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EMYRIA LIMITED — Investor Presentation 2021
Aug 22, 2021
64844_rns_2021-08-22_2dc186b7-4f09-4b5b-88c3-7e96b37e9bbd.pdf
Investor Presentation
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23/08/21
ASX Announcement
Emyria Drug Development Webinar
Emyria Limited (ASX: EMD) (Emyria or the Company), a data-backed treatment development and clinical services company, is pleased to invite shareholders to an overview of Emyria’s novel cannabinoid and MDMA drug development programs to be held on the: 24 August at 12:30 pm AEST.
Emyria’s Managing Director and CEO, Dr, Michael Winlo will present the attached presentation and cover the recently announced ‘pure CBD agreement with Altasciences to accelerate FDA and TGA cannabinoid registration programs’, Emyria’s novel MDMA-analogue drug discovery pipeline, and the imminent independent report to inform the possible re-scheduling of MDMA and psilocybin with the TGA.
Details of the event are as follows:
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Event: Emyria Drug Development Webinar
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Webinar Presenter: Emyria’s Managing Director, Dr, Michael Winlo
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Date and Time: Tuesday 24 August 2021, 12:30pm AEST
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Where : Zoom Webinar - details to be provided upon registration
To register your interest in the webinar please click through to the link below.
Registration Link:
- https://janemorganmanagement au.zoom.us/webinar/register/WN_zBsUQCCqQHavOCeJ_WIagw
After registering your interest, you will receive a confirmation email with information about joining the webinar. Participants will be able to submit questions via the panel throughout the presentation, however, we encourage shareholders and investors to send through questions via email beforehand to Lexi O’Halloran at: [email protected]
This announcement has been approved and authorised by the Board 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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This announcement has been approved and authorised by the Board of Emyria Limited. For further information on Emyria :
Dr Michael Winlo Lexi O’Halloran Managing Director Media/Investor Relations (08) 6559 2800 + 61 (0) 404 577 076 [email protected] [email protected]
Andrew Williams Media Relations +61 (0) 412 614 125 [email protected]
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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ADVANCING NOVEL
CANNABINOID and
PSYCHEDELIC THERAPIES
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August 2021 Dr Michael Winlo, CEO ASX: EMD
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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. 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.
Presentation release authorised by Michael Winlo, CEO and Managing Director
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Corporate snapshot
| Key Metrics | Value |
|---|---|
| Shares on issue | 254m |
| (Escrowed component) | 100m |
| Last close (20 Aug 2021) | A$0.175 |
| Market Capitalisation (20 Aug 2021) | A$44.5m |
| Cash (30 June 2021) | A$6.5m |
| Debt (30 June 2021) | - |
| Enterprise value | A$38m |
| Total options (exercise price $0.114-0.45) expiring. 2022-24 |
63m |
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Top 20 = 60.48% Director ownership = 27.17%
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Board with deep clinical and commercial expertise
| Key Person Role Experience Afliations |
Key Person Role Experience Afliations |
|---|---|
| Dr Stewart Washer Chairman & Founder Cynata(ASX:CYP) – stem cells Orthocell(ASX:OCC) – regenerative medicine Botanix(ASX:BOT) – synthetic CBD |
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| Dr Michael Winlo Managing Director Medical doctor Director atLinear Clinical Research- Phase 1 clinical trials Health Lead atPalantir(NYSE:PLTR) - Big Data analytics MBA fromStanford University |
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| Dr Alistair Vickery Medical Director Specialistgeneral practitioner Chair ofBlack Swan Health- mental health AssociateProfessor of Primary Health Care |
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| Matt Callahan NED & Founder FounderBotanix(ASX:BOT) - synthetic CBD FounderOrthocell(ASX:OCC) - regenerative medicine 4 products throughFDA approval More than 20 years’legal and IP experience |
|
| Professor Sir John Tooke Independent NED Knightedin the UK for Services to Medicine Senior Independent Director,BUPA Chile Head of Medical Sciences,University College London Review board,Google DeepMind Immediate pastPresident Academy of Medical Sciences |
