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EMYRIA LIMITED — Investor Presentation 2021
Mar 4, 2021
64844_rns_2021-03-04_6e580e1a-d245-496a-a2e3-2b126a373965.pdf
Investor Presentation
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General Meeting Shareholder Update Michael Winlo - MD & CEO
ASX:EMD
Disclaimer and notices
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. This presentation contains general information only and does not consider the investment objectives, financial situation and needs of individual investors. Investors should make their own independent assessment of the information in this presentation and obtain their own independent advice from a qualified financial adviser having regard to their personal objectives, financial situation and needs before taking any action. No representation or warranty, express or implied, is made as to the accuracy, completeness, reliability or adequacy of any statements, estimates, opinions or other information, or the reasonableness of any assumption or other statement, contained in this presentation. Nor is any representation or warranty (express or implied) given as to the accuracy, completeness, likelihood of achievement or reasonableness of any forecasts, prospective statements or returns contained in this presentation. Such forecasts, prospective statements or returns are by their nature subject to significant uncertainties and contingencies, many of which are outside the control of Emyria. To the maximum extent permitted by law, Emyria and its related bodies corporate, directors, officers, employees, advisers and agents disclaim all liability and responsibility (including without limitation any liability arising from fault or negligence) for any direct or indirect loss or damage which may arise or be suffered through use or reliance on anything contained in, or omitted from, this presentation. An investment in Emyria securities should be considered speculative and is subject to investment and other known and unknown risks, some of which are beyond the control of Emyria. Emyria does not guarantee any rate of return or the absolute or relative investment performance of Emyria securities. The distribution of this presentation including in jurisdictions outside Australia, may be restricted by law. Any person who receives this presentation must seek advice on and observe any such restrictions.
This release may contain certain forward-looking statements with respect to matters including but not limited to the financial condition, results of operations and business of Emyria and certain of the plans and objectives of Emyria with respect to these items. These forward-looking statements are not historical facts but rather are based on Emyria's current expectations, estimates and projections about the industry in which Emyria operates, and its beliefs and assumptions. Words such as "anticipates," "expects," "intends," "plans," "believes," "seeks," "estimates", "guidance" and similar expressions are intended to identify forward looking statements and should be considered an at-risk statement. Such statements are subject to certain risks and uncertainties, particularly those risks or uncertainties inherent in the process of developing technology and in the endeavour of building a business around such products and services. These statements are not guarantees of future performance and are subject to known and unknown risks, uncertainties and other factors, some of which are beyond the control of Emyria, are difficult to predict and could cause actual results to differ materially from those expressed or forecasted in the forward looking statements. Emyria cautions shareholders and prospective shareholders not to place undue reliance on these forward-looking statements, which reflect the view of Emyria only as of the date of this release. The forward-looking statements made in this announcement relate only to events as of the date on which the statements are made. Emyria will not undertake any obligation to release publicly any revisions or updates to these forward-looking statements to reflect events, circumstances or unanticipated events occurring after the date of this announcement except as required by law or by any appropriate regulatory authority.
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Presentation release authorised by Michael Winlo, CEO and Managing Director
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treatments
-
Emyria creates for our large, under-served populations using
-
proprietary clinical evidence
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DRAFT
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Creates Informs
•
Access to patients & clinicians •
