brainstorm cell therapeutics€¦ · u.s. annual market opportunity 7 prostate cancer is the most...

CORPORATE

PRESENTATIONAugust 2020

Corporate Presentation I©2020. All rights reserved

This presentation contains forward-looking statements & estimates made by the management of the Company with respect to the

anticipated future performance of MDxHealth & the market in which it operates. Such statements & estimates are based on various

assumptions & assessments of known & unknown risks, uncertainties & other factors, which were deemed reasonable when made but

may or may not prove to be correct. Actual events are difficult to predict & may depend upon factors that are beyond the Company’s

control. Therefore, actual results, the financial condition, performance or achievements of MDxHealth, or industry results, may turn out to

be materially different from any future results, performance or achievements expressed or implied by such statements & estimates. Given

these uncertainties, no representations are made as to the accuracy or fairness of such forward-looking statements & estimates.

MDxHealth disclaims any obligation to update any such forward-looking statement or estimates to reflect any change in the Company’s

expectations with regard thereto, or any change in events, conditions or circumstances on which any such statement or estimate is based,

except to the extent required by Belgian law.

Forward Looking Statement

2

Any opinions, estimates or forecasts made by analysts are theirs alone and do not represent opinions, forecasts or predictions of

MDxHealth or its management. Requests for copies of analyst reports should be directed at the respective analyst and institution.

Analyst Coverage

Providing clinically actionable information

to improve patient outcomes

Improving patient care while reducing

medical costs

Providing a value-based experience for

patients, clinicians and providers

Delivering life changing genomic

technologies to improve the early

detection of prostate cancer

Corporate Presentation I

Ticker: MDXH.BR

© 2020. All rights reserved 3

©2020. All rights reservedCorporate Presentation I

Experienced Leadership Team

Proven track record of success

John BellanoChief Commercial Officer

Michael K. McGarrityChief Executive Officer

Joseph SolleeExecutive Vice President

Corp. Dev. & General Counsel

Ron KalfusChief Financial Officer

Miriam ReyesExecutive Vice President

Laboratory Operations

4


Two clinically validated, commercially established,

revenue generating diagnostic tests for prostate

cancer

Address unmet need to reduce diagnostic uncertainty,

overdiagnosis and healthcare costs by informing better

treatment decisions in prostate cancer

Scalable commercial, reimbursement and medical

infrastructure, which will drive expanded market

adoption

Novel tests are based on proprietary genetic, epigenetic

(methylation) and other molecular technologies to assist

physicians with the diagnosis of urologic cancers

Current tests have Intellectual Property protection with

comprehensive portfolio of both issued and pending patents

Investment Highlights

5

Experienced management team comprised of industry

leaders in diagnostics and life sciences, with proven track

record in commercial and operating execution

Financial leverage to drive growth into current customer

base and as well as expanded applications in the prostate

cancer clinical utility pathway


Current Challenges with Diagnosing Prostate Cancer in the U.S.

2020 ACS Surveillance Research

6

3 million elevated PSA results annually(1-2)

of biopsies do not reveal

cancer and may lead to

increased complications and

hospitalization(3-6)

of negative biopsies are false

negatives leading to invasive

and costly interventions(7,8)

500,000 men undergo biopsies annually

191,930

116,300

78,30062,100 60,190

PROSTATE LUNG & BRONCHUS

COLON & RECTUM

URINARY BLADDER

MELANOMA OF THE SKIN

#1 Most Common Cancer in U.S. Men

72,500

33,33028,630 24,640

20,020

LUNG & BRONCHUS

PROSTATE COLON & RECTUM

PANCREAS LIVER & BILE DUCT

#2 Deadliest Cancer in U.S. Men

60%

30%


U.S. Annual Market Opportunity

7

Prostate Cancer is the Most Common Cancer in American Men

Estimated 3M

Men eligible for → $1.5B Market Opportunity

Who needs

a biopsy?

Who needs a

repeat biopsy?

>10% of tests

are elevated

~60% of biopsies

are negative

25MPSA tests

performed

500KProstate biopsies

performed

200KNew prostate

cancer cases

3MLiving with prostate

cancer

33,350Estimated Deaths

Who needs

treatment?

Estimated 300K

Men eligible for → $500M Market Opportunity


MDxHealth’s Prostate Cancer Menu

Positive

Negative

No Cancer

Cancer

Positive

Negative

Improving the decision for

initial prostate biopsy

Improving the decision for

repeat prostate biopsy

Routine Screening

Biopsy /Imaging

8

Clinical Pathway for Diagnosing Aggressive Prostate Cancer

Biopsy /Imaging


• Non-invasive “Rule-out”: Help improve the detection of clinically significant cancer by avoiding approximately half of excess prostate biopsies.