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| Recently appointed Key Advisors | Recently appointed Key Advisors |
|---|---|
| Key Person Role Experience Afliations Dr Karen Smith, MD, PhD, MBA, LLM Chair of Strategic Advisory Multiple Directorshipswith innovative pharmaceutical companies Ex-Chief Medical OfcerandGlobal Head of R&DatJazz Pharmaceuticals Overseen more than 100 clinical trials and20 regulatory approvals Dr Richard Magtengaard, MBBS, BSc , RAN , RTD , FRANZCP Consultant Psychiatrist Director of Military Trauma Recovery Program, Salvado Former Commissioned Ofcer within theRoyal Australian Navy Member of Australasian Military Medical Association; afliations with the ADF Joint Health Command, St John's Ambulance and WAPOL Dr Eli Kotler, MBBS, MPM, FRANZCP, AFRACMA Consultant Psychiatrist Medical DirectoratMalvern Private Hospital, specialising in drug & alcohol addiction recovery Strongresearch background Board Member,Mind Medicine Australia Assoc. Prof. Matthew Pigott, Dr, BSc PhD Medicinal Chemist, MDMA Analogues Worked onantibiotic drug discoveryin collaboration withGlaxoSmithKline Has spent the past 10 years developingMDMA analoguesfor Parkinson's disease and otherneurological conditions Prof. Mathew Martin-Iverson, BSc Alta., PhD Br.Col. Neuropharmacologist Head of Psychopharmacology, UWA Over35 yearsof experience studyingamphetaminesand otherpsychostimulants |
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| Dr Karen Smith, MD, PhD, MBA, LLM Chair of Strategic Advisory Multiple Directorshipswith innovative pharmaceutical companies Ex-Chief Medical OfcerandGlobal Head of R&DatJazz Pharmaceuticals Overseen more than 100 clinical trials and20 regulatory approvals |
|
| Dr Richard Magtengaard, MBBS, BSc , RAN , RTD , FRANZCP Consultant Psychiatrist Director of Military Trauma Recovery Program, Salvado Former Commissioned Ofcer within theRoyal Australian Navy Member of Australasian Military Medical Association; afliations with the ADF Joint Health Command, St John's Ambulance and WAPOL |
|
| Dr Eli Kotler, MBBS, MPM, FRANZCP, AFRACMA Consultant Psychiatrist Medical DirectoratMalvern Private Hospital, specialising in drug & alcohol addiction recovery Strongresearch background Board Member,Mind Medicine Australia |
|
| Assoc. Prof. Matthew Pigott, Dr, BSc PhD Medicinal Chemist, MDMA Analogues Worked onantibiotic drug discoveryin collaboration withGlaxoSmithKline Has spent the past 10 years developingMDMA analoguesfor Parkinson's disease and otherneurological conditions |
|
| Prof. Mathew Martin-Iverson, BSc Alta., PhD Br.Col. Neuropharmacologist Head of Psychopharmacology, UWA Over35 yearsof experience studyingamphetaminesand otherpsychostimulants |
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Emyria’s accelerated drug development programs
Proprietary Assets
Company Highlights
Treatment Programs
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One of the world’s largest, real-world evidence (RWE) patient registries tracking dose responses to pharmaceutical-grade cannabinoid medicines
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Growing patent portfolio covering novel treatment methods and new chemical entities
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Proprietary MDMA-analogue drug discovery pipeline (>100 entities)
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Novel synthetic cannabinoid delivery platform (FDA-compliant)
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Clinical service delivery footprint across Australia (7 sites)
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TGA approved remote patient monitoring tech (Class IIa)
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Two active cannabinoid drug development programs targeting unmet needs in Mental Health and Irritable Bowel Syndrome. Seeking registration with the TGA and FDA
● Partnership with Mind Medicine Australia to deliver scalable MDMA-assisted psychotherapy trial targeting PTSD (starting with Phase II trial)
- Exclusive agreement with UWA to screen and expand library of >100 novel MDMA analogues, aiming to develop multiple psychiatric and neurological treatments
3,4-Methylenedioxymethamphetamine (MDMA + psychotherapy / analogues )
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Pure Cannabidiol (CBD)
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Pure Tetrahydrocannabinol (THC)
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Presentation overview
1.
How Emyria accelerates treatment development
Overview of Emyria’s unique drug development assets:
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A clinical service that cares for thousands of patients
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Robust clinical data and analysis systems
2.
