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Press release

Epigenomics AG gets CE-IVD Mark for Lung Cancer Test Epi proLung(R)

Berlin (Germany) and Germantown, MD (U.S.A.), December 19, 2017 – Epigenomics AG (Frankfurt Prime Standard: ECX, OTCQX: EPGNY, “Company”) announced today that it has received CE-IVD mark for its blood-based lung cancer test Epi proLung.

Epi proLung is a highly innovative lung cancer test based on the combination of Epigenomics’ proprietary DNA methylation biomarkers. The development of the assay was partly funded by the European Commission within the framework of the Horizon 2020 program.

Lung cancer remains one of the world’s most common and deadliest forms of cancer. Most lung cancers have already spread widely and are at an advanced stage when detected. Earlier detection, less risk to the patient from diagnostic methods, more successful therapies and lower treatment costs represent a high unmet medical need. Nevertheless, no European screening recommendation or guidelines have been issued to date to screen patients with an elevated risk for lung cancer.

Greg Hamilton, CEO of Epigenomics AG stated: “Lung cancer is a deadly disease for which there are limited diagnostic options. The CE-IVD mark for Epi proLung is our first step in providing additional testing options. We will continue to enhance the product as we learn more through clinical studies in the future.”

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 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. Epi proLung(R), a blood-based test for lung cancer detection, has received CE mark in Europe.

For more information, visit www.epigenomics.com.

Contact:
Epigenomics AG, Investor Relations, Peter Vogt, Geneststrasse 5, 10829 Berlin, Tel +49 (0) 30 24345 386, Fax +49 (0) 30 24345 555, E-Mail: ir@epigenomics.com

Forward-Looking Statements

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

Supervisory Board of Epigenomics AG Appoints Albert Weber as Executive Vice President Finance and a Member of the Management Board (Vorstand)

Berlin (Germany) and Germantown, MD (U.S.A.), November 29, 2017 – Epigenomics AG (Frankfurt Prime Standard: ECX, OTCQX: EPGNY), announced today that the Supervisory Board appointed Albert Weber Executive Vice President of Finance effective January 1, 2018. Mr. Weber, who has worked at Epigenomics for the past seventeen years, will become a member of the Executive Board of Epigenomics and continue to oversee the company’s financial, accounting and controlling departments.

Mr. Weber (54), has more than 25 years of corporate finance experience including the last seventeen years at Epigenomics. Prior to this recent appointment Mr. Weber was the Senior Vice President of Finance, Accounting and Controlling for Epigenomics. Prior to joining the company, Albert served as Manager Controlling of Pironet AG, a Cologne based IT start-up and previously at EMI Group Germany as the Manager Treasury and Corporate Accounting. Mr. Weber has experience in capital raises, all corporate finance functions and IPO’s. He has a degree in Business Administration from Cologne University and is certified in IFRS accounting.

Heino von Prondzynski, Chairman of the Supervisory Board, stated: “The Supervisory Board is very happy to recognize Albert’s hard work and dedication to Epigenomics by adding him the Executive Board. Mr. Weber’s financial experience will be a valued benefit to the Executive Board as the company prepares for the next stage of growth.”

“I am excited to join the Executive Board,” said Mr. Weber. “I’ve been with Epigenomics for seventeen years and I’m truly excited about the amazing opportunity in front of the company. I look forward to helping the organization transform the colorectal screening market.”

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, Investor Relations, Peter Vogt, Geneststrasse 5, 10829 Berlin, Tel +49 (0) 30 24345 386, Fax +49 (0) 30 24345 555, E-Mail: 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 announces recent payment decision by CMS

Berlin (Germany) and Germantown, MD (U.S.A.), November 21, 2017 – Epigenomics AG (Frankfurt Prime Standard: ECX, OTCQX: EPGNY) announced the Centers of Medicare & Medicaid Services(CMS) has changed their pricing determination for Epi proColon(R), the first and only FDA-approved blood-based test for colorectal cancer (CRC) screening.

In its recently published final payment determination for the Clinical Lab Fee Schedule, CMS agreed that the original “crosswalk” determination was not appropriate and that reimbursement for Epi proColon should be determined by “gapfilling”. Gapfilling is used when a test is deemed “novel” or unique and no comparator test is available. The process requires each of the Medicare Administrative Contractors (MAC’s) to determine and publish a preliminary rate in the spring (typically April) and CMS will then issue a final determination in November based upon the MAC’s rate recommendations.

“While the determination of final pricing is prolonged, we are still pleased that CMS has finally agreed that the crosswalk to code 81287 was not appropriate as we believe it undervalues the test. The Gapfill process now gives us the opportunity to work with the MAC’s to set an appropriate price that reflects the novel nature of the first FDA approved blood test for CRC screening,” said Greg Hamilton, CEO of Epigenomics AG.

While the new payment determination process is being initiated by CMS, Epigenomics will continue its efforts to gain coverage for Epi proColon through multiple mechanisms.

