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EMYRIA LIMITED — Investor Presentation 2021
Apr 6, 2021
64844_rns_2021-04-06_cb6f5def-db54-45fc-a813-1b5215dffa6b.pdf
Investor Presentation
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Emyria’s drug registration model
EMD-003 Snapshot 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
- Emyria creates registered treatments for large, under-served populations using our proprietary clinical evidence
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“Emyria owns clinics, cares for patients, invests in technology, generates data, creates evidence and develops programs to accelerate the registration of new treatments, including our own.” Dr Michael Winlo, MD and CEO
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DRAFT
Emyria’s platform
Creates
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Access to patients & clinicians
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• Data capture technology
Informs • Ongoing patient monitoring & evaluation
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Data Drug development
•
In-house analytics data
Emyria
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Clinical trial & drug
registration expertise
Accelerates
informs
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Emyria Care Emyria Data • care • Emyria We learn from every • patient to improve care Informs informs
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Emyria’s platform
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Data
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Emyria Care
Emyria
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care Emyria
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7 sites around Australia
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2.6M data points
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GCP-trained clinical team
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Validated assessments
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3,500 patients and growing
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Source of IP
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Patients aged 2 - 96years
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Unique dose response insights
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Over 40 clinical indications
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More than 100 products informs
Emyria’s current drug development programs
Targeting mental health
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CBD medicine
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- Entering clinical outcomes studies
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- Seeking Schedule
EMD-003 3 registration Emyria data Targeting irritable bowel syndrome
- Real-world studies
underway
EMD-004
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EMD-003 A strategic partnership with to accelerate the registration of a Schedule 3, (over-the-counter), CBD medicine
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“Our first drug registration program brings together Emyria’s unique insights on what is working in which patients with a highly differentiated CBD dose form that we already have substantive real-world data on.” Dr Michael Winlo, MD and CEO
DRAFT
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EMD-003: Target indication Unmet needs in mental health
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Global unmet Emyria Data has need unique insights Affects Emyria Major growing Need for new health concern treatments patients Psychological There is a growing >60% of Emyria patients distress is growing interest for readily have Mild to Severe anxiety, in incidence available, registered depression and / or stress treatments with >10% of Emyria fewer: Affects 20.1% of patients have primary all Australians mental health concern - Adverse events - Treatment costs Real-world data There has been a 13% rise - Withdrawal already gathered on in mental health conditions symptoms efficacy and safety of in the last decade - Overdose risks target dose form
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- Sources: https://www1.racgp.org.au/newsgp/clinical/mental health issues increasing among australians + https://pubmed.ncbi.nlm.nih.gov/20051569/4 + https://www.who.int/health topics/mental health#tab=tab_2 - - - - - - - - - - https://www.aihw.gov.au/reports/mental health services/mental health services in australia/report contents/mental health related prescriptions/prescriptions
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EMD-003: Program summary Partnership accelerates registration pathway
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What works and in
whom?
Pivotal trials
Emyria Care Emyria Data
Emyria Team
Clinics IP
+
Patients Trial design
Clinical Trials
Tech Dosing insights
Commercialisation
TGA submission
EMD-003
Cann | Dose tech
Registration
IP
GMP
Novel formulation
Unique, palatable
dose form
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- EMD-003: Unique success factors in place Strategic partnership accelerates path to S3 registration
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Real-world IP on Streamlined data on “method of access to emyria safety & use” patients + efficacy at clinical trial target dose infrastructure
Protocols Regulatory Experienced developed strategy drug development team
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Longitudinal clinical data on over 3,500 patients and growing
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Over 400 prescriptions already written for target dose form
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Unique insights support growing patent portfolio
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Emyria patents cover indication and dose range
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7 locations in Australia
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All GPs, GCP-trained
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Already running a clinical-trial-grade data capture platform
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Clinical outcomes trials developed using Emyria Data insights and expertise of team
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•
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Engaged Emyria team has experienced overseen over 100 regulatory clinical trials and 25 consultant with drug approvals prior S3 successes
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Phase 1 & Unique, dose Cann Stability form protected Group data by IP
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Phase 1 complete • Covers use of novel for target dose delivery technology
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• > 30+ months (Gelpell) stability data
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Large scale, GMP manufacturing
- Factory in Europe, transferring technology to Australia
This partnership greatly accelerates Emyria’s EMD-003 drug development program by combining Emyria’s unique clinical data and drug development expertise with Cann Group’s best-in-class CBD delivery technology.
Cann Group’s CBD has already completed robust stability testing as well as Phase 1 clinical trials as required by the TGA. This allows us to move straight to pivotal clinical outcomes trials saving significant time and money.
