Pacific Edge Launches $20M Capital Raise
29 MAY 2025
PACIFIC EDGE LAUNCHES NZ$20 MILLION CAPITAL RAISE
DUNEDIN, New Zealand – Cancer diagnostics company Pacific Edge (NZX, ASX: PEB) today
announces an offer to raise NZ$20 million. The offer is to consist of a placement of NZ$15
million of new ordinary shares to be offered to selected investors and an offer of NZ$5 million
of new shares to retail investors, by way of a share purchase plan, with an ability to accept
over subscriptions in both the placement and retail offer at Pacific Edge’s sole discretion.
The share issue is priced at NZ$0.10 per share, which is at a premium to the 20-day volume
average weighted price (VWAP) and is expected to be well supported by key existing
institutional shareholders. It is aimed at ensuring Pacific Edge has the cash reserves to
capitalize on its recent clinical and commercial milestones, grow in non-Medicare channels and
regain Medicare coverage of its tests. Medicare coverage of the company’s tests ceased after
the ‘Genetic testing for Oncology; Specific Tests’ (L39365) Local Coverage Determination
became effective on 24 April 2025.
The capital raising comes as the company announces a resilient financial performance for the
year to the end of March 2025 (FY 25). The details of the FY 25 financial results are covered
in a separate announcement to NZX and ASX today.
CASH RESERVES NECESSARY FOR RECOVERAGE AND COMMERCIAL MILESTONES
Pacific Edge’s capital raising is aimed at providing it with the cash reserves to:
Extend cash runway to support operations for over 12 months without Medicare
coverage and reimbursement, or reductions in its cost base, while pursuing re-
coverage
1
Accelerate adoption of Triage in the US with AUA Guidelines as a tailwind for sales,
marketing and reimbursement
Continue clinical evidence generation in an AV, CV and CU framework for
coverage, guidelines and medical policy for Triage Plus and Monitor Plus
Invest in innovation and product development for IVD kits to support entry into
international markets in a decentralized deployment model
Chairman Chris Gallaher said: “Inclusion in the AUA guideline has allowed the company to
view the non-coverage determination differently and we have a strong desire to use those
guidelines to build on the commercial momentum we’ve already established. The robust
evidence emerging from our clinical evidence program is shifting clinical sentiment towards the
broader adoption of our tests in the US and further afield. We are determined not to lose that
momentum, and it is for this reason we have today launched a NZ$20 million offer of new
shares.
“The new capital will support the company and its operations for over 12 months, giving Pacific
Edge the ability to grow testing volume as we work to regain coverage through planned
1
Assuming at least NZ$20 million is raised in the capital raising to add to net cash of NZ$22.6 million at 31 March
2025 and an average monthly cash burn of less than NZ$2.6 million.
2
Medicare reconsideration requests and challenging the non-coverage of Cxbladder Triage
through the Medicare appeals process.
“All of Pacific Edge’s Directors and senior management intend to participate in the equity
raising. We encourage you to support this offer.”
Pacific Edge Chief Executive Dr Peter Meintjes said: “Pacific Edge has an opportunity to
entrench its first-mover advantage and the moat we have created around Cxbladder Triage
given its inclusion in the AUA microhematuria guideline.
“We are already rapidly migrating clinicians from Detect to Triage and are seeking to appeal
all Triage tests through either the Medical Appeals Process or through “external review” for
commercial payers. The capital we are seeking today will make this possible, while we work
ceaselessly to regain Medicare coverage and reimbursement for our tests.
“Additionally, this capital will enable Pacific Edge to sustain our planned investments in the
clinical evidence generation for Triage Plus and Monitor Plus – the future product portfolio of
the company. Lastly, it will also support product innovation to simplify Cxbladder into IVD kits
as part of a decentralized strategy for international markets. We encourage shareholders to
support us to take advantage of these opportunities.”
Further details of the capital raise have been included in a capital raising presentation also
released to the NZX and ASX today.
OFFER DETAILS:
Offer size and
structure
An equity raising, comprising:
A NZ$15 million Placement
A NZ$5 million Retail Offer
Placement offer
details
The Placement Price will be NZ$0.100 per share representing:
22% premium to the last closing price on NZX of NZ$0.082 per share on
29 May 2025
18% premium to the 20-day VWAP on NZX of NZ$0.085 per share
2
Shareholder approval is required to complete the Placement given the
Placement exceeds Pacific Edge's placement capacity (15% of Pacific Edge's
current shares on issue) and due to the expected presence of Related Party
participation
3
The Placement offer to selected investors will be conducted under a trading
halt
Pacific Edge reserves the right to vary the size of the Placement based on the
size and quality of investor demand
Commitments
All Pacific Edge directors intend to participate in the equity raising
Retail Offer details
Pacific Edge is offering up to NZ$5 million of shares (with the ability to scale
applications or accept oversubscriptions at the Board’s discretion) to Pacific
2
Volume weighted average price on the NZX for the period 2 May 2025 to 29 May 2025
3
The Placement will also be conditional on all necessary regulatory approvals. In this regard, the company intends
to seek a waiver from NZX Listing Rule 4.19.1 to permit the allotment of shares under the Placement after
shareholder approval is obtained.
3
Edge’s eligible existing shareholders resident in New Zealand (up to a
maximum of NZ$50,000 per shareholder) under a Retail Offer, structured as a
share purchase plan
4
The Retail Offer will be priced at the Placement Price of NZ$0.100 per share
Allotment of shares under the Retail Offer will be conditional on the Placement
becoming unconditional
Ranking
The new shares to be issued under both the Placement and Retail Offer will
be fully paid ordinary shares which, on allotment, will rank equally in all
respects with Pacific Edge’s existing ordinary shares then on issue
Financial adviser
Cameron Partners Limited is acting as financial adviser to Pacific Edge
Neither the Placement nor the Retail Offer are underwritten
TIMETABLE
Placement conducted under trading halt Friday, 30 May 2025
Announcement of the Placement results (subject to shareholder approval) and
trading halt lifted on the NZX and ASX
Tuesday, 3 June 2025
Retail Offer July/August 2025
Shareholder meeting to seek approval for the Placement By Early August 2025
Settlement, allotment and trading of Placement and Retail Offer shares on NZX
and ASX commence
By Mid August 2025
This timetable is indicative only and subject to change. The company will, in due course, send
shareholders formal notice of the meeting at which shareholder approval to the Placement will
be sought. The company will provide details of the record date, and offer period, for the Retail
Offer on or before sending the notice of meeting to shareholders.
Released for and on behalf of Pacific Edge by Grant Gibson Chief Financial Officer.
For more information:
Investors: Media:
Dr Peter Meintjes Richard Inder
Chief Executive The Project
Pacific Edge P: +64 21 645 643
P: 022 032 1263
OVERVIEW
Pacific Edge: www.pacificedgedx.com
Pacific Edge Limited (NZX/ ASX: PEB) is a global cancer diagnostics company leading the way
in the development and commercialization of bladder cancer diagnostic and prognostic tests
for patients presenting with hematuria or surveillance of recurrent disease. Headquartered in
4
The Board reserves the right to extend the Retail Offer to Australian resident shareholders, subject to obtaining
any necessary Australian regulatory relief.
4
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.
