PACIFIC EDGE LIMITED — AGM Information 2022

Jul 28, 2022

PACIFIC EDGE Annual Shareholders Meeting Fullwood Room 1 Harrop Street Dunedin 28 July 2022

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IMPORTANT NOTICE AND DISCLAIMER

Important Notice

This presentation has been prepared by Pacific Edge Limited (PEL) solely to provide interested parties with further information about PEL and its activities at the date of this presentation.

Information of a general nature

The information in this presentation is of a general nature and does not purport to be complete nor does it contain all the information which a prospective investor may require in evaluating a possible investment in PEL or that would be required in a product disclosure statement, prospectus or other disclosure document for the purposes of the New Zealand Financial Markets Conduct Act 2013 (FMCA) or the Australian Corporations Act. PEL is subject to a disclosure obligation that requires it to notify certain material information to NZX Limited (NZX) and ASX Limited (ASX) for the purpose of that information being made available to participants in the market and that information can be found by visiting www.nzx.com/companies/PEB and www2.asx.com.au/markets/company/PEB. This presentation should be read in conjunction with PEL’s other periodic and continuous disclosure announcements released to NZX and ASX.

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Forward-looking statements

by their very nature, involve inherent risks and uncertainties. Many of those risks and uncertainties are matters which are beyond PEL’s control and could cause actual results to differ from those predicted. Variations could either be materially positive or materially negative. The information is stated only as at the date of this presentation. Except as required by law or regulation (including the NZX Listing Rules and ASX Listing Rules), PEL undertakes no obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise. To the maximum extent permitted by law, the directors of PEL, PEL and any of its related bodies corporate and affiliates, and their respective officers, partners, employees, agents, associates and advisers do not make any representation or warranty, express or implied, as to the accuracy, reliability or completeness of such information, or the likelihood of fulfilment of any forward-looking statement or any event or results expressed or implied in any forwardlooking statement, and disclaim all responsibility and liability for these forward-looking statements (including, without limitation, liability for negligence).

Financial data

All dollar values are in New Zealand dollars unless otherwise stated. This presentation should be read in conjunction with, and subject to, the explanations and views of future outlook on market conditions, earnings and activities given in the announcements relating to the results, and report, for the twelve months ended 31 March 2022.

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Past performance

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Investment risk

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None of PEL or PEL’s advisers or any of their respective affiliates, related bodies corporate, directors, officers, partners, employees and agents, have authorised, permitted or caused the issue, submission, dispatch or provision of this presentation and, except to the extent referred to in this presentation, none of them makes or purports to make any statement in this presentation and there is no statement in this presentation which is based on any statement by any of them. To the maximum extent permitted by law, none of PEL and its advisers, affiliates, related bodies corporate, nor their respective directors, officers, partners, employees and agents makes any representation or warranty, express or implied, as to the currency, accuracy, reliability or completeness of information in this presentation; and none of them shall have any liability (including for negligence) for:

• any errors or omissions in this presentation; or

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By receiving this presentation, you agree to the above terms and conditions.

This presentation contains forward-looking statements that reflect PEL’s current views with respect to future events. Forward-looking statements,

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CHRIS GALLAHER
Chairman
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DIRECTORS
SARAH PARK ANATOLE MASFEN BRYAN WILLIAMS
ANNA STOVE MARK GREEN TONY BARCLAY
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MEETING AGENDA

1. CHAIRMAN AND CEO PRESENTATIONS

2. SHAREHOLDER DISCUSSION

3. RESOLUTIONS

4. GENERAL BUSINESS

5. MEETING CLOSE

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FY 22 HIGHLIGHTS: TEST VOLUMES ACCELERATE IN THE PIVOTAL US MARKET

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PACIFIC EDGE GLOBAL TEST VOLUMES [1] PACIFIC EDGE OPERATING REVENUE
25,000 23,086 $14,000
46% $11,445
$12,000 49%
20,000
16,861 $10,000
15,697 15,814
14,448
15,000 $7,701
$8,000
$6,000
10,000
$4,370
$3,817
$3,400
$4,000
5,000
$2,000
- $0
FY18 FY19 FY20 FY21 FY22 FY18 FY19 FY20 FY21 FY22
59% $105.4M
$19.8M
US TEST CASH, CASH
NET LOSS AFTER
VOLUMES [1] EQUIVALENTS [2]
TAX
TEST VOLUME
REVENUE $(000)
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1 Testing volume is measure by Total Laboratory (TLT) Throughput including commercial, pre-commercial and clinical studies testing 2 Cash, cash equivalents and short-term deposits

