Emyria Ltd · ASX:EMD
Emyria — Biotech Showcase, San Francisco 2023
54 slides from Emyria's conference presentation, Jan 10, 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 January 2023 | Biotech Showcase, San Francisco Michael Winlo, MBBS(Hons), MBA
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: neuroscience and mental health
CLINICAL Neuroscience & mental health FOCUS For personal use only COMPARATIVE ● Proprietary Real-World Data co-created w. patients in Palantir Foundry A specialist clinical service (Emerald Clinics) ADVANTAGES ● ● Unique drug formulations ● Proprietary MDMA-inspired novel chemical entity library ● G
Slide 4: Emyria's model de-risks and accelerates drug discovery
EMYRIA’S MODEL DE-RISKS AND ACCELERATES DRUG DISCOVERY CLINICAL SERVICES THAT CREATE…. DATA ASSETS TO SUPPORT… For personal use only (with validated assessments) GMP-grade, cannabinoid-based medicines DRUG DEVELOPMENT WHY? Patients not responding to standard of care are 8,000+ PATIENTS interested in
Slide 5: Emyria's model de-risks and accelerates drug discovery
EMYRIA’S MODEL DE-RISKS AND 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 6: 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 7: Clinical ambassadors: global experts in neuroscience and psychiatry
CLINICAL AMBASSADORS | GLOBAL EXPERTS IN NEUROSCIENCE AND PSYCHIATRY Dr Jen Morgan (St. Johns) Dr Richard Magtengaard Ass/Prof. Sara Ward (Temple For personal use only Anaesthetist & Pain Specialist Consultant Psychiatrist University) MBBS, FRANZCA MBBS , BSc , RAN , RTD , FRANZCP CIPN Expert PhD ●
Slide 8: Capital structure
CAPITAL STRUCTURE For personal use only TOP 20 60.48% TATTARANG owns ~7.8% DIRECTOR OWNERSHIP 27.17% KEY METRICS VALUE Market Capitalisation ~A$50M Last reported cash (at 30 Sep 2022) A$2.2M + A$3m raise completed [1] + A$2m+ R&D cash refund 1. See ASX announcement 31 October 2022
Slide 9: Advanced cannabinoid development
ADVANCED For personal use only CANNABINOID DEVELOPMENT Emyria 2023 9
Slide 10: Epidyolex: the world's only globally registered CBD oil
EPIDYOLEX™ | THE WORLD’S ONLY GLOBALLY REGISTERED CBD OIL Despite hundreds of CBD products available, only 1 product has demonstrated the clinical effectiveness and product reliability For personal use only required achieve registration with major global regulators (like the FDA), driving significant
Slide 11: Tighter CBD regulation likely in USA and Europe
TIGHTER CBD REGULATION LIKELY IN USA AND EUROPE For personal use only Only the most reliable products with the best clinical EVIDENCE will win market share. 1. https://www.wsj.com/articles/fda-concerned-about-safety-explores-regulating-cbd-in-foods-supplements-11672146030 2. https://www.efsa.europa.
Slide 12: Evidence generation
EVIDENCE For personal use only GENERATION Emyria’s national clinical service and remote monitoring technology generates evidence with patients to inform drug development and care delivery.
