Pacific Edge : Investor Update - Q1 FY23 Test Volumes Rise 32%

For personal use only

JULY 2022

INSIDE
From the CEO	2
Test volume progress	3
Executive appointments in the US	4
Clinical study progress	4
Greenlight at Kaiser	6
US succession	7
Gaining traction at US events	8

FROM THE CEO

EFFECTIVE ENGAGEMENT onlyACROSS THE CXBLADDER

VALUE CHAIN

DEAR SHAREHOLDERS,

useEffective communication and ngagement by Pacific Edge

across the breadth of stakeholders in the healthcare value chain is crucial to driving the adoption of our suite of advanced genomic biomarker Cxbladder tests.

As Pacific Edge seeks to

establish Cxbladder as the personalstandard of care for hematuria

evaluation and surveillance for the recurrence of urothelial cancer, there are many organizations and i dividual stakeholders with whom we must communicate effectively and engage in market. Foremost among these stakeholders are the clinicians. They order the tests, collect samples, administer associated paperwork and interpret the results. Then there are the patients taking the tests, the organizations funding them, the guidelines committees adjudicating

atient care protocols and our research collaborators building the evidence to support guideline inclusion.

For In this shareholder update, we highlight our enhanced focus on medical communications and our in-market activities in a few key areas. Firstly, at the start of this month, we appointed David Sosa into the new role of Vice President Market Access and Reimbursement (see page 4). This role is primarily responsible for driving additional revenue from various market access activities with government payors and private payors, increasing payment percentages and total revenue and looking at international

opportunities for growth, leveraging our US laboratory.

This follows on the appointment of Dr Tamer Aboushwareb into the new role of Vice President Medical Affairs in June. This role is responsible for the inbound enrolment of patients in our clinical studies to enhance our evidence generation program. Tamer will also drive the communication of existing and future clinical evidence to clinicians, provider administrations and payors.

"In this shareholder update, we highlight our enhanced focus on medical communications and our in-market activities in a few key areas."

Together, these positions elevate engagement and communication with key stakeholder groups.

David and Tamer will also play pivotal roles in the evolution of our commercialization strategies.

Secondly, we have increased our visibility at marquee conferences like the American Urological Association (AUA) annual conference (see page 8) and the total number of conferences we attend. Crucially, these activities, which are synergistic, are just a few among the myriad of channels we are using to engage with clinical stakeholders.

The recognition of the value we are creating similarly depends

on effective communication of our strategy and progress we are making against it to shareholders. For this reason, we have included quarterly test volumes in this update for the first time, an important leading indicator of the continued progress we are making commercializing Cxbladder. We have also provided historic figures to illustrate our progress quarter on quarter (see page 3).

Our intention is to report these figures to the NZX and ASX as soon as practicable after the end of each quarter, while continuing to deliver a comprehensive data set with our full and half year results in May and November of each year.

Before closing I want to pay tribute to Jackie Walker, who at the end of August, is retiring so stepping down as Chief Executive of Pacific Edge Diagnostics USA after 10 years with the company. She has made an enormous contribution to the business, including playing a key role is some of the company's most significant commercial achievements.

I want to thank her again on behalf of shareholders and personally for the way she has welcomed me into the business.

I look forward to seeing you at Pacific Edge's Annual Shareholder Meeting later this month.

Dr Peter Meintjes

Chief Executive

2 PACIFIC EDGE LIMITED INVESTOR UPDATE | JULY 2022

TEST VOLUME PROGRESS

BUILDING MOMENTUM FOR CXBLADDER IN THE US

onlyCxbladder test volumes continue to increase, building momentum from the early results we signaled in May.

Total tests processed at our laboratories set a record in the three months to the end of June 2022, and showed a quarter- on-quarter increase of 13% to

7,055 tests from the 6,242 tests useprocessed in the March 2022

quarter.

The result also represents an

increase of 32% over the June 2021 quarter result of 5,356 tests and reflects increasing numbers of US based unique ordering clinicians

In the Asia Pacific, where test numbers are dominated by New Zealand, volumes have been more muted, reflecting the local market's maturity relative to the US. At present 14 of the 20 new Health New Zealand, Te Whatu Ora, regional divisions representing 70% of the New Zealand population, cover the tests.

Total test volumes in the three months to the end of June in the APAC region increased 3% on the March 2022 quarter to 982 tests

from 952 but fell 9% on the 1,079 tests in the June 2021 quarter.

