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Press release

Epigenomics AG announces 2018 First Quarter Financial Results

Berlin (Germany) and Germantown, MD (U.S.A.), May 9, 2018 – Epigenomics AG (FSE: ECX, OTCQX: EPGNY), or the “Company”, today announced its financial results for the first quarter 2018 ended March 31.

Q1/2018 Financial results

– Total revenue slightly increased to EUR 309 thousand (Q1 2017: EUR 281 thousand) due to higher product sales (+38%).

– Operating costs increased to EUR 3.6 million (Q1 2017: EUR 3.1 million), mainly due to higher R&D expenses for the FDA required Epi proColon(R) post approval study.

– Operating loss (EBIT) increased to EUR 3.3 million (Q1 2017: EUR 2.7 million). EBITDA (loss) before expenses for share-based compensation increased to EUR 3.2 million (Q1 2017: EUR 2.4 million).

– Net loss increased to EUR 3.2 million (Q1 2017: EUR 2.4 million). Loss per share increased to EUR 0.13 (Q1 2017: EUR 0.10).

– Cash consumption increased to EUR 2.4 million (Q1 2017: EUR 1.6 million).

– The Company’s liquidity (cash, cash equivalents and marketable securities) at the reporting date was EUR 11.2 million (Dec 31, 2017: EUR 13.7 million).

Operational highlights

– U.S. Senators Capito and Heinrich Introduce Bi-Partisan Colorectal Cancer Detection Bill: Senators Shelley Moore Capito (R -WV) and Martin Heinrich (D – NM), introduced the “Colorectal Cancer Detection Act of 2018” to the United States Senate in Washington D.C. This Senate Bill (S. 2523) is parallel to House Bill (H.R. 1578) “Donald Payne Sr. Colorectal Cancer Detection Act” introduced by Congressman Donald M. Payne, Jr. (D – NJ). These bipartisan initiatives aim to provide payment and coverage under the Medicare program for FDA-approved qualifying colorectal cancer screening blood-based tests.

– Blood test shows promise in the detection of liver cancer: Results from two clinical studies published in EBioMedicine supported by Cell Press and The Lancet, demonstrated high accuracy of Epigenomics’ proprietary epigenetic circulating biomarker mSEPT9 in detecting liver cancer among patients with cirrhosis. In the studies, the mSEPT9 test exhibited higher diagnostic accuracy than the currently established diagnostic marker. A further independent, prospective clinical study with 440 patients was initiated.

Outlook 2018 confirmed

– The Company confirms the outlook for the financial year 2018 as provided in the Annual Report 2017 published on March 23, 2018.

– Overall, we expect that revenue will increase but will remain on low levels, ranging between EUR 2.0 million and EUR 4.0 million.

– We anticipate that EBITDA before share-based payment expenses will be in a range EUR -11.5 million and EUR -14.0 million in 2018.

Further Information

The report on the first quarter 2018 can be downloaded 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 3.30 pm CET / 9.30 am EDT, today. The presentation can be followed on the Company’s website.

The dial-in numbers for the conference call are:

Germany: +49 30 232531428
UK: +44 1635 598062
USA: +1 516-269-8980

The webcast will be made available on: https://em-tn.meetyoo.de/?token=S9v8V9jaCGQ%3D&lang=en

An audio replay of the conference call will be provided on Epigenomics’ website subsequently.

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

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 expected 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: Blood test shows promise in the detection of liver cancer

– Results from two clinical studies demonstrate high sensitivity and specificity of mSEPT9 blood test

– mSEPT9 test exhibited higher diagnostic accuracy than currently established diagnostic marker

– Further independent, prospective clinical study with 440 patients initiated

Berlin (Germany) and Germantown, MD (U.S.A.), April 19, 2018 – Epigenomics AG (FSE: ECX, OTCQX: EPGNY) today announced promising results from two clinical studies published in EBioMedicine supported by Cell Press and The Lancet, demonstrating high accuracy of Epigenomics’ proprietary epigenetic circulating biomarker mSEPT9 in detecting liver cancer among patients with cirrhosis.

