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CORPORATE PRESENTATION October 2020
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CORPORATE - mdxhealth.com...Corporate Presentation I U.S. Annual Market Opportunity 7 Prostate Cancer is the Most Common Cancer in American Men Estimated 3M Men eligible for à $1.5B

Oct 24, 2020

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  • CORPORATE PRESENTATION

    October 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 variousassumptions & 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’scontrol. Therefore, actual results, the financial condition, performance or achievements of MDxHealth, or industry results, may turn out tobe 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 ofMDxHealth 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 TeamProven 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

  • Corporate Presentation I©2020. All rights reserved

    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 cancersCurrent 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

  • Corporate Presentation I©2020. All rights reserved

    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

    116,30078,300 62,100 60,190

    PROSTATE LUNG & BRONCHUS

    COLON & RECTUM

    URINARY BLADDER

    MELANOMA OF THE SKIN

    #1 Most Common Cancer in U.S. Men

    72,500

    33,330 28,630 24,640 20,020

    LUNG & BRONCHUS

    PROSTATE COLON & RECTUM

    PANCREAS LIVER & BILE DUCT

    #2 Deadliest Cancer in U.S. Men

    60%

    30%

  • ©2020. All rights reservedCorporate Presentation I

    U.S. Annual Market Opportunity

    7

    Prostate Cancer is the Most Common Cancer in American Men

    Estimated 3MMen eligible for à $1.5B Market Opportunity

    Who needs a biopsy?

    Who needs arepeat biopsy?

    >10% of tests are elevated

    ~60% of biopsies are negative

    25MPSA testsperformed

    500KProstate biopsies

    performed

    200KNew prostate cancer cases

    3MLiving with prostate

    cancer

    33,350Estimated Deaths

    Who needs treatment?

    Estimated 300K

    Men eligible for à $500M Market Opportunity

  • Corporate Presentation I©2020. All rights reserved

    MDxHealth’s Prostate Cancer Menu

    Positive

    Negative

    No Cancer

    Cancer

    Positive

    Negative

    Improving the decision forinitial prostate biopsy

    Improving the decision forrepeat prostate biopsy

    Routine Screening

    Biopsy /Imaging

    8

    Clinical Pathway for Diagnosing Aggressive Prostate Cancer

    Biopsy /Imaging

  • ©2020. All rights reservedCorporate Presentation I

    • 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/DREBinary Actionable Results for

    patient and HCP

    Positive

    Negative RoutinelyMonitor

    Biopsy

    95% NPV

    At risk for aggressive cancer?

  • ©2020. All rights reservedCorporate Presentation I

    : Robust Clinical Evidence12 published studies on genes and technology (> 3,500 patients)

    10

    Pivotal Clinical Studies

    Analytical Validation Hessels et al., Translational Medicine Communications 2017

    >$500M In Savings To Health Care System Govers et al., Journal of Urology 2018

    Clinically Validated For a 95% NPV Haese et al., Journal of Urology 2019

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

    Clinical Utility Clinical Validity Analytical Validity Health Economics

  • ©2020. All rights reservedCorporate Presentation I

    • 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 cancer12-core needle biopsy could miss the mark

    Positive

    Negative Avoid Rebiopsy /MRI

    RebiopsyMRI

    of men with a negative biopsy result actually have

    prostate cancer (1,2)

    ~30%

    Negative biopsy 96% NPV3

    Cancer

    Biopsy CoreNeedles

    Prostate

    Biopsy Core

    Prostate

    Cancer

    Urethra

    Field Effect

    Positive

  • ©2020. All rights reservedCorporate Presentation I

    : Robust Clinical EvidenceOver 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 NPV Partin et al., Journal of Urology 2014.

    Meta Analysis Validating High NPV Partin et al., Trans. of the Am. Clin. and Clim. Assoc 2016.

