Financial Results for the Half Year to 30 September 2025
25 November 2025
UNAUDITED FINANCIAL RESULTS FOR THE SIX MONTHS TO 30 SEPTEMBER 2025
POSITIONING FOR MEDICARE-LED RECOVERY
DUNEDIN, New Zealand – Cancer diagnostics company Pacific Edge (NZX, ASX: PEB) today
announces its results for the six months to the end of September 2025 (1H 26) showing the
company positioning itself for a recovery led by Medicare reinstating reimbursement of
Cxbladder.
The company enters the second half of FY 26 in its strongest position yet for a positive update
to Medicare policy and a subsequent resumption in growth. The next catalyzing event in the
re-coverage process is the Contractor Advisory Committee (CAC) that Novitas
1
has proposed
to convene on 19 February 2026. Such expert committees are generally convened ahead of
developing new or substantially revised medical policy.
1H 26 FINANCIAL AND PERFORMANCE PROGRESS
2
• Operating revenue was down to $5.9 million from $10.9 million in 2H 25 following Medicare
coverage loss. Total revenue was down to $7.1 million from $12.5 million in 2H 25.
• With the loss of Medicare Coverage, Medicare revenue cannot be recognized until
successfully appealed, a process expected to delay revenue recognition by 6-9 months.
• Total laboratory throughput
3
(TLT) of Cxbladder tests of 13,191; down 10.1% on 2H 25;
commercial tests down 15.9% on 2H 25 to 10,371 tests
• US test sales/FTE of 403 for Q2 26, up 5.8% on 1Q 26 following sales force reduction and
a focus on the most profitable territories
• Net loss after tax of $19.1 million, higher than the $15.4 million net loss in 2H 25 following
lower revenue and strategy to position the company for a Medicare-led recovery; net
operating costs decreased 5.9% on 2H 25.
• Net cash flow to operating activities at $19.0 million is more than the $12.3 million in 2H
25, following lower revenue, and the costs associated with the strategic positioning of the
company for a Medicare led recovery
• Cash and cash equivalents and short-term deposits at $22.1 million; supported by
successful $20.7 million capital raise in August 2025; canvasing strategic options given an
extended Medicare re-coverage timeline and appeals delays
1H 26 STRATEGIC HIGHLIGHTS
• Strongest position yet for a Medicare policy change, after AUA
4
support for Cxbladder
Triage prompts Novitas to convene a CAC on 19 February 2026
• Cxbladder evidence portfolio continues to grow with key publications: Analytical Validation
of Triage Plus (Harvey et al. 2025
5
) and Clinical Validation of Triage Plus (Savage et al.
1
Novitas is the Medicare Administrative Contractor (MAC) with jurisdiction for Pacific Edge’s lab in the USA
2
All comparisons are to the second half of the prior financial year unless otherwise stated.
3
Total Laboratory Throughput (TLT) includes commercial, pre-commercial and clinical studies testing.
4
AUA: American Urological Association
5
Harvey et al. (2025) Analytical Validation of Cxbladder® Triage Plus Assay for risk stratification of hematuria patients for urothelial
carcinoma Diagnostics 2025, 15, 1739.
2
2025; the DRIVE Study
6
); a new Kaiser Permanente study covering real-world evidence of
Cxbladder Triage’s Clinical Utility is also expected to be published ahead of the CAC
• Pacific Edge’s longer-term economics reinforced after Centers for Medicare and Medicaid
Services (CMS) sets draft Triage Plus test price of US$1,328, a 75% increase over the
US$760 price of the existing products; our global addressable market expands to US$10.8
billion
7
• Commercial operations positioned for Medicare policy change; focus retained on profitable
territories, non-Medicare revenue streams and selling the clinical and economic value of
Cxbladder
Chairman Chris Gallaher said: “Pacific Edge has made significant progress over the half year
of entrenching its first-mover advantage in urine-based biomarkers for hematuria evaluation,
with a continued focus on strengthening the clinical evidence for Cxbladder Triage and Triage
Plus and driving recognition of that evidence in clinical practice.
“These achievements represent a further validation of the company’s strategic direction and
the long-term opportunity ahead. The Board recognizes that maintaining our US market
presence through the delay in Medicare coverage places pressure on capital, but this is a
deliberate decision to preserve the value created and position Pacific Edge to capitalize swiftly
when coverage is achieved.”
Chief Executive Dr Peter Meintjes said: “During the half year, we strengthened our clinical
foundation for Cxbladder with AV and CV publications and reinforced our long-term economics
gaining a favorable CMS pricing decision for Triage Plus. This latter outcome highlights how
we continue to create value through the development of next-generation products and the
clinical evidence that supports them. While the timing of Medicare coverage remains outside
our control, we are now in our strongest position yet to drive a change in Medicare policy and
to accelerate growth should recognition be achieved.”
FINANCIAL RESULTS
Operating revenue is down to $5.9 million from $10.9 million in 2H 25, with the fall largely
reflecting the loss of Medicare coverage at the start of the period and the reduction in
commercial test volumes.
Pacific Edge expects revenue to lift for 2H 26 after taking claims through the Medicare Appeals
Process, but that revenue recognition can only come after success in front of an Administrative
Law Judge (ALJ). Normal timeframes associated with appeals to the ALJ are 6-9 months,
delaying recognition of any success until, at best, in 2H 26 and there could be unknown delays
to the scheduling of ALJs on account of the 43-day government shutdown in the US.
6
Savage et al. (2025). Diagnostic Performance of Cxbladder® Triage Plus for the Identification and Stratification of Patients at
Risk for Urothelial Carcinoma: The Multicenter, Prospective, Observational DRIVE Study. Urol Oncol. Oct 31 2025;
doi:10.1016/j.urolonc.2025.10.008
7
See page 38 of the investor presentation released to the NZX and ASX today for the assumptions underlying this estimate.
3
Total laboratory throughput (TLT) of Cxbladder tests fell to 13,191, down 10.1% on 2H 25,
while commercial test volumes fell to 10,371, down 15.9% on 2H 25. The fall is primarily due
to the operating conditions in an environment of Medicare non-coverage but is compounded
by the transition of Detect customers to Triage that gives Pacific Edge the chance of successful
reimbursement on appeal to Medicare, given the AUA guideline inclusion for Triage.
Importantly, non-Medicare volumes, largely buoyed by Kaiser Permanente remain relatively
steady, and early indicators are that payment is increasing from non-Kaiser Permanente
commercial payers.
Despite the fall in commercial volumes, US test sales/FTE of 403 for Q2 26, improved 5.8%
on Q1 26 following a sales force reduction and a focus on the most profitable territories; Pacific
Edge is not reporting US ASP
8
in this period as it has recognized no revenue of Medicare tests
since the loss of coverage as it appeals non-payment through the Medicare appeals process.
Asia Pacific (APAC) TLT increased 5.4% on 2H 25 with the increase largely reflecting an
increase in non-billable tests including evaluation tests and tests for clinical studies.
Total operating expenses were down 5.9% on 2H 25 as we focused on managing costs.
Pacific Edge’s operating cost base continues to reflect our determination to maintain our
market presence, positioning the company for a faster recovery following an expected
affirmation of Medicare coverage in calendar year 2026. Because of this decision the net loss
after tax increased to $19.1 million, from the $15.4 million net loss in 2H 25.
STRATEGIC PROGRESS
The financial performance should not detract from Pacific Edge’s significant strategic
achievements of the first half of the financial year.
The company-defining recognition of Cxbladder Triage’s Clinical Utility in the AUA’s February
2025 revision to its Microhematuria Guideline — and our ground-breaking STRATA
9
study that
precipitated that recognition — are delivering early signs of shift in both Medicare and non-
Medicare medical policy.
The most tangible evidence of this was Novitas’ September 2025 decision to convene a CAC
to discuss evidence for the use of urine-based biomarkers in patients with microhematuria.
Such panels are typically convened by MACs ahead of establishing new or substantially
revised medical policy, i.e. a local coverage determination (LCD).
Novitas — which can change Medicare policy based on published evidence and evidence-
based clinical opinion — will use the panel to systematically capture clinical opinion (in addition
to the AUA guideline) and is expected to subsequently develop its LCD policy. The panel can
comprise healthcare professionals, beneficiary representatives, and representatives of medical
organizations. Pacific Edge is nominating panel members with a deep understanding of the
8
US ASP: US Average Sales Price (US Operating Revenue in USD / US Commercial Test Volumes)
9
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
4
latest clinical evidence for Cxbladder Triage and Triage Plus, other urine-based biomarkers
and the AUA Guideline.
Novitas expects any CAC member to be able to discuss “the quality and strength of the
available evidence and any compelling clinical data to assist in defining meaningful and
measurable patient outcomes”. Consequently, we expect any CAC member to be familiar with
the STRATA Study, the recently published Analytical Validation studies of our existing Triage,
Detect and Monitor tests, our Analytical Validation of Triage Plus and our DRIVE Study for the
Clinical Validation of Triage Plus, which was published in the Journal of Urologic Oncology.
We also expect Kaiser Permanente’s study demonstrating the Clinical Utility of Cxbladder
Triage in a real-world setting to be presented to the CAC.
Since learning about the CAC meeting scheduled for 19 February 2026, and as signaled in Q2
26 investor update in October 2025, it has become apparent that regaining Medicare coverage
of our tests will take longer than we anticipated. Further detail on our new anticipated timelines
is covered in the presentation released to NZX and ASX today.
The second significant strategic milestone was CMS’s decision to provide a draft price of
US$1,328 per test, a significant premium to the US$760 price of our existing tests. The price,
assuming no change, will become effective on 1 January 2026 and promises to significantly
strengthen our long-term economics.
The DRIVE publication on Triage Plus is a tangible demonstration of the value we are
generating from our Research Development & Innovation and Clinical Evidence activities.
While in an earlier phase of development, we see similar promise for our next generation test
for the surveillance of bladder cancer recurrence, Cxbladder Surveillance Plus.
Finally, we have continued to advance our process to appeal all Cxbladder Triage tests not
reimbursed by Medicare supported by the AUA Guideline and the STRATA study. The
guideline in particular supports our argument that the tests are "medically reasonable and
necessary," a key criterion under the US Social Security Act for Medicare coverage. To date
we have appealed every denied Triage and Triage Plus claim on behalf of the Medicare
beneficiary
We have yet to receive notification from the Office of Medicare Hearings and Appeals of a date
for a substantive hearing before an Administrative Law Judge on any of our claims. We are
confident of our case and expect to see many of the tests reimbursed.
BALANCE SHEET AND FUNDING
Supported by the successful $20.7 million capital raise in August 2025, Pacific Edge ended the
period with cash and cash equivalents and short-term deposits of $22.1 million, steady on the
$22.6 million at the end of March 2025.
However, given the expected delay to the reopening of the LCD and the long-time frames
associated with the Medicare appeals process, the company now expects it will either need to
complete capital initiatives and/or reduce its cash burn to see the company through to the point
5
of Medicare coverage. The company is considering a range of options and will update
shareholders as it gains more certainty on the best path forward.
OUTLOOK
Dr Meintjes said non-coverage determinations for Triage, Detect, Monitor and Triage Plus
continue to create a challenging sales and marketing environment, and additional challenges
for reimbursement. However, the company continues to see significant near-term catalysts for
value creation.
“These catalysts include medical policy change, increased sales momentum from non-
Medicare payers supported by the AUA Guideline and our growing body of clinical evidence;
reimbursement through the Medicare Appeals process and eventually a change to Medicare
policy through the multiple reconsideration requests already submitted and additional
publications we will submit in support of those requests when they are published,” Dr Meintjes
said.
“The response of the CAC to our evidence and the weight of clinical opinion will be highly
indicative of success across these initiatives and we look forward to updating shareholders on
the outcome of that meeting early in the New Year.”
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 urine-based genomic biomarker test optimized for the detection and surveillance
of bladder cancer. The Cxbladder evidence portfolio developed over the past 14 years includes
more than 20 peer reviewed publications for primary detection, surveillance, adjudication of
atypical urine cytology and equivocal cystoscopy. Cxbladder is the focal point of numerous
ongoing and planned clinical studies to generate an ever-increasing body of clinical utility
evidence supporting adoption and use in the clinic to improve patient health outcomes.
Cxbladder has been trusted by over 4,400 US urologists in the diagnosis and management of
more than 100,000 patients, including the option for in-home sample collection. In New
6
Zealand, Cxbladder is accessible to 75% of the population via public healthcare and all
residents have the option of buying the test online.