The two independent clinical studies (observational/case-control) included 289 cirrhosis patients with or without liver cancer from France (initial study) and Germany (replication study). Overall, the mSEPT9 test demonstrated high sensitivity of 90.6 percent at a specificity of 87.2 percent (using the “2 out of 3” algorithm). Importantly, a triple-negative mSEPT9 test had the highest negative predictive value for excluding liver cancer (97.2 percent), whereas a triple-positive mSEPT9 test had the highest positive predictive value for retaining a diagnosis of liver cancer (91.5 percent).

The results from the replication study were consistent with those of the initial study with regard to all diagnostic accuracy measures. Furthermore, the mSEPT9 blood test exhibited higher diagnostic accuracy compared to alpha-fetoprotein (AFP), which has been widely used as a diagnostic marker for liver cancer.

“The detection of liver cancer, one of the deadliest cancer types worldwide, still represents a high medical need,” said Abderrahim Oussalah MD, PhD, Department of Molecular Medicine at the University Hospital of Nancy (France). “Findings from two independent clinical studies reveal that the mSEPT9 test constitutes a promising opportunity in this respect. As more clinical evidence is needed, we have initiated a further, prospective clinical study with 440 patients in order to confirm the diagnostic accuracy of mSEPT9 in the diagnosis of liver cancer (SEPT9-CROSS study, ClinicalTrials ID: NCT03311152). Future prospective studies should assess the mSEPT9 test in a screening algorithm for patients with cirrhosis to improve risk prediction and the personalized therapeutic management of liver cancer.”

According to the World Health Organization, liver cancer is the fifth most common cancer in men and the seventh in women, and ranks second in annual cancer mortality rates worldwide, with liver cancer diagnosed in more than 700,000 people annually. Major risk factors for liver cancer include cirrhosis, infection with hepatitis B or C virus, alcoholic liver disease, and non-alcoholic fatty liver disease.

“We are very excited about the promising clinical results of our mSEPT9 blood test in the diagnosis of liver cancer”, said Jorge Garces, President & Chief Scientific Officer of Epigenomics AG. “In the future, an accurate blood test could offer the opportunity to closely monitor patients at high risk for developing liver cancer.”

The full-length paper is available here: http://www.ebiomedicine.com/article/S2352-3964(18)30116-6/pdf

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

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.

Epigenomics AG: Notice of Loss pursuant to § 92 par. 1 AktG

April 17, 2018 – The Executive Board of Epigenomics AG (FSE: ECX; OTCQX: EPGNY) notifies that according to its best judgment a cumulative loss of more than half of the nominal share capital of the Company has been incurred. The anticipated development of the share capital is mainly attributable to budgeted losses from regular business operations.

While current financial resources of the Company are sufficient to support the operations beyond 2018, the Executive Board expects to be able to raise additional capital in 2018.

Pursuant to Sec. 92 par. 1 German Stock Corporation Act (“Aktiengesetz”), a loss amounting to half of the nominal share capital triggers the statutory obligation to summon a general meeting of shareholders without undue delay. In this meeting, the Executive Board will notify the loss of half of the nominal share capital and outline the situation of the Company. An invitation including an agenda to the extraordinary general meeting will be provided in due time and form.

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 Reports Results for Financial Year 2017

Berlin (Germany) and Germantown, MD (U.S.A.), March 23, 2018 – Epigenomics AG (Frankfurt Prime Standard: ECX, OTCQX: EPGNY), or the “Company”, today announced its financial results (according to IFRS) for the year ended December 31, 2017.

