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PROTEOMICS INTERNATIONAL LABORATORIES LTD AGM Information 2021

Nov 24, 2021

65565_rns_2021-11-24_a1c22ac4-2c46-4d9c-a858-c4a10bfbbb71.pdf

AGM Information

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ASX Release 25 November 2021

ASX code: PIQ

AGM Chairman's Address and Investor Presentation

Proteomics International Laboratories Ltd (Proteomics International; ASX: PIQ) is pleased to release a copy of the Chairman's Address to be provided by Mr Terry Sweet and the Investor Presentation to be provided by Dr Richard Lipscombe to shareholders at the Annual General Meeting to be held in Perth commencing at 9:30 am AWST today.

Authorised by Dr Richard Lipscombe (Managing Director) on behalf of the Board of PIQ.

ENDS

About Proteomics International Laboratories (PILL) (www.proteomicsinternational.com)

Proteomics International (Perth, Western Australia) is a wholly owned subsidiary and trading name of PILL (ASX: PIQ), a medical technology company at the forefront of predictive diagnostics and bio-analytical services. The Company specialises in the area of proteomics – the industrial scale study of the structure and function of proteins. Proteomics International's mission is to improve the quality of lives by the creation and application of innovative tools that enable the improved treatment of disease.

For further information please contact:

Dr Richard Lipscombe Managing Director Proteomics International Laboratories Ltd T: +61 8 9389 1992 E: [email protected]

Dirk van Dissel Kyle Moss Investor Relations & Corporate Advisor Corporate Advisor Candour Advisory Euroz Hartleys T: +61 408 326 367 T: +61 8 9488 1400 E: [email protected] E: [email protected]

Chairman's Address

Good Morning Ladies and Gentlemen

My name is Terry Sweet, and as Chair of the company it is my pleasure to welcome you to the 7th Annual General Meeting of shareholders of Proteomics International Laboratories.

It is now after 9:30 am, and as we have a quorum of shareholders present, I declare the meeting open.

The notice convening today's meeting was made available to shareholders on the 26th of October 2021 and lodged with ASX on that date. Consequently, I will take the notice as read.

Firstly, let me introduce the members of your Board:

Present in person are Dr Richard Lipscombe, Managing Director, Mr Paul House, Mr Neville Gardiner, and Ms Karen Logan, Company Secretary. Present by video link are Dr Robyn Elliott in Melbourne and Mr Roger Moore in Sydney. Also present here today is Mr Neil Smith, representing BDO, our independent auditor.

I would particularly like to welcome Dr Elliott and Mr Gardiner, who have recently joined the board of PIQ, and who between them bring a wealth of experience in technical, corporate, financial and commercial areas.

As you will know, at the end of this AGM I will step down from the board of PIQ, and Mr Gardiner will take on the role of Chair of your company. Since listing on ASX in 2015 the company has made great progress, steadily building on the small private company founded by Dr Lipscombe twenty years ago last February.

The positive results of the initial clinical study of PromarkerD have been firmly and conclusively validated by subsequent published, peer-reviewed studies.

The clinical advantages of the use of the PromarkerD test in assessing risk of kidney disease over current standard of care is unequivocal.

The reduction of healthcare costs by predicting who is likely to suffer kidney disease, thereby allowing steps to be taken to avoid or delay the condition, are very significant.

Dr Lipscombe will speak in more detail to the above, however as I leave the company, these are milestone achievements for which I am proud to have played a small part.

Your company is now poised to deliver this diagnostic test, PromarkerD for use by doctors, for the benefit of their patients: this will not only reward those who have invested in the company, but will fulfil the company's vision "to help create a world where disease is detected early and cured simply".

I will now move to the formalities of the meeting.

Proteomics International LABORATORIES LTD

AGM Presentation

25 November 2021

Dr. Richard Lipscombe Managing Director

This Presentation is provided by Proteomics International Laboratories Ltd (Proteomics International, Proteomics, the Company, ASX: PIQ).

