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PACIFIC EDGE LIMITED — AGM Information 2025
Aug 5, 2025
65539_rns_2025-08-05_aaf0194e-a260-4880-893a-7ce45bd9b5f3.pdf
AGM Information
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6 AUGUST 2025
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PACIFIC EDGE 2025 ANNUAL SHAREHOLDERS’ MEETING
DUNEDIN, New Zealand – Cancer diagnostics company Pacific Edge (NZX, ASX: PEB) is holding its Annual Shareholder Meeting in Auckland this afternoon. It attaches Chairman Chris Gallaher’s speech notes and the company’s presentation to shareholders.
Released for and on behalf of Pacific Edge by Grant Gibson Chief Financial Officer.
For more information:
Investors: Dr Peter Meintjes Chief Executive Pacific Edge P: 022 032 1263
Media: Richard Inder The Project P: +64 21 645 643
OVERVIEW
Pacific Edge: www.pacificedgedx.com
Pacific Edge Limited (NZX/ ASX: PEB) is a global cancer diagnostics company leading the way in the development and commercialization of bladder cancer diagnostic and prognostic tests for patients presenting with hematuria or surveillance of recurrent disease. Headquartered in Dunedin, New Zealand, the company provides its suite of Cxbladder tests globally through its wholly owned, and CLIA certified, laboratories in New Zealand and the USA.
Cxbladder: www.cxbladder.com
Cxbladder is a suite of non-invasive genomic urine tests optimized for the risk stratification of urothelial cancer in patients presenting with microhematuria and those being monitored for recurrent disease. The tests help improve the overall patient experience, while prioritizing time and clinical resources to optimize practice workflow and improve efficiency.
Supported by over 20 years of research, Cxbladder’s evidence portfolio extends to more than 25 peer reviewed publications, and Cxbladder Triage is now included in the American Urological Association’s Microhematuria Guideline. To drive increased adoption and improved patient health outcomes, Cxbladder is the focal point of numerous ongoing and planned studies designed to generate further clinical utility evidence.
Cxbladder is available in the US, Australasia, and Israel and in markets throughout Asia and South America. In the US, the test has been used by over 5,000 urologists who have ordered more than 130,000 tests. In New Zealand, Cxbladder is accessible to around 70% of the population via public healthcare and all residents have the option of buying the test online.
2025 ANNUAL SHAREHOLDERS’ MEETING PRESENTATION
Chris Gallaher Chairman
Dr Peter Meintjes Chief Executive Officer
6 August 2025
CHAIRMAN’S ADDRESS
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CHRIS GALLAHER Chairman
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IMPORTANT NOTICE AND DISCLAIMER
This presentation has been prepared by Pacific Edge Limited (PEL) solely to provide interested parties with further information about PEL and its activities at the date of this presentation.
Information of a general nature
The information in this presentation is of a general nature and does not purport to be complete nor does it contain all the information which a prospective investor may require in evaluating a possible investment in PEL or that would be required in a product disclosure statement, prospectus or other disclosure document for the purposes of the New Zealand Financial Markets Conduct Act 2013 (FMCA) or the Australian Corporations Act 2001. PEL is subject to a disclosure obligation that requires it to notify certain material information to NZX Limited (NZX) and ASX Limited (ASX) for the purpose of that information being made available to participants in the market and that information can be found by visiting www.nzx.com/companies/PEB and www2.asx.com.au/markets/company/PEB. This presentation should be read in conjunction with PEL’s other periodic and continuous disclosure announcements released to NZX and ASX.
Not an offer
This presentation is for information purposes only and is not an invitation or offer of securities for subscription, purchase or sale in any jurisdiction.
Not financial product advice
This presentation does not constitute legal, financial, tax, financial product advice or investment advice or a recommendation to acquire PEL securities and has been prepared without taking into account the objectives, financial situation or needs of investors.
Forward-looking statements
This presentation may contain forward-looking statements that reflect PEL’s current views with respect to future events. Forwardlooking statements, by their very nature, are not guarantees of future outcomes and involve inherent risks and uncertainties. Many of those risks and uncertainties are matters which are
beyond PEL’s control and could cause actual results to differ from those predicted. Variations could either be materially positive or materially negative. The information is stated only as at the date of this presentation. Except as required by law or regulation (including the NZX Listing Rules and ASX Listing Rules), PEL undertakes no obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise. To the maximum extent permitted by law, the directors of PEL, PEL and any of its related bodies corporate and affiliates, and their respective officers, partners, employees, agents, associates and advisers do not make any representation or warranty, express or implied, as to the accuracy, reliability or completeness of such information, or the likelihood of fulfilment of any forward-looking statement or any event or results expressed or implied in any forward-looking statement, and disclaim all responsibility and liability for these forward-looking statements (including, without limitation, liability for negligence).
Financial data
All dollar values are in New Zealand dollars unless otherwise stated. This presentation should be read in conjunction with, and subject to, the explanations and views of future outlook on market conditions, earnings and activities given recent announcements to the NZX and ASX.
Non-GAAP financial information
This presentation contains certain financial measures that are “non-GAAP financial information” under the New Zealand Financial Markets Authority Guidance Note on disclosing nonGAAP financial information, “non-IFRS financial information” (and potentially under other regulatory guidelines or rules). Such financial information and financial measures (including EBITDA, Cash Burn and Capex) do not have standardised meanings prescribed under NZ IFRS or IFRS and therefore, may not be comparable to similarly titled measures presented by other entities, and should not be construed as an alternative to other financial measures determined in accordance with NZ IFRS, or IFRS.)
Effect of rounding
A number of figures, amounts, percentages, estimates, calculations of value and fractions in this presentation are subject to the effect of rounding. Accordingly, the actual calculation of these figures may differ from the figures set out in this presentation.
Past performance
Investors should note that past performance, including past share price performance, cannot be relied upon as an indicator of (and provides no guidance as to) future PEL performance, including future financial position or share price performance.
Disclaimer
To the maximum extent permitted by law, none of PEL and its advisers, affiliates, related bodies corporate, nor their respective directors, officers, partners, employees and agents makes any representation or warranty, express or implied, as to the materiality, currency, accuracy, reliability or completeness of information in this presentation; and none of them shall have any liability (including for negligence) for:
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any errors or omissions in this presentation; or
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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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any claim, loss or damage (whether foreseeable or not) arising from the use of any information in this presentation or otherwise arising in connection with this presentation or the information contained in it.
