Emyria Ltd · ASX:EMD
Emyria — Investor Presentation (February 2023)
30 slides from Emyria's investor presentation, Feb 24, 2023
Slide 1: Clinical stage biotech focused on neuroscience and mental health
For personal use only (ASX:EMD) A clinical stage biotech, informed by the patient experience, focused on unmet needs in neuroscience and mental health February 2023 Company Overview
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: MDMA & Psilocybin Now Recognised as Medicines by TGA
MDMA & PSILOCYBIN NOW RECOGNISED AS “MEDICINES” BY TGA For personal use only “For approval to prescribe, psychiatrists will need to demonstrate appropriate training, patient selection, evidence-based treatment protocols and patient monitoring. Further, ongoing psychotherapeutic support remains an es
Slide 4: Clinical Neuroscience & Mental Health Focus
CLINICAL Neuroscience & Mental Health FOCUS For personal use only COMPARATIVE ● Strong register - Tenmile1 7.8% / Directors 27% / Top 50 70+% ● Proprietary Real-World Data - informs clinical development ADVANTAGES ● Front-line clinical delivery (Emerald Clinics) - provides patient access ● Unique Ul
Slide 5: Highlights of Business Structure & Assets
HIGHLIGHTS OF BUSINESS STRUCTURE | & ASSETS For personal use only CARE DATA TREATMENTS ULTRA-PURE CBD Specialist cannabinoid clinics deliver care for 1,000’s of patients EMD-RX5 (low-dose, synthetic CBD for across Australia for a wide range over-the-counter indications) IN PHASE 3 of clinical indica
Slide 6: Emyria's Model De-risks & Accelerates Drug Discovery
EMYRIA’S MODEL DE-RISKS & ACCELERATES DRUG DISCOVERY 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 Registration 25%
Slide 7: Leadership: Global Drug Development & 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: Advanced Cannabinoid Development
ADVANCED For personal use only CANNABINOID DEVELOPMENT Emyria 2023 8
Slide 9: Epidyolex: World's Only Registered CBD Oil
EPIDYOLEX™ | WORLD’S ONLY REGISTERED CBD OIL > $1B / YR SALES Despite hundreds of CBD products available, only 1 product has demonstrated the clinical effectiveness and product reliability required to achieve registration with major global regulators (like the FDA), driving significant value for shar
Slide 10: Most Cannabinoid Products Have Limitations
MOST CANNABINOID PRODUCTS HAVE LIMITATIONS CBD PRODUCTS ARE PRODUCT RELIABILITY BIOAVAILABILITY For personal use only UNDIFFERENTIATED IS VARIABLE [1] IS POOR [2] There are more than Your body What’s absorbs ~6.5% 100mg of what is on the 250 label is not in taken orally the box Food dramatically aff
Slide 11: Improving CBD: The EMD-RX Platform
For personal use only IMPROVING CBD THE EMD-RX PLATFORM A world-first, proprietary formulation of synthetically-derived Ultra-Pure cannabidiol in a capsule with high bioavailability to support multiple, global, over-the-counter & prescription registration opportunities.
Slide 12: EMD-RX Platform Clinical Advantages Over Incumbents
EMD-RX PLATFORM CLINICAL ADVANTAGES OVER INCUMBENTS Vs CBD oils For personal use only EMD-RX & similar preparations PATIENT PREFERRED FORM Convenient, solid oral capsules (no spilling) Majority of products are oil preparations No detectable THC Small quantities of THC ULTRA PURITY No detectable impu
Slide 13: EMD-RX5
EMD-RX5 For personal use only Emyria’s first Ultra-Pure, low-dose CBD capsule In Phase 3 trials and pursuing multiple, global “over-the-counter” registration opportunities
Slide 14: Psychological Distress in Australia - First Indication for EMD-RX5
PSYCHOLOGICAL DISTRESS IN AUSTRALIA - FIRST INDICATION FOR EMD-RX5 INITIAL CLINICAL OPPORTUNITY NO OTC SOLUTION CURRENTLY EXISTS BUT, CANNABIDIOL MAY HELP: For personal use only Emyria’s proprietary Real-World Data on hundreds of patients receiving low-dose CBD for 6+ months has informed our choice
Slide 15: EMD-RX5 Ultra-Pure CBD Capsule vs Epidyolex Oil
EMD-RX5 | ULTRA-PURE CBD CAPSULE VS EPIDYOLEX™ OIL For personal use only In a key, head-to-head study, EMD-RX5 was safe, well tolerated and demonstrated: (1) high bioavailability (2) slow release profile (3) lower dose variability and EMD-RX5 pursuing registration with TGA: In active Phase 3 clinical
Slide 16: What's Next? Grow Market for EMD-RX5
WHAT’S NEXT? | GROW MARKET FOR EMD-RX5 (ADD INDICATIONS, EXPAND GEOGRAPHY) An Ultra-Pure cannabinoid product makes it possible to pursue registration beyond Australia in jurisdictions where product purity For personal use only rules are stricter. With the support of Emyria’s proprietary Real-World D
