CBD as a therapeutic treatment increases, the reliability and environmental impact of growing and manufacturing plant CBD show negative factors. That’s where Ultra-Pure CBD comes in. Ultra-Pure CBD is made in a lab rather than developed from plants grown outdoors or in greenhouses. That process ensures pharmaceutical-grade purity and is much less demanding on the environment than traditional ways of growing cannabis plants. It involves techniques such as microbial fermentation, molecular biology and genetic engineering. Long-term, it also means producing these medicines is more sustainable. While developing rapidly, this technology is still new – and how it is harnessed is quite remarkable. Plant-grown CBD requires 44 times as much CO2 emissions and 333 times more water to produce[1]. The bio synthesis process of Ultra-Pure CBD is a more sustainable approach, using renewable sources to produce medicines (as well as many other products) rather than fossil fuels. BOTANICAL CBD BIOLOGICAL ACTION ? Vs ULTRA-PURE CBD Ultra-Pure CBD has equivalent physiological effects to botanical CBD [2] REGULATORY CONSIDERATIONS Most CBD oils do not meet FDA requirement for CBD purity (with exception of Epidyolex®) FDA Drug Master File for API acceptance from major regulators PURITY Small quantities of THC and impurities No detectable THC and impurities INTELLECTUAL PROPERTY Most generic oils have limited IP COST Plant growth & extraction expensive Lower cost over long-term ENVIRONMENTAL IMPACT Up to 45 X CO2 emissions Up to 333 X water consumption [1] Lower energy requirements 100% Emyria-owned Ultra-Pure CBD not only has enormous potential for medical treatments - where it can provide the gold standard in predictable and reliable purity, but Ultra-Pure CBD can also dramatically reduce the cost to the environment. By ensuring we manufacture these treatments in the most environmentally friendly way possible, we also help preserve our precious environment and the plants with medicinal benefits to share. 8 cellular-goods.com/learn/articles/science/white-paper-production-of-cannabinoids-using-biotechnology [2] Maguire R, F, Wilkinson D, J, England T, J, O’Sullivan S, E: The Pharmacological Effects of Plant-Derived versus Synthetic Cannabidiol in Human Cell Lines. Med Cannabis Cannabinoids 2021. doi: 10.1159/000517120. [1] NEW DRUG DISCOVERY NH CH 3 CH 3 EXTENDING THE POTENTIAL OF MDMA with Emyria and its partner, the University of Western Australia (UWA), agreed to substantially expand their collaboration to develop novel medicines inspired by MDMA (MDMA analogues) with the potential to become treatments for unmet medical needs. The Program, “New Drug Discovery” (NDD), starting with MDMA analogues, is a key pillar of Emyria’s drug development strategy. To date, the NDD Program has successfully screened 125 analogues. Several show potential as next-generation psychedelic-assisted therapeutics or new treatments for neurological and non-neurological conditions. The most promising analogues are now being prepared for pre clinical testing to further evaluate their therapeutic potential. “Emyria’s clinical development expertise, funding and international networks have taken our MDMA analogue research to the next level. We have already identified hits for new disease indications as a result of the screening program this collaboration has enabled. We are excited at the prospect of translating these findings to the clinic, where they can improve quality of life for patients with unmet needs.” - UWA Professor Matt Piggott 9 INNOVATION Each patient’s story is unique and holds the potential to help other patients like them. BOOSTING EMYRIA’S REAL WORLD EVIDENCE (RWE) Each patient’s story is unique and holds the potential to help other patients like them. It leads Emyria to continue investing in building world-class data gathering and analysis capabilities. The robust and ethically-sourced data we gather with our patients guide our personalised care programs and our growing drug development strategy. The unique Real-World Data asset we are building involves remote monitoring and analysis. must be more than just a symptom tracker (and there are many of those on the market). REMOTE MONITORING is the collection of clinically meaningful data by remote means (i.e. telephone call or video chat) to monitor the patient’s condition and identify if intervention is necessary. But to be truly effective, a successful system By incorporating physiological measurements into the remotely