You should not rely upon anything in this presentation and/or any information obtained from the Company, its Directors or their associates in deciding whether or not to seek to purchase the shares of the Company. This is not an offer to subscribe for securities in the Company.

The Presentation may contain quantitative statements of anticipated future performance such as projections, forecasts, calculations, forward-looking statements or estimates all of which are based on certain assumptions (Forward Looking Statements). The Forward Looking Statements may involve subjective judgements and are based on a large number of assumptions and are subject to significant uncertainties and contingencies, many of which are outside the control of the Company and may not prove to be correct.

No representation or warranty is made that any Forward Looking Statements will be achieved, or occur, or that the assumptions upon which they are based are reasonable or the calculations from which they have been derived are correct. Actual future events may vary significantly from the Forward Looking Statements. Each Recipient should undertake their own independent review of the Forward Looking Statements, including the assumptions on which they are based and the financial calculations from which they are derived.

Proteomics International Laboratories Ltd ASX: PIQ

A medical technology company at the forefront of precision medicine and predictive diagnostics

Diagnostics

PromarkerD

  • Predictive test for early identification of diabetic kidney disease (DKD)
  • Cost-effective, easy to use, patented technology
  • Strong pipeline of novel tests in development Endometriosis, Asthma & COPD, Oesophageal cancer, Gastro, Diabetic retinopathy, Oxidative Stress

Bioanalytical Services

  • Growing demand from industry for specialised analytics
  • ➢ Thriving sectors of pharmacokinetic (PK) testing and biosimilars
  • State-of-the-art capabilities with >\$4m invested in cutting-edge facility
  • Revenue offsets the cash burn from R&D and product development

Financial & Corporate

  • Raised \$6m in heavily oversubscribed placement (Oct 20)
  • Senior management team expanded (Jun 21) + Board renewal (Nov 21)
  • R&D tax incentive rebate of ~A\$1.2 million due December 21
  • Implementing expansion strategies to accelerate growth
Corporate Snapshot –
19/11/2021
ASX:PIQ
ASX code PIQ
Share Price A\$0.96
Shares on issue (+8.4m options) 105m
Market Capitalisation A\$101m
Cash (30 Sept 2021) A\$4.4m
Revenue & other income –
FY21
A\$3.0m

Board of Directors ASX: PIQ

Terry Sweet FAICD, Chairman (Retiring at 2021 AGM)

ASX:PIQ South & Central America Director of several listed companies over the past 30 years in both executive and non-executive capacities. Companies include XRF Scientific Ltd, where he was MD for 4 years, Western Biotechnology Ltd, Heartlink Ltd, & Scientific Services Ltd.

Dr Richard Lipscombe PhD (London), MA (Oxon), Co-Founder & Managing Director

Led the Company from foundation through listing in 2015 to today. 30 years biotechnology experience in R&D and product commercialisation in academic and commercial entities. Technical expertise in chemistry, immunology, biomarker discovery & clinical proteomics.

Roger Moore R (Denmark), BPharm (U.Syd), Non-Executive Director

International pharmaceutical industry experience spanning 40 years, including almost 30 years as President of Novo Nordisk Japan. From 2000, he was appointed Novo Nordisk's Senior Vice President, Japan & Oceania Region. He has also served as a member of the Senior Management Board, Novo Nordisk A/S.

Paul House GAICD, BCommerce (UWA), Non-Executive Director

Over 25 years with multi-national corporations, CEO of Imdex (ASX:IMD), prior role as MD of SGS India for 8 years. Previously held CFO and COO roles, and was Senior Manager at a leading global management consultancy firm.

Dr Robyn Elliott PhD Inorganic Chemistry (Monash), BSc(Hons) Chemistry (Monash), Non-Executive Director

Proven track record in product development, clinical trials, regulatory affairs, audits, quality management, project management and operational strategy. Dr Elliott is Executive Director, Strategic Fractionation Program Delivery at CSL Behring, a subsidiary of CSL Limited. She is also a non-executive director of PolyNovo Limited (ASX:PNV).

