Pacific Edge 2024 Annual Shareholder Meeting

24 SEPTEMBER 2024


ASM PRESENTATION AND CHAIRMAN’S SPEECH NOTES
DUNEDIN, New Zealand – Cancer diagnostics company Pacific Edge (NZX, ASX: PEB) is
holding its Annual Shareholder Meeting in Auckland this afternoon. It attaches Chairman Chris
Gallaher’s speech notes and the company’s presentation for shareholders.
Released for an on behalf of Pacific Edge by Grant Gibson, Chief Financial Officer.
For more information:
Investors: Media:
Dr Peter Meintjes Richard Inder
Chief Executive The Project
Pacific Edge P: +64 21 645 643
P: +64 22 032 1263

Pacific Edge: www.pacificedgedx.com
Pacific Edge Limited (NZX/ ASX: PEB) is a global cancer diagnostics company leading the way
in the development and commercialization of bladder cancer diagnostic and prognostic tests
for patients presenting with hematuria or surveillance of recurrent disease. Headquartered in
Dunedin, New Zealand, the company provides its suite of Cxbladder tests globally through its
wholly owned, and CLIA certified, laboratories in New Zealand and the USA.
Cxbladder: www.cxbladder.com
Cxbladder is a urine-based genomic biomarker test optimized for the detection and surveillance
of bladder cancer. The Cxbladder evidence portfolio developed over the past 14 years includes
more than 20 peer reviewed publications for primary detection, surveillance, adjudication of
atypical urine cytology and equivocal cystoscopy. Cxbladder is the focal point of numerous
ongoing and planned clinical studies to generate an ever-increasing body of clinical utility
evidence supporting adoption and use in the clinic to improve patient health outcomes.
Cxbladder has been trusted by over 4,400 US urologists in the diagnosis and management of
more than 100,000 patients, including the option for in-home sample collection. In New
Zealand, Cxbladder is accessible to 75% of the population via public healthcare and all
residents have the option of buying the test online.

---

24 SEPTEMBER 2024


PACIFIC EDGE – ANNUAL SHAREHOLDERS MEETING
CHAIRMAN’S ADDRESS
It’s great to be back in Auckland.
This year has been a curate’s egg for Pacific Edge...we have experienced both significant
achievements and notable challenges in the 2024 financial year.
I am proud of the work we’ve done as a team to navigate the complexities of our environment
while at the same time remaining clear eyed and focused on delivering value to our patients
and shareholders.
I will return to this in a moment but first – as today marks what is likely to be my final Annual
Meeting as Chairman of Pacific Edge and I want to take a few moments to reflect on what has
been an incredible journey and set out to you my confidence in the future of the business.
When I was first approached to join Pacific Edge back in 2016, I was intrigued. I had spent my
career in senior leadership roles in industries far removed from bladder cancer diagnostics.
But at the same time, I could see my corporate and governance expertise could add value. I
was excited about the potential and its ambition to be a global leader.
I remember meeting Bryan Williams, then Director David Band and former CEO Dave Darling
for lunch in Melbourne and their passion and excitement for what the global future could be
for Cxbladder, a technology developed at Otago University, my old alma mater, by Professor
Parry Guilford. Parry, as you know, remains our Chief Science Officer and his vision on the
potential to detect cancers from urine biomarkers continues to underpin the vision for the
company.
The clinching factor was that Pacific Edge is from and based in Dunedin, the city where I grew
up and went to university. The role represented a great opportunity to get involved in a
business that had the potential to be a global success story from Dunedin.
Shortly after joining the company – a personal experience cemented my conviction in our
future.
A close mate of mine in Melbourne was diagnosed with bladder cancer. Over the years since,
he has suffered 13 recurrences, endured 52 cystoscopies, a procedure that he - like many
bladder cancer patients - has found invasive, painful with a heightened risk of infection and a
bit un-dignifying. He reached a point where he was going to stop undergoing anymore
cystoscopies.
I arranged for him to take one of our tests. However, because Cxbladder was not yet
incorporated into the standards of care in Australia, his urologist wouldn’t accept the results.
His disappointment was real - here was a test that could have spared him the repeated pain
and indignity of cystoscopy, yet he wasn’t able to use it.

24 SEPTEMBER 2024
Thankfully, he is still alive today, but this experience reinforced for me the real-world impact
of what we are trying to achieve at Pacific Edge. We are not just improving diagnostic
accuracy; we are giving people a better quality of life.
It also made clear to me that it is not enough to have a very good test, we must also have the
test that urologists will adopt and use. It is that second goal that has been the challenge and
the focus of Pacific Edge for the company both before I started and ever since.
When I joined the company, the team led by former Chief Executive David Darling had made
significant strides bringing the vision to reality.
We were already selling the test in New Zealand, had established operations in the US and
gained certification for our US laboratory with a clear focus on gaining Medicare coverage in
the US – the single largest reimbursement opportunity in the world.
One of the earliest achievements during my tenure that set us on the right path was the
February 2018 adoption of Cxbladder Triage into the Canterbury Community Health Pathways
for primary care referral. This milestone demonstrated that our product was not only clinically
useful but also aligned with real-world healthcare needs.
Fast forward to 2020 when we achieved two of our most significant goals and it was clear that
our vision of Cxbladder becoming incorporated into global standards of care was within our
grasp.
The first achievement was after years of groundwork, principally by Dave Darling, the
commitment by Kaiser Permanente, one of the largest healthcare providers in the US, to begin
adoption and paying for our tests, a move that was later followed by the introduction of our in-
home sampling kit during the covid 19 pandemic and later the integration of Cxbladder into its
standard of care. These successive milestones represented a significant endorsement of our
product and real reward for the years of effort by our team.
As Peter will set out shortly, we’ve seen consistent growth in test volumes from Kaiser, and
we expect this relationship to be a key part of our US business into the future.
The second milestone achievement was the 2020 decision by Novitas, the Medicare
Administrative Contractor for our laboratory in Hershey Pennsylvania, to approve Medicare
reimbursement of our tests.
This decision not only provided an important validation of our technology, but it was also a
decision that promised to underpin our drive towards financial sustainability, delivering on the
commitments we had made to shareholders who had loyally supported us through multiple
capital raisings.
It was in this environment in late 2021 that we asked investors for the capital to support the
company to realize on these significant opportunities and others it surfaced around the world.
After this, Dave Darling retired after a long career at Pacific Edge and we recruited Peter to
Meintjes, a Kiwi working in Boston, to drive the growth that these two milestones promised.
Peter spent his first six months positioning the company for growth with the expansion of the
sales team, the creation of a new medical affairs team to educate the urological community
on the clinical value of our tests. He also a reconfigured our clinical development program to
entrench our coverage and position our tests for inclusion in guidelines – a goal which if
achieved has the potential to rapidly accelerate test volume growth and adoption.

24 SEPTEMBER 2024
We were rewarded with a rapid acceleration in demand for our tests. And then the rug was
pulled out from under us in 2022 when Novitas issued a draft decision to restructure how
genetic testing is covered with a specific impact on Cxbladder, among others.
While we had always recognized the need to strengthen the basis on which our tests had
Medicare coverage with new evidence, this new approach to determining coverage was a
Black Swan event. It was completely unforeseen — and while it was not specific to Cxbladder
— it has had a profound impact on the company. For over two years, we’ve been in a state of
uncertainty, waiting for a final determination on whether Medicare will continue to reimburse
our tests.
This challenge has tested the resilience of our team, our board, and our shareholders. We
have been forced to make difficult decisions to preserve cash and restructure the business to
ensure we can weather what we see as a decision by Novitas to deny patients continued
access to tests deemed medically necessary by the physicians who order them.
It has not been easy, but I am proud of how we have responded.
Pacific Edge has shown remarkable resilience. Under the leadership of Pete, we have acted
swiftly. We restructured our sales team, and while it was painful and regressive move it has
made us more efficient and focused on profitability.
We have reconfigured the business to focus on the launch of our new tests enhanced with
DNA biomarkers Detect
+
and Monitor
+
.
We accelerated the publication of our STRATA study. This has meant the strongest evidence
yet of Cxbladder’s clinical value is not only included in Novitas’ deliberations, but also the
American Urological Association’s review of its guideline related to hematuria evaluation.
We have meanwhile continued to build our clinical evidence base, positioning ourselves to
regain coverage or secure new opportunities, no matter the outcome of the most proximate
Medicare decision.
Our financial results for FY24 are a testament to our resilience.
Operating revenue grew by 22% to $23.9 million, despite the challenges posed by the
reduction in commercial test volumes in the second half of the year. Total laboratory
throughput increased by 3%, and we saw a strong 18% improvement in the US average sales
price.
We ended the year with $50.3 million in reserves. Our cash burn fell sharply in the second half
of the year, reflecting the difficult but necessary restructuring we undertook. I believe these
results demonstrate the strength and potential of our business, even in the face of uncertainty.
The determination shown by our team, from the boardroom to the lab, has been nothing short
of extraordinary and I want to thank everyone for this commitment and effort. I have every
confidence that we are well-prepared for whatever comes next.
Looking ahead, we have several key catalysts that will shape the remainder of the year.
First is the pending decision from Novitas on Medicare reimbursement for our tests. We are
confident that - over the longer term - our clinical evidence program will position the company
for a positive Medicare decision. However, we remain uncertain if the recent developments