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NEW EXECUTIVE AND BOARD LEADERSHIP

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TONY BARCLAY Independent Director

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DR PETER MEINTJES Chief Executive Officer

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OUTLOOK: INVESTING FOR LONG TERM GROWTH

• Directors have noted the sharp shift in global share market sentiment since the start of the year and the impact that this has had on company valuations, particularly among growth companies such as Pacific Edge.

• We remain focused on the things that we can control and that is building long-term sustainable value through the execution of our strategy and prudent management of the capital shareholders have entrusted us with.

• We expect our investment in innovation, evidence, people, and brand to drive growth in total testing volumes, clinical studies enrolment and revenue generation and shareholder value.

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DR PETER MEINTJES Chief Executive Officer

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MOLECULAR DIAGNOSTICS VALUE CHAIN: PATIENT JOURNEY

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GENETIC RISK
AT BIRTH
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DISEASE SYMPTOMS MANIFESTS ONSET

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SURGICAL OR THERAPEUTIC INTERVENTION

GENOMIC SCREENING ASYMPTOMATIC SCREENING (PERSONALIZED GENETIC RISK) (EARLY DETECTION)

PATIENT/DISEASE MANAGEMENT SURVEILLANCE (CLINICAL DECISION MAKING) (RDM[1] , TRM[2] , RECURRENCE)

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INTENSIFY/DE-INTENSIFY WORKUPS ADJUDICATE DIAGNOSTIC DILEMMAS MONITOR FOR RECURRENCE

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1. RDM: Residual Disease Monitoring 2. TRM: Therapeutic Response Monitoring.

CXBLADDER IN THE PATIENT CARE PATHWAY

VALUE PROPOSITION

Cxbladder Cxbladder Cxbladder TRIAGE DETECT MONITOR Typical Primary Care Physician Urologist Urologist (CxbT) (CxbD) (CxbM) standard of Patient presents with Current guidelines for Monitor for recurrence hematuria and clinician hematuria evaluation with cystoscopy, care on the cannot rule out cancer. recommend ~95% get frequency varies patient care Patient referred to cystoscopy[1] ahead of according to patient pathway urologist diagnosis & treatment presentation For use in the PRIMARY CARE and SPECIALIST Assists clinicians to safely de-intensify settings to de-intensify hematuria workup or rule out hematuria evaluation from low incidence TRIAGE urothelial cancer (UC) populations Sensitivity 95% / NPV 99% For use by SPECIALISTS to detect Assists clinicians to the presence of dilemmas (e.g. equivocal cystoscopy & DETECT urothelial cancer and atypical cytology) in any patient population adjudicate diagnostic Sensitivity 82% / Specificity 85% / NPV 97% dilemmas Assists clinicians in monitoring for UC For use by SPECIALISTS recurrence . Intended to reduce the to monitor for recurrence frequency of surveillance cystoscopy and MONITOR at a frequency proportional improve patient compliance to risk Sensitivity 93% / NPV 97%

Assists clinicians to safely de-intensify hematuria evaluation from low incidence populations Sensitivity 95% / NPV 99%

Assists clinicians to adjudicate diagnostic dilemmas (e.g. equivocal cystoscopy & atypical cytology) in any patient population Sensitivity 82% / Specificity 85% / NPV 97%

Assists clinicians in monitoring for UC recurrence . Intended to reduce the frequency of surveillance cystoscopy and improve patient compliance Sensitivity 93% / NPV 97%

Sensitivity: the likelihood of the test to be positive in a patient with the disease Specificity: the likelihood of the test to be negative when the patient does not have the disease; NPV: the likelihood of a negative test being a true negative.

