company presentation. Development of the prostate cancer diagnostic test and in-vitro diagnostic device for the point-of-care diagnosis of prostate cancer

1. 2017 Company Presentation
Diagnostic Solution for Prostate Cancer
1

2. A low-cost
non-invasive TEST
for early DETECTION
of prostate cancer
and prostate health
MONITORING
Mission
2
Bostwick et al., 1992
Age-specific prevalence of disease

3. Poor performance of current prostate cancer diagnostics
Problem
Current diagnostic pathway:
Referral to hospital
PSA
Suspected
prostate cancer clinic
Prostate specialist
MRI
ral to hospital
Suspected
ostate cancer clinic
Prostate specialist
MRI Prostate biopsy
Main problem:
Low accuracy of the PSA test results in up to 75% negative or inconclusive biopsies
3

4. Need
1
2
AN ACCURATE PRE-BIOPSY TEST
A TEST SUITABLE FOR REGULAR
MONITORING
Negative biopsies
>1 million
USA, 2012
4.7 million PSA tests
~1.3 million biopsies
Cancer
241 K
4

5. Novel test based on chemical elements as biomarkers
Solution
Levels of
microelemens
in seminal and
prostatic fluids
Diagnostic test
for home and
professional use
Significant
reduction of
unnecessary
biopsies
Prostate
function self-
monitoring
Off-the-shelf
third party
analytical
instrument
available
Non-
degradable
easy-to-
measure
biomarkers
5
Non-invasive
rapid
low-cost
test

6. Total addressable market size
Market
Assumptions:
10% - market penetration
£20 - home test price
£50 - professional test price
Home test market:
750 million men over 50 need regular
testing =
£1.5 Billion / year
Professional test market:
Global PSA testing market size is
45 million tests annually =
£225 million / year
6

7. Customers and benefits
Value proposition
Patients Medical Professionals
NHS Medical Insurers,
Private Trusts
- Reduced anxiety
- Improved quality of life
- Improved survival rate
Cost reduction by:
- early detection of cancer
- reduced number of biopsies
- reduced costs of active surveillance
- Accurate diagnosis
- Non-invasive diagnostic tool
- Additional revenue
7

8. National phase of the PCT application
Intellectual Property
8
PCT application on 45 biomarkers of prostate cancer
• filed 19.05.2015
• titled “Method of diagnosing prostate cancer by detecting
chemical elements”;
• publication number WO2015/177536 A1;
• entered into national phase in US, UK and EU in
November 2016

9. PSA test is no longer recommended for prostate cancer screening
Competition: Why Now
PSA biomarker is used in all currently available prostate cancer tests.
Recently developed tests 4K, SelectMDx and ExoDX are costly.
Cambridge Oncometrix diagnostic algorithm is affordable, accurate and
independent of the PSA biomarker.
Test Price FDA approval NICE approval
PSA £20 yes yes
PHI £80 yes no
PCA3 £350 yes no
4K £800 no no
ExoDX £475 no no
SelectMDx £400 no no
Cambridge
Oncometrix
£20 (home test)
£50 (laboratory test)
9

10. OUR VISION - three instruments to be developed
Products
Laboratory device
Point-of-Care device
Home test
10

11. Diagnostic Score based on 6 Microelements measured in sperm
Diagnostic Technology
11Healthy BPH PCa
0.00001
0.0001
0.001
0.01
0.1
1
10
100
1000
CambridgeOncometrixScore
Cut-off level
SPERM - results on
Cambridge Oncometrix
multiple marker score.
P=0.0011
n=14
n=21
n=18

12. Affordable personalized continuous surveillance pathway to detect cancer
Novel Diagnostic Concept
Panel of markers
is (self)-monitored
regularly
Age
40 80
Visit a urologist
BENIGN PROSTATE
ENLARGEMENT
HEALTHY
12
Marker
level
CANCER

13. Traction
13
50%
Total: 400K
Time:2 years
Deadline: 12/04/2017
Innovate UK
Innovation in Health
and Life Sciences
Leeds + DEC
- XRF
- Data analysis
50%
-80% FEC-
- Sample collection
- ICP-MS
- Data analysis

