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Press release

Epigenomics AG to participate in investor conferences

Berlin (Germany) and Germantown, MD (U.S.A.), November 14, 2016 – Epigenomics AG (Frankfurt Prime Standard: ECX, OTCQX: EPGNY) today announced that Greg Hamilton, Chief Executive Officer, will participate in the following investor conferences:

– Canaccord Genuity Medical Technologies & Diagnostics Forum, Thursday November 17, 2016, New York, Westin New York Grand Central, Presentation: 10:00 am (EST)

– German Equity Forum 2016, Tuesday, November 22, 2016, Frankfurt, Sheraton Frankfurt Airport Hotel, Presentation: 5:00 PM (CET)

– goetzpartners Interdisciplinary Oncology Insight Symposium, November 29, 2016, London, Le Meridien Piccadilly, Panel discussion: 2:00 PM (GMT)

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, is a blood-based screening test for the detection of colorectal cancer. Epi proColon has 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. Epigenomics’ second product, Epi proLung(R), is in development as a blood-based test for lung cancer detection.

For more information, visit www.epigenomics.com.

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

Press release

Epigenomics AG Announces 2016 Third Quarter and Nine Months Financial Results and Reports on Operational Highlights

– Revenue increased by 83% in Q3 2016 over same period the prior year

– Full-year 2016 revenue guidance narrowed to EUR 3.5m to EUR 5.0m

– Epigenomics signs exclusive distribution agreement for Epi proColon(R) in South-East Asia

– Financial position improved by raising EUR 5.0 million in a private placement to UChip Technology Ltd, a subsidiary of SummitView Capital (China,) and to our partner BioChain

Berlin (Germany) and Germantown, MD (U.S.A.), November 9, 2016 – Epigenomics AG (Frankfurt Prime Standard: ECX, OTCQX: EPGNY) today announced its financial results for the third quarter and the nine months 2016 ending September 30.

“In the third quarter, we continued to execute along our commercialization goals including winning Sonic Labs. Within five months post launch, four of the top six laboratories in the U.S. will now offer methylated Septin9 testing. Furthermore, Congressmen Donald M. Payne, Jr. (D-NJ) and Charles Dent (R-PA) introduced bipartisan legislation for Medicare coverage of FDA approved blood CRC screening tests to drive higher participation in colorectal cancer screening”, said Greg Hamilton, CEO of Epigenomics AG. “I am also very excited about the investments by UChip Technology, a subsidiary of SummitView Capital, and BioChain. SummitView’s significant investment makes them our second largest shareholder.”

Q3/9M 2016 Financial Results

– Total Q3 2016 revenue increased by 83% to EUR 0.9 million (Q3 2015: EUR 0.5 million) and 9M 2016 revenue was up 83% to EUR 2.4 million (9M 2015: EUR 1.3 million), mainly driven by an increase in Q3 product revenue, which was up by 95% year-on-year from EUR 0.4 million to EUR 0.9 million.

– Adjusted for non-cash expenses related to phantom stock programs, EBITDA in Q3 2016 was at EUR -2.5 million (Q3 2015: EUR -2.4 million); adjusted EBITDA for 9M 2016 amounted to EUR -8.2 million (9M 2015: EUR -6.9 million). Net loss amounted to EUR 2.3 million in Q3 2016 compared to EUR 2.4 million in Q3 2015, and EUR 10.0 million for 9M 2016 (9M 2015: EUR 8.0 million).

– Due to an increased number of shares outstanding as of September 30, 2016, net loss per share for Q3 2016 decreased to EUR 0.11 (Q3 2015: EUR 0.14) and rose slightly for 9M 2016 to EUR 0.50 (9M 2015: EUR 0.48).

– Cash consumption (cash outflow from operating and investing activities) was EUR 8.8 million in 9M 2016 compared to EUR 6.3 million in 9M 2015.

– Liquid assets (including marketable securities) amounted to EUR 7.3 million at the reporting date (December 31, 2015: EUR 8.6 million).