24 SEPTEMBER 2024
are sufficient to change the evidence review by Novitas, despite the concerns we have noted
with that review and the support we have received from the urology community.
Secondly, the AUA’s review of the hematuria guidelines. Clear and or positive language for
the use of biomarkers such as ours would be used as the basis for a Medicare coverage
reconsideration request (in the event of a non-coverage determination).
We are also awaiting the pricing decision for our new product, Detect+, the next step on our
program to commercialise this test.
Any one of these decisions in our favour, as Pete will discuss shortly, could have significant
positive outcomes for the Pacific Edge and our shareholders.
I want to pay tribute to our CEO Pete Meintjes and his team for the way they have dealt with
the challenges the company has had to deal with since we first became aware of the Novitas
draft ruling back in 2022.
Their persistence, perseverance, and optimism has been remarkable and a credit to Pete in
particular who has never wavered in his commitment and belief in the long-term prospects for
Pacific Edge.
Before closing, I want to touch on the changes in governance. Over my tenure which is into is
9
th
year, the Board has undergone significant evolution, benefiting greatly from the recruitment
of Sarah Park, Anna Stove, Mark Green, and more recently, Tony Barclay. These Directors
have brought diverse perspectives and expertise that have enriched our discussions and
enhanced the quality of our decision-making.
Their contributions have been complemented by those of our longer-serving directors, Bryan
Williams and Anatole Masfen, whose experience and deep institutional knowledge have been
critical to Pacific Edge’s growth and success. Bryan's expertise in cancer research and
Anatole's strategic understanding of the business have provided continuity and stability during
times of change.
The Board’s supportive and collaborative culture has been a cornerstone of our ability to face
challenges head-on while staying focused on long-term growth. This cohesion has ensured
that, even in times of uncertainty, we remain steadfast in our mission and well-prepared for
the future.
As I mentioned earlier, this is likely to be my final Annual Meeting as Chairman. I had originally
planned to step down at the end of this year; I had advised the Board that when I got to 70
and after 9 years in the role it will be time to dial back my governance commitments (I have
no desire to do a Warren Buffett).
The continuing uncertainty over our Medicare reimbursement coverage has understandably
made recruiting a replacement for me difficult.
At the Board's request, I have agreed to remain as Chairman until we get clarity on the
Medicare decision and can move forward with the recruitment process and a good handover.
Mark Green will be stepping down at the end of September, his wife has been appointed to a
very big role with Suntory based in New York and his family have moved to the US.

24 SEPTEMBER 2024
Mark has been a terrific Director who brought a different skill set and perspective to the Board
table and we will miss him.
I do note that Directors have not had an increase to their fees for 3 years.
This year in our current circumstances the Board felt it was not appropriate to ask for
shareholders for an increase.
However, we must move fees to a market level if we are going to attract excellent directors to
our Board.
A big personal thank you to the current Board, and the previous Directors; you have been a
fantastic group of people with whom to share the highs and lows of the last 8 and a bit years.
As I prepare to step back, I remain confident that Pacific Edge is well-positioned for success.
With our world-leading products, Pete Meintjes and his committed team, and solid
governance, we are on the path to achieving our long-term goals.
Finally, I want to express my deep appreciation to our shareholders.
Your unwavering support, particularly during challenging times, has been a source of strength
for me and the company. Many of you have stood by us through periods of uncertainty, trusting
in our vision and the potential of our technology.
Your patience has been remarkable.
It is this long-term commitment and belief in our mission that has enabled Pacific Edge to
continue innovating and growing, even in the face of adversity. It has been a privilege to serve
as your Chairman, and I am confident that, with your continued support, Pacific Edge will thrive
in the years ahead.
Thank you and with that I would like to hand you back to Pete.
ends

---

Pacific Edge’s ordinary shares trade on the
NZX and the ASX under the ticker code: PEB
Pacific Edge
ANNUAL SHAREHOLDERS
MEETING
24 September 2024
Auckland

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2

3
CHRIS GALLAHER
Chairman

4
DIRECTORS
SARAH PARK
MARK GREEN
ANNA STOVE
TONY BARCLAY
BRYAN WILLIAMS
ANATOLE MASFEN

1.CHAIRMAN’S ADDRESS
2.CHIEF EXECUTIVE’S ADDRESS
3.QUESTIONS
4.US OPERATIONS
5.OUR CLINICAL PROGRAM
6.QUESTIONS
7.RESOLUTIONS
8.VOTING AND GENERAL BUSINESS
9.MEETING CLOSE
AGENDA

2011
2011
Pacific Edge
Diagnostics
New Zealand
(PEDNZ)
established
2012
Dec 2012
Launch of Pacific Edge
Diagnostics USAand
Cxb Detect
2013
May 2013
First commercial
sale (Cxb Detect)
for PEDNZ
Mar 2013
First commercial
sale (Cxb Detect)
for PEDUSA
2014
Dec 2014
Launch of
Cxbladder
Triage
2015
Dec 2015
Launch of
Cxbladder
Monitor
2016
2018
Feb 2018
Cxb Triage
adopted into
Canterbury
Community Health
Pathways with
primary care
referral
2019
2020
Jun 2020
Kaiser Permanente,
approves commercial
use of Cxbladder
Jul 2020
Medicare
reimbursement of
Cxbladderat
$760/test
2021
Aug 2021
Cxbladder reaches
70% public
healthcare
coverage in NZ
Oct 2021
PEB raises
$103.5m
(~US$72.5m)
2022
Dec 2022
Lotan et al:
Enhanced
Cxbladder
Tests Deliver
Improved
Performance.
Journal of
Urology
6
2023
Nov 2023
Kaiser
Permanente
EMR
integration
goes live
2024
May 2024
STRATA podium
presentation at
AUA 2024.
Study published
in Journal of
Urology
PACIFIC EDGE – TAKING NEW ZEALAND INNOVATION GLOBAL

FY 25 - CATALYSTS FOR GROWTH
$50.3M
CASH, CASH
EQUIVALENTS
2
$23.9m
OPERATING
REVENUE UP
22% VS
FY 23
32,633
GLOBAL TEST
VOLUMES
1
UP
3% VS FY 23
($29.5M)
NET LOSS AFTER
TAX INCREASED
9% VS FY23
1.TLT is the Total Laboratory Throughput including commercial, pre-commercial and clinical studies testing
2.Cash, cash equivalents and short-term deposits
7
24%
DROP IN MONTHLY
CASH BURN
2
IN 2H
24 VS 1H 24
FY 24 - CONSERVING CASH AMID
COVERAGE UNCERTAINTY
POSITIONED FOR GROWTH
•Commercial operations focused on profitable territories, non-Medicare revenue
streams and selling the clinical and economic value of Cxbladder
•Direct sales team efficiency improves - operating at break even
•Refocused the business on the clinical development for Detect
+
and Monitor
+
C ATA LYST S
•Medicare coverage
−Clinical evidence program positioned to deliver additional
evidence for coverage certainty
−Novitas makes a policy decision to continue Cxbladder
Medicare coverage
•Guidelines
−AUA is presently reviewing the microhematuria guidelines;
no timeframe provided
•Detect
+
Medicare pricing
−Cautiously confident of receiving a Medicare price greater
than the current tests, a result that will bolster our
economics
−Commercial launch targeted towards the end of the
current financial year (FY 25)

8
Dr PETER MEINTJES
Chief Executive Officer

9
PACIFIC EDGE IS FOUNDED ON DELIVERING POSITIVE OUTCOMES FOR SOCIETY
WE CREATE VALUE BY PRIORITISING OUR PATIENTS, OUR PHYSICIANS AND OUR PEOPLE
Our Vision
A world where the early diagnosis and better treatment
of cancer is within reach of everyone
Our Values:
Our Sustainability Priorities:

VALUE CREATION THROUGH THREE PILLARS
OUR PEOPLE
OUR PROCESSES
OUR IP, KNOWLEDGE
AND EXPERIENCE
OUR CLINICAL STUDIES
PARTNER SITES
OUR INVESTORS
EARLY DETECTION AND
CLINICALLY ACTIONABLE CARE
INNOVATION PIPELINE FOR
CLINICAL APPLICATIONS
INCLUSIVE WORKPLACE
DRIVEN BY OUTCOMES
INCREASED LONG-TERM
SHAREHOLDER VALUE
EXCELLENT PATIENT EXPERIENCE
AND ACCURATE RESULTS
INPUTSOUTPUTS
A VALUES DRIVEN, DIVERSE, RESULTS-FOCUSED CULTURE
SCALABLE PROCESSES, TRAINING & QUALITY SYSTEMS,CONTINUOUS IMPROVEMENT
DIGITALIZED ARCHITECTURE, AUTOMATED OPERATIONS, REAL-TIME ANALYSIS

17%
61%
22%
21%
57%
22%
GROWTH SLOWED AMID MEDICARE DRAFT
FY 23
TEST VOLUMES BY TYPE (TLT*)
GLOBAL COMMERCIAL TEST VOLUMES (TLT*)
GLOBAL TOTAL TEST VOLUMES (TLT*)
FY 24 TOTAL LAB THROUGHPUT (TLT*)
•Global TLT increased 3% to 32,633 with test demand moderating
amid proposed Medicare coverage changes & sales force reductions
•Global Commercial test volumes increased 2%. Global TLT is driven
by US growth in the US (predominantly Detect)
•Risk stratification during hematuria evaluation using Triage & Detect
is the largest market opportunity & reflected in current volume mix
*TLT is the Total Laboratory Throughput including commercial, pre-commercial and clinical studies testing
FY 24
11
1H
2H
1H
2H
8,147
6,864
11,136
14,920
18,240
8,714
8,950
11,950
16,645
14,393
16,861
15,814
23,086
31,565
32,633
-
5,000
10,000
15,000
20,000
25,000
30,000
35,000
FY 20FY 21FY 22FY 23FY 24
TESTS
6,573
5,591
9,192
12,422
15,401
7,054
7,385
10,004
14,269
11,946
13,627
12,976
19,196
26,691
27,347
-
5,000
10,000
15,000
20,000
25,000
30,000
FY 20FY 21FY 22FY 23FY 24
TESTS

12
FOUNDATIONS FOR GROWTH – US SALES TEAM PERFORMANCE IMPROVES
US SALES TEAM REDUCTIONS TO CONSERVE CASH DAMPEN VOLUME GROWTH IN FY24
US SALES FORCE EFFICIENCY
US CLINICAL COMMITMENT
•Commercial volumes stabilizing with a focus on profitable
sales territories and non-Medicare revenue streams (Kaiser
Permanente and Veteran’s Affairs and others)
•Sales messaging focused on the clinical and economic value of
Cxbladder
•KP volume stepped up after EMR integration, now growing
steadily month on month (every month has been a record)
•Sales force efficiency (sales/FTE) has improved dramatically
•US clinical commitment (tests/clinician) steady, though
ordering clinicians is lower due to reduced sales force reach
US COMMERCIAL VOLUMES
6,073
6,699
6,629
7,816
8,627
7,335
6,041
6,099
5,905
-
1,000
2,000
3,000
4,000
5,000
6,000
7,000
8,000
9,000
Q1 23Q2 23Q3 23Q4 23Q1 24Q2 24Q3 24Q424Q1 25
AVERAGE SALES FTE
895
978
1,082
1,150
1,232
1,147
1,016
915
869
6.8
6.8
6.1
6.8
7.0
6.4
5.9
6.7
6.8
1.0
2.0
3.0
4.0
5.0
6.0
7.0
8.0
-
500
1,000
1,500
2,000
Q1 23Q2 23Q3 23Q4 23Q1 24Q2 24Q3 24Q424Q1 25
TESTS/CLINICIAN
US ORDERING CLINICIANS
TESTS/ORDERING CLINICIAN (RHS)
27
30
33
33
30
28
21
16
15
222
226
201
239
288
265
292
381 403
-
100
200
300
400
-
20
40
60
80
100
Q1 23Q2 23Q3 23Q4 23Q1 24Q2 24Q3 24Q424Q1 25
TESTS/SALES FTE
AVERAGE SALES FTE
US TEST VOLUME/SALES FTE (RHS)

DRIVING GROWTH IN ASIA PACIFIC AND CONSOLIDATING NEW ZEALAND
*
Total Laboratory Throughput in Asia and Pacific including commercial, pre-commercial and clinical studies testing
•Quarterly total test volumes benefit from:
•Fewer evaluations and non-billable tests
•Shift in emphasis to commercial tests
•New Zealand is a mature market with Cxbladder utilized in 15 of the
20 Te Whatu Ora health regions covering >75% of the population
AUSTRALIA & ASIA PACIFIC
•Australia and Southeast Asia are still in business development
•Initial commercial testing volume direct or via distributors in
Singapore, Malaysia, and the Philippines
13
APAC TOTAL TEST VOLUMES*
Sept ’24 - ceremonial signing of partnership agreement with
Malaysia’s Premier Integrated Labs in Kuala Lumpur
983
1,165
1,139
1,061
1,079
1,199
1,142
1,111
1,283
-
200
400
600
800
1,000
1,200
1,400
Q1 23Q2 23Q3 23Q4 23Q1 24Q2 24Q3 24Q424Q1 25
APAC TEST VOLUME

14
EXTENDING OUR REACH THROUGH GLOBAL DISTRIBUTION AGREEMENTS

S T R ATA
1
– THE STRONGEST EVIDENCE YET FOR GUIDELINES INCLUSION
A MILESTONE IN OUR DRIVE FOR MEDICARE COVERAGE CERTAINTY
PARADIGM-SHIFTING STUDY DEMONSTRATES CLINICAL UTILITY OF TRIAGE
•STRATA is the first ever randomized controlled trial of a urine biomarker for
hematuria evaluation:
•This peer-reviewed study published in the AUA Journal of Urology
1

showed clinicians undertook 59% fewer cystoscopies, when provided
a Cxbladder Triage test result
•Seeking to leverage data to demonstrate the clinical utility of Detect
+
•Publication submitted to Novitas as it considers finalization of draft LCD
•New evidence for inclusion in the Pacific Edge Clinical Dossier that we use to
engage with guideline committees, private payors, government payers,
value-based clinician groups and ex-US distributors
•STRATA data available to further improve the Detect
+
algorithm
15
“Cxbladder Triage can help reduce the burden of unnecessary
cystoscopies in this population resulting in less patient morbidity and
discomfort, improved access to care, and reduced environmental
impact.” – Lotan et al. (2024)
1. Lotan et al. (2024) . A Multicenter Prospective Randomized Controlled Trial Comparing Cxbladder Triage to Cystoscopy in Patients With Microhematuria. The Safe Testing of Risk
for Asymptomatic Microhematuria Trial. The Journal of Urology Vol 212 1-8 Jul 2024.
USING CLINICAL EVIDENCE TO DRIVE CXBLADDER ADOPTION
STRATA lead author Yair Lotan presenting STRATA to the 2024 AUA
annual meeting.

AUA HEMATURIA GUIDELINES – A COMPREHENSIVE REVIEW
AN APPROACH THAT SUPPORTS OUR DRIVE FOR GUIDELINE INCLUSION
•The AUA has commenced a review of the microhematuria guideline and has asked for
professional comment on its initial draft; no timeframe provided
•Our Chief Medical Officer Dr Tamer Aboushwareb is participating in the consultation
under confidentiality and with his conflict of interest documented – no disclosure to
Pacific Edge or others is allowed
•The clinical utility of Cxbladder Triage demonstrated by the STRATA study is expected to
be considered as part of the deliberations
•A positive AUA Journal of Urology editorial in July suggests favorable direction of travel
•Clear/positive inclusion language would be used as the basis for a Medicare coverage
re -consideration request (in the event of a non-coverage determination)
16
“... these tests have the potential to improve the
management of our patients with suspected
[urothelial cancer] who would otherwise require an
invasive procedure for diagnosis.”
– Journal of Urology editorial, July 2024
www.auanet.org
•Globally the most influential and largest
urologicalassociation
•Relevant standards of care: Hematuria,
microhematuria management and non-
muscle invasive bladder cancer (NMIBC)
•Review period: with new evidence, last
updated in 2020

