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EMYRIA LIMITED — Investor Presentation 2021
Sep 27, 2021
64844_rns_2021-09-27_3fac615c-155e-4259-9ab6-a8cfedfabb8d.pdf
Investor Presentation
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28/09/21
ASX Announcement
Emyria to present at Lifesciences webinar today
Emyria Limited (ASX: EMD) (Emyria or the Company), a data-backed treatment development and clinical services company, is pleased to announce that Dr., Michael Winlo, managing director for Emyria, will be presenting at the Proactive Lifesciences webinar.
A presentation will be delivered and is attached to this cover note.
Emyria will be one of three companies presenting, which also includes Amplia Therapeutics and Patrys.
Details of the event are as follows:
-
Event: Proactive Lifesciences Webinar
-
Webinar Presenter: Emyria’s Managing Director, Dr, Michael Winlo
-
Date and Time: Tuesday 28th September 2021, 12pm Sydney time (AEST)
To register , please click on the link below:
https://event.webinarjam.com/register/91/gqy97hzy
For additional information, please contact: John Phillips at Proactive on [email protected] or call 0431 597 771.
This announcement has been approved and authorised by the Managing Director of Emyria Limited.
For further information on Emyria :
Dr Michael Winlo Lexi O’Halloran Managing Director Media/Investor Relations 1300 436 363 + 61 (0) 404 577 076 [email protected] [email protected]
Andrew Williams Media Relations +61 (0) 412 614 125 [email protected]
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About Emyria (www.emyria.com)
Emyria Limited is a data-backed, drug development company. Emyria’s Treatments target unmet needs and are focused on obtaining approval from major global regulators. Emyria’s drug development programs are informed by insights generated from extensive analysis of Emyria Data - deep, ethically-sourced clinical evidence that is gathered with patients across Emyria’s independent clinical services ( Emerald Clinics - www.emeraldclinics.com.au)
Emyria Data provides deep treatment insights and is therefore a source of unique IP, strategically designed drug development and personalised care programs.
Emyria’s first drug development program, EMD-003 is targeting unmet needs in mental health. Specifically psychological distress and the symptoms of anxiety, depression and stress.
Cautionary Note on Forward-Looking Statements
Any statements in this press release about future expectations, plans and prospects for the Company, the company’s strategy, future operations, and other statements containing the words “anticipate,” “believe,” “estimate,” “expect,” “intend,” “may,” “plan,” “predict,” “project,” “target,” “potential,” “will,” “would,” “could,” “should,” “continue,” and similar expressions, constitute forward-looking statements. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including: the Company’s ability to successfully develop its product candidates and timely complete its planned clinical programs and the Company’s ability to obtain marketing approvals for its product candidates. In addition, the forward-looking statements included in this press release represents the Company’s views as of the date hereof. The Company anticipates that subsequent events and developments will cause the Company’s views to change. However, while the Company may elect to update these forward-looking statements at some point in the future, the Company specifically disclaims any obligation to do so. These forward-looking statements should not be relied upon as representing the Company’s views as of any date subsequent to the date hereof.
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Emyria’s Unique Value Drivers
September 2021 | Dr Michael Winlo, MD & CEO
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Contents
| Emyria’s value drivers | ||
|---|---|---|
| (1) Attractive valuation | 3 | |
| (2) Proprietary Real-World Evidence (RWE) | 6 | |
| (3) Synthetic cannabinoid delivery platform | 10 | |
| (4) MDMA analogue drug discovery pipeline | 17 | |
| (5) National clinical service delivery | 20 | |
| (6) An expert, global team | 23 | |
| 2 |
(1) Attractive valuation
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Corporate snapshot
| Key Metrics | Value | Emyria share price over 12 months | Emyria share price over 12 months |
|---|---|---|---|
| Shares on issue | 254m | ||
| (Escrowed component) | 100m | ||
| Last close ( 26 Sep 2021) | A$0.22 | ||
| Market Capitalisation (17 Sep 2021) | A$56M | ||
| Cash (30 June 2021) | A$6.5m | ||
| Debt (30 June 2021) | - | ||
| Enterprise value | A~$49m | ||
| Total options (exercise price $0.114-0.45) expiring. 2022-24 |
62m |
Source: https://emyria.com/for-investors/#Stock-Information | |
Top 20 = 60.48% Director ownership = 27.17%
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Emyria (MC ~56m) is advancing in three, billion dollar verticals
Emyria has developed a clear strategy for value creation
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FDA-, and TGA-approved cannabinoid medicines
FDA-approved MDMA2 analogue therapies
World-leading real-world 3 evidence
Emyria has developed a novel, ultra-pure cannabinoid dose form that meets all FDA requirements.
