Pacific Edge Investor Update: Q1 FY23 Test Volumes Rise 32%

JULY 2022
INSIDE
From the CEO 2
Test volume progress 3
Executive appointments in the US 4
Clinical study progress 4
Greenlight at Kaiser 6
US succession 7
Gaining traction at US events 8

PACIFIC EDGE LIMITED INVESTOR UPDATE | JULY 2022
2
DEAR SHAREHOLDERS,
Effective communication and
engagement by Pacific Edge
across the breadth of stakeholders
in the healthcare value chain is
crucial to driving the adoption of
our suite of advanced genomic
biomarker Cxbladder tests.
As Pacific Edge seeks to
establish Cxbladder as the
standard of care for hematuria
evaluation and surveillance for the
recurrence of urothelial cancer,
there are many organizations and
individual stakeholders with whom
we must communicate effectively
and engage in market. Foremost
among these stakeholders are
the clinicians. They order the
tests, collect samples, administer
associated paperwork and interpret
the results. Then there are the
patients taking the tests, the
organizations funding them, the
guidelines committees adjudicating
patient care protocols and our
research collaborators building
the evidence to support guideline
inclusion.
In this shareholder update, we
highlight our enhanced focus on
medical communications and our
in-market activities in a few key
areas. Firstly, at the start of this
month, we appointed David Sosa
into the new role of Vice President
Market Access and Reimbursement
(see page 4). This role is primarily
responsible for driving additional
revenue from various market access
activities with government payors
and private payors, increasing
payment percentages and total
revenue and looking at international
opportunities for growth,
leveraging our US laboratory.
This follows on the appointment
of Dr Tamer Aboushwareb into
the new role of Vice President
Medical Affairs in June. This role
is responsible for the inbound
enrolment of patients in our clinical
studies to enhance our evidence
generation program. Tamer will also
drive the communication of existing
and future clinical evidence to
clinicians, provider administrations
and payors.
“In this shareholder
update, we highlight
our enhanced focus on
medical communications
and our in-market
activities in a few key
areas.”
Together, these positions elevate
engagement and communication
with key stakeholder groups.
David and Tamer will also play
pivotal roles in the evolution of our
commercialization strategies.
Secondly, we have increased our
visibility at marquee conferences
like the American Urological
Association (AUA) annual
conference (see page 8) and the
total number of conferences we
attend. Crucially, these activities,
which are synergistic, are just a few
among the myriad of channels we
are using to engage with clinical
stakeholders.
The recognition of the value
we are creating similarly depends
on effective communication of
our strategy and progress we are
making against it to shareholders.
For this reason, we have included
quarterly test volumes in this
update for the first time, an
important leading indicator of the
continued progress we are making
commercializing Cxbladder. We
have also provided historic figures
to illustrate our progress quarter on
quarter (see page 3).
Our intention is to report these
figures to the NZX and ASX as soon
as practicable after the end of each
quarter, while continuing to deliver
a comprehensive data set with our
full and half year results in May and
November of each year.
Before closing I want to pay
tribute to Jackie Walker, who at
the end of August, is retiring so
stepping down as Chief Executive
of Pacific Edge Diagnostics USA
after 10 years with the company.
She has made an enormous
contribution to the business,
including playing a key role is some
of the company’s most significant
commercial achievements.
I want to thank her again
on behalf of shareholders and
personally for the way she has
welcomed me into the business.
I look forward to seeing you at
Pacific Edge’s Annual Shareholder
Meeting later this month.
Dr Peter Meintjes
Chief Executive
FROM THE CEO
EFFECTIVE ENGAGEMENT
ACROSS THE CXBLADDER
VALUE CHAIN

