Announcement PDF Emyria (ASX:EMD) Broker Briefing Webinar | Michael Winlo, CEO Emyria develops biopharmaceuticals guided by Real-World Data collected with patients receiving care at our clinics 1 Emyria is a biotech that, uniquely: provides care, generates data & develops treatments Care Patients w unmet needs + new treatments 5 clinical sites (Emerald Clinics) treating more than 40 complex conditions in >6,000 patients aged 2-98. 2 Emyria is a biotech that, uniquely: provides care, generates data & develops treatments Care Data Patients w unmet needs + new treatments Insights from Real-World Data (RWD) 5 clinical sites (Emerald Clinics) treating more than 40 complex conditions in >6,000 patients aged 2-98. One of the largest patient registries of ethically sourced Real-World Data (RWD) on treatment effects of GMP-grade cannabinoids to guide biopharmaceutical development. 3 Emyria is a biotech that, uniquely: provides care, generates data & develops treatments Care Data Treatments Patients w unmet needs + new treatments Insights from Real-World Data (RWD) Proprietary drug design + global registration 5 clinical sites (Emerald Clinics) treating more than 40 complex conditions in >6,000 patients aged 2-98. One of the largest patient registries of ethically sourced Real-World Data (RWD) on treatment effects of GMP-grade cannabinoids to guide biopharmaceutical development. 2 FDA-compliant drug development programs seeking registration with major global regulators. More in development. 4 Emyria’s active clinical development programs Active programs Platform Ultra-pure cannabinoidbased medical treatments (CBMTs) EMD-RX5 Low-dose CBD for multiple indications EMD-RX7 High-dose CBD for multiple indications Initial opportunities Over-the-counter treatment for psychological distress $200m/yr (Australia alone) See ASX Announcement 19 October 2021 [1] https://www.coherentmarketinsights.com/market-insight/post-traumatic-stress-disorder-treatment-market-4433 Next 3-6 months * Complete pivotal trials * TGA registration application * New formulations * Launch US registration programs 5 Emyria’s active clinical development programs Active programs Platform Ultra-pure cannabinoidbased medical treatments (CBMTs) Next-generation MDMA analogues EMD-RX5 Low-dose CBD for multiple indications EMD-RX7 High-dose CBD for multiple indications MDMA analogues Screen and expand library of novel MDMA analogues Initial opportunities Over-the-counter treatment for psychological distress $200m/yr (Australia alone) See ASX Announcement 19 October 2021 Eg. Advanced treatment + assisted therapies for PTSD US$990m / yr (Global) [1] Next 3-6 months * Complete pivotal trials * TGA registration application * New formulations * Launch US registration programs * Advanced compound screening * Commence animal studies * Expand library * Additional IP filings See ASX Announcement 19 October 2021 [1] https://www.coherentmarketinsights.com/market-insight/post-traumatic-stress-disorder-treatment-market-4433 6 Biopharmaceutical cannabinoid development 1 Learn from real-world patients 2 Create high-performing dose form 3 Pursue global registration 7 1 Learn from real-world patients Emyria has Real-World Data with 6,000 patients (+ growing) What dose? What problem? Which patients? 0-1,200 mg 0-197 mg Range of daily CBD prescribed Range of daily THC prescribed 7.12 Average concomitant medications per patient at initial visit 53% 54% Unique primary indications Patients presenting with symptoms of depression Patients presenting with symptoms of moderate to severe anxiety 2 - 98 years 56% age range of patients female patients 44 Data summary as of 28 FEB 2022 35% Patients experiencing an adverse event 8 2 Create a high-performing dose form Plants have inspired 40% of registered medicines Medicine “1.0” “2.0” Natural origins First medical use Statins Pleurotus ostreatus (oyster mushroom) Aspirin Salix alba (white willow) 1970’s First discovered ~400 BCE First prepared as a tea “3.0” Trials & registration 1987 Synthetically developed 1899 https://www.fiercepharma.com/pharma/from-old-behemoth-lipitor-to-new-king-humira-u-s-best-selling-drugs-over-25-years True pharmaceutical Commercialisation status US$95bn lifetime sales of Lipitor alone US$750M USD for “aspirin