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Epigenomics AG Reports Financial Results for Fiscal Year 2020

DGAP-News: Epigenomics AG / Key word(s): Annual Report/Annual Results Epigenomics AG Reports Financial Results for Fiscal Year 2020 25.03.2021 / 11:00 The issuer is solely responsible for the content of this announcement. Epigenomics AG Reports Financial Results for Fiscal Year 2020

Berlin (Germany) and San Diego, CA (U.S.A.), March 25, 2021 - Epigenomics AG (FSE: ECX, OTCQX: EPGNY, the "Company") today reported financial results (according to IFRS) for fiscal year 2020.

OPERATIONAL DEVELOPMENTS

• Despite the solid foundation of scientific evidence in support of reimbursement for Epi proColon, the Centers for Medicare and Medicaid Services (CMS) issued a negative National Coverage Determination (NCD) on January 19, 2021. The Company as well as many of the experts as well as a majority of stakeholders disagree with CMS's decision as evidenced by the public NCD comments.
• The Company is currently reviewing all available options to revise the NCD decision. There are two main alternatives: First, there is the legislative pathway to coverage, which remains a viable alternative and is therefore being actively pursued. Second, there is the option of appealing against the decision and/or taking legal action. To optimize the chances of success, the Company must first wait for the new leadership within the U.S. Department of Health and Human Services and CMS to be inaugurated into their offices.
• In addition, Epigenomics AG has developed and validated a new colorectal cancer screening assay with clinical performance characteristics that meet the coverage criteria outlined by CMS in the final NCD. As a new test, a large prospective trial is required for FDA approval. Such a trial and subsequent FDA approval will take at least two to three years and require additional funding.
• The prospective study on Epigenomics' second promising blood test, the HCCBlood test for the detection of liver cancer in patients with cirrhosis, which was completed at the end of 2019, has been submitted for publication and accepted in a renowned scientific journal. The Company expects the journal to publish the article shortly.
• In addition, Epigenomics AG successfully placed a convertible bond in the amount of EUR 5.5 million in January 2021. Including the proceeds from the issue, the Company's liquidity reaches well into 2022.

STRATEGIC DEVELOPMENTS