Pivotal registration trials are in planning for multiple target indications addressing major global unmet needs
Emyria has exclusive access to a library of unique MDMA-analogues with commercialisation potential as treatments for a range of neurological disorders and psychedelic-assisted therapies
Emyria has built a robust, proprietary, clinical-trial-grade evidence asset to assist with multiple FDA and TGA registration programs
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Market leaders
Acquired for US$7.2B (Feb 2021)
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Market cap: US$2.49B (Sep 21)
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Acquired for US$2.1B (Apr 2018)
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Sources: https://investor.jazzpharma.com/news-releases/news-release-details/jazz-pharmaceuticals-completes-acquisition-gw-pharmaceuticals https://fnance.yahoo.com/quote/ATAI/ / https://www.roche.com/media/releases/med-cor-2018-04-06.htm
(2) Real-World Evidence
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Emyria’s Real-World Evidence (RWE) - 5,000 patients and counting
Our proprietary, robust and ethically-sourced clinical data:
2 - 98 years 56% 44 age range of patients female patients Unique primary indication s
* covers dose-response insights across a diverse set of patients
54% 53% 7.12 Patients presenting with symptoms of Patients presenting with symptoms Average concomitant medications moderate to severe anxiety of depression per patient at initial visit
* provides insights and IP which de-risks our drug development
programs
0-600 mg
Range of CBD prescribed doses are carefully titrated for each patient which gives Emyria unique dose response insights
0-197 mg
35%
Range of THC prescribed doses are carefully titrated for each patient Patients experiencing an adverse which gives Emyria unique dose event response insights
Data summary as of 01 DEC 2020
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RWE now used in 75% of FDA approval applications, and growing
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Source: https://aetion.com/evidence-hub/infographic-what-role-does-rwe-play-in-fda-approvals/
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Curating RWE is a valuable business globally
| Therapy area focus | Cancer | Eye disease + neurology | Diverse | 40+ clinical indications |
| Care delivery | NO | NO | NO | YES |
| Novel drug development | NO | NO | NO | YES |
| Direct input from patient | ||||
| Data asset quality | Electronic Medical Records (needs cleaning) |
Patient Registries (needs cleaning) |
Insurance claims data (needs cleaning) |
and clinicians (minimal cleaning, |
| regulatory-grade) | ||||
| $475M | $209M | $227M | ~$20M | |
| Investment to date (AUD) | ||||
| Acquired: $2.9B Apr 18 | Last funding: $152M Feb 20 | Last funding: $110M May 21 | Last funding: $5M Apr 21 |
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Source: https://www.crunchbase.com
(3) Synthetic (“pure”) cannabinoid delivery platform
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Medicinal cannabis is stuck at “2.0”; pharmaceuticals are “3.0” 40% of drugs behind the pharmacist's counter in the Western world are derived from plants that people have used for centuries. This includes the top 20 best selling prescription drugs in the United States today.
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“1.0” “2.0” “3.0” Commercialisation
Medicine Natural origins First medical use Trials & registration Synthetic formulation status
1987 US$95bn lifetime
Pleurotus ostreatus 1970’s
Statins Synthetically sales of Lipitor
(oyster mushroom) First discovered
developed alone
US$750M USD for
Salix alba ~400 BC
Aspirin (white willow) First prepared as a tea 1899 “aspirin cardio” alone in 2020
Emyria’s novel
~8000 BCE synthetic delivery and Initial targets:
Cannabis sativa
Cannabis First medicinal use drug development mental health,
(cannabis)
documented programs target insomnia and pain
multiple indications
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https://www.fiercepharma.com/pharma/from-old-behemoth-lipitor-to-new-king-humira-u-s-best-selling-drugs-over-25-years
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Unregistered botanical cannabinoids do not generate returns
There are 190 unregistered Cannabinoid products in Australia¹...