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DIRECTORS
SARAH PARK ANATOLE MASFEN BRYAN WILLIAMS
ANNA STOVE TONY BARCLAY
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AGENDA
-
CHAIRMAN’S ADDRESS
-
CHIEF EXECUTIVE’S ADDRESS
-
QUESTIONS
-
RESOLUTIONS
-
VOTING AND GENERAL BUSINESS
-
MEETING CLOSE
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COMPANY DEFINING STRATEGIC MILESTONES
28,894 24,642 GLOBAL TESTS[1] COMMERCIAL -11.5% TESTS[1] -9.9% on FY 24 on FY 24
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$21.8M
-$29.9M
OPERATING
NET LOSS AFTER
REVENUE
TAX +1.4%
-8.6% on
on FY 24
FY 24
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$22.6M CASH, CASH EQUIVALENTS[2]
RESILIENT OPERATING PERFORMANCE
RAISING NEW CAPITAL TO MAINTAIN COMMERCIAL MOMENTUM
Pacific Edge’s priority is to ensure it has the resources and capacity to capitalize on its recent clinical and commercial milestones, grow in non-Medicare channels and regain Medicare coverage
-
Placement: $16.073 million pledged, subject to approval at today’s meeting
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Share purchase plan (SPP): closed 31 July 2025 after investors pledged $4.662 million but it will not proceed if the Placement is not approved today
Funds[1 ] raised will be used to:
-
Accelerate adoption of Triage in the US with AUA Guidelines as a tailwind for sales, marketing and reimbursement
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Continue clinical evidence generation in an AV, CV and CU framework for coverage, guidelines and medical policy for Triage Plus and Monitor Plus
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Invest in innovation and product development for IVD kits to support entry into international markets in a de-centralized deployment model
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Extend cash runway to support operations while we seek Medicare re-coverage and while we maintain market momentum
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- $20,735,041 in new equity has been raised through the Placement and SPP. For key risks associated with the capital raising please refer to the appendix of this presentation
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CHIEF EXECUTIVE’S ADDRESS
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DR PETER MEINTJES Chief Executive Officer
VALUE CREATION THROUGH THREE PILLARS
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INPUTS OUTPUTS
EXCELLENT PATIENT EXPERIENCE
OUR PEOPLE
AND ACCURATE RESULTS
OUR IP, KNOWLEDGE EARLY DETECTION AND
AND EXPERIENCE CLINICALLY ACTIONABLE CARE
INNOVATION PIPELINE FOR
OUR PROCESSES
CLINICAL APPLICATIONS
OUR CLINICAL STUDIES INCLUSIVE WORKPLACE
PARTNER SITES DRIVEN BY OUTCOMES
INCREASED LONG-TERM
OUR INVESTORS
SHAREHOLDER VALUE
A VALUES DRIVEN, DIVERSE, RESULTS-FOCUSED CULTURE
SCALABLE PROCESSES, TRAINING & QUALITY SYSTEMS, CONTINUOUS IMPROVEMENT
DIGITALIZED ARCHITECTURE, AUTOMATED OPERATIONS, REAL-TIME ANALYSIS
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AUA MICROHEMATURIA GUIDELINE INCLUSION
A COMPANY-DEFINING STRATEGIC MILESTONE ACHIEVED IN FEBRUARY 2025
The 2025 amendment to the AUA microhematuria guideline supports the use of urine-based biomarkers for intermediate-risk patients as an alternative to a cystoscopy
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Primary driver for the change in the guidelines was clinical utility evidence for Cxbladder Triage from a randomized controlled trial, i.e. the STRATA Study[1]
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Cxbladder Triage specifically mentioned as the only urine-based biomarker test that has ‘Grade A’ evidence[2] cementing first-mover advantage and building a moat vs competitors
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The change was significant:
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The 2020 guideline expressly prohibited the use of urine-based biomarkers in lieu of a cystoscopy
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The 2025 guideline brings genomic testing to hematuria evaluation for bladder cancer as already established for prostate, breast, colon and other cancers
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Intermediate-risk patients represent a large cohort (~70%)[3] of microhematuria patients (up to 3.5 million patients annually in the US)
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Offers significant benefits to patients, reduces the burden of unnecessary cystoscopies, improves access to care at a lower cost and reduces legal liability for using biomarker alternatives
“… [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
AUA guideline inclusion provides significant global clinical validation for Cxbladder which is expected to pave the way for further wider global adoption by healthcare providers and payers – we have already noticed increased interest from physicians
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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.
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The AUA defines ‘Grade A’ evidence as evidence with a high certainty rating and notes evidence of this grade makes it "very confident that the true effect lies close to that of the estimate of the effect”
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Pacific Edge estimate based on the new risk categories created with the 2025 microhematuria guidelines
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PACIFIC EDGE’S EVIDENCE PROGRAM SEEKS TO CHANGE CLINICAL PRACTICE
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AUDIENCE EVIDENCE USE
HEALTHCARE PAYERS -
Change Medical Policy
(Medicare, Kaiser
(practice)
Permanente, Veterans
-
Administration, private Change Reimbursement
Policy Guidelines change:
payers, etc).
- Healthcare Payer Medical
and Reimbursement
Policies
Clinical Evidence PROFESSIONAL SOCIETIES - Change Standard of Care
AV, CV, CU (AUA, EAU, NCCN) Guidelines
Guidelines change:
- Clinical Practice
UROLOGISTS - Change Clinical Practice
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We are focused on generating the compelling clinical evidence required to drive behavior change in physicians. We seek to produce evidence that is founded on the frameworks of Analytical Validity (AV), Clinical Validity (CV) and Clinical Utility (CU), on clearly defined patient populations with the endpoints and sample sizes required for coverage decisions and guideline inclusion.
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MEDICARE NON-COVERAGE IN APRIL 2025 INCONSISTENT WITH AUA GUIDELINE AUA GUIDELINE INCLUSION PROVIDES THE BASIS FOR GREATER SUCCESS WITH COMMERCIAL PAYERS
MEDICARE REIMBURSEMENT COMMENCED IN 2020 BUT CEASED IN 2025
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Medicare reimbursed Cxbladder tests >98% since 2020 at US$760 per test – these tests have accounted for the majority of US volumes and ~61% of revenue in FY25
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Novitas – the Medicare Administrative Contractor that determines Medicare coverage for our tests – proposed non-coverage for Cxbladder in July 2022 (2H 23)
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We challenged this determination with more recent evidence and support from the American Urological Association (AUA), but Novitas finalized its non-coverage determination in January 2025 without considering the most-current evidence available
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This decision removed coverage for AUA guideline-recommended testing, after following a process that failed to review the most-current evidence
OUR RESPONSE: DRIVING CXBLADDER DEMAND WITH AUA GUIDELINE INCLUSION
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~47% of US volumes are from other contracted payers (e.g. Kaiser Permanente, the US Veterans Administration and various Blue Cross Blue Shield plans) and non-contracted private payers – these volumes are expected to continue to grow inline with historical trends
-
Our commercial team will continue to promote and supply tests to existing US users and drive demand to maintain the momentum building from the guideline
Medicare is the US national insurance payer for all US citizens over 65 years of age – the most at risk age demographic for bladder cancer
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Seeking reimbursement through the Medicare Appeals Process and External Review
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Cxbladder Detect users are being migrated to Triage, accelerating a plan previously intended to coincide with the commercial launch of Triage Plus
•
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SEEKING RE-COVERAGE VIA LCD RECONSIDERATION AND MEDICARE APPEALS RECONSIDERATION REQUESTS UNDER REVIEW; APPEALS TO RELY ON GUIDELINE INCLUSION
POSITIVE ENGAGEMENT WITH NOVITAS TO RESTORE COVERAGE FOR TRIAGE AND MONITOR
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Cxbladder Triage: A reconsideration request was submitted to Novitas in March 2025 consisting of STRATA[1] and the AUA Microhematuria guideline and is under review
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Cxbladder Monitor: A reconsideration request was submitted to Novitas in May 2025 consisting of two new realworld studies from Australia and is under review
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We are attempting to get reimbursed on Triage tests based on the 2025 AUA microhematuria guideline through the Medicare appeal process on the grounds of the test being “medically reasonable and necessary”
ESTABLISHING MEDICARE COVERAGE FOR TRIAGE PLUS
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The analytical validation (AV) for Triage Plus has been published[2] , clinical validation (CV) has been submitted for peer review and seeking publication in FY 26 Q1
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Pacific Edge expects to submit a reconsideration request for Triage Plus when CV is published or provide during the comment period if the LCD has been opened
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Inclusion of Triage in the AUA microhematuria guideline establishes medical policy to which Triage Plus can be added, meaning AV and CV should be sufficient for coverage of Triage Plus
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Further evidence for Triage published by Kaiser Permanente as a presentation at AUA and in peer review for publication by FY 26 Q3 further confirms the clinical utility and health economics of Triage (and Triage Plus)
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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.
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Harvey, J.C. et al. (2025) Analytical Validation of the Cxbladder® Triage Plus Assay for Risk Stratification of Hematuria Patients for Urothelial Carcinoma. Diagnostics 2025, 15, 1739.