Operational Highlights

– Introduction of bipartisan Colorectal Cancer Detection Act 2016: At the end of September, Congressmen Donald M. Payne, Jr. (D-NJ) and Charles Dent (R-PA) have introduced the ”Donald Payne Sr. Colorectal Cancer Detection Act of 2016”. The initiative is co-sponsored by Congressmen Leonard Lance (R-NJ) and John Delaney (D-MD). The bipartisan initiative aims to provide coverage under the Medicare program for FDA-approved qualifying colorectal cancer (CRC) screening blood-based tests.

– Expert panel on colorectal cancer screening: The legislative initiative by Congressman Donald M. Payne, Jr. was introduced at a panel entitled “Screening the Unscreened: New Approaches to Reaching the Underserved to Prevent Colorectal Cancer” included leading experts within the Colorectal Cancer and gastroenterology community. The expert discussion highlighted the need for new colorectal cancer screening options like a blood-based test in order to reach the unscreened population. There is overwhelming evidence that underserved and rural populations suffer most from low colorectal cancer screening rates.

– Distribution agreement signed for South-East Asia: Epigenomics signed an exclusive distribution agreement for South-East Asia (Thailand, Vietnam, Malaysia, and Singapore) with distributor SPD Scientific PTE Ltd. based in Singapore. In addition we have taken further steps to broaden our global distribution base and expect further international distribution agreements to be secured in the future.

– Epi proLung(R) pre-clinical data published in Journal of Thoracic Oncology: In a pre-clinical study with Epi proLung it was demonstrated that measurement of SHOX2 and PTGER4 methylation biomarkers in plasma DNA allows detection of lung cancer and differentiation of malignant from nonmalignant lung disease. These positive pre-clinical results were subsequently published in the Journal of Thoracic Oncology in September 2016.

– Capital increase announced: After the reporting period on November 7, 2016, Epigenomics AG announced that the Company is raising close to EUR 5.0 million of gross proceeds in a share capital increase by way of private placement. The Company’s share capital will be increased in the amount of EUR 1,035,196.00 by issuing 1,035,196 new registered shares of the Company against contribution in cash. The issue price has been set at EUR 4.83 per share.

Outlook for 2016

– We narrow our revenue outlook for the current financial year, forecasting full-year revenue in the range of EUR 3.5 to 5.0 million (previously EUR 3.0 to EUR 7.0 million)

– We lower our expected EBITDA loss to be in the range of EUR -9.5 to -10.5 million, adjusted for expenses related to phantom stock programs (previously EUR -9.5 to EUR -11.5 million)

– Epigenomics expects its liquid assets (incl. marketable securities) including proceeds from the capital increase announced on November 7, 2016 to be sufficient to fund operations well into 2017.

Further Information

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

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

Conference call/webcast 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 232531411
Dial-in number (within the UK): +44 203 3679216
Dial-in number (within the U.S.A.): + 1 408 9169838

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

Details and access to the webcast will be available on Epigenomics’ website at https://www.epigenomics.com/en/news-investors.html

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

– End –

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 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. Epigenomics’ second product, Epi proLung(R), is in development as a blood-based test for lung cancer detection.

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

ARUP Laboratories to Offer Epi proColon(R), Epigenomics’ Blood-Based Colorectal Cancer Screening Test

Berlin (Germany) and Germantown, MD (U.S.A.), November 8, 2016 – Epigenomics AG (Frankfurt Prime Standard: ECX, OTCQX: EPGNY), announced that ARUP Laboratories (Salt Lake City, Utah) is the next major U.S. laboratory to offer Epi proColon(R), the first and only FDA-approved blood-based test for colorectal cancer screening.

“I am excited about the inclusion of our FDA-approved cancer screening test Epi proColon into ARUP’s comprehensive test menu,” said Greg Hamilton, CEO of Epigenomics AG. “With its broad experience in blood-based cancer testing and its strong client network, ARUP Laboratories will continue to play an important role in the fight against colorectal cancer in the United States. While colorectal cancer is one of the most preventable forms of cancer, still 1 in 3 Americans are not regularly screened. Driving patient access to our blood-based test has the potential to significantly increase participation rates in colorectal cancer screening.”

