Medicare Coverage of Cxbladder Expected to Cease

7 June 2023
MEDICARE COVERAGE OF CXBLADDER EXPECTED TO CEASE
DUNEDIN, New Zealand – Cancer diagnostics company Pacific Edge (NZX, ASX: PEB) today
announces Medicare coverage of Cxbladder tests in the US market is expected to cease from 17 July
2023.
This development follows the finalization of a Local Coverage Determination (LCD) (L39365) by
Novitas, the Medicare Administrative Contractor (MAC) with jurisdiction for Pacific Edge’s laboratory in
Hershey Pennsylvania.
The finalized LCD, which includes Cxbladder and tests provided by other companies, specifically notes
the Cxbladder tests Triage, Detect, Monitor, Resolve and Detect
+
as ‘not considered medically
reasonable and necessary’, the threshold required for coverage under the US Social Security Act. A
number of other companies are also affected by the LCD.
Over the coming days Pacific Edge will seek to explore all available legal options (including a potential
appeal) with our US-based lawyers, the key opinion leaders among our customers, our partners at The
Coalition for 21
st
Century Medicine, and other impacted companies.
As a direct result of the LCD, Pacific Edge’s revenue is expected to reduce substantially from current
levels until Cxbladder tests regain coverage. In the year ended March 2023 (FY 23), tests for Medicare
and Medicare Advantage were ~60% of US commercial tests, or ~13,800 tests, and generated ~$15.3
million, or 77.3%, of FY23 total operating revenue. Post 17 July 2023 all of these tests are expected to
be impacted by this determination from Novitas.
Pacific Edge Chief Executive Dr Peter Meintjes says the company is surprised and disappointed with
the finalized LCD. He says the local coverage determination appears to materially misunderstand the
important role that biomarkers can play in “first line” diagnostics for risk stratifying patients with
hematuria into those that would benefit from further potentially more invasive medical attention and
those that would not.
Pacific Edge has consistently sought to enhance and to strengthen its research and evidence base with
a particular focus on its clinical evidence generation program over the last 18 months under the
company’s new CEO, Peter Meintjes, further accelerated since Dr. Tamer Aboushwareb joined as the
VP of Medical Affairs, now leading the medical organization as CMO. The current program focuses on
analytical validity (AV), clinical validity (CV) and clinical utility (CU) in defined patient populations, with
conventional end points and at sufficient sample size for future inclusion in guidelines.
“While Novitas appears to have reviewed all available evidence for Cxbladder, we believe that Novitas’
analysis has sought to predominantly emphasize negative comments in Cxbladder publications. We
believe that focusing predominantly on only negative comments likely mischaracterizes issues or
confounding factors with our evidence that were addressed in subsequent publications and routine
commercial testing, while also dismissing the support Cxbladder receives from key opinion leading
urologists, and the US patient advocacy group BCAN (Bladder Cancer Advocacy Network). Importantly,
urologists have identified the value for themselves and their patients as demonstrated by the record
number of urologists using the test, 1,151 in FY23Q4, and the record growth in Cxbladder testing
volume at 43% CAGR for the last two years.

“Molecular diagnostics is a developing field, and this LCD has made an unprecedented move to change
the threshold regarding what’s acceptable evidence and what’s not, by relying on third-party databases
1