Slide 13: Emerald Clinics: evidence-generating care guiding drug development
EMERALD CL | EVIDENCE-GENERATING CARE GUIDING DRUG DEVELOPMENT Emyria’s clinical service subsidiary, Emerald Clinics, provides care while generating evidence with patients on cannabinoid treatment. For personal use only Emyria analyses this data to learn what treatments work best, for which clinical
Slide 14: Emerald Clinics: world's largest real-world data set on cannabinoids
EMERALD CL | WORLD’S LARGEST REAL-WORLD DATA SET (RWD) ON CANNABINOIDS prog Emyria’s comprehensive RWD is a proprietary source of clinical insights and evidence that supports our cannabinoid drug development programs. For personal use only Read full article here https://journals.plos.org/plosone/art
Slide 15: Emerald Clinics insight example: psychological distress
EMERALD CL | INSIGHT EXAMPLE “Psychological Distress affects a high proportion of patients. Cannabinoids can help ” Emyria’s Real World Data provides unique insights for where cannabinoid treatment is most effective across a range of important, For personal use only unmet clinical indications. Each
Slide 16: CIPN case study
CIPN CASE STUDY BEN Ben is a 65-year old Vietnam 65 yoa Veteran (DVA) with persistent CIPN with bilateral peripheral neuropathy. Bowel Ca 2012 - AP resection, Chemo (FOLFOX = folinate, 5-fluorouracil, oxaliplatin) CIPN hands and feet with numbness, tingling For personal use only and burning neuropath
Slide 17: Product development: EMD-RX platform
PRODUCT For personal use only DEVELOPMENT EMD-RX PLATFORM A world-first, proprietary formulation that delivers Ultra-Pure cannabinoids in a solid, oral dose form with high bioavailability to support multiple, global, over-the-counter and prescription registration opportunities. 17
Slide 18: Most cannabinoid products have limitations
MOST CANNABINOID PRODUCTS HAVE LIMITATIONS For personal use only CBD PRODUCTS ARE PRODUCT RELIABILITY BIOAVAILABILITY UNDIFFERENTIATED IS VARIABLE [1] IS POOR [2] There are more than Your body What’s absorbs ~6.5% on the 100mg 250 label is not in of what is taken orally the box Food dramatically aff
Slide 19: 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 20: EMD-RX5
EMD-RX5 For personal use only Emyria’s first Ultra-Pure, low-dose CBD capsule is in Phase 3 trials and pursuing multiple, global “over-the-counter” registration opportunities
Slide 21: EMD-RX5: ultra-pure CBD capsule vs Epidyolex oil
EMD-RX5 | ULTRA-PURE CBD CAPSULE VS EPIDYOLEX™ OIL For personal use only In less than 12 months, Emyria developed a proprietary Ultra-Pure CBD capsule and completed both animal and human trials. Compared to Epidyolex, EMD-RX5: Slower-release profile (supports once to twice daily dosing) Lower dose va
Slide 22: EMD-RX5: ultra-pure CBD capsule vs Epidyolex oil and other products
EMD-RX5 | ULTRA-PURE CBD CAPSULE VS EPIDYOLEX™ OIL and other products For personal use only [1] See ASX announcement 17 March 202 Emyria 2023 22
Slide 23: EMD-RX5: over-the-counter treatment for psychological distress
EMD-RX5 | OVER-THE-COUNTER TREATMENT FOR PSYCHOLOGICAL DISTRESS INITIAL CLINICAL / COMMERCIAL OPPORTUNITY INDICATION SELECTION SUPPORTED BY RWD UNIQUE DOSE FORM For personal use only 15% of adults Mean anxiety score experience high or very high levels of This psychological distress & incidence is gr
Slide 24: EMD-RX5: global over-the-counter strategy
EMD-RX5 | GLOBAL OVER-THE-COUNTER STRATEGY An Ultra-Pure cannabinoid product makes it possible to pursue registration beyond Australia in jurisdictions where product purity rules are stricter. With the support of Emyria’s proprietary Real-World Data, EMD-RX5 has multi-indication potential. For perso
Slide 25: Future cannabinoid treatment development
FUTURE For personal use only CANNABINOID TREATMENT DEVELOPMENT
Slide 26: Cannabinoids can reduce opioid use by 30%
CANNABINOIDS CAN REDUCE OPIOID USE BY 30% Emyria’s Real-World Data shows cannabinoids can help reduce opioid use in some patients. An Ultra-Pure product creates an opportunity to develop a registerable treatment for an important unmet need. For personal use only BEFORE CARE AT EMYRIA CARE AT EMYRIA
Slide 27: 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 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
Slide 28: Cannabinoid drug development: what's next?