14. Potential Role of the test in NHS
14
PLiS
Figure 1. Current and proposed diagnostic pathway for prostate
cancer
Current pathway Proposed pathway
Pa#ents for whom
valua#on is
recommended
Pa#ents for whom
valua#on is
recommended
MP-MRI
CHEC
MP-MRI
BIOPSY
Cancer Cancer
Selec#on of pa#ents
who will benefit
from imaging and
biopsy
BIOPSY
Figure 1. Current and proposed diagnostic pathway for prostat
Current pathway Proposed pathway
Pa#ents for whom
valua#on is
recommended
Pa#ents for whom
valua#on is
recommended
MP-MRI
CHEC
MP-MRI
BIOPSY
Cancer Cancer
Selec#on of pa#ents
who will benefit
from imaging and
biopsy
BIOPSY
Pre-imaging and pre-biopsy triage

15. Important accomplishments to date
Track Record
Company was founded to develop
a diagnostic test based on
biomarkers (microelements)
present in prostatic tissue and
expressed prostatic secretions.
Russian subsidiary «ООО
Онкометрикс» was founded to
facilitate proof-of-concept clinical
trial.
Initiated a proof-of-concept
clinical trial in St. Petersburg,
Russia.
Developed a cloud based
clinical trial database.
Filed a patent application on
45 microelements as prostate
cancer biomarkers.
Successfully validated XRF
method and an analytical
device for use in centralized
diagnostic service or clinical
laboratory.
Initiated negotiations with
several XRF device
manufacturers.
Demonstrated high diagnostic
potential of the biomarkers in
semen.
2016201520142012 2013
Developed analytical
method.
Prizes and Awards

16. Multidisciplinary expertise
Team
CEO
M. Rossmann, Ph.D. Biochemistry
Biochemist with 12 years experience in
biochemistry, biophysics, cell biology and expertise
in microelement analysis by X-ray fluorescence.
Co-founder
CFO
Mrs I. Soltamova, M.Sc. Economics
Chartered auditor with over 20 years experience
in financial business consulting and due diligence.
CEO Oncometrix LLC, Russia
Co-founder
Principal
Scientist
Dr. D. Soloviev, Ph.D. Chemistry, MRSC
Chemist with over 25 years experience in
development of cancer diagnostic
radiopharmaceuticals for PET imaging.
Cancer Research UK
Co-founder
Principal
Investigator
Dr. D. Lebedev, MD
Consultant urologist with over 16 years
experience in clinical urology.
CEO Oncometrix LLC, Russia
Co-founder
IP protection,
regulatory affairs
Dr. I. Boros, Ph.D. Chemistry, MRSC
Organic chemist with over 8 years experience in
patent offices, for governmental and pharmaceutical
companies, quality assurance in GMP manufacture
of radiopharmaceuticals.
University of Cambridge
Co-founder
Engineering
Manager
Dr. D. Grigoriev, Ph.D., CEng MIET
Engineer with multi-disciplinary technical
expertise in sensors, instrument and test
development, test automation, electronics and IC
validation, Quality Control and Quality Assurance.
Product life cycle management and project
management experience.
Systems Characterisation Manager, Cambridge
CMOS Sensors
16