1 AUA Guidelines and Woldu SL, Ng CK, Loo RK, Slezak JM, Jacobsen SJ, Tan WS, et al. (2021a). "Evaluation of the New American Urological Association Guidelines Risk Classification for Hematuria." J Urol 205 (5): 1387-1393.

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UROTHELIAL CANCER

IS A SIGNIFICANT GLOBAL HEALTHCARE CHALLENGE

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~570K 6 [TH]
Annual cases Most common
and growing [1] cancer in men [1]
US$7.7b
Total
Addressable
Market (TAM)
~210K
>70%
Annual
Recurrence [2]
deaths [1]
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		Market opportunity	Market opportunity	TAM ($US)
			United States Americas (non-US)	$3.5bn $0.5bn
			EMEA (w/o most of Africa)	$1.5bn
			APAC (w/o China)	$2.2bn

1. Sung et al. Global Cancer Statistics 2020: GLOBOCAN Estimates of Incidence and Mortality Worldwide for 36 Cancers in 185 Countries CA: A Cancer Journal for Clinicians 2021; 71: 209-249 2. Chamie K, Litwin MS, Bassett JC, et al. Recurrence of high-risk bladder cancer: a population-based analysis. Cancer. 2013;119:3219-3227. 3. *TAM is the Total Addressable Market based on Pacific Edge estimates.

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OPERATIONAL AND FINANCIAL PERFORMANCE

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STRONG GROWTH IN THE USE PACIFIC EDGE’S LARGEST MARKET

CXBLADDER USED ACROSS THE US

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U.S. Customers Pacific Edge Diagnostics USA, Hershey, Pennsylvania

AMERICAS QUARTERLY TEST VOLUMES[1]

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Americas’ Commercial Testing represent 84% of FY22 volumes
7,000 68.7%
CAGR
6,073
6,000
5,290
5,000 4,706 4,591
4,277
3,824
4,000
3,110
2,791
3,000
2,133
2,000
1,000
-
Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1
FY 21 FY 22 FY 23
TEST VOLUMES
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1 Total Laboratory Throughput including commercial, pre-commercial and clinical studies testing

BUILDING THE ADOPTION OF CXBLADDER BY CLINICIANS

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UNIQUE ORDERING CLINICIANS (US)
1000
47.5%
894
900 CAGR
782
800
740
689
700 657
600
530
516
500 462
411
400
300
200
100
0
Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1
FY 21 FY 22 FY 23
CLINICIANS
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KEY US PAYORS ACTIVATED

• Centers for Medicare and Medicaid Services (CMS) covers more than 61.5m US citizens over 65 and people on low incomes

• 2/3 of patient population covered by Medicare

• The Kaiser Health Plan covers over 12.5m members, with >85% of those members in California

• Cxbladder rolled out across clinics in Southern California and being integrated into Kaiser EMR

• The Veterans Health Administration (VHA) within is the second largest integrated healthcare system in the US serving >9m veterans each year

• The DRIVE clinical study is an important engagement with VA urologists to determine utility in a cohort of VA patients

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APAC: NEW ZEALAND AT THE FOREFRONT WITH ADOPTION BY PRIMARY CARE

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Pacific Edge now has Cxbladder coverage in 15 of the 20 new Te Whatu Ora, Health New Zealand, regions, representing ~75% of the country’s population

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APAC QUARTERLY TEST VOLUMES [1]
Commercial tests represent 82% of FY22 volumes
7.4%
1,500 CAGR
1,117
1,088 1,073 1,079 1,074
982
943 952
852
750
-
Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1
FY 21 FY 22 FY 23
TEST VOLUMES
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1 Total Laboratory Throughput including commercial, pre-commercial and clinical studies testing