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, Investor Relations, Peter Vogt, Geneststrasse 5, 10829 Berlin, Tel +49 (0) 30 24345 386, Fax +49 (0) 30 24345 555, E-Mail: ir@epigenomics.com

Forward-Looking Statements

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 Announces 2017 Third Quarter and Nine Months Financial Results

– Third quarter performance in line with expectations; 2017 adj. EBITDA outlook improved

– Financial position significantly strengthened through successful capital measures

– Appointment of senior industry experts adds significant expertise for future growth

Berlin (Germany) and Germantown, MD (U.S.A.), November 15, 2017 – Epigenomics AG (Frankfurt Prime Standard: ECX, OTCQX: EPGNY) today announced its financial results for the third quarter and the nine months 2017 ending September 30.

“In the third quarter, we have made significant progress in securing additional funding with gross proceeds of approximately EUR 12 million”, said Greg Hamilton, CEO of Epigenomics AG. “For the remainder of the year, we are actively continuing our efforts towards Medicare reimbursement. Recent appointments of highly acknowledged industry experts add valuable expertise to Epigenomics and underscore our ambitions for future growth.”

Q3/9M 2017 Financial Results

– Total Q3 2017 revenue decreased to EUR 0.3 million (Q3 2016: EUR 0.9 million) and 9M 2017 revenue was at EUR 0.9 million (9M 2016: EUR 2.4 million). In the third quarter of the previous year, our U.S. commercialization partner Polymedco had initially stocked up on inventories of Epi proColon following the product’s FDA approval. This resulted in a relatively high revenue figure for the quarter.

– Adjusted for non-cash expenses related to share-based payment, EBITDA in Q3 2017 was at EUR -2.0 million (Q3 2016: EUR -2.5 million); adjusted EBITDA for 9M 2017 amounted to EUR -7.8 million (9M 2016: EUR -8.2 million). Net loss amounted to
EUR 1.1 million in Q3 2017 compared to EUR 2.3 million in Q3 2016, and EUR 7.6 million for 9M 2017 (9M 2016: EUR 10.0 million). The reduction in net loss was primarily attributable to a beneficial effect from the reversal of share-based payments expenses due to the decline in the Company’s share price.

– Accordingly, net loss per share for Q3 2017 decreased to EUR -0.05 (Q3 2016: EUR -0.11) and for 9M 2017 to EUR -0.33 (9M 2016: EUR -0.50).

– Cash consumption (cash outflow from operating and investing activities) was EUR 7.3 million in 9M 2017 compared to EUR 8.8 million in 9M 2016.

– Liquid assets (including marketable securities) amounted to EUR 16.9 million at September 30, 2017 (December 31, 2016: EUR 12.3 million).

Operational highlights

– In September 2017, we issued convertible bonds with a nominal value of EUR 7.1 million to Cathay Fortune International Company Limited (CFIC). The issuance of the convertible bonds, as agreed between Epigenomics and CFIC in the Business Combination Agreement on April 26, 2017, provided a cash inflow of approximately EUR 6.5 million to the Company.

– Also in September 2017, approximately 1.3 million new shares were issued by way of private placement to institutional investors with gross proceeds of approximately EUR 5.5 million. The capital increase was fully subscribed by institutional investors from Germany and the United States.

– In a preliminary determination, the Centers of Medicare & Medicaid Services (CMS) confirmed its decision to crosswalk Epi proColon to test code 81287. At the same time, CMS implemented a new method for calculating reimbursement rates for clinical laboratory services in accordance with the Protecting Access to Medicare Act of 2014 (PAMA). The newly introduced PAMA rates imply a reimbursement rate for test code 81287 of approximately USD 125 (previously approximately USD 84). The final payment determination by CMS is expected to be announced during November 2017.

Outlook for 2017

– Revenue is expected to range between EUR 1.0 million and EUR 1.5 million in fiscal year 2017.

– Due to cost reduction efforts prior to reimbursement, adjusted EBITDA (excluding share-based payment expenses) is expected to improve to a range between EUR -10.5 million and EUR -11.5 million (previously: EUR -12.5 to EUR -14.0 million).

Further Information

The full interim statement on the financial results can be obtained from Epigenomics’ website at: https://www.epigenomics.com/news-investors/financial-reports/

Conference call for analysts and investors
The Company will host a conference call and webcast at 2.30 pm CET / 8.30 am EST, today. The presentation can be followed on the Company’s website.

The dial-in numbers for the conference call are:

Germany: +49 30 232531366
UK: +44 203 7887007
USA: +1 312 4799419

A transcript of the conference call will be provided on Epigenomics’ website subsequently: https://www.epigenomics.com/news-investors/financial-reports/.

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, Investor Relations, Peter Vogt, Geneststrasse 5, 10829 Berlin, Tel +49 (0) 30 24345 386, Fax +49 (0) 30 24345 555, E-Mail: ir@epigenomics.com

Forward-Looking Statements

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: Appointment of Director Reimbursement and Medical Affairs

Berlin (Germany) and Germantown, MD (U.S.A.), November 8, 2017 – Epigenomics AG (Frankfurt Prime Standard: ECX, OTCQX: EPGNY) announced today that Nicholas T. Potter, PhD, FACMG has accepted the role of Director of Reimbursement and Medical Affairs effective November 1, 2017. Nick brings with him 25 years of experience in the delivery of MDx clinical services in both academic and commercial environments.