Neville Gardiner BBus (Accounting and Business Law) (Curtin), CA, MAICD, Non-Executive Director / Chair-elect

Seasoned finance professional with over 30 years' experience providing corporate advice to Boards of public and private companies. He was Co-Founder and MD of Torridon Partners, an independent corporate advisory firm, which was acquired Deloitte in 2016, where he became Partner in their M&A Advisory team.

Promarker – Platform Technology ASX: PIQ

PromarkerTM is a platform technology that can identify unique protein biomarkers 'fingerprints'

The platform identifies and links the unique protein biomarkers to specific diseases, enabling Proteomics International to create novel diagnostic tests

A new blood test for predicting diabetic kidney disease

Problem & Solution

The Problem

  • 463 millions diabetics globally
  • 1-in-3 diabetic adults have chronic kidney disease
  • Kidney disease is a silent killer kidney function can fall below 15-20% with no symptoms
  • Damage to kidneys is irreversible, therefore early detection is paramount
  • Diabetic kidney disease leads to renal failure which requires dialysis (US\$72,000 p.a.) or kidney transplant
  • Total cost of diabetic kidney disease = US\$130 Bn per year in USA alone

Solution

  • Existing tests (known as eGFR and ACR) can only detect chronic kidney disease once it is already present
  • Current standard-of-care tests cannot predict the onset of diabetic kidney disease
  • If unchecked, patients ultimately require dialysis and/or a kidney transplant Diseased Kidney

  • PromarkerD can predict the onset of disease before clinical symptoms appear (up to four years prior)
  • Doctors can then prescribe an early therapeutic treatment to slow or stop the onset of disease
  • Kidneys remain healthier for longer, saving healthcare systems billions of dollars and improving quality of life for patients

Healthy Kidney

PromarkerD is Revenue Ready ASX: PIQ

The PromarkerD predictive test is poised to roll-out in markets globally Enormous Market 463m adults have diabetes globally: 1-in-3 currently have diabetic kidney disease (DKD) High Statistical Performance Peer reviewed publications – Clinical & analytical validity proven (Sensitivity 86%); PromarkerD significantly outperforms current standard of care Big Pharma Collaboration Janssen (J&J) – access to global multi-centre clinical study - assessing PromarkerD vs treatment options Therapeutic Treatments Available SGLT2-inhibitor class drug (canagliflozin) improves PromarkerD risk scores – potential as Complementary Diagnostic (CDx) [drug class already used for type 2 diabetes & now approved as new treatment for DKD] Simple Technology Platform - PromarkerD Immunoassay Clinical pathology laboratories can easily introduce the PromarkerD immunoassay as an IVD kit or LDT Regulatory Approvals CE Mark (Europe) registration received for the PromarkerD Immunoassay; Secured ISO 13485 certification for the manufacture of medical devices Manufacturing scale-up Specialist companies working to enable reagent supply and ISO 13485 certified kit manufacture Reimbursement Identified pathway to obtain a unique reimbursement code & payment coverage in the USA: Economic Health Benefit & Clinical Utility demonstrated Regulatory Approvals - ongoing Engaging with partners and national regulators [US sales to utilise the LDT pathway with CLIA laboratories, prior to FDA approval] Generate Sales Revenue First distribution agreements for PromarkerD immunoassay signed – initial sales pending ✓ ✓ ✓ ✓ ✓ ✓

PromarkerD – Simple Integration & Utilisation

PromarkerD – Results & Intervention

How PromarkerDTM results are delivered

LOW RISK MODERATE RISK HIGH RISK
RISK SCORE %
0
10 20 100
Prognostic 16% indicates a moderate risk of decline in kidney function*
Risk Score Intervention
Low Risk
Standard diabetes management
Test every
12-24 months
Moderate
Risk