ACCELERATING INVESTMENT TO CAPTURE THE US OPPORTUNITY

Year to 31 March	2022 $000	2021 $000	Variance $000	Change %
Operating revenue	11,445	7,701	3,744	49%
Total revenue	13,878	10,439	3,439	33%
Operating expenses	(33,666)	(24,662)	(9,004)	37%
Total comprehensive loss	(19,674)	(14,177)	(5,497)	39%
Cash receipts from customers	10,942	6,747	4,195	62%
Net operating cash outflow	(17,552)	(13,570)	(3,982)	29%
Net cash, cash equivalents and short- term deposits	105,412	23,129	82,283	356%

• Operating revenue growth of 49%

• Operating expenses up 37%, with sales and marketing making up 56% of this growth as we invest in future growth

• Cash receipts rise strongly year on year (up 62%), as reimbursement rates continue to increase

• Strong balance sheet following the $103.5m capital raise in September / October 2021

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THE FUTURE: PACIFIC EDGE INVESTING FOR GROWTH

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FRAMING OUR INVESTMENT PROGRAM

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INPUTS OUTPUTS
RESEARCH
EXCELLENT PATIENT EXPERIENCE
OUR PEOPLE AND AND ACCURATE RESULTS
INNOVATION
EARLY DETECTION AND
OUR PROCESSES
CLINICALLY ACTIONABLE DATA
OUR IP, KNOWLEDGE INNOVATION PIPELINE FOR
AND EXPERIENCE CLINICAL APPLICATIONS
ADOPTION,
EVIDENCE,
OUR CLINICAL STUDIES RETENTION COVERAGE INCLUSIVE WORKPLACE
PARTNER SITES AND REVENUE DRIVEN BY OUTCOMES
AND
GENERATION
GUIDELINES
INCREASED LONG-TERM
OUR INVESTORS
SHAREHOLDER VALUE
A DIVERSE AND INCLUSIVE VALUES-DRIVEN CULTURE WHERE ALL EMPLOYEES CAN GROW AND THRIVE.
OUR FOUNDATIONS
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RESEARCH AND INNOVATION:

UNDERSTANDING THE ENTIRE COMMERCIALISATION PATHWAY

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RESEARCH & INTELLECTUAL TECHNOLOGY PRODUCT
PROPERTY
INNOVATION
COMMERCIALISATION
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FOCUS AREAS:

1. Evaluate ‘product concepts’ to address unmet clinical needs through market research and scientific/clinical advisory boards

2. Evaluate cutting-edge technologies to meet the market requirements of desired product concepts

3. Continue to build a patent portfolio for novel clinical applications of cutting-edge molecular technologies

4. Turn patented technology into clinically-validated molecular diagnostic tools that address an unmet clinical need

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EVIDENCE, COVERAGE AND GUIDELINES: CHANGE CLINICAL PRACTICE

FOCUS AREAS:

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EVIDENCE COVERAGE AND GUIDELINES

Generate high-quality clinical validation and utility evidence through clinical studies

Use Clinical Utility evidence to:

• Drive the adoption of Cxbladder by clinicians, insurers and hospitals ahead of guideline inclusion

• Pursue inclusion of Cxbladder in globallyrelevant standards and guidelines of clinical care across the breadth of patient pathways

• Foster trusted relationships with key opinion leaders, relevant uro-oncology centers of excellence, professional societies and patient advocacy networks to drive a broader awareness and demand for Cxbladder

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• Develop the scientific and clinical credibility of the Cxbladder brand

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STRENGTHENING THE CASE FOR CXBLADDER IN KEY GUIDELINES

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BEFORE INCLUSION

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We use clinical validity and utility evidence to attract interest from opinion-leading clinicians, and payers, drive early adoption of Cxbladder and build momentum for guideline inclusion

• Two studies pending publication

• Five more studies underway

• STRATA

• DRIVE

• DEDUCT

• LOBSTER

• MONSTER

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AFTER INCLUSION

INCLUSION

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Review
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We use clinical validity and utility evidence to strengthen the language in guidelines supporting the use of Cxbladder to expand patient types eligible for testing

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3) ADOPTION, RETENTION AND REVENUE GENERATION

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ADOPTION, RETENTION AND REVENUE GENERATION

FOCUS AREAS:

1. Diversify sales process to target Strategic Accounts differently, including education and Key Opinion Leader (KOL) engagement activities by our Medical Affairs team

