Q3 26 Results and Key Strategic Milestones

20 JANUARY 2025


Q3 26 RESULTS AND KEY STRATEGIC MILESTONES
DUNEDIN, New Zealand – Cancer diagnostics company Pacific Edge (NZX, ASX: PEB)
releases its investor update for the three months to the end of December 2025 (Q3 26) today
with reports on further strategic achievements to support a reinstatement of Medicare coverage
of Cxbladder and the volume of Cxbladder tests processed through its laboratories.
The investor update includes:
• A preview of our Medicare Administrative Contractor Novitas’ Contractor Advisory
Committee (CAC) meeting to be held on 20 February 12.00pm (NZST)
1
, including an
overview of what investors should look for from this important meeting. These meetings
are generally convened ahead of developing new or substantially revised medical
policy as a draft Local Coverage Determination (LCD).
• News that Kaiser Permanente’s Real World evidence study demonstrating Cxbladder
Triage’s Clinical Utility has been accepted for publication in Urology Practice and will
therefore likely be able to be profiled at the CAC. The study was first previewed at the
2025 American Urological Association annual meeting.
• Progress in the Medicare appeals of Cxbladder Triage tests denied reimbursement
since the finalization of the Genetic testing for Oncology LCD: Specific Tests (L39365)
that ended coverage of Cxbladder. In January we heard that our first hearing of four
cases had been set down for 24 February 2026 just after the CAC meeting.
• Total laboratory throughput (TLT) in Q3 26 fell 13.4% to 5,446 tests from 6,286 in Q2
26. US TLT was down 19.5% to 4,003 tests from 4,971 in Q2 26. APAC volumes rose
9.7% to 1,443 tests from 1,315 in Q2 26 lifted by an increase in commercial test
volumes.
• Confirmation that Cxbladder Triage has been endorsed as ‘meeting coverage criteria’
by Avalon Healthcare Systems, a large diagnostic intelligence provider that is used by
healthcare payers and providers supporting more than 44 million US lives. This is also
important evidence that can be used at the CAC.
• Detail of the farewell to retiring Chair Chris Gallaher, and a profile of our new Chair
Simon Flood.
Pacific Edge Chief Executive Dr Peter Meintjes says in the update: “Despite the ongoing
throughput challenges that have been amplified by the seasonal holiday slow down, Pacific
Edge enters 2026 in the strongest position to establish enduring Medicare coverage policy in
a LCD — the strategic focus for more than a decade. If successful, this will establish a
materially more certain environment for reimbursement for Cxbladder by Medicare and other
providers in the US."
Released for and on behalf of Pacific Edge by Grant Gibson Chief Financial Officer.
For more information:

1
19 February 2026 at 6:00pm (US ET)

2

Investors: Media:
Dr Peter Meintjes Richard Inder
Chief Executive The Project
Pacific Edge P: +64 21 645 643
P: 022 032 1263
OVERVIEW
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 suite of non-invasive genomic urine tests optimized for the risk stratification of
urothelial cancer in patients presenting with microhematuria and those being monitored for
recurrent disease. The tests help improve the overall patient experience, while prioritizing time
and clinical resources to optimize practice workflow and improve efficiency.
Supported by over 20 years of research, Cxbladder’s evidence portfolio extends to more than
25 peer reviewed publications, and Cxbladder Triage is now included in the American
Urological Association’s Microhematuria Guideline. To drive increased adoption and improved
patient health outcomes, Cxbladder is the focal point of numerous ongoing and planned studies
designed to generate further clinical utility evidence.
Cxbladder is available in the US, Australasia, and Israel and in markets throughout Asia and
South America. In the US, the test has been used by over 5,000 urologists who have ordered
more than 130,000 tests. In New Zealand, Cxbladder is accessible to around 70% of the
population via public healthcare and all residents have the option of buying the test online.

