PACIFIC EDGE 2025 ANNUAL SHAREHOLDERS’ MEETING
6 AUGUST 2025
PACIFIC EDGE 2025 ANNUAL SHAREHOLDERS’ MEETING
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 to shareholders.
Released for and 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: 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.
---
2025 ANNUAL SHAREHOLDERS’
MEETING PRESENTATION
Chris Gallaher
Chairman
Dr Peter Meintjes
Chief Executive Officer
6 August 2025
2
CHRIS GALLAHER
Chairman
CHAIRMAN’S ADDRESS
This presentation has been prepared by Pacific Edge Limited (PEL)
solely to provide interested parties with further information
about PEL and its activities at the date of this presentation.
Information of a general nature
The information in this presentation is of a general nature and
does not purport to be complete nor does it contain all the
information which a prospective investor may require in
evaluating a possible investment in PEL or that would be required
in a product disclosure statement, prospectus or other disclosure
documentfor the purposes of the New Zealand Financial Markets
Conduct Act 2013 (FMCA) or the Australian Corporations Act
2001. PEL is subject to a disclosure obligation that requires it to
notify certain material information to NZX Limited (NZX) and ASX
Limited (ASX) forthe purpose of that information being made
available to participants in the market and that information can
be found by visiting www.nzx.com/companies/PEBand
www2.asx.com.au/markets/company/PEB. This presentation
should be read in conjunction with PEL’s other periodic and
continuous disclosure announcements released to NZXand ASX.
Not an offer
This presentation is for information purposes only and is not an
invitation or offer of securities for subscription, purchase or sale
in any jurisdiction.
Not financial product advice
This presentation does not constitute legal, financial, tax, financial
product advice or investment advice or a recommendation to
acquire PEL securities and has been prepared without taking into
account the objectives, financial situation or needs of investors.
Forward-looking statements
This presentation may contain forward-looking statements that
reflect PEL’s current views with respect to future events. Forward-
looking statements, by their very nature, are not guarantees of
future outcomes and involve inherent risks and uncertainties.
Many of those risks and uncertainties are matters which are
beyond PEL’s control and could cause actual results to differ from
those predicted. Variations could either be materially positive or
materially negative. The information is stated only as at the date
of this presentation. Except as required by law or regulation
(including the NZX Listing Rulesand ASX Listing Rules), PEL
undertakes no obligation to update or revise any forward-looking
statements, whether as a result of new information, future events
or otherwise. To the maximum extent permitted by law, the
directors of PEL, PEL and any of its related bodies corporate and
affiliates, and their respective officers, partners, employees,
agents, associates and advisers do not make any representation or
warranty, express or implied, as to the accuracy, reliability or
completeness of such information, or the likelihood of fulfilment
of any forward-looking statement or any event or results
expressed or implied in any forward-looking statement, and
disclaim all responsibility and liability for these forward-looking
statements (including, without limitation, liability for negligence).
Financial data
All dollar values are in New Zealand dollars unless otherwise
stated. This presentation should be read in conjunction with, and
subject to, the explanations and views of future outlook on
market conditions, earnings and activities given recent
announcements to the NZX and ASX.
Non-GAAP financial information
This presentation contains certain financial measures that are
“non-GAAP financial information” under the New Zealand
Financial Markets Authority Guidance Note on disclosing non-
GAAP financial information, “non-IFRS financial information” (and
potentially under other regulatory guidelines or rules).Such
financial information and financial measures (including EBITDA,
Cash Burn and Capex) do not have standardised meanings
prescribed under NZ IFRS or IFRS and therefore, may not be
comparable to similarly titled measures presented by other
entities, and should not be construed as an alternative to other
financial measures determined in accordance with NZ IFRS, or
IFRS.)
Effect of rounding
A number of figures, amounts, percentages, estimates,
calculations of value and fractions in this presentation are subject
to the effect of rounding. Accordingly, the actual calculation of
these figures may differ from the figures set out in this
presentation.
Past performance
Investors should note that past performance, including past share
price performance, cannot be relied upon as an indicator of (and
provides no guidance as to) future PEL performance, including
future financial position or share price performance.
Disclaimer
To the maximum extent permitted by law, none of PEL and its
advisers, affiliates, related bodies corporate, nor their respective
directors, officers, partners, employees and agents makes any
representation or warranty, express or implied, as to the
materiality, currency, accuracy, reliability or completeness of
information in this presentation; and none of them shall have any
liability (including for negligence) for:
•any errors or omissions in this presentation; or
•any failure to correct or update this presentation, or any other
written or oral communications provided in relation to this
presentation; or
•any claim, loss or damage (whether foreseeable or not) arising
from the use of any information in this presentation or
otherwise arising in connection with this presentation or the
information contained in it.
IMPORTANT NOTICE AND DISCLAIMER
3
DIRECTORS
4
SARAH PARK
ANNA STOVETONY BARCLAY
BRYAN WILLIAMS
ANATOLE MASFEN
1. CHAIRMAN’S ADDRESS
2. CHIEF EXECUTIVE’S ADDRESS
3. QUESTIONS
4. RESOLUTIONS
5. VOTING AND GENERAL BUSINESS
6. MEETING CLOSE
AGENDA
5
FY 25 STRATEGIC GAINS OVERSHADOWED BY MEDICARE NON-COVERAGE
-$29.9M
NET LOSSAFTER
TAX +1.4%
on FY 24
$22.6M
CASH, CASH
EQUIVALENTS
2
24,642
COMMERCIAL
TESTS
1
-9.9%
on FY 24
28,894
GLOBAL TESTS
1
-11.5%
on FY 24
$21.8M
OPERATING
REVENUE
-8.6% on
FY 24
6
1. Total Laboratory Throughput (TLT) including commercial, pre-commercial and clinical studies testing
2. Cash, short-term deposits and term deposits
3. US Centersfor Medicare and Medicaid Services
COMPANY DEFINING STRATEGIC MILESTONES
Cxbladder Triage included in the American Urological
Association (AUA) Microhematuriaguideline
Medicare non-coverage determination made on stale
evidence became effective after balance date. Re-coverage
through reconsideration of new evidence is the definitive
path forward
Guideline and new evidence is shifting clinical sentiment in
favorof Cxbladder
Pacific Edge’s longer-term economics reinforced by draft
CMS
3
pricing of Triage Plus at US$1,018 per test vs. US$760
per test for the current generation of tests
RESILIENT OPERATING PERFORMANCE
Resilient operating performance amid Medicare uncertainty
Operating revenue, net losses, and cash burn steady 2H 25
vs 1H 25 as operating efficiencies and cash collection gains
retained
US Q1 26 volumes fall largely due to the transition of
customers from Detect to Triage
Opportunities emerging from the AUA guideline still
untapped
RAISING NEW CAPITAL TO MAINTAIN COMMERCIAL MOMENTUM
Pacific Edge’s priority is to ensure it has the resources and capacity to capitalize on its
recent clinical and commercial milestones, grow in non-Medicare channels and regain
Medicare coverage
-Placement: $16.073 million pledged, subject to approval at today’s meeting
-Share purchase plan (SPP): closed 31 July 2025 after investors pledged$4.662 million but
it will not proceed if the Placement is not approved today
Funds
1
raised will be used to:
•Accelerate adoption of Triage in the US with AUA Guidelines as a tailwind for sales,
marketing and reimbursement
•Continue clinical evidence generation in an AV, CV and CU framework for coverage,
guidelines and medical policy for Triage Plus and Monitor Plus
•Invest in innovation and product development for IVD kits to support entry into
international markets in a de-centralized deployment model
•Extend cash runway to support operations while we seek Medicare re-coverage and while
we maintainmarket momentum
7
1. $20,735,041in new equity has been raised through the Placement and SPP. For key risks associated with the capital raising please refer
to the appendix of this presentation
8
DR PETER MEINTJES
Chief Executive Officer
CHIEF EXECUTIVE’S ADDRESS
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
9
AUA MICROHEMATURIA GUIDELINE INCLUSION
A COMPANY-DEFINING STRATEGIC MILESTONE ACHIEVED IN FEBRUARY 2025
The 2025 amendment to the AUA microhematuria guideline supports the use of urine-based
biomarkers for intermediate-risk patients as an alternative to a cystoscopy
•Primary driver for the change in the guidelines was clinical utility evidence for Cxbladder Triage from a
randomized controlled trial, i.e. the STRATA Study
1
•Cxbladder Triage specifically mentioned as the only urine-based biomarker test that has ‘Grade A’
evidence
2
cementing first-mover advantage and building a moat vs competitors
•The change was significant:
•The 2020 guideline expressly prohibited the use of urine-based biomarkers in lieu of a cystoscopy
•The 2025 guideline brings genomic testing to hematuria evaluation for bladder cancer as already
established for prostate, breast, colon and other cancers
•Intermediate-risk patients represent a large cohort (~70%)
3
of microhematuria patients (up to 3.5 million
patients annually in the US)
•Offers significant benefits to patients, reduces the burden of unnecessary cystoscopies, improves access to
care at a lower cost and reduces legal liability for using biomarker alternatives
AUA guideline inclusion provides significant global clinical validation for Cxbladder which is
expected to pave the way for further wider global adoption by healthcare providers and
payers –we have already noticed increased interest from physicians
“... [for] intermediate-risk
patients who want to avoid cystoscopy and
accept the risk of forgoing direct visual
inspection of the bladder urothelium, clinicians
may offer urine cytology or validated urine-based
tumor markers to facilitate the decision
regarding utility of cystoscopy.”