---
Capital raising presentation
Dr Peter Meintjes
Chief Executive Officer
Grant Gibson
Chief Financial Officer
29 May 2025
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2
1.EXECUTIVE SUMMARY
2.CAPITAL RAISING OVERVIEW
3.KEY RISKS AND FOREIGN SELLING RESTRICTIONS
Contents
3
1. EXECUTIVE SUMMARY
4
SUMMARY: PACIFIC EDGE IS THE FIRST MOVER IN BLADDER CANCER DIAGNOSIS
NON-COVERED FOR MEDICARE; STRATEGY AND EXECUTION STRENGTHENED BY GUIDELINE INCLUSION
•Establishment and NZX listing
•Clinical research and
development of Cxbladder
prototypes
•Cxbladder commercial launch
•Labs opened in New Zealand
and the US
•Medicare, Kaiser Permanente
and the New Zealand
(majority) coverage
•NZ$103.5m raised and ASX
dual listing
•Quarter-on-Quarter
compound growth of 10% for
12 quarters to September 24
•Uncertainty around ongoing
Medicare coverage
•Focus on clinical evidence,
new products, growth in non-
Medicare channels and
growth in average sales price
•Kaiser EMR integration
complete
•AUA microhematuria guideline
inclusion
•Medicare non-coverage
determination on stale evidence
providing clear re-coverage process
•Triage Plus priced at US$1,018/test
(draft)
•Triage Plus in early access
•Improved average sales price (ASP)
and salesforce efficiency
2001-2011
Research and development
2011-2020
Commercialisation
2020-2023
Growth acceleration
2023-2025
Temporary uncertainty
2025+
Growth continuation
•We have navigated the last three years through:
•Refocusing clinical evidence development in a robust AV, CV, CU
1
framework in defined patient
populations in appropriately powered studies;
•Cementing relationships with key customer partners (e.g. Kaiser Permanente);
•Digitalizing our operations to increase electronic ordering and to improve rates of patient
enrollment in clinical studies;
•Disciplined focus on revenue cycle management and reimbursement to improve sales team
efficiency and average sales price; and
•Investing in product development (e.g. Cxbladder Triage Plus and Monitor Plus) and innovating
with future kitted-IVD
2
products for international markets.
•The American Urological Association’s (AUA) February 2025 guideline inclusion of Cxbladder Triage as the
only urine-based biomarker test with ‘Grade A’ evidence is a company defining milestone that improves
sales, marketing and reimbursement
1.AV is analytical validation, CV is clinical validation and CU is clinical utility
2.IVD is an in-vitro diagnostic, typically sold as a kitted product not a testing service
5
PACIFIC EDGE OVERVIEW
CLINICALLY VALIDATED AND GUIDELINE-RECOMMENDED GENOMIC TESTS
•Cxbladder is a suite of clinically-validated, urine-sampled, RNA-based diagnostic tests for hematuria evaluation and surveillance of NMIBC
1
recurrence
•Triage Plus and Monitor Plus tests are ‘multi-modal’ diagnostic tests (DNA and RNA) offering superior performance and greater penetration of existing ~US$8.5b
TAM
•Cxbladder Triage recommended in the AUA 2025 microhematuria guideline as the only urine-based biomarker test that has ‘Grade A’ evidence
•Commercial sales in the US, New Zealand, Australia and Southeast Asia
1.NMIBC is non-muscle invasive bladder cancer
2.RDM: Residual Disease Monitoring
3.TRM: Therapeutic Response Monitoring
CXBLADDER RNA TESTS IN MARKETCXBLADDER RNA+DNA TESTS COMING TO MARKET
SURVEILLANCE
(RDM
2
, TRM
3
, RECURRENCE)
SURVEILLANCE
(RDM
2
, TRM
3
, RECURRENCE)
6
Cxbladder offers improvement over the standard of care, avoids unnecessary procedures and streamlines
workflow when used to intensify or de-intensify hematuria evaluation or in the surveillance for the recurrence
of bladder cancer. For healthcare payers Cxbladder offers substantial total cost savings per patient
1
1.Tyson et al (2024) Budgetary Impact of Including the Urinary Genomic Marker Cxbladder Detect in the Evaluation of Microhematuria Patients - PubMed (PMID: 37914255)
PACIFIC EDGE OVERVIEW
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, 78% of patients can avoid cystoscopy, 22% receive
cystoscopy, 5 cancers found
Cxbladder can spare up to 1.5 million patients in the US per year from cystoscopy
CYSTOSCOPIES SAFELY AVOIDED USING CXBLADDER
Normal
Cystoscopy
Cystoscopy
undertaken and
cancer found
Cystoscopy
avoided
Microhematuria
patient with
cancer
Microhematuria
patient with no
cancer
7
PACIFIC EDGE OVERVIEW
MEDICARE REPRESENTS THE LARGEST SINGLE OPPORTUNITY GLOBALLY
COMPELLING GROWTH OPPORTUNITY
•Total addressable market for Cxbladder in the US
estimated to be more than US$4.4b
1
and US$8.5b globally
•Laboratory infrastructure in place in New Zealand and the
US with lab scalability plan to handle more than 300k tests
per annum
•First mover advantage with a “moat” from compelling
clinical evidence and guidelines
PORTFOLIO OF INTELLECTUAL PROPERTY
•Novel methods for bladder cancer diagnostics are
protected by patents
•Unique selling points are underpinned by clinical utility
evidence for novel applications
•Potential to leverage existing frameworks for evidence
generation and selling for expansion within urology and
international markets
1.Pacific Edge estimate using US$1,018 price for hematuria testing and US$760 for NMIBC surveillance in the US and have estimated appropriate prices for APAC and Europe. See slide 38
of this presentation for the sources and assumptions for the calculation of TAM
8
US$8.5b
Global TAM
1
PACIFIC EDGE OVERVIEW
CXBLADDER OFFERS A SIGNIFICANT ADDRESSABLE GLOBAL MARKET ANNUALLY
THE PATIENT CARE PATHWAY
~7m
Present with
hematuria
~3.5m
Referred for
clinical workup
~1.1m
Receive
cystoscopy
~90k
Annual cases of
bladder cancer
~750k
Living with bladder cancer
~1.5Cxb Monitor / year
US$4.4b
TAM
340m
Population
~17m
Present with
hematuria
~50%
Referred for
clinical workup
~3.3m
Receive
cystoscopy
~58k
Annual cases of
bladder cancer
~300k
Living with bladder cancer
~1.5Cxb Monitor / year
US$2.1b
TAM
830m
Population
~12m
Present with
hematuria
~50%
Referred for
clinical workup
>4.0m
Receive
cystoscopy
~180k
Annual cases of
bladder cancer
~1m
Living with bladder cancer
~1.5Cxb Monitor / year
US$2.0b
TAM
600m
Population
APAC
Focus of our
growth efforts
NZ market mature.
Australia and SE Asia
in business
development
New market accessed
via IVD / kitted tests
1.Pacific Edge estimate using US$1,018 price for hematuria testing in the US and US$760 for NMIBC surveillance and other market assumptions for APAC and Europe. See slide 38 of this
presentation for the sources and assumptions for the calculation of TAM
9
PACIFIC EDGE OVERVIEW
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
10
AUA MICROHEMATURIA GUIDELINE INCLUSION
A COMPANY-DEFINING STRATEGIC MILESTONE ACHIEVED IN FEBRUARY 2025
The 2025 amendment to the AUA microhematuria guideline supports the use of urine-based
biomarkers for intermediate-risk patients as an alternative to a cystoscopy
•Primary driver for the change in the guidelines was clinical utility evidence for Cxbladder Triage from a
randomized controlled trial, i.e. the STRATA Study
1
•Cxbladder Triage specifically mentioned as the only urine-based biomarker test that has ‘Grade A’
2
evidence cementing first-mover advantage and building a moat vs competitors
•The change was significant:
•The 2020 guideline expressly prohibited the use of urine-based biomarkers in lieu of a cystoscopy
•The 2025 guideline brings genomic testing to hematuria evaluation for bladder cancer as already
established for prostate, breast, colon and other cancers
•Intermediate-risk patients represent a large cohort (~70%)
3
of microhematuria patients (up to 3.5 million
patients annual in the US)
•Offers significant benefits to patients, reduces the burden of unnecessary cystoscopies, improves access to
care at a lower cost and reduces legal liability for using biomarker alternatives
AUA guideline inclusion provides significant global clinical validation for Cxbladder which is
expected to pave the way for further wider global adoption by healthcare providers and
payers – we have already noticed increased interest from physicians
“... [for] intermediate-risk
patients who want to avoid cystoscopy and
accept the risk of forgoing direct visual
inspection of the bladder urothelium, clinicians
may offer urine cytology or validated urine-based
tumor markers to facilitate the decision
regarding utility of cystoscopy.”