17. Experienced co-founders and advisors
Team
Honorary Head of
Advisory Board
Sir M. Snyder D.Sc., FRSA, MSI, FlnstD
Financial and business consulting.
Consultant and former Managing and Senior
Partner of Kingston Smith LLP.
Chairman of GLE Loan Finance Ltd.
Non-Executive Director of Metro Bank.
Advisor
Medicinal Physics
Prof. V. Zaichick, Ph.D., FRSC, D.Sc., C.Chem
Physicist with over 50 years experience in
medicinal physics and diagnostic method
development. World expert in micro-elemental
and chemical composition of human organs. 19
patents and over 500 publications.
Medical Radiological Research Centre, Obninsk,
Russia
Advisor
Diagnostic tests
Dr. A. Fini, Ph.D.
Renowned radiochemist and expert in the
diagnostic test development.
Founder of the Italian Group of
Radiopharmaceutical Chemistry (Gruppo
Interdisciplinare Chimica dei Radiofarmaci).
Advisor
Endocrinology
Prof. L. Schomburg, Ph.D. Biochemistry
Biochemist with over 20 years experience in
endocrinology, development and validation of novel
In-Vitro Diagnostic Assays and XRF.
Vice Director Institute for Experimental
Endocrinology, Charité - Universitätsmedizin Berlin.
Co-founder
Advisor
Business
Development
Dr. P. Shashkov, Ph.D. Physics
Physicist with 20 years experience in high-tech
business development. Successful serial
entrepreneur.
Founder of Keronite International, Cambridge
Nanotherm and Cambridge Nanolitic Ltd.
Co-founder
Sample processing
and Metrology
Dr. M. Vonsky, Ph.D. Physics and Maths.
Biophysicist, expert in clinical sample processing and
analysis, metrology in biochemical measurements.
Biomedical Technologies Institute of Cytology,
Russian Academy of Science.
Co-founder
17

18. Business development timeline
Milestones
18
2018
Analytical methods developed.
IP developed and protected.
Prototypes developed.
Laboratory instrument
approved. Clinical trials
Preparation finished.
POC device and Home test
development started.
2019 2021
Home test and POC devices
developed.
Validation Clinical trials started.
IP protected.
Home test and POC
devices approved and
certified.
Exit by
trade
sale.
2022
Value, M
Analytical
method
development
Prototype device
development
Clinical trials
Regulatory approvals and
exit
1.5
5
15
50
0.2M
0.7M
3M

19. Investment Needs
Financial Aspects
Phase 1a: completed
2014-2016
Proof-of-concept, IP development and protection.
Phase 1b: £200 K
2017-2018
Analytical method development, IP protection.
Phase 2: £700 K
2018-2019
Device prototype development, clinical trial preparation, IP protection.
Phase 3: £3 M
2019-2021
Clinical trials and regulatory approvals of tests and devices, IP protection.
19
Public
Funding,
30%
Venture
Capital, 40%
Private
funding,
30%

20. Current status – finalising proof-of-concept
Track Record
Referees
Sir David Neal - Professor of
surgical oncology
at the Nuffield Department
of Surgical Sciences
(University of Oxford)
Funding
Team Members’ Investment £30 K
Prizes & vouchers £8 K
Family & Friends Investors £31 K
Director’s Loan (Cash & expenses) £14 K
Donation-Based Crowdfunding £18 K
____________________________________________
Total £101 K
Academic partners and supporters
20

21. Contact
21
maxim.rossmann@camonx.com
/cambridgeoncometrix
@COncometrix
Maxim Rossmann, director
Cambridge Oncometrix Ltd.
3B Homefield Road
Haverhill
CB9 8QP
Suffolk, United Kingdom
Company No. 08101482
Registered in England and Wales
E-mail: office@camonx.com
http://www.camonx.com
+44 753 417 4429

22. Appendix 1
1 million PSA tests
200.000 biopsies
150.000
negative biopsies
50.000
positive
biopsies
1 million PSA tests
125.000 biopsies
75.000
negative
biopsies
200.000 men offered a
biopsy
200.000 men offered
to consider a biopsy
£10 M
test costs
(£50 / test)
£75 M
savings due to
50% less negative
biopsies (£1,000 each)
50.000
positive
biopsies
Current diagnostic pathway in the U.K. New pathway
Economical Utility for NHS

23. Proof-of-concept Clinical Trial
23
Appendix 2

24. Appendix 3
Concentration
24
Biomarker levels in seminal fluid – data from the clinical study
1 2
N
a
K
C
a
M
g
Zn
R
b
1
10
100
1000
10000
100000
SPERM
Marker
ppm
Healthy
BPH
PCa