17
‘GENETIC TESTING FOR ONCOLOGY’ LCD PROCESS EXTENDED
CMS
1
APPROVED THE EXTENSION TO GIVE NOVITAS
1
TIME TO RESPOND TO ALL COMMENTS
EXTENSION INCREASES CONFIDENCE TOWARDS MEDICARE COVERAGE CERTAINTY
•Cxbladder continues to receive reimbursement from Medicare and Medicare
Advantage payers in line with historical reimbursement rates
•We are increasingly confident that STRATA
2
is being considered as part of Novitas
deliberations
•We are seeking to publish new and independent evidence to support coverage in
the coming months
•Pacific Edge continues to engage with Novitas and CMS with the support of
professional societies, industry partners, clinicians and patient advocacy groups
27 July 2023
Novitas
1
republishes draft LCD
9 September 2023
Review and commentperiod closes
Nov 2023 – Jan 2024
Meetings between Pacific Edge and CMS
26 - 29 July 2024
Pacific Edge learns CMS has granted
Novitas an extension beyond statutory
365-day finalization timeline
DECISION (STILL) PENDING
July 2024 - Present
Pacific Edge and industry partners engage
with Novitas and CMS
CMS says extension is “not indefinite”
Finalization or retirement remain possible
MEDICARE IS PACIFIC EDGE’S LARGEST PAYER
•Medicare and Medicare Advantage is the largest global opportunity in
bladder cancer diagnostics from a single coverage decision
•In FY 24 Medicare and Medicare Advantage delivered ~14,000commercial
tests (~60% of US commercial tests) and ~$17.0m NZD in total operating
revenue (~71% of total operating revenue)
1. Novitas is the Medicare Administrative Contractor for Pacific Edge’s US laboratory. It is empowered by the Centers for Medicare and Medicaid Services (CMS) to
make the coverage determination, but it is accountable to CMS for the decision.
2. Lotan et al. (2024) . A Multicenter Prospective Randomized Controlled Trial Comparing Cxbladder Triage to Cystoscopy in Patients With Microhematuria. The
Safe Testing of Risk for Asymptomatic Microhematuria Trial. The Journal of Urology Vol 212 1-8 Jul 2024.

CLINICAL EVIDENCE CATALYSTS FOR COVERAGE CERTAINTY
18
Pacific Edge will also lodge a reconsideration request if Cxbladder is included in the American
Urological Association (AUA) or National Comprehensive Cancer Network (NCCN) guidelines
MEDICARE RECONSIDERATION AND GUIDELINE INCLUSION REQUESTS
(Novitas
1
typically handles reconsideration requests on existing LCDs within three months of submission)
CatalystTest and evidence standard
(2)
Expected date of reconsideration request
(3)
1. STRATA data published-CU of TriageNovitas notified of the publication in April
2. Automated RNA and DNA extraction-AV of Triage, Detect and MonitorQ3 2024 (Published September, Novitas notified)
3. DRIVE data published-CV of Detect
+
Q2 2025
4. Automated RNA and DNA extraction-AV of Detect
+
Q2 2025
5. STRATA concordance -CU of Detect
+
(concordance)Q2 2025
6. Kaiser Permanente RWE
4
published-CU of Triage (RWE) Q2-Q3 2025
5
7. microDRIVE published-CV of Detect
+
Q3-Q4 2025
8. AUSSIE data published-CVof Detect
+
Q4 2025-Q1 2026
9. Automated RNA and DNA extraction-AV of Monitor
+
Q2 2026
10. Pooled CV data published
6
-CV of Detect
+
Q2 2026
11. LOBSTER published-CV of Monitor/Monitor+Q1 2027
12. CREDIBLE data published-CU of Detect
+
Q3 2027
1
Novitas is the Medicare Administrative Contractor (MAC) charged with making the Medicare local coverage determination for Pacific Edge’s US laboratory
2
AV, CV CU, respectively Analytical Validity, Clinical Validity, Clinical Utility
3
All dates are calendar year rather than financial year and our best current estimates
4
RWE is Real World Evidence
5
Timeline determined by Kaiser Permanente
6
The pooled analysis brings together data from DRIVE, AUSSIE and microDRIVE

1,563
Low-risk patients took a
Cxbladder Triage test
Patients:
- Had no history of
gross hematuria; or
- Refused cystoscopy
1,200 (77%)
N EG AT I V E
Avoided a cystoscopy
363 (23%)
POSITIVE
Identified as ‘high-risk’
of cancer
310
Underwent a
cystoscopy
19
Diagnosed with cancer
(6.1% of those
examined)
INDEPENDENT REAL-WORLD EVIDENCE OF CXBLADDER’S CLINICAL UTLITY
CLINICAL UTILITY EVIDENCE OF CXBLADDER TRIAGE THAT SUPPORTS MEDICARE COVERAGE
19
1.
Real World Clinical Utility of a Urinary Biomarker (Cxbladder Triage) for Hematuria Referrals in an Integrated Managed Care Health System. Abstract accepted for presentation to the
Western Section of the American Urological Association annual conference.
KAISER PERMANENTE ABSTRACT SHOWS CLINICAL VALUE IN REAL WORLD SETTING
•Kaiser Permanente have submitted an abstract to the Western Section AUA
conference regarding their ongoing experience with Cxbladder Triage
•The abstract focuses on 1,563 low-risk patients in the Kaiser Southern California
health system with no history of gross hematuria or who refused cystoscopy
•1,200 patients avoided invasive cystoscopy, improving patient satisfaction,
urology access and lowering the overall cost of care
•A peer-reviewed publication is expected on the complete data set, targeting the
AUA conference in 2025
•Pacific Edge will use this future publication for a Medicare reconsideration request
(in the event of a non-coverage determination)
“Incorporating a highly reliable urine biomarker into clinical workflows for
hematuria reduced the burden of cystoscopy substantially, improving
patient satisfaction, urology access, and lowering overall cost of care,”
- Loo et al (2024)
1

20
STRATEGIC RESPONSES TO THE IMPENDING MEDICARE DETERMINATION
OUR RESPONSE TO AN AFFIRMATION OF COVERAGE
•Strategic review to accelerate the US adoption of
Cxbladder among patients, clinicians, and healthcare
payers​​
OUR RESPONSE TO A LOSS OF COVERAGE
•Explore legal options supported by customers, industry
partners and other impacted companies
•Further review the structure of our operations and our
strategy to reduce cash burn in line with our plan to
regain Medicare coverage within our existing cash
reserves
•Continue to explore other strategic alternatives for Pacific
Edge that could support the company through to
regaining Medicare coverage and advancing the
commercialization of Cxbladder globally.
LONG TERM VALUE CREATION STRATEGIES WILL CONTINUE
•Continue to advance our clinical evidence generation program for
inclusion in AUA and NCCN Guidelines for increased coverage
certainty​.
•Continue to invest in medical affairs and the digitalization initiatives
that will enable clinicians who continue to order Cxbladder to
follow clinical pathways on all appropriate patient types.
Distribution of Current
U.S. Customers
Pacific Edge Diagnostics
USA, Hershey,
Pennsylvania
AUA: American Urological Association; NCCN: National Comprehensive Cancer Network

RESEARCH & INNOVATION – FOCUSED ON DNA ENHANCED PRODUCTS
READYING FOR THE LAUNCH OF DETECT
+
AND MONITOR
+
•Ensure R&D, Digital and Lab Operations focus on the launch of Detect
+

and Monitor
+
•Simplifying Cxbladder:
•Aim to reduce technician time, lower cost of goods, lower
turnaround time, increase throughput and increase automation
•Aim to be IVD-ready with “kittable” Cxbladder tests for
decentralized deployment for international market expansion
•Analytical Validation (AV) of automated end-to-end lab
operations for RNA and DNA workflows.
•AV data for the automated Cxbladder (Triage, Detect and
Monitor), i.e. RNA is now published
1
•Establish in-vitro diagnostic (IVD) regulatory framework for R&D of our
next generation tests
•Continued engagement with industry and academic research and
development collaborations to address unmet clinical needs in bladder
cancer diagnosis and management
21
1. Harvey et al (2024). Analytical Validation of Cxbladder
®
Detect, Triage, and Monitor: Assays for Detection and Management of Urothelial Carcinoma.Diagnostics.
2024; 14(18):2061. https://doi.org/10.3390/diagnostics14182061
Chief Scientific Officer Parry Guilford (center) and Chief Technology
Officer Justin Harvey (right)