More frequent monitoring
Review non-glycemic
risk factors


Optimisation of lifestyle
Avoidance of potentially
nephrotoxic drugs

Review of glycemic
targets

and management
Utilisation of therapeutic drugs
Test every
6 months
High Risk
Very close monitoring

Intensive management strategies based on those for 'Moderate
risk' above with optimisation of treatments for diabetes and other
risk factors
Test every
3 months

*as defined by incident diabetic kidney disease (eGFR <60ml/min/1.73m2 ) in the next four years. Note: if eGFR level at the time of the test is already <60ml/min/1.73m2 , then the risk of a further decline in kidney function is defined as an eGFR decline >30% in the next four years 10

PromarkerD in the Clinic

PromarkerD significantly enhances diabetic kidney disease diagnosis and management
ASX:PIQ
Peer reviewed PromarkerD tested on over 5,000 patients in 4-year clinical studies
% High Accuracy PromarkerD
predicted 86% of otherwise healthy diabetics who went on to develop chronic kidney disease
('incident DKD') within 4 yrs
[Diabetes Care (2017), J Diabetes Complications (2019)]
International
validation
Janssen (J&J) collaboration stage
1 –
global clinical study -
PromarkerD predicted 'incident DKD' in the
completed CANVAS clinical trial; high-risk patients 13.5 times more likely than low-risk to develop DKD
(P = 1.3𝑥10−104) [J Clinical Medicine (2020)]
New DKD
treatment
options identified
Janssen collaboration stage 2

assessed the drug treatment effect of canagliflozin versus placebo on
PromarkerD risk scores in the completed CANVAS 4 year clinical trial:
Aim: Do 'at-risk' patients continue to decline, or stabilize, or recover?
Results: Patients predicted at baseline by PromarkerD to be high-risk
for developing DKD
-

Treated with canagliflozin had significantly lower scores at Year 3 (Δ score: -5.6%; p<0.001)

Patients on placebo remained high (Δ score: 3.2%; p=0.17) (Time*TRT
p=0.002) [ADC (Aug 2021)]
Conclusion: PromarkerD can identify 'at-risk' patients who are asymptomatic for DKD, with canagliflozin
offering a potential treatment that can improve their renal risk profile
Outperforms
Standard of Care
PromarkerD compared to standard of care tests (eGFR and ACR)
for predicting DKD.
Community based study of type 2 diabetes patients (N=857);
Patients tested for existing DKD
at baseline: 497 had normal kidney function, but
of these 9% (N=45) developed 'incident DKD' in the next 4 years –
all were missed
by standard of care tests whilst PromarkerD identified 84% (N=38) of these
[ASN (Nov 2021)]

PromarkerD Market Opportunity

Diabetes incidence and Patent portfolio

Country Patent/Application No Patent Status No. Diabetics1
Australia 2011305050 Granted 1,288,300
Brazil BR112013006740 Granted 16,780,800
Canada 2811654 Granted 2,793,500
China ZL201180053583.9 Granted 116,446,900
Europe2,3 3151012 Granted 59,322,100
Hong Kong 18115912.3 Pending 723,400
India 3012/DELNP/2013 Pending 77,005,600
Indonesia W00 2013 01585 Granted 10,681,400
Japan 2013-528474 Granted 7,390,500
Russia 2596486 Granted 8,288,500
Singapore 188527 Granted 640,400
USA2,4 US 9,146,243 Granted 30,987,900
332,349,300 Total
    1. International Diabetes Federation (IDF) Atlas 9th Edition 2019 [Age group 20-79 years; Total = Diagnosed (48.7%) + Undiagnosed 51.3%)]
    1. Australia, Europe, USA patent family also covers use of the test for any form of kidney disease (NB further studies are required to prove efficacy of PromarkerD for applications beyond DKD)
    1. Covers France, Germany, Italy, Spain, Turkey and the United Kingdom, which cumulatively have 29.6m adults with diabetes
    1. USA patent further extended to cover method for identifying drugs for abnormal kidney function using one of the PromarkerD biomarkers (CD5L)