Longer term we believe the consolidation of the New Zealand healthcare system will be positive for the adoption of Cxbladder as engagement with the national health authority may accelerate the adoption across the remainder of New Zealand's population, and the focus will shift towards increasing awareness and adoption at primary care following the example set by Canterbury and the Manawatu.

using the test, an important

measure of market penetration. personalThis metric reached a record for the quarter of 894, up 36% from

the same quarter a year ago. Growth was weighted to the

US where test volumes showed a quarter-on-quarter increase of 15% to 6,073 from the 5,290 in the three months to the end of March 2022 and a 42% increase on the 4,277 in the June 2021 quarter.

These numbers are encouraging and evidence of continued delivery against plan. The increase in volumes reflects growing awareness of the role Cxbladder can play in safely de-intensifying or intensifying the clinical workup for patients presenting with hematuria (blood in urine), resolving diagnostic dilemmas

Forduring hematuria evaluation (e.g., equivocal cystoscopy and atypical cytology), and monitoring for the recurrence of urothelial cancer in posttreatment patients. It also reflects the continued easing of COVID restrictions.

Despite a comprehensive program of virtual engagement, these restrictions had been limiting in person visits with clinicians and conference meetings. Importantly, COVID restrictions had also played a role in reducing patient visits creating significant disruption to the traditional care paradigm.

TOTAL TESTING VOLUME (PACIFIC EDGE GROUP)

	8,000
						54%
	7,000					CAGR
											982
	6,000									952
	5,000					1,079	1,074	1,117
volume					1,073
4,000
		943
Test			1,088							6,073
	3,000
									5,290
		852						4,706	4,591
					4,277
	2,000				3,824
			3,110
			2,791
		2,133
	1,000
	-
		Q1 FY21	Q2 FY21	Q3 FY21	Q4 FY21	Q1 FY22	Q2 FY22	Q3 FY22	Q4 FY22	Q1 FY23
						US	NZ

UNIQUE ORDERING CLINICIANS (US)

	1000					48%
	900					CAGR
	800
	700
	600
Clinicians	500									894
								782
	400						689	740
						657
	300
			516	530
		411	462
	200
	100
	0	Q1 FY21	Q2 FY21	Q3 FY21	Q4 FY21	Q1 FY22	Q2 FY22	Q3 FY22	Q4 FY22	Q1 FY23

PACIFIC EDGE LIMITED INVESTOR UPDATE | JULY 2022

3

EXECUTIVE APPOINTMENTS IN THE US

DRIVING GROWTH WITH GREAT TESTS AND GREAT SERVICE

only	will also develop an understanding	a depth of experience in clinical,
Pacific Edge is working to drive
both the understanding of the	of our economic value proposition	medical research, and commercial
clinical evidence supporting our	among clinicians, hospital	roles in urological medicine in
tests as well as their adoption.	systems and payors and establish	Egypt and the US. He and his team
Clinicians, healthcare funders	Cxbladder in markets where we	will also be supporting market
and providers, patients and the	do not yet operate. Finally he will	access and reimbursement efforts
committees charged with setting	also build the right relationships	from a scientific and medical
standards of care need to be made	with strategic accounts like Kaiser	perspective.
aware of, and understand, the	Permanente and the US Veterans
use	Health Administration. David comes
	vidence. At the same time the
ordering and paying for the tests	to Pacific Edge with more than 25
and the results delivery needs to be	years' experience working with
	eamless.	diagnostic companies in the US.
	Clinicians, healthcare funders	Meanwhile, Dr Tamer
and providers, patients and the	Aboushwareb has been appointed
committees charged with setting	Pacific Edge's Vice President
standards of care also need to be	of Medical Affairs and will lead
made aware of, and understand,	a new team of five Medical
personal	Science Liaison Officers providing
the evidence. At the same time the
ordering and paying for the tests	medical and scientific leadership	David Sosa
	nd results delivery needs to be	for the company. The role is
seamless.	focused on engagement with
	Two appointments in June into	key opinion leaders in urology
	ew roles at Pacific Edge are aimed	and uro-oncology, the education
	at delivering on these goals.	of clinicians in the utility of our
	David Sosa has joined Pacific	products, the enrolment of patients
Edge as its new Vice President	into our clinical studies and the
Market Access and Reimbursement.	communication of our evidence
His position is focused on payor	generation program in conferences
	elations to increase payment	across the USA and internationally.
	ates from existing payors and	Dr Aboushwareb is a urologist
contracting with new payors. He	who comes to Pacific Edge with	Dr Tamer Aboushwareb
	CLINICAL STUDY PROGRESS
For
	MARKING THE STEPS TO GUIDELINE INCLUSION
	Two important clinical studies to	demonstrate how Cxbladder	tests to be inserted into the current
	help Pacific Edge advance its case	can safely risk stratify patients	American Urological Association
	for inclusion in global standards	presenting with hematuria into	(AUA) standard, and other global
	of urothelial cancer care passed	those that may receive a less-	care standards, as part of the
	important milestones.	intense evaluation for the presence	normal care management for those
	First, the Safe Testing of Risk	of bladder cancer and those that	patients.
	for Asymptomatic Microhematuria	should continue with a standard	Meanwhile, the Longitudinal
	(STRATA) clinical study has	evaluation.	Bladder Cancer Study for Tumor
	enrolled more than 50% of its	The results from STRATA will	Recurrence (LOBSTER), which is
	subjects. The aims to further	strengthen the case for Cxbladder	seeking to benchmark the utility