that do not adequately cover the current standard of care in bladder cancer diagnosis. Consequently,
Novitas does not appear to acknowledge that Pacific Edge’s products improve the standard of care in
bladder cancer diagnosis and does not appear to consider the benefits of non-invasive testing
alternatives and may result in worse outcomes for patients” Dr Meintjes says.
Private healthcare payers in the USA make independent medical policy decisions and consequently
Pacific Edge expects to continue to bill and receive reimbursement from contracted US payers without
interruption and from non-contracted private payers in line with historic reimbursement rates. Notably,
our largest US customer Kaiser Permanente is expected to continue payment for our Triage and Monitor
products, irrespective of the Novitas determination. We also expect continued reimbursement for the
small proportion of patients insured by the US Veterans Administration and other direct bill payers.
Pacific Edge is currently unable to fully determine the impact of the new LCD on test volumes in the US
market for the 2024 financial year. For the immediate future, the company will continue to promote
Cxbladder and process all tests ordered by US clinicians whilst it further considers its strategy and
future options.
The company believes that in the short term it is prudent to continue to support Cxbladder as it
determines the best path forward, but the approach will be accompanied by cost containment initiatives
including, but not limited to an immediate hiring freeze and a halt on discretionary spending and new
capital expenditure.
“We see this LCD as a delay to our future commercialization plans. Now that Novitas has codified their
views in a finalized LCD, we are able to consider and assess the potential necessary adjustments
required to regain Medicare coverage. The generation of clinical evidence that supports the further
integration of Cxbladder into clinical practice is expected to be at the foundation of these efforts.
Chief Medical Officer, Dr Tamer Aboushwareb notes: “The language and framework adopted in this
LCD has reinforced our recent decision to develop and commercialize Cxbladder Detect
+
as a single
test for hematuria evaluation. The clinical evidence for Detect
+
has, and will be, developed in a more
structured framework for AV, CV and CU, using a defined patient population, conventional end points
and a sample size sufficient for future inclusion in guidelines.
“By building a solid and focused clinical development plan based on the foundations of AV, CV and CU
(which are requirements for guidelines inclusion and coverage), the Detect
+
test will likely be the
strongest candidate for future potential inclusion in both the NCCN
2
and AUA
2
guidelines for the
stratification of microscopic hematuria patients. We have an ongoing study (DRIVE) expected to be
ready for publication by early 2024 and another two validation studies (microDRIVE, and AUSSIE) set
to start soon with a target completion date at the end 2024,” Dr Tamer Aboushwareb says.
In light of this new LCD, management and the Board at Pacific Edge are reviewing the scenario planning
commenced last year to determine a strategic path forward that potentially includes: a) legal challenges

1
The finalized LCD relies on three knowledge bases to determine coverage. They are Clinical Genome Resource (ClinGen);
National Comprehensive Cancer Network (NCCN); Oncology Knowledge Base (OncoKB) knowledge bases.
2
NCCN: National Comprehensive Cancer Network; AUA American Urological Association.

or appeals, b) seeking to regain coverage through Novitas, c) seeking to be awarded coverage through
an alternative MAC, d) alternative billing practices that would increase patient responsibility and e)
remaining open to other strategic alternatives.
Which of these we adopt, will be determined by considering a number of factors including the potential
impact on revenue, expenditure and cash reserves, the time and resources required to regain coverage,
shareholder value implications, and the expected likelihood of success.
Chairman Chris Gallaher notes: “Pacific Edge is well funded with cash and cash equivalents and short-
term deposits of $77.8 million at the end of March 2023. Despite this current setback, the company
believes that it can still deliver on the significant opportunities we see for Cxbladder in the US and
around the world. We will update the market as we gain greater clarity and have determined our
strategic path forward.”
A copy of the LCD can be downloaded from the following link: HERE
Pacific Edge is holding a conference call at 11.00am (NZT) today (Wednesday 7 June 2023)
Webcast link: www.virtualmeeting.co.nz/pebjun23
Phone participation: NZ: 0800 449 170; AUS 1800 896 574

Released for and on behalf of Pacific Edge by Grant Gibson Chief Financial Officer.
For more information:
Investors: Media:
Dr Peter Meintjes Richard Inder
Chief Executive The Project
Pacific Edge P: +64 21 645 643
P: 022 032 1263

OVERVIEW
Pacific Edge: www.pacificedgedx.com
Pacific Edge Limited (NZX/ ASX: PEB) is a global cancer diagnostics company leading the way in the
development and commercialization of bladder cancer diagnostic and prognostic tests for patients
presenting with hematuria or surveillance of recurrent disease. Headquartered in Dunedin, New
Zealand, the company provides its suite of Cxbladder tests globally through its wholly owned, and CLIA
certified, laboratories in New Zealand and the USA.
Cxbladder: www.cxbladder.com
Cxbladder is a urine-based genomic biomarker test optimized for the detection and surveillance of
bladder cancer. The Cxbladder evidence portfolio developed over the past 14 years includes more than
20 peer reviewed publications for primary detection, surveillance, adjudication of atypical urine cytology

and equivocal cystoscopy. Cxbladder is the focal point of numerous ongoing and planned clinical
studies to generate an ever-increasing body of clinical utility evidence supporting adoption and use in
the clinic to improve patient health outcomes. Cxbladder is reimbursed by CMS and has been trusted
by over 4,400 US urologists in the diagnosis and management of more than 100,000 patients, including
the option for in-home sample collection. In New Zealand, Cxbladder is accessible to 75% of the
population via public healthcare and all residents have the option of buying the test online.