• 95% Negative Predictive Value3 for clinically significant prostate cancer

• Included in the NCCN & EAU guidelines4

• Cost effectiveness study demonstrated SelectMDx potential cost savings of >$500 million to U.S. health care system5 and >14,000 QALY gained5

Improved Patient Selection Prior to Prostate Biopsy

9

The most highly predictive test to help identify men at low risk for aggressive prostate cancer

of initial biopsies do

not reveal prostate

cancer(1,2)

~ 60%

Abnormal PSA/DRE

Binary Actionable Results for

patient and HCP

Positive

NegativeRoutinelyMonitor

Biopsy

95% NPV

At risk for

aggressive cancer?


: Robust Clinical Evidence

12 published studies on genes and technology (> 3,500 patients)

10

Pivotal Clinical Studies

Analytical ValidationHessels et al.,

Translational Medicine Communications 2017

>$500M In Savings To Health Care SystemGovers et al.,

Journal of Urology 2018

Clinically Validated For a 95% NPVHaese et al.,

Journal of Urology 2019

Significantly Impacts Prostate Biopsy Decision MakingShore et al., Urology Practice 2019

Clinical Utility Clinical Validity Analytical Validity Health Economics


• Non-invasive tissue biopsy test

• 96% Negative Predictive Value3 for clinically significant prostate cancer

• >55 published studies on genes and technology

• Included in EAU and NCCN guidelines4,5

• Covered by Medicare & commercial payers

• Significant potential savings to the health system

11

The only epigenetic test to identify men at risk for aggressive prostate cancer

12-core needle biopsy could miss the mark

Positive

NegativeAvoid Rebiopsy

/MRI

Rebiopsy

MRI

of men with a negative

biopsy result actually have

prostate cancer (1,2)

~30%

Negative biopsy 96% NPV3

Cancer

Biopsy Core Needles

Prostate

Biopsy Core

Prostate

Cancer

Urethra

Field Effect

Positive


: Robust Clinical Evidence

Over 55 published studies on genes and technology (> 5,500 patients)

12

Pivotal Clinical Studies

Analytical ValidationVan Neste et al.,

BMC Urology 2013

$500K In Savings To Health Care SystemAubry et al.,

American Health Drug and Benefits 2013

Validation of Clinical Utility/Actionability Wojno., et al 2014

Validation of High NPVPartin et al.,

Journal of Urology 2014.

Meta Analysis Validating High NPVPartin et al.,

Trans. of the Am. Clin. and Clim. Assoc 2016.

Risk Score Development NPV 96% CS PcaVan Neste et al.

The Prostate 2016

Validated In African American MenWaterhouse et al.,

Urology 2016

Clinical Utility Clinical Validity Analytical Validity Health Economics


13

2012

PSA screening

reduced/eliminated due

to US Preventive

Services Task Force

downgrading

ConfirmMDx is

included in the NCCN

Early Detection of

Prostate Cancer

Guidelines

2016 2018

PSA testing resumes

due to US Preventive

Services Task Force

upgrading

2018

MDxHealth tests

included in European

Association of Urology

Prostate Cancer

Guidelines

2020

SelectMDx is included

in the NCCN

Early Detection of

Prostate Cancer

Guidelines

NCCN NCCN

Clinical Guideline Inclusion


Proven Fundamental Foundation Driving Value Creation

Strong Commercial Focus

and Presence

Leveraging direct sales force in U.S.

Driving utilization through existing U.S.

customer base

Employ OUS distribution partners for

worldwide expansion

Proven Reimbursement

Strategy

ConfirmMDx covered by Medicare and

commercial payers

Recent inclusion in NCCN Guidelines will

drive coverage for SelectMDx

Executed necessary health economic and

clinical utility studies for broad insurance

coverage

Robust and Reliable Technology

Proprietary IP portfolio capable of

advancing our diagnostic pathway in

prostate cancer

World-class laboratory operations:

CAP and CLIA accredited / ISO

13485:2016 certified / NYSDOH approved

Extensive library of biomarkers and peer-

reviewed publications to apply into prostate

and additional disease states

14


MDxHealth Adoption and Reorder Rates Accelerating

• Considerable value in the current MDxHealth menu

and customer base will drive significant revenue

growth, as adoption progresses up the S-curve

• By driving adoption through our high-quality physician

base with the current test offering, MDxHealth

anticipates continued strong reordering from this

segment as additional coverage is initiated

15

Ad

op

tio

n r

ate

>200,000 tests ordered

Diagnostic S-curve adoption model

Time


0

20

40

60

80

100

120

2013 2014 2015 2016 2017 2018 2019 1H20

ConfirmMDx Contracts SelectMDx Contracts

✓ 2016 NCCN Guidelines inclusion

✓ 96 payer contracts – 1H20

✓ 2020 NCCN Guidelines inclusion

✓ 33 payer contracts – 1H20

MDxHealth Guideline Inclusion and Managed Care Contracts

Payer Adoption

Summary

ConfirmMDx LCD(Medicare coverage)

