Epigenomics AG. March

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Epigenomics AG

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Safe Harbor

 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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

Overview



Epi proColon®

• Unmet need & commercial opportunity for Epi proColon®

• Commercial strategy



Epi proLung® and future product opportunities



Financial Information and Summary

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DNA Methylation Diagnostic Products for Oncology

Epi proColon®

blood-based

colorectal cancer (CRC)

screening

1,2

Addressing low compliance to currently available CRC screening

Epi proLung®

tissue

assay for

lung cancer diagnosis1

Aid in difficult to diagnose lung cancer Potential to be developed into blood based assay

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

Overview



Epi proColon®

• Unmet need & commercial opportunity for Epi proColon®

• Commercial strategy



Epi proLung® and future product opportunities



Financial information and summary

(6)

Screening

is key!

Fighting Colorectal Cancer

Public Health

> 136,000

new cases

50,000

deaths1

90%

5-year survival rate in stages I and II

60%

diagnosed in

later stages

Health Economic

US$ 14 Bn

CRC treatment cost p.a. Over a

third

in

late stage

disease

1_{ACS Cancer Facts & Figures 2014,}2_{recommendation of the U.S. Preventive Services Task Force (USPSTF) for people aged between 50-75 years,}3_{American Cancer Society (ACS)}

Recommendation2_:

colonoscopy

_{every 10y or annual}

FIT

25-30 million

people not screened for CRC ACS3_{: campaign to get}

80% screened

_{by 2018}

(7)

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Blood Testing: Increased Compliance and Market Expansion

 Demonstrated

acceptance of blood test

for CRC Screening1

 Surveys in the US

confirm these results

2



Patient choice

of methods has shown to increase screening compliance3



Health economic benefit

demonstrated4

 Incremental U.S. market opportunity

estimated in excess of

US$ 1 Bn

annually5

1i_{Adler et al, BMC Gastroenterology 2014, 14:183 doi:10.1186/1471-230X-14-183}2_{. Taber et al. (2012, ASPO): Preferences for a methylated DNA blood test for colorectal cancer among a multiethnic sample of}

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Epi proColon®: Simple and Efficient for Patients and Customers



Easy for the patient

- part of routine visits - no dietary restrictions



Easy for the doctor

- test (+): colonoscopy; test (-): get screened next year

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Epi proColon®: Powerful Screening Tool with Flexible Set Up

- - -

- -

₊

-

₊

+

Epi proColon® test result (3x testing 15 _μl per well) Epi proColon® 2.0 CE

(CE marked, CFDA)

Epi proColon® (under US FDA review)

negative negative test result positive follow-up with colonoscopy test result positive follow-up with colonoscopy 10 ml blood sample min. 45 μl DNA

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Epi proColon®: Validated in Clinical Trials

- - -

- -

₊

-

₊

+

China/EU product3,4 US product1,2 Sensitivity 68-73% Specificity: 80-82% Sensitivity 75-81% Specificity: 97-99%  US data generated in

prospective trials

for FDA submission1



Non-inferiority

to FIT demonstrated in head-to-head study2

(FIT sensitivity: 68%)



Case control studies

in Europe and China using the “2 out of 3” algorithm3,4

1 _{Potter et al. , Clinical Chemistry June 2014 clinchem.2013.221044 “Validation of a Real-Time}

PCR-Based Qualitative Assay for the Detection of Methylated Sept9 DNA in Human Plasma“, 2_{Approx. 100 CRC cases from screening eligible patients and ~200 prospectively collected}

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Possible and Simple Performance Improvement

- - -

- -

₊

-

₊

+

negative (82% of all cases) positive (3% of all cases)

re-test with Epi proColon: 70% sensitivity 90% specificity overall performance!2 “1 out of 3“ positive results (15% of all cases)

1_{Based on post-hoc analysis of FIT/Sept9 comparison study} 2_{Based on post-hoc analysis of FIT/Sept9 comparison study and retesting of „weak positive“ results with Epi proColon®}

re-test

re-test with FIT:

65% sensitivity 96% specificity

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Europe:



Commercially available since 2012 –

growing sales but at low levels since no active commercial effort underway for the time being – CE marking based approval in other countries, e.g. Argentina

China:



Approved in China in December 2014

– commercialized by BioChain

U.S.A.:



PMA under review by US FDA since early 2013



Response letter June 2014

– FDA is looking for additional data supporting the

assumption that Epi proColon® will increase compliance to CRC screening recommendations in the intended use population (non-screening compliant)



PMA still on file

– additional data to complete the PMA (no resubmission)

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ADMIT (Adherence to Minimally Invasive Testing) Study

Study to demonstrate increased participation in CRC screening in patients being offered Epi proColon® blood-based test vs. FIT stool-based test

 In agreement with the FDA, the study:

 will include patients actively managed by CRC screening programs within

Kaiser Permanente

and

Geisinger Health Systems

 population which is

non-compliant to CRC screening

according to current screening guidelines is identified through electronic medical records



420 patients –

enrollment underway

 Primary endpoint:

significant increase in compliance to CRC screening

compared to current standard of care (FIT) – at least 8% improvement

 Additional endpoint:

adherence to colonoscopy

upon positive test result

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

Overview



Epi proColon®

• Unmet need & commercial opportunity for Epi proColon®

• Commercial strategy



Epi proLung® and future product opportunities



Financial information and summary

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Joint Commercialization Agreement with Polymedco Inc.