---
Pacific Edge
1H 2026 Investor Presentation
Dr Peter Meintjes
Chief Executive Officer
Grant Gibson
Chief Financial Officer
25 November 2025
This presentation has been prepared by Pacific Edge Limited (PEL)
solely to provide interested parties with further information
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undertakes no obligation to update or revise any forward-looking
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Financial data
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Effect of rounding
A number of figures, amounts, percentages, estimates,
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Past performance
Investors should note that past performance, including past share
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Disclaimer
To the maximum extent permitted by law, none of PEL and its
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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
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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
2
POSITIONING FOR MEDICARE-LED RECOVERY AFTER EVIDENCE AND PRICING WINS
-$19.1M
NET LOSSAFTER
TAX vs. -$15.4M
in 2H 25
US Total Tests
1
10,693, -13.1%
on 2H 25; APAC Total Tests
1
2,498 +5.4% on 2H 25
Operating Expenses of
$26.2M 5.9% less on 2H 25 of
$27.9M
Total Revenue of $7.1M
-42.8% on 2H 25
$22.1M
CASH, CASH
EQUIVALENTS
2
1H 26 cash flow to Operating
Activities of ($19.0M)
55.1% higher on ($12.3M) in 2H
25
10,371
COMMERCIAL
TESTS -15.9%
on 2H 25
13,191
GLOBAL TESTS
1
-10.1% on 2H 25
$5.9M
OPERATING
REVENUE
-45.4% on
2H 25
US Commercial Tests 8,386
-17.6% on 2H 25;
APAC Commercial Tests
1,985 -7.2% on 2H 25
3
•Maintaining US market presence to position Pacific Edge for Medicare appeals and re-coverage progress; operating revenue falls resulting in a rise
in net losses and cash burn after coverage loss, partially offset by operating efficiencies
•Test volumes reflect loss of coverage and disruptions of migration to Triage from Detect; US test sales/FTE rise for Q2 26 +5.8% on Q1 26 following
sales force reductions
•Expert Contractor Advisory Committee convened by Novitas acknowledges the weight of evidence supporting Cxbladder’s clinical value
•Longer term economics reinforced by draft CMS pricing of Triage Plus at US$1,328 per test vs. US$760 per test for the current generation of tests
•Considering capital initiatives to meet longer than expected Medicare re-coverage timeline
1.Total Laboratory Throughput (TLT) including commercial, pre-commercial and clinical studies testing
2.Cash, short-term deposits and term deposits
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
4
THE STRONGEST POSITION YET TO DRIVE MEDICARE POLICY CHANGE
POLICY DRIVERS – EVIDENCE AND CLINICAL OPINION – NOW IN CXBLADDER’S FAVOR
5
“... [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
NOVITAS CONVENES A CONTRACTOR ADVISORY COMMITTEE
•In September 2025, Novitas
1
called for an expert Contractor Advisory Committee (CAC)
•CACs are generally convened ahead of developing new or substantially revised medical
policy (LCD
2
)
•Precipitated by the company-defining February 2025 revision to the AUA Microhematuria
Guideline (last revised in 2020), which allowed the use of biomarkers for the first time
•Designed to systematically capture clinical opinion from practicing physicians in addition to
published evidence and the AUA guidelines
•CAC purpose: “to discuss evidence for the use of urine-based biomarkers in patients with
microhematuria.”
•Given the recent published evidence of Triage Plus (including the recently published Drive
Study)
4
Pacific Edge expects the next generation test to be included in the discussion
•Membership: healthcare professionals, beneficiary representatives, and representatives of
medical organizations
•Pacific Edge has nominated urologists who are familiar with the latest evidence, the new
AUA guideline and regularly use Cxbladder tests
•Meeting date: 19 February 2026 at 6pm (ET)
3
; open to the public and tone will be indicative of re-
coverage success.
1.Novitas is Pacific Edge’s Medicare Administrative Contractor (MAC)
2.LCD: Local Coverage Determination
3.12.00pm Friday 20 February 2026 (NZT)
4.Savage et al (2025) Accepted October 6, 2025. Diagnostic Performance of Cxbladder® Triage Plus for the Identification and Stratification of Patients at Risk
for Urothelial Carcinoma: The Multicenter, Prospective, Observational DRIVE Study
6
•Pacific Edge generates the compelling clinical
evidence required to drive behavior change in
physicians
•Clinical evidence is generated in a rigid
framework of Analytical Validity (AV), Clinical
Validity (CV) and Clinical Utility (CU)
•Clinical Studies have clearly defined patient
populations with the endpoints and sample sizes
required for coverage decisions and guideline
inclusion
•We are seeking Medicare coverage for Triage,
Monitor and Triage Plus through reconsideration
requests to Novitas based on new evidence
THE STRONGEST POSITION YET TO DRIVE MEDICARE POLICY CHANGE
A COMPELLING AND GROWING PORTFOLIO OF EVIDENCE TO ENTRENCH CXBLADDER IN CLINICAL PRACTICE
STUDY
TEST AND EVIDENCE
PUBLICATION DATE
(1)
1. STRATA Clinical Utility
- CU of Triage
Published May 2024
2. Automated RNA & DNA extraction
- AV of Triage, Detect and Monitor
Published September 2024
3. Triage Plus Analytical Validation
- AV of Triage Plus
Published July 2025
4. DRIVE Clinical Validation
- CV of Triage Plus
Published October 2025
7
5. STRATA second publication
- CU of Triage Plus (concordance
2
)
Q2 2026
6. AUSSIE Clinical Validation
- CVof Triage Plus
Q2 2026
7. microDRIVE Clinical Validation
- CV of Triage Plus
Q4 2026
8. Surveillance Plus Analytical Validation
- AV of Surveillance Plus
Q3 2026
9. Pooled Analysis MH Clinical Validation
3
- CV of Triage Plus
Q1 2027
10. Pooled Analysis GH Clinical Validation
3
- CV of Triage Plus
Q1 2027
11. LOBSTER Clinical Validation
- CV of Monitor/Surveillance Plus
Q1 2027
12. CREDIBLE Clinical Utility
- CU of Triage Plus
Q1 2028
13. OCTOPUS Clinical Utility
- CU Surveillance Plus
Not started
1
All dates are calendar year and our best current estimates
2
Concordance will be demonstrated by comparing Triage and Triage Plus on identical samples
3
The MH and GH pooled analysis brings together data from DRIVE, AUSSIE and microDRIVE
New evidence to be presented to the CAC in February 2026 to support Medicare coverage reconsideration
MEDICARE COVERAGE REQUESTCATALYST2026*2027*
Q1Q2Q3Q4Q1Q2Q3Q4
L39365 Reconsideration request (Triage)
March 2025
STRATA Study (May 2024)
AUA Microhematuria Guideline (Feb 2025)
L39365 Reconsideration request (Monitor)
May 2025
AV of Triage, Detect & Monitor (Sept 2024)
2x RWE of Monitor (March 2025)
New LCD request (Triage/Triage Plus)
November 2025
AV of Triage Plus (Q2 25)
CV of Triage Plus – DRIVE Study
2
(Q4 25)
7
Estimated Novitas determination
*Calendar year
Estimated opening of Novitas draft LCD
12-months after opening (worst case, assuming opening)
•Medicare non-coverage of Cxbladder Triage, Monitor, Detect & Triage Plus was effective on 24 April 2025
•The review was limited to evidence submitted prior to 9 September 2023
•Pacific Edge has submitted Reconsideration Requests of L39365 for Triage and Monitor
•Pacific Edge has submitted a new LCD request for hematuria evaluation for Triage/Triage Plus
•Novitas controls the timing of the LCD opening, but must finalize the LCD within 12 months of opening
•Novitas announced a CAC to meet on 19 February 2026 (ET), increasing re-coverage expectations, but
extending timelines
•Evidence published after the CAC can be submitted during the comment period of the LCD
1.Novitas is the Medicare Administrative Contractor (MAC) charged with making the Medicare local coverage determination for Pacific Edge’s US laboratory
2.Savage et al. (2025). Diagnostic Performance of Cxbladder® Triage Plus for the Identification and Stratification of Patients at Risk for Urothelial Carcinoma: The Multicenter, Prospective,
Observational DRIVE Study. Urol Oncol. Oct 31 2025;doi:10.1016/j.urolonc.2025.10.008
MEDICARE RE-COVERAGE: ESTIMATED TIMELINES
COVERAGE DECISIONS, PRIOTIZATION AND TIMELINES ARE AT THE DISCRETION OF NOVITAS
1
Contractor Advisory Meeting (CAC) Meeting – February 19, 2026
8
INDEPENDENT STUDIES SUPPLEMENT OUR EVIDENCE PORTFOLIO
INVESTIGATOR INITIATED TRIALS AND INDEPENDENT STUDIES DELIVER CLINICAL UTILITY AT MODEST SCALE
LATEST INVESTIGATOR INITIATED TRIAL (IIT) SHOWS PATIENT PREFERENCE FOR CXB MONITOR
•New study ready for publication led by Mark Tyson at the Mayo Clinic, comparing Cxbladder Monitor to cystoscopy in bladder cancer surveillance
1
•74.2% preferred Monitor vs Cystoscopy
•Comparable diagnostic performance
•Abstract to be submitted to AUA 2026
1.Mestas et al (2025) A Randomized Multicenter Crossover Study to Evaluate Patient Preference and Satisfaction with Urine-Based Molecular Testing versus Cystoscopy for Surveillance of Non-
Muscle-Invasive Bladder Cancer (NMIBC). Unpublished Manuscript.
2.BCG: Bacillus Calmette–Guérin is a bacterium instilled into the bladder that triggers an immune response that targets and destroys cancer cells.
3.MIBC: Muscle Invasive Bladder Cancer
INDEPENDENT STUDY FOCUSINSTITUTION/ LOCATION TEST AND EVIDENCEPUBLICATION DATE
Real World Utility of Triage in MH: A Matched Cohort StudyKaiser Permanente, US CU Triage (RWE)Q4 2025
Patient preference and satisfaction of “biomarkers vs cystoscopy”Mayo Clinic, USCU MonitorQ1 2026
Test utility in screening patients at risk for bladder cancerUT Southwestern, USCU Triage Plus 2027
Test utility in assessing therapy success in a reduced chemotherapy protocol for upper tract tumorsIsrael Institute of Technology,
Israel
CU Monitor
CU Surveillance Plus
2027
Test utility in assessing response to BCG
2
in high-grade bladder cancer patientsUniversity of Miami, US
CU Monitor
CU Surveillance Plus
2027
Test utility for the surveillance of MIBC
3
treated with bladder sparing methods (PRESERVE Trial)Cleveland Clinic, US
CU Monitor
CU Surveillance Plus
2028
A Randomized Trial of Apalutamide in Non-Muscle Invasive Bladder CancerNational Institutes of Health, US
CU Monitor
CU Surveillance Plus
2029
New evidence to be presented to the CAC in February 2026 to support Medicare coverage reconsideration
9
BUDGET IMPACT MODELS DEMONSTRATE ECONOMIC VALUE FOR CXBLADDER
BIMS
1
DEMONSTRATE CLINICAL UTILITY AND ECONOMIC SAVINGS FOR HEALTHCARE SYSTEMS
Incidence of bladder cancer in microhematuria populations is 5%
CANCER INCIDENCE IN MICROHEMATURIA PATIENTS
With Cxbladder, 85% of patients can avoid cystoscopy, 15%
receive cystoscopy, 5 cancers found
CYSTOSCOPIES SAFELY AVOIDED USING CXBLADDER
2
Normal
Cystoscopy
Cystoscopy
undertaken and
cancer found
Cystoscopy
avoided
Microhematuria
patient with
cancer
Microhematuria
patient with no
cancer
REDUCTIONS IN CYSTOSCOPY DRIVE SAVINGS FOR HEALTHCARE PAYERS
•Published BIMs help shift payer policy and can be tailored to specific payer needs; our models already show meaningful savings
•In the U.S., Cxbladder at scale could spare ~1.5 million hematuria patients from cystoscopy and save >US$500 per patient
3
•In bladder-cancer surveillance protocols, Cxbladder can save payers ~US$680 per patient over five years
4
•Economic and Sustainability Publications in progress:
•Triage Plus BIM — targeting publication FY27
•Surveillance Plus BIM — work commencing FY28
•Carbon Footprint impact of implementing Cxbladder at primary care for hematuria evaluation — targeting FY27
1.BIM is a Budget Impact Model
2.Harvey et al (2025) Analytical Validation of Cxbladder® Triage Plus Assay for risk stratification of hematuria patients for urothelial carcinoma Diagnostics 2025, 15, 1739.
3.Tyson et al (2024) Budgetary Impact of Including the Urinary Genomic Marker Cxbladder Detect in the Evaluation of Microhematuria Patients - PubMed (PMID: 37914255)
4.Tyson et al (2025) Economic Impact Model of Incorporating Cxbladder Monitor in the Surveillance of Non-muscle Invasive Bladder Cancer JU Open Plus 3(4):e00028, April 2025.
31%
50%
19%
FY 25 TOTAL LAB THROUGHPUT (TLT*)
•Global Commercial test volumes of 13,191 for 1H 26 down 10.1% on
2H 25 amid US challenges of selling a test not covered by Medicare,
the reduced reach sales force, offset by 5.4% uplift in APAC
MEDICARE NON-COVERAGE RESPONSE
•Cxbladder Detect migrated to Triage, accelerating a plan previously
intended to coincide with the commercial launch of Triage Plus
•Seeking reimbursement through the Medicare Appeals Process
•The sales force is focused on patients suitable for Triage, which are
younger patients with microhematuria and commercial insurance
VOLUMES REFLECT REDUCED SALES REACH AND MEDICARE UNCERTAINTY
1.TLT is the Total Laboratory Throughput including commercial, pre-commercial and clinical studies testing. Commercial volumes, and test type are only updated at the half and full
year results of each financial year.
10
TEST VOLUMES BY TYPE (TLT*)
GLOBAL COMMERCIAL TEST VOLUMES*
GLOBAL TOTAL TEST VOLUMES (TLT
1
)
1H
2H
1H
2H
2H 25
14,920
18,240
14,225
13,191
16,645
14,393
14,669
31,565
32,633
28,894
-
5,000
10,000
15,000
20,000
25,000
30,000
35,000
FY 23FY 24FY 25FY 26
TESTS
12,422
15,401
12,325
10,371
14,269
11,946
12,317
26,691
27,347
24,642
-
5,000
10,000
15,000
20,000
25,000
30,000
FY 23FY 24FY 25FY 26
TESTS
1H 26
63%
4%
18%
16%
Triage Plus
SALES PERFORMANCE IMPROVEMENTS SUSTAINED IN 1H 26
WE REGULARLY SEE OPPORTUNITIES TO EDUCATE ON THE AUA GUIDELINE
US SALES FORCE EFFICIENCY
US CLINICAL COMMITMENT
•Clinical commitment (tests/ordering clinician) fall in Q2 26 reflecting the
disruptions of transition to Triage from Detect and challenges of selling a
test not covered by Medicare
•Sales force efficiency (tests volume / sales FTE) at 403 in Q2 26 is well
ahead of the low point of 160 in Q3 22
•Sales FTE down to an average of 12 in Q2 26 from>30 in Q1 24 before
restructure to focus on cash conservation
11
30
28
21
16
15
15
15
16
15
12
288
265
292
381
403
379 379
406
381
403
200
250
300
350
400
-
5
10
15
20
25
30
35
Q1 24Q2 24Q3 24Q4 24Q1 25Q2 25Q3 25Q4 25Q1 26Q2 26
AVERAGE US TEST
VOLUME/SALES FTE
AVERAGE SALES FTE
US AVERAGE SALES FTE (LHS)
1,232
1,147
1,016
915
867
890
866
914
907
803
7.0
6.4
5.9
6.7
6.8
6.4
6.7
7.1
6.3
6.2
-
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 24Q2 24Q3 24Q4 24Q1 25Q2 25Q3 25Q4 25Q1 26Q2 26
TESTS/CLINICIAN
US ORDERING CLINICIANS
US ORDERING CLINICIANS (LHS)TESTS/ORDERING CLINICIAN (RHS)
1.ASP: US Operating Revenue in USD / US Commercial Test Volumes. Commercial volumes, and ASP are only updated at the half and full year results of each financial year.