–2025 AUA Microhematuria Guideline Amendment
10
1. Lotan et al. (2024) . A MulticenterProspective 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.
2. The AUA defines ‘Grade A’ evidence as evidence with a high certainty rating and notes evidence of this grade makes it "very confident that the true effect
lies close to that of the estimate of the effect”
3. Pacific Edge estimate based on the new risk categories created with the 2025 microhematuria guidelines
PACIFIC EDGE’S EVIDENCE PROGRAM SEEKS TO CHANGE CLINICAL PRACTICE
Clinical Evidence
AV, CV, CU
HEALTHCARE PAYERS
(Medicare, Kaiser
Permanente, Veterans
Administration,private
payers, etc).
- Change Medical Policy
(practice)
- Change Reimbursement
Policy
PROFESSIONAL SOCIETIES
(AUA, EAU, NCCN)
-ChangeStandard of Care
Guidelines
Guidelines change:
-Healthcare Payer Medical
and Reimbursement
Policies
Guidelines change:
- Clinical Practice
UROLOGISTS-Change Clinical Practice
We are focused on generating the compelling clinical evidence required to drive behavior change in physicians. We seek to produce
evidence that is founded on the frameworks of Analytical Validity (AV), Clinical Validity (CV) and Clinical Utility (CU), on clearly
defined patient populations with the endpoints and sample sizes required for coverage decisions and guideline inclusion.
AUDIENCE
EVIDENCE USE
11
MEDICARE REIMBURSEMENT COMMENCED IN 2020 BUT CEASED IN 2025
•Medicare reimbursed Cxbladder tests >98% since 2020 at US$760 per test –these tests have
accounted for the majority of US volumes and ~61% of revenue in FY25
•Novitas –the Medicare Administrative Contractor that determines Medicare coverage for
our tests –proposed non-coverage for Cxbladder in July 2022 (2H 23)
•We challenged this determination with more recent evidence and support from the
American Urological Association (AUA), but Novitas finalized its non-coverage determination
in January 2025 without considering the most-current evidence available
•This decision removed coverage for AUA guideline-recommended testing, after following a
process that failed to review the most-current evidence
OUR RESPONSE: DRIVING CXBLADDER DEMAND WITH AUA GUIDELINE INCLUSION
•~47% of US volumes are from other contracted payers (e.g. Kaiser Permanente, the US
Veterans Administration and various Blue Cross Blue Shield plans) and non-contracted
private payers –these volumes are expected to continue to grow inline with historical trends
•Our commercial team will continue to promote and supply tests to existing US users and
drive demand to maintain the momentum building from the guideline
•Seeking reimbursement through the Medicare Appeals Process and External Review
•Cxbladder Detect users are being migrated to Triage, accelerating a plan previously intended
to coincide with the commercial launch of Triage Plus
•
MEDICARE NON-COVERAGE IN APRIL 2025 INCONSISTENT WITH AUA GUIDELINE
AUA GUIDELINE INCLUSION PROVIDES THE BASIS FOR GREATER SUCCESS WITH COMMERCIAL PAYERS
12
Medicare is the US national
insurance payer for all US citizens
over 65 years of age –the most
at risk age demographic for
bladder cancer
SEEKING RE-COVERAGE VIA LCD RECONSIDERATION AND MEDICARE APPEALS
RECONSIDERATION REQUESTS UNDER REVIEW; APPEALS TO RELY ON GUIDELINE INCLUSION
POSITIVE ENGAGEMENT WITH NOVITAS TO RESTORE COVERAGE FOR TRIAGE AND MONITOR
•Cxbladder Triage: A reconsideration request was submitted to Novitas in March 2025 consisting of STRATA
1
and the
AUA Microhematuria guideline and is under review
•Cxbladder Monitor: A reconsideration request was submitted to Novitas in May 2025 consisting of two new real-
world studies from Australia and is under review
•We are attempting to get reimbursed on Triage tests based on the 2025 AUA microhematuria guideline through the
Medicare appeal process on the grounds of the test being “medically reasonable and necessary”
ESTABLISHING MEDICARE COVERAGE FOR TRIAGE PLUS
•The analytical validation (AV) for Triage Plus has been published
2
, clinical validation (CV) has been submitted for peer
review and seeking publication in FY 26 Q1
•Pacific Edge expects to submit a reconsideration request for Triage Plus when CV is published or provide during the
comment period if the LCD has been opened
•Inclusion of Triage in the AUA microhematuria guideline establishes medical policy to which Triage Plus can be
added, meaning AV and CV should be sufficient for coverage of Triage Plus
•Further evidence for Triage published by Kaiser Permanente as a presentation at AUA and in peer review for
publication by FY 26 Q3 further confirms the clinical utility and health economics of Triage (and Triage Plus)
13
1. Lotan et al. (2024) . A MulticenterProspective 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.
2. Harvey, J.C. et al. (2025) Analytical Validation of the Cxbladder® Triage Plus Assay for Risk Stratification of HematuriaPatients for
Urothelial Carcinoma. Diagnostics 2025, 15, 1739.