 Market leader in the CRC screening field

>$50m in annual sales

 Ideally positioned (CRC focus) to address

>1,500 existing laboratory customers

Joint Efforts: Key accounts Reimbursement Strategic marketing

PRODUCT

CHANNEL

Epigenomics tasks: Manufacturing IP Regulatory Clinical Medical networks Polymedco’s tasks: Marketing Sales Distribution Customer support Billing Collection

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- Guidelines -

Value Chain of Septin9 based CRC Screening

1_{Cost of goods sold (COGS)* Company estimates}

invoices payers US$ 141* Reference Laboratories sells to laboratories US$ 75-90* orders test provides result Healthcare Professionals pays COGS1 profit share

- Payors -

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Key Elements for Successful U.S. Market Penetration

Reimbursement

Medical Guidelines

fir st 6 m on ths

generate health economic data convince expert groups / medical societies

7-18

m

on

ths _{ensure reimbursement} _{perform selected KOL studies}

>18

m

on

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

Stage 1:

Epi proColon® approved in China by CFDA*

 BioChain to start commercialization in 2015

 Chinese guidelines for CRC screening in draft status

 Pricing and reimbursement discussions underway



Stage 2:

License to develop and commercialize Septin9 IVD tests

 Development underway, clinical studies started

 Epigenomics has rest of the world rights

Strategic Collaboration with BioChain in China

Enormous market opportunity –

CRC incidence increasing –

290m people screening eligible in China

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

Overview



Epi proColon®

• Unmet need & commercial opportunity for Epi proColon®

• Commercial strategy



Epi proLung® and future product opportunities



Financial information and summary

(21)

Epi proLung® in the Diagnosis of Lung Cancer

 Currently under development into a

blood-based assay

 Possible applications in

treatment

response monitoring

1

 Attractive opportunity in

screening

of high risk patients

Lung cancer diagnostic work - up including measurement of SHOX2 gene methylation

 Biomarker:

methylated SHOX2 gene

 Utilization as

reflex test

for the diagnosis of lung cancer in bronchial lavage

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Biomarker discovery, confirmation and selection

R&D Capabilities and Future Product Opportunities

>20

proprietary prognostic, predictive, response, diagnostic, and screening

biomarkers

in cancer indications

 Potential to evaluate and

clinically validate

in collaboration with BioChain

 Broad IP protection with

70 active patent families:

protection along the value chain

 Epigenetic

biomarker discovery

and IVD development capabilities

Epigenomics

core capabilities

IVD test development, validation and regulatory

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

Overview



Epi proColon®

• Unmet need & commercial opportunity for Epi proColon®

• Commercial strategy



Epi proLung® and future product opportunities



Financial information and summary

(24)

 Liquidity position at the end of 2014 around EUR 7.5m after

the

equity investment of EUR 4.2m

by BioChain in October 2014

 Liquid assets to fund operations until completion of ADMIT study and expected launch

 Up to

EUR 9.4 m

cash

inflow in 2015 possible from conversion of outstanding bonds

Key Financial Information

(in € thousand) _{9M 2014} _{9M 2013}

Revenue 1,095 961

EBIT (Operating Result) -5,390 -5,174

Net loss -5,906 -5,232

Cash consumption -5,947 -5,191

* incl. marketable securities

(in € thousand) _{Sep 30, 2014} _{Dec 31, 2013}

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Shareholder Structure

Type of shares registered shares

Security code number A11QW5

ISIN DE000A11QW50

Stock Exchange Frankfurt Stock Exchange, _{Prime Standard: ECX}

Type of program Sponsored Level 1 ADR _Program

Ratio 1 ADR = 5 shares

Ticker symbol EPGNY

Total Shares Outstanding 15.480.422* (19.2m fully diluted) Abingworth BioChain Gilbert Gerber Freefloat 9.6% 3.7% 77.6% * As of January 31, 2015 Analyst coverage Equinet First Berlin Kempen & Co Maxim 9.1%

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Why Invest in Epigenomics....

Epi proColon®

the world’s first IVD blood test intended for CRC screening:

Extensively validated in clinical trials

Proven utility

in early CRC detection

Approved in Europe and China

Under FDA review for the U.S. market

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Thank you for your attention!