cardio” alone in 2020 9 2 Create a high-performing dose form Medicinal cannabis stuck at “2.0” - registered biopharmaceuticals reach more patients Medicine “1.0” “2.0” Natural origins First medical use Statins Pleurotus ostreatus (oyster mushroom) Aspirin Salix alba (white willow) Cannabis Cannabis sativa (cannabis) 1970’s First discovered ~400 BCE First prepared as a tea “3.0” Trials & registration True pharmaceutical 1987 US$95bn lifetime sales of Lipitor alone Synthetically developed US$750M USD for “aspirin cardio” alone in 2020 1899 ~8000 BCE First medicinal use documented https://www.fiercepharma.com/pharma/from-old-behemoth-lipitor-to-new-king-humira-u-s-best-selling-drugs-over-25-years Commercialisation status Emyria’s novel synthetic delivery and drug development programs target multiple indications Initial targets: mental health, insomnia and pain 10 2 Create a high-performing dose form Oral CBD has poor bioavailability - as low as 6.5%! Ingested drug Stomach / intestine Gut wall Gut wall Liver Liver Dissolved drug Absorbed drug Drug in portal vein Available drug (~6.5mg) 100mg Undissolved drug Non-absorbed drug Metabolised by liver Unavailable drug (~93.5mg) https://www.tga.gov.au/sites/default/files/auspar-cannabidiol-210115.pdf 11 2 Create a high-performing dose form Emyria’s proprietary CBD formulations enhance bioavailability Diagram on right shows concentrations of CBD in the blood for 3 different formulations as measured over a 24 hour period in an animal model. Each formulation contained the same amount of CBD 50mg - but clear differences in bioavailability are apparent. [1] EMD-RX7 (~4x BA) EMD-RX5 (~2.2x BA) Higher bioavailability means: ● more CBD available in bloodstream ● more cost effective dosing Epidyolex (world’s only registered CBD medicine) 12 [1] See ASX announcement 17 March 2022 2 Create a high-performing dose form Emyria’s ultra-pure CBD vs comparators Emyria is developing a novel cannabinoid delivery platform with leading North American contract drug manufacturer Altasciences (See ASX Announcement 13 August 2021) Feature Biological action Emyria’s proprietary formulation Botanical alternatives Synthetic CBD has equivalent physiological effects to botanical CBD [1] Regulatory considerations FDA Drug Master File for API. Acceptance from major regulators Most CBD oils do not meet FDA requirements for CBD purity (with exception of Epidyolex) Chromatographic purity (low level, ppm) ● Delta-9-THC ● Delta-8-THC ● Sum (D8,D9) No detectable THC Synthetic API ● < 4 (*ND) ● < 4 (*ND) ● < 4 (*ND) THC present Epidyolex ● 224 ● 84 ● 328 Enantiomeric purity by HPLC ● (-)-CBD ● (+)-CBD Ultra-pure Synthetic API ● 100% ● 0.00% Epidyolex ● 99.9% ● 0.08% Enhancing bioavailability Emyria technology achieves ~1.5-2x greater (c/w Epidyolex) Generally poor BA. Sesame oils > MCT oils Intellectual property 100% Emyria-owned Generic oils - limited IP Costs Cost effective over long-term Plant extraction expensive 1. 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 13 EMD-RX# programs: Ultra-pure CBD targeting multiple indications 14 15 16 First indication: Psychological distress - a growing challenge Symptoms of psychological distress ~15% of Australian adults experience high or very high levels of psychological distress [1]. Prevalence is increasing. [2] Current treatments may include monitoring, psychotherapy, prescription medications or referral to support services. [3] Anxiety Depression Sleep disturbance Stress Pain Gastrointestinal complaints More prevalent in patients with chronic disease [1] Australian Institute of Health and Welfare 2018. Australia’s health 2018. Australia’s health series no. 16. AUS 221. Canberra: AIHW. [2] https://www.frontiersin.org/articles/10.3389/fpsyt.2020.595696/full [3] https://onlinelibrary.wiley.com/doi/pdf/10.1111/scs.12289 There is no over-the-counter treatment for psychological distress. 