---

Pacific Edge
NOVITAS LCD DECISION
Investor presentation
Chris Gallaher
Chairman
Dr Peter Meintjes
Chief Executive
7 June 2023
PacificEdge’sordinarysharestradeontheNZXand
theASXunderthetickercode:PEB

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By receiving this presentation, you agree to the above terms and
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2

NOVITAS DETERMINATION TIMELINE
3
•July 2020
•Novitas informs Pacific Edge that Cxbladder is covered under LCD 35396 with a comment in Local Coverage Article (A58529) “the CxBladdertest is now covered
utilizing the reasonable and necessary guidelines”
•June 2022
•Novitas proposed a new approach to Cxbladder coverage in Draft LCD (DL39365/DL3967) and a Draft Local Coverage Article (DA59125)
•Seeks to link coverage relying to third party knowledge bases
1
•Cxbladder not mentioned in the LCD or LCA
•July 2022
•Revision of the draft explicitly excluded Cxbladder from coverage, Pacific Edge shares put in trading halt and the market notified of the new draft determination
•Pacific Edge advised that cessation of Medicare coverage had a low chance of succeeding, was unprecedented and unlawful (21st Century Cures Act).
•July 2022 – September 2022
•With customers, the patient advocacy group BCAN (Bladder Cancer Advocacy Network) and our industry partner the Coalition for 21st Century Medicine (C21) and
several other affected diagnostic test companies submitted written comments for consideration supported by in person representations.
•September 2022 – May 2023
•Contingency planning underway for multiple outcomes amid expectations that coverage would be maintained.
•November 2022
•A58529 is retired and Pacific Edge is guided by Novitas to use A58917 as the basis for coverage with Medicare Advantage Plans
•January 2023
•Triage gains coding and then coverage under the older LCD (L35396) based on it being included in the LCA 58917
•2 June 2023 (June 3 NZT):
•Novitas finalized draft LCD (L39365), noting multiple tests, including Cxbladder Triage, Detect, Monitor, Resolve and Detect
+
as ‘not considered medically reasonable
and necessary’.
•17 July 2023:
•Medicare coverage of Cxbladder to cease
1
The knowledge bases are Clinical Genome Resource (ClinGen); National Comprehensive Cancer Network (NCCN); Oncology Knowledge Base (OncoKB)

NOVITAS DETERMINATION HAS A SIGNIFICANT IMPACT ON PACIFIC EDGE
4
•Cxbladder has a majority Medicare and Medicare
Advantage population; average age of 73 for
presentation with hematuria
•In FY23, Medicare and Medicare Advantage
delivered 13,800 tests (~60%) of US commercial
Cxbladder tests generating ~$15.3m in total
operating revenue (~77.3%)
PACIFIC EDGE US COMMERCIAL TEST VOLUMES
Finalized LCD (L39365) notes Cxbladder tests ‘not considered
medically reasonable and necessary’, the threshold required for
coverage under the US Social Security Act, based on:
•Insufficient validation in confounding clinical
circumstances
•Population and gender biases
•High numbers of false positives
•Questions credibility of Pacific Edge funded research
•L39365 is focused on diagnostic, prognostic and predictive tests
following or as an adjunct to a confirmed pathological diagnosis
of cancer
•Novitas continues to reimburse Pacific Edge at US$760/test, but
this is expected to cease on 17 July 2023
NOVITAS SUMMARY CONCLUSIONS
9,712
15,752
23,072
-
5,000
10,000
15,000
20,000
25,000
FY 21FY 22FY 23
TEST VOLUME
MEDICARE COVERS >61.5M US CITIZENS OVER 65
Novitas is the Medicare Administrative
Contactor (MAC) with jurisdiction for
Pacific Edge’s US laboratory.
▲
46%