Emyria’s leading treatment programs
Overview of Emyria’s leading drug development programs:
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Synthetic cannabinoid delivery
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MDMA-assisted psychotherapy
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Novel MDMA-analogue development
3.
Emyria’s upcoming milestones Overview of Emyria’s drug development milestones for the next 3 quarters
- Experienced drug development team
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How Emyria accelerates
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At Emyria, we believe...
There are better ways to get better.
Everyday we care for patients with complex and challenging conditions who are not reaching their health goals. We believe that by providing a safe place for our patients to access promising new treatments, we may improve their lives. By paying attention to what’s happening with rich data collection, we can also lead the discovery of the next generation of treatments and care models to help the lives of patients beyond our clinics.
Drug development can be faster.
Treatment development can take so long. We believe that by investing in better data collection at the front-line of care we can innovate faster, personalise care and protect our insights. We can also reduce the risk of our drug development programs. Helping bring new treatments to those that need them, faster and more cost effectively.
Registration matters.
Registered products (both treatments and technologies) must demonstrate the highest standards of quality, safety and efficacy. They have earned the trust of patients and clinicians, may be eligible for reimbursement, and can therefore reach larger patient populations. Registration is our goal for all our programs.
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An accelerated treatment development model
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Patients Real-world Dose Novel Global
New
with unmet evidence response delivery registration
treatments
needs (RWE) insights (IP) platforms programs
Care Data Treatments
We provide care and access to We capture ethically-sourced We use our proprietary evidence,
new treatments for patients who clinical data with patients in order to create drug registration
are not reaching their health goals to learn what’s working programs for patients in need
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An accelerated treatment development model (cont.)
Strategic ~~Care~~ pillar What we do We provide front-line care, and access to new treatments, for patients who are not reaching their health goals. How this Each of our patients have creates unmet clinical needs and value therefore represent a global opportunity for a better treatment option. Our clinics are a source of patients and can support clinical trials.
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Data Treatments
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We collect robust & ethically-sourced evidence with patients. We analyse this data for dose response insights & novel IP.
We use our proprietary evidence and in-house team to create global drug development and registration programs
Reliable, clinical-trial-grade data guides our care delivery models, novel drug development programs and also helps generate intellectual property.
Registered treatments have proven quality, safety and efficacy. They can reach large patient populations via routine prescription and reimbursement .
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Emyria’s successes to date
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Current drug
Care Data Treatments development programs
CBD medicine targeting
psychological distress
EMD-003
CBD +/- THC for
Irritable Bowel
Syndrome (IBS)
● 7 sites around Australia ● Millions of data points
EMD-004
● 4,500 patients and growing ● Validated assessments
MDMA-assisted
● Patients aged 2-98 years ● Unique dose response insights
psychotherapy for
● 40+ clinical indications ● TGA class IIa data platform
Post-Traumatic Stress
EMDMA-001 Disorder (PTSD)
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Emyria’s active treatment pipeline + global registration plans
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Submit for
Program Target Develop care real-world Gather Analysis & IP Develop Commence registration
indication model capture product pivotal trials
evidence
Psychological
EMD-003
distress
Irritable bowel
EMD-004
syndrome
EMDMA-001 Post traumatic
stress disorder
MDMA library Multiple Screening Expansion
other
Current status In planning Where we are now
indications
40+
Cannabinoids
MDMA
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Emyria focusses on
major unmet needs
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Emyria has a special focus on major mental health concerns
Mental illness is a primary presentation for ~15% of Emyria patients More than 60% of Emyria patients suffer from mental health symptoms (regardless of primary indication) Mental health is one of the largest global healthcare challenges with an urgent need for innovative approaches
SIGNIFICANT GLOBAL BURDEN
Affected people
~1bn
Global population with mental health disorders [1]
Global economic impact
Estimated global economic costs of mental health disorders by 2030 [2]
~$16tn
Increase in prevalence of anxiety and depression From March 2020 as a result of the COVID-19 pandemic [3]
~2x
URGENT NEED FOR INNOVATION
Respond inadequately
~33%
A third of patients with depression respond inadequately or relapse with current treatments within certain indications [4]
Up to 12 wks
Frontline treatments for depression and anxiety have slow onset (4-12 weeks) [5]
Psychiatry approvals since 2015
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Only 7 new drugs approved by the FDA for psychiatry disorders since 2015 – less than 10% relative to oncology (N=83) [6]
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Ritchie, “Global mental health: five key insights which emerge from the data”, Our World In Data (2018) 2. Patel et al., “The Lancet Commission on global mental health and sustainable development”, The Lancet (2018). 3. OECD, Tackling the Mental Health Impact of the COVID-19 Crisis: An Integrated, Whole-of-Society Response, OECD 2021
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Salzer, “National Estimates of Recovery-Remission From Serious Mental Illness”, Psychiatry Online (2018) 5. Tew et al., “Impact of prior treatment exposure on response to antidepressant treatment in late life” Am J Geriatr Psychiatry (2006)
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EvaluatePharma (as of 19.03.2021). New drugs include new molecular entities or new active ingredients.