– 2025 AUA Microhematuria Guideline Amendment
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.The AUA defines ‘Grade A’ evidence as evidence with a high certainty rating and notes evidence of this grade makes it "very confident that the true effect
lies close to that of the estimate of the effect”
3.Pacific Edge estimate based on the new risk categories created with the 2025 microhematuria guidelines
11
MEDICARE COVERAGE COMMENCED IN 2020 BUT CEASED IN 2025
•Medicare reimbursed Cxbladder tests >98% since 2020 at US$760 per test – these tests
have accounted for the majority of US volumes and ~61% of revenue in FY25
•Novitas – the Medicare Administrative Contractor that determines Medicare coverage for
our tests – proposed non-coverage for Cxbladder in July 2022 (2H 23).
•We challenged this determination with more recent evidence and support from the AUA
1
,
but Novitas finalized its non-coverage determination in January 2025 without considering
the most-current evidence available. Litigation has ceased.
•This decision was a poor outcome for Medicare patients and urologists. It removed
coverage for AUA guideline-recommended testing, after following a process that failed to
review the most-current evidence
•~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 without interruption
•We will continue to supply tests to existing US users and will attempt to get reimbursed
on all Triage tests based on the 2025 AUA microhematuria guideline through the
Medicare appeal process
MEDICARE NON-COVERAGE FOR CXBLADDER EFFECTIVE IN APRIL 2025
NON-COVERAGE LIKELY TO IMPACT TEST VOLUMES AND REIMBURSEMENT
1
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
US TOTAL TEST VOLUME
2
12,772
14,445
15,962
12,140
11,587
12,298
-
2,000
4,000
6,000
8,000
10,000
12,000
14,000
16,000
18,000
1H 232H 231H 242H 241H 252H 25
TEST VOLUMES
1.See "Medicare coverage uncertainty" and "Ongoing Financial Viability" risks on slide28.
2.Total Laboratory Throughput (TLT) including commercial, pre-commercial and clinical studies testing
3.AUA: American Urological Association
12
SEEKING RE-COVERAGE VIA LCD RECONSIDERATION AND MEDICARE APPEALS
RECONSIDERATION REQUESTS FOR TRIAGE AND MONITOR; APPEALS TO RELY ON GUIDELINE INCLUSION
RESTORING MEDICARE COVERAGE FOR TRIAGE AND MONITOR
•Cxbladder Triage: A reconsideration request was submitted to Novitas in March 2025 consisting of STRATA
1
and the
AUA Microhematuria guideline and is under review
•Cxbladder Monitor: A reconsideration request was submitted to Novitas in May 2025 consisting of two new real-world
studies from Australia and is under review
•Cxbladder Detect: Detect users are being migrated to Triage, accelerating a plan previously intended to coincide with
the commercial launch of Triage Plus
•Industry experts typically estimate it is likely to take 6-9 months for Novitas to consider a valid submission of a single
product with only a small number of new supporting publications to be reviewed.
•We will attempt to get reimbursed on all Triage tests based on the 2025 AUA microhematuria guideline through the
Medicare appeal process; the guideline supports our claim for reimbursement on the grounds of being “medically
reasonable and necessary” despite a non-coverage determination
ESTABLISHING MEDICARE COVERAGE FOR TRIAGE PLUS
•The analytical validation (AV) and clinical validation (CV) publications for Triage Plus have been submitted for peer
review in appropriate scientific journals seeking publication in FY26 Q1
•Pacific Edge will submit a reconsideration request for Triage Plus when the AV and CV is published
•Inclusion of Triage in the AUA microhematuria guideline provides medical policy for Medicare coverage of Triage Plus,
meaning AV and CV should be sufficient for coverage
•Further evidence for Triage published by Kaiser Permanente as a presentation at AUA and in peer review by FY26 Q3
further confirms Triage and Triage Plus clinical utility and health economics
•Draft Triage Plus pricing at US$1,018 is expected to become effective from January 2026
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.
MEDICARE RECONSIDERATION REQUESTCATALYST2025*2026*
Q1Q2Q3Q4Q1Q2Q3Q4
Reconsideration request for Triage
STRATA Study (May 2024)
AUA Macrohematuria guideline (Feb 2025)
Reconsideration request for Monitor
AV of Triage, Detect & Monitor (Sept 2024)
2x RWE of Monitor (March 2025)
Reconsideration request Triage Plus
AV of Triage Plus (Q2E 25)**
CV of Triage Plus – DRIVE Study (Q2 25)**
MEDICARE RE-COVERAGE: ESTIMATED TIMELINES
COVERAGE DECISIONS, PRIOTIZATION AND TIMELINES ARE AT THE DISCRETION OF NOVITAS
1
14
Publication Test and evidence standard
2
Expected date
3
1. STRATA Concordance -CU of Triage Plus (concordance)Q4 2025
2. Kaiser Permanente Triage RWE
4
-CU of Triage (RWE) Q3 2025
5
2. Kaiser Permanente Monitor RWE
4
-CU of MonitorQ1 2026
5
4. AUSSIE -CVof Triage PlusQ1 2026
5. microDRIVE-CV of Triage PlusQ2 2026
6. Monitor Plus Analytical Validation-AV of Monitor PlusQ2 2026
7. Pooled Analysis
6
-CV of Triage PlusQ2 2026
8. LOBSTER interim analysis-CV of Monitor/Monitor PlusQ1 2027
9. CREDIBLE -CU of Triage PlusQ1 2028
1
Novitas is the Medicare Administrative
Contractor (MAC) that covers Pacific Edge
Diagnostics USA’s lab in Pennsylvania
2
AV, CV, CU, respectively Analytical
Validity, Clinical Validity, Clinical Utility
3
Calendar year
4
RWE is Real World Evidence
5
Timeline determined by Kaiser
Permanente
6
The pooled analysis uses data from
DRIVE, AUSSIE and microDRIVE studies
Expected Novitas determination window
FUTURE CATALYSTS FOR GUIDELINES INCLUSION AND MEDICARE COVERAGE
*Calendar year
** Estimated publication quarter
DEMONSTRATED RESILIENCE DURING MEDICARE UNCERTAINTY
SIGNIFICANT OPERATIONAL IMPROVEMENTS IN THE COMMERCIAL TEAM
US SALES FORCE EFFICIENCY
US CLINICAL COMMITMENT
•Sales FTE down to an average of 16.0 in Q4 25 from 32.7 in Q4 23 as
we focused on cash conservation
•Sales force efficiency (total tests/average FTE) up 69% from 239 in Q4
23 to 405.6 in Q4 25:
•More effective core sales team
•Focus on the most profitable territories/accounts
•Tests/US ordering clinician stable, ordering clinicians steady on Q4 24:
•Change in clinical mix in favor of clinicians that understand the
clinical utility of Cxbladder
•Average US Sales Price increases with improved cash collection
SALES TEAM FOCUSED ON KEY PERFORMANCE INDICATORS
27.3
29.7
33.0
32.7
30.0
27.7
20.7
16.0
14.7
15.0
15.3
16.0
222.2
225.8
200.9
239.3
287.6
265.1
292.3
381.2
402.6
378.8 378.8
405.6
-90
10
110
210
310
410
-
10.0
20.0
30.0
40.0
50.0
60.0
70.0
80.0
Q1 23 Q2 23 Q3 23 Q4 23 Q1 24 Q2 24 Q3 24 Q4 24 Q1 25 Q2 25 Q3 25Q4 25
TEST VOLUME /SALES FTE
AVERAGE SALES FTE
US TEST VOLUME/SALES FTE (RHS)
895
978
1,082
1,150
1,232
1,147
1,016
915
867
890
866
914
6.8
6.8
6.1
6.8
7.0
6.4
5.9
6.7
6.8
6.4
6.7
7.1
-
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
1,800
Q1 23 Q2 23 Q3 23 Q4 23 Q1 24 Q2 24 Q3 24 Q4 24 Q1 25 Q2 25 Q3 25Q4 25
TEST/ORDERING CLINICIAN
US ORDERING CLINICIANS
TESTS/ORDERING CLINICIAN (RHS)
US AVERAGE SALES PRICE
7,476
8,276
10,622
12,450
13,550
9,956
9,913
$472
$470
$493
$519
$562
$613
$618
$-
$100
$200
$300
$400
$500
$600
$700
-1,000
1,000
3,000
5,000
7,000
9,000
11,000
13,000
15,000
17,000
1H 222H 221H 232H 231H 242H 241H 25
TEEST VOLUME
US ASP (RHS)
15
MEDICARE PRICE FOR TRIAGE PLUS ACCELERATES PATH TO PROFITABILITY
DRAFT PRICE FOR TRIAGE PLUS OF US$1,018.44 PER TEST PUBLISHED APRIL 2025
MEDICARE COVERAGE NEEDED BEFORE FULL-SCALE COMMERCIAL LAUNCH
•The Centers for Medicare & Medicaid Services (CMS) price of US$1,018 for Triage Plus
materially lifts margin per test from the previous pricing at US$760
•Lowers the profitability threshold for number of tests per Account Executive facilitating
more rapid scaling and a faster path to profitability
•A reconsideration request will be made to Novitas for coverage of Triage Plus as soon as the
analytical validation (AV) and clinical validation (CV) studies have been published
(estimated in June 2025)
ACCELERATING THE PATH TO PROFITABILITY
•Adding digital capabilities and FTE
1
capacity to PEDUSA laboratory
•Simplifying laboratory workflow for improved efficiency
•Optimizing sales team structure for expanded product adoption
•Sales and marketing materials to reflect AUA Guideline messaging
•Enhancing medical education with a speaker bureau, podium presentations, and evidence
development
1.FTE is a full time equivalent
16
SUCCESS IN OTHER CHANNELS CONTINUES
NON-MEDICARE TESTS IN ASIA PACIFIC CONTINUE TO GROW
NON-MEDICARE TESTING
•Non-Medicare testing was primarily from New Zealand and Kaiser Permanente
during FY25, but also smaller volumes from Australia, Southeast Asia and the
Veterans Administration
•Non-Medicare testing has grown by 22% of the testing mix to 57% since focusing on
it after reducing sales headcount in September 2023
1
DRIVING GROWTH IN SOUTHEST ASIA AND CONSOLIDATING NZ
•New Zealand continues to lead the global adoption of Cxbladder by primary care.