NOVITAS MISUNDERSTANDS THE VALUE OF CXBLADDER TO UROLOGISTS
5
WHERE WE AGREE WITH NOVITAS:
•Molecular diagnostics is a developing field, and it is important to assess genetic testing in the
context of oncology with a rigorous, evidence-based approach to facilitate the appropriate testing
for all eligible Medicare beneficiaries
•The review of Pacific Edge’s evidence emphasized negative comments and confounding factors
where further research and evidence can and are being undertaken – all research was peer reviewed
and published in well-respected journals
WHERE WE DISAGREE WITH NOVITAS:
•Does not acknowledge the support Cxbladder is attracting from urologists the US with 1151
clinicians ordering in Q4FY23 and rapidly growing testing volume of 43% CAGR over the last 2 years
•Misunderstands the value of non-invasive primary ‘first line’ testing
•Misunderstands the value of our tests in the context of the current AUA standards of urological care:
•Does not consider hematuria as substantiated suspicion of bladder cancer. Current guidelines
recognize this and require a cystoscopy, many of which Cxbladder can safely avoid
•Misunderstands the central value proposition of tests like Cxbladder with high NPV in that
they allow urologists to reduce unnecessary tests and procedures
•Misunderstands how to interpret a positive result, i.e. that physicians should continue the
evaluation of the patient for any other cause of disease, includingupper tract assessment
•The LCD is an unprecedented change to the threshold and mechanism regarding what’s acceptable
evidence and what’s not
TRIAGE
Used in primary care to:
•Assist clinicians to safely de-intensify
hematuria evaluation from low incidence
populations
•Sensitivity 95% / NPV 99%
DETECT
Used in primary and secondary care:
•Assist clinicians to adjudicate diagnostic
dilemmas (e.g., equivocal cystoscopy &
atypical cytology) in any patient population
•Sensitivity 82% / Specificity 85% / NPV
97%
MONITOR
Used in bladder cancer surveillance to
•Assist clinicians in monitoring for UC
recurrence. Intended to reduce the
frequency of surveillance cystoscopy and
improve patient compliance
•Sensitivity 93% / NPV 97%
Sensitivity: the likelihood of the test to be positive in a patient with the disease
Specificity: the likelihood of the test to be negative when the patient does not have the disease;
NPV: the likelihood of a negative test being a true negative.

STRATEGIC OPTIONS: SHORT-TERM
CONTAINING COSTS AS WE REVIEW STRATEGY
6
•Continue to promote Cxbladder and process all tests ordered
by US clinicians with the current team
•Cost containment including, but not limited to immediate
hiring freeze, and a halt on discretionary spending and new
CAPEX
•Contracted payers (Kaiser, VA and other minor health plans)
will continue to be billed and we expect to receive
reimbursement from them in line with historic rates.
The Kaiser Health Plan covers >12.5m members
•2 Kaiser sites in PEB’s Top 20 Accounts. 14 Kaiser sites
across Southern California ordering in FY23
•EMR software development and integration testing
complete; KP and PE working towards “go live”
The Veterans Administration serves >9m veterans each year
•DRIVE
1
clinical study, has enrolled 80% of target patients
•DRIVE is a key engagement with VA urologists to
determine clinical validity in a cohort of VA patients
TAKING A PRUDENT APPROACH
1
Detail of Pacific Edge’s clinical studies are included in the appendix to this presentation.

