Medlab Clinical Ltd (ASX.MDC) AGM 2020

16th October 2020, Hall Chadwick, 40/2 Park St, Sydney NSW 2000

Medlab Clinical Ltd (ASX.MDC)

AGM 2020

DISCLAIMER

This presentation has been prepared by Medlab Clinical Limited ABN 51 169 149 071 ("Company"). It does not purport to contain all the information that a prospective investor may require in connection with any potential investment in the Company. You should not treat the contents of this presentation, or any information provided in connection with it, as financial advice, financial product advice or advice relating to legal, taxation or investment matters.

No representation or warranty (whether express or implied) is made by the Company or any of its officers, advisers, agents or employees as to the accuracy, completeness or reasonableness of the information, statements, opinions or matters (express or implied) arising out of, contained in or derived from this presentation or provided in connection with it, or any omission from this presentation, nor as to the attainability of any estimates, forecasts or projections set out in this presentation.

This presentation is provided expressly on the basis that you will carry out your own independent inquiries into the matters contained in the presentation and make your own independent decisions about the affairs, financial position or prospects of the Company. The Company reserves the right to update, amend or supplement the information at any time in its absolute discretion (without incurring any obligation to do so).

Neither the Company, nor their respective related bodies corporate, officers, their advisers, agents and employees accept any responsibility or liability to you or to any other person or entity arising out of this presentation including pursuant to the general law (whether for negligence, under statute or otherwise), or under the Australian Securities and Investments Commission

Act 2001, Corporations Act 2001, Competition and Consumer Act 2010 or any corresponding provision of any Australian state or territory legislation (or the law of any similar legislation in any other jurisdiction), or similar provision under any applicable law. Any such responsibility or liability is, to the maximum extent permitted by law, expressly disclaimed and excluded.

Nothing in this material should be construed as either an offer to sell or a solicitation of an offer to buy or sell securities. It does not include all available information and should not be used in isolation as a basis to invest in the Company.

This presentation contains reference to certain intentions, expectations, future plans, strategy and prospects of the Company. Those intentions, expectations, future plans, strategy and prospects may or may not be achieved. They are based on certain assumptions, which may not be met or on which views may differ and may be affected by known and unknown risks. The performance and operations of the Company may be influenced by a number of factors, many of which are outside the control of the Company. No representation or warranty, express or implied, is made by the Company, or any of their respective directors, officers, employees, advisers or agents that any intentions, expectations or plans will be achieved either totally or partially or that any particular rate of return will be achieved. Given the risks and uncertainties that may cause the Company actual future results, performance or achievements to be materially different from those expected, planned or intended, recipients should not place undue reliance on these intentions, expectations, future plans, strategy and prospects. The Company does not warrant or represent that the actual results, performance or achievements will be as expected, planned or intended.

P.22020 AGM Presentation

MEDLAB CLINICAL

Medlab Clinical Ltd (ASX: MDC) is dedicated to finding new ways to address the biggest challenges of our time including the growing burden of cancer, suboptimal pain management, as well as enhancing drug delivery with nanotechnology.

Medlab’s strategic focus is on drug development, leading with its cannabinoid profile.

With a goal to be one of the first companies globally with an FDA approved cannabinoid treatment, Medlab is pursuing an opportunity with significant global commercial potential.

Scientifically optimised for a better life


P.4

Progressing science to formulate viable medicines and technologies for human health and beyond.

Pharmaceutical portfolio specialising in oncology

NanoCelle® - proprietary delivery platform

26 nutraceutical products - gut-centric VMS approach

NanaBis™ successful Phase I/II study in cancer pain. Preparing to initiate Phase III and seek FDA clearance

Market ready and patented with potential applications for generics, small molecules and in the near future, other areas of medical care

Continued expansion – via banner pharmacies, global partners and enhanced digital sales and marketing

2020 AGM Presentation

OUR BUSINESS MODEL

FY2020 - A PIVOTAL YEAR

This year saw Medlab accelerate our drug development business and pursue partnerships – leading with our cannabinoid portfolio