The market is now mature with Cxbladder utilized regions covering >75% of the
population
•STRATA
2
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
•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
APAC TOTAL TEST VOLUME*
2,148
2,200
2,278
2,253
2,638
2,371
-
500
1,000
1,500
2,000
2,500
1H 232H 231H 242H 241H 252H 25
TEST VOLUMES
1.As a result of right-sizing of US Sales force in response to Novitas LCD as we focused on cash conservation
2.Lotan et al. (2024) . A Multicenter Prospective Randomized Controlled Trial Comparing Cxbladder Triage to Cystoscopy in Patients With Microhematuria.
The Safe Testing of Risk for Asymptomatic Microhematuria Trial. The Journal of Urology Vol 212 1-8 Jul 2024.
* Total Laboratory Throughput (TLT) including commercial, pre-commercial and clinical studies testing
17
SUCCESS IN OTHER CHANNELS CONTINUES
NON-MEDICARE TESTS AT KAISER PERMANENTE CONTINUE TO GROW
•Kaiser Permanente is the largest non-profit healthcare provider in the US with over
12 million members and has been commercially using Cxbladder since 2020
•In November 2023, we launched our EMR integration with the Southern California
Permanente Medical Group, streamlining sample collection, test ordering, and
results for Triage and Monitor. Test volumes are steadily increasing and longer
term we are targeting other Kaiser Permanente Medical Groups
•Kaiser Permanente’s Real World Evidence
1
further demonstrates the clinical utility
evidence of Cxbladder Triage and will be used with Medicare reconsideration
requests
•Kaiser Permanente’s Southern California Region is ~35% of the total Kaiser
Permanente Group, and opportunities to expand to other regions continue to be
prioritized
1.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.
KAISER PERMANENTE PROVIDING SIGNIFICANT VALIDATION
AUA GUIDLINE 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
18
CUSTOMER EXPERIENCE INTIATIVES DELIVERING VALUE
DIGITALIZING CUSTOMER EXPERIENCE 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
•Reduced demand on the sales force and customer
service
THE PACIFIC EDGE CUSTOMER PORTAL
19
FOCUSED ON THE DNA ENHANCED PRODUCT LAUNCH AND THE IVD STRATEGY
AN IVD PRODUCT MAY EXTEND THE MARKET OPPORTUNITY AND THE ‘MOAT’ AROUND CXBLADDER
READYING FOR THE LAUNCH OF TRIAGE PLUS AND MONITOR PLUS
•Ensure R&D, Digital and Lab Operations focus on the commercial scaling of Triage
Plus and development of Monitor 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 OUR IN-VITRO STRATEGY FOR INTERNATIONAL MARKETS
•Accelerating the development of a kitted IVD (in vitro diagnostic) product from our
existing lab service called Triage Plus IVD, for decentralized lab deployment and
international market expansion
•Establish IVD regulatory framework for our next generation tests that
includes IVD-R (Europe), FDA (USA) and ISO-13485
1
(Rest of World)
•Targeting prototypes by the end of CY 25; manufacture and commencement
of clinical and analytical validation commencing in CY 26
•Achieving IVD-approved status may make it more difficult for competitors to
develop parity with Cxbladder’s level of evidence
Chief Scientific Officer Parry Guilford (center) and Chief Technology
Officer Justin Harvey (right)
20
1.IVD-R European In Vitro Diagnostic Regulation; FDA, US Food and Drug Administration; ISO International Organization for Standardization
21
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
•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
•“Client Billing” program to allow LUGPAs and hospitals to pay Pacific Edge for a test and bill
commercial insurers themselves for reimbursement
•Invest in innovation and product development for IVD kits to support entry into international
markets in a decentralized deployment model
FURTHER CATALYSTS
•Cxbladder is under consideration by Te Whatu Ora for a National Pathway in New Zealand
2. CAPITAL RAISING OVERVIEW
22
RAISING CAPITAL TO DRIVE GROWTH
Pacific Edge’s strategy has not materially changed since the capital raising in 2021. However, the implementation
of the strategy has not been as fast as intended given the focus on gaining reliable Medicare coverage
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
Funds raised will be used to:
•Accelerate adoption of Triage in the US with AUA Guidelines as a tailwind for sales, marketing and reimbursement
•Continue clinical evidence generation in an AV, CV and CU framework for coverage, guidelines and medical policy for Triage Plus and
Monitor Plus
•Invest in innovation and product development for IVD kits to support entry into international markets in a de-centralized
deployment model
•Extend cash runway to support operations for over 12 months without Medicare coverage and reimbursement, or reductions in its
cost base(assuming at least NZ$20 million is raised in the capital raising to add to net cash of NZ$22.6 million at 31 March 2025 and
an average monthly cash burn of less than NZ$2.6 million)
23
CAPITAL RAISING OVERVIEW
Offer size and
structure
•An equity raising, comprising:
•A NZ$15 million Placement
•A NZ$5 million Retail Offer
Placement
details
•The Placement Price will be NZ$0.100 per share representing:
•22% premium to the last NZX closing price of NZ$0.082 per share on 29 May 2025
•18% premium to the 20-day VWAP on NZX of NZ$0.085 per share
1
•Shareholder approval is required to complete the Placement given the Placement exceeds Pacific Edge's placement capacity (15% of Pacific Edge's
current shares on issue) and due to the expected presence of Related Party participation. The Placement will also be conditional on all necessary
regulatory approvals. In this regard, Pacific Edge intends to seek a waiver from NZX Listing Rule 4.19.1 to permit the allotment of shares under the
Placement after shareholder approval is obtained
•The Placement offer will be made to selected investors under a trading halt
•Pacific Edge reserves the right to vary the size of the placement based on the size and quality of investor demand
Retail Offer
details
•Pacific Edge is offering up to NZ$5 million of shares (with the ability to scale applications or accept oversubscriptions at the Board’s discretion) to
Pacific Edge’s eligible existing shareholders resident in New Zealand (up to a maximum of NZ$50,000 per shareholder) under a Retail Offer, structured
as a share purchase plan
2
•The Retail Offer will be priced at the Placement Priceof NZ$0.100 per share
•Allotment of shares under the Retail Offer will be conditional on the Placement becoming unconditional
Ranking
•The new shares to be issued under both the Placement and Retail Offer will be fully paid ordinary shares which, on allotment, will rank equally in all
respects with Pacific Edge’s existing ordinary shares then on issue
Financial
adviser
•Cameron Partners Limited is acting as financial adviser to Pacific Edge
•Neither the Placement nor the Retail Offer are underwritten
1.Volume weighted average price on NZX for the period 2 May 2025 to 29 May 2025
2. The Board reserves the right to extend the Retail Offer to Australian resident shareholders, subject to receiving any necessary Australian regulatory relief
24
TIMETABLE
1
Placement
Placement conducted under trading haltFriday, 30 May 2025
Announcement of the Placement results (subject to shareholder approval) and trading halt lifted on the NZX and ASX
2
Tuesday, 3 June 2025
Shareholder approval for the PlacementBy Early August 2025
Settlement, allotment and trading of Placement shares on NZX and ASX commence By Mid August 2025
Retail Offer
Record dateJuly/August 2025
Retail Offer opens and documentation sent to eligible shareholdersJuly/August 2025
Retail Offer closesAugust 2025
Announcement of results of Retail OfferAugust 2025
Settlement, allotment and trading of Retail Offer shares on NZX commence August 2025