16

ConfirmMDx and

SelectMDx in EAU

ConfirmMDx

in NCCN

SelectMDx

in NCCN

Launch

Launch(2H14)

(1H16)

(1H18)

(2H20)


Robust and Reliable Technology

17

• MDxHealth continues to be at the forefront of researching and understanding the link between cancer and methylation, andhow this link can be translated into meaningful molecular diagnostic tests.

• MDxHealth utilizes proprietary molecular technologies to advance cancer diagnosis and treatment. Individual DNAbiomarkers in the human body can become modified in the presence of cancer. MDxHealth’s solutions/technologiesidentify these modifications at the genetic level, improving the diagnosis and associated treatment of prostate cancer.

• MDxHealth owns or holds exclusive rights to a range of issued and pending patents in multiple countries covering thegenetic, epigenetic (methylation) and other molecular biomarkers and platform technologies.

– Comprehensive Intellectual Property portfolio as well as significant value associated with know-how and trade secrets

• MDxHealth laboratories located in Irvine, CA and Nijmegen, The Netherlands


U.S. Headquarters & Laboratory

15279 Alton Parkway, Ste 100

Irvine, CA 92618

United States

Global Headquarters

CAP Business Center

Rue d’Abhooz, 31

4040 Herstal, Belgium

R&D & Laboratory

Novio Tech Campus Transistorweg 5

6534 AT Nijmegen

The Netherlands

Thank You

General [email protected]

Investor Relations Contact

LifeSci Advisors, LLC (IR & PR)

US +1 646 597 6989

[email protected]

Global Operations

18


ConfirmMDx

SelectMDx &

ConfirmMDx

SelectMDx

Presentation References

19

SUMMARY REFERENCE CITATIONS

Slide 6 – Current challenges with diagnosing prostate cancer in U.S.

1. NIH 8/20/2019 Website: https://seer.cancer.gov/statfacts/html/common.html.

2. MDxHealth management estimates

3. Moyer VA, U.S. Preventive Services Task Force. Screening for prostate cancer: U.S. Preventive Services Task Force recommendation statement. Ann Intern Med. 2012;157:120–134.

4. Bhindi B, Mamdani M, Kulkarni GS, et al. Impact of the U.S. Preventive Services Task Force recommendations against prostate specific antigen screening on prostate biopsy and cancer detection rates. J Urol.

2015;193:1519–1524.

5. Loeb et al. European Urology 2013.

6. Loeb et al. Journal of Urology 2011.

7. Pinsky PF et al:. BJU International 99, no. 4 (April 2007): 775–779.

8. Resnick M et al:, Urology 2011. Mar 77: 548–552

Slide 9 – The most highly predictive test to help identify men at low risk for aggressive prostate cancer



2015;193:1519–1524.

3. Haese, A, et al. (2019) Multicenter Optimization and Validation of a 2-Gene mRNA Urine Test for Detection of Clinically Significant Prostate Cancer Prior to Initial Prostate Biopsy. J Uro. doi:

10.1097/JU.0000000000000293;

4. 2018 EAU,ESTRO,SIOG Guidelines on Prostate Cancer;

5. Govers TM, et al. (2018) Cost-Effectiveness of Urinary Biomarkernel in Prostate Cancer Risk Assessment. J Urol. doi: 10.1016/j.juro.2018.07.034A

Slide 11 – The only epigenetic test to identify men at risk for aggressive prostate cancer



2015;193:1519–1524.

3. Haese, A, et al. (2019) Multicenter Optimization and Validation of a 2-Gene mRNA Urine Test for Detection of Clinically Significant Prostate Cancer Prior to Initial Prostate Biopsy. J Uro. doi:

10.1097/JU.0000000000000293;

4. 2018 EAU,ESTRO,SIOG Guidelines on Prostate Cancer;

5. Govers TM, et al. (2018) Cost-Effectiveness of Urinary Biomarkernel in Prostate Cancer Risk Assessment. J Urol. doi: 10.1016/j.juro.2018.07.034A

https://seer.cancer.gov/statfacts/html/common.html

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