First NanoCBD™ export order received for 1,500 units to Hong Kong

UK distribution agreement for nutraceuticals

Record sales achieved with NanaBis™ and NanaBidial™ in October 2019

NanaBis™ Phase I/II study completed, with primary and secondary endpoints met

NanaBis™ Obs Study formally launched, with cases noting early reduction in pain

TASALK agreement signed to manufacture NanaBis™

First patient supplied with NanoCBD™ in Australia under SAS

New cannabinoid product, MgOptima™ + CBD, manufactured for export to UK

120 patient depression trial for NRGBiotic™ completed

Australian patent granted for NanoCelle®

(Q1 FY21)

CRO signed for NanaBis™ Phase III trial (Q1 FY21)

New York BD team currently focused on US NanaBis™ deals

Q1

Q2

Q3

Q4

Successful completion of NanaBidial™ Phase I trial

Heads of Agreement executed to expand nutraceuticals into USA


GROWTH STRATEGY

GO

AL F

OR

DR

UG

R

EG

IST

RA

TIO

N

$5.28B Global market opportunity (2017)

CAGR 4.5%, estimated to be $7.54B (2025)

Cancer Bone Pain

$1.22B Global market (2019) with CAGR of 5.4%

Cancer Bone Pain (primarily in Breast, Prostate and Lung) impacts approx. 700,000 new patients (annually) in US, AU and Canada

IMMEDIATE REGULATORY TARGET

Cancer Pain

FUTURE TARGETS

$69.3B Global market opportunity (2017)

CAGR 6.4%, estimated to be $151.7B (2030)

Chronic Pain

As cancer survival rates increase, so does the need for better approaches to address long-term pain often experienced by cancer patients. There is a market for viable alternatives that can delay or alleviate the need to use opioids for pain management.


NANABIS™ VALUE CREATION

NANABIS™ NEXT MAJOR STEPS

Our strategy is to expand the market opportunity and leadership position with regulatory approved, medical cannabis products that have been optimised for better outcomes and backed by clinical data.

US FDA IND

Phase III trial initiation:

Phase III Completion

US FDA Drug Filing

• US DEA Approval • UK MHRA / Home Office Approval • Clinical sites contracted • NanaBis™ to US & UK > first patient in,

study sites underway• Obs study quarterly progress report

• Enrolment complete• Phase III interim readout• Obs study quarterly progress

reports

• Phase III Final Report • Phase III peer review publications• Obs study completion • New Drug Application filing

2020

2021

2022

2023

• US IND Filing expected• Peer-review publication of Phase

I/II trial• Obs study consistent with clinical

trials outcomes• In market sales growth• Logistics signed in US & UK

P.8

GO

AL FO

R D

RU

G

RE

GIS

TRA

TION


PARTNERING WITH NANOCELLE®

Current Application opportunities Generics• Shown to lower dosage and reduce side effects in

generic pharmaceuticals including statins, insulin, steroids, ACEi's and antibiotics

New Chemical Entity (NCE)• New medicines in need of better delivery

Significant partnership opportunities for NanoCelle® across pharmaceuticals, food technology, consumables and other industries

Ingredients to date• Cannabinoids• Antihistamines• Ascorbate• CoQ10• Curcumin• Insulin• Steroids• ACE inhibitors• Antibiotics• Immunosuppressive

agentsP.92020 AGM Presentation

INVESTOR ENGAGEMENT IN US AND EUROPE


Show investors that Medlab is a trusted, fast-moving biotechnology company with a global market opportunity

Our progress through R&D milestones and patented innovations validates the quality and safety of our products and sets us apart as a world class offering.

• This year we are creating more opportunities to continue to validate Medlab’s commercial pathway and differentiate as market leaders

• Highlighting Medlab’s roadmap and ability to deliver on milestones, focusing on activities that will lead to improved liquidity and share price appreciation

• Showcasing real-life case studies of how Medlab’s products improve quality of life

• Demonstrating the potential blue-sky value of the NanoCelle® platform

Dr Sean HallMD, MBA (Clin Pharm Mgt) CEO & Managing Director

Michael HallB.Com, CPA Non-Executive Chairperson

Drew TownsendB.Com, CA, MAICD, Non-Executive Director

Laurence McAllisterNon-Executive Director

P.11

EXPANSION OF BOARD OF DIRECTORS

• Appointment of McPhersons (ASX: MCP) CEO Laurence McAllister as Non-Executive Director on 5 August 2020

• First director appointment since Medlab’s IPO in 2015

• Mr McAllister is a healthcare, consumer and retail leader, previously Managing Director of Sanofi in Australia and New Zealand, director of Medicines Australia