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Emyria’s leading treatment programs
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Emyria's unique treatment discovery & development engines
| Emyria’s curr | ent drug development Proprietary assets |
programs: Proprietary insights |
Proprietary delivery platform |
Proprietary programs |
Target clinical indication |
Stage of development |
| Cannabinoid- based treatments |
Real-world dataon 4,500+ patients receiving cannabinoid-based treatments for 40+ clinical indications |
What dose works for what indication. Dose-response insights support “methods of use” patents. |
Novel, FDA-compliant, highly purifed formulation of synthetic cannabinoids [3] |
EMD-003 [4] | Symptoms of psychological distress |
Preparing for registration trials |
| EMD-004 [5] | Irritable Bowel Syndrome (IBS) and symptoms |
Gathering real-world data |
||||
| EMD-00X (future programs) |
In development | Continuous analysis | ||||
| MDMA-based treatments |
Exclusive MDMA-analogue compound library developed over 10 yrs [1] |
Neurological receptor activity for unique chemical structures |
Novel MDMA-analogues |
EMDMA-00X (future programs |
Mental health and neurological disorders |
Screening program and multi-patent fling strategy underway |
| MDMA- assisted therapy |
Psychedelic-assisted therapy model delivered with partners [2] |
Expanding patient access to MDMA therapy |
MDMA-assisted psychotherapy |
EMDMA-001 [6] | Post-Traumatic Stress Disorder (PTSD) |
Preparing Phase II clinical trials |
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- ASX Announcement 15 June 2021 6. ASX Announcement 05 May 2021
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- ASX Announcement 05 August 2021 3. ASX Announcement 13 August 2021 2. ASX Announcement 19 November 2020 4. ASX Announcement 05 January 2021
Emyria’s cannabinoid pipeline
A novel cannabinoid delivery platform suitable for TGA and FDA registration
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Cannabinoids
Emyria’s cannabinoid product pipeline
| Drug program |
Target indication | Treatment platform |
Delivery |
|---|---|---|---|
| EMD-003 | Psychological distress |
Synthetic cannabidiol (CBD) |
Liquid-flled hard capsule |
| EMD-004 | Irritable bowel syndrome |
Synthetic cannabinoids (CBD +/- THC) |
In development |
| EMD-00X | Next indications are in development. Emyria has dose-response insights for cannabinoids across more than 40 clinical indications |
Synthetic cannabinoids targeting additional FDA and TGA registration |
In development |
Discovery Pre-clinical Phase 1 Phase 2 Phase 3
EMD-004 Phase 1 trial to run in-parallel with EMD-003 registration program.