KEY HIGHLIGHTS

Financial

– Total revenue of EUR 1.9 million

– EBITDA (before share-based payment expenses) loss of EUR 9.4 million

– Liquidity of EUR 13.7 million (incl. marketable securities) at year-end following successful capital raises in 2017

Corporate

– Voluntary takeover offer by Summit Hero Holding GmbH in 2017 highlighted inherent value of the Company’s products and technologies

– Epigenomics AG gets CE-IVD mark for lung cancer test Epi proLung(R)

First quarter 2018

– U.S. Senators Capito and Heinrich introduce Bi-Partisan Colorectal Cancer Detection Bill aiming to provide coverage under the Medicare program for FDA-approved qualifying blood-based colorectal cancer screening tests

Greg Hamilton, Chief Executive Officer of Epigenomics, commented: “In 2017, we remained focused on our key priorities medical guideline inclusion and initial payor coverage for our innovative blood-based colon cancer test, Epi proColon, while maintaining high cost discipline in all company areas. In 2018, we expect to reach significant milestones with regard to Medicare payment and coverage for Epi proColon. The recent bipartisan legislative initiative by U.S. Senators Capito and Heinrich addresses payment as the last remaining barrier for Medicare patients associated with colon cancer screening. The passing of this bill provides to millions of underscreened rural Americans access to colon cancer screening and has the potential to ultimately save thousands of lives.”

Financial results

– In 2017, Epigenomics’ total revenue decreased to EUR 1.9 million (2016: EUR 4.2 million). In the previous year, our U.S. commercialization partner had initially stocked up on inventories of Epi proColon following the product’s FDA approval. Revenue of about EUR 1.3 million was generated through licensing income, product sales were at EUR 0.5 million.

– Total operating costs decreased to EUR 13.2 million (2016: EUR 17.3 million). Research and development costs decreased to EUR 4.3 million (2016: EUR 5.1 million). Selling, general and administrative costs decreased to EUR 8.0 million (2016: EUR 10.2 million).

– Operating loss (EBIT) in 2017 decreased to EUR -10.3 million (2016: EUR -12.3 million). Net loss for the year decreased to EUR 10.2 million (2016: EUR 11.2 million) and loss per share decreased to EUR 0.44 (2016: EUR 0.55).

– Cash consumption in 2017 decreased to EUR 10.1 million (2016: EUR 13.7 million). Net cash inflows from financing activities reached EUR 11.5 million in 2017 (2016: EUR 17.4 million), net cash flow was at EUR 1.4 million (2016: EUR 3.8 million).

– The Company’s liquidity (incl. marketable securities) at year-end 2017 was EUR 13.7 million (Dec 31, 2016: EUR 12.3 million).

Outlook 2018

Revenue

– Our business projections for 2018 are based mainly on the commercialization of Epi proColon in the U.S.A. The commercialization of this product depends primarily on securing reimbursement from public and private health insurers. Prior to the entry into force of a reimbursement decision we expect only a slight increase in product revenue in 2018.

– Overall, we expect that revenue will increase but will remain on low levels, ranging between EUR 2.0 million and EUR 4.0 million.

EBITDA

– We anticipate that EBITDA before share-based payment expenses will be in a range EUR -11.5 million and EUR -14.0 million in 2018.

Cash consumption

– Based on our business plans for 2018, we expect cash consumption in line with our EBITDA before share-based payment expenses guidance.

– We ended the 2017 fiscal year with EUR 13.7 million in cash and marketable securities. While current financial resources are sufficient at our projected cash consumption to support the Company’s operations beyond 2018, we will raise additional capital if necessary in 2018.

– The forecast cash consumption is based on our assumption that the convertible notes maturing as of December 31, 2018 will be converted with no adverse effect on liquidity, or will be extended.

Further Information

The annual report 2017 can be downloaded 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 / 9.30 am EDT, today. The webcast can be accessed on the Company’s website: https://www.epigenomics.com/news-investors/financial-reports/

The dial-in numbers for the conference call are:

Dial-in number within Germany: +49 30 233225798

Dial-in number within the UK: +44 20 3872 0880

Dial-in number within the U.S.A.: +1 516-269-8974

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

An audio replay of the conference call will be provided on Epigenomics’ website subsequently.

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. 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

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.