Announcement PDF (ASX:EMD) New treatments for improving Australia’s mental health January 2024 Company Overview & Strategic Update DISCLAIMER to presentation 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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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. All medicines carry risks and specialist prescribers, such as registered psychiatrists, are best placed to assess the suitability of a new medication against a patient’s individual circumstances and medical history before proceeding. Adverse effects of MDMA include high blood pressure, increased pulse rate, faintness, and panic attacks, and in some rare cases it can cause loss of consciousness or trigger seizures. Other side effects include involuntary jaw clenching, decreased appetite, restless legs, nausea, headache, sweating and muscle/joint stiffness. These effects are unlikely at low doses in the treatment regimens used in psychedelic-assisted psychotherapy while appropriately managed in a controlled environment with direct medical supervision. Emyria 2024 2 With approved Authorised Prescribers, Emyria is advancing from trials to treatment which we believe is a world-first for a community-based service. Greg Hutchinson Non-Executive Chairman Emyria 2024 3 (ASX:EMD) STRATEGIC OVERVIEW The only ASX-listed entity integrating direct care delivery with drug development MENTAL HEALTH FOCUS DRUG-ASSISTED THERAPIES IMMEDIATE PATIENT IMPACT & REVENUES STRONG IP & NOVEL PRODUCTS WORLD-CLASS TEAM & PARTNERS We provide new treatments for large unmet mental health challenges, starting with PTSD We are the first, community-based private clinic to commence MDMA-assisted therapy trials under TGA guidelines We are currently generating approximately $1M in clinical billings per quarter fueling our growth and drug development initiatives Data captured through our clinics creates intellectual property and supports our drug development programs Valued partners like the NIH & the University of Western Australia support our research ambitions Emyria 2024 4 EMYRIA | CORPORATE OVERVIEW Strategic investment from leading life science institutional investors ASX: EMD TRADING INFORMATION Share Price A$0.059 1 6-Month low / high A$0.05 / 0.14 Shares Outstanding 349,226,509 Market Capitalisation A$21.6M Debt (30 Sep 2023) Nil SUBSTANTIAL SHAREHOLDERS Shareholder % Tenmile 6.8% Top 20 56.3% Sources: 1. As of close of market, 9th January 2024 Emyria 2024 5 1 LEADERSHIP IN MENTAL HEALTH - AN AREA THAT DESPERATELY NEEDS NEW SOLUTIONS DEMAND FOR MENTAL HEALTH SERVICES IS HIGH Prevalence of mental ill health in Australia 1 2 in 5 experience a mental health disorder at some time in their life ● Over ● 1 in 5 have had a mental health disorder in the past 12 months ● 15% of adults reported experiencing “high” to “very high” mental distress in the past 12 months Sources: 1. BlackDog Institute Pre-Budget Submission January 2023. Note: BlackDog Institute has not provided its consent to be named in this Presentation 1. BlackDog Institute has not provided its consent to be named or for the statement to be included in this Presentation Emyria 2024 7 BUT, SUPPLY OF MENTAL HEALTH SERVICES IS STRUGGLING More than 1 million Australians are unable to access the care they due to workforce shortages of trained mental health professionals 1 need Notably, 1 in 3 psychologists have closed books 2 Sources: 1. BlackDog Institute Pre-Budget Submission January 2023. Note: BlackDog Institute has not provided its consent to be named in this Presentation 1. BlackDog Institute has not provided its consent to be named or for the statement to be included in this Presentation 