STRATEGIC OPTIONS: LONGER TERM
ENSURING WE ARE RIGHT-SIZED IN LIGHT OF THE LCD
7
CLINICAL EVIDENCE SETS THE PATH TO REGAINING MEDICARE COVERAGE
•Reconfiguring the evidence generation program over the last 12-18
months has refocused and accelerated our path to guideline inclusion
and regaining Medicare coverage
•Detect
+
will be the strongest candidate for inclusion in the NCCN and
AUA guidelines as single product for hematuria evaluation
•Clinical studies accelerated
1
:
•DRIVE ready for publication in CY24
•microDRIVE, and AUSSIE target completion in end of CY24
REVIEWING OUR BUSINESS IN LIGHT OF THE LCD
•Management and Board are reviewing the scenario planning
commenced last year to determine a path forward that includes
•Legal challenges or appeals
•Regaining coverage through Novitas
•Regaining coverage through an alternative MAC
•Alternative billing practices, such increasing patient responsibility
•Other strategic alternatives
•Impact on revenue, expenditure, cash reserves, required time and
resources to regain coverage and shareholder value are determinative.
•Management and Board are committed to right-size the business to fit
any revision to strategy
1
Detail of Pacific Edge’s clinical studies are included in the appendix to this presentation.
•Most influential and largest urologicalassociation in
the world with 23,000 members worldwide.
•Standards of care relevant to Cxbladder are hematuria
and micro-hematuriamanagement and non-muscle
invasive bladder cancer (NMIBC) (allows for
biomarkers in surveillance)
•Guidelines reviewed as new evidence emerges
www.auanet.org
•US-based not-for-profit alliance of 32 leading US
cancer centres
•Bladder cancer standard suggests biomarkers may be
considered during surveillance of high-risk non-
muscle-invasive bladder cancer
•Guidelines reviewed annually. PEB will resubmit in
every year where there is new peer-reviewed
evidence for Cxbladder
www.nccn.org

SUMMARY AND OUTLOOK:
•Disappointed by the new LCD
•Highlights some areas of improvement in Pacific Edge’s evidence
portfolio that either have been or are being addressed
•Does not acknowledge the value Cxbladder offers in the patient
diagnosis and management, or the record demand from urologists
•The single most important determinant of coverage is high-quality clinical
evidence
•The clinical evidence program has already been accelerated
•On the back of DRIVE, microDRIVE and AUSSIE, Detect
+
is the strongest
candidate for guidelines inclusion
•We will continue to bill and collect revenue from contracted payers in the US
and in APAC
•We have world-leading technology, a strong balance sheet with $77.8 million
cash on hand at the end of March
•Despite this setback we still expect to deliver on the significant opportunities
we see for Cxbladder in the US and around the world.
8

QUESTIONS
9

APPENDIX
10

CLINICAL EVIDENCE GENERATION TOWARDS GUIDELINE INCLUSION (1/2)
STUDYAIMLOCATIONSENROLLED
SITES*
STATUS**
STRATASafe Testing of Risk for AsymptomaTIc MicrohematuriA
Demonstrate the clinical utility (CU) of Cxbladder using a prospective, two-arm randomizeddesign to risk-stratify
patients and rule out from cystoscopy
•Establish CU for CxbladderTriage in MH populations to identify patients at low risk of bladder cancer that can
safely avoid cystoscopy
•Retrospective analysis with Cxbladder Detect+ to show equivalent or greater CU in MH populations with the
improved performance characteristics
•CU evidence supports AUA/NCCN guidelines inclusion usingCxbladderTriage and/or CxbladderDetect+ to risk
stratify MH populations
USA
Canada
11 / 13-Enrolment total is 492, including 113 ‘low
risk’ subjects that are the focus of the
study
-Target enrolment: ~600 patients,
including 120 low risk subjects
randomized to test arm
-Last patient in:Q3 2023
-Follow up: until Q3 2024
DRIVE
Detection and RIsk Stratification in VEterans Presenting with Hematuria
Prospectiverecruitmentof patients to a single-arm observational studytodemonstrate the CV of Cxbladder tests in
risk stratifying Veterans presenting with hematuria
•CV evidence for Triage in MH & GH patients supplementing NZ Studies
•Demonstrate CV of Cxbladder Detect+ within a Veterans cohort
•Retrospective analysis with Cxbladder Detect+ to demonstrate CV evidence supportingAUA/NCCN Guidelines
inclusion in MH & GH patients
•Contribute data to pooled-analysis to establish CV for Detect+ in MH patients
VA Sites (USA)10 / 11-Enrolment total is 562
-Target enrolment: ~600 patients
-Last patient in: Q3 2023
-Follow up: until Q2 2025
AUSSIEAustralian Urologic risk Stratification of patientS wIth hEmaturia
Prospectiverecruitmentof patients to a single-arm observationalstudyto demonstrateCV in an Australian
healthcare setting for patients presenting with hematuria
•Demonstrate CVof CxbladderDetect+ with an Australian cohort
•Demonstrate accurate risk stratification of hematuria patients to intensify or de-intensify evaluation
•Contribute data to pooled-analysis to establish CV for Detect+ in MH patients
Australia1 / 1-Enrolment due to start May 2023
*Estimated number of enrolled sites
**All dates are best-case estimates and subject to change
11