Market assumptions

  • Patent family covers 332m diabetics1
  • Test is performed once per year per patient on average
  • Test price of US\$150 [based on stakeholder engagement responses in a market access study]
  • Standard industry royalty rates range from 5-15%

PromarkerD – Route To Market ASX: PIQ

Completed Licensing Transactions

Great Britain

  • Licence with Apacor Ltd for immunoassay test
  • 4.8m type 2 diabetics (7%)
  • Product registration expected Q1 CY22

Italy

  • Licence with Medical Horizons SRL for immunoassay test
  • 3.7m type 2 diabetics (8%)
  • Test registered for use with Italian Ministry of Health
  • Sales expected Q4 CY21 (delayed by COVID-19)

Israel

  • Licence with Zotal Ltd for immunoassay test
  • 0.6m type 2 diabetics (12%)
  • Product registration on-hold pending ISO 13485 manufacturing

Targeted Licensing Transactions

United States

• Discussions ongoing with multiple national/global US diagnostic companies

RoW

• Actively targeting potential partners in key global jurisdictions

Diagnostics Pipeline

The Promarker™️ Research Pipeline & Timeline

Further Global Potential in New Markets

  • Employs the Promarker™️ technology platform to develop novel intellectual property
  • Targeting new diagnostic tests in areas of significant unmet need
  • Enormous markets and revenue potential

Diagnostics research and development – the Promarker™️ pipeline

Biomarker PRE-START
RESEARCH
DEVELOPMENT COMMERCIALISATION
Research
Pipeline
Ethics &
Governance
Discovery Clinical Study/
Proof of
Validation
Concept
Diabetic Kidney Disease
PromarkerD
CHANGING LIVES
Endometriosis
Giardia
Asthma & COPD
Plant Dieback
Diabetic Retinopathy
Oxidative Stress (2-tag)
Oesophageal Cancer
Retinopathy (ARC Centre)

In Development: Endometriosis

What is Endometriosis?

  • A debilitating condition in which tissue that normally lines the uterus grows outside the uterus (on the ovaries, fallopian tubes or the intestines)
  • The most common symptoms are chronic pain and menstrual irregularities
  • Diagnosis typically takes 7 -12 years due to the lack of a diagnostic tool beyond invasive surgery = Significant unmet medical need
  • Affects 1 in 9 women and costs Australia \$ 9 . 7 billion a year – Global opportunity significantly higher

PromarkerTM for Endometriosis

  • Novel biomarkers identified via the Promarker ™️ platform offer potential world -first blood test for endometriosis
  • Proof of concept study performed on 54 women returned statistically significant results ; Patent filed for new invention
  • Collaboration with Royal Women ' s Hospital and University of Melbourne provides access to a large patient cohort (N=900 ) for a clinical validation study
  • Results due Q 1 CY22

Timeline & Milestones

24 Nov 2021 FDA advises De Novo pathway for PromarkerD 22 July 2021 Abcam (UK) engaged to produce specialist reagents for PromarkerD immunoassay 18 October 2021 Study shows PromarkerD significantly impacts clinical management decisions New results from the Promarker™️ diagnostics pipeline – e.g. Endometriosis, Asthma/COPD, Oesoph. cancer Reimbursement (Medicare) Code in the US Major licensing deals for PromarkerD with diagnostic, pharmaceutical, or services providers FDA regulatory submission in the US 16 July 2021 Successful results from Janssen Stage 2 study: Canagliflozin lowers PromarkerD risk scores 23 April 2021 Proteomics International receives ISO 13485 certification for medical device manufacture 10 June 2021 Senior management team expanded: CCO & CFO appointed 18 May 2021 Major analytical services contract for PK testing 29 April 2021 US FDA 513(g) application submitted 4 August 2021 Partnership with Royal Women's Hospital and Univ. Melbourne targets endometriosis clinical validation study 5 Nov 2021 Results show PromarkerD significantly outperforms standard of care tests First Sales of PromarkerD immunoassay 13 May 2021 Study demonstrates major economic health benefit of PromarkerD 25 June 2021 Health Economics presented at American Diabetes Association 2021 Targets and Achievements 2021-22 targets Manufacturing transfer to ISO 13485 completed 12 August 2021 Biotem (France) engaged for ISO 13485 manufacture of PromarkerD immunoassay Kit 23 Nov 2021 Distribution agreement for PromarkerD immunoassay – Britain 16 Nov 2021 Board strengthened