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MEDICARE RE-COVERAGE: ESTIMATED TIMELINES
COVERAGE DECISIONS, PRIOTIZATION AND TIMELINES ARE AT THE DISCRETION OF NOVITAS[1]
| MEDICARE RECONSIDERATION REQUEST | CATALYST | 2025* | 2025* | 2025* | 2025* | 2026* | 2026* | 2026* | 2026* |
|---|---|---|---|---|---|---|---|---|---|
| Q1 | Q2 | Q3 | Q4 | Q1 | Q2 | Q3 | Q4 | ||
| L39365 Reconsideration request (Triage) | STRATA Study (May 2024) AUA Macrohematuria guideline (Feb 2025) |
||||||||
| L39365 Reconsideration request (Monitor) | AV of Triage, Detect & Monitor (Sept 2024) 2x RWE of Monitor (March 2025) |
||||||||
| L39365 Reconsideration request (Triage Plus) | AV of Triage Plus (Q2 25) CV of Triage Plus – DRIVE Study (Q3 25)** |
||||||||
| Estimated Novitas determination Calendar year *Estimated publication quarter Estimated opening of Novitas draft LCD |
- Novitas has the discretion to combine reconsideration requests on the same LCD based on the Medicare Program Integrity Manual. Pacific Edge expects this is the most likely approach
12-months after opening (worst case, assuming opening)
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Pacific Edge has the discretion to submit Triage Plus as part of the Comment Period if L39365 is opened before we submit the reconsideration request
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Novitas controls the timing of the LCD opening, but LCD must finalize within 12 months of opening
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Novitas is the Medicare Administrative Contractor (MAC) charged with making the Medicare local coverage determination for Pacific Edge’s US laboratory
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PLANNED PUBLICATIONS - EMBEDDING CXBLADDER IN CLINICAL PRACTICE
(Novitas[1] has 60 days to deem a reconsideration request valid. Opening an LCD is at the discretion of Novitas)
| Catalyst (published) | Test and evidence standard (2) | Expected date of reconsideration request (3) |
|---|---|---|
| 1. STRATA Clinical Utility | -CU of Triage | Published May 2024, Novitas notified |
| 2. Automated RNA & DNA extraction Analytical Validation | -AV of Triage, Detect and Monitor | Published September 2024, Novitas notified |
| 3. Triage Plus Analytical Validation | -AV of Triage Plus | Published July 2025 |
| 4. DRIVE Clinical Validation | -CV of Triage Plus | Submitted for publication |
| 5. STRATA second publication | -CU of Triage Plus (concordance) | Q4 2025 |
| 6. Kaiser Permanente Triage RWE4 | -CU of Triage (RWE) | Q3 20255 |
| 7. AUSSIE Clinical Validation | -CV of Triage Plus | Q1 2026 |
| 8. microDRIVE Clinical Validation | -CV of Triage Plus | Q4 2026 |
| 9. Monitor Plus Analytical Validation | -AV of Monitor Plus | Q2 2026 |
| 10. Pooled Analysis MH Clinical Validation6 | -CV of Triage Plus | Q1 2027 |
| 11. Pooled Analysis GH Clinical Validation7 | -CV of Monitor/Monitor Plus | Q1 2027 |
| 12. LOBSTER Clinical Validation | -CV of Monitor/Monitor Plus | Q1 2027 |
| 13. CREDIBLE Clinical Utility | -CU of Triage Plus | Q1 2028 |
| 1Novitas is the Medicare Administrative Contractor (MAC) charged with making the Medicare | 4RWE is Real World Evidence local coverage |
|
| determination for Pacific Edge’s US laboratory | 5Timeline determined by Kaiser Permanente | |
| 2AV, CV CU, respectively Analytical Validity, Clinical Validity, Clinical Utility | 6The pooled analysis brings together data from DRIVE, AUSSIE and microDRIVE | |
| 3All dates are calendar year rather than financial year and our best current estimates | 7The pooled analysis brings together data from DRIVE and AUSSIE |
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US CONTRACTED PAYER DEMAND SUPPORTS 2H 25 VOLUME GROWTH
AUA GUIDELINE INCLUSION REMAINS AN UNTAPPED OPPORTUNITY
US TOTAL TEST VOLUME[1]
-
US commercial volumes in 2H 25 increased 2.7% against 1H 25 supported by contracted payer volumes
-
Non-Medicare volumes represented 47% of US commercial volumes (~9,366) in FY 25 vs 40% ( ~5,358) in 1H 24
-
Strong performance from the Southern California Permanente Medical Group and sustained sales force efficiency gains mitigated impact of Medicare uncertainty
-
Q1 26 volumes are resilient in the face of the Medicare noncoverage and the transition from Detect to Triage
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Volume drop was due principally to the disruption of asking physicians to switch to Triage from Detect
-
The transition to Triage is going well with sales messaging supported by the AUA microhematuria guideline
-
Volumes still to benefit from the AUA guideline
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9,000
8,000 8,627
7,000
7,335
6,000 6,490
5,000 6,041 6,099 5,905 5,682 5,808 5,717
4,000
3,000
2,000
1,000
-
Q1 24 Q2 24 Q3 24 Q4 24 Q1 25 Q2 25 Q3 25 Q4 25 Q1 26
TEST VOLUME
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Q1 26 US TESTS RECEIVED - MIX
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100%
6.0%
90% 21.2%
17.5%
80%
51.9%
70% 58.6% 16.8%
60%
50%
40% 19.0% 74.1%
30% 18.9% 59.7%
20%
28.7%
10% 22.6%
0%
Monthly Average Q4 25 Apr-25 May-25 Jun-25
% TESTS RECEIVED
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-
Total Laboratory Throughput in the US including commercial, pre-commercial and clinical studies testing
-
Real World Clinical Utility of a Urinary Biomarker (Cxbladder Triage) for Hematuria Referrals in an Integrated Managed Care Health System. Abstract accepted for presentation to the Western Section of the American Urological Association annual conference.
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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.
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PROGRESS ON COMMERCIAL PAYER OPPORTUNITIES
MICROHEMATURIA PATIENTS SKEW YOUNGER WITH COMMERCIAL HEALTH INSURANCE
-
The AUA guideline recommends Triage for intermediate risk microhematuria patients – male patients are 40-59, while female patients are >60. This is expected to drive a shift in payer mix away from Medicare and towards commercial insurance.
-
Future success in reimbursement will be driven by our ability to establish medical policy and contracting with commercial payers
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Recent progress against this opportunity leveraging STRATA and Guidelines:
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Established pricing with the BCBS GPO[1]
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Individually contracted with BCBS Texas, BCBS Illinois and Wellmark
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Gained a “favorable” 4/5 recommendation from ECRI[2] – a data curator to which many commercial payers subscribe
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Acknowledgement from Avalon Healthcare Solutions that Triage should be covered when used according to guidelines
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Secured ‘in-network’ status with Optum Veterans’ Affairs Community Care Network
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Commercial payers increased 5% since pre-May 25 to ~37% of the payer mix (excluding Kaiser Permanente) in June 25. Commercial claims success appears to be increasing
-
Expanding access to Triage Plus when reimbursement is reliable:
-
Multiple VA sites have been targeted to participate in our Early Access Program for Triage Plus at draft Medicare pricing (US$1,018)
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- BCBS GPO is Blue Cross Blue Shield Group Purchasing Organization 2. ECRI is the Emergency Care Research Institute https://home.ecri.org/
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SALES PERFORMANCE IMPROVEMENTS EMBEDDED IN FY 25 WE SEE UNEXPLOITED OPPORTUNITIES TO LEVERAGE THE AUA GUIDELINE
US SALES FORCE EFFICIENCY
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Sales force efficiency (total tests/average FTE) and clinical commitment (tests/ordering clinician) fall in Q1 26 reflecting the disruptions of transition to Triage from Detect
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Sales force efficiency at 381 is well ahead of the low point of 160 in Q3 22
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Sales FTE down to an average of 15.0 in Q1 26 from 16.0 in Q4 25 and >30 in Q1 24 before restructure to focus on cash conservation
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40 403 406
381 379 379 381 400
35
30
30 28
350
25
21
20 288 16 15 15 15 16 15 300
15 265
292
10 250
5
- 200
Q1 24 Q2 24 Q3 24 Q4 24 Q1 25 Q2 25 Q3 25 Q4 25 Q1 26
US AVERAGE SALES FTE (LHS) US TEST VOLUME/SALES FTE (RHS)
AVERAGE SALES FTE TEST VOLUME/SALES FTE
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US CLINICAL COMMITMENT
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1,600 7.0 6.7 6.8 6.7 7.1 8.0
6.4 6.4 6.3 7.0
1,400 1,232 5.9
1,147 6.0
1,200 1,016
1,000 915 867 890 866 914 907 5.0
4.0
800
600 3.0
400 2.0
200 1.0
- -
Q1 24 Q2 24 Q3 24 Q4 24 Q1 25 Q2 25 Q3 25 Q4 25 Q1 26
US ORDERING CLINICIANS (LHS) TESTS/ORDERING CLINICIAN (RHS)
TESTS/CLINICIAN
US ORDERING CLINICIANS
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FOUNDATIONS FOR GROWTH – US CASH COLLECTIONS IMPROVE
REIMBURSEMENT & CASH COLLECTIONS – A CORE COMPETENCY
-
Despite the dip in 2H 25 Average Sales Price (ASP[1] ) due to timing variances related to accruals and increased provisions against revenue, ASP per test has increased to US$594 in FY 25 from US$584 in FY 24 lifted by:
-
Enhanced Patient Responsibility - patients with noncontracted private insurance (i.e. non-Kaiser) pay a fixed dollar amount “maximum out of pocket”