---

JANUARY 2026
INVESTOR UPDATE
INSIDE
Letter from the CEO 2
Q3 26 test volumes 5
Medicare expert panel convened 5
Commercial payer gains 6
Pacific Edge’s new Chair 7
Chris Gallaher retires 7
Clinical evidence 8

Dear Shareholders,
Pacific Edge enters 2026 in the strongest position
to establish enduring Medicare coverage policy in a
Local Coverage Determination (LCD) — the strategic
focus for more than a decade. If successful this will
establish a materially more certain environment for
reimbursement for Cxbladder by Medicare and other
providers in the US.
We committed to this goal — an LCD in favor of
our tests — when we launched clinical laboratory
operations in the US in 2013. We have worked
diligently through various challenges,
developing tremendous support
along the way.
The next indication that positive
LCD language could be drafted
comes on 20 February 12.00pm
(NZST)
1
when our Medicare
Administrative Contractor (MAC)
Novitas is scheduled to hold
an expert Contractor Advisory
Committee (CAC) to review
coverage for urine-based biomarker
tests for hematuria evaluation.
The meeting, precipitated by
the February 2025 update to the
American Urological Association’s (AUA)
Microhematuria Guideline, is significant. CACs
are generally convened ahead of developing new
or substantially revised medical policy as a draft
LCD. They are designed to capture clinical opinion
from practicing physicians in addition to published
evidence and the AUA guidelines to “ensure an
unbiased and contemporary consideration of the
state-of-the-art technology and science”.
As a consequence of this and its scheduling
during NZX and ASX trading hours (and after
consulting with a range of parties) we expect the
CAC to be accompanied by a trading halt of Pacific
Edge’s shares (see page 5).
The landmark inclusion of Cxbladder Triage in the
February 2025 update to the AUA’s Microhematuria
Guideline has delivered a dramatic shift in our
engagement with Novitas and sets the scene with
Medicare. It has also led to stronger engagement
with the Centers for Medicare and Medicaid Services
(CMS) and its Coverage and Analysis Group (CAG),
the team that leads the evidence review and policy
work behind Medicare decisions.
During meetings with Novitas in 2025 we worked
hard to build professional goodwill between our two
organizations, and we are encouraged by the results.
Notably, Novitas has asked us to provide the
names of key opinion leaders (KOLs) that are familiar
with the guidelines, with urine-based biomarkers
and with our tests to ensure that they have
the best clinical information on which to
develop medical policy. This gives all
stakeholders, Novitas, urologists,
patients and Pacific Edge the best
chance of an outcome that ensures
an accurate assessment of the
clinical and economic value of
our tests.
We believe Novitas
understands the anomaly of
Medicare beneficiaries not
receiving guideline-recommended
testing and the fact that the evidence
for Cxbladder has advanced past
the current LCD (Genetic Testing for
Oncology: Specific Tests (L39365), which was
finalized in early 2025 and only considered evidence
published before September 2023). This LCD
excluded the STRATA
2
study which formed the basis
of establishing urine-based biomarkers in the AUA
guideline, and several other more-recent published
papers supporting the clinical value of Cxbladder
products. It also excludes a Kaiser Permanente
study that has recently been accepted by Urology
Practice for publication. This is the largest study ever
performed on urine-based biomarkers for hematuria
evaluation, and provides compelling real-world
evidence for the clinical utility of Cxbladder.
We also believe Novitas understands that this
anomaly could persuade an Administrative Law
Judge (ALJ), the determinative (Level 3) stage of
the Medicare Appeals process we are now pursuing
for all Cxbladder Triage tests denied reimbursement.
LETTER FROM THE CEO
Looking toward Novitas
expert panel deliberations
“Novitas has
asked us to provide
the names of key
opinion leaders (KOLs)
that are familiar
with the guidelines,
with urine-based
biomarkers and with
our tests...”
2
1
19 February 2026 at 6:00pm (US ET)
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.