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$100m
Total Australian sales in 2020
- https://freshleafanalytics.com.au/wp-content/uploads/2021/03/FreshLeaf-Analytics-H1-2021.pdf
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- https://www.globenewswire.com/news-release/2021/02/16/2175953/0/en/GW-Pharmaceuticals-plc-ReportsFourth-Quarter-and-Year-End-2020-Financial-Results-and-Operational-Progress.html
...and only 1 registered product (Epidyolex by GW Pharma)
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$686m
Total Global sales in 2020² from rare paediatric epilepsy market only
03 Feb 21, GW acquired by Jazz Pharmaceuticals (USD$7.2B)
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Emyria has appointed Dr Karen Smith , Ex-Chief Medical Officer and Global Head of R&D at Jazz Pharmaceuticals to Chair Emyria’s Strategic Advisory (ASX Announcement 22 Feb 21)
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Botanical cannabinoids are in chronic oversupply
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Source: Health Canada, MJBizDaily, a division of Anne Holland Ventures Inc. 2021
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Emyria’s unique synthetic cannabinoid platform
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Emyria is developing a novel cannabinoid delivery platform with leading North American contract drug manufacturer Altasciences (See ASX Announcement 13 August 2021)
| Feature | Emyria’s Synthetic Platform | Emyria’s Synthetic Platform | Botanical alternatives |
|---|---|---|---|
| Safety | Synthetic CBD hasequivalentphysiological efects to botanical CBD [1] | ||
| Botanical CBD can have high | |||
| Synthetically manufactured | batch-to-batch variability | ||
| Reliability | cannabinoids ensure consistent batch-to-batch quality at scale |
(see TGA audit results https://www.tga.gov.au/testing-medicinal- cannabis-products-being-supplied-sas-aus tralia) |
|
| Consistent purity ensures | Plant-extracted cannabinoid | ||
| Regulatory | acceptability from all major | acceptable by some regulatory | |
| global regulators | agencies only | ||
| Cost | Far more cost efective over long-term |
Currently expensive ($250-800/month for 150mg/day CBD) |
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- Maguire R, F, Wilkinson D, J, England T, J, O’Sullivan S, E: The Pharmacological Effects of Plant-Derived versus Synthetic Cannabidiol in Human Cell Lines. Med Cannabis Cannabinoids 2021. doi: 10.1159/000517120
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Emyria’s synthetic cannabinoid development strategy
An evidence based, synthetic (ultra-pure) cannabinoid product will create significant returns
-
Regulators will continue to ensure pharmaceutical standards at federal level in US, Aus ( eg FDA statement, down scheduling of low dose CBD in Aus ) in line with historical precedents
-
Botanical products currently non compliant (due to purity) or cost prohibitive (due to input costs)
-
Demand for CBMP’s as substitute and adjunct therapeutics will rise based on safety and efficacy profile
-
Big pharma will own API and supply chain when hurdles of safety, efficacy and scalable manufacture are met
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Emyria’s growing cannabinoid patent portfolio
| Title | Ofcial No. | Status | |
|---|---|---|---|
| Use of Cannabidiol for the Treatment of Psychological Distress | 2020904152 | Provisional fled | |
| Use Of Cannabinoid for the Treatment of Psychological Distress | 2021901086 | Provisional fled | |
| Emyria’s cannabinoid |
Use Of Cannabidiol for the Treatment of Irritable Bowel Syndrome-Related | 2021901672 | Provisional fled |
| patents cover | Psychological Distress | ||
| unique formulations, |
Use Of Cannabinoid Combination for the Treatment of Irritable Bowel | 2021901674 | Provisional fled |
| delivery | Syndrome-Related Psychological Distress | ||
| approaches and | |||
| “method of use” | Cannabidiol Dosing Regime | 2021902001 | Provisional fled |
| Others in development covering unique delivery platforms, dose responses and clinical | Multiple provisionals expected 2021 | ||
| indications |
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(4) MDMA analogue drug discovery and development
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Emyria’s MDMA analogues - a novel drug discovery pipeline
Emyria’s MDMA analogues
-
Key features ● Exclusive access to >100 unique MDMA analogues ● >10 years of development at UWA
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Entire library exclusively optioned to Emyria