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Key
Current status
Next 12 months
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Cannabinoids
Emyria’s cannabinoid patent portfolio
| Title | Ofcial No. | Status | |
|---|---|---|---|
| Emyria’s cannabinoid patents cover unique formulations, delivery approaches and “method of use” |
Use of Cannabidiol for the Treatment of Psychological Distress | 2020904152 | Provisional fled |
| Use Of Cannabidiol for the Treatment of Psychological Distress | 2021901086 | Provisional fled | |
| Use Of Cannabidiol for the Treatment of Irritable Bowel Syndrome-Related Psychological Distress | 2021901672 | Provisional fled | |
| Use Of Cannabinoid Combination for the Treatment of Irritable Bowel Syndrome-Related Psychological Distress |
2021901674 | Provisional fled | |
| Cannabidiol Dosing Regime | 2021902001 | Provisional fled | |
| Others in development covering unique delivery platforms, dose responses and clinical indications | Multiple provisionals expected 2021 |
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Cannabinoids
Emyria’s advantages in cannabinoid treatment development
ADVANTAGE 1: One of the world’s largest Real-World Data assets
At Emerald Clinics, Emyria has gathered clinical-trial grade, real-world data on over 4,500 patients providing unique insights, and IP, into what treatments work best and in whom.
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ADVANTAGE 2: A unique cannabinoid delivery technology
With partner Altasciences, Emyria is developing a novel, FDA-compliant, ultra pure, cannabinoid delivery platform in patient-preferred forms.
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ADVANTAGE 3: Experienced team to accelerate registration process
Our in-house team of clinical trial and drug registration experts have overseen multiple, successful FDA registrations.
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Cannabinoids
1. Emyria’s cannabinoid Real-World Data (RWD)
Our proprietary, robust and ethically-sourced clinical data covers dose-response insights across a diverse set of more than 4,500
patients, including clinical indications and treatment programs. We analyse for insights and IP which de-risks
our unique drug development programs
2 - 98 years 56% age range of patients female patients
44 Unique primary indication s
54% 7.12 53% Patients presenting with Average concomitant Patients presenting with symptoms of moderate to severe medications per patient at initial symptoms of depression anxiety visit
0-600 mg 0-197 mg Range of CBD prescribed doses Range of THC prescribed doses 35% are carefully titrated for each are carefully titrated for each Patients experiencing an adverse patient which gives Emyria unique patient which gives Emyria event dose response insights unique dose response insights
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Data summary as of 01 DEC 2020
Cannabinoids
2. 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 Botanical alternatives Safety Synthetic CBD has been shown to have equivalent physiological effects to plant derived options [1] Botanical CBD can have high Synthetically manufactured batch-to-batch variability Reliability cannabinoids ensure tight (see TGA audit results batch-to-batch consistency https://www.tga.gov.au/testing-medicinalcannabis-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 Far more cost effective over Currently expensive Cost long-term ($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
Cannabinoids
3. Emyria’s accelerated registration strategy
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✔ ✔ ✔ ✔ ✔ ✔ Real-world IP on “method Streamlined Protocols Regulatory Experienced data on safety of use” access to developed strategy drug & efficacy at patients & development target dose clinical trial team infrastructure
-
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Longitudinal clinical Unique insights data on over 4,500 support a strong and patients and growing growing patent
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- Each target indication portfolio -
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already has 1,000’s of Emyria’s patents cover prescriptions at target dose ranges for target dose strengths indications
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We operate 7 clinical - Patient inclusion - Emyria partnered with - Emyria’s team has sites in Australia criteria and trial experienced overseen over 100
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- All GPs are endpoints developed regulatory consultant clinical trials and 25 GCP-trained using Emyria’s data with prior registration drug approvals
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- Clinical trial-grade and in-house clinical successes data capture platform trial team in place
Drug ✔ ✔ ✔ ✔ delivery Unique dose Large scale, GMP Low cost of Synthetic API platform form and manufacturing goods also suitable for formulation FDA and other major regulators
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How drug registration
creates value
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There are 190 unregistered cannabinoids in Australia¹...