FOUNDATIONS FOR GROWTH – US CASH COLLECTIONS PROCESSES IMPROVE
•Loss of Medicare Coverage impacts US test volumes
•Denied Triage Medicare tests will be appealed to an
Administrative Law Judge (ALJ) given its guideline inclusion,
making the case that it is medically reasonable and necessary
•Appealing to the ALJ typically takes 6-9 months
•Medicare tests completed in 1H 26 that have been denied for
payment have had no revenue recognized in the half, with
revenue to be added if tests are successfully appealed
•Measures in place to mitigate the loss of Medicare coverage are
delivering
•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
•Improved medical necessity documentation to improve billing and
appeals processes for Commercial payers
•Improved cash collections are typically permanent improvements that we
expect to maintain as we scale
1.Total Laboratory Throughput in the US including commercial, pre-commercial and clinical studies testing
2.ASP: US Operating Revenue in USD / US Commercial Test Volumes; ASP not reported in 1H 26 due to accounting changes in revenue accrual while
Medicare tests are being appealed.
US COMMERCIAL TEST VOLUMES
1
AND AVERAGE SELLING PRICE
2
REIMBURSEMENT & CASH COLLECTIONS
12
10,622
12,450
13,550
9,956
9,913
10,177
8,386
$493.4
$518.8
$562.4
$613.5
$618.0
$571.5
$0
$100
$200
$300
$400
$500
$600
$700
1,000
3,000
5,000
7,000
9,000
11,000
13,000
15,000
17,000
1H 232H 231H 242H 241H 252H 251H 26
ASP
TESTS
US ASP (RHS)
CONSOLIDATING NEW ZEALAND AND DEVELOPING AUSTRALIA AND APAC
*
SEEKING A NATIONAL HEMATURIA EVALUATION PATHWAY IN NZ
•Quarterly total test volumes rise lifted by an increase in clinical
studies and non-billable tests
•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
13
1.Lotan et al. (2024) . A Multicenter Prospective Randomized Controlled Trial Comparing Cxbladder Triage to Cystoscopy in Patients With Microhematuria.
The Safe Testing of Risk for Asymptomatic Microhematuria Trial. The Journal of Urology Vol 212 1-8 Jul 2024.
2.Total Laboratory Throughput in Asia and Pacific including commercial, pre-commercial and clinical studies testing
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
1,851
1,990
2,412
2,140
1,985
427
263
226
231
513
2,278
2,253
2,638
2,371
2,498
-
500
1,000
1,500
2,000
2,500
3,000
1H 242H 241H 252H 251H 26
TESTS
Light shade: Clinical study and evaluation tests
Dark Shade: Commercial tests
DRIVING VALUE THROUGH PRODUCT INNOVATION
NEXT GENERATION TESTS HAVE SUPERIOR PERFORMANCE AND PRICING
•Cxbladder Triage Plus has been analytically validated and clinically validated for all hematuria patients (micro and gross)
•Triage Plus has provisional patents filed, AV published, CV published, priced at $1,328/ test, and coverage has been requested from Novitas.
•The draft price is significant premium to the US$760 CMS price for our existing tests, promising to strengthen the economics of the company
•Triage Plus is being trialed in ‘early access’ and we are seeking to be added to the AUA microhematuria guideline alongside Triage in FY27
•Cxbladder Surveillance Plus tests for recurrent disease in NMIBC
1
patients.
•Surveillance Plus is in development and is expected to be analytically validated and clinically validated during FY27
•Surveillance Plus uses ddPCR
4
technology, has ‘Freedom to Operate’ review completed, and has provisional patenting in progress
•We are seeking a technology crosswalk for Surveillance Plus to an US$1800 ddPCR
4
test, and claim-by-claim reimbursement until a local coverage
determination incorporating Surveillance Plus is developed
1.NMIBC is non-muscle invasive bladder cancer
2.RDM: Residual Disease Monitoring
3.TRM: Therapeutic Response Monitoring
4.ddPCR is droplet digital Polymerase Chain Reaction
CURRENT STATE
FUTURE STATE
14
DRIVE STUDY VALIDATES CXBLADDER TRIAGE PLUS IN A BROAD POPULATION
1.Savage et al (2025) Accepted October 6, 2025. Diagnostic Performance of Cxbladder® Triage Plus for the Identification and Stratification of Patients at Risk for Urothelial Carcinoma: The
Multicenter, Prospective, Observational DRIVE Study
2.Lotan et al (2024) Urinary Analysis of FGFR3 and TERT Gene Mutations Enhances Performance of Cxbladder Tests and Improves Patient Risk Stratification. The Journal of Urology, 10-109
3.Harvey et al (2025) Analytical Validation of Cxbladder® Triage Plus Assay for risk stratification of hematuria patients for urothelial carcinoma Diagnostics 2025, 15, 1739.
15
LOW RISK
PATIENT
INT RISK
PATIENT
HIGH RISK
PATIENT
MICROHEMATURIAGROSS HEMATURIA
HEMATURIA
PRIMARY SYMPTOMS
AUA Guideline
STRATA Study (Clinical Utility)
DRIVE Study (Clinical Validity)
THE DRIVE STUDY – CLINICAL VALIDATION OF TRIAGE PLUS
•The DRIVE Study — the Diagnostic Performance of Cxbladder Triage
Plus for the Identification and Priority Evaluation of Veterans at Risk
for Urothelial Carcinoma — was published in the Journal of Urologic
Oncology in October 2025
1
•The study confirmed the superior performance characteristics in
both gross and microhematuria patients, validating the proof-of-
concept study
2
and the analytical validation study
3
•Supports:
•Medicare coverage request for patients with microhematuria
and gross hematuria
•An amendment to the AUA Microhematuria Guideline
“These findings indicate that Cxbladder Triage Plus
may be safely used to rule out or detect [urothelial
cancer] in patients with hematuria.”
- DRIVE Study Authors
US$10.8b
Global TAM
1
CMS TRIAGE PLUS PRICING HAS EXPANDED THE GLOBAL OPPORTUNITY
DRAFT PRICE OF US$1,328/TEST IS A 75% PREMIUM TO CURRENT TESTS
GLOBAL COMMERCIALIZATION
Population of 598
million
1,2,3,4
~12m
present with
hematuria
5
~50%
referred for
clinical
workup
6
>3.2m
patients
receive a
cystoscopy
7
~180k
Annual cases of
bladder cancer
8
~1.0m
patients living with
bladder cancer
~1.5Cxb Monitor/yr
6
7.3 million
Test opportunities
€1.8 billion
9
TAM ($3.2bn NZD)
Primary Care Physician
Urologist/Specialist
Patient care
pathway
EU sources
1. https://www.worldometers.info/world-population/europe-population/
2. Compares with US population of 333 million
3. Compares with SEA population of 692 million
4. Compares with ANZ population of 31 million
5. https://www.sciencedirect.com/science/article/pii/S0953620521003605
6. Consistent with approach of calculating TAM in US setting
7. file:///C:/Users/Vimal%20Vincent/Downloads/EUGA_conference_poster_3_extent_of_experiencing.pdf
8. https://uroweb.org/news/bladder-cancer-the-forgotten-cancer
9. Based on an end-user price of €350 with a 40% margin for labs
~7m~3.5m~1.1m~90k ~750kUS$6.7b340m
~17m~8.5m~3.3m ~58k ~300k US$2.1b830m
~12m~6m>4.0m ~180k ~1mUS$2.0b600m
APAC
Primary growth
focus due to higher
CMS pricing
NZ market mature.
Australia and SEA in
business development
New market accessed
via IVD / kitted tests
1.Pacific Edge estimate using US$1,328 price for hematuria testing (priced by Medicare) in the US and US$1,800 for NMIBC surveillance (seeking crosswalk price – not yet priced by Medicare) with next
generation products Triage Plus and Surveillance Plus. Other market assumptions for APAC and Europe. See slide 38 for details.
2.RDM: Residual Disease Monitoring
3.TRM: Therapeutic Response Monitoring
16
Present with
hematuria
Referred for
clinical workup
Receive
cystoscopy
Annual cases of
bladder cancer
Living with bladder cancerTAMPopulation
SURVEILLANCE
(RDM
2
, TRM
3
, RECURRENCE)
PATIENT/DISEASE MANAGEMENT
(CLINICAL DECISION MAKING)
EXPANDING MARKET OPPORTUNITIES WITH INNOVATION
DEVELOPING AN IVD
1
IS THE PRIMARY AVENUE FOR INTERNATIONAL OPPORTUNITIES
Chief Scientific Officer Parry Guilford (center) and Chief Technology
Officer Justin Harvey (right)
17
1.IVD stands for in vitro diagnostic – a type of medical device for regulatory purposes
2.CAP is the College of American Pathologists, CLIA is the Clinical Laboratory Improvement Amendments and LDT is a laboratory developed test
3.IVD-R European In Vitro Diagnostic Regulation; FDA, US Food and Drug Administration; ISO International Organization for Standardization
ADVANCING IVD DEVELOPMENT FOR INTERNATIONAL MARKETS
•Pacific Edge is following a well-worn model of development and execution in the US
with a CAP/CLIA-approved LDT
2
providing service to the entire USA
•International markets require a different approach in which Pacific Edge seeks to
create a ‘kitted’ IVD medical device
•Benefits of this approach:
•IVDs can be run by any accredited lab partner in any geography
•Customer-side logistics are easier, faster and customer service is local
•Partner labs make a margin by running the IVD test – increases sales
opportunities and motivation to increase volumes
•Decentralized deployment allows faster scalability
•Research Use Only versions of the product can be used to develop business,
select partners and run evaluation programs in preparation for IVD launch
•Pacific Edge is simplifying its tests and accelerating the development of an IVD
called Triage Plus IVD, for decentralized lab deployment and international market
expansion. Key objectives:
•Establishing IVD regulatory framework for our next generation tests that
includes IVD-R (Europe), FDA (USA) and ISO-13485
3
(Rest of World)
•Targeting prototypes by the end of FY26; manufacture and commencement
of clinical and analytical validation commencing in FY27
FINANCIAL PERFORMANCE
18
8%
92%
15%
85%
LOOKING TO US CATALYSTS TO DRIVE A RECOVERY IN REVENUE
PACIFIC EDGE OPERATING REVENUE
1
1H 26
2H 25
REGIONAL REVENUE CONTRIBUTION
APAC
AMERICAS
19
$5,378
$8,707
$13,095
$10,959
$5,939
$6,067
$10,909
$10,812
$10,887
$11,445
$19,616
$23,907
$21,846
$0
$5,000
$10,000
$15,000
$20,000
$25,000
FY 22FY 23FY 24FY 25FY 26
$(000)
1H2H
1.No accrual accounting for revenue for tests performed for Medicare patients, even though a substantial number of tests have been undertaken. This revenue will be
recognized in 2H 26 if the appeals against non-reimbursement are successful.
POSITIONING PACIFIC EDGE FOR A MEDICARE APPEALS SUCCESS AND COVERAGE
COST SAVINGS MINIMIZE CASH BURN; ANY MEDICARE APPEALS SUCCESS LIKELY RECOGNISED AS REVENUE IN 2H 26
•Operating revenue falls after loss of Medicare and
Medicare Advantage coverage and reduced test
volumes
•We have not accrued any revenue from Medicare tests
while we determine the success of the appeals strategy
•Success will result in revenue for 1H 26 tests
being recognised in 2H 26
•We continue to maintain a US market presence that
positions the company for an affirmation of Medicare
coverage, while focusing on reducing operating
expenses, which fell 5.9% against 2H 25
•Operating Cash Flows of (19.0M), higher than the
($12.3M) in 2H 25 due to the revenue fall. Cash outflow
in the first half of each financial year is generally higher
than the second half of the financial year with
payments that cover a 12-month period weighted
towards the first half of the year
•Secured $20.7 million in new equity in August 2025,
but with delay to re-coverage we expect we will need
to complete capital initiatives and/or reduce cash burn;
we are considering our options
1.Net cash, cash equivalents and short-term deposits at the end of the period
20
1H 26
2H 25
1H 25
FY 25
1H 26
vs.
1H 26
vs.
1H 25
2H 25
$000
$000
$000
$000
△
%
△
%
Operating revenue
$5,939
$10,887
$10,959
$21,846
-45.8%
-45.4%
Total revenue
$7,123
$12,461
$12,155
$24,616
-41.4%
-42.8%
Operating expenses
$26,239
$27,894
$26,658
$54,552
-1.6%
-5.9%
Net Loss After Tax
-$19,116
-$15,433
-$14,503
-$29,936
31.8%
23.9%
Cash receipts from
customers
$7,985
$10,447
$11,125
$21,572
-28.2%
-23.6%
Net cash flows to operating
activities
$19,026
$12,266
$12,474
$24,740
52.5%
55.1%
Net cash, cash equivalents
and short term deposits
1
$22,121
$22,568
$35,931
$22,568
-38.4%
-2.0%
FINANCIAL PERIOD
OPERATING EXPENSES CONTAINED AMID CAPTIAL PRESERVATION DRIVE
INVESTMENT FOCUSSED ON LONG-TERM STRATEGIC INITIATIVES
•Operating expenses down 5.9% on 2H 25 as cost
management initiatives implemented.