STUDYAIMLOCATIONSENROLLED
SITES*
STATUS**
Microhematuria
Pooled-analysis
Pooled-analysisof Cxbladder Detect+ performance from multiple studies involving prospectively recruited
patients from single-arm observational studies including eligible microhematuria patients
•CV of Cxbladder Detect+ withmicrohematuria (MH) patients
•Combines data from DRIVE, AUSSIE and a future MH-focused clinical trial
•CV evidence supports AUA/NCCN guidelines inclusion usingCxbladderDetect+ to risk stratify MH
populations
USA, AusN/A-DRIVE underway, AUSSIE and
microDRIVE projected to start in 2023
microDRIVE
Detection and RIsk Stratification in VEterans Presenting with Microhematuria
•Demonstrate the clinicalvalidity of Cxbladder Detect
+
in detecting urothelial cancer in patients
presenting with microhematuria.
•MicroDRIVE will compare the performance of Detect
+
against the current gold-standard for the
detection of urothelial cancer, diagnostic cystoscopy and pathology.
USA0/1-Projected to start recruitment
Sep/Oct 2023
-Target is 1000 patients and 50
tumour confirmed
-Last patient in: March/April 2024
LOBSTERLOngitudinal Bladder Cancer Study for Tumor REcurRence
Prospectiverecruitmentof patients to a single-arm observational study to evaluate the clinical validityof
CxbM
•To safely risk stratify patients under surveillance for recurrence of UC
•To demonstrate that it is safe to alternate CxbM with cystoscopy for intermediate and high-risk
patients under surveillance for recurrence of UC
•Targeting AUA/NCCN guidelines inclusion for biomarkers as an alternative to cystoscopy in a
surveillance setting
USA (including
some VA sites)
Australia
3 / 10-Three sites are open
-Two due to open in April
-Another 6 are at pre-activation.
-Enrolment is now 63 patients with 98
samples collected to date
-Each site will enroll 100 patients
within 12 months and follow up for
another 12 months
CLINICAL EVIDENCE GENERATION TOWARDS GUIDELINE INCLUSION (2/2)
*Estimated number of enrolled sites
**All dates are best-case estimates and subject to change
12

SUMMARY OF CLINICAL EVIDENCE
StudyPop.TypeSensitivity (Sn)NPVSpecificity (Sp)Comment
Detect+
AVLotan et al., 2022MH + GH*97%99.7%90%Pooled data from US and Singapore cohorts (n=804)
CV
DRIVE (unpublished) (1)MH + GH*Study in progress
AUSSIE (unpublished) (4)MH + GH*Study to start this year
microDRIVE (unpublished)
(5)
MH*Study to start this year
Triage
AVKavalieriset al., 2015MH + GH*95.10%98.50%45%Sn, Sp, NPV values when test-negative rate is 40%
CV
Davidson et al., 2019MH + GH*95.5% (1)98.6% (1)34.3%GH only: Sn (95.1%), NPV(98%), Sp(32.8%); MH only: Sn (100%), NPV (100%), Sp(42.6%)
Konetyet al., 2019(2)100%
Cxbladder (3) correctly adjudicated all UC confirmed patients (n=26) with atypical urine cytology
results (n=153, 4)
Lotan et al., 2022MH + GH*89%99%63%Pooled data from US and Singapore cohorts (n=804)
CU
Davidson et al., 2020MH + GH*89.4% (5)98.9% (5)59% (5)
39% of patients testing negative for Cxb Triage & imaging did not get cystoscopy & were
managed at primary care (6)
STRATA (unpublished) (7)MH + GH*Study in progress
Detect
AVO'Sullivan et al., 2012GH*81.8%97%85.1%CxbDetect detected 97% of HG tumors& 100% of Stage 1 or greater tumors.
CV
Lotan et al., 2022MH + GH*74%97%82%Pooled data from US and Singapore cohorts (n=804)
DRIVE (unpublished) (1)MH + GH*Study in progress
Monitor
AVKavalieriset al., 2017(1)88% (2)97% (2)N/A(3)
CVKonetyet al., 2019(4)100%
Cxbladder(5) correctly adjudicated all UC confirmed patients (n=26) with atypical urine cytology
results (n=153, 6)
CUKoya et al., 2020(7)
Integration of CxbMonitor into the surveillance schedule reduced annual cystoscopies (39%)
(8,9)
* Referred
MH: Microhematuria, GH: Gross Hematuria. For definitions of Sensitivity, NPV and Specificity please see the glossary on page 33 of this presentation
13