CANNABINOID DRUG DEVELOPMENT - WHAT’S NEXT? Completed Next Steps DRUG DEVELOPMENT y ilit ing te cia l s ab en ple er hic al For personal use only st re m r Et prov 8m e- sc o m g m e a p 1 Pr C sin Co rtn do pa TGA-approval, indication Complete pivotal Phase 3 expansion, clinical trial for EMD-RX5 t
Slide 29: Emyria has deep insights on more than 40 indications
EMYRIA HAS DEEP INSIGHTS ON MORE THAN 40 INDICATIONS Emyria has deep clinical insights on more than 40 clinical indications creating a deep pipeline of future drug development opportunities. For personal use only Alcohol use disorder Chronic non-cancer pain Insomnia Post-traumatic stress disorder Al
Slide 30: MDMA-inspired drug discovery
MDMA-INSPIRED For personal use only DRUG DISCOVERY with
Slide 31: The MDMA-PD connection
The MDMA–PD CONNECTION For personal use only MDMA also alleviates LID in a primate model of PD Iravani, et al. J. Neurosci. 2003, 23, 9107-15 DAY 1 L-DOPA + placebo DAY 2 L-DOPA + ecstasy Footage from "Ecstasy & Agony", BBC Horizons series: www.bbc.co.uk/science/horizon/2000/ecstasyagony.shtml Emyri
Slide 32: What is MDMA?
WHAT IS MDMA (3,4-methylenedioxymethamphetamine or “ecstasy”) ? An illegal amphetamine 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 related to feelings of well
Slide 33: Why is MDMA such a promising backbone for new drug discovery?
WHY IS MDMA SUCH A PROMISING BACKBONE FOR NEW DRUG DISCOVERY? NEW DRUG DISCOVERY “Emyria is creating new chemical entities with the For personal use only potential to become neuropsychiatric treatments” MDMA and ITS ANALOGUES HAVE: Privileged chemistry ● Small, stable and brain-penetrating molecules
Slide 34: MDMA-inspired drug discovery workflow
MDMA INSPIRED DRUG DISCOVERY | WORKFLOW NEW DRUG DISCOVERY with For personal use only Take MDMA Design and synthesise Screen analogues Prioritise as inspiration new compounds (In vitro and In vivo) indications Mental health (Next-gen MDMA) Slides 32-35 ● Pharmacology (target) screens ● Safety screen
Slide 35: Early results and emerging therapeutic leads
MDMA-INSPIRED DRUG DISCOVERY | EMYRIA’S EARLY RESULTS & EMERGING THERAPEUTIC LEADS For personal use only # EMYRIA LEAD COMPOUNDS THAT MAY MEET NEXT POTENCY (of first 19 leads evaluated, EVALUATIONS THERAPEUTIC CLASS POTENCY REQUIREMENT COMMERCIALISED EXAMPLES more in screening) IN PROGRESS No approve
Slide 36: Active preclinical workflows
MDMA-INSPIRED DRUG DISCOVERY | ACTIVE PRECLINICAL WORKFLOWS NEW DRUG DISCOVERY Therapeutic Grouping Phenotypic Screening For personal use only Potent MDMA Broad neurological Synthesis & screening action with potential to engine become “next-gen” psychedelic-assisted therapies Preclinical screens ~14
Slide 37: MDMA-inspired drug discovery webinar
MDMA INSPIRED DRUG DISCOVERY | WEBINAR For personal use only For a deep dive on our MDMA-INSPIRED DRUG DISCOVERY PROGRAM go to: https://youtu.be/suZbQ3Bxuj8 Or, take a look at our MDMA-INSPIRED DRUG DISCOVERY DECK https://wcsecure.weblink.com.au/pdf/EMD/02581678.pdf MDMA is the best known member of
Slide 38: MDMA-inspired drug discovery summary
MDMA-INSPIRED DRUG DISCOVERY | SUMMARY with For personal use only Emyria-UWA MDMA analogue library captures a unique chemical space with differentiated pharmacology and novel IP ● Largest reported database of MDMA analogues currently in development with >140 compounds in the library (and growing) wi
Slide 39: Clinical opportunities
CLINICAL For personal use only OPPORTUNITIES Emyria 2023 39
Slide 40: Unique psychopharmacological effects of MDMA
UNIQUE PSYCHO- PHARMACOLOGICAL | EFFECTS OF MDMA Potential Target: MENTAL HEALTH For personal use only ● feelings of wellbeing ● sociability and extroversion ● interpersonal trust INCREASED AN ALERT STATE OF CONSCIOUSNESS DECREASED ● feelings of fear & These effects suggest MDMA could be a promising
Slide 41: MDMA-assisted therapy for post-traumatic stress disorder
MDMA-ASSISTED THERAPY FOR POST-TRAUMATIC STRESS DISORDER Potential Target: MENTAL HEALTH For personal use only In a landmark Phase 3 study (n=91) [1], patients with PTSD were randomized to receive MDMA-assisted therapy or therapy with placebo. Individuals had severe illness refractory to all convent
Slide 42: Post-traumatic stress disorder: MDMA-assisted therapy
POST-TRAUMATIC STRESS DISORDER 1 | MDMA-ASSISTED THERAPY Potential Target: MENTAL HEALTH For personal use only Prevalence: 8.4m (but with a large, undiagnosed population of ~79%) Treatment pattern: Benzodiazepines, antidepressants. High concomitant medication use. Costs: ~USD$25B/year (direct medica
Slide 43: PTSD: shorter MDMA-assisted therapy?