•Laboratory operations down 9.9% driven by lower
test volumes.
•Research costs down 4.5% on 2H 25 as some
clinical study costs decrease for those near
completion
•Sales and marketing costs down 9.0% on 2H 25
impacted by the reduction in sales FTE.
•General and administration expenses up 3.4% on
2H 25 reflecting higher legal costs from the
proceedings undertaken at the end of FY25
attempting to prevent the loss of Medicare
coverage
21
1H 26
2H 25
1H 25
FY 25
1H 26
vs.
1H 26
vs.
1H 25
2H 25
$000
$000
$000
$000
△
%
△
%
Laboratory operations
$5,884
$6,532
$5,958
$12,490
-1.2%
-9.9%
Research
$7,065
$7,401
$7,230
$14,631
-2.3%
-4.5%
Sales and marketing
$8,453
$9,285
$8,245
$17,530
2.5%
-9.0%
General and administration
$4,837
$4,676
$5,225
$9,901
-7.4%
3.4%
Total operating expenses
$26,239
$27,894
$26,658
$54,552
-1.6%
-5.9%
FINANCIAL PERIOD
22
OUTLOOK 1/2
1. Savage et al., Accepted October 6, 2025. Diagnostic Performance of Cxbladder® Triage Plus for the Identification and Stratification of Patients at Risk for
Urothelial Carcinoma: The Multicenter, Prospective, Observational DRIVE Study.
INNOVATION DRIVES LONG-TERM VALUE CREATION
•Triage Plus has a US$1,328 price, is being tested in ‘early access’ and needs only Medicare
coverage for wider commercial adoption
•Surveillance Plus remains in development, but we are seeking a direct technology
crosswalk price to US$1,800 based on its final product configuration
•Investing in innovation and product development for IVD kits to support entry into
international markets in a de-centralized deployment model
CLINICAL EVIDENCE DRIVES MEDIUM-TERM VALUE CREATION
•The DRIVE publication
1
provides the clinical validation of Triage Plus and has been
submitted to Novitas and the AUA for coverage consideration and guidelines inclusion
•The clinical evidence generation program is scheduled out for over four years to deliver
strategic milestones that driven sustained value creation for shareholders
•AUA guideline inclusion demonstrates the success of this strategy that can be repeated to
expand the indications for exist products and establish new indications for new products
23
OUTLOOK 2/2
COMMERCIAL HEADWINDS FOR NEAR-TERM VALUE CREATION
•Non-coverage determinations for Triage, Detect, Monitor and Triage Plus continue to
create a challenging sales and marketing environment, and additional challenges for
reimbursement
•The convening of the Contractor Advisory Committee is a positive move towards the
reinstatement of coverage, but delays our expected timeline for re-coverage necessitating
the Board to consider capital initiatives and/or reduce cash burn.
•COMMERCIAL CATALYSTS FOR NEAR-TERM VALUE CREATION
•AUA microhematuria guideline enables sales, marketing and reimbursement activities. We
are determined to maximize this milestone through existing and new initiatives
•Seek payment from Medicare for all Triage tests performed on Medicare patients through
the Medicare Appeals process, relying on the AUA Guideline
•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
•Cxbladder is under consideration by Te Whatu Ora for a National Pathway in New Zealand
in FY27
APPENDIX
24
PACIFIC EDGE IS FOUNDED ON DELIVERING POSITIVE OUTCOMES FOR SOCIETY
WE CREATE VALUE BY PRIORITISING OUR PATIENTS, OUR PHYSICIANS AND OUR PEOPLE
WE PUT PATIENTS FIRST IN EVERYTHING WE DO
•WE are committed to customer success
•WE are guided by data and evidence
•WE are trusting and transparent
•WE support our teammates
•WE celebrate successes, large and small
25
Our Mission
To help improve people’s lives and patient
outcomes by providing leading solutions for the
early detection and management of cancer
Our Vision
A world where the early diagnosis and better
treatment of cancer is within reach of everyone
PACIFIC EDGE IS A GLOBAL COMPANY WITH A GLOBAL OPPORTUNITY
1.Pacific Edge estimate using US$1,328 price for hematuria testing (priced by Medicare) and US$1800 for NMIBC surveillance (seeking crosswalk price – not yet priced by Medicare) with
next generation products Triage Plus and Surveillance Plus. Other market assumptions for APAC and Europe. See slide 38 for details
26
US$10.8b
1
Global Opportunity
MOLECULAR DIAGNOSTICS VALUE CHAIN: PATIENT JOURNEY
CXBLADDER – FIRST MOVER AND MARKET LEADER IN BLADDER CANCER DIAGNOSTICS
•Technology: RNA/DNA patent-protected urine biomarker tests for hematuria evaluation and NMIBC
1
surveillance
•Clinical Evidence: AV/CV/CU
2
evidence generated in a structured framework compliant with GCP
3
and IVD
4
standards
•Clinical Guidelines: Recognized by the American Urological Association (AUA) Guideline as ‘Grade A’ evidence
•Economic Utility: offering improved patient care and significant health system cost savings, estimated at >US$500 per US patient
5
•Commercial: ‘first-mover’ advantage, national sales coverage in the USA, market dominant in NZ, business development in APAC
•Pricing: Triage Plus priced by CMS at $1,328, Surveillance Plus pricing sought at $1,800 by crosswalk
Our Mission
To help improve people’s lives and patient
outcomes by providing leading solutions for the
early detection and management of cancer
Our Vision
A world where the early diagnosis and better
treatment of cancer is within reach of everyone
1.NMIBC is non-muscle invasive bladder cancer
2.AV/CV/CU is analytical validation, clinical validation and clinical utility evidence
3.GCP is ‘Good Clinical Practice’ needed for FDA or other medical device certification
4.IVD is an in vitro diagnostic medical device
SURVEILLANCE
(RDM
6
, TRM
7
, RECURRENCE)
5.Tyson et al (2024) Budgetary Impact of Including the Urinary Genomic Marker Cxbladder Detect in the Evaluation of Microhematuria Patients - PubMed
(PMID: 37914255)
6.RDM: Residual Disease Monitoring
7.TRM: Therapeutic Response Monitoring
•The number of urologists is falling in the USA – forecast to drop from 23.8/100k to as low as 15.8/100k in 2035
1
•The population in the USA is ageing, with an increasing number of patients requiring urology care
•Cxbladder avoids invasive, unnecessary procedures for patients driving down costs for health systems and payers
2
•At scale, Cxbladder can spare up to 1.5m patients in the US from cystoscopy and save >US$500/US patient
2
1.Nam et al. (2021) Projected US Urology Workforce per Capita, 2020-2060 JAMA Network Open Published Online:November16,2021
2.Tyson et al (2024) Budgetary Impact of Including the Urinary Genomic Marker Cxbladder Detect in the Evaluation of Microhematuria Patients - PubMed (PMID: 37914255)
DRIVING ECONOMIC VALUE FOR PATIENTS, HOSPITALS AND PAYERS
CXBLADDER DELIVERS CLINICAL UTILITY, PATIENT SATISFACTION AND ECONOMIC VALUE
Incidence of bladder cancer in microhematuria populations is 5%
CANCER INCIDENCE IN MICROHEMATURIA PATIENTS
With Cxbladder, 85% of patients can avoid cystoscopy, 15% receive
cystoscopy, 5 cancers found
CYSTOSCOPIES SAFELY AVOIDED USING CXBLADDER
Normal
Cystoscopy
Cystoscopy
undertaken and
cancer found
Cystoscopy
avoided
Microhematuria
patient with
cancer
Microhematuria
patient with no
cancer
28
BACKGROUND ON BLADDER CANCER AND HEMATURIA EVALUATION
•Bladder Cancer
•Bladder Cancer is the 10th most commonly occurring cancer, but is more common in men (6th most commonly occurring
cancer in Men)
•An estimated 83,190 patients were diagnosed with bladder cancer in the USA in 2024 at an average age of 73
1
•Hematuria Evaluation
•Hematuria (Blood in the urine) is the most common sign of bladder cancer with ~7m patients diagnosed each year in the
US
•Microhematuria (MH) visible with microscopy or gross hematuria (GH) visible with the naked eye
•Hematuria can be caused by bladder cancer or other causes, including BPH, infection, stones, idiopathic, etc.
•NMIBC
2
is easily treated by tumor resection, but requires surveillance due to >70% chance of recurrence
•Standard of Care
•Current standard of care requires that every patient presenting with MH receives a cystoscopy to determine if the cause is
bladder cancer
•Cystoscopy
•Cystoscopy is an invasive and costly procedure that involves a visual inspection of the lining of the bladder by inserting a
camera into the urethra
•78% of patients reported experiencing pain during cystoscopy and 25% rated as moderate to severe
3
1.American Cancer Society (https://www.cancer.org/cancer/types/bladder-cancer/about/key-statistics.html)
2.NMIBC is non-muscle invasive bladder cancer (~70% of all diagnoses)
3.Survey conducted by the Bladder Cancer Advocacy Network (patient advocacy group) and published at WSAUA Meeting 2024
BACKGROUND ON NMIBC AND MIBC
•Bladder Cancer
•An estimated 83,190 patients were diagnosed with bladder cancer in the USA in 2024 at an average age of 73
1
•Non-muscle invasive Bladder Cancer (NMIBC)
•NMIBC tumors represent approximately 75% of the bladder cancer diagnoses each year (CIS, Ta and T1)
•NMIBC tumors are localized and present on the lining of the bladder wall and shed cancer cells and cell-free DNA/RNA into the urine in the bladder
•NMIBC tumors are highly treatable with surgery/resection and deemed cancer free after surgery/resection
•NMIBC patients are placed on a surveillance protocol after surgery/resection, because recurrence can be 50-70% within the first two years
2
•NMIBC → TURBT → Surveillance
•Muscle-invasive Bladder Cancer (MIBC)
•MIBC tumors represent approximately 25% of the bladder cancer diagnoses each year (T2-4)
•MIBC tumors differ from NMIBC tumors, because they shed cells/nucleotides to the blood
•MIBC patients have advanced/serious disease, require high-levels of intervention (radical cystectomy followed by multiple therapies)
•MIBC patients are not deemed cancer free after cystectomy and frequently monitored for residual and metastatic disease
•MIBC → Cystectomy → Monitoring
1.American Cancer Society. Cancer Facts & Figures 2024
2.Holzbeierlein J, Bixler BR, Buckley DI, et al. Diagnosis and treatment of
non-muscle invasive bladder cancer: AUA/SUO guideline: 2024
amendment. J Urol. 2024;10.1097/JU.0000000000003846.
NMIBC STANDARD OF CARE: INTERVENTION AND SURVEILLANCE
•NMIBC Standard of Care – Intervention
•After NMIBC diagnosis, the standard intervention is a Trans-Urethral Resection of a Bladder Tumor (TURBT)
•TURBT involves inserting a camera into the urethra and the use of small instruments like a wire loop or laser to cut or burn away the tumor tissue
•Patients are deemed cancer free post TURBTwhen muscles and tumor margins are confirmed free of disease by pathology
•A resection biopsy taken during surgery is used to stage the tumor (T0, Ta, CIS, T1-4) and determine the grade (low or high grade) which also
provides the risk of recurrence.
•All NMIBC patients are then classified into risk categories based on this information (low, intermediate and high risk).
•NMIBC Standard of Care - Surveillance
•BCG (bacillus calmette guérin) is administered for several weeks after TURBT to initiate an immune response towards the tumor. Some
patients are ‘non-responders’
•A cystoscopy at 3 months is recommended for every patient
•Following the 3-month cystoscopy, patients are recommended for routine surveillance protocols involving cystoscopy and imaging among
others based on their risk category
•Due to the high burden of these protocols, the average patient only stays on surveillance for1.8 years not 5
1
as recommended by most
guidelines
1.AUA AQUA Registry
2011
2011
Pacific Edge
Diagnostics
New Zealand
(PEDNZ)
established
2012
Dec 2012
Launch of Pacific Edge
Diagnostics USAand
Cxb Detect
2013
Mar 2013
First commercial
sale (Cxb Detect)
for PEDUSA
May 2013
First commercial
sale (Cxb Detect)
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
Cxbladder reaches
70% public
healthcare
coverage in NZ
Oct 2021
PEB raises
$103.5m
(~US$72.5m)
2022
Dec 2022
Lotan et al:
Enhanced
Cxbladder
Tests Deliver
Improved
Performance.
Journal of
Urology
2023
Nov 2023
Kaiser
Permanente
EMR
integration
goes live
2024
May 2024
STRATA podium
presentation at
AUA 2024.