22
DAVID LEVISON
President
Pacific Edge Diagnostics USA
PACIFIC EDGE USA - OPERATIONS

23
MEDICARE & MEDICAID – THE LARGEST VOLUME FROM SINGLE DECISION
HEALTH INSURANCE IN THE US MARKET – SERVING 335 MILLION PEOPLE
1
1. United States Census Bureau
65.6%
36.1%
7.9%
0%
10%
20%
30%
40%
50%
60%
70%
PRIVATEPUBLICUNINSURED
SHARE OF THE US POPULATION
US HEALTH INSURANCE COVERAGE
1
PUBLIC FUNDED INSURNCE:
Medicare, Medicaid, Veterans Admin, etc.
•Limited options for plan design
•Little or no out of pocket expense for patient
•Coverage decisions decentralized
COMMERCIAL INSURANCE
Preferred Provider Organizations (PPO)
•Cigna, United Health, Aetna, Blue Cross Blue Shield
•Wide choice of plan designs
•Wide choice of physicians and services
•Wide variance in cost to patient
Health Maintenance Organizations (HMO)
•Kaiser, Geisinger, Intermountain Health
•Kaiser is a capitated HMO
•Limited plan designs and services offered
•Must use specific clinicians
•Lower cost to patient, often fixed costs

24
FOCUSING OUR EFFORTS ON CONCENTRATIONS OF DEMAND
1.AUA Census 2023
HOW THESE MARKET FEATURES INFLUENCE OUR EFFORTS
•We serve a population of 14,176 US practicing urologists
1

•>60% of those urologists practice in small, private groups
•Consistent clinical education is key to developing lasting
clinical patterns
•Improving patient workflow / office efficiency drives demand
and stickiness
•Macro trends are highlighting the need for less invasive
treatment options
1,061
1,424
1,730
2,112
3,881
3,968
7%10%12%15%27%28%
-
500
1,000
1,500
2,000
2,500
3,000
3,500
4,000
4,500
Solo practicesPublic or
private
hospitals
OtherMulti-specialty
groups
Single urology
groups
Academic
centers &
medical schools
UROLOGISTS
UROLOGISTS AGE
1
UROLOGISTS PLACE OF WORK
1
680
3,413
2,884
3,102
4,097
5%
24%20%22%29%
-
500
1,000
1,500
2,000
2,500
3,000
3,500
4,000
4,500
34 or under35 to 4445 to 5455 to 6465 or older
UROLOGISTS

25
For clinicians and patients, Cxbladder offers better care, avoids unnecessary procedures & improves workflow.
For healthcare payers it offers substantial total cost savings per patientwhen used to intensify or de-intensify
hematuria evaluation
1
1
Pacific Edge has developed a detailed budget impact model to understand costs to private practice, healthcare institutions and payers, over and
above the Cxbladder Detect test price of US $760/test focused on microhematuria patients.
Budgetary Impact of Including the Urinary Genomic
Marker Cxbladder Detect in the Evaluation of Microhematuria Patients - PubMed (PMID: 37914255)
SELLING CXBLADDER’S CLINICAL, ECONOMIC AND PATIENT VALUE
Pacific Edge
modelling
1

suggests avoided
procedures could
save >US$500 per
patient with
microhematuria
CURRENT PRACTICE (AUA GUIDELINES)
CXBLADDER DETECT INTRODUCED TO STANDARD OF CARE

MEDICAL AFFAIRS
- Clinical education
- Sales support
SALES
- Growing test volume
- Direct customer engagement
MARKETING
- Sales support
- Conference planning
- Product management
CUSTOMER CARE
- Issue resolution
- Logistics
- Administration
LAB OPERATIONS
- Sample management and
processing
- Quality and regulatory
management
MARKET ACCESS AND
REIMBURSEMENT
- Revenue cycle management
- Payor relationships
26
PACIFIC EDGE USA FUNCTIONAL CAPABILITIES
ACTIVITIES THAT TRAVERSE SALES AND MEDICAL AFFAIRS TO LAB OPERATIONS
AN AVERAGE WEEK
•~1,000 direct sales interactions
•400-500 samples processed
•5-10 Medical Affairs educational
sessions with clinicians
•Customer care issues managed with
~300 phone calls and emails

1. RDM: Residual Disease Monitoring,
2. TRM: Therapeutic Response Monitoring
3. Lotan et al (2022) ‘Urinary Analysis of FGFR3 and TERT Gene Mutations Enhances Performance of Cxbladder Tests and Improves Patient Risk Stratification’
27
SIMPLIFYING THE CXBLADDER VALUE PROPOSITION – DETECT
+
& MONITOR
+
ADDITION OF DNA BIOMARKERS ENHANCES TEST PERFORMANCE
3
Performance
3
SensitivitySpecificity NPVPPVROR
CxbDetect
+
97%90%99.7%44%83%
CxbTriage89%63%99%16%59%
CxbDetect74%82%97%25%78%
HEMATURIA EVALUATION TEST PERFORMANCE
The improved performance characteristics of Detect
+
mean it can do
the job of Triage (a negative test rules out the presence of urothelial
cancer) and Detect (a positive test suggests a higher probability of
cancer and justification for an intensification of a urologic workup)

28
PREPARING FOR DETECT
+
COMMERCIALIZATION
EXPANDING AND EXTENDING OUR LEADERSHIP POSITION IN HEMATURIA EVALUATION
ESSENTIAL PRE-CONDITIONS TO LAUNCHING DETECT
+
•Pricing that reflects the clinical value and economic benefit of the test
•Reliable Medicare reimbursement via (existing) coverage of our tests or through
new arrangements following Novitas policy decision on the draft ‘Genetic testing
for oncology’ LCD (DL 39365)

COMMERCIAL PREPARATORY WORK
•Driving for coverage and reimbursement of Detect
+
•Adding capabilities and capacity to PEDUSA laboratory
•Simplifying laboratory workflow for improved efficiency
•Optimizing sales team structure for expanded product adoption
•Preparing sales and marketing training materials
•Enhancing medical education with a speaker bureau, podium presentations, and
evidence development

29
DETECT
+
PRICING STANDS TO BOLSTER PACIFIC EDGE’S ECONOMICS
PRICING OF DETECT
+
IS THE NEXT STEP IN THE COMMERCIALISATION PROGRAM
•Pricing of Detect
+
is the next step in establishing
reimbursement
•The Crosswalk strategy for pricing of Detect
+
is
based on technological similarities to previously
priced tests:
•Existing CMS price for Cxbladder ($760) is the
best reference for RNA components of Detect
+
•A highly-similar match for the DNA/ddPCR
component has been identified at $1,800
•Based on this approach we are seeking a Crosswalk
price of US$2,560 with CMS
•If CMS disagree with the Crosswalk candidate and
prefer Gapfill, we will seek a ‘provisional local price’
for Detect
+
from Novitas and follow the Gapfill
process
•Gapfill requires all MACs to recommend a price and
takes 12 months to finalize
Anticipated timeframe for Detect
+
pricing - dates may change

30
STRENGTHENING OUR CUSTOMER EXPERIENCE
DRIVING ‘STICKINESS’ AND LONG-TERM MARKET SHARE
PATIENT
JOURNEY
PRE-APPOINTMENT
PHYSICIAN
EVALUATION
TEST ORDERING
1
INSURANCE
COVERAGE
APPOINTMENT
SCHEDULING
RECEIVING
RESULTS
1

ONGOING
SURVEILLANCE
PATIENT
BENEFIT
Pre-visit screening
questionnaire
Facilitates
communication of
treatment options
Real time
information on test
ordering and
sample collection
Informed on
medical coverage,
deductibles and
copays
Scheduling of
sample collection
in home or in lab
Results notifiedScheduling future
recurring
appointments
HEALTH
PROVIDER
BENEFIT
Identify testing eligibility
for patients
New result/info
incorporated into EMR
automatically
Physician prompts
(e.g. smoking
history)
No additional data
entry for paperless
test ordering
Informed on
medical coverage,
deductibles and
copays
Scheduling,
compliance and
follow up
Results notified.
Next steps
identified
Appointments,
compliance and
follow up
THE BEST AND MOST CUSTOMER-FRIENDLY TEST
•Give customers options to connect with Pacific Edge to fit their needs with
easy-to-use digital workflows
•Electronic Medical Record (EMR) integrations
•Pacific Edge Customer Portal
•Pathology Lab LIS integrations
•Improvement of end-to-end experience for patients and providers
INTEGRATED HEALTHCARE – THE POTENTIAL LONG-TERM OPPORTUNITY
1 – Current areas of functionality where Pacific Edge provides a digital experience to physicians and patients

31
OUR CUSTOMER PORTAL – STREAMLINING THE CUSTOMER EXPERIENCE
Please click the image above to launch the customer portal video

32
EMR SUPPORTING ADOPTION AT KAISER PERMANENTE
•EMR integration went live in Nov 2023 across Kaiser’s
Southern California Permanente Medical Group
streamlining sample collection, test ordering and test
resulting for Triage and Monitor
•All 15 Kaiser SoCal sites are now ordering and volumes
increasing steadily
•Primarily adopted for Triage, Monitor volume is
beginning to rise as clinicians become increasingly
familiar with Cxbladder
•Kaiser SoCal represents ~37% of the >12.6m members
covered Kaiser Permanente, longer term we are
targeting other regions