Ongoing patient
•
Data capture technology
monitoring & evaluation
Emyria Care Emyria Data Drug development
•
In-house analytics data
care
• Emyria
Emyria
We learn from every
•
Clinical trial & drug
patient to improve care
registration expertise
Accelerates
Informs informs
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Emyria positioned to rapidly & repeatedly develop new treatments
Emyria Care Emyria Data Emyria Rx
•
2.6M data points (and
• •
3,500+ patients (and Two drug programs
growing)
growing) (and growing)
•
Source of IP
• •
Experience with Pursuing global
unregistered drugs registration
•
In-house analytics
Emyria’s Digital Health Platform
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TGA-registered remote monitoring solution
-
Incorporates contactless vital sign capture
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Clinical-trial-grade evidence
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Emyria Care 6 sites in Australia + 1 clinical partner in UK
3,500+ and patients counting…
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Emyria data is the brain of our company
Emyria
Data
2.6M unique data points An intelligent model for care & drug design
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Board with deep clinical and commercial expertise
| Key Person | Role | |
|---|---|---|
| Dr Stewart Washer | Cynata(ASX:CYP) – stem cells | |
| Chairman & Founder | Orthocell(ASX:OCC) – regenerative medicine Botanix(ASX:BOT) – CBD (synthetic) |
|
| Dr Michael Winlo | Medical doctor | |
| Director atLinear Clinical | ||
| Managing Director | Health Lead atPalantir | |
| MBA fromStanford University | ||
| Dr Alistair Vickery | Specialistgeneral practitioner | |
| Medical Director | Chair ofBlack Swan Health, - mental health AssociateProfessor of Primary Health Care |
|
| Matt Callahan | FounderBotanix(ASX:BOT), FounderOrthocell(ASX:OCC) |
|
| NED & Founder | 4 products throughFDA approval. | |
| More than 20 years’legal and IP experience | ||
| Professor Sir John Tooke | Knightedin the UK for Services to Medicine | |
| Independent NED | Senior Independent Director,BUPA Chile Head of Medical Sciences atUCL |
|
| Review board ofGoogle DeepMind | ||
| Immediate pastPresident Academy of | ||
| Medical Sciences |
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Recently appointed Key Advisors
Key Person Role Dr Karen Smith M.D., Ph.D., M.B.A., L.L.M Chair of Strategic Advisory Dr Richard Magtengaard Consultant Psychiatrist
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[Experienced ] [pharmaceutical expert]
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• [Multiple Directorships][ with innovative ] pharmaceutical companies
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[Ex-] [Chief Medical Officer and Global Head of R&D ] at Jazz Pharmaceuticals
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•[Overseen more than ] [100 clinical trials and 20 ] regulatory approvals
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•[Appointment boosts Emyria’s global clinical trial ] and regulatory approval expertise to accelerate drug registration
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•[Appointment to support innovation across Emyria’s ] drug development programs, clinical studies and evidence-generating care model
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[Consultant][Psychiatrist][ and retired ] [Naval][Officer]
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•[Current ] [Director of Military Trauma Recovery ] Programme for sustained physical and psychological traumas
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[active member of the ] [Australasian Military ] Medical Association (AMMA) and has developed lasting affiliations with ADF Joint Health Command (JHC), Returned Services League WA (RSLWA), St John Ambulance (SJA), West Australian Police (WAPOL), Department of Fire and Emergency Services (DFES), Australian Federal Police (AFP) and numerous other Ex-Service Organisations (ESOs)
-
•[Appointment boosts Emyria’s clinical expertise in ] mental health care
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Corporate Structure
Share trades last 6 months
| Key Metrics | Value | ||
|---|---|---|---|
| Ordinary shares | 225.5 | 50 30.00 |
|
| Last close (04 March 2021) | A$0.165 | ||
| Market Capitalisation (Date) Cash (31 December 2020) Debt (31 December 2020) Enterprise value |
A$37.2m A$4.5m - A$33.2m |
Share Price (cents/Share) | 25 37 15.00 22.50 |
| Options (ex. price $0.45, exp. 2023) | 18.35m | 12 7.50 |
|
| Options (ex. price $0.114, exp. 2023/2024 ) | 12.50m | 0.00 | |