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Increased utilization of appropriate patient types from Kaiser Permanente after EMR integration
-
Medicare reimbursement of Triage since Jan 2023
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Improved medical necessity documentation to improve billing and appeals processes for Medicare Advantage
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Improved cash collections are typically permanent improvements that we expect to maintain as we scale
AUA GUIDELINE OFFERS NEW OPPORTUNITIES FOR CLIENT BILLING
-
With AUA guideline inclusion, a new opportunity exists to get paid per test by hospitals and large urology group practices (LUGPAs) and let them handle the commercial reimbursement
-
This provides a revenue incentive to hospitals/LUGPAs and has the potential to drive volume, since they are commonly "in-network" with commercial payers and have sophisticated billing teams
US COMMERCIAL TEST VOLUMES AND ASP* (US$)
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17,000 $700
$613 $618
15,000
$562 $571 $600
13,000 $493 $519 13,550
$472 $470 12,450 $500
11,000
10,622
9,000 9,956 9,913 10,177 $400
8,276
7,000 7,476 $300
5,000
$200
3,000
$100
1,000
-1,000 1H 22 2H 22 1H 23 2H 23 1H 24 2H 24 1H 25 2H 25 $-
US ASP (RHS)
TEEST VOLUME
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- ASP: US Operating Revenue in USD / US Commercial Test Volumes
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MEDICARE PRICE FOR TRIAGE PLUS ACCELERATES PATH TO PROFITABILITY DRAFT PRICE FOR TRIAGE PLUS OF US$1,018 PER TEST PUBLISHED
MEDICARE COVERAGE NEEDED BEFORE FULL-SCALE COMMERCIAL LAUNCH
-
The Centers for Medicare & Medicaid Services (CMS) set draft price for Triage Plus of US$1,018 via its ‘Gapfill’ process in April 2025; due to become effective Jan 2026
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We regard this as a ‘floor’ for the Triage Plus price that materially lifts margin per test from the previous pricing at US$760
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This improves the unit economics of operating an Account Executive, facilitating more rapid scaling and a faster path to profitability
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We are seeking a higher price:
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We have provided additional information to MolDX to reconsider the draft US$1,018 ‘Gapfill’ price they recommended to CMS
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If they are amenable to our arguments, a new final Gapfill price will be published in September and recommended to CMS
-
If they are not amenable to our arguments, the $1,018 will be published in September and recommended to CMS
-
-
We lodged a reconsideration request with CMS with a new Crosswalk approach seeking a price of US$1,390
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-
Recommendation from the Advisory Panel to CMS is expected in September
-
A final decision from CMS would be due in November 2025
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- For a description of the ‘Gapfill’ and ‘Crosswalk’ processes please refer to the CMS description at the following link (HERE)
DRIVING GROWTH IN ASIA PACIFIC AND CONSOLIDATING NEW ZEALAND
SEEKING A NATIONAL HEMATURIA EVALUATION PATHWAY IN NZ
-
Quarterly total test volumes benefit from:
-
Fewer evaluations and non-billable tests
-
Shift in emphasis to commercial tests from evaluations
-
STRATA[1] and AUA microhematuria guideline are well understood in Te Whatu Ora /Health New Zealand; Pacific Edge is focused on a national pathway for hematuria evaluation
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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 highvolume market for an IVD-kitted product
APAC TOTAL TEST VOLUME[2]
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1,800
1,600
1,400
1,360
1,200 1,278 1,284
1,199 1,183
1,000 1,079 1,142 1,111 1,087
800
600
400
200
-
Q1 24 Q2 24 Q3 24 Q4 24 Q1 25 Q2 25 Q3 25 Q4 25 Q1 26
TEST VOLUME
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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.
-
Total Laboratory Throughput in Asia and Pacific including commercial, pre-commercial and clinical studies testing
21
CUSTOMER EXPERIENCE INTIATIVES DELIVERING VALUE DIGITALIZATION OF INFORMATION FLOWS EMBEDS CXBLADDER IN CLINICAL PRACTICE
ENHANCING CXBLADDER’S EASE OF USE
-
We give customers options to connect with Pacific Edge to fit their needs with easy-to-use digital integrations
-
Digital channels for test ordering and results delivery
-
1-to-1 EMR Integration , e.g. Kaiser interface
-
1-to-many Integration , e.g. Lumea Digital Pathology, Awanui
-
Customer portal – available to any Customer Account
-
Improves the end-to-end experience for physicians
-
Easier ordering in-clinic or for in-home sampling systems
-
Optimized test kit management and workflow
-
Enhanced order visibility and tracking
-
Streamlined access to results
-
Pacific Edge’s operations benefit
-
Fewer errors, faster handling and results delivery
THE PACIFIC EDGE CUSTOMER PORTAL
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- Reduced demand on the sales force and customer service
22
LAUNCHING IMPROVED PRODUCTS AND IVD FOR INTERNATIONAL MARKETS AN IVD PRODUCT MAY EXTEND THE MARKET OPPORTUNITY AND THE ‘MOAT’ AROUND CXBLADDER
READYING FOR THE LAUNCH OF TRIAGE PLUS
-
Product development investments in digital systems to ensure scalable lab operations for Triage Plus
-
Simplifying Cxbladder:
-
Aim to reduce technician time, lower cost of goods, lower turnaround time, increase throughput and increase automation of our lab testing services
-
Aim to automate lab operations from end-to-end lab for RNA and DNA workflows of our lab testing services
-
Continued engagement with industry and academic research and development collaborations to address unmet clinical needs in bladder cancer diagnosis and management
ADVANCING IVD DEVELOPMENT FOR INTERNATIONAL MARKETS
-
Accelerating the development of a kitted IVD (in vitro diagnostic) product from our existing lab service called Triage Plus IVD, for decentralized lab deployment and international market expansion
-
Establish IVD regulatory framework for our next generation tests that includes IVD-R (Europe), FDA (USA) and ISO-13485[1] (Rest of World)
Chief Scientific Officer Parry Guilford (center) and Chief Technology Officer Justin Harvey (right)
-
Targeting prototypes by the end of CY 25; manufacture and commencement of clinical and analytical validation commencing in CY 26
-
Achieving IVD-approved status may make it more difficult for competitors to develop parity with Cxbladder’s level of evidence
-
IVD-R European In Vitro Diagnostic Regulation; FDA, US Food and Drug Administration; ISO International Organization for Standardization
23
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OUTLOOK
RECENT CATALYSTS FOR STRONG GROWTH – VOLUME AND PRICING
-
AUA microhematuria guideline enables sales, marketing and reimbursement activities. We are determined to maximize this milestone through existing and new initiatives
-
Triage Plus draft pricing at US$1,018 supports stronger unit economics, margins and sales force efficiency for a faster path to cash flow breakeven if successful in re-establishing Medicare coverage
GROWTH STRATEGY – TO BE ACCELERATED WITH NEW CAPITAL
-
Entrench first-mover advantage and “moat” for Triage given AUA guideline inclusion
-
Continue clinical evidence generation in an AV, CV and CU framework for coverage, guidelines and medical policy for Triage Plus and Monitor Plus
-
Increase Triage throughput, throughput/sales headcount and throughput/clinician
-
Seek reimbursement through the Medicare Appeals process, relying on the AUA guideline, ahead of the resolution of multiple reconsideration requests
-
Advance medical policy with commercial payers as the market for Triage on microhematuria patients shifts the payer mix towards commercial payers
-
Increase the percentage of electronically ordered tests and patients with commercial insurance
-
Emphasize the clinical and economic value of Cxbladder as a value-based care solution in our sales messaging for selling to institution, integrated hospital systems and payers
-
Invest in innovation and product development for IVD kits to support entry into international markets in a de-centralized deployment model
FURTHER CATALYSTS
- Cxbladder is under consideration by Te Whatu Ora for a National Pathway in New Zealand
24
25
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RESOLUTIONS
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VOTING INSTRUCTIONS
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RESOLUTION 1: AUDITORS’ REMUNERATION
RESOLUTION
“To authorise the Directors to fix the auditors’ remuneration for the ensuing year.”
27
RESOLUTION 2: RE-ELECTION OF CHRIS GALLAHER
RESOLUTION
“That Chris Gallaher, who retires by rotation and is eligible for re-election, be re-elected as a Director of the Company.”
28
RESOLUTION 3: RE-ELECTION OF SARAH PARK
RESOLUTION
“That Sarah Park, who retires by rotation and is eligible for re-election, be re-elected as a Director of the Company.”
29
RESOLUTION 4: RE-ELECTION OF TONY BARCLAY
RESOLUTION
“That Tony Barclay, who retires by rotation and is eligible for re-election, be re-elected as a Director of the Company.”
30
RESOLUTION 5: SHARE PLACEMENT
RESOLUTION
“That the issue of 160,728,498 new Shares to Placement Participants at an issue price of $0.10 cents per new Share under the Placement, with such new Shares to rank equally on issue with all existing Shares, be approved for all purposes, including NZX Listing Rules 4.2.1 and 5.2.1.”