We have lodged these appeals on the basis that
Cxbladder Triage tests are medically reasonable and
necessary — the statutory threshold for coverage
under the US Social Security Act — substantiated
by the test’s inclusion in the AUA Guideline and
that the published clinical evidence has advanced
on the evidence reviewed in the non-coverage
determination finalised last year. We have yet to make
our first appeal before an ALJ, but we were pleased
to hear in January that our first hearing of four cases
has been set down for 24 February 2026 just after
the CAC meeting (see page 6). After a December
meeting with CMS and the CAG, they are aware that
the clinical evidence has moved past the policy, that
guideline-recommended testing is not being covered
by Novitas, and the potential for medical policy to
be set by an ALJ rather than through the normal
coverage process.
Perhaps most significantly, we are entering into
this important engagement at the CAC with the
weight of clinical opinion in our favor. For instance,
the AUA continues to be a key supporter of our
efforts and through their public policy committees
have used their weight to directly engage Novitas
and Medicare regarding the importance of reviewing
their guidelines to ensure Medicare patients have
access to the latest medically reasonable and
necessary testing. The proof of this shift in clinical
sentiment will come in the language of the draft LCD
that Novitas issues in the months after the meeting.
While we don’t know the date on which that draft
LCD will be published, we expect that Novitas will act
expediently for all the reasons set out above.
An LCD, if written to cover Cxbladder, will
represent an even greater defining moment for the
company than the AUA Guideline of February 2025.
The key element that distinguishes this milestone
from our prior Medicare coverage status is that
the LCD should create medical policy language
clarifying the appropriate use of Cxbladder tests,
beyond the prior coding policy that permitted our
tests to be paid without establishing coverage
language.
3
Furthermore, positive coverage language
should provide unequivocal guidance to Medicare
Advantage payers to pay for our tests and create
new avenues to appeal denied tests from commercial
payers using “state biomarker laws” championed by
the American Cancer Society (ACS)
4
.
We expect the cumulative effects to be observed
by an increase to our Average Sales Price (ASP) on
any covered test. This is a trend we have already
observed among commercial payers since guideline
inclusion, despite the non-coverage determination
from April 2025. Similarly, with reduced
administrative challenges, we expect this to provide
the opportunity for us to drive higher demand for our
tests from the figures that we report today.
Thinking further ahead, the DRIVE publication in
late October made available the clinical validation
evidence that Triage Plus should also be covered
alongside Triage that is already in the AUA Guideline.
The US$1,328 Medicare price established for Triage
Plus — now effective since 1 January 2026 — is a
substantial increase over the US$760 Medicare price
for our existing tests.
Despite the challenges with Medicare, we
continue to make progress with commercial payers.
Significantly, a large diagnostic intelligence provider,
Avalon Healthcare Systems, which supports
healthcare payers covering 44 million lives to
determine reimbursement policies, has endorsed
Cxbladder Triage. Both developments should
support growth in non-Medicare payer volumes. The
endorsement by Avalon, and the earlier endorsement
by the Emergency Care Research Institute
5
(ECRI), an
organization that performs a similar role to Avalon,
provide authoritative templates for Novitas as it
deliberates on Medicare coverage in the coming
months.
December 2025 meanwhile saw a major change to
our leadership that we expect to substantially shape
our future with the appointment of our new Chair
Simon Flood. Simon took over from Chris Gallaher
who had delayed his retirement until a successor
was recruited. I know shareholders are as grateful
as management and the broader Pacific Edge team
for the support that Chris has provided the company
over many years.
I look forward to providing you with an update on
the outcome of the CAC meeting in February.
With my warm regards,
Dr Peter Meintjes
Chief Executive
LETTER FROM THE CEO CONTINUED
3
3
Cxbladder had received positive coding guidance on LCA58529 in July 2020, but were non-covered on L39365 in April 2025.
4
American Cancer Society (ACS) State Biomarker Law summary page at https://www.fightcancer.org/what-we-do/access-biomarker-testing
5
https://home.ecri.org/