1. These dates are indicative and subject to change.
2. NZX closed on Monday, 2 June 2025 due to King’s Birthday
25
3. KEY RISKS AND FOREIGN SELLING RESTRICTIONS
26
KEY RISKS
IMPORTANT:
Like any investment, there are risks associated with an investment in Pacific Edge shares. Before investing in Pacific Edge, you should be
aware than an investment in Pacific Edge has a number of risks, some of which are specific to Pacific Edge and some of which relate to listed
securities generally, and many of which are beyond the control of Pacific Edge. Additionally, some risks may be unknown and other risks,
currently believed to be immaterial, could turn out to be material. Whilst the section below aims to highlight some of the key risks, it is not
exhaustive.
Before deciding whether to invest in Pacific Edge shares, you must make your own assessment of the risks associated with the investment and
consider whether such an investment is suitable for you having regard to all other Pacific Edge continuous disclosure announcements and
publicly available information and consult your financial adviser and other professional advisers.
27
KEY RISKS (CONT)
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 outlined in this presentation is in part to provide
sufficient cash to regain Medicare coverage. If the capital raise is undersubscribed, 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.
Regulatory, industry
body and guideline
risks
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
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,
gain inclusion in guidelines, or the current regulatory approvals and reimbursement obtained for existing products are removed or reduced, such matters could have an adverse impact on
Pacific Edge’s financial performance and its ability to achieve its business plans. If Pacific Edge is unable to obtain the approvals required for new products in new territories, or is unable to
obtain future reimbursement for new products, this could also have an adverse impact on Pacific Edge’s financial performance 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.
General economic
conditions
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).
28
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
Any investment in equity capital markets carries general risks. 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 offer will not result in the share price trading at levels below the price paid by
investors in the offer. 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.
29
FOREIGN SELLING RESTRICTIONS
International Offer Restrictions
This document does not constitute an offer of new ordinary shares (New Shares) of Pacific Edge in any jurisdiction in which it would be unlawful. In particular,
this document may not be distributed to any person, and the New Shares, may not be offered or sold in any country outside NZ except to the extent permitted
below.
Australia
This document and the offer of New Shares are only made available in Australia to persons to whom an offer of securities can be made without disclosure in
accordance with applicable exemptions in sections 708(8) (sophisticated investors), 708(11) (professional investors), 761G (wholesale clients) of the Australian
Corporations Act 2001 (Cth) (the "Corporations Act"). This document is not a prospectus, product disclosure statement or any other formal "disclosure
document" for the purposes of Australian law and is not required to, and does not, contain all the information which would be required in a "disclosure
document" under Australian law. This document has not been and will not be lodged or registered with the Australian Securities & Investments Commission.
Prospective investors should not construe anything in this document as legal, business or tax advice nor as financial product advice for the purposes of Chapter 7
of the Corporations Act and the information provided does not take into account the investment objectives, financial situation or particular needs (including
financial and tax issues) of any prospective investor. Prospective investors should review the risks set out on slides 28 and 29before making any investment
decision
Not for distribution in the United States
This presentation is not for distribution or release in the United States. This presentation does not constitute an offer to sell, or the solicitation of an offer to buy,
any securities in the United States. The New Shares have not been, and will not be, registered under the US Securities Act of 1933, as amended, or the securities
laws of any state or other jurisdiction of the United States, and may not be offered or sold in the United States except in transactions exempt from, or not subject
to, registration under the US Securities Act of 1933, as amended, and applicable US state securities laws.
30
APPENDIX
31
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
32
Calendar
year
Pre
2023
202320242025202620272028
Q1Q2Q3Q4Q1Q2Q3Q4Q1Q2Q3Q4Q1Q2Q3Q4Q1Q2Q3Q4Q1Q2
“The 1800”
LOBSTER
OCTOPUS
*
SURVEILLANCE FIVE YEAR CLINICAL STUDIES ROADMAP
Publication Submitted
Records review / follow-up
Database lock
Legend:
Pre-activation (docs, CTA etc)
SIV
Enrollment
Data Cleaning
*
DBL
33
SUMMARY OF CXBLADDER CLINICAL EVIDENCE
Publication or StudyPopulationSensitivity
(Sn)
NPVSpecificity
(Sp)
Comment
Triage Plus
AVHarvey et al., submitted
Synthetic Analytes
MH + GH
93.6%99.4%90.8%
Publication submitted; 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 + GH94%99.3%77%Publication submitted; TNR 71%.; PPV 26% at lower cut-point, 51% at higher cut-point with a Sp of 97%
AUSSIEMH + GHTBCTBCTBCStudy in progress on MH and GH patients
microDRIVEMHTBCTBCTBCStudy in progress on MH patients
CUCREDIBLEMHTBCTBCTBCStudy in progress on MH patients
Triage
AVHarvey et al., 2024Synthetic AnalytesN/AN/AN/AMulti-product analytical validation of Cxbladder Triage, Detect and Monitor
CV
Kavalieris et al., 2015MH + GH95%98.5%45%Sn, Sp, NPV values when TNR is 40%
Davidson et al., 2019MH + GH95.5%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 &
imaging combined performance had a Sn of 97.7% & NPV of 99.8%
Lotan et al., 2023MH + GH89%99%63%Pooled data from US and Singapore cohorts (n=804); TNR 59%; PPV 16%
DRIVE (Savage et al., submitted)MH + GH93%98.5%38%Publication submitted and under peer review; TNR 35%; PPV 11%
CU
Davidson et al., 2020MH + GH89.4%98.9%59%
39% of patients testing negative for Cxb Triage & imaging did not get cystoscopy & were managed at primary
care; Study wide CV: Cxb Triage & imaging combined performance: Sn 98.1%, NPV 99.9%, Sp 98.4%
Lotan et al., 2024MH + GH90%99%56%
Clinicians using Triage used 59% fewer cystoscopies on low-risk patients presenting with MH; CV was provided
study wide (UC, n=22): Sn 90%, Sp 56%, PPV 15%, NPV 99%
Monitor
AVHarvey et al., 2024Synthetic AnalytesN/AN/AN/AMulti-product analytical validation of all Cxbladder products
CV
Kavalieris et al., 2017NMIBC93%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.