31
RESOLUTION 6: DIRECTORS’ REMUNERATION POOL
RESOLUTION
“That the total annual non-executive Directors’ remuneration pool be increased to $628,000 per annum, effective from 1 April 2025 and applied retrospectively.”
32
RESOLUTION 7: ISSUE OF SHARES TO DIRECTORS
RESOLUTION
“That the issue of up to 1,930,000 new Shares to non-executive Directors in lieu of the payment of additional Director remuneration in cash in respect of the period from 1 April 2025 to 31 March 2026 as described in the Explanatory Notes, with such new Shares to rank equally on issue with all existing Shares, be approved for all purposes, including NZX Listing Rule 4.2.1.”
33
PROXY VOTING DIRECTIONS
| RESOLUTION | FOR | OPEN | AGAINST | TOTAL |
|---|---|---|---|---|
| 1. Auditors’ remuneration | 366,678,481 (97.69%) | 8,409,599 (2.24%) | 275,480 (0.07%) | 375,363,560 |
| 2. Re-election of Chris Gallaher | 364,555,420 (97.11%) | 8,435,768 (2.25%) | 2,430,616 (0.65%) | 375,421,804 |
| 3. Re-election of Sarah Park | 366,296,037 (97.63%) |
8,435,768 (2.25%) | 453,733 (0.12%) | 375,185,538 |
| 4. Re-election of Tony Barclay | 366,304,764 (97.63%) |
8,435,768 (2.25%) | 444,342 (0.12%) | 375,184,874 |
| 5. Share placement | 284,899,303 (96.95%) |
8,303,335 (2.83%) | 660,551 (0.22%) | 293,863,189 |
| 6. Directors’ remuneration pool | 301,467,193 (87.45%) |
10,857,929 (3.15%) | 32,393,706 (9.40%) | 344,718,828 |
| 7. Issue of shares to Directors | 303,330,677 (87.92%) | 10,751,040 (3.12%) | 30,924,946 (8.96%) | 345,006,663 |
| *Percentage figures indicate proportion of total votes notified (excludes abstentions) |
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GENERAL BUSINESS
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MEETING CLOSE
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APPENDIX
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CAPITAL RAISING RISKS
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KEY RISKS
Medicare coverage uncertainty
Pacific Edge does not currently have Medicare coverage for its Cxbladder products. Medicare previously accounted for the majority of its US test volumes and, therefore, a significant percentage of Pacific Edge's revenue. Although Pacific Edge is confident that it will regain coverage for Triage as a result of recent AUA guideline inclusion and new clinical evidence, there are no guarantees as to the timing or outcome of the re-coverage process. Regaining Medicare coverage could be delayed or not achieved at all. If Medicare re-coverage was not achieved or was significantly delayed, it would have a material adverse impact on Pacific Edge's financial performance and growth and could result in the company using up all available cash before it is able to become profitable from its ongoing operations.
If the current reconsideration request is unsuccessful, Pacific Edge will likely need to complete further clinical studies to provide new published evidence when submitting another reconsideration request. That clinical study will take a number of years to undertake. Accordingly, if the current reconsideration request is unsuccessful, Pacific Edge will need to undertake a significant restructure of its business to substantially reduce costs and, potentially, seek to raise further capital.
Ongoing Financial Viability
Pacific Edge is operating at a 'cash burn', which means that the company spends more cash that it generates. The capital raise is in part to provide sufficient cash to regain Medicare coverage. If Medicare coverage is not achieved or significantly delayed, or the business is impacted adversely by other events, there is a risk to the ongoing financial viability of Pacific Edge, which may result in investors losing some or all of their investment.
Pacific Edge’s Cxbladder products and laboratories are regulated and certified by various government and industry entities in territories and markets in which the tests are performed and/or sold. Reimbursement for these tests may be influenced by reimbursement rulings from private and/or government payers. Guidelines issued by various industry bodies also Regulatory, industry influence the treatment and management regimes for patients, with the potential to impact on the uptake and use of Cxbladder. If Pacific Edge is unable to retain or, in certain markets, body and guideline gain inclusion in guidelines, or the current regulatory approvals and reimbursement obtained for existing products are removed or reduced, such matters could have an adverse impact on risks Pacific Edge’s financial performance and its ability to achieve its business plans. If Pacific Edge is unable to obtain the approvals required for new products in new territories, or is unable to obtain future reimbursement for new products, this could also have an adverse impact on Pacific Edge’s financial performance and its ability to achieve its business plans.
Competition
The global cancer diagnostics industry is highly competitive, with research undertaken by a large number of commercial and not for profit institutions globally on new diagnostic tools. There are also a large number of well capitalised diagnostics competitors operating in the industry. There is a risk that Pacific Edge’s competitors may discover, develop or commercialise products more successfully than Pacific Edge, which could render Pacific Edge’s products obsolete or otherwise uncompetitive, resulting in adverse effects on Pacific Edge’s revenue, margins and profitability.
Product and technology risk
Pacific Edge relies on the performance and reliability of its Cxbladder suite of products, laboratory operations and IT and technical systems. While the performance of Cxbladder has been demonstrated in various scientific journal publications, any change to the reliability, repeatability, reproducibility or accuracy of Cxbladder products and technology systems has the potential to impact Pacific Edge’s business and reputation. Cyber attacks on Pacific Edge digital systems and platforms also have the potential to impact the delivery of test results. Financial, reputational and litigation consequences relating to underperformance and unreliability, or the inability to deliver, test results (including due to adverse cyber incidents) have the potential to be significant and could be materially adverse to the company's financial performance and position.
Pacific Edge’s operating and financial performance is influenced by a variety of general economic and business conditions in New Zealand, the United States, Southeast Asia and globally. A prolonged deterioration in general economic conditions, which may lead to a decrease or reprioritisation of healthcare spending, has the potential to have a material adverse effect on Pacific Edge’s business or financial condition (or both).
General economic conditions
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KEY RISKS (CONT)
| Litigation | In the ordinary course of conducting its business, Pacific Edge is exposed to potential litigation and other proceedings, including through claims of intellectual property infringement or breach of agreements. If such proceedings are brought against Pacific Edge, Pacific Edge could incur considerable defence costs (even if successful), with the potential for damages and costs awards against Pacific Edge if it were unsuccessful, which could have a significant adverse financial impact on Pacific Edge. Circumstances may also arise in which Pacific Edge considers that it is reasonable or necessary to initiate litigation or other proceedings, including for example to protect its intellectual property rights. |
|---|---|
| Key Person Risk | The success of our business depends significantly on the continued contributions of our executive team, scientific leaders, and key technical staff. The unexpected departure of any of these individuals could disrupt operations, delay research and development efforts, and negatively impact strategic initiatives. Attracting and retaining top talent in a competitive biotech labor market remains a critical challenge. |
| Market volatility of Pacific Edge’s shares |
Pacific Edge’s shares are currently listed on NZX and the ASX, and are subject to the usual market-related forces which impact on Pacific Edge’s share price. There can be no assurance that trading in the shares following the allotment of shares under the capital raising will not result in the share price trading at levels below the price paid by investors. The equity markets can be subject to pronounced volatility. This volatility could have a materially adverse impact on the market price of Pacific Edge shares. Factors such as the risk factors disclosed in this presentation as well as other factors could cause the market price of Pacific Edge’s shares to decline or to materially fluctuate. It also is possible that new market risks may develop as a result of the New Zealand or Australian markets experiencing extreme stress, or due to existing risks manifesting themselves in ways that are not currently foreseeable. A weakening in the New Zealand or Australian dollar as against other currencies will cause the value of the shares to decline in any portfolio which is denominated in a currency other than New Zealand dollars. |
| New product development |
Pacific Edge continues to leverage its suite of patents and intellectual property to explore new products and applications. There is a risk that those development efforts may not be successful or may take longer and be more expensive than anticipated, and as a result Pacific Edge’s investment will be delayed or lost. This risk could arise due to a number of factors, including delays in commencement or completion of scientific studies. Any failure or significant delay in the development of one or more of Pacific Edge’s new products and product extensions may have a material negative impact on Pacific Edge’s financial performance and growth. |