-
1,000
2,000
3,000
4,000
5,000
6,000
7,000
8,000
9,000
10,000
Test volume
US
Q2 25
5,682
1,360
7,042
Q3 25
5,808
1,284
7,092
Q4 25
6,490
1,087
7,577
Q1 26
5,722
1,183
6,905
Q2 26
4,971
1,315
6,286
Q3 26
4,003
1,443
5,446
Q3 23
6,629
1,139
7,768
Q4 23
1,061
8,877
Q1 24
8,627
1,079
9,706
Q2 24
7,335
1,199
8,534
Q3 24
6,041
1,142
7,183
Q1 25
5,905
1,278
7,183
Q4 24
6,099
1,111
7,210
APAC
-
200
400
600
800
1,000
1,200
1,400
1,600
-
1.0
2.0
3.0
4.0
5.0
6.0
7.0
8.0
US Ordering Clinicians
Tests/Clinician
US ORDERING CLINICIANS (LHS)
890866
Q1 25
867
Q2 25Q3 25Q3 23
1,082
Q4 23
1,150
Q1 24
1,232
Q2 24
1,147
Q3 24
1,016
Q4 24
915914
TESTS/ORDERING CLINICIANS (RHS)
7.0
6.1
6.4
6.8
-
10
20
30
40
50
250
200
300
350
400
450
Average Sales FTE
Average US Test Volume/Sales FTE
US AVERAGE SALES FTE (LHS)
US TEST VOLUMES/SALES FTE (RHS)
3333
30
28
21
15151515
907
5.9
6.7
6.8
6.4
6.7
6.3
6.2
5.8
Q4 25Q1 26
803
Q2 26
691
Q3 26

Q3 23Q4 23Q1 24Q2 24
Q3 24Q4 24Q1 25Q2 25Q3 25Q4 25
Q1 26
12
Q2 26
12
Q3 26
1616
7.1
201
239
288
265
292
403
379379
381
381
406
403
334
7,816
FIGURE 1: TOTAL TEST VOLUMES
-
1,000
2,000
3,000
4,000
5,000
6,000
7,000
8,000
9,000
10,000
Test volume
US
Q2 25
5,682
1,360
7,042
Q3 25
5,808
1,284
7,092
Q4 25
6,490
1,087
7,577
Q1 26
5,722
1,183
6,905
Q2 26
4,971
1,315
6,286
Q3 26
4,003
1,443
5,446
Q3 23
6,629
1,139
7,768
Q4 23
1,061
8,877
Q1 24
8,627
1,079
9,706
Q2 24
7,335
1,199
8,534
Q3 24
6,041
1,142
7,183
Q1 25
5,905
1,278
7,183
Q4 24
6,099
1,111
7,210
APAC
-
200
400
600
800
1,000
1,200
1,400
1,600
-
1.0
2.0
3.0
4.0
5.0
6.0
7.0
8.0
US Ordering Clinicians
Tests/Clinician
US ORDERING CLINICIANS (LHS)
890866
Q1 25
867
Q2 25Q3 25Q3 23
1,082
Q4 23
1,150
Q1 24
1,232
Q2 24
1,147
Q3 24
1,016
Q4 24
915914
TESTS/ORDERING CLINICIANS (RHS)
7.0
6.1
6.4
6.8
-
10
20
30
40
50
250
200
300
350
400
450
Average Sales FTE
Average US Test Volume/Sales FTE
US AVERAGE SALES FTE (LHS)
US TEST VOLUMES/SALES FTE (RHS)
3333
30
28
21
15151515
907
5.9
6.7
6.8
6.4
6.7
6.3
6.2
5.8
Q4 25Q1 26
803
Q2 26
691
Q3 26

