Detecting Cancer in Blood

Transcription

Detecting Cancer in Blood
not commercially available in the U.S.
Detecting Cancer in Blood
Company presentation
Safe harbor statement
Forward Looking Statements
This communication contains certain forward-looking statements, including, without limitation, statements containing the words
“expects”, “future”, “potential” and words of similar import. Such forward-looking statements involve known and unknown risks,
uncertainties and other factors, which may cause our actual results of operations, financial condition, performance, or
achievements, or industry results, to be materially different from any future results, performance or achievements expressed or
implied by such forward-looking statements. Such factors include, among others, the following: uncertainties related to results of
our clinical trials, the uncertainty of regulatory approval and commercial uncertainty, reimbursement and drug price uncertainty, the
absence of sales and marketing experience and limited manufacturing capabilities, attraction and retention of technologically skilled
employees, dependence on licenses, patents and proprietary technology, dependence upon collaborators, future capital needs and
the uncertainty of additional funding, risks of product liability and limitations of insurance, limitations of supplies, competition from
other biopharmaceutical, chemical and pharmaceutical companies, environmental, health and safety matters, availability of licensing
arrangements, currency fluctuations, adverse changes in governmental rules and fiscal policies, civil unrest, acts of God, acts of war,
and other factors referenced in this communication. Given these uncertainties, prospective investors and partners are cautioned not
to place undue reliance on such forward-looking statements. We disclaim any obligation to update any such forward-looking
statements to reflect future events or developments.
Legal Product Disclaimer
Products by Epigenomics that are referred to in this presentation, especially Epi proColon®, are not available and are not approved
for sale in the United States. The analytical and performance characteristics of any product to be eventually sold in the U.S. based on
our technology have not been established.
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Saving lives through blood-based cancer detection
Our high-performing, minimally-invasive tests have
the potential to radically improve cancer detection.
By leveraging our expertise in epigenetics as well as
our product pipeline and strong IP, we are uniquely
positioned to drive patient access to cancer testing
through liquid biopsy.
not commercially available in the U.S.
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Targeting the most deadly cancers
Annual cancer deaths
US population
26,120
Prostate
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158,080
40,890
41,780
Breast
Pancreas
49,190
Colorectal
Source: American Cancer Society, Cancer Facts & Figures 2016, annual figures
Lung
Colorectal cancer (CRC): Early detection saves lives
Diagnosed in
Stage I or II
Diagnosed in
Stage IV
9 out of 10 survive
1 out of 10 survive
5 years
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Source: American Cancer Society, Cancer Facts & Figures 2015
5 years
CRC: One in three in the USA remains unscreened
%
65%
Unscreened eligible
population
Screened population
23 to 30 million eligible Americans are not screened for CRC
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Source: Centers for Disease Control and Prevention, “Vital Signs”, November 2013;
American Cancer Society Cancer Facts and Figures, 2015.
Stagnant screening rate
over the past years
60%
2002
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63%
2008
65%
65%
2010
2012
Screening
gap
American Cancer Society screening goal: 80% by 2018
Source: Data from the BRFSS survey reported in MMWR 60(26)884-889, MMWR 62(44):881-888.
80%
2018
Epi proColon adds convenient CRC screening option
Imaging Methods
Colonoscopy
Flexible sigmoidoscopy
Virtual colonography
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Stool Sampling
occult blood in stool
by FIT or gFOBT
Fecal DNA testing
Liquid biopsy
Septin-9 blood test
Opportunity for US market expansion
15%
80%
CRC screening
goal by ACS
Screening gap
$2 billion*
Closing the screening gap towards
the 80% goal
65%
Screened
population
* Annual revenue ex laboratory
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High patient preference for blood test
%
of patients refusing
colonoscopy accepted
minimal-invasive test
%
of those patients
chose a blood test
Source: Adler, A., et al. (2014). Improving compliance to colorectal cancer screening using blood and stool based tests in patients refusing screening colonoscopy in Germany.
BMC Gastroenterol 14: 183.
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Simple for patients and health care providers
Easy for
the patient
 Part of routine
visits
 No dietary restrictions
Easy for
the doctor
 Drives patient compliance
 Easy to explain
Easy for
the lab
 Runs on existing hardware
 No investment required
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Epi proColon - Option for non-compliant patients
Colonoscopy
Patient
managed
based on
colonoscopy
outcome
Standard of Care
Further
regular
screening
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Epi proColon detects tumor-specific DNA in blood
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Test performance established in major studies
Prospective
pivotal study
 Prospective, multicenter clinical study
 Multi-center, comparative
clinical study
 Sensitivity of 68.2% and
specificity of 80.0%
 Sensitivity of Epi proColon
was 73.2% vs. 68.0% of
FIT-test
 7,941 screening-eligible
individuals enrolled
