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Press release

Epigenomics AG Announces 2016 First Quarter Financial Results and Reports on Operational Highlights
Berlin (Germany) and Germantown, MD (U.S.A.), May 23, 2016 – Epigenomics AG (Frankfurt Prime Standard: ECX, OTCQX: EPGNY), the German-American cancer molecular diagnostics company, today announced its financial results for the first quarter 2016 ending March 31.

“During the first quarter 2016, our main efforts were focused on the final steps towards FDA approval for our blood-based colorectal cancer screening test Epi proColon^(R). After a promising product launch in the U.S. in the current second quarter and initial sales being recorded, we are fully confirming our outlook for 2016″, said Dr. Thomas Taapken, CEO/CFO of Epigenomics AG. “Together with our partner Polymedco, we are focusing our efforts on driving adoption by clinical laboratories. In this respect, the recent launch of Epi proColon^(R) by LabCorp^(R) as the first U.S. laboratory network was a significant milestone.”

Q1/2016 Financial Results

– Product revenue increased by 10% to EUR 186 thousand (Q1 2015: EUR 169 thousand)

– Total revenue decreased to EUR 295 thousand (Q1 2015: EUR 367 thousand) mainly due to a shortfall in R&D service income from EUR 157 thousand to EUR 6 thousand. Licensing income increased from EUR 41 thousand to EUR 103 thousand.

– Operating costs in Q1 2016 amounted to EUR 5.3 million, up from EUR 3.7 million in Q1 2015. The main driver for this development was a significant increase by EUR 1.6 million in non-cash expenses for share-based compensation, due to the high volatility of our share price between November 2015 and January 2016. Apart from this extraordinary one-off effect, our operating costs in Q1 2016 were at the same level as in Q1 2015.

– Net loss for Q1 2016 amounted to EUR 4.3 million (Q1 2015: EUR 3.2 million) translating into a net loss per share for this period of EUR 0.23 (Q1 2015: net loss per share of EUR 0.20).

– Cash consumption (cash outflow from operating and investing activities) was EUR 2.4 million in Q1 2016 compared to EUR 2.3 million in Q1 2015.

– Liquid assets (including marketable securities) amounted to EUR 8.1 million at the reporting date (Dec 31, 2015: EUR 8.6 million). During the first quarter 2016, four convertible notes were converted by their holders, providing the Company with additional liquidity of EUR 2.1 million.

Operational highlights

– FDA approval for Epi proColon^(R): On April 12, the U.S. Food and Drug Administration (FDA) approved our lead product Epi proColon^(R), the first and only blood-based colorectal cancer (CRC) screening test, for commercialization in the United States. This is a great achievement and a truly transformational event for Epigenomics, and it paves the way for us to offer an innovative, convenient and effective CRC screening option to millions of eligible Americans.

– Chinese FDA names Septin9 CRC test “innovative medical product”: According to the recently published “2015 Medical Device Registration Annual Report” only nine out of 7,530 approved medical devices in China received this label from the local regulators. The CFDA recognizes the domestic initiative and significant clinical value of blood-based Septin9 tests. This official recommendation will significantly support leveraging CRC screening programs in a country where CRC is a rapidly growing medical problem and where about 290 million people would be currently eligible for screening.

– License agreement with BioChain: In March 2016, we entered into another strategic license agreement with BioChain on the development and commercialization of Epi proLung^(R) in China. In the course of 2016, our partner is expected to initiate a clinical trial to validate our lung cancer detection test with the objective of gaining market approval by the CFDA for this test, too. In view of the high, rapidly growing prevalence of lung cancer among the Chinese population, the commercialization of a novel, blood-based test represents a major business opportunity for both companies. Epigenomics will receive upfront, milestone, and minimum annual payments as well as royalties on future revenues from BioChain and is entitled to commercialize this product exclusively in other markets outside China.