Q3 23Q4 23Q1 24Q2 24
Q3 24Q4 24Q1 25Q2 25Q3 25Q4 25
Q1 26
12
Q2 26
12
Q3 26
1616
7.1
201
239
288
265
292
403
379379
381
381
406
403
334
7,816
FIGURE 2: CXBLADDER CLINICAL ADOPTION
-
1,000
2,000
3,000
4,000
5,000
6,000
7,000
8,000
9,000
10,000
Test volume
US
Q2 25
5,682
1,360
7,042
Q3 25
5,808
1,284
7,092
Q4 25
6,490
1,087
7,577
Q1 26
5,722
1,183
6,905
Q2 26
4,971
1,315
6,286
Q3 26
4,003
1,443
5,446
Q3 23
6,629
1,139
7,768
Q4 23
1,061
8,877
Q1 24
8,627
1,079
9,706
Q2 24
7,335
1,199
8,534
Q3 24
6,041
1,142
7,183
Q1 25
5,905
1,278
7,183
Q4 24
6,099
1,111
7,210
APAC
-
200
400
600
800
1,000
1,200
1,400
1,600
-
1.0
2.0
3.0
4.0
5.0
6.0
7.0
8.0
US Ordering Clinicians
Tests/Clinician
US ORDERING CLINICIANS (LHS)
890866
Q1 25
867
Q2 25Q3 25Q3 23
1,082
Q4 23
1,150
Q1 24
1,232
Q2 24
1,147
Q3 24
1,016
Q4 24
915914
TESTS/ORDERING CLINICIANS (RHS)
7.0
6.1
6.4
6.8
-
10
20
30
40
50
250
200
300
350
400
450
Average Sales FTE
Average US Test Volume/Sales FTE
US AVERAGE SALES FTE (LHS)
US TEST VOLUMES/SALES FTE (RHS)
3333
30
28
21
15151515
907
5.9
6.7
6.8
6.4
6.7
6.3
6.2
5.8
Q4 25Q1 26
803
Q2 26
691
Q3 26

Q3 23Q4 23Q1 24Q2 24
Q3 24Q4 24Q1 25Q2 25Q3 25Q4 25
Q1 26
12
Q2 26
12
Q3 26
1616
7.1
201
239
288
265
292
403
379379
381
381
406
403
334
7,816
FIGURE 3: US SALES FORCE EFFICIENCY
4
Cxbladder tests processed through Pacific Edge’s laboratories in the three months to the end of
December 2026 (Q3 26) have remained subdued, even as strategic momentum mounts for a Medicare
policy decision to reimburse Cxbladder Triage.
Total laboratory throughput (TLT) in Q3 26 fell 13.4% to 5,446 tests from 6,286 in Q2 26. US TLT was
down 19.5% to 4,003 tests from 4,971 in Q2 26. APAC volumes rose 9.7% to 1,443 tests from 1,315 in Q2 26
lifted by an increase in commercial test volumes.
The challenges of the prior quarter — the continued fallout from the disruptions of transitioning US
customers from Cxbladder Detect to Triage and the ongoing challenges associated of selling a product
not covered by Medicare — continue to represent a considerable headwind to the company and were
exacerbated by the seasonal holiday slowdown.
In the US, Pacific Edge accelerated the decision to discontinue Detect following the inclusion of Triage
in the new American Urological Association (AUA) Microhematuria Guideline in February 2025 and the
non-coverage determination. Reflecting the weaker volumes our sales force efficiency metric (tests per
sales FTE) fell to 334 from 403 in Q2 26, with sales team numbers steady at 12 FTEs.
The number of ordering clinicians fell to 691 from 803 ordering clinicians in Q2 26. Tests per unique
ordering clinician were 5.8 compared to 6.2 in Q2 26.
US challenges and the seasonal slowdown
TEST VOLUMES