• 23 years’ experience in management positions at Coca-Cola, President of Trax Retail

• Additional director appointments planned in FY2021

Medlab is committed to adding to the world class expertise of its Board of Directors in-line with our global growth strategy


Drive value from NanoCelle® through partnershipsWithin pharmaceutical industry and other industries

NEXT MAJOR STEPS

Progress NanaBis™development

Further expand cannabinoid portfolio

Increase body of real-world evidence

🗸 🗸 🗸 🗸

Targeting FDA approval – a potential company-making event


Planned clinical trials for NanoCBD™, targeting possible filing for OTC in Australia

Through compassionate use sales

Assess strategic VMS opportunitiesWithin pharmaceutical industry and other industries

Clear opportunity for growth through clinical validation and partnering

🗸

OPERATIONS REVIEW

FY2020 FINANCIAL SUMMARY

Sales under SAS increasing, improved cash management, well-capitalised to accelerate clinical and commercial activities

• Growth in sales for products dispensed under compassionate use; SAS revenue 199% up YoY

• Increase in R&D investment in FY2020 including NanoCelle®

development, progression of cannabinoid portfolio and completion of NRGBiotic™ study

• Focus on cash management, with 34% YoY improvement in quarterly operating cash burn (Q4 FY20 vs Q4 FY19) after gov’t subsidies

• FY20 net loss after tax of $13.4M, in-line with acceleration of research programmes

• Receipt of FY2020 R&D tax refund of $2.4M in October 2020

$9.06M $1.98M$5.81M

$13.47M

Cash position at 30 June

2020

Q4 cash burn(after gov’t subsidies)

FY2020 revenue

IMPROVED CASH BURN


FAST SALES ADAPTATION IN COVID-19 ENVIRONMENT


• COVID-19 posed some disruption to various parts of the business, including bricks and mortar sales and short term manufacturing

• Medlab was nimble and ready to adapt to challenges, launching digital clinic and telehealth initiatives in-line with changing consumer behaviour

• Rationalisation of the nutraceutical business continued in Q1 FY21; Medlab is evaluating a number of options regarding the strategic direction of the nutraceutical business

• Retail (YoY): > 100% growth via Terry White Chemmart and approx. 25% via Priceline

• At W/S (YoY): > 100% growth via Symbion

PHARMA SALES ACCELERATING UNDER SPECIAL ACCESS SCHEME

Product sold under Special Access Scheme providing a strong proof of concept and early revenue


0

2,000

4,000

6,000

8,000

10,000

12,000

Apr-19

May-19

Jun-19

Jul-19

Aug-19

Sep-19

Oct-19

Nov-19

Dec-19

Jan-20

Feb-20

Mar-20

Apr-20

May-20

Jun-20

Jul-20

Aug-20

Sep-20

Accumulative Units

Over 10,000 units

NANABIS™PROGRAM

NANABIS™ - OUR LEAD DRUG CANDIDATE

• 1 to 1 ratio THC and CBD in nanoparticles

• High bioavailability, smaller doses and fast absorption into the bloodstream enhances performance and efficacy

• Trial programs showing improvement in pain scores:

• Robust completion of Phase I/II study with primary and secondary endpoints met, demonstrating safety, tolerability and efficacy

• Observational NanaBis™ study designed to gather real-world evidence continues; 604 of 2000 patients recruited, with 59% improvement in pain scores (as at last audit)

• Demand via Special Access Scheme continues to grow, establishing proof of concept and generating early revenue

• Supply and manufacturing agreement with TASALK signed, ramping up compliant manufacturing and increasing overall product quality

*40% improvement in pain scores recorded in Phase I/II study

Scientifically optimised to perform better


40% IMPROVEMENT

IN PAIN SCORES*

SAFE, TOLERABLE

& EFFICACIOUS

REDUCTION IN OPIOID DOSAGE

PATENTED

A NON-OPIOID ANALGESIC TO TREAT BONE PAIN

• Opioids or opioid derivatives remain the main method of treatment for cancer-related pain

• Despite the known side-effects of opioids, there’s been little advancement in the management of cancer pain

• Extended patient life increases the burden of pain

• Abuse and toxicity profiles underpin a need for opioid alternatives

• Each year in the US, more than 2M people abuse opioids. In 2016, an estimated 197,970 US hospital visits occurred for opioid-related poisonings

Up to 75% of patients with bone metastasis endure crippling bone pain…

NanaBis™ provides a fast-acting and viable alternative

to opioids, improving pain management

and quality of life

Despite known problems,

opioids are still the gold

standard for pain treatment

P.19

WHY IS NANABIS™

IMPORTANT?