monitored data, we can greatly increase the clinical data received by doctors and the quality of patient care, which in turn benefits the health care system more broadly. To extend our remote monitoring capabilities, Emyria has developed a smartphone-powered remote monitoring app - Openly - with our global partners. It is now registered as a Class IIA Medical Device. We are also working with Cydelic to enable continuous biometric monitoring. Emyria is among a few companies selected by global data analytics company Palantir to join its Foundry (PF) for Builders program. With PF, Emyria has access to advanced, highly secure data integration and analysis capabilities usually reserved for Fortune 200 companies. PF also allows Emyria to bring multiple data streams together and rapidly discover new clinical insights to guide care delivery and drug development. Openly is a Registered & Approved Class IIA Medical Device (TGA) and Recognised among the Best 2022 innovations in Australia 10 HOW does EMYRIA’S REAL-WORLD DATA IMPROVE TREATMENT DEVELOPMENT Real time Insights ? Everyday People The history of pharmaceutical development is littered with examples of treatments that showed promise under short clinical trials but revealed themselves to have longer term side effects. Accelerating Approval Major regulators worldwide, like the FDA (USA), have specifically created incentives for drug developers to incorporate RWD into their drug development programs. 78% of new drug approvals to the FDA now incorporate RWD [1]. All participants, whether patients or trial staff, must follow a strict protocol in clinical trials. By monitoring patients over a more extended period as part of a new standard of care, Real-World Data (RWD) is more likely to capture those problems before a medicine is widely available. This may mean the trial is doing things that are not common or reflective of how medicine is typically practiced and can affect the general visability of trial results. We believe Emyria’s unique RWD will help us bring new registered treatments to patients sooner. By gathering RWD with patients at the front line of care, we can help ensure that any benefits we are seeing from the new treatments we are developing are more likely to translate. 78% of new drug approvals to the FDA now incorporate RWD [1]. WHAT do we MEASURE WHAT ? do we LEARN Millions of data points from validated clinical measures Other Medication use Patient and Clinician reported outcomes Over 30,000 appointments from thousands of patients ? Which patients and clinical conditions respond most favourably to which treatment program. What dose or treatment combination is most effective for which patient population. What is the long-term safety profile for these new treatments. Safety is a priority. We’ve captured over 10,000 adverse events What are the new or emerging adverse events we need to monitor for. The affects of over 60 different treatments What are the unmet clinical needs that need better treatments. Diverse patient responses Ages 2-100 And more! OUR DATASET includes over 1 million RESPONSES (by both patients & clinicians) THIS DATA ALLOWS us to see who is RESPONDING to treatment [1] Aeiton, (2021) https://resources.aetion.com/the-role-of-real-world-evidence-in-fda-approvals-ebook-2021-update 11 Daniel’s mum Liz describes the impact of the medication as ‘life-changing’. CBD - BRINGING HOPE TO FAMILIES LIVING WITH AUTISM Just before his second birthday, Daniel* was diagnosed with a severe case of Autism Spectrum Disorder (ASD). Fast forward into adolescence, he’s 188 cm and 119 kilos, unable to shower, feed or dress. He experiences hot sweats frequently and has difficulty sleeping. Medication has been a challenging, frustrating process of trial and error that’s taken an emotional, physical and financial toll on his whole family. “Even when medications worked, they only seemed to work for a little while,” says Daniel’s mum, Liz*. Recently, Liz discovered a study investigating tolerance responses involving two low-dose medicinal cannabis products with different THC: CBD ratios in people with ASD. Daniel qualified for the study and is now getting the balance of his medication right. *Names changed to protect privacy “For the first time in his life, Daniel says he loves me regularly. That wasn’t possible just a few months ago. It has changed our lives and had a massive impact in such a short time.” - Liz, Daniel’s Mum Liz describes the impact of the medication as ‘life-changing’. She noticed a ‘softening’ in her son’s character and a feeling of renewed safety in his presence. “For the first time in 16 years, I’ve been able to comfortably sit with my child and build a connection with him.” Today, Daniel safely engages with peers at his school for short periods. For the first time, he’s developing friendships and participating in activities such as passing balls, blowing bubbles and dancing. The positive effect has been incredibly touching for his parents and the school. 