2. Drive protocolized adoption of Cxbladder at the earliest point in the patient care pathway

3. Increase event marketing, sponsorship and marketing communications to amplify our clinical evidence generation within the urology and oncology communities

4. Establish “in-network” or contracted relationships for the reimbursement of Cxbladder with government healthcare funders and private payors

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1. Empower patients through patient awareness and patient advocacy initiatives through established societies and our Cxbladder website

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FY23 INVESTMENT PROGRAM LINKED TO REVENUE MILESTONES

AMERICAS INITIATIVES

• Expanding Direct Selling Team

• Adding Strategic Account Selling Team

• Adding a new Medical Affairs Team

• Lifting marketing investment

• Improving the Customer experience

APAC INITIATIVES

• Adding remaining DHBs and positioning Cxbladder for nation-wide coverage under Te Whatu Ora Health New Zealand

• Driving Cxbladder adoption to primary care in NZ

• • Market development through clinical studies in Australia, Singapore

• Commencement of commercial revenue in Australia through hospital and state contracting

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Providing actionable clinical information at the earliest point in the patient care pathway

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PATIENTS: BUILDING THE CX BRAND AND ADVOCACY

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The Bladder Cancer Advocacy Network represents the voice of the patient in the USA

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New Zealand’s leading organisation dedicated to reducing cancer incidence, and care

Partnership activity:

• Sponsorship of Walk to End Bladder Cancer events around the country and thought leadership and networking events

• Co-development of leading patient resources

Partnership activity:

• Collaboration on patient resources.

• Promote awareness of bladder cancer symptoms and risk factors among high-risk groups

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Evolution of Cxbladder.com as a resource hub for patients and caregivers:

• Growing library of clinical and care-focused articles designed to design to address topics of interest and common questions

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A DIVERSE AND INCLUSIVE PERFORMANCE CULTURE

BLADDER CANCER AWARENESS MONTH AT PACIFIC EDGE

ATTRACTING AND RETAINING TALENT

• Building a performance culture through a shared mission and vision

• Driving engagement across all departments, and management levels for tenured and new staff

• Celebrating and driving diversity at all levels

ESG

• Pacific Edge has a social purpose of improving the detection and management of cancer

• Management of ESG factors are fundamental to our success

• Aiming to improve disclosure, including charting our carbon footprint

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DAVID LEVISON Executive Chairman Pacific Edge Diagnostics USA

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SPOTLIGHT ON: STRATEGIES AND TACTICS FOR US MARKET EXECUTION

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EXPANDING CAPACITY AND CAPABILITY

TARGET US RELATIONSHIPS

13,790 Practicing urologists[1]

1,900 Large urology group practice sites[2]

>2,000 Clinicians that used Cxbladder in FY22[3]

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AMERICAS INITIATIVES

• Direct Sales Force:

• Up to 9 additional Account Executives and 1 Regional Sales Director to be added to the sales team taking the total to up to 40*

• New Marketing & Sales Support Managers (+3 FTE)*

• New Virtual Sales Team (up to +5 FTE)* to enhance the customer experience and streamline test ordering and results delivery

• • Strategic Accounts Sales personnel (up to +2 FTE)

• Medical Affairs Team:

• VP Medical Affairs, leading a team of Medical Science Liaison (MSL) (3-5 FTE)*

• MSLs are educators and experts on clinical, scientific and medical matters relevant to products and urology in general

• Drive Key Opinion Leader (KOL) engagement with speakers’ bureaus, advisory boards and similar

• • Targeting podium presentations of our clinical evidence at major conferences

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1 American Urological Assn Census 2021, 2 BHN Network 3 Company data *All planned hires subject to achievement of business milestones.

TARGETED AND TACTICAL EXECUTION

ENGAGING WITH CLINICIANS AND CUSTOMERS

50 Urology conferences across the US and APAC

4 + 36 Planned total Sales Execs*

5 New virtual sales team members*

AMERICAS INITIATIVES

• Marketing Activities:

• Conference podiums, presentations, posters

• Conference advertising/sponsorship

• Increased and targeted marcom activities

• Customer Experience:

• Electronic Medical Records (EMR) integration – streamlining customer ordering and reporting.