PACIFIC EDGE LIMITED INVESTOR UPDATE | JULY 2022
3
TEST VOLUME PROGRESS
BUILDING MOMENTUM FOR CXBLADDER IN
THE US
Cxbladder test volumes continue
to increase, building momentum
from the early results we signaled
in May.
Total tests processed at our
laboratories set a record in the
three months to the end of June
2022, and showed a quarter-
on-quarter increase of 13% to
7,055 tests from the 6,242 tests
processed in the March 2022
quarter.
The result also represents an
increase of 32% over the June 2021
quarter result of 5,356 tests and
reflects increasing numbers of US
based unique ordering clinicians
using the test, an important
measure of market penetration.
This metric reached a record for
the quarter of 894, up 36% from
the same quarter a year ago.
Growth was weighted to the
US where test volumes showed a
quarter-on-quarter increase of 15%
to 6,073 from the 5,290 in the three
months to the end of March 2022
and a 42% increase on the 4,277 in
the June 2021 quarter.
These numbers are encouraging
and evidence of continued
delivery against plan. The increase
in volumes reflects growing
awareness of the role Cxbladder
can play in safely de-intensifying
or intensifying the clinical
workup for patients presenting
with hematuria (blood in urine),
resolving diagnostic dilemmas
during hematuria evaluation (e.g.,
equivocal cystoscopy and atypical
cytology), and monitoring for the
recurrence of urothelial cancer
in posttreatment patients. It also
reflects the continued easing of
COVID restrictions.
Despite a comprehensive
program of virtual engagement,
these restrictions had been limiting
in person visits with clinicians and
conference meetings. Importantly,
COVID restrictions had also played
a role in reducing patient visits
creating significant disruption to
the traditional care paradigm.
In the Asia Pacific, where test
numbers are dominated by New
Zealand, volumes have been
more muted, reflecting the local
market’s maturity relative to the
US. At present 14 of the 20 new
Health New Zealand, Te Whatu Ora,
regional divisions representing 70%
of the New Zealand population,
cover the tests.
Total test volumes in the three
months to the end of June in the
APAC region increased 3% on the
March 2022 quarter to 982 tests
from 952 but fell 9% on the 1,079
tests in the June 2021 quarter.
Longer term we believe the
consolidation of the New Zealand
healthcare system will be positive
for the adoption of Cxbladder as
engagement with the national
health authority may accelerate the
adoption across the remainder of
New Zealand’s population, and the
focus will shift towards increasing
awareness and adoption at primary
care following the example set by
Canterbury and the Manawatu.
TOTAL TESTING VOLUME (PACIFIC EDGE GROUP)
UNIQUE ORDERING CLINICIANS (US)
-
1,000
2,000
3,000
4,000
5,000
6,000
7,000
8,000
2,133


Q1 FY21


Q2 FY21


Q3 FY21


Q4 FY21


Q1 FY22


Q2 FY22


Q3 FY22


Q4 FY22


Q1 FY23
Test volume
USNZ
54%
CAGR
2,791
3,110
3,824
4,277
4,706
4,591
5,290
6,073
852
1,088
943
1,073
1,079
1,074
1,117
952
982
0
100
200
300
400
500
600
700
800
900
1000
Clinicians
Q1 FY21
Q2 FY21
Q3 FY21
Q4 FY21Q1 FY22
Q2 FY22Q3 FY22
Q4 FY22Q1 FY23
53.7%
CAGR
411
462
516
530
657
689
740
782
894
48%
CAGR