17 EMD-RX5: Over-the-counter CBD for psychological distress Registered, “over-the-counter” (OTC) treatments can improve patient access: - do not require a doctor’s prescription can be purchased directly from qualified pharmacists There are 5,900 pharmacies in Australia [1] and OTC market is estimated at over $20B/year [2]. The TGA permits low-dose cannabidiol (CBD) to be registered as Schedule 3 (S3) OTC medicine. [3] S3 cannabinoid medicines could generate an estimated $200m in Australia, much more globally. [4] Emyria plans to register one of the first, affordable, cannabinoid S3 medicines (EMD-RX5) EMD-RX5 will initially target psychological distress but poised to expand to adjacent indications [1] https://www.guild.org.au/__data/assets/pdf_file/0020/12908/Vital-facts-on-community-pharmacy.p [3] See ASX announcement 16 December 2021 [2] https://insights10.com/product/australia-otc-market-analysis [4] https://freshleafanalytics.com.au 18 EMD-RX5: Real World Data (RWD) guides indication selection Care Data Emyria clinicians have already prescribed low-dose CBD for psychological distress for 600+ patients over 6+ months RWD analysis reveals specific dose-responses, for a specific set of symptoms, in a specific patient population Treatments Emyria’s RWD supports an end-to-end EMD-RX5 registration program and patents (slide 27) 600+ patients [1] Australian Institute of Health and Welfare 2018. Australia’s health 2018. Australia’s health series no. 16. AUS 221. Canberra: AIHW. [2] https://www.frontiersin.org/articles/10.3389/fpsyt.2020.595696/full [3] https://onlinelibrary.wiley.com/doi/pdf/10.1111/scs.12289 19 EMD-RX5: Rapid clinical development progress 1 ✔ Formulation design ● Synthetic CBD (full DMF) ● FDA-approved excipients ● FDA-compliant CBD purity (c/w TGA purity requirements) ● Capsule dose form ● Reliable dosing ● Stable at room temp ● Increased bioavailability ● Cost effective ● Unique IP ✔ 2 3 Preformulation studies ● Dissolution studies ● Qualification of formula ● Excipient testing with validated method ● = Leading formulations evaluated in pre-clinical PK study ✔ Dog PK study ● Comparison to Epidyolex ● Full PK assessments (eg Tmax, Cmax, AUC, AEs) ● = EMD-RX5 appears to have superior bioavailability compared to Epidyolex [1] Commences March 4 Phase 1 (dosing March, 22) ● Ethics approval [2] ● 12 subject, HNV ● 2-way crossover (Epidyolex + EMD-RX5) ● Pivotal Phase 3 clinical trials are fully planned ✔ ICH-GMP-compliant manufacturing [1] See ASX announcement 15 December 2021 [2] See ASX announcement 03 March 2022 20 EMD-RX#: What’s next? New indications. More formulations. 1 Ongoing RWD collection & analysis ● ● Dose-response insights on >6,000 patients and growing Long-term AE monitoring Helps inform: ● Additional indication selection ● Pivotal study designs (eg. endpoint selection) ● Dose form preferences 2 Proprietary dose-form development 3 Launch drug registration programs ● EMD-RX5 (multiple indications) ○ Distress ○ IBS ○ Others ● EMD-RX7 (multiple indications) ● Others in development Develop a range of unique dose forms: ● CBD-only ● CBD/THC combinations 21 Cannabinoid program development milestones Commence and complete pivotal registration clinical trials EMD-RX5 Phase 1 trial Obtain ethics approval Clinical trial material available Q1 New formulations + programs EMD-RX7 Phase 1 trial Prepare product dossier and submit to TGA for registration Commercialisation Obtain & sales Schedule 3 registration IND with FDA (for US registration programs) First commercial sales as over-the-counter, Schedule 3 medicine Complete full product dossier and clinical evidence package for evaluation by TGA. Expected ~2 months from trial completion. EMD-RX5 Phase 3 clinical trial Q2 Q3 2022 TGA evaluation (takes 6-8 months from submission) Entry on Australian Register of Therapeutic Goods (ARTG) as a Schedule 3 medicine Q4 22 Leading next-generation psychedelic development 23 Psychedelic-assisted therapy addresses major unmet needs and is attracting large investment $ $100b Estimated market for psychedelic medicines 264m Number of people who suffer depression globally $10.2b (AUD) Aggregate market cap of psychedelic drug companies 2 in 3 Veterans suffer from PTSD 1 in 4 People in the world are affected by mental health disorders Emyria to leverage clinical network, data infrastructure and drug development expertise to lead innovation Care Data Treatments 24 MDMA MDMA analogue development 25 Emyria’s MDMA analogue library - a drug discovery pipeline MDMA as inspiration Growing library (100+ proprietary analogues) Screening Partnership with Treatment development