2. https://psychology.org.au/about-us/news-and-media/media-releases/2022/unpaid,-underfunded-and-overworked-psychologists-o#:~:text=1%20in%203%20(33%25),were%20not%20taking%20new%20clients Emyria 2024 8 EMYRIA DELIVERS & DEVELOPS NEW TREATMENTS TO IMPROVE MENTAL HEALTH Emyria’s 3-step strategy: DELIVER INNOVATIVE CARE: Our clinics offer care programs that comply with current regulatory standards, including treatments involving drugs that have undergone recent rescheduling CREATE REVENUE GROWTH: We apply strong commercial discipline to ensure healthy and sustainable service revenues SCALE NATIONALLY, THEN INTERNATIONALLY: We leverage our revenues to support capacity growth; We use our data to support innovation and IP creation SOURCES: 1. Combined patient count seen at Emerald Clinics and the Pax Centre, Emyria’s wholly-owned clinical services 2. See September Quarter 4C, 2023 20,000 patients cared for to date 1 $1m / qtr from clinical services and growing each year 2 30 treatments / month target first yr Emyria 2024 9 2 WE ARE EVALUATING DRUG-ASSISTED THERAPIES FOR PTSD WHY POST-TRAUMATIC STRESS DISORDER (‘PTSD’)? PTSD is a large unmet need and we are experts in caring for psychological trauma Market for MDMA-AT for PTSD 2 Anxiety disorders (28%) 1 PTSD (6%) 1 Total Addressable Market (TAM) ~1,000,000 (much greater globally) Serviceable Addressable Market (SAM) ~800,000 Eligible for MDMA-AT ~22% have some clinical exclusion Affective disorders (e.g. depression) (8%) 1 Substance abuse (3%) 1 Early Target Market ~6,000 patients 10% of patients suitable for MDMA-AT in Western Australia: SOURCES: 1. https://www.abs.gov.au/statistics/health/mental-health/national-study-mental-health-and-wellbeing/latest-release#key-statistics 2. See ASX presentation 06 September 2023 Emyria 2024 11 WHY MDMA-ASSISTED THERAPY (‘MDMA-AT’) FOR PTSD? 1 2 PTSD IS PREVALENT & NEEDS NEW TREATMENTS MDMA-AT SHOWS PROMISE IN CLINICAL TRIALS - RISKS ASSOCIATED WITH THE USE OF MDMA ARE SET OUT IN SLIDE 2 6% PTSD affects of all Australians (~1M people) 1 60% more prevalent in first-responders 2 50% of patients develop treatment resistance 3 70% After 3 treatments, of participants no longer met criteria for PTSD (compared to ~48% in placebo group). Results replicated across two, Phase 3 trials 4, 5 $132.9 3 MDMA-AT IS COST EFFECTIVE US million expected to be saved over 30 years per 1,000 treatments 6 4 EMYRIA KNOWS HOW TO DELIVER INNOVATIVE SERVICES We’ve cared for and our team is experienced in providing services compliant with regulatory standards and have managed treatments involving rescheduled drugs 5 EMYRIA HAS A BUSINESS MODEL FOR GROWTH SOURCES: 1. https://www.phoenixaustralia.org/news/ptsd-awareness-day-2022/ 2. Bryant RA. The nature of PTSD in treatment-seeking first responders. Eur J Psychotraumatol. 2022 Jan 26;13(1):2011602. 3. Committee on the Assessment of Ongoing Efforts in the Treatment of Posttraumatic Stress Disorder; Board on the Health of Select Populations; Institute of Medicine. Washington (DC): National Academies Press (US); 2014 Jun 17. 20,000+ $1m / quarter current clinical billings, and growing, supports clinic expansion and novel drug development 7 4. Mitchell, J.M., et al. MDMA-assisted therapy for severe PTSD: Nat Med 27, 1025–1033 (2021) 5. Mitchell, J.M., et al. MDMA-assisted therapy for moderate to severe PTSD: Nat Med (2023). https://doi.org/10.1038/s41591-023-02565-4 6. Marseille E., et al. Updated cost-effectiveness of MDMA-assisted therapy for the treatment of posttraumatic stress disorder in the US Findings from a phase 3 trial. PLoS One. 2022 Feb 25;17(2):e0263252. doi: 10.1371/journal.pone.0263252 7. See September Quarter 4C, 2023 Emyria 2024 12 MDMA-ASSISTED THERAPY IS ATTRACTING SIGNIFICANT GLOBAL INVESTMENT Jan 5th, 2024 MAPS raised USD $100M to pursue the FDA registration and commercialisation of their MDMA product. 