    Risk Score Development NPV 96% CS Pca Van Neste et al. The Prostate 2016

    Validated In African American Men Waterhouse et al., Urology 2016

    Clinical Utility Clinical Validity Analytical Validity Health Economics

  • Corporate Presentation I©2020. All rights reserved

    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

  • Corporate Presentation I©2020. All rights reserved

    Expanding R&D Into the Prostate Cancer Diagnostic Pathway

    14

    SCREENING ACTIVE SURVEILLANCE (AS) InterventionDIAGNOSISPATIENT SELECTION

    Active Surveillance AS monitoring

    Prostate Cancer PSA Screening Test

    InitialBiopsy

    Low-Grade Prostate Cancer

    High-grade Prostate Cancer Intervention

    Biopsy decision

    AS-MDx Monitor-MDx Intervention

    Biopsy Negative Biopsy/Imaging

  • Corporate Presentation I©2020. All rights reserved

    Low-grade prostate cancer

    AS-MDx

    AS-MDx

    Not all men diagnosed with localized prostate cancer may benefit from immediate intervention. These tumors can be slow growing and non-life threatening

    AS-MDx can help identify patients at lower risk of disease that may benefit from active surveillance, versus those at higher risk who should consider immediate intervention

    AS-MDx aids in the disposition of patients at higher risk for disease progression whom may benefit from immediate intervention

    Positive Intervention

    Negative Active Surveillance

    AS-MDx: Diagnostic Patient Disposition for Active Surveillance

    15

    134KEst. Market size (Men Annually)

  • Corporate Presentation I©2020. All rights reserved

    Under Active Surveillance

    (Low-grade cancer)

    Monitor-MDx

    Monitor-MDx

    Patients under active surveillance are currently monitored by invasive and costly prostate biopsy procedures

    • Monitor-MDx provides non-invasive risk stratification for patients under active surveillance for low grade prostate cancer

    • Monitor-MDx can help reduce the risk of patients not returning for their annual assessment due to complacency or poor compliance

    Positive Intervention

    Negative Continued Active Surveillance

    Monitor-MDx: Validates Continued Monitoring Under Active Surveillance

    Monitor-MDx can help identify patients under active surveillance that have an increased risk of disease progression

    16

    1.5MEst. Market size (Men Annually)

  • Corporate Presentation I©2020. All rights reserved

    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

    17

  • Corporate Presentation I©2020. All rights reserved

    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

    18

    Adop

    tion

    rate

    >200,000 tests ordered

    Diagnostic S-curve adoption model

    Time

  • Corporate Presentation I©2020. All rights reserved

    0

    20

    40

    60

    80

    100

    120

    2013 2014 2015 2016 2017 2018 2019 1H20

    ConfirmMDx Contracts SelectMDx Contracts

    ü 2016 NCCN Guidelines inclusionü 96 payer contracts – 1H20

    ü 2020 NCCN Guidelines inclusionü 33 payer contracts – 1H20

    MDxHealth Guideline Inclusion and Managed Care Contracts

    Payer Adoption Summary

    ConfirmMDx LCD(Medicare coverage)

    19

    ConfirmMDx and SelectMDx in EAU

    ConfirmMDxin NCCN

    SelectMDxin NCCN

    Launch

    Launch(2H14)

    (1H16)

    (1H18)

    (2H20)

  • Corporate Presentation I©2020. All rights reserved

    Robust and Reliable Technology

    20

    • MDxHealth continues to be at the forefront of researching and understanding the link between cancer and methylation,and how 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 tradesecrets

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

  • ©2020. All rights reservedCorporate Presentation I

    U.S. Headquarters & Laboratory15279 Alton Parkway, Ste 100

    Irvine, CA 92618United States

    Global HeadquartersCAP Business Center

    Rue d’Abhooz, 314040 Herstal, Belgium

    R&D & LaboratoryNovio Tech Campus Transistorweg 5

    6534 AT NijmegenThe Netherlands

    Thank You

    General [email protected]

    Investor Relations Contact

    LifeSci Advisors, LLC (IR & PR)

    US +1 949 271 9223

    [email protected]

    Global Operations

    21

  • Corporate Presentation I©2020. All rights reserved

    ConfirmMDx

    SelectMDx &ConfirmMDx

    SelectMDx

    Presentation References

    22

    SUMMARY REFERENCE CITATIONSSlide 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 estimates3. 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

    1. 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. 2. 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. 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 cancer1. 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. 2. 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. 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