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EMYRIA LIMITED — Investor Presentation 2021
Jun 17, 2021
64844_rns_2021-06-17_4a33a6e7-58de-402b-9491-cb9be4ff38cf.pdf
Investor Presentation
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June 2021 "Hidden Gems”: medicinal cannabis/ hemp Webinar
Michael Winlo 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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- large, under-served populations powered by proprietary clinical evidence
Capital Structure
12month price chart
Key Metrics Value Ordinary shares 225.5 Last close (04 March 2021) A$0.18 Market Capitalisation (Date) A$45.7m Cash (31 March 2021) A$8.5m - Debt (31 March 2021) Enterprise value A$37.2m Options (ex. price $0.45, exp. 2023 ) 18.35m Options (ex. price $0.114, exp. 2023 ) 12m Options (ex. price $0.20, exp. 2022 ) 10.7m
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DRAFT
Emyria provides care + data to support drug registration
Emyria Care
Emyria Data
Emyria’s current drug registration programs
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Millions of data points
•
Validated assessments
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7 sites around Australia
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4,000 patients and growing
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Source of unique patents
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• Unique dose response insights
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Patients aged 2 - 96years
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Over 40 clinical indications
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TGA Class IIa data platform
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Global clinical advisors
(Openly)
“Successful registration requires known what works, and for whom.”
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CBD medicine
targeting mental
health
EMD-003
CBD +/- THC for
irritable bowel
syndrome
EMD-004
MDMA for post-
traumatic stress
syndrome
EMDMA-001
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Emyria data is the brain of our company
Emyria
Data
Millions of unique data points An intelligent model for care & drug design
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Emyria provides care for more than 40 unmet needs…
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Mental Health
•
Insomnia
•
PTSD
•
Anxiety disorders
12%
Chronic Non-Cancer Pain
•
Neuropathic Cancer symptoms
• Inflammatory • Pain
66%
• Mixed 9% • CINV
• Migraine • Anorexia
6%
Neurological disorders
•
Dementia
8%
•
Multiple Sclerosis
•
Parkinson’s Disease
•
Epilepsy
Other
•
Irritable Bowel Syndrome
•
Inflammatory Bowel Disease
•
Fibromyalgia
•
Alcohol and other drug abuse
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…each unmet need is an opportunity
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Disease severity
Less Greater
(Clinical management intensity)
EMD-003 EMDMA-001
Cannabinoid medicine (over-the- Psychedelic-assisted
counter) for psychological distress therapy for PTSD
S3 S4 S8 S9
TGA Schedules
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Emyria pipeline + global registration plans
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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
EMDMA-001 MDMA
Major
Psilocybin
depression
Chronic pain
Irritable
EMD-004 bowel
syndrome
Psychedelic-
Cannabinoid
+40 other indications
therapy
Neuroscience
GI
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Registering treatments creates value
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DRAFT
Medicinal cannabis in Australia
150+ 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*
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only 1 product is registered & available via routine
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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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Medicinal cannabis vs registered prescriptions (via select drug groupings in Australia + UK over 12 months)
~ 5,833,000 / month
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Registered treatments (i.e. routine prescription)
70,000,000
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Medicinal cannabis (via Special Access Scheme)
Medicinal cannabis ~ 2,416,000 / month (via Special Access Scheme) 29,112,803 ~8,500 / month
~100,000
Medicinal cannabis . (All indications)
. . Antidepressants (AUS) Antidepressants (UK)
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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) + Freshleaf Analytics, H1, 2021
- 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 impact so far…
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DRAFT
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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 –
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duloxetine with little relief and side effects.
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• 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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- Emyria’s care model works… + our data is validated Average opioid scores by oMEDD category (Pre vs Post Emyria)
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Prior care
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Patients with 6+ months of cannabinoid usage
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Si nificant
g
168 High . >90mg/day
30+%
reduction
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The oral morphine equivalent daily dose
“oMEDD” cate ories are derived from
( ) g
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the patient’s average oMEDD score 1-year
prior to first visit with Emyria.
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72 Moderate 40-90mg/day
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Low <40mg/day
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0
-12 -11 -10 -9 -8 -7 -6 -5 -4 -3 -2 -1 0 1 2 3 4 5 6 7 8 9 10 11 12
Months since first visit
oMEDD score
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EMD-003 Snapshot
DRAFT
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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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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 |
In parallel
Commence psychedelic-assisted therapy trials >> gold-standard service for Australia Registration trials for EMD-004 >> second, unique drug treatment Launch registration programs for US, FDA >> reach global market with unique dose products
Emyria pipeline + global registration plans
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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
EMDMA-001 MDMA
Major
Psilocybin
depression
Chronic pain
Irritable
EMD-004 bowel
syndrome
Psychedelic-
Cannabinoid
+40 other indications
therapy
Neuroscience
GI
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Thank-you and questions
DRAFT
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Contact Information Michael Winlo: [email protected] Investors: [email protected] Media: [email protected] General: [email protected]
ASX:EMD
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Appendix
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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) |
|
| 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)
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•[Appointment boosts Emyria’s clinical expertise in ] mental health care
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Since listing, we have…
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Over 4,000 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 500 referring clinicians
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Over millions of validated data points
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$1M+ of data deals inc. with Canopy Growth Corp
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TGA Class IIa 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 3 drug registration 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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• EMDMA-001 (MDMA for PTSD)
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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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