12 *Names changed to protect privacy 13 E MYRIA AN NUA L R EPO RT 20 22 Directors’ Report 14 E MYRIA AN NUA L R EPO RT 20 22 Directors’ Report The directors present their report for Emyria Limited (“Emyria” or “the Company”) and its subsidiaries (“the Group”) for the financial year ended 30 June 2022. Directors The names of the directors in office at any time during or since the end of the year ended are: Dr Stewart Washer Executive Chairman Dr Michael Winlo Managing Director Professor Alistair Vickery Executive Medical Director Dr Karen Smith Executive Director (appointed 29 November 2021) Mr Matthew Callahan Non-Executive Director Professor Sir John Tooke Non-Executive Director Review of operations The Group made substantial progress on its proprietary drug development program. Emyria’s first Ultra-Pure cannabinoid, EMD-RX5, successfully completed Phase 1 clinical trials. Emyria’s specialist clinics continue to provide high-quality personalised care whilst gathering Real-World-Evidence (“RWE”) insights. Emyria continued to invest in the Group’s digital health platforms to enable improved remote data capture from its patients and enhanced data analysis and visualisation capabilities. Events after reporting date The Company secured a loan facility with Radium Capital secured against the R&D Tax Incentive refund with an interest rate of 14% pa and a maturity date of 31 December 2022. The Company drew down on the facility in August 2022 for the full amount. In August 2022, the Company received ethics approval to commence a pivotal Phase 3 clinical trial of its first Ultra-Pure CBD candidate, EMD-RX5. In August 2022, the Company issued 575,000 unlisted options under the Company’s employee incentive scheme. There are no other matters or circumstances that have arisen since the end of the financial year which have significantly affected or may significantly affect the operations of the Group, the results of those operations, or the state of affairs of the Group in future financial periods. Future development, prospects and business strategy The Group will focus on a product development and registration strategy by creating and testing proprietary formulations of Ultra-Pure cannabinoids and discovering new chemical entities inspired by MDMA. In addition, Emyria continues to deliver care to patients, capture high-quality clinical data (Real-World Data) to transform the way novel therapies are understood and researched via its clinical service subsidiary, Emerald Clinics. The Group will also combine its data with other health records and published information to generate actionable evidence for physicians, drug developers, research groups and government departments. Dividend paid and recommended See page 5 Part One 2022 Annual Report); ‘The Year That Was’ for Review of Operations. Principal activities The principal continuing activity of the Group is developing biopharmaceuticals guided by Real-World Data collected with patients across its wholly-owned clinical service subsidiaries. No dividends have been declared, provided for or paid in respect of the financial year ended 30 June 2022 (30 June 2021: nil). 15 E MYRIA AN NUA L R EPO RT 20 22 Directors’ Report Information on Directors and Company Secretary Dr Stewart Washer Executive Chairman Dr Michael Winlo Managing Director Stewart was appointed on 19 February 2018. He has 25 years of CEO and board experience in medical and agri-food biotech companies. He is director of Botanix Pharmaceuticals Ltd (ASX: BOT), a company undertaking clinical studies on CBD for antimicrobial and topical applications and Founding Chairman and current Director of Cynata Therapeutics Ltd (ASX: CYP) stem cell therapies. Appointed on 8 November 2019, Michael has a Bachelor of Medicine and Bachelor of Surgery with Honours from the University of Western Australia, as well as a Master of Business Administration from Stanford University. Before Emyria, Michael was CEO at Linear Clinical Research Ltd (Linear) until October 