It’s time to take

diagnostic testing

beyond doubt.

About Us

• Market disruptive molecular and companion diagnostic

platform company.

• Exploiting the biological advantages of mitochondrial

genomics.

• Utilizing non-invasive, blood-based, liquid biopsy format

to diagnose cancer.

• Deep product pipeline focused on cancer diagnostics and oncology.

• Unmatched rapid, agile development of diagnostic proprietary tests.

• Lowest cost testing structure translates to high profit margins.

• Head office in West Palm Beach, Florida, USA.

• R&D laboratory in Newcastle-upon-Tyne, UK.

• IVD kit manufacturing in Marseille, France.

Key Facts

1 liquid biopsy product launched / 1 near term launch

50,000 commercial test samples processed (tissue-based test)

100 granted or allowed patents / 30+ applications pending

16,000+ novel, proprietary mitochondrial DNA biomarkers

11 products successfully through proof of concept

Human Mitochondrial DNA

• 16,568 base pairs of circular, double-

stranded DNA.

• High copy number (1000 to 10,000 per cell).

• DNA mutations occur at high frequency

(10-17 fold greater than nuclear DNA).

• Mutations can occur in a subset of

mitochondrial genomes (known as

heteroplasmy) which allows for early

mutation detection.

• Limited ability to repair DNA.

• Controls apoptosis (cell death).

D-loop

ND5ND1

16s rRNA

12s rRNACyt B

ND6

ND4

ND4L

ND3

COII

COI

ND2

mtDNA Genome

Mitochondrial DNA Deletions

• Deletions are genome copies, which are

missing large parts of the genome.

• Large-scale deletions in mtDNA indicate

cellular changes that are associated with

the development of disease.

• Deletions often result in loss of complete

genes, impact energy production, and

result in production of oxidants (i.e. reactive

oxygen species).

• Cell death pathways become blocked or

shut off.

D-loop

ND5ND1

16s rRNA

12s rRNACyt B

ND6

ND4

ND4L

ND3

COII

COI

ND2

mtDNA Genome

Using Deletions for Disease Detection

• Specific deletions are involved with

specific diseases.

• A particular deletion, or a combination of

deletions, are definitive for a specific

disease, (creating an opportunity to

develop molecular tests for multiple

purposes across all diseases since

detection is possible in various sample

types – tissue, biofluids, blood).

• Importantly, deletions accumulate in a

way that enables quantitative

measurement using standard laboratory

equipment platforms (e.g. qPCR).

Positive - YES

Negative - NO

Mitochondrial DNA: The Perfect BiosensorB

iolo

gic

al Fe

atu

re

High Copy Number

Mutation at High Frequency

Lack of Repair/Cell Death

Occur in “Healthy” Cells

Disease-Specific

Enables much earlier detection

Tests are highly sensitive / specific

Mutations persist…Accumulate in detectable state

Actionable…Detects real-time disease, not hereditary risk

Multiple biomarkers per disease state

Highly quantitative…Even with low sample material

Clin

ica

l B

en

efit

Clinical Benefits Drive Commercial Advantages

Best-in-class, non-invasive blood-based tests

Can be optimized for screening, diagnosis, prognosis, and/or treatment decisions

Biomarker discovery and proof of concept development is efficient and cost effective

Low sample quantity is not a limiting factor

Layers of IP protection

Robust, yet simple clinical implementation

“Plug & Play” roll out based on extensive cross-platform validation

Early Detection

High Sensitivity / Specificity

Persistent Detection

Actionable, Real Time

Multiple Biomarkers

Quantitative and Reliable

Clin

ica

l B

en

efit

De

ve

lop

me

nt

& C

om

me

rcia

l

Ad

va

nta

ge

s

End-to-End Market Application

16,000

Proprietary

Biomarkers

Development Platform

✓ 100% Discovery Success Rate

CNS DiabetesOncology

CVD

Dermatology

Endocrinology

Product and Market Application

Molecular Dx

• Screening

• Diagnosis

• Prognosis

Companion Dx

• Drug Development

• Patient Selection

• Monitoring

Unlimited Application

Discovery to Product Launch

DISCOVERYASSAY

DEVELOPMENTCLINICAL

VALIDATIONPRODUCT LAUNCH

▪ Identify

unique

independent

biomarkers

(next-

generation

sequencing)

▪ Develop

QPCR

assay(s)

▪ Test against

control blood

samples

(blinded)

▪ Establish

clinical

performance

statistics

▪ Regulatory

submission

and market

launch

Deep Product Pipeline

Disease

Development Stage

Biomarker Discovery

Proof of Concept

Biomarker Selection

Analytical Validation

Endometriosis

Ovarian Cancer

Uterine Cancer

Cervical Cancer

Breast Cancer

Prostate Cancer

Testicular Cancer

Lung Cancer

Bladder Cancer

Colorectal Cancer

Melanoma

Clinical Validation

Imminent

Development

Priorities are focused

on Diseases with

High Unmet Needs

Significant

Women’s Health

Pipeline

Global Roll Out

Pancreatic Cancer

Liver Cancer

Stomach Cancer

Find Prostate Cancer in Blood

• Mitomic™ Prostate Test (MPT™) is the first non-

PSA linked liquid biopsy test for prostate

cancer. Launched in USA with LabCorp.

