Emyria Ltd · ASX:EMD
Emyria — Investor Presentation (June 2022)
32 slides from Emyria's investor presentation, Jun 1, 2022
Slide 1: Drug development update
For personal use only Emyria (ASX:EMD) Drug development update 01 June 2022 | Dr Michael Winlo, MD & CEO
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 For personal use only invitation by any person or to any person to sell or purchase securities in Emyria i
Slide 3: Accelerating drug development
ACCELERATING DRUG DEVELOPMENT For personal use only Traditional drug development (costly, time-intensive, high-risk) time Find a target, Create a Prove safety Regulatory approval generate a hit dose form & efficacy Accelerated with Real World Data Known targets, Improved & Evaluate safety Regulatory a
Slide 4: A biotech that, uniquely, develops treatments backed by data
For personal use only A biotech that, uniquely develops treatments, backed by data, collected with patients we care for TREATMENTS DATA CARE Proprietary drug design Clinical insights from New treatments access for and global registration Real-World Data (RWD) patients with unmet needs Emyria 2022 4
Slide 5: Leadership Team - Professionals with Purpose
For personal use only Leadership Team - Professionals with Purpose Global Experience ~10 Biotechs 20 + FDA approvals
Slide 6: Board with drug registration & deep biotech experience
BOARD WITH DRUG REGISTRATION & DEEP BIOTECH EXPERIENCE For personal use only
Slide 7: Capital structure
CAPITAL STRUCTURE For personal use only TOP 20 60.48% KEY METRICS VALUE TATTARANG owns ~5% [1] Shares on issue 254m DIRECTOR OWNERSHIP 27.17% Last close ( 31 May 2022) A$0.275 Market Capitalisation (31 May 2022) A$75.6M Cash (31 Mar 2022) A$6.6m SHARE PRICE PERFORMANCE Debt (31 Mar 2022) - Enterpris
Slide 8: Emyria's Treatments
For personal use only Emyria’s Treatments
Slide 9: Pursuing multiple, billion dollar opportunities
PURSUING MULTIPLE, BILLION DOLLAR OPPORTUNITIES For personal use only Proprietary Asset Program Status Clinical indication & commercial strategy Clinical: Real World Data on ● EMD-RX5: low-dose CBD for ● One of first to Australian OTC > 6,000 patients EMD-RX OTC indications registration (>$200m/yr) [
Slide 10: Ultra-pure cannabinoid medicines
For personal use only Ultra-Pure CANNABINOID MEDICINES Learn what works from Create reliable treatments Pursue real patients (Real (formulation development) registration World Data)
Slide 11: Problem 1: Medicinal cannabis lacks clinical evidence
PROBLEM 1: MEDICINAL CANNABIS LACKS CLINICAL EVIDENCE For personal use only informationisbeautiful.net/visualizations/snake-oil-cannabis-the-scientific-evidence-for-medical-marijuana/ Emyria 2022 11
Slide 12: Emyria's solution: learn from real-world patients
EMYRIA’S SOLUTION: LEARN FROM REAL-WORLD PATIENTS For personal use only Emyria has Real-World Data from over 6,000 Patients (and growing) 5 Australian Clinical Sites Emyria is treating more than 54% Patients 40 Complex Conditions presenting with symptoms of moderate to SEVERE ANXIETY Emyria clinicia
Slide 13: Problem 2: Medicinal cannabis stuck at 2.0
PROBLEM 2: MEDICINAL CANNABIS STUCK AT “2.0” Patient Impact & For personal use only MEDICINE 1.0 Natural Origins 2.0 1st Medical Use 3.0 Registered Drug Commercialisation Statins Lowers Cholesterol Pleurotus 1970’s 1987 US $95bn Ostreatus First discovered synthetically developed Lipitor Lifetime sal
Slide 14: Problem 3: CBD has poor bioavailability
PROBLEM 3: CANNABIDIOL (CBD) HAS POOR BIOAVAILABILITY For personal use only 100mg (oral) Oral CBD has weak 1. Stomach/ Intestine bioavailability Dissolved drug as low as 2. Gut wall 6.5% Absorbed drug 3. Liver Drug in portal vein = ~6.5mg Available Drug tga.gov.au/sites/default/files/auspar-cannabidi
Slide 15: Emyria has created its first solid oral dose form (EMD-RX5)
EMYRIA’S SOLUTION: EMYRIA HAS CREATED ITS FIRST SOLID ORAL DOSE FORM (EMD-RX5) For personal use only [1] See ASX announcement 17 March 2022 Emyria 2022 15
Slide 16: EMD-RX5 has an excellent drug release profile
EMD-RX5 HAS AN EXCELLENT DRUG RELEASE PROFILE For personal use only Representative chart EMD- RX5 DEMONSTRATES STRONG SAFETY BIOAVAILABILITY RELIABILITY [1] See ASX announcement 17 March 2022 Emyria 2022 16
Slide 17: EMD-RX5 has excellent purity (required for FDA)