Antje Zeise

Manager Investor Relations Epigenomics AG T. +49 30 24345 386 TICKER Bloomberg: ECX:GR Reuters: EXXG.DE Thomson ONE: ECX-XE ADR OTC: EPGNY

INTERNET

Contact Investor Relations

Europe U.S.A.

Lauren Kwiecinski Senior Associate The Trout Group LLC T. +1 646 378 2934

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

Overview



Epi proColon®

• Unmet need & commercial opportunity for Epi proColon®

• Commercial strategy



Epi proLung® and future product opportunities



Financial information and summary

(29)



Simple blood-based

tests widely seen as best way to close the “screening gap”

 Epi proColon® is based on a single

epigenetic biomarker:

methylated Septin9

 Septin9 in CRC tissue fully methylated in

>95%

of all cancers

 High analytical

sensitivity

(6pg/ml),

specific

for colorectal cancer

 Equal capability to detect

left and right

sided cancerous lesions

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Comparison of non-invasive Screening Tests in the US

Colonoscopy FOBT FIT

(multiple) Stool DNA (Cologuard™) CT Colonography Blood RNA (ColonSentry) Septin9 (multiple) Sample Structural

exam Stool Stool Stool

Virtual Imaging

Exam Blood Blood

Location of Testing

Endoscopy

Center Clinical Lab Clinical Lab

Company-owned CLIA

Laba

Endoscopy

Center Clinical Lab Clinical Lab

US Pricing (varies globally) $800-$3160b (variable rates) $4.54c $22.22c $599d $550-$794b (variable rates) $300-400e $135-$150f Sensitivity (for CRC) 95%g 70%g (64-80%) 65.8-88.2%h 92.3%i 70-90%j (lesion-size dependent) 61-72%k _73.3%l Specificity 95%g 95%g (87-90%) 89.7-94.6%h 86.6%i 86.0%j 66-77%k 81.5%l Availability Through specialist IVD–FDAm cleared IVD–FDA cleared IVD–FDA approved Through specialist LDT Under FDA PMA Review US:LDT / EU:IVD

a_{CLIA – Clinical Clinical Laboratory Improvement Amendments – US Center for Medicare & Medicaid Services bCost to insurance, endoscopy center, no polyp removed; Healthcare Bluebook fair pricing}

(Consumer Reports). c Maximum Medicare reimbursement rate.d Exact Sciences, published reports. eZehr L et. al. New York approval of ColonSentry, February 2012. f Cost of CE marked EU and US LDT Septin9 tests; cost to patient may not be covered by insurance. g Zauber AG et. al. Technology assessment report, project ID CRCC0608, 2009. h Colorectal Cancer Screening (PDQ®) National Cancer Institute at National Institutes of Health, newer FOBTs: nonrandomized controlled trial evidence, 2014. i Imperiale T et. al. New Engl J Med. 2014, 370(1287-1297). j Colorectal Cancer Screening (PDQ®) National Cancer Institute at National Institutes of Health,virtual colonoscopy (computer tomographic [CT] colonography), 2014. k Ganepola AP et. al. World J Gastrointest Oncolo. 2014, 6(4):83-97. l Johnson et. al. PloS One9(6): e98238. doi:10.1371/journal.pone.0098238 m IVD – In Vitro Diagnostic

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Epi proColon® pT0/Tis pT1 pT2 pT3 pT4 pTx unknown TOTAL Stage 0 / I 2/3 6/11 10/13 - - - 0/1 18/28 64.3% (45.8-79.3%) Stage II _- _- _- _14/18 _2/2 _- _- _16/20 _{80.0% (58.4-91.9%)} Stage III - 0/1 0/2 14/19 1/1 - - 15/23 65.2% (44.9-81.2%) Stage IV _- _2/2 _- _0/1 _6/6 _1/1 _3/3 _12/13 _{92.3% (66.7-99.6%)} Unknown* - - - 3/3 10/14 13/17 76.4% (52.7-90.4%) TOTAL _2/3 _{8/14 10/15 28/38} _9/9 _4/4 _13/18 _74/101 73.3% (63.9-80.9%)

Comparison Study Top Line Data:

Cancer Detection by Stage from head-to-head FIT/Septin9 trial

FIT pT0/Tis pT1 pT2 pT3 pT4 pTx unknown TOTAL

Stage 0 / I 0/3 5/11 11/13 - - - 1/1 17/28 60.7% (42.4-76.4%) Stage II - - - 14/18 2/2 - - 16/20 80.0% (58.4-91.9%) Stage III - 1/1 1/2 16/19 1/1 - - 19/23 82.6% (62.9-93.0%) Stage IV - 1/1 - 0/1 4/6 1/1 1/3 7/12 58.3% (32.0-80.7%) Unknown* - - - 1/3 6/11 7/14 50.0% (26.8-73.2%) TOTAL _0/3 _7/13 _{12/15 30/38} _7/9 _2/4 _8/15 _66/97 68.0% (58.2-76.5%)

*…Staging information incomplete or unavailable