1 This creates a massive need for clinical services with the infrastructure and team capable of delivering these treatment in a safe and commercially viable way. SOURCES: 1. https://www.wsj.com/finance/legalization-advocate-maps-raises-money-for-pharmaceutical-psychedelics-a0f1ff94 Emyria 2024 13 WHAT IS POST-TRAUMATIC STRESS DISORDER (‘PTSD’)? A chronic, debilitating mental health disorder that can occur following a traumatic event Key Stats Symptoms Current Treatments Re-experiencing: Intrusive memories, flashbacks, and nightmares ● ● ● PTSD affects ~6% of adults (with higher incidence in first responders) 1 Avoidance: Up to 50% treatment resistance 1 Increased arousal: US$232.2B annual total cost in USA 2 Evading reminders of the trauma and feeling detached Irritability, sleep issues, and easily startled Mood & cognition: Persistent negative emotions and distorted blame COUNSELLING & PSYCHOTHERAPY PRESCRIPTION DRUGS EXPOSURE THERAPY Re-imagining events in a safe environment GROUP THERAPY Physical symptoms: Palpitations, sweating, and gastrointestinal issues SOURCES: 1. Committee on the Assessment of Ongoing Efforts in the Treatment of Posttraumatic Stress Disorder; Board on the Health of Select Populations; Institute of Medicine. Washington (DC): National Academies Press (US); 2014 Jun 17. 2. Davis LL, Schein J, Cloutier M, et al. The economic burden of posttraumatic stress disorder in the United States from a societal perspective. J Clin Psychiatry. 2022;83(3):21m14116 Emyria 2024 14 WHAT IS MDMA-ASSISTED THERAPY (MDMA-AT)? Patients undergo psychotherapy sessions while under the influence of MDMA to enhance the therapeutic process MDMA + PSYCHOTHERAPY Proposed Benefits with Skilled Therapy MDMA-AT is thought to assist patients to access traumatic memories with reduced distress. Improved feelings of trust and wellbeing while under the influence of medication can support communication and strengthen the therapeutic alliance between patient and therapist. MDMA (3,4-methylenedioxymethamphetamine or “ecstasy”) Risks & Exclusions MDMA produces feelings of emotional connection, openness and fear extinction Supportive intensive, trauma-informed psychotherapy is believed to be crucial to therapeutic benefit SOURCES: 1. An evaluation of the therapeutic value, benefits and risks of methylenedioxymethamphetamine (MDMA) and psilocybin for the treatment of mental, behavioural or developmental disorders. Published 09 November 2021 (TGA website: www.tga.gov.au) Patients with cardiovascular or psychotic disease are generally excluded. Main side effects can include anxiety, restlessness, fatigue, jaw-clenching, headache and transient increases in blood pressure and / or heart rate all of which are closely monitored. 1 Emyria 2024 15 MDMA-AT SHOWING PROMISE FOR PTSD | TWO PHASE 3 TRIALS COMPLETED 1, 2 (MAPP1 & MAPP2) Improves symptoms MAPP1 Improves function Key benefits after 3 treatment sessions MAPP1 86.5% of MDMA-AT 71.2% of MDMA-AT participants reported improvement, compared to 69% in placebo group. MAPP2 MAPP2 participants no longer met PTSD criteria, compared to 47.6% in the placebo group. Risks associated with MDMA-AT are set out in Slide 2. MDMA-AT significantly reduced PTSD symptoms, as shown by the change in CAPS-5 total severity score from baseline to 18 weeks after baseline MDMA-AT significantly improved quality of life, as shown by the change in Sheehan Disability Scale score from baseline to 18 weeks after baseline Further enhancements reported in various life areas, including familial, social, and professional aspects. SOURCES: 1. Mitchell, J.M., Bogenschutz, M., Lilienstein, A. et al. MDMA-assisted therapy for severe PTSD: a randomized, double-blind, placebo-controlled phase 3 study. Nat Med 27, 1025–1033 (2021) 2. Mitchell, J.M., et al. MDMA-assisted therapy for moderate to severe PTSD: a randomized, placebo-controlled phase 3 trial. Nat Med (2023). https://doi.org/10.1038/s41591-023-02565-4 Emyria 2024 16 MDMA-AT COSTS 1 vs STANDARD OF CARE 2, 3 If Phase 3 clinical trial remission rates can be achieved in real world settings, MDMA-AT is cost effective for PTSD Ongoing care Cumulative costs ($1,000s of AUD) 60 Emyria’s intensive, 12-16 week program 1 ~ $30,000 / yr 1 Typical standard of care interventions 2 ~ $60,000 / yr 2 Neurostimulation (~$3,000) 50 2-week hospital admission 2 (~$24,500) 40 Multidisciplinary follow-up for 12m 4-week group therapy program (~$3,000) 30 Emyria’s program Studies show durability of MDMA-AT benefit holds out to at least 12m 3 20 2-week hospital admission 2 (~$24,500) 10 Screening Regular specialist appointments (~$500 / each) 1 2 3 4 5 6 7 8 9 10 11 12 Time (months) Sources: 1. Costs are estimated based on estimates of direct clinician time required to delivery program 2. Standard of care costs based on conversations with clinical specialists. WA East Metropolitan Health Service reported Specialised Mental Health Care Days average cost of $2,156 per day in FY 2022 / 2023 (https://annualreport.emhs.health.wa.gov.au/key-performance-indicators/browse-kpis/average-cost-per-bed-day-in-specialised-mental-health-inpatient-services/) 3. Marseille E, et al. The cost-effectiveness of MDMA-assisted psychotherapy for the treatment of chronic, treatment-resistant PTSD. PLoS One. 2020 Oct 14;15(10):e0239997. doi: 10.1371/journal.pone.0239997. PMID: 33052965; PMCID: PMC7556534. Emyria 2024 17 3 DELIVERING IMMEDIATE PATIENT IMPACT EMYRIA HAS MADE SIGNIFICANT PROGRESS IN THE LAST 24 MONTHS While providing care to thousands of patients, we have developed and refined our treatment environment & care models Dedicated facilities multiple, fit-for-purpose consulting rooms 1 20+ clinicians trained and ready to support psychedelic-assisted therapy 1 Robust data capture systems 3 - to generate insights that help improve care delivery and guide innovation Approved Authorised Prescribers working with a range of clinicians to provide multidisciplinary care before, during and after treatment 4 Key advantages of the Emyria model: ✓ Commercially viable clinical services ✓ Designed to scale nationally, then globally ✓ Compliant with all regulatory requirements ✓ Generates robust Real-World Data to support innovation ✓ Versatile - team and infrastructure ready to evaluate new interventions ✓ Multidisciplinary and comprehensive “wrap-around” mental health care SOURCES: 1. See ASX release 13 September 2023 2. See ASX release 21 September 2023 3. See ASX release 07 October 2021 4. See ASX release 10 January 2024 Emyria 2024 19 WHERE NEXT? LEVERAGE PTSD EXPERTISE TO TACKLE ADDITIONAL MENTAL HEALTH DOMAINS 35% of Australian adults experienced at least 1 mental health challenge in the last 12 months 1 Start with PTSD Multidisciplinary clinics providing evidence-based psychological trauma care Expand to other mental health challenges Expand globally Add new services for conditions like treatment-resistant depression Seek growth opportunities via strategic partnerships Emyria 2024 20 OUR 12m ROADMAP # PROGRAM MILESTONE 1 MILESTONE 2 1 Launch new service Emyria psychiatrists obtain Authorised Prescriber status Provide full treatment for first 20 patients 2 Scale service nationally Commence service in another AU state (via acquisition or licence) Treat first 20 patients in another AU state 3 Launch second new service for depression Obtain Authorised Prescriber status for second service Treat first 5 patients with new service 4 Engage Payers Secure a major payer partnership Secure second major Payer Secure intellectual property