LOBSTERNMIBCTBCTBCTBCStudy in progress on NMIBC patients
CU
Koya et al., 2020NMIBC10010077.8Integration of Cxb Monitor into the surveillance schedule reduced annual cystoscopies (39%)
Li et al., 2023NMIBC10010072
Cxbladder Monitor safely postpones a patient’s next scheduled cystoscopy, the current ‘gold standard’ for
bladder cancer surveillance
Guduguntla et al., 2025NMIBCN/AN/AN/A
Australian single-center study in NMIBC patients showed that alternating Cxbladder Monitor with cystoscopy
safely reduced cystoscopy use without increasing recurrence 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
34
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 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
35
Glossary
•Sensitivity (Sn) - the frequency with which a test correctly identifies patients with a disease.
•Specificity (Sp) - the frequency with which a test correctly identifies patients without a disease.
•Negative Predictive Value (NPV) - the percentage of negative tests being true negatives (by standard of care).
•Positive Predictive Value (PPV) - the percentage of positive tests being true positives (by standard of care).
•Rule-out Rate (ROR) - the percentage of tests that return a negative result.
•Evidence definitions:
•Analytical validity (AV) - Evidence that a test is repeatable in the lab for a given indication and population.
•Clinical validity (CV) - Evidence a test works in the same way on an independent eligible population for a given indication.
•Clinical utility (CU) - Evidence that a test in the hands of a physician can usefully change patient management within the context of care for the defined population and indication.
•EMR – Electronic Medical Record
•ASP – Average Sales Price
•FTE – Full Time Equivalent
36
SOURCES AND ASSUMPTIONS - TOTAL ADRESSABLE MARKET
REGIONSTATISTICSOURCE
US
Population 341,762,685 https://www.census.gov/popclock/
Incidence of hematuria7,000,000 Presentation from Dr Sia Daneshmand (Director of Urologic Oncology and Clinical Research, USC) July 2019
Referred for clinical workup3,500,000 Presentation from Dr Sia Daneshmand (Director of Urologic Oncology and Clinical Research, USC) July 2019
Receive a cystoscopy>1,000,000 Kenigsberg, A, et al. The Economics of Cystoscopy: A Microcost Analysis, Urology 157: 29−34, 2021
Annual cases of bladder cancer 84,870 National Cancer Institute
Patients living with bladder cancer 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$4.4
Europe (excluding
Russia)
Population 600,000,000 World-population - Europe; World-population – Russia
Incidence of hematuria12,000,000 Science Direct
Referred for clinical workup6,000,000 Presentation from Dr Sia Daneshmand (Director of Urologic Oncology and Clinical Research, USC) July 2019
Receive a cystoscopy4,000,000
Rindorf, D, et al. The extent of experiencing availability issues and deteriorating performance associated with reusable
cystoscopies, a multicentre study.
Annual cases of bladder cancer 180,000 Uroweb
Patients living with bladder cancer 900,000 Pacific Edge estimate - 5 years of annual cases
Test opportunities 7,350,000 Pacific Edge estimate
Price of Cxbladder EURO€ 245Pacific Edge estimate
TAM (US$b)US$2.0
APAC (excluding India
and China)
Population
830,000,000World population - Southeast Asia; Population Pyramid - Japan;
Incidence of hematuria16,600,000Science Direct
Referred for clinical workup8,300,000Presentation from Dr Sia Daneshmand (Director of Urologic Oncology and Clinical Research, USC) July 2019
Receive a cystoscopy3,320,000Pacific Edge estimate
Annual cases of bladder cancer 58,000WHO; Hong Kong
Patients living with bladder cancer 290,000Pacific Edge estimate - 5 years of annual cases
Test opportunities 3,755,000Pacific Edge estimate
Price of Cxbladder (US$)550Pacific Edge estimate
TAM (US$b)US$2.1
37
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
38
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 Micro-
hematuria
guideline
Apr 2025
Medicare non-
coverage
effective
39
INDEPENDENT DIRECTORS
SARAH PARK
ANATOLE MASFEN
BRYAN WILLIAMS
ANNA STOVE
TONY BARCLAY
CHRIS GALLAHER
Chairman
Chris has held senior positions in
both CEO and CFO roles with large
international companies and was a
partner in Arthur Young, Chartered
Accountants. Prior to retiring from
full time corporate life, he was CFO
of Fulton Hogan, a large
Australasian civil contractor
DR PETER MEINTJES
Chief Executive Officer
Peter is a molecular diagnostics and
genomics leader focused on
nascent market development of
disruptive innovations to drive
commercial success. Prior to joining
Pacific Edge, he was based in
Boston in a succession of diagnostic
leadership roles. Most recently he
was the Chief Commercial Officer
at Eurofins Transplant Genomics
and before that he was CEO at
Omixon
SENIOR LEADERSHIP TEAM
GRANT GIBSON DAVID LEVISON DR TAMER ABOUSHWAREB
Chief Financial Officer President Pacific Edge Diagnostics USA Chief Medical Officer
GLEN COSTIN DARELL MORGAN DR JUSTIN HARVEY
President Asia Pacific Chief Operating Officer Chief Technology Officer
ZOE O’DONNELL PROFESSOR PARRY GUILFORD
Global Head of People & Culture Chief Scientific Officer
PACIFIC EDGE BOARD AND MANAGEMENT
40
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
41
---
103614.6 - 2079795.5
29 May 2025
NZX Limited
Level 1, NZX Centre
11 Cable Street
Wellington 6011
ASX Limited
20 Bridge Street
Sydney NSW 2000
NOTICE PURSUANT TO CLAUSE 20(1)(A) OF SCHEDULE 8 TO THE FINANCIAL MARKETS
CONDUCT REGULATIONS 2014 AND PARAGRAPH 708(12J) OF THE CORPORATIONS ACT
2001 (CTH) AS NOTIONALLY INSERTED BY ASIC INSTRUMENT 21-0811
1. Pacific Edge Limited (NZX/ASX: PEB) (“PEB”) has announced that it intends to undertake an offer of new
fully paid ordinary shares in PEB of the same class as already quoted on the Main Board of NZX Limited
and the Australian Securities Exchange operated by ASX Limited (“New Shares”), comprising:
(a) a non-underwritten placement of New Shares to selected investors to raise up to NZ$15 million
(with the ability for PEB to increase the size of the placement at its discretion) (“Placement”); and
(b) a non-underwritten share purchase plan to PEB’s eligible existing shareholders with a registered
address in New Zealand
1
to raise up to NZ$5 million (subject to the ability for PEB to scale
applications or accept oversubscriptions at its complete discretion) (“SPP”),
(together, the “Offer”).
2. The Offer is being made to investors in New Zealand in reliance upon the exclusion in clause 19 of
Schedule 1 to the Financial Markets Conduct Act 2013.
3. This notice is provided under subclause 20(1)(a) of Schedule 8 to the Financial Markets Conduct
Regulations 2014 (the “Regulations”) and under paragraph 708A(12J) of the Corporations Act 2001 (Cth)
(“Corporations Act”), as notionally inserted by ASIC Instrument 21-0811.
4. PEB will issue the relevant shares under the Offer without disclosure to investors under Part 6D.2 of the
Corporations Act.
5. As at the date of this notice:
(a) PEB is in compliance with the continuous disclosure obligations that apply to it in relation to PEB’s
ordinary shares;
(b) PEB is in compliance with its financial reporting obligations (as defined in subclause 20(5) of
Schedule 8 to the Regulations);
(c) there is no information that is “excluded information” (as defined in subclause 20(5) of Schedule
8 to the Regulations) in respect of PEB; and
(d) PEB has complied with its obligations under Rule 1.15.2 of the listing rules of ASX Limited.
1
PEB reserves the right to extend the SPP to PEB’s eligible existing shareholders with a registered address in Australia,
subject to PEB obtaining all necessary regulatory relief to permit it to do so.
103614.6 - 2079795.5
Pg. 2
6. The Offer is not expected to have any effect on the control of PEB within the meaning set out in clause 48
of Schedule 1 to the Financial Markets Conduct Act 2013.
Ends
This notice has been authorised for release to NZX and ASX by the PEB Board.