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Verified excellent purity and stability
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Early preclinical results for neurological disorders
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Potential for use as novel psychedelic-assisted therapeutics
-
Accelerated 1. In-house expertise and partners to conduct development target-to-hit and hit-to-lead screening via program neuro-receptor analysis and validation studies 2. Lead compound selection informed by clinical, In partnership with pharmacological and medicinal chemistry experts
-
- Multiple patent families filed to protect all distinct, drug classes identified
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Psychedelic companies are attracting large valuations
| Symbol | Company | Market Cap (AUD) | |
|---|---|---|---|
| ATAI | ATAI Life Sciences N.V. | $3,216,535,666 | Multiple psychedelics R+D targeting depression, anxiety, substance use,, TBI, Schizophrenia |
| CMPS | COMPASS Pathways Plc | $1,789,730,559 | Testing synthesized psilocybin, administered with support from a trained therapist, to treat depression |
| GHRS | GH Research PLC | $1,464,094,233 | (5-MeO-DMT) for depression |
| MNMD | Mind Medicine (MindMed) Inc. | $1,145,502,960 | LSD experiential therapy for anxiety, 18-MC for substance abuse, LSD microdosing |
| CYBN:AQL | CYBIN INC. | $501,142,795 | Psilocybin for MDD, deuterated tryptamine for anxiety and alcohol, phenethylamines |
| FTRP:CA | Field Trip Health Ltd. | $492,435,180 | Ketamine-assisted psychotherapy clinical service |
| IHL:ASX | Inncannex Healthcare Ltd | $341,789,028 | Commencing phase 2b trial for Psi-GAD psilocybin, targeting Generalised Anxiety Disorder |
| SEEL | Seelos Therapeutics Inc. | $272,158,453 | Ketamine for major depressive disorder (MDD) |
| NUMI:CA | Numinus Wellness Inc. | $250,081,619 | Ketamine clinics and clinical trials in MDMA-assisted therapy for PTSD & psilocybin for substance abuse |
| EMD:ASX | Emyria Limited | $55,900,000 | Commencing phase IIb MDMA-assisted therapy trial for PTSD, Developing range of novel MDMA-analoguesfrom library of >100 compounds, real-world datageneration |
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Source: https://psychedelicinvest.com/index/(accessed August 22nd)
(5) Clinical service delivery
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Caring for Australians, developing treatments for the globe
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Headquartered in Perth ,
Emyria operates a national clinical site network (Emerald Clinics) providing thousands of patients with unmet needs safe access to new and promising treatments while also generating robust and ethically-sourced clinical data .
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Global registration targets
Northern Rivers Our data guides unique drug
Perth (HQ) development programs
Sydney targeting major unmet needs
and registration with the
Melbourne world’s largest regulators:
(USA), MHRA (UK), EMA (Europe)
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Global registration targets
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Our data guides unique drug development programs targeting major unmet needs and registration with the world’s largest regulators: FDA (USA), MHRA (UK), EMA (Europe)
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Emyria’s care model reduces opioid use by > 30%
190
Before care at
Emyria
Significant
142.5 High >90mg/day (>30%) reduction in
opioid use
The chart shows the oral morphine equivalent daily dose (“oMEDD”)
for a cohort of 220 patients presenting at Emyria’s Emerald Clinics Patients with 6+ months of
with a “HIGH” opioid consumption rating. cannabinoid usage
95
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The chart shows the oral morphine equivalent daily dose (“oMEDD”) for a cohort of 220 patients presenting at Emyria’s Emerald Clinics with a “HIGH” opioid consumption rating. 95 oMEDD scores were derived by examining linked community
oMEDD scores were derived by examining linked community pharmacy dispensing data from NostraData/IQVIA in the 12 months prior and 12 months after starting care at Emerald Clinics.
Average oral morphine equivalent daily dose (oMEDD) trend (Pre vs Post Emyria) for a cohort of high opioid users and >6 months cannabinoid usage
47.5 The analysis reveals that these patients had a sustained and significant reduction in their daily oMEDD (more than 30%) made more compelling due to stability of their oMEDD scores in the 12 months leading up to treatment.