Study published
in Journal of
Urology
PACIFIC EDGE – TAKING NEW ZEALAND INNOVATION GLOBAL
2025
Feb 2025
Triage included
in AUA
Microhematuria
Guideline
Apr 2025
Medicare non-
coverage
Effective
Oct 2025
Triage Plus gets
CMS draft price
of US$1328
32
Calendar
year
Pre
2023
202320242025202620272028
Q1Q2Q3Q4Q1Q2Q3Q4Q1Q2Q3Q4Q1Q2Q3Q4Q1Q2Q3Q4Q1Q2
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
33
Calendar
year
Pre
2023
202320242025202620272028
Q1Q2Q3Q4Q1Q2Q3Q4Q1Q2Q3Q4Q1Q2Q3Q4Q1Q2Q3Q4Q1Q2
“The 1800”
LOBSTER
OCTOPUS
*
SURVEILLANCE FIVE YEAR CLINICAL STUDIES ROADMAP
34
Publication Submitted
Records review / follow-up
Database lock
Legend:
Pre-activation (docs, CTA etc)
SIV
Enrollment
Data Cleaning
*
DBL
Scheduled surveillance visits
Note – “The 1800” is the Surveillance Plus development dataset
Note AD; Advisory Board at SUO to confirm OCTOPUS design
AD
PERFORMANCE CHARACTERISTICS OF CXBLADDER PRODUCTS
Sensitivity (Sn)Specificity (Sp)NPVPPVROR
Comment
Triage Plus94%77%99.3%26%71%Clinical Validation of Triage Plus in a veterans cohort
1
Triage89-96%34-63%98-99%11-15%35-63%Range determined by 5 publications
2,3,4,5,6
that meet specific criteria
7
Monitor92%-96%-32%Clinical Validation of Monitor in development dataset (n=543 from 424 patients, non-bootstrapped)
8
35
1.Savage et al (2025)
2.Kavaliers et al (2015)
3.Davidson et al (2019)
4.Lotan et al (2023)
5.Davidson et al (2020)
6.Lotan et al 2024)
7.The specific criteria are:
8.Kavalieris et al (2017)
NOTE #1: Full references provided on later slide
Abbreviations - MH: Microhematuria, GH: Gross Hematuria, Sn: Sensitivity, Sp: Specificity, NPV: Negative Predictive Value, PPV: Positive Predictive Value, ROR: Rule Out Rate
SUMMARY OF CXBLADDER CLINICAL EVIDENCE
Publication or StudyPopulationSnNPVSpPPVROR
Comment
Triage
Plus
AVHarvey et al., (2025)
Synthetic Analytes
MH (382) + GH (605)
93.6%99.4%90.8%46.4%84.1%Development dataset includes MH (38.7%) & GH (61.3%) to establish AV performance characteristics
CV
DRIVE (Savage et al., 2025)MH (254) + GH (267)94%99.3%77%26%71%Publication accepted; Note: at upper 0.54 threshold, PPV = 51% & Sp = 95%
AUSSIEMH + GHStudy in progress on MH + GH patients
microDRIVEMHStudy in progress on MH + GH patients
CUCREDIBLEMHStudy in progress on MH patients
Triage
AVHarvey et al., 2024Synthetic AnalytesN/AN/AN/AN/AN/AMulti-product analytical validation of Cxbladder Triage, Detect and Monitor
CV
Kavalieris et al., 2015GH (587)95%98.5%45%-40%Sn, Sp, NPV values when TNR is 40%
Davidson et al., 2019
MH (185) + GH (366)95.5%98.6%34.3%-Cxb Triage & imaging combined performance had a Sn of 97.7% & NPV of 99.8%
MH (185)100%100%42.6%-
GH (366)95.1%98%32.8%-
Lotan et al., 2023MH (320) + GH (484)89%99%63%16%59%Pooled data from US (GH) and Singapore (MH+GH) cohorts (n=804)
DRIVE (Savage et al., 2025)MH (254) + GH (267)93%98.5%38%11%35%Publication accepted
CU
Davidson et al., 2020MH (318) + GH (566)89.4%98.9%59%-53%Study wide CV: Cxb Triage & imaging combined performance: Sn 98.1%, NPV 99.9%, Sp 98.4%
Lotan et al., 2024LR MH (135) + NLR GH (255)90%99%56%15%63%Low risk MH patients (n=135) randomised; 59% relative cystoscopy reduction; 22 UC cases (270 overall)
Monitor
AVHarvey et al., 2024Synthetic AnalytesN/AN/AN/AN/AN/AMulti-product analytical validation of all Cxbladder products
CV
Kavalieris et al., 2017
NMIBC (1036)
(all risk categories)
93%97%--34%
Internally validated “bootstrap corrected estimates” from development dataset (n=1036), Sn of CxbM
was 97% (N = 70/72) for HG tumors and 85% (N = 66/78) for LG tumors
LOBSTER
NMIBC
(all risk categories)
Study in progress on NMIBC patients. 1183 patients estimated
CU
Koya et al., 2020
NMIBC (257)
(low risk only)
N/AN/AN/AN/A77.4%
Modest real world evidence study with no comparison to cystoscopies that safely reduced cystoscopies
by 39% as the primary endpoint
Li et al., 2023NMIBC (92)100%100%78%33%72%
Small (n=92), real world study, at-home Monitor testing safely reduced cystoscopy by ~72%, with no
missed recurrences & high patient satisfaction
Guduguntla et al., 2025NMIBC (98)N/AN/AN/A
Small real world evidence study with no comparison cystoscopy that safely reduced cystoscopies by 59%
as the primary endpoint
36
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, ROR: Rule Out Rate
REFERENCES SUMMARY OF CLINICAL EVIDENCE
ReferencesComment
Proof of
Concept
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
Feasibility of urine-based assay including biomarker discovery for urothelial cancer detection initial
algorithm development
O'Sullivan et al., (2012). A multigene urine test for the detection and stratification of bladder cancer in patients presenting with hematuria.The Journal of
urology,188(3), 741-747.
Development/feasibility of Cxbladder Detect assay and algorithm based on RNA expression biomarkers
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.
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.
Tyson et al., (2024). Budgetary Impact of Including the Urinary Genomic Marker Cxbladder Detect in the Evaluation of Microhematuria Patients. Urol Prac
11(1):54-60
Budget impact model for hematuria pathway, incorporating Cxbladder Detect into patient management
Triage Plus
Harvey et al., submitted. Analytical Validation of Cxbladder® Triage Plus Assay for risk stratification of hematuria patients for urothelial carcinoma Diagnostics
2025, 15, 1739.
Analytical validation of Triage Plus
Savage et al., Accepted October 6, 2025. Diagnostic Performance of Cxbladder® Triage Plus for the Identification and Stratification of Patients at Risk for Urothelial
Carcinoma: The Multicenter, Prospective, Observational DRIVE Study.
Clinical validation of Triage Plus (DRIVE Study)
Triage
Kavalieris et al., (2015). A segregation index combining phenotypic (clinical characteristics) and genotypic (gene expression) biomarkers from a urine sample to
triage outpatients presenting with hematuria who have a low probability of urothelial carcinoma.BMC urology,15(1), 1-12.
Algorithm development and clinical validation of Cxbladder Triage
Harvey et al., (2024). Analytical Validation of Cxbladder® Detect, Triage, and Monitor: Assays for Detection and Management of Urothelial Carcinoma. Diagnostics.
2024; 14(18):2061.
Analytical validation of all Cxbladder products Triage, Detect and Monitor
Davidson et al., (2019). Inclusion of a molecular marker of bladder cancer in a clinical pathway for investigation of haematuria may reduce the need for
cystoscopy.NZ Med J,132(1497), 55-64.
Clinical validation of Cxbladder Triage
Davidson et al., (2020). Assessment of a clinical pathway for investigation of haematuria that reduces the need for cystoscopy.The New Zealand Medical Journal
(Online),133(1527), 71-82.
Clinical utility of Cxbladder Triage
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 validation of Cxbladder Triage from pooled data (USPrimary and Singapore pooled analysis; n=804)
Lotan et al., (2024). A Multicenter Prospective Randomized Controlled Trial Comparing Cxbladder Triage to Cystoscopy in Patients With Microhematuria. The Safe
Testing of Risk for Asymptomatic Microhematuria Trial. The Journal of Urology Vol 212 1-8 Jul 2024.
Clinical utility of Cxbladder Triage from STRATA study showing a 59% relative reduction in cystoscopy when
comparing test and control arms
Monitor
Harvey et al., (2024). Analytical Validation of Cxbladder® Detect, Triage, and Monitor: Assays for Detection and Management of Urothelial Carcinoma. Diagnostics.
2024; 14(18):2061.
Analytical validation of all Cxbladder products Triage, Detect and Monitor
Kavalieris et al., (2017). Performance characteristics of a multigene urine biomarker test for monitoring for recurrent urothelial carcinoma in a multicenter
study.The Journal of Urology,197(6), 1419-1426.
Algorithm development and clinical validation of Cxbladder Monitor
Koya et al., (2020). An evaluation of the real-world use and clinical utility of the Cxbladder Monitor assay in the follow-up of patients previously treated for
bladder cancer.BMC urology,20(1), 1-9.
Clinical utility of Cxbladder Monitor with low risk NMIBC patients
Li et al., (2023). Cxbladder Monitor testing to reduce cystoscopy frequency in patients with bladder cancer. Urologic Oncology: Seminars and Original
Investigations, 41 (7), 326.e1 – 326.38.
Clinical utility of Cxbladder Monitor with NMIBC patients
Tyson et al., accepted. Economic Impact Model of Incorporating Cxbladder Monitor in the Surveillance of Non-Muscle Invasive Bladder Cancer. JU Open Plus,
accepted
Budgetary impact model when Cxbladder Monitor was incorporated into patient management
SOURCES AND ASSUMPTIONS - TOTAL ADRESSABLE MARKET
38
KEY CLINICAL ADVISORS AND CONSULTANTS
Associate Professor Katie Murray, DOMS, FACS
Institution: NYU Langone
Relationship: Consultant, CAB member,
Brief Bio: Published >80 articles. Deputy Editor for J Urol.
Leadership roles for SUO Young Urologic Oncology Clinical Trials
Professor Jonathan Wright, MD, MS, FACS
Institution: Fred Hutchinson Cancer Center at UW
Relationship: Consultant, CAB member, CT PI
Brief Bio: Member of ACS, SUO, AUA
Professor Wade Sexton, MD
Institution: University of South Florida & Moffitt Cancer Center
Relationship: Consultant, CAB member
Brief Bio: Published >100 articles. NCCN Bladder Cancer
Guidelines, AUA Annual Board Review Course
Professor Jay Raman, MD
Institution: Penn State and Hershey Medical Center
Relationship: Consultant, CAB member, CT PI
Brief Bio: Published >350 articles. Chair of AUA Office of Education
and Past-President of the Mid-Atlantic AUA section. Urology
Advisory Council for ACS, Hematuria Guidelines member
Associate Professor Kristen Scarpato, MD, MPH, FACS
Institution: Vanderbilt University Medical Center
Relationship: Consultant, CAB member, CT PI
Brief Bio: SUO Education Committee, AUA Core Curriculum,
Urology Practice Editorial Committee
Professor Yair Lotan, MD
Institution: UT Southwestern Medical Center
Relationship: Consultant, CAB member, IIT PI, CT PI
Brief Bio: Published >500 articles. Contributor to AUA/ASCO/ASTRO
MIBC and Hematuria Guidelines. Chair of AUA Core Curriculum. BCAN
Adboard
Professor Sam Chang, MD, MBA
Institution: Vanderbilt Cancer Center
Relationship: Consultant, CAB member
Brief Bio: Published >200 articles. Chair of AUA NMIBC Guidelines,
SUO Executive Board, ABU/AUA Examination Committee, BCAN
Adboard, AUA representative to the AJCC
Assistant Professor John Sfakianos
Institution: Icahn School of Medicine at Mount Sinai
Relationship: Consultant, CAB member
Brief Bio: Published >20 articles. Reviewer for J Urol and Urologic
Oncology
Professor Dan Barocas, MD, MPH, FACS
Institution: Vanderbilt University Medical Center
Relationship: Consultant, CAB member
Brief Bio: Published >100 articles. AUA Guidelines panel for
microscopic hematuria. Reviewer for AUA educational materials
Associate Professor, Siamak Daneshmand, MD
Institution: Keck School of Medicine at USC
Relationship: Consultant, CAB member, CT PI
Brief Bio: Published >200 articles. Editorial board of the J Urol,
Bladder Cancer Journal, Current Opinions in Urology, BCAN Adboard,
AUA/SUO Guideline Committee on NMIBC
ASCO: American Society of Clinical Oncology
ASTRO: American Society of Radiation Oncology
AUA: American Urological Association
BCAN: Bladder Cancer Advocacy Network
CAB: Clinical Advisory Board
CT PI: Clinical Trials Principal Investigator
FACS: Fellow of the American College of Surgeons
IIT PI: Investigator Initiated Trial Principal Investigator
J Urol: Journal of Urology
KOL: Key Opinion Leader
MPH: Master of Public Health
SUO: Society of Urologic Oncology
39
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
40
---
FOR THE SIX MONTHS ENDED
30 SEPTEMBER 2025
CONSOLIDATED
INTERIM FINANCIAL
STATEMENTS
PACIFIC EDGE LIMITED CONSOLIDATED INTERIM FINANCIAL STATEMENTS 2025
PACIFIC EDGE LIMITED CONSOLIDATED INTERIM FINANCIAL STATEMENTS 2025
Note: These Financial Statements are to be read in conjunction with the Notes to the Financial Statements.
FOR THE SIX MONTHS ENDED 30 SEPTEMBER 2025
CONSOLIDATED STATEMENT OF COMPREHENSIVE INCOME
NOTES
UNAUDITED
SEPT 2025
6 MONTHS
($000)
UNAUDITED
SEPT 2024
6 MONTHS
($000)
AUDITED
MARCH 2025
12 MONTHS
($000)
REVENUE
Operating Revenue 4 5,939 10,959 21,846
Total Operating Revenue 5,939 10,959 21,846
Other Income4 897 385 903
Interest Income 299 1,193 1,925
Foreign Exchange (Loss) (12) (382) (58)
Total Revenue and Other Income 7,123 12,155 24,616
OPERATING EXPENSES
Laboratory Operations 5,884 5,958 12,490
Research 7,065 7,230 14,631
Sales and Marketing 8,453 8,245 17,530
General and Administration 4,837 5,225 9,901
Total Operating Expenses526,239 26,658 54,552
NET LOSS BEFORE TAX (19,116) (14,503) (29,936)
Income Tax Expense - - -
LOSS FOR THE YEAR AFTER TAX (19,116) (14,503) (29,936)
Items that may be reclassified to profit or loss:
Translation of Foreign Operations (82) (155) 25
TOTAL COMPREHENSIVE LOSS atttributable
to equity holders of the Company
(19,198) (14,658) (29,911)
Earnings per share for loss attributable to the
equity holders of the Company during the year
Basic and Diluted Earnings per share (0.022) (0.018) (0.037)
Consolidated Interim Financial Statements
Consolidated Statement of Comprehensive Income 3
Consolidated Statement of Changes in Equity 4
Consolidated Balance Sheet 6
Consolidated Statement of Cash Flows 7
Notes to the Financial Statements
1. Summary of Accounting Policies 8
2. Investment and Advances in Subsidiaries 10
3. Dividends 10
4. Revenue and Other Income 11
5. Operating Expenses 12
6. Segment Information 13
7. Share Capital 17
8. Reconciliation of Cash Flows to Operating
Activities with Operating Net Loss 18
9. Net Tangible Assets 19
10. Contingent Liabilities 19
11. Contingent Assets 19
12. Capital Commitments 19
13. Related Parties 19
14. Local Coverage Determination (LCD) Changes 20
15. Subsequent Events 20
3 2
PACIFIC EDGE LIMITED CONSOLIDATED INTERIM FINANCIAL STATEMENTS 2025
PACIFIC EDGE LIMITED CONSOLIDATED INTERIM FINANCIAL STATEMENTS 2025
Note: These Financial Statements are to be read in conjunction with the Notes to the Financial Statements.