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FIT
comparison
study
 Epi proColon vs. FIT test
ADMIT
study
 Multi-center clinical study
 420 patients, historically
noncompliant with current
screening guidelines
 99.5% rate of adherence to
Epi proColon
Sensitivity: the percentage of cancer cases correctly identified
Specificity: the percentage of healthy individuals correctly identified as negative
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Recent FDA notification* on status of Epi proColon
Final
approval
expected
Epi proColon
would be first
and only FDA
approved blood-
Significant
milestone
towards FDA
approval
* published on Jan 8, 2016
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based colorectal
cancer test on U.S.
market
in Q1/Q2
2016
Only
minor topics
left to be
clarified with the
agency
Next steps towards approval
Secure reimbursement code
Secure national availability
upon launch
Train and inform potential
laboratory customers
Build product inventory
to serve initial demand
Finalize FDA requirements
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U.S. commercialization with partner
Nation-wide distribution
to target labs with Polymedco
Polymedco is the
biggest distributor
of CRC screening
tests in the U.S.
All incentives
aligned between
labs, partner and
Epigenomics
HQ
Ideally positioned
(CRC focus) to
address over 1,000
existing laboratory
customers
U.S. chart with target labs only illustrative
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Strong outreach through multiple sales channels
Reference
Labs
Epigenomics
Polymedco
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Leading
hospitals
Academic
Medical
Centers
Integrated
Networks
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Local
medical
doctors
Key
opinion
leaders
Healthcare
providers
Ideal partnership for commercial success
Marketing
Sales
Distribution
Customer support
Billing
Collection
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Product supply
Reimbursement
Regulatory
KOLs
Medical guidelines
Reimbursement elements
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Strategic collaboration with BioChain in China
Epi proColon®
approved in China
by CFDA1
BioChain
started
commercialization
in 2015
Pricing and
reimbursement
discussions underway
Septin9 test included in
Chinese CRC Screening Guidelines
Epi proColon® distribution and license agreement for Septin9 in place
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1
China Food and Drug Administration (CFDA)
blood test for detection of lung cancer
About lung
cancer
 Lung cancer is
#1 cancer killer
worldwide
 High medical
need for
minimally
invasive tests
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Lung cancer test
in development
Performance
 Based on
 Test sensitivity
proprietary DNA was reported
methylation
at 95% with a
biomarkers,
specificity of
SHOX2 &
64% in initial
PTGER4
studies
Target
indications
 Follow-up after
positive results
in low dose
spiral CT
 Future
opportunity
in screening
of high risk
patients
This project has received funding from the European Union’s Horizon 2020 research and innovation
programme under grant agreement No 672680.
Next steps
 Initiation of
clinical studies
in 2016 (US/EU)
Liquid biopsy will revolutionize cancer care
Disease
management
Costs
Liquid
biopsy
Compliance
Repeatability
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Early
detection
Invasiveness
“
For me the biggest payoff
in cancer research would
be the discovery of
biomarkers that can be
measured in the blood that
reflect the presence of
early-stage cancer.
Dr. Leland Hartwell, March 2008,
President, Ford Hutchison Cancer
Research Center, Nobel Prize in
Medicine and Physiology, 2001
”
R&D strategy
Broad IP protection with
over 50 active patent families
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Biomarker
discovery,
confirmation and
selection
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2
>20 proprietary
biomarkers in CRC,
lung cancer and other
solid tumor
indications
3
Test development
and validation of
regulated in-vitro
diagnostic
products
Key financial information
9M 2015
9M 2014
EBIT (Operating result)
-8,261
-5,390
Cash consumption
-7,675
Revenue
Net loss
Liquid assets*
*cash and cash equivalents incl. marketable securities
1,324
1,095
-8,033
-5,906
Sep 30,
2015
Dec 31,
2014
9,721
-5,948
7,495
Liquid assets currently sufficient to fund operations into 2017
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Epigenomics share
Share information
Types of shares
Registered shares
ISIN
DE000A11QW50
ADR program
Sponsored Level 1 ADR
Security code
number
Stock exchange
Ratio
Total shares
outstanding
Analyst
coverage
1
A11QW5
Frankfurt Stock Exchange,
Prime Standard: ECX
1 ADR = 5 common shares
18,496,2341
(20.1m fully diluted)
Edison, Equinet, First Berlin,
Kempen & Co, Maxim
As of Jan 31, 2016; 2 According the published voting right notifications
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Shareholder structure
BioChain
9.1%2
Free float
86.0%
Abingworth 4.9%2
Expected news flow topics 2016
Start of
clinical
studies with
Epi proLung®
FDA
approval
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Inclusion
in medical
guidelines
Start of
US commercialization
Market
adoption and
reimbursement
progress
Thank you for your attention!
Contact Investor Relations
Peter Vogt
Investor & Public Relations
Epigenomics AG
T. +49 30 24345 386
[email protected]
Brian Korb
Managing Director
The Trout Group LLC
T. +1 646 378 2923
[email protected]
Ticker
Bloomberg: ECX:GR
Reuters: EXXG.DE
Thomson ONE: ECX-XE
ADR OTC: EPGNY
Internet
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www.epigenomics.com
www.epiprocolon.com
www.epiprolung.com

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