33
LUMEA – ESTABLISHING DIGITAL LINKS WITH 450 CLINICS
ALIGNING OUR SYSTEMS WITH PRE-EXISTING EMRS AND CUSTOMER PORTALS
•Lumea BxLink is a Digital Pathology Lab Information
System for pathology labs that is integrated with
approximately 450 clinics (not all of which are urology)
•Approximately 200 of these clinics have previously
ordered a Cxbladder test
•BxLink is a Digital Pathology solution for those who do
not want to change their LIS
1
•By integrating with BxLink, Pathology Labs can offer
their customers the option to order a Cxbladder test
from their EMR or from BxLink
•The integration went live on 12 September US time and
is following a phased rollout plan
•The integration gives clinics the ability to electronically
order the Cxbladder tests and have the results returned
as part of the patient record in the EMR
•We expect the integration to result in a greater market
adoption and greater ordering stickiness by improving
customer experience and reducing barriers to adopt
1 – LIS: Lab Information System

34
STRENGTHENING OUR FOUNDATIONS – OPERATIONAL EXCELLENCE
DIGITALIZATION, AUTOMATION & CUSTOMER EXPERIENCE
Readying our operations to scale
•Improve Lab Operations and Customer Service with focus on increasing
automation and reducing turn around time
•An operational plan to scale to more than 250k samples after gaining
Medicare certainty and guidelines inclusion:
•Investing in people with more recruiting, training and professional
development
•Optimizing equipment utilization with swing shifts, second shifts and
extra lab operating days
•Product development to accommodate increase in throughput/FTE
•Supply Chain review to drive down COGS, reduce wastage and shorten
lead times
Data Management and Digital Information infrastructure
•Organization-wide data warehouse for storage, access and reporting of all
commercial data
•Customer Relationship Management (CRM) rollout expanded beyond sales to
all commercial teams

35
Dr TAMER ABOUSHWAREB
Chief Medical Officer
Pacific Edge Diagnostics USA
OUR CLINICAL RESEARCH
PROGRAM

36
PACIFIC EDGE’S EVIDENCE PROGRAM SEEKS TO CHANGE CLINICAL PRACTICE
Clinical Evidence
AV, C V, C U
HEALTHCARE PAYERS
(Medicare, Kaiser
Permanente, Veterans
Administration, private
payers, etc).
- Change Medical Policy
(practice)
- Change Reimbursement
Policy
PROFESSIONAL SOCIETIES
(AUA, EAU, NCCN)
- Change Standard of Care
Guidelines
Guidelines change:
- Healthcare Payer Medical
and Reimbursement
Policies
Guidelines change:
- Clinical Practice
UROLOGISTS - Change Clinical Practice
STRUCTURED CLINICAL EVIDENCE DEVELOPMENT
•Pacific Edge’s clinical study program is focused on developing clinical evidence for Cxbladder tests in a structured framework
•Analytical Validity (AV): Evidence that a test is repeatable in the lab for a given indication and population
•Clinical Validity (CV): Evidence a test works in the same way on an independent eligible population for a given indication
•Clinical Utility (CU): Evidence that a test changes clinical practice in the hands of a physician, typically in prospectively recruited RCTs
•Real World Evidence (RWE): CU verification of the real-world use of the test in clinical practice, usually through regular use of the test by physicians
•Clinical Utility evidence obtained through randomized control trials is required to change standard of care guidelines (in addition to AV and CV evidence)
AUDIENCE
EVIDENCE USE

37
EVIDENCE STANDARD DEMONSTRATED
1
TEST
ANALYTICAL
VALIDITY
CLINICAL
VALIDITY
CLINICAL
UTILITY
Cxb Triage
√√√
Cxb Detect
√√√
Cxb Monitor
√√√
Cxb Detect
+
Cxb Monitor
+
NOTE: The evidence standard may have been demonstrated in one or multiple publications
FOCUSED ON CLINICAL EVIDENCE FOR DETECT
+
AND MONITOR
+
DELIVERING CLINICAL EVIDENCE THAT DRIVES BEHAVIOR CHANGE AND GUIDELINES INCLUSION
PROGRAM TARGETS CU AND CV OF DETECT
+
•Cxb Triage, Detect and Monitor are already well established in clinical practice
•Our Clinical Dossier becomes increasingly impactful with higher grades of
evidence, e.g. CU evidence from randomized control trials like STRATA
•The evidence generation program is now weighted to demonstrating the CV
and CU of Detect
+
for the risk stratification of hematuria patients
•CV evidence for Detect
+
will be established with DRIVE, AUSSIE & microDRIVE
•Concordant CU for Detect
+
can be demonstrated by comparison with Triage:
•Concordance study (direct comparison of performance characteristics in
identical clinical conditions)
•Shared clinical pathway
•Superior performance characteristics
•Targeting completion in Q2 2025
•CREDIBLE to deliver ‘level 1’ CU evidence of Detect
+
as a gold-standard,
standalone, randomized control trial to strengthen the evidence to support
guideline inclusion
•Monitor
+
(surveillance) is in the early stages of development and requires more
time to generate the requisite evidence for adoption and guidelines
1. For detail of the studies and timelines to completion please see the appendix to this presentation

38
PACIFIC EDGE’S PROGRAM SUPPLEMENTED BY INDEPENDENT RESEARCH
INVESTIGATOR INITIATED TRIALS (IITS)
•IITs extend the Cxbladder clinical dossier with evidence for new indications of existing tests that may inform new ‘core’ clinical trials
•IITs are independent but we offer support from study conception through to publication. We may provide free testing and some other
support for the basic needs of the study
•IITs are a part of KOL engagement and lead to publications or podium presentations that give profile to Cxbladder and Pacific Edge
•The costs to Pacific Edge are low - typically no more than the cost of running the tests in our lab
INDEPENDENT STUDIES UNDERWAY
STUDYINSTITUTION/LOCATION
TEST AND EVIDENCE
STANDARD
EXPECTED
PUBLICATION
Patient preference and satisfaction of “bio-markers vs cystoscopy”Mayo Clinic, USMonitor – CU 2025
Review of the Canterbury experience of Cxbladder Triage in the primary
care setting
Canterbury DHB, New ZealandTriage – CU (RWE)2025
Can biomarkers (Detect
+
) be used to screen patients at risk for bladder
cancer
UT Southwestern, USDetect
+
– CU2027
Can biomarkers (Monitor) be used to report on therapy success in a
reduced chemotherapy protocol for the management of upper tract
tumors
Israel Institute of Technology, Israel
Monitor – CU
Monitor
+
– CU
2027
Can Cxbladder monitor be used to assess response to BCG in high grade
UC patients
University of Miami, US
Monitor – CU
Monitor
+
– CU
2027
Can Cxbladder be used for surveillance of muscle invasive bladder cancer
patients treated with bladder sparing methods. (PRESERVE Trial)
Cleveland Clinic, US
Monitor – CU
Monitor
+
– CU
2028
A Randomized Trial of Apalutamide in Non-Muscle Invasive Bladder
Cancer
National Institutes of Health, US
Monitor – CU
Monitor
+
– CU
2029

39
ENGAGING KEY OPINION LEADERS FOR CLINICAL EXCELLENCE AND ADVOCACY
•Managing Key Opinion Leaders is a core responsibility of the Medical Affairs Team
•All members of the team are non-practicing physicians, or have similar
qualifications like PhDs in biology or a Pharm D
•We engage our KOLs to:
•Review protocols of our clinical trials
•Advocate for our product’s inclusion into guidelines based on the published
clinical evidence
•Provide guidance informally as part of routine business
•Provide guidance formally as part of our Clinical Advisory Board (CAB)
•Speak to other physicians on our behalf as speakers in our Speakers Bureau
•Lead a clinical trial site (core evidence generation, ITTs, registries)
•Author research publications on basic science or health economics