– Progress with in-vitro lung-cancer biomarker: In April 2016, we presented data from our clinical research with our proprietary panel of blood-based DNA methylation biomarkers for the detection of lung cancer at the Annual Meeting 2016 of the American Association for Cancer Research (AACR) in New Orleans, LA, U.S.A. The data demonstrates the potential of our assay for the detection of lung cancer and encourages us to conduct additional, potentially larger studies to complete the development of the test.

Outlook 2016 fully confirmed

– We are forecasting revenue for 2016 to be in the range of EUR 3 to 7 million with the bulk of this in the second half of the year.

– We also confirm our expectations for EBIT and EBITDA for 2016 within ranges of EUR -9.0 to -11.0 million (EBIT) and EUR -8.5 to -10.5 million (EBITDA).

– Our expectation for cash consumption in 2016 remains unchanged within a range between EUR 8.5 and 9.5 million. Our financial situation has benefited in the meantime from five conversions of convertible notes between January and April 2016.

– The positive impact on our share price by the FDA’s approval decision has further increased the likelihood that the five convertible notes still outstanding will be converted by their holders before maturity at year-end 2016, so that we now expect that our current liquidity will take us well into 2017.

Further Information

The full interim statement on the operational highlights and financial results for Q1 2016 can be obtained from Epigenomics’ website at:

https://www.epigenomics.com/en/news-investors/investors/financial-reports/2016.html

Conference call for analysts and investors
The Company will also host an investor conference call at 2.30 pm CET / 8.30 am EDT, today. The presentation can be followed as a slide show on the website.

The dial-in numbers for the conference call are:

Dial-in number (within Germany): +49 30 232531366
Dial-in number (within the UK): +44 203 3679216
Dial-in number (within the U.S.A.): + 1 646 7129911

Participants are kindly requested to dial in 10 minutes prior to the start of the call.

Both an audio replay of the conference call and a transcript of the conference call will be provided on Epigenomics’ website subsequently: https://www.epigenomics.com.

Details of both events will be available on Epigenomics’ website at https://www.epigenomics.com/en/news-investors.html

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Contact Epigenomics AG

Peter Vogt
Vice President Corporate Communications & Investor Relations
Epigenomics AG
Geneststraße 5
10829 Berlin
Phone +49 (0) 30 24345 386
ir@epigenomics.com

https://www.epigenomics.com

About Epigenomics

Epigenomics is a molecular diagnostics company focused on blood-based detection of cancers using its proprietary DNA methylation biomarker technology. The company develops and commercializes diagnostic products across multiple cancer indications with high medical need. Epigenomics’ lead product, Epi proColon^(R), is a blood-based screening test for the detection of colorectal cancer. Epi proColon^(R) has recently received approval from the U.S. Food and Drug Administration (FDA) and is currently marketed in the United States, Europe, China and selected other countries. The company is based in Germany and the United States. For more information, visit www.epigenomics.com.

Epigenomics legal disclaimer

This communication expressly or implicitly contains certain forward-looking statements concerning Epigenomics AG and its business. Such statements involve certain known and unknown risks, uncertainties and other factors which could cause the actual results, financial condition, performance or achievements of Epigenomics AG to be materially different from any future results, performance or achievements expressed or implied by such forward-looking statements. Epigenomics AG is providing this communication as of this date and does not undertake to update any forward-looking statements contained herein as a result of new information, future events or otherwise.

Press release

LabCorp is First U.S. Laboratory Network to Offer Epigenomics’ Epi pro Colon^(R) Colorectal Cancer Screening Test, Nationally Available Immediately

Berlin (Germany) and Germantown, MD (U.S.A.), May 9, 2016 – Epigenomics AG (Frankfurt Prime Standard: ECX, OTCQX: EPGNY), the German-American cancer molecular diagnostics company, announced that Laboratory Corporation of America^(R) Holdings (LabCorp^(R)) is the first laboratory network in the U.S. to offer Epi proColon^(R), a blood-based test for colorectal cancer screening. Epi proColon^(R) was recently approved by the U.S. Food and Drug Administration (FDA) and has been made available to laboratories in the United States under a joint commercialization agreement with Polymedco, Inc.