for MDMA analogues Receive Clear Search Report from international patent examiner Secure granted patents in national phase 5 OUR INDUSTRY PEERS Innovative, premium clinical services can do well COMPANY SECTOR VALUATION or (REVENUES) 1 A US health care network of primary care centers for older adults with Medicare USD$10.7B (acquired by CVS) 1 2 An integrated allied healthcare organisation with networks of optometry, podiatry, and physiotherapy clinics A$260M (acquired by Pacific Equity Partners) 2 3 Occupational medicine and general practice services (over A$200M / year) 3 4 A US chain of primary healthcare clinics USD$3.9B 4 (acquired by Amazon) 5 A US health care network focussed on Medicare and Medicaid Has raised over USD$800M 5 SOURCES: 1. https://www.cvshealth.com/news/company-news/cvs-health-completes-acquisition-of-oak-street-health.html 2. https://www.afr.com/street-talk/moelis-tapped-for-pep-s-1-80-a-share-bid-for-healthia-20230831-p5e0ux 3. https://investors.sonichealthcare.com/FormBuilder/_Resource/_module/T8Ln_c4ibUqyFnnNe9zNRA/docs/Reports/AR/SHL_Annual_Report_2023.pdf 4. https://press.aboutamazon.com/2022/7/amazon-and-one-medical-sign-an-agreement-for-amazon-to-acquire-one-medical 5. https://www.cbinsights.com/company/cityblock-health/financials Emyria 2024 22 4 OUR DRUG DEVELOPMENT & IP PIPELINE EMYRIA’S PHARMACEUTICAL DEVELOPMENT PIPELINE Novel chemical entities and unique dose forms PROGRAM DESCRIPTION LEAD SERIES DEVELOPMENT GOAL COMMERCIAL STATUS STAGE CATEGORY LEADER Novel, MDMA-inspired medicines | Developed with the University of Western Australia With partner, the University of Western Australia, we have created the world’s largest library of novel, patentable, MDMA analogues. We’re modifying the MDMA molecule to change its affects such as its selectivity for one or more of the three major neurotransmitters, it’s onset of action and its side effect profile. Our MDMA analogues are small, brain penetrating molecules with a range of potential applications. EMD-MX1 Faster-acting MDMA, with improved side-effect profile, for drug-assisted therapies ACTIVE: Metabolic studies to evaluate half-lives of lead drug candidates. Kinoxis (Preclinical offer $273M) 1 EMD-MX2 Adjunct for Parkinson’s disease to improve the side effects of a common treatment ACTIVE: Release assays with the NIH for lead series to help identify most potent drug candidates for animal studies. Levodopa ($8B /yr) 2 EMD-MX3 Other neurological indications ACTIVE: Binding receptor screening with Eurofins to select candidates for further preclinical assays. EMD-RX7/9 Prescription medicines for complex pain & anxiety ACTIVE: FULLY FUNDED PRECLINICAL PROGRAM paid for by the NIH 3 currently preparing for rat PK studies ahead of Phase 1 & Pre-IND EMD-RX5 Pharmacy treatment for mild anxiety & stress Ultra-Pure CBD capsules | Highly bioavailable CBD Synthetically-derived Ultra-Pure cannabidiol in proprietary formulations to improve bioavailability. Phase 3 clinical trials partially completed SOURCES: 1. . https://www.sydney.edu.au/news-opinion/news/2023/05/05/sydney-spinout-kinoxis-273m-develop-drugs-psychiatric-disorders.html 2. https://www.gminsights.com/pressrelease/parkinsons-disease-therapeutics-market 3. See ASX release 28 Nov 2022 4. https://investor.jazzpharma.com/news-releases/news-release-details/jazz-pharmaceuticals-announces-full-year-and-fourth-quarter-2022 5. See ASX release 06 September 2023 6. See ASX release 04 April 2023 5 Epidiolex ($1B/yr) 4 Partnered with ASPEN PHARMACARE AUSTRALIA 6 N/A Emyria 2024 24 EMYRIA’S GROWING PATENT PORTFOLIO Emyria’s unique intellectual property (‘IP’) is guided by clinical data we collect and covers: new chemical entities, dosage forms, methods of treatment and software TITLE OFFICIAL NO. STATUS