40
KEY CLINICAL ADVISORS AND CONSULTANTS
Associate Professor Katie Murray, DOMS, FACS
Institution: NYU Langone
Relationship: Consultant, CAB member,
Brief Bio: Published >80 articles. Deputy Editor for J Urol.
Leadership roles for SUO Young Urologic Oncology Clinical Trials
Professor Jonathan Wright, MD, MS, FACS
Institution: Fred Hutchinson Cancer Center at UW
Relationship: Consultant, CAB member, CT PI
Brief Bio: Member of ACS, SUO, AUA
Professor Wade Sexton, MD
Institution: University of South Florida & Moffitt Cancer Center
Relationship: Consultant, CAB member
Brief Bio: Published >100 articles. NCCN Bladder Cancer
guidelines, AUA Annual Board Review Course
Professor Jay Raman, MD
Institution: Penn State and Hershey Medical Center
Relationship: Consultant, CAB member, CT PI
Brief Bio: Published >350 articles. Chair of AUA Office of Education
and Past-President of the Mid-Atlantic AUA section. Urology
Advisory Council for ACS, hematuria guidelines member
Associate Professor Kristen Scarpato, MD, MPH, FACS
Institution: Vanderbilt University Medical Center
Relationship: Consultant, CAB member, CT PI
Brief Bio: SUO Education Committee, AUA Core Curriculum,
Urology Practice Editorial Committee
Professor Yair Lotan, MD
Institution: UT Southwestern Medical Center
Relationship: Consultant, CAB member, IIT PI, CT PI
Brief Bio: Published >500 articles. Contributor to AUA/ASCO/ASTRO
MIBC and hematuria guidelines. Chair of AUA Core Curriculum. BCAN
Adboard
Professor Sam Chang, MD, MBA
Institution: Vanderbilt Cancer Center
Relationship: Consultant, CAB member
Brief Bio: Published >200 articles. Chair of AUA NMIBC Guidelines,
SUO Executive Board, ABU/AUA Examination Committee, BCAN
Adboard, AUA representative to the AJCC
Assistant Professor John Sfakianos
Institution: Icahn School of Medicine at Mount Sinai
Relationship: Consultant, CAB member
Brief Bio: Published >20 articles. Reviewer for J Urol and Urologic
Oncology
Professor Dan Barocas, MD, MPH, FACS
Institution: Vanderbilt University Medical Center
Relationship: Consultant, CAB member
Brief Bio: Published >100 articles. AUA guidelines panel for
microscopic hematuria. Reviewer for AUA educational materials
Associate Professor, Siamak Daneshmand, MD
Institution: Keck School of Medicine at USC
Relationship: Consultant, CAB member, CT PI
Brief Bio: Published >200 articles. Editorial board of the J Urol,
Bladder Cancer Journal, Current Opinions in Urology, BCAN Adboard,
AUA/SUO Guideline Committee on NMIBC
ASCO: American Society of Clinical Oncology
ASTRO: American Society of Radiation Oncology
AUA: American Urological Association
BCAN: Bladder Cancer Advocacy Network
CAB: Clinical Advisory Board
CT PI: Clinical Trials Principal Investigator
FACS: Fellow of the American College of Surgeons
IIT PI: Investigator Initiated Trial Principal Investigator
J Urol: Journal of Urology
KOL: Key Opinion Leader
MPH: Master of Public Health
SUO: Society of Urologic Oncology

41
Dr PETER MEINTJES
Chief Executive Officer

SUMMARY AND OUTLOOK: READY FOR ALL OUTCOMES
•We continue to manage our cash prudently while we establish coverage
certainty
•We will continue to:
•Preserve reimbursement of our existing portfolio of tests
•Focus on the clinical development of Detect
+
and Monitor
+
for
guidelines inclusion and increased coverage certainty
•Focus our commercial operations on profitable territories, non-Medicare
revenue streams and cash collections
•Emphasize the clinical and economic value of Cxbladder in our sales
messaging
HEADWINDS:
•Possible non-coverage determination from Novitas on a new proposed LCD
after following appropriate ‘notice and comment’ procedure
•Possible negative physician or patient response to enhanced patient
responsibility on commercial insurance
C ATA LYST S :
•Possible inclusion of Cxbladder Triage in AUA microhematuria guidelines
amendment
•Possible retirement of Novitas LCD (DL39365)
•Possible re-coverage determination from Novitas on new proposed LCD after
following appropriate procedure
•Crosswalk or ‘provisional pricing’ for Cxbladder Detect
+
at greater margin that
current generation of products
42

APPENDIX

BLADDER CANCER
A SIGNIFICANT GLOBAL HEALTHCARE CHALLENGE
1. World Cancer Research Fund Annual case figure is 2020.
2. American Society of Clinical Oncology
Annual death figure is 2020.
3. Average recurrence for low grade non-muscle invasive bladder cancer as published in Palou J et al (2012): Eur Urol 2012; 62: 118.
4. International Agency for Research on Cancer
52
10
th
Most common
cancer world-
wide
1
~70%
Recurrence
3
~573K
Annual cases
and growing
1
>212K
Annual
deaths
2
6
th
Most common
cancer in men
1
17
th
Most common
cancer in women
1
<1.7 1.7 to 2.7 2.7 to 5.3 5.3 to 8.6 >8.6
INCIDENCE PER 100,000 OF THE POPULATION
4

1. Pacific Edge estimates
USA – Total Addressable Market (TAM) US$3.5b
Americas (non-US) – TAM US$0.5b
EMEA (w/o most of Africa) – TAM US$1.4b
APAC (w/o China) – TAM US$2.2b
US$7.6b
To t a l
Addressable
Market
1
53
CXBLADDER IS A GLOBAL OPPORTUNITY
•US is the focus of our growth efforts
•New Zealand is a mature market
•APAC in business development
•Distribution considered in other markets
on a case-by-case basis
GLOBAL COMMERCIALIZATION

54
PACIFIC EDGE FIVE YEAR CLINICAL STUDY ROAD MAP

55
PACIFIC EDGE FIVE YEAR CLINICAL STUDY ROADMAP (continued...)

56
FY 24: REVENUE GROWS WITH INCREASED ADOPTION OF CXBLADDER
GROWTH MODERATES IN 2H 24 WITH REORGANIZATION CRIMPING SALES
•Operating revenue increased 22% in FY 24 vs FY
23with increased volumes and an increase in
average receipts.
•Operating revenuein 2H 24 drops vs 1H 24 due to
the restructuring to focus on profitable territories.
•Total revenue includes FX gains of $0.6m inFY 24,
lower than the$2.3m in FY 23.
•Operating expenses are up 11% FY 24 vs FY 23,
however are down 15% in 2H 24 vs 1H24 due to the
impactof therestructuringlate Q2 24.
•Balance sheet remains strong and expected to be
sufficient to regain coverage in the event of a non-
coverage decision.
FINANCIAL PERIOD
2H 241H 24FY24FY 23FY 24 vs.2H 24 vs.
FY 231H 24
$000$000$000$000
△
%
△
%
Operating revenue$10,812$13,095$23,907$19,61622%-17%
Total revenue$12,713$16,580$29,293$26,12412%-23%
Operating expenses$26,996$31,832$58,828$53,08911%-15%
Net Loss Before Tax-$14,283-$15,252-$29,535-$26,96510%-6%
Cash receipts from
customers
$10,561$13,576$24,137$18,46831%-22%
Net operating cash burn$10,758$14,992$25,750$25,5751%-28%
Net cash, cash equivalents
and short-term deposits
$50,261$62,174$50,261$77,791-35%-19%

SUMMARY OF CLINICAL EVIDENCE
StudyPop. TypeSensitivity (Sn)NPVSpecificity (Sp)
Comment
Detect+
Proof of
concept
Lotan et al., 2022MH + GH*97%99.7%90%Pooled data from US and Singapore cohorts (n=804)
CV
DRIVE (unpublished) (1)MH + GH*Study in progress
AUSSIE (unpublished) (4)MH + GH*Study to start this year
microDRIVE (unpublished) (5) MH*Study to start this year
CUCREDIBLE (not started)(6)MHProtocol in final development stages, site selection starting by the end of year.
Triage
AVKavalieris et al., 2015MH + GH*95.10%98.50%45%Sn, Sp, NPV values when test-negative rate is 40%
CV
Davidson et al., 2019MH + GH*95.5% (1)98.6% (1)34.3%GH only: Sn (95.1%), NPV (98%), Sp (32.8%); MH only: Sn (100%), NPV (100%), Sp (42.6%)
Konety et al., 2019(2)100%
Cxbladder (3) correctly adjudicated all UC confirmed patients (n=26) with atypical urine cytology
results (n=153, 4)
Lotan et al., 2022MH + GH*89%99%63%Pooled data from US and Singapore cohorts (n=804)
CU
Davidson et al., 2020MH + GH*89.4% (5)98.9% (5)59% (5)
39% of patients testing negative for Cxb Triage & imaging did not get cystoscopy & were
managed at primary care (6)
Lotan et al., 2024 (7)MH + GH*90%99%56%
Showed clinicians using Triage undertook 59% fewer cystoscopies on low-risk patients
presenting with hematuria.
Detect
AVO'Sullivan et al., 2012GH*81.8%97%85.1%Cxb Detect detected 97% of HG tumors & 100% of Stage 1 or greater tumors
CV
Lotan et al., 2022MH + GH*74%97%82%Pooled data from US and Singapore cohorts (n=804)
DRIVE (unpublished) (1)MH + GH*Study in progress
Health
Economics
Tyson et al., 2023 MH
Published economic model shows significant savings for healthcare payers (median savings of
$559 in direct costs per patient)
Monitor
AVKavalieris et al., 2017(1)88% (2)97% (2)N/A(3)
CVKonety et al., 2019(4)100%
Cxbladder (5) correctly adjudicated all UC confirmed patients (n=26) with atypical urine cytology
results (n=153, 6)
CUKoya et al., 2020(7)
Integration of Cxb Monitor into the surveillance schedule reduced annual cystoscopies (39%)
(8,9)
CULi et al., 2023(7)
Cxbladder Monitor safely postpones a patient’s next scheduled cystoscopy, the current ‘gold
standard’ for bladder cancer surveillance
* Referred patients. Definitions - MH: Microhematuria, GH: Gross Hematuria. For Sensitivity, NPV and Specificity please see page 41 of this presentation
57