2026*2025*CATALYSTMEDICARE RECONSIDERATION REQUEST
Q4Q3Q2Q1Q4Q3Q2Q1
STRATA Study (May 2024)
AUA Macrohematuria guideline (Feb 2025)
L39365 Reconsideration request (Triage)
AV of Triage, Detect & Monitor (Sept 2024)
2x RWE of Monitor (March 2025)
L39365 Reconsideration request (Monitor)
AV of Triage Plus (Q2 25)
CV of Triage Plus –DRIVE Study (Q3 25)**
L39365 Reconsideration request (Triage Plus)
14
Estimated Novitas determination
*Calendar year
**Estimated publication quarter
Estimated opening of Novitas draft LCD
12-months after opening (worst case, assuming opening)
MEDICARE RE-COVERAGE: ESTIMATED TIMELINES
COVERAGE DECISIONS, PRIOTIZATION AND TIMELINES ARE AT THE DISCRETION OF NOVITAS
1
•Novitas has the discretion to combine reconsideration requests on the same LCD based on the
Medicare Program Integrity Manual. Pacific Edge expects this is the most likely approach
•Pacific Edge has the discretion to submit Triage Plus as part of the Comment Period if L39365 is
opened before we submit the reconsideration request
•Novitas controls the timing of the LCD opening, but LCD must finalize within 12 months of opening
1. Novitas is the Medicare Administrative Contractor (MAC) charged with making the Medicare local coverage determination for Pacific Edge’s US laboratory
15
PLANNED PUBLICATIONS -EMBEDDING CXBLADDER IN CLINICAL PRACTICE
MEDICARE RECONSIDERATION AND GUIDELINE INCLUSION REQUESTS
(Novitas
1
has 60 days to deem a reconsideration request valid. Opening an LCD is at the discretion of Novitas)
Expected date of reconsideration request
(3)
Test and evidence standard
(2)
Catalyst (published)
Published May 2024, Novitas notified-CU of Triage
1. STRATA Clinical Utility
Published September 2024, Novitas notified-AV of Triage, Detect and Monitor
2. Automated RNA & DNA extraction Analytical Validation
Published July 2025-AV of Triage Plus
3. Triage Plus Analytical Validation
Submitted for publication -CV of Triage Plus
4. DRIVE Clinical Validation
Q4 2025-CU of Triage Plus (concordance)
5. STRATA second publication
Q3 2025
5
-CU of Triage (RWE)
6. Kaiser Permanente Triage RWE
4
Q1 2026-CVof Triage Plus
7. AUSSIE Clinical Validation
Q4 2026 -CV of Triage Plus
8. microDRIVEClinical Validation
Q22026-AV of Monitor Plus
9. Monitor Plus Analytical Validation
Q1 2027-CV of Triage Plus
10. Pooled Analysis MH Clinical Validation
6
Q1 2027-CV of Monitor/Monitor Plus
11. Pooled Analysis GH Clinical Validation
7
Q1 2027-CV of Monitor/Monitor Plus
12. LOBSTER Clinical Validation
Q1 2028-CU of Triage Plus
13. CREDIBLE Clinical Utility
4
RWE is Real World Evidence
5
Timeline determined by Kaiser Permanente
6
The pooled analysis brings together data from DRIVE, AUSSIE and microDRIVE
7
The pooled analysis brings together data from DRIVE and AUSSIE
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
US CONTRACTED PAYER DEMAND SUPPORTS 2H 25 VOLUME GROWTH
AUA GUIDELINE INCLUSION REMAINS AN UNTAPPED OPPORTUNITY
•US commercial volumes in 2H 25 increased 2.7% against 1H 25
supported by contracted payer volumes
•Non-Medicare volumes represented 47% of US commercial
volumes (~9,366) in FY 25 vs 40% ( ~5,358) in 1H 24
•Strong performance from the Southern California Permanente
Medical Group and sustained sales force efficiency gains mitigated
impact of Medicare uncertainty
•Q1 26 volumes are resilient in the face of the Medicare non-
coverage and the transition from Detect to Triage
•Volume drop was due principally to the disruption of asking
physicians to switch to Triage from Detect
•The transition to Triage is going well with sales messaging
supported by the AUA microhematuriaguideline
•Volumes still to benefit from the AUA guideline
US TOTAL TEST VOLUME
1
1. Total Laboratory Throughput in the US including commercial, pre-commercial and clinical studies testing
2. 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.
3. Lotan et al. (2024) . A MulticenterProspective 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.
16
8,627
7,335
6,041
6,099
5,905
5,682
5,808
6,490
5,717
-
1,000
2,000
3,000
4,000
5,000
6,000
7,000
8,000
9,000
Q1 24 Q2 24 Q3 24 Q4 24 Q1 25 Q2 25 Q3 25 Q4 25 Q1 26
TEST VOLUME
22.6%
28.7%
59.7%
74.1%
18.9%
19.0%
16.8%
17.5%
58.6%
51.9%
21.2%
6.0%
0%
10%
20%
30%
40%
50%
60%
70%
80%
90%
100%
Monthly Average Q4 25 Apr-25May-25Jun-25
% TESTS RECEIVED
Q1 26 US TESTS RECEIVED -MIX
PROGRESS ON COMMERCIAL PAYER OPPORTUNITIES
MICROHEMATURIA PATIENTS SKEW YOUNGER WITH COMMERCIAL HEALTH INSURANCE
1. BCBS GPO is Blue Cross Blue Shield Group Purchasing Organization
2. ECRI is the Emergency Care Research Institute https://home.ecri.org/
17
•The AUA guideline recommends Triage for intermediate risk microhematuria patients
–male patients are 40-59, while female patients are >60. This is expected to drive a
shift in payer mix away from Medicare and towards commercial insurance.
•Future success in reimbursement will be driven by our ability to establish
medical policy and contracting with commercial payers
•Recent progress against this opportunity leveraging STRATA and Guidelines:
•Established pricing with the BCBS GPO
1
•Individually contracted with BCBS Texas, BCBS Illinois and Wellmark
•Gained a “favorable” 4/5 recommendation from ECRI
2
–a data curator to
which many commercial payers subscribe
•Acknowledgement from Avalon Healthcare Solutions that Triage should be
covered when used according to guidelines
•Secured ‘in-network’ status with Optum Veterans’ Affairs Community Care
Network
•Commercial payers increased 5% since pre-May 25 to ~37% of the payer mix
(excluding Kaiser Permanente) in June 25. Commercial claims success appears
to be increasing
•Expanding access to Triage Pluswhen reimbursement is reliable:
•Multiple VA sites have been targeted to participate in our Early Access
Program for Triage Plus at draft Medicare pricing (US$1,018)
SALES PERFORMANCE IMPROVEMENTS EMBEDDED IN FY 25
WE SEE UNEXPLOITED OPPORTUNITIES TO LEVERAGE THE AUA GUIDELINE
US SALES FORCE EFFICIENCY
US CLINICAL COMMITMENT
•Sales force efficiency (total tests/average FTE) and clinical
commitment (tests/ordering clinician) fall in Q1 26
reflecting the disruptions of transition to Triage from
Detect
•Sales force efficiency at 381 is well ahead of the low point
of 160 in Q3 22
•Sales FTE down to an average of 15.0 in Q1 26 from 16.0 in
Q4 25 and >30 in Q1 24 before restructure to focus on
cash conservation
18
30
28
21
16
15
15
15
16
15
288
265
292
381
403
379 379
406
381
200
250
300
350
400
-
5
10
15
20
25
30
35
40
Q1 24 Q2 24 Q3 24 Q4 24 Q1 25 Q2 25 Q3 25 Q4 25 Q1 26
TEST VOLUME/SALES FTE
AVERAGE SALES FTE
US AVERAGE SALES FTE (LHS)US TEST VOLUME/SALES FTE (RHS)
1,232
1,147
1,016
915
867
890
866
914
907
7.0
6.4
5.9
6.7
6.8
6.4
6.7
7.1
6.3
-
1.0
2.0
3.0
4.0
5.0
6.0
7.0
8.0
-
200
400
600
800
1,000
1,200
1,400
1,600
Q1 24 Q2 24 Q3 24 Q4 24 Q1 25 Q2 25 Q3 25 Q4 25 Q1 26
TESTS/CLINICIAN
US ORDERING CLINICIANS
US ORDERING CLINICIANS (LHS)TESTS/ORDERING CLINICIAN (RHS)
FOUNDATIONS FOR GROWTH –US CASH COLLECTIONS IMPROVE
•Despite the dip in 2H 25 Average Sales Price (ASP
1
) due to
timing variances related to accruals and increased provisions
against revenue, ASP per test has increased to US$594 in FY 25
from US$584 in FY 24 lifted by:
•Enhanced Patient Responsibility -patients with non-
contracted private insurance (i.e. non-Kaiser) pay a fixed
dollar amount “maximum out of pocket”
•Increased utilization of appropriate patient types from
Kaiser Permanente after EMR integration
•Medicare reimbursement of Triage since Jan 2023
•Improved medical necessity documentation to improve
billing and appeals processes for Medicare Advantage
•Improved cash collections are typically permanent
improvements that we expect to maintain as we scale