EXECUTIVE APPOINTMENTS IN THE US
DRIVING GROWTH WITH GREAT TESTS
AND GREAT SERVICE
PACIFIC EDGE LIMITED INVESTOR UPDATE | JULY 2022
4
Dr Tamer Aboushwareb
CLINICAL STUDY PROGRESS
MARKING THE STEPS TO GUIDELINE INCLUSION
Two important clinical studies to
help Pacific Edge advance its case
for inclusion in global standards
of urothelial cancer care passed
important milestones.
First, the Safe Testing of Risk
for Asymptomatic Microhematuria
(STRATA) clinical study has
enrolled more than 50% of its
subjects. The aims to further
demonstrate how Cxbladder
can safely risk stratify patients
presenting with hematuria into
those that may receive a less-
intense evaluation for the presence
of bladder cancer and those that
should continue with a standard
evaluation.
The results from STRATA will
strengthen the case for Cxbladder
tests to be inserted into the current
American Urological Association
(AUA) standard, and other global
care standards, as part of the
normal care management for those
patients.
Meanwhile, the Longitudinal
Bladder Cancer Study for Tumor
Recurrence (LOBSTER), which is
seeking to benchmark the utility
Pacific Edge is working to drive
both the understanding of the
clinical evidence supporting our
tests as well as their adoption.
Clinicians, healthcare funders
and providers, patients and the
committees charged with setting
standards of care need to be made
aware of, and understand, the
evidence. At the same time the
ordering and paying for the tests
and the results delivery needs to be
seamless.
Clinicians, healthcare funders
and providers, patients and the
committees charged with setting
standards of care also need to be
made aware of, and understand,
the evidence. At the same time the
ordering and paying for the tests
and results delivery needs to be
seamless.
Two appointments in June into
new roles at Pacific Edge are aimed
at delivering on these goals.
David Sosa has joined Pacific
Edge as its new Vice President
Market Access and Reimbursement.
His position is focused on payor
relations to increase payment
rates from existing payors and
contracting with new payors. He
will also develop an understanding
of our economic value proposition
among clinicians, hospital
systems and payors and establish
Cxbladder in markets where we
do not yet operate. Finally he will
also build the right relationships
with strategic accounts like Kaiser
Permanente and the US Veterans
Health Administration. David comes
to Pacific Edge with more than 25
years’ experience working with
diagnostic companies in the US.
Meanwhile, Dr Tamer
Aboushwareb has been appointed
Pacific Edge’s Vice President
of Medical Affairs and will lead
a new team of five Medical
Science Liaison Officers providing
medical and scientific leadership
for the company. The role is
focused on engagement with
key opinion leaders in urology
and uro-oncology, the education
of clinicians in the utility of our
products, the enrolment of patients
into our clinical studies and the
communication of our evidence
generation program in conferences
across the USA and internationally.
Dr Aboushwareb is a urologist
who comes to Pacific Edge with
a depth of experience in clinical,
medical research, and commercial
roles in urological medicine in
Egypt and the US. He and his team
will also be supporting market
access and reimbursement efforts
from a scientific and medical
perspective.
David Sosa
continued on page 5

PACIFIC EDGE LIMITED INVESTOR UPDATE | JULY 2022
5
Study LocationsEnrolled sites*Progress and targets
STRATAUSA, Canada 10/11
- 50% enrolled
- Full data targeted Q4 2023
DRIVE USA7/ 1 1- Full data collected mid 2025
LOBSTER USA, Australia 2/10
- First patient enrolled
- Full data targeted 2025
1
AUA Guideline and Woldu SL, Ng CK, Loo RK, Slezak JM, Jacobsen SJ, Tan WS, et al. (2021a). “Evaluation of the New American
Urological Association Guidelines Risk Classification for Hematuria.” J Urol 205(5): 1387-1393
*Intiated and enrolled
of Cxbladder against the AUA
protocols for the surveillance of
recurrent urothelial cancer, has
enrolled its first patient.
Both studies are key
components of Pacific Edge’s
clinical evidence generation
program. Current AUA risk
stratification protocols based
on clinical risk factors alone are
insufficient to reliably de-intensify
urological evaluation for low-risk
patients. We expect the STRATA
study to demonstrate how
Cxbladder can satisfy this unmet
need.
At present the AUA
microhematuria guideline
recommends a shared patient-
physician decision whether to
proceed with cystoscopy for
patients classified as low-risk, a
cohort that currently represents
only 5% of referred patients
presenting with hematuria. We
expect the STRATA study to
demonstrate how Cxbladder can
safely de-intensify evaluation for
a significantly higher proportion
of patients than the current AUA
guidelines, translating to greater
focus on patients with disease.
“... the studies are
aimed at further
reinforcing the potential
for Cxbladder to reduce
the burden of invasive
cystoscopic evaluations”
The LOBSTER study is aimed
at reinforcing the potential of
Cxbladder to assist clinicians
in reducing the frequency of
cystoscopies for patients under
surveillance for the recurrence of
urothelial cancer.
In both cases the studies
are aimed at further reinforcing
the potential for Cxbladder to
reduce the burden of invasive and
expensive cystoscopic evaluations,
spare patients the potential
risks, discomfort, and anxiety
from cystoscopy and potentially
overcome entrenched patient non-
compliance with management and
surveillance regimes.
Finally, a third study the
company is conducting with the
US Veterans Health Administration
– the Detection and Risk
Stratification in Veterans Presenting
with Hematuria (DRIVE) study
– has expanded the number of
actively enrolled sites by three to
ten. The VA covers over 9 million
patients and includes 171 Medical
Centers and 1,113 outpatient
sites, representing a significant
opportunity for Cxbladder.
The DRIVE clinical study is an
important engagement with VA
urologists to determine utility in a
cohort of VA patients, but it also
has relevance to the AUA. As the
study nears completion, Pacific
Edge expects to slowly migrate the
study sites and other VA sites to
commercial adoption as part of a
site-by-site rollout.
GUIDELINE STEPS CONTINUED FROM PAGE 4