| Options (ex. price $0.20, exp. 2022) | 10.71m | 2/6/2025 2/4/2025 2/2/2025 1 9/2025 1/27/ 025 1/23/ 025 1 1/ 025 1 19/2025 1 5/ 025 1/13/ 025 1 97/ 025 / 025 1/ 025 1 3 / 024 6/ 024 1 4/2024 1 2/2024 1 18/2024 1 /16/ 024 /1 / 024 1 1 / 024 1 8 1 4/ 024 / 024 8/ 024 6/ 024 1 / 024 1 / 024 1 18/2024 1 1 / 024 1/1 / 024 1 1 / 024 6 1 / 024 31/ 024 9/ 024 7/ 024 0 3/ 024 0 1/2024 1 17/ 024 1 / 5/ 024 1 13/ 024 1 9 1 7/ 024 1 3/ 024 1/ 024 9/29/ 024 9/ 5/ 024 9/ 3/ 024 /19/ 024 9 17/ 024 9 15/ 024 9 11/ 024 9 9 9 5/ 024 3/ 024 9 1/ 024 8 8/ 024 8 6/ 024 8 / 024 8 / 024 8 18/2024 8 1 / 024 8/12/ 024 8 8 8 6/ 024 8 / 024 7 31/ 024 7 9/ 024 7 5/ 024 7 3/ 024 7 1/2024 7 17/ 024 7/ 5/ 024 7 11/ 024 7 9 7 7/ 024 7 3/ 024 1/ 024 6 7/ 024 6 5/ 024 6 3/ 024 6 19/ 024 6 17/2024 6 13/ 024 6/11/ 024 6 9 6 5/ 024 6 3/ 024 5 / 024 5 8/ 024 5 6/ 024 5 / 024 /2024 5 16/ 024 5/1 / 024 5 12/ 024 5 8 5 6/ 024 5 / 024 3 / 024 8/ 024 / 024 / 024 18/2024 16/ 024 /1 / 024 4 1 / 024 8/ 024 / 024 3 31/ 024 3 7/ 024 3 5/ 024 3 1/ 024 3 19/2024 7/ 024 3/13/ 024 3 11/ 024 3 7 3 5/ 024 3 3/ 024 8/ 024 6/ 024 / 024 / 024 18/2024 1 / 024 /1 / 024 86/ 024 / 024 31/ 024 9/ 024 1 5/ 024 1 3/ 024 1 1/2024 1 17/ 024 1/ 5/ 024 11/ 024 1 97/ 024 3/ 024 1/ 024 1 8/ 023 6/ 023 1 /2023 1 /2023 1 18/2023 1 /1 / 023 /1 / 023 1 1 / 023 1 6 1 / 023 3 / 023 8/ 023 6/ 023 1 / 023 1 /2023 1 16/ 023 1/14/ 023 1 1 / 023 1 8 1 6/ 023 / 023 1 1/ 023 9/ 023 0 5/ 023 0 / 023 1 19/2023 1 17/ 023 1 /15/ 023 1 11/ 023 1 9 1 5/ 023 / 023 1/ 023 9/27/ 023 9/ 5/ 023 9/ 1/ 023 /19/ 023 9 7/ 023 9 1 / 023 9 11/ 023 9 7 9 5/ 023 / 023 8 / 023 8 8/ 023 8 4/ 023 8 / 023 8 /2023 8 16/ 023 8/14/ 023 8 1 / 023 8 8 8 6/ 023 8 / 023 7 1/ 023 7 7/ 023 7 5/ 023 7 / 023 7 19/2023 7 17/ 023 7/1 / 023 7 11/ 023 7 9 7 5/ 023 7 / 023 |
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5000000
3750000
2500000
1250000
0
Volume
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Research & development pipeline
DRAFT
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- Emyria’s pipeline targets large, under-served markets
Analysis Program Target Develop Gather & IP Develop Commence Submit for indication care model evidence capture product pivotal trials registration Psychological EMD-003 distress PTSD MDMA Major Psilocybin depression Chronic pain Irritable EMD-004 bowel syndrome PsychedelicCannabinoid +40 other indications therapy*
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- An ethical and efficient framework to develop and register novel drugs
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DRAFT
Evidence, guiding every move
•
-
At Emyria, we offer personalised care via Emerald Clinics ( Emyria Care ); underpinned by clear evidence protocols and technology infrastructure ( Emyria Data ); to support novel drug development in compliance with key regulators (i.e. TGA, FDA).
-
This framework is efficient, safe and effective for supporting our patients, whilst we simultaneously develop and pursue registration for novel drugs ( Emyria Treatments ).
•
- Our goal is to put evidence first, always. That means leading the market with sophisticated real world evidence (RWE) generating systems too, which is a core point of difference for our Company.
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A “typical” EMD patient
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I have a
complex and
chronic disease.
I’ve been told
“nothing else to
try right now.”
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My current treatments
are not effective. I still
have health goals
that aren’t being met.
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I don’t want
to get “high”.
I want “care” not
“access”. I want
to get better.
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- People like Bob deserve personalised care, backed by reliable clinical evidence
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•
•
•
•
Emerald Clinics’ patients have often exhausted multiple avenues of conventional treatment. Typically, they have been told “there’s nothing else”
- Through our clinics, we provide a monitored environment to try novel drugs, with the right clinical evidence systems and support teams in place Our patients receive personalised care and an opportunity to contribute to, and leverage, Emyria’s growing body of aggregate clinical data and insights.
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Case Study - Bob
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Vietnam Veteran | injured by fall in 1969 | multiple fractures
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• Chronic back pain | peripheral neuropathy from Agent Orange | PTSD
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At initial visit: oxycontin | buprenorphine | pregabalin | gabapentin | PEA duloxetine – with little relief and side effects.