FOOTNOTES FOR CLINICAL EVIDENCE SUMMARY
Footnotes
Detect+
1Observational study to validate performance characteristics and clinical utility of Cxbladder tests (CxbTriage, CxbDetect, CxbDetect
+
).
2Observational study to validate performance characteristics of CxbDetect
+
in patients with UC of the upper tract.
3Patients with suspected upper tract UC (UTUC) or surveillance patients with a history of UTUC.
4Observational study to validate performance characteristics and clinical utility of Cxbladder tests (CxbTriage, CxbDetect, CxbDetect
+
).
5Observational study to validate performance characteristics of CxbDetect
+
in microhematuria(MH) patients.
Triage
1CxbTriage performance; CxbTriage & imaging combined performance had a Snof 97.7% & NPVof 99.8%.
2Patients included hematuriaevaluation (n=436) or surveillance previously diagnosed with UC (n=416) with both Cxbladder& urine cytology results.
3Cxbladder includes Cxbladder Triage & Cxbladder Monitor.
4This included n=70 for patients with hematuria& n=83 for patients with previously diagnosed UC and overall test negative rate of 30.7%.
5CxbTriage performance; CxbTriage & imaging combined performance had a Snof 98.1%,NPV of 99.9% & Spof 98.4%.
6CxbTriage negative rate was 53%; Follow-up period of 21-months showed no missed cancers, demonstrating safety.
7The intent of STRATA is to show that it is safe to risk stratify low risk microhematuriapatients and not undertake cystoscopy.
Detect
1
Observational study to validate performance characteristics and clinical utility of Cxbladder tests (CxbTriage, CxbDetect, CxbDetect
+
).
Monitor
1Surveillance patients previously diagnosed with primary or recurrent UC.
2CxbMonitor performance characteristics on surveillance patients diagnosed with primary UC; CxbMonitor had a Snof 93% and NPV of 94% on patients with recurrent UC.
3Using Kavalieriset al., (2017) data set, Lotan et al., (2017) compared relative performance of CxbMonitor against NMP22 ELISA, NMP22 BladderChekand urine cytology.
4Patients included hematuriaevaluation (n=436) or previously diagnosed UC (n=416) with both Cxbladder& urine cytology results.
5Cxbladderincludes CxbladderTriage & CxbladderMonitor.
6This included n=70 for patients with hematuria& n=83 for patients with previously diagnosed UC; test negative rate of 30.7%.
7All patients were being evaluated for recurrence of UC (n=309 providing 443 samples).
8CxbMonitor identified all seven confirmed recurrence events idnetifiedon the first cystoscopy.
9Patients returning negative CxbMonitor results (n=235) had no pathology-confirmed recurrence at 1st cystoscopy
14