Value Inflection Points

Exceptional Global Opportunity

  • ➢ Disruptive, cutting-edge technology & proven in-house diagnostics platform
  • ➢ PromarkerD test de-risked, patented, revenue ready
  • ➢ Test rolling-out in easy-to-use, scalable, low cost format with high margins
  • ➢ Whole of market appeal: pharma, clinical pathology labs, diagnostic platform developers, diabetes service providers, physicians and patients
  • ➢ Deep pipeline of potential globally significant tests in development
  • ➢ Vibrant corporate activity in the precision medicine, diagnostics and CRO (clinical trials) sectors

Share Price Catalysts 2021-22

Milestone Qtr Dec'21 Mar'22 Jun'22 Sep'22 Dec'22 Impact
PromarkerD
Licensing Deals Drive global uptake and future revenue
First Sales in Europe Drive revenue
ISO 13485 Manufacturing Site Ability to supply global markets
US Reimbursement CPT PLA code & Payor coverage
FDA Regulatory Submission Build user confidence in product & assist
second phase of test roll-out
Regulatory Approvals Assist regional roll-out of test
Promarker™️
Endometriosis Study Results New first-in-class diagnostic test
Diagnostics Pipeline Updates New IP (proof of concept results)
Analytical Services
New Contracts Off-set cash burn & engages potential
future partners

Peer Comparison

Stock Code Company Focus Market
Capitalisation
Share
Price
FY21
Revenue
ASX:PIQ
FY21
Net
Profit/Loss
Renalytix AI RENX.LSE
RNLX.US
DKD test based on AI and a combination of
predictive blood-based biomarkers, genetic
factors and electronic health records.
Expensive (US\$950 per test), non-mass
market.
~A\$965m ~A\$2.1m ~A\$43m loss
AnteoTech ADO.ASX Develops, commercialises, manufactures
and distributes products for the life sciences
research, diagnostics and medical device
markets
A\$385m A\$0.195 A\$0.9m A\$6.2m
loss
Bard1 Life
Sciences
BD1.ASX Early stage in-licensed IP for various cancer
diagnostics.
A\$104m A\$1.09 A\$0.5m A\$12.3m
loss
Rhythm
Biosciences
RHY.ASX Pre-commercialisation proteomics derived
diagnostic test for colon cancer licensed
from CSIRO.
A\$392m A\$1.81 Nil A\$6.6m
loss
Proteomics
International
Laboratories
PIQ.ASX Predictive blood test measuring novel
protein biomarkers for DKD; simple, cost
effective, commercial ready.
Pipeline of novel diagnostic tests in
development for chronic diseases.
A\$101m A\$0.96 A\$1.5m A\$2.9m
loss

Source: Company filings. Market data as at 22 November 2021, exchange rates of GBP:AUD 1.86 and USD:AUD 1.38

Dr Richard Lipscombe

Managing Director

T:+61 8 9389 1992

E: [email protected] www.proteomicsinternational.com

Kyle Moss

Corporate Advisor

Euroz Hartleys

T:+61 9488 1400

E: [email protected]

Dirk van Dissel

Investor Relations & Corporate Advisor

Candour Advisory

T:+61 408 326 367

E: [email protected]