Slide 17: What's Next? Launch Prescription-Strength CBD (EMD-RX7)
WHAT’S NEXT? | LAUNCH PRESCRIPTION-STRENGTH CBD (EMD-RX7) Chart shows concentrations of CBD in the blood for 3 different formulations as For personal use only measured over a 24 hour period in an animal model. Each formulation compared the same amount of CBD - 50mg. EMD-RX7 showed more than 4 times
Slide 18: What's Next? Advanced Cannabinoid Development
WHAT’S NEXT? | ADVANCED CANNABINOID DEVELOPMENT Completed DRUG DEVELOPMENT H1 2023 H2 2023 al l Next Steps For personal use only pr ov ity g cia ap a bil e nin m er let e s s t re m r p hic m sc Co rtne m Co sing Et 18 e- Pr pa do Over The Counter - TGA-APPROVAL Complete pivotal Phase 3 - INDICATION
Slide 19: MDMA-Inspired Therapy Innovation
MDMA-INSPIRED For personal use only THERAPY INNOVATION Emyria 2023 19
Slide 20: Post-Traumatic Stress Disorder
POST-TRAUMATIC STRESS DISORDER USA AUSTRALIA For personal use only 10M 1M 1.4M with Up to 500K with US$232B PTSD [2] symptoms “Treatment anxiety or Resistant” of Total economic burden [1] stress US$25,684 annual cost of PTSD per military personnel and veterans, (versus US$18,640 per civilian) 1. htt
Slide 21: MDMA-Assisted Therapy for PTSD: Promising Results
MDMA-ASSISTED THERAPY FOR PTSD | PROMISING RESULTS Treatment response and remission for MDMA and Placebo groups as a percentage For personal use only of total participants randomised to each arm (MDMA, n = 46; Placebo, n= 44). In a landmark Phase 3 study (n=91) [1], patients with PTSD (average of 15
Slide 22: MDMA & Psilocybin Now Recognised as Medicines by TGA
MDMA & PSILOCYBIN NOW RECOGNISED AS “MEDICINES” BY TGA For personal use only “For approval to prescribe, psychiatrists will need to demonstrate appropriate training, patient selection, evidence-based treatment protocols and patient monitoring. Further, ongoing psychotherapeutic support remains an es
Slide 23: Support Patient Delivery: MDMA-Inspired Medicines
1) SUPPORT PATIENT DELIVERY MDMA-INSPIRED MEDICINES For personal use only Drug Emyria is uniquely resourced to bridge the gap Manufacturers to facilitate psychedelic-assisted therapy GMP Manufacturing ● Scheduled Drug Importation ● Drug Procurement Community Psychiatrists ● Care Plan Design Speciali
Slide 24: Create Next-Generation MDMA
MDMA-INSPIRED MEDICINES 2) CREATE “NEXT-GENERATION” MDMA MDMA is a small, stable, brain-penetrating molecule that increases the release of 3 primary neurotransmitters For personal use only Serotonin Dopamine Noradrenaline thought to contribute associated with feelings of affects attention and relate
Slide 25: MDMA-Inspired Drug Discovery Workflow
MDMA-INSPIRED DRUG DISCOVERY | WORKFLOW NEW DRUG DISCOVERY with For personal use only Take MDMA Design & synthesise Advanced Prioritise as inspiration new analogues screening indications Mental health (Next-gen MDMA) ● Pharmacology (target) screens ● Safety screens Proprietary analogue library Movem
Slide 26: MDMA-Inspired Drug Discovery: Multiple $B Opportunities
MDMA-INSPIRED DRUG DISCOVERY | MULTIPLE $B OPPORTUNITIES For personal use only Clinical focus Role of MDMA? Goals for analogue program Early proof-of-concept? What’s next? MDMA increases feelings of Treatment Resistant compassion and sociability while reducing fear & PTSD defensiveness. Faster-actin
Slide 27: MDMA Analogue Highlight: Faster-Acting MDMA
MDMA-INSPIRED MEDICINES MDMA ANALOGUE HIGHLIGHT | FASTER-ACTING MDMA Potential Target: MDMA-ASSISTED THERAPY FOR MENTAL HEALTH For personal use only Recent in vitro metabolic studies of Emyria’s analogues demonstrate that our library has compounds with diverse half-lives, suggesting it may be possib
Slide 28: MDMA-Inspired Drug Discovery: What's Next?
MDMA-INSPIRED DRUG DISCOVERY | WHAT’S NEXT? NEW DRUG DISCOVERY with For personal use only IN THE NEXT 12 MONTHS, EMYRIA INTENDS TO: ● DELIVER RESULTS from multiple preclinical programs on select MDMA analogues ● SELECT LEADS by proof-of-concept efficacy studies in animal models ● EXPAND the MDMA-anal
Slide 29: Investment Highlights
INVESTMENT HIGHLIGHTS For personal use only 1 2 3 4 5 Proprietary Real Substantial World-class Proprietary MDMA now World Data (RWD) R&D pipeline team with formulations of recognised as engine multiple FDA Ultra-Pure CBD “medicine” One of world’s registrations largest MDMA First dose form in Emyria’
Slide 30: 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