Emyria Ltd · ASX:EMD
Emyria — Hidden Gems Webinar (March 2022)
28 slides from Emyria's conference presentation, Mar 4, 2022
Slide 1: Emyria (ASX:EMD) Hidden Gems Webinar
Emyria (ASX:EMD) Hidden Gems Webinar | Michael Winlo, CEO For personal use only Emyria develops biopharmaceuticals guided by proprietary Real-World Data collected with patients across a wholly-owned clinical service subsidiary 1
Slide 2: Emyria provides care, generates data & develops treatments
For personal use only Emyria provides care, generates data & develops treatments Care Data Treatments 5 clinical sites (Emerald Clinics) treating One of the largest patient registries of 2 FDA-compliant drug development more than 40 complex conditions in ethically sourced Real-World Data (RWD) progr
Slide 3: Emyria's active clinical development programs
For personal use only Emyria’s active clinical development programs Platform Active program Initial opportunity Next 3-6 months Ultra-pure Registration of first Over-the-counter treatment * Complete pivotal trials cannabinoid-based EMD-RX5 FDA-compliant CBD for for psychological distress * TGA regist
Slide 4: Biopharmaceutical cannabinoid development
Biopharmaceutical cannabinoid development For personal use only 4
Slide 5: Extensive Real-World Data on cannabinoid treatments: 6,000 patients and counting
For personal use only Extensive Real-World Data (RWD) on cannabinoid treatments: 6,000 patients and counting What dose? 0-1,200 mg 0-197 mg 7.12 Average concomitant medications Range of daily CBD prescribed Range of daily THC prescribed per patient at initial visit What problem? 44 53% 54% Patients
Slide 6: 40% of registered drugs are derived from plants
For personal use only 40% of registered drugs are derived from plants Medicinal cannabis is stuck at “2.0” “1.0” “2.0” “3.0” Commercialisation Medicine Natural origins First medical use Trials & registration True pharmaceutical status 1987 US$95bn lifetime Statins Pleurotus ostreatus 1970’s sales of
Slide 7: Emyria's synthetic CBD vs comparators
For personal use only Emyria’s synthetic CBD Feature Emyria’s proprietary formulation Botanical alternatives vs comparators Biological action Synthetic CBD has equivalent physiological effects to botanical CBD [1] Regulatory FDA Drug Master File for API. Most CBD oils do not meet FDA considerations A
Slide 8: EMD-RX5: ultra-pure CBD
For personal use only EMD-RX5: ultra-pure CBD Targeting multiple indications 8
Slide 9: First indication: Psychological distress - a growing challenge
For personal use only First indication: Psychological distress - a growing challenge Symptoms of psychological distress ~15% of Australian adults experience high or very high levels Current treatments may include of psychological distress [1]. monitoring, psychotherapy, prescription medications or r
Slide 10: White House fact sheet on national mental health crisis
emyria THE WHITE HOUSE @® Administration Priosiies COVIO Plan Briefing Room sparc! fe FACT SHEET: President Biden to Announce Strategy to Address Our National Mental Health Crisis, As Part of Unity Agenda in his First State of the Union In his first State of the Union, the President will outline a u
Slide 11: White House fact sheet on national mental health crisis
emyria THE WHITE HOUSE @® Administration Prlonies COVID Plan Bilefing Room Espahol ag FACT SHEET: President Biden to Announce Strategy to Address Our National Mental Health Crisis, As Part of Unity Agenda in his First State of tho Tt Our country faces an unprecedented mental health crisis among peop
Slide 12: Developing an over-the-counter cannabinoid medicine for psychological distress
For personal use only Developing an over-the-counter cannabinoid medicine for psychological distress (EMD-RX5) Access: Registered “over-the-counter” (OTC) treatments do not require a doctor’s prescription. Registered OTC treatments can be purchased directly from qualified pharmacists. There are 5,900
Slide 13: EMD-RX5: Real World Data helps with indication selection
For personal use only EMD-RX5: Real World Data helps with indication selection Care Data Treatments Emyria has generated Real World Evidence (RWE) on more than 600 patients receiving Data analysis revealed a specific Data insights support patents (see slide 22), > 6 months treatment on low-dose CBD f
Slide 14: EMD-RX5: Rapid clinical development progress
For personal use only EMD-RX5: Rapid clinical development progress 1 ✔ 2 ✔ 3 ✔ 4 Commences March Phase 1 Formulation design Preformulation studies Dog PK study (dosing March, 22) ● Synthetic CBD (full DMF) ● Dissolution studies ● Comparison to Epidyolex ● Ethics approval [2] ● FDA-approved excipient
Slide 15: EMD-RX5: Greater bioavailability compared to Epidyolex
For personal use only EMD-RX5: Greater bioavailability compared to Epidyolex 15
Slide 16: EMD-RX5: What's next? New indications. More formulations.
For personal use only EMD-RX5: What’s next? New indications. More formulations. 1 Ongoing RWD collecting & analysis 2 Proprietary dose-form development, if required 3 Launch drug registration programs ● Dose-response insights on >6,000 patients and growing ● EMD-RX5 (multiple indications) ● Long-ter
Slide 17: Cannabinoid program development milestones
For personal use only Cannabinoid program development milestones Commence and complete Prepare product Obtain Commercialisation pivotal registration clinical New formulations + dossier and submit to Schedule 3 & sales trials programs TGA for registration registration IND with FDA (for First commerci
Slide 18: Leading next generation psychedelic development
Leading next generation psychedelic development For personal use only 18
Slide 19: Psychedelic-assisted therapy addressing major unmet needs and attracting large investment
For personal use only Psychedelic-assisted therapy addressing major unmet needs and attracting large investment $ $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 medicin
Slide 20: MDMA analogue development
For personal use only MDMA MDMA analogue development 20
Slide 21: Emyria's MDMA analogue library - a drug discovery pipeline
For personal use only Emyria’s MDMA analogue library - a drug discovery pipeline 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 ● Pote
Slide 22: Emyria's clinical research
Emyria’s clinical research For personal use only 22
Slide 23: EMDMA-001: a Phase IIa trial for PTSD with advanced monitoring
For personal use only EMDMA-001: a Phase IIa trial for PTSD with advanced monitoring The study will be led by consultant psychiatrist Dr Eli Kotler (left), and will be run out of the Victorian Counselling Drug treatment + non-drug psychotherapy and Psychology Services in Melbourne Screening Preparat
Slide 24: Emyria's growing patent portfolio
For personal use only Emyria’s growing patent portfolio 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 o
Slide 25: Corporate structure
Corporate structure For personal use only 25
Slide 26: Board has multiple drug registrations, deep biotech experience
For personal use only Board has multiple drug registrations, deep biotech experience Prof Sir John Tooke Dr Stewart Washer Non-Executive Director Chairman & Founder Dr Karen Smith Matt Callahan Executive Director Non-Executive Director > 100 clinical trials & 20 FDA approvals 4 FDA approvals Dr Alis
Slide 27: Capital structure
For personal use only 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) -
Slide 28: Emyria positioned for growth
For personal use only Emyria positioned for growth World-class 1 Board/Management with 2 Proprietary data, access to clinics and patients 3 Targeting major markets and unmet needs FDA registration successes In-house expertise in drug One of the largest Real World Data Multiple clinical programs targ