Next-gen MDMA Proprietary analogue library ● ● ● ● ● ? safety ? prosocial potency ? faster acting ? peripheral effects etc Neuropsychiatric treatments Non-neurological treatments 26 Emyria’s MDMA analogue library - a drug discovery pipeline Partnership with Emyria’s MDMA analogue library Key features ● ● ● ● ● >100 unique MDMA analogues, and growing [1] >10 years of development at UWA Entire library exclusively optioned to Emyria Verified excellent purity and stability Potential as treatments for: ○ Next-gen psychedelics, neurological disorders + other conditions Progress to date 1. No “off-target” effects in first screen (~66 compounds) [2] First patent family filed Library expansion underway University of Sydney approached to develop animal models [2] NEXT: Further expansion, screening and evaluation 2. 3. 4. 5. [1] See ASX announcement 05 August 2021 [2] See ASX announcement 08 December 2021 27 Emyria’s clinical research 28 EMDMA-001: a Phase IIa trial for PTSD with advanced monitoring Drug treatment + non-drug psychotherapy Screening Preparation Cycle 1 Cycle 2 Cycle 3 Follow-Up The study will be led by consultant psychiatrist Dr Eli Kotler (left), and will be run out of the Victorian Counselling and Psychology Services in Melbourne (below) Duration = 18 months EMDMA-001 to evaluate potential of MDMA-assisted therapy for additional patients. Will involve advanced remote monitoring technology with partner Cydelic [1]. Protocol completed and clinical psychologists have completed well as Certificate of Psychedelic-Assisted Therapies (CPAT) partner, Mind Medicine Australia (MMA). training as with 29 [1] See ASX announcement 20 December 2021 Emyria’s growing patent portfolio Emyria’s cannabinoid patents cover unique formulations, delivery approaches and “method of use” Title Official No. Status Use of Cannabidiol for the Treatment of Psychological Distress 2020904152 Provisional filed Use Of Cannabidiol for the Treatment of Psychological Distress 2021901086 Provisional filed Use Of Cannabidiol for the Treatment of Irritable Bowel Syndrome-Related Psychological Distress 2021901672 Provisional filed Use Of Cannabinoid Combination for the Treatment of Irritable Bowel Syndrome-Related Psychological Distress 2021901674 Provisional filed Cannabidiol Dosing Regime 2021902001 Provisional filed Cannabinoid Dosage Form 2022900479 Provisional filed Analogues 2021903836 Provisional filed Others in development covering unique delivery platforms, dose responses and clinical indications Multiple provisionals expected 2021 30 Corporate structure 31 Board has multiple drug registrations, deep biotech experience Dr Stewart Washer Chairman & Founder Prof Sir John Tooke Non-Executive Director Dr Karen Smith Executive Director > 100 clinical trials & 20 FDA approvals Matt Callahan Non-Executive Director 4 FDA approvals Dr Alistair Vickery Smith Medical Director, Specialist GP Dr Michael Winlo Managing Director 32 Capital structure Share price over 12 months Top 20 = 60.48% | Tattarang holds ~5% [1] Director ownership = 27.17% Key Metrics Value Shares on issue 254m Last close ( 26 Oct 2021) A$0.33 Market Capitalisation (26 Oct 2021) A$90.75M Cash (31 Dec 2021) A$8.7m Debt (31 Dec 2021) - Enterprise value A~$82.05m Total options (exercise price $0.114-0.45) expiring. 2022-24 62m Source: https://emyria.com/for-investors/#Stock-Information [1] See ASX announcement 22 November 2021 33 Emyria positioned for growth 1 World-class Board/Management with FDA registration successes 2 In-house expertise in drug development, clinical trials and drug registration 4 Unique biopharmaceutical cannabinoid platform Ultra-pure CBD dose form, FDA-compliant and with bioavailability advantages Proprietary data, access to clinics and patients 3 One of the largest Real World Data assets on cannabinoid treatments guiding clinical development programs 5 Leader in development of novel MDMA-analogues Exclusive access to large and novel MDMA analogue compound library Targeting major markets and unmet needs Multiple clinical programs targeting major, unmet needs 6 Attractive valuation Compared to industry vertical peers 34 Contact Information: Michael Winlo: Investors: Media: General: mwinlo@emyria.com investors@emyria.com media@emyria.com info@emyria.com 35