POST-TRAUMATIC STRESS DISORDER | shorter MDMA-ASSISTED THERAPY? Potential Target: 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 possible to generate MDMA analogues w
Slide 44: Parkinson's disease
PARKINSON’S DISEASE 1 Potential Target: MOVEMENT DISORDERS For personal use only Prevalence: 7m worldwide (second most common neurological disorder after Alzheimer’s) Section of substantia nigra PARKINSON’S DISEASE Treatment pattern: Dopamine promoters (eg L-Dopa), antidepressants, is a neurodegener
Slide 45: Parkinson's disease: benefits of MDMA without the high?
PARKINSON’S DISEASE | Benefits of MDMA without the high? Potential Target: MOVEMENT DISORDERS For personal use only non-psychoactive + Profoundly improves PD Researchers at UWA created a series of A single enantiomer analogue therapy (i.e increases “on time” non-psychoactive MDMA analogues; (mirror i
Slide 46: Idiopathic pulmonary fibrosis
IDIOPATHIC PULMONARY FIBROSIS 1 Potential Target: FIBROTIC DISEASE For personal use only Prevalence: 1.2m people worldwide Treatment pattern: Anti-fibrosis drugs (Pirfenidone, Nintedanib), oxygen therapy, GI reflux medications Costs: ~USD$3B/year Unmet needs: Reversing fibrotic changes, reduce side-eff
Slide 47: IPF: 5HT2B antagonist potential
IDIOPATHIC PULMONARY FIBROSIS | 5HT2B ANTAGONIST POTENTIAL Potential Target: FIBROTIC DISEASE For personal use only These preliminary in vitro screens, performed by the Institute of Respiratory Health, 1 measure the deposition of collagen (dark pink shapes) in human lung fibrocytes at varying concent
Slide 48: MDMA-inspired drug discovery: what's next?
MDMA-INSPIRED DRUG DISCOVERY | WHAT’S NEXT? NEW DRUG DISCOVERY BACKED BY UWA RESEARCH 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 ● Ex
Slide 49: Corporate & IP
For personal use only CORPORATE & IP
Slide 50: Emyria's growing patent portfolio
EMYRIA’S GROWING PATENT PORTFOLIO For personal use only TITLE OFFICIAL NO. STATUS Analogues 2021903836 Provisional filed Cannabidiol Dosing Regime 2021902001 Provisional filed Cannabinoid Dosage Form 2022900479 Provisional filed Use of Cannabidiol for the Treatment of Psychological Distress 2020904152
Slide 51: Major achievements and near-term catalysts
MAJOR ACHIEVEMENTS & NEAR-TERM CATALYSTS DRUG DEVELOPMENT NEW DRUG DISCOVERY For personal use only CLINICAL PROGRAMS PRE-CLINICAL PROGRAM Ultra-Pure cannabinoid delivery platform MDMA-like analogues CORPORATE ACHIEVEMENTS EMD-RX5 “direct-to-consumer” EMD-RX7 “prescription medicine” MDMA-like drug de
Slide 52: Investment highlights
INVESTMENT HIGHLIGHTS For personal use only 1 2 3 4 5 Proprietary In phase 3 Substantial World-class Ultra-Pure CBD Proprietary Real team with clinical trials R&D pipeline formulations - World Data (RWD) multiple FDA One of world’s partnership ready registrations EMD-RX5: In pivotal largest MDMA Dem
Slide 53: Vision
| VISION For personal use only Accelerate the development of promising treatments where evidence is lacking BY COLLABORATING WITH : PATIENTS to generate CLINICAL DATA & GLOBAL EXPERTS to create NEW TREATMENT TECH (formulations & analogues) Register multiple treatments globally using our proprietary
Slide 54: 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