FOR THE SIX MONTHS ENDED 30 SEPTEMBER 2025
CONSOLIDATED STATEMENT OF CHANGES IN EQUITY
NOTES
SHARE
CAPITAL
ACCUMULATED
LOSSES
SHARE BASED
PAYMENTS
RESERVE
FOREIGN CURRENCY
TRANSLATION
RESERVE
TOTAL
EQUITY
($000)($000)($000)($000)($000)
UNAUDITED 6 MONTHS TO 30 SEPT 2024
Balance as at 31 March 2024 294,400 (246,349) 5,607 964 54,622
(Loss) After Tax - (14,503) - - (14,503)
Other Comprehensive Income - - - (155) (155)
Total Comprehensive Loss atttributable to equity holders of the Company - (14,503) - (155) (14,658)
Transactions with owners in their capacity as owners:
Share Based Payments - Employee Remuneration7 58 - - - 58
Share Based Payment - Employee Share Options7 - 63 571 - 634
Balance as at 30 September 2024 294,458 (260,789) 6,178 809 40,656
UNAUDITED 6 MONTHS TO 30 SEPT 2025
Balance as at 31 March 2025 294,458 (276,222) 6,860 989 26,085
(Loss) After Tax - (19,116) - - (19,116)
Other Comprehensive Income - - - (82) (82)
Total Comprehensive Loss atttributable to equity holders of the Company - (19,116) - (82) (19,198)
Transactions with owners in their capacity as owners:
Issue of Share Capital (net of issue costs)7 19,548 - - - 19,548
Share Based Payments - Employee Remuneration7 77 - - - 77
Share Based Payment - Employee Share Options7 - 63 321 - 384
Balance as at 30 September 2025 314,083 (295,275) 7,181 907 26,896
AUDITED 12 MONTHS TO 31 MARCH 2025
Balance as at 31 March 2024 294,400 (246,349) 5,607 964 54,622
(Loss) After Tax - (29,936) - - (29,936)
Other Comprehensive Income - - - 25 25
Total Comprehensive Loss atttributable to equity holders of the Company - (29,936) - 25 (29,911)
Transactions with owners in their capacity as owners:
Share Based Payments - Employee Remuneration7 58 - - - 58
Share Based Payment - Employee Share Options7 - 63 1,253 - 1,316
Balance as at 31 March 2025 294,458 (276,222) 6,860 989 26,085
5 4
PACIFIC EDGE LIMITED CONSOLIDATED INTERIM FINANCIAL STATEMENTS 2025
PACIFIC EDGE LIMITED CONSOLIDATED INTERIM FINANCIAL STATEMENTS 2025
Note: These Financial Statements are to be read in conjunction with the Notes to the Financial Statements.
For and on behalf of the Board of Directors:
Director Director
Dated 24th day of November 2025
AS AT 30 SEPTEMBER 2025
CONSOLIDATED BALANCE SHEET
NOTES
UNAUDITED
SEPT 2025
6 MONTHS
UNAUDITED
SEPT 2024
6 MONTHS
AUDITED
MARCH 2025
12 MONTHS
($000)($000)($000)
CURRENT ASSETS
Cash and Cash Equivalents 15,121 21,931 9,482
Short Term Deposits 7,000 14,000 13,086
Receivables 3,753 5,143 4,970
Inventory 1,933 1,335 1,607
Other Assets 1,773 1,905 1,679
Total Current Assets 29,580 44,314 30,824
NON-CURRENT ASSETS
Property, Plant and Equipment 2,583 2,728 2,980
Right of Use Assets 1,893 2,902 2,445
Intangible Assets 608 907 781
Total Non-Current Assets 5,084 6,537 6,206
TOTAL ASSETS 34,664 50,851 37,030
CURRENT LIABILITIES
Payables and Accruals 5,446 6,869 8,044
Borrowings 300 300 300
Lease Liabilities 1,471 1,260 1,413
Total Current Liabilities 7,217 8,429 9,757
NON-CURRENT LIABILITIES
Lease Liabilities 551 1,766 1,188
Total Non-Current Liabilities 551 1,766 1,188
TOTAL LIABILITIES 7,768 10,195 10,945
NET ASSETS 26,896 40,656 26,085
Represented by:
EQUITY
Share Capital7 314,083 294,458 294,458
Accumulated Losses (295,275) (260,789) (276,222)
Share Based Payments Reserve 7,181 6,178 6,860
Foreign Translation Reserve 907 809 989
TOTAL EQUITY 26,896 40,656 26,085
FURTHER INFORMATION:
Net Tangible Assets Per Share ($)9 0.026 0.049 0.031
Note: These Financial Statements are to be read in conjunction with the Notes to the Financial Statements.
FOR THE SIX MONTHS ENDED 30 SEPTEMBER 2025
CONSOLIDATED STATEMENT OF CASH FLOWS
NOTES
UNAUDITED
SEPT 2025
6 MONTHS
UNAUDITED
SEPT 2024
6 MONTHS
AUDITED
MARCH 2025
12 MONTHS
($000)($000)($000)
CASH FLOWS TO OPERATING ACTIVITIES
Cash was provided from:
Receipts from Customers 7,985 11,125 21,572
Receipts from Research Tax Incentives and
Grant Providers
-16 677
Interest Received 427 995 2,121
8,412 12,136 24,370
Cash was disbursed to:
Payments to Suppliers and Employees 27,393 24,567 49,097
Net GST inflow 45 43 13
27,438 24,610 49,110
Net Cash Flows To Operating Activities8 (19,026) (12,474) (24,740)
CASH FLOWS FROM INVESTING ACTIVITIES:
Cash was provided from:
Proceeds from Sale of Plant and Equipment--54
Proceeds from Short Term Deposits 15,086 34,000 48,000
15,086 34,000 48,054
Cash was disbursed to:
Purchase of Short Term Deposits 9,000 27,145 40,086
Capital Expenditure on Plant and Equipment 51 278 867
Capital Expenditure on Intangible Assets 14 252 406
9,065 27,675 41,359
Net Cash Flows From Investing Activities 6,021 6,325 6,695
CASH FLOWS FROM (TO) FINANCING ACTIVITIES:
Cash was received from:
Ordinary Shares Issued 20,825 - -
20,825 --
Cash was disbursed to:
Security deposited for Credit Cards - - 146
Repayment of Leases - Principal 686 614 1,266
Repayment of Leases - Interest 76 118 230
Issue Expenses 1,338
2,100 732 1,642
Net Cash Flows From (To) Financing Activities 18,725 (732) (1,642)
Net Increase (Decrease) in Cash Held 5,720 (6,881) (19,687)
Add Opening Cash Brought Forward 9,482 29,261 29,261
Effect of Exchange Rate Changes on Net Cash (81) (449) (92)
Ending Cash Carried Forward 15,121 21,931 9,482
7 6
PACIFIC EDGE LIMITED CONSOLIDATED INTERIM FINANCIAL STATEMENTS 2025
PACIFIC EDGE LIMITED CONSOLIDATED INTERIM FINANCIAL STATEMENTS 2025
FOR THE SIX MONTHS ENDED 30 SEPTEMBER 2025
NOTES TO THE FINANCIAL STATEMENTS
1 . SUMMARY OF ACCOUNTING POLICIES
The unaudited consolidated interim financial statements (“Interim Financial Statements”)
presented are those of Pacific Edge Limited (“Company”) and its subsidiaries (“Group”).
The Company is registered and domiciled in New Zealand. The Group’s purpose is to
research, develop and commercialise diagnostic and prognostic tools for the early
detection and management of cancers. Pacific Edge Diagnostics New Zealand Limited and
Pacific Edge Diagnostics USA Limited manage and operate the laboratories used for the
detection of bladder cancer. Pacific Edge (Australia) Pty Limited’s purpose is the sales and
marketing of bladder cancer products research in the Australian market and develop the
Cxbladder products and other prognostic tools. Pacific Edge Analytical Services Limited is
a dormant entity.
The Company is a for profit entity, registered in New Zealand under the Companies Act
1993 and is a reporting entity for the purposes of the Financial Markets Conduct Act
2013. The Company is dual listed, with its primary listing of ordinary shares quoted in New
Zealand on the NZX Main Board, and a secondary listing in Australia as a Foreign Exempt
Entity on the ASX.
a) Basis of Preparation of Financial Statements
The Interim Financial Statements for the six months ended 30 September 2025 have
been prepared in accordance with New Zealand Generally Accepted Accounting Practice
(GAAP) and the Financial Markets Conduct Act 2013. They comply with the New Zealand
Equivalents to International Financial Reporting Standards (NZ IFRS) and other guidance as
issued by the External Reporting Board, as appropriate for entities, and with International
Financial Reporting Standards.
The Interim Financial Statements have been prepared in accordance with NZ IAS 34 -
Interim Financial Reporting. In complying with NZ IAS 34, these consolidated Interim
Financial Statements also comply with IAS 34 - Interim Financial Reporting and should be
read in conjunction with the Company’s 2025 Annual Report.
The Interim Financial Statements are prepared on the basis of historical cost, except where
otherwise identified. The presentational currency used in the preparation of the financial
statements is New Zealand dollars and all values are rounded to the nearest thousand
dollars ($000).
b) Accounting Policies and Accounting Estimates
All material accounting policies have been applied on a basis consistent with those used in
the audited financial statements of Pacific Edge Limited for the year ended 31 March 2025.
c) Going Concern
The Interim Financial Statements have been prepared on the going concern basis which
assumes that the Company and Group will have sufficient cash to pay its debts as they fall
due for a minimum of 12 months from the signing of the Interim Financial Statements.
As at 30 September 2025, the Company and Group had $22.121m of cash, cash
equivalents and short term deposits on hand (Sept 2024: $35.931m) and net assets of
26.896m (Sept 2024: 40.656m). Net cash out flows from operating activities for the six
month period to 30 September 2025 were $19.026m (Sept 2024: $12.474m). While the
Company and Group continues to incur operating losses, the Company and Group remains
solvent and continues to pay its debts as they fall due.
The loss of Medicare Coverage on 24 April 2025 has reduced Group revenue and US test
volumes for the six months to 30 September 2025. The Company and Group continues
to focus on the paths available for re-coverage. This includes appealing all claims denied
by Medicare for Cxbladder Triage to derive payment from those tests, while the company
has made reconsideration requests for L39365 with Novitas (the Medicare Administrative
Contractor “MAC”) for Cxbladder Triage and Monitor. Novitas is expected to convene
an expert panel in February 2026 to consider coverage for urinary biomarker tests for
microhematuria evaluation given the 2025 update to the American Urological Association
(AUA) microhematuria guideline. Pacific Edge notes that under the Medicare Program
Integrity Manual, these meetings are initiated by the MAC and generally precede the
draft issuance of a new or substantially revised Local Coverage Determination (LCD).
Re-coverage would be expected to provide an uplift in revenue generation and the financial
performance of the Company and Group.
In assessing going concern, the Company and Group’s management have prepared cash
flow forecasts which indicate that, in the absence of a reduction in cash burn and/or
capital initiatives, the Company and Group may not have sufficient cash to meet its existing
minimum expenditure commitments and support its planned levels of activity for the full 12
month period from the date of signing these financial statements.
This indicates that there is a material uncertainty as at 30 September 2025 that may cast
significant doubt on the Company’s and Group’s ability to continue as a going concern and,
therefore, that it may be unable to realise its assets and discharge its liabilities in the normal
course of business. The Company and Group has a history of successful capital initiatives and
is actively pursuing a number of options. The Directors are confident that they will be able to
achieve additional funding and/or reductions in cash burn to enable the Company and Group
to meet its minimum expenditure requirements and support its planned ambitions.
d) Authorisation
The Interim Financial Statements were authorised by the Board of Directors on
24 November 2025. The Annual Financial Statements for the year ended 31 March 2025 were
authorised by the Board of Directors on 29 May 2025.
FOR THE SIX MONTHS ENDED 30 SEPTEMBER 2025
NOTES TO THE FINANCIAL STATEMENTS
9 8
PACIFIC EDGE LIMITED CONSOLIDATED INTERIM FINANCIAL STATEMENTS 2025
PACIFIC EDGE LIMITED CONSOLIDATED INTERIM FINANCIAL STATEMENTS 2025
e) Audit
The Interim Financial Statements for the six months ended 30 September 2025 are
unaudited. Comparative balances for 30 September 2024 are unaudited, whilst the
comparative balances for 31 March 2025 are audited.
f) Basis of Consolidation
The following entities and the basis of their inclusion for consolidation in these Interim
Financial Statements are as follows:
Ownership Interests
& Voting Rights
Name of Subsidiary
Place of
Incorporation
(or registration)
and Operation
Principal Activity
30 Sept
2025
(%)
30 Sept
2024
(%)
Pacific Edge Diagnostics
New Zealand Limited
New Zealand
Commercial Sales and
Diagnostic Laboratory
100100
Pacific Edge (Australia)
Pty Limited
Australia
Commercial Sales and
Biotechnology Research
& Development
100100
Pacific Edge Diagnostics
USA Limited
USA
Commercial Sales and
Diagnostic Laboratory
100100
Pacific Edge Singapore
Pte Limited
Singapore
Commercial Sales and
Biotechnology Research
& Development.