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$100m
Total Australian sales in 2020
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- https://freshleafanalytics.com.au/wp-content/uploads/2021/03/FreshLeaf-Analytics-H1-2021.pdf
...and only 1 registered product (Epidyolex by GW Pharma)
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$686m
Total Global sales in 2020²
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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- https://www.globenewswire.com/news-release/2021/02/16/2175953/0/en/GW-Pharmaceuticals-plc-Reports-Fourth-Quarter-and-Year-End-2020-Financial-Results-and-Operational-Progress.html
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Special Access Scheme vs Routine Prescription
Count of Special Access Scheme applications for unregistered cannabinoids , for all indications , in 12 months
80,417
(Only 0.28% of antidepressant prescription count shown to scale on the right)
29,112,803
Count of routine prescriptions , for registered antidepressants only, in 12 months
Registered treatments have a far greater ability to reach patients and attract reimbursement
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Sources:
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https://freshleafanalytics.com.au/wp-content/uploads/2021/03/FreshLeaf-Analytics-H1-2021 https://www.pbs.gov.au/info/browse/statistics (data from 01 Jul 2018 to 30 Jun 2019
EMD-003/004
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EMD-003: over-the-counter medicine for psychological distress
On November 2020 the TGA allowed low-dose CBD to be registered as an “over-the-counter”, pharmacist-only, Schedule 3 (S3) medicine. [1]
Registered S3 treatments do not require a doctor’s prescription. The OTC market in Australia is estimated at over $20B/year [2]
Analysis of Emyria’s clinical data showed an improvement in the symptoms of psychological distress for a specific group of patients (see chart). Emyria filed multiple ‘methods of use’ patents to cover use of low-dose CBD across a range of appropriate indications. Emyria’s EMD-003 drug registration program is guided by these insights.
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Up to 15% of Australian adults experience high or very high levels of psychological distress [1]
At August 2021 alone, Emyria has treated psychological distress symptoms in more than 400 patients with low-dose CBD for > 6 months.
- See ASX announcement 16 December 2021
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-
https://insights10.com/product/australia-otc-market-analysis/
-
Australian Institute of Health and Welfare 2018. Australia’s health 2018. Australia’s health series no. 16. AUS 221. Canberra: AIHW.
29
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EMD-003: Registration trial approach
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Phase 1 - Bioavailability
Randomised Controlled Crossover Bioavailability Trial
Phase 3 - Efficacy and Safety
Randomised Placebo Controlled Double Blind Trial EMD-003: n = 110 | Placebo: n = 110
Patients with Pain & Stress Study time/patient ~ 8 wks Total study time = 4-5 mths
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All studies designed to aid in submissions to TGA (Australia) and FDA (USA)
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EMD-004: targeting irritable bowel syndrome
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Analysis of Emyria’s RWD has revealed an improvement in symptoms related to Irritable Bowel Syndrome ( IBS ) for a specific group of patients.
In order, to evaluate this benefit more thoroughly, Emyria’ initiated a stand-alone, ethics-approved clinical trial ( CALM-GUT ) to increase the count of patients and expand the clinical evaluations and data collected on this group of patients.
IBS affects around 11% of the population globally and there is currently no approved medication [1]
Emyria has since filed multiple ‘methods of use’ patents to cover combination cannabinoid treatments for symptoms related to IBS and launched, EMD-004 , a drug registration program guided by these insights.
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31
- Canavan, C., West, J., & Card, T. (2014). The epidemiology of irritable bowel syndrome. Clinical epidemiology, 6, 71–80. https://doi.org/10.2147/CLEP.S40245
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Cannabinoid development milestones
Optimise dose form Commence and complete Prepare product Obtain Commercialisation
pivotal registration clinical dossier and submit to Schedule 3 & sales
trials TGA for registration registration
Complete full product dossier
Pivotal First commercial sales as
Confirm trial site partners to support and clinical evidence package for
registration trial over-the-counter,
Emyria’s existing site network evaluation by TGA. Expected ~2
commences Schedule 3 medicine
months from trial completion.