GREENLIGHT AT KAISER
PATIENTS WILL BE ABLE TO PROVIDE
SAMPLES AT KAISER CLINICS, AND USE
PACIFIC EDGE’S IN-HOME SAMPLING SYSTEM
The adoption of Cxbladder by Kaiser Permanente, one of the largest
healthcare providers in the US, received a significant boost in May when it
gave the greenlight to incorporate our tests within its electronic medical
records (EMR) system.
While the project will take some months, once complete it will enable
clinicians across the Kaiser Permanente Group to order Cxbladder tests
and view results directly within their clinical workflow system rather than
relying on a manual ordering system. Additionally, patients will be able to
provide urine samples for Cxbladder tests at Kaiser Clinics and laboratories
in addition to the current protocol of relying on the Cxbladder Patient in
Home Sampling System (PIHSS) initiated during COVID.
The seamless availability of the tests and delivery of results through
Kaiser’s EMR is an important step to driving adoption of our tests.
However, building understanding of the role Cxbladder can play in helping
the diagnosis and management of the tests among Kaiser’s clinicians will
also be crucial to success.
While we work hand-in-hand with numerous Kaiser teams on IT
integration, we will continue our clinic-by-clinic, clinician-by-clinician
engagement to educate clinicians and grow adoption ahead of the
deployment. We continue to see throughput volume increasing and two
Kaiser hospitals are now in the Top 20 accounts by throughput.
2
2021
PACIFIC EDGE LIMITED INVESTOR UPDATE | JULY 2022
6
PACIFIC EDGE &
KAISER PERMANENTE
Customer: Kaiser
Health Plan – the
payor arm of Kaiser
Permanente
Tests: Cxbladder Triage
and Cxbladder Monitor
About Kaiser
Permanente:
• Founded: 1945
• HQ: Oakland
California
• 12.6 million members
(85% in California)
• 39 hospitals, 734
offices
• US$93.1bn
2
operating
revenue