LabCorp, an S&P 500 company, is the world’s leading healthcare diagnostics company, providing comprehensive clinical laboratory services through LabCorp Diagnostics and end-to-end drug development support through Covance Drug Development. LabCorp is a pioneer in commercializing new diagnostic technologies and is improving people’s health by delivering the combination of world-class diagnostics, drug development services and technology-enabled solutions.

“We are excited that LabCorp is the first laboratory to launch Epi proColon^(R) in the United States, where we were recently FDA-approved,” said Dr. Thomas Taapken, CEO/CFO of Epigenomics. “LabCorp’s strong commitment and broad commercial capabilities will significantly contribute to the successful market penetration of our blood-based colorectal cancer screening test. We are already extremely pleased with the initial interest from the laboratory community. Together with our partner Polymedco, we are focusing our efforts on market adoption of the Epi proColon^(R) test.”

“Colorectal cancer is one of the most curable diseases when detected in its early stages and treated surgically,” said Dr. Mark Brecher, Chief Medical Officer for LabCorp Diagnostics. “Many people are not properly screened because they are reluctant to collect a stool sample or undergo a colonoscopy. Tested from a simple blood draw, Epi proColon^(R) is a convenient, accurate alternative for those patients who should be screened for colorectal cancer. LabCorp is committed to delivering world-class diagnostics, and Epi proColon^(R) will contribute to our mission to improve health and improve lives.”

About Epi proColon^(R)

Epi proColon^(R) is indicated for colorectal cancer screening in average-risk patients who choose not to undergo colorectal cancer screening by guideline-recommended methods, such as colonoscopy and stool-based fecal immunochemical tests (FIT).

Epi proColon^(R) has received FDA approval, based on demonstration of safety and efficacy as established in three major clinical studies. The test also demonstrated its potential to increase significantly participation rates in colorectal cancer screening.

Epi proColon^(R) is an in-vitro PCR (polymerase chain reaction) assay for the qualitative detection of Septin9 gene methylation in DNA isolated from the patient’s plasma. Cytosine residues of the Septin9 gene are methylated in colorectal cancer tissue, but not in normal colon mucosa. This tumor-specific methylation pattern can be used to detect cell-free DNA shed into the blood stream by tumor cells. Detection of colorectal cancer-derived DNA in blood plasma using the Septin9 methylation biomarker has been demonstrated, in multiple clinical studies, to be a reliable indicator of the presence of colorectal cancer. Epi proColon^(R) has received approval from the U.S. Food and Drug Administration (FDA) and is currently marketed in Europe, China and selected other countries.

About colorectal cancer

The American Cancer Society projects there will be over 134,000 new diagnosed cases of colorectal cancer, and almost 50,000 deaths, from colorectal cancer in 2016 in the United States. Colorectal cancer remains the second-leading cause of cancer death in the United States. Although screening and early detection of colorectal cancer can save lives, about 35 percent of eligible U.S. patients are not being regularly screened. While the 5-year survival rate for early colorectal cancer (stage I) is 90%, only four out of ten cases are diagnosed at this early stage. According to the American Cancer Society, this is in part due to the underuse of screening

About Epigenomics

Epigenomics is a molecular diagnostics company focused on blood-based detection of cancers using its proprietary DNA methylation biomarker technology. The company develops and commercializes diagnostic products across multiple cancer indications with high medical need. Epigenomics’ lead product, Epi proColon^(R), is a blood-based screening test for the detection of colorectal cancer. Epi proColon^(R) has recently received approval from the U.S. Food and Drug Administration (FDA) and is currently marketed in Europe, China and selected other countries. The company is based in Germany and the United States. For more information, visit www.epigenomics.com.