• Top performer and disruptive to current

standards (i.e. PSA and MRI).

• For screening at risk patients.

• Developed in collaboration with the University

of Cambridge in the UK.

• Distribution agreements signed in USA,

Australia, New Zealand, South Korea,

Germany, UK, Central Europe, the Nordics,

and Israel.

• Agreements pending in Canada, Middle East,

Africa, and Latin America.MPT MRI 4KS PCA3 PSA

#1

Uncover False Negative Biopsies

• Mitomic™ Prostate Core Test (MPCT™) identifies the 3.4kb

mitochondrial DNA deletion associated with malignant

cells in benign tissue.

• MPCT provides: (i) a confirmation of negative biopsy

results without need for additional patient sample or office

visit (92% Negative Predictive Value) and (ii) an accurate

identification of men at high risk of undiagnosed prostate

cancer missed during prior biopsy procedure (Sensitivity

85%).

• Top performer. Field extends through the entire prostate,

versus the small ‘halo’ of the competing test.

• An in-clinic observational study of 1467 men demonstrates

MPCT reduced biopsies up to 8 fold and advanced

diagnosis by an average of 2.5 months.

• Results reported on a per core basis.

MDNA Field Effect

~ Entire Prostate ~

Confirm MDx Field Effect

~ Halo Only ~

ROC of 1.2kb Del Symptomatic vs Stage I/II

100% - Specificity%

Sen

sit

ivit

y%

0 20 40 60 80 100

0

20

40

60

80

100

Sensitivity%

Identity%

First-in-Class Endometriosis Test

• The Mitomic™ Endometriosis Test (MET™) will be the first blood-based test for endometriosis.

ROC of 1.2kb Del Symptomatic vs Peritoneal Disease

100% - Specificity%

Sen

sit

ivit

y%

0 20 40 60 80 100

0

20

40

60

80

100

Sensitivity%

Identity%

• Disruptive to current standards (i.e.

surgery).

• For screening prior to laparoscopy.

• Under development in collaboration

with the University of Oxford in the UK

and Harvard University and UPMC in the

USA.

• We are ahead of all potential

competitors in endometriosis

development.

• Launching in 2019 in the USA.

• CE IVD kit to follow.

Many Future Revenue Opportunities

• Identified multiple, independent disease-specific

biomarkers in each listed category:

• Underserved with significant testing need;

• Established at-risk population;

• Reliant on invasive diagnostic procedures;

with

• Opportunity to reduce costs

• Successful proof-of-concept studies highlight

exceptional test performance in many different

disease states.

• Reveals the depth of our proprietary & patented

technology and future product launches.

Disease State

Biomarker

Performance

(AUC %)

Ovarian Cancer 99

Uterine Cancer 87

Cervical Cancer 97

Breast Cancer 89

Testicular Cancer 99

Lung Cancer 89

Bladder Cancer 89

Colorectal Cancer 84

Melanoma 96

Contact Us

Jennifer Creed

Chief Development Officer

j.creed@mdnalifesciences.comMobile: 561-596-1128

Toll Free: 844-321-6362

2054 Vista Parkway, Suite 400West Palm Beach, FL, 33411, USAwww.mdnalifesciences.com

Chris Mitton

Chief Executive Officer

c.mitton@mdnalifesciences.comMobile: 203-996-3645

Toll Free: 844-321-6362

2054 Vista Parkway, Suite 400West Palm Beach, FL, 33411, USAwww.mdnalifesciences.com

Robert Poulter

Chief Business Officer

r.poulter@mdnalifesciences.comMobile: 807-628-3135

Toll Free: 844-321-6362

2054 Vista Parkway, Suite 400West Palm Beach, FL, 33411, USAwww.mdnalifesciences.com

Andrew Harbottle, PhD.

Chief Science Officer

a.harbottle@mdnalifesciences.comTelephone: +44 191 2235605

Toll Free: 844-321-6362

The Bioincubator Suite, Medical SchoolFramlington Place, Newcastle Upon Tyne,NE2 4HH, United Kingdomwww.mdnalifesciences.com