Slide 1: A clinical stage biotech tackling unmet needs in mental health and neuroscience
For personal use only (ASX:EMD) A clinical stage biotech, informed by the patient experience, tackling unmet needs in mental health and neuroscience March 2023 Broker Briefing
Slide 2: Disclaimer
DISCLAIMER 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. T
Slide 3: Clinical focus: Mental Health & Neuroscience
CLINICAL Mental Health & Neuroscience FOCUS For personal use only COMPARATIVE ● Strong register - Tenmile1 7.8% / Directors 27% / Top 50 70+% ● Unique Ultra-Pure CBD formulations - delivers clinical advantages ADVANTAGES ● Novel MDMA-inspired chemical entities - substantial preclinical assets ● Prop
Slide 4: Major disease targets and unmet needs
‘S MAJOR DISEASE TARGETS Problem Unmet The Emyria’s Advanced Size Needs Opportunity Treatment Programs For personal use only Ultra-Pure “Over the 15% of all adults No over the counter CBD shown to be counter” CBD (slide 11) MILD from time to time treatments effective in Real-World SYMPTOMS (DOI: 10.
Slide 5: Business structure & assets
BUSINESS STRUCTURE & ASSETS For personal use only PERSONALISED CARE ADVANCED TREATMENTS + SERVICE REVENUES DATA + COMMERCIAL DEALS ULTRA-PURE CBD Specialist cannabinoid clinics EMD-RX5 (over-the-counter CBD) caring for 1,000’s of Australians IN PHASE 3 - demand is strong EMD-RX7 (prescription) PREPA
Slide 6: Delivery & data de-risks and accelerates drug registration
“DELIVERY & DATA” DE-RISKS & ACCELERATES DRUG REGISTRATION TRADITIONAL DRUG DEVELOPMENT (costly, time-intensive, high-risk) For personal use only Target Lead Preclinical Phase 1 Phase 2 Phase 3 FDA Discovery Validation Optimisation Development Clinical Trial Clinical Trial Clinical Trial Registratio
Slide 7: Leadership: global drug development and commercialisation successes
LEADERSHIP | GLOBAL DRUG DEVELOPMENT & COMMERCIALISATION SUCCESSES For personal use only Dr Stewart Washer Prof Sir John Tooke Dr Karen Smith Executive Chairman Non-Executive Director & Executive Director PhD (Microbiology) Chair of the Risk Committee MD, PhD, MBA, LLM FRCP, FMedSci ● Emyria founder
Slide 8: Market opportunity for cannabinoids
MARKET OPPORTUNITY FOR CANNABINOIDS A single registered For personal use only product sells BUT, TODAYS CBD FORMULATIONS > $1B/year 1 PRODUCTS Proprietary, solid, oral CBD $2B spent on Variable potency 6 clinical development 2 Registration for multiple (inaccurate labels) indications Acquired by Jaz
Slide 9: Anxiety disorders and cannabinoid therapy
ANXIETY CANNABINOID DISORDERS THERAPY Excessive, persistent fear and excessive worry that interferes PUBLISHED EVIDENCE: For personal use only with daily activities. “The most replicable results…related to the ability of OPPORTUNITIES 3.9% of all adults - most CBD...to ameliorate anxiety”. 3 common
Slide 10: EMD-RX5 ultra-pure CBD capsule vs Epidyolex oil
EMD-RX5 | ULTRA-PURE CBD CAPSULE VS EPIDYOLEX™ OIL IN PHASE 3 CLINICAL TRIALS (due to complete H2, 2023) For personal use only In head-to-head with Epidyolex: EMD-RX5 was safe & well tolerated with: (1) high bioavailability (2) slow release profile (3) lower dose variability EMD-RX5 currently pursuin
Slide 11: EMD-RX5 global over-the-counter opportunity
EMD-RX5 | GLOBAL OVER-THE-COUNTER OPPORTUNITY For personal use only 2.8M IRRITABLE BOWEL SYNDROME INITIAL INDICATION Adults with 1.4M Of these, Indication 15% of population 3 with Chronic Pain 1.4M have High prevalence of symptoms symptoms of of anxiety or expansions anxiety symptoms 4 anxiety stres
Slide 12: EMD-RX7 highly bioavailable ultra-pure CBD for prescription use
EMD-RX7 | HIGHLY BIOAVAILABLE ULTRA-PURE CBD FOR PRESCRIPTION USE Chart shows concentrations of CBD in the blood for 3 For personal use only different formulations of 50mg CBD as measured over a 24 hour period in an animal model. EMD-RX7 showed more than 4 times the bioavailability of Epidyolex [1]
Slide 13: What's next? Advanced cannabinoid development
WHAT’S NEXT? | ADVANCED CANNABINOID DEVELOPMENT DRUG DEVELOPMENT H1 2023 H2 2023 Completed Next Steps For personal use only EMD-RX5 OVER THE COUNTER Complete pivotal Phase 3 clinical trial for EMD-RX5 to support TGA registration TODAY JULY 2023 Dosing commenced Phase 3 clinical trial Phase 3 Clinica
Slide 14: MDMA and psilocybin recognised as medicines by TGA
MDMA & PSILOCYBIN ONLY AVAILABLE VIA RECOGNISED AS HOWEVER… PSYCHIATRISTS OR “MEDICINES” BY TGA CLINICAL TRIALS For personal use only “For approval to prescribe, psychiatrists will need to demonstrate appropriate training, patient selection, evidence-based treatment protocols and patient monitoring.