Disolved and struck off
20 February 2025
NA100
Pacific Edge Analytical
Services Limited
New ZealandDormant Company100100
2. INVESTMENT AND ADVANCES IN SUBSIDIARIES
The consolidated Interim Financial Statements incorporate the assets and liabilities and
results of Pacific Edge Diagnostics New Zealand Limited, Pacific Edge (Australia) Pty
Limited, Pacific Edge Diagnostics USA Limited, Pacific Edge Diagnostics Singapore Pte
Limited (30 September 2024 only) and Pacific Edge Analytical Services Limited, all of
which are 100% owned by the Company. Subsidiaries have a 31 March balance date. The
investments in and advances to subsidiaries are eliminated on consolidation in the Group
financial statements.
3. DIVIDENDS
The Company does not propose to pay dividends to shareholders similar to previous years.
This policy continues.
4. REVENUE AND OTHER INCOME
Unaudited
Sept 2025
6 Months
($000)
Unaudited
Sept 2024
6 Months
($000)
Audited
March 2025
12 Months
($000)
Cxbladder SalesCxbladder Sales
- US - Accrual Accounting- US - Accrual Accounting 4,115 4,115 8,8898,889 17,517 17,517
- US - Cash Accounting- US - Cash Accounting 928 928 1,1781,178 2,565 2,565
- Total US Sales- Total US Sales 5,043 5,043 10,06710,067 20,082 20,082
- Rest of World- Rest of World 896 896 892892 1,764 1,764
Total Operating Revenue Total Operating Revenue 5,939 5,939 10,95910,959 21,846 21,846
Other IncomeOther Income
Grant RevenueGrant Revenue - - - - 22 22
Research Rebates and Tax IncentivesResearch Rebates and Tax Incentives897897385385 881 881
Total Other IncomeTotal Other Income 897 897 385385 903 903
On 24 April 2025*, Local Coverage Determination (L39365) ‘Genetic Testing in Oncology:
Specific Tests’ became effective in the US, halting Medicare coverage of Cxbladder tests.
Pacific Edge had previously generated approximately 60% of its US revenue from Medicare
and approximately 56% of total Operating Revenue.
Pacific Edge is focusing on the paths available to recoverage, which include Medicare
appeals for Cxbladder Triage to get paid based on its inclusion in the AUA microhematuria
guideline despite the non-coverage determination and reconsideration requests for
Triage, Triage Plus and Monitor which have been submitted to the Medicare Approved
Contractor Novitas.
Due to the non-coverage, Medicare tests performed during the six months to
30 September 2025 have not been accrued in the six months to 30 September 2025 given
the uncertainity in determining the level of success of appeals. This accounting treatment
has changed from the treatment in the twelve months to 31 March 2025 when revenue for
tests performed for Medicare were accrued based on the anticipated funds that would be
received from Medicare.
Pacific Edge is in the process of appealing for Cxbladder Triage Medicare tests that have
been completed since the date the Local Coverage Determination became effective and
remain unpaid up to 30 September 2025. If these appeals are successful, revenue will be
recognised for tests when the proceeds are received from the appeal process.
If sufficient appeals are successful and revenue is expected to be reliably calculated, the
company may be able to recommence accounting for Medicare tests on an accrual basis
for the 31 March 2026 accounts.
*All dates with an asterisk refer to US dates
FOR THE SIX MONTHS ENDED 30 SEPTEMBER 2025
NOTES TO THE FINANCIAL STATEMENTS
FOR THE SIX MONTHS ENDED 30 SEPTEMBER 2025
NOTES TO THE FINANCIAL STATEMENTS
11 10
PACIFIC EDGE LIMITED CONSOLIDATED INTERIM FINANCIAL STATEMENTS 2025
PACIFIC EDGE LIMITED CONSOLIDATED INTERIM FINANCIAL STATEMENTS 2025
5. OPERATING EXPENSES
The note below highlights total expenses shown within total operating expenses. These
items are then split across functions laboratory, research, sales and marketing and general
and administration as reported in the annual report.
Unaudited
Sept 2025
6 Months
($000)
Unaudited
Sept 2024
6 Months
($000)
Audited
March 2025
12 Months
($000)
Operating ExpensesOperating Expenses
AmortisationAmortisation 187 187 295295571571
Auditors Remuneration Auditors Remuneration
- Group year end financial statements- Group year end financial statements 102 102 9999198198
- Half year review of financial statements- Half year review of financial statements 35 3535
- Travel Costs 6 -10
Other services provided by PricewaterhouseCoopers Other services provided by PricewaterhouseCoopers
New ZealandNew Zealand
- Assurance on Carbon Emissions - Scope 1 and 2- Assurance on Carbon Emissions - Scope 1 and 2----3030
- Financial Training WorkshopsFinancial Training Workshops - 11
Total Auditors RemunerationTotal Auditors Remuneration
143 135 274
Consultant CostsConsultant Costs 1,121 1,149 2,257
DepreciationDepreciation 418 390 842
Depreciation on Right of Use AssetsDepreciation on Right of Use Assets 682 682 661661 1,344 1,344
Directors FeesDirectors Fees 314 247 470
Employee BenefitsEmployee Benefits 12,383 12,383 12,78412,784 26,268 26,268
Employee Share Scheme ExpensesEmployee Share Scheme Expenses 77 77 5858 58 58
Employee Share OptionsEmployee Share Options 384 384 635635 1,317 1,317
Interest on Lease LiabilitiesInterest on Lease Liabilities 76 76 118118 230 230
Legal ExpensesLegal Expenses 732 732 256256 611 611
NZX / ASX / Registry FeesNZX / ASX / Registry Fees 108 108 124124 230 230
Rental and Lease ExpenseRental and Lease Expense 28 75 143
Site Fees - Clinical StudiesSite Fees - Clinical Studies 1,730 2,062 4,052
Other Operating ExpensesOther Operating Expenses 7,856 7,856 7,6697,669 15,885 15,885
Total Operating ExpensesTotal Operating Expenses 26,239 26,239 26,65826,658 54,552 54,552
Employee Share Scheme
Employee Share Scheme Expenses are a non-cash expense. These relate to shares issued
to employees in lieu of cash bonuses.
Employee Share Options
Employee Share Options are a non-cash expense. Refer to Note 8 of the Annual Report for
details of the accounting policy for Employee Share Schemes.
Other Operating Expenses
The major categories of expenditure which make up operating expenses, but are not
disclosed separately above: Laboratory costs, Information Technology costs, Compliance
and Regulatory costs, Investor Relations costs.
6. SEGMENT INFORMATION
Operating segments are reported in a manner consistent with the internal reporting
provided to the chief operating decision-maker. The chief operating decision-maker,
who is responsible for allocating resources and assessing performance of the operating
segments, has been identified as the Chief Executive Officer who makes strategic
decisions.
There are two operating segments at balance date:
1. Commercial: The sales, marketing, laboratory and support operations to run the
commercial businesses worldwide; and
2. Research: The research and development of diagnostic and prognostic products for
human cancer.
The reportable operating segment Commercial derives its revenue primarily from sales
of Cxbladder tests and the reportable operating segment Research derives its revenue
primarily from grant income. The Chief Executive Officer assesses the performance of the
operating segments based on net loss for the period.
Segment income, expenses and profitability are presented on a gross basis excluding
inter-segment eliminations to best represent the performance of each segment operating
as independent business units. The segment information provided to the Chief Executive
Officer for the reportable segments described above, for the six months ended
30 September 2025 is shown on the following page.
FOR THE SIX MONTHS ENDED 30 SEPTEMBER 2025
NOTES TO THE FINANCIAL STATEMENTS
FOR THE SIX MONTHS ENDED 30 SEPTEMBER 2025
NOTES TO THE FINANCIAL STATEMENTS
13 12
PACIFIC EDGE LIMITED CONSOLIDATED INTERIM FINANCIAL STATEMENTS 2025
PACIFIC EDGE LIMITED CONSOLIDATED INTERIM FINANCIAL STATEMENTS 2025
Unaudited 6 Months
to 30 September 2025
Commercial
($000)
Research
($000)
Less:
Eliminations
($000)
Total
External
Income
($000)
Income
Operating Revenue - External5,939 - - 5,939
Other Income 6061,251 (960)897
Interest Income5294 - 299
Foreign Exchange Gain (5) (7) - (12)
Total Income6,5451,538 (960)7,123
Expenses
Other Expenses8,4994,579 (960)12,118
Employee Benefits7,7105,124 - 12,834
Depreciation & Amortisation 953 334 - 1,287
Total Operating Expenses17,16210,037 (960)26,239
Loss Before Tax (10,617) (8,499) - (19,116)
Income Tax Expense - - - -
Loss After Tax (10,617) (8,499) - (19,116)
Net Cash Flow to Operating Activities (8,948) (10,078) - (19,026)
Unaudited 6 Months
to 30 September 2024
Commercial
($000)
Research
($000)
Less:
Eliminations
($000)
Total
External
Income
($000)
Income
Operating Revenue - External10,959- - 10,959
Other Income 617785 (1,017) 385
Interest Income71,186 - 1,193
Foreign Exchange Gain- (382) - (382)
Total Income11,5831,589 (1,017)12,155
Expenses
Other Expenses15,81410,516 (1,017)25,313
Depreciation & Amortisation890455 - 1,345
Total Operating Expenses 16,704 10,971 (1,017)26,658
Loss Before Tax (5,121) (9,382) - (14,503)
Income Tax Expense - - - -
Loss After Tax (5,121) (9,382) - (14,503)
Net Cash Flow to Operating Activities (4,109) (8,365) - (12,474)
Audited 12 Months
to 31 March 2025
Commercial
($000)
Research
($000)
Less:
Eliminations
($000)
Total
External
Income
($000)
Income
Operating Revenue - External 21,852 - (6) 21,846
Other Income 1,237 4,757 (5,091) 903
Interest Income 12 1,913 - 1,925
Foreign Exchange Gain (2) (56) - (58)
Total Income 23,099 6,614 (5,097) 24,616
Expenses
Other Expenses 19,636 9,612 (5,097) 24,151
Employee Benefits 16,532 11,111 - 27,643
Depreciation & Amortisation 1,864 894 - 2,758
Total Operating Expenses 38,032 21,617 (5,097) 54,552
Loss Before Tax (14,933) (15,003) - (29,936)
Income Tax Expense - - - -
Loss After Tax (14,933) (15,003) - (29,936)
Net Cash Flow to Operating Activities (13,031) (11,709) - (24,740)
Eliminations
These are the intercompany transactions between the subsidiaries and the Parent. These
are eliminated on consolidation of Group results. The Research segment of the business
utilise consumables and other components that are purchased by the Commercial
segments of the business, with the costs of these components allocated to Research
segment, and the Commercial segment recognising revenue from the sale.
Total Laboratory Throughput:
Unaudited
Commercial
# Tests
Research
# Tests
Total
# Tests
6 months ended 30 September 2025 10,371 2,820 13,191
6 months ended 30 September 2024 12,323 1,910 14,233
12 months ended 31 March 2025 24,642 4,252 28,894
Laboratory Throughput is a key metric for the Group. Laboratory Throughput provides
evidence of the usage of Cxbladder products globally and the rates of adoption between
different customer segments. Total Laboratory Throughput includes commercial tests,
which are invoiced to customers, and research tests which are not considered to be
billable as these tests relate to user programs or other non-chargeable activities.
FOR THE SIX MONTHS ENDED 30 SEPTEMBER 2025
NOTES TO THE FINANCIAL STATEMENTS
FOR THE SIX MONTHS ENDED 30 SEPTEMBER 2025
NOTES TO THE FINANCIAL STATEMENTS
15 14
PACIFIC EDGE LIMITED CONSOLIDATED INTERIM FINANCIAL STATEMENTS 2025
PACIFIC EDGE LIMITED CONSOLIDATED INTERIM FINANCIAL STATEMENTS 2025
Commercial test numbers are also a key metric for the Group: Commercial Tests are those
tests for which the Company is actively seeking reimbursement and cash receipts, and
tests performed at no charge in order to gain new customers.
Segment Assets and Liabilities Information:
Unaudited as at 30 September 2025
Commercial
($000)
Research
($000)
Total
($000)
Total Assets 7,542 27,122 34,664
Total Liabilities 4,151 3,617 7,768
Unaudited as at 30 September 2024
Commercial
($000)
Research
($000)
Total
($000)
Total Assets10,35940,49250,851
Total Liabilities6,1064,08910,195
Audited as at 31 March 2025
Commercial
($000)
Research
($000)
Total
($000)
Total Assets 11,257 25,773 37,030
Total Liabilities 6,449 4,496 10,945
Additions to non current assets for the period include:
Commercial
($000)
Research
($000)
Total
($000)
Property, Plant & Equipment 48 3 51
Right of Use Assets 396 - 396
Intangible Assets 14 - 14
Total Additions to Non Current Assets 458 3 461
The amounts provided to the Chief Executive Officer with respect to total assets and total
liabilities are measured in a manner consistent with that of the financial statements. These
assets and liabilities are allocated based on the operation of the segment and the physical
location of the asset.
There are no unallocated assets or liabilities.
Geographic Split of Revenue and Non-Current Assets
The Group generates most of the operating revenue from Commercial tests from the
US and New Zealand and also receives Grant revenue from New Zealand. Rest of World
consists of Revenue from Australia and Southeast Asia.