Clinical Entry on Australian
Formulation Initial Obtain Phase 1 IND with FDA (for TGA evaluation
trial Register of Therapeutic
optimisation bioanalytical material ethics trial (in US registration (takes 6-8 months Goods (ARTG) as a
complete results available approval parallel) program) from submission) Schedule 3 medicine
Sep Oct Nov Dec Q1 Q2 Q3 Q4
2021 2022
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Emyria’s MDMA programs
33
MDMA
Emyria’s MDMA-based treatment development pipeline
| Psychotherapy program |
Psychotherapy program |
Indication | Indication | Treatment Platform + Delivery |
Treatment Platform + Delivery |
Discovery | Discovery | Pre-clinical | Phase | 1 | Phase 2 | Phase 3 | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Post | |||||||||||||||
| EMDMA-001 | traumatic stress |
MDMA-assisted psychotherapy with trained therapists |
|||||||||||||
| disorder | |||||||||||||||
| Drug development program |
Indication | Treatment Platform + Delivery |
Screening & Expansion |
Validation studies |
Pre-clinical | ||||||||||
| EMDMA-00X-PSY | Major mental health disorders |
Novel MDMA-analogue psychedelics to support psychotherapy for major mental health disorders |
|||||||||||||
| Key | |||||||||||||||
| EMDMA-00X-NEU | Major neurological |
Novel MDMA-analogues as unique prescription treatments for |
Current status | ||||||||||||
| disorders | neurological disorders | Next 12 months | |||||||||||||
| 34 |
MDMA
The market opportunity for psychedelic-assisted psychotherapy
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$
$100b 264m $10.2b (AUD)
Estimated market for Number of people who suffer Aggregate market cap of
psychedelic medicines depression globally psychedelic drug companies
2 in 3 1 in 4
Veterans suffer from PTSD People in the world are affected
by mental health disorders
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Emyria can leverage an established clinical site and provider network, an experienced in-house drug development team and also has access to unique treatment assets
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35
MDMA
Psychedelic competitive landscape (top 15 by market cap)
| 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 |
| CBDT:CNX | Empower Clinics Inc. | $182,037,779 | Launched subsidiary to focus on psilocybin research for mental health treatments |
| MYCO:AQL | MYDECINE INNOVATIONS GROUP INC. | $161,289,955 | Psilocybin and entactogenic compounds for PTSD, anxiety, substance abuse |
| COPHF | Creso Pharma Limited | $135,690,356 | Developing synthetic psilocybin for treatment resistant depression |
| ALID | Allied Corp | $127,048,628 | Psilocybin and cannabis for depression and anxiety |
| TRIP:CNX | Red Light Holland Corp. | $123,501,731 | Microdose psilocybin |
| RVV:CNX | Revive Therapeutics Ltd | $107,394,777 | Psilocybin and cannabidiol for multiple indications |
| EMD:ASX | Emyria Limited | $44,466,075 | Commencing phase IIb MDMA-assisted therapy trial for PTSD, Developing range of novel MDMA-analogues from library of >100 compounds, real-world data generation |
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36
Source: https://psychedelicinvest.com/index/(accessed August 22nd)
MDMA
MDMA-assisted therapy (EMDMA-001)
37
MDMA
Developing a scalable MDMA-assisted therapy program
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is a leading charity that spurred the TGA to consider descheduling MDMA and psilocybin.
An independent panel of experts is due to provide the TGA with a recommendation on September 30th, 2021.
Mind Medicine Australia is also providing the first Certificate in Psychedelic-Assisted Therapy (CPAT ) to clinicians in Australia.
Emyria has partnered with Mind Medicine Australia [1] and their trained therapists, to deliver scalable, evidence-based psychedelic assisted therapy for sufferers of severe Post Traumatic Stress Disorder (PTSD)
PTSD is a massive contributor to the global burden of disease, affecting almost 4% of the world’s population [2].
A recent study by the Multidisciplinary Association for Psychedelic Studies (MAPS) found that 67% of participants with severe PTSD no longer met diagnostic criteria for PTSD following three sessions of MDMA-assisted psychotherapy, and 33% met the criteria for remission [3]
Emyria’s expertise in complex patients, focus on mental health and evidence-generating care model is uniquely placed to lead this emerging new field of healthcare.
- ASX Announcement 19 November 2020
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-
Koenen KC, Ratanatharathorn A, Ng L, McLaughlin KA, Bromet EJ, Stein DJ, et al. Posttraumatic stress disorder in the World Mental Health Surveys. Psychological medicine. 2017;47(13):2260–74. Epub 2017/04/08. pmid:28385165; PubMed Central PMCID: PMC6034513.
-
Mitchell, J.M., Bogenschutz, M., Lilienstein, A. et al. MDMA-assisted therapy for severe PTSD: a randomized, double-blind, placebo-controlled phase 3 study. Nat Med 27, 1025–1033 (2021). https://doi.org/10.1038/s41591-021-01336-3
38
MDMA
EMDMA-001: a Phase IIa Clinical Trial for PTSD
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Open-label interventional study
Proof of Concept for n= 12
Drug treatment + non-drug psychotherapy
Screening Preparation Follow-Up
Cycle 1 Cycle 2 Cycle 3
Duration = 18 months
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EMDMA-001 will follow a similar design to the promising Phase III trials concluded in the US but with a broader inclusion criteria to evaluate the potential to extend MDMA-assisted therapy to additional patient populations.
