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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

  • 4,000 patients and growing

  • Source of unique patents

  • • Unique dose response insights

  • Patients aged 2 - 96years

  • Over 40 clinical indications

  • TGA Class IIa data platform

  • 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*

  • only 1 product is registered & available via routine

  • prescription (Epidyolex - GW Pharma) and only for rare forms of epilepsy with an estimated prevalence of 1 in 20k-40k

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      • Source: https://www.tga.gov.au/australian register therapeutic goods

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

  • Vietnam Veteran | injured by fall in 1969 | multiple fractures

  • Chronic back pain | peripheral neuropathy from Agent Orange | PTSD

  • At initial visit: oxycontin | buprenorphine | pregabalin | gabapentin | PEA –

  • duloxetine with little relief and side effects.

  • • Now : Stable at 15mg 1:1 THC/CBD | ceased all opiates , pregabalin and PEA

Scores Initial assessment Visit 5
BPI Pain severity score 5.0 1.75
BPI Pain interference score 5.29 0.86
Visual analogue scale 5.0 1.0
Insomnia severity score 12.0 1.0
DASS 42 Depression 14 4
DASS 42 Anxiety 16 2
DASS 42 Stress 16 12

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  • Emyria’s care model works… + our data is validated Average opioid scores by oMEDD category (Pre vs Post Emyria)

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240
Prior care
216
Patients with 6+ months of cannabinoid usage
192
Si nificant
g
168 High . >90mg/day
30+%
reduction
144
The oral morphine equivalent daily dose
“oMEDD” cate ories are derived from
( ) g
120
the patient’s average oMEDD score 1-year
prior to first visit with Emyria.
96
72 Moderate 40-90mg/day
48
Low <40mg/day
24
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

  • Longitudinal clinical data on over 3,500 patients and growing

  • Over 400 prescriptions already written for target dose form

  • Unique insights support growing patent portfolio

  • Emyria patents cover indication and dose range

  • 7 locations in Australia

  • All GPs, GCP-trained

  • Already running a clinical-trial-grade data capture platform

  • Clinical outcomes trials developed using Emyria Data insights and expertise of team

  • 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

  • Phase 1 complete • Covers use of novel for target dose delivery technology

  • • > 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

  • [Experienced ] [pharmaceutical expert]

  • [Multiple Directorships][ with innovative ] pharmaceutical companies

  • •[Ex-] [Chief Medical Officer and Global Head of R&D ] at Jazz Pharmaceuticals

  • •[Overseen more than ] [100 clinical trials and 20 ] regulatory approvals

  • •[Appointment boosts Emyria’s global clinical trial ] and regulatory approval expertise to accelerate drug registration

  • •[Appointment to support innovation across Emyria’s ] drug development programs, clinical studies and evidence-generating care model

  • [Consultant][Psychiatrist][ and retired ] [Naval][Officer ]

  • •[Current ] [Director of Military Trauma Recovery ] Programme for sustained physical and psychological traumas

  • [active member of the ] [Australasian Military ] Medical Association (AMMA) and has developed lasting affiliations with ADF Joint Health Command (JHC), Returned Services League WA (RSLWA), St John Ambulance (SJA), West Australian Police (WAPOL), Department of Fire and Emergency Services (DFES), Australian Federal Police (AFP) and numerous other Ex-Service Organisations (ESOs)

  • •[Appointment boosts Emyria’s clinical expertise in ] mental health care

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Since listing, we have…

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  • Over 4,000 patients with unmet needs

  • 7 clinic locations Emerald Clinics

  • Specialist advisors & GCP-trained GPs

  • Over 500 referring clinicians

  • Over millions of validated data points

  • $1M+ of data deals inc. with Canopy Growth Corp

  • TGA Class IIa remote monitoring systems

  • Major WA Health grant award ($880k) for remote monitoring of vital signs and mental health

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  • Launched 3 drug registration programs :

  • • EMD-003 (schedule 3 medicine for psychological distress)

  • EMD-004 (cannabinoid for IBS)

  • • EMDMA-001 (MDMA for PTSD)

  • Multiple PhD-trained data analysts

  • Informing strategic trial design

  • Patents already filed

  • UK clinical partner - Sapphire Medical (London)

  • USA strategic partner - Mt Sinai (New York)

  • Partnership with Mind Medicine Australia to develop psychedelicassisted therapy model

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