Contractor Advisory Committee: what to look for
Novitas’ Contractor Advisor Committee meeting scheduled for mid-February will be an important
test of the progress Pacific Edge has made in convincing the Medicare Administrative Contractor to
change medical policy on Cxbladder. Below is a guide to what shareholders should look for from this
important meeting.
5
MEDICARE COVERAGE
MEETING DATE19 February 2026 6pm US ET (20 February 2026 12.00pm NZ ST)
FORMAL NOTICE
OF MEETING
Novitas will publish registration details to its website two weeks prior to the CAC.
HOW TO WATCHThe meeting will be streamed live. Novitas’ website is only accessible from US IP addresses, but
Pacific Edge expects to be able to provide registration details of how to join the meeting in an
announcement to shareholders ahead of the meeting.
PURPOSETo discuss evidence for the use of urine-based biomarkers in patients with microhematuria.
WHY IS IT
IMPORTANT
CACs are generally convened ahead of the development of new or substantially revised medical
policy via a Local Coverage Determination. They are intended to supplement the MAC’s internal
expertise by systematically capturing clinical opinion from practicing physicians in addition to
published evidence to ensure an unbiased and contemporary consideration of state-of-the-art
technology and science.
TRADING HALTWe expect Pacific Edge’s shares on the NZX and the ASX will enter a trading halt ahead of the
meeting until we can provide an update on the proceedings of the meeting, expected before the
commencement of trading on the NZX on Monday 23 February 2026.
PARTICIPANTS• Novitas Medical Directors and other Medical Affairs staff
• The Centers for Medicare & Medicaid Services (CMS)
• Panelists: Clinicians selected by Novitas for their expertise, their familiarity with the
guidelines, the merits of urine-based biomarkers and our tests. In a positive sign, Urologists
familiar with our tests have been confirmed as panelists
• Public (listen only)
WHAT TO LOOK
FOR
Signals that matter for coverage outcomes:
• Panelists: We will be noting who outside of our nominees have been accepted on the panel,
their level of familiarity with the published clinical evidence and their level of influence within
the AUA community
• Medical Policy supporting the need for urine-based biomarkers in hematuria evaluation:
We will be listening for comments regarding the general utility of biomarkers for hematuria
evaluation. Specifically, the appropriate patient types, how to identify those patients and
what physicians should do with a test result
• Clinical evidence for Cxbladder: We will be listening for comments regarding the evidence
portfolio for Triage and Triage Plus. Most important is the evidence not previously reviewed
by Novitas for L39365 e.g. STRATA Study, Triage AV Publication, Triage Plus AV Publication,
DRIVE Study and the Kaiser real world study accepted for publication by Urology Practice
• Medical Necessity: We will be listening for panelists to specifically tell Novitas that Cxbladder
products are medically reasonable and necessary for contemporary practice of urology care
and that CMS should pay for these tests
WHAT TO EXPECT
AFTER THE
MEETING
• A formal transcript and recording of the meeting will be posted to the Novitas website after
the meeting’s conclusion. However, given that this often takes many weeks, Pacific Edge will
make an informal transcript available prior to exiting the trading halt
• We would expect Novitas to turn their attention to the development of a draft LCD, a
potential catalyst that recognizes the value of our tests. Our expectations for the issue of this
draft range from the middle of Q2 Calendar 2026 to early Q3 Calendar 2026

First Administrative Law Judge hearing set
In January, the Office of Medicare Hearings and Appeals (OMHA) notified us that our first
reimbursement appeal has been scheduled for a hearing before an Administrative Law Judge (ALJ)
on 24 February 2026.
This ALJ hearing is a determinative stage of the Medicare appeals pathway we are pursuing for all
eligible Cxbladder Triage tests that have been denied Medicare reimbursement since the Cxbladder
non-coverage determination took effect in April 2025. We have lodged these appeals on the basis that
Cxbladder Triage tests are medically reasonable and necessary — the statutory threshold for coverage
under the US Social Security Act — substantiated by the test’s inclusion in the AUA Guideline and that
the published clinical evidence has advanced the evidence reviewed in the non-coverage determination
‘Genetic Testing for Oncology: Specific Tests’ (L39365) finalized last year.
Consistent success in overturning denials could materially influence FY26 and FY27 revenue, by
establishing a precedent for the more than 1,650 tests that have been denied reimbursement to date.
ALJs sit at the third level of the Medicare appeals process and, while a judge is expected to give
deference to Local Coverage Determinations (LCDs), they are not bound by them. They can also consider
additional evidence, including:
• The updated AUA 2025 Microhematuria Guideline
• New clinical evidence, including the STRATA study that underpinned the Guideline change and the
new Kaiser real world study
• Third-party assessments such as the Emergency Care Research Institute (ECRI), which recently
gave Triage a positive 4/5 rating and the endorsement by Avalon Healthcare Systems (see below)
Following the hearing, the ALJ has 90 days to issue a decision, unless Pacific Edge agrees to waive the
deadline and extend the timeframe.
6
MEDICARE COVERAGE CONTINUED
Cxbladder endorsed by large diagnostic test intelligence provider
Avalon Healthcare Systems
1
, a large diagnostic intelligence provider that is used by healthcare payers and
providers supporting more than 44 million US lives
2
, has declared Cxbladder Triage as ‘meeting coverage’ criteria.
Avalon’s determination, which follows closely the
wording used in the AUA Microhematuria Guideline for the
use of urine biomarkers, will be highly influential for the
more than 30 health plans that use its insights to determine
reimbursement policies. These payers include Blue Cross
Blue Shield of North and South Carolina, among others. It
is a significant achievement of our strategy to leverage the
Guideline to drive the adoption of our tests among non-
Medicare payers and we expect it to assist our discussions
to change reimbursement policies with these payers and
drive adoption of our tests.
Avalon’s policy states Triage meets coverage criteria
when it is used to facilitate the decision regarding the
utility of cystoscopy for individuals with microhematuria
when: the patient has been classified as intermediate risk; the individual has acknowledged a desire to avoid
cystoscopy; and has accepted the risk of forgoing direct visual inspection via a cystoscopy.
1
https://www.avalonhcs.com/solutions/
2
https://www.avalonhcs.com/newsroom/avalon-2025-lab-trend-report-genetic-testing-soars-as-routine-testing-stabilizes/
COMMERCIAL PAYERS