About LabCorp^(R)

Laboratory Corporation of America^(R) Holdings, an S&P 500 company, is the world’s leading healthcare diagnostics company, providing comprehensive clinical laboratory services through LabCorp Diagnostics, and end-to-end drug development support through Covance Drug Development. LabCorp is a pioneer in commercializing new diagnostic technologies and is improving people’s health by delivering the combination of world-class diagnostics, drug development services and technology-enabled solutions. With net revenue in excess of $8.5 billion in 2015 and more than 50,000 employees in approximately 60 countries, LabCorp offers innovative solutions to healthcare stakeholders. LabCorp clients include physicians, patients and consumers, biopharmaceutical companies, government agencies, managed care organizations, hospitals, and clinical labs. To learn more about Covance Drug Development, visit www.covance.com. To learn more about LabCorp and LabCorp Diagnostics, visit www.labcorp.com.

About Polymedco

Since 1980, Polymedco has evolved into a leading manufacturer, marketer, and distributor in the clinical laboratory marketplace. Polymedco supplies clinical diagnostic test kits that are specialized in hematology and cancer screening. The Company is a world leader in non-invasive colorectal cancer screening technology.

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Contact Epigenomics AG

Peter Vogt
Vice President Corporate Communications & Investor Relations
Epigenomics AG
Geneststraße 5
10829 Berlin
Phone +49 (0) 30 24345 386
ir@epigenomics.com

https://www.epigenomics.com

For U.S. press inquiries:

Deanne Eagle
Planet Communications
Tel: (917) 837-5866
deanne@planetcommunications.nyc

Epigenomics legal disclaimer

This communication expressly or implicitly contains certain forward-looking statements concerning Epigenomics AG and its business. Such statements involve certain known and unknown risks, uncertainties and other factors which could cause the actual results, financial condition, performance or achievements of Epigenomics AG to be materially different from any future results, performance or achievements expressed or implied by such forward-looking statements. Epigenomics AG is providing this communication as of this date and does not undertake to update any forward-looking statements contained herein as a result of new information, future events or otherwise.

Press release

China FDA names Epigenomics’ blood-based Septin9 colorectal cancer test a most innovative medical product for 2015

– Only 9 out of 7530 approved medical devices in 2015 were named “innovative medical product” by the Chinese regulators

– Epigenomics innovative blood-based Septin9 test Epi proColon(R) for early detection of colorectal cancer (CRC) is approved in the U.S., China and Europe

– CRC is a rapidly growing medical problem in China, about 290 million people are currently eligible for screening

Berlin (Germany) and Germantown, MD (U.S.A.), May 2, 2016 – Epigenomics AG (Frankfurt Prime Standard: ECX, OTCQX: EPGNY), the German-American cancer molecular diagnostics company, announced today that the China Food and Drug Administration (CFDA) has named the blood-based Septin9 test an “innovative medical product.” In the recently published “2015 Medical Device Registration Annual Report,” only nine out of 7530 approved medical devices were granted this label by the Chinese regulators. The CFDA recognizes the domestic initiative and significant clinical value of Septin9 tests. Epigenomics’ strategic development and commercialization partner BioChain Institute Inc. and its affiliate BioChain (Beijing) Science and Technology Corp., have developed the aforementioned product for the China market based on Epigenomics’ technologies. Septin9 was approved by the CFDA for detection of colorectal cancer in 2015.

“This is excellent news and recognizes the potentially huge contribution we can make to early colorectal cancer detection in China with our proprietary biomarker Septin9,” commented Dr. Thomas Taapken, CEO/CFO of Epigenomics. “We are proud that, together with our strategic partner BioChain, we will be able to give the Chinese population access to this innovative screening opportunity.”

“We are delighted to receive this official recommendation by the Chinese regulator,” Grace Tian, CEO of BioChain, added. “This gives us even more confidence that our emphasis on early cancer detection is immensely valuable to our society. We are excited about bringing blood-based Septin9 tests to the market in China as a truly joint effort between our two companies and we look forward to an even more fruitful collaboration going forward.”