For further information please contact:
Grant Gibson
Chief Financial Officer
+64 275 999 943
---
Corporate Action Notice
(Other than for a Distribution)
Updated January 2024
Page 1 of 3
Section 1: Issuer information (mandatory)
Name of issuer Pacific Edge Limited
Class of Financial Product Ordinary shares
NZX ticker code PEB
ISIN (If unknown, check on NZX
website)
NZPEBE0002S1
Name of Registry MUFG Pension & Market Services
Type of corporate action
(Please mark with an X in the relevant
box/es)
Share Purchase
Plan/retail offer
X Renounceable
Rights issue or
Accelerated
Offer
Capital
reconstruction
Non-
Renounceable
Rights issue or
Accelerated
Offer
Call Bonus issue
Placement X
Record Date The Record Date for the share purchase plan is yet
to be determined. It is currently anticipated that it will
be in July/August. PEB will release a further
Corporate Action Notice when this is determined.
Ex Date (one business day before the
Record Date)
The Ex Date for the share purchase plan is yet to be
determined. It is currently anticipated that it will be in
July/August. PEB will release a further Corporate
Action Notice when this is determined.
Currency NZD
External approvals required before offer
can proceed on an unconditional basis?
Yes. The placement is conditional on PEB obtaining
all necessary or desirable shareholder approvals, and
all necessary regulatory approvals, to complete the
placement. In addition, completion of the share
purchase plan will be conditional on the placement
becoming unconditional.
Details of approvals required PEB shareholder approval to the placement by
ordinary resolution, under NZX Listing Rule 4.2.1
and, if applicable, NZX Listing Rule 5.2.1.
2 of 3
PEB will also seek a waiver from NZX Listing Rule
4.19.1 to permit allotment of shares under the
placement after shareholder approval is obtained.
Section 6: Share Purchase Plans/retail offer
Number of Equity Securities to be
issued
OR
Maximum dollar amount of Equity
Securities to be issued
$5 million of new fully paid ordinary shares (subject to
the ability for PEB to scale applications or accept
oversubscriptions at its complete discretion).
Minimum application amount (if any) N/A
Maximum application amount per
Equity Security holder
$50,000
Subscription price per Equity Security The placement price of $0.100 per ordinary share
Scaling reference date The Record Date.
Closing Date The Closing Date for the share purchase plan is yet
to be determined. It is currently anticipated that it will
be in July/August. PEB will release a further
Corporate Action Notice when this is determined.
Allotment Date The Allotment Date for the share purchase plan is yet
to be determined. It is currently anticipated that it will
be in August. PEB will release a further Corporate
Action Notice when this is determined.
Section 7: Placement
Number of Equity Securities to be
issued
150,000,000 new fully paid ordinary shares, based on
a $15 million placement (with the ability for PEB to
increase the size of the placement and, therefore, the
number of shares to be issued under the placement,
at its complete discretion).
Issue price per Equity Security $0.100 per ordinary share.
Maximum dollar amount of Equity
Securities to be issued
$15 million (with the ability for PEB to increase the
size of the placement, at its discretion).
Proposed issue date The issue date for the placement is yet to be
determined, as the date for obtaining shareholder
approval is currently unknown. It is currently
anticipated that the issue date will be in August. PEB
will release a further Corporate Action Notice when
this is determined.
Existing holders eligible to participate Yes
Related Parties eligible to participate Yes
Basis upon which participation by
existing Equity Security holders will be
determined
By reference to shareholdings on 29 May 2025.
3 of 3
Purpose(s) for which the Issuer is
issuing the Equity Securities
Raise capital to ensure the company has the
resources and capacity to capitalise on its recent
clinical and commercial milestones, grow into non-
Medicare channels and regain Medicare coverage.
Reason for placement rather than a
pro-rata rights issue or an offer under a
Share Purchase Plan in which the
Issuer’s existing Equity Security holders
would have been eligible to participate
PEB considers a placement structure to be in the best
interests of PEB and its existing shareholders, as the
placement will allow PEB to access a broader pool of
potential investors, provide greater certainty around
the achievement of the targeted raising size and more
favourable pricing for PEB. A Share Purchase Plan is
intended to be offered in conjunction with the
Placement.
Equity Securities to be issued subject to
voluntary escrow
No
Number and class of Equity Securities
to be issued that will be subject to
voluntary escrow and the date from
which they will cease to be escrowed
N/A
Section 8: Lead Manager and Underwriter (mandatory)
Lead Manager(s) appointed No
Name of Lead Manager(s) N/A
Fees, commission or other
consideration payable to Lead
Manager(s) for acting as lead
manager(s)
N/A
Underwritten No
Name of Underwriter(s) N/A
Extent of underwriting (i.e. amount or
proportion of the offer that is
underwritten)
N/A
Fees, commission or other
consideration payable to Underwriter(s)
for acting as underwriter(s)
N/A
Summary of significant events that
could lead to the underwriting being
terminated
N/A
Section 9: Authority for this announcement (mandatory)
Name of person authorised to make this
announcement
Grant Gibson
Contact person for this announcement Grant Gibson
Contact phone number +64 275 999 943
Contact email address grant.gibson@pelnz.com
Date of release through MAP 29 May 2025
---
Appendix 3B - Proposed issue of securities
Appendix 3B - Proposed issue of securities
1 / 9
Announcement Summary
Entity name
PACIFIC EDGE LIMITED
Announcement Type
New announcement
Date of this announcement
29/5/2025
The Proposed issue is:
Total number of +securities proposed to be issued for an offer of securities under a securities purchase plan
ASX +security code+Security description
Maximum Number of
+securities to be issued
PEBORDINARY FULLY PAID FOREIGN EXEMPT NZX50,000,000
+Record date
28/5/2025
Offer closing date
25/7/2025
+Issue date
1/8/2025
Total number of +securities proposed to be issued for a placement or other type of issue
ASX +security code+Security description
Maximum Number of
+securities to be issued
PEBORDINARY FULLY PAID FOREIGN EXEMPT NZX150,000,000
Proposed +issue date
11/7/2025
Refer to next page for full details of the announcement
A placement or other type of issueA placement or other type of issue
An offer of securities under a securities purchase plan
Appendix 3B - Proposed issue of securities
Appendix 3B - Proposed issue of securities
2 / 9
Part 1 - Entity and announcement details
1.1 Name of +Entity
PACIFIC EDGE LIMITED
We (the entity named above) give ASX the following information about a proposed issue of +securities and, if ASX agrees
to +quote any of the +securities (including any rights) on a +deferred settlement basis, we agree to the matters set out in
Appendix 3B of the ASX Listing Rules.
If the +securities are being offered under a +disclosure document or +PDS and are intended to be quoted on ASX, we also
apply for quotation of all of the +securities that may be issued under the +disclosure document or +PDS on the terms set
out in Appendix 2A of the ASX Listing Rules (on the understanding that once the final number of +securities issued under
the +disclosure document or +PDS is known, in accordance with Listing Rule 3.10.3C, we will complete and lodge with ASX
an Appendix 2A online form notifying ASX of their issue and applying for their quotation).
1.2 Registered Number Type
ARBN
Registration Number
653308144
1.3 ASX issuer code
PEB
1.4 The announcement is
1.5 Date of this announcement
29/5/2025
1.6 The Proposed issue is:
A placement or other type of issueA placement or other type of issue
An offer of +securities under a +securities purchase plan
New announcement
Appendix 3B - Proposed issue of securities
Appendix 3B - Proposed issue of securities
3 / 9
Part 4 - Details of proposed offer under securities purchase plan
Part 4A - Conditions
4A.1 Do any external approvals need to be obtained or other conditions satisfied before the offer of +securities
under the +securities purchase plan issue can proceed on an unconditional basis?
4A.1a Conditions
Approval/Condition
+Security holder approval
Date for determination
11/7/2025
Is the date estimated or
actual?
** Approval
received/condition met?
Comments
Completion of the share purchase plan will be conditional on the placement becoming unconditional.