Unaudited
Sept 2025
6 Months
($000)
Unaudited
Sept 2024
6 Months
($000)
Audited
March 2025
12 Months
($000)
Operating and Grant Revenue
US 5,043 10,067 20,143
New Zealand 1,375 1,228 2,499
Rest of World 418 49 107
Total Operating and Grant Revenue 6,836 11,344 22,749
Unaudited
Sept 2025
6 Months
($000)
Unaudited
Sept 2024
6 Months
($000)
Audited
March 2025
12 Months
($000)
Non-Current Assets
US 2,624 3,469 3,455
New Zealand 2,459 3,066 2,750
Rest of World 1 2 1
Total Non-Current Assets 5,084 6,537 6,206
7. SHARE CAPITAL
Unaudited
Sept 2025
6 Months
Shares (000)
Unaudited
Sept 2025
6 Months
($000)
Unaudited
Sept 2024
6 Months
($000)
Audited
March 2025
12 Months
($000)
Opening Balance 811,916 294,458 294,400 294,400
Issue of Ordinary Shares
- Issue of Ordinary Shares - Placement
1
160,728 16,073 --
- Issue of Ordinary Shares - Retail Offer
2
46,622 4,662 --
- Issue of Ordinary Shares - Employee
Remuneration
3
736 77 58 58
- Issue of Ordinary Shares - Directors Fees
4
1,508 151 --
- Issue of Ordinary Shares - Share Issue
Expense
5
625 63 --
Less Share Issue Expense-(1,401) --
Movement 210,219 19,625 58 58
Closing Balance 1,022,135 314,083 294,458 294,458
FOR THE SIX MONTHS ENDED 30 SEPTEMBER 2025
NOTES TO THE FINANCIAL STATEMENTS
FOR THE SIX MONTHS ENDED 30 SEPTEMBER 2025
NOTES TO THE FINANCIAL STATEMENTS
17 16
PACIFIC EDGE LIMITED CONSOLIDATED INTERIM FINANCIAL STATEMENTS 2025
PACIFIC EDGE LIMITED CONSOLIDATED INTERIM FINANCIAL STATEMENTS 2025
1
During the period 160,728,498 shares were issued resulting from a Share Placement at an average price of
$0.100 per share. (September 2024: Nil, March 2025: Nil)
2
During the period 46,621,913 shares were issued resulting from a Share Retail Offer at an average price of $0.100
per share. (September 2024: Nil, March 2025: Nil)
3
During the period 736,475 shares were issued as part of employees remuneration in lieu of cash payments at an
average price of $0.105 per share. (September 2024: 644,630 at $0.090 and March 2025: 644,630 at $0.090).
4
During the period 1,507,600 shares were issued to Directors in lieu of Directors Fees at an average price of
$0.100 per share. (September 2024: Nil, March 2025: Nil)
5
During the period 625,000 shares were issued as Non-cash consideration, being in recognition of providing
legal advice during the capital raise an average price of $0.100 per share. (September 2024: Nil, March 2025: Nil)
There are 1,022,135,460 (September 2024: 811,915,974 and March 2025: 811,915,974)
ordinary shares on issue. All fully paid shares in the Company have equal voting rights and
equal rights to dividends. All Ordinary Shares are fully paid and have no par value.
8. RECONCILIATION OF CASH FLOWS TO OPERATING ACTIVITIES WITH
OPERATING NET LOSS
Unaudited
Sept 2025
6 Months
($000)
Unaudited
Sept 2024
6 Months
($000)
Audited
March 2025
12 Months
($000)
Net Loss for the PeriodNet Loss for the Period (19,116) (19,116) (14,503) (14,503) (29,936) (29,936)
Add Non Cash Items:Add Non Cash Items:
DepreciationDepreciation418418 390 390 842 842
(Profit) on disposal of Property, Plant and (Profit) on disposal of Property, Plant and
EquipmentEquipment
(23) (23) - - (19) (19)
AmortisationAmortisation 187 187 295 295 571 571
Employee Share options 382 635 1,317
Employee bonuses paid in shares in lieu of cash 140 58 58
Depreciation on right of use assets 682 661 1,344
Interest on finance leases shown in lease
repayments
76 118 230
Total Non Cash Items 1,862 2,157 4,343
Add Movements in Other Working Capital items:
(Increase) Decrease in Receivables and Other Assets 1,123 (978) (576)
(Increase) Decrease in Inventory (326) 353 81
Increase (Decrease) in Payables and Accruals (2,595) 116 1,289
Effect of exchange rates on net cash 26 381 59
Total Movement in Other Working CapitalTotal Movement in Other Working Capital (1,772) (1,772) (128) (128) 853 853
Net Cash Flows to Operating ActivitiesNet Cash Flows to Operating Activities (19,026) (19,026) (12,474) (12,474) (24,740) (24,740)
9. NET TANGIBLE ASSETS
Net Tangible Assets per share is a non-GAAP measure that is required to be disclosed by
the NZX Listing Rules. The calculation of the Group’s Net Tangible Assets per share and its
reconciliation to the consolidated balance sheet is presented below.
Unaudited
Sept 2025
6 Months
($000)
Unaudited
Sept 2024
6 Months
($000)
Audited
March 2025
12 Months
($000)
Total AssetsTotal Assets 34,664 34,664 50,85150,85137,03037,030
Less Intangible AssetsLess Intangible Assets 608 608 907907781781
Less Total LiabilitiesLess Total Liabilities 7,768 7,768 10,19510,195 10,945 10,945
Net Tangible Assets 26,288 39,749 25,304
Number of Shares Issued (000’s) 1,022,135 811,916 811,916
Net Tangible Assets Per ShareNet Tangible Assets Per Share $0.026 $0.026 $0.049$0.049 $0.031 $0.031
10. CONTINGENT LIABILITIES
There were no known contingent liabilities at 30 September 2025 (September 2024: Nil
and March 2025 : Nil ). The Company and Group have not granted any securities in respect
of liabilities payable by any other party whatsoever.
11. CONTINGENT ASSETS
Pacific Edge is in the process of appealing for Cxbladder Triage Medicare tests that have
been completed since the date the Local Coverage Determination became effective and
remain unpaid up to 30 September 2025. If these appeals are successful, revenue will be
recognised for tests when the proceeds are received from the appeal process.
12. CAPITAL COMMITMENTS
There are no capital commitments at 30 September 2025 (September 2024: Nil and
March 2025: Nil).
13. RELATED PARTIES
Details of all related party relationships have been disclosed in the annual report for the
year ended 31 March 2025.
In addition to these disclosures, during the six months to 30 September 2025, shareholders
resolved to increase the Director Remuneration Pool, with the increase in pool to be issued
as shares in lieu of cash.
FOR THE SIX MONTHS ENDED 30 SEPTEMBER 2025FOR THE SIX MONTHS ENDED 30 SEPTEMBER 2025
NOTES TO THE FINANCIAL STATEMENTSNOTES TO THE FINANCIAL STATEMENTS
19 18
PACIFIC EDGE LIMITED CONSOLIDATED INTERIM FINANCIAL STATEMENTS 2025
PACIFIC EDGE LIMITED CONSOLIDATED INTERIM FINANCIAL STATEMENTS 2025
13. RELATED PARTIES (continued)
Shareholders resolved to issue up to 1,930,000 shares to Directors at a price of $0.100
per share. Directors could elect to receive a reduced number of shares to offset the tax
obligation via a net settlement option, which some Directors elected to do. There were
1,507,600 Shares issued to Directors for directors fees in lieu of Cash. Shareholders
received an Independent Report which considered the terms and conditions of the issue
of shares to Directors was fair to Shareholders who were not associated with the Directors
prior to the vote agreeing to the issue.
14. LOCAL COVERAGE DETERMINATION (LCD) CHANGES
On 24 April 2025*, Local Coverage Determination (L39365) ‘Genetic Testing in Oncology:
Specific Tests’ became effective in the US, halting Medicare coverage of Cxbladder tests.
Pacific Edge had previously generated approximately 60% of its US revenue from
Medicare and approximately 56% of total Operating Revenue.
Further details on the impact of this loss of Medicare coverage is detailed on Note 4 -
Revenue.
*All dates with an asterisk refer to US dates
15. SUBSEQUENT EVENTS
There are no subsequent events.
21 20
PricewaterhouseCoopers, PwC Centre, 60 Cashel Street,
PO Box 13-244, Christchurch 8141, New Zealand
T: +64 3 374 3000
pwc.co.nz
Independent auditor’s review report
To the shareholders of Pacific Edge Limited
Report on the consolidated interim financial statements
Our conclusion
We have reviewed the consolidated interim financial statements of Pacific Edge Limited (the Company) and its
subsidiaries (the Group), which comprise the consolidated balance sheet as at 30 September 2025, and the
consolidated statement of comprehensive income, the consolidated statement of changes in equity and the
consolidated statement of cash flows for the six months ended on that date, and notes, comprising material
accounting policy information and other explanatory information.
Based on our review, nothing has come to our attention that causes us to believe that the accompanying
consolidated interim financial statements of the Group do not present fairly, in all material respects, the financial
position of the Group as at 30 September 2025, and its financial performance and cash flows for the six months
then ended, in accordance with International Accounting Standard 34 Interim Financial Reporting (IAS 34) and
New Zealand Equivalent to International Accounting Standard 34 Interim Financial Reporting (NZ IAS 34).
Basis for conclusion
We conducted our review in accordance with the New Zealand Standard on Review Engagements 2410 (Revised)
Review of Financial Statements Performed by the Independent Auditor of the Entity (NZ SRE 2410 (Revised)).
Our responsibilities are further described in the Auditor’s responsibilities for the review of the consolidated interim
financial statements section of our report.
We are independent of the Group in accordance with the relevant ethical requirements in New Zealand relating to
the audit of the annual financial statements, and we have fulfilled our other ethical responsibilities in accordance
with these ethical requirements.
Other than in our capacity as auditor and assurance practitioner, we have no other relationships with, or interests
in, the Group.
Material uncertainty related to going concern
We draw attention to the disclosures in Note 1 to the consolidated interim financial statements, which indicates that
the Company, as at 30 September 2025, had $22.121m of cash, cash equivalents and short term deposits on hand
(Sept 2024: $35.931m), net assets of $26.896m (Sept 2024: $40.656m), and n et cash outflows from operating
activities for the six month period to 30 September 2025 were of $19.026m (Sept 2024: $12.474m).
As stated in Note 1, if the Company is unable to achieve additional funding and/or achieve appropriate cash burn
reduction measures it may not have sufficient funds to meet its obligations and be unable to realise its assets and
discharge its liabilities in the normal course of business. These events or conditions, along with other matters set
forth in Note 1, indicate that a material uncertainty exists that may cast significant doubt on the Company's ability
to continue as a going concern. Our opinion is not modified in respect of this matter.
Responsibilities of Directors for the consolidated interim financial statements
The Directors of the Company are responsible on behalf of the Company for the preparation and fair presentation of
these consolidated interim financial statements in accordance with IAS 34 and NZ IAS 34 and for such internal
control as the Directors determine is necessary to enable the preparation and fair presentation of the consolidated
interim financial statements that are free from material misstatement, whether due to fraud or error.
Auditor’s responsibilities for the review of the consolidated interim financial
statements
Our responsibility is to express a conclusion on the consolidated interim financial statements based on our review.
NZ SRE 2410 (Revised) requires us to conclude whether anything has come to our attention that causes us to
believe that the consolidated interim financial statements, taken as a whole, are not prepared in all material
respects, in accordance with IAS 34 and NZ IAS 34.
A review of consolidated interim financial statements in accordance with NZ SRE 2410 (Revised) is a limited
assurance engagement. We perform procedures, primarily consisting of making enquiries, primarily of persons
responsible for financial and accounting matters, and applying analytical and other review procedures. The
procedures performed in a review are substantially less than those performed in an audit conducted in accordance
with International Standards on Auditing (New Zealand) and consequently does not enable us to obtain assurance
that we might identify in an audit. Accordingly, we do not express an audit opinion on these consolidated interim
financial statements.
Who we report to
This report is made solely to the Company’s Shareholders, as a body. Our review work has been undertaken so that
we might state those matters which we are required to state to them in our review report and for no other purpose.
To the fullest extent permitted by law, we do not accept or assume responsibility to anyone other than the Company
and the Company’s Shareholders, as a body, for our review procedures, for this report or for the conclusion we have
formed.
The engagement partner on the review resulting in this independent auditor’s review report is Nathan Wylie.
For and on behalf of:
PricewaterhouseCoopers Christchurch
24 November 2025
87 St David Street, PO Box 56, Dunedin, New Zealand
P 0800 555 563 (NZ) | +64 3 577 6733 (Outside NZ)
F +64 3 974 9393
www.pacificedgedx.com
---
Template
Results announcement
(for Equity Security issuer/Equity and Debt Security issuer)
Updated as at March 2025
Please do not amend or delete individual rows. As this template relates to prescribed content, changes to content
should only be made where it is clearly indicated that this is permitted, otherwise, if an Issuer considers a particular
element does not apply, mark the row as N/A, Any other changes to this prescribed form must first be approved by
NZX as required under NZX Listing Rule 3.26.1.
Results for announcement to the market
Name of issuer Pacific Edge Limited
Reporting Period 6 months to 30 September 2025
Previous Reporting Period 6 months to 30 September 2024
Currency NZD (New Zealand Dollar)
Amount (000s) Percentage change
Revenue from continuing
operations
$5,939 46% Decrease
Total Revenue $7,123 41% Decrease
Net profit/(loss) from
continuing operations
($19,116) 32% Larger Loss
Total net profit/(loss) ($19,116) 32% Larger Loss
Interim/Final Dividend
Amount per Quoted Equity
Security
The Company does not propose to pay dividends to
shareholders
Imputed amount per Quoted
Equity Security
Not Applicable
Record Date Not Applicable
Dividend Payment Date Not Applicable
Current period Prior comparable period
Net tangible assets per
Quoted Equity Security (in
dollars and cents per
security)
$0.026 $0.049
A brief explanation of any of
the figures above necessary
to enable the figures to be
understood
For commentary on the results, please refer to the commentary
in the accompanying NZX release. Further information is also
set out in the unaudited financial statements of the Company for
the 6 months to 30 September 2025 which accompany this
Results Announcement.
Authority for this announcement
Name of person
authorised
to make this announcement
Grant Gibson
Contact person for this
announcement
Grant Gibson
Contact phone number 0800 555 563
Contact email address grant.gibson@pelnz.com
Date of release through MAP
25/11/2025
Unaudited financial statements accompany this announcement.
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.
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