PAIN SCALE

10

5

0

EMA STEPWISEPAIN GUIDELINES

Mixed Opioids & Adjuvants

Low Dose Opioids& Adjuvants

NSAIDs & Other Non-Opioid Medications

NanaBisTM

Therapeutic Entry Point

• NanaBis™ provides a viable alternative that can delay or alleviate the need to use opioids for pain management

• Effective and safe at the lower end of the pain scale – and used before progression to opioids

• Efficacious in patients with “unmanageable pain” that is not being controlled by opioids and other pain medication

64% of all bone cancer patients are currently not helped by existing pain therapy


“Taking cannabis oil to manage the side effects of the cancer has been very successful. I have regained the 20kg I lost, regained my appetite and I no longer have issues with sleep”

- SAS NanaBis™ Patient

NANOCELLE®

NanoCelle® offers a solution

• NanoCelle® is our unique drug delivery platform enabling faster and more effective absorption into the bloodstream, without needles or pills

• Convenient oral spray for faster, more effective drug absorption

• Overcomes drug solubility issues

• Cost effective, commercially viable production

Medlab is pursuing global partnership opportunities for NanoCelle® in drug development and other areas

A game-changer for human health and beyond

NANOCELLE®


Patented technologyAustralian patent granted September 2020, providing protection until March 2036.Patent applications filed in US, EU, SG, HK, Canada


In multiple studies, NanoCelle® has demonstrated efficacy at a fraction of the dose of its tablet or liquid counterparts.

This means patients don’t need to take as much medicine and are at lower risk of side effects or drug-on-drug interactions.

Over 100,000 units dispensed

to patients

60% marketed drugs are via

oral gastrointestinal administration

NanoCelle® creates nano-sized water-soluble particles that carry a medicine or active ingredient. NanoCelle® is optimised for buccal delivery, bypassing the gut for faster absorption and metabolism

NANOTECHNOLOGY CAN PROGRESS MEDICINES

NANOCBD™

• NanoCBD™ is a highly refined cannabidiol (CBD) product

• Unlike other CBD preparations, NanoCBD™ does not contain ethanol. Commonly used CBD contains ~25% of ethanol, which can have significant local and systemic effects

• Differentiated by our NanoCelle® delivery platform, manufactured in FDA approved, GMP-certified drug facility, validated by research and trials-backed approach

• Initial order of 1,500 units exported to Hong Kong

Submicron spray

utilising NanoCelle®

delivery platform Trial

program in development

for near future TGA application

(S3)

Manufactured to a drug

standard in US, in FDA-

approved, GMP certified facility

NANOCBD™ – REFINED CBD, WITH NO THC

Opportunity to enter markets where CBD from hemp has been legalised

P.26

Sales underway under SAS and via export

agreement

NANOCBD™ VALUE CREATION

P.27

• TGA has down-scheduled CBD only products to Schedule 3, for over-the-counter sales

• Sales of NanoCBD™ have commenced under SAS in Australia; first patient supplied in June 2020

• Highly purified, standardised, strong CMC, GMP manufacturing –transferable from NanaBis™

• Robust clinical trials in planning, with aim to achieve regulatory approvals and drug registration


Targeting existing global markets and OTC use in Australia

Two clinical trials are in design phase

🗸 🗸 🗸Ability to surrogate CMC data

from NanaBis™

Progress and path to market

Clinical progress delivered for NRGBiotic™, a probiotic formula combined with Coenzyme Q10 and Magnesium Orotate

Established digital and telehealth platforms to increase remote access to ensure COVID-19 readiness. Deals executed to expand nutraceutical range to US, UK, India and overseas.

NUTRACEUTICAL BUSINESS – FY2020 HIGHLIGHTS

Adaptive, nimble strategy to ensure COVID-19 readiness, focus on driving digital and telehealth sales alongside distribution into pharmacies via Symbion, API, Sigma

Commercial deals include American Nutritional Corp in the US, FeverMates and Cultech Pty Ltd.