The placement is conditional on PEB obtaining all necessary or desirable shareholder approvals, and all necessary
regulatory approvals, to complete the placement.
Estimated
Yes
Appendix 3B - Proposed issue of securities
Appendix 3B - Proposed issue of securities
4 / 9
Part 4B - Offer details
+Class or classes of +securities that will participate in the proposed issue and +class or classes of +securities
proposed to be issued
ASX +security code and description
PEB : ORDINARY FULLY PAID FOREIGN EXEMPT NZX
Will the proposed issue of this
+security include an offer of
attaching +securities?
Details of +securities proposed to be issued
ASX +security code and description
PEB : ORDINARY FULLY PAID FOREIGN EXEMPT NZX
Maximum total number of those +securities that could be issued
if all offers under the +securities purchase plan are accepted
50,000,000
Will the offer be conditional on applications for a minimum
number of +securities being received or a minimum amount
being raised (i.e. a minimum subscription condition)?
Will the offer be conditional on applications for a maximum
number of +securities being received or a maximum amount
being raised (i.e. a maximum subscription condition)?
Will individual security holders be required to accept the offer for
a minimum number or value of +securities (i.e. a minimum
acceptance condition)?
Will individual security holders be limited to accepting the offer
for a maximum number or value of +securities (i.e. a maximum
acceptance condition)?
Is the maximum acceptance unit based or dollar based?
Please enter the maximum acceptance value
$ 50,000
Describe all the applicable parcels available for this offer in number of securities or dollar value
Right to subscribe for up to NZ $50,000 in new shares. Applicable parcels to be determined.
Offer price details
Has the offer price been determined?
In what currency will the offer
No
Dollar based ($)
Yes
No
No
No
No
No
Dollar based ($)
Yes
No
No
No
No
No
Dollar based ($)
Yes
No
No
No
No
Appendix 3B - Proposed issue of securities
Appendix 3B - Proposed issue of securities
5 / 9
In what currency will the offer
be made?
NZD - New Zealand Dollar
How and when will the offer price be determined?
Same price as Placement
Oversubscription & Scale back details
Will a scale back be applied if the offer is over-subscribed?
Describe the scale back arrangements
To be confirmed.
Will these +securities rank equally in all respects from their issue date with the existing issued
+securities in that class?
Part 4C - Timetable
4C.1 Date of announcement of +security purchase plan
29/5/2025
4C.2 +Record date
28/5/2025
4C.3 Date on which offer documents will be made available to investors
11/7/2025
4C.4 Offer open date
11/7/2025
4C.5 Offer closing date
25/7/2025
4C.7 +Issue date and last day for entity to announce results of +security
purchase plan offer
1/8/2025
Part 4E - Fees and expenses
4E.1 Will there be a lead manager or broker to the proposed offer?
4E.2 Is the proposed offer to be underwritten?
4E.3 Will brokers who lodge acceptances or renunciations on behalf of eligible +security holders be paid a
handling fee or commission?
No
No
Yes
Yes
Yes
Yes
Yes
Yes
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4E.4 Details of any other material fees or costs to be incurred by the entity in connection with the proposed offer
Standard legal, registry costs and corporate advisory fees to Cameron Partners in line with customary levels for
transactions of this nature.
Part 4F - Further Information
4F.01 The purpose(s) for which the entity intends to use the cash raised by the proposed issue
Raise capital to ensure the company has the resources and capacity to capitalise on its recent clinical and commercial
milestones, grow into non-Medicare channels and regain Medicare coverage
4F.1 Will the entity be changing its dividend/distribution policy if the proposed offer is successful?
4F.2 Countries in which the entity has +security holders who will not be eligible to accept the proposed offer
All jurisdictions except New Zealand
4F.3 URL on the entity's website where investors can download information about the proposed offer
https://www.pacificedgedx.com/
4F.4 Any other information the entity wishes to provide about the proposed offer
Pacific Edge reserves the right to extend the share purchase plan to shareholders / beneficial owners with a registered
address in Australia, subject to obtaining any necessary relief. If Pacific Edge decides to do so, it will provide details when
it releases a further Corporate Action Notice to the NZX and an updated Appendix 3B.
The Record Date for the share purchase plan is yet to be determined. It is currently anticipated that it will be in
July/August. PEB will release a further Corporate Action Notice and updated Appendix 3B when this is determined.
The Ex Date for the share purchase plan is yet to be determined. It is currently anticipated that it will be in July/August.
PEB will release a further Corporate Action Notice and updated Appendix 3B when this is determined.
The Closing Date for the share purchase plan is yet to be determined. It is currently anticipated that it will be in
July/August. PEB will release a further Corporate Action Notice and updated Appendix 3B when this is determined.
The Record Date for the share purchase plan is yet to be determined. It is currently anticipated that it will be in
July/August. PEB will release a further Corporate Action Notice and updated Appendix 3B when this is determined.
No
No
Appendix 3B - Proposed issue of securities
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Part 7 - Details of proposed placement or other issue
Part 7A - Conditions
7A.1 Do any external approvals need to be obtained or other conditions satisfied before the placement or other
type of issue can proceed on an unconditional basis?
7A.1a Conditions
Approval/Condition
+Security holder approval
Date for determination
11/7/2025
Is the date estimated or
actual?
** Approval
received/condition met?
Comments
Yes. The placement is conditional on PEB obtaining all necessary or desirable shareholder approvals, and all necessary
regulatory approvals, to complete the placement.
Part 7B - Issue details
Is the proposed security a 'New
class' (+securities in a class that is
not yet quoted or recorded by ASX)
or an 'Existing class' (additional
securities in a class that is already
quoted or recorded by ASX)?
Will the proposed issue of this
+security include an offer of
attaching +securities?
Details of +securities proposed to be issued
ASX +security code and description
PEB : ORDINARY FULLY PAID FOREIGN EXEMPT NZX
Number of +securities proposed to be issued
150,000,000
Offer price details
Are the +securities proposed to be issued being issued for a cash
consideration?
In what currency is the cash
consideration being paid?
NZD - New Zealand Dollar
What is the issue price per
+security?
NZD 0.10000
AUD equivalent to issue price amount per +security
0.093000
FX rate (in format AUD 1.00 / primaryFX rate (in format AUD rate/primary
Yes
No
Existing class
Estimated
Yes
Appendix 3B - Proposed issue of securities
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FX rate (in format AUD 1.00 / primary
currency rate):
AUD 1.00
FX rate (in format AUD rate/primary
currency rate) Primary Currency rate
NZD 1.08000000
Will these +securities rank equally in all respects from their issue date with
the existing issued +securities in that class?
Part 7C - Timetable
7C.1 Proposed +issue date
11/7/2025
Part 7D - Listing Rule requirements
7D.3 Will any of the +securities to be issued be +restricted securities for the purposes of the listing rules?
7D.4 Will any of the +securities to be issued be subject to +voluntary escrow?
Part 7E - Fees and expenses
7E.1 Will there be a lead manager or broker to the proposed issue?
7E.2 Is the proposed issue to be underwritten?
7E.4 Details of any other material fees or costs to be incurred by the entity in connection with the proposed issue
Standard legal, registry costs and corporate advisory fees to Cameron Partners in line with customary levels for
transactions of this nature.
Part 7F - Further Information
7F.01 The purpose(s) for which the entity is issuing the securities
Raise capital to ensure the company has the resources and capacity to capitalise on its recent clinical and commercial
milestones, grow into non-Medicare channels and regain Medicare coverage.
7F.1 Will the entity be changing its dividend/distribution policy if the proposed issue proceeds?
7F.2 Any other information the entity wishes to provide about the proposed issue
7F.3 Any on-sale of the +securities proposed to be issued within 12 months of their date of issue will comply with
the secondary sale provisions in sections 707(3) and 1012C(6) of the Corporations Act by virtue of:
No
No
No
No
No
Yes
Appendix 3B - Proposed issue of securities
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the secondary sale provisions in sections 707(3) and 1012C(6) of the Corporations Act by virtue of:
An applicable ASIC instrument or class order
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.