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PACIFIC EDGE – BACKGROUND INFORMATION
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PACIFIC EDGE’S GLOBAL REACH
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42
PACIFIC EDGE OVERVIEW
CXBLADDER OFFERS A SIGNIFICANT ADDRESSABLE GLOBAL MARKET ANNUALLY
THE PATIENT CARE PATHWAY
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US$8.5b
Global TAM [1]
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~7m ~3.5m ~1.1m ~90k ~750k
340m US$4.4b
Present with Referred for Receive Annual cases of Living with bladder cancer
Population TAM
hematuria clinical workup cystoscopy bladder cancer ~1.5 Cxb Monitor / year
~17m ~50% ~3.3m ~58k ~300k
830m US$2.1b
APAC Present with Referred for Receive Annual cases of Living with bladder cancer
Population TAM
hematuria clinical workup cystoscopy bladder cancer ~1.5 Cxb Monitor / year
~12m ~50% >4.0m ~180k ~1m
600m US$2.0b
Present with Referred for Receive Annual cases of Living with bladder cancer
Population TAM
hematuria clinical workup cystoscopy bladder cancer ~1.5 Cxb Monitor / year
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Focus of our growth efforts NZ market mature. Australia and SE Asia in business development
New market accessed via IVD / kitted tests
- Pacific Edge estimate using US$1,018 price for hematuria testing in the US and $760 for Non-Muscle Invasive Bladder Cancer (NIMBC) surveillance and other market assumptions for APAC and Europe. See slide 44 of this presentation for the sources and assumptions for the calculation of TAM
SOURCES AND ASSUMPTIONS - TOTAL ADRESSABLE MARKET
| REGION | STATISTIC | STATISTIC | SOURCE |
|---|---|---|---|
| US | Population | 341,762,685 | https://www.census.gov/popclock/ |
| Incidence of hematuria | 7,000,000 | Presentation from DrSiaDaneshmand (DirectorofUrologic Oncology andClinical Research, USC) July2019 | |
| Referred for clinical workup | 3,500,000 | Presentation from Dr Sia Daneshmand(Director of Urologic Oncologyand Clinical Research,USC)July2019 | |
| Receive a cystoscopy | >1,000,000 | Kenigsberg,A,et al. The Economics of Cystoscopy: A Microcost Analysis,Urology157: 29−34,2021 | |
| Annualcases ofbladdercancer | 84,870 | National Cancer Institute | |
| Patientslivingwithbladdercancer | 744,044 | National Cancer Institute | |
| Test opportunities | 4,616,066 | Pacific Edge estimate | |
| Price of Cxbladder(US$) | US$1,018(Triage Plus),US$760(Monitor) | ||
| TAM(US$b) | US$4.4 | ||
| Europe (excluding Russia) |
Population | 600,000,000 | World-population - Europe;World-population – Russia |
| Incidence of hematuria | 12,000,000 | Science Direct | |
| Referredforclinical workup | 6,000,000 | Presentation from DrSiaDaneshmand (DirectorofUrologic Oncology andClinical Research, USC) July2019 | |
| Receive a cystoscopy | 4,000,000 | Rindorf, D, et al. The extent of experiencing availability issues and deteriorating performance associated with reusable cystoscopies, amulticentre study. |
|
| Annualcases ofbladdercancer | 180,000 | Uroweb | |
| Patientslivingwithbladdercancer | 900,000 | PacificEdge estimate-5 years ofannualcases | |
| Testopportunities | 7,350,000 | PacificEdge estimate | |
| Price of Cxbladder EURO | € 245 | PacificEdge estimate | |
| TAM(US$b) | US$2.0 | ||
| APAC (excluding India and China) |
Population | 830,000,000 | World population-Southeast Asia; Population Pyramid-Japan; |
| Incidence of hematuria | 16,600,000 | Science Direct | |
| Referredforclinical workup | 8,300,000 | Presentation from DrSiaDaneshmand (DirectorofUrologic Oncology andClinical Research, USC)July2019 | |
Receive a cystoscopy |
3,320,000 | Pacific Edge estimate | |
Annualcases ofbladdercancer |
58,000 | WHO; Hong Kong | |
| Patientslivingwithbladdercancer | 290,000 | PacificEdge estimate-5 years ofannualcases | |
| Testopportunities | 3,755,000 | PacificEdge estimate | |
| Price of Cxbladder(US$) | 550 | PacificEdge estimate | |
| TAM(US$b) | US$2.1 |
44
HEMATURIA EVALUATION FIVE YEAR CLINICAL STUDIES ROADMAP
| Calendar year |
Pre 2023 |
Pre 2023 |
2023 | 2023 | 2023 | 2023 | 2023 | 2023 | 2024 | 2024 | 2024 | 2024 | 2025 | 2025 | 2025 | 2025 | 2026 | 2026 | 2026 | 2026 | 2027 | 2027 | 2027 | 2027 | 2028 | 2028 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Q1 | Q2 | Q3 | Q4 | Q1 | Q2 | Q3 | Q4 | Q1 | Q2 | Q3 | Q4 | Q1 | Q2 | Q3 | Q4 | Q1 | Q2 | Q3 | Q4 | Q1 | Q2 | |||||
| STRATA | * | DBL | ||||||||||||||||||||||||
| DRIVE | * | DBL | ||||||||||||||||||||||||
| AUSSIE | ||||||||||||||||||||||||||
| microDRIVE | * | |||||||||||||||||||||||||
| Pooled CV | ||||||||||||||||||||||||||
| CREDIBLE | ||||||||||||||||||||||||||
Legend:
Pre-activation (docs, CTA etc) Publication Submitted * SIV Records review / follow-up Enrollment DBL Database lock
Data Cleaning
45
SURVEILLANCE FIVE YEAR CLINICAL STUDIES ROADMAP
| Calendar year |
Pre 2023 |
2023 | 2023 | 2023 | 2023 | 2023 | 2024 | 2024 | 2024 | 2024 | 2025 | 2025 | 2025 | 2025 | 2026 | 2026 | 2026 | 2026 | 2027 | 2027 | 2027 | 2027 | 2028 | 2028 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Q1 | Q2 | Q3 | Q4 | Q1 | Q2 | Q3 | Q4 | Q1 | Q2 | Q3 | Q4 | Q1 | Q2 | Q3 | Q4 | Q1 | Q2 | Q3 | Q4 | Q1 | Q2 | |||
| “The 1800” | ||||||||||||||||||||||||
| LOBSTER | * | |||||||||||||||||||||||
| OCTOPUS | ||||||||||||||||||||||||
| Publication Submitted Records review / follow-up Database lock Legend: Pre-activation (docs, CTA etc) SIV Enrollment Data Cleaning * DBL |
46
SUMMARY OF CXBLADDER CLINICAL EVIDENCE
| Publication or Study | Specificity (Sp) NPV Sensitivity (Sn) Population |
Specificity (Sp) NPV Sensitivity (Sn) Population |
Specificity (Sp) NPV Sensitivity (Sn) Population |
Specificity (Sp) NPV Sensitivity (Sn) Population |
Comment | ||
|---|---|---|---|---|---|---|---|
| Triage Plus | AV | Harvey et al., (2025) | Synthetic Analytes MH + GH |
93.6% | 99.4% | 90.8% | Development dataset (n=987) including MH (38.7%) & GH (61.3%) producing defined Sn, NPV and Sp. TNR in development data set is 84.1% |
| CV | DRIVE(Savage et al., submitted) | MH + GH | 94% | 99.3% | 77% | Publication submitted; TNR 71%.; PPV 26% at lower cut-point, 51% at higher cut-point with a Spof 97% | |
| AUSSIE | MH + GH | TBC | TBC | TBC | Studyinprogress on MH and GHpatients | ||
| microDRIVE | MH | TBC | TBC | TBC | Studyinprogress on MHpatients | ||
| CU | CREDIBLE | MH | TBC | TBC | TBC | Studyinprogress on MHpatients | |
| Triage | AV | Harveyet al.,2024 | Synthetic Analytes | N/A | N/A | N/A | Multi-product analytical validation of Cxbladder Triage,Detect and Monitor |
| CV | Kavalieris et al., 2015 | MH + GH | 95% | 98.5% | 45% | Sn, Sp, NPV values when TNR is 40% | |
| Davidson et al., 2019 | MH + GH | 95.5% | 98.6% | 34.3% | GH only: Sn (95.1%), NPV (98%), Sp (32.8%); MH only: Sn (100%), NPV (100%), Sp (42.6%); Cxb Triage & imagingcombinedperformance had a Sn of 97.7% & NPV of 99.8% |
||
| Lotan et al., 2023 | MH + GH | 89% | 99% | 63% | Pooled data from US and Singapore cohorts(n=804); TNR 59%; PPV 16% | ||
| DRIVE(Savage et al., submitted) | MH + GH | 93% | 98.5% | 38% | Publication submitted and underpeer review; TNR 35%; PPV 11% | ||
| CU | Davidson et al., 2020 | MH + GH | 89.4% | 98.9% | 59% | 39% of patients testing negative for Cxb Triage & imaging did not get cystoscopy & were managed at primary care; Studywide CV: Cxb Triage & imagingcombinedperformance: Sn 98.1%,NPV 99.9%,Sp98.4% |
|
| Lotan et al., 2024 | MH + GH | 90% | 99% | 56% | Clinicians using Triage used 59% fewer cystoscopies on low-risk patients presenting with MH; CV was provided studywide(UC, n=22): Sn 90%, Sp56%, PPV 17%, NPV 99% |
||
| Monitor | AV | Harveyet al., 2024 | Synthetic Analytes | N/A | N/A | N/A | Multi-product analytical validation of all Cxbladderproducts |
| CV | Kavalieris et al., 2017 | NMIBC | 93% | 97% | N/A | Internally validated “bootstrap corrected estimates” from development dataset (n=1036), TNR 34%; Sn of CxbM was 97%(N = 70/72)for HG tumors and 85%(N = 66/78)for LG tumors. |
|
| LOBSTER | NMIBC | TBC | TBC | TBC | Study in progress on NMIBC patients | ||
| CU | Koya et al., 2020 | NMIBC | 100 | 100 | 77.8 | Integration of Cxb Monitor into the surveillance schedule reduced annual cystoscopies (39%) | |
| Li et al., 2023 | NMIBC | 100 | 100 | 72 | Cxbladder Monitor safely postpones a patient’s next scheduled cystoscopy, the current ‘gold standard’ for bladder cancer surveillance |
||
| Guduguntla et al., 2025 | NMIBC | N/A | N/A | N/A | Australian single-center study in NMIBC patients showed that alternating Cxbladder Monitor with cystoscopy safelyreduced cystoscopyuse without increasingrecurrence risk |
NOTE #1: Full references provided on following slide
NOTE #2: Development, feasibility and/or proof of concept studies are detailed within the references on the following slide Abbreviations - MH: Microhematuria, GH: Gross Hematuria, Sn: Sensitivity, Sp: Specificity, NPV: Negative Predictive Value, PPV: Positive Predictive Value, TNR: Test Negative Rate
47
REFERENCES SUMMARY OF CLINICAL EVIDENCE