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The study will be led by consultant psychiatrist Dr Eli Kotler (left), and will be run out of the Victorian Counselling and Psychology Services in Melbourne (below)
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39
MDMA
Emyria poised to lead psychedelic-assisted therapy in Australia
1st CPAT-trained MMA submits EMD to application to therapists graduate submit Psychedelic treatments TGA to have Phase 2a to MDMA trial to downgraded EMD forms MMA runs inaugural EMD appoints Dr ethics commence from S9 to S8 partnership Certificate in Eli Kotler, PI for committee in Australia with MMA [1] Psychedelic-Assisted EMDMA-001 [2] Therapies (CPAT) course 2020 2021 Jul Aug Sep Oct Nov Dec Jan Feb Mar Apr May Jun Jul Aug Sep Oct Nov Dec
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TGA TGA announces assembles interim Independent MAPS publish decision not Expert Panel results of to down- Review to pivotal Phase Schedule review interim 3 MDMA MDMA decision study
TGA to TGA to publish announce Independent final Panel’s rescheduling Report decision
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40
- ASX Announcement 19 November 2021 2. ASX Announcement 29 June 2021
MDMA
Novel MDMA analogue development
41
MDMA
Emyria’s MDMA-analogues - a novel drug discovery pipeline
| Emyria’s MDMA-analogues | Emyria’s MDMA-analogues | ||
|---|---|---|---|
| Scope | >10 years in development, portfolio of >100 | ||
| MDM-analogues | |||
| (1) In-house expertise and partners to | conduct | ||
| Accelerated | target-to-hit and hit-to-lead screening via | ||
| exemplifcation | neuro-receptor analysis and validation studies | ||
| and patent | |||
| strategy | (2) Lead compound selection informed | by clinical, | |
| pharmacological and medicinal chemistry experts | |||
| (3) Multiple patent families fled to protect all | |||
| distinct, drug classes identifed | |||
In partnership with
42
MDMA
Compound screening and expansion program
Commence Expand library via Select most promising neuroreceptor novel compound compounds for further screening synthesis program pre-clinical validation
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Engage Initial Select lead
Expansion
screening results & compounds for
of library
provider analysis further validations
File multiple
patent Expand Dose optimisation
families team & preclinical trials
Sep Oct Nov Dec Q1 Q2 Q3 Q4
2021 2022
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Dr Matthew Piggott (above) has spent the past 10 years developing MDMA analogues for Parkinson’s and other neurological diseases
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Dr Mathew Martin-Iverson (above), is the Head of Psychopharmacology at UWA, and has over 35 years of experience studying amphetamines and other psychostimulants
43
- ASX Announcement 05 August 2021 2. ASX Announcement 20 August 2021
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3
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Emyria’s upcoming milestones
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Upcoming milestones
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-
Q3 2021
-
● Optimise synthetic cannabinoid dose form
-
Additional formulation development for new indications
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Q4 Q1
2021 2022
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-
Review of bioavailability and toxicology data
-
● New indications generated for FDA registration programs
-
● Ethics approval for Phase I and EMD-003 pivotal clinical trials
-
Commence pivotal clinical trials for EMD-003
-
Complete Phase 1 trials for synthetic platform
-
Prepare for FDA registration
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-
Commence MDMA analogue screening program with UWA
-
● File multiple MDMA-analogue patent families
-
● Independent report on MDMA de-registration provided to TGA (Sep 30)
-
Validation studies on highest priority novel MDMA-analogues
-
● Phase IIb MDMA-assisted psychotherapy trials for PTSD
-
● Final TGA decision expected on MDMA de-registration
-
Commence expansion of MDMA-analogue library
-
Conduct preclinical validation studies and dose optimisation on highest priority MDMA compounds
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Contact Information:
Michael Winlo: [email protected]
Investors: [email protected]
Media: [email protected]
General: [email protected]
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