1. ASP: US Operating Revenue in USD / US Commercial Test Volumes
US COMMERCIAL TEST VOLUMES AND ASP* (US$)
REIMBURSEMENT & CASH COLLECTIONS –A CORE COMPETENCY
19
7,476
8,276
10,622
12,450
13,550
9,956
9,913
10,177
$472
$470
$493
$519
$562
$613
$618
$571
$-
$100
$200
$300
$400
$500
$600
$700
-1,000
1,000
3,000
5,000
7,000
9,000
11,000
13,000
15,000
17,000
1H 22 2H 22 1H 23 2H 23 1H 24 2H 24 1H 25 2H 25
TEEST VOLUME
US ASP (RHS)
AUA GUIDELINE OFFERS NEW OPPORTUNITIES FOR CLIENT BILLING
•With AUA guideline inclusion, a new opportunity exists to get paid
per test by hospitals and large urology group practices (LUGPAs) and
let them handle the commercial reimbursement
•This provides a revenue incentive to hospitals/LUGPAs and has the
potential to drive volume, since they are commonly "in-network"
with commercial payers and have sophisticated billing teams
MEDICARE PRICE FOR TRIAGE PLUS ACCELERATES PATH TO PROFITABILITY
DRAFT PRICE FOR TRIAGE PLUS OF US$1,018 PER TEST PUBLISHED
MEDICARE COVERAGE NEEDED BEFORE FULL-SCALE COMMERCIAL LAUNCH
•The Centers for Medicare & Medicaid Services (CMS) set draft price for Triage
Plus of US$1,018 via its ‘Gapfill’ process in April 2025; due to become effective
Jan 2026
•We regard this as a ‘floor’ for the Triage Plus price that materially lifts
margin per test from the previous pricing at US$760
•This improves the unit economics of operating an Account Executive,
facilitating more rapid scaling and a faster path to profitability
•We are seeking a higher price:
•We have provided additional information to MolDXto reconsider the
draft US$1,018 ‘Gapfill’ price they recommended to CMS
•If they are amenable to our arguments, a new final Gapfillprice
will be published in September and recommended to CMS
•If they are not amenable to our arguments, the $1,018 will be
published in September and recommended to CMS
•We lodged a reconsideration request with CMS with a new Crosswalk
approach seeking a price of US$1,390
•Recommendation from the Advisory Panel to CMS is expected in
September
•A final decision from CMS would be due in November 2025
20
1. For a description of the ‘Gapfill’ and ‘Crosswalk’ processes please refer to the CMS description at the following link (HERE)
DRIVING GROWTH IN ASIA PACIFIC AND CONSOLIDATING NEW ZEALAND
*
SEEKING A NATIONAL HEMATURIA EVALUATION PATHWAY IN NZ
•Quarterly total test volumes benefit from:
•Fewer evaluations and non-billable tests
•Shift in emphasis to commercial tests from evaluations
•STRATA
1
and AUA microhematuria guideline are well understood in
Te Whatu Ora/Health New Zealand; Pacific Edge is focused on a
national pathway for hematuria evaluation
21
1. Lotan et al. (2024) . A MulticenterProspective 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.
2. Total Laboratory Throughput in Asia and Pacific including commercial, pre-commercial and clinical studies testing
1,079
1,199
1,142
1,111
1,278
1,360
1,284
1,087
1,183
-
200
400
600
800
1,000
1,200
1,400
1,600
1,800
Q1 24 Q2 24 Q3 24 Q4 24 Q1 25 Q2 25 Q3 25 Q4 25 Q1 26
TEST VOLUME
APAC TOTAL TEST VOLUME
2
AUSTRALIA & ASIA PACIFIC
•Southeast Asia is still in business development, and we are extending
our reach into the market through a distributor network which has
seen testing volumes grow
•While our primary near-term focus remains on the US, Southeast
Asia has large population centers, private healthcare systems, and
favorable cultural and demographic considerations to be a high-
volume market for an IVD-kitted product
CUSTOMER EXPERIENCE INTIATIVES DELIVERING VALUE
DIGITALIZATION OF INFORMATION FLOWS EMBEDS CXBLADDER IN CLINICAL PRACTICE
ENHANCING CXBLADDER’S EASE OF USE
•We give customers options to connect with Pacific Edge to fit
their needs with easy-to-use digital integrations
•Digital channels for test ordering and results delivery
•1-to-1 EMR Integration, e.g. Kaiser interface
•1-to-many Integration, e.g. LumeaDigital Pathology,
Awanui
•Customer portal –available to any Customer Account
•Improves the end-to-end experience for physicians
•Easier ordering in-clinic or for in-home sampling
systems
•Optimized test kit management and workflow
•Enhanced order visibility and tracking
•Streamlined access to results
•Pacific Edge’s operations benefit
•Fewer errors, faster handling and results delivery
•Reduced demand on the sales force and customer
service
22
THE PACIFIC EDGE CUSTOMER PORTAL
LAUNCHING IMPROVED PRODUCTS AND IVD FOR INTERNATIONAL MARKETS
AN IVD PRODUCT MAY EXTEND THE MARKET OPPORTUNITY AND THE ‘MOAT’ AROUND CXBLADDER
READYING FOR THE LAUNCH OF TRIAGE PLUS
•Product development investments in digital systems to ensure scalable lab
operations for Triage Plus
•Simplifying Cxbladder:
•Aim to reduce technician time, lower cost of goods, lower turnaround time,
increase throughput and increase automation of our lab testing services
•Aim to automate lab operations from end-to-end lab for RNA and DNA
workflows of our lab testing services
•Continued engagement with industry and academic research and development
collaborations to address unmet clinical needs in bladder cancer diagnosis and
management
ADVANCING IVD DEVELOPMENT FOR INTERNATIONAL MARKETS
•Accelerating the development of a kitted IVD (in vitro diagnostic) product from our
existing lab service called Triage Plus IVD, for decentralized lab deployment and
international market expansion
•Establish IVD regulatory framework for our next generation tests that
includes IVD-R (Europe), FDA (USA) and ISO-13485
1
(Rest of World)
•Targeting prototypes by the end of CY 25; manufacture and commencement
of clinical and analytical validation commencing in CY 26
•Achieving IVD-approved status may make it more difficult for competitors to
develop parity with Cxbladder’slevel of evidence
Chief Scientific Officer Parry Guilford (center) and Chief Technology
Officer Justin Harvey (right)
23
1. IVD-R European In Vitro Diagnostic Regulation; FDA, US Food and Drug Administration; ISO International Organization for Standardization
24
OUTLOOK
RECENT CATALYSTS FOR STRONG GROWTH –VOLUME AND PRICING
•AUA microhematuria guideline enables sales, marketing and reimbursement activities. We are
determined to maximize this milestone through existing and new initiatives
•Triage Plus draft pricing at US$1,018 supports stronger unit economics, margins and sales force
efficiency for a faster path to cash flow breakeven if successful in re-establishing Medicare
coverage
GROWTH STRATEGY –TO BE ACCELERATED WITH NEW CAPITAL
•Entrench first-mover advantage and “moat” for Triage given AUA guideline inclusion
•Continue clinical evidence generation in an AV, CV and CU framework for coverage, guidelines and
medical policy for Triage Plus and Monitor Plus
•Increase Triage throughput, throughput/sales headcount and throughput/clinician
•Seek reimbursement through the Medicare Appeals process, relying on the AUA guideline, ahead
of the resolution of multiple reconsideration requests
•Advance medical policy with commercial payers as the market for Triage on microhematuria
patients shifts the payer mix towards commercial payers
•Increase the percentage of electronically ordered tests and patients with commercial insurance
•Emphasize the clinical and economic value of Cxbladder as a value-based care solution in our sales
messaging for selling to institution, integrated hospital systems and payers
•Invest in innovation and product development for IVD kits to support entry into international
markets in a de-centralized deployment model
FURTHER CATALYSTS
•Cxbladder is under consideration by Te Whatu Ora for a National Pathway in New Zealand
RESOLUTIONS
25
VOTING INSTRUCTIONS
26
RESOLUTION 1: AUDITORS’ REMUNERATION
27
RESOLUTION
“To authorisethe Directors to fix the auditors’ remuneration for the ensuing year.”