“ARUP Laboratories is delighted to offer the Epi proColon test for colorectal cancer screening to our patients,” said Dr. Edgar Braendle, ARUP President and CEO. “In 2010, ARUP was one of the first two labs to offer blood-based testing for colorectal cancer based on the Septin 9 biomarker. We were eager to have the opportunity to transition our testing to the newly FDA approved test. Blood-based colorectal cancer testing has the capability of reaching those patients who have been offered and declined other screening methods. Unlike stool-based testing, the Epi proColon test utilizes a routine blood specimen collected in the physician’s office.”

1 in 3, or approximately 23 million Americans remain unscreened for colorectal cancer. A blood test is an acceptable testing method in healthcare. A blood test mitigates the typical screening barriers such as patient preparation and medication modifications associated with colonoscopy and handling of stool sample. Epi proColon is intended for the unscreened patient population who are unwilling or unable to complete typical screening methods (colonoscopy or stool tests).

About colorectal cancer (CRC)

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 Epi proColon

Epi proColon is indicated for colorectal cancer screening in average-risk patients who are unwilling or unable to perform colorectal cancer screening by colonoscopy and stool-based methods.

For patients, the test only requires a simple blood sample 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 national or regional diagnostic laboratory.

Epi proColon 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 was demonstrated in multiple clinical studies, to be a reliable indicator of the presence of colorectal cancer.

Clinical evidence of Epi proColon

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

The approval was based on multiple trials. In the performance evaluation trial using the PRESEPT prospective collection from 7.941 average risk patients (NCT00855348), samples from all patients with colorectal cancer or advanced adenomas, and a stratified random collection of patients with small polyps or no evidence of disease were blinded, randomized to batches and tested at independent laboratories. In this study, the test detected 68% of all cancer cases at 80% specificity. In a second study, conducted head-to-head against FIT, it was shown that Epi proColon is statistically non-inferior to FIT, a USPSTF recommended method in detecting colorectal cancer. Additionally, in the ADMIT (Adherence to Minimally Invasive Testing) trial, it was demonstrated that blood-based testing with Epi proColon has the potential to increase compliance with colorectal cancer screening, compared to FIT stool-based testing. In the ADMIT trial, Epi proColon reached an adherence rate of 99.5% among previously screening resistant participants.

For more information on Epi proColon, visit www.epiprocolon.com.

About ARUP Laboratories

Founded in 1984, ARUP Laboratories is a leading national reference laboratory and a nonprofit enterprise of the University of Utah and its Department of Pathology. ARUP offers more than 3,000 tests and test combinations, ranging from routine screening tests to esoteric molecular and genetic assays. ARUP serves clients across the United States, including many of the nation’s top university teaching hospitals and children’s hospitals, as well as multihospital groups, major commercial laboratories, group purchasing organizations, military and other government facilities, and major clinics. In addition, ARUP is a worldwide leader in innovative laboratory research and development, led by the efforts of the ARUP Institute for Clinical and Experimental Pathology(R).

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, is a blood-based screening test for the detection of colorectal cancer. Epi proColon has received approval from the U.S. Food and Drug Administration (FDA) and is currently marketed in the United States, Europe, and China and selected other countries. Epigenomics’ second product, Epi proLung(R), is in development as a blood-based test for lung cancer detection.

For more information, visit www.epigenomics.com.

Contact in the U.S.
David Bull
Director of Marketing
Phone: 240.912.6430
David.Bull@Epigenomics.com

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

Epigenomics AG: Journal of the American Medical Association (JAMA) publishes “letter to the editor” that clarifies clinical performance data for Epi proColon(R)

Berlin (Germany) and Germantown, MD (U.S.A.), October 26, 2016 – The Journal of the American Medical Association (JAMA) published a “letter to the editor” discussing the importance of participation and clarifying clinical performance data for Epi proColon, the first and only FDA-approved blood test for colorectal cancer screening.