| Comment References Feasibility of urine-based assay including biomarker discovery for urothelial cancer detection initial algorithm development Holyoake et al., (2008). Development of a Multiplex RNA Urine Test for the Detection and Stratification of Transitional Cell Carcinoma of the Bladder. Clin Cancer Res 14(3): 742-749 Development/feasibility of Cxbladder Detect assay and algorithm based on RNA expression biomarkers 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. Pooled data from MH and GH cohorts (n=804) for ‘multi-modal’ (RNA+DNA) assay and algorithm development for next generation Cxbladder product including TERT and FGFR3 SNPs. Called Detect+ in publication. Lotan et al., (2023). Urinary Analysis of FGFR3 and TERT Gene Mutations Enhances Performance of Cxbladder Tests and Improves Patient Risk Stratification. The Journal of Urology, 10-1097. Budget impact model for hematuria pathway, incorporating Cxbladder Detect into patient management 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 Analytical validation of 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. Clinical validation of Triage Plus (DRIVE Study) Savage et al., submitted. Diagnostic Performance of Cxbladder® Triage Plus for the Identification and Stratification of Patients at Risk for Urothelial Carcinoma: The Multicenter, Prospective, Observational DRIVE Study. Algorithm development and clinical validation of Cxbladder 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. Analytical validation of all Cxbladder products Triage, Detect and 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. Clinical validation of Cxbladder Triage Davidson et al., (2019). Inclusion of a molecular marker of bladder cancer in a clinical pathway for investigation of haematuria may reduce the need for cystoscopy. NZ Med J, 132(1497), 55-64. Clinical utility 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 validation of Cxbladder Triage from pooled data (USPrimary and Singapore pooled analysis; n=804) Lotan et al., (2023). Urinary Analysis of FGFR3 and TERT Gene Mutations Enhances Performance of Cxbladder Tests and Improves Patient Risk Stratification. The Journal of Urology, 10-1097. Clinical utility of Cxbladder Triage from STRATA study showing a 59% relative reduction in cystoscopy when comparing test and control arms Lotan et al., (2024). A 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. Analytical validation of all Cxbladder products Triage, Detect and 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. Algorithm development and clinical validation of Cxbladder 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. Clinical utility of Cxbladder Monitor with low risk NMIBC patients 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 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. Budgetary impact model when Cxbladder Monitor was incorporated into patient management Tyson et al., accepted. Economic Impact Model of Incorporating Cxbladder Monitor in the Surveillance of Non-Muscle Invasive Bladder Cancer. JU Open Plus, accepted |
Comment References Feasibility of urine-based assay including biomarker discovery for urothelial cancer detection initial algorithm development Holyoake et al., (2008). Development of a Multiplex RNA Urine Test for the Detection and Stratification of Transitional Cell Carcinoma of the Bladder. Clin Cancer Res 14(3): 742-749 Development/feasibility of Cxbladder Detect assay and algorithm based on RNA expression biomarkers 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. Pooled data from MH and GH cohorts (n=804) for ‘multi-modal’ (RNA+DNA) assay and algorithm development for next generation Cxbladder product including TERT and FGFR3 SNPs. Called Detect+ in publication. Lotan et al., (2023). Urinary Analysis of FGFR3 and TERT Gene Mutations Enhances Performance of Cxbladder Tests and Improves Patient Risk Stratification. The Journal of Urology, 10-1097. Budget impact model for hematuria pathway, incorporating Cxbladder Detect into patient management 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 Analytical validation of 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. Clinical validation of Triage Plus (DRIVE Study) Savage et al., submitted. Diagnostic Performance of Cxbladder® Triage Plus for the Identification and Stratification of Patients at Risk for Urothelial Carcinoma: The Multicenter, Prospective, Observational DRIVE Study. Algorithm development and clinical validation of Cxbladder 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. Analytical validation of all Cxbladder products Triage, Detect and 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. Clinical validation of Cxbladder Triage Davidson et al., (2019). Inclusion of a molecular marker of bladder cancer in a clinical pathway for investigation of haematuria may reduce the need for cystoscopy. NZ Med J, 132(1497), 55-64. Clinical utility 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 validation of Cxbladder Triage from pooled data (USPrimary and Singapore pooled analysis; n=804) Lotan et al., (2023). Urinary Analysis of FGFR3 and TERT Gene Mutations Enhances Performance of Cxbladder Tests and Improves Patient Risk Stratification. The Journal of Urology, 10-1097. Clinical utility of Cxbladder Triage from STRATA study showing a 59% relative reduction in cystoscopy when comparing test and control arms Lotan et al., (2024). A 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. Analytical validation of all Cxbladder products Triage, Detect and 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. Algorithm development and clinical validation of Cxbladder 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. Clinical utility of Cxbladder Monitor with low risk NMIBC patients 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 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. Budgetary impact model when Cxbladder Monitor was incorporated into patient management Tyson et al., accepted. Economic Impact Model of Incorporating Cxbladder Monitor in the Surveillance of Non-Muscle Invasive Bladder Cancer. JU Open Plus, accepted |
Comment References Feasibility of urine-based assay including biomarker discovery for urothelial cancer detection initial algorithm development Holyoake et al., (2008). Development of a Multiplex RNA Urine Test for the Detection and Stratification of Transitional Cell Carcinoma of the Bladder. Clin Cancer Res 14(3): 742-749 Development/feasibility of Cxbladder Detect assay and algorithm based on RNA expression biomarkers 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. Pooled data from MH and GH cohorts (n=804) for ‘multi-modal’ (RNA+DNA) assay and algorithm development for next generation Cxbladder product including TERT and FGFR3 SNPs. Called Detect+ in publication. Lotan et al., (2023). Urinary Analysis of FGFR3 and TERT Gene Mutations Enhances Performance of Cxbladder Tests and Improves Patient Risk Stratification. The Journal of Urology, 10-1097. Budget impact model for hematuria pathway, incorporating Cxbladder Detect into patient management 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 Analytical validation of 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. Clinical validation of Triage Plus (DRIVE Study) Savage et al., submitted. Diagnostic Performance of Cxbladder® Triage Plus for the Identification and Stratification of Patients at Risk for Urothelial Carcinoma: The Multicenter, Prospective, Observational DRIVE Study. Algorithm development and clinical validation of Cxbladder 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. Analytical validation of all Cxbladder products Triage, Detect and 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. Clinical validation of Cxbladder Triage Davidson et al., (2019). Inclusion of a molecular marker of bladder cancer in a clinical pathway for investigation of haematuria may reduce the need for cystoscopy. NZ Med J, 132(1497), 55-64. Clinical utility 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 validation of Cxbladder Triage from pooled data (USPrimary and Singapore pooled analysis; n=804) Lotan et al., (2023). Urinary Analysis of FGFR3 and TERT Gene Mutations Enhances Performance of Cxbladder Tests and Improves Patient Risk Stratification. The Journal of Urology, 10-1097. Clinical utility of Cxbladder Triage from STRATA study showing a 59% relative reduction in cystoscopy when comparing test and control arms Lotan et al., (2024). A 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. Analytical validation of all Cxbladder products Triage, Detect and 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. Algorithm development and clinical validation of Cxbladder 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. Clinical utility of Cxbladder Monitor with low risk NMIBC patients 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 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. Budgetary impact model when Cxbladder Monitor was incorporated into patient management Tyson et al., accepted. Economic Impact Model of Incorporating Cxbladder Monitor in the Surveillance of Non-Muscle Invasive Bladder Cancer. JU Open Plus, accepted |
||
|---|---|---|---|---|
| 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., submitted. 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 | |||
KEY CLINICAL ADVISORS AND CONSULTANTS
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
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
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
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
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
==> picture [43 x 45] intentionally omitted <==
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
==> picture [55 x 54] intentionally omitted <==
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
49
PACIFIC EDGE – TAKING NEW ZEALAND INNOVATION GLOBAL
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----- Start of picture text -----
Aug 2021
Cxbladder reaches
70% public Feb 2025
healthcare
Triage included
coverage in NZ in AUA Micro-
Nov 2023
hematuria
Kaiser
Oct 2021 Permanente guideline
Dec 2012 Dec 2014 PEB raises
Launch of Pacific Edge Launch of $103.5m EMR Apr 2025
Diagnostics USA and Cxbladder (~US$72.5m) integration Medicare non-
goes live
Cxb Detect Triage coverage
effective
2011 2013 2015 2018 2020 2022 2024
2012 2014 2016 2019 2021 2023 2025
May 2024
2011 Mar 2013 Feb 2018 Dec 2022 STRATA podium
Pacific Edge First commercial Dec 2015 Cxb Triage Jun 2020 Lotan et al: presentation at
Kaiser Permanente, AUA 2024.