RESOLUTION 2: RE-ELECTION OF CHRIS GALLAHER
28
RESOLUTION
“That Chris Gallaher, who retires by rotation and is eligible for re-election, be
re-elected as a Director of the Company.”
RESOLUTION 3: RE-ELECTION OF SARAH PARK
29
RESOLUTION
“That Sarah Park, who retires by rotation and is eligible for re-election, be
re-elected as a Director of the Company.”
RESOLUTION 4: RE-ELECTION OF TONY BARCLAY
30
RESOLUTION
“That Tony Barclay, who retires by rotation and is eligible for re-election, be
re-elected as a Director of the Company.”
RESOLUTION 5: SHARE PLACEMENT
31
RESOLUTION
“That the issue of 160,728,498 new Shares to Placement Participants at an issue price
of $0.10 cents per new Share under the Placement, with such new Shares to rank
equally on issue with all existing Shares, be approved for all purposes, including NZX
Listing Rules 4.2.1 and 5.2.1.”
RESOLUTION 6: DIRECTORS’ REMUNERATION POOL
32
RESOLUTION
“That the total annual non-executive Directors’ remuneration pool be increased to
$628,000 per annum, effective from 1 April 2025 and applied retrospectively.”
RESOLUTION 7: ISSUE OF SHARES TO DIRECTORS
33
RESOLUTION
“That the issue of up to 1,930,000 new Shares to non-executive Directors in lieu of the
payment of additional Director remuneration in cash in respect of the period from 1
April 2025 to 31 March 2026 as described in the Explanatory Notes, with such new
Shares to rank equally on issue with all existing Shares, be approved for all purposes,
including NZX Listing Rule 4.2.1.”
PROXY VOTING DIRECTIONS
34
TOTALAGAINSTOPENFORRESOLUTION
375,363,560275,480 (0.07%)8,409,599 (2.24%)366,678,481 (97.69%)
1. Auditors’ remuneration
375,421,8042,430,616 (0.65%)8,435,768 (2.25%)364,555,420 (97.11%)
2. Re-election of Chris Gallaher
375,185,538453,733 (0.12%)8,435,768 (2.25%)366,296,037 (97.63%)
3. Re-election of Sarah Park
375,184,874444,342 (0.12%)8,435,768 (2.25%)366,304,764 (97.63%)
4. Re-election of Tony Barclay
293,863,189660,551 (0.22%)8,303,335 (2.83%)284,899,303 (96.95%)
5. Share placement
344,718,82832,393,706 (9.40%)10,857,929 (3.15%)301,467,193 (87.45%)
6. Directors’ remuneration pool
345,006,66330,924,946 (8.96%)10,751,040 (3.12%)303,330,677 (87.92%)
7. Issue of shares to Directors
*Percentage figures indicate proportion of total votes notified (excludes abstentions)
GENERAL BUSINESS
35
MEETING CLOSE
36
APPENDIX
37
CAPITAL RAISING RISKS
38
KEY RISKS
Pacific Edge does not currently have Medicare coverage for its Cxbladder products. Medicare previously accounted for the majority of its US test volumes and, therefore, a
significant percentage of Pacific Edge's revenue. Although Pacific Edge is confident that it will regain coverage for Triage as a result of recent AUA guideline inclusion and new
clinical evidence, there are no guarantees as to the timing or outcome of the re-coverage process. Regaining Medicare coverage could be delayed or not achieved at all. If
Medicare re-coverage was not achieved or was significantly delayed, it would have a material adverse impact on Pacific Edge's financial performance and growth and could result
in the company using up all available cash before it is able to become profitable from its ongoing operations.
If the current reconsideration request is unsuccessful, Pacific Edge will likely need to complete further clinical studies toprovide new published evidence when submitting
another reconsideration request. That clinical study will take a number of years to undertake.Accordingly,if the current reconsideration request is unsuccessful, Pacific Edge will
need to undertake a significant restructure of its business to substantially reduce costs and, potentially, seek to raise further capital.
Medicare coverage
uncertainty
Pacific Edge is operating at a 'cash burn', which means that the company spends more cash that it generates. The capital raise is in part to provide sufficient cash to regain
Medicare coverage. If Medicare coverage is not achieved or significantly delayed, or the business is impacted adversely by otherevents, there is a risk to the ongoing financial
viability of Pacific Edge, which may result in investors losing some or all of their investment.
Ongoing Financial
Viability
Pacific Edge’s Cxbladder products and laboratories are regulated and certified by various government and industry entities interritories and markets in which the tests are performed
and/or sold. Reimbursement for these tests may be influenced by reimbursement rulings from private and/or government payers.Guidelines issued by various industry bodies also
influence the treatment and management regimes for patients, with the potential to impact on the uptake and use of Cxbladder.IfPacific Edge is unable to retain or, in certain markets,
gain inclusion in guidelines, or the current regulatory approvals and reimbursement obtained for existing products are removed or reduced, such matters could have an adverse impact on
Pacific Edge’s financial performance and its ability to achieve its business plans. If Pacific Edge is unable to obtain the approvals required for new products in new territories, or is unable to
obtain future reimbursement for new products, this could also have an adverse impact on Pacific Edge’s financial performance andits ability to achieve its business plans.
Regulatory, industry
body and guideline
risks
The global cancer diagnostics industry is highly competitive, with research undertaken by a large number of commercial and not for profit institutions globally on new diagnostic
tools. There are also a large number of well capitalised diagnostics competitors operating in the industry. There is a risk that Pacific Edge’s competitors may discover, develop or
commercialise products more successfully than Pacific Edge, which could render Pacific Edge’s products obsolete or otherwise uncompetitive, resulting in adverse effects on
Pacific Edge’s revenue, margins and profitability.
Competition
Pacific Edge relies on the performance and reliability of its Cxbladder suite of products, laboratory operations and IT and technical systems. While the performance of Cxbladder
has been demonstrated in various scientific journal publications, any change to the reliability, repeatability, reproducibility or accuracy of Cxbladder products and technology
systems has the potential to impact Pacific Edge’s business and reputation. Cyber attacks on Pacific Edge digital systems and platforms also have the potential to impact the
delivery of test results. Financial, reputational and litigation consequences relating to underperformance and unreliability,orthe inability to deliver, test results (including due to
adverse cyber incidents) have the potential to be significant and could be materially adverse to the company's financial performance and position.
Product and
technology risk
Pacific Edge’s operating and financial performance is influenced by a variety of general economic and business conditions in NewZealand, the United States, Southeast Asia and
globally. A prolonged deterioration in general economic conditions, which may lead to a decrease or reprioritisation of healthcare spending, has the potential to have a material
adverse effect on Pacific Edge’s business or financial condition (or both).