REFERENCES SUMMARY OF CLINICAL EVIDENCE
References
Detect+
Lotan et al., (2022). Urinary Analysis of FGFR3 and TERT Gene Mutations Enhances Performance of CxbladderTests and Improves Patient Risk Stratification.The Journal of Urology, 10-
1097.
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.
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.
Kavalieriset al., (2015). A segregation index combining phenotypic (clinical characteristics) and genotypic (gene expression) biomarkers from a urine sample to triage out patients presenting with hematuria
who have a low probability of urothelial carcinoma.BMC urology,15(1), 1-12.
Konety et al., (2019). Evaluation of cxbladder and adjudication of atypical cytology and equivocal cystoscopy.European urology,76(2), 238-243.
Lotan et al., (2022). Urinary Analysis of FGFR3 and TERT Gene Mutations Enhances Performance of CxbladderTests and Improves Patient Risk Stratification.The Journal of Urology, 10-1097.
Detect
Lotan et al., (2022). Urinary Analysis of FGFR3 and TERT Gene Mutations Enhances Performance of Cxbladder Tests and Improves Patient Risk Stratification.The Journal of Urology, 10-
1097.
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.
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.
Konety et al., (2019). Evaluation of cxbladder and adjudication of atypical cytology and equivocal cystoscopy.European urology,76(2), 238-243.
Koya et al., (2020). An evaluation of the real world use and clinical utility of the Cxbladder Monitor assay in the follow-up ofpatients previously treated for bladder cancer.BMC
urology,20(1), 1-9.
Lotan et al., (2017). Clinical comparison of noninvasiveurine tests for ruling out recurrent urothelial carcinoma. Urologic Oncology: Seminars and Original Investigations, 35 (8), 531-539.
15

GLOSSARY
•Sensitivity - the frequency with which a test correctly identifies patients with a disease.
•Specificity - 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: Develop a test that is repeatable in the lab for a given indication and population.
•Clinical validity: Make sure the test works in the same way on an independent eligible population for the given indication.
•Clinical utility: Put the test in the hands of a physician to establish that it can usefully change patient management within the
context of care for the defined population and indication.
16

PACIFIC EDGE: RESEARCH, INNOVATION, COMMERCIALIZATION
2001
2001
Pacific Edge
established
2007
2007
Commercial
pivot to
focus on
urothelial
cancer
diagnostics
2008
Holyoake et al: Urine-
based RNA detection
of urothelial cancer.
Clin Cancer Res
2008
2011
2010
Pacific Edge
Diagnostics
New Zealand
(PEDNZ)
established
2012
2012
O’Sullivan et al:
Cxbladder Detect
performance
validation.
Journal of Urology
Dec 2012
Launch of Pacific Edge
Diagnostics USAand
Cxb Detect
2013
Mar 2013
PEDUSA receives
CLIA
accreditation
May 2013
First commercial
sale (Cxb Detect)
for PEDNZ
Mar 2013
First commercial
sale (Cxb Detect)
for PEDUSA
2014
Dec 2014
Launch of Cxbladder
Triage
2015
Mar 2015
Kavalieris et al:
Cxb Triage
performance
validation. BMC
Urology
Dec 2015
Launch of
Cxbladder
Monitor
2016
Nov 2016
Clinical trials
commence in
Singapore
2018
Feb 2018
Cxb Triage
adopted into
Canterbury
Community Health
Pathways with
primary care
referral
2019
Aug 2019
Konety et al: Clinical
Utility of Cxb Detect
in adjudicating
atypical cytology and
equivocal
cystoscopy.European
Urology
2020
Apr 2020
Patient in-home
sampling initiated in
the US
Jun 2020
Kaiser Permanente,
approves commercial
use of Cxbladder
Jul 2020
CMS confirms
reimbursement of
Cxbladderat
$760/test
2021
Aug 2021
Cxbladder reaches
70% public
healthcare
coverage in NZ
Oct 2021
PEB raises
$103.5m
(~US$72.5m)
Dec 2021
First commercial
sale of Cxbladder
in Australia
2003
Listed on
the NZX
Cxbladder
TRIAGE
Cxbladder
DETECT
Cxbladder
MONITOR
2022
Dec2022
Lotan et al:
Enhanced
Cxbladder
Tests Deliver
Improved
Performance.
Journal of
Urology
17

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 3 479 5800 F +64 3 479 5801
email: investors@pacificedge.co.nz
www.pacificedgedx.com
18