2019 –a company providing clinical trial services for US- and Asia-based biotech companies. Linear was the first site in Australia and one of only a few in the world to successfully adopt electronic data capture technology. Under Michael’s leadership, Linear’s revenues grew over 300% in just over three years (to over $23 million per year). Michael retains a Directorship at Linear. Before Linear, Michael was Health Lead at Palantir Technologies – a Big Data company based in Silicon Valley, California. Stewart has held several Board positions in the past, including Chairman of Hatchtech Pty Ltd, which was sold in 2015 for A$279m and was a director of iCeutica, which was sold to a US Pharma. He was also a Senator with Murdoch University and was a Director of AusBiotech Ltd. Other current directorships of a public listed company Cynata Therapeutics Limited (ASX: CYP) Appointed as Director on 1 August 2013 Orthocell Limited (ASX: OCC) Appointed as Chairman on 7 April 2014 Former directorships in last three years of a public listed company Zelira Therapeutics Limited (ASX: ZLD) 17 November 2016 to 2 December 2019 Interest in shares and options 49,325,599 29,725,599 shares are in the control of Dr Stewart Washer and Dr Patrizia Washer. Options 1,500,000 Options held are in the control of Dr Stewart Washer and Dr Patrizia Washer. None Former directorships in last three years of a public listed company None Botanix Pharmaceuticals Limited (ASX: BOT) Appointed as Director on 21 February 2019 Shares Other current directorships of a public listed company Interest in shares and options Shares 60,000 Options 7,500,000 16 E MYRIA AN NUA L R EPO RT 20 22 Directors’ Report Information on Directors and Company Secretary Professor Alistair Vickery Executive Medical Director Dr Karen Smith Executive Director Appointed on 12 November 2018, Alistair is the Medical Director of Emyria and has a wealth of expertise in clinical practice, health service management, clinical and educational research and Appointed on 29 November 2021, Dr Smith’s experience is highly global. As a Biotech/ Pharmaceutical Executive, Board Director and Clinical/ Scientific Advisor in the US, Europe, Canada and Australia, board director skills. He is an adjunct Clinical Professor of Primary Health Care at the University of Western Australia and Notre Dame University and an active specialist general practitioner. He was the clinical lead of the CHASM research group (The Collaborative for Health Care Analysis and Statistical Modelling), providing high-level analysis and statistical modelling to inform clinical service planning and evaluation. Alistair is Board Chair of Black Swan Health, one of the largest NFP primary health care service providers in Western Australia, a Fellow of the Australasian College Dr Smith has overseen more than 50+ clinical trials and more than 20 major regulatory approvals in multiple jurisdictions. Many have led to product launches across diverse therapeutic areas, including neuroscience, a rare disease, oncology, cardiology, dermatology, and anti-infectives. of Health Service Management and an AICD graduate. Other current directorships of a public listed Group None Former directorships in last three years of a public listed Group None Interest in shares and options Shares 128,000 Options 4,000,000 Over the past 20 years, Dr Smith has held various executive roles, including President, CEO, Global Head of R&D, and Chief Medical Officer. She has built companies from the ground up and is a strong advocate for women in science and diversity in the Boardroom. Earlier in her career, she held senior leadership roles at Allergan, AstraZeneca and Bristol Myers Squibb. Dr Smith holds several degrees, including an MD from the University of Warwick (UK), a PhD in Oncology from UCLA (USA)/UWA (Australia), an MBA (Masters in Business) from the University of New England, and an LLM (Masters in Law) from the University of Salford (UK). Dr Smith has been a member of the Board of Directors since November 2021. Other current directorships of a public listed Group Sangamo Therapeutics (NASDAQ: SGMO) Talaris Therapeutics (NASDAQ: TALS) Former directorships in last three years of a public listed Group Forward Pharma (NASDAQ: CM) Sucampo Pharma (NASDAQ: SCMP) Acceleron Pharma (NASDAQ: XLRN) Antares Pharm (NASDAQ: ATRS) Interest in shares and options Shares 550,000 Options 1,500,000 17 E MYRIA AN NUA L R EPO RT 20 22 Directors’ Report Information on Directors and Company Secretary Mr