• PIHSS – continued promotion of our patient in-home sampling system

• Market Access and Reimbursement:

• Establishing medical intent for simplifying EOB, billing and claims processing

• Agreeing medical policy, prior to “in-network” contracting at VA and Private Payors

• Ex-US business opportunities in the Americas

• Performance Management:

• Extending access to performance data for sales and service organizations

• Adoption of focused selling strategies

• • Tracking impact of key activities in sales process

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1 American Urological Assn Census 2021, 2 BHN Network 3 Company data *36 Account Execs and 4 Regional Sales Directors. Executives All planned hires subject to achievement of business milestones.

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DR PETER MEINTJES Chief Executive Officer

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BUILDING SHAREHOLDER VALUE

• We are setting the foundations for strong throughput and revenue growth over the upcoming years.

• Operating costs will rise the business, but investment is linked to growth milestones.

• We are focused on long-term shareholder value and we are well positioned to deliver that over the coming years.

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QUESTIONS

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CHRIS GALLAHER
Chairman
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RESOLUTIONS

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BRYAN WILLIAMS Independent Director

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RESOLUTION 1:

That Chris Gallaher, who retires by rotation and is eligible for re-election, be re-elected as a director of the company.

RESOLUTION 1:

That Chris Gallaher, who retires by rotation and is eligible for re-election, be re-elected as a director of the company.

Proxy Votes Received

FOR	OPEN	AGAINST	TOTAL	ABSTAIN
312,476,188 (96.0%)	8,772,307 (2.7%)	4,168,995 (1.3%)	325,417,490	15,039

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CHRIS GALLAHER
Chairman
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RESOLUTION 2:

That Sarah Park, who retires by rotation and is eligible for re-election, be re-elected as a Director of the Company

RESOLUTION 2:

That Sarah Park, who retires by rotation and is eligible for re-election, be re-elected as a Director of the Company

Proxy Votes Received

FOR	OPEN	AGAINST	TOTAL	ABSTAIN
315,139,015 (96.9%)	8,795,835 (2.7%)	1,262,324 (0.4%)	325,197,174	235,355

RESOLUTION 3:

That Tony Barclay, who was appointed as a Director by the Board during the year, be elected as a Director of the Company.

RESOLUTION 3:

That Tony Barclay, who was appointed as a Director by the Board during the year, be elected as a Director of the Company.

Proxy Votes Received

FOR	OPEN	AGAINST	TOTAL	ABSTAIN
315,303,523 (97.0%)	8,810,804 (2.7%)	1,062,847 (0.3%)	325,177,174	255,355

RESOLUTION 4:

To record the re-appointment of PricewaterhouseCoopers as auditor of the Company and to authorise the Directors to fix the auditors’ remuneration for the ensuing year.

RESOLUTION 4:

To record the re-appointment of PricewaterhouseCoopers as auditor of the Company and to authorise the Directors to fix the auditors’ remuneration for the ensuing year.

