Emyria Ltd · ASX:EMD
Emyria — Investor Presentation (March 2022)
35 slides from Emyria's investor presentation, Mar 24, 2022
Slide 1: Broker Briefing Webinar
Emyria (ASX:EMD) Broker Briefing Webinar | Michael Winlo, CEO For personal use only Emyria develops biopharmaceuticals guided by Real-World Data collected with patients receiving care at our clinics 1
Slide 2: Emyria provides care, generates data & develops treatments
For personal use only 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
Slide 3: Emyria provides care, generates data & develops treatments
For personal use only Emyria is a biotech that, uniquely: provides care, generates data & develops treatments Care Data Patients w Insights from unmet needs + Real-World new Data (RWD) treatments 5 clinical sites (Emerald Clinics) treating One of the largest patient registries of more than 40 comple
Slide 4: Emyria provides care, generates data & develops treatments
For personal use only Emyria is a biotech that, uniquely: provides care, generates data & develops treatments Care Data Treatments Patients w Proprietary Insights from unmet needs + drug design + Real-World new global Data (RWD) treatments registration 5 clinical sites (Emerald Clinics) treating One
Slide 5: Emyria's active clinical development programs
For personal use only Emyria’s active clinical development programs Platform Active programs Initial opportunities Next 3-6 months Ultra-pure Low-dose CBD for Over-the-counter treatment * Complete pivotal trials cannabinoid- EMD-RX5 based medical multiple indications for psychological distress * TGA
Slide 6: Emyria's active clinical development programs
For personal use only Emyria’s active clinical development programs Platform Active programs Initial opportunities Next 3-6 months Ultra-pure Low-dose CBD for Over-the-counter treatment * Complete pivotal trials cannabinoid- EMD-RX5 based medical multiple indications for psychological distress * TGA
Slide 7: Biopharmaceutical cannabinoid development
Biopharmaceutical cannabinoid development For personal use only 1 Learn from real-world patients 2 Create high-performing dose form 3 Pursue global registration 7
Slide 8: Learn from real-world patients
1 Learn from real-world patients For personal use only Emyria has Real-World Data with 6,000 patients (+ growing) 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% Pati
Slide 9: Create a high-performing dose form
Create a high-performing dose 2 form For personal use only Plants have inspired 40% of registered medicines “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 o
Slide 10: Medicinal cannabis stuck at 2.0
Create a high-performing dose 2 form For personal use only Medicinal cannabis stuck at “2.0” - registered biopharmaceuticals reach more patients “1.0” “2.0” “3.0” Commercialisation Medicine Natural origins First medical use Trials & registration True pharmaceutical status 1987 US$95bn lifetime Stati
Slide 11: Oral CBD has poor bioavailability
Create a high-performing dose 2 form For personal use only Oral CBD has poor bioavailability - as low as 6.5%! Stomach / Gut wall Gut wall Liver Liver intestine Dissolved drug Absorbed drug Drug in portal vein Ingested Available drug drug (~6.5mg) 100mg Unavailable Undissolved drug Non-absorbed Meta
Slide 12: Proprietary CBD formulations enhance bioavailability
Create a high-performing dose 2 form For personal use only Emyria’s proprietary CBD formulations enhance bioavailability Diagram on right shows concentrations of CBD in the blood for 3 different formulations as EMD-RX7 (~4x BA) Higher bioavailability means: measured over a 24 ● more CBD available in
Slide 13: Ultra-pure CBD vs comparators
Create a high-performing dose 2 form For personal use only Emyria’s ultra-pure 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
Slide 14: EMD-RX# programs: Ultra-pure CBD targeting multiple indications
For personal use only EMD-RX# programs: Ultra-pure CBD targeting multiple indications 14
Slide 15: White House mental health strategy fact sheet
emyria THE WHITE HOUSE & Administation Proties COVID Plan BriefingRoom Espaiol iE 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 unity
Slide 16: White House mental health strategy fact sheet
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 17: First indication: Psychological distress
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 18: EMD-RX5: Over-the-counter CBD for psychological distress
For personal use only 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 OT
Slide 19: EMD-RX5: Real World Data guides indication selection
For personal use only EMD-RX5: Real World Data (RWD) guides indication selection Care Data Treatments Emyria clinicians have already prescribed RWD analysis reveals specific dose-responses, Emyria’s RWD supports an end-to-end low-dose CBD for psychological distress for for a specific set of symptoms,
Slide 20: 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 21: EMD-RX#: What's next?
For personal use only EMD-RX#: What’s next? New indications. More formulations. 1 Ongoing RWD collection & analysis 2 Proprietary dose-form development 3 Launch drug registration programs ● Dose-response insights on ● EMD-RX5 (multiple indications) >6,000 patients and growing ○ Distress ● Long-term
Slide 22: 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 23: Leading next-generation psychedelic development
Leading next-generation psychedelic development For personal use only 23
Slide 24: Psychedelic-assisted therapy addresses major unmet needs
For personal use only Psychedelic-assisted therapy addresses major unmet needs and is 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 medic
Slide 25: MDMA analogue development
For personal use only MDMA MDMA analogue development 25
Slide 26: Emyria's MDMA analogue library - a drug discovery pipeline
Partnership with For personal use only Emyria’s MDMA analogue library - a drug discovery pipeline MDMA as Growing library Screening Treatment inspiration (100+ proprietary development analogues) Next-gen MDMA ● ? safety ● ? prosocial potency ● ? faster acting Neuropsychiatric Proprietary analogue li
Slide 27: Emyria's MDMA analogue library - a drug discovery pipeline
Partnership with 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
Slide 28: Emyria's clinical research
Emyria’s clinical research For personal use only 28
Slide 29: EMDMA-001: a Phase IIa trial for PTSD
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 30: 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 31: Corporate structure
Corporate structure For personal use only 31
Slide 32: 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 33: 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 34: 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
Slide 35: 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 35