In 2013, BioChain and Epigenomics entered into a license agreement for the development and commercialization of a Septin9-based colorectal cancer blood-test in China. In 2015, BioChain successfully introduced the test into the Chinese market. Shortly after this, the companies reported that CRC testing, based on Epigenomics’ proprietary Septin9 biomarker, was included in the Chinese Guideline on Screening, Endoscopic Diagnosis and Treatment of Early Colorectal Cancer (CRC).

Epigenomics’ blood-based Septin9 test Epi proColon(R) is the first CE-marked, FDA and CFDA-approved blood-based colorectal cancer detection diagnostic. It is strongly protected by patents in multiple global jurisdictions, including China, where both the marker itself and the detection technology are widely protected by granted and pending patents. Both parties, BioChain and Epigenomics remain highly committed to take all necessary steps to enforce these IP rights that will protect and strengthen BioChain’s market exclusivity in China.

In March 2016 the collaboration between the two partners was extended for a strategic license agreement on the development and commercialization of a novel, blood-based lung cancer test for China.

About Colorectal Cancer in China

In accordance with various international guidelines, about 290 million people are currently eligible for CRC screening in China and effective testing methods that are accepted by patients will be vital to significantly reduce CRC deaths. CRC is a rapidly growing medical problem. In a recently published report, the independent market research firm Decision Resources estimates that the number of incident cases of CRC in urban areas of China will almost double between 2012 and 2022. This is demanding for better, simple to use and affordable screening methods. Hence, the Chinese government has elected CRC screening as one of its key focus areas in cancer prevention.

About Epigenomics

Epigenomics is a molecular diagnostics company focused on blood-based detection of cancers using its proprietary DNA methylation biomarker technology. The company develops and commercializes diagnostic products across multiple cancer indications with high medical need. Epigenomics’ lead product, Epi proColon(R), is a blood-based screening test for the early detection of colorectal cancer. Epi proColon(R) has recently received approval from the U.S. Food and Drug Administration (FDA) and is currently marketed in Europe, China and selected other countries. For more information, visit www.epigenomics.com.

About BioChain

BioChain (www.biochain.com, www.biochainbj.com) is a pioneer of molecular genetics diagnostics in the US and China. It is also the owner and operator of an independent reference laboratory, equivalent of a CLIA lab, in China – Beijing BioChain Medical Laboratory (BBML).

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Contact Epigenomics AG

Peter Vogt
Vice President Corporate Communications & Investor Relations
Epigenomics AG
Geneststraße 5
10829 Berlin
Phone +49 (0) 30 24345 386
ir@epigenomics.com

https://www.epigenomics.com

For U.S. press inquiries:

Deanne Eagle
Planet Communications
Tel: (917) 837-5866
deanne@planetcommunications.nyc

Epigenomics legal disclaimer

This communication expressly or implicitly contains certain forward-looking statements concerning Epigenomics AG and its business. Such statements involve certain known and unknown risks, uncertainties and other factors which could cause the actual results, financial condition, performance or achievements of Epigenomics AG to be materially different from any future results, performance or achievements expressed or implied by such forward-looking statements. Epigenomics AG is providing this communication as of this date and does not undertake to update any forward-looking statements contained herein as a result of new information, future events or otherwise.

Press release

Epigenomics announces commercial launch of Epi proColon^(R) in the U.S.

Berlin (Germany) and Germantown, MD (U.S.A.), April 26, 2016 – Epigenomics AG (Frankfurt Prime Standard: ECX, OTCQX: EPGNY), the German-American cancer molecular diagnostics company, announced today that Epi proColon(R), its blood-based test for colorectal cancer screening, has now been made commercially available in the U.S. under a joint commercialization agreement with Polymedco, Inc.