continued on page 5

4 PACIFIC EDGE LIMITED INVESTOR UPDATE | JULY 2022

	GUIDELINE STEPS CONTINUED FROM PAGE 4
	of Cxbladder against the AUA	a significantly higher	proportion	risks, discomfort, and anxiety
	protocols for the surveillance of	of patients than the current AUA	from cystoscopy and potentially
	recurrent urothelial cancer, has	guidelines, translating to greater	overcome entrenched patient non-
	enrolled its first patient.	focus on patients with disease.	compliance with management and
		Both studies are key							surveillance regimes.
	components of Pacific Edge's							Finally, a third study the
		"	... the studies are
	c inical evidence generation			company is conducting with the
	program. Current AUA risk			aimed at further		US Veterans Health Administration
	stratification protocols based			reinforcing the potential		- the Detection and Risk
	on clinical risk factors alone are				Stratification in Veterans Presenting
		for Cxbladder to reduce
	insufficient to reliably de-intensify			with Hematuria (DRIVE) study
		the burden of invasive
	urological evaluation for low-risk			- has expanded the number of
only				cystoscopic evaluations"		actively enrolled sites by three to
	patients. We expect the STRATA
	study to demonstrate how							ten. The VA covers over 9 million
	Cxbladder can satisfy this unmet							patients and includes 171 Medical
	need.			The LOBSTER study is aimed	Centers and 1,113 outpatient
		At present the AUA	at reinforcing the potential of	sites, representing a significant
	microhematuria guideline	Cxbladder to assist clinicians	opportunity for Cxbladder.
	recommends a shared patient-	in reducing the frequency of	The DRIVE clinical study is an
	physician decision whether to	cystoscopies for patients under	important engagement with VA
	proceed with cystoscopy for	surveillance for the recurrence of	urologists to determine utility in a
use		as low-risk, a	urothelial cancer.				cohort of VA patients, but it also
For personal	patients classified
cohort that currently represents		In both cases the studies	has relevance to the AUA. As the
only 5% of referred patients	are aimed at further reinforcing	study nears completion, Pacific
presenting with hematuria. We	the potential for Cxbladder to	Edge expects to slowly migrate the
expect the STRATA study to	reduce the burden of invasive and	study sites and other VA sites to
demonstrate how Cxbladder can	expensive cystoscopic evaluations,	commercial adoption as part of a
safely de-intensify evaluation for	spare patients the potential	site-by-site rollout.
	Study	Locations			Enrolled sites*		Progress and targets
	STRATA	USA, Canada		10/11		- 50% enrolled
			- Full data targeted Q4 2023
	DRIVE	USA		7/11		- Full data collected mid 2025
	LOBSTER	USA, Australia		2/10		- First patient enrolled
			- Full data targeted 2025

1 AUA Guideline and Woldu SL, Ng CK, Loo RK, Slezak JM, Jacobsen SJ, Tan WS, et al. (2021a). "Evaluation of the New American Urological Association Guidelines Risk Classification for Hematuria." J Urol 205(5): 1387-1393

*Intiated and enrolled

PACIFIC EDGE LIMITED INVESTOR UPDATE | JULY 2022

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