General economic
conditions
39
KEY RISKS (CONT)
In the ordinary course of conducting its business, Pacific Edge is exposed to potential litigation and other proceedings, including through claims of intellectual property infringement or
breach of agreements. If such proceedings are brought against Pacific Edge, Pacific Edge could incur considerable defence costs (even if successful), with the potential for damages and
costs awards against Pacific Edge if it were unsuccessful, which could have a significant adverse financial impact on PacificEdge.
Circumstances may also arise in which Pacific Edge considers that it is reasonable or necessary to initiate litigation or other proceedings, including for example to protect its intellectual
property rights.
Litigation
The success of our business depends significantly on the continued contributions of our executive team, scientific leaders, and key technical staff. The unexpected departure of any of
these individuals could disrupt operations, delay research and development efforts, and negatively impact strategic initiatives.Attracting and retaining top talent in a competitive biotech
labor market remains a critical challenge.
Key Person Risk
Pacific Edge’s shares are currently listed on NZX and the ASX, and are subject to the usual market-related forces which impact on Pacific Edge’s share price. There can be no assurance that
trading in the shares following the allotment of shares under the capital raising will not result in the share price trading at levels below the price paid by investors. The equity markets can
be subject to pronounced volatility. This volatility could have a materially adverse impact on the market price of Pacific Edge shares.
Factors such as the risk factors disclosed in this presentation as well as other factors could cause the market price of PacificEdge’s shares to decline or to materially fluctuate. It also is
possible that new market risks may develop as a result of the New Zealand or Australian markets experiencing extreme stress, or due to existing risks manifesting themselves in ways that
are not currently foreseeable.
A weakening in the New Zealand or Australian dollar as against other currencies will cause the value of the shares to declineinany portfolio which is denominated in a currency other than
New Zealand dollars.
Market volatility of
Pacific Edge’s shares
Pacific Edge continues to leverage its suite of patents and intellectual property to explore new products and applications. There is a risk that those development efforts may not
be successful or may take longer and be more expensive than anticipated, and as a result Pacific Edge’s investment will be delayed or lost. This risk could arise due to a number of
factors, including delays in commencement or completion of scientific studies. Any failure or significant delay in the development of one or more of Pacific Edge’s new products
and product extensions may have a material negative impact on Pacific Edge’s financial performance and growth.
New product
development
40
PACIFIC EDGE –BACKGROUND INFORMATION
41
PACIFIC EDGE’S GLOBAL REACH
42
US$8.5b
Global TAM
1
PACIFIC EDGE OVERVIEW
CXBLADDER OFFERS A SIGNIFICANT ADDRESSABLE GLOBAL MARKET ANNUALLY
THE PATIENT CARE PATHWAY
~7m
Present with
hematuria
~3.5m
Referred for
clinical workup
~1.1m
Receive
cystoscopy
~90k
Annual cases of
bladder cancer
~750k
Living with bladder cancer
~1.5CxbMonitor / year
US$4.4b
TAM
340m
Population
~17m
Present with
hematuria
~50%
Referred for
clinical workup
~3.3m
Receive
cystoscopy
~58k
Annual cases of
bladder cancer
~300k
Living with bladder cancer
~1.5Cxb Monitor / year
US$2.1b
TAM
830m
Population
~12m
Present with
hematuria
~50%
Referred for
clinical workup
>4.0m
Receive
cystoscopy
~180k
Annual cases of
bladder cancer
~1m
Living with bladder cancer
~1.5Cxb Monitor / year
US$2.0b
TAM
600m
Population
APAC
Focus of our
growth efforts
NZ market mature.
Australia and SE Asia
in business
development
New market accessed
via IVD / kitted tests
1. Pacific Edge estimate using US$1,018 price for hematuria testing in the US and $760 for Non-Muscle Invasive Bladder Cancer (NIMBC) surveillance and other market assumptions for
APAC and Europe. See slide 44 of this presentation for the sources and assumptions for the calculation of TAM
SOURCES AND ASSUMPTIONS -TOTAL ADRESSABLE MARKET
SOURCE STATISTICREGION
https://www.census.gov/popclock/341,762,685 Population
US
Presentation from Dr Sia Daneshmand (Director of Urologic Oncology and Clinical Research, USC) July 20197,000,000 Incidence of hematuria
Presentation from Dr Sia Daneshmand (Director of Urologic Oncology and Clinical Research, USC) July 20193,500,000 Referred for clinical workup
Kenigsberg, A, et al. The Economics of Cystoscopy: A MicrocostAnalysis, Urology 157: 29−34, 2021>1,000,000 Receive a cystoscopy
National Cancer Institute84,870 Annual cases of bladder cancer
National Cancer Institute744,044 Patients living with bladder cancer
Pacific Edge estimate4,616,066 Test opportunities
US$1,018 (Triage Plus), US$760 (Monitor) Price of Cxbladder (US$)
US$4.4TAM (US$b)
World-population -Europe; World-population –Russia600,000,000 Population
Europe (excluding
Russia)
Science Direct12,000,000 Incidence of hematuria
Presentation from Dr Sia Daneshmand (Director of Urologic Oncology and Clinical Research, USC) July 20196,000,000 Referred for clinical workup
Rindorf, D, et al. The extent of experiencing availability issues and deteriorating performance associated with reusable
cystoscopies, a multicentrestudy.
4,000,000 Receive a cystoscopy
Uroweb180,000 Annual cases of bladder cancer
Pacific Edge estimate -5 years of annual cases900,000 Patients living with bladder cancer
Pacific Edge estimate7,350,000 Test opportunities
Pacific Edge estimate€ 245Price of Cxbladder EURO
US$2.0TAM (US$b)
World population -Southeast Asia; Population Pyramid -Japan; 830,000,000
Population
APAC (excluding India
and China)
Science Direct16,600,000Incidence of hematuria
Presentation from Dr Sia Daneshmand (Director of Urologic Oncology and Clinical Research, USC) July 20198,300,000Referred for clinical workup
Pacific Edge estimate3,320,000Receive a cystoscopy
WHO; Hong Kong58,000Annual cases of bladder cancer
Pacific Edge estimate -5 years of annual cases290,000Patients living with bladder cancer
Pacific Edge estimate3,755,000Test opportunities
Pacific Edge estimate550Price of Cxbladder (US$)
US$2.1TAM (US$b)
44
202820272026202520242023
Pre
2023
Calendar
year
Q2Q1Q4Q3Q2Q1Q4Q3Q2Q1Q4Q3Q2Q1Q4Q3Q2Q1Q4Q3Q2Q1
STRATA
DRIVE
AUSSIE
microDRIVE
Pooled CV
CREDIBLE
HEMATURIA EVALUATION FIVE YEAR CLINICAL STUDIES ROADMAP
*
*
*
*
*
Publication Submitted
Records review / follow-up
Database lock
Legend:
Pre-activation (docs, CTA etc)
SIV
Enrollment
Data Cleaning
*
DBL
DBL
DBL
45
202820272026202520242023
Pre
2023
Calendar
year
Q2Q1Q4Q3Q2Q1Q4Q3Q2Q1Q4Q3Q2Q1Q4Q3Q2Q1Q4Q3Q2Q1
“The 1800”
LOBSTER
OCTOPUS
*
SURVEILLANCE FIVE YEAR CLINICAL STUDIES ROADMAP
46
Publication Submitted
Records review / follow-up
Database lock
Legend:
Pre-activation (docs, CTA etc)
SIV
Enrollment
Data Cleaning
*
DBL
SUMMARY OF CXBLADDER CLINICAL EVIDENCE
Comment
Specificity
(Sp)
NPVSensitivity
(Sn)
PopulationPublicationor Study
Development dataset (n=987) including MH (38.7%) & GH (61.3%) producing defined Sn, NPV and Sp. TNR in
development data set is 84.1%
90.8%99.4%93.6%
Synthetic Analytes
MH + GH
Harvey et al., (2025)AV
Triage Plus
Publication submitted; TNR 71%.; PPV 26% at lower cut-point, 51% at higher cut-point with a Sp of 97%77%99.3%94%MH + GHDRIVE (Savage et al., submitted)
CVStudy in progress on MH and GH patientsTBCTBCTBCMH + GHAUSSIE
Study in progress on MH patientsTBCTBCTBCMHmicroDRIVE
Study in progress on MH patientsTBCTBCTBCMHCREDIBLECU
Multi-product analytical validation of CxbladderTriage, Detect and MonitorN/AN/AN/ASynthetic AnalytesHarvey et al., 2024AV
Triage
Sn, Sp, NPV values when TNR is 40%45%98.5%95%MH + GHKavalieriset al., 2015
CV
GH only: Sn (95.1%), NPV (98%), Sp(32.8%); MH only: Sn (100%), NPV (100%), Sp(42.6%); CxbTriage &
imaging combined performance had a Sn of 97.7% & NPV of 99.8%
34.3%98.6%95.5%MH + GHDavidson et al., 2019
Pooled data from US and Singapore cohorts (n=804); TNR 59%; PPV 16%63%99%89%MH + GHLotan et al., 2023
Publication submitted and under peer review; TNR 35%; PPV 11%38%98.5%93%MH + GHDRIVE (Savage et al., submitted)
39% of patients testing negative for Cxb Triage & imaging did not get cystoscopy & were managed at primary
care; Study wide CV: Cxb Triage & imaging combined performance: Sn 98.1%, NPV 99.9%, Sp 98.4%
59%98.9%89.4%MH + GHDavidson et al., 2020
CU
Clinicians using Triage used 59% fewer cystoscopies on low-risk patients presenting with MH; CV was provided
study wide (UC, n=22): Sn 90%, Sp 56%, PPV 17%, NPV 99%
56%99%90%MH + GHLotan et al., 2024
Multi-product analytical validation of all Cxbladder productsN/AN/AN/ASynthetic AnalytesHarvey et al., 2024AV
Monitor
Internally validated “bootstrap corrected estimates” from development dataset (n=1036), TNR 34%; Sn of
CxbMwas 97% (N = 70/72) for HG tumorsand 85% (N = 66/78) for LG tumors.