Development of new CBD and nutraceutical product, MgOptima™ and CBD (export only)

Clinical Partnering

FY20 Sales up 39% in invoiced sales YoY up until end Q3, softer final quarter due to COVID-19’s impact to bricks and mortar retail

September quarter FY21 performance indicating sales improvement and recovery

Sales

Driving revenue for growth


Data from Phase 2A trial will strengthen initial findings of Phase I trials, showing NRGBiotic™ delivers significant improvement in combination with an antidepressant.

P.30

• 120 patient trial completed in April 2020, investigating NRGBiotic™

• As an adjuvant to an SSRI and SNRI for people diagnosed with depression

• Trial closed and completed at Queensland University of Technology (QUT); now awaiting results

• Pathology and independent review has now resumed following COVID-19 restrictions in Queensland

Patented formulation addressing a $864M USD global market

for adjunct depression

treatment, expected to reach $1.2B by

2024

Next steps: continued listed

medicine sales via pharmacy, trial

readout, product optimisation, TGA

consultant


NRGBIOTIC™ DEPRESSION TRIAL COMPLETED

• Lead candidate NanaBis™ targeting a global market for cancer bone pain, Phase I/IIa primary and secondary endpoints met, now advancing toward Phase III study and Investigational New Drug (IND) filing

• NanaBis™ and NanoCBD™ generating proof of concept, prescribers and revenue under Australian Special Access Scheme

• US market a priority for NanaBis™ entry; New York business development team focused on US NanaBis™ deals

• Increasing strategic opportunities for NanoCBD™, with TGA in Australia down-scheduling CBD only products to schedule 3 for OTC sales

• Focus on partnering for NanoCelle® both in and out of drug delivery, with initial focus on Generics and NCE

• Improvement in normalised cash burn, well-capitalised to accelerate clinical and commercial activities

An opportunity with significant global commercial potential

INVESTMENT SUMMARY

P.312020 AGM Presentation46 Patents 80+ Publications 45 Conferences

CORPORATE

EXECUTIVE AND MANAGEMENT TEAM

Prof Luis VitettaBSc (Hons), PhD, MD, GradDipNutr/Environ Med, Grad Dip IntegMedDirector of Medical Research

Alan DworkinCA, ACSA, GAICD, Chief Financial Officer, Chief Operations Officer, Company Secretary

Ian CurtinsmithAssocDip Technology, GAICD, Chief Information Officer

Dr Patrick MillerDr. rer. nat (PhD), MSC, BSc, Director of Pharmacovigilance & Regulatory Affairs

Tony PotterBSc (Hons), Dip Management GM Pharma, Commercialisation & Education

Dr Jeremy HensonMBBS PhD BSc (Hons) Medical Affairs Director

Dr David Rutolo, Jr.,PhD, JD, Director of Science


Dr Sean HallMD, MBA (Clin Pharm Mgt) CEO & Managing Director

MEDICAL & SCIENTIFIC CONSULTING TEAM

Prof Stephen ClarkeMBBS MD PhD FRACP FAChPM FAAHMS

Ass Prof Wojciech ChrzanowskiMSc, PhD, DSc

Dr Andrew McLachlanBPharm (Hons1 Medal), PhD, FPS, FACP, McPA, MSHPA

Dr Mathew BamblingPhD

Dr Esben StrodlBS’s (Hons), MPsucjClin, PhD


CONSULTANTS AND COMMERCIAL PARTNERS

Margot RothwellCommercialisation and Business Consultant - MBA (Clin Pharm Mgt), Executive Director at BioAdvantagePty Ltd

Benjamin L. EnglandRegulatory Representation and Counsel - Founding Member/CEO Benjamin L England & Associates, LLC | FDAImports.com, LLC

ERA Consulting Group

Tasmanian AlkaloidsManufacture, biomass supply, analytical

Agliex Biolabs Pty LtdHuman Assay, pathology

Nitto Avecia Analytical


HEAD OFFICE

Medlab ClinicalUnits 5 & 6 11 Lord St, BotanyNSW 2019, Australia

P +61 2 8188 0311E [email protected] +61 411 603 378

CALIFORNIA OFFICE (USA)

Medlab Clinical US, Inc30021 TomasSuite 150 Rancho Santa Margarita, CA 92679, USA

P +1 949 636-4123

THANK YOU

QUESTIONS?

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Medlab Clinical Ltd (ASX.MDC) AGM 2020

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