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Epigenomics AG: Dr. Garces transitions to Company Advisor

Berlin (Germany) and San Diego, CA (USA), January 27, 2021 – Epigenomics AG (Frankfurt Prime Standard: ECX, OTCQX: EPGNY; the “Company”) announces that Dr. Jorge Garces, President and Chief Scientific Officer is resigning as an Executive Board member effective January 31, 2021. Dr. Garces will transition to a Company Advisor role to assist the company through the end of 2021 with execution of strategic alternatives. “Dr. Garces has been an important member of the Epigenomics management team and the Supervisory Board is very happy to have his help as an advisor as we look to plan on strategic options for the company”, said Heino von Prondzynski Chairman of the Supervisory Board of Epigenomics.
 

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, and HCCBloodTest, a blood-based test for liver cancer detection in cirrohtic patients, have received CE mark in Europe.

For more information, visit www.epigenomics.com.
 

Contact:
Company
Epigenomics AG, Geneststrasse 5, 10829 Berlin,
Tel +49 (0) 30 24345 0, Fax +49 (0) 30 24345 555, E-Mail: contact@epigenomics.com

Investor Relations
IR.on AG, Frederic Hilke, Tel +49 221 9140 970, 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.

NOT TO BE PUBLISHED, DISSEMINATED OR PASSED ON TO OR WITHIN THE UNITED STATES OF AMERICA, CANADA, JAPAN AND AUSTRALIA

Publication of inside information pursuant to Article 17 MAR

Epigenomics AG successfully places mandatory convertible bond in the full amount of EUR 5.5 million

Berlin, Germany, 27 January 2021 – Epigenomics AG (Frankfurt Prime Standard: ECX, OTCQX: EPGNY; the “Company”) today successfully completed the placement of the subordinated mandatory convertible notes, which the Company’s Executive Board resolved to issue with the approval of the Supervisory Board on January 7, 2021. In total, the mandatory convertible bond in the nominal amount of EUR 5,500,000.00 was fully placed. The offering was significantly oversubscribed. The mandatory convertible bond consists of 500,000 bonds, which are convertible into 5,000,000 registered shares of the Company. The gross proceeds from the issuance of the mandatory convertible bond amount to EUR 5.5 million.

The full terms and conditions of the bond are available on Epigenomics AG’s website at www.epigenomics.com/news-investors/convertible-bonds/.

Contact:
Company
Epigenomics AG, Geneststraße 5, 10829 Berlin
Tel +49 (0) 30 24345 0, fax +49 (0) 30 24345 555, e-mail: contact@epigenomics.com

Investor Relations
IR.on AG, Frederic Hilke, Fabian Kirchmann, tel +49 221 9140 970, e-mail: ir@epigenomics.com

Important Notice

This publication does not constitute or form part of, and should not be construed as an offer or an invitation to sell, or issue or the solicitation of any offer to buy or subscribe for, any securities. This publication does, in particular, not constitute an offer to sell or a solicitation of an offer to purchase any securities in the United States. The securities referred to herein have not been and will not be registered under the U.S. Securities Act of 1933, as amended (the “Securities Act”) or the laws of any state within the U.S., and may not be offered or sold in the United States or to or for the account or benefit of U.S. persons, except that the offered shares may be offered or sold to qualified institutional buyers in reliance on certain exemptions from the registration requirements of the Securities Act and applicable state securities laws. This publication and the information contained herein may not be distributed or sent into the United States, or in any other jurisdiction in which offers or sales of the securities described herein would be prohibited by applicable laws, and should not be distributed to United States persons or by way of publications with a general circulation in the United States. No public offering of the shares is being made in the United States. Subject to certain exceptions, the securities referred to herein may not be offered or sold in Australia, Canada or Japan or to, or for the account or benefit of, any national, resident or citizen of Australia, Canada or Japan. The securities referred to herein have not been and will not be registered under the applicable securities laws of Australia, Canada or Japan.

Note on future-looking statements

This publication expressly or implicitly contains forward-looking statements concerning Epigenomics AG and its business. These statements involve certain known and unknown risks, uncertainties and other factors that may cause Epigenomics AG’s actual results, financial condition and performance to be materially different from any future results, performance or achievements expressed or implied by such statements. Epigenomics makes this announcement as of the date of this release and does not intend to update any forward-looking statements contained herein as a result of new information or future events or otherwise.

Epigenomics AG Plans to Challenge NCD Decision and Unveils Its Next Generation Liquid Biopsy Test for Colorectal Cancer Screening

• Company evaluating all options to challenge CMS’ decision to non-cover the Epi proColon test
• New blood-based test demonstrates performance characteristics that would satisfy the latest sensitivity and specificity requirements outlined in the final National Coverage Determination (NCD) issued by CMS: Decision Memo for Screening for Colorectal Cancer – Blood-Based Biomarker Tests (CAG-00454N)

Berlin (Germany) and San Diego, CA (USA), January 21, 2020 – Epigenomics AG (Frankfurt Prime Standard: ECX, OTCQX: EPGNY; the “Company”) announces that the management disagrees and is extremely disappointed with the non-coverage decision for Epi proColon as part of the NCD issued by CMS on Tuesday. While the Company was pleased to see the elimination of guideline requirements as part of the final NCD, it was disappointed that CMS chose to retain the concept of performance criteria and a fixed testing interval. Together with several professional societies such as the American Cancer Society, which outlined its concerns as part of the public comment period for the NCD, Epigenomics believes the arbitrary performance criteria in the NCD is in conflict with the scientific evidence. The company is currently evaluating all available alternatives (appeal and/or litigation) to challenge the final decision.

“Randomly selecting sensitivity, specificity, and testing interval values from various tests and assuming it will reduce CRC mortality is not the appropriate way to make evidence-based coverage decisions”, said Greg Hamilton, CEO of Epigenomics AG. “By denying coverage for the only FDA approved blood test at this time, a portion of Medicare beneficiaries will needlessly die of colorectal cancer. This is especially true for underserved populations including minority groups and the impoverished.”

Despite the egregious decision by CMS, the Company will continue to pursue a leadership position in the colorectal cancer screening market and in liquid biopsy technology. Building on its expertise in liquid biopsy and DNA methylation biomarkers, Epigenomics AG has developed and validated a new colorectal cancer screening assay with clinical performance characteristics that meet the coverage criteria outlined in the final NCD.

The interpretive algorithm for this novel assay was trained in a study with 454 samples comprising CRC patients and clinical controls. Clinical performance was then established using a total of 2,504 plasma specimens, including 136 well-characterized colorectal cancer samples, available from two independent clinical screening trials in the average-risk population. This next generation multi-target real-time PCR blood test is based on a new proprietary core DNA methylation technology. The automated assay is highly robust, providing valid results for greater than 99% of samples analyzed, and provides a fast, easy to use and affordable option for detecting CRC in a liquid biopsy.

Greg Hamilton, CEO of Epigenomics AG: “We have been working on this new technology for the past few years and are extremely excited by the data. We look forward to pursuing multiple strategic options with this new assay either as a stand-alone entity or in partnership with other key players in our industry.”
 

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, and HCCBloodTest, a blood-based test for liver cancer detection in cirrohtic patients, have received CE mark in Europe.

For more information, visit www.epigenomics.com.
 

Contact:
Company
Epigenomics AG, Geneststrasse 5, 10829 Berlin
Tel +49 (0) 30 24345 0, Fax +49 (0) 30 24345 555, E-Mail: contact@epigenomics.com

Investor Relations
IR.on AG, Frederic Hilke, Tel +49 221 9140 970, 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.