US SUCCESSION
WRITING THE NEXT CHAPTER
Pacific Edge Diagnostics USA Chief Executive Jackie Walker is
stepping aside at the end of August after ten years leading the
organization.
In that role she has overseen some of Pacific Edge’s most significant
commercial achievements, including CMS coverage of Cxbladder and the
Kaiser Permanente commercial agreement.
Why did you take the role to lead PEDUSA?
I was really impressed by the company, the people, the vision, and all the
work that had been done to develop its new cancer diagnostics technology.
I was also very interested in getting into the molecular diagnostics
field, which was changing the healthcare industry, and this was a great
opportunity to do so.
What have been the standout points over your ten years with the
company?
There are many. Establishing the laboratory and headquarters in Hershey,
Pennsylvania; building a great PEDUSA team and culture and bringing
new non-invasive genomic tests to urologists that improve their clinical
practice and quality of life for their bladder cancer patients were great
achievements. Of course, gaining CMS coverage and the commercial
agreement for Cxbladder with Kaiser Permanente, one of the country’s
leading healthcare providers, were very rewarding as well.
I’ve also really enjoyed the trips I have made to New Zealand and
working with the team there. (Former CEO) Dave Darling and I were great
partners.
Along with Jack Atchason and the PEDUSA team, we worked long
hours together to overcome the challenges of the US healthcare market to
steadily grow the business. It has been a great experience.
What are you most proud of during your period of leadership?
In addition to all the milestone achievements above, I’m most proud of
our PEDUSA team and the culture we’ve built. They are all passionate,
hardworking, results-oriented, innovative, team players, who also like to
have some fun, which has been at the core of our success.
Why are you leaving and how do you feel about it?
It was a hard decision. I’ve had a wonderful and rewarding career and have
truly enjoyed my role at Pacific Edge, but it’s time for me to spend more
time with my husband and family, who have been waiting patiently for me
to retire and do the many things we love and have plans to do.
I am going to miss the people. We have an amazing team both in the
US and New Zealand. I’m also going to miss our urology community and
commercializing new innovative products. I want to thank my PEDUSA
executive team for their hard work and leadership and the PEDUSA team
for all they do as well as the PENZ team, the Board, and our shareholders
for their continued support of our vision and mission.
Pacific Edge is at a great inflection point, and I know the team will
continue to successfully build the business. I look forward to continuing to
support the company after I retire and wish Pete, David and the rest of the
team every success.
What’s next?
I am on several boards and work with community organizations and look
forward to continuing my work with them. My husband, Roy, and I are
building a beach house and plan to spend a lot more time there. We also
love to travel, bike, hike, golf, fly fish, and do just about anything outdoors.
We have lots of great plans, and it’s time to write the next chapter.
PACIFIC EDGE LIMITED INVESTOR UPDATE | JULY 2022
7
JACKIE WALKER
- Pacific Edge Diagnostics
USA Chief Executive Officer
- Flinchbaugh Engineering,
Director
- RETTEW Associates,
Director
Education:
- Duke University BSE
(Engineering and French)
- University of North
Carolina-Chapel Hill MBA
Prior roles:
- OSspray President
(biomaterials), President
and CEO
- Ondine Biopharma
(biotech), COO
- Dentsply International
(medical equipment),
Vice President & General
Manager
- Ohmeda/BOC Healthcare
(medical equipment),
Director of Marketing
Following Ms Walker’s
departure, PEDUSA
Executive Chairman David
Levison will assume the new
role of PEDUSA President,
reporting directly to Chief
Executive Dr Peter Meintjes.

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 Zealandd
T: +64 3 479 5800
E: investors@pacificedge.co.nz
PACIFIC EDGE LIMITED INVESTOR UPDATE | JULY 2022
8
GAINING TRACTION AT US EVENTS
INTEREST IN CXBLADDER STRONG AMONG
US CLINICIANS
Pacific Edge saw strong interest
in Cxbladder at the American
Urological Association (AUA)
annual conference in New Orleans
in May. The AUA meeting, which
this year returned after a two-year
COVID impacted hiatus, is the
biggest event on the US and global
urological conference calendar,
attracting thousands of urologists,
oncologists, researchers, educators,
and healthcare professionals and
companies.
Pacific Edge has been a long
time and significant sponsor of the
AUA and significantly increased its
presence in the main exhibition hall
(pictured), while also sponsoring
key sessions for Veterans Affairs
and the newly created “Bladder
Cancer Forum” where clinicians
discussed bladder cancer
management, as well as treatment
strategies in challenging disease
states.