7
GOVERNANCE
Simon Flood takes over as Chair
Pacific Edge has a new
Chair.
Simon Flood was
appointed as an
Independent Director
of the company in
early December and at
the conclusion of the
December Board meeting
was appointed Chair,
replacing Chris Gallaher
who retired after nine
years at the helm.
Simon says he is excited to join Pacific Edge at a
pivotal time, describing the company as a first mover
and market leader in bladder cancer diagnostics. He
is looking forward to working with the Board and
Management Team as Pacific Edge continues to drive
towards reimbursement certainty in the US.
“Pacific Edge’s tests offer clinical utility, patient
satisfaction and economic value to healthcare payers
around the world. It is differentiated from other
companies as the first mover, for having the highest
quality clinical evidence and an ongoing robust
evidence generation program that will entrench its
leadership. It is a significant opportunity, and I am
delighted to lead the governance function,” Simon said.
Simon brings deep global capital markets and
investment management experience, having held
senior roles in London, Hong Kong and Singapore with
Mercury Asset Management / Merrill Lynch Investment
Managers, Axa Investment Managers, and Lion Global
Investors.
He has also worked as an Executive Director at
UK-based, technology-focused venture capital firm
Imprimatur Capital, building additional expertise in
scaling innovative businesses.
Since returning to New
Zealand in 2015, Simon
has taken on a range
of governance roles,
including Chairman
of Queenstown
Airport and a recent
appointment to the
Tertiary Education
Commission, alongside
several South Island
organizations.
“Pacific Edge’s
tests offer clinical
utility, patient
satisfaction and
economic value to
healthcare payers
around the
world...”
Mana and
guardianship
A patu pounamu, a symbol
of mana, guardianship and
leadership, was gifted to retiring
Chair Chris Gallaher by Deputy
Chair Bryan Williams on behalf of
the Directors and Management in
acknowledgement of nine years
of steadfast commitment to the
company.
Following the December Board
meeting, Pacific Edge Directors
and guests marked Chris’
tenure as Chair with a dinner
where he was presented with a
ceremonial patu in recognition
of his leadership. Over the past
nine years, particularly through
the more recent challenges over
Medicare reimbursement in the
US, he provided stability and
confidence for shareholders and
stakeholders alike, deferring
his retirement at the request of
the Board until a successor was
appointed.
The Board and Management
thanks Chris for his leadership
and wishes him well in his long-
delayed retirement.