Dr Michael Winlo, MD and CEO
EMD-003: Milestones in year ahead Value drivers next 12 months
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| Commence | Complete | Prepare product | Obtain | Finalise | Commence |
|---|---|---|---|---|---|
| pivotal | trial and | dossier and submit | Schedule 3 | commercialisation | international |
| registration | commence | to TGA for | registration | agreements + | registration |
| clinical trials | analysis | registration | commence sales | activities | |
| • Contingent on successful ethics committee review • Expected May/ June 2021 |
• Contingent on recruitment success • Expected 4-8 months after commencement |
• Preparation of full product dossier and clinical evidence package for evaluation • Expected 6-8 months after submission |
• Entry on Australian Register of Therapeutic Goods (ARTG) as a Schedule 3 medication |
• Finalise commercialisation models • Sales as over-the- counter, Schedule 3 medicine |
• Initiate activities to pursue global registrations |
EMD-003: Proposed patient channel A registered, over-the-counter, Schedule 3 medicine
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Y Y Y Y
Find suitable Purchase
Consultation
practitioner Suitable for Qualify for Apply Consent to medicine
Current ‘Special with medical Application
(referral may medicinal Special to unregistered from
practitioner approved? medicine?
Access Scheme' be required) cannabis? Access? TGA pharmacy
$
$ $
Path
Y
Purchase
Potential
Suitable for
medicine Potential out-of-
Approach
Schedule 3 Path registered from $ pocket expenses for
pharmacy medicinal
pharmacy patients
If a low-dose CBD product can be cannabis?
$
successfully registered
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- Sources: https://www.tga.gov.au/form/special access scheme - - - - - - https://www.tga.gov.au/media release/over counter access low dose cannabidiol
Drug registration changes patient access
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“Achieving formal drug registration demonstrates a product’s quality, safety and efficacy, makes a medicine mainstream and can improve patients’ access.” Dr Michael Winlo, MD and CEO
DRAFT
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Medicinal cannabis vs registered prescriptions (via select drug groupings in Australia over 12 months) Registered treatments (i.e. routine prescription)
Medicinal cannabis (via Special Access Scheme) This figure represents <0.08% of comparison prescriptions shown here Significant potential for registered treatments ~100,000
29,112,803 22,605,395 This figure represents <0.08% of comparison prescriptions shown here Significant potential for registered treatments 9,600,633 ~100,000 ~~52,876~~ . . . . Medicinal cannabis Psycholeptics Analgesics Psychoanaleptics (All indications) ~5,000 / month (eg. Anti-anxiety meds) ~ 800,000 / month ~ 1,883,000 / month (eg. Pain relievers) ~ 2,416,000 / month (eg. Antidepressants)
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) + Freshleaf Analytics, H1, 2021
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Medicinal cannabis access in Australia
190 medicinal cannabis products available in Australia - most “unregistered”
Most medicinal cannabis products in Australia are
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“ unregistered ” and only available only via:
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Special Access Schemes
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Authorised Prescriber programs or;
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Clinical trials
1
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Only 1 registered product is available via prescription
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[Epidyolex - GW Pharma] for rare forms of epilepsy with an estimated prevalence of 1 in 20k-40k
GW Pharma spent an estimated $560M on R&D between 2017 & 2020
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- Sources: https://www.tga.gov.au/australian register therapeutic goods + Freshleaf Analytics, H1 2021 Report + https://mjbizdaily.com/gw-pharmaceuticals-sale-might-spur-pharma-cannabis-deal-making/
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Recent deals | Jazz acquires GW Pharma ($7.2B USD)
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Emyria recently appointed Dr Karen Smith, Ex-Chief Medical Officer and Global Head of Research & Development at Jazz Pharmaceuticals to Chair Emyria’s Strategic Advisory (See ASX Announcement 22 February 2021)
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Emyria’s growing drug registration pipeline
Given our unique assets and the high-quality data we generate during care, the Emyria platform can generate multiple, independent drug development programs for new and emerging treatments.” Dr Michael Winlo, MD and CEO
DRAFT
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Emyria’s pipeline targets large, under-served markets
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Program Target Develop Gather real- Analysis Develop Commence Submit for
indication care model world & IP product pivotal registration
evidence capture trials
Aus FDA/EMA
Psychological
EMD-003
distress
PTSD
MDMA
Major
Psilocybin
depression
Chronic pain
Irritable
EMD-004 bowel
syndrome
Psychedelic-
Cannabinoid
+40 other indications
therapy
Neuroscience
GI
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Emyria’s experienced drug development team
“Our team has overseen more than 100 clinical trials and multiple drug registrations including with the FDA.” Dr Michael Winlo, MD and CEO
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DRAFT
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) |
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| 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 |
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| Matt Callahan | FounderBotanix(ASX:BOT), FounderOrthocell(ASX:OCC) |
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| 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 |
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| 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)
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•[Appointment boosts Emyria’s clinical expertise in ] mental health care
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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 Australia to develop psychedelicassisted therapy model
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Emyria positioned to rapidly & repeatedly develop new treatments
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Emyria Care Emyria Data Emyria Rx
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Commence pivotal
Create insights
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Grow patient base
trials
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Capture unique IP
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Grow care &
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Pursue global
treatment options
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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