EMD-RX5 HAS EXCELLENT PURITY (required for FDA) For personal use only Ultra-Pure CBD Botanical CBD Vs BIOLOGICAL Ultrapure CBD has equivalent physiological effects to botanical CBD [1] ACTION REGULATORY CONSIDERATIONS Most CBD oils do not meet FDA requirements FDA Drug Master File for API. for CBD pu
Slide 18: Ultra-pure cannabinoid medicines pipeline
ULTRA-PURE CANNABINOID MEDICINES For personal use only EMYRIA’S ULTRA-PURE CANNABINOID TREATMENTS: FAST TRACKED WITH ● Target indications informed by Emyria’s Real World Data PLANNING PHASE REAL WORLD DATA ● Formulated to meet FDA requirements ACTIVE MODE COMPLETE ● Have excellent safety, tolerabili
Slide 19: Commercialising EMD-RX5
For personal use only Commercialising EMD-RX5
Slide 20: EMD-RX5 Schedule 3 over-the-counter drug
EMD-RX5 SCHEDULE 3 (S3) OVER THE COUNTER (‘OTC’) DRUG For personal use only Commercialisation strategy Emyria plans to register one of the first, affordable, cannabinoid S3 medicines in Australia (EMD-RX5) [1]. 5,900 pharmacies in Australia [2]. OTC market estimated at over $20B/year [3]. Emyria’s uni
Slide 21: Psychological distress - a growing problem
PSYCHOLOGICAL DISTRESS - A GROWING PROBLEM For personal use only Australian Adults experience 3.8M HIGH or VERY HIGH levels of psychological distress [1] AND it’s prevalence is on the RISE. [2] [1] abs.gov.au/articles/first-insights-national-study-mental-health-and-wellbeing-2020-21 Emyria 2022 21 [2
Slide 22: Psychological distress - symptoms & treatments
PSYCHOLOGICAL DISTRESS - SYMPTOMS & TREATMENTS For personal use only More prevalent in patients with chronic disease Anxiety Depression Current treatments may include: Monitoring, psychotherapy, prescription Stress medications or , referral to support services. [1] Gastrointestinal Complaints Sleep
Slide 23: Accelerated drug development for EMD-RX5
ACCELERATED DRUG DEVELOPMENT FOR EMD-RX5 For personal use only 1. Formulation Design 2. PK study 3. Phase 2 Trial 4. Pivotal Phase 3 Rapid development <9 months Real-World Data allows advancement to Phase 3 August 2021 May 2022 Expected Q2 2022 Emyria 2022 23
Slide 24: Upcoming pivotal phase study
UPCOMING PIVOTAL PHASE 3 STUDY For personal use only Phase 3 - Efficacy & Safety Randomised Placebo Controlled Double Blind Trial EMD-RX5: n = ~200 | Placebo: n = 110 Patients with Pain & Stress Study time per patient ~ 8 wks Each patient to have 4 weeks treatment, 4 weeks follow-up 5-6 sites around A
Slide 25: Leading next-generation psychedelic development
For personal use only Leading next-generation Psychedelic Development
Slide 26: Psychedelic-assisted therapy
PSYCHEDELIC-ASSISTED THERAPY Addressing MAJOR UNMET NEEDS & attracting LARGE INVESTMENT For personal use only $ $100b 264m $10.2b (AUD) 2 in 3 1 in 4 Estimated market for Number of people who suffer Aggregate market cap of Veterans suffer from PTSD People in the world are affected psychedelic medicines
Slide 27: MDMA-like medicine development partnership
MDMA-LIKE MEDICINE DEVELOPMENT PARTNERSHIP with For personal use only Entire library exclusively optioned to Emyria MDMA as Growing Library Screening Treatment Inspiration (100+ proprietary analogues) (In vitro & In vivo) Development Next-gen MDMA ● Safety screens ● Prosocial effects ● Metabolism stu
Slide 28: MDMA-like medicine development partnership: the analogue library
MDMA-LIKE MEDICINE DEVELOPMENT PARTNERSHIP with For personal use only Entire library exclusively optioned to Emyria THE MDMA ANALOGUE LIBRARY WHY MDMA? KEY FEATURES OF LIBRARY PROGRESS TO DATE ● >100 unique MDMA analogues, and growing [1] ● No “off-target” effects in first screens (~85 compounds) [2] ●
Slide 29: MDMA-like medicines (MDMA analogues)
MDMA-LIKE MEDICINES (“MDMA ANALOGUES”) For personal use only With partner, the University of Western Australia, Emyria is creating a one-of-a-kind library of unique compounds inspired by -3. 4 -Methylenedioxymethamphetamine (also known as “MDMA” or “ecstasy”). ADVANCED CLINICAL AND IP DEVELOPMENT ST
Slide 30: Emyria's growing patent portfolio
EMYRIA’S GROWING PATENT PORTFOLIO For personal use only 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
Slide 31: Emyria is positioned for growth
EMYRIA IS POSITIONED FOR GROWTH For personal use only 1 World-class team with FDA registration successes 2 Proprietary data, access to clinics & patients 3 Pursuing multiple drug registrations In-house expertise in drug One of the largest Real World Data Multiple clinical programs development, clini
Slide 32: 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