FOOTNOTES FOR CLINICAL EVIDENCE SUMMARY
Footnotes
Detect
+
1Observational study to validate performance characteristics and clinical utility of Cxbladder tests (Cxb Triage, Cxb Detect, Cxb Detect
+
).
2Observational study to validate performance characteristics of Cxb Detect
+
in patients with UC of the upper tract.
3Patients with suspected upper tract UC (UTUC) or surveillance patients with a history of UTUC.
4Observational study to validate performance characteristics and clinical utility of Cxbladder tests (Cxb Triage, Cxb Detect, Cxb Detect
+
).
5Observational study to validate performance characteristics of Cxb Detect
+
in microhematuria (MH) patients.
6Clinical utility study comparing the reduction of cystoscopy use when implementing the new clinical pathway to SOC in a defined MH population.
Triage
1
Cxb Triage performance; Cxb Triage & imaging combined performance had a Sn of 97.7% & NPV of 99.8%.
2
Patients included hematuria evaluation (n=436) or surveillance previously diagnosed with UC (n=416) with both Cxbladder & urine cytology results.
3
Cxbladder includes Cxbladder Triage & Cxbladder Monitor.
4
This included n=70 for patients with hematuria & n=83 for patients with previously diagnosed UC and overall test negative rate of 30.7%.
5Cxb Triage performance; Cxb Triage & imaging combined performance had a Sn of 98.1%, NPV of 99.9% & Sp of 98.4%.
6Cxb Triage negative rate was 53%; Follow-up period of 21-months showed no missed cancers, demonstrating safety.
7
Cxb Triage demonstrated to have clinical utility in safely risk stratifying low risk microhematuria patients and not undertake cystoscopy.
Detect
1
Observational study to validate performance characteristics and clinical utility of Cxbladder tests (Cxb Triage, Cxb Detect, Cxb Detect
+
).
Monitor
1
Surveillance patients previously diagnosed with primary or recurrent UC.
2
Cxb Monitor performance characteristics on surveillance patients diagnosed with primary UC; Cxb Monitor had a Sn of 93% and NPV of 94% on patients with recurrent UC.
3
Using Kavalieris et al., (2017) data set, Lotan et al., (2017) compared relative performance of Cxb Monitor against NMP22 ELISA, NMP22 BladderChek and urine cytology.
4Patients included hematuria evaluation (n=436) or previously diagnosed UC (n=416) with both Cxbladder & urine cytology results.
5Cxbladder includes Cxbladder Triage & Cxbladder Monitor.
6
This included n=70 for patients with hematuria & n=83 for patients with previously diagnosed UC; test negative rate of 30.7%.
7
All patients were being evaluated for recurrence of UC (n=309 providing 443 samples).
8
Cxb Monitor identified all seven confirmed recurrence events idnetified on the first cystoscopy.
9
Patients returning negative Cxb Monitor results (n=235) had no pathology-confirmed recurrence at 1st cystoscopy
58

REFERENCES SUMMARY OF CLINICAL EVIDENCE
References
Detect
+
Lotan et al., (2022). Urinary Analysis of FGFR3 and TERT Gene Mutations Enhances Performance of Cxbladder Tests and Improves Patient Risk Stratification.The Journal of Urology, 10-1097.
Triage
Davidson et al., (2019). Inclusion of a molecular marker of bladder cancer in a clinical pathway for investigation of haematuria may reduce the need for cystoscopy.NZ Med J,132(1497), 55-64.
Davidson et al., (2020). Assessment of a clinical pathway for investigation of haematuria that reduces the need for cystoscopy.The New Zealand Medical Journal (Online),133(1527), 71-82.
Kavalieris et al., (2015). A segregation index combining phenotypic (clinical characteristics) and genotypic (gene expression) biomarkers from a urine sample to triage outpatients presenting with hematuria who
have a low probability of urothelial carcinoma.BMC urology,15(1), 1-12.
Konety et al., (2019). Evaluation of Cxbladder and adjudication of atypical cytology and equivocal cystoscopy.European urology,76(2), 238-243.
Lotan et al., (2022). Urinary Analysis of FGFR3 and TERT Gene Mutations Enhances Performance of Cxbladder Tests and Improves Patient Risk Stratification.The Journal of Urology, 10-1097.
Lotan et al. (2024) . A Multicenter Prospective Randomized Controlled Trial Comparing Cxbladder Triage to Cystoscopy in Patients With Microhematuria. The Safe Testing of Risk for Asymptomatic
Microhematuria Trial. The Journal of Urology Vol 212 1-8 Jul 2024.
Detect
Lotan et al., (2022). Urinary Analysis of FGFR3 and TERT Gene Mutations Enhances Performance of Cxbladder Tests and Improves Patient Risk Stratification.The Journal of Urology, 10-1097.
O'Sullivan et al., (2012). A multigene urine test for the detection and stratification of bladder cancer in patients presenting with hematuria.The Journal of urology,188(3), 741-747.
Monitor
Kavalieris et al., (2017). Performance characteristics of a multigene urine biomarker test for monitoring for recurrent urothelial carcinoma in a multicenter study.The Journal of Urology,197(6), 1419-1426.
Konety et al., (2019). Evaluation of cxbladder and adjudication of atypical cytology and equivocal cystoscopy.European urology,76(2), 238-243.
Koya et al., (2020). An evaluation of the real-world use and clinical utility of the Cxbladder Monitor assay in the follow-up of patients previously treated for bladder cancer.BMC urology,20(1), 1-9.
Lotan et al., (2017). Clinical comparison of non-invasive urine tests for ruling out recurrent urothelial carcinoma. Urologic Oncology: Seminars and Original Investigations, 35 (8), 531-539.
Li et al., (2023). Cxbladder Monitor testing to reduce cystoscopy frequency in patients with bladder cancer. Urologic Oncology: Seminars and Original Investigations, 41 (7), 326.e1 – 326.38.
59

INDEPENDENT DIRECTORS
SARAH PARK
ANATOLE MASFEN
BRYAN WILLIAMS
ANNA STOVE
MARK GREEN
TONY BARCLAY
CHRIS GALLAHER
Chairman
Chris has held senior positions in
both CEO and CFO roles with large
international companies and was a
partner in Arthur Young, Chartered
Accountants. Prior to retiring from
full time corporate life, he was CFO
of Fulton Hogan, a large New
Zealand civil contractor
DR PETER MEINTJES
Chief Executive Officer
Peter is a molecular diagnostics and
genomics leader focused on
nascent market development of
disruptive innovations to drive
commercial success. Prior to joining
Pacific Edge, he was based in
Boston in a succession of diagnostic
leadership roles. Most recently he
was the Chief Commercial Officer
at Eurofins Transplant Genomics
and before that he was CEO at
Omixon
SENIOR LEADERSHIP TEAM
GRANT GIBSON DAVID LEVISON DR TAMER ABOUSHWAREB
Chief Financial Officer President Pacific Edge Diagnostics USA Chief Medical Officer
GLEN COSTIN DARELL MORGAN DR JUSTIN HARVEY
President Asia Pacific Chief Operating Officer Chief Technology Officer
ANDY MCINTOSH PROFESSOR PARRY GUILFORD
Chief Digital Officer Chief Scientific Officer
PACIFIC EDGE BOARD AND MANAGEMENT
60

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 3 577 6733 Within NZ 0800 555 562
email: investors@pacificedge.co.nz
www.pacificedgedx.com
61