-
• Now : Stable at 15mg 1:1 THC/CBD | ceased all opiates , pregabalin and PEA
| Scores | Initial assessment | Visit 5 |
|---|---|---|
| BPI Pain severity score | 5.0 | 1.75 |
| BPI Pain interference score | 5.29 | 0.86 |
| Visual analogue scale | 5.0 | 1.0 |
| Insomnia severity score | 12.0 | 1.0 |
| DASS 42 Depression | 14 | 4 |
| DASS 42 Anxiety | 16 | 2 |
| DASS 42 Stress | 16 | 12 |
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- Registering novel drugs is a noble and profitable pursuit
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DRAFT
Medicinal cannabis access in Australia
52 medicinal cannabis products available in Australia
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Medicinal cannabis products are “unregistered” meaning, they are only available to patients via Special Access Schemes, Authorised Prescriber programs or clinical trials*
- only 1 product is registered & available via routine prescription (Epidyolex - GW Pharma) and only for rare forms of epilepsy with an estimated prevalence of 1 in 20k-40k
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-
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- Source: https://www.tga.gov.au/australian register therapeutic goods
-
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Recent deals | Jazz acquires GW Pharma ($7.2B USD)
*
* Recent Chair of Emyria’s Strategic Advisory is Dr Karen Smith, ex-CMO and Global Head of R&D at Jazz Pharmaceuticals
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Prescription counts by select drug groupings in Australia in 12 months
Registered treatments (i.e. routine prescription)
Proper registration of treatments facilitates greater patient access. This is Emyria’s path…
Medicinal cannabis (via Special Access Scheme)
29,112,803 22,605,395 This figure represents <0.08% of comparison prescriptions shown here Significant potential for registered treatments 9,600,633 _ ~~52,876~~ Medicinal cannabis . Psycholeptics . Analgesics . Psychoanaleptics . _ 0.08% of registered prescriptions (All indications) shown to the right (eg. Anti-anxiety meds) (eg. Pain relievers) (eg. Antidepressants)
This figure represents <0.08% of comparison prescriptions shown here Significant potential for registered treatments
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Sources: https://www.pbs.gov.au/info/browse/statistics (data from 01 Jul 2018 to 30 Jun 2019 - - - https://www.tga.gov.au/medicinal cannabis role tga (data from 01 Nov 2019 to 31 Oct 2020)
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EMD
patient
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Large under-served patient market
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20.1% of all
Australians
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Psychological distress is growing in incidence
Major growing Mental Health health concern
11% of all Australians No targeted drug treatment IBS 44+ indications Emyria Data provides unique dose-response insights Emyria Care has increasing Future indications treatment options
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Emyria is poised for growth
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DRAFT
Within 12 months we have…
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Over 3,500 patients with unmet needs
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7 clinic locations Emerald Clinics
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Specialist advisors & GCP-trained GPs
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Over 400 referring clinicians
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Over 2.6M validated data points
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$1M of data deals inc. with Canopy Growth Corp
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TGA registered remote monitoring systems
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Major WA Health grant award ($880k) for remote monitoring of vital signs and mental health
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Launched 2 drug development programs :
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• EMD-003 (schedule 3 medicine for psychological distress)
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EMD-004 (cannabinoid for IBS)
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Multiple PhD-trained data analysts
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Informing strategic trial design
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Patents already filed
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UK clinical partner - Sapphire Medical (London)
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USA strategic partner - Mt Sinai (New York)
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Partnership with Mind Medicine -
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Australia to develop psychedelic assisted therapy models
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Timeline (to date)
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Emyria Initial
Public Offering Partners with Thought Leaders
Adds consultant psychiatrist to
in Psychedelic Therapy
Medical Advisory
Signs Real-World Data TGA Ruling on CBD
Agreement with Zelira Medicines
Receives $954,000 R&D
Adds second clinic
tax incentive refund
in Melbourne
Sees Strong Interest
Pursuing
in IBS Study
Registration of
EMD-003 in
CY2021
FY20 FY21
SEPTEMBER OCTOBER NOVEMBER DECEMBER JANUARY FEBRUARY
Global
FDA position on Pharmaceutical
RWE to guide CBD expert joins
Enters Data Deal
regulation opens Advisory Board
with ZLD to
pathway to US
Support Autism
Enters into
Trial
Partnership with
Sapphire Medical Completes $1.2m Wins digital health monitoring
Launches Drug
Clinics Strategic grant with UWA
Development Program
Placement
Based on RWE
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Emyria positioned to rapidly & repeatedly develop new treatments
Emyria Care Emyria Data Emyria Rx
•
•
Commence pivotal
Create insights
•
Grow patient base
trials
•
Capture unique IP
•
Grow care &
•
Pursue global
treatment options
•
registration
Launch new programs
Emyria’s Digital Health Platform
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Obtain further TGA registrations
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Incorporate best-in-class vital sign technology to develop digital biomarkers
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Work with partners (eg Mt Sinai) to extend platform capability
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Contact Information Michael Winlo: [email protected] Investors: [email protected] Media: [email protected] General: [email protected]
ASX:EMD