Proxy Votes Received

FOR	OPEN	AGAINST	TOTAL	ABSTAIN
313,744,228 (96.4%)	8,803,443 (2.7%)	2,861,689 (0.9%)	325,409,360	23,169

VOTING

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GENERAL BUSINESS

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MEETING CLOSE

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APPENDIX

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1. PACIFIC EDGE: A HISTORY OF RESEARCH-LED INNOVATION AND GROWTH

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Aug 2021
Cxbladder reaches
70% public
healthcare
2012 coverage in NZ
2001
O’Sullivan et al:
Pacific Edge Cxbladder Detect Oct 2021
established
performance validation Aug 2019 PEB raises $103.5m
Journal of Urology Konety et al: Clinical (~US$72.5m)
2001-2006 2008 Utility of CxbD in
The era of the Holyoake et al: Urine- Dec 2012 Nov 2016 adjudicating atypical Dec 2021
Microarray. Cancer based RNA detection Launch of Pacific Edge Dec 2014 Clinical trials cytology and First commercial
biomarker panel of urothelial cancer Diagnostics USA and Launch of Cxbladder commence in equivocal cystoscopy sale of Cxbladder in
exploration Clin Cancer Res CxbD Triage Singapore European Urology Australia
2007 2011 2013 2015 2018 2020
2001 2008 2012 2014 2016 2019 2021
2007 2011 Mar 2013 Mar 2015 Feb 2018 Apr 2020
Commercial Pacific Edge PEDUSA receives Kavalieris et al: CxbT adopted into Patient in-home sampling
pivot to focus Diagnostics CLIA CxbT performance Canterbury initiated in the US
on urothelial New Zealand accreditation validation BMC Community Health
cancer (PEDNZ) Urology Pathways with Jun 2020
diagnostics established May 2013 primary care Kaiser Permanente,
First commercial Dec 2015 referral approves commercial use
sale (CxbD) for Launch of of Cxbladder
PEDNZ Cxbladder Monitor
Jul 2020
Mar 2013 CMS confirms
First commercial reimbursement of
sale (CxbD) for Cxbladder at $760/test
PEDUSA
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2. UROTHELIAL CANCER IN THE US MARKET

VALUE PROPOSITION

4TH Most common US$220,000 cancer in men Average lifetime in the US[1] cost[2] per patient

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US$4.9B
Forecast direct costs
associated with
urothelial cancer
in 2020 [2]
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Cxbladder Cxbladder Cxbladder TRIAGE DETECT MONITOR (CxbT) (CxbD) (CxbM)

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Patient care
pathway Primary Care Physician Urologist
The US has >55m ~7m ~3.4m >1.0m ~83k ~800k US$3.5B
and >63m women
present with require clinical patients receive Annual cases of monitored for recurrence opportunity [6]
aged 50+
Hematuria [2] workup [2] a cystoscopy [3] bladder cancer [4] Avg1.5 CxbM/yr [5] (hematuria,
surveillance)
MORE THAN 4.6M TEST OPPORTUNITIES
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1 American Cancer Society

2 Presentation from Dr Sia Daneshmand (Director of Urologic Oncology and Clinical Research, USC) July 2019 2. NIH National Cancer Institute, 2021 4. Bladder Cancer Advocacy Network, 2017

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3 Kenigsberg, A, et al. The Economics of Cystoscopy: A Microcost Analysis, Urology 157: 29−34, 2021.

4 National Cancer Institute 2021 forecast

5 Pacific Edge Estimate

6 Pacific Edge estimates at US$760/Per test

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3a. GLOBAL GUIDELINES PIVOTAL TO THE WIDESPREAD ADOPTION OF CXBLADDER

Recognition in national guidelines deepens and accelerates commercial use of Cxbladder tests and entrenches coverage by nationally relevant healthcare institutions.

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• Most influential and largest • Leading urologic authority in Europe • US-based not-for-profit alliance of 32 urological association in the world • Netherlands-based, 18,000 members leading US cancer centres

• • • U.S. based - 23,000 members worldwide. • Standards relevant to Cxbladder Bladder cancer standard suggests

• • Standards of care relevant to Cxbladder: • biomarkers may be considered during Non-muscle invasive bladder

• • Hematuria and micro-hematuria cancer (NMIBC) surveillance of high-risk non-muscleinvasive bladder cancer

• management • Guidelines loosely followed in New

• • Non-muscle invasive bladder Zealand, Australia and Singapore, • Guidelines reviewed annually cancer (NMIBC). (Standard makes but localised at a national and www.nccn.org

• an allowance for the use of regional level biomarkers in surveillance) • Guidelines recently reviewed with

• • Guidelines reviewed as new evidence favourable biomarker language and are emerges updated regularly

• • Pacific Edge can influence this process by www.uroweb.org

• publishing new clinical evidence

www.auanet.org

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3b. CLINICAL EVIDENCE GENERATION TOWARDS GUIDELINE INCLUSION (1/2)