N/A97%93%NMIBCKavalieriset al., 2017
CV
Study in progress on NMIBC patientsTBCTBCTBCNMIBCLOBSTER
Integration of CxbMonitor into the surveillance schedule reduced annual cystoscopies (39%)77.8100100NMIBCKoya et al., 2020
CU
Cxbladder Monitor safely postpones a patient’s next scheduled cystoscopy, the current ‘gold standard’ for
bladder cancer surveillance
72100100NMIBCLi et al., 2023
Australian single-center study in NMIBC patients showed that alternating Cxbladder Monitor with cystoscopy
safely reduced cystoscopy use without increasing recurrence risk
N/AN/AN/ANMIBCGuduguntlaet al., 2025
47
NOTE #1: Full references provided on following slide
NOTE #2: Development, feasibility and/or proof of concept studies are detailed within the references on the following slide
Abbreviations -MH: Microhematuria, GH: Gross Hematuria, Sn: Sensitivity, Sp: Specificity, NPV: Negative Predictive Value, PPV: Positive Predictive Value, TNR: Test Negative Rate
REFERENCES SUMMARY OF CLINICAL EVIDENCE
CommentReferences
Feasibility of urine-based assay including biomarker discovery for urothelial cancer detection initial
algorithm development
Holyoake et al., (2008). Development of a Multiplex RNA Urine Test for the Detection and Stratification of Transitional Cell Carcinoma of the Bladder. Clin Cancer
Res 14(3): 742-749
Proof of
Concept
Development/feasibility of Cxbladder Detect assay and algorithm based on RNA expression biomarkersO'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.
Pooled data from MH and GH cohorts (n=804) for ‘multi-modal’ (RNA+DNA) assay and algorithm
development for next generation Cxbladder product including TERT and FGFR3 SNPs. Called Detect+ in
publication.
Lotan et al., (2023). Urinary Analysis of FGFR3 and TERT Gene Mutations Enhances Performance of Cxbladder Tests and Improves Patient Risk Stratification.The
Journal of Urology, 10-1097.
Budget impact model for hematuria pathway, incorporating Cxbladder Detect into patient managementTyson et al., (2024). Budgetary Impact of Including the Urinary Genomic Marker Cxbladder Detect in the Evaluation of Microhematuria Patients. UrolPrac
11(1):54-60
Analytical validation of Triage PlusHarvey et al., submitted. Analytical Validation of Cxbladder® Triage Plus Assay for risk stratification of hematuriapatients for urothelial carcinoma Diagnostics
2025, 15, 1739.
Triage Plus
Clinical validation of Triage Plus (DRIVE Study)Savage et al., submitted. Diagnostic Performance of Cxbladder® Triage Plus for the Identification and Stratification of Patientsat Risk for Urothelial Carcinoma:
The Multicenter, Prospective, Observational DRIVE Study.
Algorithm development and clinical validation of Cxbladder TriageKavalieris 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.
Triage
Analytical validation of all Cxbladder products Triage, Detect and MonitorHarvey et al., (2024). Analytical Validation of Cxbladder® Detect, Triage, and Monitor: Assays for Detection and Management of Urothelial Carcinoma. Diagnostics.
2024; 14(18):2061.
Clinical validation of Cxbladder TriageDavidson et al., (2019). Inclusion of a molecular marker of bladder cancer in a clinical pathway for investigation of haematuriamay reduce the need for
cystoscopy.NZ Med J,132(1497), 55-64.
Clinical utility of Cxbladder TriageDavidson 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.
Clinical validation of Cxbladder Triage from pooled data (USPrimary and Singapore pooled analysis; n=804)Lotan et al., (2023). Urinary Analysis of FGFR3 and TERT Gene Mutations Enhances Performance of Cxbladder Tests and Improves Patient Risk Stratification.The
Journal of Urology, 10-1097.
Clinical utility of Cxbladder Triage from STRATA study showing a 59% relative reduction in cystoscopy when
comparing test and control arms
Lotan et al., (2024). A MulticenterProspective 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.
Analytical validation of all Cxbladder products Triage, Detect and MonitorHarvey et al., (2024). Analytical Validation of Cxbladder® Detect, Triage, and Monitor: Assays for Detection and Management of Urothelial Carcinoma. Diagnostics.
2024; 14(18):2061.
Monitor
Algorithm development and clinical validation of Cxbladder MonitorKavalieriset 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.
Clinical utility of Cxbladder Monitor with low risk NMIBC patientsKoya et al., (2020). An evaluation of the real-world use and clinical utility of the Cxbladder Monitor assay in the follow-up ofpatients previously treated for
bladder cancer.BMC urology,20(1), 1-9.
Clinical utility of Cxbladder Monitor with NMIBC patientsLi et al., (2023). CxbladderMonitor testing to reduce cystoscopy frequency in patients with bladder cancer. Urologic Oncology: Seminars and Original
Investigations, 41 (7), 326.e1 –326.38.
Budgetary impact model when Cxbladder Monitor was incorporated into patient managementTyson et al., accepted. Economic Impact Model of Incorporating Cxbladder Monitor in the Surveillance of Non-Muscle Invasive Bladder Cancer. JU Open Plus,
accepted
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 Uroland 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
49
2011
2011
Pacific Edge
Diagnostics
New Zealand
(PEDNZ)
established
2012
Dec 2012
Launch of Pacific Edge
Diagnostics USAand
CxbDetect
2013
Mar 2013
First commercial
sale (CxbDetect)
for PEDUSA
May 2013
First commercial
sale (CxbDetect)
for PEDNZ
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
US$760/test
2021
Aug 2021
Cxbladderreaches
70% public
healthcare
coverage in NZ
Oct 2021
PEB raises
$103.5m
(~US$72.5m)
2022
Dec2022
Lotan et al:
Enhanced
Cxbladder
Tests Deliver
Improved
Performance.