MDMA Analogues 2021903836 PCT filed Cannabidiol Dosing Regime 2021902001 PCT filed Cannabinoid Dosage Form 2022900479 PCT filed Use of Cannabidiol for the Treatment of Psychological Distress 2020904152 PCT filed Use Of Cannabidiol for the Treatment of Psychological Distress 2021901086 Provisional filed Use Of Cannabidiol for the Treatment of Irritable Bowel Syndrome Symptoms 2021901672 Provisional filed Use Of Cannabinoid Combination for the Treatment of Irritable Bowel Syndrome Symptoms 2021901674 Provisional filed Others in development covering unique delivery platforms, dose responses and clinical indications Additional provisionals expected Emyria 2024 25 5 EMYRIA’S WORLD-CLASS TEAM & PARTNERS WORLD-CLASS BOARD AND MANAGEMENT TEAM Founded and scaled innovative clinical services; commercialised novel drug treatments Greg Hutchinson Non-Executive Chairman Prof Sir John Tooke Non-Executive Director Dr Karen Smith Non-Executive Director Dr Mohit Kaushal Non-Executive Director Dr Michael Winlo Managing Director ● Health Service Expansion: ● Clinical Leadership: ● Biopharma Authority: 100+ ● Health IT Strategist: Key role ● Clinical Data Expertise: clinical trials and 20+ regulatory approvals Strategic Growth: Former Chief Medical Officer and Global Head of R&D at Jazz Pharma; drove growth through acquisitions & partnerships in Oak Street Health's $10.6B acquisition by CVS Health; experienced driving growth in tech-centric organisations Health Policy Expert: Served in Obama administration's Health IT task force; Adjunct Professor at Stanford ● Spearheads growth and innovation as CEO Sonic HealthPlus and through 5D Clinics; leads 40+ clinics Strategic Vision: Influential in Australia's health sector, aligning with mission to expand and innovate mental health treatment services ● Former President of the Academy of Medical Sciences, recognised for innovative clinical service design and policy Global Health Payer Expertise: Influential roles at BUPA and past advisor to Google DeepMind ● ● ● Ex-Palantir healthcare lead, merging Medical Doctor and Stanford MBA credentials to drive health innovation Startup Scaling: Utilising digital technology, frontline medical experience and business network to drive growth Emyria 2024 27 EMYRIA’S GLOBAL CLINICAL ADVISORS Experts in mental health, psychedelic-assisted therapies, neuroscience and drug development Dr Jon Laugharne MBBS, FRCP (UK), FRANZCP Claire Kullak BSc (Nursing) Dr Ben Sessa MBBS(MD), MRCPsych Dr Jenny Morgan MBBS, FRANZCA Consultant psychiatrist and specialist in treatment of psychological trauma. Trained psychedelic therapist and MDMA-assisted therapy researcher Trauma-informed mental health nurse, psychotherapist and nationally recognised EMDR trainer. Trained in psychedelic-assisted therapy and MDMA researcher Specialist psychiatrist and psychedelic and cannabis researcher. Has led studies on LSD, psilocybin, and MDMA over 15 years, significantly advancing psychedelic-assisted therapy and mental health treatment Consultant pain specialist with 25 years of experience managing complex chronic pain conditions Dr David Gunn MBBS, FRACGP Prof Matt Piggott BSc, PhD (Chemistry) Dr Jeremy Tannenbaum BSc, MBBS (Hons), FRANZCP Prof Mat-Martin Iverson Professor, BSc Alta., PhD Br.Col. Cannabinoid expert with special interest in the management of substance abuse & mental health treatment Professor and specialist in amphetamine chemistry and novel drug design Dual specialist in Pain Medicine and Psychiatry. Researched psychedelics at Imperial College, London Neuropharmacologist and oxytocin expert Emyria 2024 28 CONTACT INFORMATION Michael Winlo Investors Media General INVESTOR HUB: https://investorhub.emyria.com/ mwinlo@emyria.com investors@emyria.com media@emyria.com info@emyria.com