In his role at Epigenomics, he will establish the strategic approach to payers for the blood based menu of methylated cancer detection technologies. Nick will interact with MDx thought leaders on key clinical issues. Additionally, he will represent the voice of the customer in our development and lead our technical support efforts.

Most recently, Nick spent over 14 years at MPLN, Inc. in Maryville, TN as the Laboratory’s Director of Molecular Diagnostics, CSO, and finally EVP of Clinical Affairs. At the executive level at MPLN he played a pivotal role in driving value and strategic growth by pursuing business partnerships with IVD manufacturers, BioPharma, molecular diagnostics companies, and other CLIA certified/CAP accredited laboratories to allow access to new platforms, technologies, MDx tests, and clinical trials in addition to leading payment efforts focusing on women’s health, genomics, oncology and personalized medicine. Additionally, over this time frame, he served as a CAP inspector for molecular diagnostic laboratories.

Nick received his PhD from Duke University in immunology in 1986 following his undergraduate education at Bucknell University. He held post-graduate positions at Harvard, University of Connecticut and the University of Tennessee where he maintains a faculty appointment.

“We are pleased to have Nick as part of our team and look forward to his future contributions. Nick’s expertise in reimbursement and medical affairs will be a significant benefit as Epigenomics expands its commercial efforts. He truly understands the issues that impact the successful delivery of new molecular diagnostic tests” added Greg Hamilton, CEO of Epigenomics AG.

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, Investor Relations, Peter Vogt, Geneststrasse 5, 10829 Berlin, Tel +49 (0) 30 24345 386, Fax +49 (0) 30 24345 555, E-Mail: 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

Supervisory Board of Epigenomics AG Appoints Dr. Jorge Garces as President and Chief Scientific Officer

– Dr. Jorge Garces is a proven senior executive with deep technology and development expertise

– Appointment underscores Epigenomics’ commitment to clinical, technical and operational excellence

– New President and Chief Scientific Officer to join Epigenomics on December 1, 2017

Berlin (Germany) and Germantown, MD (U.S.A.), November 5, 2017 – Epigenomics AG (Frankfurt Prime Standard: ECX, OTCQX: EPGNY), the German-American cancer molecular diagnostics company, announced today that the Supervisory Board appointed Dr. Jorge Garces as President and Chief Scientific Officer with effect from December 1, 2017. Dr. Garces, who has held senior management positions in the U.S. molecular diagnostics industry, will become a member of the Executive Board of Epigenomics and oversee Operations, Research and Development, Clinical Affairs, Regulatory and Quality.

Dr. Garces, (46), has over 20 years of management experience in the molecular diagnostics and life sciences industries. Prior to joining Epigenomics, Jorge served as CEO and President of AltheaDx Inc. and previously at Enigma Diagnostics, Inc. in the same capacity. Dr. Garces was also Vice President and Site Operations Manager at Hologic, Inc., where he led the development and submission to FDA for approval of their Cystic Fibrosis and HPV products. Additionally, he was a senior executive at GenMark Diagnostics and Third Wave Technologies. Earlier in his career, he held positions in major clinical diagnostic laboratories including Genzyme Genetics and Athena Diagnostics. Dr. Garces earned his doctorate in Cell and Molecular Biology from the City University of New York. He completed his post-doctoral training in neurobiology at the University of Massachusetts Medical School and received an MBA from the Kellogg Graduate School of Management at Northwestern University.

Heino von Prondzynski, Chairman of the Supervisory Board, stated: “The Supervisory Board is excited to add the significant executive management, clinical and technical expertise that Jorge brings to the Executive Board of Epigenomics. Dr. Garces has continually demonstrated the ability to build strong teams that deliver innovative products to solve important clinical needs. He is an example of the breadth and depth of experience and expertise that is necessary for Epigenomic’s continued growth.”

“I am excited to join the Epigenomics team and partner with all of the stakeholders as we build the foundation for significant growth.,” said Dr. Garces. “The Epigenomics blood-based cancer test, Epi proColon has the potential to significantly improve colon cancer screening rates and save lives. Epigenomics’ liquid biopsy platform is uniquely positioned to play a major role in non-invasive cancer detection over the next couple of decades.”

Additionally, Dr. Uwe Staub, who has served as Chief Operating Officer and member of the Executive Board since 2013, will leave the company with effect March 31, 2018. The duration between the appointment of Dr. Garces and the departure of Dr. Staub will allow for an ample time for transition. “The Supervisory Board would like to express its great appreciation for Dr. Staub’s outstanding contributions to the development of the company”, added Heino von Prondzynski. “Dr. Staub played a critical leadership role during the development and product approval phase for the company. The Supervisory Board wishes Dr. Staub all the best for the future.”

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, Investor Relations, Peter Vogt, Geneststrasse 5, 10829 Berlin, Tel +49 (0) 30 24345 386, Fax +49 (0) 30 24345 555, E-Mail: 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.