Slide 15: What is MDMA?
WHAT IS MDMA? For personal use only MDMA (3,4-methylenedioxymethamphetamine or “ecstasy”) - an amphetamine that causes release of 3 neurotransmitters: Serotonin Dopamine Noradrenaline contributes to mood, associated with reward, stimulant activity, prosocial effects euphoria attention MDMA is the be
Slide 16: Unique psychopharmacological effects of MDMA
UNIQUE PSYCHOPHARMACOLOGICAL EFFECTS OF MDMA For personal use only ● feelings of wellbeing ● sociability and extroversion ● interpersonal trust INCREASED AN ALERT BUT ALTERED STATE OF CONSCIOUSNESS DECREASED ● feelings of fear & defensiveness These effects suggest MDMA could be a promising adjunct t
Slide 17: PTSD and MDMA-assisted therapy
POST-TRAUMATIC MDMA-ASSISTED TGA Schedule 8 Medicine (from July 1st) STRESS DISORDER THERAPY A chronic, debilitating mental Providing of MDMA with therapy. health disorder that can occur For personal use only following a traumatic event 67% of OPPORTUNITIES USA participants in the MDMA 10M ($262B)1
Slide 18: Building an MDMA-assisted therapy network
1) BUILDING AN MDMA-ASSISTED THERAPY NETWORK emyria For personal use only Revenues Drug Data Care Plan Supply Gathering Design Real-World Data ● Cost-effectiveness analysis ● Care model improvement & ● Novel drug development Psychiatry Patients Trained Practices Therapists Specialists MDMA-Assisted
Slide 19: Creating next-gen MDMA
2) CREATING “NEXT-GEN” MDMA with For personal use only Take MDMA Design & synthesise Advanced Prioritise as inspiration new analogues screening indications PTSD (Faster MDMA) ● Pharmacology (target) screens Proprietary analogue library L-DOPA Induced ● Safety screens Dyskinesia ● Behavioural studies
Slide 20: Analogue development goal: faster-acting MDMA
ANALOGUE DEVELOPMENT GOAL For personal use only FASTER-ACTING MDMA EARLY RESULTS: Metabolic studies performed to-date demonstrate Emyria’s compound library contains novel MDMA analogues with both WHY? MDMA-assisted therapy has rapid-, and long-acting metabolism profiles. potential to address PTSD. Th
Slide 21: Analogue development goal: MDMA without the high
ANALOGUE DEVELOPMENT GOAL For personal use only MDMA WITHOUT THE “HIGH” WHY? MDMA improves symptoms of “L-DOPA induced dyskinesia”. 1 A common side-effect of Parkinson’s treatment. BUT MDMA has unwanted side-effects (euphoria, increased sociability, amphetamine effects) GOAL: An “MDMA-like” drug tha
Slide 22: Early results (UWA-101): MDMA without the high
ANALOGUE DEVELOPMENT GOAL EARLY RESULTS (UWA-101): For personal use only MDMA WITHOUT THE “HIGH” In gold-standard preclinical model: Increased the total duration of L-DOPA-induced WHY? MDMA improves symptoms of antiparkinsonian benefit (total ON-time) by ~30%. “L-DOPA induced dyskinesia”. 1 A common
Slide 23: MDMA-inspired drug discovery: multiple $B opportunities
MDMA-INSPIRED DRUG DISCOVERY | MULTIPLE $B OPPORTUNITIES For personal use only Goals for analogue Clinical focus Role of MDMA? Early proof-of-concept? What’s next? program Treatment MDMA increases feelings of compassion and sociability while Faster-acting MDMA Resistant PTSD reducing fear & defensiv
Slide 24: MDMA-inspired drug discovery: next months
MDMA-INSPIRED DRUG DISCOVERY NEXT 12 MONTHS with For personal use only ● EXPAND the MDMA-analogue library ● DELIVER RESULTS from preclinical screening ● FILE ADDITIONAL PATENTS and pursue commercialisation discussions ● SELECT LEADS for further proof-of-concept efficacy studies in animal models Lead
Slide 25: Investment highlights
INVESTMENT HIGHLIGHTS For personal use only 1 2 3 4 5 Advanced clinical Favourable Substantial Advanced Significant target regulatory capabilities & markets programs R&D pipeline environment world-class team Emyria’s treatment First Ultra-Pure CBD TGA rescheduled One of world’s Emyria’s in-house prog
Slide 26: Contact information
For personal use only CONTACT INFORMATION Michael Winlo mwinlo@emyria.com Investors investors@emyria.com Media media@emyria.com General info@emyria.com