Diagnostics sale (Cxb Detect) Launch of adopted into Enhanced
New Zealand for PEDUSA Cxbladder Canterbury approves commercial use of Cxbladder Cxbladder Study published in Journal of
(PEDNZ) Monitor Community Health Tests Deliver
established Pathways with Improved Urology
May 2013 Jul 2020
First commercial primary care Medicare Performance.
referral Journal of
sale (Cxb Detect) reimbursement of
for PEDNZ Cxbladder at Urology
US$760/test
----- End of picture text -----
50
FOR MORE INFORMATION:
Dr. Peter Meintjes Chief Executive Officer email: [email protected]
Grant Gibson
Chief Financial Officer email: [email protected]
Pacific Edge
87 St David Street, PO Box 56, Dunedin, New Zealand P +64 3 577 6733 Within NZ 0800 555 563 email: [email protected] www.pacificedgedx.com
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2025 ANNUAL SHAREHOLDERS’ MEETING
DATE: 6 August 2025 TIME: 3.00pm VENUE:
MUFG Corporate Markets Board Room Level 30, PwC Tower 15 Customs Street West Auckland 1010
SLIDE 6: CHAIR’S ADDRESS
I would now like to reflect on our performance over the past year and the company’s current position.
FY25 was a year in which Pacific Edge achieved some of the most strategically important milestones in its history, with far-reaching implications for both the clinical adoption of our tests and long-term shareholder value creation.
Foremost among them was the inclusion of Cxbladder Triage in the American Urological Association’s microhematuria guideline, with the highest possible ‘Grade A’ evidence rating.
This is not only a major clinical endorsement — it is also a powerful validation of Pacific Edge’s evidence generation capability, which has long been a core pillar of our approach to market development.
The AUA’s decision to assign the ‘Grade A’ evidence rating reflects the depth and rigour of the data we’ve produced, particularly the STRATA randomized controlled trial, which demonstrated compelling real-world utility for Cxbladder.
This milestone serves as a reminder that our commitment to robust scientific validation of our intellectual property is a critical enabler of test adoption, payer recognition, and ultimately sustainable commercial growth.
This milestone also:
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Reinforces Pacific Edge’s position as the leading provider of non-invasive bladder cancer diagnostics;
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Establishes Cxbladder as the clinically preferred urine biomarker test for evaluating hematuria in the US; and
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Strengthens the commercial moat around our business as we scale.
In addition, we received draft pricing from the Centers for Medicare and Medicaid Services for Triage Plus of US$1,018 — up from the US$760 price of our current tests.
This pricing reflects the enhanced performance of the test, the novel benefit for patients that arises from “genomic risk stratification” without the use of clinical risk factors and stands to strengthen the commercial foundation for growth once coverage is secured.
1
Of course, the year also brought a major setback: the loss of Medicare coverage in April 2025. This ended reimbursement that accounted for around 56% of our FY 25 operating revenue.
We were disappointed by this decision — particularly because Novitas did not evaluate the most current clinical evidence, including both the STRATA trial and the newly updated AUA guideline.
I am proud of the way the Pacific Edge team navigated the uncertainty that preceded this decision and the decision itself. We delivered a resilient financial performance, demonstrating the strength of our business model and the commitment of our team:
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Operating revenue was $21.8 million, down 8.6% year-on-year;
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Total laboratory throughput was 28,894 tests, down 11.5%, but stable in the second half;
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Our average US sales price increased to US$594 from US$584 in the prior year supported by improved cash collections;
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Throughput per sales FTE and tests per ordering clinician both rose, reflecting greater focus and productivity in the field.
This resilience continued into the first three months of the new financial year — our first quarter without Medicare coverage since 2020. After taking into account the loss of one salesperson and the disruption caused by the strategic decision to discontinue Cxbladder Detect in the US, volumes were relatively stable.
We believe the ease with which clinicians have accepted the transition to Triage in place of Detect demonstrates the shift in sentiment among the early adopters of our tests and an understanding of the AUA guideline.
In summary in FY25 and into the new financial year we have demonstrated the strengths of our business model and our ability to adapt to changing conditions. And now with the tail wind of the AUA guideline, we see significant opportunities to accelerate test adoption and deepen engagement with clinicians.
SLIDE 7: RAISING NEW CAPITAL TO MAINTAIN COMMERCIAL MOMENTUM
Our success with the guideline has allowed us to look upon the Medicare non-coverage determination that came into effect in April 2025 differently and build on the momentum already established – rather than cutting costs sharply while we pursue re-coverage for our tests.
That’s why we launched a capital raise alongside the announcement of our FY25 results.
We’ve secured $16.1 million via a Placement, and a further $4.7 million through the Share Purchase Plan, which closed at the end of July. Both tranches are subject to shareholder approval today.
This capital will:
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Extend our cash runway to support operations while we seek Medicare re-coverage;
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• Advance the commercialisation of Triage and Triage Plus; and
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Maintain investment in clinical research and evidence development.
Your support for today’s resolutions will give Pacific Edge the financial flexibility and strategic stability needed to deliver on our strategy and assist the return to sustained growth.
Before I close, I want to speak briefly about my continued leadership of the company.
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Last year, I informed the Board of my intention to retire. However, we have faced several challenges in recruiting my successor including:
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the uncertainty over Medicare coverage of our tests and the challenges this has presented to recruiting a new Director to replace me; and
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the commitments of our existing Directors, which have prevented any of them being able to commit to taking over the Chair role.
Considering these challenges and the importance of continuity in leadership, I accepted the Board’s invitation to remain as Chair. I will therefore be standing for re-election later in today’s meeting.
It remains my intention to step down once we have greater clarity on the company’s outlook and we are able to recruit a Director also willing to take on the role of Chair. That said, I continue to lead the company with complete confidence in our science, our people, and our prospects.
Peter will shortly speak to the year ahead and provide detail on our strategy to achieve the broad aims of capital raising.
But before he does, let me finish with a simple thank you.
Your continued support has enabled us to navigate an exceptionally challenging year — and your belief in our mission has kept us focused, motivated, and optimistic for what lies ahead.
And with that I would like to hand you over to Peter.
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