STUDY	AIM	LOCATIONS	ENROLLED SITES*	STATUS**
US Primary study	Prospective, single-arm, observational study to develop clinical evidence for Cxbladder tests in facilitating early detection, intensifying or de-intensify hematuria evaluation and assistance in adjudicating equivocal cystoscopy	USA	12/12	Enrolment complete Analysis complete Publication pending
Singapore Study	Prospective, single-arm, observational study to develop clinical evidence for Cxbladder tests in facilitating early detection, intensifying or de-intensify hematuria evaluation and assistance in adjudicating equivocal cystoscopy	Singapore	4 / 4	Enrolment complete Analysis complete Publication pending
STRATA (formerly RCT)	S afeT esting of R isk for A symptomaT ic MicrohematuriA Demonstrate the clinical utility of Cxbladder using a prospective, two-arm randomized design to safely risk-stratify patients and rule out from further hematuria evaluation • Safely risk stratifying patients in order to rule out from cystoscopy • Demonstrate the clinical utility of Cxbladder against the AUA guidelines	USA Canada	10 / 11	Recruitment re-started after COVID-related delays Full data collected 2023 Q4
DRIVE (formerly VA Study)	D etection andRI sk Stratification inVE terans Presenting with Hematuria Prospective, single-arm, observational study to demonstrate the performance and utility of Cxbladder tests in risk stratifying Veterans presenting with hematuria • Demonstrate performance with Veterans and contribute to commercial adoption of Cxbladder for use with Veterans • Pivotal for the adoption of Cxbladder by Veterans Affairs but relevant to the AUA • Recruitment re-started after COVID-related delays • Targeting inclusion of all veterans presenting for evaluation of hematuria	VA Sites (USA)	7 / 11	Study expanded to get more data on low-risk patients Full data collected mid 2025

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*Estimated number of enrolled sites

**All dates are best-case estimates and subject to change

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3c. CLINICAL EVIDENCE GENERATION TOWARDS GUIDELINE INCLUSION (2/2)

STUDY		AIM	LOCATIONS	ENROLLED SITES*	STATUS**
DEDUCT		DE tection ofD isease in theU pper traCT Prospective, single-arm, observational study to validate performance of Cxbladder for the detection of urothelial carcinoma (UC) in the upper tract (UTUC) • Evaluate Cxbladder to safely avoid ureteroscopy • Safely risk stratify patients suspected to have UTUC and avoid unnecessary ureteroscopy and radiation exposure through imaging • Targeting inclusion of Cxbladder utility for UTUC in AUA guidelines	USA	0 / 4	Pilot data analysed in early 2024 – decision point to expand the study
LOBSTER		LO ngitudinal B ladder CancerS tudy for T umorRE curR ence Prospective, single-arm, observational study to evaluate the performance characteristics and clinical utility of CxbM in a new surveillance protocol vs standard of care over four visits • Safely risk stratify patients under surveillance for recurrence of UC • Safely alternate CxbM with cystoscopy for intermediate and high-risk patients under surveillance for recurrence of UC • Targeting AUA guidelines inclusion for biomarkers as an alternative to cystoscopy in a surveillance setting	USA (including some VA sites) Australia	2 / 10	First patient expected in 2022 Q2
MONSTER		MON itoring S tudy of post-T reatment E ffectiveness forR esidual Disease Single-arm, observational study to validate the performance characteristics of Cxbladder against white light cystoscopy during surveillance of UC • Christchurch District Health Board study to measure tumor burden • To safely risk stratify patients for residual disease prior to the 6-week re-resection for high grade patients or the 3-month flexible cystoscopy check for all patients	NZ	0 / 1	In planning, once pilot analysed then consider expansion to USA

*Estimated number of enrolled sites

**All dates are best-case estimates and subject to change

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FOR MORE INFORMATION: Dr. Peter Meintjes Chief Executive Officer email: peter.meintjes@pelnz.com

Grant Gibson Chief Financial Officer email: grant.gibson@pelnz.com

Pacific Edge 87 St David Street, PO Box 56, Dunedin, New Zealand P +64 3 479 5800 F +64 3 479 5801 email: investors@pacificedge.co.nz www.pacificedgedx.com

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