Journal of
Urology
2023
Nov2023
Kaiser
Permanente
EMR
integration
goes live
2024
May2024
STRATA podium
presentation at
AUA 2024.
Study published
in Journal of
Urology
PACIFIC EDGE –TAKING NEW ZEALAND INNOVATION GLOBAL
2025
Feb 2025
Triage included
in AUA Micro-
hematuria
guideline
Apr 2025
Medicare non-
coverage
effective
50
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 555 563
email: investors@pacificedge.co.nz
www.pacificedgedx.com
51
---
1
2025 ANNUAL SHAREHOLDERS’ MEETING
DATE:
6 August 2025
TIME:
3.00pm
VENUE:
MUFG Corporate Markets
Board Room
Level 30, PwC Tower
15 Customs Street West
Auckland 1010
SLIDE 6: CHAIR’S ADDRESS
I would now like to reflect on our performance over the past year and the company’s current
position.
FY25 was a year in which Pacific Edge achieved some of the most strategically important
milestones in its history, with far-reaching implications for both the clinical adoption of our tests
and long-term shareholder value creation.
Foremost among them was the inclusion of Cxbladder Triage in the American Urological
Association’s microhematuria guideline, with the highest possible ‘Grade A’ evidence rating.
This is not only a major clinical endorsement — it is also a powerful validation of Pacific Edge’s
evidence generation capability, which has long been a core pillar of our approach to market
development.
The AUA’s decision to assign the ‘Grade A’ evidence rating reflects the depth and rigour of the
data we’ve produced, particularly the STRATA randomized controlled trial, which demonstrated
compelling real-world utility for Cxbladder.
This milestone serves as a reminder that our commitment to robust scientific validation of our
intellectual property is a critical enabler of test adoption, payer recognition, and ultimately
sustainable commercial growth.
This milestone also:
Reinforces Pacific Edge’s position as the leading provider of non-invasive bladder cancer
diagnostics;
Establishes Cxbladder as the clinically preferred urine biomarker test for evaluating
hematuria in the US; and
Strengthens the commercial moat around our business as we scale.
In addition, we received draft pricing from the Centers for Medicare and Medicaid Services for
Triage Plus of US$1,018 — up from the US$760 price of our current tests.
This pricing reflects the enhanced performance of the test, the novel benefit for patients that
arises from “genomic risk stratification” without the use of clinical risk factors and stands to
strengthen the commercial foundation for growth once coverage is secured.
Page 2 of 3
Of course, the year also brought a major setback: the loss of Medicare coverage in April 2025.
This ended reimbursement that accounted for around 56% of our FY 25 operating revenue.
We were disappointed by this decision — particularly because Novitas did not evaluate the most
current clinical evidence, including both the STRATA trial and the newly updated AUA guideline.
I am proud of the way the Pacific Edge team navigated the uncertainty that preceded this decision
and the decision itself. We delivered a resilient financial performance, demonstrating the strength
of our business model and the commitment of our team:
• Operating revenue was $21.8 million, down 8.6% year-on-year;
• Total laboratory throughput was 28,894 tests, down 11.5%, but stable in the second half;
• Our average US sales price increased to US$594 from US$584 in the prior year supported
by improved cash collections;
• Throughput per sales FTE and tests per ordering clinician both rose, reflecting greater
focus and productivity in the field.
This resilience continued into the first three months of the new financial year — our first quarter
without Medicare coverage since 2020. After taking into account the loss of one salesperson and
the disruption caused by the strategic decision to discontinue Cxbladder Detect in the US,
volumes were relatively stable.
We believe the ease with which clinicians have accepted the transition to Triage in place of Detect
demonstrates the shift in sentiment among the early adopters of our tests and an understanding
of the AUA guideline.
In summary in FY25 and into the new financial year we have demonstrated the strengths of our
business model and our ability to adapt to changing conditions. And now with the tail wind of the
AUA guideline, we see significant opportunities to accelerate test adoption and deepen
engagement with clinicians.
SLIDE 7: RAISING NEW CAPITAL TO MAINTAIN COMMERCIAL MOMENTUM
Our success with the guideline has allowed us to look upon the Medicare non-coverage
determination that came into effect in April 2025 differently and build on the momentum already
established – rather than cutting costs sharply while we pursue re-coverage for our tests.
That’s why we launched a capital raise alongside the announcement of our FY25 results.
We’ve secured $16.1 million via a Placement, and a further $4.7 million through the Share
Purchase Plan, which closed at the end of July. Both tranches are subject to shareholder approval
today.
This capital will:
• Extend our cash runway to support operations while we seek Medicare re-coverage;
• Advance the commercialisation of Triage and Triage Plus; and
• Maintain investment in clinical research and evidence development.
Your support for today’s resolutions will give Pacific Edge the financial flexibility and strategic
stability needed to deliver on our strategy and assist the return to sustained growth.
Before I close, I want to speak briefly about my continued leadership of the company.
Page 3 of 3
Last year, I informed the Board of my intention to retire. However, we have faced several
challenges in recruiting my successor including:
- the uncertainty over Medicare coverage of our tests and the challenges this has presented
to recruiting a new Director to replace me; and
- the commitments of our existing Directors, which have prevented any of them being able
to commit to taking over the Chair role.
Considering these challenges and the importance of continuity in leadership, I accepted the
Board’s invitation to remain as Chair. I will therefore be standing for re-election later in today’s
meeting.
It remains my intention to step down once we have greater clarity on the company’s outlook and
we are able to recruit a Director also willing to take on the role of Chair. That said, I continue to
lead the company with complete confidence in our science, our people, and our prospects.
Peter will shortly speak to the year ahead and provide detail on our strategy to achieve the broad
aims of capital raising.
But before he does, let me finish with a simple thank you.
Your continued support has enabled us to navigate an exceptionally challenging year — and your
belief in our mission has kept us focused, motivated, and optimistic for what lies ahead.
And with that I would like to hand you over to Peter.
Data sourced from publicly available filings. Our datasets may not be complete. Automated analysis can produce errors. If you believe any data on this page is incorrect, please contact us at hello@nzxplorer.co.nz. For informational purposes only. Not investment advice.
Other issuers discussed similar conditions around this time
Matched by meaning across NZX announcement text, not keywords — based on our semantic index of announcement bodies.
- NZK — New Zealand King Salmon Investments Limited: ASM Meeting Materials2025-06-10
“THREEWORKSTREAMSTOIMPROVERESILIENCE 1.Breeding for resilience 2.Diet development 3.Vaccinedeployment Diet development -RuakākāTrialPensBreeding for resilience - thermotolerance R&D (Image: Cawthron Institute) Vaccinedeployment 2025 ANNUAL SHAREHOLDERS MEETING 12 VACCINATION…”
- PCT — Precinct Properties New Zealand Limited: PCT Notice of Meeting 20252025-10-20
“Precinct Auckland Head Office Wellington Office E hello@precinct.co.nz Level 12, 188 Quay Street, Auckland 1010 T 0800 400 599 Level 3, 31 Waring Taylor Street,…”
- BPG — Black Pearl Group Limited: Blackpearl Group FY25 Results2025-05-28
“BLACKPEARL GROUP | INVESTOR ANNOUNCEMENT Blackpearl ended the year with $6.7m in cash and retains access to a $4m undrawn non-dilutive loan facility with the BNZ. We are sufficiently capitalised with resources already in place to support continued product expansion and market…”