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Months since first Emyria visit
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6. Team of global experts
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Board with deep clinical and commercial expertise
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|||||
|---|---|---|---|
|Key Person|Role|Experience|Affiliations|
|Dr Stewart Washer|Cynata|(ASX:CYP) – stem cells|
|Chairman & Founder|Orthocell|(ASX:OCC) – regenerative medicine|
|Botanix|(ASX:BOT) – synthetic CBD|
|Dr Michael Winlo|Medical doctor|
|Managing Director|Director at|Linear Clinical Research|- Phase 1 clinical trials|
|Health Lead at|Palantir|(NYSE:PLTR) - Big Data analytics|
|MBA from|Stanford University|
|Dr Alistair Vickery|Specialist|general practitioner|
|Medical Director|Chair of|Black Swan Health|- mental health|
|Associate|Professor of Primary Health Care|
|Matt Callahan|Founder|Botanix|(ASX:BOT) - synthetic CBD|
|NED & Founder|Founder|Orthocell|(ASX:OCC) - regenerative medicine|
|4 products through|FDA approval|
|More than 20 years’|legal and IP experience|
|Professor Sir John|Knighted|in the UK for Services to Medicine|
|Tooke|Senior Independent Director,|BUPA Chile|
|Independent NED|Head of Medical Sciences,|University College London|
|Review board,|Google DeepMind|
|Immediate past|President Academy of Medical Sciences|
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Emyria’s key advisors
| Key | Person | Role | Experience | Afliations |
|---|---|---|---|---|
| Dr Karen Smith, MD, PhD, MBA, | Multiple Directorshipswith innovative pharmaceutical companies | |||
| LLM | Ex-Chief Medical OfcerandGlobal Head of R&DatJazz Pharmaceuticals | |||
| Chair of Strategic Advisory | Overseen more than 100 clinical trials and20 regulatory approvals | |||
| Assoc. Prof. Matthew Pigott, Dr, | Worked onantibiotic drug discoveryin collaboration withGlaxoSmithKline | |||
| BSc PhD | Has spent the past 10 years developingMDMA analoguesfor Parkinson's disease and | |||
| Medicinal Chemist, MDMA | otherneurological conditions | |||
| Analogues | ||||
| Prof. Mathew Martin-Iverson, BSc | Head of Psychopharmacology, UWA | |||
| Alta., PhD Br.Col. | Over35 yearsof experience studyingamphetaminesand otherpsychostimulants | |||
| Neuropharmacologist |
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Psychiatry leadership
| Name | Role | Experience | Afliations |
|---|---|---|---|
| Dr Eli Kotler, MBBS, | Medical DirectoratMalvern Private Hospital, specialising in drug & alcohol addiction | ||
| MPM, FRANZCP, | recovery | ||
| AFRACMA | Strongresearch background | ||
| Principal Investigator | Board Member,Mind Medicine Australia | ||
| Participant, inauguralCPAT course | |||
| Dr Jeremy Tannenbaum, | Psychiatrist & Specialist Pain Medicine Physician trainee,Hollywood Private Hospital, | ||
| MBBS(Hons), BSc, FRANZCP |
The Anodyne Centre (holistic pain management clinic)&Fiona Stanley Hospital Completed medical elective withProf. David NuttatImperial College, London |
||
| Consultant Psychiatrist | |||
| Dr Richard | Director of Military Trauma Recovery Program, Salvado | ||
| Magtengaard, MBBS, | Former Commissioned Ofcer within theRoyal Australian Navy | ||
| BSc, RAN, RTD, FRANZCP |
Member of Australasian Military Medical Association; afliations with the ADF Joint Health Command, St John's Ambulance and WAPOL |
||
| Consultant Psychiatrist |
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Six reasons to invest in Emyria (ASX: EMD)
1
Attractive valuation
2 Proprietary RWE
Synthetic cannabinoid 3 delivery platform
Compared to industry vertical peers
Unique insights into what treatment is working and in whom, source of IP
Designed to meet FDA requirements, favourable COGS
4
MDMA-analogue drug discovery pipeline
National clinical service 5 delivery
6 Team of global experts
Multiple potential treatments for neurological and psychiatric conditions
Front-line experience treating patients with unmet needs
Over 24 FDA approvals, over 100 clinical trials, clinical and commercial experience
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For more information, please contact:
Dr. Michael Winlo, Managing Director
[email protected]
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