In June 2016, JAMA had published the United States Preventive Services Task Force (USPSTF) recommendation statement on colorectal cancer screening. The statement listed a number of screening tests, including serologic testing for methylated SEPT9 DNA (Epi proColon). However, the data cited for SEPT9 DNA was based on an earlier version of the assay and does not reflect the test that was granted Premarket Approval (PMA) by the U.S. Food and Drug Administration. The approved Epi proColon assay incorporated significant technology enhancements including improved DNA extraction, bisulfite conversion reagents and protocol and refined primer and probe sequences.

“We are pleased by JAMA’s decision to publish this important clarification on the clinical evidence and the publication status of the FDA-approved, optimized version of Epi proColon. An effective screening test has performance as well as a high participation rate – Epi proColon provides both,” said Greg Hamilton, Chief Executive Offer of Epigenomics AG. “We will continue to work closely with U.S. medical guideline bodies to further broaden the adoption of our blood-based test, which has the potential to remove the existing barriers for colorectal cancer screening and thereby save thousands of lives, as still 1 in 3 or almost 23 million Americans are not screened for colorectal cancer.”

In their “letter to the editor”, the study authors Klaus Mergener, MD, PhD, Digestive Health Specialists, Tacoma, WA, and Nicholas T. Potter, PhD, Molecular Pathology Laboratory Network, Inc. highlight the performance data of the FDA-approved and commercially available Epi proColon as published in peer-reviewed journals.

In the performance trial submitted to the FDA, which used the prospective PRESEPT sample collection (NCT00855348), the Epi proColon had a sensitivity* of 68% and a specificity* of 80%. In a second study, the SEPT9 DNA colorectal cancer detection test was non-inferior to fecal immunochemical test (FIT) with a test sensitivity of 72% compared with 68% for FIT while specificity was 81% compared with 97% for FIT. Epi proColon received FDA approval based on demonstration of safety and efficacy, as established in those clinical studies. The Epi proColon blood test has also demonstrated its potential to increase participation rates in colorectal cancer screening by eliminating the barriers of patient preparation and stool handling.

*Sensitivity: the percentage of cancer cases correctly identified; Specificity: the percentage of healthy individuals correctly identified as negative

About colorectal cancer (CRC)

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 Epi proColon

Epi proColon is a blood test indicated for colorectal cancer screening in average-risk patients who are unwilling or unable to perform colorectal cancer screening by colonoscopy and stool-based methods.

For patients, the test only requires a blood sample 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 national or regional diagnostic laboratory.

Epi proColon is an in-vitro PCR (polymerase chain reaction) assay for the qualitative detection of SEPT9 gene methylation in DNA isolated from the patient’s plasma. Cytosine residues of the SEPT 9 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 was demonstrated in multiple clinical studies, to be a reliable indicator of the presence of colorectal cancer.

Clinical evidence of Epi proColon

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

The approval was based on multiple trials. In the performance evaluation trial using the PRESEPT prospective collection from 7.941 average risk patients (NCT00855348), samples from all patients with colorectal cancer or advanced adenomas, and a stratified random collection of patients with small polyps or no evidence of disease were blinded, randomized to batches and tested at independent laboratories. In this study, the test detected 68% of all cancer cases at 80% specificity. In a second study, conducted head-to-head against FIT, it was shown that Epi proColon is statistically non-inferior to FIT, a USPSTF recommended method in detecting colorectal cancer. Additionally, in the ADMIT (Adherence to Minimally Invasive Testing) trial, it was demonstrated that blood-based testing with Epi proColon has the potential to increase compliance with colorectal cancer screening, compared to FIT stool-based testing. In the ADMIT trial, Epi proColon reached an adherence rate of 99.5% among previously screening resistant participants.

For more information on Epi proColon, visit www.epiprocolon.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, is a blood-based screening test for the detection of colorectal cancer. Epi proColon has received approval from the U.S. Food and Drug Administration (FDA) and is currently marketed in the United States, Europe, and China and selected other countries. Epigenomics’ second product, Epi proLung(R), is in development as a blood-based test for lung cancer detection.

For more information, visit www.epigenomics.com.

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