Epi proColon(R) was recently approved by the U.S. Food and Drug Administration (FDA) for colorectal cancer screening in average-risk patients who are non-compliant to other screening tests such as colonoscopy and FIT.

For patients, the test only requires a simple blood sample to be drawn as part of routine healthcare provider visits. There are no dietary restrictions or alterations in medication required for the test. The sample will be analyzed at a local or regional diagnostic laboratory.

“We are very excited to be able to start the commercialization of Epi proColon(R) as the first and only approved blood-based colorectal cancer screening test just two weeks after its approval by the US FDA,” said Dr. Thomas Taapken, CEO/CFO of Epigenomics. “I would like to thank our employees and our partners at Polymedco for their commitment and hard work to make this happen so quickly. We look forward to making Epi proColon(R) available through laboratories nationwide.”

According to the American Cancer Society, there are projected to be over 134,000 new diagnosed cases of colorectal cancer and almost 50,000 deaths from colorectal cancer in 2016 in the United States. Colorectal cancer remains the second-leading cause of cancer death in the United States. Although screening and early detection of colorectal cancer can save lives, about 35 percent of eligible U.S. patients are not being regularly screened.

About Epi proColon(R)

Epi proColon(R) is indicated for colorectal cancer screening in average-risk patients who choose not to undergo colorectal cancer screening by guideline-recommended methods such as colonoscopy and stool-based fecal immunochemical tests (FIT).

Epi proColon(R) has received FDA approval based on demonstration of safety and efficacy as established in three major clinical studies. The test has also demonstrated its potential to significantly increase participation rates in colorectal cancer screening.

Epi proColon(R) is an in-vitro PCR (polymerase chain reaction) assay for the qualitative detection of Septin9 gene methylation in DNA isolated from the patient’s plasma. Cytosine residues of the Septin9 gene are methylated in colorectal cancer tissue but not in normal colon mucosa. This tumor-specific methylation pattern can be used to detect cell-free DNA shed into the blood stream by tumor cells. Detection of colorectal cancer-derived DNA in blood plasma using the Septin9 methylation biomarker has been demonstrated in multiple clinical studies to be a reliable indicator of the presence of colorectal cancer. Epi proColon(R) has received approval from the U.S. Food and Drug Administration (FDA) and is currently marketed in Europe, China and selected other countries.

About Epigenomics

Epigenomics is a molecular diagnostics company focused on blood-based detection of cancers using its proprietary DNA methylation biomarker technology. The company develops and commercializes diagnostic products across multiple cancer indications with high medical need. Epigenomics’ lead product, Epi proColon^(R), is a blood-based screening test for the early detection of colorectal cancer. Epi proColon^(R) has recently received approval from the U.S. Food and Drug Administration (FDA) and is currently marketed in Europe, China and selected other countries. For more information, visit www.epigenomics.com.

About Polymedco

Since 1980, Polymedco has evolved into a leading manufacturer, marketer, and distributor in the clinical laboratory marketplace. Polymedco supplies clinical diagnostic test kits that are specialized in hematology and cancer screening. The Company is a world leader in non-invasive colorectal cancer screening technology.

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Contact Epigenomics AG

Peter Vogt
Vice President Corporate Communications & Investor Relations
Epigenomics AG
Geneststraße 5
10829 Berlin
Phone +49 (0) 30 24345 386
ir@epigenomics.com

https://www.epigenomics.com

For U.S. press inquiries:

Deanne Eagle
Planet Communications
Tel: (917) 837-5866
deanne@planetcommunications.nyc

Epigenomics legal disclaimer

This communication expressly or implicitly contains certain forward-looking statements concerning Epigenomics AG and its business. Such statements involve certain known and unknown risks, uncertainties and other factors which could cause the actual results, financial condition, performance or achievements of Epigenomics AG to be materially different from any future results, performance or achievements expressed or implied by such forward-looking statements. Epigenomics AG is providing this communication as of this date and does not undertake to update any forward-looking statements contained herein as a result of new information, future events or otherwise.