CLINICAL EVIDENCE PROGRAM
Evidence to drive clinical practice change
Our clinical study program is at the foundation of Pacific Edge’s value. We are focused on generating the compelling
clinical evidence required to drive behavior change in physicians. Specifically, we seek to produce evidence that
is founded on the frameworks of Analytical Validity (AV), Clinical Validity (CV), and Clinical Utility (CU), with the
endpoints and sample sizes required for coverage decisions and Guideline inclusion.
STUDYGOALPOPULATION AND
USE
STATUS
STRATA
Safe Testing of Risk
for AsymptomaTic
MicrohematuriA
• CU Triage (lower
risk MH) and
CU Triage Plus
(retrospective)
• MH
• Risk stratification
• Recruitment closed with 555 patients including
223 low risk patients (test and control)
• Interim analysis results published leading to AUA
Guidelines inclusion in 2025 update
DRIVE
Detection and Risk
stratification In
VEterans presenting
with hematuria
• CV of Triage Plus
(MH or GH)
• Data for MH & GH
pooled analyses
• MH and GH
• Risk stratification
• Enrolment closed with 710 patients including 48
tumour confirmed patients from 10 US VA sites
• Database lock completed and manuscript published
microDRIVE
Detection and
Risk stratification
In VEterans
presenting with
microhematuria
• CV of Triage Plus
(MH or GH)
• Data for MH & GH
pooled analyses
• MH and GH
• Risk stratification
• Study expanded to 3 active sites, 421 samples,
not including protocol deviations, received to date
including 16 UC confirmed (35 targeted)
• Study design has been changed to include high risk
patients presenting with GH
• The target is 35 or more UC confirmed subjects
AUSSIE
Australian Urologic
risk Stratification
of patientS wIth
hEmaturia
• CV Triage Plus
(MH or GH)
• Data for MH & GH
pooled analyses
• MH and GH
• Risk stratification
• There are 753 subjects enrolled including 55 UC
confirmed (GH+MH) including 10 MH UC patients
• Recruitment target achieved
• Enrolment is closed, clinical database lock occurred
Dec-2025, final Triage Plus data expected Jan-2026
and publication submission expected March-May
2026
POOLED
ANALYSES
• CV Triage Plus MH
Patients
• CV Triage Plus GH
Patients
• MH and GH
• Risk stratification
• Patient data from DRIVE, AUSSIE and microDRIVE
will be pooled and analyzed in two studies for MH
and GH
• MH pooled analysis is expected for submission in
late 2026
• GH pooled analysis is expected for submission in
late 2026
CREDIBLE
Cystoscopic
REDuction
In BLadder
Evaluations for
microhematuria
• CU Triage Plus • MH
• Risk stratification
• All sites have completed contracts and IRB approvals
• All fifteen sites now activated, 128 patients enrolled
of 1000 targeted
• Enrollment lower than expected, we will add up to
6 more sites to the study
• Enrollment phase expected to continue until Q2 27
LOBSTER
LOngitudinal
Bladder cancer
Study for
Tumor Recurrence
• CV Cxbladder
Surveillance
(low-, int.- and
high-risk)
• Surveillance
• Risk stratification
• Enrolment completed Q3 25 for an interim
analysis — 75 UC recurrences observed (78 UCs
confirmed as of 01 Dec 2025, however, only the first
75 will form the basis of the interim analysis)
• Currently 481 subjects enrolled with 1,211 samples
• Protocol amendment provides for continued
scheduled surveillance visits and urine collections
into 2027
OCTOPUS
Ongoing Cxbladder
Testing for
Optimized Patient
Experience
in Urothelial
Surveillance
• CU Cxbladder
Surveillance
(low-, int.- and
high-risk)
• Surveillance
• Risk stratification
• Currently at the planning stage
• Advisory Board completed Dec-2025
• Business case and protocol under development
• First patient anticipated for mid to late 2027
8
• Microhematuria (MH), Gross hematuria (GH)
• Cxbladder Triage Plus (Triage Plus)
• Cxbladder Monitor Plus is now called Cxladder Surveillance
• Quarterly dates are calendar year not financial year

ABOUT US
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.
VISIT US ONLINE:
www.pacificedgedx.com
www.cxbladder.com
FOLLOW US ON SOCIAL MEDIA:
www.facebook.com/PacificEdgeLtd
www.facebook.com/Cxbladder
www.twitter.com/PacificEdgeLtd
www.twitter.com/Cxbladder
www.linkedin.com/company/pacific-edge-ltd
CONTACT US:
Centre for Innovation
87 St David Street
PO Box 56
Dunedin 9016, New Zealand
T: 0800 555 563 (NZ)
+64 3 577 6733 (Overseas)
E: investors@pacificedge.co.nz